Reporte zur Charge ASKU

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Pulmonary embolism, coughing, chest pain and haemoptysis; small DVT in the popliteal fossa of the non-operated leg; arm was sore; sore joints; felt very lousy; myalgias/ sore muscles; This spontaneous case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism, coughing, chest pain and haemoptysis) and DEEP VEIN THROMBOSIS (small DVT in the popliteal fossa of the non-operated leg) in a 67-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Knee replacement (7.5 weeks earlier. Had taken anticoagulation with that. Had leg pumps for 4 weeks and was moving around. Was asymptomatic from any DVT symptoms.) in September 2023. Previously administered products included for Product used for unknown indication: FLUZONE [INFLUENZA VACCINE] on 05-Nov-2023 and COVID-19 VACCINE (4 previous doses of COVID-19 vaccines). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE and FLUZONE [INFLUENZA VACCINE]. On 11-Nov-2023 at 4:00 PM, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 11-Nov-2023 at 10:00 PM, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PAIN IN EXTREMITY (arm was sore). On 14-Nov-2023, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism, coughing, chest pain and haemoptysis) (seriousness criterion medically significant) and DEEP VEIN THROMBOSIS (small DVT in the popliteal fossa of the non-operated leg) (seriousness criterion medically significant). In November 2023, the patient experienced FEELING ABNORMAL (felt very lousy), MYALGIA (myalgias/ sore muscles) and ARTHRALGIA (sore joints). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In November 2023, MYALGIA (myalgias/ sore muscles) and ARTHRALGIA (sore joints) outcome was unknown. At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism, coughing, chest pain and haemoptysis), DEEP VEIN THROMBOSIS (small DVT in the popliteal fossa of the non-operated leg), FEELING ABNORMAL (felt very lousy) and PAIN IN EXTREMITY (arm was sore) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Nov-2023, Computerised tomogram thorax: diagnosed him with a pulmonary embolism. On 14-Nov-2023, Laboratory test: diagnosed him with a pulmonary embolism. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. It was reported that six hours after receiving the vaccine patient's arm was sore. He had myalgias, sore muscles, sore joints, and felt very lousy for a couple of days, but had no fever. He took some Non-steroidal anti-inflammatory drugs (NSAIDs). On 14-NOV-2023 he was on his way to a physio appointment when he had a lot of coughing with chest pain and hemoptysis. During his Emergency visit he noted he had a small DVT in the popliteal fossa of the non-operated leg. Company comment: This spontaneous case concerns a 67 ? year ? old male patient, with medical history of knee arthroplasty (approximately 2 months prior the onset of the events), who experienced the unexpected, serious (medically significant) AESI deep vein thrombosis (DVT) and pulmonary embolism. The events occurred 3 days after a dose of Spikevax 2023 ? 2024 vaccine (Andusomeran) reported as fifth dose of his COVID ? 19 immunization schedules (no information about previous doses was provided). The report stated that 6 hours after receiving the vaccine the patient experienced arm sore, myalgias, sore joints, and felt very lousy for a couple of days. He took some non-steroidal anti-inflammatory drugs and Tylenol. Three days after vaccination he had a lot of coughing with chest pain and haemoptysis. He went to the emergency room where unspecified labs and a computed tomography angiography diagnosed him with a pulmonary embolism. It was also noted that he had a small DVT in the popliteal fossa of the non-operated leg. No further clinical details were provided for medical reviewing. Patient?s medical history remains as confounder for deep vein thrombosis and pulmonary embolism. The benefit-risk relationship of Spikevax 2023 ? 2024 vaccine (Andusomeran) is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2023-751196 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2023-751196:Different patient

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stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria death and medically significant). The reported cause of death was complication of stroke. An autopsy was not performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant and treatment medications were not reported. Company comment: This spontaneous case concerns a 26-year-old male patient, with no medical history reported, who experienced the unexpected and serious (death and medically significant) AESI of CEREBROVASCULAR ACCIDENT and died. The vaccination date with an unspecified dose of mRNA-1273 (Moderna COVID-19 Vaccine) vaccine was not reported; hence, latency could not be properly assessed. The reported cause of death was complication of a stroke. It is unknown if an autopsy was performed. Information regarding clinical evaluation, diagnostic tests, autopsy report, and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) vaccine is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2023-750562, US-MODERNATX, INC.-MOD-2023-750508 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2023-750562:Same Reporter Different Patient US-MODERNATX, INC.-MOD-2023-750508:Same Reporter Different Patient; Reported Cause(s) of Death: complication of stroke

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passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (passed away) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant and treatment medications were not reported. Company comment: This spontaneous case concerns a 17-year-old patient of an unknown gender, with no medical history reported, who died an unknown time after a dose of mRNA-1273 (Moderna COVID-19 Vaccine) (seriousness assessment reported as fatal and medically significant). Cause of death was not reported. Information regarding clinical evaluation, diagnostic tests, autopsy report, and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2023-750558, US-MODERNATX, INC.-MOD-2023-750508 (Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2023-750558:Same Reporter Patient US-MODERNATX, INC.-MOD-2023-750508:Same Reporter Patient; Reported Cause(s) of Death: Unknown cause of death

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COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19) (seriousness criterion death). The reported cause of death was covid-19. It is unknown if an autopsy was performed. No relevant concomitant medications were reported. It was reported that the patient passed away from COVID-19. It was unknown if they previously received COVID-19 vaccines. They closed his primary healthcare clinic because of this. No treatment medication reported. Company Comment: This is a spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the serious, fatal, unexpected, event of COVID-19, which occurred on an unknown date after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine (unknown COVID-19 vaccination schedule). The reported cause of death was Covid-19. It is unknown if an autopsy was performed. No further information was disclosed. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2021-396655 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-396655:Reporter's case; Reported Cause(s) of Death: COVID-19

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Had a stroke the day after the second Moderna shot/Couldn't speak hardly at all for 6 months. Has trouble speaking and thinking/ Next morning couldn't talk because having a bunch of mini strokes; allergic reaction to second shot/hives; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Had a stroke the day after the second Moderna shot/Couldn't speak hardly at all for 6 months. Has trouble speaking and thinking/ Next morning couldn't talk because having a bunch of mini strokes) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In March 2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced CEREBROVASCULAR ACCIDENT (Had a stroke the day after the second Moderna shot/Couldn't speak hardly at all for 6 months. Has trouble speaking and thinking/ Next morning couldn't talk because having a bunch of mini strokes) (seriousness criteria hospitalization and medically significant) and URTICARIA (allergic reaction to second shot/hives). At the time of the report, CEREBROVASCULAR ACCIDENT (Had a stroke the day after the second Moderna shot/Couldn't speak hardly at all for 6 months. Has trouble speaking and thinking/ Next morning couldn't talk because having a bunch of mini strokes) and URTICARIA (allergic reaction to second shot/hives) was resolving. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medication and treatment medication were not reported. Patient had an allergic reaction to the second shot and a stroke the day after the second Moderna shot. He couldn't remember anyone's name. Next morning couldn't talk because having a bunch of mini strokes. He was in the hospital for 4-5 days. Couldn't speak for that period of time. He had hives about 1 week later. Couldn't speak hardly at all for 6 months. His speech slowly improved. Still scribbles his name. Has trouble speaking and thinking, and that sort of stuff. He stated, it almost killed him. He doesn't think very well anymore. Received doses in March and April of 2021. His symptoms have continued to bother him for 2.5 years. Declined contact information. Company comment- This is a regulatory authority case concerning a male patient of unknown age with no medical history reported who experienced the unexpected and serious (hospitalization and medically significant) AESI cerebrovascular accident. Two doses of mRNA-1273 vaccine were administered on unknown exact days. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination dates. It was reported patient had a stroke the day after the second Moderna shot. He couldn't remember anyone's name. Next morning couldn't talk because he was having a bunch of mini strokes. He was in the hospital for 4-5 days. Couldn't speak for that period. The patient also had an allergic reaction to the second shot with hives about 1 week later. Couldn't speak hardly at all for 6 months. His speech slowly improved. He still scribbles his name, has trouble speaking and thinking and that sort of stuff. His symptoms have continued to bother him for 2.5 years. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

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heart attacks; strokes; cancers; COVID-19; nerve damage; Tumour; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (heart attacks), CEREBROVASCULAR ACCIDENT (strokes) and NEOPLASM MALIGNANT (cancers) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (heart attacks) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (strokes) (seriousness criterion medically significant), NEOPLASM MALIGNANT (cancers) (seriousness criterion medically significant), COVID-19 (COVID-19), NERVE INJURY (nerve damage) and NEOPLASM (Tumour). At the time of the report, MYOCARDIAL INFARCTION (heart attacks), CEREBROVASCULAR ACCIDENT (strokes), NEOPLASM MALIGNANT (cancers), COVID-19 (COVID-19), NERVE INJURY (nerve damage) and NEOPLASM (Tumour) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information provided. No treatment information provided. Company comment: This is a spontaneous concerning a unspecified age and gender of the patient, with no medical history, who experienced the unexpected serious (medically significant) AESI events of myocardial infraction, cerebrovascular accident and unexpected serious (medically significant) event of neoplasm malignant, which occurred unspecified days after a dose of (dose number not specified) mRNA-1273 bivalent BA.4/ BA.5 vaccine. At the time of reporting outcome of the event is unknown. No further information for medical review. The benefit-risk relationship of mRNA-1273 bivalent BA.4/ BA.5 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2023: Follow up contains non significant information.

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stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. It was reported that patient had a stroke after the booster. Company Comment: This is a spontaneous case concerning an adult patient of unknown age and gender with no reported medical history, who experienced the serious (due to medically significant) unexpected, AESI event of Cerebrovascular accident which occurred on an unknown date after a booster dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine (unknown COVID-19 vaccination schedule). It was reported that patient had a stroke after the booster. No further clinical or diagnostic information was disclosed. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.

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schizophrenia; cardiac arrest; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC ARREST (cardiac arrest) and SCHIZOPHRENIA (schizophrenia) in an adult male patient who received TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: COVID-19 VACCINE and COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE and COVID-19 VACCINE. On an unknown date, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form at an unspecified frequency. In August 2022, the patient experienced CARDIAC ARREST (cardiac arrest) (seriousness criteria death and medically significant). On an unknown date, the patient experienced SCHIZOPHRENIA (schizophrenia) (seriousness criterion medically significant). The patient died in August 2022. The reported cause of death was Cardiac arrest. It is unknown if an autopsy was performed. At the time of death, SCHIZOPHRENIA (schizophrenia) outcome was unknown. No concomitant medication information was reported. It was reported that, patient died of a cardiac arrest ,on the streets, some time in Aug 2022. No treatment medication information was reported. It was reported that a few weeks ago and one of the things she had mentioned during that call was that her son died this past summer, but she stated it had nothing to do with the Moderna COVID-19 vaccine. In fact, her son had received the Pfizer vaccine and was living in another state at the time of vaccination. He was living with her when he had the cardiac arrest and she again claims that it had nothing at all to do with any vaccines. Now, she is getting emails with Moderna thinking that the cardiac arrest was caused by the Moderna vaccine when her son didn't even receive the Moderna COVID-19 vaccine. This case was linked to US-MODERNATX, INC.-MOD-2023-704428, US-MODERNATX, INC.-MOD-2023-704425 (Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2023: Significant follow up information included patients demographics (date of birth) and narrative updated. Patient did not receive Moderna suspect hence case classification changed into tracking only.; Sender's Comments: US-MODERNATX, INC.-MOD-2023-704425:Husband case US-MODERNATX, INC.-MOD-2023-704428:Wife case; Reported Cause(s) of Death: cardiac arrest

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heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (heart attack) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that a patient had a heart attack after taking the Moderna COVID-19 vaccine. No treatment medications were reported. Company Comment :This is a spontaneous case concerns an adult female patient of unspecified age, with no relevant medical history reported, who experienced the expected serious (medically significant) AESI event of Myocardial infarction that occurred on unspecified day after a dose of mRNA-1273 bivalent BA4-5 vaccine. Vaccination dose number and vaccination schedule not disclosed. The event outcome was reported unknown. No further information on risk factors, clinical course, relevant medical history, diagnostic investigations, and treatment received were available for review. The benefit-risk relationship of mRNA-1273 bivalent BA4-5 vaccine is not affected by this report.

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Friend who passed away after having the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Friend who passed away after having the Moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. An autopsy was performed, but no results were provided. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered DEATH (Friend who passed away after having the Moderna vaccine) to be related. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who died after receiving a dose of mRNA-1273.222 vaccine, latency is unknown. An autopsy was performed and it was reported that it may have been a result of the vaccine but no further information was provided. The benefit-risk relationship of mRNA-1273.222 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who died after receiving a dose of mRNA-1273.222 vaccine, latency is unknown. An autopsy was performed and it was reported that it may have been a result of the vaccine but no further information was provided. The benefit-risk relationship of mRNA-1273.222 Vaccine is not affected by this report.; Reported Cause(s) of Death: may have been a result of the vaccine

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stroke; Completely lost vision in right eye which came back; migraine; fatigued kicked in, very tired,exhausted; nauseated; throwing up; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) and BLINDNESS TRANSIENT (Completely lost vision in right eye which came back) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU and ASKU) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Stroke. Concomitant products included METFORMIN, LISINOPRIL, GLIMEPIRIDE, ROSUVASTATIN CALCIUM (CRESTOR), PIOGLITAZONE HYDROCHLORIDE (ACTOS) and CANAGLIFLOZIN (INVOKANA [CANAGLIFLOZIN]) for an unknown indication. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced MIGRAINE (migraine), FATIGUE (fatigued kicked in, very tired,exhausted), NAUSEA (nauseated) and VOMITING (throwing up). On 06-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion hospitalization) and BLINDNESS TRANSIENT (Completely lost vision in right eye which came back) (seriousness criterion medically significant). The patient was hospitalized from 06-Apr-2021 to 09-Apr-2021 due to CEREBROVASCULAR ACCIDENT. On 01-Apr-2021, MIGRAINE (migraine), FATIGUE (fatigued kicked in, very tired,exhausted), NAUSEA (nauseated) and VOMITING (throwing up) had resolved. On 09-Apr-2021, CEREBROVASCULAR ACCIDENT (stroke) and BLINDNESS TRANSIENT (Completely lost vision in right eye which came back) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment reported during hospital included IV blood thinner ,Xarelto 20mg. Metoprolol Tartrate 25mg, Amiodarone 200mg, after second dose. Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. This case was linked to MOD-2021-076248 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. .

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5 to 6 months after the stress test, caller passed out a few times, a case of syncope from coughing a lot; pericarditis; This spontaneous case was reported by a pharmacist and describes the occurrence of SYNCOPE (5 to 6 months after the stress test, caller passed out a few times, a case of syncope from coughing a lot) and PERICARDITIS (pericarditis) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU, ASKU and ASKU) for COVID-19 prophylaxis. The patient's past medical history included Local reaction (local reaction around eyes from eye drops.). Family history included Heart disorder. Concurrent medical conditions included Hypertension and Drug allergy (Thiomersal drug allergy). Concomitant products included METOPROLOL TARTRATE (METOPROLOL XL) and VALSARTAN for an unknown indication. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced SYNCOPE (5 to 6 months after the stress test, caller passed out a few times, a case of syncope from coughing a lot) (seriousness criteria hospitalization and medically significant) and PERICARDITIS (pericarditis) (seriousness criterion medically significant). The patient was hospitalized on sometime in 2022 due to SYNCOPE. At the time of the report, SYNCOPE (5 to 6 months after the stress test, caller passed out a few times, a case of syncope from coughing a lot) and PERICARDITIS (pericarditis) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Scan myocardial perfusion: had a nuclear stress test done the previous fall that they passed with flying colors. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment medications were not reported clearly. Patient was taking a statin. Patient had coughing, shortness of breath, fluid around their heart and fluid retention. Patient received third dose in Dec2021 or Jan2022. Then in Mar/Apr2022 patient developed a diagnosis of pericarditis. Patient started coughing and could not figure out why. Patient thought he had a respiratory issue. The coughing continued for a number of weeks and caller experienced shortness of breath going upstairs. 5 to 6 months after the stress test, patient passed out a few times, a case of syncope from coughing a lot. Patient had fluid around heart and fluid retention. Patient was diagnosed with inflammation in the pericardium and tried to treat it with anti-inflammatory drugs that did not work. Patient had a pericardiectomy. Patient current age was 71 years. Company comment This is a spontaneous case concerning a 69-year-old male patient with no relevant medical history reported, who experienced the serious (due to medically significant) expected, event of pericarditis and the serious (due to medically significant and hospitalization) unexpected (expected according to Fact Sheet and insert), event of syncope, which occurred about 3-4 months after the third dose of mRNA-1273 vaccine. It was reported that Patient had coughing, shortness of breath, fluid around their heart and fluid retention. Patient thought he had a respiratory issue. The coughing continued for a few weeks, and he experienced shortness of breath going upstairs. The patient developed a diagnosis of pericarditis. 5 to 6 months after the stress test, patient passed out a few times, a case of syncope from coughing a lot. Patient had fluid around heart and fluid retention. Patient was diagnosed with inflammation in the pericardium and tried to treat it with anti-inflammatory drugs that did not work. He had a pericardiectomy. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

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cerebral venous sinus thrombosis; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL VENOUS SINUS THROMBOSIS (cerebral venous sinus thrombosis) in a 48-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. Patient reported that she had no history of clotting issues nor family history. The patient also took Tylenol or Ibuprofen. Patient had no known allergies. The patient's past medical history included COVID-19 (Her symptoms were sore throat cough, fever, chest congestion, sneezing a lot a, and felt stuffy in the nose.) in January 2022 and Vertigo (unusual episode over the summer 2023, was not able to stay upright like room was pulling to one side, Felt like gravity was pulling her, had to hold wall to walk , she had to walk on the outside by closet and push myself from wall to get my bed. had 3-4 episodes like this in July 2023) in 2023. Previously administered products included for COVID-19 vaccination: Pfizer (Dose 1, LOT : EL0142) on 05-Jan-2021, Pfizer (Dose 2, LOT : EL3248) on 26-Jan-2021, Pfizer Bivalent (Dose 3 and LOT: GH9702) on 17-Sep-2022; for COVID-19 prophylaxis: Moderna Vaccine (Dose 4 and LOT: 051F21A) on 04-Nov-2021; for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine, Moderna Vaccine, Pfizer, Pfizer and Pfizer Bivalent. Concurrent medical conditions included Migraine. Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX), DICLOFENAC POTASSIUM (CAMBIA) and UBROGEPANT (UBRELVY) for an unknown indication. On 19-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced CEREBRAL VENOUS SINUS THROMBOSIS (cerebral venous sinus thrombosis) (seriousness criterion medically significant). At the time of the report, CEREBRAL VENOUS SINUS THROMBOSIS (cerebral venous sinus thrombosis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, Magnetic resonance imaging head: Cerebral Venous Sinus Thrombosis (CVST). On 23-Oct-2023, C-reactive protein: elevated. On 23-Oct-2023, Factor VIII activity test: elevated. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. On an unspecified date, an Angiogram and Venogram to ensure adequate blood flow. The patient stated that she didn't have a stroke, they wanted to rule out. Blood clot was recanalizing. Treatment medication was not reported. Company comment This spontaneous case concerns a 48-year-old female patient, with medical history of Vertigo (had 3-4 episodes about 3 months before the vaccine), who experienced the unexpected, serious (medically significant) AESI of Cerebral venous sinus thrombosis which occurred the same year that the fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) was administered. Previously, the patient received 3 doses of Pfizer COVID-19 vaccine and 1 Bivalent. It was reported that a magnetic resonance imaging head revealed Cerebral Venous Sinus Thrombosis (CVST). C-reactive protein and factor VIII activity test were elevated. An Angiogram and Venogram were performed to ensure adequate blood flow. The patient stated that she didn't have a stroke, they wanted to rule out. Blood clot was recanalizing. No further clinical information was provided for medical review. The medical history of Vertigo could be a confounder for the event. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.

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She felt like she was going to pass out; high blood pressure; moaning; She didn't had any taste; vomiting; stomach was in terrible Pain; migraine; headache; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (She felt like she was going to pass out) in an 8-decade-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Chemotherapy (She states because of the cancer treatment in 2019, sometimes she tries to say something, and it doesn't always come out the way she intended.) in 2019. Concurrent medical conditions included Cancer since 2019, Epilepsy (She states the Epilepsy medication makes her whole body slow. That is why she is slow to respond. My whole system is like that, just in general without a vaccination, that's just from every day. She states this part didn't change after vaccination.) and Blood pressure high (She did mention that they were monitoring her blood pressure and had not prescribed any medication for it.). Concomitant products included PRIMIDONE (MYSOLINE) for Epilepsy, COLECALCIFEROL (VIT D3) for an unknown indication. On 27-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced HEADACHE (headache). On 28-Oct-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced MIGRAINE (migraine), ABDOMINAL PAIN UPPER (stomach was in terrible Pain) and VOMITING (vomiting). On 29-Oct-2023, the patient experienced AGEUSIA (She didn't had any taste). On 31-Oct-2023, the patient experienced SYNCOPE (She felt like she was going to pass out) (seriousness criterion medically significant), HYPERTENSION (high blood pressure) and MOANING (moaning). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 29-Oct-2023 at an unspecified dose and frequency. At the time of the report, SYNCOPE (She felt like she was going to pass out), MIGRAINE (migraine), HYPERTENSION (high blood pressure), ABDOMINAL PAIN UPPER (stomach was in terrible Pain), AGEUSIA (She didn't had any taste) and MOANING (moaning) had not resolved and HEADACHE (headache) and VOMITING (vomiting) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Oct-2023, Blood pressure measurement: She states it could had been high. Company Comment This spontaneous case concerns a 8-decade-old female patient with medical history of Cancer treated with Chemotherapy since 2019, Epilepsy and Blood pressure high; Concomitant products included PRIMIDONE (MYSOLINE) for Epilepsy who experienced the unexpected medically significant seriousness criteria event of syncope; the unexpected events of ageusia (AESI), migraine, hypertension, abdominal pain upper, moaning and other expected events beginning the following day after 5th. dose of mRNA-1273.815 vaccine. The medical history of Blood pressure high is a contributor for hypertension and migraine event; epilepsy for migraine event. The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2023-748132, US-MODERNATX, INC.-MOD-2023-748135 (E2B Linked Report). This case was linked to MOD-2023-748132, MOD-2023-748135 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2023-748132:Monovalent case US-MODERNATX, INC.-MOD-2023-748135:Bi-valent case

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the patient had Bell's Palsy; This spontaneous case was reported by a pharmacist and describes the occurrence of BELL'S PALSY (the patient had Bell's Palsy) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 vaccination. Previously administered products included for COVID-19 vaccination: moderna (Dose 1), moderna (Dose 3) and moderna (Dose 2). Past adverse reactions to the above products included No adverse event with moderna, moderna and moderna. On 17-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (the patient had Bell's Palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (the patient had Bell's Palsy) had not resolved. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter did not provide any causality assessments. No Concomitant and treatment medications were reported. About 3 weeks ago, the patient had Bell's Palsy. Company comment- This is a spontaneous case concerning an 80-year-old female patient with no medical history reported, who experienced the expected and serious (medically significant) AESI Bell?s Palsy. A dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine was administered. Exact onset date of the event was not provided; hence, latency cannot be assessed. No further information was provided for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.

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She has no neurological damage but has some bumps and memory problems; she has a concussion; she had passed out in the kitchen/She fainted 2 times; Patient says she received Spikevax on 11Oct2023 and then she felt like a little weak; She got into bed with chills and feeling achy; she felt like "crap"/She is used to feel like this after receiving vaccines: crudy, fever, body aches, lethargic; She got into bed with chills; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (she had passed out in the kitchen/She fainted 2 times) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (the original strain, she had a cough, felt achy, had fever, felt like having the flu and felt like having 200 extra pounds in her body.) in March 2020 and Passed out (she passed out in the kitchen.) in March 2020. Previously administered products included for Product used for unknown indication: Flu vaccine 25Sep on 25-Sep-2023. Past adverse reactions to the above products included No adverse event with Flu vaccine 25Sep. Concurrent medical conditions included Allergy to antibiotic since 2023. On 11-Oct-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 11-Oct-2023, the patient experienced ASTHENIA (Patient says she received Spikevax on 11Oct2023 and then she felt like a little weak), MYALGIA (She got into bed with chills and feeling achy), FEELING ABNORMAL (she felt like "crap"/She is used to feel like this after receiving vaccines: crudy, fever, body aches, lethargic) and CHILLS (She got into bed with chills). On 12-Oct-2023, the patient experienced LOSS OF CONSCIOUSNESS (she had passed out in the kitchen/She fainted 2 times) (seriousness criterion medically significant), MEMORY IMPAIRMENT (She has no neurological damage but has some bumps and memory problems) and CONCUSSION (she has a concussion). At the time of the report, LOSS OF CONSCIOUSNESS (she had passed out in the kitchen/She fainted 2 times) outcome was unknown and ASTHENIA (Patient says she received Spikevax on 11Oct2023 and then she felt like a little weak), MYALGIA (She got into bed with chills and feeling achy), MEMORY IMPAIRMENT (She has no neurological damage but has some bumps and memory problems), CONCUSSION (she has a concussion), FEELING ABNORMAL (she felt like "crap"/She is used to feel like this after receiving vaccines: crudy, fever, body aches, lethargic) and CHILLS (She got into bed with chills) had not resolved. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered LOSS OF CONSCIOUSNESS (she had passed out in the kitchen/She fainted 2 times) to be related. No further causality assessments were provided for ASTHENIA (Patient says she received Spikevax on 11Oct2023 and then she felt like a little weak), MYALGIA (She got into bed with chills and feeling achy), MEMORY IMPAIRMENT (She has no neurological damage but has some bumps and memory problems), CONCUSSION (she has a concussion), FEELING ABNORMAL (she felt like "crap"/She is used to feel like this after receiving vaccines: crudy, fever, body aches, lethargic) and CHILLS (She got into bed with chills). The patient received first dose: Moderna 012M20A - 28-Jan-2021 second dose: Moderna 014M20A - 25-Feb-2021 third dose: Moderna 012F21A - 22-Oct-2021 forth dose: Moderna 048L21A - 01-Apr-2022 fifth dose: Moderna AS7144B - 07-Sep-2022 sixth dose: Moderna AS7644C - 11-Aug-2023. After receiving Spikevax, she felt not quite herself. She did not faint, she was not shaking, she went home. She got into bed with chills and feeling achy - which was normal for her. Next morning: she felt like "crap". She went to the kitchen to take an Advil - next thing she remembered was someone was slapping her face trying to wake her up. It was her husband trying to wake her up, she had passed out in the kitchen. Her head bounced over the kitchen counter and she has a concussion. She ended up in the hospital, in the emergency room. She felt the exact same feeling when she got covid then when she received Spikevax. So, she was sure this had to do with the vaccine. She fainted 2 times in her entire life. She stated now she was scared to death. Company comment: This spontaneous case concerns a 68-year-old female patient, with no relevant medical history, who experienced the unexpected and serious (medically significant) event of LOSS OF CONSCIOUSNESS, on the following day of the seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine, among other non serious events. She has no neurological damage but has some bumps and memory problems. Considering the nature of event and non-suggestive relation causality CONCUSSION was assessed as not related, as it occurred as a consequence of loss of consciousness. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report. This case was linked to MOD-2023-747068 (Patient Link).

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myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis) in a 29-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) had not resolved. The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Had myocarditis from Covid vaccine. It was a very different story. A 29 year old male with a young child, who can't work, limited whole body function, currently looking at blood transfusions, hospitals in disarray because they don't know what to do. No treatment medications were provided. Company Comment This spontaneous case concerns a 29 years-old male patient with no medical history reported who experienced the expected seriousness criterion medically significant event of myocarditis unknown days after a dose of mRNA-1273.815 vaccine. Concomitant medication details nor Treatment details were reported The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2023: Live follow up received contains new reporter added.

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arm is sore; she almost passed out; nauseous; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (arm is sore), PRESYNCOPE (she almost passed out) and NAUSEA (nauseous) in an 87-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On 10-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 10-Oct-2023, the patient experienced PAIN IN EXTREMITY (arm is sore), PRESYNCOPE (she almost passed out) and NAUSEA (nauseous). On 10-Oct-2023, PAIN IN EXTREMITY (arm is sore) and NAUSEA (nauseous) had resolved. At the time of the report, PRESYNCOPE (she almost passed out) outcome was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. It had been reported that patient arm was sore and she was a little nauseous at morning once she got breakfast but patient was ok at the time of reporting but she almost passed out. Treatment information was not provided.

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Blood clots; Felt like they had flu/ symptoms for long Covid but never had Covid; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (Blood clots) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant) and INFLUENZA LIKE ILLNESS (Felt like they had flu/ symptoms for long Covid but never had Covid). At the time of the report, THROMBOSIS (Blood clots) and INFLUENZA LIKE ILLNESS (Felt like they had flu/ symptoms for long Covid but never had Covid) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Patient reported that it's really awful, that none of the medical department will talk to those that had really bad permanent issues because of the booster shots. Patient underwent all kinds of tests and blood work and doctors determined that it's from shots. She had a feeling that many more other people had these issues. Treatment information was not reported. Company comment- This is a spontaneous case concerning a female patient of unknown age with no medical history reported who experienced the serious (medically significant) and unexpected AESI thrombosis. A dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, given as a booster dose of COVID vaccine schedule, was administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. Patient reported that she is not the only one having issues from these shots. There are people who are experiencing the same she is. They have blood clots and feel like they have flu every day, or symptoms for long COVID but never had COVID. There are people who are having long term problems. The benefit-risk relationship of the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2023-705410 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2023: Follow-up received and added patient initials, gender, updated event verbatim and updated narrative. On 18-Jul-2023: Follow-up received and had no new information.; Sender's Comments: US-MODERNATX, INC.-MOD-2023-705410:Other people case

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Pass out; Misfire heartbeat; Heart episode/heart now permanently damaged; Fell; Broke foot; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Pass out) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Patient had Covid in the first part of February 2020, and as a driver, the patient picked up some people from the airport, and some from casinos. They were wearing masks and the patient asked him about it. The patient's past medical history included COVID-19 (Patient had Covid the first part of February 2020, was sick for 10 weeks) in February 2020. Previously administered products included for COVID-19 vaccination: COVID-19 vaccine (Dose 1) on 20-Apr-2021 and COVID-19 vaccine (Dose 2) on 13-May-2021. Past adverse reactions to the above products included No adverse event with COVID-19 vaccine and COVID-19 vaccine. Concurrent medical conditions included Seasonal allergy (Seasonal allergies) and Drug allergy (allergic to Ibuprofen). On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Pass out) (seriousness criterion medically significant), HEART RATE IRREGULAR (Misfire heartbeat), CARDIAC DISORDER (Heart episode/heart now permanently damaged), FALL (Fell) and FOOT FRACTURE (Broke foot). At the time of the report, LOSS OF CONSCIOUSNESS (Pass out), HEART RATE IRREGULAR (Misfire heartbeat), CARDIAC DISORDER (Heart episode/heart now permanently damaged), FALL (Fell) and FOOT FRACTURE (Broke foot) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: Patient had a misfire heartbeat and not an irregular heart. At every 3rd, 4th, and 5th beat, it would misfire.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The patient received the initial booster dose of Moderna vaccine on 23-Dec-2021. Patient had a heart episode in January and it was really bad. Patient thought that he was having a heart attack. The patient's heart was now permanently damaged. The patient's heart beats but not pumping blood to brain and since it was not getting oxygen, hence patient passes out. Patient had a total of 5 episodes. The patient reported that he had a really bad episode about 3 weeks ago. Patient confirmed that he had not been hospitalized after any episodes. The patient went to the hospital because he passed out, fell and broke the foot. X-Ray was conducted at last hospital visit (result not reported) and HCP (healthcare provider) had wrapped the foot. Patient could not walk and work and was under Regulatory Authority care and housing support. Patient had undergone an EKG (electrocardiogram) test and was on heart monitor in Jan of 2022. Heart specialist did not provide a diagnosis but mentioned that patient had a misfire heartbeat and not an irregular heart. He wore a heart monitor so that it could be seen that at every 3rd, 4th, and 5th beat, it would misfire. It was not beating normally. He explained what happened to his physician. HCP asked the patient about the vaccines. Patient told him about the episodes after the booster dose. The physician stated that it happened because of the vaccine. One of the physicians who the patient saw for his foot told that they were supposed to cover it because patient absolutely would not. The patient stated that this incident prompted him to do some research about the Moderna vaccine and he was reading about autopsies that they were doing on people who got these vaccines and boosters and the patient found it to be appalling. No treatment information was provided. Company comment : This spontaneous case concerns a male patient aged 59 years with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Loss of consciousness and unexpected non-serious AESI of Heart rate irregular that occurred in the context of third dose of mRNA-1273 vaccination in covid -19 vaccination series. Latency cannot be assessed since onset date of events was not disclosed. It was reported that patient had a heart episode, he thought he was having a heart attack. He states that his heart beats, but not pumping blood to his brain and so it's not getting oxygen. He had a total of 5 episodes of passing out. He went to the hospital because he passed out, fell and broke his foot. X-Ray was conducted and HCP wrapped the foot. Patient stated, he can't walk, can't work. Patient had an EKG and was on Heart monitor, Heart specialist mentioned that patient have a misfire heartbeat and not an irregular heart. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the events was not resolved at the time of report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient aged 59 years with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Loss of consciousness and unexpected non-serious AESI of Heart rate irregular that occurred in the context of third dose of mRNA-1273 vaccination in covid -19 vaccination series. Latency cannot be assessed since onset date of events was not disclosed. It was reported that patient had a heart episode, he thought he was having a heart attack. He states that his heart beats, but not pumping blood to his brain and so it's not getting oxygen. He had a total of 5 episodes of passing out. He went to the hospital because he passed out, fell and broke his foot. X-Ray was conducted and HCP wrapped the foot. Patient stated, he can't walk, can't work. Patient had an EKG and was on Heart monitor, Heart specialist mentioned that patient have a misfire heartbeat and not an irregular heart. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the events was not resolved at the time of report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

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paralysis; pain all over the place; Slight very base on the side of his left hand back there is weakness.; COVID-19/Pneumonia; He used to ride a bike but now he can't even cut his grass with a mower, can't run or pick up anything because he's inflamed.; pain in the base of his spine.He feels like it inflamed his spinal cord.; Any place he was previously injured he gets inflamed like his chest and shoulders.; now he has pain down his legs.; He used to ride a bike but now he can't even cut his grass with a mower, can't run or pick up anything because he's inflamed.; blockage of nerves going into his legs; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (paralysis) and COVID-19 PNEUMONIA (COVID-19/Pneumonia) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARALYSIS (paralysis) (seriousness criterion medically significant), PAIN (pain all over the place), ASTHENIA (Slight very base on the side of his left hand back there is weakness.), COVID-19 PNEUMONIA (COVID-19/Pneumonia) (seriousness criterion medically significant), MOBILITY DECREASED (He used to ride a bike but now he can't even cut his grass with a mower, can't run or pick up anything because he's inflamed.), SPINAL PAIN (pain in the base of his spine.He feels like it inflamed his spinal cord), INFLAMMATION (Any place he was previously injured he gets inflamed like his chest and shoulders.), PAIN IN EXTREMITY (now he has pain down his legs.), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He used to ride a bike but now he can't even cut his grass with a mower, can't run or pick up anything because he's inflamed) and NERVE BLOCK (blockage of nerves going into his legs). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN N) for Pain, at an unspecified dose and frequency. At the time of the report, PARALYSIS (paralysis), PAIN (pain all over the place) and ASTHENIA (Slight very base on the side of his left hand back there is weakness) had not resolved, COVID-19 PNEUMONIA (COVID-19/Pneumonia) was resolving and MOBILITY DECREASED (He used to ride a bike but now he can't even cut his grass with a mower, can't run or pick up anything because he's inflamed.), SPINAL PAIN (pain in the base of his spine.He feels like it inflamed his spinal cord.), INFLAMMATION (Any place he was previously injured he gets inflamed like his chest and shoulders.), PAIN IN EXTREMITY (now he has pain down his legs), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He used to ride a bike but now he can't even cut his grass with a mower, can't run or pick up anything because he's inflamed) and NERVE BLOCK (blockage of nerves going into his legs) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: In June he got back x-rays. He says he has blockage of nerves going into his legs.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that A month after the second injection he had a year of paralysis and Guillain-Barre which had gone away a bit. Now when his little boy was sick around him he gets inflamed. He used to ride a bike but now he could not even cut his grass with a mower. His life had changed. He has pain in the base of his spine. In June he got back x-rays. He says he has blockage of nerves going into his legs. Now he wants to know what to do. He's very upset and feels like he was lied to. It was the worst mistake he was made. Some days he was perfectly fine. He gets pain all over the place. Any place he was previously injured he gets inflamed like his chest and shoulders. Slight very base on the side of his left hand back there was weakness. There was nothing wrong in his x-rays. He feels like it inflamed his spinal cord and now he had pain down his legs. He wants to know if there was a reversal of this. He talked to VAERS and made a report. He sees his doctor tomorrow. Doctor said he did not had Guillain-Barre. He had not ride a bike since he got the second shot two years ago. He can be in pain for 10 days at a time. He could not run or pick up anything because he was inflamed. He feels like he was conned or tricked. He had COVID-19 for two months at a time. That was gone now and he could breathe again after the pneumonia. He stated if I can get a lawyer I would. He took aspirin once in a while for the pain as well to get rid of the pain. No treatment medication information was reported. Company comment: This spontaneous case concerns a 67-year-old male patient, with no medical history reported, who experienced the serious (medically significant) and unexpected events of PARALYSIS and COVID-19 PNEUMONIA (among other non-serious events). A month after the second dose of mrNA-1273 vaccine, he had a year of paralysis and experienced pain in the base of his spine and felt blockage of nerves of the legs. He had pain all over, and any place that was previously injured got inflamed, making it difficult to ride a bike or even cut the grass. X-rays were performed with no findings and Guillain-Barre was ruled out by the doctor. He also had COVID-19 for two months with pneumonia, which has improved (onset was not reported; hence, latency to the first or second dose of mRNA-1273 vaccine could not be properly assessed). He took aspirin occasionally to relieve pain. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 67-year-old male patient, with no medical history reported, who experienced the serious (medically significant) and unexpected events of PARALYSIS and COVID-19 PNEUMONIA (among other non-serious events). A month after the second dose of mrNA-1273 vaccine, he had a year of paralysis and experienced pain in the base of his spine and felt blockage of nerves of the legs. He had pain all over, and any place that was previously injured got inflamed, making it difficult to ride a bike or even cut the grass. X-rays were performed with no findings and Guillain-Barre was ruled out by the doctor. He also had COVID-19 for two months with pneumonia, which has improved (onset was not reported; hence, latency to the first or second dose of mRNA-1273 vaccine could not be properly assessed). He took aspirin occasionally to relieve pain. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 is not affected by this report.

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blood clots; developed blood clots which went to his spleen and killed half of it; feels hot all the time; headaches; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (blood clots) and SPLENIC INJURY (developed blood clots which went to his spleen and killed half of it) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1) and Moderna COVID-19 Vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criterion medically significant), SPLENIC INJURY (developed blood clots which went to his spleen and killed half of it) (seriousness criterion medically significant), FEELING HOT (feels hot all the time) and HEADACHE (headaches). At the time of the report, THROMBOSIS (blood clots), FEELING HOT (feels hot all the time) and HEADACHE (headaches) had not resolved and SPLENIC INJURY (developed blood clots which went to his spleen and killed half of it) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram ambulatory: not able to see afib on both occasions. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered SPLENIC INJURY (developed blood clots which went to his spleen and killed half of it) to be not related. No further causality assessments were provided for THROMBOSIS (blood clots), FEELING HOT (feels hot all the time) and HEADACHE (headaches). Concomitant medication was not provided. It was reported that patient had the 2 shots of the vaccine one and a half years ago the a few months later had the booster dose. He did not have his vaccination card with him at the time of the call so he was not able to provide the vaccination details. After an unspecified period of time, he developed blood clots which went to his spleen and killed half of it. His doctor said that this could not be due to the vaccine. He had headaches towards the end of the day and felt hot all the time. He was also hooked to heart monitor twice to see where the clot is coming from but they were not able to see afib on both occasions. He had blood thinners for a long time. Company Comment: This is a Spontaneous case reported by a patient, concerning a male patient of unknown age, with no medical history reported, who experienced the unexpected and serious (due to medically significant) events of Thrombosis (AESI) and Splenic injury, which occurred on an unknown date after a booster dose of mRNA-1273.222 vaccine. Patient reported that after an unspecified period of time after vaccination, he developed blood clots, which went to his spleen and "killed half of it". His doctor said that this could not be due to the vaccine. Heart monitor was performed twice, with no finding of atrial fibrillation. Patient has received blood thinners for a long time. At the time of the report, Thrombosis had not resolved, and Splenic injury outcome was unknown. The benefit-risk relationship of mRNA- 1273.222 vaccine is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2023-697477, US-MODERNATX, INC.-MOD-2023-697513, US-MODERNATX, INC.-MOD-2023-697562 (Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2023-697477:brother case US-MODERNATX, INC.-MOD-2023-697513:Son's case US-MODERNATX, INC.-MOD-2023-697562:older brother case

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Moderna COVID-19 vaccines have large clots in the circulation system. The funeral director has a difficult time pushing embalming fluid through the patients as the clots are so large.; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Moderna COVID-19 vaccines have large clots in the circulation system. The funeral director has a difficult time pushing embalming fluid through the patients as the clots are so large.) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Moderna COVID-19 vaccines have large clots in the circulation system. The funeral director has a difficult time pushing embalming fluid through the patients as the clots are so large.) (seriousness criteria death and medically significant). The reported cause of death was moderna covid-19 vaccines have large clots in the circulation system. the funeral director has a difficult time pushing embalming fluid through the patients as the clots are so large.. It is unknown if an autopsy was performed. The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. No concomitant medications details were reported. The caller stated that he had a friend who was a funeral director who told him that a large number of deceased patients that have been vaccinated with the Moderna COVID-19 vaccines have large clots in the circulation system. The funeral director had a difficult time pushing embalming fluid through the patients as the clots were so large. No treatment medications details were reported. Company Comment: This is a Spontaneous case reported by a consumer, concerning an adult patient of unknown exact age and gender, with no medical history reported, who experienced the unexpected and serious (due to medically significant) fatal of Thrombosis, which occurred on an unknown date after an unspecified dose of mRNA-1273.222 vaccine. The caller said that he had a friend who is a funeral director who told him that a large number of deceased patients that had been vaccinated with Moderna vaccine, had large clots in the circulation system. The funeral director had a difficult time pushing embalming fluid through the patients as the clots were so large. The reported cause of death was large clots in the circulation system. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA- 1273.222 vaccine is not affected by this report. Sender's Comments: This is a Spontaneous case reported by a consumer, concerning an adult patient of unknown exact age and gender, with no medical history reported, who experienced the unexpected and serious (due to medically significant) fatal of Thrombosis, which occurred on an unknown date after an unspecified dose of mRNA-1273.222 vaccine. The caller said that he had a friend who is a funeral director who told him that a large number of deceased patients that had been vaccinated with Moderna vaccine, had large clots in the circulation system. The funeral director had a difficult time pushing embalming fluid through the patients as the clots were so large. The reported cause of death was large clots in the circulation system. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA- 1273.222 vaccine is not affected by this report. Reported Cause(s) of Death: Moderna COVID-19 vaccines have large clots in the circulation system. The funeral director has a difficult time pushing embalming fluid through the patients as the clots are so large.

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blood clot/many people have gotten clots and died from it; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot/many people have gotten clots and died from it) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clot/many people have gotten clots and died from it) (seriousness criteria death and medically significant). The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. No treatment information was provided by the reporter. Company comment This spontaneous case reported by a consumer, concerns a child patient of unknown age and gender, with no reported medical history, who experienced the unexpected, serious (Fatal, medically significant) AESI event of Thrombosis (blood clot/many people have gotten clots and died from it), on an unspecified day after receiving an unspecified dose of mRNA-1273 vaccine. Further details on the comorbidities, medical history, clinical course, diagnostics, concomitant and treatment details were not reported. The event was reported with a fatal outcome. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns a child patient of unknown age and gender, with no reported medical history, who experienced the unexpected, serious (Fatal, medically significant) AESI event of Thrombosis (blood clot/many people have gotten clots and died from it), on an unspecified day after receiving an unspecified dose of mRNA-1273 vaccine. Further details on the comorbidities, medical history, clinical course, diagnostics, concomitant and treatment details were not reported. The event was reported with a fatal outcome. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death

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pericarditis; My husband was in a lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (pericarditis) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Dialysis. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced PERICARDITIS (pericarditis) (seriousness criterion medically significant) and PAIN (My husband was in a lot of pain). At the time of the report, PERICARDITIS (pericarditis) and PAIN (My husband was in a lot of pain) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. No Concomitant medication was reported. No treatment information was provided. Wife called to report that her 70-year-old husband received a bivalent booster on unknown date (About 3 months ago) and 2-3 weeks later had pericarditis and ended up in the hospital. Caller does not have the vaccination card and her husband is gone to dialysis right now. He has been on dialysis for 3 years. Wife states that he had a healthy heart prior to vaccination. Agent tried to get more information, but wife states to follow up via mail for more information from her husband. She states her husband was in a lot of pain and he could have died.. Company comment: This spontaneous case concerns a 70 year old male patient with no cardiovascular pathology identified, and no known prior COVID 19 infection, who experienced the expected, serious (medically significant) AESI of Pericarditis , about 2 to 3 weeks after receiving a dose (additional booster) with mRNA-1273.222 bivalent vaccine. The patient experienced pain along with the event and ended up in the hospital. No information on risk factors, detailed clinical course, investigations, treatment of the event, outcome and details pertaining to the previous doses was available in the report. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2022-689723.; Sender's Comments: This spontaneous case concerns a 70 year old male patient with no cardiovascular pathology identified, and no known prior COVID 19 infection, who experienced the expected, serious (medically significant) AESI of Pericarditis , about 2 to 3 weeks after receiving a dose (additional booster) with mRNA-1273.222 bivalent vaccine. The patient experienced pain along with the event and ended up in the hospital. No information on risk factors, detailed clinical course, investigations, treatment of the event, outcome and details pertaining to the previous doses was available in the report. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-689723:Wife's case

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blood clots/He had blood clots in his heart; shortness of breath; cough; fever of 104?F; heart rate increased; This spontaneous case was reported by a patient and describes the occurrence of INTRACARDIAC THROMBUS (blood clots/He had blood clots in his heart) in a 73-year-old male patient who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In July 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In August 2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INTRACARDIAC THROMBUS (blood clots/He had blood clots in his heart) (seriousness criterion medically significant), DYSPNOEA (shortness of breath), COUGH (cough), PYREXIA (fever of 104?F) and HEART RATE INCREASED (heart rate increased). At the time of the report, INTRACARDIAC THROMBUS (blood clots/He had blood clots in his heart), DYSPNOEA (shortness of breath) and COUGH (cough) had not resolved, PYREXIA (fever of 104?F) had resolved and HEART RATE INCREASED (heart rate increased) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 fernite. On an unknown date, Heart rate: 192 beats a minute, fast. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications provided by the reporter. It has been reported that after first Moderna vaccine patient was sent to bed for 3-4 days with a fever of 104-degree Fahrenheit and then he got well. After 30 days of 1st vaccination, patient received the second shot of Moderna Covid-19 vaccine. After receiving the second shot, patient was unable to breathe. He called the physician and physician gave him treatment medication. Patient also received blood thinners as treatment medication. He was currently being monitored with a heart monitor. Patient had an appointment with cardiologist. He never experienced something like this in the past. Patient did not receive a diagnosis of myocarditis or pericarditis. Company Comment This spontaneous case concerns a 73-year-old male patient with no medical history reported who experienced the unexpected medically significant AESI of intracardiac thrombus; the unexpected events of heart rate increased, dyspnoea, cough and other expected event in the context of 2nd. dose of mRNA-1273 vaccine. The unexpected events occurred after the mentioned dose. At the time of the report, only Pyrexia event had resolved. The age is a contributor for the events. The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2023-753415 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 12-Dec-2023: Live significant information has been appended which included Reporter details, patent age, gender), Vaccination and event details were updated.; Sender's Comments: US-MODERNATX, INC.-MOD-2023-753415:Same Reporter other patient

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had TIA 9 days after shot had every test all negative something spiked my blood pressure to 189 over 105; had TIA 9 days after shot had every test all negative something spiked my blood pressure to 189 over 105; This spontaneous case was reported by a patient and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (had TIA 9 days after shot had every test all negative something spiked my blood pressure to 189 over 105) in an elderly patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (had TIA 9 days after shot had every test all negative something spiked my blood pressure to 189 over 105) (seriousness criterion medically significant) and HYPERTENSION (had TIA 9 days after shot had every test all negative something spiked my blood pressure to 189 over 105). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (had TIA 9 days after shot had every test all negative something spiked my blood pressure to 189 over 105) and HYPERTENSION (had TIA 9 days after shot had every test all negative something spiked my blood pressure to 189 over 105) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 189 over 105. On an unknown date, Laboratory test: (Negative) after shot had every test all negative. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. Patient's age was over 65. Patient had TIA 9 days after shot had every test all negative. It was reported that something was spiked that the blood pressure was 189 over 105. Treatment information was not reported. Company Comment This spontaneous case concerns an elderly patient of an unknown gender with no medical history reported who experienced the unexpected medically significant AESI of transient ischaemic attack; and the unexpected event of hypertension unknown days after 5th. dose of mRNA-1273.815 vaccine. At the time of the report, the outcome of the events was unknown. Concomitant medication nor Treatment details were reported. The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report.

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Patient was really sick, occasional brain fog, huge body aches, fatigue, blinding headache, Shortness of breath; Tachycardia; This spontaneous case was reported by a patient and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (Patient was really sick, occasional brain fog, huge body aches, fatigue, blinding headache, Shortness of breath) and TACHYCARDIA (Tachycardia) in a 63-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On 26-Nov-2021, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 20-May-2022, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2022, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2023, received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 28-Jul-2023, received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In September 2023, the patient experienced POST-ACUTE COVID-19 SYNDROME (Patient was really sick, occasional brain fog, huge body aches, fatigue, blinding headache, Shortness of breath) and TACHYCARDIA (Tachycardia). The patient was treated with MAGNESIUM at an unspecified dose and frequency and ZINC at an unspecified dose and frequency. At the time of the report, POST-ACUTE COVID-19 SYNDROME (Patient was really sick, occasional brain fog, huge body aches, fatigue, blinding headache, Shortness of breath) and TACHYCARDIA (Tachycardia) outcome was unknown. No concomitant medication was reported. Patient was not hospitalized, but quite sick each time got the vaccine. Patient did not receive any other cardiac-related diagnosis and no other diagnosis.

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injection site arm hurt for a little bit.; If he doesn?t receive an answer he will end up killing himself, he says he doesn?t got much reason to live.; patient experienced ED problems; On November 7, 2023 I got an erection for 30 minutes but had delayed ejaculation; The patient could not have an orgasim; heart palpitations; This spontaneous case was reported by a patient and describes the occurrence of ERECTILE DYSFUNCTION (patient experienced ED problems) in a 67-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product TADALAFIL (CIALIS) tablet for Erectile dysfunction. The patient's past medical history included Heart valve replacement NOS in 2001 and Stent placement in 2001. Concomitant products included WARFARIN and LISINOPRIL for an unknown indication. In 2019, the patient started TADALAFIL (CIALIS) (unknown route) 5 milligram as required. On 19-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 18-Nov-2023, TADALAFIL (CIALIS) (unknown route) dosage was changed to 10 milligram. On 07-Nov-2023, the patient experienced ERECTILE DYSFUNCTION (patient experienced ED problems) (seriousness criterion medically significant), EJACULATION DELAYED (On November 7, 2023 I got an erection for 30 minutes but had delayed ejaculation) and ANORGASMIA (The patient could not have an orgasim). In November 2023, the patient experienced PALPITATIONS (heart palpitations). On an unknown date, the patient experienced VACCINATION SITE PAIN (injection site arm hurt for a little bit.) and SELF-INJURIOUS IDEATION (If he doesn?t receive an answer he will end up killing himself, he says he doesn?t got much reason to live.). At the time of the report, ERECTILE DYSFUNCTION (patient experienced ED problems), EJACULATION DELAYED (On November 7, 2023 I got an erection for 30 minutes but had delayed ejaculation), ANORGASMIA (The patient could not have an orgasim), PALPITATIONS (heart palpitations), VACCINATION SITE PAIN (injection site arm hurt for a little bit.) and SELF-INJURIOUS IDEATION (If he doesn?t receive an answer he will end up killing himself, he says he doesn?t got much reason to live.) outcome was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered ERECTILE DYSFUNCTION (patient experienced ED problems), EJACULATION DELAYED (On November 7, 2023 I got an erection for 30 minutes but had delayed ejaculation) and ANORGASMIA (The patient could not have an orgasim) to be related. No further causality assessments were provided for PALPITATIONS (heart palpitations), VACCINATION SITE PAIN (injection site arm hurt for a little bit.) and SELF-INJURIOUS IDEATION (If he doesn?t receive an answer he will end up killing himself, he says he doesn?t got much reason to live.). The patient received the first Moderna Covid-19 vaccine on FEB-2021, second Moderna Covid-19 vaccine about 28 days after the first Moderna Covid-19 vaccine, first Moderna booster dose in Oct-2021. The patient received additional booster doses in 2022. The patient experienced ED (erectile dysfunction) problems while taking Cialis Tadalofil 5mg tablets. On 07-Nov-2023 patient got an erection for 30 minutes but had delayed ejaculation. The patient could not have an orgasm. Before 07-Nov-2023, the patient was fine with Tadalafil 5mg tablets and always worked great. On 18-NOV-2023 the patient's physician increased the Tadalafil to 10mg tablet to achieve an erection. The patient complained that with Tadalafil 10mg that he got heart palpitations. With 10mg of Tadalafil the patient might get an erection but also might have heart issues. Patient stated that he could be doing better if he could figure out how to detox from the Covid vaccine he received in October. He already checked with his primary care and was going to see an urologist. It was also reported that if patient does not receive an answer he would end up killing himself, he stated he does not got much reason to live. He stated as he was set by all this, he was really, really sad. Company Comment: This is a spontaneous case concerning a 67-year-old male patient with a history of Heart valve replacement and Stent placement, and use of Tadalafil for erectile disfunction since 2019, who experienced the serious (due to medically significant) unexpected, event of erectile dysfunction, together with other non-serious events which occurred approximately 20 days after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine. The mentioned medical history remains as a confounder. Tadalafil was considered as a co-suspect drug. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2023-751281 (Linked Report). This case was linked to MOD-2023-751295 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2023: Live follow up received. Reporter details, narrative and reference id updated.; Sender's Comments: US-MODERNATX, INC.-MOD-2023-751281:same reporter/different patient

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Caller has been in the hospital for two days this weekend because their blood pressure shot up to 209/180; Caller is short of breath/Caller is having to use their oxygen again because it doesn't seem like they are getting enough; Just walking to the kitchen has her trembling; Nose runs and eyes water; Nose runs and eyes water; head is driving her crazy; Caller says everything taste like cardboard; Blood pressure is still fluctuating up and down; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Caller has been in the hospital for two days this weekend because their blood pressure shot up to 209/180) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cardiac operation (5 years ago, rebuilt their aortic veins.). Concurrent medical conditions included Heart disorder (congestive heart problem). On an unknown date, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (Caller has been in the hospital for two days this weekend because their blood pressure shot up to 209/180) (seriousness criterion hospitalization), DYSPNOEA (Caller is short of breath/Caller is having to use their oxygen again because it doesn't seem like they are getting enough), TREMOR (Just walking to the kitchen has her trembling), RHINORRHOEA (Nose runs and eyes water), LACRIMATION INCREASED (Nose runs and eyes water), HEAD DISCOMFORT (head is driving her crazy), TASTE DISORDER (Caller says everything taste like cardboard) and BLOOD PRESSURE FLUCTUATION (Blood pressure is still fluctuating up and down). At the time of the report, BLOOD PRESSURE INCREASED (Caller has been in the hospital for two days this weekend because their blood pressure shot up to 209/180), DYSPNOEA (Caller is short of breath/Caller is having to use their oxygen again because it doesn't seem like they are getting enough), TREMOR (Just walking to the kitchen has her trembling), RHINORRHOEA (Nose runs and eyes water), LACRIMATION INCREASED (Nose runs and eyes water), HEAD DISCOMFORT (head is driving her crazy), TASTE DISORDER (Caller says everything taste like cardboard) and BLOOD PRESSURE FLUCTUATION (Blood pressure is still fluctuating up and down) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: shot up to 209/180. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided. Patient was experiencing trouble now. Patient couldn't do jack. Patient's heart doctor said that the symptoms the patient was experiencing, was not due to congestive heart problem. It was reported that it was really pissing the patient off that the patient couldn't do what suppose to do. No treatment medications were provided. Company comment: This is a spontaneous case concerning a female patient of unknown age, with medical history of aortic veins and congestive heart problems, who experienced the unexpected serious (hospitalization) event of Blood pressure increased, among other non-serious events. one day after the administration of SPIKEVAX 2023-2024 vaccine, used as a fourth dose. Blood pressure raised up to 209/180 and required hospitalization for 2 days. She complaint of dyspnoea, tremor, lacrimation, taste changed and still with blood pressure fluctuation. No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of SPIKEVAX 2023-2024 Vaccine is not affected by this report.

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cold; tachycardia; cramping; flu; body aches; low back pain; diarrhea; chills; fever; joint pain; fatigue; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of NASOPHARYNGITIS (cold), TACHYCARDIA (tachycardia), MUSCLE SPASMS (cramping), INFLUENZA (flu) and PAIN (body aches) in an 8-decade-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for COVID-19 prophylaxis: Pfizer (all prior doses were Pfizer). Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Hypometabolism (sensitive person to medication, meaning slow metabolizer of medication.). On 17-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 17-Nov-2023, the patient experienced NASOPHARYNGITIS (cold), TACHYCARDIA (tachycardia), MUSCLE SPASMS (cramping), INFLUENZA (flu), PAIN (body aches), BACK PAIN (low back pain), DIARRHOEA (diarrhea), CHILLS (chills), PYREXIA (fever), ARTHRALGIA (joint pain), FATIGUE (fatigue) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Nov-2023, NASOPHARYNGITIS (cold), TACHYCARDIA (tachycardia), MUSCLE SPASMS (cramping), INFLUENZA (flu), PAIN (body aches), BACK PAIN (low back pain), DIARRHOEA (diarrhea), CHILLS (chills), PYREXIA (fever), ARTHRALGIA (joint pain), FATIGUE (fatigue) and HEADACHE (headache) had resolved. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Patient had received Spikevax around 2 PM on Friday, 17-Nov-2023 4 hours after vaccination she experienced extreme chills, never felt this cold before, tachycardia which she attributes to her fever, achy, body aches, low back pain, which caused her to worry as she was a Registered NP. Joint pain, pronounced fatigue, didn't want to move at all, terrible headache, diarrhea and cramping, a 103 which went down to 102 after taking Tylenol. Reported that back ache, terrible headache, lasted until Sunday evening. HCP stated that it felt like I had a bad Flu. Concomitant medications were not reported.

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The most recent one was slightly more intense; soreness at the injection site; fatigue; This spontaneous case was reported by a patient and describes the occurrence of CONDITION AGGRAVATED (The most recent one was slightly more intense), INJECTION SITE PAIN (soreness at the injection site) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: INFLUENZA. Past adverse reactions to the above products included No adverse event with INFLUENZA. Concurrent medical conditions included Chronic lung disease and Polyneuropathy. In 2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (The most recent one was slightly more intense), INJECTION SITE PAIN (soreness at the injection site) and FATIGUE (fatigue). At the time of the report, CONDITION AGGRAVATED (The most recent one was slightly more intense), INJECTION SITE PAIN (soreness at the injection site) and FATIGUE (fatigue) had resolved. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment medication were reported. Patient tolerated all shots well and has not gotten sick. Patient had a little bit of soreness at the injection site and fatigue with all of the doses. Events lasted about 1.5 days before resolving with each dose. The most recent one was slightly more intense, lasting 2 days. Patient had taken another 5 doses of the Moderna COVID-19 vaccine as on 24FEB2021 with lot number 006M20A, 26MAR2021with lot number 026A21A, 9NOV2021 with lot number 004F21N, 3JUN2022 with lot number 05A22A, 28NOV2022 with lot number 016H22A. This case was linked to MOD-2023-749424, MOD-2023-749425, MOD-2023-749427.

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She has COPD and she was told that she has having COPD "in exasperation"; her problem with breathing; she feels that her chest is tight and heavy; She went to see her doctor and was told that her lungs "were not moving any air"; It's like having a flu - she has body aches, bad headache that lasted for 2-3 days, slight fever (100 degrees), chills, congestion in the sinuses (which she normally has); It's like having a flu - she has body aches, bad headache that lasted for 2-3 days, slight fever (100 degrees), chills, congestion in the sinuses (which she normally has); It's like having a flu - she has body aches, bad headache that lasted for 2-3 days, slight fever (100 degrees), chills, congestion in the sinuses (which she normally has); she had been very sick; It's like having a flu - she has body aches, bad headache that lasted for 2-3 days, slight fever (100 degrees), chills, congestion in the sinuses (which she normally has); It's like having a flu - she has body aches, bad headache that lasted for 2-3 days, slight fever (100 degrees), chills, congestion in the sinuses (which she normally has); This spontaneous case was reported by a patient and describes the occurrence of PAIN (It's like having a flu - she has body aches, bad headache that lasted for 2-3 days, slight fever (100 degrees), chills, congestion in the sinuses (which she normally has)), SINUS CONGESTION (It's like having a flu - she has body aches, bad headache that lasted for 2-3 days, slight fever (100 degrees), chills, congestion in the sinuses (which she normally has)), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (She has COPD and she was told that she has having COPD "in exasperation"), ILLNESS (she had been very sick) and LUNG DISORDER (She went to see her doctor and was told that her lungs "were not moving any air") in a 62-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:COPD, high blood pressure (before the vaccine), previous heart attack (before the vaccine), lung cancer 2x (2019, 2021 not sure if after the 1st dose) and was radiated and osteoporosis (just diagnosed a few months ago). The patient's past medical history included Heart attack (b), Lung cancer (2019, 2021 not sure if after the first dose and was radiated.) and Radiation therapy. Concurrent medical conditions included COPD, Blood pressure high (Before the vaccine) and Osteoporosis (diagnosed a few months ago). Concomitant products included PREDNISONE for an unknown indication. On 29-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 30-Oct-2023, the patient experienced PAIN (It's like having a flu - she has body aches, bad headache that lasted for 2-3 days, slight fever (100 degrees), chills, congestion in the sinuses (which she normally has)), SINUS CONGESTION (It's like having a flu - she has body aches, bad headache that lasted for 2-3 days, slight fever (100 degrees), chills, congestion in the sinuses (which she normally has)), ILLNESS (she had been very sick), PYREXIA (It's like having a flu - she has body aches, bad headache that lasted for 2-3 days, slight fever (100 degrees), chills, congestion in the sinuses (which she normally has)), CHILLS (It's like having a flu - she has body aches, bad headache that lasted for 2-3 days, slight fever (100 degrees), chills, congestion in the sinuses (which she normally has)) and HEADACHE (It's like having a flu - she has body aches, bad headache that lasted for 2-3 days, slight fever (100 degrees), chills, congestion in the sinuses (which she normally has)). On 02-Nov-2023, the patient experienced LUNG DISORDER (She went to see her doctor and was told that her lungs "were not moving any air"). On an unknown date, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (She has COPD and she was told that she has having COPD "in exasperation"). an unknown date, the patient experienced DYSPNOEA (her problem with breathing) and CHEST DISCOMFORT (she feels that her chest is tight and heavy). At the time of the report, PAIN (It's like having a flu - she has body aches, bad headache that lasted for 2-3 days, slight fever (100 degrees), chills, congestion in the sinuses (which she normally has)) and HEADACHE (It's like having a flu - she has body aches, bad headache that lasted for 2-3 days, slight fever (100 degrees), chills, congestion in the sinuses (which she normally has)) had resolved, SINUS CONGESTION (It's like having a flu - she has body aches, bad headache that lasted for 2-3 days, slight fever (100 degrees), chills, congestion in the sinuses (which she normally has)), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (She has COPD and she was told that she has having COPD "in exasperation"), DYSPNOEA (her problem with breathing), CHEST DISCOMFORT (she feels that her chest is tight and heavy), PYREXIA (It's like having a flu - she has body aches, bad headache that lasted for 2-3 days, slight fever (100 degrees), chills, congestion in the sinuses (which she normally has)) and CHILLS (It's like having a flu - she has body aches, bad headache that lasted for 2-3 days, slight fever (100 degrees), chills, congestion in the sinuses (which she normally has)) outcome was unknown and ILLNESS (she had been very sick) and LUNG DISORDER (She went to see her doctor and was told that her lungs "were not moving any air") was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 degrees. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. The patient was treated with antibiotics. The patient's vaccination details were as follows: 1st dose - 09Jan2021, lot number 025J20-2A 2nd dose - 11Feb2021. lot number 012M20A 3rd dose - 15Oct2021, lot number 039D21A 4th dose - 04Apr2022, lot number 0661221A (?) 5th dose - 17Nov2022, lot number 062F22A. The patient had no coughing. This case was linked to MOD-2023-748628, MOD-2023-748631 (Patient Link).

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Interchange of vaccine products; Revaccination with different COVID-19 vaccine; sweating; feeling absolutely terrible; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), FEELING ABNORMAL (feeling absolutely terrible), HEADACHE (headache), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) in a 65-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. Co-suspect product included non-company product INFLUENZA VACCINE for Influenza immunisation. The patient's past medical history included COVID-19 (2 months ago). Previously administered products included for COVID-19 immunisation: Johnson and Johnson (had 2 Johnson and Johnson COVID-19 Vaccines previously.). Past adverse reactions to the above products included No adverse event with Johnson and Johnson. Concurrent medical conditions included CLL. On 30-Oct-2023, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 30-Oct-2023 at 10:30 AM, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 30-Oct-2023, the patient experienced HYPERHIDROSIS (sweating), FEELING ABNORMAL (feeling absolutely terrible) and HEADACHE (headache). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweating) and HEADACHE (headache) had not resolved and FEELING ABNORMAL (feeling absolutely terrible), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. Reported that patient was feeling absolutely terrible. He has been in bed since Monday night. He was sweating, had headache and he just felt terrible. His oncologist recommended to get the vaccine. Patient had lot of water. He felt like he had COVID-19 again.

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Caller had the shot 4 hours ago and all they are doing is sneezing; nose running; a little breathing problem; they feel tired; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Caller had the shot 4 hours ago and all they are doing is sneezing), RHINORRHOEA (nose running), DYSPNOEA (a little breathing problem) and FATIGUE (they feel tired) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On 31-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced SNEEZING (Caller had the shot 4 hours ago and all they are doing is sneezing), RHINORRHOEA (nose running), DYSPNOEA (a little breathing problem) and FATIGUE (they feel tired). At the time of the report, SNEEZING (Caller had the shot 4 hours ago and all they are doing is sneezing), RHINORRHOEA (nose running), DYSPNOEA (a little breathing problem) and FATIGUE (they feel tired) outcome was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant and treatment medications were not reported. Reported that caller had the shot 4 hours ago and all they are doing is sneezing. 20 sneezing in a row, nose running, they feel tired. Nothing really really bad, a little breathing problem.

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arm from the area of the shot to her finger tips was swollen so bad; urinary issues; loss of energy; tingling in fingers; still swollen with pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm from the area of the shot to her finger tips was swollen so bad), URINARY INCONTINENCE (urinary issues), ASTHENIA (loss of energy), PARAESTHESIA (tingling in fingers) and PAIN IN EXTREMITY (still swollen with pain) in an 89-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. In 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced PERIPHERAL SWELLING (arm from the area of the shot to her finger tips was swollen so bad), URINARY INCONTINENCE (urinary issues), ASTHENIA (loss of energy), PARAESTHESIA (tingling in fingers) and PAIN IN EXTREMITY (still swollen with pain). In 2023, PERIPHERAL SWELLING (arm from the area of the shot to her finger tips was swollen so bad) had resolved. At the time of the report, URINARY INCONTINENCE (urinary issues), ASTHENIA (loss of energy), PARAESTHESIA (tingling in fingers) and PAIN IN EXTREMITY (still swollen with pain) had not resolved. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant medication and treatment were not provided. Patient just received the latest covid shot. She woke up during the night and her arm from the area of the shot to her fingertips was swollen so bad she could go back to sleep, and the next day, still swollen with pain and tingling in fingers, and urinary issues and extreme loss of energy. It's been over a week, and the swelling is gone but still pain and tingling in fingers, and urinary issues and still no energy. Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2023: Live fallow-up received with IRD 29-Oct-2023. reference number was updated.

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bled from the site way more than other times; Experienced freezing, temperature of 103F; Caller says the HCP told them that they believe this happened because of the way the vaccine is labeled. Each vial is labeled as a single dose of 0.25mL but there is 0.5mL in the vial.; Caller says the HCP told them that they believe this happened because of the way the vaccine is labeled. Each vial is labeled as a single dose of 0.25mL but there is 0.5mL in the vial.; shaking uncontrollably; injected with a nearly adult dose; body pains; experienced puking, vomiting 5 or 6 times; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TREMOR (shaking uncontrollably) in a 10-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Patient had no known allergies. The reporter did not have the vaccination card at the time but reported that every available COVID-19 dose had been given to the patient. Previously administered products included for Product used for unknown indication: FLU VACCINE VII (Flut shot). Past adverse reactions to the above products included No adverse event with FLU VACCINE VII. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for an unknown indication. On 11-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 11-Oct-2023, the patient experienced TREMOR (shaking uncontrollably) (seriousness criterion medically significant), PAIN (body pains), VOMITING (experienced puking, vomiting 5 or 6 times) and OVERDOSE (injected with a nearly adult dose). On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (bled from the site way more than other times), PYREXIA (Experienced freezing, temperature of 103F), PRODUCT LABEL CONFUSION (Caller says the HCP told them that they believe this happened because of the way the vaccine is labeled. Each vial is labeled as a single dose of 0.25mL but there is 0.5mL in the vial.) and PRODUCT PACKAGING QUANTITY ISSUE (Caller says the HCP told them that they believe this happened because of the way the vaccine is labeled. Each vial is labeled as a single dose of 0.25mL but there is 0.5mL in the vial.). At the time of the report, TREMOR (shaking uncontrollably), VACCINATION SITE HAEMORRHAGE (bled from the site way more than other times), PAIN (body pains), VOMITING (experienced puking, vomiting 5 or 6 times), PYREXIA (Experienced freezing, temperature of 103F), OVERDOSE (injected with a nearly adult dose), PRODUCT LABEL CONFUSION (Caller says the HCP told them that they believe this happened because of the way the vaccine is labeled. Each vial is labeled as a single dose of 0.25mL but there is 0.5mL in the vial.) and PRODUCT PACKAGING QUANTITY ISSUE (Caller says the HCP told them that they believe this happened because of the way the vaccine is labeled. Each vial is labeled as a single dose of 0.25mL but there is 0.5mL in the vial.) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 F. The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant medication details included dose of 44 mcg of Flovent steroid inhaler. The patient experienced puking, freezing, temperature of 103-degree Fahrenheit, vomiting 5 or 6 times, body pains, aches, bled from the site way more than other times, might had nicked a vein and was shaking uncontrollably. The HCP told the reporter that they believed this happened because of the way the vaccine was labeled. Each vial was labeled as a single dose of 0.25 mL dose but there was 0.5 mL dose in the vial. The reporter's daughter (patient) was injected with a nearly adult dose. They were blaming Moderna for it. No treatment medications were reported. Rationale for no investigation was reported as: the paediatric Single Dose Vial (SDV) are filled to the same volume as the adult SDV. However, the final volume for administration varies between the population groups, with paediatrics receiving 0.25ml and adults receiving 0.5ml. In both cases, the final volume of the vial will have a slight overfill. In paediatrics, as only 0.25mL from the total volume is drawn for administration, it is expected to have roughly half the vial content remaining in the vial after drawing. As instructed in the Fact Sheet for Moderna covid-19 vaccine (2023-2024 formula), for individuals 6 months through 11 years of age, section 2 "Dosage and Administration", the vial is to be discarded after single use. Additionally, the Medical Information call center has updated their FAQs for inquiries around the remaining volume in the SDV after drawing the dose. Company Comment: This is a spontaneous case concerning a 10-year-old female patient with no relevant medical history reported who experienced the unexpected and serious (medically significant) event tremor after a dose of SPIKEVAX 2023-2024 vaccine was administered, exact latency is unknown. It was reported that the caller's daughter was injected with a nearly adult dose. After caller's daughter received the new Moderna vaccine she experienced puking, freezing, temperature of 103F, vomiting 5 or 6 times, body pains, aches, bled from the site way more than other times, they may have nicked a vein and shaking uncontrollably. It was also reported that caller says the HCP told them that they believe this happened because of the way the vaccine is labeled. Each vial is labeled as a single dose of 0.25mL but there is 0.5mL in the vial. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 30-Oct-2023: Live follow-up received: Closed investigation summary report received, narrative updated, reference numbers added.

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no appetite; ill; earache; high blood pressure; dehydrated; No fever, but felt very warm; headache; rash; nausea; fatigue; body aches; This spontaneous case was reported by a patient and describes the occurrence of DECREASED APPETITE (no appetite), MALAISE (ill), EAR PAIN (earache), HYPERTENSION (high blood pressure) and DEHYDRATION (dehydrated) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccines (Dose 1) on 29-Mar-2021, Moderna COVID-19 vaccines (Dose 2) on 26-Apr-2021 and Moderna COVID-19 vaccines (Dose 3) on 28-Dec-2021; for Product used for unknown indication: Flu vaccine (3 weeks prior). Past adverse reactions to the above products included No adverse event with Flu vaccine, Moderna COVID-19 vaccines, Moderna COVID-19 vaccines and Moderna COVID-19 vaccines. On 18-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 19-Oct-2023, the patient experienced DECREASED APPETITE (no appetite), MALAISE (ill), EAR PAIN (earache), HYPERTENSION (high blood pressure), DEHYDRATION (dehydrated), FEELING HOT (No fever, but felt very warm), HEADACHE (headache), RASH (rash), NAUSEA (nausea), FATIGUE (fatigue) and MYALGIA (body aches). At the time of the report, DECREASED APPETITE (no appetite), MALAISE (ill), EAR PAIN (earache), HYPERTENSION (high blood pressure), HEADACHE (headache), RASH (rash), NAUSEA (nausea), FATIGUE (fatigue) and MYALGIA (body aches) had not resolved and DEHYDRATION (dehydrated) and FEELING HOT (No fever, but felt very warm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2023, Blood pressure measurement: 165. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Reported that she saw her doctor on 20-Oct-2023 and started taking blood pressure medication.

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I'm just a little shaky; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (I'm just a little shaky) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On 18-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 18-Oct-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced TREMOR (I'm just a little shaky). At the time of the report, TREMOR (I'm just a little shaky) outcome was unknown. The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant and treatment medications were not reported. It was reported that caller called just to find out that patient just had, this Spikevax shot today and feel fine. Patient just a little shaky and patient wonder can i take Advil, if somebody gets this vaccine, can they take Advil? or should they take Tylenol. Reporter did not allow further contact

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can't move; has not been eating or drinking anything; been week; diarrhea; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (can't move), FEEDING DISORDER (has not been eating or drinking anything), ASTHENIA (been week), DIARRHOEA (diarrhea) and VOMITING (throwing up) in an 87-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. In September 2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 04-Oct-2023, the patient experienced MOBILITY DECREASED (can't move), FEEDING DISORDER (has not been eating or drinking anything), ASTHENIA (been week), DIARRHOEA (diarrhea) and VOMITING (throwing up). At the time of the report, MOBILITY DECREASED (can't move), FEEDING DISORDER (has not been eating or drinking anything) and ASTHENIA (been week) outcome was unknown and DIARRHOEA (diarrhea) and VOMITING (throwing up) had not resolved. The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. No Concomitant medication was reported. Patient has received 3 doses of the Moderna COVID-19 vaccines before receiving a dose of the SPIKEVAX vaccine on either 26-SEP-2023 or 27-SEP-2023. Lot number unknown. Since yesterday he has been throwing up, had diarrhea, been week, can't move, and has not been eating or drinking anything. He has not taken any medications or treatments for his symptoms. He has not spoken to his healthcare professional.

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coughing; heart racing; short of breath; her arm was swollen up; Also got so week; arm was hot where covid-19 shot went in; Could not lift up left arm at all; fever; chills; left arm (injection arm) was hurting her horrible; This spontaneous case was reported by a patient and describes the occurrence of COUGH (coughing), PALPITATIONS (heart racing), DYSPNOEA (short of breath), PERIPHERAL SWELLING (her arm was swollen up) and ASTHENIA (Also got so week) in a 55-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication. The patient's past medical history included Heart attack. Previously administered products included for Product used for unknown indication: Influenza vaccine on 28-Sep-2023; for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Dose 2) and Moderna COVID-19 vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with Influenza vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine. Concurrent medical conditions included Asthma and Heart disorder. On 28-Sep-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 28-Sep-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced INJECTION SITE PAIN (left arm (injection arm) was hurting her horrible). On 29-Sep-2023, the patient experienced PERIPHERAL SWELLING (her arm was swollen up), ASTHENIA (Also got so week), INJECTION SITE WARMTH (arm was hot where covid-19 shot went in), MOBILITY DECREASED (Could not lift up left arm at all), PYREXIA (fever) and CHILLS (chills). On 30-Sep-2023, the patient experienced COUGH (coughing), PALPITATIONS (heart racing) and DYSPNOEA (short of breath). At the time of the report, COUGH (coughing), PALPITATIONS (heart racing), DYSPNOEA (short of breath), PYREXIA (fever) and CHILLS (chills) had not resolved and PERIPHERAL SWELLING (her arm was swollen up), ASTHENIA (Also got so week), INJECTION SITE WARMTH (arm was hot where covid-19 shot went in), MOBILITY DECREASED (Could not lift up left arm at all) and INJECTION SITE PAIN (left arm (injection arm) was hurting her horrible) outcome was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. On 28-SEP-2023, patient had new covid shot and flu shot at a pharmacy. She has also had previous Moderna COVID-19 vaccines. When she tried to go to bed her left arm (injection arm) was hurting her horrible. On 29-Sep-2023, morning she woke up, her arm was swollen up, she had fever, and chills. Also got so week, arm was hot where covid-19 shot went in. Could not lift up left arm at all. Used ice packs on arm and took Tylenol. 30-Sep-2023, coughing, arm hurting, heart was racing. Pharmacist recommended using heat on her left arm. Heart racing and short of breath. No treatment medications were provided.

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sleepy; exhausted; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy), FATIGUE (exhausted), CHILLS (chills) and HEADACHE (headache) in a 72-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. Concurrent medical conditions included Diabetes, Blood pressure high and Hypothyroidism. Concomitant products included LOSARTAN for Blood pressure high, TIRZEPATIDE (MOUNJARO) and INSULIN for Diabetes, THYROID (ARMOUR THYROID) for Hypothyroidism. On 01-Oct-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 02-Oct-2023, the patient experienced SOMNOLENCE (sleepy), FATIGUE (exhausted), CHILLS (chills) and HEADACHE (headache). At the time of the report, SOMNOLENCE (sleepy), FATIGUE (exhausted), CHILLS (chills) and HEADACHE (headache) had not resolved. The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Patient had a total of 3 Moderna COVID-19 vaccine so far. The previous vaccine was administered about a year ago, but patient could not be sure. Patient did not find her vaccination card. On 02Oct2023 patient started having chills and spent 2 days in bed. Patient did not even get up to eat. Patient still felt very sleepy, slight headache and exhausted. Patient did not have other vaccines within the last 4 months. Treatment medications were not reported.

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weak; chilled and very cold and then felt hot; headache; problems with chest; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weak), CHEST DISCOMFORT (problems with chest), FEELING OF BODY TEMPERATURE CHANGE (chilled and very cold and then felt hot) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The patient's past medical history included COVID-19 (year ago). Concurrent medical conditions included Dust allergy and Allergy. Concomitant products included INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE for an unknown indication. On 29-Sep-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Sep-2023, the patient experienced CHEST DISCOMFORT (problems with chest). On 29-Sep-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced ASTHENIA (weak), FEELING OF BODY TEMPERATURE CHANGE (chilled and very cold and then felt hot) and HEADACHE (headache). The patient was treated with GUAIFENESIN (MUCINEX) for Chest discomfort, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. In 2023, HEADACHE (headache) had resolved. At the time of the report, ASTHENIA (weak) and CHEST DISCOMFORT (problems with chest) had not resolved and FEELING OF BODY TEMPERATURE CHANGE (chilled and very cold and then felt hot) outcome was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Patient got the Moderna vaccine in the morning and got very sick the same evening. This was the third day and patient were still very sick. Patient had problems with her chest. Patient could only get out of bed for a short period of time. Patient was weak which was why patient went back to bed. Patient took Mucinex for her chest, but it not helped. Patient used a whole big box of Kleenex it just runs out of her. Patient was not a person who takes pills, but it was so bad that patient had and it did help. Patient called the pharmacy and they said if patient was not better by tomorrow then patient should go to the emergency room (ER) since it was the weekend and there were no doctors available. Patient never had problems before, but this time patient was sick. Patient had no problems with the influenza and pneumonia shot patient got. Patient was chilled and was very cold and then patient was hot.

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Lost 8 pounds since the adverse event; has no energy; trouble breathing upon exertion; her arm was left sore and uncomfortable; She stated she was feeling heart failure symptoms at the time; allergic reactions; hives; her arm was left sore; itching; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (her arm was left sore), PRURITUS (itching), WEIGHT DECREASED (Lost 8 pounds since the adverse event), ASTHENIA (has no energy) and DYSPNOEA EXERTIONAL (trouble breathing upon exertion) in a 75-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no.) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hives. Concomitant products included ACRIVASTINE (BENADRYL OTC) for Hives, CORTISONE for an unknown indication. On an unknown date, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 31-May-2023, the patient experienced PAIN IN EXTREMITY (her arm was left sore), PRURITUS (itching), HYPERSENSITIVITY (allergic reactions) and URTICARIA (hives). On an unknown date, the patient experienced WEIGHT DECREASED (Lost 8 pounds since the adverse event), ASTHENIA (has no energy), DYSPNOEA EXERTIONAL (trouble breathing upon exertion), LIMB DISCOMFORT (her arm was left sore and uncomfortable) and CARDIOVASCULAR SYMPTOM (She stated she was feeling heart failure symptoms at the time). The patient was treated with TRIAMCINOLONE DIACETATE (PROCTOSTEROID) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (her arm was left sore), PRURITUS (itching), HYPERSENSITIVITY (allergic reactions) and URTICARIA (hives) was resolving, WEIGHT DECREASED (Lost 8 pounds since the adverse event), ASTHENIA (has no energy), LIMB DISCOMFORT (her arm was left sore and uncomfortable) and CARDIOVASCULAR SYMPTOM (She stated she was feeling heart failure symptoms at the time) outcome was unknown and DYSPNOEA EXERTIONAL (trouble breathing upon exertion) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: loss. It was reported that patient had to go to urgent care for these symptoms. The urgent care physician prescribed her a steroid injection and tablets to take for the week. She stated she was feeling heart failure symptoms at the time.

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blood pressure of 200/100; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure of 200/100) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. Previously administered products included for COVID-19 immunization: Moderna Covid-19 vaccine (dose 1), Moderna Covid-19 vaccine (dose 3, booster) and Moderna Covid-19 vaccine (dose 2). Past adverse reactions to the above products included No adverse event with Moderna Covid-19 vaccine, Moderna Covid-19 vaccine and Moderna Covid-19 vaccine. On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (blood pressure of 200/100). At the time of the report, HYPERTENSION (blood pressure of 200/100) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 200/100 high. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported.

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Migraine Headaches (Frequency every 2 weeks); This spontaneous case was reported by a patient family member or friend and describes the occurrence of MIGRAINE (Migraine Headaches (Frequency every 2 weeks)) in a 62-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. Family history included Migraine (Brother also had 3-4 migraines per year prior to vaccination). Concurrent medical conditions included Migraine (3-4 Migraines per year prior to vaccination). On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Migraine Headaches (Frequency every 2 weeks)). At the time of the report, MIGRAINE (Migraine Headaches (Frequency every 2 weeks)) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. It was reported that patient had an increase in Migraine Headaches (Frequency every 2 weeks) after vaccination. The patient received 4 Moderna COVID-19 vaccines, the last one about 2 months ago. Patient had received dose 1, 2 and 3 of Moderna vaccine previously on an unknown date. No treatment medication was provided. This case was linked to US-MODERNATX, INC.-MOD-2023-734616 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2023: Live follow-up received contains non significant information; Sender's Comments: US-MODERNATX, INC.-MOD-2023-734616:Patient's brother case

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disability; chest pain; a little thick bladder wall; After vaccination on 20FEB2023 his health went down to Since 20FEB2023 he has been having sharp pain on his pudendal lower left nerves/I just have been pain all the time; This spontaneous case was reported by a consumer and describes the occurrence of DISABILITY (disability) in a 40-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included COVID-19 (had COVID Disease twice/the second time he had COVID Disease was NOV2021). Concomitant products included HYDROMORPHONE HYDROCHLORIDE (DILAUDID), GABAPENTIN and LORAZEPAM (ATIVAN) for an unknown indication. On 20-Feb-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Feb-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced NEURALGIA (Since 20FEB2023 he has been having sharp pain on his pudendal lower left nerves/I just have been pain all the time). On an unknown date, the patient experienced DISABILITY (disability) (seriousness criteria disability and medically significant), CHEST PAIN (chest pain), BLADDER HYPERTROPHY (a little thick bladder wall) and IMMUNISATION REACTION (After vaccination on 20FEB2023 his health went down to H....). At the time of the report, DISABILITY (disability), NEURALGIA (Since 20FEB2023 he has been having sharp pain on his pudendal lower left nerves/I just have been pain all the time), CHEST PAIN (chest pain) and BLADDER HYPERTROPHY (a little thick bladder wall) had not resolved and IMMUNISATION REACTION (After vaccination on 20FEB2023 his health went down to H..) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: CT scan of abdomen and pelvic area was normal except a little thick bladder wall. On an unknown date, Electrocardiogram: His EKG shows that his heart is healthier. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. Patient received 3 Moderna COVID-19 vaccine so far. The last dose was administered on 20FEB2023. Prior to this vaccine he was totally healthy and never went to a doctor. He does not have his vaccination card available. Spikevax was reported as suspect and was administered in two shotsShot #1: First Primary monovalent dose on (Lot# & Exp. Date: unknown). Shot #2: 2nd Primary monovalent dose on (Lot# & Exp. Date: unknown) and the indication for the suspect was COVID-19 Prophylaxis Patient states that he still can not smell poop right does not remember the date first time COVID. Treatment information was not reported. Company Comment This spontaneous case concerns a 40-years-old-male patient, with medical history of COVID-19 disease on two opportunities (the second one on NOV2021); concomitant products included HYDROMORPHONE, GABAPENTIN and LORAZEPAM who experienced the unexpected seriousness criterion disability and medically significant event of disability; the unexpected events of neuralgia, chest pain, bladder hypertrophy and immunisation reaction in the context of 3rd. dose of mRNA- 1273 bivalent vaccine. Neuralgia event began the same day of the injection; the other events occurred on unknown dates. The current condition of Covid-19 is a contributor for the events. The benefit-risk relationship of mRNA-1273 bivalent vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.

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cant lift right arm without great difficulty/i can't work/I can't work. I can't lift my right arm like I want; hold up for very long sharp pain shooting thru arm with numbness,/It's a shooting pain up and down my arm, it's not supposed to be like that./I personally crippled in my way./ Being in pain, come right back; hold up for very long sharp pain shooting thru arm with numbness,/My arm goes numb; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (cant lift right arm without great difficulty/i can't work/I can't work. I can't lift my right arm like I want), PAIN (hold up for very long sharp pain shooting thru arm with numbness,/It's a shooting pain up and down my arm, it's not supposed to be like that./I personally crippled in my way./ Being in pain, come right back) and HYPOAESTHESIA (hold up for very long sharp pain shooting thru arm with numbness,/My arm goes numb) in a 45-year-old male patient who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (cant lift right arm without great difficulty/i can't work/I can't work. I can't lift my right arm like I want), PAIN (hold up for very long sharp pain shooting thru arm with numbness,/It's a shooting pain up and down my arm, it's not supposed to be like that./I personally crippled in my way./ Being in pain, come right back) and HYPOAESTHESIA (hold up for very long sharp pain shooting thru arm with numbness,/My arm goes numb). At the time of the report, MOBILITY DECREASED (cant lift right arm without great difficulty/i can't work/I can't work. I can't lift my right arm like I want), PAIN (hold up for very long sharp pain shooting thru arm with numbness,/It's a shooting pain up and down my arm, it's not supposed to be like that./I personally crippled in my way./ Being in pain, come right back) and HYPOAESTHESIA (hold up for very long sharp pain shooting thru arm with numbness,/My arm goes numb) had not resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. It was reported that from last couple of years, patient had side effects couldn't lift right arm without great difficulty and hold up for very long. sharp pain shooting through arm with numbness. Patient went to hospital and doctor last couple weeks, patient was enquiring what needed to be done to rectify the condition. Patient further reported that if it would be like that for the rest of my life as he didn't wanted to be like that. Patient is right handed and had been going to the doctor lately. Because of the last two years, patient had this side effect and they haven't stopped. Doctor had has given the medicine for the arm and it didn't work. It's only temporary. Patient didn't had this problem until he got the Moderna shot. Patient felt personally crippled in his way. Patient reported that he was going to call his lawyer and sue Moderna. No treatment medication information was provided. Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2023: Follow-up received, Patient demographic and narrative updated.

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blood pressure was high; The arm they gave me the shot in is sore; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (The arm they gave me the shot in is sore) and HYPERTENSION (blood pressure was high) in a 0-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. Patient took blood pressure medicine. On 16-May-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-May-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced VACCINATION SITE PAIN (The arm they gave me the shot in is sore). On an unknown date, the patient experienced HYPERTENSION (blood pressure was high). At the time of the report, VACCINATION SITE PAIN (The arm they gave me the shot in is sore) had not resolved and HYPERTENSION (blood pressure was high) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: High 196/101. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. Treatment medication not reported.

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vertigo; palpitations; sick; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VERTIGO (vertigo), PALPITATIONS (palpitations) and ILLNESS (sick) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo), PALPITATIONS (palpitations) and ILLNESS (sick). At the time of the report, VERTIGO (vertigo), PALPITATIONS (palpitations) and ILLNESS (sick) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The reporter reported that her husband ended up with vertigo and heart palpitations. They were in the hospital. He got sick. No treatment medications were reported.

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pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE. In October 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (pneumonia) outcome was unknown. The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. She stated that she had her last vaccine in October and caught pneumonia 4 weeks ago. Patient was not taking prednisone and worried about lacking immunity especially while going out of tow. Patient was recommended to get another vaccine by the provider but as per the pharmacist, due to cdc guidelines, they could not administer another vaccine to patient . Patient had already had both primary series and 3 boosters already. No treatment information was provided. Company comment: This spontaneous case concerns a female patient of unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Pneumonia, unknown days after receiving a dose of COVID 19 vaccine with mRNA-1273.222 bivalent vaccine. It was reported that the patient had received the primary series and 3 booster doses already with unspecified product. No information on risk factors, detailed clinical course, investigations, treatment of the event and outcome was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.

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I ended up with iih, palpdemia of the eyes, and arrhythmia of my heart from your booster vaccine.; I ended up with iih, palpdemia of the eyes, and arrhythmia of my heart from your booster vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (I ended up with iih, palpdemia of the eyes, and arrhythmia of my heart from your booster vaccine.) and IDIOPATHIC INTRACRANIAL HYPERTENSION (I ended up with iih, palpdemia of the eyes, and arrhythmia of my heart from your booster vaccine.) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (I ended up with iih, palpdemia of the eyes, and arrhythmia of my heart from your booster vaccine.) (seriousness criterion medically significant) and IDIOPATHIC INTRACRANIAL HYPERTENSION (I ended up with iih, palpdemia of the eyes, and arrhythmia of my heart from your booster vaccine.) (seriousness criterion medically significant). At the time of the report, ARRHYTHMIA (I ended up with iih, palpdemia of the eyes, and arrhythmia of my heart from your booster vaccine.) and IDIOPATHIC INTRACRANIAL HYPERTENSION (I ended up with iih, palpdemia of the eyes, and arrhythmia of my heart from your booster vaccine.) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided by reporter. Palpdemia of the eyes, and arrhythmia of my heart from your booster vaccine. So, what are you going to do about it, diagnosis and documented. No treatment medication was provided by reporter. Company Comment: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the unexpected and serious (due to medically significant) events of Arrhythmia (AESI) and Idiopathic intracranial hypertension, which occurred on an unknown date after mRNA-1273.222 vaccine, administered as a booster dose within COVID-19 vaccination schedule. Papilledema was also reported. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.

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throbbing And major joint pain; tingling; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (throbbing And major joint pain), PARAESTHESIA (tingling) and ARTHRALGIA (joint pain) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (throbbing And major joint pain), PARAESTHESIA (tingling) and ARTHRALGIA (joint pain). At the time of the report, PAIN (throbbing And major joint pain), PARAESTHESIA (tingling) and ARTHRALGIA (joint pain) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information provided. No treatment information provided.

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Grandiose visions and thoughts; trouble breathing; shot altered his DNA; injection site hurt; This spontaneous case was reported by a consumer and describes the occurrence of DELUSION OF GRANDEUR (Grandiose visions and thoughts), DYSPNOEA (trouble breathing), GENE MUTATION (shot altered his DNA) and VACCINATION SITE PAIN (injection site hurt) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DELUSION OF GRANDEUR (Grandiose visions and thoughts), DYSPNOEA (trouble breathing), GENE MUTATION (shot altered his DNA) and VACCINATION SITE PAIN (injection site hurt). At the time of the report, DELUSION OF GRANDEUR (Grandiose visions and thoughts), DYSPNOEA (trouble breathing), GENE MUTATION (shot altered his DNA) and VACCINATION SITE PAIN (injection site hurt) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: weight gain. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant products reported. It was reported that the patient had trouble breathing and weight gain after receiving his Primary Series of the Moderna Covid 19 booster dose. The patient received his first Moderna Covid in the winter of 2021. Patient did not had his Immunization card. Patient did not had lot numbers, dates of administration or expiration dates. The patient took his Primary Series of the Moderna Covid -19 shots because he moved and he felt that he had to take the shot. The patient had a lot of Grandiose visions and thoughts. He thought that the shot might had been given to him to kill him. The patient was concerned that the shot altered his DNA. The patient received his second Moderna Covid-19 vaccine in the winter of 2021 about 30 days later. Patient said that his injection site hurt. Patient breathing was not the same. No treatment products reported. Reporter did not allow further contact

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it had gradually getting worse./ In both eye, left was worse; My granddaughter has 'ptseubotatill' (edema of optic nerve)./ Her eye problems started; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAPILLOEDEMA (My granddaughter has 'ptseubotatill' (edema of optic nerve)./ Her eye problems started) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In August 2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2022, the patient experienced PAPILLOEDEMA (My granddaughter has 'ptseubotatill' (edema of optic nerve)./ Her eye problems started) (seriousness criterion medically significant). On an unknown date, the patient experienced CONDITION AGGRAVATED (it had gradually getting worse./ In both eye, left was worse). At the time of the report, PAPILLOEDEMA (My granddaughter has 'ptseubotatill' (edema of optic nerve)./ Her eye problems started) and CONDITION AGGRAVATED (it had gradually getting worse./ In both eye, left was worse) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. Patient 1st dose was in August 2022, the 2nd in September 2022. Her eye problems started in October 2022. Patient went to the eye Dr (Optometrist) & he found it. Physician gave some medicine, but it didn't help. Since then it had gradually worsened. No treatment medication was reported. Company Comment: This is a spontaneous case concerning a female patient of unknown age with no medical history reported who experienced the unexpected and serious (medically significant) event of papilloedema approximately 1 month after a second dose of mRNA-1273 vaccine was administered. It was reported that patient had edema of optic nerve in both eyes, left was worse. She was seen by the eye Dr (Optometrist) and he gave patient some medicine, but it didn't help. Since then, it has gradually got worse. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.

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the patient stopped breathing after receiving the 1st dose of Moderna /Patient experienced trouble breathing; throat swelled up; the 1st dose of Moderna and received Jansen as a second dose; the 1st dose of Moderna and received Jansen as a second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSPNOEA (the patient stopped breathing after receiving the 1st dose of Moderna /Patient experienced trouble breathing), PHARYNGEAL SWELLING (throat swelled up), INTERCHANGE OF VACCINE PRODUCTS (the 1st dose of Moderna and received Jansen as a second dose) and COVID-19 IMMUNISATION (the 1st dose of Moderna and received Jansen as a second dose) in an elderly female patient who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (the patient stopped breathing after receiving the 1st dose of Moderna /Patient experienced trouble breathing), PHARYNGEAL SWELLING (throat swelled up), INTERCHANGE OF VACCINE PRODUCTS (the 1st dose of Moderna and received Jansen as a second dose) and COVID-19 IMMUNISATION (the 1st dose of Moderna and received Jansen as a second dose). At the time of the report, DYSPNOEA (the patient stopped breathing after receiving the 1st dose of Moderna /Patient experienced trouble breathing), PHARYNGEAL SWELLING (throat swelled up), INTERCHANGE OF VACCINE PRODUCTS (the 1st dose of Moderna and received Jansen as a second dose) and COVID-19 IMMUNISATION (the 1st dose of Moderna and received Jansen as a second dose) outcome was unknown. mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant information was reported. It was reported that, patient received JANSSEN Covid-19 vaccine as second dose. No treatment information was reported.

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After the Bivalent booster on 30DEC2022, he started having pain in the right arm (Injected Arm), and can not the lift arm.; he started having pain in the right arm (Injected Arm),; This spontaneous case was reported by a consumer and describes the occurrence of INJECTED LIMB MOBILITY DECREASED (After the Bivalent booster on 30DEC2022, he started having pain in the right arm (Injected Arm), and can not the lift arm.) and VACCINATION SITE PAIN (he started having pain in the right arm (Injected Arm),) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. Previously administered products included for Drug use for unknown indication: COVID-19 VACCINE JANSSEN (First dose (lot number and expiry date was unknown)); for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Second dose. First Monovalent Moderna COVID-19 Booster dose more than 2 months ago (lot number and expiry date was unknown)). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN and Moderna COVID-19 Vaccine. On 30-Dec-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 30-Dec-2022, the patient experienced VACCINATION SITE PAIN (he started having pain in the right arm (Injected Arm),). On an unknown date, the patient experienced INJECTED LIMB MOBILITY DECREASED (After the Bivalent booster on 30DEC2022, he started having pain in the right arm (Injected Arm), and can not the lift arm.). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of Unknown. At the time of the report, INJECTED LIMB MOBILITY DECREASED (After the Bivalent booster on 30DEC2022, he started having pain in the right arm (Injected Arm), and can not the lift arm.) outcome was unknown and VACCINATION SITE PAIN (he started having pain in the right arm (Injected Arm),) had not resolved. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications details were reported. Moderna was not authorized to communicate with the vaccine recipient's primary healthcare professional. Patient received 2 Moderna COVID-19 booster vaccine. After the Bivalent booster on 30-Dec-2022, patient started having pain in the right arm (Injected Arm), and can not the lift arm. Patient stated that trying to change gear in the car his right arm hurts. Patient's arm has not improved even with taking Ibuprofen. Patient was on his way to urgent care. Reporter did not allow further contact

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patient had high blood pressure; had COVID very bad, a lot has happened; person receives Moderna as a 1st vaccine and as a 2nd vaccine dose another brand of COVID19 vaccine,; person receives Moderna as a 1st vaccine and as a 2nd vaccine dose another brand of COVID19 vaccine,; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (patient had high blood pressure), COVID-19 (had COVID very bad, a lot has happened), INTERCHANGE OF VACCINE PRODUCTS (person receives Moderna as a 1st vaccine and as a 2nd vaccine dose another brand of COVID19 vaccine,) and COVID-19 IMMUNISATION (person receives Moderna as a 1st vaccine and as a 2nd vaccine dose another brand of COVID19 vaccine,) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis. Co-suspect product included non-company product COVID-19 VACCINE for an unknown indication. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and second dose of COVID-19 VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (patient had high blood pressure), COVID-19 (had COVID very bad, a lot has happened), INTERCHANGE OF VACCINE PRODUCTS (person receives Moderna as a 1st vaccine and as a 2nd vaccine dose another brand of COVID19 vaccine,) and COVID-19 IMMUNISATION (person receives Moderna as a 1st vaccine and as a 2nd vaccine dose another brand of COVID19 vaccine,). At the time of the report, HYPERTENSION (patient had high blood pressure), COVID-19 (had COVID very bad, a lot has happened), INTERCHANGE OF VACCINE PRODUCTS (person receives Moderna as a 1st vaccine and as a 2nd vaccine dose another brand of COVID19 vaccine,) and COVID-19 IMMUNISATION (person receives Moderna as a 1st vaccine and as a 2nd vaccine dose another brand of COVID19 vaccine,) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication list was not provided. The reporter stated that the patient had COVID very bad, a lot has happened and patient had to be resuscitated and all of this happened after receiving the vaccine. Reporter was hospitalized and someone told them that patient received another brand of COVID19 vaccine as a second dose while looking through patients immunization records. Reporter stated that the patient had high blood pressure and that patient was at risk. Reporter wanted to know if was normal to receive another brand of COVID19 vaccine as a second dose. Treatment medication information was not provided. Reporter did not allow further contact

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Numbness / numb fingers to this day; Tingling in hamstrings(GBS like symptoms); This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness / numb fingers to this day) and PARAESTHESIA (Tingling in hamstrings(GBS like symptoms)) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness / numb fingers to this day) and PARAESTHESIA (Tingling in hamstrings(GBS like symptoms)). At the time of the report, HYPOAESTHESIA (Numbness / numb fingers to this day) and PARAESTHESIA (Tingling in hamstrings(GBS like symptoms)) had not resolved. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. It has been reported that after fifteen days of second Moderna booster patient experienced symptoms. Additionally patient quickly moved to arms and settle in the hands with numb fingers to this day. Patient questioned about 5th mRNA vaccine shot and effectivity of Novavax vaccine against Omicron. Because it had been suggested by neurologists and virologist for Novavax vaccine as booster. Treatment information was not provided.

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pain in her legs; she had big, large chest pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her legs) and CHEST PAIN (she had big, large chest pain) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in her legs) (seriousness criterion hospitalization) and CHEST PAIN (she had big, large chest pain) (seriousness criterion hospitalization). At the time of the report, PAIN IN EXTREMITY (pain in her legs) and CHEST PAIN (she had big, large chest pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac function test: 86 % heart was functioning at 86%. On an unknown date, Cardiac stress test: they did a stress test which came back normal. On an unknown date, Laboratory test: They also did lab work and images. Everything is normal. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. 1 to 2 weeks after receiving the vaccine patient had deep pain in both legs which lasted 2 to 3 minutes. The next day patient also had pain in legs but not as strong as last day. 1 week after this patient had big, large chest pain. For this reason, patient visits cardiologist, and they did a stress test. Doctor also checked for clogs in veins and arteries and patient had none. Patient never had any heart conditions before. Treatment drug was not reported. Company comment: This spontaneous case concerns a patient of unknown age and gender, with no medical history reported , who experienced the unexpected serious (hospitalization) events of Pain in extremity (Pain in leg) and Chest pain that occurred after receiving mRNA-1273 Bivalent BA.4/BA.5 vaccine in COVID-19 vaccination series. Approximately 1 to 2 weeks after receiving the vaccine patient experienced deep pain in both legs which lasted 2 to 3 minutes. 1 week later patient had chest pain . Patient visited cardiologist, stress test was done which came back normal. It was reported that other lab tests including imagining studies were done which were normal. There were no clots in veins and arteries. Patients' heart is functioning at 86% as reported by physician. No further information regarding risk factors, medical history, concurrent condition, concomitant medication, additional vaccination details, additional lab reports and treatment received were provided. The outcome of the events was recovered. The benefit-risk relationship of mRNA-1273 Bivalent BA.4/BA.5 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, with no medical history reported , who experienced the unexpected serious (hospitalization) events of Pain in extremity (Pain in leg) and Chest pain that occurred after receiving mRNA-1273 Bivalent BA.4/BA.5 vaccine in COVID-19 vaccination series. Approximately 1 to 2 weeks after receiving the vaccine patient experienced deep pain in both legs which lasted 2 to 3 minutes. 1 week later patient had chest pain . Patient visited cardiologist, stress test was done which came back normal. It was reported that other lab tests including imagining studies were done which were normal. There were no clots in veins and arteries. Patients' heart is functioning at 86% as reported by physician. No further information regarding risk factors, medical history, concurrent condition, concomitant medication, additional vaccination details, additional lab reports and treatment received were provided. The outcome of the events was recovered. The benefit-risk relationship of mRNA-1273 Bivalent BA.4/BA.5 is not affected by this report.

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This spontaneous case was reported by a patient and describes the occurrence of IMPAIRED WORK ABILITY (i missed work), INSOMNIA (still not able to sleep properly), MOBILITY DECREASED (Could not move properly, bathroom properly), DYSGEUSIA (food tasting like metallic) and FRUSTRATION TOLERANCE DECREASED (frustrated) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMPAIRED WORK ABILITY (i missed work), INSOMNIA (still not able to sleep properly), MOBILITY DECREASED (Could not move properly, bathroom properly), DYSGEUSIA (food tasting like metallic), FRUSTRATION TOLERANCE DECREASED (frustrated) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not bathroom properly). At the time of the report, IMPAIRED WORK ABILITY (i missed work) had resolved and INSOMNIA (still not able to sleep properly), MOBILITY DECREASED (Could not move properly, bathroom properly), DYSGEUSIA (food tasting like metallic), FRUSTRATION TOLERANCE DECREASED (frustrated) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not bathroom properly) had not resolved. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered IMPAIRED WORK ABILITY (i missed work) to be related. No further causality assessments were provided for INSOMNIA (still not able to sleep properly), MOBILITY DECREASED (Could not move properly, bathroom properly), DYSGEUSIA (food tasting like metallic), FRUSTRATION TOLERANCE DECREASED (frustrated) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not bathroom properly). Concomitant medication list was not provided. It was reported that the patient received the vaccine and missed work for 2 weeks because of it. Patient wanted to know when these symptoms were going to leave the patient. The patient was more frustrated than before after this shot was given to patient. Treatment information was not provided.

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heart razing; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PALPITATIONS (heart razing) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart razing). At the time of the report, PALPITATIONS (heart razing) outcome was unknown. Age of patient was reported as 58 or 59 years old. No concomitant product use was reported. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Reporter stated that her sister had heart razing with the booster. No treatment information was provided.

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tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (tachycardia) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (tachycardia). At the time of the report, TACHYCARDIA (tachycardia) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Patient had a lot of Tachycardia after taking the Moderna COVID-19 vaccines. No treatment information was reported. Reporter did not allow further contact

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The only thing they have experienced is a real sore arm each time; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (The only thing they have experienced is a real sore arm each time) in a 67-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch nos. ASKU, ASKU, ASKU, ASKU and ASKU) for COVID-19 prophylaxis. Concurrent medical conditions included Seasonal allergy. On 06-Feb-2021, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In April 2022, received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced PAIN IN EXTREMITY (The only thing they have experienced is a real sore arm each time). At the time of the report, PAIN IN EXTREMITY (The only thing they have experienced is a real sore arm each time) outcome was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. Concomitant and treatment medications were not reported. Caller reported they want to stay with Moderna because they had it before. The only thing they have experienced is a real sore arm each time. Nothing else. Just a little soreness after the shot was given. Patient had sore arm but it was not that bad. It was for one day.

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I got the new, uh COVID, uh, Moderna booster on the 13th of December. And I, um, was wondering if I test positive, um, because I've had a headache and some swollen glands; I got the new, uh COVID, uh, Moderna booster on the 13th of December. And I, um, was wondering if I test positive, um, because I've had a headache and some swollen glands; I tested myself for COVID and it was positive; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (I got the new, uh COVID, uh, Moderna booster on the 13th of December. And I, um, was wondering if I test positive, um, because I've had a headache and some swollen glands), LYMPHADENOPATHY (I got the new, uh COVID, uh, Moderna booster on the 13th of December. And I, um, was wondering if I test positive, um, because I've had a headache and some swollen glands) and COVID-19 (I tested myself for COVID and it was positive) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Moderna (never had swollen glands with the other actual Moderna shots.). Past adverse reactions to the above products included No adverse event with Moderna. On 13-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced HEADACHE (I got the new, uh COVID, uh, Moderna booster on the 13th of December. And I, um, was wondering if I test positive, um, because I've had a headache and some swollen glands), LYMPHADENOPATHY (I got the new, uh COVID, uh, Moderna booster on the 13th of December. And I, um, was wondering if I test positive, um, because I've had a headache and some swollen glands) and COVID-19 (I tested myself for COVID and it was positive). At the time of the report, HEADACHE (I got the new, uh COVID, uh, Moderna booster on the 13th of December. And I, um, was wondering if I test positive, um, because I've had a headache and some swollen glands), LYMPHADENOPATHY (I got the new, uh COVID, uh, Moderna booster on the 13th of December. And I, um, was wondering if I test positive, um, because I've had a headache and some swollen glands) and COVID-19 (I tested myself for COVID and it was positive) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, SARS-CoV-2 test: Positive. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant and treatment medications were not reported.

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polymyalgia; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (polymyalgia) in an elderly male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication. Previously administered products included for Product used for unknown indication: COVID-19 vaccine (dose 1 (lot number 014M20A)) on 26-Feb-2021, COVID-19 vaccine (dose 2 (lot number 008B21A)) on 26-Mar-2021 and PFIZER BIONTECH COVID-19 VACCINE (dose 3 (lot number GJ6739)) on 20-Oct-2022. Past adverse reactions to the above products included No adverse event with COVID-19 vaccine, COVID-19 vaccine and PFIZER BIONTECH COVID-19 VACCINE. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication. On 28-Nov-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. In 2023, the patient experienced MYALGIA (polymyalgia). The patient was treated with PREDNISONE in 2023 at a dose of 20 for 15 days then went to 10 for 5 days. At the time of the report, MYALGIA (polymyalgia) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Blood test: seds were elevated.. The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine. 1.5 weeks after the shot the patient had a blood test. The patient was put on a prednisone taper 20 for 15 days then went to 10 for 5 days. The prednisone was whacking afib into the heart from it. 1 week ago the patient was weened off of prednisone. Currently the patient was unable to get up, get dressed, or get out of bed at night.

Symptomtext

She started having watery Diarrhea on 02DEC2023 through 06DEC2023; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (She started having watery Diarrhea on 02DEC2023 through 06DEC2023) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Underlying GI problems and immune problems way before the vaccination. Concurrent medical conditions included GI upset and Immune disorder (NOS). On 30-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 02-Dec-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced DIARRHOEA (She started having watery Diarrhea on 02DEC2023 through 06DEC2023). At the time of the report, DIARRHOEA (She started having watery Diarrhea on 02DEC2023 through 06DEC2023) had not resolved. The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. Treatment medication was not reported. The patient started having watery diarrhea on 02-Dec-2023 through 06-Dec-2023 December 5th was the worst day with watery diarrhea. It's not pathogens. On 07-DEC-2023, the patient woke up in the middle of the night with wet pads and throughout the day she had wet panties. The patient states, by watery diarrhea she means the stool character changed from pasty to runny from sticking to the toilet to watery for six days. The patient states that the watery diarrhea was still going on. It was not pathogen. This case was linked to US-MODERNATX, INC.-MOD-2023-753542 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2023-753542:Other people case (invalid case)

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not able to move her neck, it was very painful; her heart drops; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (not able to move her neck, it was very painful) and CARDIAC DISCOMFORT (her heart drops) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The patient's past medical history included Hormone implant. Previously administered products included for COVID-19 prophylaxis: Moderna (Dose 2) and Moderna (Dose 1). Past adverse reactions to the above products included No adverse event with Moderna and Moderna. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for Hormone implant. On 02-Dec-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (not able to move her neck, it was very painful) and CARDIAC DISCOMFORT (her heart drops). The patient was treated with PARACETAMOL (TYLENOL) for Neck pain, at an unspecified dose and frequency. At the time of the report, NECK PAIN (not able to move her neck, it was very painful) and CARDIAC DISCOMFORT (her heart drops) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: Her heart drops. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Patient stated that, she experienced a reaction following administration of the vaccine. Patient received so far 3 Moderna COVID19 vaccine doses in total. Patient received her last dose on last Sunday 02-Dec-2023 at 5 PM. She did not have her vaccination records at the time of the call. Following vaccination 1 week exactly after, almost to the hour patient was not able to move her neck, it was very painful, her heart drops, could not move her neck more than a Quarter of the way, left side being the worst. The patient was treated with Tylenol which was not helping.

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itching, hives. She has these on her neck arms and trunk; dry skin; itching, hives. She has these on her neck arms and trunk; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching, hives. She has these on her neck arms and trunk), DRY SKIN (dry skin) and URTICARIA (itching, hives. She has these on her neck arms and trunk) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (Dose 2) and Moderna (Dose 1). Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE and Moderna . On an unknown date, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching, hives. She has these on her neck arms and trunk), DRY SKIN (dry skin) and URTICARIA (itching, hives. She has these on her neck arms and trunk). The patient was treated with ZOLEDRONIC ACID (XOLAREX) at a dose of 3 injections. At the time of the report, PRURITUS (itching, hives. She has these on her neck arms and trunk), DRY SKIN (dry skin) and URTICARIA (itching, hives. She has these on her neck arms and trunk) had resolved. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. The Moderna vaccine (she got the 1st two then the booster) and it was after the 3rd dose (12 days after that) when she had the symptoms. This woman was given double doses of anti histamines and when the hives did not resole, she was given Xolar and after 3 injections - it finally resolved. This case was linked to US-MODERNATX, INC.-MOD-2023-753307, US-MODERNATX, INC.-MOD-2023-753341 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2023-753307:Different patient, same reporter US-MODERNATX, INC.-MOD-2023-753341:Case for patient

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arm got sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm got sore) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication. No Medical History information was reported. In 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. In 2023, the patient experienced PAIN IN EXTREMITY (arm got sore). At the time of the report, PAIN IN EXTREMITY (arm got sore) was resolving. The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Suspect vaccine dosage text was reported as unknown. Patient received a flu vaccine before the COVID-19 vaccine. It was reported that His most recent dose was sometime this year, he thinks a couple months ago. A few days after receiving the most recent dose his arm got sore. When he moves his arm a certain way he still feels it. Patient had no medications or treatments. This case was linked to US-MODERNATX, INC.-MOD-2023-752704 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2023-752704:Girlfriend case

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LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.; LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.; LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.; LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.; This spontaneous case was reported by a nurse practitioner and describes the occurrence of CHILLS (LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.), NAUSEA (LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.), DIZZINESS (LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.) and HEADACHE (LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.) in a 68-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication. No Medical History information was reported. On 04-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 04-Dec-2023, the patient experienced CHILLS (LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.), NAUSEA (LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.), DIZZINESS (LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.) and HEADACHE (LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.). At the time of the report, CHILLS (LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.), NAUSEA (LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.), DIZZINESS (LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.) and HEADACHE (LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.) had not resolved. The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided.

Symptomtext

he had pain and pinching that was localized to the back of the Neck. It was a towards the upper right side and upper right shoulder area; He was also very tired; sore arm; headache; fever; chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN (he had pain and pinching that was localized to the back of the Neck. It was a towards the upper right side and upper right shoulder area), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) in a 33-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. It was reported that patient was healthy. Previously administered products included for Product used for unknown indication: Flu Vaccine on 01-Nov-2023, Pfizer (previously had 4 Pfizer shots.), Pfizer (previously had 4 Pfizer shots.), Pfizer (previously had 4 Pfizer shots.) and Pfizer (previously had 4 Pfizer shots.). Past adverse reactions to the above products included No adverse event with Flu Vaccine, Pfizer, Pfizer, Pfizer and Pfizer. On 30-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 01-Dec-2023, the patient experienced PAIN IN EXTREMITY (sore arm), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced PAIN (he had pain and pinching that was localized to the back of the Neck. It was a towards the upper right side and upper right shoulder area) and FATIGUE (He was also very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-Dec-2023, PAIN IN EXTREMITY (sore arm), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, PAIN (he had pain and pinching that was localized to the back of the Neck. It was a towards the upper right side and upper right shoulder area) and FATIGUE (He was also very tired) had resolved. The concomitant medication was not reported by reporter. It was reported that on 04-DEC-2023, patient was perfectly fine. Over the weekend, on Saturday, the headache went away. But then he had pain and pinching that was localized to the back of the Neck. It was a towards the upper right side and upper right shoulder area. It was as if someone was pinching him in a split second and then it would go away. Then he would scratch the area. But there was nothing physically observable on the skin. He stated whatever it was, It felt like pinching. The next two days after the vaccination, he was pretty tired. The very next day, he was in bed. The following day, he didn't have to be in bed, but was still tired like he couldn't do a lot.

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today has a temp of 99.5, joint aches, chills, and weakness; today has a temp of 99.5, joint aches, chills, and weakness.; today has a temp of 99.5, joint aches, chills, and weakness; today has a temp of 99.5, joint aches, chills, and weakness; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (today has a temp of 99.5, joint aches, chills, and weakness), ARTHRALGIA (today has a temp of 99.5, joint aches, chills, and weakness.), CHILLS (today has a temp of 99.5, joint aches, chills, and weakness) and PYREXIA (today has a temp of 99.5, joint aches, chills, and weakness) in an elderly male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer Biontech COVID-19 vaccine (Dose 1) on 18-Jan-2021, Pfizer Biontech COVID-19 vaccine (Dose 2) on 06-Feb-2021, Pfizer Biontech COVID-19 vaccine (Dose 3) on 23-Aug-2021, Pfizer Biontech COVID-19 vaccine (Dose 4) on 01-Mar-2022, Pfizer Biontech COVID-19 vaccine (Dose 5) on 29-Sep-2022 and Flu. Past adverse reactions to the above products included No adverse event with Flu, Pfizer Biontech COVID-19 vaccine, Pfizer Biontech COVID-19 vaccine, Pfizer Biontech COVID-19 vaccine, Pfizer Biontech COVID-19 vaccine and Pfizer Biontech COVID-19 vaccine. Concurrent medical conditions included Kidney disorder. On 29-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 30-Nov-2023, the patient experienced ASTHENIA (today has a temp of 99.5, joint aches, chills, and weakness), ARTHRALGIA (today has a temp of 99.5, joint aches, chills, and weakness.), CHILLS (today has a temp of 99.5, joint aches, chills, and weakness) and PYREXIA (today has a temp of 99.5, joint aches, chills, and weakness). At the time of the report, ASTHENIA (today has a temp of 99.5, joint aches, chills, and weakness), ARTHRALGIA (today has a temp of 99.5, joint aches, chills, and weakness.), CHILLS (today has a temp of 99.5, joint aches, chills, and weakness) and PYREXIA (today has a temp of 99.5, joint aches, chills, and weakness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.5. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant and treatment medications were not reported.

Symptomtext

he states the next day after receiving the shot, she had a terrible Headache, Nausea, her body hurts, and she has diarrhea.; he states the next day after receiving the shot, she had a terrible Headache, Nausea, her body hurts, and she has diarrhea.; he states the next day after receiving the shot, she had a terrible Headache, Nausea, her body hurts, and she has diarrhea.; he states the next day after receiving the shot, she had a terrible Headache, Nausea, her body hurts, and she has diarrhea.; This spontaneous case was reported by a patient and describes the occurrence of PAIN (he states the next day after receiving the shot, she had a terrible Headache, Nausea, her body hurts, and she has diarrhea.), DIARRHOEA (he states the next day after receiving the shot, she had a terrible Headache, Nausea, her body hurts, and she has diarrhea.), HEADACHE (he states the next day after receiving the shot, she had a terrible Headache, Nausea, her body hurts, and she has diarrhea.) and NAUSEA (he states the next day after receiving the shot, she had a terrible Headache, Nausea, her body hurts, and she has diarrhea.) in a 71-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 vaccination. She takes High Blood Pressure medications, Diabetes medications, and Cholesterol medications. She declined providing the names. Previously administered products included for Drug use for unknown indication: FLU Shot on 03-Nov-2023. Past adverse reactions to the above products included No adverse reaction with FLU Shot. Concurrent medical conditions included Hypertension, Diabetes and Cholesterosis. On 28-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 29-Nov-2023, the patient experienced DIARRHOEA (he states the next day after receiving the shot, she had a terrible Headache, Nausea, her body hurts, and she has diarrhea.), HEADACHE (he states the next day after receiving the shot, she had a terrible Headache, Nausea, her body hurts, and she has diarrhea.) and NAUSEA (he states the next day after receiving the shot, she had a terrible Headache, Nausea, her body hurts, and she has diarrhea.). On an unknown date, the patient experienced PAIN (he states the next day after receiving the shot, she had a terrible Headache, Nausea, her body hurts, and she has diarrhea.). The patient was treated with LOPERAMIDE HYDROCHLORIDE, SIMETICONE (IMODIUM COMPLEX) on 30-Nov-2023 at a dose of 1 dosage form; LOPERAMIDE HYDROCHLORIDE, SIMETICONE (IMODIUM COMPLEX) on 01-Dec-2023 at a dose of 3 dosage form and PARACETAMOL (TYLENOL) for Headache and Pain, at an unspecified dose and frequency. At the time of the report, PAIN (he states the next day after receiving the shot, she had a terrible Headache, Nausea, her body hurts, and she has diarrhea.), DIARRHOEA (he states the next day after receiving the shot, she had a terrible Headache, Nausea, her body hurts, and she has diarrhea.), HEADACHE (he states the next day after receiving the shot, she had a terrible Headache, Nausea, her body hurts, and she has diarrhea.) and NAUSEA (he states the next day after receiving the shot, she had a terrible Headache, Nausea, her body hurts, and she has diarrhea.) had not resolved. The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment medications were reported.

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A general feeling of mild not quite like the flu; Soreness for 2 days in the injection site arm.; I had chills but no fever or nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (A general feeling of mild not quite like the flu), VACCINATION SITE PAIN (Soreness for 2 days in the injection site arm.) and CHILLS (I had chills but no fever or nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU, ASKU and ASKU) for COVID-19 prophylaxis. Concurrent medical conditions included Penicillin allergy (Penicillin allergy from 50 years ago) and Breast cancer (survivor of 5 years ago which was before her first Covid-19 vaccine and is currently in remission.). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (A general feeling of mild not quite like the flu), VACCINATION SITE PAIN (Soreness for 2 days in the injection site arm.) and CHILLS (I had chills but no fever or nausea). At the time of the report, FEELING ABNORMAL (A general feeling of mild not quite like the flu), VACCINATION SITE PAIN (Soreness for 2 days in the injection site arm.) and CHILLS (I had chills but no fever or nausea) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. The patient generally experienced the following after each of her Moderna Covid-19 vaccines. 2 days of symptoms to the vaccine.

Symptomtext

Her husband had their backs hurting; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Her husband had their backs hurting) in an elderly male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. Concurrent medical conditions included Heart disorder (Controlled). On 28-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 28-Nov-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced BACK PAIN (Her husband had their backs hurting). At the time of the report, BACK PAIN (Her husband had their backs hurting) outcome was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant and treatment medications were not reported. This case was linked to US-MODERNATX, INC.-MOD-2023-751634. Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2023-751634:Wife case

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he is not feeling so good; He also experienced severe muscle stiffness and soreness.; He had a fever for a couple of days; soreness; muscle stiffness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (muscle stiffness), MALAISE (he is not feeling so good), TENDERNESS (soreness), MYALGIA (He also experienced severe muscle stiffness and soreness.) and PYREXIA (He had a fever for a couple of days) in a 63-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The patient's past medical history included COVID-19. Previously administered products included for COVID-19 vaccination: Pfizer (2 doses) in 2020 and Pfizer (1 dose) in 2021; for Product used for unknown indication: Flu shot on 16-Oct-2023. Past adverse reactions to the above products included No adverse event with Flu shot, Pfizer and Pfizer. Concurrent medical conditions included Muscle disorder (experienced a rare systemic muscle disease that prompts to anaphylaxis and allergies.), Allergy to antibiotic, Allergy to NSAIDs, Drug allergy (aspirins and related drug), Drug allergy (caused severe nerve pain once.) and Drug allergy (experienced anaphylaxis to most of the medications.). In October 2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 24-Nov-2023, the patient experienced MUSCULOSKELETAL STIFFNESS (muscle stiffness), TENDERNESS (soreness) and PYREXIA (He had a fever for a couple of days). On an unknown date, the patient experienced MALAISE (he is not feeling so good) and MYALGIA (He also experienced severe muscle stiffness and soreness.). At the time of the report, MUSCULOSKELETAL STIFFNESS (muscle stiffness), TENDERNESS (soreness) and PYREXIA (He had a fever for a couple of days) was resolving and MALAISE (he is not feeling so good) and MYALGIA (He also experienced severe muscle stiffness and soreness.) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, Body temperature: 100?F, 99?F and 99.5?F. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant and treatment medications were not reported. He had a fever for a couple of days. Patient received Spikevax about 3 weeks ago. He believed that he received the vaccine on the week of 23Oct2023. Then on Friday night he started having fever. He said that in the past he had Covid, and the symptoms he experienced are similar to the ones from Covid. Patient doesn?t have a fever anymore. That has improved. He did not vomit but had a very low fever and over the weekend it climbed over 100?F. Then 99?F, 99.5?F He didn?t see a doctor yet because this happened over the weekend. He thought it was a normal thing, but he was getting progressibly worse with the covid-type symptoms.

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The patient complains of a sore injection site arm for a day.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (The patient complains of a sore injection site arm for a day.) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (The patient complains of a sore injection site arm for a day.). At the time of the report, VACCINATION SITE PAIN (The patient complains of a sore injection site arm for a day.) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2023-750747 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2023-750747:Same reporter, different patient

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Patient had a sore injections site arm; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Patient had a sore injections site arm) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Patient had a sore injections site arm). At the time of the report, VACCINATION SITE PAIN (Patient had a sore injections site arm) had resolved. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. Treatment medication was not reported. This case was linked to US-MODERNATX, INC.-MOD-2023-750747 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2023-750747:Same reporter, different patient

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lethargy for 3 days after receiving a Moderna Covid-19 vaccine; She also had a sore arm for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargy for 3 days after receiving a Moderna Covid-19 vaccine) and PAIN IN EXTREMITY (She also had a sore arm for 3 days) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2023, the patient experienced LETHARGY (lethargy for 3 days after receiving a Moderna Covid-19 vaccine) and PAIN IN EXTREMITY (She also had a sore arm for 3 days). On 22-Nov-2023, LETHARGY (lethargy for 3 days after receiving a Moderna Covid-19 vaccine) and PAIN IN EXTREMITY (She also had a sore arm for 3 days) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided.

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he has been having a low grade headache; little pain on his injection site and it went away; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (he has been having a low grade headache) and INJECTION SITE PAIN (little pain on his injection site and it went away) in a 68-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer vaccine (He said the injection site pain was worst than when he had Pfizer. He had 5 or 6 Pfizer shots previously.). Past adverse reactions to the above products included Injection site pain with Pfizer vaccine. On 16-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 16-Nov-2023, the patient experienced HEADACHE (he has been having a low grade headache) and INJECTION SITE PAIN (little pain on his injection site and it went away). In November 2023, INJECTION SITE PAIN (little pain on his injection site and it went away) had resolved. At the time of the report, HEADACHE (he has been having a low grade headache) had not resolved. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. On 16-Nov-2023, the patient went to his local pharmacy and they did not have Pfizer COVID-19 shots, so they administered Spikevax to the patient. He stated that since 16-Nov-2023, he had been having a low-grade headache. He had a little pain on his injection site and it went away. He said that the injection site pain was worst than when he had Pfizer vaccine. No treatment medications were reported. Reporter did not allow further contact

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she is not feeling well; She is itchy. She is itching on her arm, chest, back; She received Spikevax about 2 weeks ago and she has been experiencing allergies all over her body since then; This is the first time she receives Moderna vaccines, all her past doses were Pfizer and she didn?t experience anything like this; This is the first time she receives Moderna vaccines, all her past doses were Pfizer and she didn?t experience anything like this; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (she is not feeling well), PRURITUS (She is itchy. She is itching on her arm, chest, back), HYPERSENSITIVITY (She received Spikevax about 2 weeks ago and she has been experiencing allergies all over her body since then), INTERCHANGE OF VACCINE PRODUCTS (This is the first time she receives Moderna vaccines, all her past doses were Pfizer and she didn?t experience anything like this) and COVID-19 IMMUNISATION (This is the first time she receives Moderna vaccines, all her past doses were Pfizer and she didn?t experience anything like this) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer. On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (she is not feeling well), PRURITUS (She is itchy. She is itching on her arm, chest, back), HYPERSENSITIVITY (She received Spikevax about 2 weeks ago and she has been experiencing allergies all over her body since then), INTERCHANGE OF VACCINE PRODUCTS (This is the first time she receives Moderna vaccines, all her past doses were Pfizer and she didn?t experience anything like this) and COVID-19 IMMUNISATION (This is the first time she receives Moderna vaccines, all her past doses were Pfizer and she didn?t experience anything like this). At the time of the report, MALAISE (she is not feeling well) and PRURITUS (She is itchy. She is itching on her arm, chest, back) had not resolved and HYPERSENSITIVITY (She received Spikevax about 2 weeks ago and she has been experiencing allergies all over her body since then), INTERCHANGE OF VACCINE PRODUCTS (This is the first time she receives Moderna vaccines, all her past doses were Pfizer and she didn?t experience anything like this) and COVID-19 IMMUNISATION (This is the first time she receives Moderna vaccines, all her past doses were Pfizer and she didn?t experience anything like this) outcome was unknown. The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment medication were reported.

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flu like symptoms; throat is swollen; feels achy; tired; sleeping a lot; His chest feels restricted while breathing; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PHARYNGEAL SWELLING (throat is swollen), PAIN (feels achy), FATIGUE (tired) and HYPERSOMNIA (sleeping a lot) in a 71-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 11-Nov-2023, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PHARYNGEAL SWELLING (throat is swollen), PAIN (feels achy), FATIGUE (tired), HYPERSOMNIA (sleeping a lot) and CHEST DISCOMFORT (His chest feels restricted while breathing). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) had not resolved and PHARYNGEAL SWELLING (throat is swollen), PAIN (feels achy), FATIGUE (tired), HYPERSOMNIA (sleeping a lot) and CHEST DISCOMFORT (His chest feels restricted while breathing) outcome was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Contact has received 3 prior doses of the Moderna COVID-19 vaccines without any symptoms. He received his most recent Moderna COVID-19 vaccine on 25 OCT 2023. On 11 NOV 2023 he started feeling flu like symptoms, throat swollen, feels achy, tired, and sleeping a lot. His chest feels restricted while breathing. Went on to my provider website which said that symptoms may be related to the COVID-19 vaccines for 3 weeks after receipt of the vaccines. Has taken there flu once a day for the past couple of days. Got a shingles shot the same day. 2 weeks prior got a flu vaccine. Company Comment: This is a spontaneous case concerning 71-year-old male patient with no reported medical history, who experienced the non-serious unexpected, AESI event of hypersomnia, together with other non-serious events, which occurred approximately 15 days after a dose mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine, received as the fourth dose of COVID-19 vaccination schedule. It was reported that patient got a shingles shot the same day, and that 2 weeks prior he got a flu vaccine. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.

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muscles aches; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (muscles aches) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscles aches). At the time of the report, MYALGIA (muscles aches) outcome was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment medication were reported. Patient states that she had the 1st 2 vaccines and 2 booster doses. She is getting the new vaccine and would like to know how long does the protection last for the new vaccine.

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She states that the effectiveness of the last booster that she had was only 7% effective; She is gradually getting a sore throat. At this point it is very sore.; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (She is gradually getting a sore throat. At this point it is very sore.) and DRUG INEFFECTIVE (She states that the effectiveness of the last booster that she had was only 7% effective) in a 75-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On 15-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced OROPHARYNGEAL PAIN (She is gradually getting a sore throat. At this point it is very sore.). On an unknown date, the patient experienced DRUG INEFFECTIVE (She states that the effectiveness of the last booster that she had was only 7% effective). At the time of the report, OROPHARYNGEAL PAIN (She is gradually getting a sore throat. At this point it is very sore.) had not resolved and DRUG INEFFECTIVE (She states that the effectiveness of the last booster that she had was only 7% effective) outcome was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient stated that the effectiveness of the last booster that she had was only 7% effective. She was calling to find out if that is correct. The last vaccine she received was on 15 Oct 2023, and she confirmed it was Spikevax. She read that information from a political email. She was gradually getting a sore throat. At this point it was very sore. She was concerned that the booster was not effective. Company Comment This spontaneous case concerns a 75-year-old female patient with no medical history reported who experienced the unexpected events of sore throat and drug ineffective unknown days after a dose of mRNA-1273.815 vaccine. Concomitant medication details nor Treatment details were reported. She was calling to find out if that is correct, concerned that the booster was not effective. The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report.

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his hands were screwed up. He could not make a fist.; trigger finger; He states that his feet hurt a little bit, but not a lot; fever; This spontaneous case was reported by a patient and describes the occurrence of ARTHROPATHY (his hands were screwed up. He could not make a fist.), TRIGGER FINGER (trigger finger), PAIN IN EXTREMITY (He states that his feet hurt a little bit, but not a lot) and PYREXIA (fever) in a 53-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication. Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (He stated that all the previous vaccines he received were Pfizer. His last shot was in 2022.) in 2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE. On 13-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 14-Nov-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced ARTHROPATHY (his hands were screwed up. He could not make a fist.). In November 2023, the patient experienced TRIGGER FINGER (trigger finger), PAIN IN EXTREMITY (He states that his feet hurt a little bit, but not a lot) and PYREXIA (fever). At the time of the report, ARTHROPATHY (his hands were screwed up. He could not make a fist.), TRIGGER FINGER (trigger finger), PAIN IN EXTREMITY (He states that his feet hurt a little bit, but not a lot) and PYREXIA (fever) had not resolved. No concomitant medications were reported. The patient received Spikevax vaccine on 13-Nov-2023 around 6 PM in the left arm. He had received a Flu shot in the right arm at the same time. He stated that all the previous vaccines he received were of Pfizer. His last shot was in 2022. On 14-Nov-2023, in the morning, his hands were screwed up. He could not make a fist. He now had trigger fingers. He stated that he never had trigger fingers prior to vaccination. He refused to share the physician's name who diagnosed him with trigger fingers. The physician told him that he had trigger finger in 8 fingers. He had a little fever. He stated that his left hand was much worst than the right hand. He still could not use the left hand to hold anything. The right hand was a little better. He stated that his feet hurt a little bit, but not a lot. No treatment medications were reported.

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sore arm; little fever; tiredness; achy joints; she noticed a red spot on the injection site; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (little fever), FATIGUE (tiredness), ARTHRALGIA (achy joints) and VACCINATION SITE ERYTHEMA (she noticed a red spot on the injection site) in a 71-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The patient's past medical history included Pre-diabetic. Previously administered products included for Product used for unknown indication: covid-19 vaccine (Lot number: EN6198) on 05-Mar-2021, covid-19 vaccine (lot number: ER7828) on 26-Mar-2021, covid-19 vaccine (lot number: FF2590) on 23-Oct-2021 and covid-19 vaccine (lot number: 049L27A) on 15-May-2022. Past adverse reactions to the above products included No adverse event with covid-19 vaccine, covid-19 vaccine, covid-19 vaccine and covid-19 vaccine. Concurrent medical conditions included Blood pressure high and Stress. On 13-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 14-Nov-2023, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (little fever), FATIGUE (tiredness) and ARTHRALGIA (achy joints). In November 2023, the patient experienced VACCINATION SITE ERYTHEMA (she noticed a red spot on the injection site). At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (little fever), FATIGUE (tiredness), ARTHRALGIA (achy joints) and VACCINATION SITE ERYTHEMA (she noticed a red spot on the injection site) had not resolved. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. A consumer stated that she had the Spikevax on 13-Nov-2023. On 14-Nov-2023, she had a little fever, achy joints and tiredness and sore arm. The pharmacist, she stated did not use the usual band aid - it was like a foam that was placed on the injection site and it came off last night, 15-Nov-2023. That was when she noticed a red spot on the injection site. No treatment medication information was provided.

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pain in the area between ring and pinky finger.; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in the area between ring and pinky finger.) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the area between ring and pinky finger.). At the time of the report, PAIN IN EXTREMITY (pain in the area between ring and pinky finger.) had not resolved. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant medication and treatment information were not provided. Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2023: Live significant follow-up received on 15 Nov 2023, Reporter, patient, Product, Event information.

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yellowing of eyes indicating liver damage; yellowing of eyes indicating liver damage; bronchitis; UTI; severe stomach cramping; diarrhea; This spontaneous case was reported by a patient and describes the occurrence of LIVER INJURY (yellowing of eyes indicating liver damage) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIVER INJURY (yellowing of eyes indicating liver damage) (seriousness criterion medically significant), OCULAR ICTERUS (yellowing of eyes indicating liver damage), BRONCHITIS (bronchitis), URINARY TRACT INFECTION (UTI), ABDOMINAL PAIN UPPER (severe stomach cramping) and DIARRHOEA (diarrhea). At the time of the report, LIVER INJURY (yellowing of eyes indicating liver damage), OCULAR ICTERUS (yellowing of eyes indicating liver damage), BRONCHITIS (bronchitis), URINARY TRACT INFECTION (UTI), ABDOMINAL PAIN UPPER (severe stomach cramping) and DIARRHOEA (diarrhea) outcome was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Since receiving the vaccine, the patient experienced yellowing of eyes which indicated liver damage, bronchitis, UTI, severe stomach cramping and diarrhea. No treatment medications were reported. Company comment: This is a spontaneous case concerning a patient of unknown age and gender, with no medical history reported, who experienced serious (medically significant) unexpected AESI of liver injury (reported as yellowing of eyes indicating liver damage) which occurred in context of SPIKEVAX 2023-2024 dose administration which was described as unknown dose of COVID-19 vaccination schedule. Latency cannot be calculated due to event onset date unknown. The event was reported along with non-serious events of ocular icterus, bronchitis, urinary tract infection, abdominal pain upper and diarrhoea. There is no information provided regarding medical history, concomitant medications, diagnostic tests performed, clinical course, etiologic and diagnostic work up with treatment received. The benefit-risk relationship of the SPIKEVAX 2023-2024 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2023: Follow-up information included reference number updated.

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Patient said 12 hours after Moderna shot in 2020 she got very itchy Even in throat and mouth; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Patient said 12 hours after Moderna shot in 2020 she got very itchy Even in throat and mouth) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis. The patient's past medical history included Heart disease, unspecified. On 15-Jun-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2020, the patient experienced PRURITUS (Patient said 12 hours after Moderna shot in 2020 she got very itchy Even in throat and mouth). On 23-May-2020, PRURITUS (Patient said 12 hours after Moderna shot in 2020 she got very itchy Even in throat and mouth) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. Patient said 12 hours after Moderna shot in2020 she got very itchy Even in throat and mouth. She never had a problem breathing. It subsided within 12 hours. Treatment information was not provided.

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Having a bad reaction; worst headache; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Having a bad reaction) and HEADACHE (worst headache) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On 08-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Having a bad reaction) and HEADACHE (worst headache). At the time of the report, IMMUNISATION REACTION (Having a bad reaction) outcome was unknown and HEADACHE (worst headache) had not resolved. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. Patient has received 2 Vaccines and 3 boosters. She received a Moderna vaccine yesterday and was having the worst headache. Having a bad reaction. was this usual. No treatment information was reported.

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diarrhea; fatigue; chills; pain and redness near the injection site; pain and redness near the injection site; fever; muscle aches; hypothermia; This spontaneous case was reported by a patient and describes the occurrence of HYPOTHERMIA (hypothermia) in a 75-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: Flu shot (at the beginning of October) in October 2023, Prevnar(Pneumonia) 20 (a few days later) in October 2023, Multivitamin, Vitamin D, Vitamin B 100 complex, iron Eurofer, Synthroid and levothyroxine (0.088). Past adverse reactions to the above products included No adverse event with Flu shot, Multivitamin, Prevnar(Pneumonia) 20, Synthroid, Vitamin B 100 complex, Vitamin D, iron Eurofer and levothyroxine. Concurrent medical conditions included Hypothyroidism, Osteoporosis, Allergy to antibiotic (Macrolide) and Penicillin allergy (Possibly penicillin). On 14-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 14-Oct-2023, the patient experienced DIARRHOEA (diarrhea), FATIGUE (fatigue), CHILLS (chills), VACCINATION SITE PAIN (pain and redness near the injection site), VACCINATION SITE ERYTHEMA (pain and redness near the injection site), PYREXIA (fever) and MYALGIA (muscle aches). In October 2023, the patient experienced HYPOTHERMIA (hypothermia) (seriousness criterion medically significant). At the time of the report, HYPOTHERMIA (hypothermia) outcome was unknown and DIARRHOEA (diarrhea), FATIGUE (fatigue), CHILLS (chills), VACCINATION SITE PAIN (pain and redness near the injection site), VACCINATION SITE ERYTHEMA (pain and redness near the injection site), PYREXIA (fever) and MYALGIA (muscle aches) had not resolved. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. Patient experienced various side effects the next few days. A lot of side effects. But now it was 3 weeks after the shot and they were till suffering for overwhelming fatigue. Patient had 4 Pfizer and 2 Moderna. Got the vaccine Toronto. She was in bed and cannot access vaccines records at this time. No treatment information was reported. Company comment This spontaneous case concerns a patient of a 75-year-old female patient with relevant medical history of Hypothyroidism, who experienced the unexpected, serious (medically significant), event of hypothermia, which occurred on the same month that a dose of mRNA-1273.815 (SPIKEVAX 2023-2024) was administered. It was reported that 3 weeks after the shot she was still suffering from overwhelming fatigue. She had chills, pain and redness near the injection site. Sometimes she had a fever and sometimes very very low temperature like hypothermia, muscle aches, diarrhea. She had 4 Pfizer and 2 Moderna COVID-19 vaccine. No further clinical information was provided for review. The medical history of Hypothyroidism could be a contributory factor for hypothermia and the non-serious events of fatigue and myalgia. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.

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aches and pain for a day or two; little fever (99?F); This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (aches and pain for a day or two) and PYREXIA (little fever (99?F)) in an 83-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis. Patient has lots of allergies (not specified), she has a loop recorder. Patient taken medication for blood pressure. The patient's past medical history included Pericarditis (since 12 years ago) in 2011, GERD and Renal aneurysm. Previously administered products included for Blood pressure: Losartan (80 mg once a day) and Amlodipine (225 mg once a day); for GERD: Prevacid (30 mg once a day); for Hypercholesterolemia: Livalo (2.5 mg once a day); for Product used for unknown indication: HCTZ (25 mg once a day), Vitamin D (500 mcg,), Vitamin B12 (500), Multivitamin, Pregabalin (100 mg twice a day) and Aspirin (81 mg once a day); for an unreported indication: NASALCROM (nose drops twice a day.). Past adverse reactions to the above products included No adverse event with Amlodipine, Aspirin, HCTZ, Livalo, Losartan, Multivitamin, Pregabalin, Prevacid, Vitamin B12 and Vitamin D. Concurrent medical conditions included Angiomyolipoma and Hypercholesterolemia. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (aches and pain for a day or two) and PYREXIA (little fever (99?F)). At the time of the report, PAIN (aches and pain for a day or two) and PYREXIA (little fever (99?F)) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 ?F. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. No Concomitant medication was reported, she already received all her Moderna COVID-19 Vaccines (She did not remember dates) without any major issues, just maybe a little fever (99?F), aches and pain for a day or two. She currently wanted to get Spikevax, but she wanted to know: what was the recommendation if she has pericarditis. No treatment information was reported.

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aches; feeling crappy; runny nose; coughing; wheezing; fatigue; thinks it is Hemolytic Anemia/believes it is an auto immune anemia; severe bronchospasm attack; This spontaneous case was reported by a physician and describes the occurrence of HAEMOLYTIC ANAEMIA (thinks it is Hemolytic Anemia/believes it is an auto immune anemia), PAIN (aches), IRRITABILITY (feeling crappy), RHINORRHOEA (runny nose), COUGH (coughing), WHEEZING (wheezing), BRONCHOSPASM (severe bronchospasm attack) and FATIGUE (fatigue) in a 35-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Flu vaccine and estrogen. Past adverse reactions to the above products included No adverse event with Flu vaccine and estrogen. Concomitant products included BROMHEXINE HYDROCHLORIDE, GUAIFENESIN, SALBUTAMOL (PROVENTIL PLUS) for Bronchospasm, TRIAMCINOLONE DIACETATE (PROCTOSTEROID) and PREDNISONE for an unknown indication. In October 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced HAEMOLYTIC ANAEMIA (thinks it is Hemolytic Anemia/believes it is an auto immune anemia) (seriousness criteria hospitalization and medically significant) and BRONCHOSPASM (severe bronchospasm attack) (seriousness criterion hospitalization). In October 2023, the patient experienced PAIN (aches) (seriousness criterion hospitalization), IRRITABILITY (feeling crappy) (seriousness criterion hospitalization), RHINORRHOEA (runny nose) (seriousness criterion hospitalization), COUGH (coughing) (seriousness criterion hospitalization), WHEEZING (wheezing) (seriousness criterion hospitalization) and FATIGUE (fatigue) (seriousness criterion hospitalization). At the time of the report, HAEMOLYTIC ANAEMIA (thinks it is Hemolytic Anemia/believes it is an auto immune anemia), PAIN (aches), IRRITABILITY (feeling crappy), RHINORRHOEA (runny nose), COUGH (coughing), WHEEZING (wheezing), BRONCHOSPASM (severe bronchospasm attack) and FATIGUE (fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, Full blood count: hemoglobin 7 and hemoglobin was 10. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Patient received Spikevax about 2-3 week ago and soon after developed fatigue aches, feeling crappy, right after, upper respiratory symptoms, runny nose, coughing, wheezing about a week after that she developed bronchospasm attack. The frightening thing is that she eventually had a severe bronchospastic attack that she was given inhalation therapy, Proventil. The patient was prescribed inhaled steroid. Week after getting the vaccine, the patient had CBC drawn and her hemoglobin came back as 7 and it was repeated 5 days later, 2 hours prior to repeating CBC, the patient received Prednisone 20mg taken orally and hemoglobin was 10. HCP states that it appears to be an auto immune anemia. The patient has never been hospitalized. HCP stated that last night 06Nov2023, the patient had second severe bronchospastic attack . HCP states that it appears that he thinks it is Hemolytic Anemia. Patient requires immediate steriod treatment. HCP states that this occurred closely after receiving the vaccine, and believes it is an auto immune anemia. He has searched for journals and studies and not able to find much information. HCP didn't have lot numbers to current nor previous Moderna vaccines. Treatment information was not reported. Company Comment; This is a Spontaneous case reported by a physician, concerning a 35-year-old transgendered female patient, with no relevant medical history, who experienced the unexpected and serious (due to hospitalization and medically significant) event of Haemolytic anaemia, and the unexpected and serious (due to hospitalization) events of Pain, Irritability, Rhinorrhoea, Cough, Wheezing, Bronchospasm and Fatigue, which occurred after an unspecified dose of SPIKEVAX 2023-2024 vaccine. As reported, soon after vaccination the patient developed fatigue aches and feeling crappy. Right after, she experienced upper respiratory symptoms, runny nose, coughing and wheezing. 1 week after that, she developed bronchospasm attack. Patient was treated with inhalation therapy, salbutamol. She was also prescribed inhaled steroid. 1 week after vaccination, the patient had complete blood count drawn and her hemoglobin came back as 7. HCP stated that it appears to be a hemolytic anemia. Patient required immediate steroid treatment. At the time of the report, the events had not resolved. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.

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I haven't been able to eat anything because I am super Nauseous; Im in Just total pain; dizziness; I haven't been able to eat anything because I am super Nauseous; Fever of 102; Excruciating headaches; body aches; Extreme stiffness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Extreme stiffness), FEEDING DISORDER (I haven't been able to eat anything because I am super Nauseous), PAIN (Im in Just total pain), DIZZINESS (dizziness) and NAUSEA (I haven't been able to eat anything because I am super Nauseous) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 08-Nov-2023, the patient experienced MUSCULOSKELETAL STIFFNESS (Extreme stiffness), PAIN (Im in Just total pain), DIZZINESS (dizziness), NAUSEA (I haven't been able to eat anything because I am super Nauseous), PYREXIA (Fever of 102), HEADACHE (Excruciating headaches) and MYALGIA (body aches). On an unknown date, the patient experienced FEEDING DISORDER (I haven't been able to eat anything because I am super Nauseous). At the time of the report, MUSCULOSKELETAL STIFFNESS (Extreme stiffness), FEEDING DISORDER (I haven't been able to eat anything because I am super Nauseous), DIZZINESS (dizziness), NAUSEA (I haven't been able to eat anything because I am super Nauseous), PYREXIA (Fever of 102), HEADACHE (Excruciating headaches) and MYALGIA (body aches) had not resolved and PAIN (Im in Just total pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102. The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown Route) was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown Route), the reporter did not provide any causality assessments. Concomitant medication was not reported. Patient got Moderna vaccine on 08-Nov-2023 and had severe side effects to it. Excruciating headaches, body aches, Dizziness. Extreme Stiffness. Patient haven't Left since yesterday. Patient haven't been able to eat anything because patient was super Nauseous. Patient was in just total pain and had a fever of 102. Treatment medication was not reported. Reporter did not allow further contact

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was having problems with her stomach; She states she has had mostly Pfizer; she had one Moderna; She states she has had mostly Pfizer; she had one Moderna; vomiting; dizziness; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (was having problems with her stomach), VOMITING (vomiting), DIZZINESS (dizziness), COVID-19 IMMUNISATION (She states she has had mostly Pfizer; she had one Moderna) and INTERCHANGE OF VACCINE PRODUCTS (She states she has had mostly Pfizer; she had one Moderna) in an 81-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. Previously administered products included for Drug use for unknown indication: Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer. On 08-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 09-Nov-2023, the patient experienced VOMITING (vomiting) and DIZZINESS (dizziness). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (was having problems with her stomach), COVID-19 IMMUNISATION (She states she has had mostly Pfizer; she had one Moderna) and INTERCHANGE OF VACCINE PRODUCTS (She states she has had mostly Pfizer; she had one Moderna). On 09-Nov-2023, VOMITING (vomiting) and DIZZINESS (dizziness) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (was having problems with her stomach) had resolved and COVID-19 IMMUNISATION (She states she has had mostly Pfizer; she had one Moderna) and INTERCHANGE OF VACCINE PRODUCTS (She states she has had mostly Pfizer; she had one Moderna) outcome was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. The patient confirmed contact information. She had very bad symptoms, felt very dizzy and was having problems with her stomach. She threw up. She states she is better now, but it was bad when she had it in the morning. The patient states she has been getting the COVID vaccines regularly. The last one was a year ago in November. The dates and vaccines are unknown. She states she has had mostly Pfizer; she had one Moderna. The patient was not sure if she received Spikevax yesterday, but she did get a COVID19 vaccine yesterday 8 Nov 2023. Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2023: Significant live follow-up received. Reporter details, event details , LRN added.

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On 31Oct2023 she noticed that she had a welted red marks while she was in the tub; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (On 31Oct2023 she noticed that she had a welted red marks while she was in the tub) in a 3-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On 14-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 31-Oct-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced URTICARIA (On 31Oct2023 she noticed that she had a welted red marks while she was in the tub). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) at a dose of UNK, bid. At the time of the report, URTICARIA (On 31Oct2023 she noticed that she had a welted red marks while she was in the tub) outcome was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. On 31Oct2023 patient's mother noticed that patient had a welted red mark while she was in the tub. But reporter later noticed that they will disappear only to reappear in some other areas of patient's body - from her eyelids to the bottom of her feet and on her buns. Patient's mother gave her Benadryl initially but she noticed that there was no improvement after 2 days so she shifted to Allegra giving her 2x a day. Patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. This case was linked to US-MODERNATX, INC.-MOD-2023-748711 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2023-748711:different patient case

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6 hours later it turns red, hot to the touch and swollen. She developed a blister in the middle of the red area, possibly at the actual injection site.; 6 hours later it turns red, hot to the touch and swollen. She developed a blister in the middle of the red area, possibly at the actual injection site.; 6 hours later it turns red, hot to the touch and swollen. She developed a blister in the middle of the red area, possibly at the actual injection site.; 6 hours later it turns red, hot to the touch and swollen. She developed a blister in the middle of the red area, possibly at the actual injection site.; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE VESICLES (6 hours later it turns red, hot to the touch and swollen. She developed a blister in the middle of the red area, possibly at the actual injection site.), INJECTION SITE WARMTH (6 hours later it turns red, hot to the touch and swollen. She developed a blister in the middle of the red area, possibly at the actual injection site.), INJECTION SITE SWELLING (6 hours later it turns red, hot to the touch and swollen. She developed a blister in the middle of the red area, possibly at the actual injection site.) and INJECTION SITE ERYTHEMA (6 hours later it turns red, hot to the touch and swollen. She developed a blister in the middle of the red area, possibly at the actual injection site.) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. Patient took medication for each condition. Patient also takes ambient for sleep. Previously administered products included for Product used for unknown indication: Covid-19 vaccine (Lot number: -0311420A and Dose 1) on 11-Feb-2021. Past adverse reactions to the above products included No adverse event with Covid-19 vaccine. Concurrent medical conditions included Blood pressure high, Depression, Anxiety, Hypothyroidism, Cholesterol and Sleep disorder. Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) for Sleep disorder, INFLUENZA VACCINE and RSV VACCINE for an unknown indication. On 07-Nov-2023 at 10:30 AM, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 07-Nov-2023 at 4:30 PM, the patient experienced INJECTION SITE VESICLES (6 hours later it turns red, hot to the touch and swollen. She developed a blister in the middle of the red area, possibly at the actual injection site.), INJECTION SITE WARMTH (6 hours later it turns red, hot to the touch and swollen. She developed a blister in the middle of the red area, possibly at the actual injection site.), INJECTION SITE SWELLING (6 hours later it turns red, hot to the touch and swollen. She developed a blister in the middle of the red area, possibly at the actual injection site.) and INJECTION SITE ERYTHEMA (6 hours later it turns red, hot to the touch and swollen. She developed a blister in the middle of the red area, possibly at the actual injection site.). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, INJECTION SITE VESICLES (6 hours later it turns red, hot to the touch and swollen. She developed a blister in the middle of the red area, possibly at the actual injection site.), INJECTION SITE WARMTH (6 hours later it turns red, hot to the touch and swollen. She developed a blister in the middle of the red area, possibly at the actual injection site.), INJECTION SITE SWELLING (6 hours later it turns red, hot to the touch and swollen. She developed a blister in the middle of the red area, possibly at the actual injection site.) and INJECTION SITE ERYTHEMA (6 hours later it turns red, hot to the touch and swollen. She developed a blister in the middle of the red area, possibly at the actual injection site.) had not resolved. It was reported that patient receives other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient receives moderna covid-19 vaccine 2nd dose on 11-Mar-2021 (lot number: - 040A21A), 3rd dose on 22-Oct-2021 (lot number: - 012F21A) and 4th dose on 19-Apr-2022 (lot number: - 057M21A). It was reported that the shot went right with no pain. She came home and took an Aleve (She read it was recommended after the shot to help with onset of something you did not want). She put an ice pack on the injection site. 6 hours later it turns red, hot to the touch and swollen. She developed a blister in the middle of the red area, possibly at the actual injection site. She went to the pharmacy and the pharmacist stated she should wait 24 hours before seeing a physician.

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sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. Concurrent medical conditions included Immune system disorder. On 08-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 09-Nov-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. Patient had an immune deficiency and has taken previous Moderna vaccines and has had severe side effects with each one for 36 hours. Symptoms reported have She states that she felt horrific. She received Spikevax and felt nothing except a sore arm. In the past she has shown that she didn't maintain antibodies. Treatment information was not reported. This case was linked to US-MODERNATX, INC.-MOD-2023-748891 (Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2023-748891:Same Patient, Different dose

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achy shoulder; itching all over/His chest, neck and back were covered/They are gone from his shoulders and chest but mid to lower back is still there; hives; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching all over/His chest, neck and back were covered/They are gone from his shoulders and chest but mid to lower back is still there), URTICARIA (hives) and ARTHRALGIA (achy shoulder) in a 75-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. Concurrent medical conditions included Drug allergy (Cipro), Penicillin allergy, Pollen allergy and Ragweed allergy (and others that he cannot think of at the moment.). On 04-Nov-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 04-Nov-2023, the patient experienced PRURITUS (itching all over/His chest, neck and back were covered/They are gone from his shoulders and chest but mid to lower back is still there) and URTICARIA (hives). On an unknown date, the patient experienced ARTHRALGIA (achy shoulder). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CLOBETASOL for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching all over/His chest, neck and back were covered/They are gone from his shoulders and chest but mid to lower back is still there) had not resolved, URTICARIA (hives) was resolving and ARTHRALGIA (achy shoulder) outcome was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. It was reported that patient had allergies to several things. He has had allergic reactions before like to cipro and the exact same thing happened, it was like Deja vu. His pharmacist said to take Benadryl and if it still gets worse then go to the doctor but it did not get worse. He had Clobetasol ointment which he used and it knocked the itch down quickly. They were gone from his shoulders and chest but mid to lower back was still there. He was currently at work at the time of reporting so he does not have information regarding his previous Moderna vaccinations. .

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The patient was drowsy all day. Similar to a hangover; Vaccine has caused him to overthink like a Philosopher; The patient says that he is not sleeping and when he does sleep it is with his eyes open; headache; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (The patient was drowsy all day. Similar to a hangover), THINKING ABNORMAL (Vaccine has caused him to overthink like a Philosopher), SLEEP DISORDER (The patient says that he is not sleeping and when he does sleep it is with his eyes open) and HEADACHE (headache) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (The patient was drowsy all day. Similar to a hangover), THINKING ABNORMAL (Vaccine has caused him to overthink like a Philosopher), SLEEP DISORDER (The patient says that he is not sleeping and when he does sleep it is with his eyes open) and HEADACHE (headache). At the time of the report, SOMNOLENCE (The patient was drowsy all day. Similar to a hangover) and HEADACHE (headache) had not resolved and THINKING ABNORMAL (Vaccine has caused him to overthink like a Philosopher) and SLEEP DISORDER (The patient says that he is not sleeping and when he does sleep it is with his eyes open) outcome was unknown. No concomitant medication was reported. The patient received his first Moderna Covid-19 vaccine in 2020 or 2021. The patient was drowsy all day. Similar to a hangover. The patient also had pain in the head or a headache. Patient reports that the pain in his head was a 10 out of 10. The patient received his second dose of the Moderna Covid-19 vaccine and is not clear when he received the second dose of the Moderna Covid-19 vaccine. The patient does not know the lot number of the vaccine and does not remember which arm that he received his vaccine in. This caused a lot of drowsiness. The patient cannot stop thinking after he received his first vaccine. The patient was overthinking about the whole world. The patient thinks that the Moderna Covid-19 vaccine has caused him to overthink like a philosopher. The patient wonders about the clouds in the sky pollution from Smokestacks. Also mentions tobacco and alcohol in relation to being a philosopher and then the patient asked the agent to forget about it. The patient tries not to use alcohol as it causes Cirrhosis and organ damage. The patient was not sleeping and when he does sleep it was with his eyes open. The patient said that the planet looks unbelievably real. The planet looks beautiful. The patient looks at the Sun and wonders if it was another planet on fire. The patient looks at the moon and wonders if it was real. No treatment medication was reported.

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I am still experiencing some numbness and pain in my left arm, where I received the vaccination; I am still experiencing some numbness and pain in my left arm, where I received the vaccination; pain in the armpit; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HYPOAESTHESIA (I am still experiencing some numbness and pain in my left arm, where I received the vaccination), INJECTION SITE PAIN (I am still experiencing some numbness and pain in my left arm, where I received the vaccination) and AXILLARY PAIN (pain in the armpit) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On 01-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE HYPOAESTHESIA (I am still experiencing some numbness and pain in my left arm, where I received the vaccination), INJECTION SITE PAIN (I am still experiencing some numbness and pain in my left arm, where I received the vaccination) and AXILLARY PAIN (pain in the armpit). At the time of the report, INJECTION SITE HYPOAESTHESIA (I am still experiencing some numbness and pain in my left arm, where I received the vaccination), INJECTION SITE PAIN (I am still experiencing some numbness and pain in my left arm, where I received the vaccination) and AXILLARY PAIN (pain in the armpit) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy breast: two biopsies recently in the left breast and left armpit (lymph node) - both benign.. On an unknown date, Biopsy lymph gland: two biopsies recently in the left breast and left armpit (lymph node) - both benign.. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant and treatment medications were not reported. Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2023: Significant Live follow-up received on 05-Nov-23: Reference numbers added

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soreness; Itchy area around the injection site; a very red, swollen & itchy area around the injection site.; a very red, swollen & itchy area around the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (soreness), VACCINATION SITE PRURITUS (Itchy area around the injection site), VACCINATION SITE ERYTHEMA (a very red, swollen & itchy area around the injection site.) and VACCINATION SITE SWELLING (a very red, swollen & itchy area around the injection site.) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication. Previously administered products included for Product used for unknown indication: Pfizer Covid Vaccines (Patient had 5 Pfizer Covid Vaccines since 2020 & never had an itchy rash. Just the soreness). Past adverse reactions to the above products included No adverse reaction with Pfizer Covid Vaccines. On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (soreness), VACCINATION SITE PRURITUS (Itchy area around the injection site), VACCINATION SITE ERYTHEMA (a very red, swollen & itchy area around the injection site.) and VACCINATION SITE SWELLING (a very red, swollen & itchy area around the injection site.). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, TENDERNESS (soreness) and VACCINATION SITE PRURITUS (Itchy area around the injection site) had not resolved and VACCINATION SITE ERYTHEMA (a very red, swollen & itchy area around the injection site.) and VACCINATION SITE SWELLING (a very red, swollen & itchy area around the injection site.) outcome was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. Patient received Covid booster vaccine 2 days ago along with flu shot. Just this morning, patient awoke with soreness (no big deal) & a very red, swollen & itchy area around the injection site. Patient applying Hydrocortisone Cream to help contain the itch. Patient just wanted to know how long will this last and if it gets worse, what should she do. Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2023: Live follow-up received with significant information. AE reference number added.

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Knee pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Knee pain) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On 31-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Knee pain). At the time of the report, ARTHRALGIA (Knee pain) outcome was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant and treatment medications were not reported. Patient was asking that she can take ibuprofen for several days due to knee pain. Will ibuprofen reduce the effectiveness of the vaccine. Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2023: Live follow-up received contains significant information: Patient details, event details, references and narrative were updated.

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