Reporte zur Charge #1802068

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Admission Diagnoses: Acute hypoxemic respiratory failure [J96.01]COVID [U07.1] Discharge Diagnoses: Active Problems: Asthma exacerbation with COPD (chronic obstructive pulmonary disease) Acute bronchitis due to COVID-19 virus; Hypoxemia; Type 2 diabetes mellitus with hyperglycemia, without long-term current use of insulin; Panlobular emphysema (*); Overview: had asthma in her 20's Smoker with COPD presents with dyspnea and is found to have COVID without pneumonia. She was admitted and treated with nebs and steroids with resolution of symptoms and resolution of hypoxemia. She was discharge to home at her request. She was advised to stop smoking.

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Clinical Summary Patient is a 66 year old female with a history of COPD (baseline 4-5L NC), CAD (s/p CABG), chronic HFpEF, T2DM, HTN, and multiple recent admissions for COPD and CHF exacerbations last 7/28/23-8/2/23 for same. Patient represented to hospital on 8/9/23 with persistent SOB. Labs and imaging on admission: Cr 1.4, Trop 32, NT-Pro BNP 10k, WBC 11.9. CXR diffuse pulmonary edema with inflammatory changes possible pneumonitis. Patient found to have Covid-19. 1. Covid-19: pt endorsed worsening SOB and cough with green sputum 3-4 days PTA. Covid-19 on admission. Vaccinated. CXR on admit with diffuse pulmonary edema with inflammatory changes possible pneumonitis. Improved with pulmonary hygiene, diuresis. 1. Covid-19: pt endorsed worsening SOB and cough with green sputum 3-4 days PTA. Covid-19 on admission. Vaccinated. CXR on admit with diffuse pulmonary edema with inflammatory changes possible pneumonitis. Improved with pulmonary hygiene, diuresis and steroids. Continued decadron (end 8/18/23) 2. Acute on Chronic Respiratory Failure: Baseline uses 4-5L NC, stable on admission. CXR as discussed above. Suspect multifactorial in setting of Covid-19, acute CHF and underlying COPD. Continued treatment of underlying factors. Improved. Requiring 2-3L on discharge. 3. Acute on Chronic HFpEF: Follows with Heart Failure Clinic as an outpatient. Last TTE on 7/17/23 with RV slightly decreased dysfunction. NTProBNP on admission 10k. CXR with pulmonary edema. S/p IV Lasix, transitioned to PO Bumex last admit and HDMC followed at that time with increased bumex and added spironolactone on discharge. IV Lasix 20 on admit, and 8/10/23 with improvement. Continued home diuretics. 4. Remote COPD Exacerbation: Follows with outpatient pulm. S/p steroid, azithromycin last admission for exacerbation. No current AE on admit. Steroids as discussed. Continued home inhalers. Outpatient follow-up with pulmonologist. 5. Leukocytosis: Afebrile, WBC 11 on admit. Procal low risk. CXR without concern for pneumonia. Monitored. 6. CAD: per history, s/p CABG. Continued DAPT and statin. 7. CKD stage 3b: Baseline Cr 1.3?1.4. Admission Cr 1.40. Avoid nephrotoxic meds. Monitored. 8. NIDDM2: Last A1c 6.9 on 6/23/23. Held home orals. SSI on admit. Monitor and titrate PRN. 9. Generalized Psoriatic Rash: Follows with Dermatology as an outpatient. 10. HLD: per history. Continued statin. 11. Hypothyroidism: Continued Levothyroxine.

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FINAL DIAGNOSIS: 1. Covid 19 2. Acute hypoxemic respiratory failure secondary to COVID-19 3. A. Fib with chronic anticoagulation 4. BMI 44 5. HTN 6. HLD 7. OSA 9. Hypokalemia 10. Asthma REASON FOR HOSPITALIZATION AND ADMITTING DIAGNOSIS: Shortness of Breath, Chest Pain, and Fever Hypokalemia Acute respiratory failure with hypoxia (HCC) Pneumonia due to COVID-19 virus HOSPITAL COURSE: Per HPI: Patient is a 64 y.o. year-old male, who presented with SOB. Patient reports has been not feeling well for about a week. Has previously received COVID-vaccine 2 years ago Johnson & Johnson. States that he took a COVID test this past weekend and it was positive he started to feel much worse and presented to the emergency department. In the ER he had an oxygen saturation in the mid 80s. He does not normally wear oxygen but does have obstructive sleep apnea. Denies any chest pains. .Covid-19 Virus Infection Date of onset of symptoms: 3/28/2023 Symptoms present on admission: Hypoxemia/cough Date of covid positive test: 4/4/2023 Vaccination status: Received J&J Imaging: Chest x-ray with new patchy density suggesting infiltrates within the perihilar aspect of the left mid chest and the right lung base/CT pulmonary artery study revealed no evidence of pulmonary embolism. Moderate involvement of all lobes of the lung by patchy and groundglass airspace disease compatible with multifocal pneumonia such as viral COVID-pneumonia. No pneumothorax or pleural effusion. Oxygen requirements on admission: 1 L nasal cannula Current oxygen requirements: Currently on room air at discharge Medical therapy: Completed remdesivir regimen/Decadron for 10 days Consultants following: Evaluated by infectious disease Anticipated special isolation end date: 5 days of quarantine/5 days a mask at discharge. Consultants following: Evaluated by infectious disease Anticipated special isolation end date: 5 days of quarantine/5 days a mask at discharge. Potassium was 3.3 on day of discharge and this is likely secondary to patient's use of Lasix and hydrochlorothiazide. I will keep him on potassium 20 mill equivalents daily until he follows with his family physician and they can continue to refill and check the patient's potassium level. His sodium is additionally 133 and this is likely secondary to Decadron use as well as diuretic use. Blood cultures revealed no growth to date. Troponin was negative x2 and patient had recent heart cath. Procalcitonin was normal this is likely not a bacterial pneumonia or infection at this time. Patient reports he did not require any oxygen supplementation last night during sleep. He reports that he does not need any assistance from care management at discharge.

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Blood Clots in left leg and Pulmonary Embolism causing 12 day hospitalization placed on blood thinners and blood testing done to check for genetic history. only factor of 5 that was found was the Lupus Anticoag PL . Doctors explained since no other factor 5 indicators exist I was not born with this diagnosis. acquired at some point in the last few years due to no history prior.

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The patient is a 66 y.o. female patient of Physician with a history of atrial fibrillation, IDDM2, asthma, COPD, chronic respiratory failure on 4L of O2, HLD, HTN, and depression/anxiety who initially presented to another hospital and transferred to reporting hospital's ICU on 01/29/23 with respiratory failure requiring BIPAP, found to be in shock secondary to COVID-19, and subsequently intubated on 02/03/23. Hospital course complicated by atrial fibrillation with RVR versus SVT, elevated transaminases requiring N-acetylcysteine, acute parotiditis, and acute encephalopathy. Was eventually extubated on 02/10/23 but rapid clinical decline hours after with hypotension unresponsive to vasopressors. Eventually went into PEA arrest but decision was made to end the code after exhaustive measures were performed and all reversible causes were considered. Discharge Diagnoses: PEA arrest Shock, unspecified Acute on chronic respiratory failure with hypoxemia COVID-19 viral pneumonia Atrial fibrillation with RVR Acute parotiditis Acute encephalopathy Incidental CT finding of adrenal mass - Time of death 23:19. Contacted family during cardiac arrest. Resident met with patient's family on their arrival and offered emotional support (see quick notes).

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A 83 y.o. male patient of MD with history of CABG 2006, ICM s/p ICD, atrial fibrillation on coumadin, HTN, HLD, pulm HTN, CKD, dementia presented on 1/17/2023 with ADHD. Initial workup consistent with COVID as well as CHF exacerbation. Took over as primary post ICU transfer. Patient received aggressive diuresis with lasix gtt and transitioned to oral torsemide. Initiated on midodrine and metoprolol held due to persistent hypotension. Respiratory status improved and currently on 2 L O2. Given the duration of COVID no treatment was indicated. PT/OT recommended SNF, seen by palliative care team CODE STATUS changed to DNR CCA/DNI. Patient is medically stable to be discharged with outpatient follow up as outlined. Ischemic Cardiomyopathy, Acute on chronic HFrEF, CAD, s/p CABGx3 2006; Symptomatic Hypotension. Has CRT-D in place, AV paced seen on EKG. Recent device interrogation with 99-100% CRT-P. Echo: severely enlarged left ventricle with an EF of 25% and inferior and inferolateral akinesis. He has moderate tricuspid regurgitation and an RVSP of 50. Initiated on lasix gtt (briefly required levophed) with significant diuresis; Transitioned to oral torsemide; Metoprolol DC due to hypotension; Given persistently low symptomatic hypotension initiated on midodrine with improvement. Cortisol normal. No evidence of sepsis. strict I's and O's, daily weight, salt and fluid restriction. Cardiology signed off, outpatient follow up. Acute Hypoxemic Respiratory Failure, Covid 19 Positive, COPD without exacerbation, Acute bronchitis. Persistent acute on chronic left-sided pleural effusion, Hypoxia resolved on RA; Date of COVID positive 1/17/2023, isolation end date 1/27/2022 Chest x-ray with persistent left-sided basilar opacity with moderate to large pleural effusion. ID consulted, recommended supportive measures. Given persistent improvement in hypoxia held off on to thoracentesis for now. Pleural effusion seems to be chronic likely dependent as well as fluid extravasation with possible trapped lung. If respiratory status gets worse then will recommend left-sided thoracentesis. Given persistent cough with thick sputum and mucus meds, doxycycline, vibratory therapy, incentive spirometer. Improved over all. Patient stable to get out of isolation from 1/28/2023. Paroxysmal Atrial Fibrillation/SSS. Supratherapeutic INR. On warfarin and toprol at home. Admit INR 3.7, currently 2.4, 2.3. HR controlled off metoprolol held due to soft BPs. Resume low dose metoprolol if SBP improves Continue with daily PT/INR Lower back pain-Palpable tenderness midline upper lumbar -Suspect musculoskeletal-Discontinue ibuprofen. Would avoid NSAID in this age group with increased risk of GI and renal risks in the setting of patient on Coumadin with subtherapeutic INR.-Continue with lidocaine patch -Tylenol - x-ray lumbar spine with DJD -Frequent turns, patient needs to get out of the bed to the chair.- Improved Elevated Troponin; Likely 2/2 to demand ischemia; Initially a STEMI alert on arrival, evaluated and was deemed not a STEMI rather his abnormal EKG 2/2 to pacemaker; Continue to monitor; Hyperkalemia- resolved; Admit K 5.2, current K 4.1; Monitor with serial RFPs; Stable; Potassium 3.8, keep >4; Hypophosphatemia; Hypomagnesemia Replace; Goals of care; Palliative care discussion noted with patient's wife and daughter. CODE STATUS changed to DNR CCA/DNI. At this point patient wants to attempt rehab and go home subsequently. Discussed with social worker. Severe Physical deconditioning - due to above - PT/OT eval recommending SNF, CM consulted - Pre-cert obtained - Patient medically stable for discharge- Transport arranged for 1/28.

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Admission Date: 2/1/2023 Discharge Date: 2/16/23 PRESENTING PROBLEM: Acute respiratory insufficiency Acute respiratory failure with hypoxia HOSPITAL COURSE: Patient is a 51-year-old female with PMH significant for hypertension, OSA/CPAP, epilepsy on antiepileptics, type 2 diabetes, history of malignant brain tumor status post excision/VP shunt, thyroid cancer, anoxic brain injury/developmental delay and right hemiplegia with associated dysphagia/feeding tube, nonverbal/non communicative, wheelchair-bound complete care at baseline at home with mom as being primary caregiver, hypothyroidism presents to the hospital on 2/1---with complaints of increased blood pressure at home, facial swelling, abdominal distension and labored breathing. Patient was noted to be hypoxic in ER at 88%, tachypneic, needing supplemental oxygen and chest x-ray showing cardiomegaly and pulmonary congestion. Patient was admitted with suspicion for pulmonary congestion related to uncontrolled blood pressures, echo without any significant findings, was given diuretics. Echo showed EF of 70%. Blood pressure medications were further adjusted resulting in better control. Patient developed fever and 2/6 and with continued hypoxia further workup with chest x-ray that showed infiltrates, CT thorax/abdomen and pelvis without any acute changes. Urinalysis was negative. Patient did not have any meningeal signs. Ultimately she did test positive for COVID-19 on film array and interestingly her film array was negative at admit with prior COVID infection in Dec 2022. Patient was started on remdesivir and antibiotics discontinued. Her hypoxia and respiratory status worsened so she was started on dexamethasone with gradual improvement. Patient also developed increased lethargy around 2/5 of unclear etiology. Further workup with CT head without any acute changes, TSH, VBG, ammonia, B12 were all normal. Neurology consultation was obtained who recommended MRI brain (no acute changes), EEG (which was abnormal with occasional LR DA and GRDA and interictal epileptiform discharges) her home Keppra and Tegretol doses were increased. She had significant improvement with steroids. She was weaned down to RA and ultimately discharged home is stable conditions with plans to continue increased dose of BP meds and to finish steroids. It was discussed to the mother/caregiver to return if respiratory status worsened after stopping steroids for covid with the possibility of post-covid ILD.

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DEATH; UTERINE HAEMORRHAGE; FACIAL PARALYSIS; DYSARTHRIA; COVID-19; MENTAL STATUS CHANGES; MUSCULAR WEAKNESS; RED BLOOD CELL TRANSFUSION; HAEMOGLOBIN DECREASED; SARS-COV-2 TEST POSITIVE; COMPUTERISED TOMOGRAM HEAD ABNORMAL; CEREBROVASCULAR ACCIDENT; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID Unknown) concerned a 70 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: progressive macular hypomelanosis (PMH), significant of HTN (hypertension), type 2 DM (diabetes mellitus), hyperlipidemia, PE (pulmonary embolism), uterine sarcoma, lung metastases, and recurrent TIAs (transient ischemic attacks). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: UNKNOWN) dose was not reported, 1 total administered on 15-MAR-2021 for an unspecified indication. Age at time of vaccination 70 years old. No concomitant medications were reported. Number of days between vaccine administration and onset of the events was reported as: 568 days. On 04-OCT-2022, patient was brought in by EMS (Emergency Medical Services) for altered mentation (mental status changes) and abnormal uterine bleeding (uterine haemorrhage). The patient was admitted to hospital for L MCA stroke (cerebrovascular accident) with slurred speech (dysarthria), facial droop (facial paralysis) and RUE weakness (muscular weakness). The patient had history of multiple strokes since SEP-2022 and presented with significant AUB (uterine haemorrhage) with Hb of 6 (haemoglobin decreased). The patient received 2 units pRBC (red blood cell transfusion) in ED (emergency department). CT (computerized tomography) head showed findings suggestive of recurrent stroke. Patient and family requested comfort care only. Hospice consulted initially not in hospital candidate as symptoms were adequately managed by palliative care Comfort medications were started and patient was kept comfortable. On 04-OCT-2022, the patient experienced covid-19 (sars-cov-2 test (severe acute respiratory syndrome coronavirus 2) positive). Laboratory data included: Computerised tomogram head abnormal, Haemoglobin Decreased, Laboratory test Micro - detected, SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) test Positive, and SARS-CoV-2 test COVID-19. Laboratory data (dates unspecified) included: Haemoglobin 6 (units unspecified), and head CT findings suggestive of recurrent stroke. On 01-NOV-2022, the patient died from covid-19, cerebrovascular accident, computerised tomogram head abnormal, dysarthria, facial paralysis, haemoglobin decreased, mental status changes, muscular weakness, red blood cell transfusion, sars-cov-2 test positive, and uterine haemorrhage. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused / Prolonged). This report was associated with a product quality complaint Unknown. The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related. Batch and lot tested and found within specifications based on the PQC evaluation/investigation performed. Additional information received from Central Complaint department on 08-FEB-2023. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V3: This follow up adds information about Product quality complaint investigation result. This does not alter previous causality assessment of the reported events. Death, cerebrovascular accident, computerised tomogram head abnormal, covid 19, dysarthria, facial paralysis, haemoglobin decreased, mental status changes, muscular weakness, red blood cell transfusion, sars-cov-2 test positive, and uterine haemorrhage. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.; Reported Cause(s) of Death: COVID-19; CEREBROVASCULAR ACCIDENT; COMPUTERISED TOMOGRAM HEAD ABNORMAL; DYSARTHRIA; FACIAL PARALYSIS; HAEMOGLOBIN DECREASED; MENTAL STATUS CHANGES; MUSCULAR WEAKNESS; RED BLOOD CELL TRANSFUSION; SARS-COV-2 TEST POSITIVE; UTERINE HAEMORRHAGE

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Patient is a 84 y.o. male patient of MD. Patient presented to emergency room for generalized weakness. Patient states that yesterday he became severely weak. Patient also reports a cough. Patient denies any chest pain or shortness of breath. Patient denies any fever at home. Patient does not use oxygen at baseline. Hospital course as below. Patient improved with medical treatment. Patient weaned to room air on discharge. Patient instructed to follow-up primary care provider within a week at discharge. 1. COVID PNA, +1/5, symptoms 1/5, vaccinated: -CXR with atelectasis versus infection -Remdesivir -Decadron -heparin SC DVT prophylaxis 2. Acute hypoxic respiratory failure: -Secondary to above -Wean oxygen as able 3. Generalized weakness: -Secondary to above -PT/OT -Social work for discharge needs 4. AKI: -monitor labs -IVF -hold home nephrotoxic meds

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DEATH; This spontaneous report received from a health care professional via Regulatory Authority, Vaccine Adverse Event Reporting System (VAERS) (VAERS ID 1100865) through social media concerned a 77 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, obesity, and pneumonia (Hospitalized on 08-FEB-2021). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068 expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-MAR-2021 on left arm for an unspecified indication. Age at time of vaccination 8 decade old. Concomitant medications included amoxicillin, atenolol, cefuroxime, fluticasone, lansoprazole, lisinopril, azulfidine, tenormin and sulfasalazine. On 14-MAR-2021, the patient died within 24 hours of vaccination from an unknown cause of death. It was unknown whether an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20230123132, 20230124166, 20210650125 and 20230123136.; Sender's Comments: V0: 20230123126- Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

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DEATH; This spontaneous report received from a health care professional via Regulatory Authority, Vaccine Adverse Event Reporting System (VAERS) (VAERS ID 1100865) through social media concerned a 77 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, obesity, and pneumonia (Hospitalized on 08-FEB-2021). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068 expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-MAR-2021 on left arm for an unspecified indication. Age at time of vaccination 8 decade old. Concomitant medications included amoxicillin, atenolol, cefuroxime, fluticasone, lansoprazole, lisinopril, azulfidine, tenormin and sulfasalazine. On 14-MAR-2021, the patient died within 24 hours of vaccination from an unknown cause of death. It was unknown whether an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20230123132, 20230124166, 20210650125 and 20230123136.; Sender's Comments: V0: 20230123126- Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

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DEATH; This spontaneous report received from a health care professional via Regulatory Authority, Vaccine Adverse Event Reporting System (VAERS) (VAERS ID 1100865) through social media concerned a 77 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, obesity, and pneumonia (Hospitalized on 08-FEB-2021). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068 expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-MAR-2021 on left arm for an unspecified indication. Age at time of vaccination 8 decade old. Concomitant medications included amoxicillin, atenolol, cefuroxime, fluticasone, lansoprazole, lisinopril, azulfidine, tenormin and sulfasalazine. On 14-MAR-2021, the patient died within 24 hours of vaccination from an unknown cause of death. It was unknown whether an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20230123132, 20230124166, 20210650125 and 20230123136.; Sender's Comments: V0: 20230123126- Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

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Date of Admission: 10/20/2022 Date of Expiration: 10/29/2022 Diagnoses on Admission Order: COVID-19 [U07.1] Hypotension due to blood loss [I95.89, R58] Hypotension [I95.9] COVID [U07.1] Hospital Principal Problem (Discharge Diagnoses): COVID-19

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This is a 71y.o. female with PMH significant of HTN, type 2 DM, hyperlipidemia, PE, uterine sarcoma with lung metastates, recurrent TIAs, who was brought in by EMS for altered mentation and abnormal uterine bleeding. Admitted for L MCA stroke with slurred speech, facial droop, and RUE weakness. History of multiple strokes since September. Presented with significant AUB with Hb of 6. Received 2 units pRBC in ED. CT head showed findings suggestive of recurrent stroke. Patient and family requesting comfort care only. Hospice consulted, initially not in hospital candidate as symptoms were adequately managed by palliative care. Comfort medications were started and patient was kept comfortable. She was reevaluated by

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RHABDOMYOLYSIS; INTENSIVE CARE; COMA; TYPE 1 DIABETES MELLITUS; SARS-COV-2 TEST POSITIVE; LOSS OF CONSCIOUSNESS; DEVICE INFUSION ISSUE; DIABETIC KETOACIDOSIS; BLISTER; ISCHAEMIC HEPATITIS; CONFUSIONAL STATE; BLISTER; RHABDOMYOLYSIS; CONDITION AGGRAVATED; TYPE 1 DIABETES MELLITUS; CONFUSIONAL STATE; LOSS OF CONSCIOUSNESS; DEHYDRATION; DIABETIC KETOACIDOSIS; DEVICE INFUSION ISSUE; ISCHAEMIC HEPATITIS; INTENSIVE CARE; CONDITION AGGRAVATED; LIVER FUNCTION TEST INCREASED; DEHYDRATION; SARS-COV-2 TEST POSITIVE; LIVER FUNCTION TEST INCREASED; This spontaneous report received from a health care professional by a Regulatory Authority (VAERS (Vaccine Adverse Event Reporting System)(VAERS ID 2425263), FDA Inbound Unit) and concerned a 58 year old female of an unspecified race and ethnicity. Initial information was processed along with the additional information received on 13-SEP-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: Latex allergy, abilify allergy, adhesive allergy, dilaudid allergy, morphine allergy, vancomycin allergy, chronic obstructive pulmonary disease, chronic hypothyroidism, renal insufficiency, bipolar ii disorder, chronic hyperlipidemia, gastroesophageal reflux disease, neuropathy, hypertension, smoker, diabetes type 1 (controlled dx 1989), overweight, insulin pump in place, diabetic retinopathy associated with type 1 diabetes mellitus, and anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1802068 expiry: UNKNOWN) dose was not reported, administered 1 in total on 05-APR-2021 for an unspecified indication. Age at time of vaccination 58 years old. No concomitant medications were reported. On 21-AUG-2022, the patient was brought to hospital since the patient was unconscious at home, Initially thought to suffer from pump failure but later it was discovered that patients pump's battery died and she had actually ignored 2 warnings about line obstruction and low battery. It is plausible that patient had suffered covid-19 encephalopathy and due to the confusion was not able to manage her insulin pump and so it powered down causing her to go into DKA (Diabetic ketoacidosis) and coma. Patient was initially managed in ICU (intensive care unit) and is now stable on the floors. Rhabdomyolysis was resolved and improved with IV fluid hydration. Encourage continued hydration T1DM (type 1 diabetes mellitus). Patient is confident she is capable of managing her insulin pump. Patient was managed here with basal and prandial insulin. Plan is to go home and set up her pump. Home care ordered to check on the patient tomorrow to make sure patients insulin is set up with her pump. Patient was not having any COVID-19 sign of respiratory distress. No indication for covid-19 directed therapy. Patient was continued with supportive care. Superficial blisters on back and right butt cheek, blister on head local wound care was given, patients LFT's (liver function test) was Elevate unclear etiology may be due to shock in liver from dehydration. Hepatitis panel ordered. Patient was hospitalized for 6 days. date of discharge was not reported. Latency was 503 days. On 21-AUG-2022, the patient experienced rhabdomyolysis, coma, type 1 diabetes mellitus, loss of consciousness, diabetic ketoacidosis, ischaemic hepatitis, blister, condition aggravated, confusional state, dehydration, device infusion issue, intensive care, liver function test increased, sars-cov-2 test positive. Laboratory data included: SARS-CoV-2 PCR (polymerase chain reaction) test Positive. Liver function test Elevate. Patient has an appointment with endocrinology on 01-SEP-2022. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rhabdomyolysis, coma, type 1 diabetes mellitus, loss of consciousness, diabetic ketoacidosis, ischaemic hepatitis, blister, condition aggravated, confusional state, dehydration, device infusion issue, intensive care, liver function test increased, and sars-cov-2 test positive. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000251280 The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. Additional information was received from central complaint vigilance department on 04-OCT-2022. The following information was updated and incorporated into the case narrative: product quality complaint investigation result was added.; Sender's Comments: V1: This follow up version updates- Product quality complaint investigation result. This updated information does not alter the causality of previously reported events. 20220922861-covid-19 vaccine ad26.cov2.s-Rhabdomyolysis, Blister, sars-cov-2 test positive. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.(Event of rhadomyolysis reported around 16 months post vaccination and the patient experienced covid-19 encephalopathy which precipitated Rhabdomyolysis in patient with multiple co-morbidities, provides more plausible explanation) 20220922861-covid-19 vaccine ad26.cov2.s- coma, type 1 diabetes mellitus, loss of consciousness, diabetic ketoacidosis, ischaemic hepatitis, condition aggravated, confusional state, dehydration, device infusion issue, intensive care, liver function test increased. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.

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Breakthrough case admission after 1 Janssen vaccine; patient expired

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Breakthrough case admission after 1 Janssen vaccine; patient expired

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Provider d/c note: "59yr old female with a history of T1DM, GERD, COPD, Hypothyroidism, who was brought here after she was found unconscious at home. Initially thought to suffer from pump failure but later it was discovered that her pump's battery died and she had actually ignored 2 warnings about line obstruction and low battery. It is plausible that she had suffered covid encephalopathy and due to the confusion was not able to manage her insulin pump and so it powered down causing her to go into DKA and coma. She was initially managed in ICU and is now stable on the floors. I agree with the students assessment and plan including: DKA - Resolved Rhabdomyolysis - improved with IV fluid hydration. Encourage continued hydration T1DM - Patient is confident she is capable of managing her insulin pump. She was managed here with basal and prandial insulin. Plan is to go home and set up her pump. Home care ordered to check on her tomorrow to make sure her insulin is set up with her pump. She has an appointment with endocrinology on Sept 1st. COVID - no sign of respiratory distress. No indication for covid directed therapy. Continue with supportive care. Superficial Blisters on back and right butt cheek, blister on head - local wound care Elevate LFT's - unclear etiology, may be due to shock liver from dehydration. Hepatitis panel ordered - PCP to follow up. Plan is for repeat CMP on Monday and patient to follow up with PCP and consider liver imaging outpatient as indicated."

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Pt presented to the ED on 12/1 with CC of shortness of breath. His O2 saturation per his wife was 51%, was brought to the hospital. Per pt he had been short of breath for the past 12 hours prior to presentation. In ED pt was found to be positive for COVID-19. CXR showed bilateral infiltrates. His white blood cell was elevated at 22.63, Lactic acid was 6.5, His blood glucose was elevated at 477, sodium low at 129, elevated procalcitonin of 0.75, and CRP elevated at 12.5. The patient was admitted to moderate care with high-flow nasal cannula. He was started on remdesivir and decadron. Per wife at home his oxygen levels would be low in 80s when he wakes up and after up for a bit will come up with supplemental oxygen otherwise first hour or so runs in 80s. For Patient's acute on chronic hypoxemic respiratory failure is likely secondary to covid inflammation. Patient wears 4-6 L of oxygen at home. Patient received steroids and remdesivir in addition to azithromycin and vancomycin for 3 days. He was on a steroid taper however on 01/03/2022 patient's respiratory status worsened requiring BiPAP. His Decadron needed to be resumed at 6 mg on 01/04/2022. Sepsis workup was reinitiated and although previously Blood cx diptherioids and micrococcus 1/2 positive on 12/1. Repeat cx NG on 12/11. he received cefepime for 16d. Blood culture again positive for staph 2/2 on 01/04/2022. Repeat cultures are negative. Repeat Fungitell and Aspergillus negative. Patient was restarted on vancomycin per infectious disease. On 01/07/2022 patient was able to be weaned down to nasal cannula. Patient has COPD and needs his Trilogy set up at home. It was recalled. Pulmonary recommends decreasing his steroid by 1 mg every 3 days. Patient's hospitalization complicated by alcohol withdrawal requiring phenobarb taper. Patient also noted to have dysphagia. He is currently on dysphagia mechanically altered diet per speech recommendation. On the day of discharge patient denied any significant shortness of breath while on nasal cannula, chest pain, nausea, vomiting, shortness of breath. He was tolerating his oral intake.

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VAERS reporting as required by law, death occurred on 01/06/2022. janssen COVID 19 vaccine completed on 3/13/2021..

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Patient was hospitalized for Covid -19 on 12/21/2021 and subsequently developed pneumonia. Patient was hospityalized for 20 days and died on 1/9/22

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Patient presented to the ER presented to the emergency department with a chief complaint of shortness of breath. He tested positive for COVID-19 previously and was scheduled to have a monoclonal antibody infusion. When he went to the clinic and he was noted to be hypoxemic so he was sent here for further evaluation. Patient was complaining of generalized fatigue over the last 2-3 days. The degree of hypoxia was not reported or charted at the outlying facility. Patient denied any syncopal episode, chest pain, fever, chills, nausea, vomiting, diarrhea. Was diagnosed with COVID-19 recently, tested positive for COVID-19 and noted to be hypoxemic saturating 88% on room air in the emergency department. Chest x-ray showed pulmonary hyperexpansion with bilateral code infiltrates. He was transferred to the ICU as he developed pneumothorax, patient passed away on 01/06/2022.

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Patient presented to emergency department on 11/5/2021 with cough, fever, diarrhea, shortness of breath, and passing out. She had tested positive for COVID-19 on 10/29/2021. She was admitted for management of COVID-19 infection due to acute hypoxic respiratory failure. She was treated with dexamethasone, remdesivir, barcitinib, and supplemental oxygen. Her condition gradually improved and she was discharged to inpatient rehab facility on 11/15/2021.

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symptomatic COVID-19 after being vaccinated with 1 dose of J&J vaccine 1/11/22: pt starts having productive cough and weakness 1/19/22: COVID-19 positive test Acute hypoxemic respiratory failure COVID-19 Virus Infection Severe sfepsis, POA, d/t above Respiratory alkalosis d/t above Date of onset of symptoms: 1/11/2022 Symptoms present on admission: Productive cough, weakness Date of covid positive test: 1/18/2022 Vaccination status: vaccinated J&J vaccine Imaging: CXR -right mid and lower lung suspicious for pneumonitis/atypical pneumonia Oxygen requirements on admission: 4 L NC Medical therapy: Decadron Discharge home with oxygen and remainder of decadron course/albuterol.

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Discharged. Per ICU Course: " Patient is a 59-year-old female with a history of chronic obstructive pulmonary disease, coronary artery disease who presented to the emergency department on 01/14 with approximately 2 weeks of chest pain and shortness of breath. She was found to have increasing oxygen requirements, likely secondary to chronic obstructive pulmonary disease exacerbation with overlying COVID pneumonia. During workup in the emergency department patient had abrupt decompensation during which she desaturated and required intubation and 1 round of CPR before obtaining ROSC. At that point patient was placed on pressors for persistent hypotension post cardiac arrest and admitted to the medical intensive care unit intubated and sedated for further care of acute hypoxic respiratory failure. Patient was treated for COVID pneumonia and chronic obstructive pulmonary disease exacerbation, pressors and sedation or slowly weaned. Patient was able to be extubated on 01/16 and has been stable on 6 L nasal cannula since that time, she is on 2.5 L at baseline. She was initially found to have elevated troponins in the 200s, however there were stable and thought to be likely secondary to cardiac arrest. She had an abrupt elevation of her troponins on 1/16 with continued ST depressions in the lateral leads most notably V4 through V6, cardiology was consulted at this time for further evaluation. Patient remained hemodynamically stable off pressors and sedation, continued to maintain oxygen saturation above 95% on 6 L nasal cannula, and was improving from symptomatic standpoint. Cardiology has requested left heart catheterization some point during hospitalization although this is not urgent at this time. She is no longer requiring intensive care unit level of care secondary to no need for further pressors or respiratory support." Post ICU Care: - she continued to do well post extubation. She was able to wean off of her oxygen and she was placed on oral steroid taper. Cardiology did left heart cath with successful PCI with DES to proximal right posterior lateral branch. She was started on brillinta and eliquis after cath. She was started on metoprolol and lisinopril at lower dose than at home. Her oxygen saturation improved and she was at her baseline 2-3 liters of oxygen and 4 liters with exertion. She was also given prescription for norco as she was having rib pain following chest compression. Report from controlled medication registry has been reviewed. This patient will be prescribed an opioid analgesic at discharge. I have discussed the risks of taking this type of medication. This includes the risk of substance use disorder, addiction, overdose, and mixing with other sedating medications. For female patients of child bearing age I reviewed the risks of taking these medications while pregnant. I also reviewed the safe disposal of opioids and the fact that it is a felony to distribute these medications without a prescription. A "Start Talking" form will be signed by the patient at discharge.

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Patient is a 91-year-old female with history of CHF and last ejection fraction 3 years ago was 41%, atrial fibrillation on Coumadin With her daughter/caregiver presenting to the emergency departmentfor shortness of breath. Patient had a televisit with Dr. today who is covering for Dr., and noticed patient to appear short of breath and recommended she go to the emergency department. Daughter at bedside states yesterday patient was outside in the cold, and she is afraid she developed pneumonia. She also notes she has had diarrhea over the past couple of days, and patient stated she was nauseous last night. She also has had a decreased appetite over the past 3 days, daughter states all she had was a piece of toast yesterday. She did receive the Johnson & Johnson Covid vaccine. Associated Symptoms: appetite changes, bruise easily, cough, diarrhea, fatigue, nausea, shortness of breath

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Event occurred after vaccination. Patient tested positive for COVID Patient died

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Stroke. Continually falling over to right side after coming home from vaccine. Right eyelid drooping and blurry vision in right eye. Sight and eyelid drooping got worse over a period of two weeks and have remained this way since.

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Hospitalized 12/6/2021; COVID-19 positive 12/01/2021; fully vaccinated BRIEF OVERVIEW: Discharge Provider: Primary Care Provider at Discharge: Admission Date: 12/6/2021 Discharge Date: 12/21/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Community acquired pneumonia, bilateral [J18.9] Acute hypoxemic respiratory failure due to COVID-19 (HCC) [U07.1, J96.01] COVID-19 [U07.1] HOSPITAL COURSE: 32-year-old man presented to the ER on 12/06/2021 with shortness of breath. Had been vaccinated with Jane J vaccine however tested positive for COVID. Chest x-ray consistent with bilateral pulmonary opacifications. Patient was started on dexamethasone and remdesivir. He was also started on antibiotics for community-acquired bacterial pneumonia with ceftriaxone and azithromycin. Unfortunately he developed worsening respiratory failure requiring high-flow nasal cannula plus non-rebreather. The patient's course was tenuous. He received escalating doses of IV furosemide and weight based methylprednisolone. He did respond well to this with diuresis and improvement in oxygenation. D-dimer was markedly elevated and DVT workup with ultrasound was negative. Appreciate virtual intensive care unit consultation during this patient's stay. Transthoracic echocardiogram revealed an LVEF of 65% with a poorly visualized right ventricle. He ultimately did not require intubation and mechanical ventilation. Diuretics and steroids were weaned as he continue to improve. He did have a protracted recovery requiring gentle step down in oxygen support. He was placed on a prednisone taper. He was ultimately discharged on 12/21/2021 after evaluation for ambulatory oxygen

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ACUTE KIDNEY INJURY; CAROTID ARTERIOSCLEROSIS; CAROTID ARTERY STENOSIS; CEREBRAL SMALL VESSEL ISCHAEMIC DISEASE; CEREBROVASCULAR ACCIDENT; CONGENITAL CEREBROVASCULAR ANOMALY; ENCEPHALOPATHY; FACIAL BONES FRACTURE; HYPERTENSIVE EMERGENCY; VERTEBRAL ARTERY OCCLUSION; CONFIRMED CLINICAL VACCINATION FAILURE; COVID-19; BACK PAIN; ATELECTASIS; EXOSTOSIS; CENTRAL VENOUS CATHETERISATION; COGNITIVE DISORDER; EYE HAEMANGIOMA; FALL; GLIOSIS; CONDITION AGGRAVATED; HYPERTENSION; INJURY; HYPERTROPHY; LUNG DISORDER; LYMPH NODE CALCIFICATION; MASS; MENTAL STATUS CHANGES; OSTEOARTHRITIS; PAIN; POSTURE ABNORMAL; SCIATICA; SOFT TISSUE SWELLING; SCOLIOSIS; SPINAL OSTEOARTHRITIS; VERTEBRAL FORAMINAL STENOSIS; VERTEBRAL OSTEOPHYTE; WHITE MATTER LESION; BLOOD CULTURE NEGATIVE; ANGIOGRAM CEREBRAL ABNORMAL; ARTERIOGRAM CAROTID ABNORMAL; ANGIOGRAM NORMAL; PERFUSION BRAIN SCAN NORMAL; COMPUTERISED TOMOGRAM SPINE; COMPUTERISED TOMOGRAM ABDOMEN ABNORMAL; COMPUTERISED TOMOGRAM THORAX ABNORMAL; COMPUTERISED TOMOGRAM HEAD ABNORMAL; ELECTROENCEPHALOGRAM ABNORMAL; IMAGING PROCEDURE; INTERVERTEBRAL DISC SPACE NARROWING; MAGNETIC RESONANCE IMAGING; MAGNETIC RESONANCE IMAGING HEAD ABNORMAL; MAGNETIC RESONANCE IMAGING NECK; MAGNETIC RESONANCE IMAGING SPINAL ABNORMAL; SARS-COV-2 TEST POSITIVE; SCAN WITH CONTRAST ABNORMAL; This spontaneous report received from a other health professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1889703) concerned a 77 year old female. Initial information was processed along with the additional information received on 02-DEC-2021. The patient's height, and weight were not reported. The patient's past medical history included: diarrhea, decrease in appetite, sleep disturbance, weakness, and frequent falls, and concurrent conditions included: circulatory vertebral artery occlusion left, chronic kidney disease stage 2, benign paroxysmal positional vertigo, pulmonary embolism, hypothyroidism, anxiety, depression, nervous peripheral neuropathy, restless legs syndrome, sciatica, back pain, and etoh abuse. The patient was previously treated with hydralazine for hypertension, nicardipine for hypertension; and experienced agitation when treated with codeine. The patient received Covid-19 vaccine ad26.cov2. s (suspension for injection, intramuscular, batch number: 1802068 and expiry: unknown) dose was not reported, 1 total administered on left arm on 18-MAR-2021 for an unspecified indication. Concomitant medications included fosfomycin for chronic kidney disease, amlodipine besilate and Lisinopril for hypertension, acetylsalicylic acid, atorvastatin, atorvastatin calcium, levothyroxine sodium, salbutamol, salbutamol sulfate for unknown indication. On 10-NOV-2021, the patient fell while walking down the stairs to do laundry. She was referred to emergency room after being found down by her son. She was worked up for the fall with no acute findings on imaging. Her son states that after the fall patient had no facial bruising. She was noted to had an acute kidney injury (AKI) at that time and possible urinary tract infection (UTI) and was given a dose of fosfomycin. Since that fall she was doing fine. She had lot of pain because she was unable to get her usual injection (unspecified) for back pain with sciatica that she normally gets. She was found to be extremely hypertensive and was given hydralazine with no improvement and eventually was started on a nicardipine drip. The head computed tomography (CT) was done to rule out intracerebral brain hemorrhage (ICH) and Computed Tomography Perfusion (CTP) and computed tomography angiography (CTA) of head were done that ruled out ischemic stroke. CTA did show an occlusion of the left cervical vertebral artery of unknown chronicity. She was also found to have an acute kidney injury and be COVID positive. Her pulse oxygen was stable on room air. She was placed on NC due to encephalopathy, Encephalopathy unclear etiology and she had Continuous electroencephalogram (cEEG0 with presence of generalized periodic discharges with triphasic morphology was suggestive of an underlying encephalopathy which was nonspecific but typically seen in the setting of toxic or metabolic dysfunction. The Neck magnetic resonance imaging (MRI) was negative for fracture. The COVID infection did not meet protocol for remdesivir and Decadron The hypertensive emergency was not well controlled. The cardine drip was stopped and started on oral blood pressure medications including Lisinopril Norvasc and Hydrochlorothiazide. On 12-NOV-2021, the patient tested positive for sars-cov (severe acute respiratory syndrome coronavirus)-2 test and experienced confirmed clinical vaccination failure and covid-19, acute kidney injury, carotid arteriosclerosis, carotid artery stenosis, cerebral small vessel ischemic disease, cerebrovascular accident, congenital cerebrovascular anomaly, encephalopathy, facial bones fracture, hypertensive emergency, vertebral artery occlusion, angiogram cerebral abnormal, angiogram normal, arteriogram carotid abnormal, atelectasis, blood culture negative, central venous catheterization, cognitive disorder. The following events were also reported computerized tomogram abdomen abnormal, computerized tomogram head abnormal, computerized tomogram spine, computerized tomogram thorax abnormal, condition aggravated, electroencephalogram abnormal, exostosis, eye hemangioma, fall, gliosis, hypertension, hypertrophy, imaging procedure, injury, intervertebral disc space narrowing, lung disorder, lymph node calcification, magnetic resonance imaging, magnetic resonance imaging head abnormal, magnetic resonance imaging neck, magnetic resonance imaging spinal abnormal, mass, mental status changes, osteoarthritis, pain, perfusion brain scan normal, posture abnormal, scan with contrast abnormal, sciatica, scoliosis, soft tissue swelling, spinal osteoarthritis, vertebral foraminal stenosis, vertebral osteophyte, white matter lesion. Patient discharged after inpatient 6 day stay on 18-NOV-2021. Laboratory data included: Angiogram (NR: not provided) Normal, Angiogram cerebral (NR: not provided) was performed at 17:09 and there is no evidence of intracranial aneurysm or other vascular lesion was found, Arteriogram carotid (NR: not provided) was performed at 18:03 and there is occlusion of the left cervical vertebral artery proximally found, Blood culture (NR: not provided) negative, Computerized tomogram abdomen (NR: not provided) abnormal, Computerized tomogram head (NR: not provided) abnormal, Computerized tomogram thorax (NR: not provided) abnormal, Computerized tomography (NR: not provided) No acute fracture dislocation, Normal, Electroencephalogram (NR: not provided) abnormal, Imaging procedure (NR: not provided) not specified, Magnetic resonance imaging (NR: not provided) not specified, Magnetic resonance imaging head (NR: not provided) abnormal, Magnetic resonance imaging neck (NR: not provided) negative, Magnetic resonance imaging spinal (NR: not provided) abnormal, Perfusion brain scan (NR: not provided) was performed at 17:19 and there is no regional abnormality of relative cerebral blood flow (rCBF), relative cerebral blood volume (rCBV), Infarct core volume CBF greater than 30percent : 0 mL and Critical hypoperfusion volume Tmax less than 6 sec was found, and Scan with contrast (NR: not provided) abnormal, Magnetic resonance imaging spine cervical with and without contrast performed at 15:14 and no discrete lesion was found in the cervical spinal cord Vertebrae, Magnetic resonance imaging brain with and without contrast performed at 15:06 and had no evidence of acute infarction, Computerized tomography chest, abdomen and pelvis with contrast in which There is no lymph node, heart has a normal size and No contusion Pleural Space. The pancreas is normal Spleen. The stomach and small bowel are normal with no obstruction or inflammation. Computerized tomography interpret spine lumbar with contrast performed at 18:23 Lumbar spine scoliosis and degeneration and no acute fracture dislocation was found. Computerized tomography interpret spine thoracic with contrast at 18:20. Thoracic spine scoliosis and degeneration and no acute fracture dislocation was found. Computerized tomography spine cervical with contrast at 18:16. No acute fracture dislocation was found. Computerized tomography maxillofacial without iv contrast performed 18:07 and there is a nondisplaced acute left nasal bone fracture was found. Single view chest was normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the acute kidney injury, angiogram cerebral abnormal, angiogram normal, arteriogram carotid abnormal, atelectasis, back pain, blood culture negative, carotid arteriosclerosis, carotid artery stenosis, central venous catheterization, cerebral small vessel ischemic disease, cerebrovascular accident, cognitive disorder, computerized tomogram abdomen abnormal, computerized tomogram head abnormal, computerized tomogram spine, computerized tomogram thorax abnormal, condition aggravated, congenital cerebrovascular anomaly, electroencephalogram abnormal, encephalopathy, exostosis, eye haemangioma, facial bones fracture, fall, gliosis, hypertension, hypertensive emergency, hypertrophy, imaging procedure, injury, intervertebral disc space narrowing, lung disorder, lymph node calcification, magnetic resonance imaging, magnetic resonance imaging head abnormal, magnetic resonance imaging neck, magnetic resonance imaging spinal abnormal, mass, mental status changes, osteoarthritis, pain, perfusion brain scan normal, posture abnormal, sars-cov-2 test positive, scan with contrast abnormal, sciatica, scoliosis, soft tissue swelling, spinal osteoarthritis, vertebral artery occlusion, vertebral foraminal stenosis, vertebral osteophyte, white matter lesion, covid-19, confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This case is associated with product quality complaint: 90000205225 The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. Additional information received from Central Complaint Vigilance department on 21-DEC-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1:This version updates PQC, previous causality assessment retained. 20211201324-Covid-19 vaccine ad26.cov2.s-Acute kidney injury, vertebral artery occlusion, Sciatica. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORYCovid-19 vaccine ad26.cov2.s- Angiogram cerebral abnormal,angiogram normal,arteriogram carotid abnormal,atelectasis,back pain,blood culture negative,carotid arteriosclerosis,carotid artery stenosis, central venous catheterization,cerebral small vessel ischemic disease,cerebrovascular accident, cognitive disorder,CT abdomen abnormal,CT head abnormal,CT spine,CT thorax abnormal,condition aggravated,congenital cerebrovascular anomaly,EEG abnormal,encephalopathy,exostosis, eye haemangioma,facial bones fracture,fall, gliosis,HTN,hypertensive emergency,hypertrophy,imaging procedure,injury,intervertebral disc space narrowing,lung disorder,lymph node calcification,MRI,MRI head abnormal,MRI neck,MRI spinal abnormal,mass,mental status changes,osteoarthritis,pain,perfusion brain scan normal,posture abnormal,sars-cov-2 test positive, scan with contrast abnormal,scoliosis,soft tissue swelling,spinal osteoarthritis,vertebral foraminal stenosis,vertebral osteophyte,white matter lesion,covid-19.This event is considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, have unknown scientific plausibility.There is no information on any other factors potentially associated with the events.Covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure.This event is considered not related.The event has a compatible/suggestive temporal relationship,is unlabeled, has unknown scientific plausibility.There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

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ACUTE KIDNEY INJURY; CAROTID ARTERIOSCLEROSIS; CAROTID ARTERY STENOSIS; CEREBRAL SMALL VESSEL ISCHAEMIC DISEASE; CEREBROVASCULAR ACCIDENT; CONGENITAL CEREBROVASCULAR ANOMALY; ENCEPHALOPATHY; FACIAL BONES FRACTURE; HYPERTENSIVE EMERGENCY; VERTEBRAL ARTERY OCCLUSION; CONFIRMED CLINICAL VACCINATION FAILURE; COVID-19; BACK PAIN; ATELECTASIS; EXOSTOSIS; CENTRAL VENOUS CATHETERISATION; COGNITIVE DISORDER; EYE HAEMANGIOMA; FALL; GLIOSIS; CONDITION AGGRAVATED; HYPERTENSION; INJURY; HYPERTROPHY; LUNG DISORDER; LYMPH NODE CALCIFICATION; MASS; MENTAL STATUS CHANGES; OSTEOARTHRITIS; PAIN; POSTURE ABNORMAL; SCIATICA; SOFT TISSUE SWELLING; SCOLIOSIS; SPINAL OSTEOARTHRITIS; VERTEBRAL FORAMINAL STENOSIS; VERTEBRAL OSTEOPHYTE; WHITE MATTER LESION; BLOOD CULTURE NEGATIVE; ANGIOGRAM CEREBRAL ABNORMAL; ARTERIOGRAM CAROTID ABNORMAL; ANGIOGRAM NORMAL; PERFUSION BRAIN SCAN NORMAL; COMPUTERISED TOMOGRAM SPINE; COMPUTERISED TOMOGRAM ABDOMEN ABNORMAL; COMPUTERISED TOMOGRAM THORAX ABNORMAL; COMPUTERISED TOMOGRAM HEAD ABNORMAL; ELECTROENCEPHALOGRAM ABNORMAL; IMAGING PROCEDURE; INTERVERTEBRAL DISC SPACE NARROWING; MAGNETIC RESONANCE IMAGING; MAGNETIC RESONANCE IMAGING HEAD ABNORMAL; MAGNETIC RESONANCE IMAGING NECK; MAGNETIC RESONANCE IMAGING SPINAL ABNORMAL; SARS-COV-2 TEST POSITIVE; SCAN WITH CONTRAST ABNORMAL; This spontaneous report received from a other health professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1889703) concerned a 77 year old female. Initial information was processed along with the additional information received on 02-DEC-2021. The patient's height, and weight were not reported. The patient's past medical history included: diarrhea, decrease in appetite, sleep disturbance, weakness, and frequent falls, and concurrent conditions included: circulatory vertebral artery occlusion left, chronic kidney disease stage 2, benign paroxysmal positional vertigo, pulmonary embolism, hypothyroidism, anxiety, depression, nervous peripheral neuropathy, restless legs syndrome, sciatica, back pain, and etoh abuse. The patient was previously treated with hydralazine for hypertension, nicardipine for hypertension; and experienced agitation when treated with codeine. The patient received Covid-19 vaccine ad26.cov2. s (suspension for injection, intramuscular, batch number: 1802068 and expiry: unknown) dose was not reported, 1 total administered on left arm on 18-MAR-2021 for an unspecified indication. Concomitant medications included fosfomycin for chronic kidney disease, amlodipine besilate and Lisinopril for hypertension, acetylsalicylic acid, atorvastatin, atorvastatin calcium, levothyroxine sodium, salbutamol, salbutamol sulfate for unknown indication. On 10-NOV-2021, the patient fell while walking down the stairs to do laundry. She was referred to emergency room after being found down by her son. She was worked up for the fall with no acute findings on imaging. Her son states that after the fall patient had no facial bruising. She was noted to had an acute kidney injury (AKI) at that time and possible urinary tract infection (UTI) and was given a dose of fosfomycin. Since that fall she was doing fine. She had lot of pain because she was unable to get her usual injection (unspecified) for back pain with sciatica that she normally gets. She was found to be extremely hypertensive and was given hydralazine with no improvement and eventually was started on a nicardipine drip. The head computed tomography (CT) was done to rule out intracerebral brain hemorrhage (ICH) and Computed Tomography Perfusion (CTP) and computed tomography angiography (CTA) of head were done that ruled out ischemic stroke. CTA did show an occlusion of the left cervical vertebral artery of unknown chronicity. She was also found to have an acute kidney injury and be COVID positive. Her pulse oxygen was stable on room air. She was placed on NC due to encephalopathy, Encephalopathy unclear etiology and she had Continuous electroencephalogram (cEEG0 with presence of generalized periodic discharges with triphasic morphology was suggestive of an underlying encephalopathy which was nonspecific but typically seen in the setting of toxic or metabolic dysfunction. The Neck magnetic resonance imaging (MRI) was negative for fracture. The COVID infection did not meet protocol for remdesivir and Decadron The hypertensive emergency was not well controlled. The cardine drip was stopped and started on oral blood pressure medications including Lisinopril Norvasc and Hydrochlorothiazide. On 12-NOV-2021, the patient tested positive for sars-cov (severe acute respiratory syndrome coronavirus)-2 test and experienced confirmed clinical vaccination failure and covid-19, acute kidney injury, carotid arteriosclerosis, carotid artery stenosis, cerebral small vessel ischemic disease, cerebrovascular accident, congenital cerebrovascular anomaly, encephalopathy, facial bones fracture, hypertensive emergency, vertebral artery occlusion, angiogram cerebral abnormal, angiogram normal, arteriogram carotid abnormal, atelectasis, blood culture negative, central venous catheterization, cognitive disorder. The following events were also reported computerized tomogram abdomen abnormal, computerized tomogram head abnormal, computerized tomogram spine, computerized tomogram thorax abnormal, condition aggravated, electroencephalogram abnormal, exostosis, eye hemangioma, fall, gliosis, hypertension, hypertrophy, imaging procedure, injury, intervertebral disc space narrowing, lung disorder, lymph node calcification, magnetic resonance imaging, magnetic resonance imaging head abnormal, magnetic resonance imaging neck, magnetic resonance imaging spinal abnormal, mass, mental status changes, osteoarthritis, pain, perfusion brain scan normal, posture abnormal, scan with contrast abnormal, sciatica, scoliosis, soft tissue swelling, spinal osteoarthritis, vertebral foraminal stenosis, vertebral osteophyte, white matter lesion. Patient discharged after inpatient 6 day stay on 18-NOV-2021. Laboratory data included: Angiogram (NR: not provided) Normal, Angiogram cerebral (NR: not provided) was performed at 17:09 and there is no evidence of intracranial aneurysm or other vascular lesion was found, Arteriogram carotid (NR: not provided) was performed at 18:03 and there is occlusion of the left cervical vertebral artery proximally found, Blood culture (NR: not provided) negative, Computerized tomogram abdomen (NR: not provided) abnormal, Computerized tomogram head (NR: not provided) abnormal, Computerized tomogram thorax (NR: not provided) abnormal, Computerized tomography (NR: not provided) No acute fracture dislocation, Normal, Electroencephalogram (NR: not provided) abnormal, Imaging procedure (NR: not provided) not specified, Magnetic resonance imaging (NR: not provided) not specified, Magnetic resonance imaging head (NR: not provided) abnormal, Magnetic resonance imaging neck (NR: not provided) negative, Magnetic resonance imaging spinal (NR: not provided) abnormal, Perfusion brain scan (NR: not provided) was performed at 17:19 and there is no regional abnormality of relative cerebral blood flow (rCBF), relative cerebral blood volume (rCBV), Infarct core volume CBF greater than 30percent : 0 mL and Critical hypoperfusion volume Tmax less than 6 sec was found, and Scan with contrast (NR: not provided) abnormal, Magnetic resonance imaging spine cervical with and without contrast performed at 15:14 and no discrete lesion was found in the cervical spinal cord Vertebrae, Magnetic resonance imaging brain with and without contrast performed at 15:06 and had no evidence of acute infarction, Computerized tomography chest, abdomen and pelvis with contrast in which There is no lymph node, heart has a normal size and No contusion Pleural Space. The pancreas is normal Spleen. The stomach and small bowel are normal with no obstruction or inflammation. Computerized tomography interpret spine lumbar with contrast performed at 18:23 Lumbar spine scoliosis and degeneration and no acute fracture dislocation was found. Computerized tomography interpret spine thoracic with contrast at 18:20. Thoracic spine scoliosis and degeneration and no acute fracture dislocation was found. Computerized tomography spine cervical with contrast at 18:16. No acute fracture dislocation was found. Computerized tomography maxillofacial without iv contrast performed 18:07 and there is a nondisplaced acute left nasal bone fracture was found. Single view chest was normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the acute kidney injury, angiogram cerebral abnormal, angiogram normal, arteriogram carotid abnormal, atelectasis, back pain, blood culture negative, carotid arteriosclerosis, carotid artery stenosis, central venous catheterization, cerebral small vessel ischemic disease, cerebrovascular accident, cognitive disorder, computerized tomogram abdomen abnormal, computerized tomogram head abnormal, computerized tomogram spine, computerized tomogram thorax abnormal, condition aggravated, congenital cerebrovascular anomaly, electroencephalogram abnormal, encephalopathy, exostosis, eye haemangioma, facial bones fracture, fall, gliosis, hypertension, hypertensive emergency, hypertrophy, imaging procedure, injury, intervertebral disc space narrowing, lung disorder, lymph node calcification, magnetic resonance imaging, magnetic resonance imaging head abnormal, magnetic resonance imaging neck, magnetic resonance imaging spinal abnormal, mass, mental status changes, osteoarthritis, pain, perfusion brain scan normal, posture abnormal, sars-cov-2 test positive, scan with contrast abnormal, sciatica, scoliosis, soft tissue swelling, spinal osteoarthritis, vertebral artery occlusion, vertebral foraminal stenosis, vertebral osteophyte, white matter lesion, covid-19, confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This case is associated with product quality complaint: 90000205225 The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. Additional information received from Central Complaint Vigilance department on 21-DEC-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1:This version updates PQC, previous causality assessment retained. 20211201324-Covid-19 vaccine ad26.cov2.s-Acute kidney injury, vertebral artery occlusion, Sciatica. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORYCovid-19 vaccine ad26.cov2.s- Angiogram cerebral abnormal,angiogram normal,arteriogram carotid abnormal,atelectasis,back pain,blood culture negative,carotid arteriosclerosis,carotid artery stenosis, central venous catheterization,cerebral small vessel ischemic disease,cerebrovascular accident, cognitive disorder,CT abdomen abnormal,CT head abnormal,CT spine,CT thorax abnormal,condition aggravated,congenital cerebrovascular anomaly,EEG abnormal,encephalopathy,exostosis, eye haemangioma,facial bones fracture,fall, gliosis,HTN,hypertensive emergency,hypertrophy,imaging procedure,injury,intervertebral disc space narrowing,lung disorder,lymph node calcification,MRI,MRI head abnormal,MRI neck,MRI spinal abnormal,mass,mental status changes,osteoarthritis,pain,perfusion brain scan normal,posture abnormal,sars-cov-2 test positive, scan with contrast abnormal,scoliosis,soft tissue swelling,spinal osteoarthritis,vertebral foraminal stenosis,vertebral osteophyte,white matter lesion,covid-19.This event is considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, have unknown scientific plausibility.There is no information on any other factors potentially associated with the events.Covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure.This event is considered not related.The event has a compatible/suggestive temporal relationship,is unlabeled, has unknown scientific plausibility.There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

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11/17/21 pt started having COVID-19 symptoms 11/22/21 tested positive for COVID-19 11/27/21 admitted with SOB 11/29/21 intubated after failing bipap 12/01/2021 pt expired

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Pt COVID positive 11/21/21 and admitted to ED on 11/24/21 with cough and dyspnea During her hospitalization, she developed MRSA pneumonia and was treated with a course of ceftaroline. She was on bipap until 12/04 when her respiratory statu declined and she required intubation. Her pressor requirement increased as did her oxygenation status and palliative was consulted for goals of care. She began to have acute renal failure likely secondary to sepsis, hypotension and increasing pressor requirements. The family decided that the patient would have wanted to be DNR-CCA and code status was changed. The patient expired shortly after.

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2019 Novel Coronavirus RNA detected 11/17/1021 Hospitalized 11/17/2021 Patient died

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Patient deceased on 11/28/2021. Patient fully vaccinated against covid-19 with booster dose administered on 11/12/2021. Janssen vaccine, Lot # 1822811.

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Patient expired 12/1/21 following discharge from inpatient admission and transferred to hospice care. Patient was admitted for (7) days 11/23-11/30/2021. Patient is an 82-year-old male with past medical history significant for AFib, hypertension, asthma/chronic obstructive pulmonary disease, type 2 diabetes, nonischemic cardiomyopathy, history of VFib status post ICD placement who presented to the emergency department with chief complaint of fatigue, fever and confusion. In the emergency department, patient was hypoxemic and placed on supplemental oxygen. Chest x-ray revealed peripheral opacities. Patient was positive for COVID-19. Patient is vaccinated with Johnson & Johnson, no booster. He was admitted to the Internal Medicine Service. He was started on Decadron. CT head was obtained which revealed no acute intracranial hemorrhage but with areas of age indeterminate regions of low attenuation potentially subacute an additional areas of age indeterminate mild small-vessel ischemic changes and a chronic appearing small infarct. Neurology was consulted. Neurology felt findings were likely chronic cardioembolic infarcts that the patient likely has undiagnosed dementia, mixed type Alzheimer and vascular. They recommended outpatient follow-up in the dementia clinic in 3 months. The patient had poor oral intake and a Corpak was placed and the patient was started on tube feeds. DGMS was consulted to help manage blood sugars. Palliative care was consulted for goals of care; the patient requested a meeting with hospice.. Family met with hospice and decided to discharge home with hospice. Xarelto stopped per family request. Discharged with oral morphine, haldol & ativan per hospice recommendations

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Deceased 11/12/2021; Hospitalized 11/11/2021; COVID-19 positive 11/10/2021; fully vaccinated BRIEF OVERVIEW: Discharge Provider: DO Primary Care Physician at Discharge: MD Admission Date: 11/11/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute UTI Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present COVID-19 HOSPITAL COURSE: Patient is a 88 y.o. female, with a PMH of atrial fibrillation, CHF, CKD stage 3, hypertension, asthma, depression, anxiety, chronic pain, hypothyroidism, mild cognitive impairment, who presented to the emergency department with ongoing nausea/vomiting and diarrhea. In the ED the patient was noted to be hypertensive with an elevated heart rate. EKG confirmed AFib with RVR. She was noted to be hypoxic and placed on 3 L. Laboratory evaluation revealed an elevated white blood cell count and a lactate of 5.6 which trended down to 5.1 following 1 L of normal saline. Chest x-ray showed extensive multifocal pulmonary opacities. CT of the abdomen and pelvis showed evidence of COVID-19 pneumonia with small to moderate pleural effusions and marked cardiomegaly. She did test positive for COVID-19. Urinalysis was suspicious for urinary tract infection. Patient was given a total of 2 L of normal saline, Decadron Rocephin. She was admitted to the hospitalist service for further care. She has an out of hospital DNR on file. Overnight her work of breathing increased as well as oxygen demand. She also became hyopthermic and hypotensive. Due to decline overnight and wishes to be DNR patient's family was contacted and planned to be at bedside by morning however a RAP was called at 715am for hypotension. On evaluation the patient had no chest rise and was not breathing. Tele showed asystole. Pronunciation of death was completed at 0720 and family was informed (daughter and son-2 children. Her other son was not able to be reached) along with patients PCP. Death certification to be completed by admitting physician.

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Pt has Hodgkin's lymphoma (receiving weekly Rituxan treatments) and severe terminal idiopathic pulmonary fibrosis (requiring home oxygen). Pt has a productive cough, fever, chills, and body aches. Pt admitted with COVID-19 infection with pneumonia with acute on chronic respiratory failure.

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ACUTE KIDNEY INJURY; ACUTE RESPIRATORY FAILURE; CHRONIC KIDNEY DISEASE; THROMBOCYTOPENIA; INSULIN-REQUIRING TYPE 2 DIABETES MELLITUS; COVID-19; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAERS ID: 1814711) concerned a 55 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068 expiry: UNKNOWN) dose was not reported, frequency 1 total administered on 01-APR-2021 on left arm for an unspecified indication. Drug start period was 204 days. No concomitant medications were reported. On 22-OCT-2021, the patient experienced acute kidney injury, acute respiratory failure (acute hypoxemic respiratory failure due to COVID-19), chronic kidney disease (stage III), insulin-requiring type 2 diabetes mellitus, thrombocytopenia and covid-19 (suspected clinical vaccination failure) and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from acute kidney injury, acute respiratory failure, covid-19, chronic kidney disease, insulin-requiring type 2 diabetes mellitus, and thrombocytopenia, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000201376. The suspected product quality complaint has been confirmed to be Disposition: Undetermined. The reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. Additional information received from Central Complaint Vigilance department on 16-NOV-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V2: Additional version created for follow up information as- Product quality complaint investigation result. This updated information does not alter the causality of previously reported events 20211115317-covid-19 vaccine ad26.cov2.s-acute kidney injury, acute respiratory failure, covid-19, chronic kidney disease, insulin-requiring type 2 diabetes mellitus, and thrombocytopenia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211115317-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

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Shortness of breath; pneumonia due to COVID-19 virus; acute respiratory failure with hypoxia

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Patient presented to emergency room on 9/4/2021 with generalized body aches and loss of consciousness. He was found to be COVID-19 positive on 9/3/2021. Patient's symptom were mild at that time and was discharged home with instructions for further management. Patient presented to emergency room again on 9/7/2021 with chest pain and shortness of breath. He was immediately placed on high-flow nasal cannula and admitted for further management. He was treated with dexamethasone and baricitinib and was transferred to the ICU on 9/8/2021. Patient's condition continued to deteriorate and he was intubated on 9/24/2021. Patient's condition was further complicated with bacterial infection, septic shock, acute renal failure requiring CRRT, acute toxic metabolic encephalopathy, and GI bleeding. Patient went into PEA arrest on 10/18/2021 and was unable to be resuscitated. Patient expired on 10/18/2021.

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Hospitalized (10.19.21 - current); COVID-19 positive (10.17.21); Fully vaccinated Chief complaint Shortness of breath History of Present Illness: Patient is a 61 y.o. male with a PMH including diabetes, COPD, T2DM, hypertension, obesity who presents for a 6 day history of worsening shortness of breath. He reports that symptoms started approximately last Thursday and have consisted of shortness of breath, cough productive of clear sputum, decreased appetite. He reports he was unable to ambulate very short distances without getting winded. He is not on oxygen at baseline. Additionally, he notes that his eyes have been burning, with some yellow discharge which has improved. He also endorses intermittent headaches since symptom onset. He was previously seen in the emergency department yesterday as well as the day before and diagnosed with COVID-19 on 10/17/2021. With these previous visits he was given Decadron 6 mg oral. He also got a nebulizer and tried to use this for his breathing, but reports that his oxygen was still in the mid 80s. He reports he is vaccinated against COVID-19, his wife was also recently diagnosed. On presentation to the emergency department, patient arrived hypoxic at 84% on room air, tachycardic, afebrile. He was placed on 6 L nasal cannula. Patient given dose of Decadron and Remsevere. He is admitted for further management of COVID-19 pneumonia. Progress Note from 10.26.21 (still admitted): Subjective LOS: 7; Patient seen lying on left side in bed. States his breathing is about the same as yesterday but he does note that change from the high-flow nasal cannula to the intermediate flow nasal cannula. He said this current setup is much more comfortable and easy to sleep. He does not feel significantly short of breath with oxygen in place at rest but does continue to note dyspnea with ambulation. Denies any additional symptoms such as chest pain, belly pain, nausea, vomiting. Assessment/Plan COVID 19 Pneumonia Acute Hypoxic Respiratory Failure Oxygen requirement decreasing very slowly, still short of breath with minimal exertion Presenting symptoms: Shortness of breath, cough Vaccinated COVID 19 detected by PCR: 10/17/21. CXR with findings of streaky basilar airspace disease on 10/18/21. Current oxygen requirement 60% FiO2 HFNC Severe Respiratory isolation Dexamethasone 6 mg oral daily (day 10/10) Completed 5 day course of remdesivir 10/23 Daily labs CBC with differential, CMP, D-dimer Tessalon pearls Monitor I/O Continuous pulse oximetry Recommend proning VTE prophylaxis with Lovenox Renal function stable, continue IV Lasix 20mg daily COPD Acute exacerbation of COPD, now resolved Initially with acute exacerbation given increased SOB and sputum production. - s/p azithromycin 500mg x 3d - Albuterol, dulera ordered

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I woke up one morning and I couldn't move the right side of my face I thought I was having a stroke. I went to the ER for treatment where I was diagnosed with Bell's Palsy. I had a CT Scan of my head and brain and I also had bloodwork done. I experienced paralysis on my face.

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Patient required hospitalization due to breakthrough infection. Patient received J&J vaccine on 03/11/21. Patient was hospitalized from 08/01/2021 - 08/17/2021. Below is copied from patients discharge (death) summary: Hospital Course: a 67 y.o. male with a PMH of Type II DM and HFpEF who initially presented to the ED complaining of shortness of breath with a recent COVID positive result. Patient stated this started around 7/26/2021 along with a nonproductive cough, subjective fevers, loss of appetite and nausea, with minimal diarrhea. He described the cough as being nonproductive. On the morning of 8/01/2021 the cough worsened which prompted him to call EMS. On arrival to the ED his SpO2 was at 81%-86% on room air. He was then placed on HFNC at 60L and FiO2 on 60% which brought his SpO2 at 94%. Pt stated he was vaccinated on March with J&J. He finished coverage. MICU consulted for increasing oxygen requirements. At the time of consult, he was sating 90% of max settings on HFNC, however pt was intubated on 8/9 due to respiratory failure. Upon discussion patient confirmed he is full code. On 8/10 pt desatted with development of SubQ emphysema. Stat CXR revealed large pneumomediastinum and pneumothorax. Emergent right sided Pigtail catheter was placed with increase in O2 sats. Patient self-extubated on 8/14 followed by desaturation to the 50s, he was subsequently re-intubated. I was called to patient?s bedside to pronounce that patient has expired. No spontaneous movements were present. There was not response to verbal or tactile stimuli. Pupils were dilated and fixed. No breath sounds were appreciated over either lung field. No carotid pulses or peripheral pulses were palpable. No heart sounds were auscultated over entire precordium. Patient pronounced dead at 1903. Dr. notified. Family were notified. Condolences offered. Chaplain and postmortem services offered. Pt was Full code. Time of death was 1903, confirmed and witnessed by Nurse.

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LEFT SIDED WEAKNESS; STROKE; BRAIN BLEED; WEAKNESS; TIRED; SORE ARM; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 200 pounds, and height was 61 inches. The patient's concurrent conditions included: diabetes, non smoker, and non-alcoholic, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with metformin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 25-MAR-2021 on left arm for prophylactic vaccination. Concomitant medications included atorvastatin calcium, citalopram hydrobromide, clopidogrel, empagliflozin, famotidine, ferrous sulfate, gabapentin, levothyroxine sodium, meclozine hydrochloride/nicotinic acid, meloxicam, and ropinirole hydrochloride, unspecified Vitamins 11 pills, 3 pills, then 7 pills throughout the day for drug used for unknown indication. On 25-MAR-2021, the patient experienced sore arm for a couple days after receiving the vaccine. On 29-MAR-2021, four days after vaccination the patient experienced stroke and brain bleed, an ambulance was called for where she stated that she had a brain bleed and they gave her Alteplase (tPA). The patient underwent Computed tomography (CAT) scan done in the first hospital. She was taken by ambulance to a second hospital, where she was admitted to the Intensive care unit (ICU) for 4 to 6 days, and then on the regular unit for a couple. The patient was not admitted to the first hospital, she was admitted to the second hospital after testing and unspecified bloodwork. The patient was hospitalized for three months. The patient started getting tired and weak she believed sometime in APR-2021, her memory regarding the whole event was foggy. On an unspecified day, the patient was sent to a nursing home and at the nursing home, she had rehab done for her left sided weakness. They wanted her to stay in the nursing home, but she wanted to go home. The patient ended up staying in the nursing home for all of APR-2021, MAY-2021 and JUN-2021. She had caretakers that came to visit her at home. She was unaware for the reason for the hospital visits, she did not remember much about these events, only what was been told to her. On follow-up visit with a nurse at the end of MAY-2021, where the nurse noted that the brain bleed had resolved. All of the symptoms had resolved, except for residual left-sided weakness. She did not currently have a PCP. She had a doctor that visited her house, who wanted to send her to a cardiologist, but the cardiologist said her heart was clear. This doctor was aware of all of the events that took place, and she stated that the nursing home notified the doctor of everything that happened. Laboratory data (dates unspecified) included: Blood test (NR: not provided) not provided, CAT scan (NR: not provided) not provided. Treatment medications (dates unspecified) included: alteplase. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from brain bleed on MAY-2021, and sore arm, weakness, and tired, had not recovered from left sided weakness, and the outcome of stroke was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210949921-COVID-19 VACCINE AD26.COV2.S-Stroke, Brain bleed, Left sided weakness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

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Strokes approximately 5 months after vaccine

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73 y.o. male patient with PMH of DM, HTN, HLD presented to the ED on 8/26/21 due to not feeling well. He states over the past few days he has felt off, but nothing in particular hurt Covid-19 Virus Infection Acute hypoxic respiratory failure Date of onset of symptoms: Few days ago Symptoms present on admission: fatigue Date of covid positive test: 8/26/2021 Vaccination status: vaccinated-JJ vaccine 3/8/21 Imaging: CXR reviewed with no acute process. Oxygen requirements on admission: Room air Current oxygen requirements: RA Medical therapy: Dexamethasone against hypoxemia Consultants following: Pulmonology Anticipated special isolation end date: 9/4 Remdesivir held against AKI DKA Diabetes Mellitus type 2 Due to non-compliance and infection as above Glucose 620, pH 7.08, AG >27, BHB 5.6 Holding home diabetes medications A1c 8.9 Started on DKA protocol Out of acidosis, transition to Lantus 20U BID with ssi Discharge on home insulin regimen and off steroids to avoid hyperglycemia AKI Cr 2.06 on admission, baseline unknown Suspect pre-renal due to dehydration from DKA IVF given Cr 0.6 on 8/30, remains resolved. HTN Continue Norvasc BP stable

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Pulmonary embolism; COVID-19 pneumonia; Pneumomediastinum; Angiogram pulmonary abnormal; Anticoagulant therapy; Subcutaneous emphysema; SARS-CoV-2 test positive; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID:1662854) concerned a 61 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: gastroesophageal reflux disease (GERD), and hypercholesteremia, and other pre-existing medical conditions included: No known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068 and expiry: unknown) dose was not reported, 1 total was administered on 01-APR-2021 for prophylactic vaccination. Concomitant medications included apixaban, escitalopram oxalate, rosuvastatin calcium and omeprazole for drug used for unknown indication. On 29-JUL-2021, the patient underwent COVID-19 polymerase chain reaction (PCR) test which was found to be positive (Sars-cov-2 test positive; confirmed clinical vaccination failure). On 05-AUG-2021, he experienced pulmonary embolism, Covid-19 pneumonia, pneumomediastinum, angiogram pulmonary abnormal, anticoagulant therapy, subcutaneous emphysema. He was fully vaccinated and tested positive for Covid-19 (confirmed clinical vaccination failure). He was hospitalized for 16 days. Laboratory data (dates unspecified) included: computed tomography (CT) scan (NR: not provided) computed tomography angiography (CTA) positive for pulmonary embolism. Patient was having antibiotics for pseudomonal pneumonia. Treatment medications (dates unspecified) included: dexamethasone for unknown indication and apixaban for pulmonary embolism. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the angiogram pulmonary abnormal, anticoagulant therapy, Covid-19 pneumonia, pneumomediastinum, pulmonary embolism, Sars-cov-2 test positive, subcutaneous emphysema and confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint:90000193187. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. Additional information received from Central Complaint Vigilance department on 17-SEP-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result were added.; Sender's Comments: V1: The follow up information in this version updates Product quality complaint investigation result, vaccine dose. This updated information does not alter the causality of previously reported events. 20210920388-Covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20210920388-Covid-19 vaccine ad26.cov2.s-Angiogram pulmonary abnormal, anticoagulant therapy, covid-19 pneumonia, pneumomediastinum, pulmonary embolism, sars-cov-2 test positive, subcutaneous emphysema. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

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Pt. w/ "multiple medical problems including failed renal transplant x 2 with ESRD on HD, SAH, HTN, OSA 2018, afib and acute DVT in Dec 20 on eliquis, orthostatic hypotension, adrenal insuff (secondary), recent pseudomonas sepsis who presented to facility on 3/25/2021 with infection of L leg wound. Was sent from surgeon's office when noted to have increased pain, increased drainage from wound. Left lower extremity wound with exposed muscle and tendons."... "initially transferred to a different department on 4/23/21 but transferred off on 5/8/21 due to cough and fevers to 104.4 attributed to new diagnosis of COVID-19." Pt. died on 08/24/21 in hospice, after D/C from ICU due to MRSA bacteremia, ESRD, Arrest, Shock, Septic Emboli to the brain.

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1015 , I found my mother on the floor. She had a contusion on her head from hitting a table edge on the way down. Her right hand was curled up near her face. She was unconscious and breathing with a very loud rasping sound. She was taken to the hospital by ambulance. The Dr told us she had a catastrophic event. One side of her brain was filled with blood. Surgery or comfort care was the only choice. At 1317 they removed everything and began comfort care. Approximately 2000 she was moved to the hospice floor and passed away at approximately 2200..

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Sequence of events: March 29 - patient given Covid vaccine , by reports the patient started to experience progressive weakness after the vaccine April 9 - patient admitted to the hospital with Covid infection April 20 - patient still very ill with Covid April 23 - admitted again due to altered mental status, acute respiratory failure with hypoxia May 13 - Admitted for acute CHF June 12 - Admitted for altered mental status and acute respiratory failure June 21 - Admitted for altered mental status and acute respiratory failure July 8 - Admitted for altered mental status and acute respiratory failure August 6 - admitted with Guillan Barre Syndrome Currently - patient still having significant weakness, falls, etc

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Shortness of breath and chest pain starting on 7/29/21, prompting ED visit on 7/31/21 where she arrived hypoxic, tachypnic, and tachycardic. She was found to have bilateral pulmonary emboli and was hospitalized until 8/1/21 for further evaluation and treatment. Patient was placed on 4L of oxygen via nasal cannula and given Lovenox in the hospital. A transthoracic echo was done and revealed no right heart strain. A 6-minute walk test prior to discharge was performed and resulted in patient requiring 2L/min of oxygen with exertion but not at rest. She was discharged with Eliquis, which she was advised to continue for 3 months, and home oxygen. It is important to consider patient's sedentary lifestyle and recent 4-5hr road trips as potential provoking factors as well. She was stable upon discharge.

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Pt. preSARS-CoV-2 (COVID-19) by NAA, Micro sented to EC w/ shortness of breath, chest tightness, and hypoxemia; diagnosed with PE; discharged home on 04/15/21.

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death 4/24/2021 causes of death listed on death certificate: 1) Pneumonia Due to COVID 19 2) Acute Respiratory Failure with Hypoxia 3) COVID 19 4) Acute Exacerbation of Chronic Obstructive Pulmonary Disease

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Janssen Covid-19 EUA 3/22 started feeling ill. 4/4 went for nasal swab Covid test 4/9 results negative. 4/12 went to doctor with extreme abdominal pain, shortness of breath, blurred vision. Ran bloodwork. Sent to ER for cat-scan. Results were colitis. Back to ER x3. Finally admitted and put on antibiotics, and fluids. Released home to hospice after 4 days. Died on 4/30 with cause of death, colitis.

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There are two adverse events. First is that the skilled nursing facility (SNF) clinical staff incorrectly listed the patient as unvaccinated when requesting SNF patients be vaccinated by the local health department. The patient was previously vaccinated with Moderna on 1/26 (Lot # 004M20A). This should be listed as a vaccine administration error. Second- Approximately, 1 week after being vaccinated with Janssen on 3/24/2021, the patient tested positive for COVID-19 (4/1/21). At the time, the patient was documented to have an asymptomatic infection, picked up on weekly surveillance testing due to a large outbreak at the nursing facility. I was informed on 6/9/21 that the patient had been referred to hospice on 5/4/21 and died on 5/6/21. The medical records are not yet available (pending from the SNF and hospice agency) but the referral was made due to her COVID illness leading to worsening of her general health status. During this period from 4/1 to 5/4, she remained at the SNF. Notably, she was not hospitalized and did not present to the emergency department for care.

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Sore arm for a month and these blood clots

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STROKE; SORE ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and diabetes type 2.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 04-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On unspecified date, the patient had sore arm. On 28-MAR-2021, the patient's right peripheral vision was gone and went to emergency room and diagnosed with stroke. The patient got hospitalized. At hospital, alteplase was administered as the treatment medication for stroke. Patient was discharged on 02-APR-2021. The magnetic resonance imaging (MRI) has shown small spot (stroke confirmed) while Computerized axial tomography scan (CAT) scan did not show the stroke. The patient was hospitalized for 5 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stroke on 02-APR-2021 and the outcome of sore arm was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0;20210518127-covid-19 vaccine ad26.cov2.s-Stroke. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.

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STEMI with 100% blockage in LAD with clot. Emergency cath lab with stents. Symptoms started at 330am on 3-29-21. Came to ED shortly after. Initial testing and labs were negative. Began to have severe symptoms shortly after. Multiple doses of nitro and morphine given for chest pain with no relief. Taken for emergency heart cath by 7am.

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Pt presented to ED w/SOB, cough, tachycardic, febrile, and headaches. Pt resides in independent apt w/roommate who tested positive for COVID 04/07/21. Pt developed symptoms on 04/08/21 but was tested negative at the time. Progression of cough resulted in ED visit. Pt received Janssen vaccine on 3/25/21 w/no complications. Was admitted for additional management of acute respiratory failure w/hypoxia due to COVID-19 infection and pneumonia requiring bipap, dexamethasone & tocilizumab. Rapidly escalating O2 requirements required intubation (4/16) and trach/PEG insertion (5/1). On 4/23- developed MSSA pneumonia in which 10 days of cefazolin was given. Pt currently still in ICU.

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Symptoms of fever, nausea, and weakness started 3 days following vaccination. Denies any exposure to COVID positive person. Presented to local emergency department on 3/27/21 with nausea, fever, chills, dizziness, and confusion. Due to patient's condition, he was transferred to larger facility for further management. Patient was admitted to hospital and subsequently transferred to ICU on 4/17/21. He was intubated at that time. Patient went into multisystem organ failure and died on 4/18/21.

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80 yo male received J&J COVID-19 vaccination on 2/5/21. Pt with history of bladder cancer (s/p TURBT 11/04/2020), COPD (quit smoking 1 month ago) on 2 L nocturnal O2, HTN, CAD, MI s/p CABG x3v, apical cardiac aneurysm s/p repair, recent hematuria requiring cessation of chronic warfarin therapy who presented on 2/14 as a direct admission for evaluation of NSTEMI and new LLE DVT. He was initially placed on heparin and was stopped due to anemia and hematuria. DVT at outside hospital, repeat dopplers negative at our institution. Acute R femoral DVT likely due to patient being taken off chronic anticoagulation with warfarin. Discussed case with heme and not needed for IVC filter......and even though cardiology would like him on long-term AC given high risk for LV thrombus, bleed risk outweigh benefit at this point. He was diagnosed with new HFrEF and NSTEMI. He will stay on hydralazine, imdur, lasix every other day, baby asa, and statin.

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52 yo female received J&J COVID-19 vaccination on 3/10. On 3/18, she presented to the ED with chief complaint of SOB and anemia. CT confirms bilateral submassive PE seen in segmental and subsegmental lobes. Symptomatic with tachypnea, pleuritic CP, tachycardia. Patient has history of PE 3 years ago as well, and was on warfarin for 6 months. Only family history of clots is elderly grandmother with DVT's. No sudden death in family. Age-appropriate cancer screening up to date. Patient is wheelchair bound and was dehydrated 2/2 gastroenteritis which made her high risk for VTE. Less likely due to hypercoagulable disorder. At discharge, she is hemodynamically stable...Tachypnea and pleuritic chest pain resolved. Myeloproliferative neoplasm panel negative. She was started on apixaban (will finish loading doses 3/26, and continue 5mg BID indefinitely). Will be referred to hematology as outpatient for PE + anemia.

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Vomiting, vision impairment (read very slow to me), and seizure(s). Rushed to ER in ambulance. Was put on a ventilator (sedation). Received a CT scan showing a CVST and hemorrhaging in her right temporal lobe. Life-Lined to Hospital. Wore an EEG on her head to monitor seizure activity for 4-5 days. Was put on 4 types of seizure medication and blood thinner for the clot. Did another CT scan which showed her Mid-Line shift was pushing into the left side of the brain by 15mm. Discharged from Hospital on 3/27/21 to Rehabilitation Hospital. She was discharged to home with a caregiver on 4/16/21. She will continue outpatient therapy at the rehabilitation hospital. She will see Speech, Vision, PT, and OT every week until further notice.

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"I received the Johnson and Johnson Covid vaccine on March 9th. On March 30 I was admitted to the hospital with excessive blood clots in my right leg and right lung. My Pulmonary Dr felt I should report this to you. I did have blood clots last year and recently ( February 8th) had back surgery both circumstances could of contributed to the issue. If you need any further information or have questions please do not hesitate to contact me.

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Abdominal pain, vomiting, headache, hypotension, syncope, coma, shock, death at 2:00 pm 03/08/2021

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Sudden death. His father was holding him during a seizure. When it was over, patient relaxed, exhaled, and stopped breathing.

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2 days after vaccination, patient started having vertigo, nausea and headaches. That day she tried to notify her doctor unsuccessfully. 2 days after that patient's headache became extreme and she lost her vision in one eye. Family doctor prescribed migraine medication and referred her to her eye doctor for the next day. The eye doctor told her he believes she had a stroke after a full exam. Stroke confirmed with MRI per family doctor. The stroke was in the occipital area. Referred to neurologist at present time. Vision loss persists. Patient is starting physical therapy and following up with neurologist, eye doctor and cardiologist.

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Patient died of a brain stem bleed on 4/11/21. It is unknown if the vaccine received on 3/8/21 is in any way related to his passing.

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PATIENT CALLED AND STATED THAT HE HAD A HEART ATTACK ON 3/14/21. (TEN DAYS AFTER THE VACCINATION) HE STATES THAT HE CALLED THE DEPARTMENT OF HEALTH AND WAS TOLD TO CONTACT THE LOCATION WHERE HE RECEIVED THE VACCINATION.

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Mother called health department today, 4/14/21, to report reactions son experienced after receiving vaccine 3/4/21. She stated that on 3/6/21 he started having headaches, weakness and leg cramps. He went to the hospital two times with complaints. On 3/15/21 he was unable to walk/drive because headaches were severe. On 3/30/21 he passed out, squad was called. He was not responsive and was put on a vent at the hospital. A "scan" showed blood clots in brain and heart. This individual passed away on 4/4/21.

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3 weeks post vaccination patient developed chest pain and shortness of breath. Was able to tolerate symptoms, then had radiation treatment and developed more shortness of breath. Was transported via EMS to hospital where an xray and MRI were completed and showed multiple blood clots in her lungs. Venous Doppler was also completed and blood clots were found in her legs. She was subsequently admitted to hospital.

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On 3/11/21, patient had a CVA, resulting in hospitalization. Testing during admission indicated a need for a carotidectomy. Pt had the procedure on 3/17/21, when a second CVA occurred. Pt has returned home, but requires assistance with ADL's. Family notes that patient had an ultrasound of arteries completed January of 2021, results were "normal".

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Had a stroke

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Unknown

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My husband died 18 days after the shot

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ACUTE RESPIRATORY DISTRESS SYNDROME (LOWER RESPIRATORY SYMPTOMS, PNEUMONITIS ON IMAGING AND BRONCHOSCOPY, FLUID IN THE LUNGS, HYPOXIA SPO2 IN THE 80S, COUGH AND NAUSEA); This spontaneous report received from a pharmacist concerned a 67 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On an unspecified date in MAR-2021, the patient experienced acute respiratory distress syndrome, fluid in the lungs, and hypoxia spo2 in the 80s. On 10-MAR-2021, the patient experienced lower respiratory symptoms, pneumonitis on imaging and bronchoscopy, cough and nausea. On 11-MAR-2021, the patient was presented to emergency room. On 11-MAR-2021, the patient was hospitalized. The patient was hospitalized for 14 days. It was reported that the patient had been intubated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from acute respiratory distress syndrome (lower respiratory symptoms, pneumonitis on imaging and bronchoscopy, fluid in the lungs, hypoxia spo2 in the 80s, cough and nausea). This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: 20210348785-covid-19 vaccine ad26.cov2.s -Acute respiratory distress syndrome. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

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Janssen COVID vaccine was administered on 3/13/21- patient was screened twice and denied receiving any vaccines in the past 2 weeks. after administration it was noted today (3/15/21) that the patient received the Moderna COVID vaccine (one dose) on 3/4/21. I attempted to reach out to patient to discuss and noted that she is admitted to Hospital for a NSTEMI. Per chart notes patient reported symptoms of fever, nausea, malaise on 3/13/21 after vaccination. The next day 3/14/21 developed syncope and chest pain. Patient reported to emergency room and was admitted with NSTEMI

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She got her vaccine at a drive through area. The next day she noticed that she had two boils on her face, one on her forehead near the hairline and one inside her nose. A few days later she had a blood clot in her eye, blood over her left eye. It went away and she did not go to a doctor as she felt there was nothing they could do. Then she noticed that she had coughing, a lot of mucous and trouble breathing, and constantly clearly her throat. A few months later she noticed that she has a racing heartbeat. She didn't think about it until she went to the doctor and he informed her that she may have an enlarged heart. They did an echocardiogram which showed that she had an enlarged valve. They want her to do an MRI as she is allergic to the contrast material, and she wore the monitor. That showed that it was not serious as sometimes it was short and sometimes it goes away. It seems that is more at nighttime. She notices that she is starting to have more racing heartbeat. Her doctor gave her some medicine to take only when she really needed it and to do some exercises. She has been having a lot of pain on her cheeks and her jaw, and she has not been paying much attention to other stuff. Otherwise she is very healthy. States that she got hacked, but was always on the go as a realtor. She tries not to take the medicine if she does not need it, but she notices that her heart is running fast, speeding and then it goes away after about 15-20 times. She feels her heart beating on her stomach and on her chest. She also severe joint pain, and has had COVID twice with vomiting and dizziness. She was traveling and had to check into a hotel for 3 days as she was too sick and dizzy to drive. She also had a severe rash under her hairline, behind her neck, behind her ears, mini blisters in her head nonstop and could not sleep for a month as she itched nonstop. She went to a dermatologist 3 times and her PCP 3 times to get medications. It was then all over her body and back, and would go away and then come back. She has a patch of blisters on her back, and sometimes on her elbows has a blister area. Her skin gets real hot and when she lies down it is more irritated, and she continues to have that issue and is on 5-6 prescriptions to treat it. She was getting better and then got the 2nd vaccine Moderna and still continues to have the rash. She has brown spots all over her body, stomach, arms, legs, thighs. All different sizes which happened about the same time as the rashes.

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Patient is a 63-year-old female with history of hypertension, GERD, asthma and obesity presenting to the emergency department via EMS from home for having generalized weakness. Patient states she tested positive for COVID on Friday as she was having fatigue, nasal congestion and body aches. She states she has not been eating or drinking very well because she just does not have the energy to do so. She admits to nausea without vomiting, denies abdominal pain or diarrhea. She does states she started to have a cough this morning, denies chest pain. This morning when she was going to the bathroom she felt very weak and as if she was going to pass out, however she did assist herself down to the floor, she did not have an injury from this. Upon arrival to the ED, her main complaint is feeling very weak and tired. She did receive the Johnson & Johnson COVID-vaccine. She denies any fever or chills. Associated Symptoms: cough, fatigue, nausea, weakness

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Patient with single J+J COVID vaccine who admitted with COVID detected PCR. Provider d/c note: "72 YO male with PMH of AKI, COPD, CAD, HTN, DM2 who presents to the ER with shortness of breath and difficulty breathing on exertion. Patient was found to be hypertensive BP 205/144 and elevated BNP. He was given blood pressure medication to decrease his blood pressure slowly. He also presented with edema in his lower extremities. He was given diuresis with IV lasix 40mg bid and his edema improved. He was on 2 to 2.5L of O2 while in the hospital and on a walk test was able to sustain above 90% saturations. He also complained of chest pain, back pain, and abdominal pain difficult to relieve with any pain medications. This pain is possibly due to his COVID infection as most of it occurs when he coughs. As a result we have aggressively treated his cough with dextromethorphan - mucinex & tessalon. It is our assessment that the patient is back to his respiratory status at baseline and can safely be discharged home. He should follow up with his primary care physician and cardiologist. "

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08/28/22 presents to EC ED for "Synocope". PMHx of "falls with intracranial hemorrhage, CVA, CAD, and orthostatic hypotension"

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Severely immunocompromised patient due for booster who presented to ED and subsequently admitted with GI and respiratory distress. Provider discharge note below: "Brief Summary of Hospital Stay: Patient is a 53 yo male with history of alcoholic cirrhosis and hepatocellular carcinoma, hemorrhoids who presented with fever and hematochezia and found with acute anemia with Hgb 5.8. Patient was given 2U pRBC with improvement. GI was consulted who recommended ceftriaxone, octreotide and IV protonix due to concern for SBP. These were stopped by discharge following a steady clinical course and paracentesis inconsistent with SBP. Rectal bleeding was suspected to be from diverticulosis and/or hemorrhoids. Patient discharged in stable and improved condition with instructions to follow-up for outpatient colonoscopy and repeat paracentesis. Patient was noted to be COVID-19 positive on admission despite being vaccinated March/April 2021 and acquiring and recovering from COVID-19 itself in 12/2021. Patient did not show any signs of acute COVID-19 symptoms while inpatient and he was instructed to get a colonoscopy once deemed safe by GI. He was prescribed iron supplementation for his iron deficiency anemia and Anusol rectal cream for his hemorrhoids on discharge. He was recommended to have IR outpatient perform a repeat paracentesis but with cytology on discharge."

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this is a male who was recently diagnosed with covid who was prescribed paxlovid. Apparently when getting up this am to use the bathroom he felt dizzy, and apparently after sitting down, he apparently did per his wife have a brief episode of syncope. NO n/v/d, no shortness of breath. He is one of our former respiratory therapists. Patient states his heart rate often is about 40s. he did not take his bp meds this am per the patient.

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Burning at injection site and down arm to fingertips immediately felt, lasting couple minutes, eventually went away, months later woke up from sleep with severe pressure above left eye, after 4 hours went away, 2 days later seizure as a result of pressure from intracranial hemorrhage which was the pressure above left eye. Thrombosis and continued blood pressure issues are ongoing. Numbness in arms, light headedness, dizziness, headaches, difficulty breathing, confusion, anxiousness, rapid heart rate, irritable to light, chest pains, fuzzy vision and hot flashes.

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This is a 71y.o. male with significant past medical history of HTN, T2DM, CAD, IHD, chronic systolic HF, and S/P AICD that presented to the hospital from clinic with chief complaint of shortness of breath. He was noted by clinic staff to be in mild respiratory distress with complaints of dyspnea. He was found to be 91% on room air and transferred to the ED for further evaluation. In the ED, patient normotensive, afebrile, stable SPO2 on 2 L nasal cannula COVID positive. Elevated acute phase level reactants. He has been admitted for further evaluation and management with ID consultation. Patient seen and examined only by the attending physician; NP only responsible for chart review in an effort to limit exposure given the patient's COVID positive status.

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Pt arrives with confusion, syncope, and fall 2 days ago along with vomiting and diarrhea.

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EMBOLIC STROKE; ISCHAEMIC STROKE; COVID-19 PNEUMONIA; DELIRIUM; DEPRESSED LEVEL OF CONSCIOUSNESS; ENCEPHALOPATHY; THALAMIC INFARCTION; UNRESPONSIVE TO STIMULI; SYNCOPE; COVID-19; SARS-COV-2 TEST POSITIVE; COUGH; AGITATION; CONFUSIONAL STATE; DYSPNOEA; HYPERSOMNIA; HYPOPHAGIA; HEADACHE; ANTICOAGULANT THERAPY; GASTROINTESTINAL TUBE INSERTION; BLOOD FOLATE NORMAL; BLOOD THYROID STIMULATING HORMONE DECREASED; VITAMIN B12 NORMAL; GLYCOSYLATED HAEMOGLOBIN NORMAL; URINE ANALYSIS NORMAL; COMPUTERISED TOMOGRAM HEAD ABNORMAL; DRUG SCREEN NEGATIVE; COMPUTERISED TOMOGRAM; MAGNETIC RESONANCE IMAGING HEAD; CHEST X-RAY ABNORMAL; FATIGUE; ASTHENIA; LETHARGY; PATIENT RESTRAINT; SOMNOLENCE; FALL; HEAD INJURY; HAEMATURIA; INCONTINENCE; TREMOR; URINARY TRACT INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional by a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAERS ID: 1949212) and concerned a 69 years old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: bruxism, des (Diethylstilbestrol) exposure in utero, heart attack (date unknown), lateral myocardial infarction (in 2001 - minimal coronary disease, for medical treatment), atrial fibrillation (in 2012) treated with Xarelto (rivaroxaban) and bariatric surgery. Concurrent conditions included: heart failure (2008); non-insulin dependent diabetes mellitus type 2 without retinopathy, and myocardial infarct (25-JUL-2012); low serum iron (NR: not provided) (28-OCT-2013); coronary artery disease (12-JUN-2014) involving native coronary artery of native heart without angina pectoris, smoker (tobacco use presenting hazards to health); senile nuclear cataract bilateral and myopia of both eyes (22-MAR-2017); bilateral carotid artery disease (CAD) (19-JUL-2017), 50-69% predicted stenosis right internal carotid artery (RICA) and less than 50 % stenosis of the left internal carotid artery (LICA) (as per carotid doppler done on 16-AUG-2017); mild asymmetric left ventricular hypertrophy (LVH) [echocardiogram (ECHO) done on 16-AUG-2018 showed ejection fraction (EF) 71 % with mild asymmetric LVH but no echo findings of outflow tract obstruction and there was no significant valve pathology]; right breast cancer (15-MAR-2021) with malignant cells in regional lymph nodes no greater than 0.2 millimeter (mm) and no more than 200 cells; bladder prolapse congenital, colon polyps, continuous positive airway pressure dependence (CPAP), degenerative disc disease (DDD), gastroesophageal reflux disease (GERD), hiatal hernia, hypertension, hyperlipidemia, interstitial cystitis, menopause (at age 50 years old), mitral regurgitation, morbid obesity with body mass index (BMI) of 50.0-59.9 adult HCC (sic), obstructive sleep apnea (OSA) and on CPAP, osteoarthritis, sleep apnea, vitamin D deficiency, epistaxis, and depression. The patient experienced nausea and vomiting when treated with Demerol (pethidine hydrochloride). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068, and expiry: unknown) dose was not reported, dose number in series was 1, 1 total, administered on 30-MAR-2021 for an unspecified indication. Concomitant medications included ascorbic acid/iron (iron plus C) for low serum iron; unspecified medications for delirium; Aspirin (acetylsalicylic acid), Arimidex (anastrozole), Vitamin D (colecalciferol), Cymbalta (duloxetine hydrochloride), Neurontin (gabapentin), and Mucinex (guaifenesin), all drugs for unknown indications. On 09-NOV-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced haematuria, incontinence, tremor, urinary tract infection and was seen by a primary care physician (PCP) who prescribed cephalexin as treatment. On 29-NOV-2021, the patient fell while shopping, hit her head in the parking lot, had a head injury, following which the Emergency Medical Services (EMS) was called and the patient was assessed. On 30-NOV-2021, the patient was seen at the emergency department (ED). On the same date, the patient experienced shortness of breath (dysnpnea), confusion, cough, worsening headache, asthenia (weak), was tested positive for severe acute respiratory syndrome coronavirus 2 polymerase chain reaction (SARS-CoV-2 PCR) test (covid-19 and confirmed clinical vaccination failure) and presented to the ED with these complaints. A computerized tomogram (CT) brain without acute pathology and without inferior vena cava (IVC) was done which was abnormal (positive for new hypodensity in the left thalamus with suspicion for infarction of unclear chronicity); another CT showed the patient had covid-19 infection and was discharged home. The patient had worsening lethargy, poor oral intake (hypophagia), delirium, and weakness over the past several days and workup in the ED was concerning for left thalamic infarction. On 30-NOV-2021, the patient also experienced syncope, embolic stroke, ischaemic stroke, depressed level of consciousness, encephalopathy, thalamic infarction, unresponsive to stimuli, agitation, hypersomnia (sleeping about 14-16 hours a day), patient was restraint, had somnolence, fatigue, gastrointestinal tube insertion, blood folate was normal, blood thyroid stimulating hormone (TSH) decreased to 1.84 (NR: not provided), vitamin b12 was normal, glycosylated haemoglobin was normal at 5.5 (NR: not provided), urine analysis normal (negative for UTI), urine drug screen (UDS) was negative, magnetic resonance imaging head (result not reported), chest x-ray was abnormal and showed covid-19 pneumonia (dose number in series was 1). The patient visited the emergency room (ER) for all reported events. The patient had an episode of confusion on a 03-DEC-2021 (Friday) when she was trying to sort out her medications for the next week and she has taken care of her own medications for years but was having a lot of difficulty on Friday. On 05-DEC-2021, the patient was again tested positive for covid-19. On 06-DEC-2021, the patient was hospitalized with chief complaint of pneumonia due to covid-19. She was examined at bedside and was groggy but arousable. She denied any pain, shortness of breath, headache when asked but then falls asleep and does not answer any questions. A plan was made to continue stroke power plan. The patient was unable to take per oral intake (improvement awaited in her mentation). The patient was agitated and received Benadryl (diphenhydramine) and then Haldol (haloperidol). In regard to covid pneumonia, she did not require supplemental oxygen but was required to complete 10 days of Decadron (dexamethasone). The etiology for acute encephalopathy was unclear as patient was unable to consistently follow commands to rule out focal deficits, possible stroke vs hypertensive urgency, emergency vs infection, delirium. Continuous pulse oximetry was warranted for the patient. Psychiatry was consulted for agitation and confusion. The patient remained confused and had bilateral wrist restraint. On 09-DEC-2021, neuropsychiatry assessed the patient to have capacity to assign durable power of attorney (DPOA) but not to determine a discharge plan. Unfortunately, this DPOA document had not been completed. On 13-DEC-2021, upon doctor's assessment, the patient was unable to name a medical DPOA hence, guardianship would be pursued as discussed with social worker. A court-appointed guardianship was awaited as patient was no longer able to assign DPOA at the time of reporting. On 13-DEC-2021, the patient was continuing unspecified medications for delirium (recommendations ongoing). Upon interview on 14-DEC-2021, the patient was still had waxing and waning levels of alertness but was able to respond to more questions. She denied any current physical complaints, reported that she has been sleeping well, felt tired in the morning and acknowledged feeling confused. The patient slept well overnight but continued to wax and wane. Acute encephalopathy was ongoing likely due to acute delirium, embolic ischemic stroke (CT brain was concerning for left thalamic stroke and MRI brain findings were noted). The patient's anti-coagulant therapy with Xarelto was replaced with Lovenox (enoxaparin sodium) while patient was refusing to take orally; acetylsalicylic acid (ASA) and Crestor (rosuvastatin calcium) was for home. Since patient was experiencing delirium or is at a high risk of delirium, it was advised to keep the blinds open and lights on during daylight hours; to frequently re-orient to situation, location, city, state, time, time of day, date, month, season; to make every effort to obtain assistive devices such as glasses, hearing aids, dentures and other medical prostheses; to minimize daily naps to less than three per day and less than 60 minutes if possible; to keep room lights at full brightness If patient is experiencing delirium during naps to maximize daytime suppression of physiological melatonin production and minimize circadian rhythm disruption; to consider requesting scheduled melatonin if patient has it ordered PRN (when necessary); to minimize extraneous noise and interruptions as well as artificial ambient lighting during night time hours; and to minimize unnecessary vital checks and lab draws attempting to obtain these while patient is awake if at all possible. At the time of reporting, the patient was awake, interacted with her son appropriately, was still eating and drinking and has been falling more (as per patient's son). The patient's headaches improved and she denied having headache, but still has cough (not continuous) at the time of report. The patient was hospitalized for 9 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, had not recovered from agitation, anticoagulant therapy, asthenia, blood folate normal, blood thyroid stimulating hormone decreased, covid-19, covid-19 pneumonia, chest x-ray abnormal, computerised tomogram, computerised tomogram head abnormal, confusional state, cough, delirium, depressed level of consciousness, drug screen negative, dyspnoea, embolic stroke, encephalopathy, fall, fatigue, gastrointestinal tube insertion, glycosylated haemoglobin normal, haematuria, head injury, hypersomnia, hypophagia, incontinence, ischaemic stroke, lethargy, magnetic resonance imaging head, patient restraint, sars-cov-2 test positive, somnolence, syncope, thalamic infarction, tremor, unresponsive to stimuli, urinary tract infection, urine analysis normal, and vitamin b12 normal, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with product quality complaint: 90000208917. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified, based on the PQC evaluation/investigation performed. Additional information was received from Central Complaint Vigilance Department (CCVUSA) on 07-JAN-2022. The following information was updated and incorporated into case narrative: Product Quality Complaint (PQC) investigation results.; Sender's Comments: V1: Follow up information updates about PQC investigation result. No change in prior causality assessment. 20211255660 -Covid-19 vaccine ad26.cov2.s -Confirmed clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. 20211255660-Covid-19 vaccine ad26.cov2.s-Ischaemic stroke. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE 20211255660-Covid-19 vaccine ad26.cov2.s-agitation, anticoagulant therapy, blood folate normal, blood thyroid stimulating hormone decreased, covid-19, covid-19 pneumonia, chest x-ray abnormal, computerised tomogram, computerised tomogram head abnormal, confusional state, cough, delirium, depressed level of consciousness, drug screen negative, dyspnoea, embolic stroke, encephalopathy, fall, gastrointestinal tube insertion, glycosylated haemoglobin normal, haematuria, head injury, hypersomnia, hypophagia, incontinence, lethargy, magnetic resonance imaging head, patient restraint, sars-cov-2 test positive, somnolence, syncope, thalamic infarction, tremor, unresponsive to stimuli, urinary tract infection, urine analysis normal, vitamin b12 normal, Headache.. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211255660-Covid-19 vaccine ad26.cov2.s-Asthenia, Fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.

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Narrative: Patient was in his baseline state of health until 4/6 when he noted R hemibody numbness, which began with right-sided facial numbness when brushing teeth. He was evaluated by his PCP (no exam noted) and initiated on regimen of doxycyclnine 100mg BID, acyclovir 800mg TID, and prednisone 40mg for 'Bells Palsy'. On 4/9, a referral to neurology was made after pt returnedd to clinic w/ burning deep low back pain that radiates up to his shoulder, and his b/l temples. Neuro exam documented at that time denote a L sided Bells Palsy only. CBC, CMP, PSA, RPR, TSH, B12, ESR, CRP, RPR, Iron lvls were all normal. MRI brain and Lumbar spine were ordered and pt was to obtain expedited LP. Pt again re-presented to urgent care on 4/12 due to severe burning back pain that resolved w/ activity. At this time again only L sided facial weakness noted (documented as reduced ability to close eyelid, raise eyebrow, weakness puffing out cheeck, and reduced smile on L), no other weakness, drift, or sensory findings. Pt was instructed to continue doxycycline 100mg BOD 10d course (4/6-4/15), prednisone 40mg 7d course (4/6-4/12), acyclovir 800mg TID 7d course (4/6/-4/15), prednisone 40mg 7d course (4/6-4/12), acyclovir 800mg TID 7d course (4/6-4/12). Pt was instructed to obtain MRI and LP in expedited fashion. Telephone note Addendum on 4/14 noted improve in Bell Palsy symptoms and back/shoulder/head pain w/ tylenol. Given persistent back pain and J&J COVID19 vaccine, pt was instructed to present to urgent Care. He deferred until the following day. On 4/15 pt woke up w/ worsening facial numbness. He presented to urgent care w/ b/l inability to close eyes and 'when attempting both eyes roll up into his head . He also complained of sharp pain upon extending his RUE and RLE. Exam showed b/l inability to close eyes, description of Bells phenomenon, and palpable tenderness at base of C spine w/ mild spasms. CTH was obtained and was unremarkable. CT C spine showed multilevel degenerative cahgnes w/ neuroforaminal narrowing at C5-C7. Given inability for pt to obtain an expedited MRI and LP to r/o inflammatory or malignancy process at outside hospital case was discussed and accepted for transfer on 4/15. Of note pt obtained J&J vaccine on 3/18 by outside hospital. On presentation patient confirms the timelime detailed above and additionally notes that he has lost his sense of taste. Pt underwent MRI scan on day of admission 4/15/21 which showed enhancement of the bilateral facial nerves and oculomotor nerves, and possible trigeminal nerve enhancement. He underwent LP which showed 6 WBCs and 346 protein;negative cytology and flow cytometry. Given his clinical presentation and imaging/CSF findings, high suspicion for atypical GBS/AIDP which EMG done on April 20th, 2021 was most consistent with. He underwent CT C/A/P which were all negative for malignancy. He was treated with IVIG for presumed AIDP/GBS. Discharged on April 21st, 2021.

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Narrative: Patient was in his baseline state of health until 4/6 when he noted R hemibody numbness, which began with right-sided facial numbness when brushing teeth. He was evaluated by his PCP (no exam noted) and initiated on regimen of doxycyclnine 100mg BID, acyclovir 800mg TID, and prednisone 40mg for 'Bells Palsy'. On 4/9, a referral to neurology was made after pt returnedd to clinic w/ burning deep low back pain that radiates up to his shoulder, and his b/l temples. Neuro exam documented at that time denote a L sided Bells Palsy only. CBC, CMP, PSA, RPR, TSH, B12, ESR, CRP, RPR, Iron lvls were all normal. MRI brain and Lumbar spine were ordered and pt was to obtain expedited LP. Pt again re-presented to urgent care on 4/12 due to severe burning back pain that resolved w/ activity. At this time again only L sided facial weakness noted (documented as reduced ability to close eyelid, raise eyebrow, weakness puffing out cheeck, and reduced smile on L), no other weakness, drift, or sensory findings. Pt was instructed to continue doxycycline 100mg BOD 10d course (4/6-4/15), prednisone 40mg 7d course (4/6-4/12), acyclovir 800mg TID 7d course (4/6/-4/15), prednisone 40mg 7d course (4/6-4/12), acyclovir 800mg TID 7d course (4/6-4/12). Pt was instructed to obtain MRI and LP in expedited fashion. Telephone note Addendum on 4/14 noted improve in Bell Palsy symptoms and back/shoulder/head pain w/ tylenol. Given persistent back pain and J&J COVID19 vaccine, pt was instructed to present to urgent Care. He deferred until the following day. On 4/15 pt woke up w/ worsening facial numbness. He presented to urgent care w/ b/l inability to close eyes and 'when attempting both eyes roll up into his head . He also complained of sharp pain upon extending his RUE and RLE. Exam showed b/l inability to close eyes, description of Bells phenomenon, and palpable tenderness at base of C spine w/ mild spasms. CTH was obtained and was unremarkable. CT C spine showed multilevel degenerative cahgnes w/ neuroforaminal narrowing at C5-C7. Given inability for pt to obtain an expedited MRI and LP to r/o inflammatory or malignancy process at outside hospital case was discussed and accepted for transfer on 4/15. Of note pt obtained J&J vaccine on 3/18 by outside hospital. On presentation patient confirms the timelime detailed above and additionally notes that he has lost his sense of taste. Pt underwent MRI scan on day of admission 4/15/21 which showed enhancement of the bilateral facial nerves and oculomotor nerves, and possible trigeminal nerve enhancement. He underwent LP which showed 6 WBCs and 346 protein;negative cytology and flow cytometry. Given his clinical presentation and imaging/CSF findings, high suspicion for atypical GBS/AIDP which EMG done on April 20th, 2021 was most consistent with. He underwent CT C/A/P which were all negative for malignancy. He was treated with IVIG for presumed AIDP/GBS. Discharged on April 21st, 2021.

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Hospitalized (12.6.21); COVID-19 positive (11/30/21); Fully vaccinated Admitted 12.6.21 - Chief complaint - Pneumonia due to COVID-19 Brief history and medical decision making: Pt is a 70 yr old F with extensive PMHx of atrial fib with Xarelto, CAD/MI, NIDDM II, GERD, HPL, Obesity, OSA on CPAP, smoker presented to ED with shortness of breath and confusion. Per son - pt became weak and fell while shopping on 11/29 - EMS was called and assessed pt; recommend going to ED but pt declined. She had worsening HA on 11/30 so son took pt ED - CT brain w/o acute pathology but pt found to have COVID-19 infection - discharged home. Had worsening lethargy, poor oral intake, weakness over the past several days - workup in the ED concerning for left thalamic infarction. Pt seen and examined at bedside - groggy but arousable. AAOx0 - denies any pain, shortness of breath, headache when asked but then falls asleep and does not answer any questions. Plan - continue stroke powerplan, PT/OT and SLP eval. Pt currently not able to take PO intake- await improvement in her mentation and SLP eval. Holding off MRI brain until pt able to follow some commands (overnight -was agitated and received Bendadryl and then Haldol). In regards to COVID-19 PNA - not requiring supplemental O2. Complete 10 days of Decadron, as started. Will discuss with mAb team to determine if pt meets criteria for monoclonal antibodies. Acute encephalopathy -unclear etiology, pt unable to consistently follow commands to rule out focal deficits, possible stroke vs hypertensive urgency/emergency vs infection delerium -Head CT without IVC positive for new hypodensity in the left thalamus suspicious for infarction of unclear chronicity, consider brain MRI -neuro consult, await recommendations -allow for permissive hypertension -start neuro checks -PT/OT/SLP covid 19 pneumonia -covid 19 PCR positive 11/30/21 -CXR showed covid PNA -start decadron -continuous pulse ox Progress Notes from 12.14.21: Interval History Patient is a 70 y.o. female with history of Afib, T2DM, GERD, HLD, OSA on CPAP, bariatric surgery, CAD, tobacco use, breast cancer admitted for COVID pneumonia. Psychiatry was consulted for agitation, confusion. Per chart, son applying for guardianship. Remains confused in bilateral wrist restraints. Corpak placed. B12 and folate WNL. On interview, patient still with waxing and waning levels of alertness. Was able to respond to more questions today. Thought she was at a facility and the year was "19 something". Was able to state "I think I had a stroke". Informed her she was also treated for COVID and she states "oh yeah I think that's right". Denies any current physical complaints. Reports she has been sleeping well. Feels tired this am and acknowledges feeling confused. Collateral: Spoke with RN who reports patient has been pleasant but confused. Did know her name and the year this AM but did not know where she was or why she was here. Trialed out of restraints but she was trying to pull at Corpak so they were resumed. Sleeping well overnight. Continues to wax and wane. Acute Encephalopathy: ongoing, likely due to acute delirium Embolic Ischemic Strokes - CT brain concerning for left thalamic stroke - MRI brain findings noted - home ASA,, Crestor, Xarelto; replace with Lovenox while refusing to take orally - Neurology consulted and followed, since signed off, plan to f/u in stroke clinic - HbA1c of 5.5, TSH of 1.84, UDS negative, UA negative for UTI - Psychiatry consult placed to assist with patient's agitation 12/13 - continuing current medications for delirium - recommendations ongoing - Patient is at high risk for or is experiencing delirium. - During daylight hours, please keep blinds open and lights on. - Frequently re-orient to situation, location (city, state), time (time of day, date, month/season). - Make every effort to obtain assistive devices such as glasses, hearing aids, dentures, and other medical prostheses, as studies have shown that having these things present and available can reduce the duration of acute delirium. - Minimize daily naps to less than three per day and less than 60 minutes if possible. - If patient is experiencing delirium, during naps keep room lights at full brightness to maximize daytime suppression of physiological melatonin production and minimize circadian rhythm disruption. - Consider requesting scheduled melatonin if patient has it ordered PRN. - During nighttime hours, minimize extraneous noise and interruptions as well as artificial ambient lighting. - Minimize unnecessary vital checks and lab draws, attempting to obtain these while patient is awake if at all possible. Neuropsych assessed patient to have capacity to assign DPOA on 12/9, but not to determine a discharge plan. Unfortunately this DPOA document has not been completed. - 12/13 per Dr.: Upon assessment today 12/13 patient unable to name a medical DPOA hands guardianship would be pursued as discussed with social worker. - Will await court-appointed guardianship now that patient is no longer able to assign DPOA

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Chest Pain "i think i test positive for covid too" ? Breathing Problem HPI Patient seen and examined here for shortness of breath it's been progressing for the past couple days. Patient states she's had body aches and mild headache and low-grade cough for the past 9 days. Patient returned yesterday on the airplane home from and symptoms worsened. Patient took her home Covid 19 test which was positive. Patient was vaccinated by J&J 4 months ago. She does have some mild chest pain significant shortness of breath worse with exertion. Patient is coughing with production of phlegm. She denies abdominal pain she admits to lower extremity swelling. She was with her sister in a different state who has been coughing for the past 5 days as well. Covid-19 Vaccine (Janssen) 04/12/2021 Review of Systems Constitutional: Positive subjective fevers, +chills, and malaise. Eyes: No eye pain or discharge. ENMT: No ENT changes. No neck pain or stiffness. Cardiac: No chest pain. Respiratory: Positive cough or positive exertional respiratory distress. GI: Positive nausea, some vomiting, bowel changes or abdominal pain. GU: No dysuria, frequency or burning. MS: No myalgia, muscle weakness, joint pain or back pain. Neuro: No headache or weakness. No LOC. Skin: No skin rash. Endocrine: No history of thyroid disease or DM.

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Chief Complaint: Shortness of breath Additional Medical History: Patient is a 84-year-old female with a history of COPD as well as CHF on 4 L nasal cannula at home at all times who presents the emergency department via EMS for acute onset of shortness of breath over the evening. Patient was found to be saturating in the low 80s on first responder arrival. On EMS arrival they placed her on a nonrebreather and she continues to in the high 80s and was placed on CPAP which improved her saturations to the low 90s. Patient denies any chest pain. She does report feeling very tight in her chest and wheezing. No fevers or chills. No productive cough.

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chest pain BP 250/195 pulse rate 40's blacking out

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Symptoms similar to Shingles in head without rash. 7/7 to 7/21 Diagnosed with bells palsy. 7/22 to 8/19 Random hives and muscle pain 8/20 to 9/10

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Bilateral Bells Palsy. I had vaccine shot on 3/5/21. I woke up on 3/22/21 with right sided facial paralysis. Went to ER. 5 days later I also had paralysis on the left side of my face. It has been 5 months and I still have left sided paralysis. I cannot close my mouth, close my left eye, cannot move my eyebrow,, drool, no gag reflex. I have lost 10 pounds since eating and drinking is difficult.

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