- Staat
- RI
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2022
- Impfdatum
- 03.08.2022
- Beginn
- 03.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Blood bicarbonate decreased
C-reactive protein normal
Infant irritability
Laboratory test
Lip discolouration
Liver function test normal
Metabolic acidosis
Metabolic function test abnormal
Pulse absent
Pyrexia
Respiratory arrest
Skin discolouration
Urine leukocyte esterase positive
White blood cell count increased
Symptomtext
Suddenly her lips and face became white/ gray; it appeared that she was not breathing; Suddenly her lips and face became white/ gray; febrile to 100.6; She was fussy/ clingy all day/ mother has not been able to put her down; Blood bicarbonate increased; Blood Culture; C-Reactive protein normal; Mother could not feel a heart beat; Laboratory test; Liver function test normal; Metabolic acidosis; Metabolic function test abnormal; Respiratory viral panel; Urine ketone body present; White blood cell count increased; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID: 2413525-1. The original narrative from the sender is as follows: pt. rec'd Vaxcelis- previous DTAP/HEPB/POLIO administered at two months of age was Pediarix. Pt. presents after a spell. Her mother provided the history. She received her 4 mo immunizations this morning. Upon arrival home she was fussy. Mother gave her a dose of Tylenol. Despite that she has been clingy all day, mother has not been able to put her down. She was sleeping in mother's arms and suddenly her lips and face became white/gray. Mother could not feel a heart beat and it appeared that she was not breathing. Mother rubbed her back and jostled her and eventually she came back to herself but it took a few minutes. Lab Data: febrile to 100.6, exam reassuring. Due to 4min episode, and fever they did labs. US: 1+leuks, BMP: unremarkable aside from mild metab acid w bicarb 19, WBC: 19k, 14N. LFT: normal. CRP: normal. Blood culture: pending. RVP: pending. +admit for monitoring-to the floor. History/ Allergies: polydactyly- followed by Ortho/ Hand-f/u 10/2022, ABO incompatibility baby A+ DAT + / IAT +, Fail newborn hearing scree, passed the repeat, Normal newborn metabolic screen.,NKDA The reporter did not assess the causal relationship between Vaxelis and "Suddenly her lips and face became white/ gray", "it appeared that she was not breathing", "She was fussy/ clingy all day/ mother has not been able to put her down" and "Mother could not feel a heart beat". The causal relationship between Vaxelis and "febrile to 100.6", "Blood bicarbonate increased", "Blood Culture", "C-Reactive protein normal", "Laboratory test", "Liver function test normal", "Metabolic acidosis", "Metabolic function test abnormal", "Respiratory viral panel", "Urine ketone body present" and "White blood cell count increased" is not applicable due to the nature of the events. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Respiratory arrest
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- ABO incompatibility (baby A+ DAT+/IAT+); Polydactyly (Followed by Ortho/Hand-f/u 10/2022)
- Vorgeschichte
- -
- Andere Medikamente
- ERGOCALCIFEROL
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- RI
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 17.08.2022
- Impfdatum
- 03.08.2022
- Beginn
- 03.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Blood bicarbonate increased
Blood culture
C-reactive protein normal
Heart rate decreased
Irritability
Laboratory test
Lip discolouration
Liver function test normal
Metabolic acidosis
Metabolic function test abnormal
Pyrexia
Respiratory arrest
Respiratory viral panel
Skin discolouration
Urine ketone body present
White blood cell count increased
Symptomtext
pt. rec'd Vaxcelis- previous DTAP/HEPB/POLIO administered at two months of age was Pediarix. Pt. presents after a spell. Her mother provided the history. She received her 4 mo immunizations this morning. Upon arrival home she was fussy. Mother gave her a dose of Tylenol. Despite that she has been clingy all day, mother has not been able to put her down. She was sleeping in mother's arms and suddenly her lips and face became white/gray. Mother could not feel a heart beat and it appeared that she was not breathing. Mother rubbed her back and jostled her and eventually she came back to herself but it took a few minutes.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Respiratory arrest
- Hospital-Tage
- -
- Labordaten
- febrile to 100.6, exam reassuring. Due to 4min episode, and fever they did labs. UA:1+leuks, BMP:unremarkable aside from mild metab acid w bicarb 19, WBC:19k, 14N. LFTs:normal. CRP:normal. Blood culture:pending. RVP:pending. +admit for monitoring- to the floor.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- polydactyly- followed by Ortho/Hand- f/u 10/2022, ABO incompatibility baby A+ DAT+/IAT+, Fail newborn hearing screen, passed the repeat, Normal newborn metabolic screen.
- Andere Medikamente
- Ergocalciforal 200 MCG/ML - 0.1 mL po daily
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- KS
- Alter
- -
- Geschlecht
- M
- Eingang
- 29.09.2022
- Impfdatum
- 13.06.2022
- Beginn
- 19.06.2022
- Tage bis Beginn
- 6,0
- Dosis
- 2
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Irritability postvaccinal
Seizure like phenomena
Staring
Tremor
Unresponsive to stimuli
Irritability
Symptomtext
He was staring and not responsive to her voice like he typically is; He was staring and not responsive to her voice like he typically is; 2 back to back episodes of shaking, 2 minutes apart, lasting 3 seconds each ('like a seizure'); Infant had 2 more episodes of shaking, the first 3-4 sec long and 2 minutes later the second episode lasting 7-10 minutes, with obvious head and arm shaking; Infant was a little more fussy during that 6 days after vaccination than usual; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2331704-1. The original narrative from the sender is as below: 6 days after vaccination on 6-19-22, mother observed infant to have 2 back to back episodes of shaking, 2 minutes apart, lasting 3 seconds each ('like a seizure'). On 6-21-22, infant had 2 more episodes of shaking, the first 3-4 sec long and 2 minutes later the second episode lasting 7-10 minutes, with obvious head and arm shaking. She videoed this episode and showed to her Pediatrician. Mother reported that after the 7-10 second episode, she held baby to comfort him, he was staring and not responsive to her voice like he typically is. No reported fever after vaccination or other illness symptoms. No medications given during that time. Infant was a little more fussy during that 6 days after vaccination than usual. Pediatrician Dr. referred infant to Neurologist for evaluation. Mother waiting on appointment. Current illness reported as none.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure like phenomena
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ID
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 26.05.2022
- Impfdatum
- 13.04.2022
- Beginn
- 21.04.2022
- Tage bis Beginn
- 8,0
- Dosis
- 2
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Blood glucose normal
Electroencephalogram normal
Generalised tonic-clonic seizure
Laboratory test normal
Metabolic function test normal
Ultrasound head normal
Symptomtext
Generalized tonic-clonic seizure; This spontaneous serious safety report with reference number 02153746 (Interaction number 02153745) was received by a partner on 25-APR-2022 and forwarded to Agency on 26-APR-2022 from a health care professional. A 4-month-old female patient, with medical history of ventricular septal defect, had been vaccinated with a 2nd dose of Vaxelis (Batch number U7125AA, expiration date 15-JUL-2024) on 13-APR-2022 for routine vaccination. The following concomitant vaccinations were reported: Prevnar 13 and RotaTeq administered on 13-APR-2022 for routine vaccination. On 21-APR-2022, eight days after receiving the vaccination with Vaxelis, the patient experienced generalized compulsive seizures that lasted for 45 seconds. The patient was taken to the emergency department and kept under observation for several hours. On an unspecified date, head ultrasound and labs were performed, and results were normal. It was reported that the patient did not experience any seizure activity since the initial seizure on 21-APR-2022. Action taken with Vaxelis was not applicable. At the time of this report, the outcome of the event was Recovered/Resolved. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of generalized compulsive seizures. Further information is expected. FOLLOW-UP INFORMATION with reference number 02153746 (Interaction number 02153745) was received by MSD on 02-May-2022 and forwarded to Agency on 03-May-2022 from a health care professional. On 22-Apr-2022, head ultrasound was normal. CMP and blood glucose were normal. On 29-Apr-2022, EEG was normal. At the time of this report, the outcome of the event was Recovered/Resolved. The reporter assessed the event of generalized compulsive seizures to have reasonable possibility of causal relationship to Vaxelis, providing "unknown, possible" to suggest a causal relationship. Further information is expected. FOLLOW-UP INFORMATION was received by Fax on 18-May-2022, from a health care professional (HCP). The HCP reported that the patient was seen in ER, the seizure had resolved and no medicines were given to the patient. Moreover, the patient did not present any fever around the time of the event. The reporter confirm that the seizure experienced by the patient was a "Generalized tonic-clonic seizure". No further information is expected given that the reporter replied to all the queries. COMPANY COMMENT: Generalized tonic-clonic seizure is assessed as serious due to the event being medically significant. Generalized tonic-clonic seizure is unlisted for Vaxelis as per the Reference Safety Information (CCDS). Considering the reporter's causality (related), and despite the long onset latency for the Generalized tonic-clonic seizure (8 days after vaccination), and the existence of alternative explanations (co-suspect vaccines), the causal relationship between Vaxelis and the event Generalized tonic-clonic seizure cannot be excluded and is assessed as related. Given the incidence of this event among the pediatric population, a spontaneous event has been taken into consideration for this assessment. This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.; Sender's Comments: Generalized tonic-clonic seizure is assessed as serious due to the event being medically significant. Generalized tonic-clonic seizure is unlisted for Vaxelis as per the Reference Safety Information (CCDS). Considering the reporter's causality (related), and despite the long onset latency for the Generalized tonic-clonic seizure (8 days after vaccination), and the existence of alternative explanations (co-suspect vaccines), the causal relationship between Vaxelis and the event Generalized tonic-clonic seizure cannot be excluded and is assessed as related. Given the incidence of this event among the pediatric population, a spontaneous event has been taken into consideration for this assessment. This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Generalised tonic-clonic seizure
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Ventricular septal defect
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ID
- Alter
- -
- Geschlecht
- F
- Eingang
- 04.05.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Blood glucose normal
Metabolic function test
Metabolic function test normal
Seizure
Ultrasound head normal
Symptomtext
Generalized convulsive seizure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 4-month-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 2, single (Lot number: EX1979, Expiration Date: 31Dec2023) for immunisation; diphtheria vaccine toxoid, hepatitis B vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (VAXELIS), as dose 2, single (Lot number: U7125AA, Expiration Date: 15Jul2024) for immunisation; rotavirus vaccine live reassort oral 5v (ROTATEQ), as dose 2, single (Lot number: 1742434, Expiration Date: 16Mar2023) for immunisation. The patient's relevant medical history included: "Ventricular septal defect" (unspecified if ongoing), notes: 'not' receiving any treatment or medication for such. The patient's concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "Generalized convulsive seizure". The event "generalized convulsive seizure" required emergency room visit. The patient underwent the following laboratory tests and procedures: Ultrasound head: normal; Metabolic function test: normal; Blood glucose: normal. Follow-up (28Apr2022): Follow-up attempts are completed. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- -
- Labordaten
- Test Name: Glucose; Result Unstructured Data: Test Result:normal; Test Name: CMP; Result Unstructured Data: Test Result:normal; Test Name: head ultrasound; Result Unstructured Data: Test Result:normal
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Ventricular septal defect ('not' receiving any treatment or medication for such)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ID
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 02.05.2022
- Impfdatum
- 13.04.2022
- Beginn
- 21.04.2022
- Tage bis Beginn
- 8,0
- Dosis
- 2
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Blood glucose normal
Metabolic function test normal
Seizure
Ultrasound head normal
Generalised tonic-clonic seizure
Laboratory test normal
Symptomtext
Generalized Convulsive Seizure x 45 seconds on 4/21/22 @8pm
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Generalised tonic-clonic seizure
- Hospital-Tage
- -
- Labordaten
- Head Ultrasound (4/22/22): Normal CMP: NL Glucose: NL
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- Ventricular Septal Defect
- Andere Medikamente
- None
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- ID
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 02.05.2022
- Impfdatum
- 13.04.2022
- Beginn
- 21.04.2022
- Tage bis Beginn
- 8,0
- Dosis
- 2
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Blood glucose normal
Metabolic function test normal
Seizure
Ultrasound head normal
Generalised tonic-clonic seizure
Laboratory test normal
Symptomtext
Generalized Convulsive Seizure x 45 seconds on 4/21/22 @8pm
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Generalised tonic-clonic seizure
- Hospital-Tage
- -
- Labordaten
- Head Ultrasound (4/22/22): Normal CMP: NL Glucose: NL
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- Ventricular Septal Defect
- Andere Medikamente
- None
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- -
- Geschlecht
- M
- Eingang
- 29.09.2022
- Impfdatum
- 22.03.2022
- Beginn
- 22.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Mobility decreased
Pain in extremity
Peripheral swelling
Symptomtext
Swelling from R thigh to the R ankle in the 24hr following the vaccine. Leg was swollen and he seemed to have pain and less mobility. The swelling resolved and he is able to move leg with no pain.; Swelling from R thigh to the R ankle in the 24hr following the vaccine. Leg was swollen and he seemed to have pain and less mobility. The swelling resolved and he is able to move leg with no pain.; Swelling from R thigh to the R ankle in the 24hr following the vaccine. Leg was swollen and he seemed to have pain and less mobility. The swelling resolved and he is able to move leg with no pain.; This non-serious spontaneous case was received during the Reporting System monitoring on 12-Jul-2022 with the following Primary ID 2213945-1. The original narrative from the sender is the following: Swelling from R thigh to the R ankle in the 24hr following the vaccine. Leg was swollen and he seemed to have pain and less mobility. The swelling resolved and he is able to move leg with no pain. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Mobility decreased
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- -
- Geschlecht
- M
- Eingang
- 29.09.2022
- Impfdatum
- 27.05.2022
- Beginn
- 27.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Discomfort
Dyskinesia
Lethargy
Mobility decreased
Nystagmus
Pyrexia
Respiratory tract congestion
Rhinorrhoea
Vision blurred
Weight decreased
Symptomtext
Discomfort; Dyskinesia; Mobility decreased; Nystagmus; Respiratory tract congestion; Rhinorrhea; Vision blurred; Weight decreased; Lethargy; Pyrexia; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System(VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2315452-1. The original narrative from the sender is as below: "mother states after getting most recent vaccines, patient developed fever, congestion, abnormal movements. He was unable to hold his head up, was lethargic, '"'whining like a puppy,"" and eyes were unfocused. She took him to the ED 6/1/22, but they were unable to do anything for the patient. She states he seems to be feeling better, but she would like the reaction documented and to discuss with provider the best way to proceed with vaccinations. PCP office received a call on 6/1/22 from patient's physical therapist reporting patient's eyes were not focusing, he had nystagmus, and he had lost weight. PT was concerned there was a neurological issue. PCP office directed them to ED. ED note from 6/1/22: 9 month old male with hx of neonatal abstinence syndrome, cerebral palsy, seizure disorder, was brought to the ED by his mother for general evaluation. She was advised by PT to to come to the ED for evaluation for possible seizure. While patient was at physical therapy today he seemed uncomfortable, had some rhythmic movements with bobbing his head and arching his back for a few seconds. Patient had immunizations 4 days ago and had a couple fevers after the shots. He also has runny nose and congestion for the last 5 days."
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Mobility decreased
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Cough
- Vorgeschichte
- Medical History/Concurrent Conditions: Congestion nasal; Cryptorchidism (bilateral cryptorchidism); Developmental delay; Eczema; Gross motor delay; Seizures (Seizure disorder); Vision abnormal
- Andere Medikamente
- PHENOBARBITAL; MCT OIL [COCOS NUCIFERA OIL]; HYDROCORTISONE ACCORD; TRIAMCINOLONE ACETONIDE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- M
- Eingang
- 03.07.2022
- Impfdatum
- 11.03.2022
- Beginn
- 11.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dyspnoea
Hypotonia
Lethargy
Symptomtext
He was having trouble breathing.; Tone went limp; Was lethargic; This non-serious case was received during the monitoring on 11-APR-2022 with the following Primary ID 2180696-1. The original narrative from the sender is as below: While sleeping the night after the vaccines, mom woke to him gasping. He was having trouble breathing. Tone went limp. Was lethargic. Responded after mother provided stimulation. Similar issues occurred after 4 mo vaccinations. Lab data included none this time. After 4mo vaccinations, he was evaluated by neuro and seizures were ruled out. Current illness included mild viral URI the week prior. Adverse Events After Prior Vaccinations included similar issue after 4 mo vaccinations. Medications At Time Of Vaccination included Peanut allergy supplementation. No allergies. No medical history.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dyspnoea
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Upper respiratory infection (mild viral URI the week prior)
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- -
- Geschlecht
- M
- Eingang
- 04.04.2022
- Impfdatum
- 22.03.2022
- Beginn
- 22.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Injection site swelling
Mobility decreased
Pain
Symptomtext
Swelling from R thigh to the R ankle in the 24hr following the vaccine. Leg was swollen and he seemed to have pain and less mobility. The swelling resolved and he is able to move leg with no pain.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Mobility decreased
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- N/A
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 0,4
- Geschlecht
- M
- Eingang
- 15.03.2022
- Impfdatum
- 11.03.2022
- Beginn
- 11.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dyspnoea
Hypotonia
Lethargy
Symptomtext
While sleeping the night after the vaccines, mom woke to him gasping. He was having trouble breathing. Tone went limp. Was lethargic. Responded after mother provided stimulation. Similar issues occurred after 4 mo vaccinations.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dyspnoea
- Hospital-Tage
- -
- Labordaten
- None this time. After 4mo vaccinations, he was evaluated by neuro and seizures were ruled out.
- Aktuelle Erkrankungen
- mild viral URI the week prior.
- Vorgeschichte
- no
- Andere Medikamente
- Peanut allergy supplementation
- Allergien
- no
- Vorherige Impfungen
- similar issue after 4 mo vaccinations
- Staat
- CO
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2023
- Impfdatum
- 16.06.2023
- Beginn
- 01.06.2023
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Abnormal faeces
Diarrhoea
Dyschezia
Malaise
Pain
Symptomtext
FOC reported his daughter had loose and sometimes "jelly-like" stools every day; she was in quite a bit of pain when she had her diarrhea; FOC reported his daughter had loose and sometimes "jelly-like" stools every day, usually multiple times for weeks; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary 2656445-1. The original narrative from the sender is the following: "7/10/23 FOC, called this nurse to ask what company manufactured the RotaTeq vaccine his daughter received on 6/16/23. He explained his daughter had a "bad reaction" and was wanting to see if they could try a different rotavirus vaccine. RN asked about pts reaction and FOC reported his daughter had loose and sometimes "jelly-like" stools every day, usually multiple times for weeks, and is "just not starting to feel better" (approx. 1 month after vaccine). FOC talked to their pediatrician but would also appreciate talking to the medical director of the clinic. This RN informed Dr. who called pt. Dr. emailed RN with this summary: "I called him, and we discussed his child at some length. It turns out she was in quite a bit of pain when she had her diarrhea and so though they didn't see any blood the possibility of a spontaneous resolution of intussusception is a possibility. I advised to discuss with their pediatrician Dr. and deferred the decision to further vaccinate with rotavirus to them". The reporter did not provide an assessment of causal relationship between Vaxelis and the events "FOC reported his daughter had loose and sometimes "jelly-like" stools every day", " she was in quite a bit of pain when she had her diarrhea", "FOC reported his daughter had loose and sometimes "jelly-like" stools every day, usually multiple times for weeks". Of note, these events do not concern Vaxelis, but rather Rotateq vaccine. Vaxelis should have been considered as a concomitant. However, the case was databased to mirror what was reported in VAERS. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Diarrhoea
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2023
- Impfdatum
- 16.06.2023
- Beginn
- 01.06.2023
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Abnormal faeces
Diarrhoea
Dyschezia
Malaise
Pain
Symptomtext
FOC reported his daughter had loose and sometimes "jelly-like" stools every day; she was in quite a bit of pain when she had her diarrhea; FOC reported his daughter had loose and sometimes "jelly-like" stools every day, usually multiple times for weeks; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary 2656445-1. The original narrative from the sender is the following: "7/10/23 FOC, called this nurse to ask what company manufactured the RotaTeq vaccine his daughter received on 6/16/23. He explained his daughter had a "bad reaction" and was wanting to see if they could try a different rotavirus vaccine. RN asked about pts reaction and FOC reported his daughter had loose and sometimes "jelly-like" stools every day, usually multiple times for weeks, and is "just not starting to feel better" (approx. 1 month after vaccine). FOC talked to their pediatrician but would also appreciate talking to the medical director of the clinic. This RN informed Dr. who called pt. Dr. emailed RN with this summary: "I called him, and we discussed his child at some length. It turns out she was in quite a bit of pain when she had her diarrhea and so though they didn't see any blood the possibility of a spontaneous resolution of intussusception is a possibility. I advised to discuss with their pediatrician Dr. and deferred the decision to further vaccinate with rotavirus to them". The reporter did not provide an assessment of causal relationship between Vaxelis and the events "FOC reported his daughter had loose and sometimes "jelly-like" stools every day", " she was in quite a bit of pain when she had her diarrhea", "FOC reported his daughter had loose and sometimes "jelly-like" stools every day, usually multiple times for weeks". Of note, these events do not concern Vaxelis, but rather Rotateq vaccine. Vaxelis should have been considered as a concomitant. However, the case was databased to mirror what was reported in VAERS. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Diarrhoea
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- -
- Geschlecht
- M
- Eingang
- 27.06.2023
- Impfdatum
- 03.01.2023
- Beginn
- 03.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Back pain
Extra dose administered
Pain
Symptomtext
Seeming mild soreness; PedVaxHib was accidentally given in addition to Vaxelis, resulting in an extra dose of Hib vaccine; This case was retrieved during monitoring on 12-APR-2023 with the following Primary ID 2554760-1. The original narrative from the sender is as follows : Patient came in to get caught up on routine vaccines. PedVaxHib was accidentally given in addition to Vaxelis, resulting in an extra dose of Hib vaccine. No reaction noted at time of vaccination. Child tolerated vaccines well. Mom was contacted on 04-JAN-2023 to notify of extra dose and to ask how child was doing. Mom stated patient was doing well with no fever and seeming mild soreness. No concerns from mom other than to ask if child received all the vaccines he needed. The causal relationship between Vaxelis and the reported event Seeming mild soreness" was not provided. Due to the nature of the event, the causal relationship between Vaxelis and "PedVaxHib was accidentally given in addition to Vaxelis, resulting in an extra dose of Hib vaccine" was not applicable. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Back pain
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- 1,5
- Geschlecht
- M
- Eingang
- 09.01.2023
- Impfdatum
- 03.01.2023
- Beginn
- 03.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Extra dose administered
Pain
Symptomtext
Patient came in to get caught up on routine vaccines. PedVaxHib was accidentally given in addition to Vaxelis, resulting in an extra dose of Hib vaccine. No reaction noted at time of vaccination. Child tolerated vaccines well. Mom was contacted on 1/4/2023 to notify of extra dose and to ask how child was doing. Mom stated patient was doing well with no fever and seeming mild soreness. No concerns from mom other than to ask if child received all the vaccines he needed.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pain
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- None
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2022
- Impfdatum
- 09.08.2022
- Beginn
- 09.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Crying
Erythema
Irritability
Poor feeding infant
Pyrexia
Vomiting
Symptomtext
She wouldn't breastfeed; Mother saw she was crying then turned red; Mother saw she was crying; Mother notices severe irritability; Tactile fever; She had 2 episodes of vomiting; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2407394-1. The original narrative from the sender is as follows: Shortly after vaccines, mother noticed severe irritability. She wouldn't breastfeed. She had 2 episodes of vomiting approximately EMS hours after vaccines. Tactile fever. Mother saw she was crying then turned red, no cyanosis. Called ambulance, went to local ER, was evaluated and sent home, no testing done. Current illness included Viral bronchiolitis. The causal relationship between Vaxelis and the events, " "She wouldn't breastfeed", "Mother saw she was crying then turned red", "Mother saw she was crying", "Mother notices severe irritability", "Tactile fever" and "She had 2 episodes of vomiting" was not reported. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pyrexia
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Bronchiolitis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MT
- Alter
- -
- Geschlecht
- U
- Eingang
- 28.12.2022
- Impfdatum
- 16.05.2022
- Beginn
- 17.05.2022
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Injection site bruising
Injection site erythema
Injection site swelling
Injection site warmth
Symptomtext
Patient developed heat from injection site; patient developed bruising from injection site; patient developed a softball size redness from injection site; patient developed swelling from injection site; This case was retrieved during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2444885-1. The original narrative from the sender is the following: On 17-May-2022 patient developed a softball size redness, bruising, swelling and heat from injection site. On 18May2022 patient's redness continued and progressed to be a bit bigger in size, redness and bruising still present. On 19May2022 patient's parents took child to the hospital to be evaluated. Antibiotics was prescribed, but not taken. On 28May2022 redness, swelling, heat and bruising resolved. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Patient developed a softball size redness, bruising, swelling and heat from injection site". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site bruising
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2022
- Impfdatum
- 24.08.2022
- Beginn
- 24.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Feeling abnormal
Injection site erythema
Injection site swelling
Irritability
Symptomtext
Patient became very fussy; Patient became very fussy and had erythema and swelling on the left thigh; Patient became very fussy and had erythema and swelling on the left thigh; This case was retrieve during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2022 with the following VAERS Primary ID 2420027-1. The original narrative from the sender is the following: Approximately 3 hours after vaccines were administered, patient became very fussy and had erythema and swelling on the left thigh at the site of the PCV13 vaccine. Mom was able to soothe infant to sleep. Three hours later, the swelling and redness increased in size to about 3-5 inches in diameter, and infant was inconsolable. Mom gave tylenol and cool compress. Three hours later, the erythema and swelling had resolved. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Patient became very fussy, and had erythema and swelling on the left thigh". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- VITAMIN D [COLECALCIFEROL]
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 1,3
- Geschlecht
- M
- Eingang
- 21.12.2022
- Impfdatum
- 16.12.2022
- Beginn
- 18.12.2022
- Tage bis Beginn
- 2,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Rash
Urticaria
Symptomtext
Generalized allergic urticaria involving entire body without systemic symptoms (wheezing, cough, abdominal pain, vomiting, swelling) Rash originally was treated with PO Benadryl but due to progression required oral steroid administration.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Rash
- Hospital-Tage
- -
- Labordaten
- Tele-visit - 12/18/2022 In Office visit - 12/19/2022
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- NONE
- Allergien
- NONE
- Vorherige Impfungen
- -
- Staat
- ID
- Alter
- 0,2
- Geschlecht
- F
- Eingang
- 01.11.2022
- Impfdatum
- 03.08.2022
- Beginn
- 03.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- SYR / LG
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Abdominal discomfort
Depressed mood
Diarrhoea
Haematochezia
Symptomtext
Had two stools with blood in them the day of vaccination and the following day (one stool with blood each day). Had extra loose stools for 2-3 weeks afterward and seemed to have and upset stomach and was often unhappy for 2-3 weeks following the vaccines. All seemed to be related to stooling and stomach concerns.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Diarrhoea
- Hospital-Tage
- -
- Labordaten
- None. Mom described the events to me 2 months later.
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- LA
- Alter
- -
- Geschlecht
- M
- Eingang
- 29.09.2022
- Impfdatum
- 08.08.2022
- Beginn
- 08.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Crying
Diarrhoea
Pyrexia
Symptomtext
Crying excessively; He got diarrhea five times; High fever; This non-serious spontaneous safety report with reference number # 02222997( Interaction # 02222985) was received by a partner on 23-AUG-2022 and forwarded on 20-SEP-2022 from a physician. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events of "He got diarrhea five times, high fever and crying excessively". Further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Diarrhoea
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Dermatitis (Started 2 weeks ago. Hydrocortisone cream was prescribed.); Prophylaxis
- Vorgeschichte
- Medical History/Concurrent Conditions: Clinical death (Died at birth because umbilical cord chocked him, was resuscitated)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 29.09.2022
- Impfdatum
- 19.04.2022
- Beginn
- 19.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Pyrexia
Vomiting
Symptomtext
Fever 105F after VAXELIS vaccine and vomiting; Fever 105F after VAXELIS vaccine + vomiting; This non-serious spontaneous Safety Report, with reference numbers 02208144/02208142, was received on 19-JUL-2022 and forwarded on 20-JUL-2022 from a physician. The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "fever". No further information is expected. FOLLOW-UP INFORMATION was received by a partner on 07-SEP-2022 and forwarded on 09-SEP-202. Additional information was received on 12-SEP-2022. The case is maintained as non-serious. The reporter assessed the causal relationship between Vaxelis and the reported events "Fever 105F after Vaxelis vaccine and vomiting" as related. Further information is expected to clarify patient's duration of hospitalization.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pyrexia
- Hospital-Tage
- -
- Labordaten
- Test Date: 20211203; Test Name: Birth weight; Result Unstructured Data: 6 pounds 10 oz
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TN
- Alter
- -
- Geschlecht
- F
- Eingang
- 29.09.2022
- Impfdatum
- 08.06.2022
- Beginn
- 09.06.2022
- Tage bis Beginn
- 1,0
- Dosis
- 3
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Urticaria
Symptomtext
Urticaria; This non-serious spontaneous case was received during the Reporting System monitoring on 12-JUL-2022 with the following Primary ID 2317412-1. The original narrative from the sender is as below: Pt. had the above vaccines, awakened 24hrs later with hives over entire body, went to ER and received steroids and antihistamine. Resolved within 2 days. Mom had also given regular whole milk the same day as shots because of the formula shortage. Possible reaction to milk
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Urticaria
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- -
- Geschlecht
- M
- Eingang
- 29.09.2022
- Impfdatum
- 30.05.2022
- Beginn
- 30.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Urticaria
Symptomtext
About 10-15 min after vaccines on the way out patient developed defuse urticaria to face and chest; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2302595-1. The original narrative from the sender is the following: About 10-15 min after vaccines on the way out patient developed defuse urticaria to face and chest. 8 mg dexamethasone given and monitored in office with resolution of urticaria after about 45 min. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "defuse urticaria to face and chest". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Urticaria
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NH
- Alter
- -
- Geschlecht
- F
- Eingang
- 29.09.2022
- Impfdatum
- 02.05.2022
- Beginn
- 09.05.2022
- Tage bis Beginn
- 7,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site mass
Soft tissue swelling
Ultrasound scan abnormal
Symptomtext
Lump at site of injection, size comparable to a dime.; Lump at site of injection, size comparable to a dime.; Left thigh ultrasound revealed soft tissue swelling; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2267700-1. The original narrative from the sender is as below: Lump at site of injection, size comparable to a dime.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site mass
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Premature baby 33 to 36 weeks (Preterm at 33 1/7 w gestation.)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NH
- Alter
- -
- Geschlecht
- F
- Eingang
- 29.09.2022
- Impfdatum
- 02.05.2022
- Beginn
- 09.05.2022
- Tage bis Beginn
- 7,0
- Dosis
- UNK
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site mass
Soft tissue swelling
Ultrasound scan abnormal
Symptomtext
Lump at site of injection, size comparable to a dime.; Lump at site of injection, size comparable to a dime.; Left thigh ultrasound revealed soft tissue swelling; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2267700-1. The original narrative from the sender is as below: Lump at site of injection, size comparable to a dime.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site mass
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Premature baby 33 to 36 weeks (Preterm at 33 1/7 w gestation.)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MT
- Alter
- 1,8
- Geschlecht
- M
- Eingang
- 14.09.2022
- Impfdatum
- 16.05.2022
- Beginn
- 17.05.2022
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Injection site bruising
Injection site erythema
Injection site swelling
Injection site warmth
Symptomtext
5/17/2022 patient developed a softball size redness, bruising, swelling and heat from injection site. 5/18/2022 Patients redness continued and progressed to be a bit bigger in size, redness, and bruising still present. 5/19/2022 Patient parents took child in to hospital to be evaluated. Antibiotics where prescribed, but not taken. 5/28/22 redness, swelling, heat, and bruising resolved.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site bruising
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 12.09.2022
- Impfdatum
- 19.04.2022
- Beginn
- 19.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: ja
Pyrexia
Vomiting
Symptomtext
fever; vomiting; This spontaneous report was received from a physician via a company representative, referring to a 4-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-APR-2022, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) oral liquid, orally, lot #U037808, expiration date: 26-MAR-2023, (strength was not provided); the patient also was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection, lot number reported as "EW2019", expiration date: 15-APR-2024, (strength and route of administration were not provided) and with a dose of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, 0.5 milliliter, lot #U7125AA, expiration date: 15-JUL-2024 (strength and route of administration were not provided); all vaccines administered for prophylaxis. On the same date (19-APR-2022), the patient was taken to emergency room due to fever (body temperature showed 105 (units not provided)) and vomiting. It was reported that the patient was hospitalized on an unspecified date due to the events. On an unknown date in 2022, the patient recovered from the events. No treatment was given for fever or the vomiting. The causal relationship between fever and vomiting with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was unknown and the causal relationship between the aforementioned events and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) was reported as related.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pyrexia
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- 0,2
- Geschlecht
- F
- Eingang
- 10.08.2022
- Impfdatum
- 09.08.2022
- Beginn
- 09.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Crying
Erythema
Feeding disorder
Irritability
Pyrexia
Vomiting
Symptomtext
Shortly after vaccines, mother noticed severe irritability. She wouldn't breastfeed. She had 2 episodes of vomiting approximately EMS hours after vaccines. Tactile fever. Mother saw she was crying then turned red, no cyanosis. Called ambulance, went to local ER, was evaluated and sent home, no testing done.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pyrexia
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- Viral bronchiolitis
- Vorgeschichte
- None
- Andere Medikamente
- Vitamin D oral drops
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- TN
- Alter
- 0,6
- Geschlecht
- F
- Eingang
- 13.06.2022
- Impfdatum
- 08.06.2022
- Beginn
- 09.06.2022
- Tage bis Beginn
- 1,0
- Dosis
- 3
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Urticaria
Symptomtext
Pt. had the above vaccines, awakened 24 hr later with hives over entire body, went to ER and received steroids and antihistamine. Sx resolved within 2 days. Mom had also given regular whole milk the same day as shots because of the formula shortage. Possible reaction to milk.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Urticaria
- Hospital-Tage
- -
- Labordaten
- No
- Aktuelle Erkrankungen
- No
- Vorgeschichte
- No
- Andere Medikamente
- No
- Allergien
- No
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 3,0
- Geschlecht
- M
- Eingang
- 30.05.2022
- Impfdatum
- 30.05.2022
- Beginn
- 30.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Urticaria
Symptomtext
About 10-15 min after vaccines on the way out patient developed defuse urticaria to face and chest. 8 mg dexamethasone given and monitored in office with resolution of urticaria after about 45 min.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Urticaria
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- non
- Vorgeschichte
- non
- Andere Medikamente
- non
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.09.2023
- Impfdatum
- 05.05.2023
- Beginn
- 05.05.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- SC / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Incorrect route of product administration
Symptomtext
Vaccine given as SQ instead of IM; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2637292-1. The original narrative from the sender is the following: Vaccine given as SQ instead of IM. The case is considered as off label use. The causal relationship between Vaxelis and the event "Vaccine given as SQ instead of IM." was assessed as not applicable due to the nature of the reported event. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect route of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Runny nose
- Vorgeschichte
- Medical History/Concurrent Conditions: Febrile seizure
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.09.2023
- Impfdatum
- 10.05.2023
- Beginn
- 10.05.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- SC / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Incorrect route of product administration
Off label use
Symptomtext
Vaccine given SQ instead of IM; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2637291-1. The original narrative from the sender is the following: Vaccine given SQ instead of IM. The case is considered as off label use. The causal relationship between Vaxelis and the event "Vaccine given SQ instead of IM" was assessed as not applicable due to the nature of these reported event. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect route of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 0,6
- Geschlecht
- F
- Eingang
- 08.09.2023
- Impfdatum
- 02.08.2023
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 3
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Symptomtext
Provider administered covid-19 Bivalent Booster 0.2mL (NDC 80777-0283-99) yellow box pink lid instead of Moderna Bivalent dose 0.25mL (NDC 80777-282-99) gray border, dark blue lid as second dose in primary series. No adverse reaction.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- N/A
- Andere Medikamente
- N/A
- Allergien
- N/A
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.06.2023
- Impfdatum
- 26.01.2023
- Beginn
- 26.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Wrong product administered
Symptomtext
Patient received Vaxelis instead of getting varicella; This non-serious case was received during monitoring on 12-APR-2023 with the following Primary ID 2570580-1. The original narrative from the sender is the following: Patient received Vaxelis instead of getting varicella. Patients mother was notified, manufacturer , and safety report from office was completed. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Patient received Vaxelis instead of getting varicella". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Wrong product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- SD
- Alter
- -
- Geschlecht
- M
- Eingang
- 27.06.2023
- Impfdatum
- 09.01.2023
- Beginn
- 09.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
No adverse event
Symptomtext
Patient was given both Vaxelis and Hib vaccinations. No adverse reactions reported by parents.; Patient was given both Vaxelis and Hib vaccinations. No adverse reactions reported by parents.; This non-serious case was received during monitoring on 12-APR-2023 with the following Primary ID 2561510-1. The original narrative from the sender is the following: Patient was given both Vaxelis and Hib vaccinations. No adverse reactions reported by parents. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Patient was given both Vaxelis and Hib vaccinations. No adverse reactions reported by parents.". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- BABY'S VITAMIN D3
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- -
- Geschlecht
- M
- Eingang
- 27.06.2023
- Impfdatum
- 22.03.2023
- Beginn
- 22.03.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Product administered to patient of inappropriate age
Symptomtext
No adverse event; Product administered to patient of inappropriate age (13 years old); This case was retrieved during the monitoring on 12-APR-2023 with the following Primary ID 2602334-1. The original narrative from the sender is as follows: No symptoms or adverse effects. Due to the nature of the event, the causal relationship between Vaxelis and "no symptoms or adverse effects and Product administered to patient of inappropriate age (13 years old)" was not applicable. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 1,5
- Geschlecht
- M
- Eingang
- 26.05.2023
- Impfdatum
- 17.05.2023
- Beginn
- 17.05.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- SC / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Incorrect route of product administration
Symptomtext
Vaccine was given SQ instead of IM
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect route of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- F
- Eingang
- 07.04.2023
- Impfdatum
- 03.11.2022
- Beginn
- 11.10.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Poor quality product administered
Symptomtext
VAXELIS was administered to 6 patients after product experienced an excursion was not suitable to use.; This non-serious spontaneous safety report was received on 23-FEB-2023, from an HCP. This case is linked to case MCM-004541 (reference number 2023SA055890 and number 01495388). Due to the nature of the event, the causality between the reported event "VAXELIS was administered to 6 patients after product experienced an excursion was not suitable to use" and Vaxelis was not applicable. No further information is expected given that there were no adverse events following Vaxelis administration post-excursion. For reference purposes this case is linked to MCM-004541 (source case), MCM-004562, MCM-004564, MCM-004563, and MCM-004566, due to same reporter.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- -
- Geschlecht
- F
- Eingang
- 04.04.2023
- Impfdatum
- 14.03.2023
- Beginn
- 14.03.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Off label use
Product administered to patient of inappropriate age
Wrong product administered
Symptomtext
20 year old patient was administered Vaxelis instead of TD; 20 year old patient was administered Vaxelis instead of TD; This non-serious spontaneous safety report, with case number 2023SA085919/01534523, was received by partner on 15-MAR-2023 on 16-MAR-2023 from a physician. Due to the nature of the event the causal relationship between Vaxelis and the reported event "20-year-old patient was administered Vaxelis instead of TD" was assessed as not applicable. Case was considered off-label use due to Vaxelis being administered to a 20-year-old patient. Further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Off label use
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 0,5
- Geschlecht
- M
- Eingang
- 04.04.2023
- Impfdatum
- 09.02.2023
- Beginn
- 11.10.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Poor quality product administered
Product storage error
Symptomtext
VAXELIS was administered to 6 patients after product experienced an excursion was was not suitable to use.; This non-serious spontaneous safety report, was received on 23-FEB-2023, from a HCP. This case is linked to case MCM-004541 (reference number 2023SA055890 and Inquiry number 01495388). Due to the nature of the event, the causality between the reported event "VAXELIS was administered to 6 patients after product experienced an excursion was not suitable to use" and Vaxelis was not applicable. No further information is expected given that there were no adverse events following Vaxelis administration post-excursion. For reference purposes this case is linked to MCM-004541 (source case), MCM-004562, MCM-004564, MCM-004565, and MCM-004563, due to same reporter.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- F
- Eingang
- 04.04.2023
- Impfdatum
- 05.12.2022
- Beginn
- 11.10.2022
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
VAXELIS was administered to 6 patients after product experienced an excursion was was not suitable to use.; This non-serious spontaneous safety report was received on 23-FEB-2023, from a HCP. This case is linked to case MCM-004541 (reference number 2023SA055890 and Inquiry number 01495388). Due to the nature of the event, the causality between the reported event "VAXELIS was administered to 6 patients after product experienced an excursion was not suitable to use" and Vaxelis was not applicable. No further information is expected given that there were no adverse events following Vaxelis administration post-excursion. For reference purposes this case is linked to MCM-004541, MCM-004563, MCM-004564, MCM-004565, and MCM-004566, due to same reporter.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 04.04.2023
- Impfdatum
- 25.10.2022
- Beginn
- 11.10.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Poor quality product administered
Product storage error
Symptomtext
VAXELIS was administered to 6 patients after product experienced an excursion was was not suitable to use.; This non-serious spontaneous safety report, with reference number 2023SA055890 (Inquiry number # 01495388), was received by the partner on 16-FEB-2023 and forwarded on 17-FEB-2023, from other health professional. This case was considered non-valid due to no patient identifiers (temperature excursion only). Due to the nature of the event, the causality between the reported event "VAXELIS was administered to 6 patients after product experienced an excursion was not suitable to use." and Vaxelis was assessed as not applicable. Further information is expected. FOLLOW-UP INFORMATION was received on 23-FEB-2023, from a HCP. The case is maintained as non-serious and upgraded to valid. The HCP confirmed that there were no adverse events following Vaxelis administration. Due to the nature of the event, the causality between the reported event "VAXELIS was administered to 6 patients after product experienced an excursion was not suitable to use" and Vaxelis remained not applicable. No further information is expected given that there were no adverse events following Vaxelis administration post-excursion. For reference purposes this case is linked to MCM-004562, MCM-004563, MCM-004564, MCM-004565, and MCM-004566, due to same reporter.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Poor quality product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- UT
- Alter
- -
- Geschlecht
- F
- Eingang
- 04.04.2023
- Impfdatum
- 04.01.2023
- Beginn
- 04.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Exposure during pregnancy
Product administered to patient of inappropriate age
Symptomtext
Vaxelis was accidentally administered to an adult patient; The caller states that the physician ordered a Tdap vaccine and the MA administered Vaxelis.; Caller with medical facility called to report that Vaxelis was accidentally administered to an adult patient. Patient was 28 weeks and 1 day pregnant; This non-serious spontaneous safety report, with reference number 2023SA049850/ Inquiry# 01487665 was received by a partner on 10-FEB-2023 and forwarded on 13-FEB-2023 from a non-health professional. Due to the nature of the event, the causality between the events "Vaxelis was accidentally administered to an adult patient", "the caller states that the physician ordered a Tdap vaccine and the MA administered Vaxelis" and "Caller with medical facility called to report that Vaxelis was accidentally administered to an adult patient. Patient was 28 weeks and 1 day pregnant" and Vaxelis was not applicable. Further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Exposure during pregnancy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- -
- Geschlecht
- F
- Eingang
- 04.04.2023
- Impfdatum
- 26.01.2023
- Beginn
- 26.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Wrong product administered
Symptomtext
Caller reported VAXELIS was administered instead of the intended VARICELLA vaccination.; This non-serious spontaneous safety report with reference number # 2023SA031533 (Inquiry # 01465069) was received by a partner on 26-JAN-2023 and forwarded on 27-JAN-2023 from a health care professional. Due to the nature of the event, the causality between the event "Caller reported VAXELIS was administered instead of the intended VARICELLA vaccination." and Vaxelis was not applicable. Further information is expected. FOLLOW-UP INFORMATION was received from the health care professional, by Fax, on 24-FEB-2023. No adverse event was reported. Due to the nature of the event, the causal relationship between Vaxelis and the event "Caller reported VAXELIS was administered instead of the intended VARICELLA vaccination" was not applicable. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- Medical History/Concurrent Conditions: COVID-19
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- 13,0
- Geschlecht
- M
- Eingang
- 23.03.2023
- Impfdatum
- 22.03.2023
- Beginn
- 22.03.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Product administered to patient of inappropriate age
Symptomtext
No symptoms or adverse effects
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 1,0
- Geschlecht
- F
- Eingang
- 30.01.2023
- Impfdatum
- 26.01.2023
- Beginn
- 26.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Wrong product administered
Symptomtext
Patient received Vaxelis instead of getting varicella. Patients mother was notified, manufacture , and safety report from office was completed.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Wrong product administered
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- SD
- Alter
- 0,5
- Geschlecht
- M
- Eingang
- 17.01.2023
- Impfdatum
- 09.01.2023
- Beginn
- 09.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Extra dose administered
No adverse event
Symptomtext
Patient was given both Vaxelis and Hib vaccinations. No adverse reactions reported by parents.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- Baby vitamin D3 OTC
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- -
- Geschlecht
- M
- Eingang
- 28.12.2022
- Impfdatum
- 06.07.2022
- Beginn
- 06.07.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Pallor
Somnolence
Symptomtext
Sudden onset of extreme pallor; Somnolent, went to sleep for several hours; Vaccine administered to 1 month child; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2393248-1. The original narrative from the sender is the following: sudden onset of extreme pallor. Somnolent, went to sleep for several hours, awoke appearing normal and back to baseline. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "sudden onset of extreme pallor", "Somnolent, went to sleep for several hours" and "Vaccine administered to 1 month child". No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pallor
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- VITAMIN D [VITAMIN D NOS]
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NJ
- Alter
- -
- Geschlecht
- U
- Eingang
- 28.12.2022
- Impfdatum
- -
- Beginn
- 09.09.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Improperly stored vaccine was administered to a patient. Temperature: 46.5F.; This spontaneous safety report, with reference number 02260497, was received by a partner on 04-OCT-2022 and forwarded on the same day, from a Health Professional. Due to the nature of the event, the causality between the event "Improperly stored vaccine was administered to a patient. Temperature: 46.5F." and Vaxelis was not applicable. Further information is expected. FOLLOW-UP INFORMATION was received by a partner on 06-OCT-2022 and forwarded on 07-OCT-2022. The case is maintained as non-serious. Due to the nature of the event, the causality between the event "Improperly stored vaccine was administered to a patient. Temperature: 46.5F." and Vaxelis was not applicable. Further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NC
- Alter
- 74,0
- Geschlecht
- M
- Eingang
- 15.12.2022
- Impfdatum
- 15.12.2022
- Beginn
- 15.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Symptomtext
Patient had no side effects
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- Obesity
- Andere Medikamente
- N/A
- Allergien
- N/A
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 0,5
- Geschlecht
- M
- Eingang
- 08.11.2022
- Impfdatum
- 01.11.2022
- Beginn
- 01.11.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
NO REACTION. MODERNA VACCINE EXPIRED 10-29-2022. VACCINE WAS GIVEN ON 11-01-2022.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 1,5
- Geschlecht
- F
- Eingang
- 30.09.2022
- Impfdatum
- 30.09.2022
- Beginn
- 30.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
No adverse event
Symptomtext
No treatments or adverse events
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- -
- Geschlecht
- U
- Eingang
- 29.09.2022
- Impfdatum
- 29.08.2022
- Beginn
- 01.08.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Nurse calling for evaluation on refrigerated products states 3 doses of VAXELIS in PFS involved in this excursion have been administered to patients; This spontaneous safety report, with interaction number 02237963 (case# 02238021), was received by the partner on 01-SEP-2022 and forwarded on 02-SEP-2022, from other health professional. Due to the nature of the event, the causality between the event "Nurse calling for evaluation on refrigerated products states 3 doses of VAXELIS in PFS involved in this excursion have been administered to patients; VAXELIS :Temperature/Time frame (48.2F) for 40 minutes", and Vaxelis was not applicable. Further information is expected. For reference purposes, cases is linked to MCM-003999 and MCM-003974 (same reporter).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- -
- Geschlecht
- F
- Eingang
- 29.09.2022
- Impfdatum
- 22.06.2022
- Beginn
- 22.06.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Symptomtext
no adverse reactions noted at visit; This non-serious case was received during the Reporting System monitoring on 12-JUL-2022 with the following Primary ID 2342230-1. The original narrative from the sender is as below: No adverse reactions noted at visit. Current illness was reported as none.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- -
- Geschlecht
- M
- Eingang
- 29.09.2022
- Impfdatum
- 13.06.2022
- Beginn
- 13.06.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Symptomtext
Extra dose administered; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System(VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2317328-1. The original narrative from the sender is as below: Patient was inadvertently given an IPV when IPV is contained in the combination vaccine which resulted in a double dose of IPV being given in the same visit.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WV
- Alter
- -
- Geschlecht
- F
- Eingang
- 29.09.2022
- Impfdatum
- 11.05.2022
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product administered to patient of inappropriate age
Wrong product administered
Symptomtext
2 month old infant was given Pneumovax 23 instead of the ordered Prevnar 13; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2290665-01. The original narrative from the sender is as below: 2 month old infant was given Pneumovax 23 instead of the ordered Prevnar 13. Current illness reported as none.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Wrong product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WV
- Alter
- -
- Geschlecht
- F
- Eingang
- 29.09.2022
- Impfdatum
- 11.05.2022
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product administered to patient of inappropriate age
Wrong product administered
Symptomtext
2 month old infant was given Pneumovax 23 instead of the ordered Prevnar 13; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2290665-01. The original narrative from the sender is as below: 2 month old infant was given Pneumovax 23 instead of the ordered Prevnar 13. Current illness reported as none.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Wrong product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OR
- Alter
- 0,1
- Geschlecht
- M
- Eingang
- 27.09.2022
- Impfdatum
- 09.09.2022
- Beginn
- 18.09.2022
- Tage bis Beginn
- 9,0
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: ja
Blood bilirubin
Blood test
Decreased appetite
Full blood count
Haematochezia
Infantile spitting up
Influenza virus test
Intussusception
Irritability
Lethargy
Metabolic function test
Mucous stools
SARS-CoV-2 test
Somnolence
Ultrasound abdomen abnormal
Symptomtext
9/17 WAS LETHARGIC ONLY OPEING EYES BRIEFLY AND THEN FALLS BACK ASLEEP. NOT INTERESTED IN EATING. TOOK ONLY A SMALL AMOUNT WHICH IS NOT LIKE HIM NORMALLY TAKES 90-110ML PER FEED. CALLED PCP WHO ADVISED TO TAKE HIM TO ED. TOOK ANOTHER 80ML IN THE ED AND HE THEN SPIT UP CURDLED BREAKMILK. NO BLOOD OR BILE AND THIS IS NOT NORMAL FOR HIM AND HE IS MORE FUSSY THEN NORMAL. RIGHT BEFORE COMING TO THE HPSITAL HAD A LARGE STOOL MIXED WITH BLOOD AND MUCOS. ADMITTED TO THE HOSPOITAL FOR OBSERVATION AN ULTRASOUND DORDERD WHICH CONFIRMED INTUSSUSCEPTION
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Blood bilirubin
- Hospital-Tage
- 2,0
- Labordaten
- BLOOD WORK cbc, cmp, bILI LEVELS SARS AND FLU TESTING ULTRASOUND
- Aktuelle Erkrankungen
- NO ILLNESSES NOTED AT TIME OF VACCINATION AND UP TO ONE MONTH PRIOR
- Vorgeschichte
- NONE
- Andere Medikamente
- VITAMIN D DROPS
- Allergien
- NONE
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- 0,1
- Geschlecht
- M
- Eingang
- 27.07.2022
- Impfdatum
- 06.07.2022
- Beginn
- 06.07.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Pallor
Somnolence
Symptomtext
sudden onset of extreme pallor. Somnolent, went to sleep for several hours, awoke appearing normal and back to baseline.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pallor
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- no
- Vorgeschichte
- none
- Andere Medikamente
- vitamin D drops
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 03.07.2022
- Impfdatum
- 18.05.2022
- Beginn
- 18.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
During temperature excursion call, customer reports that improperly stored VAXELIS was administered to unknown patient; This spontaneous non-serious safety report was received by partner (Ref: 02169914) on 20-May-2022 and forwarded on 23-May-2022 from a consumer. Due to the nature of the event, the causality between the event and the product is not applicable. This case is non-valid due to no patient identifiers. Further information is expected. FOLLOW-UP INFORMATION was received by a partner on 03-Jun-2022 from a consumer, with reference number: 02169906 (interaction number) and forwarded on 06-Jun-2022. The case was maintained as non-serious. The case is now considered valid as patient identifiers (initials and age) were provided. It was reported that there was no adverse event. Due to the nature of the event, the causality between "During temperature excursion call, customer reports that improperly stored VAXELIS was administered to unknown patient" and Vaxelis is not applicable. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TN
- Alter
- -
- Geschlecht
- F
- Eingang
- 03.07.2022
- Impfdatum
- 14.01.2022
- Beginn
- 14.01.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Symptomtext
Pt was given combination vaccine containing Hep B while pt had already completed 3 doses of Hep B; This case was retrieved during monitoring on 11-APR-2022 with the following reference number: 2194500-1. The original narrative is as below. Pt was given combination vaccine containing Hep B while pt had already completed 3 doses of Hep B. Vaccine made Hep B #4
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TN
- Alter
- -
- Geschlecht
- F
- Eingang
- 03.07.2022
- Impfdatum
- 15.02.2022
- Beginn
- 15.02.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Inappropriate schedule of product administration
Symptomtext
Given combination vaccine containing Hep B & Hep B wasnt due. Vaccine (Hep B) before minimum interval; This non-serious case was received during the monitoring on 11-APR-2022 with the following Primary ID 2194488-1. The original narrative from the sender is as below: Pt was given combination vaccine containing Hep B & Hep B wasnt due. Vaccine (Hep B) before minimum interval.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 03.07.2022
- Impfdatum
- -
- Beginn
- 18.03.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
VAXELIS was administered after a temperature excursion; This non-serious spontaneous safety report was received by the partner on 04-Apr-2022 and forwarded on 05-Apr-2022 from another health care professional. Due to the nature of the event, the causality assessment between the event "VAXELIS was administered after a temperature excursion" and the product is not applicable. Further information is expected. FOLLOW-UP INFORMATION was received by a health care professional on 22-APR-2022. The case is maintained as non-serious. The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient. Due to the nature of the event, the causality assessment between the event "VAXELIS was administered after a temperature excursion" and the product remains not applicable. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 03.07.2022
- Impfdatum
- 18.03.2022
- Beginn
- 18.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
VAXELIS was administered after three major temperature excursions: Temperature/Time frame: 35.1 F for 4 hours 40 minutes; 35.2 F for 54 hours, 35.3 F for 30minutes; This spontaneous safety report, with reference number 02140661 was received by the partner on 04-APR-2022 and forwarded to agency on 05-APR-2022, from a nurse. Due to the nature of the event, the causality between the event "VAXELIS was administered after three major temperature excursions" and Vaxelis is not applicable. Further information is expected. NON-SIGNIFICANT Follow-up information, with reference number 02140661, was received by a partner on 13-APR-2022, and forwarded to agency on 14-APR-2022, from a nurse. This case is maintained as non-serious. Due to the nature of the event, the causality between Vaxelis and the event "VAXELIS was administered after three major temperature excursions" remains not applicable. No further information is expected. The reporter had no new information to offer just wanted to know if the AE letter had to be sent back because there was no other information about the event.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- 1,5
- Geschlecht
- F
- Eingang
- 29.06.2022
- Impfdatum
- 22.06.2022
- Beginn
- 22.06.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Symptomtext
no adverse reactions noted at visit
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- none
- Andere Medikamente
- None
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- LA
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 16.06.2022
- Impfdatum
- 08.06.2022
- Beginn
- 14.06.2022
- Tage bis Beginn
- 6,0
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Enema administration
Intussusception
Ultrasound scan abnormal
Symptomtext
Intussusception Hospitalization & reduction with enema No surgery Discharged 36 hours later
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Enema administration
- Hospital-Tage
- -
- Labordaten
- Ultrasound
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TN
- Alter
- 4,0
- Geschlecht
- F
- Eingang
- 23.03.2022
- Impfdatum
- 14.01.2022
- Beginn
- 14.01.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Extra dose administered
Symptomtext
Pt was given combination vaccine containing Hep B while pt had already completed 3 doses of Hep B. Vaccine made Hep B #4
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TN
- Alter
- 0,5
- Geschlecht
- F
- Eingang
- 23.03.2022
- Impfdatum
- 15.02.2022
- Beginn
- 15.02.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Inappropriate schedule of product administration
Symptomtext
Pt was given combination vaccine containing Hep B & Hep B wasnt due. Vaccine (Hep B) before minimum interval.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -