VAERS Reports UJ411AA

VAERS 2010161

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ411AA

schwer

Staat: KY
Alter: 1,5
Geschlecht: M
Eingang: 06.01.2022
Impfdatum: 01.06.2021
Beginn: 06.06.2021
Tage bis Beginn: 5,0
Dosis: 4
Route/Site: IM / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: ja

Dermatitis diaper Eczema Febrile convulsion Pharyngeal erythema Pharyngitis Rash Rash papular Rhinorrhoea SARS-CoV-2 test negative Seizure Streptococcus test negative Tonsillar disorder Tonsillar erythema Urticaria Viral infection Vomiting

Symptomtext

The patient developed a febrile seizure on 6/6/2021 just after midnight. The generalized seizure lasted 4-5 minutes. Temp was 39 degrees. He vomited shortly after that. I had him evaluated at Hospital E.R. and clinically looked good with Temp 38 degrees.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Febrile convulsion
Hospital-Tage: -
Labordaten: On follow-up in my office on 6/7, patient was still febrile at home with Tmax 39 degrees the previous evening. He had 2+/4+ tonsils with erythema moderate erythema pharynx, nose with clear drainage. In diaper area, he had an urticarial rash with red, raised red patches that extended to upper thighs. He had eczematous rash lower abdomen. COVID 19 PCR and Strep tests both negative Diagnoses: Viral syndrome with pharyngitis and associated rash. History of febrile seizure most likely due to viral illness.
Aktuelle Erkrankungen: none
Vorgeschichte: food allergy
Andere Medikamente: -
Allergien: egg
Vorherige Impfungen: -

VAERS 1835796

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ411AA

gering

Staat: DE
Alter: 2,0
Geschlecht: M
Eingang: 02.11.2021
Impfdatum: -
Beginn: 25.10.2021
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / RL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Expired product administered No adverse event

Symptomtext

patient was administered the PENTACEL, then came and told her it was expired no reported adverse event; Initial information received on 25-Oct-2021 regarding an unsolicited valid non-serious case received from a other health professional and non-health care professional via Medical Information number: 00826991. This case involves a 24 months old male patient who was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered). The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided. On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number: UJ411AA and expiry date not reported via intramuscular route in the right thigh prophylactic vaccination. It was case of an actual medication error due to expired vaccine used (latency: same day). At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 1813137

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ411AA

gering

Staat: TX
Alter: -
Geschlecht: U
Eingang: 23.10.2021
Impfdatum: 14.10.2021
Beginn: 14.10.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Expired product administered

Symptomtext

an expired dose of PENTACEL was given to a patient with no AE; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from other health professional and consumer/non-healthcare professional via call center via the Regulatory Authority (Reference number- 00815089). This case involves a (unknown demographic) patient who received an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. On 14-Oct-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ411AA, UJ385AA and expiry date: 12-Oct-2021) via an unknown route at an unknown administration site for prophylactic vaccination. It was an actual medication error case due to expired vaccine used (latency: same day). It was reported "Caller wanted to know if the patient needs another dose." At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -