VAERS Reports UJ352AAA

VAERS 2595167

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ352AAA

mild

Staat: TX
Alter: 1,3
Geschlecht: F
Eingang: 12.03.2023
Impfdatum: 03.03.2023
Beginn: 06.03.2023
Tage bis Beginn: 3,0
Dosis: 4
Route/Site: IM / RL

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

Injection site erythema Injection site reaction Rash maculo-papular Vaccination site swelling

Symptomtext

Redness swelling and rash (maculopapular) at site of vaccine

Weitere VAERSDATA-Felder

Praegender Schweregrund: Injection site erythema
Hospital-Tage: -
Labordaten: None
Aktuelle Erkrankungen: none
Vorgeschichte: none
Andere Medikamente: none
Allergien: none
Vorherige Impfungen: -

VAERS 1518324

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ352AAA

gering

Staat: NM
Alter: 1,0
Geschlecht: F
Eingang: 31.07.2021
Impfdatum: 23.07.2021
Beginn: 23.07.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / RL

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

Expired product administered

Symptomtext

an expired dose of ActHIB was given with no adverse event; Initial information regarding an unsolicited valid non-serious case from other health care professional via Regulatory Authority (Reference number- 00697016) and transmitted to Sanofi on 26-Jul-2021. This case involves a 01-year-old female patient for whom it was reported that an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] was given (expired product administered) to her (lot number: UJ352AAA and expiration date: 13-Jul-2022) at a dose of 0.5 ml via intramuscular route in the right thigh for prophylactic vaccination on 23-Jul-2021. Medical history, past medical treatments, past vaccinations and family history were not provided. Concomitant medications were not reported. It was an actual medication error case due to expired vaccine used (latency: same day). At the time of reporting, the patient experienced no adverse event. 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: -