VAERS 1813068
SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ402AAA
- Staat
- FL
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 23.10.2021
- Impfdatum
- 11.10.2021
- Beginn
- 11.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / RL
Symptomtext
was given expired Pentacel with no reported adverse event; Initial information was received on 13-Oct-2021 regarding an unsolicited valid non-serious case from other health professional via call center via Medical Information (Reference number- 00811243). This case involves a two-month-old male patient who was vaccinated with an expired dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered). The patient's past medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination. On 11-Oct-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ402AAA and expiry date: 10-Oct-2021) (frequency: once) via intramuscular route in the right thigh for prophylactic vaccination. It was reported "nurse told him it may not be necessary to re-administer because it is only one day expired, however, to follow-up with manufacturer." It was an actual medication error case 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
- PREVNAR; ROTATEQ
- Allergien
- -
- Vorherige Impfungen
- -