VAERS 2592232
UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ623AA
- Staat
- OH
- Alter
- 0,3
- Geschlecht
- M
- Eingang
- 07.03.2023
- Impfdatum
- 27.02.2023
- Beginn
- 27.02.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / RL
Symptomtext
expired dose of pentacel was administered with no reported adverse event; Initial information received on 01-Mar-2023 regarding an unsolicited valid non-serious case received via health professional. number: 01512650. This case involves 3 months old male patient who received expired dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was administered with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis B Vaccine (HEPATITIS B) for Immunization; Rotavirus Vaccine Live Oral 1V (Rotarix) for Immunization; and Pneumococcal Vaccine CONJ 13V (CRM197) (Prevnar 13) for Immunization. On 27-Feb-2023, the patient received expired dose of suspect Pentacel (VERO) Vaccine at dose 0.5ml once (lot: UJ623AA, expiry date: 25-Feb-2023) via intramuscular route in the right thigh for Immunization with no reported adverse event (expired product administered) at same day latency. Action taken: Not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the 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
- HEPATITIS B [HEPATITIS B VACCINE]; ROTARIX; PREVNAR 13
- Allergien
- -
- Vorherige Impfungen
- -