VAERS 2599721
SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ642AA
- Staat
- FL
- Alter
- 1,0
- Geschlecht
- M
- Eingang
- 20.03.2023
- Impfdatum
- 06.03.2023
- Beginn
- 06.03.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LL
Symptomtext
ACTHIB diluent was expired, and the powder was good (with no reported adverse event); Initial information received on 16-Mar-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Non-healthcare professional). This case is linked to case 2023SA087047. This case involves a 1 years old male patient and reporter reported Hib (Prp/T) Vaccine [Act-Hib] diluent was expired, and the powder was good (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 Pneumococcal Vaccine Conj 13v (Crm197) (Prevnar 13) for Immunization. On 06-Mar-2023, the patient received 0.5 ml Total dose of suspect Hib (Prp/T) Vaccine Powder and solvent for solution for injection (lot number: UJ642AA, Expiry date: 27-Mar-2023; Diluent) (lot number: U7247AB, Expiry date: 02-Mar-2023;Powder) (Frequency = once) (Strength = standard) via intramuscular route in the left thigh for immunization. On 06-Mar-2023, the reporter reported Hib (Prp/T) Vaccine diluent was expired, and the powder was good (with no reported adverse event) (expired product administered) (latency: same day). It was reported, It was given to two patients after the expiration date. Action taken: not applicable. At time of reporting, the outcome was Unknown for the event acthib diluent was expired, and the powder was good (with no reported 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
- PREVNAR 13
- Allergien
- -
- Vorherige Impfungen
- -