Received Feb 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | W1C83IM | OT / LL |
ipol vials punctured and they were also administered post excursion to 3 patients.the temperature reached 8.1 degrees c for 6 minutes with no ae; Initial information received on 21-Nov-2024 regarding an unsolicited non-valid non-serious case received from Nurse. This case is linked to US-SA-2024SA351869 This case involves, a 4 year old child male patient who was administered punctured vials IPV (Vero) [IPOL] post excursion and.the temperature reached 8.1 degrees c for 6 minutes with no adverse event The unspecified patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Nov-2024, the unspecified patient received 0.5 ml dose of suspect punctured IPV (VERO) Suspension for injection post excursion (lot-W1C83IM, expiry date: 21-Nov-2025) (strength was unknown) via intramuscular route in left thigh as prophylactic vaccination and the temperature reached 8.1 degrees c for 6 minutes with no adverse event (poor quality product administered) (latency: same day). Reportedly, There had been no adverse event at this time. 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. Additional information regarding the unsolicited valid non-serious case received on 03-Feb-2025; follow up information includes gender, route, Anatomical Location, dosage, start date, expiry date, batch number, clinical course added, indication updated and narrative amended accordingly.; Sender's Comments: US-SA-2024SA351869:linked case