Received May 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | — | OT |
product administered after the excursion with no reported adverse event; Initial information received on 09-May-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who received after the excursion with no reported adverse event IPV (VERO) [IPOL]. The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On an unknown date, the patient received unknown dose of suspect IPV (VERO) Suspension for injection (Unknown strength, lot and expiry date) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) after the excursion with no reported adverse event (poor quality product administered) (Latency same day) Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, Max/low temperature reached: Lowest temperature reached was 21.7F and maximum was 43.2F. Duration out of labelled range: 15 minutes. Human error not involved, but caller is unsure which vaccines were administered and will follow up if they decide to deem the products not viable. Caller stated that their back up log showed a 43.5 F maximum temperature and a 39.0F minimum temperature. Action taken was not applicable. 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.