Received Jun 1, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | Y1A201M | IM / LA |
negative disposition and product used/product was actually administered after the excursion with no AE; Initial information received on 19-May-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (HCP) other. This case involves a 9-year-old female patient who was administered with the suspect IPV (VERO) [IPOL] post excursion with no adverse event (AE). The patient's past medical history, past drugs, vaccination(s), family history were not provided. Concomitant medication(s) included measles vaccine live (Enders-Edmonston), rubella vaccine live (Wistar RA 27/3), varicella zoster vaccine live (Oka/Merck), and mumps vaccine live (Jeryl Lynn) (PROQUAD) for Prophylactic vaccination (immunization). On 06-Apr-2026, the patient received 0.5 ml dose 4 of suspect IPV (VERO) [IPOL]suspension for injection (Strength = standard, frequency: once) via intramuscular route in the left deltoid for immunization were exposed with temperature excursion maximum/low temperature reached was 50°F. The duration was 8 hours with no AE (Poor quality product administered) (latency: same day) (batch: Y1A201M, expiry date: 31-Jan-2027). It was reported "no human error was involved. The excursion occurred on 30-MAR-2026. Reason: Power outage with Maximum/lowest temperature reached: 50 F Duration: 8 hours. Previous Excursion: None." Action taken: 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.
Comments: NONE
Proquad