Received Apr 3, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | Y1D49T1 | SC / LL |
IPOL (punctured)Cause: Unknown, might be due to defrost cycle/max/Low Temperature reached: 53.2?Duration out of labelled range: 35 minutes/ Human Error: Unknown, with no reported adverse event; Initial information received on 09-Mar-2026 regarding an unsolicited valid non-serious case received from Licensed Practical Nurse (LPN)/Clinical Supervisor This case involves a 20-month-old male patient who administered punctured poliomyelitis vaccine (inactivated) (IPOL) Cause: Unknown, might be due to defrost cycle/max/Low Temperature reached: 53.2?Duration out of labelled range: 35 minutes/ Human Error: Unknown, with no reported adverse event The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. Concomitant medication(s) included hepatitis a vaccine. On 24-Feb-2026, the patient received punctured poliomyelitis vaccine (inactivated) suspension for injection (strength: standard, site: SQ left vastus lateralis) as 0.5 mL subcutaneous injection for immunization (poor quality product administered, latency: same day) (batch: Y1D49T1, expiry date: 30-Sep-2027)]. IPOL was exposed to a lot of excursions. Cause: Unknown, might be due to defrost cycle Max/Low Temperature reached: 53.2?. Duration out of labelled range: 35 minutes Previous excursions: January (already punctured and administered) 2nd 49.3? 17 minutes 5th 48.6? 18 minutes 9th 49? 31 minutes 12th 50.4? 19 minutes 14th 50.4? 21 minutes 17th 51.4? 26 minutes 20th 48.9? 8 minutes 23rd 50.1? 11 minutes 26th 47.1? 17 minutes 30th 49.5? 5 minutes February 2nd 49.4? 19 minutes 5th 47.8? 18 minutes 8th 47.6? 10 minutes 11th 51.7? 15 minutes 14th 49.3? 18 minutes 18th 49? 24 minutes 20th 48.9? 22 minutes 24th 47.6? 16 minutes 26th 49.5? 16 minutes March 1st 48? 15 minutes 4th 53.2? 35 minutes Total excursion time: 381 minutes Administered post-excursion? Yes to 2 patients Suitable for use after the excursion? No Human Error: Unknown 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
Hepatitis A