Received May 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPV | DTAP + IPV (QUADRACEL) | SANOFI PASTEUR | UNK | U8729AB | IM |
Temperature excursion occurred and post excursion vaccine administration to a patient with no reported adverse event; Initial information received on 11-May-2026 regarding an unsolicited valid non-serious case received from other or unknown health care professional (healthcare professional). This case involves a 4-year-old female patient who administered acellular pertussis vaccine, diphtheria toxoid, poliomyelitis vaccine (inactivated), tetanus toxoid (QUADRACEL) which was exposed to temperature excursion occurred with no reported adverse event. The patient's past medical history, past drugs, family history were not provided. Concomitant medication(s) included [Measles vaccine, Mumps vaccine, Rubella vaccine (MMRV)]. On 08-May-2026, the patient started taking acellular pertussis vaccine, diphtheria toxoid, poliomyelitis vaccine (inactivated), tetanus toxoid (QUADRACEL) (strength: standard) as 0.5 mL once intramuscular in left deltoid for immunisation and there was Temperature excursion occurred and post excursion vaccine was administered with no reported adverse event (Poor quality product administered, onset: 08-May-2026, latency: same day) (Batch: U8729AB, Expiry date: 31-Dec-2027). It was reported "Medical Assistant reported multiple temperature excursions and requested extended stability information post excursion. Caller noted there were 5 different alarms from 11pm until 4am. Reason: UNKNOWN; The excursions occurred in the middle of the night. Max/low temperature reached and duration: One excursion reached 27.12 F and lasted 3 hours and 45 minutes out of range. This was the lowest temperature reached. The next excursion reached 31.95 F and lasted1 hour and 30 minutes out of range. Another excursion lasted 15 mins out of range and reached 35.64 F. Another excursion lasted 45 mins out range and reached 32.88 F. The last excursion lasted 45 minutes and reached 32.54 F. Total time out of range= 7 hours Previous Excursion? No Human error? UNKNOWN Administered post-excursion? QUADRACEL was administered." 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
Mmr