Received Oct 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTPPVHBHPB | DTAP+IPV+HIB+HEPB (VAXELIS) | MSP VACCINE COMPANY | UNK | U8313AA | OT |
| HEPA | HEP A (VAQTA) | MERCK & CO. INC. | UNK | Y014585 | — |
No additional AE/ no PQC.; HCP reports that patients have been administered vaccines that suffered temperature excursions. After running an assessment its been found that the vaccines have a supported outcome (02793998). Dates of administration and patient demographics are unk; This spontaneous invalid report was received from an Other health professional and refers to patients of unknown ages and genders. The patients' medical history was not reported. The patients' concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown dates, the patients started therapy with Hepatitis A Vaccine, Inactivated (VAQTA), Injection, dose not provided (lot #Y014585, expiration date: 01-Feb-2026) as prophylaxis. On an unknown dates, the patients started therapy with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, (VAXELIS), Injection (lot #U8313AA, expiration date: 30-Sep-2027) dose 0.5 ml, as prophylaxis. The vaccines that suffered temperature excursions (temperature 9.38C, for 10 minutes, previous temperature excursion was 1 Hour, 52 Minutes; Temp: 11.33C]. No adverse event was reported. This is an invalid report due to lack of multiple patients identifiers. Follow-up information was received from a clinic volunteer in the form of a questionnaire, on 30-Sep-2025. The patient was a 12-month-old female (at the time of vaccination). It was reported that there were no adverse reactions. There was a temperature excursion which was revolved and the vaccine given was viable. The reporter provided details only for Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, (VAXELIS) with new information: route of administration was intramuscular and date of administration was 18-Apr-2025. There was no mention of Hepatitis A Vaccine, Inactivated (VAQTA) (which was conservatively left in the case). This is now a valid case.; Reporter's Comments: Keywords : ; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02794007-02793990 , CLIC number : , ESTAR number : , IRMS number : 500UW00000ZFCzGYAX|30092025230036|1922 , Central date : 2025-10-01 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2279933 , MNSC case number : 02794007 , MNSC interaction number : 02793990 , Integration log UniqueID : 500UW00000ZFCzGYAX|30092025230036|1922 , Service cloud CaseID : 500UW00000ZFCzGYAX