Received May 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| HIBV | HIB (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | 1 | — | — |
lethargic; fever; This is a spontaneous report received from a Physician from a sales representative. A 2-month-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 1, single (Batch/Lot number: unknown) at the age of 2 months for immunisation; hib vaccine (HIB), as dose number unknown, single for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP), as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (hospitalization) with onset Jan2026, outcome "recovered" (2026), described as "fever"; LETHARGY (hospitalization) with onset Jan2026, outcome "recovered" (2026), described as "lethargic". The patient was hospitalized for lethargy, pyrexia (start date: 2026, discharge date: 2026, hospitalization duration: 1 day(s)). It was unknown if therapeutic measures were taken as a result of lethargy, pyrexia. Clinical course: Pt received 3 vaccines at the 2 month appointment (PCV, Hib, DTAP) then had a one day hospital stay. Pt became lethargic and had fever that drove the stay in the hospital. It is thought that PCV was the cause from the providers. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the limited information currently available, the possible contribution of the administration of suspect drug pneumococcal 13-val conj vac to the events lethargy and pyrexia cannot be excluded due to a plausible temporal relationship and consistency with the drug's known safety profile on causing pyrexia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.