Received Apr 10, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| HBHEPB | HIB + HEP B (COMVAX) | MERCK & CO. INC. | UNK | — | — |
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
FBE calling on behalf of HCP to report an adverse event for PEDVAX HIB. HCP stated they had a 4 month old patient that received their 4 month old vaccines and learned today that the baby is in the ICU due to seizures. Caller stated the patient receiv; This spontaneous report was received from a physician via a company representative, concerning a 4-month-old patient of unknown gender. The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided. On an unspecified date in April 2026 (reported as yesterday or the day before"), the patient was vaccinated with the following vaccines: Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), (strength, dose, route, anatomical location, lot # and expiration date were not reported) as prophylaxis; with diphtheria vaccine toxoid (+) Hepatitis b vaccine rHBsAg (yeast) (+) Pertussis vaccine acellular 3-component (+) Polio vaccine inact 3v (Vero) (+) Tetanus vaccine toxoid (PEDIARIX); and with Rotavirus vaccine live oral 1v (ROTARIX) (strength, dose, route, anatomical location, lot number, expiration date and indication were not reported). On an unspecified date in April 2026 (reported as yesterday or the day before"), the patient learned today that the baby was in the intensive care unit ICU due to seizures. At the reporting time, the patient was stable, however the outcome of the event was unknown. The causal relationship between the event and the suspect vaccines was not provided. Lot # is being requested and will be submitted if received.