Received Jan 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 9C295 | OT |
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 3Z34K | OT |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | Y018677 | OT / LL |
Temperature excursion; No additional AE; This spontaneous report was received from a Nurse and refers to a 6-month-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 05-Sep-2025, the patient was vaccinated with the first dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), (lot #Y018677, expiration date: 10-Apr-2027), administered by Intramuscular route in the Left Thigh; with a dose of Diphtheria vaccine toxoid;Hepatitis b vaccine rHBsAg (yeast);Pertussis vaccine acellular 3-component;Polio vaccine inact 3v (Vero);Tetanus vaccine toxoid) (PEDIARIX) (lot #9C295, expiration date: 02-Feb-2027) administered by Intramuscular route in the Right thigh; and with a dose of Rotavirus vaccine live oral 1v) (ROTARIX) (lot #3Z34K, expiration date: 09-Nov-2026) administered by Oral route, all administered as Prophylaxis; vaccines which underwent a temperature excursion (between September October 2025). It was reported that the vaccines were moved to back up lection in early November 2025. No additional Adverse event reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : @merck.com , Index date : 2025-12-17 , MNSC number : 02902189 , CLIC number : , ESTAR number : , IRMS number : , Central date : 2025-12-16 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :