Received Mar 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 95BJ9 | IM / RA |
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | 1 | Y1A201M | SC / RA |
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | 1 | Y017208 | SC / LA |
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | CX4HL | IM / RA |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 95BJ9 | OT |
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | Y1A201M | OT |
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | CX4HL | OT |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | Y017208 | OT / RA |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
No additional adverse event was reported; Improper storage of product in use; This spontaneous report was received from a nurse and refers to a 9-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 31-Jan-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y017208, expiration date: 13-Apr-2026), dose number 1, administered by Subcutaneous route in Right Arm for prophylaxis. On 31-Jan-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported) for prophylaxis. On 31-Jan-2025, the patient started therapy with Engerix b (Hepatitis b vaccine rHBsAg (yeast)) (lot #95BJ9) (Dose 1, right arm), administered by Intramuscular route (expiration date was not reported) for prophylaxis. On 31-Jan-2025, the patient started therapy with Boostrix (Diphtheria vaccine toxoid;Pertussis vaccine acellular 3-component;Tetanus vaccine toxoid) (lot #CX4HL) (Dose 1, right arm), administered by Intramuscular route (expiration date was not reported) for prophylaxis. On 31-Jan-2025, the patient started therapy with Ipol (Polio vaccine inact 3v (Vero)) (lot #Y1A201M) (Dose 1, right arm), administered by Subcutaneous route (expiration date was not reported) for prophylaxis. Those vaccines underwent temperature excursion (Product storage error). No additional adverse events were reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 12/08/2015 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :