Received Jan 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 223Y9 | OT |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 33CM4 | OT |
| HIBV | HIB (PEDVAXHIB) | MERCK & CO. INC. | 3 | Y018677 | OT / RL |
NAE; Incorrect product storage; device or device component malfunction checked; This spontaneous report was received from a Nurse and refers to a 3-month-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 30-Sep-2025, the patient was vaccinated with improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), (lot #Y018677, expiration date: 10-Apr-2027), dose number 3, administered by Intramuscular route in Right Thigh; with Influenza vaccine (Influenza vaccine) (lot #33CM4, expiration date: 28-Jun-2026) (location: right thigh, dose #3), administered by Intramuscular route and with Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid (DTAP) (lot #223Y9, expiration date: 07-Sep-2026) (location: left thigh, dose #4), administered by Intramuscular route (Incorrect product storage). All as prophylaxis. On 2025, the patient experienced device or device component malfunction (field was checked on source document, however it was also reported that there was no product quality complaint discrepancy). There was no adverse event. Vaccines were used in accordance with the leaflet instructions. Temperature excursion in the facility was reported as ranging from an unspecified date in September 2025 to an unspecified date in October 2025. Vaccines were moved to back up location on an unspecified date in November 2025. At the reporting time, the outcome of the events was unknown. The action taken with suspect products was reported not applicable. Causality was not reported. This is one of multiple reports from the same reporter.