Received Oct 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 300214A | IM |
Received expired BioThrax vaccine; This initial spontaneous case report was received on 06OCT2025, and additional information was received on 09OCT2025 from physician assistant regarding a male adult patient who was "received expired BioThrax vaccine" (PT: Expired product administered). The patient's concomitant medications, concurrent conditions and allergies were not reported. On 06OCT2025, patient administered expired BioThrax [(Anthrax Vaccine); lot number: 300214A, 0.5 mL, intramuscularly) for immunization. A Physician Assistant (PA) reported that the administration of expired BioThrax vaccine as described on the labeling, 0.5 mL intramuscularly. The PA reported that five adult patients, aged between 20 and 30 years, received BioThrax vaccine doses. Among them, two patients were female and three were male. None of the patients had any underlying health issues or prior adverse reactions to vaccinations. Two patients received BioThrax as their annual booster dose, two patients received it as their first-ever dose, and one patient received it as the third dose in the six-dose primary series. The PA reported that the expiration dates on the BioThrax packaging were unclear. The carton displayed the date as "11082025," while the vial label stated "11Aug2025". Following administration, the PA reported that none of the five patients experienced any side effects. There was no lab/imaging reported. The outcome of reported events was not applicable. No additional information was reported. Based on the available information in the source document, five individual case safety reports (25000053 through 25000057, three male, two female cases) were created and linked in the database as reported by same reporter.; Sender's Comments: US-EMERGENT BIOSOLUTIONS-25000154:Linked case-same reporter US-EMERGENT BIOSOLUTIONS-25000155:Linked case-same reporter US-EMERGENT BIOSOLUTIONS-25000156:Linked case-same reporter US-EMERGENT BIOSOLUTIONS-25000157:Linked case-same reporter
Comments: Patient history: unknown