Received Sep 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | AX4605A | — |
Developed anaphylactic symptoms / Allergic reaction to vaccination; This spontaneous case, initially received on 19-Sep-2025, was reported by a non-health professional and concerns a patient of unknown age/gender. Past medical history included patient had been receiving the flu vaccine for years. Administration of company suspect drug: On 08-Sep-2025, the patient received Afluria (TIV) for indication Not reported, Dose regimen: Not reported, Route of administration: Not reported, Anatomical location: Not reported, Lot number: AX4605A. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date in Sep-2025, the patient Developed anaphylactic symptoms / Allergic reaction to vaccination(Medically Significant, outcome: Not Reported). Case was upgraded to serious upon company assessment of the reported event's (Developed anaphylactic symptoms / Allergic reaction to vaccination) clinical significance. The patient wanted to make a report about the vaccination causing an allergic reaction. The patient was a second-year medical student and had been receiving the flu vaccine for years due to working in the medical field, with no issues. However, that year the patient received the Afluria Influenza vaccine Lot #AX4605A on 08-Sep-2025 and developed anaphylactic symptoms that sent the to the emergency room. The patient was working with their allergist to mitigate symptoms and create a plan moving forward. The patient asked for a list of ingredients in the vaccine to try to get to the bottom of what caused the reaction. They also wondered if there had been any changes in the formulation of the vaccine. Afluria (TIV) action taken: Not Applicable Reporter's assessment: The primary reporter did not provide a seriousness or causality assessment for the event.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, event is considered related for reporting purposes. Considering pharmacological plausibility and considering implied temporal relationship (developed anaphylactic symptoms after vaccination). Further information required on final/confirmed diagnosis, symptoms experienced, exact temporality, onset date, relevant medical history, etc. for meaningful causal assessment. Brighton collaboration criteria is assessed as level 4 due to insufficient information provided.
Medical History/Concurrent Conditions: Vaccination