Received Oct 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Soreness of arm; Headache; Weakness; Felt very sick; Pain at the injection site; Dizziness; This spontaneous case from United States, initially received on 30-Sep-2025, was reported by a health professional and concerns a patient of unknown age and gender. Administration of company suspect drug: On 30-SEP-2025 10:00, the patient received Flucelvax (TIV) for Indication not reported, dose: not reported, route of administration: not reported, anatomical location: not reported. Lot number: No batch number available and requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Soreness of arm (outcome: Not Reported), Headache (outcome: Not Reported), Weakness (outcome: Not Reported), Felt very sick (outcome: Not Reported), Pain at the injection site (outcome: Not Reported), Dizziness (outcome: Not Reported). Patient received a Flucelvax vaccine at the office at 10 AM on Tuesday, 30-Sep-2025. Patient typically experienced side effects after getting vaccinated, and this time was not an exception. Medical Product: Flucelvax (patient did not know the batch number) Adverse Event: soreness of arm, headache, weakness (on the day patient received it, felt very sick and slept right after work), pain at the injection site, dizziness. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter id not provided seriousness and causality for Soreness of arm, Headache, Weakness, Felt very sick, Pain at the injection site, Dizziness.; Reporter's Comments: Due to the spontaneous nature of the case, events are considered related for reporting purposes.
Comments: None