Received Nov 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 406999 | — |
Local tenderness after taking the vaccine; Redness after taking the vaccine; Pain after taking the vaccine; Chills; This spontaneous case, initially received on 06-Nov-2025, was reported by a non health professional and concerns an adult female patient. Concomitant Medications: Unknown Medical History: Unknown Administration of company suspect drug: On 05-Nov-2025, the patient received Flucelvax (TIV) for Influenza prophylaxis, Dose regimen: 0.5 ml, route of administration: other, specified as PFS (pre-filled syringe), anatomical location: not reported, Lot number: 406999. No additional suspect drugs. Adverse reactions/events and outcomes: On 05-Nov-2025, the patient experienced Local tenderness after taking the vaccine (outcome: Unknown), Redness after taking the vaccine (outcome: Unknown), Pain after taking the vaccine (outcome: Unknown), Chills (outcome: Unknown). The consumer reported having received a Flucelvax shot on 05-Nov-2025. The patient stated that right before the healthcare professional was about to administer the vaccine, there had been something in a very small bottle from which some fluid was withdrawn, and this was not documented on the patient's visit summary. The patient inquired what that liquid could have been and whether that was normal procedure, since Flucelvax comes in a pre-filled syringe. The caller stated that she had been in contact with the clinic, but they had not called her back. The patient mentioned having experienced some local tenderness, redness and pain, and some chills, but nothing serious after taking the vaccine. Flucelvax (TIV) action taken: Not Applicable Treatment measures associated with the event was reported as unknown Reporter's assessment: The reporter considered the events as non serious and did not provide the causality assessment.; Reporter's Comments: The events are related due to chronological plausibility.
Comments: none