Received Feb 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
The patient experienced lip swelling; This spontaneous case initially received on 05-Feb-2025, was reported by a health professional and concerns a child female patient. Concomitant medication: unknown. Medical history: no previous allergies to vaccines, medications or food. Administration of company suspect drug: On 04-Oct-2024, the patient received Afluria (TIV) for prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine., dose 0.5 ml, route of administration: not reported. Dose regimen, route of administration: not reported, Lot number not reported and requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On 04-Oct-2025, the patient experienced the patient experienced Lip swelling (outcome: Recovered / Resolved). A patient received Afluria prefilled syringe and experienced lip swelling right after vaccination and least for a week. No breathing issue was reported. Afluria (TIV) action taken: Not Applicable Reporter´s assessment: The reporter considered Lip swelling as non-serious and causality not provided.; Reporter's Comments: Lip swelling is related
Comments: None