Received Nov 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | AX5812A | — |
Coughing; Only half of the Afluria dose was administered after the patient; This spontaneous case, initially received on 07-Nov-2025, was reported by a health professional and concerns a male patient of unknown age. Concomitant Medications and Medical History were reported as Unknown . Administration of company suspect drug: On 07-Nov-2025, the patient received Afluria (TIV) for Prevention of Influenza Disease, dose: not reported, route of administration: not reported, anatomical location: not reported. Lot number: AX5812A. No additional suspect drugs. Adverse reactions/events and outcomes: On 07-Nov-2025, the patient experienced Coughing (outcome: Unknown), Only half of the Afluria dose was administered after the patient (outcome: Not Reported). The nurse reported that only half of the Afluria dose was administered after the patient began coughing during the administration. Afluria (TIV) action taken: Not Applicable Reporter's assessment: The reporter assessed Coughing, Only half of the Afluria dose was administered after the patient as non-serious and causality was not provided.; Reporter's Comments: Due to the spontaneous nature of the case, event Coughing is considered related for reporting purposes. Only half of the Afluria dose was administered after the patient is not related due to nature of event (special situation).
Comments: None