Received Nov 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Swelling in his left eye; Increased blood pressure, currently at 155/87; This spontaneous case initially received on 15-Nov-2025, was reported by a non health professional and concerns a male patient. At the time of the event the patient had hypertension. Concomitant medication: refer to appropriate report section. Administration of company suspect drug: On 10-Nov-2025, the patient received Flucelvax (TIV) for Not reported. Dosing regimen: Not reported, Route of administration: not reported, Anatomical location: Not reported, Lot number: No batch number available and Will not be requested upon follow up as no follow-up consent. No additional suspect drugs. Adverse reactions/events and outcomes: On 13-Nov-2025, the patient experienced Swelling in his left eye (outcome: Unknown), Increased blood pressure, currently at 155/87 (outcome: Unknown). The caller had stated that he had received Flucelvax on 10-Nov-2025 and, two days later (13-Nov-2025), had begun experiencing swelling in his left eye and increased blood pressure. His blood pressure (BP) had been 155/87. The caller had also started amlodipine for his blood pressure on 10-Nov-2025. He had wanted to know if these side effects had been related to receiving his flu shot Lab data : on 13-Nov-2025 Blood pressure was 155/87 (Units and reference range not provided). Flucelvax (TIV) action taken: Not Applicable Treatment medication: Amlodipine for Increased blood pressure. Reporter's assessment: The Primary reporter assessed the event as non serious and did not provide the causality assessment.; Reporter's Comments: Due to the spontaneous nature of the case, it is considered related for reporting purposes
Hypertension
Tdap; Pneumococcal vaccine; Amlodipine
Test Name: Blood pressure; Result Unstructured Data: currently at 155/87