Received Oct 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 407242 | — |
A little slower than usual; Heart beating so fast; Palpitation; Dizziness; Felt lightheaded; Feeling ill; This spontaneous case, initially received on 29-Sep-2025, was reported by a non health professional and concerns an elderly female patient. Drug history included Fluad. Concomitant medication: refer to appropriate report section. It also included Vitamins, glaucoma eye drops. Administration of company suspect drug: On 26-Sep-2025, the patient received Fluad (TIV) for Active immunization for the prevention of influenza disease., Dose regimen: 0.5 units no reported, Route of administration: Not reported, Anatomical location: Not reported, Lot number: 407242. No additional suspect drugs. Adverse reactions/events and outcomes: On 26-Sep-2025, the patient experienced Heart beating so fast (outcome: Recovering / Resolving, stop date: 27-Sep-2025), Palpitation (outcome: Recovering / Resolving, stop date: 27-Sep-2025), Dizziness (outcome: Recovering / Resolving, stop date: 27-Sep-2025), Felt lightheaded (outcome: Recovering / Resolving, stop date: 27-Sep-2025), Feeling ill (outcome: Recovering / Resolving, stop date: 27-Sep-2025). On an unknown date, the patient experienced A little slower than usual (outcome: Not Reported). Consumer called to report an adverse reaction for Fluad on behalf of their mother. Consumer stated they were calling to report an adverse reaction for Fluad for their mother. The mother had rapid heartbeat, palpitation, dizziness. Consumer stated they probably would not have called if it was a one-time thing. Consumer stated if it was a bad day or whatever, they gave her some electrolytes after when she was feeling ill. Consumer stated they had this shot last year, they had the Fluad shot, and they had it before, and she had it before, no adverse reactions, but last year they thought they were going to die after they had it, that's how bad the reaction was, their heart was beating so fast, it was so lightheaded. The mother did not have the extant pains too much, she did take Tylenol and it helped. Consumer stated they took Tylenol too, but they felt like they had a full flu, she did not have that, but they were wondering why they were getting cardiac adverse events here. The mother had it for years and she never had a problem before. Consumer stated they did not report it last year because they just thought that was them, but since their mother also had the adverse event this year, they were thinking something was definitely with the shot. Outcome of event: Patient was feeling better now, but a little slower than she usually is Fluad (TIV) action taken: Not Applicable Treatment medication: Tylenol, electrolytes and liquids Reporter's assessment: The primary reporter (consumer) assessed the events Dizziness, Feeling ill, Felt lightheaded, Heart beating so fast, Palpitation related to the administration of Fluad (TIV) and non-serious. The primary reporter (consumer) did not provide the seriousness and causality for the event A little slower than usual.; Reporter's Comments: Due to the spontaneous nature of the case, the events are considered related for reporting purposes
Metoprolol