Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 388479 | — |
Full flu; Heartbeat issue/ heart was beating so fast; Gurgling sensation; Thought I was going to die; Felt lightheaded; This spontaneous case, initially received on 29-Sep-2025, was reported by a non health professional and concerns an adult female patient. Historical vaccinations included Fluad (Reaction: No adverse reactions). Administration of company suspect drug: On 19-Sep-2024, the patient received Fluad (TIV) for Active immunization for the prevention of influenza disease., Dose regimen: not reported, Route of administration: not reported, Anatomical location: not reported, Lot number: 388479. No additional suspect drugs. Adverse reactions/events and outcomes: On 19-Sep-2024, same day of vaccination, the patient experienced Heartbeat issue/ heart was beating so fast (outcome: Recovered / Resolved, stop date: 20-Sep-2024), Gurgling sensation (outcome: Recovered / Resolved, stop date: 20-Sep-2024), Thought I was going to die (outcome: Recovered / Resolved, stop date: 20-Sep-2024), Felt lightheaded (outcome: Recovered / Resolved, stop date: 20-Sep-2024). On an unknown date, the patient experienced Full flu (Medically Significant, outcome: Not Reported). Case was upgraded to serious upon company assessment of the reported event (Full flu) clinical significance. The consumer reported that on 2024 she thought she was going to die after she had the Fluad shot, that was how bad the reaction was, her heart was beating so fast, it was so lightheaded. The patient took Tylenol and it helped, but she felt like she had a full flu. Patient reported she had heartbeat issue and had gurgling sensation, she thought she was going to die. She felt lightheaded at the pharmacy, it happened almost immediately. The patient also reported that she took Tylenol at home but mentioned that she felt like she should have gone to the hospital, but she didn't because she had been too sick to drive and didn't want to call an ambulance. Fluad (TIV) action taken: Not Applicable Treatment medication: Tylenol Reporter's assessment: The primary reporter assessed the events Heartbeat issue/ heart was beating so fast, Gurgling sensation, Thought I was going to die, Felt lightheaded as non-serious and did not provide causality assessment. The primary reporter did not provide the seriousness and causality assessment of the event Full flu.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, events are considered related for reporting purposes. Considering plausible temporal relationship (reported as almost happened immediately after vaccination for events heart rate increased, gurgling sensation, fear of death, dizziness and flu). For event Flu, the event occurred post vaccination (reported as immediately) before 21 days of vaccination (outside the window period of 21-180 days), hence not considered vaccination failure.