Received Oct 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
I could not even walk; Felt extremely sick at night; Feeling very dizzy; This spontaneous case, initially received on 07-Oct-2025, was reported by a non health professional and concerns a female patient. Medical history: unknown Concomitant medication: refer to appropriate section. It was also reported over the counter medicines. Administration of company suspect drug: On 05-Oct-2025, the patient received Fluad (TIV) for Active immunization for the prevention of influenza disease, dose: 0.5 ml, Route of administration: not reported, Anatomical location: not reported, Lot number: No batch number available and will be asked on follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On 05-Oct-2025, the patient experienced Felt extremely sick at night (outcome: Unknown). On 06-Oct-2025, the patient experienced I could not even walk (outcome: Unknown). On unknown date in Oct-2025, the patient experienced Feeling very dizzy (outcome: Unknown). The patient had taken the Fluad vaccine on Sunday (05-Oct-2025), which was intended for patients over 65 years of age. That night, the patient had felt extremely sick, and the previous day of report had been unable to walk due to feeling very dizzy. As a result, the patient had requested to speak with someone from the research team - a doctor - who could explain why such a dangerous and powerful vaccine was being given to older people. The patient had questioned why something meant to help was causing such effects and had insisted on receiving a call back the same day for a full explanation. (The patient was persistent on having a call back from someone from the research team to have all the explanations.) Fluad (TIV) action taken: Not Applicable Treatment medication: Tylenol Reporter's assessment: The reporter assessed Felt extremely sick at night, Felt extremely sick at night, Feeling very dizzy as seriousness unknown and causality was not provided.; Reporter's Comments: Due to the spontaneous nature of the case, events are considered related for reporting purposes.
Asprin; Pepcid