Received Jul 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUN3 | INFLUENZA (SEASONAL) (FLUMIST) | MEDIMMUNE VACCINES, INC. | UNK | Unknown | — |
Almost passed out after receiving a COVID vaccine; Terrible case of nerves; Pure panic; A report has been received from a non-health professional, regarding a subject enrolled in study (withheld). The report concerns a male patient (age not provided). The patient's past and current medical history included coronavirus test (dates not reported). No concomitant products were reported. On an unknown date, the patient experienced almost passed out after receiving a covid vaccine (preferred term: Near death experience), pure panic (preferred term: Panic attack) and terrible case of nerves (preferred term: Neuralgia). The dose of Flumist (flumist, influenza virus vaccine polyvalent, q/laiv) was not changed. The outcome of the event(s) of almost passed out after receiving a covid vaccine, pure panic and terrible case of nerves was unknown. The following event(s) were considered serious due to medically significant:almost passed out after receiving a covid vaccine. The following events were considered non-serious:pure panic and terrible case of nerves. The reporter did not consider that there was a reasonable possibility of a causal relationship between Accuspray Single Dose and the following event(s): almost passed out after receiving a covid vaccine, pure panic and terrible case of nerves. The reporter did not consider that there was a reasonable possibility of a causal relationship between Flumist and the following event(s): almost passed out after receiving a covid vaccine, pure panic and terrible case of nerves. The company physician did not consider that there was a reasonable possibility of a causal relationship between Accuspray Single Dose and the following event(s): almost passed out after receiving a covid vaccine, pure panic and terrible case of nerves. The company physician did not consider that there was a reasonable possibility of a causal relationship between Flumist and the following event(s): almost passed out after receiving a covid vaccine, pure panic and terrible case of nerves. Device Information: Combination Product Report: Yes Product As Reported: Flumist Brand Name: FLUENZ TETRA, FLUENZ TETRA Product Role:Suspect Manufacturer Name:ASTRAZENECA Labeled for single use:No; Sender's Comments: Presyncope is not a listed event for the core data sheet for Q/LAIV. Due to limited information on patient demographics, underlying comorbidities, past medical history and concomitant medications, suspect product start date, indication, and action taken, circumstances leading to event, details of the event including onset date and outcome, risk factors, treatment details, clinical course, detailed etiological, diagnostic workup as clinical examination, complete blood workup, the evaluation did not find evidence to suggest a causal relationship between event and suspect drug.
Medical History/Concurrent Conditions: Coronavirus test