Received Dec 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUN4 | INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) | MEDIMMUNE VACCINES, INC. | UNK | Unknown | — |
She DIED; completely paralyzed; unable to dress, bathe or feed herself; She required catheterization to express her bladder; A solicited report has been received from a consumer in Patient Support Program concerning a patient of unknown gender (age not provided). No medical history and no concomitant products were reported. On an unknown date, the patient experienced completely paralyzed (preferred term: Paralysis), she required catheterization to express her bladder (preferred term: Bladder disorder) and unable to dress, bathe or feed herself (preferred term: Activities of daily living decreased). It is unknown if any action was taken with Flumist (flumist, influenza virus vaccine polyvalent, q/laiv). The outcome of the event(s) of completely paralyzed, she required catheterization to express her bladder and unable to dress, bathe or feed herself was unknown. The patient died (preferred term: Death) on an unspecified date. The patient died on an unknown date. It is not known whether an autopsy was performed. The cause of death was unknown. The following event(s) were considered serious due to medically significant:completely paralyzed. The following event(s) were considered serious due to death:she died. The following events were considered non-serious:she required catheterization to express her bladder and unable to dress, bathe or feed herself. The reporter considered that there was a reasonable possibility of a causal relationship between Flumist and the following event(s): she died. 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): completely paralyzed, she died, she required catheterization to express her bladder and unable to dress, bathe or feed herself. The company physician considered that there was a reasonable possibility of a causal relationship between Flumist and the following event(s): completely paralyzed, she died, she required catheterization to express her bladder and unable to dress, bathe or feed herself. Device Information: Combination Product Report: Yes Product As Reported: Flumist Brand Name: FLUMIST Product Role:Suspect Device Problem code:A24 - Adverse Event Without Identified Device or Use Problem Manufacturer Name:ASTRAZENECA Labeled for single use:No Significant correction on 24-Nov-2025: company clinical comment updated, narrative amended Non-Significant correction on 27-Nov-2025: Null flavor removed from vaccine facility state field. Narrative amended. Non-significant correction on 05-Dec-2025: null flavor added. narrative amended. Significant correction on 24-Nov-2025: company clinical comment updated, narrative amended Non-Significant correction on 27-Nov-2025: Null flavor removed from vaccine facility state field. Narrative amended. Non-significant correction on 10-Dec-2025: Primary reporter country added. narrative amended. Non-significant correction on 15-Dec-2025: null flavor added. narrative amended.; Sender's Comments: This is a case report of a patient with reported fatal outcome (Preferred term: Death) in association with flumist, influenza virus vaccine polyvalent, q/laiv. Serious event of Paralysis is also reported. Due to limited information on date and cause of death, circumstances leading to fatal outcome, autopsy details, medical history, concurrent diseases, concomitant medications, etiological and diagnostic workup, other risk factors; the evaluation did not find evidence to exclude a causal relationship between death, paralysis and flumist, influenza virus vaccine polyvalent, q/laiv.; Reported Cause(s) of Death: she died
Comments: Comment on social media post: m, no she didn't! She DIED!!! She live 8 years completely paralyzed, unable to dress, bathe or feed herself. She required catheterization to express her bladder. Yes, she learned how to use a mouth stick & was able to do kids' things in her own way. She was a happy & intelligent young lady, but did die as a result of the flu mist. It was proven through studies at [withheld]. Is our family anti-vaxx, absolutely not. But, that is the TRUTH about what happened to her. I do agree, however, that the reaction is rare, but she wasn't the only child to have this same reaction.