Received May 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | — |
| FLUN3 | INFLUENZA (SEASONAL) (FLUMIST) | MEDIMMUNE VACCINES, INC. | UNK | — | — |
diarrhea; feel like crap; low blood pressure; A spontaneous report has been received from a consumer. The report concerns a male elderly patient (age 71 years). No medical history was reported. No concomitant products were reported. The patient received Covid-19 Vaccine, via unspecified route, on an unknown date. The patient received 1 dose(s). The patient started treatment with Lenvima (lenvatinib mesilate) (batch number(s) 36066 09) 10 milligram qd, Oral use, on 11-AUG-2023 for liver cell carcinoma and with Flumist (flumist, influenza virus vaccine polyvalent, q/laiv), on an unknown date. A OTHER administered NA. On an unknown date, the patient experienced diarrhea (preferred term: Diarrhoea), low blood pressure (preferred term: Hypotension) and feel like crap (preferred term: Frustration tolerance decreased). It is unknown if any action was taken with Covid-19 Vaccine (covid-19 vaccine), Flumist (flumist, influenza virus vaccine polyvalent, q/laiv) and Lenvima (lenvatinib mesilate). The outcome of the event(s) of diarrhea, feel like crap and low blood pressure was unknown. The events were considered non-serious. The reporter considered that there was a reasonable possibility of a causal relationship between Covid-19 Vaccine and the following event(s): diarrhea. The reporter considered that there was a reasonable possibility of a causal relationship between Flumist and the following event(s): diarrhea. The reporter considered that there was a reasonable possibility of a causal relationship between Luer Pre-Filled Syringe and the following event(s): diarrhea. Device Information: Combination Product Report: Yes Product As Reported: Flumist Brand Name: FLUENZ TETRA, FLUENZ TETRA, FLUMIST Product Role:Suspect Manufacturer Name:ASTRAZENECA Labeled for single use:No All required follow-up attempts have been completed to obtain the Lot / Batch number for Flumist and Covid-19 Vaccine, however the Lot / Batch number was not received. Summary of follow-up information received by AstraZeneca on 05-Dec-2024 from Marketing company: Summary of unsuccessful Lot/Batch number attempts added. Narrative updated.
Medical History/Concurrent Conditions: Liver cell carcinoma recurrent
Lenvima