Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
local reaction(s) impacted performing daily life activities, taking care of themselves, performing household chores, their ability to work, their ability to do social activities, their ability to exercise; local reaction(s) impacted A LITTLE falling asleep, changing positions during the night; local reaction(s) impacted moving or lifting the arm; Initial information received on 30-Sep-2025 regarding a solicited valid serious case received from a consumer/non-hcp (healthcare professional), in the scope of post-marketing sponsored study (withheld). Study Title: Cross-sectional study to assess tolerability of the trivalent recombinant vaccine in individuals between 18 and 64 years old using the Vaccinees Perception of Injection. This case involves Adult male patient who experienced local reaction(s) impacted performing daily life activities, taking care of themselves, performing household chores, their ability to work, their ability to do social activities, their ability to exercise, local reaction(s) impacted a little falling asleep, changing positions during the night and local reaction(s) impacted moving or lifting the arm after receiving Influenza Trivalent Recombinant Vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Influenza Trivalent Recombinant Vaccine, Solution for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunisation). Information regarding batch number corresponding to the one at time of event occurrence is requested. On an unknown date the patient developed local reaction(s) impacted performing daily life activities, taking care of themselves, performing household chores, their ability to work, their ability to do social activities, their ability to exercise (loss of personal independence in daily activities), impacted a little falling asleep, changing positions during the night (initial insomnia) and impacted moving or lifting the arm (vaccination site movement impairment) (unknown latency) Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Recovered / Resolved on an unknown date for all the events. Reporter causality: Not reported for all the events. Company causality: Reportable for all the events. Seriousness Criteria- This event was leading to disability.; Sender's Comments: Sanofi company comment dated 07-Oct-2025: This case involves Adult male patient who experienced local reaction(s) impacted performing daily life activities, taking care of themselves, performing household chores, their ability to work, their ability to do social activities, their ability to exercise, local reaction(s) impacted a little falling asleep, changing positions during the night and local reaction(s) impacted moving or lifting the arm after receiving Influenza Trivalent Recombinant Vaccine. Further information regarding exact timing of vaccination and symptom onset,specific age of the patient,medical history, particularly any history of hypersensitivity reactions or previous vaccine reactions,concomitant medications,detailed description of the local reaction (size, appearance, temperature, etc.),duration of symptoms before resolution,any medical intervention was sought or provided,specific injection technique and site,results of any physical examination or diagnostic procedures will aid in comprehensive case assessment. Based upon the reported information, the role of the suspect vaccine cannot be assessed.