Received Aug 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (AFLURIA) | SEQIRUS, INC. | UNK | No batch number | — |
Mobility issues; Shoulder pain; Needle goes into the tendon instead of the muscle when administering Afluria PFS; This spontaneous case, initially received on 25-Jul-2025, was reported by a health professional and concerns a patient of unknown age/gender. Administration of company suspect drug: On an unknown date in 2025, the patient received Afluria (TIV) for Influenza prophylaxis, Dose regimen: Not reported, Route of administration: Not reported, Anatomical site: Not reported, Lot number: No batch number available would be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date in 2025, the patient experienced Mobility issues (outcome: Not Reported), Shoulder pain (outcome: Not Reported), Needle goes into the tendon instead of the muscle when administering Afluria PFS (outcome: Not Reported). Healthcare professional (HCP) inquired about any records of adverse events where needle went into the tendon instead of the muscle when administering Afluria Prefilled syringe (PFS). When asked if there was a patient involved in this question, Healthcare professional (HCP states that they are still investigating and event was not yet confirmed; therefore, they did not wish to report any details yet. She mentioned a situation involving a patient who received Afluria 6 months ago and has been experienced shoulder pain and mobility issues. Caller stated that patient was given the 2023-2024 season formula, but mentions that this occurred last winter, in Jan (Sic!). Healthcare professional (HCP stated not knowing the size of the needle and that they were trying to figure out if the needle was long enough to go that deep; also mentions not having that much of clinical knowledge about the situation to share any details Afluria (TIV) action taken: Not Applicable Reporter's assessment: The reporter did not provide the seriousness and causality assessment for the events Mobility issues, Shoulder pain and Needle goes into the tendon instead of the muscle when administering Afluria PFS.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, events are considered related for reporting purposes. There is insufficient information regarding events for meaningful causal assessment (events onset dates, temporality, site of vaccination and shoulder pain, route of administration, etc.). Of note, wrong technique in product usage process might be considered as confounding factors for the events occurrence.
Comments: None