Received Jan 12, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Chest pain; Shoulder pain; Pain started to go the arm; Pain all the way to back; This spontaneous case initially received on 26-Dec-2025, was reported by a health professional and concerns an adult female patient. The patient's concomitant medication reported as Unknown. Administration of company suspect drug: On an unknown date in Nov-2025, the patient received INN Flu Vaccine Seasonal for not reported Indication, Dose regimen: Not reported, Route of administration: Not reported, Anatomical location: Not reported, Lot number: Not reported and will be requested with follow up. No additional suspect drugs. Adverse reactions/events and outcomes: On Nov-2025, the patient had Chest pain (outcome: Unknown), Shoulder pain (outcome: Unknown), Pain started to go the arm (outcome: Unknown), Pain all the way to back (outcome: Unknown). The health care professional (HCP) declared having some side effects the night of the administration started with shoulder pain, then chest pain, and all the way to the back. The reporter stated that after that the pain started to go to the arm. The HCP described that the vaccine was administered at her workplace in Nov-2025, and did not have information on the vaccine name or lot number. The HCP went to emergency care and there was made an Electrocardiogram (ECG). The physician on emergency care told that the here was nothing wrong with the heart and prescribed Vicodin just for that night. The symptoms started 10 hours after the administration of the vaccine. Start date of event: The Night of the administration of the vaccine. 10 hours after. INN Flu Vaccine Seasonal action taken: Not Applicable Treatment medication: Vicodin Reporter assessment: The reporter did not provide seriousness and causality assessment for all events; Reporter's Comments: Due to the spontaneous nature of the case, the events are considered related for reporting purposes
Medical History/Concurrent Conditions: Electrocardiogram