Received Aug 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUAD) | SEQIRUS, INC. | UNK | No batch number | RA |
It hurt like a normal vaccine, but after two or three hours it started getting even worse; It was from her elbow to shoulder, the vaccine was on the right hand side/ The pain went to entire upper arm; The pain went down almost to waist and the right side of upper torso; The pain landed in the breast; This spontaneous case, initially received on 30-Jul-2025, was reported by a non health professional and concerns an elderly female patient. Past medical history included biopsy. Concomitant Medications reported as unknown Administration of company suspect drug: On an unknown date in Nov-2022, the patient received Fluad (TIV) for influenza prophylaxis. Dose regimen: Not reported. Route of administration: Not reported. Anatomical location: right hand side. Lot number: No batch number available and would be requested upon follow up. No additional suspect drugs. Adverse reactions/events and outcomes: On Nov-2022, the patient experienced It hurt like a normal vaccine, but after two or three hours it started getting even worse (Medically Significant, outcome: Recovered/resolved), It was from her elbow to shoulder, the vaccine was on the right hand side / The pain went to entire upper arm (Medically Significant, outcome: recovered/resolved), The pain went down almost to waist and the right side of upper torso (Medically Significant, outcome: recovered/resolved), The pain landed in the breast (Medically Significant, outcome: recovered/resolved). Patient stated that she received Fluad back in Nov-2022 and blew up in her arm and upper torso. When asked if the adverse reaction started right after taking the vaccine, caller states: Not really. It hurt like a normal vaccine, but after two or three hours it started getting even worse. Through the night, it was from her elbow to shoulder, the vaccine was on the right hand side. The pain went to entire upper arm, and down almost to waist and the right side of upper torso. No hives, no breathing issues, it was just severe pain. When asked if there was any treatment associated with the adverse reaction, patient mentioned that once she got a hold of her doctor, the pain had already subsided except for the upper half portion of her torso. Transcribed from call: The pain lasted and eventually, she ended up going to the doctor, because the pain landed in the breast, and eventually went to the breast surgeon. Nobody could see anything but they could recognize that she was in a lot of pain. It went away everywhere else, except there. Patient ended up going to two different breast surgeons, two different hospitals, because everybody acknowledged that she was in pain but nobody could find anything. Gradually, it took about a year for the pain to finally dimmish. After the fact, she was hospitalized to get a biopsy done when she told her doctor about the symptoms she had experienced following vaccination; patient was then told by the doctor that due to the severity of the reaction, she should have gone directly to the emergency room. When asked to confirm if the hospitalization was due to the adverse reactions from the vaccine, caller said not for that. Stated that after consulting with two different breast surgeons, she was referred to an allergist so she could be tested for every component in the vaccine. Stated needing the PI for the 2022-2023 season so the doctors could be made aware of which ingredients to test for. Fluad (TIV) action taken: Not Applicable Reporter assessment: The reporter (patient), reporting 30-Jul-2025, on considered the events as serious (Medically Significant) and did not provide the causality assessment.; Reporter's Comments: Causality : Due to the spontaneous nature of the case, the events are considered related for reporting purposes. Related for events vaccination site pain, pain in extremity and radiating pain due to close temporal association and anatomical proximity (after2-3 hours of vaccine). Related for breast pain due to plausible temporal association (reported as "eventually pain landed in breast"). However there is insufficient information on biopsy details.
Medical History/Concurrent Conditions: Biopsy