Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUA4 | INFLUENZA (SEASONAL) (FLUAD QUADRIVALENT) | SEQIRUS, INC. | UNK | No batch number | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | No batch number | — |
Ear pain; Neck pain; Head pain; This spontaneous case, initially received on 24-Feb-2025, was reported by a non health professional and concerns an elderly female patient. Administration of company suspect drug: On 20-Sep-2023, the patient received Fluad Quadrivalent for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and types B contained in the vaccine, Dose regimen: .5 ml, route of administration and anatomical location: not reported. Lot number: No batch number available and will be requested upon followup. Non-company suspect drugs: Shingrix (Varicella zoster vaccine rgE (CHO), Indication not reported, Dose, route of administration and anatomical location were not reported. Lot number: No batch number available and will be requested upon follow-up. Adverse reactions/events and outcomes: On Sep-2023, the patient experienced Ear pain (outcome: Recovered / Resolved, stop date: 2023), Neck pain (outcome: Recovered / Resolved, stop date: 2023), Head pain (outcome: Recovered / Resolved, stop date: 2023). Because patient had a severe reaction from both the flu shot and a Shingrix shot, she was interested in obtaining a list of ingredients in the flu shot. She received the Fluad Quadrivalent (Influenza Vaccine, Adjuvanted) on 20-Sep-2023. She was interested in the components of Fluad 2023. She did not have the batch number. Her reaction was the same for the flu shot and the Shingles vaccine- ear, head, neck pain that lasted 2 weeks after the shingles shot but only a few days after the flu shot. She was trying to determine what ingredient was in both medications. She did not take medication for the symptoms and until the second shot, she didn't realize the cause of the problem. She was not hospitalized. She had never previously had reactions to any shots. She was happy to discuss the event if someone wants to reach out to her. The patient had event a few days after the flu shot. Fluad Quadrivalent action taken: Not Applicable Reporter's assessment: The reporter considered the events as non-serious and causality was not reported.; Reporter's Comments: All events were considered related.
Comments: None