Received Feb 27, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | UNK | — |
| FLU3 | INFLUENZA (SEASONAL) (FLUAD) | SEQIRUS, INC. | UNK | UNK | — |
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
passed out; Fever; Chills; feeling unwell; This serious case was reported by a other health professional via other manufacturer and described the occurrence of passed out in a 70-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included Tozinameran (Comirnaty) for prophylaxis and Influenza vaccine inact sAg 3v (Fluad) for prophylaxis. On 10-APR-2023, the patient received Arexvy, Comirnaty and Fluad. On 10-MAY-2023, 30 days after receiving Arexvy, Comirnaty and Fluad, the patient experienced fever (Verbatim: Fever) (serious criteria disability), chills (Verbatim: Chills) (serious criteria disability) and feeling unwell (Verbatim: feeling unwell) (serious criteria disability). On 11-MAY-2023, the patient experienced passed out (Verbatim: passed out) (serious criteria disability and GSK medically significant). The outcome of the passed out, fever, chills and feeling unwell were not reported. The reporter considered the passed out, fever, chills and feeling unwell to be possibly related to Arexvy. The company considered the passed out, fever, chills and feeling unwell to be unrelated to Arexvy. Additional Information: GSK receipt date: 20-FEB-2026 The patient received three immunizations at once, developed fever and chills, and felt unwell afterward. The next day the patient reported that he had passed out, but he was not hospitalized immediately. The patient later saw his regular physician and then a cardiologist, who determined that the patient needed a pacemaker. The patient believed that one of the vaccines might have contributed to this. The batch number was not provided, and unable to contact the reporter.; Sender's Comments: A case of Loss of consciousness, Pyrexia (BCWG Level 2), Chills, and Malaise 30 days after vaccination with unknown dose of Arexvy, in a 70-year-old male patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received.