Received Sep 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
got shingles in his lungs two years ago; Nearly died several times; This serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. The patient's past medical history included shingles. Concurrent medical conditions included rheumatoid arthritis (immunocompromised with rheumatoid arthritis). On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced shingles (Verbatim: got shingles in his lungs two years ago) (serious criteria hospitalization) and near death experience (Verbatim: Nearly died several times) (serious criteria hospitalization and GSK medically significant). The outcome of the shingles and near death experience were not resolved. It was unknown if the reporter considered the shingles and near death experience to be related to RSV vaccine. The company considered the shingles and near death experience to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 04-SEP-2025 This case was reported by a patient's wife via interactive digital media. The patient previously gotten shingles, so he got vaccinated. Nevertheless, he got shingles in his lungs two years ago and he was on a ventilator for 21 days and nearly died several times. Now (during the reporting days) he takes medicine for it daily and they could not go out in public without masks. The reporter said that if he had not been vaccinated that he would have died for sure. The reporter said take care and be very careful because you are still at risk even though it was lowered with vaccination; Sender's Comments: A case of Herpes zoster and Near death experience, unknown time after receiving RSV vaccine in a male patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factors (h/o shingles and concurrent immunocompromised with rheumatoid arthritis).
Rheumatoid arthritis (immunocompromised with rheumatoid arthritis)
Medical History/Concurrent Conditions: Shingles