Received Sep 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
He does not know much because he was in an induced coma; Sickness; This serious case was reported by a consumer via interactive digital media and described the occurrence of artificial coma in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine and Shingles vaccine. On an unknown date, an unknown time after receiving RSV vaccine and Shingles vaccine, the patient experienced artificial coma (Verbatim: He does not know much because he was in an induced coma) (serious criteria GSK medically significant) and sickness (Verbatim: Sickness). The outcome of the artificial coma was resolved and the outcome of the sickness was not reported. It was unknown if the reporter considered the artificial coma to be related to RSV vaccine and Shingles vaccine. The reporter considered the sickness to be unrelated to RSV vaccine. The reporter considered the sickness to be related to Shingles vaccine. The company considered the artificial coma and sickness to be unrelated to RSV vaccine. The company considered the artificial coma to be unrelated to Shingles vaccine. The company considered the sickness to be related to Shingles vaccine. Additional Information: This case was reported by a patient via interactive digital media. The reporter stated that RSV was not what had made patient sick, it was shingles. The patient had been flown to the hospital as well. The patient did not think that he had be interested in talking about it and had not known much because he had been in an induced coma.; Sender's Comments: A case of Medical induction of coma, unknown time after receiving RSV vaccine and Shingles vaccine in a male patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility.