Received Jun 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
I had a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine; I had a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine; This male subject of an unknown age was involved in an other study and received COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) for COVID-19 prophylaxis. The report describes a case of IMMUNISATION REACTION (I had a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine) and SYNCOPE (I had a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine). No Medical History information was reported. On an unknown date, the subject received dose of COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (unknown route) 1 dosage form at an unspecified frequency. On an unknown date, received dose of COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (unknown route) dosage was changed to 1 dosage form at an unspecified frequency. On an unknown date, the subject experienced IMMUNISATION REACTION (I had a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine) (seriousness criterion medically significant) and SYNCOPE (I had a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine) (seriousness criterion medically significant). At the time of the report, IMMUNISATION REACTION (I had a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine) and SYNCOPE (I had a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine) outcome was unknown. For COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (Unknown), the reporter did not provide any causality assessments. ID was reported as DCP-0420-25. Regulatory Agency name was reported as mRNA-1083 Life Cycle Management Concept Evaluation. Concomitant medication use information was not provided by reporter. It was reported that there was a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine, and he just did not want to take the vaccine. He had taken two doses and did not want to take it. The reporter thought that vaccine side effects were a significant issue as well. Treatment medication use information was not provided by reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-786903 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 22-May-2025: Live follow up received that contains no new information. On 26-May-2025: Live follow up received that contains no new information. On 27-May-2025: Live follow up received that contains significant information includes ID number was added, and narrative was updated.; Reporter's Comments: Company comment: The causality for the events was not provided by the reporter and is assessed as related to the vaccine based on close temporal association, in the absence of alternative explanation. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-786903:Master case