Received Sep 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
wounded up having a seizure; anxiety; wounded up having a seizure; COVID; Flu; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (wounded up having a seizure) in a 77-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products Influenza vaccine (Flu) for an unknown indication, Buspirone hydrochloride (Buspar) for Anxiety and Nirmatrelvir, Ritonavir (Paxlovid) for COVID-19. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS. Past adverse reactions to the above products included No adverse effect with Spikevax NOS. In August 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In August 2025, the patient started Buspirone hydrochloride (Buspar) (unknown route) at an unspecified dose and Nirmatrelvir, Ritonavir (Paxlovid) (unknown route) at an unspecified dose. On an unknown date, the patient received dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. In January 2025, the patient experienced COVID-19 (COVID). In 2025, the patient experienced INFLUENZA (Flu). In August 2025, the patient experienced SEIZURE (wounded up having a seizure) (seriousness criterion medically significant), ANXIETY (anxiety) and WOUND (wounded up having a seizure). At the time of the report, SEIZURE (wounded up having a seizure), ANXIETY (anxiety), COVID-19 (COVID), INFLUENZA (Flu) and WOUND (wounded up having a seizure) outcome was unknown. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. Concomitant medication was not reported. Patient had received all her vaccinations. The patient was afraid of getting COVID again. The patient had COVID in Jan-2025 and around 10-Aug-2025 got COVID again. The patient took Paxlovid for 5 days, and then on that Sunday, she took a dose of Buspar for anxiety and wounded up having a seizure. Treatment medication was not reported.; Reporter's Comments: Co-suspect products Influenza vaccine, Buspar and Paxlovid are confounders for the events. In view of the long non-suggestive onset latency the causality of the events flu, seizure and anxiety were assessed as not related to the vaccine. Wound was also assessed as not related due it was a consequence of seizure. The benefit -risk relationship of product is not affected by this report.
BUSPAR; PAXLOVID