Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
leaving her too weak to stand for several minutes; chills; passed out the following morning/weak; body aches; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out the following morning/weak) 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. No Medical History information was reported. On 03-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 04-Oct-2024, the patient experienced LOSS OF CONSCIOUSNESS (passed out the following morning/weak) (seriousness criterion medically significant), PAIN (body aches) and CHILLS (chills). On an unknown date, the patient experienced DYSSTASIA (leaving her too weak to stand for several minutes). At the time of the report, LOSS OF CONSCIOUSNESS (passed out the following morning/weak), PAIN (body aches), DYSSTASIA (leaving her too weak to stand for several minutes) and CHILLS (chills) outcome was unknown. No concomitant medications were reported. Patient received all recommended doses and confirmed no other vaccines were received in the past four weeks. The doctor advised not to get another dose in April (appointment already scheduled) unless the formula had been updated. Patient was unsure of full vaccination history but had received all recommended doses. No lot number was provided. Patient was inquired whether can take Pfizer vaccine instead of moderna vaccine since experienced severe side effects with the last dose of modern vaccine. It is unknown if the patient experienced any additional symptoms/events. Reporter causality was not reported. No treatment medications were reported. Reporter did not allow further contact; Reporter's Comments: The age is a contributor for the events. The benefit -risk relationship of product is not affected by this report.