Received Dec 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052734 | IM |
part of head hurts when apply pressure on it/headache; passed out/having no recollection of it/sweaty/felt very hot; dizzy/this time feeling even more dizzy/felt dizzy for most of the day; later said that fall knocked a soap dish off from where it had been; have no recollection of it; problem moving right hand at first to take the glass, so used left hand; left thigh still hurts quite a bit - there is a bruise there; did not have much appetite; felt unwell; Felt tired earlier than normal; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out/having no recollection of it/sweaty/felt very hot) in a 54-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052734) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection (batch no. 3052734) for COVID-19 prophylaxis. No Medical History information was reported. On 24-Nov-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 25-Nov-2025, the patient experienced LOSS OF CONSCIOUSNESS (passed out/having no recollection of it/sweaty/felt very hot) (seriousness criterion medically significant), DIZZINESS (dizzy/this time feeling even more dizzy/felt dizzy for most of the day), FALL (later said that fall knocked a soap dish off from where it had been; have no recollection of it), MOBILITY DECREASED (problem moving right hand at first to take the glass, so used left hand), CONTUSION (left thigh still hurts quite a bit - there is a bruise there), DECREASED APPETITE (did not have much appetite), MALAISE (felt unwell) and FATIGUE (Felt tired earlier than normal). On 26-Nov-2025, the patient experienced HEADACHE (part of head hurts when apply pressure on it/headache). The patient was treated with Ibuprofen sodium (Ibuprofen) on 25-Nov-2025 at an unspecified dose and frequency. In November 2025, LOSS OF CONSCIOUSNESS (passed out/having no recollection of it/sweaty/felt very hot) had resolved. At the time of the report, DIZZINESS (dizzy/this time feeling even more dizzy/felt dizzy for most of the day), FALL (later said that fall knocked a soap dish off from where it had been; have no recollection of it), CONTUSION (left thigh still hurts quite a bit - there is a bruise there), DECREASED APPETITE (did not have much appetite), MALAISE (felt unwell), FATIGUE (Felt tired earlier than normal) and HEADACHE (part of head hurts when apply pressure on it/headache) was resolving and MOBILITY DECREASED (problem moving right hand at first to take the glass, so used left hand) had resolved. No concomitant medications were reported. It was reported that patient passed out on the floor of the bathroom, had no recollection of it. The first few seconds patient couldn't place where she was, but then recognized that she was in the bathroom. Patient felt very hot and sweaty. Patient had a problem moving right hand at first to take the glass, so used the left hand, but it got resolved shortly afterwards. Patient felt dizzy for most of the day and unwell. The left thigh was still hurting quite a bit there was a bruise there. Patient had guessed that she got hit when she passed out. Again, patient had no recollection. On 26-Nov-2025 in the afternoon it was reported that a part of head hurts when she applied pressure on it, but it does not felt like there was a bump on the head. Patient did not have much appetite that day which delayed taking ibuprofen. Patient took ibuprofen later in afternoon of 25-Nov-2025 with some food. Patient had headache that persisted for a bit, with a bit of dizziness. On 26-Nov-2025 patient had a headache and dizziness in the morning as well, but it went away later the next morning. Patient was concerned that patient did not remember passing out and falling on the bathroom floor. Patient was not entirely sure how long patient was on the floor conked out. It was unknown if the patient experienced any additional symptoms/events. This case was linked to MOD-2025-791917 (Patient Link).; Reporter's Comments: The events bruise and fall were assessed as not related since they are secondary to loss of consciousness. The benefit-risk relationship of the product is not affected by this report.