Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
passed out; right arm and breast have extreme bruising with pain./ have severe bruising on my right cheek and busted my chin; chest, ribs, and upper back are very painful; chest, ribs, and upper back are very painful; chest, ribs, and upper back are very painful; also have cuts on right elbow and both knees; fell on the ceramic tiled tub and landed on the tiled floor; also have cuts on right elbow and both knees; extreme chills; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 74-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 16-Oct-2025 at 12:30 PM, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 16-Oct-2025, the patient experienced CHILLS (extreme chills). On 17-Oct-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), CONTUSION (right arm and breast have extreme bruising with pain./ have severe bruising on my right cheek and busted my chin), CHEST PAIN (chest, ribs, and upper back are very painful), MUSCULOSKELETAL CHEST PAIN (chest, ribs, and upper back are very painful), BACK PAIN (chest, ribs, and upper back are very painful), SKIN LACERATION (also have cuts on right elbow and both knees), FALL (fell on the ceramic tiled tub and landed on the tiled floor) and JOINT INJURY (also have cuts on right elbow and both knees). In October 2025, LOSS OF CONSCIOUSNESS (passed out) and CHILLS (extreme chills) had resolved. At the time of the report, CONTUSION (right arm and breast have extreme bruising with pain./ have severe bruising on my right cheek and busted my chin), CHEST PAIN (chest, ribs, and upper back are very painful), MUSCULOSKELETAL CHEST PAIN (chest, ribs, and upper back are very painful) and BACK PAIN (chest, ribs, and upper back are very painful) had not resolved and SKIN LACERATION (also have cuts on right elbow and both knees), FALL (fell on the ceramic tiled tub and landed on the tiled floor) and JOINT INJURY (also have cuts on right elbow and both knees) outcome was unknown. No concomitant medications provided by the reporter. It was reported that the patient had vaccination at 12:30, post vaccination the patient felt fine all day, and the patient went to bed at 11 pm and woke up with extreme chills during the night and the symptom was lasted for the patient a couple of hours. The patient got up around 7:30 am and she went to the bathroom and passed out. she fell on the ceramic tiled tub and landed on the tiled floor. She was in extreme pain and unable to move or get up. EMS had been called, and EMS checked the patient vital signs and wounds. EMS helped the patient get up. The patient experienced severe bruising on her right cheek and busted on her chin. She also had cuts on her right elbow and both knees. Her right arm and breast have extreme bruising with pain. The patient chest, ribs, and upper back were very painful with limited movement. It was 10 days from the vaccination, but the patient was still in pain. It was unknown if the patient experienced any additional symptoms/events. No treatment medications provided by the reporter.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.