Received Sep 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | IM |
Never when she's completely fainted/Stood up and walked about 10 feet and began collapsing/had trouble talking for a very short period of time/Was a little incoherent for a very short time; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Never when she's completely fainted/Stood up and walked about 10 feet and began collapsing/had trouble talking for a very short period of time/Was a little incoherent for a very short time) in a 78-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. Concurrent medical conditions included Allergy and Low blood pressure. On 08-Sep-2025 at 2:00 PM, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Never when she's completely fainted/Stood up and walked about 10 feet and began collapsing/had trouble talking for a very short period of time/Was a little incoherent for a very short time) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Never when she's completely fainted/Stood up and walked about 10 feet and began collapsing/had trouble talking for a very short period of time/Was a little incoherent for a very short time) had resolved. The action taken with mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) was unknown. Concomitant medication was not provided. The patient had not received any other vaccines 4 weeks prior to the vaccine. Patient had allergy shots within 4 weeks. Patient had no other medical conditions and heart related problems. It was reported that the patient had received the vaccine at pharmacy. On that morning, the patient felt fine when she got up. About one hour later when she had been sitting and starting to have breakfast, she had not been able eat at first then she felt bad. Afterwards, she had stood up, and walked about 10 feet, and had begun collapsing. The reporter had held her up as she became a dead weight. She had been a little incoherent for a very short time. Then the reporter lowered her to the floor where she had sat for a few minutes. Then she had been able to get up with assistance and had laid down on a couch. And after a few minutes, she recovered. It was reported that the patient had low blood pressure and that she had experienced a couple of similar episodes of feeling the same with low blood pressure, but never when she had completely fainted. It was clarified that the patient had not lost consciousness, but she had trouble talking for a very short period of time and she broke out in sweat and felt clammy. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. Reporter causality was not provided.; Reporter's Comments: Concurrent medical condition Low blood pressure is a contributor for the event. The benefit -risk relationship of product is not affected by this report.
Allergy; Low blood pressure