Received Sep 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | 7+ | 3052549 | IM / RA |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Loss of consciousness/Cold sweat; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness/Cold sweat) in a 65-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052549) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Dose 1) in January 2021, Moderna COVID-19 vaccine (Dose 3), Moderna COVID-19 vaccine (Dose 7), Moderna COVID-19 vaccine (Dose 5), Moderna COVID-19 vaccine (Dose 6), Moderna COVID-19 vaccine (Dose 2) and Moderna COVID-19 vaccine (Dose 4). Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine. On 19-Sep-2025, the patient received eighth dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient received dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 19-Sep-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness/Cold sweat) (seriousness criterion medically significant). On 19-Sep-2025, LOSS OF CONSCIOUSNESS (Loss of consciousness/Cold sweat) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 70/50. Concomitant medication was not provided. It was reported that the patient had experienced old sweat and loss of consciousness at a public restaurant and had been transported to the emergency room. The patient had regained consciousness prior to ambulance transport. She was discharged after 4 hours in the emergency room. The doctor had wanted the patient to be admitted. It was further reported that the patient had received the 65+ Flu shot at the same time. Patient underwent Blood test, Urinalysis test, and Chest X-ray at the emergency room; however, no results were reported. It was unknown if the patient experienced any additional symptoms or events. The patient was given IV while enroute to the emergency room. Reporter causality was not reported.; Reporter's Comments: Co-suspect product Influenza vaccine is a confounder for the event. The benefit -risk relationship of product is not affected by this report.
Test Name: Blood Pressure; Result Unstructured Data: 70/50