Received Jun 28, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | — | — |
Walked to go sit down and woke up on the floor, as she had fainted; Had an allergic reaction; Feet got really hot and she felt the heat going up her body; Had a reaction the first two times she got it; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Walked to go sit down and woke up on the floor, as she had fainted) in an 8-decade-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cancer (Cancer survivor - diagnosed prior to receiving any COVID vaccines). On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Walked to go sit down and woke up on the floor, as she had fainted) (seriousness criterion medically significant), HYPERSENSITIVITY (Had an allergic reaction), FEELING HOT (Feet got really hot and she felt the heat going up her body) and IMMUNISATION REACTION (Had a reaction the first two times she got it). At the time of the report, SYNCOPE (Walked to go sit down and woke up on the floor, as she had fainted), HYPERSENSITIVITY (Had an allergic reaction), FEELING HOT (Feet got really hot and she felt the heat going up her body) and IMMUNISATION REACTION (Had a reaction the first two times she got it) outcome was unknown. Concomitant medication use information was not provided by reporter. At the time of reporting, the patient was 76 years old. The patient had always received the Moderna COVID vaccine and had a reaction the first two times she got it. After receiving the booster dose, the patient was standing in the kitchen when her feet became very hot, and she felt the heat rising up through her body. After fainting, a nurse told the patient to eat a lot of salt and drink a lot of water the day before immunization, the day of immunization, and the day after immunization, and stated that the patient had been doing fine with the rest of the COVID vaccines. Since the reaction, patient had received Spikevax every two years without any issues. The patient was told not to receive the mNEXSPIKE vaccine if the patient ever had a reaction to a COVID-19 vaccine, or if there were any issues with the immune system. The patient had an allergic reaction, and reporter believed that it was caused by the vaccine. It was unknown if the patient experienced any additional symptoms/events. Treatment medication use information was not provided by reporter. This case was linked to MOD-2026-797802 (Patient Link). Reporter did not allow further contact; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Medical History/Concurrent Conditions: Cancer (Cancer survivor - diagnosed prior to receiving any COVID vaccines)