Received Nov 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 3042879 | IM / LA |
bright red, very hot face; soreness in the left arm; red rash; hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (bright red, very hot face), PAIN IN EXTREMITY (soreness in the left arm), RASH ERYTHEMATOUS (red rash) and HYPERSENSITIVITY (hypersensitivity reaction) in a 72-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042879) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3042879) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer (1st dose) in 2021, Pfizer (3 weeks later another Pfizer) in 2021, Pfizer in September 2021 and Pfizer in 2023. Past adverse reactions to the above products included No adverse effect with Pfizer, Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Asthma NOS and Blood pressure high. On 14-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 14-Oct-2024, the patient experienced HOT FLUSH (bright red, very hot face), PAIN IN EXTREMITY (soreness in the left arm), RASH ERYTHEMATOUS (red rash) and HYPERSENSITIVITY (hypersensitivity reaction). On 14-Oct-2024, HOT FLUSH (bright red, very hot face) had resolved. In October 2024, PAIN IN EXTREMITY (soreness in the left arm) had resolved. At the time of the report, RASH ERYTHEMATOUS (red rash) and HYPERSENSITIVITY (hypersensitivity reaction) had resolved. No concomitant medications were reported. The patient had no other vaccines in the past 4 weeks before receiving the Spikevax 2024-2025. She had always waited at least 2 weeks for flu vaccine, so she received Fluzone for age 65 years old and up with a label that said "HD 65+" on 01-Dec-2024 which was received 6 weeks after the Spikevax 2024-2025. She had very bright red, very hot face on the same day she had received the Moderna Spikevax 2024-2025 by the time she got home and stayed that way until she went to bed which lasted until about 10 pm or 11 pm and lasted roughly for 10 to12 hours despite using cold compress continuously. She had soreness in the left arm than previous experiences with COVID-19 vaccines, a red rash that spread across her upper arm and a little bit below where the shot was and straight across the outside of her arm, emphasizing that the rash appeared across the whole arm following the administration but could not exactly remember when it started but remembered it lasted for about 6-7 days post administration. She took a photo of her left arm 3 days after the reaction in that area started, to show to her doctor. She had a hypersensitivity reaction. It was her very first-time experiencing reactions following administrations of COVID-19 vaccines. She did not have that rash reaction before. The next day post administration, her face was okay, but the arm was sore, and she thought that it was rather typical. The patient did not experience any additional symptoms/events. No treatment information was provided. This case was linked to MOD-2025-790546, MOD-2025-790547 (Patient Link).
Asthma NOS; Blood pressure high