Received Oct 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
she felt achy; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (she felt achy) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer (previous vaccines). Past adverse reactions to the above products included No adverse effect with Pfizer. On 21-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 21-Oct-2025, the patient experienced PAIN (she felt achy) and CHILLS (chills). On 22-Oct-2025, PAIN (she felt achy) and CHILLS (chills) had resolved. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) was reported as unknown. No concomitant medication was reported. Patient never had a reaction to any vaccination. The patient had received every vaccination recommended since the beginning of the COVID pandemic. Since the first one given was by Pfizer, she continued with that specific vaccine until this booster. The patient received a Moderna booster on Tuesday morning, 21-Oct-2025. The patient never gave it another thought. Around 9pm, the patient started feeling achy, then began having chills. The patient was perplexed (could not remember the last time she was sick) and began getting ready for bed. By 10:00 or so, the patient was bundled up, climbed into bed & slept through the night. The patient was a little slow starting the next morning, but otherwise everything seemed fine. Sometimes that morning she had a moment, realizing that patient must had a reaction to the vaccine. The patient had no complaints. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter did not allow further contact