Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
shaking; incapacitated; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), ASTHENIA (incapacitated), CHILLS (chills) and PYREXIA (fever) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (shaking), ASTHENIA (incapacitated), CHILLS (chills) and PYREXIA (fever). At the time of the report, TREMOR (shaking), CHILLS (chills) and PYREXIA (fever) had resolved with sequelae and ASTHENIA (incapacitated) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. The patient had previously taken Moderna and Pfizer COVID-19 vaccines and experienced side effects every time for about 9 hours after the injection. She experienced chills, fever, shaking, and was incapacitated for at least a day and a half, sometimes up to 2 to 3 days. Then it would resolve all by itself. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided.