Received Oct 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | OT |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT |
shaking; incapacitated; chills; fever; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-789857. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as 1 df, single intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine moderna (experienced side effects every time for about 9 hours after the injection), for covid-19 immunization, reaction(s): "side effects"; Bnt162b2 (Dose number unknown, Pfizer COVID-19 vaccines. Patient experienced side effects every time for about 9 hours after the injection.), for covid-19 immunization, reaction(s): "side effects". The following information was reported: TREMOR (non-serious), outcome "recovered with sequelae", described as "shaking"; ASTHENIA (non-serious), outcome "recovered", described as "incapacitated"; CHILLS (non-serious), outcome "recovered with sequelae"; PYREXIA (non-serious), outcome "recovered with sequelae", described as "fever". Additional information: This case describes the occurrence of TREMOR (shaking), ASTHENIA (incapacitated), CHILLS (chills) and PYREXIA (fever) in a patient who received SPIKEVAX NOS (SPIKEVAX NOS) and Pfizer BioNTech COVID-19 vaccine. The patient had previously taken Moderna and Pfizer COVID-19 vaccines and experienced side effects every time for about 9 hours after the injection. The patient 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. Batch/lot number is not provided, and it cannot be obtained.