Received May 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
taking naps, and will end up sleeping 16+hrs; exhausted; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: HYPERSOMNIA (non-serious), outcome "unknown", described as "taking naps, and will end up sleeping 16+hrs"; FATIGUE (non-serious), outcome "unknown", described as "exhausted". Additional information: Patient inquired about had Covid vaccine (2 of the regular shots, 3 boosters). Patient now cannot make it through the day without being exhausted, taking naps, and will end up sleeping 16+hrs. Patient asked is that a side effect of the Covid vaccine. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.