Received May 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
have my bones hurt so much that I felt nearly unable to walk; tired; sore arm; dry heaves; not be able to stay awake to eat for over 30 hours; have blood in my urine; fever; chills; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in May2025 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, single, manufacturer unknown), for Immunisation; Covid-19 vaccine (dose 2, single, manufacturer unknown), for Immunisation; Covid-19 vaccine (dose 3, single, manufacturer unknown), for Immunisation; Covid-19 vaccine (dose 4, single, manufacturer unknown), for Immunisation; Covid-19 vaccine (dose 5, single, manufacturer unknown), for Immunisation. The following information was reported: CHILLS (non-serious) with onset May2025, outcome "unknown"; RETCHING (non-serious) with onset May2025, outcome "unknown", described as "dry heaves"; PYREXIA (non-serious) with onset May2025, outcome "unknown", described as "fever"; BLOOD URINE PRESENT (non-serious) with onset May2025, outcome "unknown", described as "have blood in my urine"; BONE PAIN (medically significant) with onset May2025, outcome "unknown", described as "have my bones hurt so much that I felt nearly unable to walk"; HYPERSOMNIA (non-serious) with onset May2025, outcome "unknown", described as "not be able to stay awake to eat for over 30 hours"; PAIN IN EXTREMITY (non-serious) with onset May2025, outcome "unknown", described as "sore arm"; FATIGUE (non-serious) with onset May2025, outcome "unknown", described as "tired". The patient specified that he/she recently had 6th COVID vaccine. The patient had a mix of Pfizer and Moderna. This past Friday the patient had the Pfizer shot. The patient expected to be tired and had a sore arm. He/she did not expect to have dry heaves; the patient had bones hurt so much that he/she felt nearly unable to walk, not be able to stay awake to eat for over 30 hours, had blood in urine and of course had fever and chills.