Received Oct 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
chills; body aches; nausea; This is a spontaneous report received from a Consumer or other non HCP. A 54-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 29Sep2025 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Oesophageal achalasia" (unspecified if ongoing); "allergy to herbal tea" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII, on 24Sep2025 as right arm; AZELASTINE HYDROCHLORIDE; BUDESONIDE; B12-VITAMIIN; D3; ELDERBERRY [SAMBUCUS NIGRA]; MAGNESIUM; WOMEN'S MULTIVITAMIN & MINERAL; WOMEN'S MICROFLORA PROBIOTIC; VITAMIN E [VITAMIN E NOS]. Past drug history included: Benadryl, reaction(s): "allergy"; Levaquin, reaction(s): "allergy". The following information was reported: PAIN (non-serious) with onset 29Sep2025 at 23:00, outcome "recovered" (30Sep2025), described as "body aches"; CHILLS (non-serious) with onset 29Sep2025 at 23:00, outcome "recovered" (30Sep2025); NAUSEA (non-serious) with onset 29Sep2025 at 23:00, outcome "recovered" (30Sep2025). Therapeutic measures were not taken as a result of chills, pain, nausea. Additional information: Facility where vaccine was administered was workplace clinic. The patient did not receive any other vaccines on the same date as the covid-19 vaccine. The patient was taking any other medications within 2 weeks of the event starting. Approx 10 hours after receiving the vaccination, chills, body aches and nausea symptoms started. These symptoms lasted approximately 12 hours and then resolved. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Achalasia; Food allergy
AZELASTINE HYDROCHLORIDE; BUDESONIDE; B12-VITAMIIN; D3; ELDERBERRY [SAMBUCUS NIGRA]; MAGNESIUM; WOMEN'S MULTIVITAMIN & MINERAL; WOMEN'S MICROFLORA PROBIOTIC; VITAMIN E [VITAMIN E NOS]