Received Jun 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Severe back aches and pain; cough; chills; stomach nausea; This is a spontaneous report received from a Consumer or other non HCP. A 62-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 04Jun2025 at 11:30 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Covid in January 2023 with some continuing symptoms.", start date: Jan2023 (ongoing), notes: Covid in January 2023 with some continuing symptoms. The patient took concomitant medications. The following information was reported: BACK PAIN (non-serious) with onset 05Jun2025, outcome "not recovered", described as "Severe back aches and pain"; CHILLS (non-serious) with onset 05Jun2025, outcome "not recovered"; COUGH (non-serious) with onset 05Jun2025, outcome "not recovered"; NAUSEA (non-serious) with onset 05Jun2025, outcome "not recovered", described as "stomach nausea". Therapeutic measures were not taken as a result of back pain, cough, chills, nausea. Additional information: The patient was received unspecified concomitant on 03Mar2025 and no allergies were reported. The patient received vaccine on upper arm. The patient did not receive any other vaccines on the same date as the vaccine(s). The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s). The patient was taking other medications within 2 weeks of the event starting. Reported Event: Severe back aches and pain, chills, stomach nausea, cough (which continues thru this reporting date). The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
COVID-19 (Covid in January 2023 with some continuing symptoms.)