Received Sep 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT / LA |
Headache; sore arm; wheezy; fatigue; joint pain (all mild); This is a spontaneous report received from a Consumer or other non HCP. A 52-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 18Sep2025 at 09:00 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "iodine contrast dye allergies" (unspecified if ongoing); "sulfa allergies" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "GERD" (unspecified if ongoing); "depression" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFATURE UNKNOWN), for immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFATURE UNKNOWN), for immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, MANUFATURE UNKNOWN), for immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, MANUFATURE UNKNOWN), for immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, MANUFATURE UNKNOWN), for immunization. The following information was reported: HEADACHE (non-serious) with onset 18Sep2025 at 10:15, outcome "not recovered"; FATIGUE (non-serious) with onset 18Sep2025 at 10:15, outcome "not recovered"; ARTHRALGIA (non-serious) with onset 18Sep2025 at 10:15, outcome "not recovered", described as "joint pain (all mild)"; PAIN IN EXTREMITY (non-serious) with onset 18Sep2025 at 10:15, outcome "not recovered", described as "sore arm"; WHEEZING (non-serious) with onset 18Sep2025 at 10:15, outcome "not recovered", described as "wheezy". Therapeutic measures were not taken as a result of headache, pain in extremity, wheezing, fatigue, arthralgia. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Medical History/Concurrent Conditions: Asthma; Depression; GERD; Iodine contrast media allergy; Sulfonamide allergy