Received Apr 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
constant pain/the second dose was very painful/Spot where she had the 2nd one that every now and then has pain there; hand pain with cramping; hand pain with cramping; spot there is a boil or a bump at the injection site/bump started coming up 2 weeks ago; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 71-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 omicron (kp.2) (dose 1), for COVID-19 immunization, reaction(s): "everything was ok". The following information was reported: VACCINATION SITE MASS (non-serious) with onset Mar2025, outcome "unknown", described as "spot there is a boil or a bump at the injection site/bump started coming up 2 weeks ago"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "constant pain/the second dose was very painful/Spot where she had the 2nd one that every now and then has pain there"; PAIN IN EXTREMITY (non-serious), MUSCLE SPASMS (non-serious), outcome "unknown" and all described as "hand pain with cramping". Additional information: Patient is currently taking a blood pressure medication. Patient had three of the Pfizer Covid vaccines. The first one and third one were fine. The second was very painful and took a long time before the pain went away. Spot where she had the 2nd one that every now and then has pain there that comes and goes. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. Follow-up (01Apr2025): This is a spontaneous follow-up report received from a Consumer or other non HCP. Updated information: reporter contact details, event Pain recoded to Vaccination site pain, Vaccination site mass verbatim updated, clinical course. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.