Received Jun 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
non zero rheumatoid so I'm flared up all over the place; broke my ankle; broke my heel; a stye in my eye; Stress causes my disease to flare up; keep losing my voice; stuff in my chest; degenerative bone; degenerative disc; not feeling good/I fell ill; fever; 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)), 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: Bnt162b2 (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "non zero rheumatoid so I'm flared up all over the place"; ANKLE FRACTURE (medically significant), outcome "unknown", described as "broke my ankle"; FOOT FRACTURE (medically significant), outcome "unknown", described as "broke my heel"; HORDEOLUM (non-serious), outcome "unknown", described as "a stye in my eye"; STRESS (non-serious), outcome "unknown", described as "Stress causes my disease to flare up"; APHONIA (non-serious), outcome "unknown", described as "keep losing my voice"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "stuff in my chest"; DEGENERATIVE BONE DISEASE (non-serious), outcome "unknown", described as "degenerative bone"; INTERVERTEBRAL DISC DEGENERATION (non-serious), outcome "unknown", described as "degenerative disc"; MALAISE (non-serious), outcome "unknown", described as "not feeling good/I fell ill"; PYREXIA (non-serious), outcome "unknown", described as "fever". Therapeutic measures were taken as a result of ankle fracture, foot fracture, chest discomfort. Clinical course: Caller was transferred to the escalations department to speak with a supervisor to provide their feedback regarding the changes to the patient assistance program for the medication Xeljanz. During the call caller stated the following." I'm sick I have crap in my chest I'm on enough antibiotics. I have nothing but good things to say about Pfizer, I got all the Pfizer boosters. Stress causes my disease to flare up. apparently I have a stye in my eye. Tuesday I got a shot in my ankle the foot doctor said yeah you got a stye in your eye. I'm permanently disabled, I'm handicapped. Unfortunately I fell ill I keep losing my voice I'm just not feeling good I'm running a fever I got stuff in my chest. I have rods and screws in my back I need a knee replacement, I broke my heel I was misdiagnosed and as a result I broke my ankle it never healed right that's why I gotta get shots every 4 months. It's all on my right leg. Unfortunately I got sick. I can't sit down and type up a whole paragraph I'm too sore. I have degenerative bone, degenerative disc. and I have non zero rheumatoid so I'm flared up all over the place I'm swollen and sore right now." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.