Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Myalgia, SARS-CoV-2 test, Wrong product administered
Clinical narrative: sudden onset of arthralgias in myalgias, hips, quadriceps; sudden onset of arthralgias in myalgias, hips, quadriceps; sudden onset of arthralgias in myalgias, hips, quadriceps; acutely swollen bursitis of the left knee; acutely swollen bursitis of the left knee; progressive difficulty ambulating; more than 100 200 yards morning stiffness unable to bend or get up from chairwithout two hands; more than 100 200 yards morning stiffness unable to bend or get up from chairwithout two hands; Pfizer bioNTech Bivalent/Dose Number: 1; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 12:00 as dose 1 (bivalent), single (Lot number: GH9697) at the age of 69 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Peripheral neuropathy feet" (unspecified if ongoing), notes: Peripheral neuropathy, feet gerd traumatic injury to aorta and heart repaired; "GERD" (unspecified if ongoing), notes: Peripheral neuropathy, feet gerd traumatic injury to aorta and heart repaired; "traumatic injury to aorta" (unspecified if ongoing), notes: Peripheral neuropathy, feet gerd traumatic injury to aorta and heart repaired; "heart repaired" (unspecified if ongoing), notes: Peripheral neuropathy, feet gerd traumatic injury to aorta and heart repaired. Concomitant medication(s) included: BABY ASPIRIN; GABAPENTIN. Past drug history included: Tcy, reaction(s): "Known allergies: Tcy". The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 05Oct2022 at 12:00, outcome "unknown", described as "Pfizer bioNTech Bivalent/Dose Number: 1"; JOINT SWELLING (disability), BURSITIS (disability) all with onset 19Oct2022 at 07:00, outcome "recovered with sequelae" and all described as "acutely swollen bursitis of the left knee"; MUSCULOSKELETAL STIFFNESS (disability), JOINT RANGE OF MOTION DECREASED (disability) all with onset 19Oct2022 at 07:00, outcome "recovered with sequelae" and all described as "more than 100 200 yards morning stiffness unable to bend or get up from chairwithout two hands"; GAIT DISTURBANCE (disability) with onset 19Oct2022 at 07:00, outcome "recovered with sequelae", described as "progressive difficulty ambulating"; MUSCULOSKELETAL PAIN (disability), ARTHRALGIA (disability), MYALGIA (disability) all with onset 19Oct2022 at 07:00, outcome "recovered with sequelae" and all described as "sudden onset of arthralgias in myalgias, hips, quadriceps". The events "sudden onset of arthralgias in myalgias, hips, quadriceps", "acutely swollen bursitis of the left knee", "progressive difficulty ambulating" and "more than 100 200 yards morning stiffness unable to bend or get up from chairwithout two hands" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Oct2022) Unknown Result. Therapeutic measures were taken as a result of musculoskeletal pain, arthralgia, myalgia, joint swelling, bursitis, gait disturbance, musculoskeletal stiffness, joint range of motion decreased. Clinical courses is as follows: The patient didn't receive other vaccine in four weeks.  No new medication's baby aspirin gabapentin hundre in two weeks. Two week status post immunization, sudden onset of arthralgias in myalgias, hips, quadriceps and acutely swollen bursitis of the left knee, progressive difficulty ambulating, more than 100 200 yards morning stiffness unable to bend or get up from chair without two hands. Scene by orthopedics, physiatry and family medicine. Finally Rheumatology who advised me yesterday it was due to the immunization. The events resulted in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The patient received treatment Prednisone 20 mg a day.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate