Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy, Gait disturbance, Hypertension, Inappropriate schedule of product administration
Clinical narrative: severe polyarthralgia of every joint including all major joints, spine, hands, and feet; polymyalgia; I required help to walk; medication resistant hypertension; joints popping and cracking; joints popping and cracking; Dose 1 on 23Jan2021 and dose 2 on 01Feb2021; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: BNT162b2 (DOSE 1, administration time: 12:00 PM, vaccine location: Left arm), administration date: 23Jan2021, when the patient was 44-year-old, for Covid-19 Immunization, reaction(s): "muscle pain in the left arm". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 01Feb2021 at 13:00, outcome "unknown", described as "Dose 1 on 23Jan2021 and dose 2 on 01Feb2021"; GAIT DISTURBANCE (disability) with onset 06Feb2021 at 13:00, outcome "recovered with sequelae", described as "I required help to walk"; ARTHROPATHY (disability), JOINT NOISE (disability) all with onset 06Feb2021 at 13:00, outcome "recovered with sequelae" and all described as "joints popping and cracking"; HYPERTENSION (disability) with onset 06Feb2021 at 13:00, outcome "recovered with sequelae", described as "medication resistant hypertension"; MYALGIA (disability, medically significant) with onset 06Feb2021 at 13:00, outcome "recovered with sequelae", described as "polymyalgia"; ARTHRALGIA (disability, medically significant) with onset 06Feb2021 at 13:00, outcome "recovered with sequelae", described as "severe polyarthralgia of every joint including all major joints, spine, hands, and feet". The events "severe polyarthralgia of every joint including all major joints, spine, hands, and feet", "polymyalgia", "i required help to walk", "medication resistant hypertension" and "joints popping and cracking" required physician office visit. Therapeutic measures were taken as a result of arthralgia, myalgia, gait disturbance, hypertension, arthropathy, joint noise. Clinical course: It was with the second vaccine and afterwards, she developed severe polyarthralgia of every joint including all major joints, spine, hands, and feet, and severe polymyalgia. So severe in the first 36hrs after the vaccine (as reported) she required help to walk, even to the toilet. The initial severity faded, as she reported, after about 36 hours. Her joints had never been back to pre-vaccine. Without any history of RA or OA, she had continued to have severe polyarthralgia to this day, with her joints popping and cracking in addition to the pain. She also began experiencing medication resistant hypertension later on as well. Patient recovered with lasting effects. AE treatment included Anti-inflammatory medications and steroid dose pac. No other vaccine in four weeks. No covid prior vaccination. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a temporal association and known drug safety profile, the causal relationship between the reported events and the suspect drug BNT162B2 cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a 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.,Linked Report(s) : US-PFIZER INC-202300132926 Same product, patient, different AEs, different dose;US-PFIZER INC-202300135597 Same product, patient and different event;