Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Pain, Pain in extremity
Clinical narrative: Wednesday's night she woke up with her left hand with a feeling of burning and excruciating pain; triggered fingers; frozen shoulder; She felt excruciating pain, swelling and she couldn't walk.; suspecting PMR Polymyalgia Rheumatica, but laboratory blood test didn't corresponde.; she woke up with the pain again; excruciating right shoulder pain and left wrist pain; but she had flare ups from her right shoulder and hand to her left shoulder and few days also felt same in right elbow; She felt excruciating pain, swelling and she couldn't walk.; She felt excruciating pain, swelling and she couldn't walk.; feeling debilitated; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Breast cancer", start date: 2015 (unspecified if ongoing), notes: Now she is clear of cancer. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant) with onset 06Dec2021, outcome "not recovered", described as "suspecting PMR Polymyalgia Rheumatica, but laboratory blood test didn't corresponde."; SLEEP DISORDER (non-serious) with onset 06Dec2021, outcome "not recovered", described as "she woke up with the pain again"; ARTHRALGIA (non-serious) with onset 06Dec2021, outcome "not recovered", described as "excruciating right shoulder pain and left wrist pain"; ARTHRITIS (non-serious) with onset 06Dec2021, outcome "not recovered", described as "but she had flare ups from her right shoulder and hand to her left shoulder and few days also felt same in right elbow"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "feeling debilitated"; SWELLING (non-serious), GAIT DISTURBANCE (non-serious), PAIN (non-serious) all with onset 06Dec2021, outcome "not recovered" and all described as "She felt excruciating pain, swelling and she couldn't walk."; BURNING SENSATION (non-serious) with onset 14Feb2022, outcome "not recovered", described as "Wednesday's night she woke up with her left hand with a feeling of burning and excruciating pain"; TRIGGER FINGER (non-serious) with onset 06Dec2021, outcome "not recovered", described as "triggered fingers"; PERIARTHRITIS (non-serious) with onset 06Dec2021, outcome "not recovered", described as "frozen shoulder". The events "suspecting pmr polymyalgia rheumatica, but laboratory blood test didn't corresponde." and "but she had flare ups from her right shoulder and hand to her left shoulder and few days also felt same in right elbow" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: unknown results. Therapeutic measures were taken as a result of polymyalgia rheumatica, sleep disorder, arthralgia, arthritis, gait disturbance, burning sensation, trigger finger, periarthritis, pain.  Clinical course: She had her booster shot on 22Nov2021, but in 06Dec2022, she started to notice adverse reactions, that are remaining up to today, 18Feb2022. On 06Dec2021 she woke up in the night with excruciating right shoulder pain and left wrist pain, frozen shoulder, triggered fingers, she didn't relate it to vaccine at that time. Her nurse friend helped her, covered her shoulders and eyes. She started on Motrin 600 mg every 8h (not stating how long). Same things happened to left shoulder few days later, the pain subsided and her right shoulder, where she got the shot, but she had flare ups from her right shoulder and hand to her left shoulder and few days also felt same in right elbow. Her physician gave her prednisone 30mg for one and half week, 3 days after finishing the prednisone she woke up with the flare ups. She felt excruciating pain, swelling and she couldn't walk. She saw a rheumatologist, suspecting PMR Polymyalgia Rheumatica, but laboratory blood test didn't correspond. The Physician treated her as PMR but didn't gave her a definitive diagnosis. She lowers the doses to 10 mg of prednisone. When she lowers the dose to 9 mg, she woke up with the pain again, she took additional dose of 10 mg but the pain remained, so she took Motrin. She said she was always on excruciating pain. She started again on 10 mg prednisone this Monday. 14Feb2022. Wednesday's night she woke up with her left hand with a feeling of burning and excruciating pain, she took additional 10mg prednisone and Tylenol. She stated that she hasn't had health problems before. Caller was concerned because, since her booster shoot, she had been feeling debilitated.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Polymyalgia Rheumatica cannot be totally 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.