Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Glycosylated haemoglobin increased, Inflammation, Inflammation scan, Investigation
Clinical narrative: TSH, a test for thyroid function, which was 9.7 ulU/mL; inflammation; Fibromyalgia; The pain was in her armpits, shoulder, back, hips and ankles/ calves; The pain was in her armpits, shoulder, back, hips and ankles/ calves; The pain was in her armpits, shoulder, back, hips and ankles/ calves; She could hardly walk; Joint and muscle pain/ The pain was in her armpits, shoulder, back, hips and ankles/ calves; Joint and muscle pain; Pain in her cheeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) . A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Apr2021 (Lot number: EW0153) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia", start date: 09Dec2014, stop date: Feb2015, notes: Pertinent Details: Triggered by contrast dye injected prior to CT scan. Family history included: "lung cancer" (unspecified if ongoing), notes: father died of lung cancer at age 70; "pneumonia" (unspecified if ongoing), notes: mother died of pneumonia at age 78. Concomitant medication(s) included: MIRTAZAPINE taken for fibromyalgia, start date: Feb2015 (ongoing). The following information was reported: ARTHRALGIA (non-serious) with onset 18Apr2021, outcome "not recovered", described as "Joint and muscle pain/ The pain was in her armpits, shoulder, back, hips and ankles/ calves"; MYALGIA (non-serious) with onset 18Apr2021, outcome "not recovered", described as "Joint and muscle pain"; PAIN (non-serious) with onset 17Apr2021 17:00, outcome "not recovered", described as "Pain in her cheeks"; FIBROMYALGIA (non-serious) with onset 18Apr2021 08:00, outcome "not recovered", described as "Fibromyalgia"; AXILLARY PAIN (non-serious), BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 18Apr2021, outcome "not recovered" and all described as "The pain was in her armpits, shoulder, back, hips and ankles/ calves"; GAIT DISTURBANCE (non-serious) with onset 18Apr2021, outcome "not recovered", described as "She could hardly walk"; BLOOD THYROID STIMULATING HORMONE INCREASED (non-serious) with onset 22Oct2021, outcome "recovered", described as "TSH, a test for thyroid function, which was 9.7 ulU/mL"; INFLAMMATION (non-serious) with onset May2021, outcome "unknown", described as "inflammation". The events "joint and muscle pain/ the pain was in her armpits, shoulder, back, hips and ankles/ calves", "joint and muscle pain", "fibromyalgia" and "the pain was in her armpits, shoulder, back, hips and ankles/ calves" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, myalgia, fibromyalgia, pain in extremity, gait disturbance, blood thyroid stimulating hormone increased. Therapeutic measures were not taken as a result of pain.  Additional information: It was reported that prior to receiving the Pfizer vaccine the morning of 16Apr2021, patient was in good health, and her fibromyalgia, which was triggered in Dec2014 by contrast dye injected for a CT scan, had been under control since 2015 with 30 mg of Mirtizapine. Approximately 17:00 on 17Apr2021, she began feeling pain in her cheeks. By the next morning, the same pain that she felt in the early days of fibromyalgia returned. Two days later she began feeling joint and muscle pain, and nearly 7 months later it has not gone away. She has been to 4 doctors and taken several medications to no avail. The pain was in her armpits, shoulders, back, hips and ankles/calves. She was in so much pain that she could hardly walk or do any strenuous activities. Following discussions with her doctor, 75 mg of Lyrica was added to her medication, and the Mirtazapine was increased to 45 mg. However, there was not much improvement. In late May, patient first saw Doctor, a rheumatologist. He ordered many of the same tests as (withheld) primary care physician, Dr. The test results were normal except for sedimentation rate, a test for inflammation, which was 61 mm/hr, and TSH, a test for thyroid function, which was 9.7 ulU/mL. Dr. prescribed 25 mcg of levothyroxine, and Dr. prescribed 15 mg of prednisone to be tapered down to 5 mg over three weeks. She has further reduced her prednisone dose to 2.5 mg and maintained it over the past four months, and she stopped taking Lyrica. The prednisone had some benefit in terms of pain reduction, and the levothyroxine has brought (withheld) TSH level within the normal range. Subsequent sedimentation rate results have been up and down, with values as low as 31. Results of sedimentation test indicated high levels of inflammation but the most recent test on 22Oct was 84 mm/hr. After seven months, (withheld) still has pain that she didn't have when she received the first injection on 16Apr. She has not received a second vaccine dose because of the pain she experienced (and continues to experience). She is justifiably unhappy that she got the vaccine at all.. All other tests were normal. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EW0181 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EW0181, fill lot EP8732, and bulk formulation lot EP8613. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6203 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. and product type. The final scope included the reported finished goods lot EN6203, fill lot EN5336, and the formulated drug product lot EN5324. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The final scope included the reported finished goods lot EL3247, fill lot EL3230, and the formulated drug product lot EL3223. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.