Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Polymyalgia rheumatica, Rash, Rash pruritic, Red blood cell sedimentation rate
Clinical narrative: Sever pain in legs; rash on her back at the base of her spine and moving up her spine; Shoulder pain; polymyalgia rheumatica; Rash with pruritus; severe muscle cramps; fatigue; This spontaneous case was reported by a physician and describes the occurrence of POLYMYALGIA RHEUMATICA (polymyalgia rheumatica) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroidectomy in 2007. Concurrent medical conditions included Hypothyroidism, Proteinuria, Hyperlipidemia and Drug allergy (Combigan Reaction-Red eyes). Concomitant products included ATORVASTATIN from 2003 to an unknown date for Hyperlipidaemia, LEVOTHYROXINE SODIUM (SYNTHROID) from 1985 to an unknown date for Hypothyroidism, LOSARTAN from 2005 to an unknown date for Proteinuria.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced MUSCLE SPASMS (severe muscle cramps). On 10-Mar-2021, the patient experienced RASH PRURITIC (Rash with pruritus). In May 2021, the patient experienced POLYMYALGIA RHEUMATICA (polymyalgia rheumatica) (seriousness criterion medically significant). In 2021, the patient experienced FATIGUE (fatigue). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sever pain in legs), RASH (rash on her back at the base of her spine and moving up her spine) and ARTHRALGIA (Shoulder pain). The patient was treated with PREDNISONE (oral) ongoing from 27-Jul-2021 for Polymyalgia rheumatica, at a dose of 10 mg once a day; PREDNISONE on 27-Jul-2021 for Polymyalgia rheumatica, at a dose of 20 mg, qd for 2 wks and PREDNISONE for Polymyalgia rheumatica, at a dose of 15 mg once a day. On 27-Feb-2021, MUSCLE SPASMS (severe muscle cramps) had resolved. At the time of the report, POLYMYALGIA RHEUMATICA (polymyalgia rheumatica), PAIN IN EXTREMITY (Sever pain in legs), ARTHRALGIA (Shoulder pain) and FATIGUE (fatigue) had not resolved and RASH PRURITIC (Rash with pruritus) and RASH (rash on her back at the base of her spine and moving up her spine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Aug-2021, C-reactive protein: 20 (abnormal) 20. On 09-Aug-2021, Red blood cell sedimentation rate: 10 (normal) 10. On an unknown date, Blood pressure measurement: low (Low) lower than usual--often in the 100-110/50-65. On an unknown date, C-reactive protein: 40 (High) High. On an unknown date, Red blood cell sedimentation rate: 81 (abnormal) 81 and 16 (normal) ESR down to 16 during week 3 of Rx.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Her blood pressure was also lower than usual--often in the 100-110/50-65 even though her Losartan was discontinued. Patient was treated with steroids 20 mg daily orally from 27-JUL-2021  Action taken was not applicable.  Patient went to doctor's office for treatment of adverse event.  Dermatologist prescribed steroid ointment for rash.  Inflammation, fatigue and pain were part of the diagnosis of POLYMYALGIA RHEUMATICA.  Company comment: This case concerns a 76 AGE year-old male patient , who experienced the unexpected event Polymyalgia rheumatica . The event occurred approximately 4 months after the first dose of mRNA-1273 Moderna vaccine and 3 months after the most recent dose (second dose).  Patient´s elderly age could be a potentially  confounder. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.   This case was linked to MOD-2021-303204, MOD-2021-303279 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Significant Follow up. Added Patient demographics, medical history, lab test, concomitant medication and events. On 09-Sep-2021: Added anatomical location of vaccine, allergy to combigan, added start date of prednisone,added events-Shoulder pain, fatigue and pain in extremity, updated narrative with treatment medications.; Sender's Comments: This case concerns a 76-year-old male patient , who experienced serious unexpected event Polymyalgia rheumatica . The event occurred approximately 4 months after the first dose of mRNA-1273 Moderna vaccine and 3 months after the most recent dose (second dose).  Patient´s elderly age could be a potential confounder. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report