Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Muscular weakness, Myalgia, Nausea, Neuralgic amyotrophy
Clinical narrative: immunization triggered Parsonage Turner Syndrome; developed muscle weaknessin my right bicep; unable to lift her arm up; sudden and extremely intense pain from her shoulder to elbow with a pain of 10/10; 3 dyas of fever; 3 days ofnausea; 3 days of muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (unable to lift her arm up), NEURALGIC AMYOTROPHY (immunization triggered Parsonage Turner Syndrome), MUSCULAR WEAKNESS (developed muscle weaknessin my right bicep), VACCINATION SITE PAIN (sudden and extremely intense pain from her shoulder to elbow with a pain of 10/10) and PYREXIA (3 dyas of fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy and Iodine contrast media allergy. Concomitant products included FAMOTIDINE for Heartburn, CALCIUM and COLECALCIFEROL (VITAMIN D 3) for Osteoporosis, CYANOCOBALAMIN (VITAMIN B-12) for Vitamin B12 deficiency.   On 14-Jan-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021 at 11:40 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced NAUSEA (3 days ofnausea) and MYALGIA (3 days of muscle aches). On 12-Feb-2021 at 11:30 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sudden and extremely intense pain from her shoulder to elbow with a pain of 10/10) and PYREXIA (3 dyas of fever). On 23-Feb-2021, the patient experienced LIMB DISCOMFORT (unable to lift her arm up). On 26-Feb-2021, the patient experienced MUSCULAR WEAKNESS (developed muscle weaknessin my right bicep). On an unknown date, the patient experienced NEURALGIC AMYOTROPHY (immunization triggered Parsonage Turner Syndrome). The patient was treated with DICLOFENAC SODIUM, MISOPROSTOL (DICLOFENAC + MISOPROSTOL AUROVITAS) on 22-Feb-2021 for Pain, at a dose of 50 milligram. On 14-Feb-2021, PYREXIA (3 dyas of fever), NAUSEA (3 days ofnausea) and MYALGIA (3 days of muscle aches) had resolved. At the time of the report, LIMB DISCOMFORT (unable to lift her arm up) and VACCINATION SITE PAIN (sudden and extremely intense pain from her shoulder to elbow with a pain of 10/10) had not resolved and NEURALGIC AMYOTROPHY (immunization triggered Parsonage Turner Syndrome) and MUSCULAR WEAKNESS (developed muscle weaknessin my right bicep) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NEURALGIC AMYOTROPHY (immunization triggered Parsonage Turner Syndrome), PYREXIA (3 dyas of fever), NAUSEA (3 days ofnausea) and MYALGIA (3 days of muscle aches) to be possibly related. No further causality assessments were provided for LIMB DISCOMFORT (unable to lift her arm up), MUSCULAR WEAKNESS (developed muscle weaknessin my right bicep) and VACCINATION SITE PAIN (sudden and extremely intense pain from her shoulder to elbow with a pain of 10/10).    Treatment for the event included 50 mg diclofenac every 8 hours over the following 4 days (February 22-25); this knocked the pain back to a level 3. The pain intensity seemed to lessen by February 25  patient reduced the dose to  50 mg tab of diclofenac an hour or two before bed only. Had similar events 2 years ago.   This case was linked to MOD-2021-018926 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: Added patient's demographics, concomitant medications, vaccine batch number and anatomical location. Events outcome was updated from unknown to not resolved. Added new events along with event outcome provided in description and causality.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This report also refers to a case of Inappropriate schedule of product administration for mRNA-1273 (lot # unknown), with no associated AEs. Further information has been requested.