Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Depression, Emotional poverty, Insomnia, Magnetic resonance imaging, Neck pain
Clinical narrative: could not put his shoes on and went into a depression; polymyalgia rheumatica; pain and discomfort on his neck; pain and discomfort down both arms/sore arm; terrible pain/pain even when resting; difficulty sleeping; no range of emotion; dropped 20 pounds; This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (polymyalgia rheumatica) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0011521A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jul-2021, the patient experienced NECK PAIN (pain and discomfort on his neck), PAIN IN EXTREMITY (pain and discomfort down both arms/sore arm), PAIN (terrible pain/pain even when resting), INSOMNIA (difficulty sleeping), EMOTIONAL POVERTY (no range of emotion) and WEIGHT DECREASED (dropped 20 pounds). On 03-Sep-2021, the patient experienced POLYMYALGIA RHEUMATICA (polymyalgia rheumatica) (seriousness criterion medically significant). On an unknown date, the patient experienced DEPRESSION (could not put his shoes on and went into a depression). The patient was treated with HYDROCODONE for Pain, at an unspecified dose and frequency and PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, POLYMYALGIA RHEUMATICA (polymyalgia rheumatica), NECK PAIN (pain and discomfort on his neck), PAIN IN EXTREMITY (pain and discomfort down both arms/sore arm), PAIN (terrible pain/pain even when resting), INSOMNIA (difficulty sleeping), EMOTIONAL POVERTY (no range of emotion), DEPRESSION (could not put his shoes on and went into a depression) and WEIGHT DECREASED (dropped 20 pounds) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2021, Magnetic resonance imaging: abnormal (abnormal) polymyalgia rheumatica. On 03-Sep-2021, X-ray: abnormal (abnormal) polymyalgia rheumatica.         Patient took blood pressure medication and cholesterol medication as concomitant medication.  Company comment: This case concerns a 65 years old male under medication described as ¨blood pressure and cholesterol medication¨ NOS, whose medical history was not provided. The patient experienced the serious unlisted event Polymyalgia rheumatica (IME listed), that started 81 days after the second dose of a proper schedule of product administration (34 days between doses); and other non serious unlisted events. For all the events rechallenge is not applicable as per no further doses are expected, and the reported events for the second dose were not reported for the first dose. The events were ongoing at the time of the report. The benefit-risk relationship of Moderna nMRNA-1273 is not affected by this report. Further information has been requested.   This case was linked to MOD-2021-331680 (Patient Link).; Sender's Comments: This case concerns a 65 years old male under medication described as ¨blood pressure and cholesterol medication¨ NOS, whose medical history was not provided. The patient experienced the serious unlisted event Polymyalgia rheumatica (IME listed), that started 81 days after the second dose of a proper schedule of product administration (34 days between doses); and other non serious unlisted events. For all the events rechallenge is not applicable as per no further doses are expected, and the reported events for the second dose were not reported for the first dose. The events were ongoing at the time of the report. The benefit-risk relationship of Moderna nMRNA-1273 is not affected by this report. Further information has been requested.