Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis, Myalgia, Polymyalgia rheumatica
Clinical narrative: body ache after moderna vaccine (general body pain); it gets bad at night with Polymyalgia rheumatica; Hashimoto's disease; This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (it gets bad at night with Polymyalgia rheumatica) and AUTOIMMUNE THYROIDITIS (Hashimoto's disease) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Polymyalgia rheumatica.    Concurrent medical conditions included Polymyalgia rheumatica. Concomitant products included METHOTREXATE for Polymyalgia rheumatica, HYDROXYCHLOROQUINE SULFATE (HYDROXYCHLOROQUINE [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.   On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 27-Jun-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2022, the patient experienced POLYMYALGIA RHEUMATICA (it gets bad at night with Polymyalgia rheumatica) (seriousness criterion medically significant) and AUTOIMMUNE THYROIDITIS (Hashimoto's disease) (seriousness criterion medically significant). In June 2022, the patient experienced MYALGIA (body ache after moderna vaccine (general body pain)). In June 2022, MYALGIA (body ache after moderna vaccine (general body pain)) had resolved. At the time of the report, POLYMYALGIA RHEUMATICA (it gets bad at night with Polymyalgia rheumatica) and AUTOIMMUNE THYROIDITIS (Hashimoto's disease) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.  On an unknown date of Jun-2022, the patient experienced body ache after after moderna vaccine. On an unknown date of Jun-2022, body ache recovered.    The reporter causality for event of body ache after moderna vaccine with moderna covid-19 vaccine was no reasonable possibility. The reporter causality for the events of Hashimotos and it got bad at night with Polymyalgia rheumatica with Adalimumab Solution for Injection was Not Provided.  Company comment: This spontaneous case concerns a 55-year-old, female patient with no medical history information reported, who experienced the unexpected serious (medically significant)event of polymyalgia rheumatica and AESI of autoimmune thyroiditis and non serious event of myalgia. The events occurred on an unknown date. The patient received four doses of mRNA-1273 and it is unclear if the events occurred after 3rd or 4th dose. Latency following the dose is also unclear. As reported, the patient had body ache following Moderna vaccine and it was stated it gets bad at night with Polymyalgia rheumatica. It was reported that patient was using adalimumab for polymyalgia rheumatica. No further information was provided. It is unclear if patient had Polymyalgia prior to COVID 19 vaccination as no information was provided about medical history and limited information was provided about treatment of event. Polymyalgia is also a confounder for pain experienced following vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 55-year-old, female patient with no medical history information reported, who experienced the unexpected serious (medically significant)event of polymyalgia rheumatica and AESI of autoimmune thyroiditis and non serious event of myalgia. The events occurred on an unknown date. The patient received four doses of mRNA-1273 and it is unclear if the events occurred after 3rd or 4th dose. Latency following the dose is also unclear. As reported, the patient had body ache following Moderna vaccine and it was stated it gets bad at night with Polymyalgia rheumatica. It was reported that patient was using adalimumab for polymyalgia rheumatica. No further information was provided. It is unclear if patient had Polymyalgia prior to COVID 19 vaccination as no information was provided about medical history and limited information was provided about treatment of event. Polymyalgia is also a confounder for pain experienced following vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.