Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Polymyalgia rheumatica, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up/Walking difficulty/ Joint pain/ Difficulty in standing/ Hand pain; Polymyalgia rheumatica/Cartilage injury/Ruptured right labrum; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up/Walking difficulty/ Joint pain/ Difficulty in standing/ Hand pain) and POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica/Cartilage injury/Ruptured right labrum) in a 64-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe Rheumatoid arthritis), Smoker (one pack cigarette per day), Alcohol use (socially), Drug allergy (Opioid allergy manifested by tingling all over body) and Polymyalgia rheumatica (was diagnosed with the condition before he started Humira and did not worsen). Concomitant products included LISINOPRIL and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 01-Dec-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up/Walking difficulty/ Joint pain/ Difficulty in standing/ Hand pain) (seriousness criteria hospitalization and medically significant) and POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica/Cartilage injury/Ruptured right labrum) (seriousness criteria hospitalization and medically significant). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up/Walking difficulty/ Joint pain/ Difficulty in standing/ Hand pain) had not resolved and POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica/Cartilage injury/Ruptured right labrum) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2022, Magnetic resonance imaging: Showed worsening raptured right labrum.         The patient had the second COVID shot, he had a reaction and that was when all the rheumatoid arthritis issues began. Rheumatoid arthritis came back at a horrendous level and thus Prednisone  was added to the HUMIRA. The vaccine was the reason patient had polymyalgia rheumatica. patient stopped Humira due to upcoming surgery. On 21-Jul-2022, patient had hip surgery and was off Humira for six weeks. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Company Comment: This is a spontaneous  case concerning  a  64-year-old, male patient with concurrent medical conditions of Rheumatoid arthritis and Polymyalgia rheumatica, who experienced the unexpected serious (hospitalization and medically significant) events of Rheumatoid arthritis and Polymyalgia rheumatica. The exact date of administration of first and second dose of mRNA-1273 vaccine and onset of the events was not specified, hence latency could not be assessed. The patient was treated with Prednisone . Patients Magnetic resonance imaging, Showed worsening raptured right labrum. It was reported patient had the second covid shot, he had a reaction and that was when all the rheumatoid arthritis issues began. Rheumatoid arthritis came back at a horrendous level and thus Prednisone was given at an unspecified dose and frequency  was added to the Adalimumab which is a co-suspect drug. Patient reported the vaccine was the reason patient he had polymyalgia rheumatica.  Adalimumab was discontinued due to the hip surgery and was off Adalimumab for six weeks. The concurrent medical conditions of Rheumatoid arthritis and Polymyalgia rheumatica remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous  case concerning  a  64-year-old, male patient with concurrent medical conditions of Rheumatoid arthritis and Polymyalgia rheumatica, who experienced the unexpected serious (hospitalization and medically significant) events of Rheumatoid arthritis and Polymyalgia rheumatica. The exact date of administration of first and second dose of mRNA-1273 vaccine and onset of the events was not specified, hence latency could not be assessed. The patient was treated with Prednisone . Patients Magnetic resonance imaging, Showed worsening raptured right labrum. It was reported patient had the second covid shot, he had a reaction and that was when all the rheumatoid arthritis issues began. Rheumatoid arthritis came back at a horrendous level and thus Prednisone was given at an unspecified dose and frequency  was added to the Adalimumab which is a co-suspect drug. Patient reported the vaccine was the reason patient he had polymyalgia rheumatica.  Adalimumab was discontinued due to the hip surgery and was off Adalimumab for six weeks. The concurrent medical conditions of Rheumatoid arthritis and Polymyalgia rheumatica remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.