Age: 58.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Arthritis reactive, Blood test, Inflammatory marker test, Red blood cell sedimentation rate, SARS-CoV-2 test
Clinical narrative: patient experiencing reactive arthritis since day 2/ The second day he had a "scary reaction", it got so bad/ low back burns,both hips burn/ cannot swim/ neck hurts; This spontaneous case was reported by a patient and describes the occurrence of ARTHRITIS REACTIVE (patient experiencing reactive arthritis since day 2/ The second day he had a "scary reaction", it got so bad/ low back burns,both hips burn/ cannot swim/ neck hurts) in a 58-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027E22A) for COVID-19 prophylaxis.     No Allergies with medications, food and other products. No Medical history related to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.     On 08-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Oct-2022, the patient experienced ARTHRITIS REACTIVE (patient experiencing reactive arthritis since day 2/ The second day he had a "scary reaction", it got so bad/ low back burns,both hips burn/ cannot swim/ neck hurts) (seriousness criterion medically significant). At the time of the report, ARTHRITIS REACTIVE (patient experiencing reactive arthritis since day 2/ The second day he had a "scary reaction", it got so bad/ low back burns,both hips burn/ cannot swim/ neck hurts) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: blood work done, sedimentation rate, everything was normal.. On an unknown date, Inflammatory marker test: normal. On an unknown date, Red blood cell sedimentation rate: normal. On an unknown date, SARS-CoV-2 test: Negative.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Patient received first dose of Moderna vaccine on 30Dec2020, Lot number: 011G20A  Patient received Second dose of Moderna vaccine on 27Jan2021, Lot number: 025L20A  Patient received Third dose of Moderna vaccine on 01Nov2021, Lot number: 032F2IA  Events immunisation reaction, burning sensation, mobility decreased, neck pain were subsumed under the event Arthritis reactive.  On 09 Oct 2022, patient felt a bit stiffed however per patient this was normal. Patient's shoulders, neck, back hip and hands hurt. The low back burns, both of his hips burn. It had been a month and it did not go away. There was nothing patient can do. Patient gets up from a chair and it was like he was 90 years old. Doctors did not know what to do. It can get worse/better/worse on the same day. The patient did not experience a similar event in the past. They improved but sometimes they can get worse again, patient could not understand.  No treatment drug were reported.  Company Comment: This spontaneous case concerns a male patient aged 58 years with no medical history reported, who experienced the unexpected serious (Medically significant) AESI event of Arthritis reactive about two days after 4th dose of mRNA-1273 Bivalent BA.4/BA.5 vaccination in covid-19 vaccination series. Patient had a scary reaction on day two and reactive arthritis. About 10 days later he had burning sensation in low back, both hips. He could not cough, sneeze or swim as it would hurt. He also had neck pain. He sought medical care, symptoms would improve and worsen again. Inflammatory markers, Red blood cell sedimentation rate, other blood tests done on unknown dates were normal. SARS-CoV-2 test done was negative. No further information on risk factors, detailed clinical course, other investigations, treatment of the event was available in the report. Outcome of the event was not resolved at the time of report. Patient had received initial three doses of mRNA-1273, the last dose about 11 months prior to current vaccination. The benefit-risk relationship of mRNA-1273 Bivalent BA.4/BA.5 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient aged 58 years with no medical history reported, who experienced the unexpected serious (Medically significant) AESI event of Arthritis reactive about two days after 4th dose of mRNA-1273 Bivalent BA.4/BA.5 vaccination in covid-19 vaccination series. Patient had a scary reaction on day two and reactive arthritis. About 10 days later he had burning sensation in low back, both hips. He could not cough, sneeze or swim as it would hurt. He also had neck pain. He sought medical care, symptoms would improve and worsen again. Inflammatory markers, Red blood cell sedimentation rate, other blood tests done on unknown dates were normal. SARS-CoV-2 test done was negative. No further information on risk factors, detailed clinical course, other investigations, treatment of the event was available in the report. Outcome of the event was not resolved at the time of report. Patient had received initial three doses of mRNA-1273, the last dose about 11 months prior to current vaccination. The benefit-risk relationship of mRNA-1273 Bivalent BA.4/BA.5 Vaccine is not affected by this report.