Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Limb injury, Pain
Clinical narrative: Injury to shoulder NOS; Fatigue; Ache; This spontaneous case was reported by a consumer and describes the occurrence of LIMB INJURY (Injury to shoulder NOS), FATIGUE (Fatigue) and PAIN (Ache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    The patient's past medical history included Ankylosing spondylitis and Shoulder operation on 11-Apr-2022.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant) and PAIN (Ache) (seriousness criterion medically significant). On an unknown date, the patient experienced LIMB INJURY (Injury to shoulder NOS) (seriousness criterion medically significant). At the time of the report, LIMB INJURY (Injury to shoulder NOS), FATIGUE (Fatigue) and PAIN (Ache) outcome was unknown. Not Provided          No concomitant medication has been provided.  No treatment drug has been provided.  Company Comment:  This is a spontaneous case concerning a 59-year-old male patient with relevant medical history of Ankylosing Spondylitis, who experienced the unexpected serious (medically significant) events of Limb injury, Fatigue and Pain in the context of the second dose of mRNA-1273. Latency cannot be properly assessed since exact vaccination date nor exact event onset date were provided. Patient received 2 doses of mRNA-1273 vaccine on the same month. On an unknown date, the patient experienced right shoulder injury. Patient also had fatigue and achiness on the same year post-vaccination. The next year, patient underwent shoulder surgery due to right shoulder injury. No further details about the diagnostic procedures were provided. Outcome of the events were unknown. The medical history of Ankylosing Spondylitis remains as a confounder for the events Limb injury and Pain. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-569248.; Sender's Comments: This is a spontaneous case concerning a 59-year-old male patient with relevant medical history of Ankylosing Spondylitis, who experienced the unexpected serious (medically significant) events of Limb injury, Fatigue and Pain in the context of the second dose of mRNA-1273. Latency cannot be properly assessed since exact vaccination date nor exact event onset date were provided. Patient received 2 doses of mRNA-1273 vaccine on the same month. On an unknown date, the patient experienced right shoulder injury. Patient also had fatigue and achiness on the same year post-vaccination. The next year, patient underwent shoulder surgery due to right shoulder injury. No further details about the diagnostic procedures were provided. Outcome of the events were unknown. The medical history of Ankylosing Spondylitis remains as a confounder for the events Limb injury and Pain. The benefit-risk relationship of mRNA-1273 is not affected by this report.