Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal disorder, Spinal operation
Clinical narrative: SURGERY ON LOWER L3 S1 BACK; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL DISORDER (SURGERY ON LOWER L3 S1 BACK) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second 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. On an unknown date, the patient experienced SPINAL DISORDER (SURGERY ON LOWER L3 S1 BACK) (seriousness criterion medically significant). At the time of the report, SPINAL DISORDER (SURGERY ON LOWER L3 S1 BACK) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Spinal operation: Back surgery.         Formulation of Humira was reported as Solution for injection in pre-filled pen.   No concomitant medication was reported.   Patient had surgery on the lower L3-S1 back, from the back and rods were added. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This spontaneous case concerns a 75-year-old, female patient with a concurrent condition of rheumatoid arthritis treated with adalimumab, who experienced an unexpected, medically significant event of Spinal disorder in association with a dose of mRNA-1273 vaccine. Patient underwent surgery on her lower 3rd lumbar vertebra until 1st sacral vertebra where rods were added on an unknown date. Outcome of the event was reported as resolved.  Vaccination history included a 2-dose primary series of mRNA-1273 vaccine. Further details on the medical history, the exact adverse event reported, clinical course, diagnostics, and additional treatments were not reported. Patient's elderly age and underlying rheumatoid arthritis remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns a 75-year-old, female patient with a concurrent condition of rheumatoid arthritis treated with adalimumab, who experienced an unexpected, medically significant event of Spinal disorder in association with a dose of mRNA-1273 vaccine. Patient underwent surgery on her lower 3rd lumbar vertebra until 1st sacral vertebra where rods were added on an unknown date. Outcome of the event was reported as resolved.  Vaccination history included a 2-dose primary series of mRNA-1273 vaccine. Further details on the medical history, the exact adverse event reported, clinical course, diagnostics, and additional treatments were not reported. Patient's elderly age and underlying rheumatoid arthritis remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.