Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Surgery
Clinical narrative: HURTS AND WAS SICK FROM MODERNA COVID 19 VACCINATION; LOWER BACK HURTS; Shingles; LEG PROBLEMS; SHOULDER HURTS; UNKNOWN KIND OF SURGERY; This spontaneous case was reported by a patient and describes the occurrence of SURGERY (UNKNOWN KIND OF SURGERY) in a 54-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) solution for injection for Psoriatic arthritis.    No Medical History information was reported.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 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) Solution for injection in pre-filled pen. In 2021, the patient experienced SURGERY (UNKNOWN KIND OF SURGERY) (seriousness criterion medically significant). On an unknown date, the patient experienced ILLNESS (HURTS AND WAS SICK FROM MODERNA COVID 19 VACCINATION), BACK PAIN (LOWER BACK HURTS), HERPES ZOSTER (Shingles), PAIN IN EXTREMITY (LEG PROBLEMS) and ARTHRALGIA (SHOULDER HURTS). At the time of the report, SURGERY (UNKNOWN KIND OF SURGERY) and ILLNESS (HURTS AND WAS SICK FROM MODERNA COVID 19 VACCINATION) outcome was unknown and BACK PAIN (LOWER BACK HURTS), HERPES ZOSTER (Shingles), PAIN IN EXTREMITY (LEG PROBLEMS) and ARTHRALGIA (SHOULDER HURTS) was resolving. Concomitant drugs were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the events of UNKNOWN KIND OF SURGERY, SHOULDER HURTS, LOWER BACK HURTS, SHINGLES and LEG PROBLEMS/HURTS AND WAS SICK FROM MODERNA COVID 19 VACCINATION unknown onset was not provided.   Opinion is that there is no reasonable possibility that the events of UNKNOWN KIND OF SURGERY, SHOULDER HURTS, LOWER BACK HURTS and LEG PROBLEMS/HURTS AND WAS SICK FROM MODERNA COVID 19 VACCINATION unknown onset are related to HUMIRA(ADALIMUMAB). Opinion is that the event of SHINGLES is not assessable.  Treatment details were not given.  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 54  year  old female patient, with current condition of psoriatic arthritis, who received two doses of mRNA  1273 vaccine, and experienced the serious medically significant unexpected event of surgery, which occurred in the same year of vaccination with mRNA  1273 vaccine. Exact onset date of the event was not provided; hence latency and temporal association cannot be properly assessed. The report mentioned the patient had an unknown kind of surgery. No further clinical information was available for medical reviewing. Co-suspect product included Adalimumab. Patient´s mentioned medical history could be a confounding factor. The benefit risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 54  year  old female patient, with current condition of psoriatic arthritis, who received two doses of mRNA  1273 vaccine, and experienced the serious medically significant unexpected event of surgery, which occurred in the same year of vaccination with mRNA  1273 vaccine. Exact onset date of the event was not provided; hence latency and temporal association cannot be properly assessed. The report mentioned the patient had an unknown kind of surgery. No further clinical information was available for medical reviewing. Co-suspect product included Adalimumab. Patient´s mentioned medical history could be a confounding factor. The benefit risk relationship of mRNA-1273 is not affected by this report.