Age: 64.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Procedural pain, Spinal operation, Vaccination site pain
Clinical narrative: Post procedural pain; Back surgery; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL OPERATION (Back surgery) in a 64-year-old male 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) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to Severe).   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 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) Citrate Free. In April 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). In November 2021, the patient experienced SPINAL OPERATION (Back surgery) (seriousness criterion medically significant). On an unknown date, the patient experienced PROCEDURAL PAIN (Post procedural pain). At the time of the report, SPINAL OPERATION (Back surgery) was resolving, PROCEDURAL PAIN (Post procedural pain) had not resolved and VACCINATION SITE PAIN (Vaccination site pain) had resolved.            No concomitant medications were reported.  In Apr-2021, the patient experienced injection site hurt with second dose of covid-19 vaccine which was resolved on unknown date. In Nov-2021, the patient underwent back surgery. On an unknown date, the patient experienced back surgery pain.  It was unknown if patient was enrolled in a covid-19 vaccine trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna were missed to be booked-in No treatment information was reported.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a 64-year-old male patient, with no relevant medical history, who experienced the unexpected and serious (due to medically significant) event of Spinal operation, which occurred approximately 7 months after the second dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for rheumatoid arthritis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event was resolving. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 64-year-old male patient, with no relevant medical history, who experienced the unexpected and serious (due to medically significant) event of Spinal operation, which occurred approximately 7 months after the second dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for rheumatoid arthritis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event was resolving. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.