Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Intervertebral disc protrusion, Nerve compression
Clinical narrative: Herniated disc compresses a nerve; Herniated disc compresses a nerve; This spontaneous case was reported by a consumer and describes the occurrence of INTERVERTEBRAL DISC PROTRUSION (Herniated disc compresses a nerve) and NERVE COMPRESSION (Herniated disc compresses a nerve) in a 48-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) for Hidradenitis suppurativa.    The patient's past medical history included Gallbladder removal, Appendectomy (appendix removal), Neck surgery and Hip surgery. Concurrent medical conditions included Food allergy, Non-smoker, Abstains from alcohol and Hidradenitis suppurativa (MODERATE TO SEVERE HIDRADENITIS SUPPURATIVA).   In 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) .8 milliliter. On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to .8 milliliter. On 11-Sep-2021, the patient experienced INTERVERTEBRAL DISC PROTRUSION (Herniated disc compresses a nerve) (seriousness criterion medically significant) and NERVE COMPRESSION (Herniated disc compresses a nerve) (seriousness criterion medically significant). The patient was treated with Surgery (On 11-Sep-2021, the patient underwent a back surgery in L5-S1 area) for Intervertebral disc protrusion and Surgery (On 11-Sep-2021, the patient underwent a back surgery in L5-S1 area) for Nerve compression. In 2022, INTERVERTEBRAL DISC PROTRUSION (Herniated disc compresses a nerve) and NERVE COMPRESSION (Herniated disc compresses a nerve) had resolved.            Company comment: This is a spontaneous case concerning a 48-year-old male patient with Hidradenitis suppurativa on treatment with Adalimumab, who experienced the serious (medically significant) unexpected events intervertebral disc protrusion and nerve compression, more than 4 months after the second dose of mRNA-1273. It was reported that herniated disc compresses a nerve. X-ray and MRI were performed without reported results. The patient was treated with Back surgery on L5-S1 area. Adalimumab was reported as a co-suspect product. Events seriousness captured as per SD. The benefit-risk relationship of mRNA-1273 is not affected by this report.  No concomitant medication were reported.  It was reported that lab data included MRI and X-ray on ??-Sep-2021 with unknown results.  The reporters causality for the events of HERNIATION DISK COMPRESSES A NERVE onset 11 Sep 2021 and HERNIATION DISK COMPRESSES A NERVE onset 11 Sep 2021 with HUMIRA 40MG/0.8ML(ADALIMUMAB) was no reasonable possibility. The reporters causality for the event(s) of HIDRADENITIS SUPPURATIVA FLARE UP NEAR PELVIC AREA/ONE HEALS THEN ANOTHER POPPED OUT/HIDRADENITIS SUPPURATIVA BREAK/OUTBREAK/BREAKING OUT with HUMIRA 40MG/0.8ML(ADALIMUMAB) was a reasonable possibility. The reporters causality for the events of RASH ON HIS PELVIS AREA AND BELLY AREA was not 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.   This case was linked to MOD-2021-623189 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2022: Follow up received contains non significant information. On 05-Apr-2022: Follow up received contains significant information patient demographics updated, start dates of moderna suspect were updated, dose details of HUMIRA suspect were added and events were updated.; Sender's Comments: Company comment: This is a spontaneous case concerning a 48-year-old male patient with Hidradenitis suppurativa on treatment with Adalimumab, who experienced the serious (medically significant) unexpected events intervertebral disc protrusion and nerve compression, more than 4 months after the second dose of mRNA-1273. It was reported that herniated disc compresses a nerve. X-ray and MRI were performed without reported results. The patient was treated with Back surgery on L5-S1 area. Adalimumab was reported as a co-suspect product. Events seriousness captured as per SD. The benefit-risk relationship of mRNA-1273 is not affected by this report.