Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Intervertebral disc protrusion
Clinical narrative: Herniated disc; Went through some reactions after the Covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTERVERTEBRAL DISC PROTRUSION (Herniated disc) in a 67-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.    Concurrent medical conditions included Psoriatic arthritis.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-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) 40 milligram every two weeks. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. In 2021, the patient experienced IMMUNISATION REACTION (Went through some reactions after the Covid vaccine). On an unknown date, the patient experienced INTERVERTEBRAL DISC PROTRUSION (Herniated disc) (seriousness criterion medically significant). The patient was treated with Surgery (5 surgeries in 2021) for Intervertebral disc protrusion. At the time of the report, INTERVERTEBRAL DISC PROTRUSION (Herniated disc) and IMMUNISATION REACTION (Went through some reactions after the Covid vaccine) outcome was unknown.            No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. In 2021 the patient had five surgeries for a herniated disc. The Humira drug was available as Solution for injection in pre-filled pen. The reporter causality for the events of Herniated disc and vaccination adverse reaction was  assessed as No Reasonable possibility for cosuspect humira. No treatment medications were reported. 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 is a Spontaneous case reported by a consumer, concerning a 67-year-old female patient, with relevant medical condition of psoriatic arthritis, who experienced the unexpected and serious (due to medically significant) event of Intervertebral disc protrusion, which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for psoriatic arthritis. No information disclosed about diagnostic tests performed, clinical course or treatments received. Underlying psoriatic arthritis could be a confounder for the event. 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 67-year-old female patient, with relevant medical condition of psoriatic arthritis, who experienced the unexpected and serious (due to medically significant) event of Intervertebral disc protrusion, which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for psoriatic arthritis. No information disclosed about diagnostic tests performed, clinical course or treatments received. Underlying psoriatic arthritis could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.