Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Disability, Immunisation reaction, Magnetic resonance imaging, Musculoskeletal disorder, Nerve compression
Clinical narrative: Disability / became disabled after back surgery; Nerve compression / L4 and L5 was pushing to nerves; Pain; Unknown bad reaction; Upper extremity dysfunction / problems with arms; Walker user; This spontaneous case was reported by a consumer and describes the occurrence of DISABILITY (Disability / became disabled after back surgery) in a 59-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) tablet for Rheumatoid arthritis.    The patient's past medical history included Back surgery. Concurrent medical conditions included Non-smoker, Abstains from alcohol, Asthma, Allergy (Allergy to turmeric manifested for rash and hives), Latex allergy (Latex allergy manifested for rash, asthma and shortness of breath), Allergy (Powder allergy manifested for rash, asthma and shortness of breath) and Rheumatoid arthritis. Concomitant products included LISINOPRIL, MELOXICAM, OXYCODONE, FOLIC ACID, CALCIUM, VITAMIN C [ASCORBIC ACID], LOPERAMIDE, TRAMADOL and FISH OIL for an unknown indication.   In 2021, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. On 04-May-2022, UPADACITINIB (RINVOQ) (Oral) dosage was changed to 15 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. In 2022, the patient experienced MUSCULOSKELETAL DISORDER (Upper extremity dysfunction / problems with arms) and WALKING AID USER (Walker user). On an unknown date, the patient experienced DISABILITY (Disability / became disabled after back surgery) (seriousness criterion medically significant), NERVE COMPRESSION (Nerve compression / L4 and L5 was pushing to nerves), PAIN (Pain) and IMMUNISATION REACTION (Unknown bad reaction). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, DISABILITY (Disability / became disabled after back surgery) and MUSCULOSKELETAL DISORDER (Upper extremity dysfunction / problems with arms) was resolving and NERVE COMPRESSION (Nerve compression / L4 and L5 was pushing to nerves), WALKING AID USER (Walker user), PAIN (Pain) and IMMUNISATION REACTION (Unknown bad reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: showed L4 and L5 was pushing nerves.. On an unknown date, X-ray: showed L4 and L5 was pushing nerves..         Fish oil was used as a food supplement.  Patient stopped taking Rinvoq for six weeks as patient had back surgery. Patient restarted Rinvoq, and had been talking it for three weeks. It did not help like it did before stopped it for the surgery. Patient now had problems with arms that did not had before surgery and patient used a walker now.  Patient was still recovering from surgery and in pain.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The patient was treated with prednisone.  Company comment  This is a Spontaneous case concerning a 59-year-old female patient, with medical history of Back surgery and having concurrent Rheumatoid Arthritis and taking treatment with Upadacitinib, who experienced the unexpected, serious (Medically significant) event of Disability (Disability / became disabled after back surgery), unknown days after receiving a dose of mRNA1273 vaccine in the covid 19 vaccination series along with other non serious events of nerve compression (nerve compression / l4 and l5 was pushing to nerves), pain, musculoskeletal disorder (upper extremity dysfunction / problems with arms) and was a walking aid user. Magnetic resonance imaging and X-ray: showed L4 and L5 was pushing nerves. Patient stopped taking Rinvoq for six weeks as patient had back surgery. Patient now had problems with arms that were not present before surgery and patient used a walker now. Patient was still recovering from surgery and was in pain. The patient was treated with prednisone. The events were resolving. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed per medical judgement.; Sender's Comments: This is a Spontaneous case concerning a 59-year-old female patient, with medical history of Back surgery and having concurrent Rheumatoid Arthritis and taking treatment with Upadacitinib, who experienced the unexpected, serious (Medically significant) event of Disability (Disability / became disabled after back surgery), unknown days after receiving a dose of mRNA1273 vaccine in the covid 19 vaccination series along with other non serious events of nerve compression (nerve compression / l4 and l5 was pushing to nerves), pain, musculoskeletal disorder (upper extremity dysfunction / problems with arms) and was a walking aid user. Magnetic resonance imaging and X-ray: showed L4 and L5 was pushing nerves. Patient stopped taking Rinvoq for six weeks as patient had back surgery. Patient now had problems with arms that were not present before surgery and patient used a walker now. Patient was still recovering from surgery and was in pain. The patient was treated with prednisone. The events were resolving. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed per medical judgement.