Sex: F
Vaccine: COVID19
Symptoms: Back disorder, Bursitis, Cardiac stress test, Computerised tomogram, Echocardiogram
Clinical narrative: LOWER LUMBAR L4 AND L5 DISCS OF VERTEBRAE AND BETWEEN THOSE AND F1 VERTEBRAE BACK CONDITION; Latex allergy; HEART CONDITION/ELEVATED ENZYME TROPININ IN HEART; CONTINUOUS POSITIVE AIRWAY PRESSURE MACHINE FOR LUNGS; HIP BURSITIS; Sleep apnea; Runner's knee; FREQUENT BATHROOM BREAKS; Pain; Pinched nerve; STUCK FOUR TIMES WITH NEEDLE FOR DYE CONTRAST BEFORE TESTING; FIBROMYALGIA IN SHOULDER BLADES/BACK; FATIGUE AFTER SOME ACTIVITIES EXHAUSTED; This spontaneous case was reported by a consumer and describes the occurrence of BACK DISORDER (LOWER LUMBAR L4 AND L5 DISCS OF VERTEBRAE AND BETWEEN THOSE AND F1 VERTEBRAE BACK CONDITION), RUBBER SENSITIVITY (Latex allergy), TROPONIN INCREASED (HEART CONDITION/ELEVATED ENZYME TROPININ IN HEART), POSITIVE AIRWAY PRESSURE THERAPY (CONTINUOUS POSITIVE AIRWAY PRESSURE MACHINE FOR LUNGS) and BURSITIS (HIP BURSITIS) in an adult 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) for Rheumatoid arthritis.    The patient's past medical history included Chest pain and Night sweats. Concurrent medical conditions included Rheumatoid arthritis.   On 04-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 22-Oct-2021, received third 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) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced BACK DISORDER (LOWER LUMBAR L4 AND L5 DISCS OF VERTEBRAE AND BETWEEN THOSE AND F1 VERTEBRAE BACK CONDITION), RUBBER SENSITIVITY (Latex allergy), TROPONIN INCREASED (HEART CONDITION/ELEVATED ENZYME TROPININ IN HEART), POSITIVE AIRWAY PRESSURE THERAPY (CONTINUOUS POSITIVE AIRWAY PRESSURE MACHINE FOR LUNGS), BURSITIS (HIP BURSITIS), SLEEP APNOEA SYNDROME (Sleep apnea), PATELLOFEMORAL PAIN SYNDROME (Runner's knee), UNEVALUABLE EVENT (FREQUENT BATHROOM BREAKS), PAIN (Pain), NERVE COMPRESSION (Pinched nerve), INJURY ASSOCIATED WITH DEVICE (STUCK FOUR TIMES WITH NEEDLE FOR DYE CONTRAST BEFORE TESTING), FIBROMYALGIA (FIBROMYALGIA IN SHOULDER BLADES/BACK) and FATIGUE (FATIGUE AFTER SOME ACTIVITIES EXHAUSTED). At the time of the report, BACK DISORDER (LOWER LUMBAR L4 AND L5 DISCS OF VERTEBRAE AND BETWEEN THOSE AND F1 VERTEBRAE BACK CONDITION) and RUBBER SENSITIVITY (Latex allergy) had not resolved, TROPONIN INCREASED (HEART CONDITION/ELEVATED ENZYME TROPININ IN HEART), POSITIVE AIRWAY PRESSURE THERAPY (CONTINUOUS POSITIVE AIRWAY PRESSURE MACHINE FOR LUNGS), BURSITIS (HIP BURSITIS), SLEEP APNOEA SYNDROME (Sleep apnea), PATELLOFEMORAL PAIN SYNDROME (Runner's knee), UNEVALUABLE EVENT (FREQUENT BATHROOM BREAKS), PAIN (Pain) and NERVE COMPRESSION (Pinched nerve) outcome was unknown, INJURY ASSOCIATED WITH DEVICE (STUCK FOUR TIMES WITH NEEDLE FOR DYE CONTRAST BEFORE TESTING) and FATIGUE (FATIGUE AFTER SOME ACTIVITIES EXHAUSTED) was resolving and FIBROMYALGIA (FIBROMYALGIA IN SHOULDER BLADES/BACK) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Dec-2021, Cardiac stress test: UNKNOWN. On 02-Dec-2021, Computerised tomogram: UNKNOWN. On 02-Dec-2021, Echocardiogram: UNKNOWN. On an unknown date, Troponin: Elevated enzyme Troponin in heart was found.         No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of HEART CONDITION/ELEVATED ENZYME TROPININ IN HEART WAS FOUND, CONTINUOUS POSITIVE AIRWAY PRESSURE MACHINE FOR LUNGS, LATEX ALLERGY, SLEEP APNEA and LOWER LUMBAR L4 AND L5  DISCS OF VERTEBRAE AND BETWEEN THOSE AND F1 VERTEBRAE BACK CONDITION with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of HIP BURSITIS, STUCK FOUR TIMES WITH NEEDLE FOR DYE CONTRAST BEFORE TESTING, FATIGUE AFTER SOME ACTIVITIES EXHAUSTED, FIBROMYALGIA IN SHOULDER BLADES/BACK, PINCHED NERVES, RUNNERS KNEE, FREQUENT BATHROOM BREAKS and PAIN was not provided.  No treatment medication was 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   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Follow-up received included medical history added.