Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthritis, Back pain, Fatigue, Gait disturbance
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SPINAL COMPRESSION FRACTURE (Thoracic spine compression) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE, CANDESARTAN, AMLODIPINE BESYLATE, OMEPRAZOLE and ATORVASTATIN for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced ABDOMINAL PAIN (Terrific stomach pains/Abdominal pain) and BACK PAIN (Abdominal pain and back pain (extreme)). On 28-Apr-2021, the patient experienced MENISCUS INJURY (Meniscus tear/maniscus in my left knee detached from the bone) and ARTHRITIS (Arthritis/ both of her knees gave out/ is going to have surgery: knee replacement on the left knee). On 05-May-2021, the patient experienced VISION BLURRED (Left eye started like coating over/ would not go totally blind but it was like a shade was being pulled over/Left eye filming over). On an unknown date, the patient experienced SPINAL COMPRESSION FRACTURE (Thoracic spine compression) (seriousness criterion medically significant), MUSCULOSKELETAL DISCOMFORT (There was something in her thoracic spine), GAIT DISTURBANCE (difficult to walk) and FATIGUE (Fatigue). The patient was treated with CORTISONE for Adverse event, at a dose of shots. On 15-Apr-2021, ABDOMINAL PAIN (Terrific stomach pains/Abdominal pain) and BACK PAIN (Abdominal pain and back pain (extreme)) had resolved. At the time of the report, SPINAL COMPRESSION FRACTURE (Thoracic spine compression), MUSCULOSKELETAL DISCOMFORT (There was something in her thoracic spine), GAIT DISTURBANCE (difficult to walk), VISION BLURRED (Left eye started like coating over/ would not go totally blind but it was like a shade was being pulled over/Left eye filming over), ARTHRITIS (Arthritis/ both of her knees gave out/ is going to have surgery: knee replacement on the left knee) and FATIGUE (Fatigue) outcome was unknown and MENISCUS INJURY (Meniscus tear/maniscus in my left knee detached from the bone) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication include a couple of blood pressure medication, thyroid medication, digestive medication, cholesterol drug, over the counter vitamins.  Lab data also includes two CAT scans were performed and results of the scans were inconclusive - except for compression of thoracic spine  and  MRI's and X-Rays on both knees were performed with results showed cartilage in both knees was severely depleted.   Patient uses a gel type injection for arthritis treatment and is planned for left knee replacement surgery scheduled for August 27.  Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded for the event of Fatigue; however, the other events started over at least three weeks after the second dose so causality is suspect. Also, the Company believes the events of Meniscus injury, Spinal compression fracture, Gait disturbance and Arthritis are unlikely related due to the natural history of the diseases that must pre-date the product use.   This case was linked to MOD-2021-030872 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up information received on 09 Aug 2021 contained significant information. Added events, concomitant medications and anatomical site location for the suspect drug; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded for the event of Fatigue; however, the other events started over at least three weeks after the second dose so causality is suspect. Also, the Company believes the events of Meniscus injury, Spinal compression fracture, Gait disturbance and Arthritis are unlikely related due to the natural history of the diseases that must pre-date the product use.