Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Haematocrit, Haemoglobin, Haemoglobin abnormal, Leukaemia, Mean cell volume
Clinical narrative: Multiple myeloma; Blood cancer in the bone marrow; Shortness of breath; Anemic; Being tired; Fall in her garage and landed on her butt resulting in the fracturing of 5 vertebrae/ The patient already had a previous injury so this resulted in 6 vertebrae being broken; Pericarditis.; Fall in her garage and landed on her butt resulting in the fracturing; Muscle spasms; Felt like an alien was inside her as her body healed; Hemoglobin abnormal; NT-ProBMP Protein increased; This spontaneous case was reported by an other health care professional and describes the occurrence of SPINAL FRACTURE (Fall in her garage and landed on her butt resulting in the fracturing of 5 vertebrae/ The patient already had a previous injury so this resulted in 6 vertebrae being broken), PLASMA CELL MYELOMA (Multiple myeloma), LEUKAEMIA (Blood cancer in the bone marrow) and PERICARDITIS (Pericarditis.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), MAGNESIUM, OMEPRAZOLE, ESTRADIOL, AMLODIPINE BESILATE (AMLODIPINE [AMLODIPINE BESILATE]), ASPIRIN [ACETYLSALICYLIC ACID], IBUPROFEN, TRAMADOL, TIZANIDINE HYDROCHLORIDE (TIZANIDINE [TIZANIDINE HYDROCHLORIDE]) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced HAEMOGLOBIN ABNORMAL (Hemoglobin abnormal) and N-TERMINAL PROHORMONE BRAIN NATRIURETIC PEPTIDE INCREASED (NT-ProBMP Protein increased). On 29-Apr-2021, the patient experienced SPINAL FRACTURE (Fall in her garage and landed on her butt resulting in the fracturing of 5 vertebrae/ The patient already had a previous injury so this resulted in 6 vertebrae being broken) (seriousness criterion medically significant), PERICARDITIS (Pericarditis.) (seriousness criterion medically significant), FALL (Fall in her garage and landed on her butt resulting in the fracturing), MUSCLE SPASMS (Muscle spasms) and FEELING ABNORMAL (Felt like an alien was inside her as her body healed). On an unknown date, the patient experienced PLASMA CELL MYELOMA (Multiple myeloma) (seriousness criterion medically significant), LEUKAEMIA (Blood cancer in the bone marrow) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath), ANAEMIA (Anemic) and FATIGUE (Being tired). At the time of the report, SPINAL FRACTURE (Fall in her garage and landed on her butt resulting in the fracturing of 5 vertebrae/ The patient already had a previous injury so this resulted in 6 vertebrae being broken), PLASMA CELL MYELOMA (Multiple myeloma), LEUKAEMIA (Blood cancer in the bone marrow), PERICARDITIS (Pericarditis.), FALL (Fall in her garage and landed on her butt resulting in the fracturing), MUSCLE SPASMS (Muscle spasms), FEELING ABNORMAL (Felt like an alien was inside her as her body healed), DYSPNOEA (Shortness of breath), ANAEMIA (Anemic), HAEMOGLOBIN ABNORMAL (Hemoglobin abnormal), N-TERMINAL PROHORMONE BRAIN NATRIURETIC PEPTIDE INCREASED (NT-ProBMP Protein increased) and FATIGUE (Being tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jul-2021, Haemoglobin: low (Low) low,  bottomed out. On 15-Jul-2021, Protein total: elevated (High) elevated. On 15-Jul-2021, White blood cell count: low (Low) low,  bottomed out. On 04-Aug-2021, Haematocrit: 26 (abnormal) 26. On 04-Aug-2021, Haemoglobin: 10 (Low) 10. On 04-Aug-2021, Mean cell volume: 108 (abnormal) 108. On 04-Aug-2021, White blood cell count: 2.5 (abnormal) 2.5. On an unknown date, Haemoglobin: 10.2 (abnormal) 10.2%. On an unknown date, Protein total: 10 (abnormal) 10.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not reported.  Other lab investigation include Hemocratic was at 26 on 04-Aug-2021 , hemoglobulin elevated on 15-July-2021 , NT PROBMP protein was extremely high.  On 12-Jan-2021, Patient received first dose of Moderna COVID-19 vaccine and on 12-Feb-2021 received second dose.  In April2021, the patient underwent a bloodwork exam and it was found that Hemoglobin was at 10.2%, total protein was at 10 and the NT PROBMP protein was extremely high.   On 29-Apr-2021, patient had a fall in garage and landed on butt resulting in the fracturing of 5 vertebrae. Patient already had a previous injury so this resulted in 6 vertebrae being broken that resulted muscle spasms and felt like an alien was inside, as patient's body healed. While the patient was in the Emergency Room being treated for the fall it was found that patient had a heart murmur and was diagnosed with pericarditis.   On 15-Jul-2021, patient underwent more blood work and it was shown that white blood cell count had bottomed out, hemoglobin bottomed out, total protein elevated and hemoglobulin elevated.   On 04-Aug-2021, the doctor performed another blood panel test and white blood cell count was 2.5, hemoglobin fell to 10, Hemocratic was at 26 and MCV was 108. The patient recently had another panel done and the blood work has remained consistent and was referred to a hematologist and oncologist. The doctor believe that patient had multiple myeloma and blood cancer in the bone marrow and was seeking out medical attention to gain a diagnosed.  Currently her side effects are being tired, shortness of breath and anemic.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded