Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphocyte count, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Metabolic function test
Clinical narrative: Mass in ovary and uterus; Mass in ovary and uterus; Pneumonia; INFLAMMATION HIGH; Stiffness in the joints; Tired/Fatigue; Shortness of breath; Achiness in joints/achiness in left elbow and shoulders/Metacarpophalangeal joints hurt; Achiness in Fingers/Feet; Pain; Tumors/nodule; This spontaneous case was reported by a consumer and describes the occurrence of OVARIAN MASS (Mass in ovary and uterus), UTERINE MASS (Mass in ovary and uterus), NEOPLASM (Tumors/nodule) and PNEUMONIA (Pneumonia) in a 63-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) for Rheumatoid arthritis.    The patient's past medical history included ANA positive, Drug hypersensitivity, Drug hypersensitivity, Drug hypersensitivity, Colonoscopy in 2017 and Mammogram in 2020. Previously administered products included for Drug use for unknown indication: Penicillin since an unknown date, Avelox and Sulfasalazine. Past adverse reactions to the above products included No adverse event with Avelox, Penicillin and Sulfasalazine. Concurrent medical conditions included Gout, Rheumatoid factor positive, Osteoporosis, Neoplasm of the mouth, Thoracic disc degeneration, Neuropathy peripheral, Vitamin B12 deficiency, Alcohol use, Hypoxic respiratory failure, Cigarette smoker, Carpal tunnel syndrome, Rheumatoid arthritis, Pulmonary hypertension, Seasonal allergy, Emphysema pulmonary and Hidradenitis suppurativa. Concomitant products included BENZONATATE (TESSALON PERLE) for Cough, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA RESPIMAT), NAPROXEN, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), MONTELUKAST SODIUM, OMEPRAZOLE, BUDESONIDE (PULMICORT), CALCIUM, MIRABEGRON (MYRBETRIQ), CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]), FERROUS FUMARATE, ERGOCALCIFEROL (VITAMIN D [ERGOCALCIFEROL]), FERROUS SULFATE, METOPROLOL SUCCINATE, SALBUTAMOL SULFATE (ALBUTEROL SULFATE HFA), FLUTICASONE PROPIONATE;SALMETEROL XINAFOATE, GLUCOSAMINE, ALLOPURINOL and FEXOFENADINE HCL for an unknown indication.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 31-Mar-2022, the patient experienced NEOPLASM (Tumors/nodule) (seriousness criterion medically significant). On 02-Apr-2022, the patient experienced PAIN (Pain). On an unknown date, the patient experienced OVARIAN MASS (Mass in ovary and uterus) (seriousness criterion medically significant), UTERINE MASS (Mass in ovary and uterus) (seriousness criterion medically significant), PNEUMONIA (Pneumonia) (seriousness criterion medically significant), INFLAMMATION (INFLAMMATION HIGH), JOINT STIFFNESS (Stiffness in the joints), FATIGUE (Tired/Fatigue), DYSPNOEA (Shortness of breath), ARTHRALGIA (Achiness in joints/achiness in left elbow and shoulders/Metacarpophalangeal joints hurt) and PAIN IN EXTREMITY (Achiness in Fingers/Feet). At the time of the report, OVARIAN MASS (Mass in ovary and uterus), UTERINE MASS (Mass in ovary and uterus), PNEUMONIA (Pneumonia), JOINT STIFFNESS (Stiffness in the joints), FATIGUE (Tired/Fatigue), DYSPNOEA (Shortness of breath), ARTHRALGIA (Achiness in joints/achiness in left elbow and shoulders/Metacarpophalangeal joints hurt) and PAIN IN EXTREMITY (Achiness in Fingers/Feet) outcome was unknown, NEOPLASM (Tumors/nodule) and PAIN (Pain) had resolved and INFLAMMATION (INFLAMMATION HIGH) had resolved with sequelae. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jun-2022, Blood chloride: 100. On 06-Jun-2022, Blood potassium: 4.3. On 06-Jun-2022, Blood sodium: 137. In 2022, Basophil count: 0.05 and 1 %. In 2022, Blood pressure measurement: 125/80 mmHg, 115/60 mmHg and 138/88 mmHg. In 2022, Body height: 172.72 centimetre, 172.72 centimetre and 172.72 centimetre. In 2022, Body mass index: 20.52 index, 20.34 and 20.80 Index. In 2022, Body surface area: 1.71 index, 1.7 and 1.72 index. In 2022, Body temperature: 98.2 98.2 F, 98.8 98.8 F and 96.7 96.7 F. In 2022, C-reactive protein: 21 and 10.6 10.6 H. In 2022, Eosinophil count: 0.18 % and 2 %. In 2022, Haematocrit: 43.5. In 2022, Haemoglobin: 13.4 and Stable. In 2022, Heart rate: 88, 82 and 69. In 2022, Immature granulocyte count: 0.03 0.03 H. In 2022, Lymphocyte count: 0.860 % and 10 %. In 2022, Mean cell haemoglobin: 30.8 l. In 2022, Mean cell haemoglobin concentration: 95.2. In 2022, Mean cell volume: 29-3. In 2022, Metabolic function test: showed the alkaline phosphatase was mildly elevated. In 2022, Monocyte count: 7 %. In 2022, Neutrophil count: 7.070 % and 80 %. In 2022, Oxygen saturation: 86 %, 86 % and 88 %. In 2022, Pain assessment: 4-6/10, 6, 4 and 6. In 2022, Platelet count: 214 and Stable. In 2022, Red blood cell count: 4.57. In 2022, Red blood cell sedimentation rate: Normal and Still elevated 56. In 2022, Red cell distribution width abnormal: 16.2 16.2 H. In 2022, Weight: 61.240 kg, 60.690 kg and 62.050 kg. In 2022, Weight abnormal: 1.1 lb, 1.2 lb and 0.8 lb. In 2022, White blood cell count: 8.8 and 11.9.         Lab data also consist of Comprehensive Metabolic Panel: Carbon, Lab test: RR 16. On 2022, Ultrasound, Magnetic Resonance Imaging and PAP smear with Unknown result.  The reporter causality for Humira, for the events of Surgeries was not provided, APPENDIX REMOVAL, Achiness in Fingers/Feet, HIGH INFLAMMATION DUE TO SURGERY, Mass in ovary and uterus unknown onset, PAIN DUE TO SURGERY, PNEUMONIA was not reported, Achiness in joints/achiness in left elbow and shoulders/Metacarpophalangeal joints hurt and Tumors/nodule was No Reasonable Possibility, INFLAMMATION HIGH, PAIN, Stiffness in the joints, Tired/Fatigue, shortness of breath and stress was No Reasonable Possibility. No treatment medicine were reported.  The patient mentioned achiness in her feet and shoulders. At times the pain level was 4 to 6 out of 10. Stiffness was less. She used to have stiffness for two to three hours, but it was getting better. In the morning, it took her 14 minutes and at times up to 45 minutes to loosen. Since her last appointments. She had her PAP smear. Later, she had ultrasound and MRI. There was concern about mass in her ovary and uterus. At times, she felt very tired and fatigued. She was under a lot of stress as she changed her job. She had a total hysterectomy with bilateral ovarian surgery. Her appendix was removed too. It was all benign. She was healing well. She had one Humira injection so far. Her hand joints, fingers and wrists were doing better. She thought Humira might be helping some, but she just felt stiff and achy. No recent infection was reported. She reported readjusting medication due to surgery affecting medication had a nodule. She reported off surgery for a month for removal of tumors. The patient reported of having high inflammation due to surgery and postoperative pain.  Company Comment: This spontaneous case concerns a 63-year-old female patient, with relevant medical history of drug hypersensitivity, chronic gout, osteoporosis, positive ANA, neuropathy hands and feet, pulmonary emphysema, carpal tunnel, thoracolumbar degenerative disc disease, alcohol use, hypoxemic respiratory failure, smoker, with multiple concomitant medications, who experienced the unexpected serious (medically significant) events of Ovarian mass, Uterine mass, Neoplasm, and Pneumonia on unknown dates after receiving the mRNA-1273 vaccine as 3rd dose, along with other non-serious events. Onset latency could not be determined as onset dates of events were not provided. Blood tests were done as well as pap smear, magnetic resonance imaging, and ultrasound. On an unknown date, patient underwent total hysterectomy with bilateral ovarian surgery and appendectomy.  The outcome of events was reported as unknown. Patient received 2-dose primary series of mRNA-1273 vaccine at interval of 31 days, and approximately 8 months later, 3rd dose of mRNA-1273 vaccine was administered. On an unspecified date, patient received co-suspect Adalimumab which remains as confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.  Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2022: Non-significant follow-up appended; Sender's Comments: This spontaneous case concerns a 63-year-old female patient, with relevant medical history of drug hypersensitivity, chronic gout, osteoporosis, positive ANA, neuropathy hands and feet, pulmonary emphysema, carpal tunnel, thoracolumbar degenerative disc disease, alcohol use, hypoxemic respiratory failure, smoker, with multiple concomitant medications, who experienced the unexpected serious (medically significant) events of Ovarian mass, Uterine mass, Neoplasm, and Pneumonia on unknown dates after receiving the mRNA-1273 vaccine as 3rd dose, along with other non-serious events. Onset latency could not be determined as onset dates of events were not provided. Blood tests were done as well as pap smear, magnetic resonance imaging, and ultrasound. On an unknown date, patient underwent total hysterectomy with bilateral ovarian surgery and appendectomy.  The outcome of events was reported as unknown. Patient received 2-dose primary series of mRNA-1273 vaccine at interval of 31 days, and approximately 8 months later, 3rd dose of mRNA-1273 vaccine was administered. On an unspecified date, patient received co-suspect Adalimumab which remains as confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.