Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Glomerular filtration rate, Haematocrit, Haemoglobin, Heart rate, International normalised ratio
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VENETOCLAX (VENCLEXTA) for Acute myeloblastic leukemia.    The patient's past medical history included Cervical intraepithelial neoplasia I, Pelvic pain, Smoker, Abstains from alcohol, Acute myeloid leukemia, Anemia, Spontaneous abortion, Motor vehicle accident, Splenomegaly (PREDIABETIC SPLENOMEGLY) and Bone marrow transplant on 28-Sep-2021. Concurrent medical conditions included Drug allergy (HYDROXYUREA, CIPRO,ABACAVIR), HIV disease, Neck pain, Endometriosis, Irritable bowel syndrome, Drug use disorder and Polycythemia vera. Concomitant products included ACETAMINOPHEN, ALLOPURINOL from 19-Jun-2021 to an unknown date, BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY), RILPIVIRINE HYDROCHLORIDE (EDURANT), FERROUS SULFATE, LOSARTAN, PLANTAGO OVATA (METAMUCIL [PLANTAGO OVATA]), PROCHLORPERAZINE, TRAMADOL, VITAMIN D3, ONDANSETRON (ZOFRAN [ONDANSETRON]), DICLOFENAC SODIUM (VOLTAREN ACTIGO [DICLOFENAC SODIUM]), LEVOFLOXACIN (LEVAQUIN), LOPERAMIDE HYDROCHLORIDE (IMODIUM), LOSARTAN POTASSIUM (COZAAR), AZACITIDINE (VIDAZA) and RUXOLITINIB PHOSPHATE (JAKAFI) from 10-Oct-2021 to an unknown date for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient started VENETOCLAX (VENCLEXTA) (Oral) 100 milligram. On 17-Jun-2021, VENETOCLAX (VENCLEXTA) (Oral) dosage was changed to 400 milligram four times per day. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion hospitalization). On 03-Sep-2021, PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2021, Pyrexia: 102.3 degree Celsius. On an unknown date, Alanine aminotransferase: 10. On an unknown date, Anion gap: 15.4. On an unknown date, Blood albumin: 4.0 and 1.3. On an unknown date, Blood bilirubin: 2.1, Direct 0.7 and Indirect 1.4. On an unknown date, Blood calcium: 9.7. On an unknown date, Blood chloride: 104. On an unknown date, Blood creatinine: 0.91. On an unknown date, Blood glucose: 122. On an unknown date, Blood potassium: 4.4. On an unknown date, Blood pressure measurement: 126/70 (BP position: Lying). On an unknown date, Blood sodium: 138. On an unknown date, Blood urea: 11.0. On an unknown date, Body mass index: 31.95 kilogram per square metre. On an unknown date, Body temperature: 37.7 degree Celsius. On an unknown date, C-reactive protein: 1.87. On an unknown date, Carbon dioxide: 23. On an unknown date, Chest X-ray: No pneumonia or focal infiltrate. On an unknown date, Creatinine renal clearance: ADULTS- 81.5. On an unknown date, Electrocardiogram: Sinus tachycardia, rate 111 bpm. Nonspecific ST ST wave changes noted.. On an unknown date, Globulin: 3.2. On an unknown date, Glomerular filtration rate: Greater than 60. On an unknown date, Haematocrit: 27.5. On an unknown date, Haemoglobin: 8.8. On an unknown date, Heart rate: 97. On an unknown date, International normalised ratio: 1.4. On an unknown date, Lymphocyte count: 24.0. On an unknown date, Mean cell haemoglobin: 29.1. On an unknown date, Mean cell haemoglobin concentration: 32.0. On an unknown date, Mean cell volume: 91.1. On an unknown date, Metamyelocyte count: 7.0. On an unknown date, Monocyte count: 6.0. On an unknown date, Myelocyte count: 1.0. On an unknown date, Neutrophil count: 11.0 and 51.0. On an unknown date, Oxygen saturation: 100 %. On an unknown date, Platelet count: 104. On an unknown date, Prothrombin level: Time 15.9. On an unknown date, Red blood cell count: 3.02. On an unknown date, Red cell distribution width: 21.9. On an unknown date, Respiratory rate: 18. On an unknown date, White blood cell count: 1.2.         The patient height : 1.651 m (5' 5")  and weight was reported as 87.1 kg (192 Ib). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 01 Sep 2021, the patient went to the emergency room the day after receiving the third covid vaccine.  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.  Company comment This spontaneous case reported by a consumer, concerns a 49 year old female patient, with relevant medical history of Cervical Intra epithelial Neoplasia, Acute Myeloid leukemia, and having concurrent illness of Drug Allergy, HIV disease, Polycythemia vera, and taking VENETOCLAX for Acute Myeloid Leukemia, who experienced the unexpected, serious, (hospitalization) event of Pyrexia, the day after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series. On the day of event onset, body temperature was 102.3 degree Celsius. Labs were non significant. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Significant follow-up appended contains; Lab data , Medical history, narrative updated.; Sender's Comments: This spontaneous case reported by a consumer, concerns a 49 year old female patient, with relevant medical history of Cervical Intra epithelial Neoplasia, Acute Myeloid leukemia, and having concurrent illness of Drug Allergy, HIV disease, Polycythemia vera, and taking VENETOCLAX for Acute Myeloid Leukemia, who experienced the unexpected, serious, (hospitalization) event of Pyrexia, the day after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series. On the day of event onset, body temperature was 102.3 degree Celsius. Labs were non significant. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.