Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Blast cells, Dizziness, Fatigue, Platelet count, White blood cell count
Clinical narrative: Dizziness; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizziness) and FATIGUE (Fatigue) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a22a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine), Drug allergy (Mepivacaine), Dementia and Memory impaired (memory problems). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], SIMVASTATIN, FUROSEMIDE SODIUM (LASIX [FUROSEMIDE SODIUM]), MEMANTINE, LISINOPRIL, APIXABAN, AMLODIPINE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and RIVASTIGMINE for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced DIZZINESS (Dizziness) (seriousness criterion hospitalization) and FATIGUE (Fatigue) (seriousness criterion hospitalization). The patient was hospitalized on 22-Jun-2022 due to DIZZINESS and FATIGUE. The patient was treated with CEFTRIAXONE SODIUM (ROCEPHIN IV) (intravenous) at an unspecified dose and frequency and HEPARIN (subcutaneous) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blast cells: 34 34 percent. On an unknown date, Platelet count: 85 85. On an unknown date, White blood cell count: high High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient experienced 34 percent blast cells, fatigue and dizziness and admitted to the emergency room on Jun 22 2022 7 42PM, high white count, platelets at 85 The symptoms were ongoing yes but look a little better, not showed blast cells any more, not longer showing, platelets stay the same at 85. Treatment medication included Rocephin Intravenous heparin subcutaneous injection and iv fluids.  Company comment: This spontaneous case concerns a 90 year old female patient with no relevant medical history, who experienced the unexpected serious (hospitalization) events of Dizziness and Fatigue, unknown days after receiving the fourth dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the previous three doses with the same vaccine, the last dose being given about 6.5 months ago with no reported adverse events. Patient was admitted to emergency department after she developed dizziness and fatigue following vaccination. Her blood investigations showed 34 percent blast cells and platelets were reported as 85. No further information on detailed clinical course and treatment of the events was available in the report. The events were not resolved. Elderly age of the patient could be a risk factor for the events. Concomitant medications could be confounding for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 90 year old female patient with no relevant medical history, who experienced the unexpected serious (hospitalization) events of Dizziness and Fatigue, unknown days after receiving the fourth dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the previous three doses with the same vaccine, the last dose being given about 6.5 months ago with no reported adverse events. Patient was admitted to emergency department after she developed dizziness and fatigue following vaccination. Her blood investigations showed 34 percent blast cells and platelets were reported as 85. No further information on detailed clinical course and treatment of the events was available in the report. The events were not resolved. Elderly age of the patient could be a risk factor for the events. Concomitant medications could be confounding for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.