Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Moderna (Dose number: unknown Batch/Lot No: Unknown.  Location of injection: Arm Left  Vaccine Administration Time: 12:15 PM) on 14-Jan-2021 and Moderna (Dose number: unknown Batch/Lot No: Unknown.  Location of injection: Arm Left  Vaccine Administration Time: 09:00 AM) on 11-Feb-2021; for Drug use for unknown indication: cipro. Past adverse reactions to the above products included Allergy with cipro; and No adverse event with Moderna and Moderna. Concurrent medical conditions included Chronic lymphocytic leukemia. Concomitant products included AMLODIPINE from 01-Jan-1990 to an unknown date for an unknown indication.    On 20-Aug-2021 at 12:15 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2022 at 12:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 17-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid) had not resolved.            Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 vaccine. Device date was reported as 29-May-2022.  Company comment: This is a spontaneous case concerning a 84-year-old, female patient with relevant concurrent medical condition of chronic lymphocytic leukemia (CLL) and with vaccine history of receiving 2 doses of unknown dose number of mRNA-1273 vaccine. Patient experienced the unexpected non-serious AESI event of Covid-19. The event occurred approximately 263 days after the unknown dose of mRNA-1273 vaccine administration. Approximately 3 days after the occurrence of the event, patient received treatment with Nirmatrelvir + Ritonavir (Paxlovid). No other information surrounding the event was reported. The outcome of the event was reported as not resolved from the time of last observation. The current Covid-19 pandemic, patient's age and concurrent medical condition of chronic lymphocytic leukemia (CLL) remain confounders for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 84-year-old, female patient with relevant concurrent medical condition of chronic lymphocytic leukemia (CLL) and with vaccine history of receiving 2 doses of unknown dose number of mRNA-1273 vaccine. Patient experienced the unexpected non-serious AESI event of Covid-19. The event occurred approximately 263 days after the unknown dose of mRNA-1273 vaccine administration. Approximately 3 days after the occurrence of the event, patient received treatment with Nirmatrelvir + Ritonavir (Paxlovid). No other information surrounding the event was reported. The outcome of the event was reported as not resolved from the time of last observation. The current Covid-19 pandemic, patient's age and concurrent medical condition of chronic lymphocytic leukemia (CLL) remain confounders for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.