Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 12 days since patient first tested positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (12 days since patient first tested positive) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027221A, 061E21A, 014M20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Unspecified.).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (12 days since patient first tested positive). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 21-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (12 days since patient first tested positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive It was 12 days since patient first tested positive..         Concomitant medication information was not provided by the reporter.  While taking Paxlovid the patient became symptom free. Runny and stuffy nose cleared up and no fatigue.   On 23-May-2022, two days after patient finished Paxlovid, runny and stuffy nose resumed and some sneezing coughing. Patient never tested negative. It was reported as 12 days since patient first tested positive and still have a mild runny nose and coughing.  Device date was reported as 29-May-2022.  Company comment: This is a spontaneous case concerning a 71-year-old, female patient with no relevant medical history and with vaccine history of receiving first, second and third dose of mRNA-1273 vaccine with appropriate dosage interval of 28 days for the first and second dose. Patient experienced the unexpected non-serious AESI event of Covid-19. The event occurrence was unknown with respect to the fourth dose of mRNA-1273 vaccine administration. Allegedly the event was described as, on unknown date patient tested positive. Approximately 20 days after the fourth dose of mRNA-1273 vaccine administration, patient took Nirmatrelvir + Ritonavir (Paxlovid) for treatment of Covid-19. While taking Paxlovid, patient became symptoms free. Runny and stuffy nose cleared up and no fatigue. However, 2 days after the patient finished taking Paxlovid runny and stuffy nose resumed accompanied with sneezing and coughing. At the time of report, it has been 12 days since the patient tested positive and mild runny nose and coughing were still persistent. No other information surrounding the events was reported. The outcome of the event was reported as not resolved. The current Covid-19 pandemic remain confounder 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 71-year-old, female patient with no relevant medical history and with vaccine history of receiving first, second and third dose of mRNA-1273 vaccine with appropriate dosage interval of 28 days for the first and second dose. Patient experienced the unexpected non-serious AESI event of Covid-19. The event occurrence was unknown with respect to the fourth dose of mRNA-1273 vaccine administration. Allegedly the event was described as, on unknown date patient tested positive. Approximately 20 days after the fourth dose of mRNA-1273 vaccine administration, patient took Nirmatrelvir + Ritonavir (Paxlovid) for treatment of Covid-19. While taking Paxlovid, patient became symptoms free. Runny and stuffy nose cleared up and no fatigue. However, 2 days after the patient finished taking Paxlovid runny and stuffy nose resumed accompanied with sneezing and coughing. At the time of report, it has been 12 days since the patient tested positive and mild runny nose and coughing were still persistent. No other information surrounding the events was reported. The outcome of the event was reported as not resolved. The current Covid-19 pandemic remain confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.