Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID - 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID - 19) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O31H21A) for COVID-19 vaccination.     The patient's past medical history included Allergy (unspecified drug). Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE BESYLATE and ATORVASTATIN for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, received third 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 (COVID - 19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 22-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID - 19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2022, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After completing 4 days Paxlovid COVID symptoms was returned and  tested positive Device date: 30.  Company comment: This is a spontaneous case concerning a 78-year-old, female patient with no relevant medical history and with vaccine history of receiving first and second dose of mRNA-1273 vaccine with appropriate dosage interval of 28 days, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred approximately 5 months after the third dose of mRNA-1273 vaccine administration. Allegedly the event was described as, approximately 164 days after the third dose of mRNA-1273 vaccine administration, patient took Nirmatrelvir + Ritonavir (Paxlovid) for Covid-19 treatment with approximately 5 days duration. However, 4 days after completing the treatment, Covid-19 symptoms returned, and patient tested positive. No other information surrounding the event was reported. The outcome of the event was reported as resolving from the time of last observation. The current Covid-19 pandemic remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 78-year-old, female patient with no relevant medical history and with vaccine history of receiving first and second dose of mRNA-1273 vaccine with appropriate dosage interval of 28 days, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred approximately 5 months after the third dose of mRNA-1273 vaccine administration. Allegedly the event was described as, approximately 164 days after the third dose of mRNA-1273 vaccine administration, patient took Nirmatrelvir + Ritonavir (Paxlovid) for Covid-19 treatment with approximately 5 days duration. However, 4 days after completing the treatment, Covid-19 symptoms returned, and patient tested positive. No other information surrounding the event was reported. The outcome of the event was reported as resolving from the time of last observation. The current Covid-19 pandemic remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.