Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Nasopharyngitis, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19 / Symptoms rebounded; Bad cold; slight sore throat; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Treatment of COVID-19 / Symptoms rebounded), NASOPHARYNGITIS (Bad cold), OROPHARYNGEAL PAIN (slight sore throat) and FATIGUE (Fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 026C21A, 006MZOA and 041620A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer, Blood pressure high, Overweight and Allergy. Concomitant products included AMLODIPINE BESILATE (NORVASC), ANASTROZOLE (ARIMIDEX) and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-May-2022 at 4:00 AM, the patient experienced COVID-19 (Treatment of COVID-19 / Symptoms rebounded), NASOPHARYNGITIS (Bad cold), OROPHARYNGEAL PAIN (slight sore throat) and FATIGUE (Fatigue). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-May-2022 to 19-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Treatment of COVID-19 / Symptoms rebounded), NASOPHARYNGITIS (Bad cold), OROPHARYNGEAL PAIN (slight sore throat) and FATIGUE (Fatigue) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative. Two home antigen tests (48 and 90 hours after last dose) both negative. and negative (Negative) negative. Two home antigen tests (48 and 90 hours after last dose) both negative..         Patient had an unknown drug allergy.Patient had 2 home antigen test (48 and 90 hours after last dose) and both were negative.  Company Comment: This is a spontaneous case  concerning  a  70-year-old, female patient with Concurrent medical conditions of breast cancer, Blood pressure high, Overweight, who experienced the unexpected AESI non-serious events of Covid-19. The event occurred 22 days after the fourth dose of mRNA-1273 COVID 19 Vaccine. Patient treated with nirmatrelvir, ritonavir tablets. On May 22, 2022, patient experienced fatigue, oropharyngeal pain and fatigue. Patient tested for SARS-CoV-2 test, results showed negative. Repeat home antigen test kits, both were negative. The event was reported as resolving.  The Concurrent medical conditions of breast cancer, Blood pressure high, Overweight remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: Company Comment: This is a spontaneous case concerning  a  70-year-old, female patient with Concurrent medical conditions of breast cancer, Blood pressure high, Overweight, who experienced the unexpected AESI non-serious events of Covid-19. The event occurred 22 days after the fourth dose of mRNA-1273 COVID 19 Vaccine. Patient treated with nirmatrelvir, ritonavir tablets. On May 22, 2022, patient experienced fatigue, oropharyngeal pain and fatigue. Patient tested for SARS-CoV-2 test, results showed negative. Repeat home antigen test kits, both were negative. The event was reported as resolving.  The Concurrent medical conditions of breast cancer, Blood pressure high, Overweight remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.