Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive Covid rapid home test on Wednesday May 11th with recurrence of symptoms - sore throat, fatigue, stuffy nose, cough; Lack of drug effect; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Positive Covid rapid home test on Wednesday May 11th with recurrence of symptoms - sore throat, fatigue, stuffy nose, cough) and DRUG INEFFECTIVE (Lack of drug effect) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, the patient experienced COVID-19 (Positive Covid rapid home test on Wednesday May 11th with recurrence of symptoms - sore throat, fatigue, stuffy nose, cough) and DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 30-Apr-2022 to 03-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Positive Covid rapid home test on Wednesday May 11th with recurrence of symptoms - sore throat, fatigue, stuffy nose, cough) was resolving and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2022, SARS-CoV-2 test: positive (Positive) Positive COVID-19 rapid home test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's race was reported. No Concomitant medication were reported. On 08 May 2022 the patient had the symptoms sore throat, fatigue, stuffy nose, and cough.   Company comment: This spontaneous case concerns a 48 year old female patient with no relevant medical history, who experienced the unexpected non serious AESI of COVID-19, about 6 months and 17 days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Drug ineffective was also reported. The patient received the primary doses of mRNA-1273 vaccine in an interval of 30 days. Patient reported of recurrence of sore throat, fatigue, stuffy nose and cough. She tested positive for COVID-19 rapid home test. She was treated with Paxlovid. The event was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 48 year old female patient with no relevant medical history, who experienced the unexpected non serious AESI of COVID-19, about 6 months and 17 days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Drug ineffective was also reported. The patient received the primary doses of mRNA-1273 vaccine in an interval of 30 days. Patient reported of recurrence of sore throat, fatigue, stuffy nose and cough. She tested positive for COVID-19 rapid home test. She was treated with Paxlovid. The event was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.