Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus, Asthma and Latex allergy. Concomitant products included METFORMIN, ATORVASTATIN, LORATADINE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), MONTELUKAST, ACETAMINOPHEN, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (WIXELA INHUB) and SEMAGLUTIDE (OZEMPIC) for an unknown indication.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 23-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): In May 2022, SARS-CoV-2 test: positive (Positive) tested positive for COVID on day 12 after initial COVID diagnosis. On 17-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.   In May 2022, the patient had COVID rebound and re-appearance of COVID symptoms.  The patient did not receive any treatments for COVID rebound.  Company comment This spontaneous case reported by a physician, concerns a 60-year-old female patient with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19 about 5 months after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Details of primary doses was not provided. SARS-CoV-2 test was positive on 17 May 2022, It was reported that the patient received Nirmatrelvir, Ritonavir (paxlovid) from 19 May to 23 May 2022 for 5 days, for covid 19 treatment. Covid 19 Test was positive again on an unknown date in May 2022 , 12 days after initial COVID diagnosis. In May 2022, the patient had COVID rebound and re-appearance of COVID symptoms. Concurrent medical conditions Type 2 diabetes mellitus, Asthma, Age of the subject and the ongoing Covid 19 pandemia are confounders. The patient did not receive any treatments for COVID rebound. The event was reported as resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.; Sender's Comments: This spontaneous case reported by a physician, concerns a 60-year-old female patient with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19 about 5 months after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Details of primary doses was not provided. SARS-CoV-2 test was positive on 17 May 2022, It was reported that the patient received Nirmatrelvir, Ritonavir (paxlovid) from 19 May to 23 May 2022 for 5 days, for covid 19 treatment. Covid 19 Test was positive again on an unknown date in May 2022 ,12 days after initial COVID diagnosis. In May 2022, the patient had COVID rebound and re-appearance of COVID symptoms. Concurrent medical conditions Type 2 diabetes mellitus, Asthma, Age of the subject and the ongoing Covid 19 pandemia are confounders. The patient did not receive any treatments for COVID rebound. The event was reported as resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.