Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 symptoms and positive test on 18-May-2022/ on 30-May-2022 again had symptoms and tested positive; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19 symptoms and positive test on 18-May-2022/ on 30-May-2022 again had symptoms and tested positive) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2022, the patient experienced COVID-19 (COVID-19 symptoms and positive test on 18-May-2022/ on 30-May-2022 again had symptoms and tested positive). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-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 symptoms and positive test on 18-May-2022/ on 30-May-2022 again had symptoms and tested positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 22-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 30-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.   No concomitant medications were reported.  It was unknown that patient taking any other medication within 2 week of starting covid-19 treatment.  On 18-may-2022, the patient had COVID-19 symptoms and tested positive. On the same day, Paxlovid was started. On 22-May-2022 day 5, the patient tested with negative antigen and symptoms resolved. On 30-May-2022, the patient again had symptoms and tested positive for COVID again. The patient did travel in between negative COVID test and second positive COVID test.  Company comment: This spontaneous case concerns a 41-year-old female patient with no medical history reported, who experienced the unexpected non-serious AESI of Covid-19, on an unspecified date/interval after receiving a dose of mRNA-1273 vaccine as 3rd dose. SARS-CoV-2 test was positive She was treated with Paxlovid (Nirmatrelvir + Ritonavir) for five days. Following this she tested negative. Eight days later she had rebound symptoms and tested positive again. The outcome of Covid-19 was reported as not resolved. Details of clinical course, investigation reports and further treatment details were not provided. Details of first two vaccines were not provided. The current pandemic situation of Covid-19 could be a confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 41-year-old female patient with no medical history reported, who experienced the unexpected non-serious AESI of Covid-19, on an unspecified date/interval after receiving a dose of mRNA-1273 vaccine as 3rd dose. SARS-CoV-2 test was positive She was treated with Paxlovid (Nirmatrelvir + Ritonavir) for five days. Following this she tested negative. Eight days later she had rebound symptoms and tested positive again. The outcome of Covid-19 was reported as not resolved. Details of clinical course, investigation reports and further treatment details were not provided. Details of first two vaccines were not provided. The current pandemic situation of Covid-19 could be a confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.