Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Initial COVID-19 after vaccine/ tested positive again for COVID-19/ Rebound Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Initial COVID-19 after vaccine/ tested positive again for COVID-19/ Rebound Covid-19) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism and Drug allergy (Unspecified drug). Concomitant products included LEVOTHYROXINE from 01-Jan-2019 to an unknown date for an unknown indication.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (Initial COVID-19 after vaccine/ tested positive again for COVID-19/ Rebound Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 19-May-2022 for COVID-19 treatment, at a dose of UNK, for 5 days. At the time of the report, COVID-19 (Initial COVID-19 after vaccine/ tested positive again for COVID-19/ Rebound Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 01-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. On 19-May-2022, She took Paxlovid at first onset of symptoms for 5 days. Symptoms cleared up and she tested negative for Covid on 29-May-2022. On 31-May-2022 at 21:00, her cough and runny nose returned. On 01-Jun-2022, she tested positive again for Covid-19. Device date was given as 01-JUN-2022.  Company comment: This spontaneous case concerns a 49-year-old female patient with no relevant medical history, who experienced the unexpected non-serious AESI of Covid-19, approximately 6 months after receiving a dose of mRNA-1273 vaccine as 3rd dose. She was treated with Paxlovid (Nirmatrelvir + Ritonavir) for five days. Following this she tested negative. Ten days later she had rebound symptoms of Cough and nasal discharge and tested positive again. The outcome of Covid-19 was reported as unknown. 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 49-year-old female patient with no relevant medical history, who experienced the unexpected non-serious AESI of Covid-19, approximately 6 months after receiving a dose of mRNA-1273 vaccine as 3rd dose. She was treated with Paxlovid (Nirmatrelvir + Ritonavir) for five days. Following this she tested negative. Ten days later she had rebound symptoms of Cough and nasal discharge and tested positive again. The outcome of Covid-19 was reported as unknown. 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.