Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Fatigue, Headache, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Tested positive again on home covid test; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Tested positive again on home covid test) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. J22A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Hypercholesterolemia, Obesity and Penicillin allergy.    On 31-Mar-2022 at 4:30 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive again on home covid test). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 22-May-2022 to 26-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive again on home covid test) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2022, SARS-CoV-2 test: negative (Negative) Tested negative 2 days after finishing Paxlovid.. On 01-Jun-2022, SARS-CoV-2 test: positive (Positive) Tested positive again on home covid test..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  On 31-May-2022 COVID symptoms returned.   Device Date was reported as 01-Jun-2022.  Patient did not took treatment medication after testing positive on 01-Jun-2022.  CC: This spontaneous case concerns a 65 year-old female patient, with no relevant medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19,  which occurred unknown days after the fourth dose of mRNA-1273 vaccine administration. The ongoing COVID-19 pandemic could be a confounder for the event. The outcome of the event was reported as not resolved. The date of the initial COVID-19 diagnosis was not provided. Patient received Paxlovid as treatment of COVID-19 for duration of 5 days and reported testing negative 2 days after finishing Paxlovid. However 3 days later COVID-19 symptoms returned and tested positive again 1 day later. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 65 year-old female patient, with no relevant medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19,  which occurred unknown days after the fourth dose of mRNA-1273 vaccine administration. The ongoing COVID-19 pandemic could be a confounder for the event. The outcome of the event was reported as not resolved. The date of the initial COVID-19 diagnosis was not provided. Patient received Paxlovid as treatment of COVID-19 for duration of 5 days and reported testing negative 2 days after finishing Paxlovid. However 3 days later COVID-19 symptoms returned and tested positive again 1 day later. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.