Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Symptoms were gone on 5/25. Tested negative with an at home test on 5/26. Symptoms returned on 5/27 -diarrhea, sneezing, congestions. The symptoms are milder this time, no cough; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Symptoms were gone on 5/25. Tested negative with an at home test on 5/26. Symptoms returned on 5/27 -diarrhea, sneezing, congestions. The symptoms are milder this time, no cough) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Asthma and Drug allergy.   On 11-Apr-2022 at 12:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. In May 2022, the patient experienced COVID-19 (Symptoms were gone on 5/25. Tested negative with an at home test on 5/26. Symptoms returned on 5/27 -diarrhea, sneezing, congestions. The symptoms are milder this time, no cough). At the time of the report, COVID-19 (Symptoms were gone on 5/25. Tested negative with an at home test on 5/26. Symptoms returned on 5/27 -diarrhea, sneezing, congestions. The symptoms are milder this time, no cough) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2022, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medication information was provided. It was reported as on 27-May-2022 the symptoms returned as diarrhea, sneezing and congestions. The symptoms were milder and no cough. It was also reported that no need to use inhaler. Patient was not taking any medications/products within 2 weeks of starting COVID-19 treatment Patient did not received any treatment. Company comment: This spontaneous case concerns a 64-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19, approximately a month after the fourth dose of mRNA-1273 vaccine. No details of previous doses were provided. As per source document, symptoms were gone while she was under Paxlovid treatment and had a negative home test, but a day after she experienced milder symptoms of diarrhea, sneezing and congestion. Concomitant PAXLOVID remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 64-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19, approximately a month after the fourth dose of mRNA-1273 vaccine. No details of previous doses were provided. As per source document, symptoms were gone while she was under Paxlovid treatment and had a negative home test, but a day after she experienced milder symptoms of diarrhea, sneezing and congestion. Concomitant PAXLOVID remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.