Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: covid-19 prior to Paxlovid treatment; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid-19 prior to Paxlovid treatment) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Asthma and Drug allergy. Concomitant products included LOSARTAN, METOPROLOL, ROSUVASTATIN and HYDROCHLOROTHIAZIDE for an unknown indication.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid-19 prior to Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 24-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid-19 prior to Paxlovid treatment) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-2022, SARS-CoV-2 antibody test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive (first occurrence), negative (Negative) Negative, negative (Negative) Negative and negative (Negative) Negative.         Patient was taking other medications, products within two weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine. It was reported that after taking paxlovid and subsequently testing negative 3 times, COVID was returned on 02-Jun-2022 (nine days after completion of treatment). Patient took over the counter medicines as treatment. Device date was reported as 02-Jun-2022.  Company Comment: This spontaneous case concerns a 74-year-old female patient, with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 19 th to 24 th May 2022 for Covid-19, after the treatment she was tested negative for 3 times. However, covid was returned on 02-Jun-2022 (nine days after completing the treatment with paxlovid). The current pandemic situation of COVID-19 may remain as confounder to 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 74-year-old female patient, with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 19 th to 24 th May 2022 for Covid-19, after the treatment she was tested negative for 3 times. However, covid was returned on 02-Jun-2022 (nine days after completing the treatment with paxlovid). The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.