Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Obesity and Ex-smoker. Concomitant products included BUPROPION, GABAPENTIN, METFORMIN, MEMANTINE and PANTOPRAZOLE for an unknown indication.   On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 22-Apr-2022 to 26-Apr-2022 for COVID-19 treatment, at a dose of 300 mg/100 mg and NIRMATRELVIR, RITONAVIR (PAXLOVID) from 06-May-2022 to 10-May-2022 for COVID-19 treatment, at a dose of 300 mg/100 mg. At the time of the report, COVID-19 (COVID-19) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive. On 28-Apr-2022, SARS-CoV-2 test: negative (Negative) Negative. On 29-Apr-2022, SARS-CoV-2 test: negative (Negative) Negative. On 06-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.   None of the preexisting disease of the patient were worsened during SARS Co V-2 infection.  Patient did not experience any new or worsening symptoms or signs other than recurrence upper respiratory infection symptoms during covid-19 illness.  It was reported that patient's symptoms improved while taking Paxlovid. Patient was not hospitalized or did not require supplemental oxygen and patient's serostatus was not assessed.  Sequencing for SARS Co V-2 virus variant identification was not performed and no other diagnostic evaluation performed.  Company Comment:  This is a spontaneous case concerning a patient of an unknown age and gender with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, supported by a positive COVID-19 rapid antigen test, which occurred approximately 5 months after receiving the third dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine with no reported adverse event, given at an interval of 28 days which falls within the recommended vaccine dosing schedule, approximately 8 months prior to third mRNA-1273 vaccination. Patient was treated with a five-day-course of Paxlovid (300 mg/100 mg) for the initial COVID-19 infection and tested negative for COVID-19 antigen after 2 days. However, patient reported recurrence of symptoms and tested positive again for COVID-19 antigen, ten days after the treatment with Paxlovid. Patient was again treated with a five-day-course of Paxlovid. Patient reported that the initial COVID-19 infection was resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of an unknown age and gender with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, supported by a positive COVID-19 rapid antigen test, which occurred approximately 5 months after receiving the third dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine with no reported adverse event, given at an interval of 28 days which falls within the recommended vaccine dosing schedule, approximately 8 months prior to third mRNA-1273 vaccination. Patient was treated with a five-day-course of Paxlovid (300 mg/100 mg) for the initial COVID-19 infection and tested negative for COVID-19 antigen after 2 days. However, patient reported recurrence of symptoms and tested positive again for COVID-19 antigen, ten days after the treatment with Paxlovid. Patient was again treated with a five-day-course of Paxlovid. Patient reported that the initial COVID-19 infection was resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.