Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Developed COVID-19 symptoms after Moderna Dose 3; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Developed COVID-19 symptoms after Moderna Dose 3) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C219) for COVID-19 vaccination.     The patient's past medical history included Drug allergy. Concurrent medical conditions included Overweight, Hypertension and Depression. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) from 01-Jun-2020 to an unknown date for an unknown indication.    On 27-Oct-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 (Developed COVID-19 symptoms after Moderna Dose 3). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-May-2022 to 18-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. In May 2022, COVID-19 (Developed COVID-19 symptoms after Moderna Dose 3) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive.         The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  Patient stated that very sour, metallic taste while taking it. all symptoms went away and tested negative only to test positive and symptoms returned again  Company Comment: This spontaneous case concerns a 50-year-old, male patient with relevant medical history of Hypertension, Depression and Overweight, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 6 months after receiving the third dose of the mRNA-1273 vaccine. The patient developed COVID-19, however, the symptoms experienced were not reported. He took and completed a 5-day course of Paxlovid (nirmatrelvir, ritonavir) from 14May2022 to 18May2022. It was reported that the patient experienced a very sour, metallic taste while taking the drug. Of note, altered sense of taste is a common side effect of Paxlovid. On an unspecified date, all symptoms had resolved. However, the patient tested positive for SARS-CoV-2 after testing negative on an unspecified date. It was also reported that the patient again developed COVID-19 symptoms (unspecified) 4 days after treatment with Paxlovid. No additional details were provided at the time of the report. The medical history of Hypertension, Depression and Overweight, which are known risk factors for COVID-19, remain as confounders. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 50-year-old, male patient with relevant medical history of Hypertension, Depression and Overweight, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 6 months after receiving the third dose of the mRNA-1273 vaccine. The patient developed COVID-19, however, the symptoms experienced were not reported. He took and completed a 5-day course of Paxlovid (nirmatrelvir, ritonavir) from 14May2022 to 18May2022. It was reported that the patient experienced a very sour, metallic taste while taking the drug. Of note, altered sense of taste is a common side effect of Paxlovid. On an unspecified date, all symptoms had resolved. However, the patient tested positive for SARS-CoV-2 after testing negative on an unspecified date. It was also reported that the patient again developed COVID-19 symptoms (unspecified) 4 days after treatment with Paxlovid. No additional details were provided at the time of the report. The medical history of Hypertension, Depression and Overweight, which are known risk factors for COVID-19, remain as confounders. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.