Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Covid-19) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A22A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose Number: 1 Batch/Lot No: EH9899 Location of injection: Arm Right) on 15-Dec-2020, Pfizer / BioNTech (Dose Number: 3 Batch/Lot No: 30145BA Location of injection: Arm Right) on 29-Sep-2021 and Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: EJ1686 Location of injection: Arm Right) on 06-Jan-2022. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech, Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Hypertension, Type 2 diabetes mellitus, Obesity (BMI 30) and Drug allergy (No drug was reported). Concomitant products included METFORMIN, HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN & HCTZ), TADALAFIL and AMLODIPINE for an unknown indication.    On 17-May-2022, 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 (Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 24-May-2022 to 28-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19) had resolved. Not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. On 16-Jun-2022, patient had Rebound COVID symptoms with positive antigen test, 10 days after finishing Paxlovid. Company Comment: This is a spontaneous case concerning  a  59-year-old, male patient with concurrent medical conditions of Hypertension, Type 2 diabetes mellitus, Obesity, who experienced the unexpected non-serious event of Covid-19. The event occurred on an unknown date day after the fourth dose of mRNA-1273 COVID 19 Vaccine, which was administered on May 17, 2022. Patient was treated with nirmatrelvir and ritonavir from 24-May-2022 to 28-May-2022 at an unspecified dose and frequency. Patient re-developed symptoms of Covid-19, 10 days after finishing course of nirmatrelvir and ritonavir (Paxlovid). The event was reported as resolved. The concurrent medical conditions of Hypertension, Type 2 diabetes mellitus, Obesity  remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  a  59-year-old, male patient with concurrent medical conditions of Hypertension, Type 2 diabetes mellitus, Obesity, who experienced the unexpected non-serious  event of Covid-19. The event occurred on an unknown date day after the fourth dose of mRNA-1273 COVID 19 Vaccine, which was administered on May 17, 2022. Patient was treated with nirmatrelvir and ritonavir from 24-May-2022 to 28-May-2022 at an unspecified dose and frequency. Patient re-developed symptoms of Covid-19, 10 days after finishing course of nirmatrelvir and ritonavir (Paxlovid). The event was reported as resolved. The concurrent medical conditions of Hypertension, Type 2 diabetes mellitus, Obesity  remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.