Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F211A, 037B21A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included Post-traumatic stress disorder. Concurrent medical conditions included GERD, Eosinophilic esophagitis, Depression, Herpes simplex (In the right eye), Seasonal allergy, Lactose intolerance, Allergy to grains (Minor wheat) and Dairy intolerance. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), OMEPRAZOLE, VALACYCLOVIR [VALACICLOVIR], BUPROPION and LORATADINE for an unknown indication.   On 16-Mar-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021 at 12:00 PM, 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). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-May-2022 to 29-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.            On 1-JUN-2022 22:15, the covid-19 symptoms including congestion, runny nose and cough restarted which had worsened but stabilized the next morning. Patient also had sore throat and body aches.  It was reported that patient didn't had fever in either case.  Device Date : 02-Jun-2022  Company Comment: This is a spontaneous case concerning a 35-year-old male patient with no reported relevant medical history, who experienced the unexpected non-serious AESI COVID-19 which occurred unknown number of days after the third dose of mRNA -1273 vaccine, administered 7 months 3 days after the   2nd dose. Dose 1 and 2 of the mRNA-1273 were administered with interval of 29 days. Approximately 6 months after the third dose, patient was given Nirmatrelvir, Ritonavir (Paxlovid) for 5 days as treatment for COVID-19. No information was available regarding treatment outcome. Approximately 2 days after the last dose of Paxlovid, patient reported restart of Covid Symptoms- congestion, runny nose, and cough. Symptoms worsened but stabilized the following morning- congestion, runny nose, sore throat, and body aches. The date of the initial diagnosis of COVID-19, date of the initial COVID-19 test, and associated clinical manifestations of COVID-19 were not provided in this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 35-year-old male patient with no reported relevant medical history, who experienced the unexpected non-serious AESI COVID-19 which occurred unknown number of days after the third dose of mRNA -1273 vaccine, administered 7 months 3 days after the   2nd dose. Dose 1 and 2 of the mRNA-1273 were administered with interval of 29 days. Approximately 6 months after the third dose, patient was given Nirmatrelvir, Ritonavir (Paxlovid) for 5 days as treatment for COVID-19. No information was available regarding treatment outcome. Approximately 2 days after the last dose of Paxlovid, patient reported restart of Covid Symptoms- congestion, runny nose, and cough. Symptoms worsened but stabilized the following morning- congestion, runny nose, sore throat, and body aches. The date of the initial diagnosis of COVID-19, date of the initial COVID-19 test, and associated clinical manifestations of COVID-19 were not provided in this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.