Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Positive COVID test 5/28/22 (No Fever)/ Oropharyngeal pain/ Rhinorrhoea/ Malaise) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. D71F32A, 028L20A and 011J20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Cephalosporins and Penicillin. Past adverse reactions to the above products included Allergy NOS with Cephalosporins and Penicillin. Concurrent medical conditions included Lichen planus and Hypertension. Concomitant products included HYDROXYCHLOROQUINE from May 2020 to an unknown date, HCTZ from December 2021 to an unknown date, OMEPRAZOLE from January 2021 to an unknown date, FAMOTIDINE from March 2021 to an unknown date, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) from January 2020 to an unknown date, MULTIVITAMIN [VITAMINS NOS] from January 1984 to an unknown date, FISH OIL and POLICOSANOL from January 2020 to an unknown date for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2022 at 12:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Positive COVID test 5/28/22 (No Fever)/ Oropharyngeal pain/ Rhinorrhoea/ Malaise). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 23-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Positive COVID test 5/28/22 (No Fever)/ Oropharyngeal pain/ Rhinorrhoea/ Malaise) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         The patient received other medications/products within 2 weeks of starting COVID-19 treatment.  The symptom Free 21-May-2022 - 26-May-2022.  On 27-May-2022 the patient had malaise. On an unknown date, the patient had sore throat and runny nose. On 28-May-2022, the patient had positive COVID test (No Fever).  Company Comment: This is a spontaneous case concerning  a  61-year-old, female patient with concurrent medical condition of Hypertension, who experienced the unexpected non-serious  event of Covid-19. The event occurred 44 day after the third dose of mRNA-1273 COVID 19 Vaccine. Patient underwent treatment wih nirmatrelvir and ritonavir, at an unspecified dose on May 18, 2022, it is noted that patient tested positive for SARS-CoV-2 test on May 28, 2022. The event was reported as not resolved. The concurrent medical condition of Hypertension remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.Sender's Comments: Company Comment: This is a spontaneous case concerning  a  61-year-old, female patient with concurrent medical condition of Hypertension, who experienced the unexpected non-serious  event of Covid-19. The event occurred 44 day after the third dose of mRNA-1273 COVID 19 Vaccine. Patient underwent treatment wih nirmatrelvir and ritonavir, at an unspecified dose on May 18, 2022, it is noted that patient tested positive for SARS-CoV-2 test on May 28, 2022. The event was reported as not resolved. The concurrent medical condition of Hypertension remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.