Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Injection site pain, SARS-CoV-2 test
Clinical narrative: Covid positive on 21-JAN-2022; 21Jan2022: Covid positive; pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid positive on 21-JAN-2022) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE PAIN (pain at the injection site). On 21-Jan-2022, the patient experienced COVID-19 (Covid positive on 21-JAN-2022) (seriousness criterion hospitalization) and DRUG INEFFECTIVE (21Jan2022: Covid positive). At the time of the report, COVID-19 (Covid positive on 21-JAN-2022) and INJECTION SITE PAIN (pain at the injection site) had resolved and DRUG INEFFECTIVE (21Jan2022: Covid positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication was reported.     Patient received treatment of Monoclonal antibody infusion on 28-Jan-2022.  Company Comment: This is a spontaneous case concerning a female patient of an unknown age with no medical history reported, who experienced the unexpected serious (hospitalization) adverse event of special interest COVID-19, supported by a positive SARS-CoV-2 test, which occurred approximately 12 months and 1 week after receiving the first dose of mRNA-1273 vaccine and approximately 11 months and 1 week after receiving the second dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 26 days. Additionally, Drug ineffective was also reported. Patient was given a Monoclonal antibody infusion and reported that the event COVID-19 had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-611900, MOD-2022-611797 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a female patient of an unknown age with no medical history reported, who experienced the unexpected serious (hospitalization) adverse event of special interest COVID-19, supported by a positive SARS-CoV-2 test, which occurred approximately 12 months and 1 week after receiving the first dose of mRNA-1273 vaccine and approximately 11 months and 1 week after receiving the second dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 26 days. Additionally, Drug ineffective was also reported. Patient was given a Monoclonal antibody infusion and reported that the event COVID-19 had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.