Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Had Covid with the symptoms sore throat, headache, fluish, and congestion) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second 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 (Had Covid with the symptoms sore throat, headache, fluish, and congestion). At the time of the report, COVID-19 (Had Covid with the symptoms sore throat, headache, fluish, and congestion) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. No concomitant medications details were reported. Reporter had 2 friends who had the 1st doses of the Moderna COVID-19 vaccine, without the booster, and had COVID with the following symptoms - sore throat, headache, "fluish" and congestion. No treatment information details were reported. Company comment: This case concerns a 50-year-old female patient with no medical history provided, who experienced non serious unexpected event of COVID-19 after she had received two doses of the mRNA-1273 vaccine. It was stated that the patient's symptoms were sore throat, headache, flush, and congestion. The temporal relationship between the event occurrence and vaccine administration cannot be determined since dates of vaccination and the start date of the event was not provided. No additional details regarding the clinical course of the event were provided and the outcome of the event remained unknown at the time of this report. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-470217, MOD-2022-470205 (Patient Link). Sender's Comments: This case concerns a 50-year-old female patient with no medical history provided, who experienced non serious unexpected event of COVID-19 after she had received two doses of the mRNA-1273 vaccine. It was stated that the patient's symptoms were sore throat, headache, flush, and congestion. The temporal relationship between the event occurrence and vaccine administration cannot be determined since dates of vaccination and the start date of the event was not provided. No additional details regarding the clinical course of the event were provided and the outcome of the event remained unknown at the time of this report. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.