Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: lack of drug effect; mild breakthrough covid case; Felt horrible; 1 degree fever; body was sore,body was achy; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (lack of drug effect), FEELING ABNORMAL (Felt horrible), PYREXIA (1 degree fever), MYALGIA (body was sore,body was achy) and COVID-19 (mild breakthrough covid case) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 402L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced FEELING ABNORMAL (Felt horrible), PYREXIA (1 degree fever) and MYALGIA (body was sore,body was achy). On 24-Sep-2021, the patient experienced DRUG INEFFECTIVE (lack of drug effect) and COVID-19 (mild breakthrough covid case). On 27-Feb-2021, FEELING ABNORMAL (Felt horrible), PYREXIA (1 degree fever) and MYALGIA (body was sore,body was achy) had resolved. At the time of the report, DRUG INEFFECTIVE (lack of drug effect) and COVID-19 (mild breakthrough covid case) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Body temperature: 1 degree fever (abnormal) 1 degree fever.         No concomitant medication details was reported. Treatment includes IV antibodies.  Company Comment: This spontaneous case concerns a 70-year-old, male patient with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19 and drug ineffective with other associated unexpected and expected, non-serious events. The unexpected and expected, non-serious events occurred 1 day after administration of the second dose of the Moderna mRNA-1273 vaccine. Treatment information was not provided. However, the events had resolved at the time of the report. The patient then experienced mild COVID-19 almost 7 months after administration of the second dose of the Moderna mRNA-1273 vaccine. The patient received intravenous antibodies but was not hospitalized. The outcome of the event COVID-19 was unknown at the time of the report. The patient's age remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 70-year-old, male patient with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19 and drug ineffective with other associated unexpected and expected, non-serious events. The unexpected and expected, non-serious events occurred 1 day after administration of the second dose of the Moderna mRNA-1273 vaccine. Treatment information was not provided. However, the events had resolved at the time of the report. The patient then experienced mild COVID-19 almost 7 months after administration of the second dose of the Moderna mRNA-1273 vaccine. The patient received intravenous antibodies but was not hospitalized. The outcome of the event COVID-19 was unknown at the time of the report. The patient's age remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.