Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for covid; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid) and DRUG INEFFECTIVE (Lack of drug effect) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A, 007C21A and 067H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for covid) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.  Company comment: This case concerns a 41-year-old male patient with no medical history provided, who experienced non-serious unexpected events of SARS-COV-2 test positive and Drug ineffective. The events occurred approximately 9 months and one week after the first dose of the mRNA-1273 vaccine, approximately 8 months after the second dose and seven days after the third (booster) dose of the mRNA-1273 vaccine. The patient was only tested positive for COVID-19, however, no information regarding patient's accompanying symptoms has been provided at this time. The rechallenge was not applicable since the patient experienced the events following the booster dose of the vaccine. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for SARS-COV-2 test positive is not applicable, while the causality for the event of Vaccination failure is assessed as possibly related. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 41-year-old male patient with no medical history provided, who experienced non-serious unexpected events of SARS-COV-2 test positive and Drug ineffective. The events occurred approximately 9 months and one week after the first dose of the mRNA-1273 vaccine, approximately 8 months after the second dose and seven days after the third (booster) dose of the mRNA-1273 vaccine. The patient was only tested positive for COVID-19, however, no information regarding patient's accompanying symptoms has been provided at this time. The rechallenge was not applicable since the patient experienced the events following the booster dose of the vaccine. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for SARS-COV-2 test positive is not applicable, while the causality for the event of Vaccination failure is assessed as possibly related. The benefit-risk relationship of mRNA-1273 is not affected by this report.