Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Vaccination complication
Clinical narrative: tested positive for COVID; Lack of efficacy; had minimal side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had minimal side effects), COVID-19 (tested positive for COVID) and DRUG INEFFECTIVE (Lack of efficacy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (had minimal side effects). In November 2021, the patient experienced COVID-19 (tested positive for COVID) and DRUG INEFFECTIVE (Lack of efficacy). At the time of the report, VACCINATION COMPLICATION (had minimal side effects), COVID-19 (tested positive for COVID) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were provided. No treatment medications were provided.  The patient took no medication for COVID disease. The physician reported that if the patient did not take medications, the patient would be fine and others told the patient to wait for 90 days.  Company comment: This case concerns a 67-years-old female patient, with no medical history reported in this case, who experienced the non-serious AESI of COVID-19. Additionally, Drug ineffective was also reported. The events were reported to occur approximately 9 months after the administration of the second dose of a proper schedule of vaccination with the mRNA-1273 vaccine (29 days between doses).  Further information received states that the patient did not require treatment for the event.  The rechallenge is not applicable as the events occurred after the administration of the second dose of the mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 15-Dec-2021: Significant follow up: Patient information (demographics) updated.; Sender's Comments: This case concerns a 67-years-old female patient, with no medical history reported in this case, who experienced the non-serious AESI of COVID-19. Additionally, Drug ineffective was also reported. The events were reported to occur approximately 9 months after the administration of the second dose of a proper schedule of vaccination with the mRNA-1273 vaccine (29 days between doses).  Further information received states that the patient did not require treatment for the event.  The rechallenge is not applicable as the events occurred after the administration of the second dose of the mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.