Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: Lack of efficacy; tested positive for COVID/Breakthrough COVID infection; Exposed to COVID; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of efficacy), EXPOSURE TO SARS-COV-2 (Exposed to COVID) and COVID-19 (tested positive for COVID/Breakthrough COVID infection) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 030M20A) for COVID-19 vaccination.     Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) and ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Exposed to COVID). On 22-Oct-2021, the patient experienced DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (tested positive for COVID/Breakthrough COVID infection). At the time of the report, DRUG INEFFECTIVE (Lack of efficacy), EXPOSURE TO SARS-COV-2 (Exposed to COVID) and COVID-19 (tested positive for COVID/Breakthrough COVID infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Oct-2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment: This case concerns a 74-year-old male patient with recent Exposure to SARS-CoV-2, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). Additionally, drug ineffective was captured. The event occurred approximately 9 months and 15 days after the second dose of mRNA- 1273 vaccine. The disease was mild. Clinical manifestations included upper respiratory symptoms and cough. The rechallenge is not applicable due to the nature of the event. Patient´s age may be a confounder, since it is a risk factor for severe COVID-19. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report Patient was given Regeneron antibody infusion on 22-Oct-2021.  The patient had undergone through PCR test and nasopharyngeal swab was taken from the patient.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Follow up document received, new event was added.; Sender's Comments: This case concerns a 74-year-old male patient with recent Exposure to SARS-CoV-2, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). Additionally, drug ineffective was captured. The event occurred approximately 9 months and 15 days after the second dose of mRNA- 1273 vaccine. The disease was mild. Clinical manifestations included upper respiratory symptoms and cough. The rechallenge is not applicable due to the nature of the event. Patient´s age may be a confounder, since it is a risk factor for severe COVID-19. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report