Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Expired product administered, Overdose, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; Booster Moderna dose administered two days after expiration date; Overdose; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Tested positive for COVID-19), DRUG INEFFECTIVE (Tested positive for COVID-19), EXPIRED PRODUCT ADMINISTERED (Booster Moderna dose administered two days after expiration date) and OVERDOSE (Overdose) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A092621) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (no change in condition occurred recently.).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021 at 3:45 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 24-Sep-2021 at 3:45 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster Moderna dose administered two days after expiration date) and OVERDOSE (Overdose). On 05-Jan-2022, the patient experienced COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19), DRUG INEFFECTIVE (Tested positive for COVID-19), EXPIRED PRODUCT ADMINISTERED (Booster Moderna dose administered two days after expiration date) and OVERDOSE (Overdose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  The vial was received on 30-Aug-2021 and refrigerated. Dose was administered after 25 days of receiving.  No treatment medication was reported by reporter.  Company Comment: This spontaneous case concerns a 52-year-old, male patient with no relevant medical history reported, who experienced the unexpected, non- serious, AESI of COVID-19. Additional events of Drug ineffective, Expired product administered and Overdose were also reported. The events occurred 3 months 12 days after the booster dose of mRNA-1273 vaccine.  SARS-CoV-2 test done on 5-Jan-22 was positive. Current COVID-19 pandemic is a confounder. Outcome of the events was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-505997, MOD-2022-508155 (Patient Link).; Sender's Comments: This spontaneous case concerns a 52-year-old, male patient with no relevant medical history reported, who experienced the unexpected, non- serious, AESI of COVID-19. Additional events of Drug ineffective, Expired product administered and Overdose were also reported. The events occurred 3 months 12 days after the booster dose of mRNA-1273 vaccine.  SARS-CoV-2 test done on 5-Jan-22 was positive. Current COVID-19 pandemic is a confounder. Outcome of the events was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.