Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Expired product administered, Overdose, SARS-CoV-2 test
Clinical narrative: tested postive for COVID-19 3 days post vaccine/had symptoms as vertigo, body aches; dose of the Moderna Covid-19 Vaccine was given past the beyond use date of 15-Jan-2022; Patient taken 0.5ml as a booster dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (tested postive for COVID-19 3 days post vaccine/had symptoms as vertigo, body aches), EXPIRED PRODUCT ADMINISTERED (dose of the Moderna Covid-19 Vaccine was given past the beyond use date of 15-Jan-2022) and OVERDOSE (Patient taken 0.5ml as a booster dose of vaccine) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022 at 11:54 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose of the Moderna Covid-19 Vaccine was given past the beyond use date of 15-Jan-2022) and OVERDOSE (Patient taken 0.5ml as a booster dose of vaccine). On 22-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (tested postive for COVID-19 3 days post vaccine/had symptoms as vertigo, body aches). At the time of the report, COVID-19 (tested postive for COVID-19 3 days post vaccine/had symptoms as vertigo, body aches), EXPIRED PRODUCT ADMINISTERED (dose of the Moderna Covid-19 Vaccine was given past the beyond use date of 15-Jan-2022) and OVERDOSE (Patient taken 0.5ml as a booster dose of vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. No treatment information was provided.  The vial was initially stored in the refrigerator on 16-Dec-2021. The vial did not undergo any temperature excursions.  On 26-Jan-2022, the staff brought it to the reporter's attention that it was still in the fridge and had expired.  The Moderna vaccine was pulled from freezer on 16-Dec-2021 and the beyond use date of the vaccine of 15-Jan-2022 was printed in red and taped to the top of the boxes of vials.  All other clinics were found to have same error of not noticing the beyond use date. The staff was re-educated.  Patient had vertigo and body aches as symptoms and the patient felt that those symptoms were from the COVID disease and not due to the vaccine.  On 31-Jan-2022, the reporter was informed that revaccination was not required for the patient. The patient was notified that revaccination was not required.  Company Comment: This spontaneous case of Expired product administered and Overdose concerns a 52-year-old female patient, with no medical history reported, who experienced the unexpected AESI of COVID-19. The event occurred approximately 3 days after receiving the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Significant follow up appended- Secondary reporter added, laboratory data added and new events of overdose and COVID-19 were added.; Sender's Comments: This spontaneous case of Expired product administered and Overdose concerns a 52-year-old female patient, with no medical history reported, who experienced the unexpected AESI of COVID-19. The event occurred approximately 3 days after receiving the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.