Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Expired product administered, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: I got COVID after booster; Interchange of vaccine products; expired dose given; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (I got COVID after booster), ANOSMIA (lost sense of smell and taste), AGEUSIA (lost sense of smell and taste), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vacciine administered) and EXPIRED PRODUCT ADMINISTERED (expired dose given) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Janssen COVID-19 vaccine. Past adverse reactions to the above products included No adverse event with Janssen COVID-19 vaccine. Concomitant products included SPIRONOLACTONE for an unknown indication.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vacciine administered) and EXPIRED PRODUCT ADMINISTERED (expired dose given). On 31-Oct-2021, the patient experienced COVID-19 (I got COVID after booster). On an unknown date, the patient experienced ANOSMIA (lost sense of smell and taste) and AGEUSIA (lost sense of smell and taste). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 25-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vacciine administered) and EXPIRED PRODUCT ADMINISTERED (expired dose given) had resolved. At the time of the report, COVID-19 (I got COVID after booster), ANOSMIA (lost sense of smell and taste) and AGEUSIA (lost sense of smell and taste) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Oct-2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had very mild symptoms other than that. Expiration date of vaccine was  24 OCT 2021.  This is a spontaneous case concerning a 54-year-old, female patient with medical history of receiving another brand of COVID-19 vaccine (COVID-19 vaccine Janssen) as previous dose who experienced the unexpected, non-serious, AESI event of COVID-19. Additionally the patient received a 1-day expired mRNA-1273 vaccine for her booster shot (Expiration date: 24 October 2021, mRNA-1273 Booster dose given: 25 October 2021). The event COVID-19 occurred 7 days after the booster dose of mRNA-1273 vaccine administration. The rechallenge not applicable as the events occurred after the third dose and no other dose is expected at this moment. The event of expired product administered remains confounder for reported event of COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 54-year-old, female patient with medical history of receiving another brand of COVID-19 vaccine (COVID-19 vaccine Janssen) as previous dose who experienced the unexpected, non-serious, AESI event of COVID-19. Additionally the patient received a 1-day expired mRNA-1273 vaccine for her booster shot (Expiration date: 24 October 2021, mRNA-1273 Booster dose given: 25 October 2021). The event COVID-19 occurred 7 days after the booster dose of mRNA-1273 vaccine administration. The rechallenge not applicable as the events occurred after the third dose and no other dose is expected at this moment. The event of expired product administered remains confounder for reported event of COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.