Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Maternal exposure during pregnancy, No adverse event
Clinical narrative: No adverse event; Patient is Pregnant Not known how many weeks Pregnant The Pharmacist was reporting and the patient was not there. The Pharmacist did not have specific information on the patient's pregnancy; Patient received a Moderna bivalent booster dose on April 20, 2023 that had been punctured more than 12 hours ago. Lot number 011H22A; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient is Pregnant Not known how many weeks Pregnant The Pharmacist was reporting and the patient was not there. The Pharmacist did not have specific information on the patient's pregnancy), EXPIRED PRODUCT ADMINISTERED (Patient received a Moderna bivalent booster dose on April 20, 2023 that had been punctured more than 12 hours ago. Lot number 011H22A) and NO ADVERSE EVENT (No adverse event) in a 36-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Monovalent booster) on 22-Nov-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine. Concomitant products included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for an unknown indication.    On 20-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 20-Apr-2023, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient is Pregnant Not known how many weeks Pregnant The Pharmacist was reporting and the patient was not there. The Pharmacist did not have specific information on the patient's pregnancy) and EXPIRED PRODUCT ADMINISTERED (Patient received a Moderna bivalent booster dose on April 20, 2023 that had been punctured more than 12 hours ago. Lot number 011H22A). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 20-Apr-2023, MATERNAL EXPOSURE DURING PREGNANCY (Patient is Pregnant Not known how many weeks Pregnant The Pharmacist was reporting and the patient was not there. The Pharmacist did not have specific information on the patient's pregnancy) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a Moderna bivalent booster dose on April 20, 2023 that had been punctured more than 12 hours ago. Lot number 011H22A) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for MATERNAL EXPOSURE DURING PREGNANCY (Patient is Pregnant Not known how many weeks Pregnant The Pharmacist was reporting and the patient was not there. The Pharmacist did not have specific information on the patient's pregnancy) and EXPIRED PRODUCT ADMINISTERED (Patient received a Moderna bivalent booster dose on April 20, 2023 that had been punctured more than 12 hours ago. Lot number 011H22A).    It was reported that patient received a bivalent booster dose that had been punctured more than 12 hours ago.  No information was available on her primary vaccination series.  No treatment medication was reported.  Company Comment: This is a spontaneous case concerning a 36 year-old, female patient with no reported medical history, with Maternal exposure during pregnancy (exact gestation age or last menstrual period not provided) related to the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as the booster dose of COVID-19 vaccination schedule. The patient didn´t experience any adverse events. Additionally, Expired product administered was reported in the case since the vial had been punctured for more than 12 hours at the time of administration. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.