Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Maternal exposure during pregnancy, Product storage error
Clinical narrative: Received dose that expired on 9Jul2022; The vial was expired on 9-Jul-2022 and stored in refrigerator on 11Jul2022; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose that expired on 9Jul2022), PRODUCT STORAGE ERROR (The vial was expired on 9-Jul-2022 and stored in refrigerator on 11Jul2022) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 22-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 049L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose that expired on 9Jul2022), PRODUCT STORAGE ERROR (The vial was expired on 9-Jul-2022 and stored in refrigerator on 11Jul2022) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 11-Jul-2022, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received dose that expired on 9Jul2022) and PRODUCT STORAGE ERROR (The vial was expired on 9-Jul-2022 and stored in refrigerator on 11Jul2022) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  The vial did not undergo any temperature excursions.  Company Comment: This is a spontaneous case of expired product administered and product storage error for this 22-year-old, female patient with no medical history reported. It was reported that the expiration date of the administered vaccine was on 09Jul2022 and it was initially stored in the refrigerator in the morning of 11Jul2022. The patient received the first dose of the mRNA-1273 vaccine on 11Jul2022 which was 2 days after the expiration date. Additionally, information regarding pregnancy/breastfeeding was reported; however, it is not clear whether the patient was pregnant or breastfeeding at the time of the vaccination. No symptoms were reported. No further details were provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.- MOD-2022-607244 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2022: Live follow-up received on 13-JUl-2022 contains non-significant information. Reporter's name and email address updated.; Sender's Comments: This is a spontaneous case of expired product administered and product storage error for this 22-year-old, female patient with no medical history reported. It was reported that the expiration date of the administered vaccine was on 09Jul2022 and it was initially stored in the refrigerator in the morning of 11Jul2022. The patient received the first dose of the mRNA-1273 vaccine on 11Jul2022 which was 2 days after the expiration date. Additionally, information regarding pregnancy/breastfeeding was reported; however, it is not clear whether the patient was pregnant or breastfeeding at the time of the vaccination. No symptoms were reported. No further details were provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.- MOD-2022-607244:Master case