Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Maternal exposure during pregnancy
Clinical narrative: concerned and was pregnant; There was a paperwork error when she gave the patient 0.25 mL and the paperwork was incorrect; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (concerned and was pregnant) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (There was a paperwork error when she gave the patient 0.25 mL and the paperwork was incorrect) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. Last menstrual period and estimated date of delivery were not provided. On 28-Apr-2022, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (concerned and was pregnant) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (There was a paperwork error when she gave the patient 0.25 mL and the paperwork was incorrect). On 28-Apr-2022, MATERNAL EXPOSURE DURING PREGNANCY (concerned and was pregnant) had resolved. At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (There was a paperwork error when she gave the patient 0.25 mL and the paperwork was incorrect) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication and treatment information were not reported by the reporter.  The pharmacist gave the patient 0.25 mL and the paperwork was incorrect and said 0.5mL.  HCP said the concern was that the patient might have got a full dose instead of the half dose.  Company comment-This spontaneous case concerns a 30-year-old, female patient with no medical history reported, who was with noted an unexpected non-serious event of Maternal exposure during pregnancy in association with third dose of mRNA-1273 vaccine. Additionally, an event of Circumstance or information capable of leading to medication error was also reported. It was reported that there was a paperwork error wherein the patient received 0.25 mL and the paperwork incorrectly mentioned 0.5 mL; however, the concern here is that the patient may have got a full dose instead of the half dose. Outcome of the event was not known at the time of report. No further details regarding primary dosage schedule and period of gestation available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2022: Follow-up received on 28-APR-2022 contains no new information.; Sender's Comments: This spontaneous case concerns a 30-year-old, female patient with no medical history reported, who was with noted an unexpected non-serious event of Maternal exposure during pregnancy in association with third dose of mRNA-1273 vaccine. Additionally, an event of Circumstance or information capable of leading to medication error was also reported. It was reported that there was a paperwork error wherein the patient received 0.25 mL and the paperwork incorrectly mentioned 0.5 mL; however, the concern here is that the patient may have got a full dose instead of the half dose. Outcome of the event was not known at the time of report. No further details regarding primary dosage schedule and period of gestation available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.