Age: 29.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Exposure during pregnancy, Ultrasound antenatal screen normal
Clinical narrative: This spontaneous prospective pregnancy report as received from a licensed practical nurse (LPN) via Poison and Drug Center (PDC) refers to a 29 year old female patient. The patient do not have any pertinent medical history and drug reactions/allergies. On 02-AUG-2017, the patient was vaccinated with M-M-R II lot # M045400; expiry date: 14-NOV-2018 (dose, route and frequency details unspecified) for prophylaxis in her second trimester (Contraindicated product administered; Exposure during pregnancy). Other suspect therapies included sterile diluent for prophylaxis (lot#, expiration date, strength, dose, and route were not reported). Concomitant therapies included hepatitis b vaccine (manufacturer unknown), folic acid and unspecified pre-natal vitamins. The patient became pregnant with a last menstrual period (LMP) of approximately 11-MAR-2017, estimated date of conception (EDC) was 25-MAR-2017 and estimated due date (EDD) of 16-DEC-2017. The LPN reported that the patient came for a medical visit and not as prenatal visit and the provider ordered the vaccination. The relevant medical history of the fetus was unknown. On 09-AUG-2017, the patient came back to office and an ultrasound scan was performed which showed "the patient and the baby are ok". The reporter further stated that the physician ordered M-M-R II to be administered to the patient in error (Vaccination error). It was also reported that, it was noticed during a chart review on 14-SEP-2017 that the patient was pregnant while receiving the vaccination. The LPN reported that vaccination with M-M-R II was contraindicated in pregnant women. However, hepatitis b vaccine (manufacturer unknown) could be administered during pregnancy. The LPN reported that usually during a medical visit, they would perform a pregnancy test however it was overlooked as the clinic was crowded on the day of vaccination. It was unknown, if any relevant laboratory work was performed. As of 14-SEP-2017, it was unknown if the fetus would receive or be exposed to another dose of M-M-R II in the future. The LPN was not able to provide a lot number and expiration date for the diluent. At the time of the report, the pregnancy outcome was pending and the outcome of the fetus was unknown. No product quality complaint was involved. The reporter considered, contraindicated product administered and exposure during pregnancy to be serious as important medical events. Follow-up information has been received with an earlier aware date than that of the initial information. Therefore, case # US-009507513-1709USA008301 is being deleted and all the information has been consolidated in to case # US-009507513-1709USA011530. Company Causality Assessment: Based on the clinically relevant information currently available for this individual case, the reported event are considered unlikely related to  M-M-R II vaccine and the Sterile diluent. The evidence is not sufficient to suggest a relationship between the M-M-R II vaccine and the Sterile diluent and the reported serious adverse events. Errors in the schedule of administration or indication of use of the vaccine are not causally related to it. The non serious event of  Vaccine error was also reported. Company Comment- No changes to the M-M-R II vaccine and the Sterile diluent safety information are warranted at this time. Merck and Co., Inc., continues to monitor the safety profile of the M-M-R II vaccine and the Sterile diluent.