Sex: F
Vaccine: RAB
Symptoms: Exposure during pregnancy, Premature delivery, Premature labour, Uterine contractions abnormal, Uterine contractions during pregnancy
Clinical narrative: Exposure during pregnancy; Baby was born at 37 weeks of pregnancy and 2 days post 4th dose of rabies vaccine; Contractions began at week 36 of pregnancy; Case reference number US-BN-2021-002492, initially downloaded from Vaccine Adverse Event Reporting System (VAERS) on 06-Dec-2021, is a spontaneous case received from a consumer via health authority VAERS (1843554-1) and concerns a 34-year-old pregnant female patient.  The patient's medical history was not provided.  The patient's concomitant medications included prenatal vitamins.  On an unspecified date in 2021, the patient was vaccinated with the first two doses of RabAvert (inactivated rabies virus vaccine, batch number was not provided) at an unknown dose or route of administration, for unknown indication (explicitly coded as 'Exposure during pregnancy'). It was reported that the patient did not experience any adverse events after administration of the first two doses of RabAvert.  On unspecified day in Jun-2021, reported as one week post first injection, the patient was vaccinated with the third dose of RabAvert (inactivated rabies virus vaccine, batch number was not provided) at an unknown dose or route of administration, for unknown indication.  On unspecified day in Jun-2021 (also reported as 06-Jul-2021), unknown amount of time after receiving the third dose of RabAvert, reported as at 36 week of pregnancy, the patient experienced contractions. It was reported that the contractions subsided after staying home for one week.  On 28-Jun-2021, the patient was vaccinated with the fourth dose of RabAvert (inactivated rabies virus vaccine, batch number was not provided) in the left arm, at an unknown dose or route of administration, for unknown indication.  On 30-Jun-2021, also reported as two days after the fourth dose of RabAvert, the patient prematurely gave birth to a baby. Gestation period was 37 weeks. Delivery type, foetal outcome, weight and APGAR score were not provided.  The reporter assessed the events as non-serious. Causality assessment was not provided.  No further information was provided.; Reporter's Comments: A 34-year old female patient was vaccinated with the first two doses of RabAvert at an unknown dose or route of administration, for unknown indication, on an unknown date in 2021. On unspecified day, unknown amount of time after receiving the third dose of RabAvert, reported as at 36 week of pregnancy, the patient experienced contractions. Premature labor and abnormal uterine contractions are unlisted for RabAvert according to Datasheet. Exposure during pregnancy is listed per company convention. The patient's medical history was not provided. The patient's concomitant medications included prenatal vitamins. Due to implied temporal relationship, the causality for both reported events is assessed as related. Exposure during pregnancy is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: A 34-year old female patient was vaccinated with the first two doses of RabAvert at an unknown dose or route of administration, for unknown indication, on an unknown date in 2021. On unspecified day, unknown amount of time after receiving the third dose of RabAvert, reported as at 36 week of pregnancy, the patient experienced contractions. Premature labor and abnormal uterine contractions are unlisted for RabAvert according to Datasheet. Exposure during pregnancy is listed per company convention. The patient's medical history was not provided. The patient's concomitant medications included prenatal vitamins. Due to implied temporal relationship, the causality for both reported events is assessed as related. Exposure during pregnancy is not related to RabAvert, but to a human factor. The case is non-serious.