Reporte zur Charge U745OAA

Symptomtext

pregnancy test was done and it was positive, with no reported AE; Initial information was received on 15-May-2023 regarding an unsolicited valid non-serious case received from a physician. This case involves a 16 years old female pregnant patient who was exposed to vaccine meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] in context of pregnancy test was done and it was positive, with no reported ae. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known occurred at unknown gestation period, the gestation period at onset and gestation period at exposure data needs to be populated, if available. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had previous pregnancy/ies Unknown. Concomitant medications included influenza vaccine (fluzone) for Prophylactic vaccination (Immunisation); and meningococcal vaccine b for Prophylactic vaccination (Immunisation). On 19-Dec-2022, the patient received a dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection at dose of 0.5 ml total once (1X) (lot number: U745OAA, expiration date: 10-Oct-2024, dose, strength, route: Unknown) in the right deltoid for Immunization (immunization). On an unknown date the patient developed a non-serious event of pregnancy test was done and it was positive, with no reported ae (maternal exposure timing unspecified) (unknown latency) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine. Relevant laboratory test results included: Oestrogen receptor assay - On an unknown date: [does not have the results] Pregnancy test - On an unknown date: Negative; on an unknown date: Positive Action taken: not applicable. At time of reporting, the outcome was Unknown for the event pregnancy test was done and it was positive, with no reported ae. Additionally, at time of reporting, the outcome of the pregnancy is unknown.