Reporte zur Charge UH456AB

Symptomtext

had Pots syndrome; heart racing; after receiving the vaccine she had non-stop vomiting; dizziness; syncope; reporting at the time of vaccine administration she was 8 1/2 months pregnant.; Initial information received on 18-Jan-2022 regarding an unsolicited valid serious case received via a patient. This case involves a 19 years old female patient who experienced pots syndrome, heart racing, after receiving the vaccine she had non-stop vomiting, dizziness, syncope and reporting at the time of vaccine administration she was 8 1/2 months pregnant while receiving vaccine INFLUENZA VACCINE. Data regarding this pregnancy were received retrospectively, i.e. after pregnancy outcome was known. All the reported events occurred at 36 Weeks of pregnancy. The date of last menstrual period was not reported. The estimated due date was not reported. The actual date of delivery was 22-Mar-2012. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies. On 19-Oct-2011, the patient received a (0.25 to 2 mL) dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot UH456AB and expiry 0f 30-Jun-2012 via unknown route in the left deltoid for immunization. On 19-OCT-2011 the patient developed a serious had pots syndrome (postural orthostatic tachycardia syndrome), heart racing (palpitations), after receiving the vaccine she had non-stop vomiting (vomiting), dizziness, reporting at the time of vaccine administration she was 8 1/2 months pregnant (exposure during pregnancy) and syncope (latency same day) following the administration of INFLUENZA VACCINE. The patient was hospitalized for all the events and event Syncope was assessed as medically significant. In 2011 the patient developed a serious (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event. It was reported that baby was delivered and had a lot of medical issues like malrotation, Ladd's procedure at 2 weeks, heart condition (extra beats), she had other developmental issues in the labia, had another invasive procedure to fix valve by kidneys which had backflow of urine/reflux. Caller did report she had another child 3 years ago and he has no medical issues. Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable for all the events. It was not reported if the patient received a corrective treatment for any event. At time of reporting, the outcome was unknown for event exposure during pregnancy and Recovered / Resolved on an unknown date for all the other events. Additionally, at time of reporting, the patient delivered the baby on 22-Mar-2012.; Sender's Comments: Sanofi Company Comment dated: 25-Jan-2022: This case involves a 19 years old female patient who experienced pots syndrome, heart racing, after receiving the vaccine she had non-stop vomiting, dizziness, syncope and reporting at the time of vaccine administration she was 8 1/2 months pregnant while receiving vaccine INFLUENZA VACCINE. However, patient's medical condition at the time of vaccination and laboratory tests ruling out alternate etiologies were not reported. Further information regarding previous vaccination tolerance and laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.