Reporte zur Charge N1G102N

Symptomtext

slurred speech; incoherent; blood pressure went sky high; heart beat went sky high; Based on information received on 23-Mar-2021, the report previously considered as non-valid became valid: [reason for non-validity (adverse event not otherwise specified) and validity (event was reported)]. Initial information received on 22-Jan-2021 regarding an unsolicited non-valid serious case received from a other health care professional. This case involves a 60 years old male patient (121.9 cm and 81.633 kg) who experienced slurred speech (dysarthria), incoherent, blood pressure went sky high (blood pressure increased) and heart beat went sky high (heart rate increased), while he received vaccine TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI]. It was unknown if the patient had any medical history, concomitant disease or risk factor. Past vaccination included TYPHOID VACCINE (none but had typhoid vaccine twice in the past). Medical treatment, concomitant medication and family history were not provided. In September 2017, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot N1G102N and expiry date: 30-jun-2019) (injection) via an unknown route in the arm for prophylactic vaccination. In September 2017, the patient developed a serious slurred speech (dysarthria), incoherent, blood pressure went sky high (blood pressure increased) and heart beat went sky high (heart rate increased), (45-90 minutes) following the administration of TYPHOID VI POLYSACCHARIDE VACCINE. These events were assessed as medically significant. It was also reported that reported adverse event information: Unknown if patients physician provided consent to be contacted the adverse reaction occurred 45-90 minutes after the initial vaccine. Total out of pocket co-pay (with good insurance) was over 10000 to take ambulance ride literally next door. Doctor thinks it was a reaction to antigen not an allergic reaction just severed reaction with delay in onset no treatment in ER (emergency room) except observation. Supposedly the pharmacist reported this incident to Sanofi. We have our doubts that this was ever reported. The pharmacist kept saying that it was not his fault he did not want to be send. We assured him we would not consider suing but that it needed to be reported (required by law). Relevant laboratory test results included: Blood pressure measurement - In September 2017: [increased blood pressure (220 or 230)] Heart rate - In September 2017: [increased heart rate over 200] It was unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment. On an unknown date, the patient recovered from the all events (also reported that Patient recovered after approximately one hours in the ER). Follow-up information received on 23-Mar-2021 regarding an unsolicited valid serious case received from a other health care professional. New event was added. Lab data was added and accordingly narrative was updated.; Sender's Comments: Follow-up information was received on 23-Mar-2021 changes the previous assessment of the case: This case involves a 60 years old male patient who had dysarthria, incoherent, blood pressure increased and heart rate increased after vaccination with TYPHIM VI. The time to onset is compatible. Past vaccination included TYPHOID VACCINE. Lab data increased heart rate over 200 and increased blood pressure (220 or 230). The patient's medical history, medical condition at time of vaccination, concomitant medication and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of a vaccine cannot be assessed.