Reporte zur Charge UT473AB

Symptomtext

an episode of idiopathic thrombocytopenic purpura (ITP); bleed out; getting blisters in the mouth; Initial information received on 26-Apr-2021 regarding an unsolicited valid serious case from a consumer. This case involves male patient (in his early 60s in 2011) who experienced an episode of idiopathic thrombocytopenic purpura (ITP) (immune thrombocytopenia), getting blisters in the mouth (oral mucosal blistering) and bleed out (haemorrhage), after receiving INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication(s) were given to the patient. In Nov-2011, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (lot UT473AB and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination. The patient reported that the he only had the lot number and no other identifiers of the vaccine and that the provider told the consumer that he had a Sanofi vaccine. In 2011, the patient developed a serious episode of idiopathic thrombocytopenic purpura (ITP) (immune thrombocytopenia) (one week latency), described as getting blisters in the mouth (oral mucosal blistering) (one week latency), had a platelet count of 1000 from 190000 the week prior and being a bleed out (haemorrhage) (one week latency). These events were assessed as medically significant. The patient was in inpatient hospitalization and reported that a week before the vaccine he had a physical and his platelet count then was 190000. The patient remained in the hospital for 4 weeks. The patient was treated with chemotherapy to get the immune system on track, while he was in the hospital. The patient recovered from all the reported events on an unknown date. It was reported that he was now looking into getting the COVID-19 (coronavirus disease) vaccine but was informed that the COVID-19 vaccine should not be given if someone experienced ITP after receiving a vaccine with the same ingredients as the Covid-19 vaccine; that the consumer did not get the high dose in 2011. Reported that he does not have good site and was needing to transfer the phone to the spouse to type in a website for him. There was no more information for this report due to the consumer not having the information.; Sender's Comments: This case involves male patient who had immune thrombocytopenia, oral mucosal blistering and haemorrhage, a week after vaccination with FLUZONE. The time to onset is compatible. Platelet count of the patient was 1000 from 190000 (the week prior before the vaccination). However, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of a vaccine cannot be assessed.