Sex: U
Vaccine: COVID19
Symptoms: Immune thrombocytopenia, Platelet count
Clinical narrative: ITP EXACERBATIONS AND DE NOVO ITP; This spontaneous report was received from literature. This report concerned multiple patients =18 years old. The study investigated longer-term outcomes of patients with ITP (Immune thrombocytopenic purpura) de novo or relapsed post-SARS-CoV-2 vaccination requiring treatment. The outcomes following SARS-CoV-2 booster vaccines were included and considered that some post-vaccination relapses may not be related to vaccination. An "ITP exacerbation" was defined as: a) =50% decline in platelet count from pre-vaccination baseline; b) >20% decline from pre-vaccination baseline to a platelet nadir <30x109/L; and/or c) receiving rescue therapy for ITP. The patient's height, and weight were not reported. The patient's concurrent conditions included: immune thrombocytopenic purpura. Methodology: This is a single-center retrospective study of patients =18 years old with pre-existing ITP or de novo ITP following SARS-CoV-2 vaccination. The study included consecutive ITP patients with at least one platelet count following initial SARS-CoV-2 vaccinations or boosters. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. No concomitant medications were reported.  Among 95 patients with pre-existing ITP, sixteen (17%) experienced at least one ITP exacerbation after one (or several) vaccination. Ten of 84 (12%) had an ITP exacerbation after dose 1. Among these, 7 experienced another exacerbation: 6 after dose 2 (with 3 receiving boosters, all without exacerbation) and 1 only after a booster.  Seventy-four patients received dose 2. Nine (12%) experienced ITP exacerbations, including 6 who also had exacerbations following dose 1. Eleven of 16 patients experiencing ITP exacerbation(s) following the vaccination received rescue treatment, of whom seven (64%) had difficult-to-control ITP on chronic treatment, including intravenous immune globulin (IVIG) every 2 to 8 weeks. All patients responded to rescue treatment; the frequency of intermittent IVIG infusions did not increase following SARS-CoV-2 vaccination. Six patients had presumed de novo ITP post-SARS-CoV-2 vaccine: 2 females, 4 males, median age 35 years (range 30-72), and median follow-up 11 months (range 3-15) post ITP diagnosis. All presented with mucocutaneous bleeding and a median platelet count of 4 x109/L (1-29x109/L) at a median of 12 days post-vaccination (range 1-21). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the ITP exacerbations and de novo ITP was not reported. This report was serious (Other Medically Important Condition). The study concluded that ITP exacerbations and de novo ITP can occur with subsequent vaccination doses (including boosters) of the SARS-CoV-2 vaccine despite tolerance to previous doses. Conversely, many tolerate subsequent doses well, implying that the mechanism is unlikely to involve the generation of anti-platelet antibodies. Furthermore, in certain patients, ITP "exacerbations" may not be due to the vaccination but part of the course of their ITP.; Sender's Comments: V0-Immune thrombocytopenia. The event has a compatible/suggestive temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.