Report #2883047

Overview

Sex

Unknown

Age

Age unknown

State

NY

Recovered

Not recovered

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

Inappropriate schedule of vaccine administered (dose 2of mRNA 1273 5 months after dose 1); de novo immune thrombocytopenia (ITP); This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (de novo immune thrombocytopenia (ITP)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: No Medical History information was reported. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced IMMUNE THROMBOCYTOPENIA (de novo immune thrombocytopenia (ITP)) (seriousness criterion medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (dose 2of mRNA 1273 5 months after dose 1)). The patient was treated with Immunoglobulins nos (Immunoglobulin i.v) (intravenous use) in 2021 for Immune thrombocytopenia, at an unspecified dose and frequency and Dexamethasone in 2021 for Immune thrombocytopenia, at a dose of UNK (once). At the time of the report, IMMUNE THROMBOCYTOPENIA (de novo immune thrombocytopenia (ITP)) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (dose 2of mRNA 1273 5 months after dose 1)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was identified during a retrospective clean-up activity initiated under [withheld] in response to a Health Inspection Observation. This case referred to patient 1 from Fig 2 who had de novo immune thrombocytopenia. Concomitant medications were not reported. Patient had ITP after dose 1 (mRNA-1273), treated with IVIG and dexamethasone once, tolerated dose 2 and two boosters well. Patient received dose 2 of mRNA 1273 five months after dose 1, followed by two booster doses with mRNA-1273, remaining stably in complete response (CR) off-treatment 15 months since ITP diagnosis. This report describes patients with the initiation or exacerbation of ITP post-SARS CoV-2 vaccination, in particular providing short- and long-term outcomes of serial vaccinations in such individuals. This single-center retrospective study included patients more than or equal to 18 years old with pre-existing ITP5 or apparent de novo ITP following SARS CoV-2 vaccination at NYP-WCM from Jan-2021 to May-2022. Patients with ITP were included if they had at least one platelet count following SARS-CoV-2 vaccination (initial series or booster). Six patients (4 men and 2 women) developed de novo ITP post-SARS-CoV-2 vaccine: 4 following dose 1 (mRNA 1273=2). The median age at diagnosis was 35 years (range: 30–72), and they were followed for a median of 11 months (range: 4–15). Three patients had normal platelets within 4 months pre-vaccination; the other 3 denied preceding thrombocytopenia or mucocutaneous bleeding. Two had autoimmune conditions (lichen planus, hyperthyroidism). All patients presented with mucocutaneous bleeding at a median of 12 days postvaccination (range: 1–21), with a median platelet count of 4x10^9/L (1–29 10^9/L). Author concluded that De novo ITP, too, could seemingly occur after any dose of SARS-CoV-2 vaccine, 2/6 in our series following booster vaccination. Reassuringly, these six patients responded well to standard treatments for ITP and the majority are in CR off-treatment up to 15 months following exacerbation(s). Neither of the two patients who proceeded with subsequent vaccination developed recurring thrombocytopenia. This case was linked to US-MODERNATX, INC.-MOD-2023-791181, US-MODERNATX, INC.-MOD-2023-791180 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2023: Case was unlocked on 10-Nov-2025 as a part of Health Inspection to perform significant correction. Case was upgraded from invalid to valid, classification updated, Literature information added, suspect product details, event, treatment and narrative updated.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2023-791181:Patient 3 out of 03 US-MODERNATX, INC.-MOD-2023-791180:Patient 2 out of 03