Received Jan 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | — | — |
Inappropriate schedule of vaccine administered (received dose 2 of mRNA 1273 12 months later); De Novo Immune Thrombocytopenia; This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (De Novo Immune Thrombocytopenia) 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) (seriousness criterion medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (received dose 2 of mRNA 1273 12 months later)). The patient was treated with Dexamethasone sodium succinate (Dexamethasone) in 2021 for Immune thrombocytopenia, at an unspecified dose and frequency. At the time of the report, IMMUNE THROMBOCYTOPENIA (De Novo Immune Thrombocytopenia) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (received dose 2 of mRNA 1273 12 months later)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: 222 10^9/L 3 days post vaccination. 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 2 from Fig 2 who had de novo immune thrombocytopenia. Concomitant medications were not reported. Patient had ITP after dose 1 (mRNA-1273) treated with dexamethasone. No ITP exacerbation after dose 2. Patient received dose 2 of mRNA-1273, 12 months later, with platelet count of 222 10^9/L 3 days post vaccination. 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 equal to18 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: 3072), and they were followed for a median of 11 months (range: 415). 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 (129 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-2023-710835 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2023-710835:Master case (patient 1 out of 03)
Test Name: platelet count; Result Unstructured Data: Test Result: 222 10*9/L;3 days post vaccination