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Life Threatening? Yes
Write-up: IDIOPATHIC THROMBOCYTOPENIC PURPURA; This spontaneous report received from a company representative concerned a 60 year old female. Initial information was processed with additional information received from the patient''s physician, in response to telephone follow-up, on 26-APR-2021. The patient''s weight and weight were not reported. The patient''s concurrent conditions included hypertension, hyperlipidemia, and obesity. She was a non-smoker and had no history of acute illness. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included blood pressure medication, vitamins, and a statin (all unspecified). On 21-APR-2021, the patient experienced Idiopathic thrombocytopenic purpura and was in critical condition. The patient presented with petechiae on her legs. Her platelet count was low, less than 9000 and all other labs were normal. The patient was hospitalized on 21-APR-2021 and the duration of hospitalization was not reported. The patient did not have any clots and she was treated with decadron and Intravenous immunoglobulin. On 22-APR-2021, the patient''s and improved the next day with platelet of 30,000 and she was discharged same day. on an unspecified date anti-PF 4 antibodies were performed and were normal. Fibrin D-dimer tests were not performed. The reporter stated the discharge diagnosis was Idiopathic thrombocytopenic purpura which could have been related to recent vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from Idiopathic thrombocytopenic purpura. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Life Threatening).; Sender''s Comments: V0: This 60-year-old female was hospitalized for immune thrombocytopenia 25 days after receiving the Janssen Covid-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection. Concurrent conditions included hypertension, hyperlipidemia, and obesity. She was a non-smoker and had no history of acute illness. Concomitant medications included unspecified blood pressure medication, a statin, and vitamins. Twenty-five days post-vaccination, she developed petechiae on her legs and was found to have a platelet count of 9000; all other labs were normal including anti-platelet factor 4. She did not have clots. She was admitted to the hospital the same day and was treated with dexamethasone and iv immunoglobulin. The next day, her platelet count improved to 30,000 and was discharged. Based on the available information, the relationship with Janssen Covid-19 vaccine is considered indeterminate. Additional information has been requested.
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