Age: 76.0
Sex: M
Vaccine: PNC20
Symptoms: Blood test, Immune thrombocytopenia, Platelet count increased
Clinical narrative: ITP; This is a spontaneous report received from a Physician from medical information team.  A 76-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 16Apr2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 76 years for immunisation. Dose quantity reported as 0.5. Indication is preventative. An immunization to prevent getting stringent Pneumonia. It is recommended for everybody over 65. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: ZETIA; TIMOLOL; LOTREL [LOTEPREDNOL ETABONATE] taken for blood pressure abnormal; RAPAFLO; CRESTOR. The patient took a statin, Rosuvastatin. Okay, Crestor is the brand name.(Further not clarified if the consumer was taking generic Crestor or brand Rosuvastatin). Rapaflo, which is Silodosin (Further not clarified if the consumer was taking generic or brand). The following information was reported: IMMUNE THROMBOCYTOPENIA (hospitalization, medically significant), outcome "not recovered", described as "ITP". The patient was hospitalized for immune thrombocytopenia (start date: 03Jun2024). The event "itp" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: Unknown Results, notes: blood test for routine; Platelet count: Varying, notes: platelets are varying; 20000, notes: should be 140. Therapeutic measures were taken as a result of immune thrombocytopenia. Clinical courses:  Doctor calling as a patient, he received the Prevnar 20 shot and developed ITP, his hematologist said this is known with this shot, and is under reported. He is calling to get this reported. The patient ended up in the hospital on 03Jun. He is now under the care of hematologist. The patient has a feeling this is under diagnosed side effects, unless it is a bad batch. The patient saw primary care doctor who was doing blood test for routine and his platelets count was 20,000, should be 140, and repeated the test and send he to the hospital. The hematologist pulled out all the other causes because it was in the hepatic, you know idiopathy and they mostly said it is probably the Prevnar. Reason of hospitalization (ITP) is the diagnose thing yes, and they ruled out the other causes. They ruled out Multiple Myeloma, Lymphoma cancer, you know all the other stuff that you test for.(further clarification unknown). As for the lab work, the patient get platelets every week and that is amazed down, they are all done at laboratory. His platelets are varying. He still have thrombocytopenia, one steroid, he was being treated with the, that goes Prednisone (Intent: Treatment).   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: A possibly contributory role of PREVNAR 20 in triggering the onset of IMMUNE THROMBOCYTOPENIA might not be fully excluded, considering the plausible temporal relationship.  More epidemiologic and clinical data, together with immunological and biomolecular workups would be needed to determine the causal link The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.