Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head, Full blood count, Head injury, Loss of consciousness, Platelet count
Clinical narrative: Passed out when platelets were low; hit head when platelets were low; Platelets decreased; This is a spontaneous report received from a contactable reporter(s) (Pharmacist), Program ID: (Unknown). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Lot number: PJ8757) at the age of 62 years intramuscular, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Date and Time of Start of Drug: 04Feb2021, Batch/lot number: EZ9265, Dosage text: unknown dose one time intramuscular injection right arm), administration date: 04Feb2021, when the patient was 61-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Date: 25Feb2021 Time: Not provided Anatomical Site of injection: right arm. Route of Administration: intramuscular; if other, please specify: Batch/Lot number: EN6201), administration date: 25Feb2021, when the patient was 61-year-old, for COVID-19 Immunization, reaction(s): "She had the Pfizer mRNA Covid vaccine in Feb2021. In Mar2021 her platelets were at 135,000". The following information was reported: PLATELET COUNT DECREASED (hospitalization, medically significant) with onset Mar2022, outcome "not recovered", described as "Platelets decreased"; LOSS OF CONSCIOUSNESS (hospitalization, medically significant) with onset 07Apr2022, outcome "recovered with sequelae" (07Dec2022), described as "Passed out when platelets were low"; HEAD INJURY (hospitalization) with onset 07Apr2022, outcome "recovered with sequelae" (07Apr2022), described as "hit head when platelets were low". The patient was hospitalized for platelet count decreased, loss of consciousness, head injury (start date: 07Apr2022, discharge date: 08Apr2022, hospitalization duration: 2 day(s)). The events "platelets decreased", "passed out when platelets were low" and "hit head when platelets were low" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram head: (07Apr2022) Unknown Results; Full blood count: (unspecified date) Unknown Results; Platelet count: (unspecified date) 187,000, notes: In 2020 before any vaccine at her physical her platelets were 187,000; (Mar2021) 135000; (Mar2022) 57; (2022) 54; (unspecified date) Unknown results. Therapeutic measures were taken as a result of platelet count decreased, loss of consciousness, head injury.  Clinical course: It was reported that, source of assessment was Primary Source Reporter, Method of assessment was Global Introspection and Result of Assessment was provided as Yes. No Other Conditions and Other Products. Patient who mentioned that she wanted to report an adverse event for Pfizer Covid 19 vaccine. Did not specify the adverse event. Clarified that she was the patient. In 2020 before any vaccine at her physical her platelets were 187,000. She had the Pfizer mRNA Covid vaccine in Feb2021 had two doses three weeks apart. In Mar2021 her platelets were at 135,000. In Dec2021 she had the first booster. Her platelets in Mar2022 went down to 57. Repeated the lab the next week and they were down to 54. Was referred to a hematologist and had been treated by them since then. Clarified the booster as Pfizer booster. Event details: Platelets decreased: Confirmed are still decreased. Treatment: Hematologist puts her on Prednisone when the platelets went down below 30 due to the vaccine and she would be on it to bring them up and it would bring them up. Cannot stay on Prednisone indefinitely. The Hematologist would take her off Prednisone for a few weeks and the platelets will continue to go down so this was not a temporary situation. Was hooked up to an 30 day event monitor to monitor to cardiac activity. No further details provided. Outcome: When probed for details she initially stated it would not stabilize without Prednisone so would say it worsened. Later stated, had recovered but her platelets are still down. Unable to clarify outcome further. Passed out when platelets were low: Happened twice once at house and after her head CT on 07Apr2022. Onset Date was 07Apr2022 Onset Time 10:00 for Passed out when platelets were low and Hit her head when platelets were low. No further details provided about her head CT. Had recovered but her platelets are still down. Treatment: None, was seeing the hematologist five days later when treatment was set. Later clarified no treatment. Hit her head when her platelets were low: Happened on 07Apr2022. Had recovered but her platelets are still down. Treatment: None, was seeing the hematologist five days later when treatment was set. Later clarified no treatment. Prior Vaccinations (within 4 weeks): If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was None. Specific Relevant Test: For Thromboembolic Events with Thrombocytopenia: Yes had a CBC with differential and that was how they discovered the decreased platelet. It was first noticed at her physical. Initially, they were not specifically looking for it. They also did titrated platelet level. Test: Antibody test to platelet factor IV was None. Adverse Events: Note: For Thromboembolic Events with Thrombocytopenia Include specific relevant test above; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "PLATELET COUNT DECREASED ","LOSS OF CONSCIOUSNESS " and "HEAD INJURY . The impact of this report on the benefit/risk profile of the Pfizer drug 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.