Sex: F
Vaccine: COVID19, UNK
Symptoms: Immunodeficiency, Lacrimation increased, Malaise, Nausea, Pain in extremity
Clinical narrative: Immunocompromised; Low platelets/down to 3000; Gum bleeding; Emotional disorder; Nose bleed; Queasy; Feeling unwell; Lacrimation; Bruising; Tiredness; Petechiae; Pain in arm; This is a non-interventional study report from the marketing program received from a non-contactable 82-year-old female consumer (patient) based on information received by Pfizer from (manufacturer control number: 21K-163-3901514-00) that:  Solicited report by a consumer of an 82 year old female with events of non-serious little blood from tooth, emotional issues, immune system is compromised, little blood from left nostril, gets queasy, tired alot, not well, bursts out in tears sometimes, platelets low down 3 thousands, bruising everywhere, petechiae everywhere and sore arm with imbruvica (ibrutinib). the patient had a relevant medical history of vitiligo.  In may2021, the patient experienced little blood from tooth, emotional issues, immune system is compromised, little blood from left nostril, gets queasy, tired alot, not well, bursts out in tears sometimes, platelets low down 3 thousands, bruising everywhere, petechiae everywhere and sore arm. covid-19 vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer, lot number unknown,  expiration date unknown. On unknown date, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer, lot number unknown,  expiration date unknown. Patient had a little blood from tooth and left nostril, got quesy, tired a lot. Coping but not well. Had emotional issues, bursted out in tears sometimes. Stated her immune system was compromised. Platelets were low down to 3000. Had brusing and petechiae everywhere. She had also experienced sore arm.  Relevant Laboratory & Other Diagnostic Tests: May 2021 Platelets count: Low, down to 3000  Causality for IMBRUVICA and COVID-19 VACCINE: the reporters causality for the event(s) of little blood from tooth, emotional issues, immune system is compromised, little blood from left nostril, gets queasy, tired alot, not well, bursts out in tears sometimes, platelets low down 3 thousands, bruising everywhere, petechiae everywhere and sore arm was not provided.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of immunodeficiency, platelet count decreased and other. The case will be reassessed once new information is available. 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