Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: admitted to the hospital through the ER with 2 DVTs and 3 PEs; admitted to the hospital through the ER with 2 DVTs and 3 PEs; This is a spontaneous report received from contactable reporter (Pharmacist).  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as DOSE 4 (BOOSTER), SINGLE (lot number: GH9703) at the age of 48 years old, intramuscular, administered in the left arm for COVID-19 immunization. The patient's relevant medical history included: "COVID" start date: Apr2020, stop date: Apr2020; "COVID", start date: Jul2020, stop date: Jul2020; "COVID", start date: Jul2022, stop date: Jul2022; "HA (Headache)" (unspecified if ongoing), notes: since 2nd episode of COVID; "brain fog" (unspecified if ongoing), notes: since 2nd episode of COVID; "severe with vomiting" (unspecified if ongoing), notes: last HA (headache); "Migraine" (unspecified if ongoing). Patient had no allergy. Concomitant medications included: AJOVY [FREMANEZUMAB] subcutaneous; CLONAZEPAM; ONDANSETRON; RIZATRIPTAN taken for migraine; and VENLAFAXINE. List of any other medications the patient received within 2 weeks of vaccination also included unspecified birth control pills. Vaccination history included: Covid-19 vaccine (first dose (manufacturer unknown) via an unspecified route of administration, on an unspecified date (batch/lot number: unknown) as DOSE 1, SINGLE) for COVID-19 Immunization; Covid-19 vaccine (second dose (manufacturer unknown) via an unspecified route of administration, on an unspecified date (batch/lot number: unknown) as DOSE 2, SINGLE) for COVID-19 Immunization; Covid-19 vaccine (third dose (manufacturer unknown) via an unspecified route of administration, on an unspecified date (batch/lot number: unknown) as DOSE 3 (BOOSTER), SINGLE) for COVID-19 Immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: DEEP VEIN THROMBOSIS (hospitalization, medically significant, life threatening), PULMONARY EMBOLISM (hospitalization, medically significant, life threatening) all with onset 27Jan2023, outcome "recovering" and all described as "admitted to the hospital through the ER with 2 DVTs and 3 Pes." The patient was hospitalized for deep vein thrombosis, pulmonary embolism (hospitalization duration: 1 day). The events "admitted to the hospital through the er with 2 dvts and 3 pes" required emergency room visit. Therapeutic measures were taken as a result of deep vein thrombosis, pulmonary embolism which included heparin (stopped APTT >400X2), transitioned to Eliquis. Since the vaccination, it was unknown if the patient has been tested for COVID-19.; Sender's Comments: Based on information in the case , the causal relationship between reported events cannot be excluded as there is no conclusive evidence to deny the causality. 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.