Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Immunoglobulin therapy, Injection site rash, Noninfective gingivitis
Clinical narrative: petechial rash around injection site and mouth; found to have platelet count of 2,000.; patient had ITP; extreme headaches; fatigue; This is a spontaneous report from a contactable pharmacist.  A 55-year-old non-pregnant female patient of received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 21Jan2021 as first single dose for covid-19 immunization.  Medical history included hypertension, diabetes, arthritis from unknown dates. Concomitant medication within two weeks included albuterol (salbutamol), dulaglutide (TRULICITY), escitalopram oxalate (LEXAPRO), glimepiride (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), insulin glargine (BASAGLAR), lisinopril (MANUFACTURER UNKNOWN), lorazepam (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN).  The patient previously took ibuprofen (MOTRIN) and experienced allergies and drug intolerance.  The patient experienced serious events, that involved hospitalization and were life threatening illness (immediate risk of death from the event) as follows: The patient experienced extreme headaches on 21Jan2021 with outcome of recovering; fatigue on 21Jan2021 with outcome of recovering;  petechial rash around injection site and mouth on 25Jan2021 with outcome of recovering; patient had immune thrombocytopenia (ITP) on 21Jan2021 with outcome of recovering; found to have platelet count of 2,000 on 25Jan2021 with outcome of recovering.  The patient was hospitalized for extreme headaches, fatigue, petechial rash around injection site and mouth, patient had ITP and found to have platelet count of 2,000 for five days.  The events were also serious as they were considered life-threatening. The patient underwent lab tests and procedures which included platelet count 2,000  on 25Jan2021; platelet count 1,000 on 25Jan2021.  Details were as follows: following the vaccine , which had been 21Jan2021 and had extreme headaches and fatigue for the next two days. On 25Jan2021, the patient developed petechial rash around injection site and mouth. Patient was seen at emergency department and found to have platelet count of 2,000. Patient transferred to the reports facility on 25Jan2021 for hematology consult,  and was found to have platelets of 1,000. Extensive hematology workup was completed and it was determined patient had ITP.  Therapeutic measures were taken as a result of extreme headaches, fatigue, petechial rash around injection site and mouth (petechiae), patient had ITP and found to have platelet count of 2,000. Therapeutic measures included platelet transfusion, dexamethasone 40mg daily, 3 doses of IVIG. The patient was recovering from the events as aforementioned.  The patient has not been COVID tested post vaccination.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event due to temporal association. However patient underlying medical conditions cannot be ruled out as contributing to the reported events