Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sinusitis, Somnolence, Suspected COVID-19, Tooth fracture
Clinical narrative: Anxiety; COVID; Sick; Fractured a Molar; Explosive diarrhea; Fatigue extreme; Weight loss; sleeps all the time; falls; White blood cell count double but came down overtime; Nausea; Joint pain; Muscle pain; Ear infection; Sinus infection; COVID; Vomiting; This is a solicited report from a  Study from a contactable consumer (patient), based on information received by Pfizer from, manufacturer control number: 21K-163-4077159-00.   A contactable 53-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown) intramuscularly on an unspecified date in Dec2020 as DOSE 1, SINGLE for COVID-19 immunization (at the age of 53-year-old). Patient also received ibrutinib (IMBRUVICA, Tablet, Lot number: unknown) orally on 28Jun2021 at a dose of 420 mg one in one day and was ongoing for chronic lymphocytic leuk of B-cell type not achieve remis. There was no reported medical history and no known allergies. Concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. On an unspecified date, the patient experienced sickness and anxiety. In 2021, the patient experienced vomiting/could not keep anything down, white blood cell count double but came down over time, nausea, muscle pain, joint pain, explosive diarrhea, fatigue extreme, weight loss, sleeps all the time and falls, Suspected covid 19 , sinus infection and ear infection. On 10Sep2021, patient had fractured a molar. In 2021, the patient underwent relevant laboratory and other diagnostic tests which included WBC test: it was double on an unspecified date and came down over time was abnormal and weight: weight loss of 12 lbs and SARS-CoV-2 test. Outcome of the event tooth fracture, sickness, white blood cell count abnormal and COVID was recovering, for event explosive diarrhea, fatigue extreme and falls was not recovered, for event anxiety, weight loss, Sinus infection, Ear infection and sleeps all the time was unknown, for events muscle pain, nausea, vomiting and joint pain was recovered/resolved in 2021. Action taken with IMBRUVICA was dose not changed.   Causality for IMBRUVICA(IBRUTINIB): The reporter's causality for the event(s) of fractured a molar, sick, sleeps all the time, couldn't keep anything down/vomting, anxiety, nausea, explosive diarrhea, severe fatigue, weight lost 12 pounds, falls, covid, sinus infection and ear infection was not provided. the reporter's causality for the event(s) of white blood cell count double but came down overtime, muscle pain and joint pain with Imbruvica(Ibrutinib) was a reasonable possibility. Causality for bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE): The reporter's causality for the event with bnt162b2 was not reported.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (19Nov2021): This is a follow-up solicited report from a Study based on information received by Pfizer from  (manufacturer control number: 21K-163-4077159-00). A contactable 53-year-old female patient reported herself that: Updated patient details, added new events sleeps all the time, explosive diarrhea, severe fatigue, weight lost 12 pounds and falls. The event of could not keep anything down was amended to could not keep anything down/vomiting. Updated reporter opinion of causality and narrative description. Updated relevant laboratory and other diagnostic tests of weight loss. Updated the outcome of the event nausea from not recovered to recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information was expected.  Follow-up (28Dec2021): This is a solicited follow-up report based on the information received by Pfizer from (Mfr. Control No.:21K-163-4077159-00). A 53-year-old female consumer (patient) reported that: New events were added.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on possible dose- event relationship post-vaccination the causal role of BNT162B2 vaccine cannot be excluded for the reported events