Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Immunisation reaction, Rash, Sarcoidosis
Clinical narrative: Sarcoidosis/ Rash on leg; Sarcoidosis/ Rash on leg; bad reaction to covid-19 vaccine; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-22K-163-4419006-00.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 22Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Date: 24Aug2021), administration date: 24Aug2021, when the patient was 57-year-old, for COVID-19 Immunization, reaction(s): "Cataract", "Diabetes", "Liver issues", "High blood pressure", "Calcification in lungs", "bad reaction to covid-19 vaccine". The following information was reported: RASH (non-serious) with onset 2021, outcome "not recovered", SARCOIDOSIS (medically significant) with onset 01Oct2021, outcome "not recovered" and all described as "Sarcoidosis/ Rash on leg"; IMMUNISATION REACTION (non-serious) with onset 2021, outcome "unknown", described as "bad reaction to covid-19 vaccine". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High. The action taken for adalimumab was dosage not changed.  The reporter's assessment of the causal relationship of "sarcoidosis/ rash on leg" with the suspect product(s) BNT162b2 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. The reporter considered "bad reaction to covid-19 vaccine" related to BNT162b2.  Causality for HUMIRA (adalimumab) : The reporter's causality for the event(s) of calcification in lungs, diabetes, high blood pressure, liver issues, Sarcoidosis/rash on leg onset 01Oct2021, sarcoidosis/rash on leg unknown onset, bad reaction to covid-19 vaccine and cataract in eye with adalimumab solution for injection was not provided and not assessable. AbbVie's opinion was that the causality for the event(s) of diabetes, high blood pressure, bad reaction to covid-19 Vaccine and cataract in eye with Adalimumab solution for injection was no reasonable possibility. Agency's alternative etiology for cataract in eye with Adalimumab solution for injection: more likely related to Increased risk due to advanced age of the patient with diabetes and hypertension. Agency's alternative etiology for high blood pressure with adalimumab solution for injection: more likely related to Increased risk due to underlying rheumatoid arthritis in this advanced age patient with diabetes. Agency's alternative etiology for diabetes with adalimumab solution for injection: more likely related to increased Risk due to underlying rheumatoid arthritis in this advanced age patient. Agency's alternative etiology for bad reaction to covid-19 vaccine with Adalimumab solution for injection: more Likely related to covid-19 vaccine.  The Assessment Results of Non-Health Care Professional, Global Introspection with Humaira for all events were not reported and not assessable and No Reasonable Possibility with the agency for all events.  Causality for Pfizer Biontech covid-19 vaccine: The reporter's causality for the event(s) of calcification in lungs, diabetes, high blood pressure, liver issues, Sarcoidosis/rash on leg onset 01Oct2021, sarcoidosis/rash on leg unknown onset and cataract in eye with Pfizer Biontech covid-19 vaccine was not provided (Institute withheld) opinion was that the causality for the event(s) of calcification in lungs, liver issues, sarcoidosis/rash on leg onset 01Oct2021 and sarcoidosis/rash on leg unknown onset with adalimumab solution for injection was not Assessable. Agency's opinion was that the causality for the event(s) of calcification in lungs, diabetes, high blood pressure, liver issues, sarcoidosis/rash on leg onset 01Oct2021, sarcoidosis/rash on leg unknown onset, bad reaction to covid-19 vaccine and cataract in eye with pfizer biontech covid-19 vaccine was not provided.   The Assessment Results of Non-Health Care Professional, Global Introspection, agency was possible with Pfizer Biontech Covid-19 vaccine for Vaccination adverse reaction and not reporter for other events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events Sarcoidosis, Rash, Immunisation reaction and the suspect drug BNT162B2.  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.