Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Blood pressure measurement, Hypertension, Psoriatic arthropathy
Clinical narrative: Recurrent psoriatic arthritis; High Blood pressure; Arthritis in hands; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4158756-00.  A 56 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 56 years as dose 1, single and intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "Recurrent psoriatic arthritis"; HYPERTENSION (non-serious) with onset 2021, outcome "recovering", described as "High Blood pressure"; ARTHRITIS (non-serious) with onset 2021, outcome "recovering", described as "Arthritis in hands". The patient underwent the following laboratory tests and procedures: blood pressure measurement: high. The action taken for adalimumab was unknown.   Suspect drug(s) :  1. HUMIRA(Solution for injection in pre-filled pen)(ADALIMUMAB), 1146119,1158135 Daily dose: Citrate free, Route of administration: Subcutaneous, Indications for use: Psoriatic Arthritis, Therapy dates : Unknown Product-Reaction level: Seq. No: 1 Drug: Humira (Solution for injection in pre-filled pen) (Adalimumab) 1146119,1158135Daily Dose : 2)Citrate free, Route of Admin : 1)Subcutaneous 2)Subcutaneous, Causality: 1. Blood pressure high (Hypertension) Action taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): No reasonable possibility, Dechallenge: NA, 2. Hand arthritis (arthritis) Action taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): No reasonable possibility, Dechallenge: NA, 3. Recurrent psoriatic arthritis(Psoriatic arthropathy), Action taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Reasonable possibility, Dechallenge: NA. 2. 2. Pfizer Biontech Covid-19 Vaccine(Tozinameran)(Tozinameran),Unknown, Unknown, Unknown  Daily dose: (1 in 1 Once)Route of administration: Intramuscular, Indications for use: COVID-19 Vaccination, Therapy dates :01Mar2021 Seq. No: 2 Drug: PFIZER BIONTECH COVID-19, VACCINE(TOZINAMERAN)(TOZINAMERAN),UNKNOWN,UNKNOWN,UNKNOWN, Daily Dose: 1) (1 in 1 once) 2. (1 in 1 once) 3) Booster (1 in 1 once), Route of Admin:  1) Intra-muscular, 2) Intra-muscular, 3) Intra-muscular, Therapy Dates/Duration: 1) 01Mar2021 - 01Mar2021  2) 01Apr2021 - 01Apr2021  3) Oct2021 - Oct2021, Causality: 1. Blood pressure high (Hypertension), Action taken with drug: Not Applicable, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: NA, 2. Hand arthritis (arthritis) Action taken with drug: Not Applicable, Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: NA, 3. Recurrent psoriatic arthritis(Psoriatic arthropathy), Action taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Possible, Dechallenge: NA   Additional information: Relevant Laboratory & Other Diagnostic Tests: Unknown date BLOOD PRESSURE: High. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's assessment of the causal relationship of the (Recurrent psoriatic arthritis, High Blood pressure, Arthritis in hands) 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 possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (15Feb2022): This is a follow-up solicited report from a Non-interventional Study (FACILITATED COLLECT) based on information received by Pfizer. (MFR Control No: 21K-163-4158756-00). A contactable 56-year-old female consumer (patient) reported for herself that included Updated information of Event added.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Sender's Comments: Based on known drug safety profile, there is  reasonable possibility of causal association between the events PSORIATIC ARTHROPATHY, HYPERTENSION, ARTHRITIS, and the suspect drug BNT162B2