Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Blood pressure measurement, Hypertension, Pain in extremity, Peripheral swelling
Clinical narrative: Recurrent psoriatic arthritis; Swelling in hand; Sore arm/ pain in hands; High Blood pressure; Arthritis in hands;   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 (Abbvie).  A 56 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Oct2021 (Batch/Lot number: unknown) at the age of 56 years as dose 3, (booster) 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. Vaccination history included: Bnt162b2 (Dose 1), administration date: 01Mar2021, when the patient was 56 years old, for COVID-19 Immunization, reaction(s): "Blood pressure high", "Hand arthritis"; Bnt162b2 (Dose 2), administration date: 01Apr2021, when the patient was 56 years old, for COVID-19 Immunization, reaction(s): "Blood pressure high", "Hand arthritis". 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"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "not recovered", described as "Sore arm/ pain in hands"; PERIPHERAL SWELLING (non-serious) with onset Nov2021, outcome "not recovered", described as "Swelling in hand". The patient underwent the following laboratory tests and procedures: blood pressure measurement: high. The action taken for adalimumab was unknown. .  Clinical course:  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, 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. 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, 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  The reporter considered "sore arm/ pain in hands" related to bnt162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.   The reporter's causality for the event(s) of HIGH BLOOD PRESSURE and ARTHRITIS IN HANDS with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of SORE ARM/PAIN IN HANDS with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of SWELLING IN HAND was not provided.  The reporter's assessment of the causal relationship of the events blood pressure high, hand arthritis and hand swelling with the suspect product was not provided at the time of this report. The reporter's assessment of the causal relationship of the event pain in upper extremities with the suspect product was provided as possible at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend the previously reported information: updated causality for the event booster'.  Follow-up (15Feb2022): New information from a Non-interventional Study based on information received by Pfizer from AbbVie Inc. (MFR Control No: 21K-163-4158756-00). A contactable 56-year-old female consumer (patient) reported for herself that: Added new event "Recurrent psoriatic arthritis" and clinical information.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.   The impact of this report on the benefit/risk profile of the Pfizer product 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.