Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Arthralgia, Hypoaesthesia, Rash, Systemic lupus erythematosus
Clinical narrative: Lupus erythematosus; Numbness of upper extremities; Arthralgia aggravated; Rash trunk; This is a solicited report based on the information received  (MFR Control No. # 21K-163-3837845-00).   A non-contactable consumer reported that a 65-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 intramuscular on Feb2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 vaccination and adalimumab (HUMIRA), subcutaneous from 05Mar2021 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe chronic plaque psoriasis. Medical history included tobacco user from 1985 to at one pack a day and abstains from alcohol. Concomitant medications included levothyroxine taken for thyroid disorder, start and stop date were not reported; atenolol taken for blood pressure, start and stop date were not reported and paroxetine taken for antidepressant, start and stop date were not reported. The patient previously received first dose of bnt162b2 in Jan2021 for Covid-19 vaccination.  Solicited report by a consumer of an elderly female with events of Lupus and non-serious worsened arms, worsened joint pain in hip and faint rash in stomach with humira 40mg/0.4ml (Adalimumab). In April2021, the patient experienced faint rash in stomach. On 09Apr2021, the patient experienced worsened arms numbness and worsened joint pain in hip and knee. On 21Apr2021, the patient experienced Lupus. Covid-19 Vaccine was also considered suspect. On 09Apr2021, she experienced joint pain on hips and knees and arms went numb as well and this worsened in 23Apr2021 so she went to see physician last week for a follow up and informed physician that she did not want to take Humira anymore, and clarified that the physician did not made any changes with the Humira dose but instead she was asked to make that decision if she wants to continue Humira or not. Patient claimed that Humira was doing a fabulous job on scalp psoriasis. She had antinuclear antibody test in which was high and was diagnosed with Lupus. She also had rash on her stomach which was gone. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  On Jan2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On Feb2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. The patient underwent lab test and procedure which includes antinuclear antibody: Lupus on 21Apr2021. The outcome of the event was not recovered. Causality for the events was not reported.  No follow-up attempts are possible. No further information is expected.  The reporter's assessment of the causal relationship of the event 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.; Sender's Comments: A contributory role of BNT162B2 to events faint rash in stomach, worsened arms numbness and worsened joint pain in hip and knee and Lupus cannot be excluded based on temporal association and available information. 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 Committees and Investigators, as appropriate.