Age: 42.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ankylosing spondylitis, Fatigue, Headache, Pain in extremity, Pruritus
Clinical narrative: Spondylitis ankylosing aggravated; Fatigue; Injection site itching; Headache; Pain in arm; Itchy; Large Welts; This is a solicited report based on the information received by Pfizer (MFR Control No. # 21K-163-4057970-00).   A 42-years-old contactable female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 intramuscular on 30Apr2021 (age at vaccination 42 years) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for ankylosing spondylitis. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 intramuscular on 01Apr2021 as dose 1, single for covid-19 immunisation. It was unknown if patient was enrolled in a covid-19 vaccine trial. On unknown date, the patient experienced ankylosing Spondylitis flare up. In 2021, the patient experienced fatigue, headache, Injection site itching, pain in arm, itchy and large welts. The reporter's causality for the event(s) of fatigue, headache and sore arm with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event of itch at injection site with Humira (Adalimumab) was a reasonable possibility. The patient causality as per reported events was not related for Pfizer BioNTech covid-19 vaccine. The reporter's causality for the events of itchy, large welts was unknown. The reporter's causality for the events of ankylosing spondylitis flare up with humira (adalimumab) was a reasonable possibility. The outcome of event was Injection site itching and ankylosing spondylitis was not recovered, and rest of all events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (03Dec2021) This is a follow-up solicited report Facilitated Collect based on the information received by Pfizer (MFR Control No. 21K-163-4181817-00). This contactable female consumer (patient) reported for herself that: new events ankylosing spondylitis flare up, itchy and large welts were added. Dose 1 onset date updated to 01Apr2021, inappropriate schedule of vaccine administered was removed from the event tab and narrative was updated.  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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As per available information, the causal association between the events ankylosing spondylitis, urticaria, pruritus, fatigue, vaccination site pruritis, headache and pain in extremity and the suspect drug BNT162B2 cannot be excluded. 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.