Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis, Wound
Clinical narrative: psoriasis flare up with stinging, itching, pain; open wound on legs/open wound on arms; This is a solilcited report from the marketing program facilitated collect received from a non-contactable consumer based on information received by Pfizer from via AbbVie (manufacturer control number: 21K-163-4075221-00). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on 26Apr2021 (batch/lot number ER8733 and expiry date Jul2021), at 48 years of age as dose 2, single for covid-19 immunisation, and adalimumab (HUMIRA, 40 mg/0.4 ml), subcutaneous from Mar2019 (also reported as Mar2021) (batch/lot number and expiry date were not reported) and ongoing, at 40 mg (citrate free, 1 in 2 weeks) for psoriasis. Medical history tobacco use from 1991 (19 pack of cigarettes a week which started in 1991), abstains from alcohol, hip was not functioning, blood pressure abnormal, cholesterol abnormal, ongoing psoriasis. The reporter informed that it was unknown if patient was enrolled in a COVID-19 vaccine trial. The patient previously took dose 1 of bnt162b2, intramuscular on 05Apr2021 (batch/lot number ER8733 and expiry date Jul2021), at 48 years of age for covid-19 immunisation. Concomitant medications included lisinopril taken for cholesterol abnormal, atorvastatin taken for blood pressure abnormal, vitamins NOS taken for an unspecified indication: all start and stop date were not reported. The reporter informed that the patient experienced events of disabled and non-serious psoriasis flare up, "Humira not working", "open wound on arms and open wound on legs with Humira 40mg/0.4ml (adalimumab)". The reporter informed that the patient experienced "disabled" on unknown date. The reporter informed that in May2021, the patient experienced psoriasis flare up, "Humira not working" and open wound on legs. In May 2021, patient experienced psoriasis flare up with stinging, itching, pain and open wound on arms. The patient was prescribed betamethasone as a treatment but it did not help. The patient stated that it all started after taking the covid 19 vaccine. The reporter informed that in Aug2021, the patient experienced open wound on arms; the Pfizer Biontech covid-19 vaccine was also considered suspect. The reporter informed that no emergency room visit, or hospitalization was mentioned. The reporter informed that the events were considered serious (medically significant and disability). The action taken in response to the events for adalimumab was unknown. The outcome of the events was not recovered. The reporter informed that the causality for stinging sensation and itching was reported as not related. The reporter informed that the causality for HUMIRA 40MG/0.4ML(ADALIMUMAB) for the events of disabled, psoriasis flare up, "Humira not working", open wound on arms and open wound on legs was not provided. The reporter informed that the event psoriasis flare-up, lack of drug effect, upper limb wound, lower limb wound causality as per reporter (drug/vaccine) was not reported. The reporter informed that the Abbvie's opinion was that there was no reasonable possibility that the events of disabled, psoriasis flare up, "Humira not working", open wound on arms and open wound on legs were related to Humira 40 mg/0.4 ml (adalimumab).; Sender's Comments: Based on the information in narrative the reported events of open wound and psoriasis were consider unrelated to suspected vaccine BNT612B2, more likely due to ongoing medical history of Psoriasis.  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.