Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: soreness in arm with second covid vaccine; Vaccination site pain; 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): 22K-163-4256978-00.  A 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Mar2021 (Batch/Lot number: unknown) at the age of 66 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Lot number: 115591) and second regimen subcutaneous (Lot number: 115591) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st, Route of admin: Intramuscular), administration date: 20Feb2021, when the patient was 66 years old, for COVID-19 immunization, reaction(s): "had first covid vaccine was tender at the injection site". The following information was reported: VACCINATION SITE PAIN (medically significant) with onset 20Mar2021, outcome "recovered" (22Mar2021), described as "Vaccination site pain"; PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "soreness in arm with second covid vaccine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown  results. The action taken for adalimumab was dosage permanently withdrawn.  Clinical Course: Vaccination adverse reaction Start on 01Sep2021 and stop on 03Sep2021 outcome with Recovered/ Resolved. Respiratory tract congestion outcome with Recovering/resolving. Psoriasis flare-up outcome with Recovering/resolving. On unknown dates, the patient experienced eye surgery, covid test it came back positive/congestion and plaque psoriasis flare up. On  On 01Sep2021, the patient experienced booster covid vaccine caused adverse events. On 03Sep2021, the booster covid vaccine caused adverse events resolved. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. The patient had covid test it came back positive for covid and had congestion but its subsiding. She had 1st covid-19 vaccine was tender at the injection site and second vaccine caused sore arm and booster vaccine caused adverse events for a couple of days. she had eye surgery and had to be off humira for a couple of weeks so been a plaque psoriasis flare up but since starting back humira she was feeling better. It was unknown if patient was enrolled in a covid-19 vaccine trial.   Causality for Humira(Adalimumab): The reporter's causality for the event(s) of eye surgery, covid test it came back positive/congestion unknown onset, had first covid vaccine was tender at the injection site, soreness in arm with second covid vaccine, booster covid vaccine caused adverse events, covid test it came back positive/congestion unknown onset and plaque psoriasis flare up was not provided. Company's opinion is that there is no reasonable possibility that the events of eye surgery, covid test it came back positive/congestion unknown onset, had first covid vaccine was tender at the injection site, soreness in arm with second covid vaccine, booster covid vaccine caused adverse events, covid test it came back positive/congestion unknown onset and plaque psoriasis flare up are related to humira(adalimumab).   relevant laboratory & other diagnostic tests unknown date covid-19 test: positive. Change history on 16Feb2022, received updates to suspect drug information. on 25Feb2022, received updates to narrative description. on 01Mar2022, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. the events of "eye surgery", "booster covid vaccine caused adverse events" and "plaque psoriasis flare up" were added. the event of "soreness in arm with covid booster" was amended to "soreness in arm with second covid vaccine. Indications for Use: moderate to severe chronic plaque psoriasis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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.