Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: Psoriatic arthritis aggravated; Exposure to COVID-19; Hangover; Anxiety; Migraine; Limb reconstructive surgery; Surgery; Numbness in hand; Vaccination site discoloration; Automobile accident; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4030961-00.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 31Jul2021 as dose 1, single (Batch/Lot number: unknown) at the age of 38 years, on 20Aug2021 as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Batch/Lot number: unknown) till Aug2021, second regimen since 22Sep2021 (Batch/Lot number: unknown) at unk (discontinued) and third regimen since 2022 (Batch/Lot number: unknown), all subcutaneous for psoriatic arthropathy. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: ROAD TRAFFIC ACCIDENT (hospitalization, medically significant) with onset 2002, outcome "unknown", described as "Automobile accident"; HYPOAESTHESIA (hospitalization, medically significant) with onset 2021, outcome "not recovered", described as "Numbness in hand"; VACCINATION SITE DISCOLOURATION (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Vaccination site discoloration"; LIMB RECONSTRUCTIVE SURGERY (hospitalization, medically significant) with onset Sep2021, outcome "recovering"; SURGERY (hospitalization, medically significant) with onset Sep2021, outcome "unknown"; MIGRAINE (hospitalization, medically significant) with onset 21Mar2022, outcome "not recovered"; PSORIATIC ARTHROPATHY (hospitalization, medically significant), outcome "unknown", described as "Psoriatic arthritis aggravated"; EXPOSURE TO SARS-COV-2 (hospitalization, medically significant), outcome "unknown", described as "Exposure to COVID-19"; HANGOVER (hospitalization, medically significant), outcome "unknown"; ANXIETY (hospitalization, medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of psoriatic arthropathy, exposure to sars-cov-2, limb reconstructive surgery, surgery, hangover, anxiety, migraine, hypoaesthesia, road traffic accident, vaccination site discolouration. Clinical course: The events of exposed to covid, reconstructive surgery to left leg and wide range of additional corrective surgery and non-serious vaccinated for covid with only side effect of white ring on upper left arm at injection site, humira hangover, anxiety, migraines, numbness left thumb, accident/hit by car and psoriatic arthritis flares came back really bad with HUMIRA (ADALIMUMAB). On unknown dates, the patient experienced exposed to covid, wide range of additional corrective surgery, humira hangover, anxiety, migraines and psoriatic arthritis flares came back really bad. In 2002, the patient experienced accident/hit by car. In 2021, the patient experienced vaccinated for covid with only side effect of white ring on upper left arm at injection site and numbness left thumb. In September 2021, the patient experienced reconstructive surgery to left leg. Pfizer biontech covid-19 vaccine (TOZINAMERAN) was also considered suspect. In 2002, the patient had accident where he run over by a car and in Sep2021, he had a reconstructive or reparative surgery to left leg and mentioned a wide range of additional corrective surgeries. Due to this, he stopped Humira. He was taking Oxycodone, Celebrex anti blood clotting Injection because of the leg reconstructive surgery. He had numbness to the left thumb without Humira. On 22Sep2021, he restarted his Humira. Since restarting his Humira, he had experienced several significant migraines, the most recent was on 21Mar2022. He stated that his side effects mimic known online as the Humira Hangover. He was vaccinated for covid with the only side effect being a white ring on his upper left arm at injection site. He was exposed to covid while in the long term hospital setting but did not ever test positive and did not had covid. When second time off Humira, his psoriatic arthritis flared came back really bad. He was also taking Tylenol, 3000 milligrams a day. He was not taking any concomitant drugs. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient was treated with tylenol, oxycodone and celebrex. No known allergies. (Company name) opinion is that there is no reasonable possibility that the events of exposed to covid, reconstructive surgery to left leg, wide range of additional corrective surgery, vaccinated for covid with only side effect of white ring on upper left arm at injection site, anxiety, numbness left thumb, accident/hit by car and psoriatic arthritis flares came back really bad are related to humira(adalimumab). (Company name) opinion is that there is a reasonable possibility that the events of humira hangover and migraines are related to HUMIRA (ADALIMUMAB).   The reporter's assessment of the causal relationship of "psoriatic arthritis aggravated", "exposure to covid-19", "limb reconstructive surgery", "surgery", "hangover", "anxiety", "migraine", "numbness in hand" and "automobile accident" with the suspect product(s) BNT162b2 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. The reporter considered "vaccination site discoloration" related to BNT162b2.  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 information in the case report, a possible causal relationship between the reported events and the suspect drug BNT162B2 cannot be completely 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.