Sex: F
Vaccine: COVID19
Symptoms: Ulcer, Vaccination site pain, Vaccination site swelling
Clinical narrative: Recurrent psoriatic arthritis; Scalp pain; COVID-19; COVID-19; Viral pneumonia; Ear infection; Ear pain; Vaccination site swelling; Vaccination site pain; Ulcer; Local swelling; Migraine; pain; Fever; Headache; Scar; 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-163-4272404-00.  A 61 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 15Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) till Jan2022 at 40 mg (40 mg / 0.4 ml, citrate free (1 in 2 wk)) for psoriatic arthropathy. Relevant medical history included: "Non Tobacco User" (unspecified if ongoing); "Abstains From Alcohol" (unspecified if ongoing); "Brain Tumor" (unspecified if ongoing); "Nerve Damage" (unspecified if ongoing); "Trigeminal Neuralgia" (unspecified if ongoing); "Latex Allergy Manifested By Itching Swelling And Hives" (unspecified if ongoing); "Latex Allergy Manifested By Itching Swelling And Hives" (unspecified if ongoing); "Latex Allergy Manifested By Itching Swelling And Hives" (unspecified if ongoing); "Latex Allergy Manifested By Itching Swelling And Hives" (unspecified if ongoing); "Pain" (unspecified if ongoing). Concomitant medication(s) included: CELEBREX taken for pain. Past drug history included: Erythromycin, reaction(s): "Erythromycin Allergy Manifested By Affecting Stomach", notes: Unknown Indication; Erythromycin, reaction(s): "Erythromycin Allergy Manifested By Affecting Stomach", notes: Unknown Indication; Otezla, notes: Unknown Indication. The following information was reported: COVID-19 (medically significant) with onset 10Jan2022, outcome "recovered" (Feb2022), DRUG INEFFECTIVE (medically significant) with onset 10Jan2022, outcome "unknown" and all described as "COVID-19"; VACCINATION SITE SWELLING (non-serious) with onset Mar2021, outcome "unknown", described as "Vaccination site swelling"; VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Vaccination site pain"; ULCER (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Ulcer"; SWELLING (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Local swelling"; MIGRAINE (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Migraine"; SCAR (non-serious) with onset 2021, outcome "not recovered", described as "Scar"; PNEUMONIA VIRAL (non-serious) with onset Jan2022, outcome "recovering", described as "Viral pneumonia"; EAR INFECTION (non-serious) with onset 31Dec2021, outcome "recovering", described as "Ear infection"; EAR PAIN (non-serious) with onset Dec2021, outcome "recovering", described as "Ear pain"; PSORIATIC ARTHROPATHY (non-serious) with onset 09Feb2022, outcome "not recovered", described as "Recurrent psoriatic arthritis"; PAIN OF SKIN (non-serious) with onset 09Feb2022, outcome "not recovered", described as "Scalp pain"; PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "pain"; PYREXIA (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Fever"; HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Headache". The patient underwent the following laboratory tests and procedures: chest x-ray: (Jan2022) viral pneumonia; sars-cov-2 test: (10Jan2022) positive - omicron; (Feb2022) negative; (10Jan2022) positive; (Feb2022) negative. The action taken for adalimumab was unknown.  The reporter stated that there was a reasonable possibility of causal relationship between the vaccine BNT162b2 and the following events: Vaccination site swelling, Vaccination site pain, Ulcer, Local swelling, Migraine, Scar, Pain, Fever, Headache.  The reporter did not reported any causal relationship between the vaccine BNT162b2 and the following events: Viral pneumonia, Ear infection, Ear pain, Recurrent psoriatic arthritis, Scalp pain, Covid-19 and drug ineffective.  The reporter stated that there was no reasonable possibility of causal relationship between the vaccine Humira and the following events: Ulcer, Local swelling, Migraine, Scar, COVID-19, Viral pneumonia, Scalp pain, Pain, Fever and Headache.  The reporter did not reported any causal relationship between the vaccine Humira and the following events: Vaccination site swelling, Vaccination site pain, Ear infection, Ear pain and Recurrent psoriatic arthritis.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information, a causal association between the suspect product BNT162B2 and the reported events Drug ineffective, Covid-19, Psoriatic arthropathy, Pneumonia viral cannot be totally 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.