Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis, SARS-CoV-2 test, Thinking abnormal, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4097346-00 (RA). A 36 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 15Sep2021 (Batch/Lot number: unknown) at the age of 36 years as dose 3 (booster), single, intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) as dose 1, single and intramuscular, administration date 30Apr2021 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1143015) till 2021 at unknown (citrate free) for psoriasis. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 30Sep2021, outcome "recovered" (14Nov2021) and all described as "COVID-19"; GENERAL SYMPTOM (non-serious) with onset 2021, outcome "unknown", described as "General symptom"; THINKING ABNORMAL (non-serious), outcome "not recovered", described as "Patient could not think right"; HIDRADENITIS (non-serious), outcome "unknown", described as "Hidradenitis suppurativa on head"; BRONCHOSPASM (non-serious), outcome "recovering", described as "Bronchial tubes tight"; PSORIASIS (non-serious) with onset 30Sep2021, outcome "recovered" (14Nov2021), described as "Plaque psoriasis flare-up while had COVID"; NASOPHARYNGITIS (non-serious) with onset 2021, outcome "unknown", described as "Had mild symptoms similar to that of head cold". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Oct2021) positive. The action taken for adalimumab was dosage permanently withdrawn on 2021. Solicited report from "PRIVATE" by a consumer of a 36-year-old female with events of non-serious had mild symptoms similar to that of head cold, patient could not think right, hidradenitis suppurativa on head, plaque psoriasis flare up while had COVID and bronchial tubes tight with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced patient could not think right, hidradenitis suppurativa on head and bronchial tubes tight. In 2021, the patient experienced had mild symptoms similar to that of head cold. On 30Sep2021, the patient experienced plaque psoriasis flare up while had COVID. In Oct2021, the patient experienced plaque psoriasis flare up while had COVID. On 14Nov2021, the plaque psoriasis flare up while had COVID resolved. On an unknown date, plaque psoriasis flare up while had COVID resolved. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. 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 had mild symptoms similar to that of head cold, patient could not think right, hidradenitis suppurativa on head, bronchial tubes tight and plaque psoriasis flare up while had COVID onset in Oct2021 was not provided. The reporter's causality for the event(s) of plaque psoriasis flare up while had COVID onset 30Sep2021 with Humira (Adalimumab) was no reasonable possibility. On 15Nov2021, received updates to event information, reporter opinion of causality, concomitant drug information and narrative description. The events of "Elbow cracked and started bleeding", "patient could not think right", " hidradenitis suppurativa on head", "COVID" and "Bronchial tubes tight" were added. On 17Dec2021, received updates to event information, reporter opinion of causality, suspect drug information, concomitant drug information, laboratory/diagnostic procedures and narrative description. The event of "Tested positive for COVID" was removed. On 21Feb2022, received updates to event information, reporter opinion of causality, concomitant drug information, laboratory/diagnostic procedures and narrative description. The event of "Elbow cracked and started bleeding" was removed. On 16Mar2022, received updates to event information, reporter opinion of causality, suspect drug information, concomitant drug information, narrative description and medical history. Causality as per reporter (BNT162B2) for the events General symptom, Thought disorder (Thinking abnormal), Hidradenitis suppurativa (Hidradenitis) COVID-19, Bronchial spasm (Bronchospasm) and Psoriasis flare-up was Not related. Causality as per reporter (Humira) for the events General symptom, Thought disorder (Thinking abnormal), Hidradenitis suppurativa (Hidradenitis), Bronchial spasm (Bronchospasm) and Psoriasis flare-up was Not related while for Covid-19 it was No reasonable possibility. The lot number for bnt162b2 was not provided and will be requested during follow up.