Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Drug hypersensitivity, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: Autoimmune disorder; Drug allergy; Injection site itching; Injection site reaction; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4455489-00.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 13Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 52 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous; upadacitinib (RINVOQ), (Batch/Lot number: unknown), oral for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown"; DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Drug allergy"; VACCINATION SITE PRURITUS (non-serious), outcome "not recovered", described as "Injection site itching"; VACCINATION SITE REACTION (non-serious), outcome "not recovered", described as "Injection site reaction". The action taken for adalimumab and upadacitinib was unknown.  Clinical information: Solicited report from the (Country name withheld) by a consumer of an adult female with events of non-serious 2 covid-19 injections threw into an autoimmune disorder, allergic reaction to humira, fourth shot gave a rash around injection site and fourth injection got huge patches on abdomen, itchy with rinvoq (upadacitinib) and humira (adalimumab). On unknown dates, the patient experienced 2 covid-19 injections threw into an autoimmune disorder, allergic reaction to humira, fourth shot gave a rash around injection site and fourth injection got huge patches on abdomen, itchy. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. The patient had two covid-19 injections, and said injections threw her into an autoimmune disorder. The physician prescribed humira. She was injecting into abdomen. She had an allergic reaction to humira. Her first three shots went fine; the fourth shot gave her a rash around injection site. After the fourth injection, she got huge patches on her abdomen, they were itchy, and each injection made it worse and worse. She then had two astrazeneca evusheld injections simultaneously without any side effects. She was prescribed rinvoq at the time of report. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter contact for lot number information, because the packaging was discarded. Drug: RINVOQ (UPADACITINIB), Causality: 1) Autoimmune disorder (Autoimmune disorder): Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A, 2) Drug allergy (Drug hypersensitivity): Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A, 3) Injection site rash (Injection site rash),Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A, 4) Injection site reaction (Injection site reaction), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A, 5) Drug allergy (Drug hypersensitivity, Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A. Drug: PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN (TOZINAMERAN): 1) Autoimmune disorder (Autoimmune disorder), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Possible, Dechallenge: N/A, 2) Drug allergy (Drug hypersensitivity): Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Possible, Dechallenge: N/A, 3) Injection site rash (Injection site rash): Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Possible, Dechallenge: N/A, 4) Injection site itching (Injection site pruritus), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Possible, Dechallenge: N/A, 5) Injection site reaction (Injection site reaction: Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Possible, Dechallenge: N/A.  Drug: HUMIRA (ADALIMUMAB): Causality: 1) Autoimmune disorder (Autoimmune disorder), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A, 2) Drug allergy (Drug hypersensitivity), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A, 3) Injection site rash (Injection site rash), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A, 4) Injection site itching (Injection site pruritus), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A, 5) Injection site reaction (Injection site reaction), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A.  Causality for rinvoq (upadacitinib): The reporter's causality for the event(s) of 2 covid-19 injections threw into an autoimmune disorder, allergic Reaction to humira, fourth shot gave a rash around injection site, fourth injection got huge patches on Abdomen, itchy unknown onset and fourth injection got huge patches on abdomen, itchy unknown onset was not provided. Causality for humira (adalimumab): The reporter's causality for the event(s) of 2 covid-19 injections threw into an autoimmune disorder, allergic Reaction to humira, fourth shot gave a rash around injection site, fourth injection got huge patches on Abdomen, itchy unknown onset and fourth injection got huge patches on abdomen, itchy unknown onset was not Provided.  The reporter considered "autoimmune disorder", "drug allergy", "injection site itching" and "injection site reaction" 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 known safety profile of the vaccine BNT162b2, a causal relation between the reported event "autoimmune disorder" and the administration of the vaccine is unlikely. Based on the nature of the events "drug allergy", "injection site itching" and "injection site reaction", a causal relation between the reported events and the administration of the vaccine BNT162b2 cannot be excluded