Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Headache, Hidradenitis, Pustule
Clinical narrative: Skin ulcer; Pustule; Hidradenitis suppurativa; COVID-19; COVID-19; Headache; 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-163-4287870-00.  A 33 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular, administration date Jul2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Lot number: 1154508) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown", COVID-19 (medically significant) with onset Dec2021, outcome "recovered" and all described as "COVID-19"; SKIN ULCER (non-serious), outcome "recovering", described as "Skin ulcer"; PUSTULE (non-serious), outcome "recovering", described as "Pustule"; HIDRADENITIS (non-serious), outcome "unknown", described as "Hidradenitis suppurativa"; HEADACHE (non-serious) with onset Jul2021, outcome "recovered" (Jul2021), described as "Headache"; VACCINATION SITE PAIN (non-serious) with onset Jul2021, outcome "recovered" (Jul2021), described as "Vaccination site pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The action taken for upadacitinib was unknown. The events of non-serious covid, had a sore on leg, pustules, hidradenitis suppurativa and headache and sore arm after covid vaccine with Rinvoq (Upadacitinib). There was no reported medical history. On unknown dates, the patient experienced had a sore on leg, pustules and hidradenitis suppurativa. In July2021, the patient experienced headache and sore arm after covid vaccine. In July2021, the headache and sore arm after covid vaccine resolved. In Dec2021, the patient experienced COVID. On an unknown date, COVID resolved. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. The patient had a bad headache and a sore arm after her first Covid vaccine in Jul2021, but it went away after a few hours. She had Covid in Dec2021, she had fully recovered. She also had hidradenitis suppurativa, she had it under control and was doing well. She had a sore on her leg as of 21Feb2022. She had pustules in the past but they were under control. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for Rinvoq (Upadacitinib) to the event(s) of covid, had a sore on leg and pustules with Rinvoq (Upadacitinib) was no reasonable possibility. The reporter's causality for the event(s) of hidradenitis suppurativa, headache and sore arm after covid vaccine onset in July2021 and headache and sore arm after covid vaccine onset in July2021 was not provided. The reporter's causality for PFIZER BIONTECH COVID-19 Vaccine (Tozinameran) to the events COVID-19, Skin ulcer it was reported as possible and for events Pustule, Hidradenitis suppurativa, Headache and vaccination site pain was not reported. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.