Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Culture, Eye infection staphylococcal, Eye ulcer
Clinical narrative: staph infection in eye; ulcer in eye; This is a solicited report by a non-contactable consumer (patient) from the facilitated collect received by Pfizer.  A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 26Mar2021 (Lot Number: ER8733) at the age of 63-year-old as single dose for COVID-19 vaccination; upadacitinib (RINVOQ, tablet), orally from Nov2020 (Lot Number: 1139128) and ongoing at 15 mg, 1x/day for moderate to severe rheumatoid arthritis. Medical history included alcohol use from 1975, tobacco use three cigarette sticks per week, left shoulder replacement, right knee replacement, left hand and knuckles joint replacement, problems with eye, both ankles and feet replacement, eye dryness, dryness in mouth, migraine, heart burn/indigestion, rheumatoid arthritis and arthritis. Patient mentioned that she started smoking when she was 19 to 20 years old and quit 40 years ago when she gave birth to her child. She quit drinking alcohol years ago because it was causing migraines. She had a lot of titanium metals placed due to surgeries and replacements. She did not have any history of illicit drug use, immunosuppressive disorders, latent tuberculosis, and diabetes mellitus. Concomitant medication included methotrexate taken for rheumatoid arthritis; lifitegrast (XIIDRA) taken for eye dryness; cevimeline taken for dryness in mouth; folic acid; topiramate taken for migraine; omeprazole taken for heart burn/indigestion; paracetamol (TYLENOL) taken for arthritis. The patient previously oxycodone hydrochloride;paracetamol (PERCOCET) and experienced allergy manifested by throat closing up and rash; oxycodone and experienced allergy manifested by throat closing up and rash; pethidine hydrochloride (DEMEROL) and experienced allergy manifested by throwing up. In Mar2021, the patient experienced ulcer in eye and staph infection in eye with COVID-19 shot. In Apr2021, the ulcer in eye and staph infection in eye with COVID-19 shot resolved. Pfizer-BioNTech COVID-19 Vaccine (TOZINAMERAN) was also considered suspect. The patient had ulcer and it turned into staff in eye. She took an unknown antibiotic for the staph infection in eye and for the ulcer in eye. She had problems with the eye and it developed into ulcer in eye then she got her first Covid-19 shot. The physician told her it was a staph infection but she stated that it was just their speculation. She did not have any blood work done for the reported adverse events. The alternative etiology reported for event ulcer in eye was rheumatoid arthritis. The alternative etiology reported for event staph infection in eye was covid-19 shot. Primary reporter did not have the lot number information of the second dose of Covid-19 vaccine because it was not written on the vaccination card. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. On 26Mar2021, she received 1st dose COVID-19 Vaccine manufactured by Pfizer, lot number ER8733. On 16Apr2021, she received 2nd dose COVID-19 Vaccine manufactured by Pfizer. The patient underwent lab tests and procedures which included swab culture: eye Staph infection in eye on Apr2021. The action taken in response to the events for upadacitinib was dose not changed.    Causality for upadacitinib: The reporter's causality for the events of ulcer in eye and staph infection in eye with covid-19 shot with upadacitinib was no reasonable possibility. Manufacturer's opinion was that there was a reasonable possibility that the events of ulcer in eye and staph infection in eye with covid-19 shot were related to upadacitinib.  Causality for BNT162B2: The reporter's causality for the event of ulcer in eye with BNT162B2 was no reasonable possibility. The reporter's causality for the event of staph infection in eye with BNT162B2 was probable.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available, there was not a reasonable possibility that the reported events of ulcer in eye and staph infection in eye were related to BNT162B2 vaccine. The events are attributed to  intercurrent medical conditions. The impact of this report on the benefit/risk profile of the Pfizer product 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.