Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio, Joint range of motion decreased, Knee operation, Osteoarthritis, Peripheral swelling
Clinical narrative: This is a non-interventional study report from the marketing program received from a contactable consumer (patient) based on information received by Pfizer. A 76-year-old female patient received BNT162B2 (Pfizer BioNTech covid-19 Vaccine, solution for injection, Batch/Lot number was not reported), dose 1 intramuscular on 12Apr2021 (at the age of 76-year-old) as dose 1, single for covid-19 immunisation. The co-suspect included upadacitinib (RINVOQ), oral from Oct2020 (Batch/Lot number was not reported) to an unspecified date, at 15 mg for moderate to severe rheumatoid arthritis. The patient's medical history included diabetes mellitus from 1960 to an unknown date, rheumatoid arthritis from 1987 to an unknown date, internal haemorrhage from 2018 to an unknown date, small intestinal resection from Dec2018 to an unknown date, abdominal hernia from 2019 to 02Jun2021, non-tobacco user from an unknown date and unknown if ongoing, knee arthroplasty from 15Feb2021 to an unknown date, difficulty in walking. It was unknown if she was enrolled in a COVID-19 vaccine trial. Concomitant medications included methotrexate taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for rheumatoid arthritis, start and stop date were not reported; gabapentin (NEURONTIN) taken for rheumatoid arthritis, start and stop date were not reported; prednisone taken for rheumatoid arthritis, start and stop date were not reported; flecainide taken for heart rate decreased, start and stop date were not reported; metoprolol taken for heart rate, start and stop date were not reported; warfarin sodium (JANTOVEN) taken for an unspecified indication, start and stop date were not reported; venlafaxine taken for pain, start and stop date were not reported. On an unknown date in Apr2021, patient experienced knee surgery. On 13May2021, patient had another procedure for her abdominal hernia. Patient mentioned that her hernia was located in five different places, there were two on her left lower abdominal area and three on the right lower area. She stayed in the hospital for six days until 20May2021 and was treated with unrecalled antibiotics and pain relievers. On 13May2021, the patient experienced could not open and close left hand and swelling of left hand. On an unknown date in 2021, patient stated that "Her first dose of Covid-19 vaccine that was caused pain in her rheumatoid arthritis and elevated blood sugar level with a result of over 400 milligrams per decilitre", knee osteoarthritis. The reporter causality for the events knee surgery, knee osteoarthritis was not reported, blood sugar abnormal was possible, joint range of motion decreased, peripheral swelling, arthritic pains were not related. The manufacturer causality for all the events were no reasonable possibility. The patient underwent lab tests and procedures which included blood glucose abnormal: unknown mg/dl on an unknown date, blood glucose abnormal: unknown mg/dl on 09Jun2021, blood glucose abnormal: over 400 mg/dl on an unknown date in 2021, computerised tomogram: unknown on an unknown date, international normalised ratio: unknown on 09Jun2021, x-ray: unknown on an unknown date. The outcome of the events "Her first dose of Covid-19 vaccine that was caused pain in her rheumatoid arthritis and elevated blood sugar level with a result of over 400 milligrams per decilitre" were not recovered. The outcome of the events, knee surgery, knee osteoarthritis, could not open and close left hand and swelling of left hand were recovering and the outcome of had another procedure for her abdominal hernia was unknown.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: As per the information provided in narrative, the events hernia repair, knee operation, Osteoarthritis is assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association. The events hyperglycemia, joint range of motion decreased, peripheral swelling, and arthralgia is assessed as possibly unrelated to the suspect drug BNT162B2 since the reporter denies causality. Also, consider possible contributory effects from patient's medical history and/or concomitant medications. 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.