Sex: F
Vaccine: COVID19, UNK
Symptoms: SARS-CoV-2 test, Staphylococcal infection
Clinical narrative: Cardiac pacemaker insertion; Slurred speech; Low blood pressure; Methicillin-resistant Staphylococcus aureus infection; COVID-19; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer from a company (manufacturer control number: 21K-163-4154049-00).   A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), intramuscular on an unspecified date (at an unspecified age) as dose number unknown, single for COVID-19 immunization; upadacitinib (RINVOQ), oral from an unspecified date (Lot Number: 1150513), at unspecified dose for moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. The patient experienced COVID-19 (medically significant) on Jan2021, cardiac pacemaker insertion (medically significant) on an unspecified date, slurred speech on an unspecified date, low blood pressure on an unspecified date, methicillin-resistant staphylococcus aureus infection on an unspecified date. The patient underwent lab tests and procedures which included blood pressure: low on an unspecified date, COVID 19: covid 19 on Jan2021. The patient went to hospital for low blood pressure and slurring words. She had Covid 19 in Jan2021. She had methicillin resistant staphylococcus aureus infection. She had a pacemaker put in. The adverse event information provided by patient was related to covid vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received COVID-19 Vaccine manufactured by Pfizer BioNTech. The action taken in response to the events for upadacitinib was unknown. The outcome of the events was unknown.  Causality for BNT162B2: The reporter's causality for the events Cardiac pacemaker insertion, Low blood pressure, COVID-19, Methicillin-resistant Staphylococcus aureus infection, Slurred speech was possible.  Causality for RINVOQ (upadacitinib): The reporter's causality for the events of put pacemaker in, low blood pressure, covid 19, methicillin resistant staphylococcus aureus infection and slurred words was not provided.  Conpany's opinion is that there is no reasonable possibility that the events of put pacemaker in and covid 19 are related to rinvoq (upadacitinib). Company's opinion is that the events of low blood pressure, methicillin resistant staphylococcus aureus infection and slurred words are not assessable.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The events of COVID-19, Cardiac pacemaker insertion, Dysarthria, Hypotension and Staphylococcal infection are related to the suspect product BNT162B2 based on plausible temporal relationship. 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