Age: 46.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Peripheral swelling, Pneumonia, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Pneumonia; Swelling of limbs; 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-163-4237492-00 (Agency).  A 46-year-old female patient received BNT162b2 (BNT162B2), on 17Feb2022 as dose 1, single (Batch/Lot number: unknown) and on 10Mar2022 as dose 2, single (Batch/Lot number: unknown) at the age of 46 years, all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown) at 15 mg, oral for rheumatoid arthritis. The patient's relevant medical history included: "Asthma", start date: Dec2021 (unspecified if ongoing); "covid related illness ", start date: Dec2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 17Feb2022, outcome "unknown", described as "Swelling of limbs"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19"; PNEUMONIA (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. The action taken for upadacitinib was dosage permanently withdrawn.  The reporter's assessment of the causal relationship of "covid-19", "pneumonia" and "swelling of limbs" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Additional information: Solicited report from a consumer of a 45 year old female with events of non-serious Covid, Asthma from Covid Related Illness, Armpits swelled and Pneumonia with Rinvoq (Upadacitinib). There was no reported medical history. On unknown dates, the patient experienced COVID and Pneumonia. In Dec2021, the patient experienced Asthma from Covid related Illness. On 17Feb2022, the patient experienced Armpits Swelled. Pfizer Biontech COVID-19 Vaccine (Tozinameran) was also considered suspect. In Dec2021 the patient had asthma from covid related illness and was taken off Rinvoq. She had armpits swelled from covid first and second shot. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 17Jun2022, received updates to patient demographics, event information, reporter opinion of causality, suspect drug information and narrative description. The events of "asthma from Covid related illness" and "Armpits Swelled" were added.  Causality for Rinvoq (Upadacitinib): The reporter's causality for the event(s) of Covid, Asthma from Covid related illness, Armpits swelled and Pneumonia was not provided.  Causality for Pfizer biontech covid-19 Vaccine (Tozinameran): Causality as per reporter (Drug/Vaccine), Swelling of limbs (Peripheral swelling), Pneumonia (Pneumonia) was not Reported  The lot number for vaccine [BNT162B2] was not provided and will be requested during follow-up.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of covid-19", drug ineffective,"pneumonia" and "swelling of limbs" 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