Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Immunisation reaction, Loss of consciousness, Rhinorrhoea, Weight, Weight increased
Clinical narrative: Passed out; Runny nose; Weight gain; severe reaction to the one dose of Pfizer Covid vaccine; This is a solicited report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4497361-00, 22K-163-4495094-00.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 03Sep2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 73 years intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown) oral. The patient's relevant medical history included: "rheumatoid arthritis" (ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION REACTION (medically significant) with onset 03Sep2021, outcome "unknown", described as "severe reaction to the one dose of Pfizer Covid vaccine"; LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "Passed out"; RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose"; WEIGHT INCREASED (non-serious), outcome "unknown", described as "Weight gain". The event "passed out" required physician office visit. The patient underwent the following laboratory tests and procedures: Weight: Gain. The action taken for upadacitinib was dosage permanently withdrawn. Clinical course: Solicited report from by a consumer of a 73 year old female with events of Severe reaction to the one dose of Pfizer COVID Vaccine and passed out and non-serious runny nose and weight gain with Rinvoq (Upadacitinib). On unknown dates, the patient experienced passed out, runny nose and weight gain. On 03Sep2021, the patient experienced Severe reaction to the one dose of Pfizer COVID Vaccine. Pfizer Biontech COVID-19 Vaccine (Tozinameran) was also considered suspect. On 03Sep2021, the patient had severe reaction to the one dose of Pfizer Covid vaccine. She had runny nose from time to time and it was common with rheumatoid arthritis. She gained weight. She passed out and had to went to the hospital. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Rinvoq (Upadacitinib): The reporter's causality for the event(s) of Severe reaction to the one dose of Pfizer COVID Vaccine and passed out was not provided. The reporters causality for the event(s) of runny nose with Rinvoq (Upadacitinib) was no reasonable possibility (Not Related). The reporters causality for the event(s) of weight gain with Rinvoq (Upadacitinib) was a reasonable possibility (Probable). Opinion is that there is no reasonable possibility that the event of Severe reaction to the one dose of Pfizer COVID Vaccine is related to Rinvoq (Upadacitinib). Opinion is that the events of passed out, runny nose and weight gain are not assessable. Reporter's causality (Pfizer BIontech COVID-19 Vaccine (Tozinameran)): for Vaccination adverse reaction was probable, for Passed out, Runny nose and Weight gain was Not Related.  The reporter considered "passed out", "runny nose" and "weight gain" not related to BNT162b2. The reporter considered "severe reaction to the one dose of pfizer covid vaccine" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and a possible contributory role of the suspect BNT162B2 to the reported events of  loss of consciousness", "runny nose" and "weight gain" can be completely excluded/unrelated and the event immunization reaction is related to the suspect BNT162B2  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