Age: 39.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Gastrointestinal disorder, Mast cell activation syndrome, Muscle spasms, Vaccination site reaction
Clinical narrative: Stomach upset; Cramps; Gastrointestinal disturbance; Chronic diarrhea; Food allergy; Vaccination site reaction; Loss of voice; Mast cell activation syndrome; This is a solicited report based on the information received by Pfizer (Manufacturer Control No: 21K-163-3794962-00) form a contactable consumer (patient).  A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 12Apr2021 (Batch/Lot number was not reported) and second dose on 04May2021 (Batch/Lot number was not reported) both via intramuscular as single dose for covid-19 vaccination; upadacitinib (RINVOQ), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe rheumatoid arthritis. Patient medical history included heart issues (started 2000). Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and epinephrine (EPIPEN) both taken for an unspecified indication, start and stop date were not reported. Solicited report by a consumer of a female patient with events of mast cell activation syndrome, stomach upset, cramping, gastrointestinal disturbance, chronic diarrhea, food allergies/allergic to egg product, possible reaction to covid vaccine and loss of voice with RINVOQ (UPADACITINIB). The patient had a relevant medical history of heart issues from 2000. On unknown dates, the patient experienced stomach upset, cramping, gastrointestinal disturbance, chronic diarrhea, food allergies/allergic to egg product, possible reaction to covid vaccine, vaccination site reaction and loss of voice. In Mar2021, the patient experienced mast cell activation syndrome. On unknown dates, stomach upset, cramping, gastrointestinal disturbance and chronic diarrhea resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient had two instances, that lasted one day of diarrhea, cramping and overall stomach upset over a period of ten days and her symptoms subsided. She had colonoscopy due to chronic diarrhea and food allergies, in the process of testing. She had mast cell activation syndrome that was diagnosed in Mar2021, histamines were having intagatlic reaction. She had adjusted her diet, seemed like it was improving, but still feeling it. She had diarrhea, severe cramps, loss of voice lasting a day or two. She was taking Zyrtec four times daily. Carried Epipen. Possible reaction to covid vaccine, but was allergic to egg product and had egg product day of second dosage. Adverse event information provided by her was related to covid vaccine: It was unknown if she was enrolled in a COVID-19 Vaccine Trial. On 12Apr2021, she received 1st dose COVID-19 Vaccine manufactured by Pfizer biontech. On 04May2021, she received 2nd dose COVID-19 Vaccine manufactured by Pfizer biontech. The patient underwent lab tests and procedures which included colonoscopy: unknown result on an unspecified date. The action taken in response to the events for upadacitinib was unknown. The outcome of events mast cell activation syndrome was not recovered/not resolved; outcome of events stomach upset, cramps, gastrointestinal disturbance and chronic diarrhea was recovered/resolved; outcome of food allergy was recovering/resolving; outcome of events vaccination site reaction and loss of voice was unknown.  Causality for RINVOQ(UPADACITINIB): The reporter's causality for the events of mast cell activation syndrome, stomach upset, cramping, gastrointestinal disturbance, chronic diarrhea, food allergies/allergic to egg product, vaccination site reaction and loss of voice was not provided.  Causality for BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE): The reporter's causality for the events of mast cell activation syndrome, stomach upset, cramping, gastrointestinal disturbance, chronic diarrhea, food allergies/allergic to egg product, vaccination site reaction and loss of voice was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information.  The impact of this report on the benefit/risk profile of the Pfizer drug 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