Age: 51.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Pyrexia, Rash
Clinical narrative: Developed diarrhea; COVID vaccine on May 1st and developed a low grade fever, felt lethargic, and ill; Developed a low grade fever, felt lethargic, and ill; Severe itching of the back skin, rash, eczema, constipation, fatigue/tiredness, dizziness, stomach pain/discomfort; Developed a low grade fever, felt lethargic, and ill; Severe itching of the back skin, rash, eczema, constipation, fatigue/tiredness, dizziness, stomach pain/discomfort; Severe itching of the back skin, rash, eczema, constipation, fatigue/tiredness, dizziness, stomach pain/discomfort; Severe itching of the back skin, rash, eczema, constipation, fatigue/tiredness, dizziness, stomach pain/discomfort; Severe itching of the back skin, rash, eczema, constipation, fatigue/tiredness, dizziness, stomach pain/discomfort; Severe itching of the back skin, rash, eczema, constipation, fatigue/tiredness, dizziness, stomach pain/discomfort; Severe itching of the back skin, rash, eczema, constipation, fatigue/tiredness, dizziness, stomach pain/discomfort; Severe itching of the back skin, rash, eczema, constipation, fatigue/tiredness, dizziness, stomach pain/discomfort; This is a spontaneous report based on the information received by Pfizer from biopharmaceutical company (Manufacturer Control No: PM2021001578). A contactable consumer reported that a 51-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01May2021 (at the age of 51-years-old) as dose number unknown, single (30 mcg) for covid-19 immunisation; obeticholic acid (OCALIVA, tablet) orally from 29Apr2021 (Expiration Date: 05Jun2023) to an unspecified date, at 5 mg, daily (therapy duration was unknown) for primary biliary cirrhosis; ursodiol via unknown route of administration from an unknown date for an unknown indication. Medical history included ongoing primary biliary cirrhosis and ongoing allergy to penicillin. Concomitant medication included fish oil; magnesium; multivitamins (vitamins NOS); colecalciferol (D3); menaquinone-7 (K2) and zinc via unknown route of administration from an unknown date for an unspecified indication. On 12May2021, patient reported that, she developed a low-grade fever, felt lethargic, ill on an unknown date in May2021 after receiving COVID-19 vaccine. Then last week in May2021 she developed diarrhea and she was not sure if it was due to the shot or combination of the Ursodiol. Additional information was received on 14Jun2021 and new information included new events eczema, constipation, dizziness, stomach pain, stomach discomfort, fatigue, rash, itchy skin in May2021. The outcome of the events diarrhea, eczema, constipation, dizziness, stomach pain, stomach discomfort, fatigue, rash and itchy skin was not recovered and the events lethargy, illness and low-grade fever was unknown. Company Comment: Per the safety information, the reported events of diarrhoea, lethargy and illness are unlisted and pyrexia, eczema, constipation, dizziness, abdominal pain upper, abdominal discomfort, fatigue, rash, pruritus is listed. In view of insufficient evidence of biological plausibility, the causality for the events of diarrhoea, lethargy and illness is considered unlikely and is more likely due to the concurrent administration of Ursodiol and COVID-19 vaccine. Based on contributory role and known safety profile of Ocaliva, the causality for pyrexia, eczema, constipation, dizziness, abdominal pain upper, abdominal discomfort, fatigue, rash, pruritus is considered as possible. The causal relationship of the events with Ocaliva was not reported.