Age: 72.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Autoimmune thyroiditis, Catheterisation cardiac, Haemorrhage
Clinical narrative: she has a bleeding disorder/ a cardiac procedure in the groin to stop bleeding; Hashimotos' Disease; Mixed Connective Tissue Autoimmune Disease; allergies (experienced rashes and hives) to contrast dyes; allergies to adhesive, and polymers; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Bristol-Myers Squibb (Manufacturer Control Number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-005628), license party for apixaban (ELIQUIS).   This case was received via Pfizer Inc (Reference number: 2021040024) on 18Jan2021 and was forwarded to BMS on 19Jan2021. This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE THYROIDITIS (Hashimotos' Disease), MIXED CONNECTIVE TISSUE DISEASE (Mixed Connective Tissue Autoimmune Disease) and HAEMORRHAGE (she has a bleeding disorder/ a cardiac procedure in the groin to stop bleeding) in 72-year-old female patient who received apixaban (ELIQUIS) for an unknown indication. The occurrence of additional non-serious events is detailed below CO-SUSPECT PRODUCTS included COVID-19 VACCINE for an unknown indication. On an unknown date, the patient started ELIQUIS (unknown route) and COVID-19 VACCINE (Intramuscular). On an unknown date, the patient experienced AUTOIMMUNE THYROIDITIS (seriousness criterion medically significant), MIXED CONNECTIVE TISSUE DISEASE (seriousness criterion medically significant), HAEMORRHAGE (seriousness criterion medically significant), CONTRAST MEDIA ALLERGY (allergies (experienced rashes and hives) to contrast dyes) and DERMATITIS CONTACT (allergies to adhesive, and polymers). The action taken with ELIQUIS (Unknown) was unknown. At the time of the report, AUTOIMMUNE THYROIDITIS, MIXED CONNECTIVE TISSUE DISEASE, HAEMORRHAGE, CONTRAST MEDIA ALLERGY and DERMATITIS CONTACT outcome was unknown. Consumer reported that she had read the EUA Fact Sheet for Recipients and have some questions to the "What should you mention to your vaccination provider". Caller mentioned that she has allergies (experienced rashes and hives) to contrast dyes, adhesive, and polymers such as the angio-seal that was used on her for a cardiac procedure in the groin to stop bleeding. She has irritation from the polymer and described it as a sponge that was meant to be absorbed for a month. Her first question was does the COVID-19 vaccine contain latex, mold (polymers) and adhesive? Response: For latex. For mold (polymer) and adhesive: "A review of the ingredients list on the product label show that mold (polymer) and adhesive are not part of the formulation, however, Pfizer does not specifically manufacture the vaccine to be free of mold (polymer) and adhesive, therefore, we cannot assure that it was "mold (polymer)-free and adhesive free". We cannot guarantee that minute amounts of substances are not contained in raw materials obtained from our suppliers. She had the PPSD23/Pneumonia 23 vaccine last 05Jan2021 and was told not to get the COVID-19 vaccine for 14 days. Is it because of the injection site or is it for systemic reasons? Consumer mentioned that she was on ELIQUIS. She has Hashimoto's Disease and Mixed Connective Tissue Autoimmune Disease. She said that she was not immunocompromised. She mentioned that she has a bleeding disorder. The Pfizer- BioNTech COVID-19 Vaccine can only be administered as an intramuscular injection For ELIQUIS (Unknown), the reporter did not provide any causality assessments.   Reporter's causality assessment was not provided.  Bristol-Myers Squibb Causality assessment for ELIQUIS: Events: Hashimoto's disease, Contrast media allergy, Topical adhesive allergy, Mixed connective tissue disease were considered unrelated while bleeding was considered related.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: BMS Medical Evaluation Comment: This patient had autoimmune thyroiditis, mixed connective tissue disease and hemorrhage after receiving apixaban therapy. This patient also had COVID-19 vaccination. Based on the anticoagulant action of apixaban, its role in the event hemorrhage is considered as possible. Based on the etiology of the reported events, auto immune thyroiditis and mixed connective tissue disorder are considered not related to apixaban.