Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Injection site bruising, Pulmonary embolism, Pulmonary mass, Thyroid disorder
Clinical narrative: Deep vein thrombosis; Pulmonary embolism; Hashimoto's disease; Lung nodule; Thyroiditis; Fatigue aggravated; Dysfunction thyroid; Iron low; Injection site bruising; 1st dose therapy date 15Nov2021, 2nd dose therapy date 29Nov2021; 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-163-4324871-00 (AbbVie).  A 60-year-old female patient received BNT162b2 (BNT162B2), on 15Nov2021 as dose 1, single (Batch/Lot number: unknown) and on 29Nov2021 as dose 2 , single (Batch/Lot number: unknown) at the age of 60 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), on 22Feb2021 (ongoing) as citrate free (Batch/Lot number: unknown) subcutaneous for psoriatic arthropathy. The patient's relevant medical history included: "chronic cough" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DEEP VEIN THROMBOSIS (hospitalization), outcome "recovered"; PULMONARY EMBOLISM (medically significant), outcome "recovered"; AUTOIMMUNE THYROIDITIS (medically significant), outcome "not recovered", described as "Hashimoto's disease"; PULMONARY MASS (medically significant), outcome "unknown", described as "Lung nodule"; THYROIDITIS (medically significant), outcome "unknown"; FATIGUE (medically significant), outcome "recovered", described as "Fatigue aggravated"; THYROID DISORDER (medically significant), outcome "not recovered", described as "Dysfunction thyroid"; BLOOD IRON DECREASED (medically significant), outcome "recovered", described as "Iron low"; INJECTION SITE BRUISING (medically significant), outcome "recovered"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "1st dose therapy date 15Nov2021, 2nd dose therapy date 29Nov2021". The patient was hospitalized for deep vein thrombosis (hospitalization duration: 4 day(s)). The patient underwent the following laboratory tests and procedures: Blood iron: low. The action taken for adalimumab was unknown.  Additional information: Solicited report by a consumer from an adult female with event of Deep vein thrombosis and pulmonary embolism in right lung and not-serious nodule in chest, inflamed thyroid, hashimotos, felt extra tired, thyroid was dying off, low iron and bruishing at injection site with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced Deep vein thrombosis, pulmonary embolism in right lung, nodule in chest, inflamed thyroid, hashimotos, felt extra tired, thyroid was dying off, low iron and bruishing at injection site. On unknown dates, Deep vein thrombosis, pulmonary embolism in right lung, felt extra tired, low iron and bruishing at injection site resolved. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. The patient developed Deep vein thrombosis after second covid-19 Pfizer vaccine. She was hospitalized for four days and was also found out that she had a mutated gene. She also had Hashimotos, her thyroid was dying off. She had chronic cough and also felt extra tired after taking Humira injection so she started taking Humira at night. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of Deep vein thrombosis, hashimotos, thyroid was dying off and low iron with HUMIRA (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of pulmonary embolism in right lung, nodule in chest, inflamed thyroid and bruishing at injection site was not provided. The reporter's causality for the event(s) of felt extra tired with HUMIRA (ADALIMUMAB) was a reasonable possibility. The Causality as per Mfr. (Drug/Vaccine) for the event(s) of Deep vein thrombosis, Pulmonary embolism, Thyroiditis, Hashimoto's disease, Dysfunction thyroid, Iron low was No reasonable possibility whereas for Fatigue aggravated was Reasonable possibility and causality for Lung nodule was not provided. AbbVie's opinion is that there is no reasonable possibility that the events of Deep vein thrombosis, pulmonary embolism in right lung, inflamed thyroid, hashimotos, thyroid was dying off and low iron are related to HUMIRA (ADALIMUMAB). AbbVie's opinion is that the events of nodule in chest and bruishing at injection site are not assessable. AbbVie's opinion is that there is a reasonable possibility that the event of felt extra tired is related to HUMIRA (ADALIMUMAB).  Causality for PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) (TOZINAMERAN): The reporter's causality for the event(s) of Deep vein thrombosis was possible while that causality for all the other events was not reported.  The reporter considered "deep vein thrombosis" and "fatigue aggravated" related to BNT162b2. The reporter's assessment of the causal relationship of "pulmonary embolism", "hashimoto's disease", "lung nodule", "thyroiditis", "dysfunction thyroid", "iron low", "injection site bruising" and "1st dose therapy date 15nov2021, 2nd dose therapy date 29nov2021" 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Deep vein thrombosis, pulmonary embolism, Hashimoto's disease, pulmonary mass, thyroiditis, fatigue, thyroid disorder, iron low, injection site bruising, inappropriate schedule of product administration, and the suspect drug cannot be established, hence the causality was kept as Unrelated. The case will be reassessed once new information is available.