Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, Pulmonary mass, Thyroid disorder, Thyroiditis
Clinical narrative: Pulmonary embolism; Hashimoto's disease; Lung nodule; Thyroiditis; Fatigue aggravated; Dysfunction thyroid; Iron low; Injection site bruising; 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.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 15Nov2021 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation; adalimumab (HUMIRA), on 22Feb2021 (ongoing) as unk (citrate free) (Batch/Lot number: unknown) subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: 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". The patient underwent the following laboratory tests and procedures: Blood iron: Low. The action taken for adalimumab was dosage not changed.  The reporter's assessment of the causal relationship of "pulmonary embolism", "hashimoto's disease", "lung nodule", "thyroiditis", "fatigue aggravated", "dysfunction thyroid", "iron low" and "injection site bruising" 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.  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, nodules in chest, inflamed thyroid and bruising at injection site was not provided. The reporter's causality for the event(s) of felt extra tired with Aumira (Adalimumab) was a reasonable possibility.  The 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). The opinion is that the events of nodules in chest and bruising at injection site are not assessable. The opinion is that there is a reasonable possibility that the event of felt extra tired is related to Humira (Adalimumab).; Sender's Comments: Based on available information the events of pulmonary embolism, autoimmune thyroiditis, pulmonary mass, thyroiditis, fatigue aggravated, thyroid disorder, blood iron decreased and injection site bruising are assessed as possibly related to the suspect vaccine BNT162B2 based on  temporal association.