Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler, Ultrasound scan, Ultrasound scan abnormal, Vascular access site thrombosis
Clinical narrative: DEEP VEIN THROMBOSIS; VASCULAR ACCESS SITE THROMBOSIS; THROMBOCYTOPENIA; ANTICOAGULANT THERAPY; ANGIOGRAM PULMONARY NORMAL; ARTERIOGRAM CAROTID NORMAL; COMPUTERISED TOMOGRAM NECK; COMPUTERISED TOMOGRAM THORAX; MAGNETIC RESONANCE IMAGING HEAD NORMAL; PLATELET COUNT NORMAL; SCAN WITH CONTRAST NORMAL; ULTRASOUND DOPPLER; ULTRASOUND SCAN ABNORMAL; This spontaneous report received from a health professional via a Regulatory Authority concerning a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included breast cancer, hypertension, rheumatoid arthritis, attention deficit hyperactivity disorder (ADHD), depression, and chemotherapy, and other pre-existing medical conditions included no known allergies. The patient was not pregnant at the time of vaccination The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route not provided, batch number: Unknown) dose was not reported, 1 total administered on 09-APR-2021 for prophylactic vaccination. Anatomical site of vaccine administration not reported.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included paclitaxel for chemotherapy ( 2 days prior), apixaban, citalopram, docusate sodium/sennoside a+b "Senna-c", lisinopril, lorazepam, melatonin, potassium chloride, and prednisone.  Adverse events reported by VAERS, with an onset date of 23-APR-2021: Deep vein thrombosis, Vascular access site thrombosis, Angiogram pulmonary normal, Anticoagulant therapy, Arteriogram carotid normal, Computerised tomogram neck, Computerised tomogram thorax, , Magnetic resonance imaging (MRI) head normal, Platelet count normal, Scan with contrast normal, Ultrasound Doppler, Ultrasound scan abnormal. In addition, the event of thrombocytopenia was captured, with the patient's platelet count being 16,000 on 25-APR-2021, 18,000 on 26-APR-2021 and 27,000 on 27-APR-2021 (units and normal range not reported). The patient developed deep vein thrombosis and vascular access site thrombosis. She was hospitalized on an unspecified date.  She was initially started on heparin, and then switched to rivaroxaban. "Thrombocytopenia-supportive treatment and monitoring". On unspecified dates, ultrasound duplex scans revealed multifocal deep venous thrombosis of left upper extremity. CTA (computed tomography angiography) of the chest showed no acute pulmonary embolism; no infiltrate, effusion or pneumothorax. CTA head and neck scan with and without contrast showed no evidence of cerebral venous sinus thrombosis.  MRI brain scans with and without contrast showed no hemorrhage, demyelination or acute stroke detected in the brain. There was no abnormal enhancement detected in the brain after contrast injection.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from deep vein thrombosis, vascular access site thrombosis, anticoagulant therapy, angiogram pulmonary normal, arteriogram carotid normal, computerised tomogram neck, computerised tomogram thorax, magnetic resonance imaging head normal, platelet count normal, scan with contrast normal, ultrasound doppler, ultrasound scan abnormal and thrombocytopenia. This report was serious (caused/prolonged hospitalization).  Additional information was received on 06-JUN-2021. It was determined that Manufacturer Case Number 20210546127 was a duplicate of this case. All relevant information regarding this case will be submitted under 20210515187. Upon review, the following information was amended: the serious adverse event of thrombocytopenia was added to the case.; Sender's Comments: V3: Follow-up adds the serious adverse event of thrombocytopenia.  This spontaneous report received from a health professional via VAERS (ID: 1263150) concerned a 41-year-old woman who experienced deep vein thrombosis (DVT) and vascular access site thrombosis 14 days after vaccine, and thrombocytopenia (16,000) 16 days after vaccine. Relevant conditions included breast cancer, hypertension, rheumatoid arthritis and chemotherapy. The patient was not pregnant at the time of vaccination. Relevant concomitant medications included paclitaxel for chemotherapy (2 days prior), apixaban, citalopram, and prednisone. The patient developed DVT and vascular access site thrombosis on day 14 and she was hospitalized on an unspecified date.  She was initially started on heparin and then switched to rivaroxaban. On unspecified dates, ultrasound duplex scans revealed multifocal deep venous thrombosis of left upper extremity. CTA (computed tomography angiography) of the chest showed no acute pulmonary embolism; no infiltrate, effusion or pneumothorax. CTA head and neck scan with and without contrast showed no evidence of cerebral venous sinus thrombosis.  MRI brain scans with and without contrast showed no hemorrhage, demyelination or acute stroke detected in the brain. In addition, the patient experienced thrombocytopenia with platelet counts of 16,000 (day 16), 18,000 (day 17), and 27,000 (day 18). "Thrombocytopenia-supportive treatment and monitoring" was reported. As of this report, the patient had not recovered from the events. The subject's concurrent breast cancer, chemotherapy, and indwelling vascular access/port may have increased the risk for the events to occur. However, considering the temporal relationship with vaccination, a relationship with Janssen Covid-19 vaccine cannot be ruled out. Therefore, the relationship is considered indeterminate.