Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: International normalised ratio increased, Lacunar infarction, Lymphocyte percentage, Lymphocyte percentage decreased, Muscular weakness
Clinical narrative: LEFT FRONTO-PARIETAL SUBARACHNOID HEMORRHAGE; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; VACCINE INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA; CEREBRAL VENOUS SINUS THROMBOSIS; BILATERAL PULMONARY EMBOLISM; ACTIVATED PARTIAL THROMBOPLASTIN TIME SHORTENED; BLOOD BILIRUBIN INCREASED; HAEMOGLOBIN NORMAL; INTERNATIONAL NORMALISED RATIO INCREASED; LYMPHOCYTE PERCENTAGE DECREASED; NEUTROPHIL PERCENTAGE INCREASED; PLATELET COUNT DECREASED; WHITE BLOOD CELL COUNT NORMAL; MUSCULAR WEAKNESS; PAIN IN EXTREMITY; ASTHENIA; FATIGUE; HEADACHE; CHRONIC SINUSITIS; CONTUSION; DECREASED APPETITE; DYSPNOEA EXERTIONAL; EPISTAXIS; PARANASAL SINUS INFLAMMATION; RHINORRHOEA; SKIN DISCOLOURATION; VISUAL IMPAIRMENT; LACUNAR INFARCTION; THROMBOCYTOPENIA; DEEP VEIN THROMBOSIS; This spontaneous report was received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting (VAER) and literature. Platelets. 2022 May 09.  This report concerned a 57 year old male. The objective of this study was to describe Vaccine-induced immune thrombotic thrombocytopenia in a male after Ad26.COV2.S vaccination presenting as cerebral venous sinus thrombosis.  The patient's height, and weight were not reported. The patient's concurrent conditions included: sinus surgery (on 04-MAY-2021 (day 8) patient underwent endoscopic sinus surgery with septoplasty, turbinate reduction, nasal swell body reduction, and left concha bullosa reduction.), sinuplasty, and septoplasty, and other pre-existing medical conditions included: The patient had no known allergies. Patient had no other illness at the time of vaccination and up to one month prior. Patient had no chronic or long standing health conditions. The patient was scheduled for sinuplasty and had preoperative evaluation on 21-APR-2021, in which laboratory data included: Hemoglobin (NR: not provided) 15.5, Platelet count (NR: not provided) 193000, and WBC count (NR: not provided) 5.8. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, expiry: unknown) dose was not reported, 1 total (First dose) administered on 27-APR-2021 on left arm for an unspecified indication. Age at time of vaccination 57 years old. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine induced immune thrombotic thrombocytopenia, cerebral venous sinus thrombosis, bilateral pulmonary embolism, left fronto-parietal subarachnoid hemorrhage and right hand paresthesia. On 08-MAY-2021, the patient experienced deep vein thrombosis, thrombocytopenia, chronic sinusitis, contusion, decreased appetite, dyspnoea, exertional, epistaxis, lacunar infarction, paranasal sinus inflammation, rhinorrhea, skin discolouration, visual impairment, muscular weakness, pain in extremity, asthenia (weakness), fatigue, headache. On 11-MAY-2021, the patient was presented to emergency department (ED) and underwent laboratory tests included international normalised ratio increased (INR) 1.4, activated partial thromboplastin time shortened (PTT) 33, blood bilirubin increased 2.1, haemoglobin (Hg) normal 15.2, lymphocyte percentage decreased 9%, neutrophil percentage (seg) increased 77%, platelet count decreased 6000 (plus head bleeding) and 30.2, white blood cell count (WBC) normal 8.7, Urine normal, no dark colored urine (NR: not provided for all the lab tests). Treatment medications (dates unspecified) included: hydrocodone bitartrate/paracetamol, tramadol, and dexamethasone. It was reported that after the sinuplasty, subsequent to the surgery he had headache, had some nasal discharge with blood. The patient took tramadol but had persistent pain. The patient's symptoms were worsening up with some weakness of his right upper extremity. The patient had generalized fatigue and weakness. The patient was getting short of breath with a flight of stairs, decreased appetite. The patient was given Vicodin for his headache with some improvement. The patient noted discoloration and bruising with pain in his left internal thigh and noticed some changes in his vision but no loss of vision. The patient was treated with dexamethasone 40 mg. There was tiny focus of restricted diffusion in the both cerebellar hemispheres measuring up to 0.4 cm white matter left cerebellar hemisphere of left parietal junction measuring 0.5 cm compatible small lacunar infarcts. Chronic paranasal sinusitis. Patient described minimal blood with flushing his sinuses. Patient was ultimately transferred to hospital for all the events after 3 days (on 11-MAY-2021) for further acute care management given the multiple clots and bleeds associated with severe. The patient was hospitalized for all the events on 11-MAY-2021 for 3 days. upon follow up it was reported that, on 11-MAY02021, treatment included a non-heparin anticoagulation bivalirudin (Day 1417), methylprednisolone 1 g daily (Day 1416), plasma exchange once to remove circulating antibodies (Day 14), and IVIG 1 g/kg twice (Day 14 and 15). Of note, plasma exchange and intravenous immune globulin (IVIG) treatment were both after the anti-PF4 ELISA was completed. By Day 17, the platelet count normalized to 176 × 103/µL and anti-PF4 ELISA was 0.858 OD (optical density), changing from strong positive to positive. Of note, the serotonin release assay unfractionated heparin test was negative; the low dose (0.1 units/mL) heparin was 1% release of serotonin and the high dose (100 units/mL) heparin was 0% release of serotonin. Additionally, on Day 17, a prednisone taper starting at 40 mg was initiated, and bivalirudin was switched to rivaroxaban, starting with a loading dose of 15 mg twice daily for 21 days, followed by a maintenance dose of 20 mg daily. By Day 21, platelets had increased to 278 × 103/µL. The patient was stable without further bleeding events, with resolution of headaches and focal deficits, and ultimately discharged with a short prednisone taper with outpatient hematology and neurology follow-up. At three-month follow-up in hematology clinic, patient remained symptom free, platelets were stable at 186 x 103/µL, anti-PF4 ELISA was negative at 0.19 OD, and the patient remained on therapeutic rivaroxaban. At nine-month follow-up, patient remained symptom free, platelets were stable at 176 x 103/µL, anti-PF4 ELISA was negative at 0.16 OD, and rivaroxaban was discontinued. The patient elected to forgo any further COVID-19 vaccination including mRNA COVID-19 vaccines due to fears of side effects. At ten months, the patient contracted COVID-19, developing mild upper respiratory tract symptoms with a quick recovery (suspected covid-19 infection which led to suspected clinical vaccination failure). At eleven months after hospital discharge and two months after discontinuation of anticoagulation, the patient had not had a relapse of thrombus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of activated partial thromboplastin time shortened, asthenia, blood bilirubin increased, chronic sinusitis, contusion, decreased appetite, deep vein thrombosis, dyspnoea exertional, epistaxis, fatigue, haemoglobin normal, headache, international normalised ratio increased, lacunar infarction, lymphocyte percentage decreased, muscular weakness, neutrophil percentage increased, pain in extremity, paranasal sinus inflammation, platelet count decreased, thrombocytopenia, rhinorrhoea, skin discolouration, visual impairment, white blood cell count normal, vaccine induced immune thrombotic thrombocytopenia, suspected clinical vaccination failure, cerebral venous sinus thrombosis, bilateral pulmonary embolism and left fronto-parietal subarachnoid hemorrhage was not reported. The authors emphasized on the rapid decrease in anti-PF4 antibodies after initiation of treatment and continuing to work toward gaining public trust in the safety and efficacy of vaccination in protecting against COVID-19 is still of upmost importance. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This report was associated with product quality complaint: 90000232640.   Additional information was received from on 17-MAY-2022. The following information was updated and incorporated into the case narrative: Added literature as source, literature article details and reporters added. Patient medical history added (The patient underwent patient underwent endoscopic sinus surgery with septoplasty, turbinate reduction, nasal swell body reduction, and left concha bullosa reduction.), Events added (vaccine induced immune thrombotic thrombocytopenia, suspected covid-19 infection, suspected clinical vaccination failure, cerebral venous sinus thrombosis, bilateral pulmonary embolism and left fronto-parietal subarachnoid hemorrhage), Laboratory data added (platelet count of 6 × 103/µL (normal value: 150 400 × 103/µL), D-dimer was significantly elevated at 114,166 ng/mL FEU (normal value: 0570 ng/mL FEU), fibrinogen was low at 174 mg/dL (normal value: 200393 mg/dL)). Treatment medications added (dexamethasone, bivalirudin, methylprednisolone, prednisone and rivaroxaban). Narrative updated accordingly, Product quality complaint number added.; Sender's Comments: V2. This follow up version updates: Added literature as source, literature article details and reporters added. Patient medical history added (The patient underwent patient underwent endoscopic sinus surgery with septoplasty, turbinate reduction, nasal swell body reduction, and left concha bullosa reduction.), Events added (vaccine induced immune thrombotic thrombocytopenia, confirmed covid-19 infection, confirmed clinical vaccination failure and right hand paresthesia, cerebral venous sinus thrombosis, bilateral pulmonary embolism and left fronto-parietal subarachnoid hemorrhage), Laboratory data added (platelet count of 6 × 103/µL , D-dimer was significantly elevated at 114,166 ng/mL FEU, fibrinogen was low at 174 mg/dL. Treatment medications added.Data updated.  20210556513-covid-19 vaccine ad26.cov2.s -cerebral venous sinus thrombosis, bilateral pulmonary embolism. Follow-up received regarding Clinical Details. This event(s) is labeled per Agency and is therefore considered potentially related. 20210556513-covid-19 vaccine ad26.cov2.s -left fronto-parietal subarachnoid hemorrhage, Suspected covid 19 infection. Follow-up received regarding Clinical Details. The event(s) has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20210556513-covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. Follow-up received regarding Clinical Details. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.