Sex: M
Vaccine: COVID19, COVID19
Symptoms: ADAMTS13 activity abnormal, Blood bilirubin increased, Blood fibrinogen normal, Blood lactate dehydrogenase increased, Blood test
Clinical narrative: THROMBOTIC THROMBOCYTOPENIC PURPURA; THROMBOCYTOPENIA; PLATELET COUNT DECREASED; ADAMTS13 ACTIVITY ABNORMAL; SCHISTOCYTOSIS; HAPTOGLOBIN DECREASED; HAEMOGLOBIN DECREASED; BLOOD BILIRUBIN INCREASED; BLOOD LACTATE DEHYDROGENASE INCREASED; COOMBS TEST NEGATIVE; BLOOD FIBRINOGEN NORMAL; CONTUSION; PETECHIAE; INCREASED TENDENCY TO BRUISE; SPEECH DISORDER; FATIGUE; Additional information was received from a patient and telephone follow-up with patient on 07-JUN-2021 and 16-JUN-2021. It was determined that Manufacture Case Number 20210614056 was a duplicate of this case [20210515085]. All relevant information regarding this case will be submitted under Manufacture Case Number [20210515085].  This spontaneous report received from a health care professional via the VAERS (Vaccine Adverse Event Reporting System; VAERS ID: 1267091) concerned a 60 year old male patient.  The patient's height, and weight were not reported. The patient's past medical history included a spinal cord injury in 1984, and concurrent conditions included constipation, paraplegia for many years due to motor vehicle accident in the past, penicillin allergy, alcohol use (2 drinks in a week), non-smoker and wheelchair bound. The patient had no family history of any blood/clotting disorders. He was reported as being "healthy".  The patient, at age 60, received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025) dose was not reported, administered on the left deltoid  09-MAR-2021 for prophylactic vaccination. Concomitant medications included bisacodyl for constipation, atorvastatin, sertraline and oxybutynin for unknown indication.  On 14-MAR-2021 (also reported as 15-MAR-2021), 5 days (also reported as 6 days) after receiving the vaccine, the patient experienced speech difficulty, fatigue mild headaches, dizzy spells, stuttered speech, petechiae, bruising of skin, dark urine, hand dexterity problems. The doctor thought the patient had a stroke and asked him to go to the emergency room (ER).   On 19-MAR-2021, 10 days after the vaccine, the patient went to the Emergency Room because he was having mild headaches, dizzy spells, stuttered speech, and manual dexterity was affected.  He was hospitalized.  Thrombotic thrombocytopenic purpura (TTP) was confirmed by a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member (13ADAMTS13) activity level < 5% and the presence of inhibitor. In addition the patient experienced schistocytes, thrombocytopenia, and elevated lactate dehydrogenase. Additional laboratory tests on 19-MAR-2021: Blood bilirubin increased 2.6 mg/dL, Blood fibrinogen normal 251 (unit unspecified), Blood lactate dehydrogenase increased 671 U/L, Coombs test negative, Haemoglobin decreased 6.4 g/dL, Haptoglobin decreased <17 mg/dL and Platelet count decreased 13000 (unit unspecified). Computerized tomography scan was negative for stroke.  On 20-MAR-2021, the patient was diagnosed with thrombotic thrombocytopenic purpura. Hospital staff  "placed a marker in his neck", and he began receiving regular plasma exchanges (PLEX) which made him feel better and also raised platelet count to 214,000 on 28-MAR-2021. From 30-MAR-2021 to 16-APR-2021, plasma exchanges were done daily and Rituximab infusions weekly for a total of 4 infusions. Additional treatment medications (dates unspecified) included: aciclovir, prednisone, and fluconazole. The patient stated that there were no blood clots found during his hospital stay.  On 16-APR-2021, he was discharged, and his symptoms had since been improving; headaches, stuttered speech, dizzy spells resolved and manual dexterity problems were resolving. The patient continued to perform blood test once a week, and his maintenance medications (unspecified) were stopped. The patient was hospitalized for 28 days (also reported as 26 days). Approximately 2 weeks prior to the latest contact with the patient on 16-JUN-2021, his platelet count was 159,000.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from thrombotic thrombocytopenic purpura, thrombocytopenia, schistocytosis, haptoglobin decreased, haemoglobin decreased, adamts13 activity abnormal, platelet count decreased, blood bilirubin increased, blood lactate dehydrogenase increased, contusion, petechiae, increased tendency to bruise, speech disorder, fatigue, negative coombs test and blood fibrinogen normal. This report was serious (Hospitalization Caused / Prolonged and Life Threatening).  Additional information was received from patient and telephone follow-up with patient on 07-JUN-2021 and 16-JUN-2021. The following information was updated and incorporated into the case narrative: reporter details, patient demographics, batch/lot number, concomitant medications, treatment medications, laboratory data and event details. The information received on 07-JUN-2021 and 16-JUN-2021 were assessed as medically significant.; Sender's Comments: V1: Follow-up from the patient provided clinical details. This report received from a health care professional via VAERS (VAERS ID 1267091) & the patient concerns a 60-year-old male who experienced thrombotic thrombocytopenic purpura (TTP) 5 or 6 days after receiving Janssen Covid-19 vaccine. Concurrent conditions included constipation & paraplegia for many years due to motor vehicle accident. Concomitant medications included bisacodyl, atorvastatin and sertraline. Initial symptoms included speech difficulty, fatigue mild headaches, dizzy spells, stuttered speech, petechiae, bruising of skin, dark urine, hand dexterity problem; his doctor advised him to go to the Emergency Department (ER). Ten days post-vaccination, he went to the ER and was hospitalized. TTP was confirmed by  A disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS13) activity level < 5% and the presence of inhibitor. Labs also showed schistocytes, thrombocytopenia (Platelet count 13K), elevated lactate dehydrogenase 671 U/L, blood bilirubin increased 2.6 mg/dL, normal blood fibrinogen normal, Blood lactate dehydrogenase increased, Coombs test negative, Hemoglobin decreased 6.4 g/dL, & Haptoglobin decreased <17 mg/dL. CT scan was negative for stroke; work up did not show blood clots. Patient was treated with plasma exchange, steroids, rituximab, acyclovir, & fluconazole and platelet count improved to 214K. Last reported platelet count was 159K. The patient was hospitalized for 26 days and recovered. Per Brighton Collaboration (BC) criteria this is NOT a case of Thrombocytopenia Thrombosis Syndrome (TTS) (BC Level 5). However, given the close temporal relationship to vaccine, a relationship with Janssen Covid-19 vaccine cannot be ruled out. Therefore, the relationship is considered indeterminate.