Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haemoglobin, Haemoglobin decreased, Immunoglobulin therapy, Lymphocyte count, Metabolic function test
Clinical narrative: PLATELET COUNT DECREASED; IMMUNOGLOBULIN THERAPY; PETECHIAE; HAEMOGLOBIN DECREASED; THROMBOCYTOPENIC PURPURA; CONTUSION; WHITE BLOOD CELL COUNT INCREASED; ULTRASOUND DOPPLER NORMAL; This spontaneous report received from a patient via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1504952) concerned a 39 year old white (non-Hispanic or Latino) male. The patient's weight was 190 pounds, and height was 182.88 centimeters. The patient was previously treated with influenza vaccine (reported as fall's flu shot) last year (2020) for prophylactic vaccination. The patient's concurrent conditions included herpes simplex type 1 and alcohol user two drinks per week. The patient had no known drug allergies. In MAR-2020, the patient's base line for blood platelets was 246000 as per his blood test. The patient had no any previous medical history, had no adverse event with previous vaccination including boosters through childhood, nursing school and the military. The patient family mother had auto immune disease, vitiligo his maternal aunt had multiple sclerosis, which is in the auto immune disease type world and no significant history on either sides of the family to vaccination. The patient also mentioned that his younger sister passed in 2005, she developed a cold or pneumonia and she had same type of cytokine storm. The patient stated that his sister died from technically acute respiratory distress syndrome and her immune response reacted which caused lung failure. He stated that she was on an ECMO (extracorporeal membrane oxygenation) machine and she died of complications of an ECMO change over. The patient had no family history had no illness at time of vaccination, no previous doses of this vaccine, no past history of similar events, no adverse event after any previous vaccination and of allergy to vaccine, drug or food. The patient had no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days with cause and was negative for Covid-19. The patient received Covid-19 vaccine ad26.cov2. s (suspension for injection, intramuscular, batch number: 043A21A, 043A21 and expiry: unknown) dose was not reported, 1 total administered at right arm (deltoid) on 13-JUL-2021 (Tuesday) at 12:15 for prophylactic vaccination. The patient was previously treated with Vitamin C (ascorbic acid), Vitamin D3 (colecalciferol), Probiotic and L-lysine (lysine) all were used for dietary supplements for 10 years and stopped after adverse event was reported. On 14-JUL-2021 (Wednesday), the patient developed quarter sized spontaneous bruising (contusion) to bilateral calves. His lab test was performed and found that his haemoglobin and white blood cell count was decreased. On the same day, his ultrasound doppler test was performed which was normal. On 15-JUL-2021 (Thursday), he had dollar sized spontaneous bruising to bilateral calves petechial rash noted to bilateral ankles and calves. On 16-JUL-2021 (Friday), he developed petechiae rash on bilateral calf bruising and it was continued to spread from ankles to mid-thigh bilaterally. In evening, the rash started to spread on the bilateral shoulders and back. He knew at that point that he is having a reaction. On 17-JUL-2021 (Saturday), the patient went to emergency department (physician office) he was admitted to the hospital and underwent laboratory test included full blood test and complete blood count (CBC) with differential were performed. It was within normal ranges except for the platelets count was 7000. His CBC was high 5.6, haemoglobin was 16, hematocrit was 48.41 percent, lymphocyte count was 3.5, and white blood cell count was 6.7. His bilateral lower extremity ultrasound was performed and found to be negative and ruled out for blood clots in the extremities or any thrombotic thrombocytopenia were reported. It was reported that he had treated with intravenous Immune globulin (IVIG) and dexamethasone for four days. It was also mentioned that he tested for several platelets count after treated with IVIG and steroids.  On 18-JUL-2021 (Sunday), his platelets count was improved to 29000 and he was discharged from hospital on same day. Upon follow-up, he was newly diagnosed with immune thrombocytopenia purpura. On 20-JUL-2021 (Tuesday), his outpatient lab test was performed which included haemoglobin was 13.7, platelet count was 198000, and white blood cell count was 14. On 23-JUL-2021 (Friday) after treatment his platelets count were back which was 264000 and other lab test included haemoglobin which was 14.7, and white blood cell count which was 8.7. On 26-JUL-2021 (Monday), outpatient lab test was performed and his platelets count was dropped down to 45000. Later, he received treatment with prednisone 40 mg. On 29-JUL-2021, his platelets count was 38000. On 02-AUG-2021, his platelets count was 40000. On 05-AUG-2021, his platelets count was 37000. At the time of this reporter, he was still on prednisone and he was seeing his Hematologist for dose adjustment. On unspecified date the patient underwent through laboratory test included heparin anti PF 4 (platelet factor) antibody HIT (heparin-induced thrombocytopenia) which was found to be negative, CMP (comprehensive metabolic panel), electrolytes, ultrasound leg with results not reported, Covid 19 test which was found to be negative. The action taken with Covid-19 vaccine ad26.cov2. s was not applicable. The patient had not recovered from petechiae, contusion, haemoglobin decreased, immunoglobulin therapy, platelet count decreased, thrombocytopenic purpura, ultrasound doppler normal and white blood cell count increased. This report was serious (Hospitalization Caused / Prolonged, Life Threatening, and Disability Or Permanent Damage).  Additional information was received from patient on 17-AUG-2021. The following information was updated and incorporated into the case narrative: The patient's height, weight and premedical history was updated. In past medication probiotic was added along with this indication for vitamin C, vitamin D3, and L-lysine were updated as dietary supplements. The laboratory data were added.; Sender's Comments: V1: The additional information received in this version updates patient's height, weight, premedical history, lab data, past medication. The event in MAC is rephrased.  20210812177-COVID-19 VACCINE AD26.COV2.S- Immune Thrombocytopenia Purpura (coded to-Thrombocytopenic purpura), contusion,  petechiae,  haemoglobin decreased, platelet count decreased,  white blood cell count increased, ultrasound doppler normal, immunoglobulin therapy. This event(s) is considered unassessable. The event(s) has a 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).