Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer, Fibrin degradation products, Flow cytometry, Full blood count, Full blood count abnormal
Clinical narrative: Pancytopenia; Platelet count decreased; White blood cell count decreased; Biopsy bone marrow abnormal; Full blood count abnormal; Haemoglobin decreased; Increased tendency to bruise; Neutrophil count decreased; Vaccination complication; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting Systems) (VAERS ID:1574475) and from literature concerned a 55 year old male of unspecified race and ethnic origin.  This article contain information regarding vaccine induced pancytopenia after administration of Johnson and Johnson vaccine. The patient's height, and weight were not reported. The patient's concurrent conditions included eczema, penicillin allergy and non alcohol user, and other pre-existing medical conditions included: Patient had no illness. Patient denied any fever, joint pain, and recent travel. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: unknown) dose was not reported, 1 total administered on 03-MAY-2021 for prophylactic vaccination. Age at time of vaccination 55 years old. Drug Start Period was 53 days. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included alprazolam, furosemide, gabapentin, hydromorphone, lisinopril, pantoprazole, and tadalafil.  More likely than not the covid vaccine was involved with patients pancytopenia. Patient was found to have worsening pancytopenia with no other cause. On 25-JUN-2021, the patient experienced pancytopenia, platelet count decreased, white blood cell count decreased, biopsy bone marrow abnormal, full blood count abnormal, haemoglobin decreased, increased tendency to bruise, neutrophil count decreased, vaccination complication. He had easy bruising but no bleeding, no infections fevers or chills, no symptoms of anemia. Thee patient presented mild gum bleeding and denied any fever, joint pain. Laboratory data included: Complete blood count (CBC) (NR: not provided) worsening blood counts. On 03-AUG-2021, Laboratory data included: Hemoglobin (NR: not provided) 11.3. On 05-AUG-2021, Laboratory data included: Bone marrow biopsy (NR: not provided) Inflammatory or consumptive cause to the pancytopenia, Hematology test (NR: not provided) Inflammatory or consumptive cause to the pancytopenia, and Platelet count (NR: not provided) 48000. On 16-AUG-2021, Laboratory data included: Absolute neutrophil count (NR: not provided) 1300, and White blood cells (NR: not provided) 2600.Laboratory data (dates unspecified) included: Activated partial thromboplastin time ratio normal within normal limit, Anti-cyclic citrullinated peptide antibody (ANTI-CCP)Negative, Anti-smith antibody negative, Antinuclear antibody Negative, Bone marrow biopsy confirmed a normal consumptive process consistent with reaction to medication or vaccine use and no evidence of any dysplasia; Computed Tomography Scan(CT scan) chest abdomen pelvis scan was negative for any mass or lymph node with no evidence of liver disease or splenomegaly, Complete blood count no abnormalities prior to receiving COVID-19 vaccine, Copper within normal limit, Creatinine within normal limit, Cryoglobulins Negative, Double stranded DNA (deoxyribonucleic acid) antibody Negative, Epstein-Barr virus antibody negative Negative, fibrin degradation products (FDPs) within normal limit, Fibrin D dimer normal within normal limit, Fibrinogen within normal limit, Flow cytometry Negative, Folate within normal limit, HIV (human immunodeficiency virus) Negative, Haptoglobin within normal limit, Hemoglobin (NR: not provided) 11 g/dL, Hepatitis Negative, Iron within normal limit, Lactate dehydrogenase within normal limit, Leukocyte count (NR: not provided) 3000 uL, Liver function tests within normal limit, Platelet count (NR: not provided) 63000 uL, Prothrombin time test within normal limit, Rheumatoid factor Negative, Ribonucleoprotein antibody Negative, Serum protein electrophoresis normal, Serum total protein within normal limit, Smear did not show any schistocytes, blasts or dysplastic cells; Thyroid stimulating hormone within normal limit, Vitamin B12 within normal limit, antineutrophil cytoplasmic antibodies (c-ANCA) Negative, and peripheral cytoplasmic antibodies (p-ANCA) negative. Patient was started on a prednisone 1mg/kg with improvement of counts (White blood cells (WBC):5100/uL, Hemoglobin 13.2 g/DL, Platelet counts 130000/uL) but as soon as dose was tapered to less than 40 mg/day, petechiae and pancytopenia worsened. Patient was transitioned to mycophenolate mofetil (MMF) and remains on MMF 500 mg twice daily which allowed the tapering and eventual discontinuation of prednisone. Patient continues to be on MMF and attempts to taper MMF has so far been unsuccessful. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from biopsy bone marrow abnormal, full blood count abnormal, haemoglobin decreased, increased tendency to bruise, neutrophil count decreased, pancytopenia, platelet count decreased, vaccination complication, and white blood cell count decreased. The author concluded that though its very rare, this case highlights the importance of considering COVID-19 vaccination as a rare cause of pancytopenia in the appropriate setting. This report was serious (Other Medically Important Condition). This case is a duplicate of 20230819957.  Additional information was received from a health care professional on 06-AUG-2023. It was determined that 20230819957 was a duplicate of this case. All relevant information regarding this case will be submitted under 20210857375. The following information was updated and incorporated into the case narrative: Patient history, Lab test added (leukocyte count, hemoglobin, platelet, creatinine, lactate dehydrogenase test (LDH), haptoglobin, total protein, liver function tests, thyroid-stimulating hormone test (TSH), iron studies, vitamin b12, folate, copper, prothrombin time test and inr (pt/inr), partial thromboplastin time (PTT), fibrinogen, fibrin degradation products (FDP), d dimers, peripheral smear, serum protein electrophoresis with immunofixation, HIV, hepatitis, epstein-barr virus (EBV) test, cryoglobulin, complement levels, antinuclear antibody (ANA) test, double stranded DNA (ds-dna), anti-smith antibody, antinuclear ribonucleoprotein (anti-rnp), rheumatoid factor), treatment product added (prednisone, mycophenolate mofetil).; Sender's Comments: V1: This follow up version updates-  Patient history, Lab test added, treatment product added (prednisone, mycophenolate mofetil). AER- 20230819957 was a duplicate of this case. This updated information does not alter the causality of previously reported events.  20210857375-COVID-19 VACCINE AD26.COV2.S-Pancytopenia, Platelet count decreased, White blood cell count decreased. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.