Age: 1.08
Sex: F
Vaccine: UNK
Symptoms: Immunoglobulin therapy, Increased tendency to bruise, Injection site haemorrhage, Injection site induration, Injection site urticaria
Clinical narrative: This 13-month-old female subject was enrolled in a blinded study. The subject received the 1st dose of PRIORIX vs MMR II+VARIVAX (+ PREVNAR) (subcutaneous) on 19th March 2015. Concurrent medical conditions included upper respiratory infection, fever, and allergic Urticaria. Concomitant products included BENADRYL, ibuprofen, DECADRON, acetaminophen, PREMIXEL, lidocaine cream, and nystatin. On 21st March 2015, 2 days after receiving PRIORIX vs MMR II+HAVRIX+VARIVAX (+PREVNAR), the subject developed severe - grade 3 idiopathic thrombocytopenia. Serious criteria included hospitalization and medically significant. The subject was treated with OCTAGAM, WINRHO, FLEBOGAMMA, and prednisone. Priorix vs MMR II+HARVIX+VARIVAX+ (+PREVNAR) was continued with no change. The outcome of idiopathic thrombocytopenia was not recovered/not resolved. The investigator considered that there was a reasonable possibility that the idiopathic thrombocytopenia may have been caused by PRIORIX vs. MMR II+HARVIX+VARIVAX (+ PREVNAR). Relevant Tests: platelets-decrease. Diagnostic results (unless otherwise stated, normal values were not provided): On 22nd March 2015, band neutrophil count result was 1 unknown. Haematocrit result was 32.3 unknown. Haemoglobin result was 10.4 unknown, Lymphocyte count result was 50 unknown, Lymphocyte morphology abnormal result was 1 unknown, Mean cell volume result was 77 unknown, Monocyte count result was 17 unknown, Myelocyte count result was 1 unknown, Neutrophil count result was 30 unknown, Platelet count result was 6 K/uL. Red blood cell count result was 4.20 M/uL, Red cell distribution width increased result was 15.9 unknown and White blood cell count result was 11.9 K/uL. On 31st March 2015, Platelet count was 4 K/uL. On 16th April 2015, Platelet count result was 5 K/uL. On 30th April 2015, Platelet count result was 15 K/uL. On 4th May 2015, Platelet count result was 395 K/uL. On 12th May 2015, Platelet count result was 32 K/uL. On 19th May 2015, Platelet count result was 22 K/uL. On 20th June 2015, Platelet count result was negative for bleeding unknown. In June 2015, Platelet count result was 43 K/uL. On 20th June 2015, Platelet count result was 0 K/uL. On 1st July 2015, Platelet count result 47 K/uL. On 24th July 2015, Platelet count result was 26 K/uL. On 4th August 2015, Platelet count result was 12 K/uL. On 6th August 2015, Platelet count result was 17 K/uL. On 9th August 2015, Platelet count result was 8 K/uL. On 14th August 2015, Platelet count result 52 K/uL. On 20th August 2015, Platelet count result was 68 K/uL. On 27th August 2015, Platelet count result was 38 K/uL. On 2nd September 2015, Platelet count result was 88 K/uL. On 10th September 2015, Platelet count result was 219 K/uL. On 18th September 2015, Platelet count was 175 K/uL. On 30th September 2015, Platelet count result was 84 K/uL. On 9th October 2015, Platelet count result was 18 K/uL. On 23rd October 2015, Platelet count result was 3 K/uL. Investigator text: Subject presented to emergency department 21Mar2015 with fever, upper respiratory infection and hives on arms and legs near injection sites. DECADRON, BENADRYL and ibuprofen given-rash resolved. Subject discharged home. Impression allergic reaction, URI, fever vaccination vs URI. Subject returned to emergency department 22Mar2015 with fever cough and rash-petechial scattered across some areas of coalescence at neck and legs. Vaccine sites with bruising-no cellulitis or abscess. Consult with pediatrics as petechia were concerning. CBC drawn-platelet count 6K/uL. Admitted for idiopathic thrombocytopenia, observation and potential transfusion. Admitting exam notes scattered pinpoint petechial rash with petechia convalescing into purpuric plaques on back of neck. Previous injection sites on arm and legs with indurated eccymoses, largest 2 cm. Numerous small bruises on arms and legs. Hematology consult sent. Assessment URI symptoms, fever and petechial rash and easy bruising. Most likely acute idiopathic thrombocytopenic. Event assessed temporally as related due to time and date of vaccine in relation to time and date of event. 08Apr2015-additional narrative-During hospitalization subject also diagnosed with bilateral otitis media and startd on amoxicillin. Subject discharged to home 24Mar2015 with diagnosis of thrombocytopenia, viral syndrome, otitis media and petechiae. Office visit with primary care giver 25Mar2015 for hospital follow up revealed new bluish ecchymosis on right cheek after bumping into doorway. No induration and no new petechiae per parent. Subject readmitted to hospital 31Mar2015 for intravenous immune globulin therapy after laboratory results revealed platelets of 4K/uL. In the hospital they were unable to obtain intravenous access so subject discharged to home 01Apr2015. Follow up appoint with primary care giver on 02Apr2015 and again 03Apr2015 for diaper dermatitis. Telephone appointment with pediatric hematologist scheduled for 07Apr2015. 21May2015-additional narrative-07Apr2015 telephone appointment with pediatric hematologist-assessment acute idiopathic thrombocytopenia purpura. Plan-repeat complete blood count weekly. Platelets 5K/uL on 16Apr2015. 30Apr2015 subject readmitted to hospital due to epistaxis, blood streaked stool and plaelet count of 15K/uL on admission. Received intravenous immune globulin 1g/kg overnight and tolerated well. Discharged home 01May2015. Follow up platelet counts: 04May2015=395K/uL, 12May2015=32K/uL, 14May2015 telephone appointment with pediatric hematologist-impression acute idiopathic thrombocytopenia purpura with excellent response to intravenous immune globulin therapy but thrombocytopenia returned less than 2 weeks after treatment. Plan-continue to monitor platelet counts. May repeat IVIG if subject develops clinical bleeding, if platelets fall below 10K/uL if parent requests. Complete blood counts weekly until signs of improvement. Check titers for measles, mumps and rubella prior to any booster dose of MMR and do not give if immune. 19May2015 Platelet count 22K/uL. 03Jun2015 Parent brought subject to Emergency Department due to a minor head injury. Neurological exam within normal limits and Computerized Tomography scan negative for bleeding. Due to ongoing idiopathic thrombocytopenia, subject readmitted to hospital for treatment. Subject discharged homeon 04June2015 following treatment. Update 23Jun2015-20June2015 subject seen in the emergency department for nosebleeds. Complete blood count revealed platelet count of 0 K/uL. Consultation with hematologist recommended hospital admission for treatment with intravenous immune globulin. Subject tolerated treatment well with platelet count of 43 K/uL on discharge. 01Jul2015 Subject seen in clinic for runny nose and rash that parent thought might be petechial. Physician impression was viral syndrome with possible heat rash. No petechial. Complete blood count results-platelets=47Ku/L. Additional information on 18SEP2015: Head injury is a non-serious AE. Allergic reaction - Hives is not a sign or symptom of the SAE Additional information on 25SEP2015 (Narrative 1st update received on paper SAE form): 24JUL2015: Office visit with haematologist. Assessment acute idiopathic thrombocytopenia. Plan repeat complete blood count today, continue to watch closely for bleeding. Will treat if non-cutaneous bleeding occurs. Platelets 26 K/uL. 04AUG2015: Platelets 12 K/uL. 06AUG2015: Subject presented to Emergency Department following a fall. Subject was wearing a helmet but hit face on the ground. She initially had some bleeding from the lips which was resolved by the time she reached the Emergency Department. No loss of consciousness, vomiting or other bleeding noted. Diagnosis minor face trauma. Platelets 17 K/uL. 09AUG2015: Telephone visit with hematology/oncology physician due to epistaxis over night and continued bleeding from injured lip. Medical decision was made to start oral steroids, continue weekly complete blood counts and taper steroid if there was a response. Platelets 8 Ku/L. 14AUG2015: Platelets 52 KU/L. 20AUG2015: Platelets 68 Ku/L. 27AUG2015: Clinic visit for runny nose and cough. Impression: mild upper respiratory infection and candidiasis likely due to oral steroid. Nystatin suspension started. Platelets 38 Ku/L. 02SEP2015 Emergency Department visit for vomiting thought to be caused by swallowing Nystatin suspension instead of swabbing and spitting. Platelets 88 Ku/L. Additional information on 26OCT2015 (Narrative 2nd update received on SAE form): Update 21OCT2015: 10SEP2015 Platelets 219 K/uL. 18SEP2015 Platelets 175 K/uL. 30SEP2015 Platelets 84 K/uL. 09OCT2015 Platelets 18 K/uL. Subject started 20 mg oral prednisone 09AUG2015. "Prednisone reduced to 10 mg/day on 11SEP2015. Prednisone reduced to 5 mg/day on 23 SEP2015. Prednisone reduced to 2.5 mg/day on 02OCT2015. Confirmed - bilateral otitis media, viral syndrome/upper respiratory infection, candidiasis and vomiting are non-serious adverse events and not serious adverse events. Dermatitis (diaper) is medical history, atopic mostly diaper area. Confirmed - mucosal bleeding (epistaxis, blood streaked stool) and minor face trauma are non-serious adverse events and not serious adverse events. 23OCT2015: Subject readmitted for IVIG treatment for platelet count of 3 K/uL Tolerated well and discharged home 23OCT2015. Additional information on 14JAN2016 (Narrative 3rd updated received on paper SAE form - no new info): As of last contact with subject on 13NOV2015 - Not recovered/not resolved. There is no further information available. Additional information on 16FEB2016 (Narrative 4th update received on paper SAE form): No new information available as of date of last contact on 13NOV2015. Subject no longer seeks or receives care at this healthcare facility. Subject lost to follow-up. Case unblinded due to end of study. Unblinding date is 14July2016.