Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Haemoglobin normal, Immune thrombocytopenic purpura, Immunoglobulin therapy, International normalised ratio normal, Low density lipoprotein increased
Clinical narrative: Information has been received from a 76 year old male patient with cholesterol and blood pressure abnormal concerning himself. The patient had no drug reactions/allergies. On 25-NOV-2014 the patient was vaccinated with one injection of ZOSTAVAX (dose, lot# and route were not reported) (recommended by his primary care physician) at the pharmacy. Concomitant therapies included an unspecified cholesterol medication, an unspecified blood pressure medication, one baby aspirin/day, and one multivitamin/day. The patient had a blood test performed "three days prior" to receiving the ZOSTAVAX on 22-NOV-2014. At that time his blood platelet count was 222 (unit unspecified). On 28-NOV-2014 the patient woke up with a bloody nose "that would not stop bleeding". He visited an unspecified emergency room on the same day. The emergency room treated "it as a regular blood nosy" (the type of treatment unspecified) and sent the patient home. On 30-NOV-2014, he was still experiencing the bloody nose and went to another Hospital Emergency Room. In the emergency room blood test was performed which determined his blood count was at "1". The patient was then admitted into hospital on 30-NOV-2014 where he was diagnosed with thrombocytopenia. The patient was treated with an unspecified "immune-globulin" for two days and was also receiving prednisone (manufacturer unknown) (unspecified dose and frequency) intravenously while in the hospital. He was released from the hospital on 03-DEC-2014 and was prescribed prednisone (manufacturer unknown) 20mg tablets that he took once daily for an unspecified amount of time. The patient reported he was continuing to see an unspecified hematologist (demographics unknown) and he reported his blood platelet count was "back up", however it was unspecified if the blood platelet count had fully recovered. It was also unspecified if the patient was still experiencing a bloody nose. Additional information was received on 30-MAR-2015 from a consumer and medical records. On 25-NOV-2014, a 76 year old male with no known allergies was vaccinated with a dose of ZOSTAVAX at 0930 (site not reported). On 21-NOV-2014, the patient had blood work drawn prior to his appointment with the physician. Laboratory results included platelet count 222 K/UL (normal 150 to 379), total cholesterol 210 mg/dl (normal 100 to 199), Low density lipoprotein (LDL) 116 mg/dl (normal 0 to 99) and vitamin D 26.3 ng/dl (normal 30 to 100). On 28-NOV-2014, the patient awoke with a profusely bloody nose and presented to the emergency room. The patient reported that at the hospital they "sprayed the inside of my nose, cauterized and packed my nose to no avail." The patient reported no blood work was done and he was discharged the same day. On 30-NOV-2014, the patient still had a bloody nose and presented to the emergency room at another hospital. Blood work was drawn and the platelet count result was 1. The patient was admitted and was administered immunoglobulin intravenously (dosage, frequency not reported) and he began a schedule of oral prednisone 20 mg tablets with a decreasing daily dosage. On 03-DEC-2014 the platelet count was 136. The patient was discharged with the diagnosis of idiopathic thrombocytopenia purpura and to follow up with his physician. The patient had his platelet count monitored with the following results: platelet count 430 on 06-JAN-2015, and platelet count was 245 on 03-FEB-2015. At the time of this report it was reported that the patient has recovered. Information was received from medical records regarding a case in litigation. On 25-NOV-2014, a 76 year old male (170 pounds, 69 inches) was vaccinated with ZOSTAVAX. The patient has no known allergies, ex-smoker (1 pack per day for 35 years, quit 2004) with hypertension, hyperlipidemia, right knee pain (16-NOV-2014), and history of infected finger (OCT-2014), hernia repair (2004) and circumcision (2004). Family history of pancreatic cancer. On 30-NOV-2014, the patient presented to the Emergency Room with several days of nosebleed and red spots on his leg. Current medications include: simvastatin, aspirin (81 mg daily which he had held past two days), multivitamins, and NAPROSYN for past few days. It was reported that the patient was in his usual state of health until 28-NOV-2014 when the patient awoke with bleeding from both nares. The patient stated he presented to a Emergency Room where he was given NEO-SYNEPHRINE and the patient reported that his right nares was cauterized then packed and the patient was sent home. It was reported that no blood work was done at that time. The patient stated his nares had continued to bleed. The patient reported red spots on his legs bilaterally since 28-NOV-2014. The Hematologist reported that on 30-NOV-2014, the patient noticed unexplained bruises over his distal right arm and also had a loose dark bowel movement and a new blister in the area of the left buccal mucosa. The patient also reported some aphthous ulcers on lower lip for several days. The patient reported back pain for about five days with sciatic type features. The physician reported white blood cell count 7.5, hemoglobin 14, hematocrit 42.2, platelet count of 1000, prothrombin time 12.2, partial thromboplastin time (PTT) 28.5 and International normalised ratio (INR) 0.97. The hematologist impression: patient with epistaxia and petechiae now found to have severe thrombocytopenia. The physician noted patient had of ZOSTAVAX two days before onset of symptoms and noted no evidence that idiopathic thrombocytopenia purpura is an adverse event after of ZOSTAVAX administration. The patient was admitted and treated with IV immunoglobulin, 1 gram/kilogram daily for two days as well as SOLU-MEDROL 60 mg twice daily intravenously. It was reported the patient platelet count improved and reached 136,000 upon discharge. The patient nasal packing was removed and nosebleed did not recur. The patient was discharged to home in stable condition on 03-DEC-2014. Discharge diagnoses: idiopathic thrombocytopenia purpura status post immunoglobulin infusion and steroids, epistaxis post nasal packing that is resolved. Upon internal review Immune thrombocytopenic purpura was determined to be a medically significant event. All available medical records will be provided upon request. Additional information has been requested.