Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: No reaction on previous exposure to drug, Oropharyngeal blistering, Platelet count decreased, Platelet transfusion, Spleen scan normal
Clinical narrative: This case was reported by a consumer and described the occurrence of low blood platelets in a 56-year-old male who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included hepatitis at age of 4 and swine influenza back in 1978. Concurrent medical conditions included allergy to molds, asthma and dust allergy (nos). The subject did not have any allergies to eggs or other foods. Concurrent medications included Lisinopril, TRICOR, SINGULAIR, FLONASE, PROAIR HFA and Multivitamins. He reported he doesn't use his inhaler very often. He stated he may use an inhaler twice a month maximum or once every 6 months, depending on conditions. He last had a flu shot 10 to 12 years ago and had no reactions to the vaccine. He stated he has not had any vaccines since his childhood. On 21 September 2010 at 11:00 the subject received dose of FLULAVAL (unknown, left arm). At the time of vaccination, on 21 September 2010, the subject experienced maladministration (unspecified). On 21 September 2010, less than one day after vaccination with FLULAVAL, the subject experienced low blood platelets. On 06 October 2010, 15 days after vaccination with FLULAVAL, the subject reported he experienced bruising like crazy and blood blisters in mouth. On 07 October 2010, 16 days after the vaccination, he experienced no blood platelets. On unspecified dates in October 2010, after receiving vaccination with FLULAVAL, the subject experienced being very sick and nodule at injection site that was tender to touch. The subject was hospitalised for 7 days. The subject was treated with platelet concentrate, normal immunoglobulin and hydrogen peroxide solution. At the time of reporting, the low blood platelets, no blood platelets, bruising, and blood blisters in mouth were improved. The subject stated he still had a nodule from the vaccine site that is still tender to touch almost one month later. The outcome of the being sick was unspecified. The subject stated that on 21 September 2010 he was given the FLULAVAL vaccine ordered by his physician. The subject said that he did not want to take the vaccine, but his physician insisted. The subject said on the day he was given the vaccine, he had just gone into the office to have regular CBC bloodwork done. The subject said on Friday, 24 September 2010, he received a card in the mail from his physician asking him to make an appointment to test his blood platelets. He said that he did not have a problem with platelets before, but the card showed platelets at 109,000. On 06 October 2010, the subject said he did notice that he was bruising like crazy and he had blood blisters in his mouth. He said that because of conflicts with both himself and the physician he did not go see the doctor until 07 October 2010. The physician did a CBC in the office and the results showed a platelet level at zero. The physician asked to run another CBC test the same afternoon and the platelets were still at zero. The physician sent the subject immediately to the hospital. In the emergency room, they ran a CBC scan the same day and the platelets levels were at 4000 and 4005. The subject said he spent hours in the ER with them running tests. He had to be admitted to the hospital and at 11:00pm that night. He was given eight units of platelets. The next morning on 08 October 2010, at around 8:30am, another CBC scan was done and the platelet levels were at 2000. The subject had actually lost platelets. The physicians also ran a bone marrow biopsy to test for leukemia. The bone marrow biopsy came back on 11 October 2010 and the results indicated that the subject did not have leukemia. Also on 08 October 2010, the physicians did a full viral and bacterial scans. They did an ultrasound of the liver and spleen to watch to see if fluid was leaking out of the spleen. They also looked for the spleen to pass liquid to the liver. The tests on the liver and spleen came back on 12 October 2010 with no noticeable damage to the organs. On Saturday, 09 October 2010, the subject was tested again and platelets were still at 2000. He was again given eight units of platelets that night. On Sunday, 10 October 2010, the platelet numbers were back up to 4000. On 11 October 2010 and 12 October 2010, the subject received another eight units of platelets. He stated he was really sick, but all tests had come back fine. On 12 October 2010 and 13 October 2010, he was given an immunoglobulin purge with 1100mL IV. The platelets levels were up to 13,000 after the purge. On 13 October 2010, after the purge, the platelets were up to 22,000, which was still below critical but ok enough to go home. The subject had spent seven days in the hospital. The subject said that he feels his platelet numbers must be coming up because the bruising is clearing up. He also said that the blood blisters in his mouth are almost gone. He had treated them with rinsing with hydrogen peroxide eight times a day. The subject mentioned that he still has a nodule from the vaccine site that is still tender to the touch almost one month later. The subject was scheduled to see his hematologist on 19 October 2010. The subject has not been in contact with his primary care physician since he was given the flu vaccine. The subject feels that his primary physician may have maladministered the vaccine at the time.