Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Blood bilirubin increased, Chills
Clinical narrative: (OMIC) Initial report received from a physician on Aug 17 2005. An 18 year old, male patient felt his head swimming, 2 hours after he received an intra muscular injection in the left deltoid of Menactra ( lot number U1574AA) on Aug 08 2005. He lied down to nap. 3-6 hours post vaccination, fever and joint stiffness was noted. 12-36 hours post vaccination, he continued with his head still feeling swimmy. Frequent, loose bowl movements were noted (with blood). He had fever and chills that evening (Tuesday). On Wednesday, he continued to have head symptoms, swelling in the neck and slight swelling in the face, and continued with frequent bowel movements. At the time of reporting, the patient did not recover. Seriousness criteria other medically significant. Follow up information received from a physician on Oct 24 2005. Based on the follow up information this case was considered serious. The patient was examined on Aug 12 2005 and continued to complain of nausea, fatigue and face puffiness. He did have some obvious puffiness of the face, but no other significant physical findings. he was treated with Imodium for loose bowels and Tylenol as needed for fever, aches and pains. he was also advised to take loratadine 10mg daily. He was examined again on Aug 15 2005 for continued symptoms of head feeling full, eyes feeling swollen, intermittent fever and feeling tired. Temperature was 99. Blood pressure, pulse rate and respiratory rate were normal. He was prescribed Naprosyn 500 mg. twice daily for aches. On Aug 15 2005. the patient had the following laboratory tests. A complete blood count which showed a platelet count that was slightly low at 149,000 and an absolute neutrophil count that was slightly low at 1900. The white blood cell count, hemoglobin and hematocrit were normal. Sedimentation rate was normal. Complete metabolic profile results were bilirubin 1.5, AST 629, A:T 611 and alkaline phosphatase 171. All other chemistries were unremarkable. Total and C3 complement test were performed but results were not provided. On Aug 17 2005, the patient had a liver panel and hepatitis screening studies. On the date, white blood count, hemoglobin and hematocrit were normal. AST was 466 and alkaline phosphatase was 207. Total bilirubin was 1.3 Hepatitis B surface antibody titer was 1429. Hepatitis B surface antigen screen was negative. Cytomegalovirus report was equivocal at 0.9. Mononucleosis test, Hepatitis A antibody and Hepatitis C antibody test were negative. On Aug 18 2005, lab studies revealed AST 764, alt 1058, alkaline phosphatase of 212 and total bilirubin of 1.0. Total protein and albumin remained normal throughout the illness. Symptomatically, the patient was improving and away at college. On Sep 3 2005, lab studied revealed a total protein of 0.5, AST 36, ALT 67. Hepatitis B surface antibody remained elevated at greater than 2000, and the hepatitis b Surface antigen remained negative. The patient was contacted by phone on Sept 14 2005 and revealed that he was feeling fine and that his energy level had returned to normal. Per the reporter, liver function test will probably be repeated at a not yet determined later date. Other prescription medications include Retin A ointment topically for acne. the patient also has a history of asthma although the physician is unaware whether he was taking any asthma medicines during the course of his illness or immediately preceding his illness. The patient has a history of erythromycin upsets his stomach. The patients parent indicated that he had adverse reactions to other unknown immunizations in the past that caused generalized malaise and fever. The events began on Aug 8 2005. Other than the medication prescribed, he was on no other specific treatment or therapy for the symptoms. Per the reporter, the Sept 3 2005 lab studies reflected that the liver function studies had still not returned to normal range although they were very close. As of Sept 14 2005, the patients symptoms had resolved. The adverse events for this case were reranked due to the additional information that was received in this report. At the time of this report, the patient had not recovered.