Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Protein total normal, Prothrombin time prolonged, Pyrexia, Rales, Red blood cell count
Clinical narrative: This case was reported in a literature article and described the occurrence of endocarditis staphylococcal in a 31-year-old female patient who received HepB vaccine. The patient's past medical history included bacterial infection due to staphylococcus aureus, pneumonia, sinusitis, cystitis, pyelonephritis, back pain, superficial thrombophlebitis of leg and homeless. Concurrent medical conditions included drug allergy, opioid type dependence (started consuming drugs when she was 14, including cocaine and heroin), smoker, alcohol use, viral hepatitis C (diagnosed at 15 years of age), abscesses of skin (on her hands, arms, legs and back), enterobacter cloacae infection, anxiety, hyperhidrosis, cholelithiasis and vasomotor rhinitis. Concomitant products included ibuprofen and methadone. On an unknown date, the patient received hepatitis B vaccine (unknown). On an unknown date, unknown after receiving hepatitis B vaccine, the patient experienced endocarditis staphylococcal (serious criteria hospitalization and GSK medically significant), dyspnea, chest pain, fever, chills, urticaria, low back pain, knee pain, lymphadenopathy inguinal, skin warm, effusion (R) knee, pain in spine, heart murmur, fungal endocarditis (serious criteria GSK medically significant), bacterial infection due to staphylococcus aureus (serious criteria GSK medically significant), sinus tachycardia, septic emboli (serious criteria GSK medically significant), hilar lymphadenopathy and tricuspid regurgitation (serious criteria GSK medically significant). The patient was treated with Methadone, antibiotics nos and buprenorphine. On an unknown date, the outcome of the endocarditis staphylococcal, dyspnea, chest pain, fever, chills, urticaria, low back pain, knee pain, lymphadenopathy inguinal, skin warm, effusion (R) knee, pain in spine, heart murmur, fungal endocarditis, bacterial infection due to staphylococcus aureus, sinus tachycardia, septic emboli, hilar lymphadenopathy and tricuspid regurgitation were unknown. It was unknown if the reporter considered the endocarditis staphylococcal, dyspnea, chest pain, fever, chills, urticaria, low back pain, knee pain, lymphadenopathy inguinal, skin warm, effusion (R) knee, pain in spine, heart murmur, fungal endocarditis, bacterial infection due to staphylococcus aureus, sinus tachycardia, septic emboli, hilar lymphadenopathy and tricuspid regurgitation to be related to hepatitis B vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of tricuspid-valve endocarditis in a 31-year-old female subject who had received an unspecified hepatitis B vaccine (manufacturer unknown). The subject reported to be allergic to buprenorphine and naloxone in combination as it had triggered "withdrawal symptoms" in the past. She lived with a roommate but had been homeless previously. She worked with animals and had traveled abroad the previous year. She had started consuming drugs when she was 14 including cocaine and heroin and had been on several treatments including methadone maintenance treatment. She smoked cigarettes and reported that she drank alcohol infrequently. Her concurrent medical conditions included hepatitis C virus infection diagnosed at 15 years of age; skin abscesses on her hands, arms, legs and back, some of which had required incision and drainage and had tested positive for Enterobacter cloacae, coagulase-negative staphylococcus and methicillin-sensitive Staphylococcus aureus in the past; anxiety; axillary hyperhidrosis; cholelithiasis and vasomotor rhinitis. She had a previous history of pneumonia, sinusitis, cystitis, pyelonephritis, back pain and superficial thrombophlebitis of the left leg. Concomitant medication included ibuprofen and methadone (acquired by her, taken the day before the admission). Her sister suffered from a thyroid condition and both her parents were well. No further information on the subject's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, the subject received a dose of an unspecified hepatitis vaccine (dosage, administration route and site unknown; batch number not provided). On an unspecified date, an unknown period after the administration of the vaccine, the subject was admitted with complaints of dyspnoea, chest pain and a 10-day intermittent history of fever (up to 40.3 deg. C; 38.9 deg. C after the administration of ibuprofen the evening before the admission) that was accompanied by chills, rigors, diffuse urticaria and pain in the chest, low back and knees. Upon clinical examination she was alert and orientated; her temperature was 37.1 deg. C, her blood pressure 105/58 mmHg, her pulse was 111 bpm, respiratory rate was 18 rpm and her oxygen saturation on air was 100%. On auscultation scattered focal pulmonary crackles were noted, heart sounds were normal and an intermittent soft murmur was heard at the left lower sternal border that was not augmented on inspiration. In addition to this, inguinal lymphadenopathy was noted, as well as marks on arms, legs and femoral region that were consistent with intravenous drug administration and without evidence of abscesses or infection. Both knees were warm; there was a small effusion on the medial aspect of the right knee, with mild tenderness, normal range of motion, and no erythema. The spine was tender between the T12 and the L3 vertebrae, without paraspinal discomfort. The remainder of the examination was reported to be normal. The subject remained febrile, with a temperature as high as 38.3 degrees C during her stay in hospital and she was found to have soft murmur at the left sternal border that had not been identified earlier. She was eventually discharged home but subsequently hospitalised again 3 months later with recurrent endocarditis. Again she recovered but relapsed after 2 months and developed another endocarditis, this time of fungal origin. This was a serious case as the subject required hospitalisation. The platelet count and prothrombin-time international normalized ratio were normal, as were her levels of sodium, chloride, carbon dioxide, calcium, phosphorus, magnesium, urea nitrogen, glucose, total protein, globulin, direct and total bilirubin, aspartate aminotransferase, alanine aminotransferase and lactic acid, plasma anion gap and white-cell count (10,300 cell/mm3). The following results were under the reference range: haematocrit 27.8%; haemoglobin 9.7 g/dl; mean corpuscular volume 76 um3; erythrocyte count 3,680,000 cells/mm3; potassium level 3.1 mmol/L, creatinine 0.51 mg/dl and albumin 3.1 g/dL. The alkaline phosphatase level was elevated (332 U/L) and the percentage of differential count was the following: neutrophils 89%, band forms 3.0%, lymphocytes 7.0% and monocytes 1.0%. A microcytosis was seen on smear description. She tested negative for urinary human chorionic gonadotropin and a urinalysis revealed clear yellow urine, with a specific gravity of 1.020, a pH of 6.0, trace of ketones and albumin, 2+ urobilinogen, and 1+ bilirubin. Three sets of blood cultures were obtained over a 46-minute period from different sites; 6 out of 6 had grown gram positive cocci in clusters by the morning of hospital day 2 and 9 of the 10 blood cultures drawn over a 48-hour period grew Staphylococcus aureus. An electrocardiogram performed on admission showed sinus tachycardia (109 bpm) but was otherwise normal. Posteroanterior and lateral chest radiographs showed low inspiratory volumes and multiple, bilateral, ill-defined nodular opacities, throughout the right lung and left apex that measured up to approximately 1 cm in their greatest dimension. The cardiomediastinal silhouette was slightly enlarged, but there were no pleural or pericardial effusions. Ten hours after presentation a chest computed tomography scan performed without administration of contrast material because of difficulty obtaining intravenous access showed multiple thick-walled nodular opacities throughout both lungs, many of which had central cavitation that was suggestive of septic emboli, as well as more confluent consolidative opacities in the dependent right lower lobe. The largest opacity measured 3.7 cm by 2.3 cm and was located in the right upper lobe along the major fissure. There was also bilateral hilar lymphadenopathy. A transthoracic echocardiography revealed tricuspid-valve thickening, with a large, mobile echodense mass, as well as a patent foramen ovale; no previous studies were available for comparison. There was no evidence of vegetations on the aortic, mitral or pulmonic valves, neither was there evidence of intracardiac thrombus. There was mild tricuspid regurgitation but the size and function of the right ventricle were normal. A transesophageal echocardiography was performed on hospital day 4 and it showed no aortic- or mitral-valve disease; but confirmed the presence of two separate echodense masses on the tricuspid valve: one on the anterior leaflet that measured 14 mm by 9 mm and one on the septal leaflet that measured 12 mm by 10 mm. The authors felt that the microbiologic and echocardiographic findings presented fulfilled the modified Duke criteria for definite endocarditis. Treatment for the endocarditis consisted of bactericidal therapy and a brief detoxification therapy with methadone. On discharge, she was scheduled to complete a course of intravenous antibiotics at another facility but she relapsed. Valve replacement surgery had been considered but it was decided that it was not indicated. She was commenced on buprenorphine during her second admission, enrolled in an intensive outpatient program, and started attending meetings of Alcoholics Anonymous and Narcotics Anonymous. She was reported to have done well for 2 months and then relapsed and she developed a fungal endocarditis. She resumed taking buprenorphine in the hospital, reconnected with the intensive outpatient program, and returned to Alcoholics Anonymous and Narcotics Anonymous. At the time of reporting the outcome of the endocarditis was unspecified. The authors reported that she had been sober for more than 1 year; she was working with a community coalition targeting substance use, and still receiving treatment with buprenorphine. The authors did not comment on any causal relationship between the vaccine and the event. The authors did not include any conclusion.