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Write-up: This spontaneous report was received from a consumer (the patient''s mother) and refers to an 18 year old female patient. No information about the patient''s medical history and concurrent conditions was reported. On 10-FEB-2014, the patient was vaccinated with the first dose of GARDASIL injection (dose, route of administration, anatomical location, lot # and expiry date were not specified) for prophylaxis. Concomitant therapies included omeprazole and levothyroxine sodium (manufacturer unknown). In February 2014, the patient started to feel headaches. On an unknown date, an unspecified blood exams were performed and the results were reported as good, nothing wrong. On 17-SEP-2015, the patient was vaccinated with the second dose of GARDASIL injection (dose, route of administration, anatomical location, lot # and expiry date were not specified). In approximately September 2015, the patient experienced pulmonary thrombosis, photosensitivity, systemic lupus erythematous (SLE), and possible autoimmune hepatitis. On 02-OCT-2015, the patient started feeling dizziness with syncope, and nausea when she was at the school, and had to be retired from the school in those days because she felt very sick (she had cold sweats, and felt very tired). Since that time, the patient was investigated through unspecified tests until the report time. On an unspecified date in 2016, the patient was diagnosed with hypothyroidism, juvenile rheumatism (which had been treated with corticoids, 6 pills a day). Due to corticoids use, on an unknown date in 2016, the patient developed hair in the body, her weight increased, and all her appearance had changed "very much". Additionally, due to the corticoids, she was presenting at the time of the report, skin problems such as dry white skin color, just as the skin after a tan in the sun, for which she had to apply very high cost creams for hydrating and sun protector (120 or 150 protection factor). When she stopped the corticoids, her joint pains increased and reduced her walking, so she had to use a wheelchair (considered as disabling) during this timeframe. On an unknown date in 2016, the patient had an unspecified biopsy that resulted negative. The outcome of autoimmune hepatitis, hypothyroidism, systemic lupus erythematosus, rheumatism and pulmonary thrombosis was reported as not recovered. The outcome of cold sweat, dizziness, syncope, headache, fatigue, nausea, "her appearance had changed", felt sick, "developed hair in her body", photosensitivity, dry white skin and weight increased was not reported. The reporter did not provide the causality assessment between the events and GARDASIL. Upon internal review, the events of pulmonary thrombosis, systemic lupus erythematosus (SLE), and possible autoimmune hepatitis were considered to be medically significant. Follow up information has been received from the patient''s mother on 25-OCT-2016. The patient had no surgeries, previous hospitalization, traumas, allergies or toxicity. The patient presented to the hospital on 01-JUN-2016, at 11:46 am, with the following symptoms: 2-3 days of evolution with thoracic pain (irradiated retrosternal region) (oppressive type) when breathing, associated with mild dyspnea, also referred pleuritic pain and subjective fever, dyspnea with little effort and she also had paresthesias in hands with distal cyanosis. Vital signs were as follows: respiratory rate 16/min, oxygen saturation 92% (without oxygen), arterial pressure (at 14:42 pm) 133 mmHg (systolic), 81 mmHg (diastolic). Physical exam showed normal head, pink wet mucous, normal neck, normal movements without adenopathies, normal thorax with maculopapular lesions in anterior part, cardiac sounds rhythmic without heart murmur, normal respiratory sounds, soft abdomen without pain, extremities were normal with distal acrocyanosis with suitable capillary refill. Skin, neurologic, psychic and dorsal examination was found normal. At that moment, the patient presented normoxemia and was hemodinamically stable without auscultation abnormalities. Evaluation by systems (skin) showed 4 month evolution of facial, hands and thorax erythema (exposed areas), flaking, with lupus suspicion vs. dermatomyositis. The patient was followed by dermatology. An electrocardiogram and thorax X-ray were performed on 01-JUN-2016, at 14:50 pm. Electrocardiogram showed sinus rhythm without signs of ischemia or lesion. Thorax X-ray showed no consolidations or outpouring. Laboratory results were as follows: leukocytes 3.04 (units not provided), neutrophil 67.8%, hemoglobin 14.6 (units not provided), hematocrit 41.4 (units not provided), platelet count of 146.000 (units not provided), D-dimer 0.63 (units not provided), blood urea nitrogen (BUN) 11.7 (units not provided), blood creatinine 0.67 (units not provided) and T-troponin 0.037 (units not provided). A test to evaluate control troponin was performed on an unknown date (20+51) and resulted as 0.038 (units not provided). After examinations, it was decided to hospitalize the patient on 01-JUN-2016, at 23:59, with venous catheter and the following medications were initiated: enoxaparin sodium (50 mg, subcutaneously, every 12 hours), omeprazole (20 mg, once a day), tramadol (oral solution, 6 drops, every 8 hours). Vital signs showed arterial pressure 126/77 mmHg (systolic), 93 mmHg (diastolic), cardiac frequency 99 beats/min, respiratory frequency 19/min; temperature 36.5 degrees Celsius, oxygen saturation 97% (without supplemental oxygen). According to the results, the patient had leukopenia, was D-dimer positive, troponin T was increased, renal function was preserved and an electrocardiogram showed sinus tachycardia. In that moment, the patient had clinical stability with improvement of cephalea, tachycardia without dysthermia and without signs of respiratory difficulty or oxygen requirements, joint pain persisted. On 02-JUN-2016, the following laboratory results were obtained: erythrocyte sedimentation rate 8 (units not provided) (PCR 2.4), antistreptolysine 89.2 (units not provided), brain natriuretic peptide (BNP) 8.2 (units not provided), glutamic oxaloacetic transaminase 159 (units not provided), alanine aminotransferase 136 (units not provided), prothrombin time 15.7 (units not provided), partial thromboplastin time (PTT) 37.3 (units not provided), international normalized ratio (INR) 1.18 (units not provided), urinalysis showed leukocyte esterase 25, protein 25, erythrocytes 10, few bacterias, epithelial cells 1, leukocytes 2, erythrocytes 1, D-dimer positive, urinalysis with proteinuria. The patient continued with total anticoagulation (enoxaparin sodium, 40 mg, subcutaneously, every 12 hours) and gastroprotection (omeprazole 20 mg capsule, once a day). On the same date, a coronary computed tomography angiogram (Angio-TAC) resulted negative for pulmonary embolism and showed left systolic function conserved with mild tricuspid insufficiency and no masses or thrombus evidence. Cardiomyopathy was discarded. Enoxaparin sodium dose was changed to 60 mg, subcutaneously, once a day. On 03-JUN-2016, the patient was seen by a nutritionist, who said that the patient was at high nutritional risk. A therapeutic diet was programmed. Due to elevation of hepatic enzymes, an anti-smooth muscle antibodies test was requested to discard autoimmune hepatitis. Due to joint pain persistence, a rheumatoid factor test and a urine Gram test was requested. On that day, the patient received omeprazole 20mg capsule (1 capsule daily, orally) and tramadol hydrochloride (100mg/ml, 10%, oral solution, 6 drops oral, every 8 hours). On 04-JUN-2016, the patient received omeprazole 20mg capsule (1 capsule oral, once every 24 hours) and enoxaparin sodium 40mg (40mg, subcutaneously, once every 24 hours). On 05-JUN-2016, leukocyte count was 2.72 (units not provided), neutrophil count 55%, hematocrit 37.9 (units not provided), hemoglobin was 13.7 (units not provided), platelets 129000 (units not provided), anti-DNA antibodies were negative, complement component C3 was 103 (units not provided), creatine phosphokinase test was 111 (units not provided), anti-Ro antibodies were at 32.1 (units not provided), 24-hour urine protein test was 129 (units not provided), proteinuria 9.6 (units not provided), urine volume was 1350 (units not provided). La/SSB auto-antigens were 3.2 (units not provided), anti-Smith antibodies were 1.7 (units not provided), anti-ribonucleoprotein (RNP) antibody was 1.3 (units not provided). The patient started therapy with prednisolone (manufacturer unknown) (50 mg tablet, orally, once a day), maintained with omeprazole (20 mg capsule, once a day) and tramadol hydrochloride (100 mg/ml, oral solution, 6 drops, oral, every 8 hours). On 06-JUN-2016, the following analysis was reported: the patient was stable without inflammatory answer or respiratory difficulty, afebrile, without pain, 24-hour urine proteins between normal range, without proteinuria. Clinic criteria of lupus with malar erythema, photosensitivity rash, thrombocytopenia and leukopenia, immunological criteria negative. In that moment, the patient had lumbar pain and joint pain improvement in superior extremities. On the same date, the patient called the physician because she presented precordial pain with pressure associated with dyspnea, not irradiated within 1 hour of evolution, without evidence of lesions in echocardiogram, without contractility disorders, so analgesics were indicated (tramadol hydrochloride 25 mg, intravenously). On that day, the patient received omeprazole (1 capsule, orally, every 24 hours), enoxaparin sodium (40 mg, subcutaneously, every 24 hours) and prednisone (manufacturer unknown) (1 tablet, every 24 hours, orally). On 07-JUN-2016, it was determined that autoimmune profile was negative, the patient had leukopenia and anemia, but she did not meet criteria for lupus. Stopping therapy with steroids and enoxaparin sodium was considered. The following laboratory results were obtained: total bilirubin (BT) was 0.22 (units not provided), direct bilirubin (BD) was 0.13 (units not provided), bilirubin indirect (BI) was 0.09 (units not provided), Fanconi anemia (FA) test was 53 (20-141) (units not provided). On that day, the patient received tramadol hydrochloride (100 mg/ml, 6 drops, oral, q8h), and omeprazole (1 capsule, qd). On 08-JUN-2016, the patient received omeprazole (as previously taken), tramadol hydrochloride (as previously taken) and enoxaparin sodium (as previously taken). On 09-JUN-2016, the patient was discharged from the hospital with the following diagnosis: chest pain when breathing (admission diagnosis), pulmonary embolism without mention of acute pulmonary heart (related diagnosis) and other forms of systemic erythematous lupus (principal diagnosis). The patient was discharged in good condition and all the diagnoses continued under study. On 14-JUN-2016, the patient was scheduled to visit the rheumatology department. On 14-JUN-2016, the patient went for rheumatology consultation with antecedent of systemic lupus erythematous, joint pain, head rash and general malaise. Physical examination showed good condition without respiratory difficulty, rash in thorax and superior extremities, mobility limitation because of pain without any other alterations. The patient was very symptomatic for which it was decided to maintain the analgesic treatment under observation. On that day, the patient received the following medications: tramadol hydrochloride 100 mg/ml (10% oral solution, 6 drops, q8h), acetaminophen (manufacturer unknown) (500 mg tablet,orally, 1 tablet, every 6 hours) and enoxaparin sodium (40 mg, subcutaneous, q24h). On the same day, the patient visited medical consultation and laboratory results were as follows: leukocytes 3460 (units not provided), neutrophils 75%, lymphocytes 15%, monocytes 7.5%, hematocrit 40.6 (units not provided), hemoglobin 14.2 (units not provided) and platelet count 180.000 (units not provided). The patient had plaque lesions (erythematous) in thoracic region that should be evaluated by dermatology department. The patient continued with medical management from rheumatology department. The patient''s human immunodeficiency virus (HIV) test result was 0.17 (negative), hepatic profile and cytomegalovirus test resulted negative. The recommendation was to hospitalize the patient again for a better study of the pathology. On 15-JUN-2016, during hospitalization, the laboratory tests were performed with result: thyroid-stimulating hormone (TSH) 12.350 (units not provided), rheumatoid factor: 12 (units not provided), cytomegalovirus test was negative, anticitruline <7 (negative) (units not provided), cytomegalovirus (CMV) Immunoglobulin (IgG) 55.3 (positive) (units not provided), Immunoglobulin M (IgM) 0.2 (negative) (units not provided), ferritin 416.2 (units not provided), glutamic-oxaloacetic transaminase (TGO) 73 (units not provided), glutamic pyruvic transaminase (TGP) 55, BUN 9.5 (units not provided), creatinine 0.5 (units not provided), leukocyte count 3460 (units not provided), "N" 75.2 (units not provided), hemoglobin 14.2 (units not provided), hematocrit 40.6 (units not provided) and platelet count 180000 (units not provided). On 20-JUN-2016, thyroid antimicrosomal antibodies resulted as 6.0 (units not provided), thyreoglobulin <10 (units not provided), anti-Sm antibodies 1.5 (units not provided), anticardiolipine 1.2 (units not provided) and Lupic anticoagulant <1.2 (units not provided). On 21-JUN-2016, the patient was seen by psychiatry department and the patient was prescribed with hydromorphone, naproxen and acetaminophen (manufacturer unknown), to treat the pain. As the patient did not show improvement, the therapy with hydromorphone was stopped. On 23-JUN-2016, the patient''s evolution was reported as follows: diagnostic exhausted evolution showed improvement, without deterioration found in studies by connective tissue disease, rheumatology integrated management initiated, with a favorable evolution after agreement on pain control. At that moment, the patient was full modulated, with tight management and pain management. Upon pharmacological adjustment, the patient might be given discharge. The patient was instructed to continue with prednisolone (manufacturer unknown), chloroquine, to claim laboratory results and continue with rheumatology outpatient control. She was discharged from the hospital on an unknown date in 2016. Evolution plan: discharge with the following medications: prednisolone (manufacturer unknown) 15 mg (orally, qd), omeprazole (20 mg, oral, q24h), levothyroxine sodium (manufacturer unknown) (75 mcg, qd, on empty stomach), analgesics according to pain, ambulatory physiotherapy and control with rheumatology pending. In July 2016, the patient''s had a transaminase report of TGO 155 (units not provided) and TGP 245 (units not provided). On 09-AUG-2016, the patient went to medical consultation remitted by rheumatology. The patient with systemic erythematosus lupus treated by rheumatology area, referred polyarticular pains, lumbar pain (severe) and temporal cephalea in the right side associated with vertigo (onset date unspecified). The patient referred that the pain was constant (intensity of 8/10) with pain crisis of 10/10, which presented minimum once during the week. No factor that caused or triggered the disease was identified, nor a factor that improved the pain. It was stated that the pain limited her functionally and she also had trouble sleeping (onset date unspecified). The patient had taken tramadol hydrochloride drops with improvement of symptoms but developed tachycardia and somnolence (unspecified date in 2016). The patient''s vital signs were as follows: arterial tension 120 mm Hg, cardiac frequency 74/min, temperature 36 degrees Celsius with IMC of 32.8125. Physical examination showed general good condition; head, eyes, ears, nose, mouth, throat, neck, thorax, pulmonary, heart, breasts, abdomen, genitourinary, extremities, psychiatric, neurologic, skin examination results were reported as "no". Osteoarticular examination showed cervical mobility arches preserved with pain on the right paravertebral palpation and palpation of the greater occipital. Lumbar spinous showed tenderness. Diagnosis: systemic erythematous lupus without other specification. Medication prescribed and administered was tramadol hydrochloride (capsule, 50 mg, 1 tab, every 12 hours for 3 months). Conduct: patient with active systemic erythematosus lupus (diagnosed in June 2016), treated with chloroquine, prednisolone (manufacturer unknown), levothyroxine sodium (manufacturer unknown), omeprazole and calcium. Due to significant and progressive increase of hepatic enzymes, the patient had pending evaluation by hepatologist. It was considered that at that moment, she was not a candidate for intervention treatment and also she should not start analgesic therapy with acetaminophen (manufacturer unknown). On 14-SEP-2016, the patient went to the rheumatology institute. It was reported that the patient was diagnosed previously with systemic erythematosus lupus and hypothyroidism. The patient referred that hepatologist consultation suggested a possible autoimmune hepatitis so corticoid dose was increased and a hepatic biopsy was requested (scheduled for 16-SEP-2016). For that moment, increase of azathioprine dose and corticosteroids dose reduction was considered. Pregabalin was added for pain in lumbar region with attempt to stop the treatment with tramadol hydrochloride. The patient continued with the headaches and recovered from pulmonary embolism on an unspecified date in 2016. The outcome of the events of vertigo, trouble sleeping and somnolence was not reported. The relatedness between GARDASIL and those events was not provided. Follow up information has been received on 07-FEB-2018 from a lawyer regarding a case in litigation concerning an eighteen year old female patient. On 10-FEB-2014, the patient received her first dose of GARDASIL (lot number and expiration unknown) intramuscular for prophylaxis. On 17-SEP-2105, the patient received her second dose of GARDASIL (lot number and expiration unknown) intramuscular for prophylaxis. The patient did not received the third dose of GARDASIL. On an unknown date, the patient experienced the symptoms of tiredness, joint pain, nausea, headache, loss of appetite, weakness, rash on the face, neck, chest, face and arms, dizziness and fainting. On an unknown date, the patient was diagnosed with hypothyroidism, juvenile arthritis, systemic lupus erythematosus (SLE), autoimmune hepatitis and photosensitivity. No further information was provided. Upon internal review Possible autoimmune hepatitis, Systemic lupus erythematosus (SLE), Pulmonary thrombosis/ pulmonary embolism, and rheumatism (joint swelling pain)/juvenile rheumatism/joint pain increase/reduce her walking so she had to use the wheelchair sometimes were determined to be medically significant. Additional information has been requested. Sender''s Comments: MERCK 1610COL012600:Mfr number.
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