chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Neutrophil count normal, Pyrexia, Rash, White blood cell count normal, White blood cell disorder
Clinical narrative: Information has been received from Sentrx and was assigned manufacturer report number MC200800078, concerning a 61 year old male who is a smoker and has a history of hyperlipidaemia, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA)/PCI and a family history of coronary artery disease who on 02-FEB-2008, was vaccinated IM into his right deltoid muscle with a 25 "ug" dose of pneumococcal 23v polysaccharide vaccine for pneumonia prevention. The patient experienced right arm cellulitis while enrolled in protocol TMC-CAN-05-02, a clinical trial comparing cangrelor to clopidogrel in subjects undergoing percutaneous coronary intervention (PCI). Other concomitant therapy included bivalirudin. On 31-JAN-2008, the patient was admitted to the hospital, enrolled in the study and underwent PCI. He received an intravenous bolus dose of the blinded study medication 5.8 ml on 01-FEB-2008 at 17:09, followed by an infusion of 95.48 mL from 17:11 to 19:15. Additionally, the patient received an oral dose of blinded study medication, four pre-procedure capsules on 01-FEB-2008 at 17:11 and four post procedure capsules on 01-FEB-2008 at 19:20. On 02-FEB-2008 at 13:00, the patient was discharged immediately after receiving the pneumococcal 23v polysaccharide vaccine. On 02-FEB-2008 at 13:30, the patient experienced right arm cellulitis. He developed redness and gradual swelling of the injection site and later in the day he developed fever and chills. Additional presenting symptoms included pain at the injection site, cough, myalgia, rash and anxiety. The patient presented back to the emergency room on 03-FEB-2008 for treatment. Laboratory tests performed included absolute neutrophil count of 10.2 Thou/uL and a white blood cell count of 12.4 Thou/uL. A blood culture was negative with no growth seen on a culture taken from the peripheral line on the right arm. The patient was treated with IV cefepime, 1 g bid from 04-FEB-2008 at 07:00 to 06-FEB-2008 at 07:00 and IV vancomycin, 1g every day on 04-FEB-2008 at 20:00 to 06-FEB-2008 at 12:15 for an infection in the right arm. Laboratory results normalized on 06-FEB-2008 with absolute neutrophils of 5.8 Thou/uL and WBC of 8.4 Thou/uL. On 13-FEB-2008, the event was considered to be resolved. This was originally reported by a physician. The reporting investigator considered the event to be probably related to the pneumococcal 23v polysaccharide vaccine and unrelated to the study medications. No further information is available.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Information has been received from a health professional concerning an 82 year old, retired, 70 inch, 129 pound, Asian male who on 03-NOV-2007 was vaccinated with his second dose of pneumococcal 23v polysaccharide vaccine (Lot #658449/0989U) intramuscularly. The patient received his first dose in 2002. On 03-NOV-2007 at 7:00 PM, the patient developed a severe local reaction with injection site redness and warmth. The patient was seen by the physician and required medical intervention. The patient was treated with fexofenadine hydrochloride (ALLEGRA) 60 mg/every 12 hours, ciprofloxacin hydrochloride (CIPRO) 500 mg/twice a day for 7 days, ibuprofen (ADVIL) and warm compresses. The patient was reexamined on 08-NOV-2007 and the pain on the right forearm, right elbow and the redness were better. The patient was fully recovered by 12-NOV-2007. The reporting physician considered local severe reaction, redness and warmth of the right arm to be other important medical events. This is one of several reports received from the same source. Additional information is not expected.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pyrexia, Rash maculo-papular
Clinical narrative: Information has been received from a physician concerning a 57 year old female with a history of metastatic colo-rectal carcinoma and no drug allergies, who on 05-FEB-2008 was vaccinated SC with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included influenza virus vaccine (unspecified). Within 24 hours post vaccination the patient experienced a 103 degree fever. The patient developed an area of 3cm of swelling at the injection site and a "non-purpuric macular papular" rash all over her body except the face. The patient was seen by the physician. No laboratory diagnostics were performed. It was reported by the physician that the patient started to feel better. The fever was slowly fading, the rash was improving, and the injection site swelling was coming down. No therapeutic treatment was given to the patient. The physician reported that this was a severe reaction and that he was going to contact the patient later that day to see how she was doing. At the time of the report, the patient was recovering. No product quality complaint was involved. The physician believed the high fever, rash, and injection site swelling to be related to the vaccination with pneumococcal 23v polysaccharide vaccine. The physician considered the high fever and rash to be disabling. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Anaphylactic reaction, Blood pressure normal, Body temperature, Cough, Dizziness
Clinical narrative: Initial and follow up information has been received from a physician concerning an 8 year old white male who on 03-JAN-2008 was vaccinated with a "single dose series" of pneumococcal 23v polysaccharide vaccine (lot# 658555/0964U) IM in the left by his allergist. Information was received from an allergist and reported the history was taken from th patient's mother. The patient has a history of chronic urticaria of uncertain etiology and pressure equalization tubes "PE Tubes." The patient had the urticaria for about 14 months but has not had any urticaria since the beginning of October 2007. The mother reported that the urticaria tends to flare up when he gets the sinus infection. The patient had a runny nose for 5 days with no cough prior to vaccination. The patient went to see the allergist and was given a pneumococcal 23v polysaccharide vaccine and within minutes at 2:20 PM the patient began coughing, having difficulty breathing, his face turned red and began to swell. The patient felt dizzy, looked pale and sweaty. The patient was given epinephrine 0.3 mL IM, ranitidine 25 mg IM, BENADRYL 50 mg IM and 45 mg PO of PRELONE. The patient also had 100% oxygen provided. 9-1-1 was called and transferred the patient to a hospital ER department. All of the patient's symptoms resolved with the exception that the voice remained somewhat hoarse. The patient's systems were reviewed. The patient had no fever. The patient does have a positive skin test to dogs. He did get some swelling under his eyes with the allergic reaction. There were no complaints of chest pain during the allergic reaction. There was no cough prior to the allergic reaction, but did have coughing and difficulty breathing with the allergic reaction. The patient looked like he was gagging, but did not throw up. The patient had no diarrhea. There were no complaints of extremity pain. There were no hives. The patient complained of dizziness during the allergic reaction. On 03-JAN-2008, the patient was alert and a non toxic child. The patient also had abdominal discomfort and recovered on an unspecified date. The patient's body temperature measurement was 36.7 centigrade orally, the total heartbeat count was 96, respiratory rate measurement was 18 and blood pressure measurement was 117/7. The patient's voice is slightly hoarse. The physician reviewed the findings and he felt that the patient has had an anaphylactic reaction to the pneumococcal 23v polysaccharide. The physician had recommended overnight observation in the short stay unit in case he has a late reaction in addition to the early reaction, which is now almost completely resolved. The mother is in agreement with the plan. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Dysphonia, Dyspnoea, Erythema, Eye swelling, Heart rate normal
Clinical narrative: Initial and follow up information has been received from a physician concerning an 8 year old white male who on 03-JAN-2008 was vaccinated with a "single dose series" of pneumococcal 23v polysaccharide vaccine (lot# 658555/0964U) IM in the left by his allergist. Information was received from an allergist and reported the history was taken from th patient's mother. The patient has a history of chronic urticaria of uncertain etiology and pressure equalization tubes "PE Tubes." The patient had the urticaria for about 14 months but has not had any urticaria since the beginning of October 2007. The mother reported that the urticaria tends to flare up when he gets the sinus infection. The patient had a runny nose for 5 days with no cough prior to vaccination. The patient went to see the allergist and was given a pneumococcal 23v polysaccharide vaccine and within minutes at 2:20 PM the patient began coughing, having difficulty breathing, his face turned red and began to swell. The patient felt dizzy, looked pale and sweaty. The patient was given epinephrine 0.3 mL IM, ranitidine 25 mg IM, BENADRYL 50 mg IM and 45 mg PO of PRELONE. The patient also had 100% oxygen provided. 9-1-1 was called and transferred the patient to a hospital ER department. All of the patient's symptoms resolved with the exception that the voice remained somewhat hoarse. The patient's systems were reviewed. The patient had no fever. The patient does have a positive skin test to dogs. He did get some swelling under his eyes with the allergic reaction. There were no complaints of chest pain during the allergic reaction. There was no cough prior to the allergic reaction, but did have coughing and difficulty breathing with the allergic reaction. The patient looked like he was gagging, but did not throw up. The patient had no diarrhea. There were no complaints of extremity pain. There were no hives. The patient complained of dizziness during the allergic reaction. On 03-JAN-2008, the patient was alert and a non toxic child. The patient also had abdominal discomfort and recovered on an unspecified date. The patient's body temperature measurement was 36.7 centigrade orally, the total heartbeat count was 96, respiratory rate measurement was 18 and blood pressure measurement was 117/7. The patient's voice is slightly hoarse. The physician reviewed the findings and he felt that the patient has had an anaphylactic reaction to the pneumococcal 23v polysaccharide. The physician had recommended overnight observation in the short stay unit in case he has a late reaction in addition to the early reaction, which is now almost completely resolved. The mother is in agreement with the plan. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Hyperhidrosis, Hypersensitivity, Pallor, Respiratory rate, Retching
Clinical narrative: Initial and follow up information has been received from a physician concerning an 8 year old white male who on 03-JAN-2008 was vaccinated with a "single dose series" of pneumococcal 23v polysaccharide vaccine (lot# 658555/0964U) IM in the left by his allergist. Information was received from an allergist and reported the history was taken from th patient's mother. The patient has a history of chronic urticaria of uncertain etiology and pressure equalization tubes "PE Tubes." The patient had the urticaria for about 14 months but has not had any urticaria since the beginning of October 2007. The mother reported that the urticaria tends to flare up when he gets the sinus infection. The patient had a runny nose for 5 days with no cough prior to vaccination. The patient went to see the allergist and was given a pneumococcal 23v polysaccharide vaccine and within minutes at 2:20 PM the patient began coughing, having difficulty breathing, his face turned red and began to swell. The patient felt dizzy, looked pale and sweaty. The patient was given epinephrine 0.3 mL IM, ranitidine 25 mg IM, BENADRYL 50 mg IM and 45 mg PO of PRELONE. The patient also had 100% oxygen provided. 9-1-1 was called and transferred the patient to a hospital ER department. All of the patient's symptoms resolved with the exception that the voice remained somewhat hoarse. The patient's systems were reviewed. The patient had no fever. The patient does have a positive skin test to dogs. He did get some swelling under his eyes with the allergic reaction. There were no complaints of chest pain during the allergic reaction. There was no cough prior to the allergic reaction, but did have coughing and difficulty breathing with the allergic reaction. The patient looked like he was gagging, but did not throw up. The patient had no diarrhea. There were no complaints of extremity pain. There were no hives. The patient complained of dizziness during the allergic reaction. On 03-JAN-2008, the patient was alert and a non toxic child. The patient also had abdominal discomfort and recovered on an unspecified date. The patient's body temperature measurement was 36.7 centigrade orally, the total heartbeat count was 96, respiratory rate measurement was 18 and blood pressure measurement was 117/7. The patient's voice is slightly hoarse. The physician reviewed the findings and he felt that the patient has had an anaphylactic reaction to the pneumococcal 23v polysaccharide. The physician had recommended overnight observation in the short stay unit in case he has a late reaction in addition to the early reaction, which is now almost completely resolved. The mother is in agreement with the plan. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Swelling face
Clinical narrative: Initial and follow up information has been received from a physician concerning an 8 year old white male who on 03-JAN-2008 was vaccinated with a "single dose series" of pneumococcal 23v polysaccharide vaccine (lot# 658555/0964U) IM in the left by his allergist. Information was received from an allergist and reported the history was taken from th patient's mother. The patient has a history of chronic urticaria of uncertain etiology and pressure equalization tubes "PE Tubes." The patient had the urticaria for about 14 months but has not had any urticaria since the beginning of October 2007. The mother reported that the urticaria tends to flare up when he gets the sinus infection. The patient had a runny nose for 5 days with no cough prior to vaccination. The patient went to see the allergist and was given a pneumococcal 23v polysaccharide vaccine and within minutes at 2:20 PM the patient began coughing, having difficulty breathing, his face turned red and began to swell. The patient felt dizzy, looked pale and sweaty. The patient was given epinephrine 0.3 mL IM, ranitidine 25 mg IM, BENADRYL 50 mg IM and 45 mg PO of PRELONE. The patient also had 100% oxygen provided. 9-1-1 was called and transferred the patient to a hospital ER department. All of the patient's symptoms resolved with the exception that the voice remained somewhat hoarse. The patient's systems were reviewed. The patient had no fever. The patient does have a positive skin test to dogs. He did get some swelling under his eyes with the allergic reaction. There were no complaints of chest pain during the allergic reaction. There was no cough prior to the allergic reaction, but did have coughing and difficulty breathing with the allergic reaction. The patient looked like he was gagging, but did not throw up. The patient had no diarrhea. There were no complaints of extremity pain. There were no hives. The patient complained of dizziness during the allergic reaction. On 03-JAN-2008, the patient was alert and a non toxic child. The patient also had abdominal discomfort and recovered on an unspecified date. The patient's body temperature measurement was 36.7 centigrade orally, the total heartbeat count was 96, respiratory rate measurement was 18 and blood pressure measurement was 117/7. The patient's voice is slightly hoarse. The physician reviewed the findings and he felt that the patient has had an anaphylactic reaction to the pneumococcal 23v polysaccharide. The physician had recommended overnight observation in the short stay unit in case he has a late reaction in addition to the early reaction, which is now almost completely resolved. The mother is in agreement with the plan. Additional information is not expected.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pain
Clinical narrative: Information has been received from a physician concerning a male who "around October, November or December 2007" was vaccinated in the arm with a 1st dose of pneumococcal 23v polysaccharide vaccine (lot# not reported). Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unknown) administered in the same arm. Subsequently the patient experienced severe body aches and pain after receiving his vaccinations. The patient outcome was not reported. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a patient who on an unspecified date received a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient experienced an injection site reaction. At the time of this report the patient's outcome was unknown. This is one of three reports from the same source . Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse concerning her father, a 65 year old caucasian male (a pest control technician), with a sensitivity to meperidine hydrochloride (DEMEROL), hypertension and a history of aortic valve stenosis, aortic valve replacement, mitral valve prolapse and gastrooesophageal reflux who on 19-MAR-2008, at 10:30 am, was vaccinated with the second dose, 0.5 ml, of pneumococcal 23v polysaccharide vaccine (Lot #658673/0990U) intramuscularly in the left deltoid. Concomitant suspect therapy included the first dose, 0.5 ml, of zoster vaccine live (Oka/Merck) (Lot #659763/1875U) intramuscularly in the left deltoid on the same day. Other concomitant therapy included rosuvastatin calcium (CRESTOR), metoprolol tartrate (APO-METOPROLOL), valsartan (DIOVAN) and omeprazole. There was no illness at the time of vaccination. The nurse stated that on 20-MAR-2008 her father developed a swollen, painful and reddened arm in the left biceps area. The patient sought unspecified medical attention (date not reported) and the doctor advised the patient to take diphenhydramine hydrochloride (BENADRYL) for the symptoms. Other treatment included rest, ice and non-steroidal anti-inflammatory drugs (NSAID"S). On 28-MAR-2008, the patient recovered from the events. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain, Injection site rash
Clinical narrative: Initial and follow up information has been received from a registered nurse and a physician (physician's notes provided), concerning a 50 year old caucasian female with drug hypersensitivity (ciprofloxacin hydrochloride (CIPRO), tramadol hydrochloride (ULTRAM), levofloxacine (LEVAQUIN), moxifloxacin hydrochloride (AVELOX) and norfloxacine (NOROXIN)), asthma, gastrooesophageal reflux disease, hypothyroidism and chronic sinusitis and a history of Hodgkin's disease (in remission), spleen disorder ("post-splenic") and skin cancer (excised in 1984) who on 20-MAR-2008, at 10:21 am, was vaccinated IM into the right deltoid with the fourth dose, 0.5 mL, of pneumococcal 23v polysaccharide vaccine (Lot# 659150/1384U). Concomitant vaccine therapy included a dose in the left upper arm of tetanus toxoid (SP, lot # U1959BB). Other concomitant therapy included tetanus toxoid, levothyroxine Na (SYNTHROID), acetaminophen (+) propoxyphene napsylate (DARVOCET-N), alprazolam (XANAX), testosterone, formoterol fumarate (FORADIL), guaifenesin (MUCINEX), triamcinolone acetonide (NASACORT AQ), prednisone, montelukast sodium (SINGULAIR), carisoprodol (SOMA) and cetirizine hydrochloride (+) pseudoephedrine hydrochloride (ZYRTEC-D). There was no illness at the time of vaccination.The physician indicated that on 20-MAR-2008, the patient's right upper arm was red, hot and tender around the immunization site of the "pneumovax vaccine," and added "there is a 8 x 10 cm area of induration and erythema." On 24-MAR-2008 the patient came into the office with a fever of 10.3.9F, chills, rash at injection site redness and welt that extended from the injection site down towards elbow, stopping about 3 inches above the right elbow. The patient was treated with 1 gram ceftriaxone sodium (ROCEPHIN) injection on 24-MAR-2008, and amoxicillin (+) clavulanate potassium (AUGMENTIN) 875 mg, 1 tablet BID for 10 days was prescribed. The physician advised an ice pack and ibuprofen. At the time of the report, the outcome of the events was unknown. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Injection site warmth, Pyrexia, Urticaria
Clinical narrative: Initial and follow up information has been received from a registered nurse and a physician (physician's notes provided), concerning a 50 year old caucasian female with drug hypersensitivity (ciprofloxacin hydrochloride (CIPRO), tramadol hydrochloride (ULTRAM), levofloxacine (LEVAQUIN), moxifloxacin hydrochloride (AVELOX) and norfloxacine (NOROXIN)), asthma, gastrooesophageal reflux disease, hypothyroidism and chronic sinusitis and a history of Hodgkin's disease (in remission), spleen disorder ("post-splenic") and skin cancer (excised in 1984) who on 20-MAR-2008, at 10:21 am, was vaccinated IM into the right deltoid with the fourth dose, 0.5 mL, of pneumococcal 23v polysaccharide vaccine (Lot# 659150/1384U). Concomitant vaccine therapy included a dose in the left upper arm of tetanus toxoid (SP, lot # U1959BB). Other concomitant therapy included tetanus toxoid, levothyroxine Na (SYNTHROID), acetaminophen (+) propoxyphene napsylate (DARVOCET-N), alprazolam (XANAX), testosterone, formoterol fumarate (FORADIL), guaifenesin (MUCINEX), triamcinolone acetonide (NASACORT AQ), prednisone, montelukast sodium (SINGULAIR), carisoprodol (SOMA) and cetirizine hydrochloride (+) pseudoephedrine hydrochloride (ZYRTEC-D). There was no illness at the time of vaccination.The physician indicated that on 20-MAR-2008, the patient's right upper arm was red, hot and tender around the immunization site of the "pneumovax vaccine," and added "there is a 8 x 10 cm area of induration and erythema." On 24-MAR-2008 the patient came into the office with a fever of 10.3.9F, chills, rash at injection site redness and welt that extended from the injection site down towards elbow, stopping about 3 inches above the right elbow. The patient was treated with 1 gram ceftriaxone sodium (ROCEPHIN) injection on 24-MAR-2008, and amoxicillin (+) clavulanate potassium (AUGMENTIN) 875 mg, 1 tablet BID for 10 days was prescribed. The physician advised an ice pack and ibuprofen. At the time of the report, the outcome of the events was unknown. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Borrelia burgdorferi serology, Brain oedema, Dysarthria
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 20-JUN-2008 was vaccinated with GARDASIL.  Approximately two weeks after vaccination with GARDASIL, the patient travelled to another country.  Approximately two weeks prior to travelling to another country, the patient had attended a picnic in a wooded area and one of the other people at the picnic had developed a skin lesion and was commenced on antibiotic treatment for Lyme disease.  Subsequently, on 25-JUN-2008 the patient experienced headache, ataxia, dysarthria, malaise, mental impairment and somnolence and on 05-JUL-2008 she was hospitalised.  The report description was as follows: "Five days of intermittent headache, 5 days of malaise, 2 days of dysarthria and ataxia, drowsiness, slow mentation.  Never febrile, no rash, purely cerebellar signs, no bulbar signs, speech is dysarthric and very slow with poverty of words.  There is no dysphasia".  The patient had no significant medical history.  Laboratory tests results were as follows (dates of tests and units not specified): C-Reactive protein - <3; white blood cells and differential were normal; creatinine and liver function tests were all normal; haemoglobin - 128; platelets - 223.  On 05-JUL-2008 a magnetic resonance imaging scan showed features corresponding most closely with cerebellitis (cerebellar encephalitis).  No associated cerebral encephalitis.  Mass effect protruding inferior cerebellar tonsillar ectopia.  No hydrocephalus.  On 07-JUL-2008 an MRI showed acute cerebellitis.  The differential diagnosis is quite wide and includes lead and cyanide toxicity, demyelination, vasculitis, childhood viral illnesses and a manifestion of acute disseminated encephalomyelitis.  The patient was discussed with a paediatric neurologist.  Treatment was as follows:  "She was commenced on acyclovir, dexamethasone 4mg every six hours since 05-JUL-2008 and added on 07-JUL-2008 were ceftriaxone 2g twice daily (for Lyme disease) and ampicillin 2g every four hours (for Listeria, seems unlikely epidemiologically).  Arithromycin was recommended but not started today after a minor improvement with the current antibiotics."  Comment from the patient's treating doctor.  "We have found several case reports of cerebellitis associated with Lyme neuroborelliosis, but all had subacute presentations.  A variety of serologies for viral infections and Lyme disease have been sent.  LP is precluded by the evidence of tonsillar herniation".  At the time of reporting to the agency on 14-JUL-2008, the patient had not yet recovered from headache, ataxia, dysarthria, malaise, mental impairment and somnolence.  The reporter considered that headache, ataxia, dysarthria, malaise, mental impairment and somnolence were possibly related to vaccination with GARDASIL.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Encephalitis, Headache, Herpes simplex serology, Lethargy, Mumps antibody test
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 20-JUN-2008 was vaccinated with GARDASIL.  Approximately two weeks after vaccination with GARDASIL, the patient travelled to another country.  Approximately two weeks prior to travelling to another country, the patient had attended a picnic in a wooded area and one of the other people at the picnic had developed a skin lesion and was commenced on antibiotic treatment for Lyme disease.  Subsequently, on 25-JUN-2008 the patient experienced headache, ataxia, dysarthria, malaise, mental impairment and somnolence and on 05-JUL-2008 she was hospitalised.  The report description was as follows: "Five days of intermittent headache, 5 days of malaise, 2 days of dysarthria and ataxia, drowsiness, slow mentation.  Never febrile, no rash, purely cerebellar signs, no bulbar signs, speech is dysarthric and very slow with poverty of words.  There is no dysphasia".  The patient had no significant medical history.  Laboratory tests results were as follows (dates of tests and units not specified): C-Reactive protein - <3; white blood cells and differential were normal; creatinine and liver function tests were all normal; haemoglobin - 128; platelets - 223.  On 05-JUL-2008 a magnetic resonance imaging scan showed features corresponding most closely with cerebellitis (cerebellar encephalitis).  No associated cerebral encephalitis.  Mass effect protruding inferior cerebellar tonsillar ectopia.  No hydrocephalus.  On 07-JUL-2008 an MRI showed acute cerebellitis.  The differential diagnosis is quite wide and includes lead and cyanide toxicity, demyelination, vasculitis, childhood viral illnesses and a manifestion of acute disseminated encephalomyelitis.  The patient was discussed with a paediatric neurologist.  Treatment was as follows:  "She was commenced on acyclovir, dexamethasone 4mg every six hours since 05-JUL-2008 and added on 07-JUL-2008 were ceftriaxone 2g twice daily (for Lyme disease) and ampicillin 2g every four hours (for Listeria, seems unlikely epidemiologically).  Arithromycin was recommended but not started today after a minor improvement with the current antibiotics."  Comment from the patient's treating doctor.  "We have found several case reports of cerebellitis associated with Lyme neuroborelliosis, but all had subacute presentations.  A variety of serologies for viral infections and Lyme disease have been sent.  LP is precluded by the evidence of tonsillar herniation".  At the time of reporting to the agency on 14-JUL-2008, the patient had not yet recovered from headache, ataxia, dysarthria, malaise, mental impairment and somnolence.  The reporter considered that headache, ataxia, dysarthria, malaise, mental impairment and somnolence were possibly related to vaccination with GARDASIL.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Mycoplasma serology, Nuclear magnetic resonance imaging brain, Rubella antibody test
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 20-JUN-2008 was vaccinated with GARDASIL.  Approximately two weeks after vaccination with GARDASIL, the patient travelled to another country.  Approximately two weeks prior to travelling to another country, the patient had attended a picnic in a wooded area and one of the other people at the picnic had developed a skin lesion and was commenced on antibiotic treatment for Lyme disease.  Subsequently, on 25-JUN-2008 the patient experienced headache, ataxia, dysarthria, malaise, mental impairment and somnolence and on 05-JUL-2008 she was hospitalised.  The report description was as follows: "Five days of intermittent headache, 5 days of malaise, 2 days of dysarthria and ataxia, drowsiness, slow mentation.  Never febrile, no rash, purely cerebellar signs, no bulbar signs, speech is dysarthric and very slow with poverty of words.  There is no dysphasia".  The patient had no significant medical history.  Laboratory tests results were as follows (dates of tests and units not specified): C-Reactive protein - <3; white blood cells and differential were normal; creatinine and liver function tests were all normal; haemoglobin - 128; platelets - 223.  On 05-JUL-2008 a magnetic resonance imaging scan showed features corresponding most closely with cerebellitis (cerebellar encephalitis).  No associated cerebral encephalitis.  Mass effect protruding inferior cerebellar tonsillar ectopia.  No hydrocephalus.  On 07-JUL-2008 an MRI showed acute cerebellitis.  The differential diagnosis is quite wide and includes lead and cyanide toxicity, demyelination, vasculitis, childhood viral illnesses and a manifestion of acute disseminated encephalomyelitis.  The patient was discussed with a paediatric neurologist.  Treatment was as follows:  "She was commenced on acyclovir, dexamethasone 4mg every six hours since 05-JUL-2008 and added on 07-JUL-2008 were ceftriaxone 2g twice daily (for Lyme disease) and ampicillin 2g every four hours (for Listeria, seems unlikely epidemiologically).  Arithromycin was recommended but not started today after a minor improvement with the current antibiotics."  Comment from the patient's treating doctor.  "We have found several case reports of cerebellitis associated with Lyme neuroborelliosis, but all had subacute presentations.  A variety of serologies for viral infections and Lyme disease have been sent.  LP is precluded by the evidence of tonsillar herniation".  At the time of reporting to the agency on 14-JUL-2008, the patient had not yet recovered from headache, ataxia, dysarthria, malaise, mental impairment and somnolence.  The reporter considered that headache, ataxia, dysarthria, malaise, mental impairment and somnolence were possibly related to vaccination with GARDASIL.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Dysarthria, Fatigue, Gait disturbance, Headache
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 20-JUN-2008 was vaccinated with GARDASIL.  Approximately two weeks after vaccination with GARDASIL, the patient travelled to another country.  Approximately two weeks prior to travelling to another country, the patient had attended a picnic in a wooded area and one of the other people at the picnic had developed a skin lesion and was commenced on antibiotic treatment for Lyme disease.  Subsequently, on 25-JUN-2008 the patient experienced headache, ataxia, dysarthria, malaise, mental impairment and somnolence and on 05-JUL-2008 she was hospitalised.  The report description was as follows: "Five days of intermittent headache, 5 days of malaise, 2 days of dysarthria and ataxia, drowsiness, slow mentation.  Never febrile, no rash, purely cerebellar signs, no bulbar signs, speech is dysarthric and very slow with poverty of words.  There is no dysphasia".  The patient had no significant medical history.  Laboratory tests results were as follows (dates of tests and units not specified): C-Reactive protein - <3; white blood cells and differential were normal; creatinine and liver function tests were all normal; haemoglobin - 128; platelets - 223.  On 05-JUL-2008 a magnetic resonance imaging scan showed features corresponding most closely with cerebellitis (cerebellar encephalitis).  No associated cerebral encephalitis.  Mass effect protruding inferior cerebellar tonsillar ectopia.  No hydrocephalus.  On 07-JUL-2008 an MRI showed acute cerebellitis.  The differential diagnosis is quite wide and includes lead and cyanide toxicity, demyelination, vasculitis, childhood viral illnesses and a manifestion of acute disseminated encephalomyelitis.  The patient was discussed with a paediatric neurologist.  Treatment was as follows:  "She was commenced on acyclovir, dexamethasone 4mg every six hours since 05-JUL-2008 and added on 07-JUL-2008 were ceftriaxone 2g twice daily (for Lyme disease) and ampicillin 2g every four hours (for Listeria, seems unlikely epidemiologically).  Arithromycin was recommended but not started today after a minor improvement with the current antibiotics."  Comment from the patient's treating doctor.  "We have found several case reports of cerebellitis associated with Lyme neuroborelliosis, but all had subacute presentations.  A variety of serologies for viral infections and Lyme disease have been sent.  LP is precluded by the evidence of tonsillar herniation".  At the time of reporting to the agency on 14-JUL-2008, the patient had not yet recovered from headache, ataxia, dysarthria, malaise, mental impairment and somnolence.  The reporter considered that headache, ataxia, dysarthria, malaise, mental impairment and somnolence were possibly related to vaccination with GARDASIL.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Ataxia, Blood creatinine normal, Blood cyanide, Blood lead, C-reactive protein normal
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 20-JUN-2008 was vaccinated with GARDASIL.  Approximately two weeks after vaccination with GARDASIL, the patient travelled to another country.  Approximately two weeks prior to travelling to another country, the patient had attended a picnic in a wooded area and one of the other people at the picnic had developed a skin lesion and was commenced on antibiotic treatment for Lyme disease.  Subsequently, on 25-JUN-2008 the patient experienced headache, ataxia, dysarthria, malaise, mental impairment and somnolence and on 05-JUL-2008 she was hospitalised.  The report description was as follows: "Five days of intermittent headache, 5 days of malaise, 2 days of dysarthria and ataxia, drowsiness, slow mentation.  Never febrile, no rash, purely cerebellar signs, no bulbar signs, speech is dysarthric and very slow with poverty of words.  There is no dysphasia".  The patient had no significant medical history.  Laboratory tests results were as follows (dates of tests and units not specified): C-Reactive protein - <3; white blood cells and differential were normal; creatinine and liver function tests were all normal; haemoglobin - 128; platelets - 223.  On 05-JUL-2008 a magnetic resonance imaging scan showed features corresponding most closely with cerebellitis (cerebellar encephalitis).  No associated cerebral encephalitis.  Mass effect protruding inferior cerebellar tonsillar ectopia.  No hydrocephalus.  On 07-JUL-2008 an MRI showed acute cerebellitis.  The differential diagnosis is quite wide and includes lead and cyanide toxicity, demyelination, vasculitis, childhood viral illnesses and a manifestion of acute disseminated encephalomyelitis.  The patient was discussed with a paediatric neurologist.  Treatment was as follows:  "She was commenced on acyclovir, dexamethasone 4mg every six hours since 05-JUL-2008 and added on 07-JUL-2008 were ceftriaxone 2g twice daily (for Lyme disease) and ampicillin 2g every four hours (for Listeria, seems unlikely epidemiologically).  Arithromycin was recommended but not started today after a minor improvement with the current antibiotics."  Comment from the patient's treating doctor.  "We have found several case reports of cerebellitis associated with Lyme neuroborelliosis, but all had subacute presentations.  A variety of serologies for viral infections and Lyme disease have been sent.  LP is precluded by the evidence of tonsillar herniation".  At the time of reporting to the agency on 14-JUL-2008, the patient had not yet recovered from headache, ataxia, dysarthria, malaise, mental impairment and somnolence.  The reporter considered that headache, ataxia, dysarthria, malaise, mental impairment and somnolence were possibly related to vaccination with GARDASIL.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Demyelination, Dysarthria, Encephalitis, Haemoglobin normal, Headache
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 20-JUN-2008 was vaccinated with GARDASIL.  Approximately two weeks after vaccination with GARDASIL, the patient travelled to another country.  Approximately two weeks prior to travelling to another country, the patient had attended a picnic in a wooded area and one of the other people at the picnic had developed a skin lesion and was commenced on antibiotic treatment for Lyme disease.  Subsequently, on 25-JUN-2008 the patient experienced headache, ataxia, dysarthria, malaise, mental impairment and somnolence and on 05-JUL-2008 she was hospitalised.  The report description was as follows: "Five days of intermittent headache, 5 days of malaise, 2 days of dysarthria and ataxia, drowsiness, slow mentation.  Never febrile, no rash, purely cerebellar signs, no bulbar signs, speech is dysarthric and very slow with poverty of words.  There is no dysphasia".  The patient had no significant medical history.  Laboratory tests results were as follows (dates of tests and units not specified): C-Reactive protein - <3; white blood cells and differential were normal; creatinine and liver function tests were all normal; haemoglobin - 128; platelets - 223.  On 05-JUL-2008 a magnetic resonance imaging scan showed features corresponding most closely with cerebellitis (cerebellar encephalitis).  No associated cerebral encephalitis.  Mass effect protruding inferior cerebellar tonsillar ectopia.  No hydrocephalus.  On 07-JUL-2008 an MRI showed acute cerebellitis.  The differential diagnosis is quite wide and includes lead and cyanide toxicity, demyelination, vasculitis, childhood viral illnesses and a manifestion of acute disseminated encephalomyelitis.  The patient was discussed with a paediatric neurologist.  Treatment was as follows:  "She was commenced on acyclovir, dexamethasone 4mg every six hours since 05-JUL-2008 and added on 07-JUL-2008 were ceftriaxone 2g twice daily (for Lyme disease) and ampicillin 2g every four hours (for Listeria, seems unlikely epidemiologically).  Arithromycin was recommended but not started today after a minor improvement with the current antibiotics."  Comment from the patient's treating doctor.  "We have found several case reports of cerebellitis associated with Lyme neuroborelliosis, but all had subacute presentations.  A variety of serologies for viral infections and Lyme disease have been sent.  LP is precluded by the evidence of tonsillar herniation".  At the time of reporting to the agency on 14-JUL-2008, the patient had not yet recovered from headache, ataxia, dysarthria, malaise, mental impairment and somnolence.  The reporter considered that headache, ataxia, dysarthria, malaise, mental impairment and somnolence were possibly related to vaccination with GARDASIL.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Liver function test normal, Malaise, Mental impairment, Nuclear magnetic resonance imaging abnormal, Platelet count normal
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 20-JUN-2008 was vaccinated with GARDASIL.  Approximately two weeks after vaccination with GARDASIL, the patient travelled to another country.  Approximately two weeks prior to travelling to another country, the patient had attended a picnic in a wooded area and one of the other people at the picnic had developed a skin lesion and was commenced on antibiotic treatment for Lyme disease.  Subsequently, on 25-JUN-2008 the patient experienced headache, ataxia, dysarthria, malaise, mental impairment and somnolence and on 05-JUL-2008 she was hospitalised.  The report description was as follows: "Five days of intermittent headache, 5 days of malaise, 2 days of dysarthria and ataxia, drowsiness, slow mentation.  Never febrile, no rash, purely cerebellar signs, no bulbar signs, speech is dysarthric and very slow with poverty of words.  There is no dysphasia".  The patient had no significant medical history.  Laboratory tests results were as follows (dates of tests and units not specified): C-Reactive protein - <3; white blood cells and differential were normal; creatinine and liver function tests were all normal; haemoglobin - 128; platelets - 223.  On 05-JUL-2008 a magnetic resonance imaging scan showed features corresponding most closely with cerebellitis (cerebellar encephalitis).  No associated cerebral encephalitis.  Mass effect protruding inferior cerebellar tonsillar ectopia.  No hydrocephalus.  On 07-JUL-2008 an MRI showed acute cerebellitis.  The differential diagnosis is quite wide and includes lead and cyanide toxicity, demyelination, vasculitis, childhood viral illnesses and a manifestion of acute disseminated encephalomyelitis.  The patient was discussed with a paediatric neurologist.  Treatment was as follows:  "She was commenced on acyclovir, dexamethasone 4mg every six hours since 05-JUL-2008 and added on 07-JUL-2008 were ceftriaxone 2g twice daily (for Lyme disease) and ampicillin 2g every four hours (for Listeria, seems unlikely epidemiologically).  Arithromycin was recommended but not started today after a minor improvement with the current antibiotics."  Comment from the patient's treating doctor.  "We have found several case reports of cerebellitis associated with Lyme neuroborelliosis, but all had subacute presentations.  A variety of serologies for viral infections and Lyme disease have been sent.  LP is precluded by the evidence of tonsillar herniation".  At the time of reporting to the agency on 14-JUL-2008, the patient had not yet recovered from headache, ataxia, dysarthria, malaise, mental impairment and somnolence.  The reporter considered that headache, ataxia, dysarthria, malaise, mental impairment and somnolence were possibly related to vaccination with GARDASIL.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Skin lesion, Somnolence, Speech disorder, Vasculitis, White blood cell count normal
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 20-JUN-2008 was vaccinated with GARDASIL.  Approximately two weeks after vaccination with GARDASIL, the patient travelled to another country.  Approximately two weeks prior to travelling to another country, the patient had attended a picnic in a wooded area and one of the other people at the picnic had developed a skin lesion and was commenced on antibiotic treatment for Lyme disease.  Subsequently, on 25-JUN-2008 the patient experienced headache, ataxia, dysarthria, malaise, mental impairment and somnolence and on 05-JUL-2008 she was hospitalised.  The report description was as follows: "Five days of intermittent headache, 5 days of malaise, 2 days of dysarthria and ataxia, drowsiness, slow mentation.  Never febrile, no rash, purely cerebellar signs, no bulbar signs, speech is dysarthric and very slow with poverty of words.  There is no dysphasia".  The patient had no significant medical history.  Laboratory tests results were as follows (dates of tests and units not specified): C-Reactive protein - <3; white blood cells and differential were normal; creatinine and liver function tests were all normal; haemoglobin - 128; platelets - 223.  On 05-JUL-2008 a magnetic resonance imaging scan showed features corresponding most closely with cerebellitis (cerebellar encephalitis).  No associated cerebral encephalitis.  Mass effect protruding inferior cerebellar tonsillar ectopia.  No hydrocephalus.  On 07-JUL-2008 an MRI showed acute cerebellitis.  The differential diagnosis is quite wide and includes lead and cyanide toxicity, demyelination, vasculitis, childhood viral illnesses and a manifestion of acute disseminated encephalomyelitis.  The patient was discussed with a paediatric neurologist.  Treatment was as follows:  "She was commenced on acyclovir, dexamethasone 4mg every six hours since 05-JUL-2008 and added on 07-JUL-2008 were ceftriaxone 2g twice daily (for Lyme disease) and ampicillin 2g every four hours (for Listeria, seems unlikely epidemiologically).  Arithromycin was recommended but not started today after a minor improvement with the current antibiotics."  Comment from the patient's treating doctor.  "We have found several case reports of cerebellitis associated with Lyme neuroborelliosis, but all had subacute presentations.  A variety of serologies for viral infections and Lyme disease have been sent.  LP is precluded by the evidence of tonsillar herniation".  At the time of reporting to the agency on 14-JUL-2008, the patient had not yet recovered from headache, ataxia, dysarthria, malaise, mental impairment and somnolence.  The reporter considered that headache, ataxia, dysarthria, malaise, mental impairment and somnolence were possibly related to vaccination with GARDASIL.  Additional information has been requested.