chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: HIBV, MMR
Symptoms: Haematology test, Pyrexia
Clinical narrative: Information has been received from a consumer concerning a 4 year old male with penicillin allergy, autism and decreased immune system who on 05-MAY-2005 was vaccinated with a dose of MMR II. Suspect therapy included PEDVAX HIB. On approximately 08-MAY-2005 the patient experienced high fever of 105.7 reading and was hospitalized. The patients mother stated that the high fever started "3 days after receiving vaccinations. The patient was brought to the hospital on 10-May-2008 and was admitted for 2 days. Per reporter, "if the patient gets fever sometimes it goes as high as 104. Reporter noted that the patient has not had any fever recently. Unspecified blood work was performed. It was noted that the patient was recovering at the time of the report. Unspecified medical attention was sought. No product quality complaint. No further information is available.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Body temperature increased, Convulsion, Dyskinesia, Gaze palsy, Pyrexia
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 5 year old female with a history of febrile seizure at 6 months of age and no allergies who on 30-JUL-2007 at 11:00 was vaccinated in the left arm with a 0.5ml subcutaneous dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (Lot # 655414/1470F).  There was no concomitant medication.  There was no illness at the time of vaccination.  On 13-AUG-2007 the patient had a generalized seizure while in daycare.  The seizure happened about two weeks after the child was vaccinated with MMR II.  The seizure included rolling of the eyes and body jerking and lasted for about 1.5 minutes.  The patient developed a fever of 101.6 degrees Fahrenheit the following day, on 14-AUG-2007 (also reported as the patient had no fever).  Unspecified medical attention was sought.  On 15-AUG-2007 the patient fully recovered.  There was no product quality complaint involved.  No further information was provided.  Upon internal review, the event of seizure was determined to be an other important medical event.  Additional information is not expected.
Sex: F
Vaccine: MMR
Symptoms: Idiopathic thrombocytopenic purpura
Clinical narrative: Information has been received from a registered nurse concerning a female (age not reported) who on unspecified date was vaccinated with MMR II. Subsequently the patient experienced idiopathic thrombocytopenic purpura. The outcome of the event was unknown. Upon internal review, the idiopathic thrombocytopenic purpura was considered to be an other important medical event. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Body temperature increased, Febrile convulsion, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 13-month-old male who on 24-MAR-2008 was vaccinated with a dose of MMR II (lot# 657356/1314U). Suspect vaccination included a dose of VARIVAX (lot# 659720/1657U). Other concomitant vaccination that day included a dose of ACTHIB. On 26-MAR-2008 the patient experienced a febrile seizure and a 103.6 degree fever 2 days after receiving vaccinations. Unspecified medical attention was sought and the patient improved on therapy. On an unspecified date the patient recovered. No product quality complaint was involved. Follow-up information has been received from a nurse who indicated that the patient did not have any concurrent conditions or pertinent medical history. The treatment for the seizure was MOTRIN and ROCEPHIN. The nurse noted that the physician believed that febrile seizure was caused by MMR II (lot# 657356/1314U) (expiration 17-Aug-2009). Secondary suspect was VARIVAX (lot# 659720/1657U) (expiration 13-Oct-2009). Upon internal review, febrile seizure was considered to be an other important medical event. Additional information is not expected.
Age: 1.19
Sex: F
Vaccine: MMR
Symptoms: Febrile convulsion
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 16 month old female who on 05-MAY-2004 was vaccinated with a first dose of MMR II (lot number not known). On 23-JUN-2004 the patient experienced febrile seizure seven weeks after the vaccine was administered. She was not a patient of the physician at the time; however there was fear of febrile seizure with the second dose. There was no product quality complaint. The febrile seizure was considered to be an other important medical event. Additional information has been requested. Follow-up information from the physician indicated that the febrile seizure was not related to MMR II. Upon internal review, febrile seizure was considered to be an other important medical event. Additional information is not available.
Sex: F
Vaccine: MMR
Symptoms: Febrile convulsion
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a dose of MMR II. It was reported that the patient stated she has a history of febrile seizure after receiving childhood vaccines. The physician was not sure which vaccines but believes "MMR was one of the vaccines." Subsequently, the patient recovered. No product quality complaint was involved. Upon internal review, febrile seizures was considered to be an other important medical event. Additional information is not expected.
Age: 1.3
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 month old male who in approximately 2005, (about 3 years ago") was vaccinated subcutaneously with the 1st dose of MMR II. In approximately 2005 the patient experienced very bad rash. The patient was treated with steroids. Subsequently, the patient recovered from very bad rash and it was considered to be disabling. Unspecified medical attention was sought. No product quality complaint. Additional information has been requested. Follow-up information received by the nurse practitioner indicating that the patient was actually a 1 year old female (initially reported as male) who on 03-May-2005, was vaccinated subcutaneously with the 1st dose of MMR II (lot#649225/0938P). On 12-May-2005, approximately 10 days after the vaccination, the child experienced morbilliform rash (initially reported as "bad rash") and a fever. The patient was treated with prednisone and the patient recovered 4 days later. It was initially reported that the AE's were considered disabling, but it is now a non-serious report. Further information is not expected.
Sex: F
Vaccine: MMR
Symptoms: Deafness
Clinical narrative: Information has been received from a healthcare worker concerning her daughter who on an unspecified date was vaccinated with a dose of MMR II. In approximately 1993 ("15 years ago") the patient experienced deafness after receiving MMR II. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. The adverse event, deafness, was considered disabling by the reporter. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Ataxia, Convulsion
Clinical narrative: Information has been received from a registered nurse concerning a six year old male, who at 15 months of age, in approximately 2002, was vaccinated with MMR II. One week post vaccination, in approximately 2002, the patient developed a seizure with ataxia. The nurse reported that "the child completely recovered" (on an unspecified date). Medical attention was sought. There was no product quality complaint. Upon internal review the event of seizure was considered as a other medically important event (OME). No further information is available.
Sex: F
Vaccine: MMR
Symptoms: Anaphylactic reaction, Rubella antibody negative
Clinical narrative: Information has been received from a pharmacist concerning a female with a latex allergy who was vaccinated with MMR II. Subsequently the patient experienced an anaphylactic reaction and had a negative titer for rubella. Upon internal review anaphylactic reaction was determined to be an other important medical event. Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: MMR
Symptoms: Blood immunoglobulin M, Measles, Measles antibody positive, Pyrexia, Rash generalised
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 14 month old male with a history of asthma who on 13-JUL-2007 was vaccinated with a dose of MMR II. It was noted that 3 weeks prior to vaccination the patient had pneumonia which was treated with amoxicillin. By the end of August 2007, the patient developed a very low grade fever, generalized rash all over the body, kopliks spots and nasal drainage. At that time the patient was hospitalized and placed into isolation with the diagnosis of viral illness, IGM positive for measles. The patient was hospitalized for 2 days received unspecified treatment and was released. The nurse states the case was not life threatening and there was no significant disability. No further information was provided. There was no product quality complaint involved. The patient's events were considered serious for hospitalization. Additional information has been requested. This is one of several reports from the same source.
Age: 1.2
Sex: M
Vaccine: MMR
Symptoms: Rhinorrhoea
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 14 month old male with a history of asthma who on 13-JUL-2007 was vaccinated with a dose of MMR II. It was noted that 3 weeks prior to vaccination the patient had pneumonia which was treated with amoxicillin. By the end of August 2007, the patient developed a very low grade fever, generalized rash all over the body, kopliks spots and nasal drainage. At that time the patient was hospitalized and placed into isolation with the diagnosis of viral illness, IGM positive for measles. The patient was hospitalized for 2 days received unspecified treatment and was released. The nurse states the case was not life threatening and there was no significant disability. No further information was provided. There was no product quality complaint involved. The patient's events were considered serious for hospitalization. Additional information has been requested. This is one of several reports from the same source.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Blood culture, Body temperature increased, Culture urine, Cyanosis, Febrile convulsion
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 12-month-old male who on 14-AUG-2007 was vaccinated with the left leg with a first dose of MMR II (lot# 654984/1169F). Suspect vaccination included a first dose in the right left of VARIVAX (Oka/Merck) (lot# reported as "07160"). Concomitant vaccinations included a fourth dose in the left leg of PREVNAR (lot# B26510A) and a first dose of in the right leg of HAVRIX (lot# AHAVB13BA). On approximately 14-AUG-2007, the patient experienced fevers that lasted until 20-Aug-2007. It is reported that he did well from the fevers. The fevers abated for 4 days and then recurred on 24-Aug-2007. TYLENOL was given at home. On 25-Aug-2007, he had an episode of full body rigidity, cyanosis, and rhythmic shaking of all his limbs for 2-3 minutes and was brought to the emergency room by ambulance. On arrival to the emergency room, he had a temperature of 106 and was started on ceftriaxone sodium. Blood and urine cultures were taken. He was observed overnight tolerated a regular diet and did well with no further episodes of seizure activity. A second dose of ceftriaxone sodium IV was administered on 26-Aug-2007. He recovered on 26-Aug-2007 and was discharged from the hospital in good condition. The reporter felt that fevers was related to therapy with MMR II. Febrile seizures are considered to be an other important medical event. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Muscle rigidity, Pyrexia, Tremor
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 12-month-old male who on 14-AUG-2007 was vaccinated with the left leg with a first dose of MMR II (lot# 654984/1169F). Suspect vaccination included a first dose in the right left of VARIVAX (Oka/Merck) (lot# reported as "07160"). Concomitant vaccinations included a fourth dose in the left leg of PREVNAR (lot# B26510A) and a first dose of in the right leg of HAVRIX (lot# AHAVB13BA). On approximately 14-AUG-2007, the patient experienced fevers that lasted until 20-Aug-2007. It is reported that he did well from the fevers. The fevers abated for 4 days and then recurred on 24-Aug-2007. TYLENOL was given at home. On 25-Aug-2007, he had an episode of full body rigidity, cyanosis, and rhythmic shaking of all his limbs for 2-3 minutes and was brought to the emergency room by ambulance. On arrival to the emergency room, he had a temperature of 106 and was started on ceftriaxone sodium. Blood and urine cultures were taken. He was observed overnight tolerated a regular diet and did well with no further episodes of seizure activity. A second dose of ceftriaxone sodium IV was administered on 26-Aug-2007. He recovered on 26-Aug-2007 and was discharged from the hospital in good condition. The reporter felt that fevers was related to therapy with MMR II. Febrile seizures are considered to be an other important medical event. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: MMR
Symptoms: Convulsion, Dyskinesia, Electrocardiogram, Haematochezia, Weight bearing difficulty
Clinical narrative: Information has been received from a consumer concerning a 15 month old daughter with no pertinent medical history or drug allergies, who on 01-JUL-2002 was vaccinated with a 0.5ml dose of MMR II. There was no concomitant medication. On approximately 3-JUL-2002 the first seizure occurred. The patient was unable to hold up head or control body; the seizure lasted about a minute. The patient developed a total of 4 seizures after vaccination. On approximately 03-JUL-2002 the patient's mother also reported blood in stool. Unspecified medical attention was sought. Diagnostic studies included an ECG, no labs were performed. The child's recovery status was unknown and the child's last seizure was in 2003. There was no product quality complaint. Upon internal review, convulsion considered an other important medical event. No further information is available.
Sex: U
Vaccine: MMR
Symptoms: Encephalitis
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of MMR II. Subsequently the patient experienced a bad case of encephalitis. Unspecified medical attention was sought. There was no product quality complaint. Upon internal review, encephalitis was considered to be an other important medical event. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/30/2008.   No further information was available.
Age: 15.0
Sex: F
Vaccine: MMR
Symptoms: Deafness
Clinical narrative: Information has been received from a nurse practitioner concerning a 15-year-old female who in approximately 1997 was vaccinated with a dose of MMR II. Subsequently the patient experienced gradual/significant hearing loss. The patient now uses a bilateral hearing aid. The patient's gradual/significant hearing loss persisted. Unspecified medical attention was sought. There was no product quality complaint. Gradual/significant hearing loss was considered to be disabling. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: Information has been received from a registered nurse concerning a 15-month-old male with no drug reactions/allergies and with a history of croup who on 10-MAR-2004 was vaccinated with a first dose of MMR II. There was no concomitant medication. On 19-MAR-2004, nine days post vaccination, the patient had a fever, and subsequently experienced a febrile seizure. Unspecified medical attention was sought. Subsequently, the patient recovered. The office reported being cautious of giving the child his second dose for his 4-5 year old vaccination visit. There was no product quality complaint. The event was considered to be an other important medical event. Additional information has been requested.
Age: 0.08
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a female who approximately 2 months ago in March 2008, was vaccinated PO with her first dose of ROTATEQ (lot# not provided). A couple of days after vaccination, the baby experienced vomiting and diarrhea. The patient sought unspecified medical attention. No labs or diagnostic studies were performed. Subsequently, the patient recovered. No additional information was provided. there was no product quality complaint. Additional information has been requested. Follow-up information from the reporting physician indicated that an 8 week old female who on 31-MAR-2008 at 08:00 was vaccinated PO with her first dose of ROTATEQ (lot# 659918/0141X). There was no illness at the time of vaccination. On the same day at 20:00, the patient experienced vomiting and loose watery stools. Subsequently, the patient recovered from vomiting and diarrhea, several loose watery stools. No medical atention was sought. No intraveneous or medial intervention was necessary. The patient recovered spontanwously on 03-APR-2008. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Anorexia, Campylobacter infection, Culture stool positive, Diarrhoea, Haematochezia
Clinical narrative: Information has been received from a health professional concerning a 6 month old male who on 10-OCT-2007, 13-DEC-2007 and 12-FEB-2008 was vaccinated with a dose of ROTATEQ. Concomitant therapy included HIB, PEDIARIX, PREVNAR and influenza (unspecified). On approximately 29-JAN-2008, the patient experienced a fever. On 31-JAN-2008the patient went to the physician's office because he had a fever for the past 2 days and he experienced emesis (4 times), had 8 loose stools with blood and mucous. He was seen in the emergency room (ER) 2 days ago. The infant's mother was instructed to give fluids. His last emesis was at 0600 and he did have 2 normal stools on this date. The infant's appetite was down, he was only taking 2 oz of formula. The infant was also reported to have started with upper respiratory infection symptoms on the Monday prior. The physician's impression was otitis. He prescribed AMOXICILLIN 25 mg three times a day, stool for culture and sensitivity and PEDIALYTE. On 3-FEB-2008, the infant's stool culture revealed campylobacter jejuni\coli. On 5-FEB-2008, the patient still has some loose and water stools, there was no blood in the stool and he was not vomiting. He continued on the AMOXICILLIN. The physician's recommendation was to try lactose free formula during diarrhea illness. On 12-FEB-2008, the patient was seen by the physician. It was reported that the infant was doing much better and that he was trying to roll over. This was considered a well child visit by the physician. On 17-MAR-2008, the infant was seen again. It was reported that he still had some congestion. On this day the infant received a second dose of influenza virus vaccine (unspecified). At the time of this report, the infant's outcome was unknown. Additional information has been requested. All medical records are available upon request.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Mucous stools, Nasal congestion, Otitis media, Pyrexia, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 6 month old male who on 10-OCT-2007, 13-DEC-2007 and 12-FEB-2008 was vaccinated with a dose of ROTATEQ. Concomitant therapy included HIB, PEDIARIX, PREVNAR and influenza (unspecified). On approximately 29-JAN-2008, the patient experienced a fever. On 31-JAN-2008the patient went to the physician's office because he had a fever for the past 2 days and he experienced emesis (4 times), had 8 loose stools with blood and mucous. He was seen in the emergency room (ER) 2 days ago. The infant's mother was instructed to give fluids. His last emesis was at 0600 and he did have 2 normal stools on this date. The infant's appetite was down, he was only taking 2 oz of formula. The infant was also reported to have started with upper respiratory infection symptoms on the Monday prior. The physician's impression was otitis. He prescribed AMOXICILLIN 25 mg three times a day, stool for culture and sensitivity and PEDIALYTE. On 3-FEB-2008, the infant's stool culture revealed campylobacter jejuni\coli. On 5-FEB-2008, the patient still has some loose and water stools, there was no blood in the stool and he was not vomiting. He continued on the AMOXICILLIN. The physician's recommendation was to try lactose free formula during diarrhea illness. On 12-FEB-2008, the patient was seen by the physician. It was reported that the infant was doing much better and that he was trying to roll over. This was considered a well child visit by the physician. On 17-MAR-2008, the infant was seen again. It was reported that he still had some congestion. On this day the infant received a second dose of influenza virus vaccine (unspecified). At the time of this report, the infant's outcome was unknown. Additional information has been requested. All medical records are available upon request.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Local swelling, Muscle twitching, Myalgia
Clinical narrative: Initial report received on 25 March 2008 from a health care professional. A 26-year-old male patient had received a first dose, left deltoid, intramuscular injection of ADACEL, lot number C2609AA, on 13 November 2006. Eight hours post-vaccination, the patient experienced swelling of the neck (size or specific area not reported); muscle twitching of the leg, arm, neck and jaw; muscle soreness; and diarrhea. The muscle twitching was clinically evident on an unspecified follow-up examination. The patient was treated with diazepam at night and gradually improved over the next six days. The patient recovered from the event.
Sex: F
Vaccine: DTAP, MMR
Symptoms: Psychomotor hyperactivity
Clinical narrative: Information has been received from a consumer concerning her daughter who on an unspecified date was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (manufacturer unknown). Concomitant therapy included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid. The patient's mother reported that the patient"could not calm down after getting either measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) or diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid as a baby." The patient also experienced dizziness and syncope post vaccination with HPV (WAES# 0708USA03219). No further information is available.
Age: 48.0
Sex: F
Vaccine: DTP, HEPAB, HEPAB, TDAP
Symptoms: Bronchitis, Cough, Fatigue, Increased upper airway secretion, Influenza like illness
Clinical narrative: This case was received from a physician on 24 March 2008, and is part of a cluster of three patients. A 48-year-old female patient received a left deltoid intramuscular injection of ADACEL (lot number C2769AA) and a right deltoid intramuscular injection of TWINRIX (GlaxoSmithKline, lot number AHABB103AA) on 28 February 2008. Medical history included allergies to codeine and TYLENOL 3. On 03 March 2008, three days after 2008 she was seen in a pharmacy clinic and diagnosed with bronchitis. Treatment included amoxicillin. The patient recovered. The physician who reported this event also reported two other similar, non-serious events; these are captured in 2006-00916 and 2008-00917.
Age: 48.0
Sex: F
Vaccine: DTP, HEPAB, HEPAB, TDAP
Symptoms: Bronchitis
Clinical narrative: This case was received from a physician on 24 March 2008, and is part of a cluster of three patients. A 48-year-old female patient received a left deltoid intramuscular injection of ADACEL (lot number C2769AA) and a right deltoid intramuscular injection of TWINRIX (GlaxoSmithKline, lot number AHABB103AA) on 28 February 2008. Medical history included allergies to codeine and TYLENOL 3. On 03 March 2008, three days after 2008 she was seen in a pharmacy clinic and diagnosed with bronchitis. Treatment included amoxicillin. The patient recovered. The physician who reported this event also reported two other similar, non-serious events; these are captured in 2006-00916 and 2008-00917.
Age: 56.0
Sex: M
Vaccine: DTP, HEP, HEPA, HEP, HEPA, TDAP
Symptoms: Body temperature increased, Bronchitis, Chills, Nasal congestion, Productive cough
Clinical narrative: This case was reported by physician on 24 March 2008 and is one of a cluster of three patients. A 54-year-old male patient, with a history of penicillin allergy, received the following vaccinations on 29 February 2008: an intramuscular left deltoid injection of ADACEL (lot number C2769AA), an intramuscular right deltoid injection of hepatitis A vaccine (Merck, lot number 0019U), and an intramuscular right deltoid injection of hepatitis B vaccine (Merck, lot number IP09U). The day after vaccination, on 01 March 2008, the patient reported shivers and chills. Five days after vaccination he complained of productive cough, nasal and chest congestion, and a temperature of 99.9 degrees. He was diagnosed with bronchitis, and treatment included ZITHROMAX. Per the reporter, the symptoms had "essentially resolved." The health professional who reported this case also reported two other similar cases; these events were captured in case numbers 2008-00917 and 2008-00918.
Age: 56.0
Sex: M
Vaccine: DTP, HEP, HEPA, HEP, HEPA, TDAP
Symptoms: Respiratory tract congestion
Clinical narrative: This case was reported by physician on 24 March 2008 and is one of a cluster of three patients. A 54-year-old male patient, with a history of penicillin allergy, received the following vaccinations on 29 February 2008: an intramuscular left deltoid injection of ADACEL (lot number C2769AA), an intramuscular right deltoid injection of hepatitis A vaccine (Merck, lot number 0019U), and an intramuscular right deltoid injection of hepatitis B vaccine (Merck, lot number IP09U). The day after vaccination, on 01 March 2008, the patient reported shivers and chills. Five days after vaccination he complained of productive cough, nasal and chest congestion, and a temperature of 99.9 degrees. He was diagnosed with bronchitis, and treatment included ZITHROMAX. Per the reporter, the symptoms had "essentially resolved." The health professional who reported this case also reported two other similar cases; these events were captured in case numbers 2008-00917 and 2008-00918.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Impaired driving ability, Muscle disorder
Clinical narrative: Information has been received from the physician concerning a 17 year old female who was vaccinated with a first dose of GARDASIL. Three weeks to the day of the vaccination, the patient came into the office for a follow up visit with discomfort of leg muscles. It was reported by the physician that this might be sensory variant GUILLAIN BARRE. The patient was being treated on a outpatient basis and with over the counter ADVIL as need but no prescriptions. At the time of this report, the patient had not recovered. No product quality complaint was involved. Upon internal review, GUILLAIN-BARRE was considered to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Guillain-Barre syndrome, Limb discomfort
Clinical narrative: Information has been received from the physician concerning a 17 year old female who was vaccinated with a first dose of GARDASIL. Three weeks to the day of the vaccination, the patient came into the office for a follow up visit with discomfort of leg muscles. It was reported by the physician that this might be sensory variant GUILLAIN BARRE. The patient was being treated on a outpatient basis and with over the counter ADVIL as need but no prescriptions. At the time of this report, the patient had not recovered. No product quality complaint was involved. Upon internal review, GUILLAIN-BARRE was considered to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Arthralgia, Band neutrophil percentage, Basophil count normal, Blood creatine phosphokinase, Eosinophil count normal
Clinical narrative: Information has been received from the physician concerning a 17 year old female who was vaccinated with a first dose of GARDASIL. Three weeks to the day of the vaccination, the patient came into the office for a follow up visit with discomfort of leg muscles. It was reported by the physician that this might be sensory variant GUILLAIN BARRE. The patient was being treated on a outpatient basis and with over the counter ADVIL as need but no prescriptions. At the time of this report, the patient had not recovered. No product quality complaint was involved. Upon internal review, GUILLAIN-BARRE was considered to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Haematocrit normal, Haemoglobin normal, Lymphocyte count normal, Mean cell haemoglobin concentration normal, Mean cell volume normal
Clinical narrative: Information has been received from the physician concerning a 17 year old female who was vaccinated with a first dose of GARDASIL. Three weeks to the day of the vaccination, the patient came into the office for a follow up visit with discomfort of leg muscles. It was reported by the physician that this might be sensory variant GUILLAIN BARRE. The patient was being treated on a outpatient basis and with over the counter ADVIL as need but no prescriptions. At the time of this report, the patient had not recovered. No product quality complaint was involved. Upon internal review, GUILLAIN-BARRE was considered to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Mean platelet volume normal, Monocyte count normal, Muscular weakness, Myalgia, Neurological examination
Clinical narrative: Information has been received from the physician concerning a 17 year old female who was vaccinated with a first dose of GARDASIL. Three weeks to the day of the vaccination, the patient came into the office for a follow up visit with discomfort of leg muscles. It was reported by the physician that this might be sensory variant GUILLAIN BARRE. The patient was being treated on a outpatient basis and with over the counter ADVIL as need but no prescriptions. At the time of this report, the patient had not recovered. No product quality complaint was involved. Upon internal review, GUILLAIN-BARRE was considered to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Neutrophil count normal, Platelet count normal, Red blood cell count normal, Red blood cell sedimentation rate normal, Red cell distribution width normal
Clinical narrative: Information has been received from the physician concerning a 17 year old female who was vaccinated with a first dose of GARDASIL. Three weeks to the day of the vaccination, the patient came into the office for a follow up visit with discomfort of leg muscles. It was reported by the physician that this might be sensory variant GUILLAIN BARRE. The patient was being treated on a outpatient basis and with over the counter ADVIL as need but no prescriptions. At the time of this report, the patient had not recovered. No product quality complaint was involved. Upon internal review, GUILLAIN-BARRE was considered to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: White blood cell count normal
Clinical narrative: Information has been received from the physician concerning a 17 year old female who was vaccinated with a first dose of GARDASIL. Three weeks to the day of the vaccination, the patient came into the office for a follow up visit with discomfort of leg muscles. It was reported by the physician that this might be sensory variant GUILLAIN BARRE. The patient was being treated on a outpatient basis and with over the counter ADVIL as need but no prescriptions. At the time of this report, the patient had not recovered. No product quality complaint was involved. Upon internal review, GUILLAIN-BARRE was considered to be an other important medical event. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Erythema, Pruritus, Rash papular, Varicella
Clinical narrative: Information has been received from a physician concerning a 12 month old male who on 15-OCT-2007 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot number: 657244/0527U). Concomitant therapy included varicella virus vaccine live (Oka/Merck) (lot number: 658586/1272U) and influenza virus vaccine (unspecified). On 26-OCT-2007 the patient had a severe measles like rash that was all over the patient's body from scalp to the foot. The physician reported that this rash cleared up within a day or two. No further adverse event information. There were no lab diagnostics studies performed. Unspecified medical attention was sought. The outcome is reported as recovered. There was no product quality complaint. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: Information has been received from a physician concerning a 12 month old male who on 15-OCT-2007 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot number: 657244/0527U). Concomitant therapy included varicella virus vaccine live (Oka/Merck) (lot number: 658586/1272U) and influenza virus vaccine (unspecified). On 26-OCT-2007 the patient had a severe measles like rash that was all over the patient's body from scalp to the foot. The physician reported that this rash cleared up within a day or two. No further adverse event information. There were no lab diagnostics studies performed. Unspecified medical attention was sought. The outcome is reported as recovered. There was no product quality complaint. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Syncope
Clinical narrative: PATIENT FAINTED 5 MINUTES AFTER HPV ADMINSTRATION. RECOVERED AFTER AMONIA SALTS BROKEN. SEEN BY PHYSICIAN. STAYED IN OFFICE FOR 40 MINUTES FOR OBSERVATION AND RECOVERY. PATIENT WAS ABLE TO AMBULATE AND STAND ON HER OWN BEFORE LEAVING THE OFFICE.
Age: 3.0
Sex: M
Vaccine: DTP, HEP, HEPA, HIBV, IPV, PPV
Symptoms: Anorexia, Convulsion, Crying, Drooling, Dyskinesia
Clinical narrative: My son was administered 8 shots at once (4 sticks) on 6-16-08 and within two hours, began screaming, sweating, and crying uncontrollably for over an hour.  He also complained that his arms hurt bad at the site of injection and there are red rashed on both arms.  I gave him a dose of motrin and he took a nap.  He was irritable and and had no appetite all night.  In the a.m. 6-17-08 at 8:00am, he lost consciousness and had a seizure which lasted almost 15 minutes of jerking and staring blankly, eyes rolling back in his head, heavy drooling and then complete unresponsiveness.  He was terrified and so was I. He was then transported by ambulance to hospital and the whole time he was yawning (which the paramedics told me was neurological) and staring blankly. He was monitored and then administered childrens tylenol.  They released us at 11:00 am.
Age: 3.0
Sex: M
Vaccine: DTP, HEP, HEPA, HIBV, IPV, PPV
Symptoms: Gaze palsy, Hyperhidrosis, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: My son was administered 8 shots at once (4 sticks) on 6-16-08 and within two hours, began screaming, sweating, and crying uncontrollably for over an hour.  He also complained that his arms hurt bad at the site of injection and there are red rashed on both arms.  I gave him a dose of motrin and he took a nap.  He was irritable and and had no appetite all night.  In the a.m. 6-17-08 at 8:00am, he lost consciousness and had a seizure which lasted almost 15 minutes of jerking and staring blankly, eyes rolling back in his head, heavy drooling and then complete unresponsiveness.  He was terrified and so was I. He was then transported by ambulance to hospital and the whole time he was yawning (which the paramedics told me was neurological) and staring blankly. He was monitored and then administered childrens tylenol.  They released us at 11:00 am.
Age: 3.0
Sex: M
Vaccine: DTP, HEP, HEPA, HIBV, IPV, PPV
Symptoms: Irritability, Loss of consciousness, Screaming, Unresponsive to stimuli, Yawning
Clinical narrative: My son was administered 8 shots at once (4 sticks) on 6-16-08 and within two hours, began screaming, sweating, and crying uncontrollably for over an hour.  He also complained that his arms hurt bad at the site of injection and there are red rashed on both arms.  I gave him a dose of motrin and he took a nap.  He was irritable and and had no appetite all night.  In the a.m. 6-17-08 at 8:00am, he lost consciousness and had a seizure which lasted almost 15 minutes of jerking and staring blankly, eyes rolling back in his head, heavy drooling and then complete unresponsiveness.  He was terrified and so was I. He was then transported by ambulance to hospital and the whole time he was yawning (which the paramedics told me was neurological) and staring blankly. He was monitored and then administered childrens tylenol.  They released us at 11:00 am.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discharge, Injection site pruritus, Injection site rash, Musculoskeletal pain, Neck pain
Clinical narrative: Rash, itching, discharge at rash site; 4-5 days after administration, pain L and R shoulder and neck.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Musculoskeletal pain, Pain, Pain in extremity, Pruritus
Clinical narrative: Rash, itching, discharge at rash site; 4-5 days after administration, pain L and R shoulder and neck.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular, Varicella zoster virus serology positive
Clinical narrative: Rash, itching, discharge at rash site; 4-5 days after administration, pain L and R shoulder and neck.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Blood culture, Convulsion, Culture urine, Pyrexia
Clinical narrative: Fever and seizure on evening of the day he got vaccination. Pt admitted to hospital. Got spinal tap and started on antibiotics. Also urine and blood cultures sent.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Blood culture, Convulsion, Culture urine, Lumbar puncture, Pyrexia
Clinical narrative: Fever and seizure on evening of the day he got vaccination. Pt admitted to hospital. Got spinal tap and started on antibiotics. Also urine and blood cultures sent.
Sex: F
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who on an unspecified date, was vaccinated with a first dose of GARDASIL. Subsequently, the patient experienced arthralgias. On an unspecified date the patient was vaccinated with a third dose of GARDASIL.  Subsequently, the patient experienced symptoms of GUILLAIN-BARRE syndrome.The patient sought unspecified medical attention. At the timf of the report, the patient had not recovered. No product quality complaint was involved. Follow-up information indicated that the physician did not know the name of the patient. The physician reported that he received infromation on the event through a contact of a friend and he did not have additional infromation on the patient. The physician considered the symptoms of GUILLAIN-BARRE syndrome and arthralgia to be disabling. This is a consolidation of two reports concerning the same patient. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female patient with seasonal allergies who on 28-APR-2008 was vaccinated intramuscularly with a 0.5 mL dose of GARDASIL (Lot #660387/1967U). On 28-APR-2008, the patient experienced hives all over. On 30-APR-2008, the patient recovered. Hives were considered to be an other important medical event. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Malaise, Nausea, Pallor, Pregnancy test positive
Clinical narrative: Information has been received from a mother, for the Pregnancy Registry for GARDASIL vaccine (yeast), concerning her 15 year old daughter with a history of latex allergy and tonsillectomy who on 24-APR-2008 was vaccinated with her first dose of GARDASIL vaccine (yeast) (Lot #, size, and route not reported). There was no concomitant medication. On 24-APR-2008 the patient "became pale, and she was nauseous and sick for one day". On an unspecified date, the patient took a pregnancy test which was positive (not further specified) (LMP approximately 05-FEB-2008, "estimated date of conception is 27-Feb-2008"). On 25-APR-2008, the patient fully recovered from paleness, nausea and being sick. The patient sought unspecified medical attention. No additional information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/13/2008.
Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Biopsy, Colposcopy, Fatigue, Injection site pain
Clinical narrative: Initial and follow up information has been received from a physician, nurse and a 35 year old female with a shell fish allergy, and a history of abnormal PAP test (February 2008), colposcopy (April 2003), biopsy (April 2003), and low grade CIN 1, who on 01-MAY-2008 was vaccinated intramuscularly in the lateral part of the thigh (unspecified which thigh) with her first dose of GARDASIL vaccine (yeast) (Lot # 660387/1967U). On 01-MAY-2008 the patient experienced injection site pain. On approximately 03-MAY-2008, also reported as "a couple of days later", the patient experienced leg muscle pain, muscle pain in the hands, knees and ankles, joint pain in the hands, knees and ankles and general tiredness. On 08-MAY-2008, the patient called the doctor's office and was treated with over the counter ibuprofen. The patient was to call the office if symptoms did not improve. At the time of the report, the patient had not contacted the doctor's office again. Subsequently on an unspecified date, the patient recovered from the injection site pain, arthralgia, fatigue, leg muscle pain, and muscle pain in the hands, knees and ankles. No further information was provided. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Smear cervix abnormal
Clinical narrative: Initial and follow up information has been received from a physician, nurse and a 35 year old female with a shell fish allergy, and a history of abnormal PAP test (February 2008), colposcopy (April 2003), biopsy (April 2003), and low grade CIN 1, who on 01-MAY-2008 was vaccinated intramuscularly in the lateral part of the thigh (unspecified which thigh) with her first dose of GARDASIL vaccine (yeast) (Lot # 660387/1967U). On 01-MAY-2008 the patient experienced injection site pain. On approximately 03-MAY-2008, also reported as "a couple of days later", the patient experienced leg muscle pain, muscle pain in the hands, knees and ankles, joint pain in the hands, knees and ankles and general tiredness. On 08-MAY-2008, the patient called the doctor's office and was treated with over the counter ibuprofen. The patient was to call the office if symptoms did not improve. At the time of the report, the patient had not contacted the doctor's office again. Subsequently on an unspecified date, the patient recovered from the injection site pain, arthralgia, fatigue, leg muscle pain, and muscle pain in the hands, knees and ankles. No further information was provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Smear cervix
Clinical narrative: Information has been received from a certified nurse midwife concerning five or six 18 to 19 year old females, concomitant medications and pertinent medical histories not specified, who were vaccinated (dates unspecified) with the first doses of GARDASIL vaccine (yeast) (Lot #'s, and routes unspecified). It was reported that several weeks after receiving the GARDASIL vaccine (yeast) 5 or 6 patients unfortunately came back with hundreds of genital warts. At first they thought it may be just a chance occurrence not only did the nurse midwife see these , the doctor saw a few of these instances as well. The patients came in and had a pap, the pap smears came back and after that the first dose of GARDASIL vaccine (yeast) was administered, and after that they saw these outbreaks of genital warts come back. "It was so bad that these girls needed laser therapy and sometimes they continued laser therapy and even after that continued laser therapy. The patients still had genital warts." Some continued to receive the second and third dose and some may not, but at least some did finish the doses. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female with concomitant medications and pertinent medical history reported as unspecified, who on 24-MAY-2007 was vaccinated with her first dose of GARDASIL vaccine (yeast) (Lot # not reported). On 25-MAY-2007, the patient felt weak, dizzy and fainted, and sought unspecified medical attention. The patient recovered completely a short time later (date unspecified). No product quality complaint was involved. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female with a sulfonamide allergy and no medical history, who on 08-APR-2008 was vaccinated intramuscularly with the first dose of GARDASIL vaccine (yeast). There was no concomitant medication. On 08-APR-2008 the patient developed a hard lump with pain at the injection site. It was reported that the patient called the physician's office. No diagnostic laboratory studies were performed. At the time of this report the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a nurse practitioner concerning a female with a history of asthma who was vaccinated intramuscularly on an unspecified date with her first dose of GARDASIL vaccine (yeast) (lot# not reported). Subsequently the patient experienced a headache 10 minutes after the dose. The patient still had the headache 4 hours later. The patient was instructed to take diphenhydramine hydrochloride (BENADRYL) and go to bed. Subsequently, the patient recovered from the headache the next morning. Additional information has been requested.