chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Echocardiogram abnormal, Heart valve insufficiency, Immunoglobulins, Myocarditis, Nasopharyngitis
Clinical narrative: Information has been received from an agency concerning a 20 year old female who on 12-FEB-2007 was vaccinated intramuscularly into the right arm with a first dose of Gardasil (Lot #654389/0961F). Concomitant suspect therapy included Varivax (Lot #652550/1111R) subcutaneously into the right arm. The patient had no symptoms until 04-MAR-2007 when in the morning, the patient's mother noted that she had a cold/URI symptoms with cough. At 11am, the patient developed emesis after eating soup at 10am. The patient was napping at 3pm when her mother got home but she was difficult to arouse. The mother called 911 and started rescue breathing. The paramedics initially called in stable vital signs but required active CPR on the gurney by the time they came into the emergency department. The patient was in disorganized ventricular fibrillation in the emergency room and was resuscitated with PALS and cardiology was consulted for ECHO. The patient was hospitalized. The patient was cannulated for VA ECMO on full flow support after 1.5 hours. The heart was completely akinetic. The patient went to the catherization lab to get biopsies, CADs and assessment of integrity of heart with very poor tone/strength to heart muscle noted which was presumed to be acute viral myocarditis. The patient received IVIG. The patient neurologic function could not be assessed due to significant drug load. The patient currently remained with very disorganized rhythm. An EPS study was considered as well as the possibility of family inherited rhythm disturbances. The patient received ECMO support for cardiac arrest secondary to myocarditis. An endomyocardial biopsy showed acute lymphocytic myocarditis with scattered eosinophils. An echocardiogram revealed dilated right ventricle, severely decreased biventricular systolic function, mild tricupsid/mitral insufficiency, atrial septum bulges, and small right pleural effusion. The patient was discharged on 23-MAR-2007. At the time of this report, the outcome was unknown. Cough, emesis, cardiac arrhythmia, oxygen supplementation, acute viral myocarditis, respiratory arrest, cold/uri, difficult to arouse and cardiac arrest secondary to myocarditis were considered to be immediately life-threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements and was released. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Oxygen supplementation, Pleural effusion, Respiratory arrest, Resuscitation, Upper respiratory tract infection
Clinical narrative: Information has been received from an agency concerning a 20 year old female who on 12-FEB-2007 was vaccinated intramuscularly into the right arm with a first dose of Gardasil (Lot #654389/0961F). Concomitant suspect therapy included Varivax (Lot #652550/1111R) subcutaneously into the right arm. The patient had no symptoms until 04-MAR-2007 when in the morning, the patient's mother noted that she had a cold/URI symptoms with cough. At 11am, the patient developed emesis after eating soup at 10am. The patient was napping at 3pm when her mother got home but she was difficult to arouse. The mother called 911 and started rescue breathing. The paramedics initially called in stable vital signs but required active CPR on the gurney by the time they came into the emergency department. The patient was in disorganized ventricular fibrillation in the emergency room and was resuscitated with PALS and cardiology was consulted for ECHO. The patient was hospitalized. The patient was cannulated for VA ECMO on full flow support after 1.5 hours. The heart was completely akinetic. The patient went to the catherization lab to get biopsies, CADs and assessment of integrity of heart with very poor tone/strength to heart muscle noted which was presumed to be acute viral myocarditis. The patient received IVIG. The patient neurologic function could not be assessed due to significant drug load. The patient currently remained with very disorganized rhythm. An EPS study was considered as well as the possibility of family inherited rhythm disturbances. The patient received ECMO support for cardiac arrest secondary to myocarditis. An endomyocardial biopsy showed acute lymphocytic myocarditis with scattered eosinophils. An echocardiogram revealed dilated right ventricle, severely decreased biventricular systolic function, mild tricupsid/mitral insufficiency, atrial septum bulges, and small right pleural effusion. The patient was discharged on 23-MAR-2007. At the time of this report, the outcome was unknown. Cough, emesis, cardiac arrhythmia, oxygen supplementation, acute viral myocarditis, respiratory arrest, cold/uri, difficult to arouse and cardiac arrest secondary to myocarditis were considered to be immediately life-threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements and was released. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Ventricular fibrillation, Vomiting
Clinical narrative: Information has been received from an agency concerning a 20 year old female who on 12-FEB-2007 was vaccinated intramuscularly into the right arm with a first dose of Gardasil (Lot #654389/0961F). Concomitant suspect therapy included Varivax (Lot #652550/1111R) subcutaneously into the right arm. The patient had no symptoms until 04-MAR-2007 when in the morning, the patient's mother noted that she had a cold/URI symptoms with cough. At 11am, the patient developed emesis after eating soup at 10am. The patient was napping at 3pm when her mother got home but she was difficult to arouse. The mother called 911 and started rescue breathing. The paramedics initially called in stable vital signs but required active CPR on the gurney by the time they came into the emergency department. The patient was in disorganized ventricular fibrillation in the emergency room and was resuscitated with PALS and cardiology was consulted for ECHO. The patient was hospitalized. The patient was cannulated for VA ECMO on full flow support after 1.5 hours. The heart was completely akinetic. The patient went to the catherization lab to get biopsies, CADs and assessment of integrity of heart with very poor tone/strength to heart muscle noted which was presumed to be acute viral myocarditis. The patient received IVIG. The patient neurologic function could not be assessed due to significant drug load. The patient currently remained with very disorganized rhythm. An EPS study was considered as well as the possibility of family inherited rhythm disturbances. The patient received ECMO support for cardiac arrest secondary to myocarditis. An endomyocardial biopsy showed acute lymphocytic myocarditis with scattered eosinophils. An echocardiogram revealed dilated right ventricle, severely decreased biventricular systolic function, mild tricupsid/mitral insufficiency, atrial septum bulges, and small right pleural effusion. The patient was discharged on 23-MAR-2007. At the time of this report, the outcome was unknown. Cough, emesis, cardiac arrhythmia, oxygen supplementation, acute viral myocarditis, respiratory arrest, cold/uri, difficult to arouse and cardiac arrest secondary to myocarditis were considered to be immediately life-threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements and was released. No further information is available.
Age: 13.0
Sex: F
Vaccine: DTAP, HEPA, HPV4, MNQ, DTAP, HEPA, HPV4, MNQ
Symptoms: Blood pressure increased, Chest discomfort, Cough, Dyspnoea, Hypersensitivity
Clinical narrative: Information has been received from an agency concerning a 13 year old female with an allergy to cats (the patient owns a cat) who on 22-FEB-2007 was vaccinated intramuscularly into the right arm with a dose of Gardasil (Lot # 655205/1426F). Concomitant therapy included Menactra (Lot # U2158AA) in the left arm, Infanrix (Lot # AC52B007AA) in the left arm, Havrix (Lot # AHAVB141AA) in the right arm and mometasone furoate (NASONEX). On 22-FEB-2007, 30 minutes after receiving the vaccines, the patient developed cough, wheezing and shortness of breath. The patient was seen in the emergency department for an allergic reaction to the vaccines. Initially, the patient returned to her primary care physician with complaints of chest tightness, difficulty breathing and tremors. The patient was treated with epinephrine (EPI-PEN) and dihydrohydramine hydrochloride (BENADRYL) and sent to the emergency room. There was no swelling of the mouth, lips or tongue. Vital signs were performed and the patient had a pulse of 141, respiratory rate of 20 and blood pressure of 130/91. The patient was treated with methylprednisolone sodium succinated (SOLU-MEDROL) and ranitidine. A physical exam was unremarkable (lungs clean, no rhonchi, no wheezes). The patient was admitted to the hospital for IV steroid treatment. At the time of this report, the outcome was unknown. Cough, wheezing, shortness of breath, chest tightness, difficulty breathing, allergic reaction to vaccines and tremors were considered to be immediately life-threatening. The original reporting source was not indicated. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 13.0
Sex: F
Vaccine: DTAP, HEPA, HPV4, MNQ, DTAP, HEPA, HPV4, MNQ
Symptoms: Lymphocyte count normal, Neutrophil count normal, Oxygen saturation, Respiratory rate, Tremor
Clinical narrative: Information has been received from an agency concerning a 13 year old female with an allergy to cats (the patient owns a cat) who on 22-FEB-2007 was vaccinated intramuscularly into the right arm with a dose of Gardasil (Lot # 655205/1426F). Concomitant therapy included Menactra (Lot # U2158AA) in the left arm, Infanrix (Lot # AC52B007AA) in the left arm, Havrix (Lot # AHAVB141AA) in the right arm and mometasone furoate (NASONEX). On 22-FEB-2007, 30 minutes after receiving the vaccines, the patient developed cough, wheezing and shortness of breath. The patient was seen in the emergency department for an allergic reaction to the vaccines. Initially, the patient returned to her primary care physician with complaints of chest tightness, difficulty breathing and tremors. The patient was treated with epinephrine (EPI-PEN) and dihydrohydramine hydrochloride (BENADRYL) and sent to the emergency room. There was no swelling of the mouth, lips or tongue. Vital signs were performed and the patient had a pulse of 141, respiratory rate of 20 and blood pressure of 130/91. The patient was treated with methylprednisolone sodium succinated (SOLU-MEDROL) and ranitidine. A physical exam was unremarkable (lungs clean, no rhonchi, no wheezes). The patient was admitted to the hospital for IV steroid treatment. At the time of this report, the outcome was unknown. Cough, wheezing, shortness of breath, chest tightness, difficulty breathing, allergic reaction to vaccines and tremors were considered to be immediately life-threatening. The original reporting source was not indicated. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 13.0
Sex: F
Vaccine: DTAP, HEPA, HPV4, MNQ, DTAP, HEPA, HPV4, MNQ
Symptoms: Wheezing, Wrong drug administered
Clinical narrative: Information has been received from an agency concerning a 13 year old female with an allergy to cats (the patient owns a cat) who on 22-FEB-2007 was vaccinated intramuscularly into the right arm with a dose of Gardasil (Lot # 655205/1426F). Concomitant therapy included Menactra (Lot # U2158AA) in the left arm, Infanrix (Lot # AC52B007AA) in the left arm, Havrix (Lot # AHAVB141AA) in the right arm and mometasone furoate (NASONEX). On 22-FEB-2007, 30 minutes after receiving the vaccines, the patient developed cough, wheezing and shortness of breath. The patient was seen in the emergency department for an allergic reaction to the vaccines. Initially, the patient returned to her primary care physician with complaints of chest tightness, difficulty breathing and tremors. The patient was treated with epinephrine (EPI-PEN) and dihydrohydramine hydrochloride (BENADRYL) and sent to the emergency room. There was no swelling of the mouth, lips or tongue. Vital signs were performed and the patient had a pulse of 141, respiratory rate of 20 and blood pressure of 130/91. The patient was treated with methylprednisolone sodium succinated (SOLU-MEDROL) and ranitidine. A physical exam was unremarkable (lungs clean, no rhonchi, no wheezes). The patient was admitted to the hospital for IV steroid treatment. At the time of this report, the outcome was unknown. Cough, wheezing, shortness of breath, chest tightness, difficulty breathing, allergic reaction to vaccines and tremors were considered to be immediately life-threatening. The original reporting source was not indicated. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 13.0
Sex: F
Vaccine: DTAP, HEPA, HPV4, MNQ, DTAP, HEPA, HPV4, MNQ
Symptoms: Blood pressure, Chest discomfort, Cough, Dyspnoea, Full blood count
Clinical narrative: Information has been received from an agency concerning a 13 year old female with an allergy to cats (the patient owns a cat) who on 22-FEB-2007 was vaccinated intramuscularly into the right arm with a dose of Gardasil (Lot # 655205/1426F). Concomitant therapy included Menactra (Lot # U2158AA) in the left arm, Infanrix (Lot # AC52B007AA) in the left arm, Havrix (Lot # AHAVB141AA) in the right arm and mometasone furoate (NASONEX). On 22-FEB-2007, 30 minutes after receiving the vaccines, the patient developed cough, wheezing and shortness of breath. The patient was seen in the emergency department for an allergic reaction to the vaccines. Initially, the patient returned to her primary care physician with complaints of chest tightness, difficulty breathing and tremors. The patient was treated with epinephrine (EPI-PEN) and dihydrohydramine hydrochloride (BENADRYL) and sent to the emergency room. There was no swelling of the mouth, lips or tongue. Vital signs were performed and the patient had a pulse of 141, respiratory rate of 20 and blood pressure of 130/91. The patient was treated with methylprednisolone sodium succinated (SOLU-MEDROL) and ranitidine. A physical exam was unremarkable (lungs clean, no rhonchi, no wheezes). The patient was admitted to the hospital for IV steroid treatment. At the time of this report, the outcome was unknown. Cough, wheezing, shortness of breath, chest tightness, difficulty breathing, allergic reaction to vaccines and tremors were considered to be immediately life-threatening. The original reporting source was not indicated. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 13.0
Sex: F
Vaccine: DTAP, HEPA, HPV4, MNQ, DTAP, HEPA, HPV4, MNQ
Symptoms: Heart rate increased, Hypersensitivity, Inappropriate schedule of drug administration, Lymphocyte count normal, Neutrophil count normal
Clinical narrative: Information has been received from an agency concerning a 13 year old female with an allergy to cats (the patient owns a cat) who on 22-FEB-2007 was vaccinated intramuscularly into the right arm with a dose of Gardasil (Lot # 655205/1426F). Concomitant therapy included Menactra (Lot # U2158AA) in the left arm, Infanrix (Lot # AC52B007AA) in the left arm, Havrix (Lot # AHAVB141AA) in the right arm and mometasone furoate (NASONEX). On 22-FEB-2007, 30 minutes after receiving the vaccines, the patient developed cough, wheezing and shortness of breath. The patient was seen in the emergency department for an allergic reaction to the vaccines. Initially, the patient returned to her primary care physician with complaints of chest tightness, difficulty breathing and tremors. The patient was treated with epinephrine (EPI-PEN) and dihydrohydramine hydrochloride (BENADRYL) and sent to the emergency room. There was no swelling of the mouth, lips or tongue. Vital signs were performed and the patient had a pulse of 141, respiratory rate of 20 and blood pressure of 130/91. The patient was treated with methylprednisolone sodium succinated (SOLU-MEDROL) and ranitidine. A physical exam was unremarkable (lungs clean, no rhonchi, no wheezes). The patient was admitted to the hospital for IV steroid treatment. At the time of this report, the outcome was unknown. Cough, wheezing, shortness of breath, chest tightness, difficulty breathing, allergic reaction to vaccines and tremors were considered to be immediately life-threatening. The original reporting source was not indicated. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 13.0
Sex: F
Vaccine: DTAP, HEPA, HPV4, MNQ, DTAP, HEPA, HPV4, MNQ
Symptoms: Oxygen saturation, Respiratory rate, Tremor, Wheezing
Clinical narrative: Information has been received from an agency concerning a 13 year old female with an allergy to cats (the patient owns a cat) who on 22-FEB-2007 was vaccinated intramuscularly into the right arm with a dose of Gardasil (Lot # 655205/1426F). Concomitant therapy included Menactra (Lot # U2158AA) in the left arm, Infanrix (Lot # AC52B007AA) in the left arm, Havrix (Lot # AHAVB141AA) in the right arm and mometasone furoate (NASONEX). On 22-FEB-2007, 30 minutes after receiving the vaccines, the patient developed cough, wheezing and shortness of breath. The patient was seen in the emergency department for an allergic reaction to the vaccines. Initially, the patient returned to her primary care physician with complaints of chest tightness, difficulty breathing and tremors. The patient was treated with epinephrine (EPI-PEN) and dihydrohydramine hydrochloride (BENADRYL) and sent to the emergency room. There was no swelling of the mouth, lips or tongue. Vital signs were performed and the patient had a pulse of 141, respiratory rate of 20 and blood pressure of 130/91. The patient was treated with methylprednisolone sodium succinated (SOLU-MEDROL) and ranitidine. A physical exam was unremarkable (lungs clean, no rhonchi, no wheezes). The patient was admitted to the hospital for IV steroid treatment. At the time of this report, the outcome was unknown. Cough, wheezing, shortness of breath, chest tightness, difficulty breathing, allergic reaction to vaccines and tremors were considered to be immediately life-threatening. The original reporting source was not indicated. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.5
Sex: M
Vaccine: HEPA, PNC, TDAP, HEPA, PNC, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Tdap & HepA given in error
Age: 56.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Oedema peripheral, Pruritus, Rash, Tinnitus
Clinical narrative: rash with itching. Torso spreading to extremities. Ringing in ear. Benedryl 50mg + zertac + Claritin with no improvement. next day edema in arms. Prednison, epinepherin, Benedryl. 5-6 days rash & itching gone.
Age: 56.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Oedema peripheral, Rash, Rash pruritic, Tinnitus
Clinical narrative: rash with itching. Torso spreading to extremities. Ringing in ear. Benedryl 50mg + zertac + Claritin with no improvement. next day edema in arms. Prednison, epinepherin, Benedryl. 5-6 days rash & itching gone.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL, DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Rash generalised
Clinical narrative: Per pt mother developed hives 8/23/07 am called MD brought in for appt Rx given for Benadryl 12.5/4 cc. One tsp every 4 hr prn, mother states hives never completely dissipated. on 8/26/07 Sunday took child to Med Express urgent care increased hives c/o tightness, sore throat; hoarse. Tx'd at urgent care with Prednisone
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL, DTAP, MMR, VARCEL
Symptoms: Dysphonia, Pharyngolaryngeal pain, Throat tightness, Urticaria
Clinical narrative: Per pt mother developed hives 8/23/07 am called MD brought in for appt Rx given for Benadryl 12.5/4 cc. One tsp every 4 hr prn, mother states hives never completely dissipated. on 8/26/07 Sunday took child to Med Express urgent care increased hives c/o tightness, sore throat; hoarse. Tx'd at urgent care with Prednisone
Age: 8.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Headache, Herpes zoster, Injection site pain, Rash vesicular
Clinical narrative: Pain, diffuse shingles-like reaction
Age: 8.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Herpes zoster, Pain
Clinical narrative: Pain, diffuse shingles-like reaction
Age: 13.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Aphasia, Computerised tomogram, Convulsion, Electroencephalogram, Hypokinesia
Clinical narrative: Swelling and Pain at sight of shot. 2 days later patient was in school and her arm started to shake uncontrollably, she tried raising her other hand to get teachers attention and could not, then tried to speak at was unable to.  At that time she dropped to the floor.  The instructor said she seized for about 5 minutes. The School Called 911 then they brought her to Hospital.  09/11/2007 Reviewed hospital medical records which reveal patient experienced right sided seizure which became generalized tonic clonic seizure w/LOC while at school working on computer. Admitted 8/31/07-9/1/07.  Neuro consult obtained FAMILY HX: paternal aunt, great aunts/uncles w/seizure disorder. FINAL DX: New onset seizures.
Age: 13.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Inappropriate schedule of drug administration, Injection site pain, Injection site swelling, Loss of consciousness, Nuclear magnetic resonance imaging
Clinical narrative: Swelling and Pain at sight of shot. 2 days later patient was in school and her arm started to shake uncontrollably, she tried raising her other hand to get teachers attention and could not, then tried to speak at was unable to.  At that time she dropped to the floor.  The instructor said she seized for about 5 minutes. The School Called 911 then they brought her to Hospital.  09/11/2007 Reviewed hospital medical records which reveal patient experienced right sided seizure which became generalized tonic clonic seizure w/LOC while at school working on computer. Admitted 8/31/07-9/1/07.  Neuro consult obtained FAMILY HX: paternal aunt, great aunts/uncles w/seizure disorder. FINAL DX: New onset seizures.
Age: 13.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Syncope, Tremor
Clinical narrative: Swelling and Pain at sight of shot. 2 days later patient was in school and her arm started to shake uncontrollably, she tried raising her other hand to get teachers attention and could not, then tried to speak at was unable to.  At that time she dropped to the floor.  The instructor said she seized for about 5 minutes. The School Called 911 then they brought her to Hospital.  09/11/2007 Reviewed hospital medical records which reveal patient experienced right sided seizure which became generalized tonic clonic seizure w/LOC while at school working on computer. Admitted 8/31/07-9/1/07.  Neuro consult obtained FAMILY HX: paternal aunt, great aunts/uncles w/seizure disorder. FINAL DX: New onset seizures.
Age: 13.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Aphasia, Computerised tomogram, Convulsion, Electroencephalogram abnormal, Fall
Clinical narrative: Swelling and Pain at sight of shot. 2 days later patient was in school and her arm started to shake uncontrollably, she tried raising her other hand to get teachers attention and could not, then tried to speak at was unable to.  At that time she dropped to the floor.  The instructor said she seized for about 5 minutes. The School Called 911 then they brought her to Hospital.  09/11/2007 Reviewed hospital medical records which reveal patient experienced right sided seizure which became generalized tonic clonic seizure w/LOC while at school working on computer. Admitted 8/31/07-9/1/07.  Neuro consult obtained FAMILY HX: paternal aunt, great aunts/uncles w/seizure disorder. FINAL DX: New onset seizures.
Age: 13.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Injection site pain, Injection site swelling, Loss of consciousness, Nuclear magnetic resonance imaging, Tongue biting
Clinical narrative: Swelling and Pain at sight of shot. 2 days later patient was in school and her arm started to shake uncontrollably, she tried raising her other hand to get teachers attention and could not, then tried to speak at was unable to.  At that time she dropped to the floor.  The instructor said she seized for about 5 minutes. The School Called 911 then they brought her to Hospital.  09/11/2007 Reviewed hospital medical records which reveal patient experienced right sided seizure which became generalized tonic clonic seizure w/LOC while at school working on computer. Admitted 8/31/07-9/1/07.  Neuro consult obtained FAMILY HX: paternal aunt, great aunts/uncles w/seizure disorder. FINAL DX: New onset seizures.
Age: 13.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Tremor, Trismus
Clinical narrative: Swelling and Pain at sight of shot. 2 days later patient was in school and her arm started to shake uncontrollably, she tried raising her other hand to get teachers attention and could not, then tried to speak at was unable to.  At that time she dropped to the floor.  The instructor said she seized for about 5 minutes. The School Called 911 then they brought her to Hospital.  09/11/2007 Reviewed hospital medical records which reveal patient experienced right sided seizure which became generalized tonic clonic seizure w/LOC while at school working on computer. Admitted 8/31/07-9/1/07.  Neuro consult obtained FAMILY HX: paternal aunt, great aunts/uncles w/seizure disorder. FINAL DX: New onset seizures.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Pruritus, Urticaria
Clinical narrative: Information has been received from an agency concerning a 20 year old female with a tetracycline allergy and a history of dry skin who on 07-MAR-2007 was vaccinated intramuscular into the left arm with a dose of Gardasil (Lot # 656049/0187U). Concomitant therapy included ethinyl estradiol/ethynodiol diacetate (DEMULEN), telithromycin (KETEK) and dextromethorphan hydrobromide (+) guaifenesin (+) phenylpropanolamine hydrochloride (AQUATAB C). on 07-MAR-2007, within 1 hour of receiving the vaccination, the patient developed whole body hives, diffuse urticaria, itching and her chest felt heavy. A physical exam was performed and was within normal limits with the exception of confluent hives on arms. No laboratory diagnostic studies were performed. The patient responded to injected diphenhydramine hydrochloride (BENADRYL) and methylprednisolone acetate (DEPONMEDROL). At the time of this report, the outcome was unknown. Whole body hives, diffuse urticaria and chest felt heavy were considered to be immediately life-threatening. The original reporting source was not indicated.   A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigations was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Haemorrhage, Ultrasound scan
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female with asthma who on 12-MAR-2007 was vaccinated with a first dose of Gardasil. On 18-MAY-2007, the patient was vaccinated with a second dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). The nurse reported that the patient was given the second dose of Gardasil when she was possibly pregnant. Date of LMP was 06-MAY-2007. On 04-JUN-2007, a pregnancy test was positive. Subsequently, a small amount of bleeding was noted. On 30-JUL-2007, an ultrasound was performed (results not reported). At the time of the report on 21-AUG-2007, the patient was still pregnant. The patient's bleeding was considered an other important medical event by the registered nurse. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Abortion spontaneous complete, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a nurse practitioner through a Merck pregnancy registry regarding a 16 year old female who on 07-DEC-2006 was vaccinated IM with the first dose of Gardasil (Lot# not reported). On 08-DEC-2006 the patient had a positive pregnancy test result (test not specified). Unspecified medical attention was sought. At the time of this report no symptoms were reported and the outcome of the event was unknown. Follow up information was received from the nurse practitioner which stated that on an unspecified date the patient experienced a miscarriage at 13 weeks. Upon internal medical review the spontaneous abortion was considered to be an other important medical event. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC, UNK, VARCEL
Symptoms: Body temperature increased, Bronchial hyperreactivity, Cough, Dyspnoea, Pyrexia
Clinical narrative: Information has been received from GlaxoSmithKline for Hib-MenCY-TT (manufacturer report # B0484182A). A 12 month old male with a history of respiratory syncytial virus bronchiolitis at 3 months of age (from 26-NOV-2006 to 28-NOV-2006) was enrolled in the prophylactic booster study 105067 (Hib-MenCY-TT-010) which is single blind on study vaccines but double-blind on lot numbers of Hib-MenCY-TT. On 09-AUG-2007, the patient was vaccinated SC in the left upper arm with a dose of MMR II. Suspect vaccination on the same day included an IM dose in the right upper thigh of PedvaxHIB, a SC dose in the right upper arm of Varivax, and an IM Dose in the left upper thigh of Prevnar. On 13-AUG-2007, four days after the fourth dose of Hib-MenCY-TT, four days after the first dose of MMR II, four days after the first dose of Varivax and four days after the fourth dose of Prevnar, the patient developed reactive airway disease. The patient was hospitalized. The patient was treated with salbutamol sulphate and prednisolone. The event resolved on 20-AUG-2007. The investigator considered that there was a reasonable possibility that the reactive airway disease may have been caused by Hib-MenCY-TT, MMR II, Varivax, and Prevnar and that the event was possibly due to the patient's medical conditions. The investigator comments indicated that the event began with symptoms on 13-AUG-2007 with complaints of fever of 103 rectal, coughing, difficulty breathing, and wheezing. The patient was taken to the emergency room on 15-AUG-2007 where he was treated with albuterol nebulizers and oral prednisolone. He was admitted for observation and continued on albuterol nebulizers and oral prednisolone. He was discharged from the hospital on 16-AUG-2007. All symptoms resolved on 20-AUG-2007. Follow-up was received on 23-AUG-2007 which indicated that the patient received the fourth dose of the study vaccine on 09-AUG-2007. Symptoms of fever, cough, and wheeze started on 13-AUG-2007 and the patient was admitted to another hospital on 15-16-AUG-2007 where he was treated for reactive airway disease with albuterol and prednisolone. All symptoms resolved by 20-AUG-2007. This possibly could represent an allergic reaction to the fourth dose of investigational vaccine or just an episode of reactive airway disease in an infant predisposed to reactive airway disease on the basis of past history and respiratory syncytial virus bronchiolitis and a history of asthma in the maternal grandmother and the patient's siblings. This was originally reported by a physician. No further information is available.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC, UNK, VARCEL
Symptoms: Wheezing
Clinical narrative: Information has been received from GlaxoSmithKline for Hib-MenCY-TT (manufacturer report # B0484182A). A 12 month old male with a history of respiratory syncytial virus bronchiolitis at 3 months of age (from 26-NOV-2006 to 28-NOV-2006) was enrolled in the prophylactic booster study 105067 (Hib-MenCY-TT-010) which is single blind on study vaccines but double-blind on lot numbers of Hib-MenCY-TT. On 09-AUG-2007, the patient was vaccinated SC in the left upper arm with a dose of MMR II. Suspect vaccination on the same day included an IM dose in the right upper thigh of PedvaxHIB, a SC dose in the right upper arm of Varivax, and an IM Dose in the left upper thigh of Prevnar. On 13-AUG-2007, four days after the fourth dose of Hib-MenCY-TT, four days after the first dose of MMR II, four days after the first dose of Varivax and four days after the fourth dose of Prevnar, the patient developed reactive airway disease. The patient was hospitalized. The patient was treated with salbutamol sulphate and prednisolone. The event resolved on 20-AUG-2007. The investigator considered that there was a reasonable possibility that the reactive airway disease may have been caused by Hib-MenCY-TT, MMR II, Varivax, and Prevnar and that the event was possibly due to the patient's medical conditions. The investigator comments indicated that the event began with symptoms on 13-AUG-2007 with complaints of fever of 103 rectal, coughing, difficulty breathing, and wheezing. The patient was taken to the emergency room on 15-AUG-2007 where he was treated with albuterol nebulizers and oral prednisolone. He was admitted for observation and continued on albuterol nebulizers and oral prednisolone. He was discharged from the hospital on 16-AUG-2007. All symptoms resolved on 20-AUG-2007. Follow-up was received on 23-AUG-2007 which indicated that the patient received the fourth dose of the study vaccine on 09-AUG-2007. Symptoms of fever, cough, and wheeze started on 13-AUG-2007 and the patient was admitted to another hospital on 15-16-AUG-2007 where he was treated for reactive airway disease with albuterol and prednisolone. All symptoms resolved by 20-AUG-2007. This possibly could represent an allergic reaction to the fourth dose of investigational vaccine or just an episode of reactive airway disease in an infant predisposed to reactive airway disease on the basis of past history and respiratory syncytial virus bronchiolitis and a history of asthma in the maternal grandmother and the patient's siblings. This was originally reported by a physician. No further information is available.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Laboratory test, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Information has been received from a 55 year old male pharmacist with diabetes and no allergies who on 16-APR-2007 was vaccinated IM with a first 1.0 ml dose Recombivax HB (Lot # 654436/1106F) and on 20-MAY-2007 was vaccinated IM with a second 1.0 ml dose of Recombivax HB. Concomitant therapy included insulin glargine (LANTUS) and insulin lispro (HUMALOG). It was reported that after vaccination, on 01-JUN-2007 the patient experienced pain and stiffness in his wrists and shoulders. The patient began to experience pain and stiffness in the wrists and shoulders of both arms but the symptoms were more severe in the left arm. The patient also stated that the pain had become progressively worse and pain often caused him to wake up at 3:00 in the morning. A diagnostic laboratory test of blood work was done (results not provided). Unspecified medical attention was sought. At the time of report the patient had not recovered. A product quality complaint was not involved. The patient's experiences were considered to be disabling. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Skin exfoliation
Clinical narrative: Information has been received from a physician concerning a 16 year old female with penicillin allergy who on 14-AUG-2007 was vaccinated intramuscularly (IM) with the first dose of Gardasil (Lot #654702/0011U). Subsequently, the patient experienced peeling of the skin on the palms of both hands and the soles of both feet. The physician felt that this incident had caused a significant disability because it was very painful for the patient to walk with the skin on the soles of her feet peeling off. As of 28-AUG-2007, the patient had not recovered from the peeling of the skin on the palms of both hands and the soles of both feet. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Dizziness, Hyperhidrosis, Loss of consciousness, Muscle spasms
Clinical narrative: Information has been received from a healthcare worker concerning a 14 year old female with a history of ankle surgery (May 2006) who on 20-JUL-2007 was vaccinated with the first dose of Gardasil (lot #656051/0244U). On 20-JUL-2007 the patient felt fine before and during the administration of Gardasil, but within 5 minutes of receiving it she experienced seizure-like activity and diaphoresis. The healthcare worker indicated that the patient felt lightheaded and blacked out and then experienced muscle spasms for 2-3 minutes. The patient was shaky initially but recovered completely the same day. Her blood pressure after receiving Gardasil was 94/60 and later that day it was 108/72. Upon internal review, seizure-like activity was determined to be an other important medical event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor
Clinical narrative: Information has been received from a healthcare worker concerning a 14 year old female with a history of ankle surgery (May 2006) who on 20-JUL-2007 was vaccinated with the first dose of Gardasil (lot #656051/0244U). On 20-JUL-2007 the patient felt fine before and during the administration of Gardasil, but within 5 minutes of receiving it she experienced seizure-like activity and diaphoresis. The healthcare worker indicated that the patient felt lightheaded and blacked out and then experienced muscle spasms for 2-3 minutes. The patient was shaky initially but recovered completely the same day. Her blood pressure after receiving Gardasil was 94/60 and later that day it was 108/72. Upon internal review, seizure-like activity was determined to be an other important medical event. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Abnormal behaviour, Anger, Anorexia, Brain injury, Convulsion
Clinical narrative: My son had seizure hospitalized 10 days cannot play anymore not talking as before, continues fever, lost appetite and sleeps frequently.  9/25/07 Reviewed hospital medical records which reveals patient experienced episode of unconsciousness then was confused & pale.  Had HA evening prior to LOC which had resolved.  Had 2 witnessed seizures in ER.  Admitted7/24-7/26/2007.  Neurology consult done.  No further seizures s/p med dosing.  D/C home on antiseizure meds. FINAL DX: Partial complex seizures w/secondary generalization. Per 60 day follow up: Patient has long term seizure, brain damage, fatigue, not listening, angry all the time, fussiness. Continue taking seizure medication TRILEPTAL 150 mg tablet 2 tablets in morning 3 at night. 1/12/2010 Continue having seizure, mood changes, behave changes.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Disturbance in attention, Fatigue, Hypersomnia, Mood altered, Pyrexia
Clinical narrative: My son had seizure hospitalized 10 days cannot play anymore not talking as before, continues fever, lost appetite and sleeps frequently.  9/25/07 Reviewed hospital medical records which reveals patient experienced episode of unconsciousness then was confused & pale.  Had HA evening prior to LOC which had resolved.  Had 2 witnessed seizures in ER.  Admitted7/24-7/26/2007.  Neurology consult done.  No further seizures s/p med dosing.  D/C home on antiseizure meds. FINAL DX: Partial complex seizures w/secondary generalization. Per 60 day follow up: Patient has long term seizure, brain damage, fatigue, not listening, angry all the time, fussiness. Continue taking seizure medication TRILEPTAL 150 mg tablet 2 tablets in morning 3 at night. 1/12/2010 Continue having seizure, mood changes, behave changes.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Speech disorder
Clinical narrative: My son had seizure hospitalized 10 days cannot play anymore not talking as before, continues fever, lost appetite and sleeps frequently.  9/25/07 Reviewed hospital medical records which reveals patient experienced episode of unconsciousness then was confused & pale.  Had HA evening prior to LOC which had resolved.  Had 2 witnessed seizures in ER.  Admitted7/24-7/26/2007.  Neurology consult done.  No further seizures s/p med dosing.  D/C home on antiseizure meds. FINAL DX: Partial complex seizures w/secondary generalization. Per 60 day follow up: Patient has long term seizure, brain damage, fatigue, not listening, angry all the time, fussiness. Continue taking seizure medication TRILEPTAL 150 mg tablet 2 tablets in morning 3 at night. 1/12/2010 Continue having seizure, mood changes, behave changes.
Age: 17.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Severe arm swelling, redness, 3d after Pneumovax given. Hospitalized. IV antibiotic given.  1/15/08 Reviewed hospital medical records which reveal patient experienced fever, redness, rash & tenderness at RA injection site x 2 days & HA.  Admitted 8/11-8/13/07.  Tx w/IV antibiotics.  ID consult done.  D/C to home on condinued oral antibiotics. FINAL DX: none provided but ID consult states right arm cellulitis s/p pneumovax injection.
Age: 1.1
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Herpes zoster, Viral DNA test positive
Clinical narrative: Shingles (R) arm - acyclovir, antibiotics.  9/28/07 Reviewed hospital medical records which reveal patient experienced rash over right arm & hand.  Had reached into brushpile & received abrasion of right palm.  Next day blister had formed on palm & additional vesicles & erythema formed over her hand.  Seen by PCP & dx w/contact dermatitis.  That evening became restless w/poor sleep.  Next morning large red blisters & erythema were noted over her right hand, arm & shoulder & had fever of 102.  Taken to ER on 8/16, dx w/staph infection, c/s of lesion done, received IV antibiotic in ER & d/c to home on oral antibiotics. Continued to have fever, palm excoriation & pain increased.  Admitted 8/18-8/19/2007.  ID consult done.  Tx w/IV antibiotics & antivirals. FINAL DX: herpes zoster & allergic dermatitis.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Hypotonia, Pallor, Pneumocardiogram
Clinical narrative: Hypotonicity, Pallor.  10/2/07 Reviewed hospital medical records which reveal patient experienced a period of unresponsiveness, pale & limpness approx 4 hrs s/p vax.  Admitted to ICU for monitored observation 8/21-8/23/2007. Temp 100.5 on admit.  ID consult done.  No further episodes while hospitalized. FINAL DX: hypotonic-hyporesponsive episode, possibly secondary to vaccinations.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood culture, Chest X-ray, Crying, Full blood count, Laboratory test
Clinical narrative: Hypotonicity, Pallor.  10/2/07 Reviewed hospital medical records which reveal patient experienced a period of unresponsiveness, pale & limpness approx 4 hrs s/p vax.  Admitted to ICU for monitored observation 8/21-8/23/2007. Temp 100.5 on admit.  ID consult done.  No further episodes while hospitalized. FINAL DX: hypotonic-hyporesponsive episode, possibly secondary to vaccinations.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Oxygen saturation, Pallor, Respiratory arrest, Unresponsive to stimuli, Urine analysis
Clinical narrative: Hypotonicity, Pallor.  10/2/07 Reviewed hospital medical records which reveal patient experienced a period of unresponsiveness, pale & limpness approx 4 hrs s/p vax.  Admitted to ICU for monitored observation 8/21-8/23/2007. Temp 100.5 on admit.  ID consult done.  No further episodes while hospitalized. FINAL DX: hypotonic-hyporesponsive episode, possibly secondary to vaccinations.
Age: 34.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Cardiac ventriculogram abnormal, Catheterisation cardiac, Echocardiogram normal, Electrocardiogram ST segment elevation, Local swelling
Clinical narrative: Neck tightness/swelling (exterior) rept'd by pt without dyspnea or other cardiopulmonary difficulty. Found EGC abnormal consistent w/STEMI. Underwent cardiac catherization-> normal coronaries, abnl ventriculogram Next day echocardiogram (TTE) normal, Troponin peak @ approx 5. Completely asymptomatic w/in 24 hours.  1/4/08 Reviewed hospital medical records which reveal patient experienced lump in throat when swallowing, swollen neck lymph nodes & chest tightness.  Left deltoid vaccine injection site red, swollen & indurated.  Admitted8/25-8/29/2007  FINAL DX: myopericarditis, smallpox vaccine induced.
Age: 34.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Muscle tightness, Troponin increased
Clinical narrative: Neck tightness/swelling (exterior) rept'd by pt without dyspnea or other cardiopulmonary difficulty. Found EGC abnormal consistent w/STEMI. Underwent cardiac catherization-> normal coronaries, abnl ventriculogram Next day echocardiogram (TTE) normal, Troponin peak @ approx 5. Completely asymptomatic w/in 24 hours.  1/4/08 Reviewed hospital medical records which reveal patient experienced lump in throat when swallowing, swollen neck lymph nodes & chest tightness.  Left deltoid vaccine injection site red, swollen & indurated.  Admitted8/25-8/29/2007  FINAL DX: myopericarditis, smallpox vaccine induced.