chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Memory impairment, Metrorrhagia, Mood altered, Oropharyngeal pain, Pain in extremity
Clinical narrative: Information has been received from a gynecologist, concerning a 21 year old female patient with history of pollinosis who was vaccinated with a third dose GARDASIL (Lot number 0277U, Batch number NG00020, injection route and site not reported) On 13-MAR-2008. On 28-MAR-2008, the patient developed gastrointestinal cramps with postprandial diarrhea for, the first time. She recurrently complained of abdominal cramps with diarrhoea. After one of these episodes, in September 2008, she went to the emergency room. Clinical examination, lab tests and abdominal sonography were without pathologies. Suspected diagnosis was enteritis. During months she had a weight loss of 5 kg of weight. Within a few months p.v. the patient also experienced generalized itching and an eczema on the right hand. The patient additionally complained of impaired memory, amnesic aphasia, concentration impairment, bad mood, aggression, listlessness, arthralgia, headache, pain and numbness in the whole left arm (from shoulder to fingertips) so that temporarily driving a car was not possible. Also, the patient experienced intermenstrual bleeding, sleeping disorder because of pain in legs, dizziness, feeling of weakness and near fainting, loss of appetite, sore throat with dizziness, feeling of weakness and near fainting, loss of appetite, sore throat with lymphadenopathy followed by ear pain and reduced hearing. In June 2008, the patient consulted a pneumologist because of frequent dyspnoea and unusual cough. Diagnosis of allergic bronchial asthma was diagnosed for the first time (long time history of pollinosis). Treatment with beclometasone and salbutamole inhalatives was started. The outcome was not reported. Upon internal review report considered medically significant. Other business partner numbers included: E2009-00384. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Presyncope, Pruritus generalised, Sleep disorder, Ultrasound abdomen normal, Weight decreased
Clinical narrative: Information has been received from a gynecologist, concerning a 21 year old female patient with history of pollinosis who was vaccinated with a third dose GARDASIL (Lot number 0277U, Batch number NG00020, injection route and site not reported) On 13-MAR-2008. On 28-MAR-2008, the patient developed gastrointestinal cramps with postprandial diarrhea for, the first time. She recurrently complained of abdominal cramps with diarrhoea. After one of these episodes, in September 2008, she went to the emergency room. Clinical examination, lab tests and abdominal sonography were without pathologies. Suspected diagnosis was enteritis. During months she had a weight loss of 5 kg of weight. Within a few months p.v. the patient also experienced generalized itching and an eczema on the right hand. The patient additionally complained of impaired memory, amnesic aphasia, concentration impairment, bad mood, aggression, listlessness, arthralgia, headache, pain and numbness in the whole left arm (from shoulder to fingertips) so that temporarily driving a car was not possible. Also, the patient experienced intermenstrual bleeding, sleeping disorder because of pain in legs, dizziness, feeling of weakness and near fainting, loss of appetite, sore throat with dizziness, feeling of weakness and near fainting, loss of appetite, sore throat with lymphadenopathy followed by ear pain and reduced hearing. In June 2008, the patient consulted a pneumologist because of frequent dyspnoea and unusual cough. Diagnosis of allergic bronchial asthma was diagnosed for the first time (long time history of pollinosis). Treatment with beclometasone and salbutamole inhalatives was started. The outcome was not reported. Upon internal review report considered medically significant. Other business partner numbers included: E2009-00384. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: ANTH, MEN, TYP
Symptoms: Amnesia, Anxiety, Arthralgia, Asthenia, Back pain
Clinical narrative: Whole body aches, anxiety, high Cholesterol, concentration difficulty, constipation, cramps arms, depression, digestive problems, dry mouth, energy loss, muscle fatigue and pain, fever, headaches continuous, impotence, sleep insomnia, joint pain strong, hepatitis (liver enzymes), memory loss, mood; anxious, nervousness (anxiety), numbness and tingling: fingers, arms, legs and abdominal, lower back pain (scale 10), pain: knees, ankles, muscle and joint, sensitivity to chemicals, sinusitis, skin discoloration, sleep problems, suicide attempt, TENS needed for pain control (I have one), vision problems, weakness.   2/27/09 MR received for multiple visits 2006-2008. DX:  Hypercholesterolemia, Microhematuria, Accident caused by burning materials, substance use and abuse, redness or d/c of eye, pinguecuela, opiod dependance, nicotine dependance, cocaine dependance, cannabis dependance, alcohol abuse, anxiolytic dependance, substance induced, mood d/o, Hep B, Hep C, knee arthralgia, conductive hearing loss. Head injury 2003 and 2008 with infected scalp lac-abscessed. DX with Bipolar d/o 1/2008 with visual hallucinations and fear of being persecuted. HIV (+) 1/2008. Hearing eval for conductive hearing loss due to impacted cerumen.  Headache, kidney problems, stomach pain, articulation bursitis, no sleep, depression, anxiety, back pain, shoulder bursitis, arthryty. The anthrax have at least 250 condition, please focus on this event, because I had to many friend (soldiers) with a lot of disease, thank you.
Age: 34.0
Sex: M
Vaccine: ANTH, MEN, TYP
Symptoms: Blood cholesterol increased, Condition aggravated, Constipation, Depression, Disturbance in attention
Clinical narrative: Whole body aches, anxiety, high Cholesterol, concentration difficulty, constipation, cramps arms, depression, digestive problems, dry mouth, energy loss, muscle fatigue and pain, fever, headaches continuous, impotence, sleep insomnia, joint pain strong, hepatitis (liver enzymes), memory loss, mood; anxious, nervousness (anxiety), numbness and tingling: fingers, arms, legs and abdominal, lower back pain (scale 10), pain: knees, ankles, muscle and joint, sensitivity to chemicals, sinusitis, skin discoloration, sleep problems, suicide attempt, TENS needed for pain control (I have one), vision problems, weakness.   2/27/09 MR received for multiple visits 2006-2008. DX:  Hypercholesterolemia, Microhematuria, Accident caused by burning materials, substance use and abuse, redness or d/c of eye, pinguecuela, opiod dependance, nicotine dependance, cocaine dependance, cannabis dependance, alcohol abuse, anxiolytic dependance, substance induced, mood d/o, Hep B, Hep C, knee arthralgia, conductive hearing loss. Head injury 2003 and 2008 with infected scalp lac-abscessed. DX with Bipolar d/o 1/2008 with visual hallucinations and fear of being persecuted. HIV (+) 1/2008. Hearing eval for conductive hearing loss due to impacted cerumen.  Headache, kidney problems, stomach pain, articulation bursitis, no sleep, depression, anxiety, back pain, shoulder bursitis, arthryty. The anthrax have at least 250 condition, please focus on this event, because I had to many friend (soldiers) with a lot of disease, thank you.
Age: 34.0
Sex: M
Vaccine: ANTH, MEN, TYP
Symptoms: Dry mouth, Dyspepsia, Erectile dysfunction, Headache, Hepatitis C
Clinical narrative: Whole body aches, anxiety, high Cholesterol, concentration difficulty, constipation, cramps arms, depression, digestive problems, dry mouth, energy loss, muscle fatigue and pain, fever, headaches continuous, impotence, sleep insomnia, joint pain strong, hepatitis (liver enzymes), memory loss, mood; anxious, nervousness (anxiety), numbness and tingling: fingers, arms, legs and abdominal, lower back pain (scale 10), pain: knees, ankles, muscle and joint, sensitivity to chemicals, sinusitis, skin discoloration, sleep problems, suicide attempt, TENS needed for pain control (I have one), vision problems, weakness.   2/27/09 MR received for multiple visits 2006-2008. DX:  Hypercholesterolemia, Microhematuria, Accident caused by burning materials, substance use and abuse, redness or d/c of eye, pinguecuela, opiod dependance, nicotine dependance, cocaine dependance, cannabis dependance, alcohol abuse, anxiolytic dependance, substance induced, mood d/o, Hep B, Hep C, knee arthralgia, conductive hearing loss. Head injury 2003 and 2008 with infected scalp lac-abscessed. DX with Bipolar d/o 1/2008 with visual hallucinations and fear of being persecuted. HIV (+) 1/2008. Hearing eval for conductive hearing loss due to impacted cerumen.  Headache, kidney problems, stomach pain, articulation bursitis, no sleep, depression, anxiety, back pain, shoulder bursitis, arthryty. The anthrax have at least 250 condition, please focus on this event, because I had to many friend (soldiers) with a lot of disease, thank you.
Age: 34.0
Sex: M
Vaccine: ANTH, MEN, TYP
Symptoms: Hypoaesthesia, Insomnia, Multiple chemical sensitivity, Muscle fatigue, Muscle spasms
Clinical narrative: Whole body aches, anxiety, high Cholesterol, concentration difficulty, constipation, cramps arms, depression, digestive problems, dry mouth, energy loss, muscle fatigue and pain, fever, headaches continuous, impotence, sleep insomnia, joint pain strong, hepatitis (liver enzymes), memory loss, mood; anxious, nervousness (anxiety), numbness and tingling: fingers, arms, legs and abdominal, lower back pain (scale 10), pain: knees, ankles, muscle and joint, sensitivity to chemicals, sinusitis, skin discoloration, sleep problems, suicide attempt, TENS needed for pain control (I have one), vision problems, weakness.   2/27/09 MR received for multiple visits 2006-2008. DX:  Hypercholesterolemia, Microhematuria, Accident caused by burning materials, substance use and abuse, redness or d/c of eye, pinguecuela, opiod dependance, nicotine dependance, cocaine dependance, cannabis dependance, alcohol abuse, anxiolytic dependance, substance induced, mood d/o, Hep B, Hep C, knee arthralgia, conductive hearing loss. Head injury 2003 and 2008 with infected scalp lac-abscessed. DX with Bipolar d/o 1/2008 with visual hallucinations and fear of being persecuted. HIV (+) 1/2008. Hearing eval for conductive hearing loss due to impacted cerumen.  Headache, kidney problems, stomach pain, articulation bursitis, no sleep, depression, anxiety, back pain, shoulder bursitis, arthryty. The anthrax have at least 250 condition, please focus on this event, because I had to many friend (soldiers) with a lot of disease, thank you.
Age: 34.0
Sex: M
Vaccine: ANTH, MEN, TYP
Symptoms: Myalgia, Nervousness, Pain, Paraesthesia, Pyrexia
Clinical narrative: Whole body aches, anxiety, high Cholesterol, concentration difficulty, constipation, cramps arms, depression, digestive problems, dry mouth, energy loss, muscle fatigue and pain, fever, headaches continuous, impotence, sleep insomnia, joint pain strong, hepatitis (liver enzymes), memory loss, mood; anxious, nervousness (anxiety), numbness and tingling: fingers, arms, legs and abdominal, lower back pain (scale 10), pain: knees, ankles, muscle and joint, sensitivity to chemicals, sinusitis, skin discoloration, sleep problems, suicide attempt, TENS needed for pain control (I have one), vision problems, weakness.   2/27/09 MR received for multiple visits 2006-2008. DX:  Hypercholesterolemia, Microhematuria, Accident caused by burning materials, substance use and abuse, redness or d/c of eye, pinguecuela, opiod dependance, nicotine dependance, cocaine dependance, cannabis dependance, alcohol abuse, anxiolytic dependance, substance induced, mood d/o, Hep B, Hep C, knee arthralgia, conductive hearing loss. Head injury 2003 and 2008 with infected scalp lac-abscessed. DX with Bipolar d/o 1/2008 with visual hallucinations and fear of being persecuted. HIV (+) 1/2008. Hearing eval for conductive hearing loss due to impacted cerumen.  Headache, kidney problems, stomach pain, articulation bursitis, no sleep, depression, anxiety, back pain, shoulder bursitis, arthryty. The anthrax have at least 250 condition, please focus on this event, because I had to many friend (soldiers) with a lot of disease, thank you.
Age: 34.0
Sex: M
Vaccine: ANTH, MEN, TYP
Symptoms: Sinusitis, Skin discolouration, Sleep disorder, Suicide attempt, Visual impairment
Clinical narrative: Whole body aches, anxiety, high Cholesterol, concentration difficulty, constipation, cramps arms, depression, digestive problems, dry mouth, energy loss, muscle fatigue and pain, fever, headaches continuous, impotence, sleep insomnia, joint pain strong, hepatitis (liver enzymes), memory loss, mood; anxious, nervousness (anxiety), numbness and tingling: fingers, arms, legs and abdominal, lower back pain (scale 10), pain: knees, ankles, muscle and joint, sensitivity to chemicals, sinusitis, skin discoloration, sleep problems, suicide attempt, TENS needed for pain control (I have one), vision problems, weakness.   2/27/09 MR received for multiple visits 2006-2008. DX:  Hypercholesterolemia, Microhematuria, Accident caused by burning materials, substance use and abuse, redness or d/c of eye, pinguecuela, opiod dependance, nicotine dependance, cocaine dependance, cannabis dependance, alcohol abuse, anxiolytic dependance, substance induced, mood d/o, Hep B, Hep C, knee arthralgia, conductive hearing loss. Head injury 2003 and 2008 with infected scalp lac-abscessed. DX with Bipolar d/o 1/2008 with visual hallucinations and fear of being persecuted. HIV (+) 1/2008. Hearing eval for conductive hearing loss due to impacted cerumen.  Headache, kidney problems, stomach pain, articulation bursitis, no sleep, depression, anxiety, back pain, shoulder bursitis, arthryty. The anthrax have at least 250 condition, please focus on this event, because I had to many friend (soldiers) with a lot of disease, thank you.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Culture stool positive, Diarrhoea, Pyrexia, Rotavirus test positive, Vomiting
Clinical narrative: After receiving the vaccinations, the patient was hospitalized for six days.  The patient's symptoms included vomiting, diarrhea, fever. 5/7/09 - Hosp records received. DOS 1/26/09 to 2/2/09. FINAL DIAGNOSIS: AGE, dehydration Admitted to PICU, multiple episodes of daily emesis and frequent watery stools. Fever. Metabolic acidosis. Possible post-diarrheal lactose intolerance. Physiologic anemia. Gradual improvement. Generally well appearing infant with PE WNL.  To be followed by PMD.  5/20/09 - Addnl hosp records received DOS 1/26/09 to 2/2/09. FINAL DIAGNOSIS: vomiting and diarrhea POST Vaccination: Presented at ED with nausea, vomiting, fever and diarrhea. Dehydrated. Fussy. Low bicarb.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Abdominal distension, Abdominal pain, Crying, Diarrhoea, Enema administration
Clinical narrative: Information has been received from the FDA under the Freedom of Information Act concerning a 5 month old male with no history reported who on the morning of 18-DEC-2007, was vaccinated PO with the third dose of ROTATEQ (LOT # 657672/0903U). Concomitant therapy also given included the third dose of  IPOL SC in the left leg (LOT # A0169), the third IM dose in the left leg of DAPTACEL (LOT # C2765AA) and the third IM dose in the right leg PREVNAR (LOT # C45888). On 08-MAY-2008, the patient experienced abdominal distension, abdominal pain, crying, diarrhoea, gastrointestinal sounds abnormal, haematochezia, intussusceptions and vomiting. On 10-MAY-2008, the patient was admitted for hospitalization for vomiting, diarrhea and bloody stools. The abdomen was distended and he had hypoactive bowel sounds. A diagnostic ultrasound was performed showing ileocecal intussusceptions, stool occult blood test was positive and kidney ureter and bladder (KUB) X-ray showed possible gas in right side of abdomen. Air reduction Kit utilized and no obstruction and a successful reduction of the intussusceptions were done. The patient had been hospitalized for 4 days. Abdominal distention, abdominal pain, crying, diarrhoea, gastrointestinal sounds abnormal, haematochezia, intussusception and vomiting were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # 312391. Additional information has been received on request from the FDA under the Freedom of Information Act. It was reported that the patient was 6 months old. This was originally reported by a healthcare professional. 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: 0.5
Sex: M
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Gastrointestinal sounds abnormal, Haematochezia, Intussusception, Occult blood positive, Ultrasound scan abnormal
Clinical narrative: Information has been received from the FDA under the Freedom of Information Act concerning a 5 month old male with no history reported who on the morning of 18-DEC-2007, was vaccinated PO with the third dose of ROTATEQ (LOT # 657672/0903U). Concomitant therapy also given included the third dose of  IPOL SC in the left leg (LOT # A0169), the third IM dose in the left leg of DAPTACEL (LOT # C2765AA) and the third IM dose in the right leg PREVNAR (LOT # C45888). On 08-MAY-2008, the patient experienced abdominal distension, abdominal pain, crying, diarrhoea, gastrointestinal sounds abnormal, haematochezia, intussusceptions and vomiting. On 10-MAY-2008, the patient was admitted for hospitalization for vomiting, diarrhea and bloody stools. The abdomen was distended and he had hypoactive bowel sounds. A diagnostic ultrasound was performed showing ileocecal intussusceptions, stool occult blood test was positive and kidney ureter and bladder (KUB) X-ray showed possible gas in right side of abdomen. Air reduction Kit utilized and no obstruction and a successful reduction of the intussusceptions were done. The patient had been hospitalized for 4 days. Abdominal distention, abdominal pain, crying, diarrhoea, gastrointestinal sounds abnormal, haematochezia, intussusception and vomiting were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # 312391. Additional information has been received on request from the FDA under the Freedom of Information Act. It was reported that the patient was 6 months old. This was originally reported by a healthcare professional. 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: 0.5
Sex: M
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Urinary system X-ray, Vomiting
Clinical narrative: Information has been received from the FDA under the Freedom of Information Act concerning a 5 month old male with no history reported who on the morning of 18-DEC-2007, was vaccinated PO with the third dose of ROTATEQ (LOT # 657672/0903U). Concomitant therapy also given included the third dose of  IPOL SC in the left leg (LOT # A0169), the third IM dose in the left leg of DAPTACEL (LOT # C2765AA) and the third IM dose in the right leg PREVNAR (LOT # C45888). On 08-MAY-2008, the patient experienced abdominal distension, abdominal pain, crying, diarrhoea, gastrointestinal sounds abnormal, haematochezia, intussusceptions and vomiting. On 10-MAY-2008, the patient was admitted for hospitalization for vomiting, diarrhea and bloody stools. The abdomen was distended and he had hypoactive bowel sounds. A diagnostic ultrasound was performed showing ileocecal intussusceptions, stool occult blood test was positive and kidney ureter and bladder (KUB) X-ray showed possible gas in right side of abdomen. Air reduction Kit utilized and no obstruction and a successful reduction of the intussusceptions were done. The patient had been hospitalized for 4 days. Abdominal distention, abdominal pain, crying, diarrhoea, gastrointestinal sounds abnormal, haematochezia, intussusception and vomiting were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # 312391. Additional information has been received on request from the FDA under the Freedom of Information Act. It was reported that the patient was 6 months old. This was originally reported by a healthcare professional. 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: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Anorexia, Aphasia, Blood test, Convulsion, Deafness
Clinical narrative: Right after she recieved her last Gardasil shot patient felt sick, severe headaches, dizzy, ached all over, not hungry, extremely tired her arm hurt. This lasted for 2-3 weeks. She thought she felt better and tried to go to work.  Patient collapsed at work, found unresponsive, extremely low blood pressure, low heart rate, unable to start IV. Once in Ambo. they were able to start IV on the way to hospital they had to give more medicine to keep heart rate going. Rushed to Medical Center. In ER they cut off clothes called for crash cart were able to start central line. They did all tox screens nothing found in blood work up. Heart rate at 37 she was transferred to Progressive Cardiac Care unit. They started her on 2 medications.  She started having seizures that lasted 3-5 minutes she had at least 12 in one day.When she stood up her heart rate would go to 180 and she would pass out or have seizure. She had multiple EEG's and EKG's and a few other test towards the end of the week her seizures went to 25-55 minutes in length. She was transfered to clinic by a Medivac ambulance. Once there she went thru a battery of test they found that the seizures were none epilectic in nature. Her seizure state was glassy eyes, trouble breathing, couldn't hear, mouth would lock, unable to talk throat would move rapidly. When the seizure was done she would sleep for a long time.  The only thing patient had was the Gardasil HPV shot. She still has difficulty with her left arm. She was a healthy 19 year old girl until she had the shot.  Follow-up: In regards to treatments they wanted to put a pacemaker in for her heart rate. She still has seizures and alot of kidney infections which she never had before we are at 5 mths since last seizure. More testing needs to be done on this vaccine.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Electroencephalogram, Fall
Clinical narrative: Right after she recieved her last Gardasil shot patient felt sick, severe headaches, dizzy, ached all over, not hungry, extremely tired her arm hurt. This lasted for 2-3 weeks. She thought she felt better and tried to go to work.  Patient collapsed at work, found unresponsive, extremely low blood pressure, low heart rate, unable to start IV. Once in Ambo. they were able to start IV on the way to hospital they had to give more medicine to keep heart rate going. Rushed to Medical Center. In ER they cut off clothes called for crash cart were able to start central line. They did all tox screens nothing found in blood work up. Heart rate at 37 she was transferred to Progressive Cardiac Care unit. They started her on 2 medications.  She started having seizures that lasted 3-5 minutes she had at least 12 in one day.When she stood up her heart rate would go to 180 and she would pass out or have seizure. She had multiple EEG's and EKG's and a few other test towards the end of the week her seizures went to 25-55 minutes in length. She was transfered to clinic by a Medivac ambulance. Once there she went thru a battery of test they found that the seizures were none epilectic in nature. Her seizure state was glassy eyes, trouble breathing, couldn't hear, mouth would lock, unable to talk throat would move rapidly. When the seizure was done she would sleep for a long time.  The only thing patient had was the Gardasil HPV shot. She still has difficulty with her left arm. She was a healthy 19 year old girl until she had the shot.  Follow-up: In regards to treatments they wanted to put a pacemaker in for her heart rate. She still has seizures and alot of kidney infections which she never had before we are at 5 mths since last seizure. More testing needs to be done on this vaccine.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Hypotension, Immediate post-injection reaction, Impaired work ability
Clinical narrative: Right after she recieved her last Gardasil shot patient felt sick, severe headaches, dizzy, ached all over, not hungry, extremely tired her arm hurt. This lasted for 2-3 weeks. She thought she felt better and tried to go to work.  Patient collapsed at work, found unresponsive, extremely low blood pressure, low heart rate, unable to start IV. Once in Ambo. they were able to start IV on the way to hospital they had to give more medicine to keep heart rate going. Rushed to Medical Center. In ER they cut off clothes called for crash cart were able to start central line. They did all tox screens nothing found in blood work up. Heart rate at 37 she was transferred to Progressive Cardiac Care unit. They started her on 2 medications.  She started having seizures that lasted 3-5 minutes she had at least 12 in one day.When she stood up her heart rate would go to 180 and she would pass out or have seizure. She had multiple EEG's and EKG's and a few other test towards the end of the week her seizures went to 25-55 minutes in length. She was transfered to clinic by a Medivac ambulance. Once there she went thru a battery of test they found that the seizures were none epilectic in nature. Her seizure state was glassy eyes, trouble breathing, couldn't hear, mouth would lock, unable to talk throat would move rapidly. When the seizure was done she would sleep for a long time.  The only thing patient had was the Gardasil HPV shot. She still has difficulty with her left arm. She was a healthy 19 year old girl until she had the shot.  Follow-up: In regards to treatments they wanted to put a pacemaker in for her heart rate. She still has seizures and alot of kidney infections which she never had before we are at 5 mths since last seizure. More testing needs to be done on this vaccine.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Joint lock, Kidney infection, Loss of consciousness, Malaise, Oesophageal spasm
Clinical narrative: Right after she recieved her last Gardasil shot patient felt sick, severe headaches, dizzy, ached all over, not hungry, extremely tired her arm hurt. This lasted for 2-3 weeks. She thought she felt better and tried to go to work.  Patient collapsed at work, found unresponsive, extremely low blood pressure, low heart rate, unable to start IV. Once in Ambo. they were able to start IV on the way to hospital they had to give more medicine to keep heart rate going. Rushed to Medical Center. In ER they cut off clothes called for crash cart were able to start central line. They did all tox screens nothing found in blood work up. Heart rate at 37 she was transferred to Progressive Cardiac Care unit. They started her on 2 medications.  She started having seizures that lasted 3-5 minutes she had at least 12 in one day.When she stood up her heart rate would go to 180 and she would pass out or have seizure. She had multiple EEG's and EKG's and a few other test towards the end of the week her seizures went to 25-55 minutes in length. She was transfered to clinic by a Medivac ambulance. Once there she went thru a battery of test they found that the seizures were none epilectic in nature. Her seizure state was glassy eyes, trouble breathing, couldn't hear, mouth would lock, unable to talk throat would move rapidly. When the seizure was done she would sleep for a long time.  The only thing patient had was the Gardasil HPV shot. She still has difficulty with her left arm. She was a healthy 19 year old girl until she had the shot.  Follow-up: In regards to treatments they wanted to put a pacemaker in for her heart rate. She still has seizures and alot of kidney infections which she never had before we are at 5 mths since last seizure. More testing needs to be done on this vaccine.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Staring, Toxicologic test normal, Unresponsive to stimuli
Clinical narrative: Right after she recieved her last Gardasil shot patient felt sick, severe headaches, dizzy, ached all over, not hungry, extremely tired her arm hurt. This lasted for 2-3 weeks. She thought she felt better and tried to go to work.  Patient collapsed at work, found unresponsive, extremely low blood pressure, low heart rate, unable to start IV. Once in Ambo. they were able to start IV on the way to hospital they had to give more medicine to keep heart rate going. Rushed to Medical Center. In ER they cut off clothes called for crash cart were able to start central line. They did all tox screens nothing found in blood work up. Heart rate at 37 she was transferred to Progressive Cardiac Care unit. They started her on 2 medications.  She started having seizures that lasted 3-5 minutes she had at least 12 in one day.When she stood up her heart rate would go to 180 and she would pass out or have seizure. She had multiple EEG's and EKG's and a few other test towards the end of the week her seizures went to 25-55 minutes in length. She was transfered to clinic by a Medivac ambulance. Once there she went thru a battery of test they found that the seizures were none epilectic in nature. Her seizure state was glassy eyes, trouble breathing, couldn't hear, mouth would lock, unable to talk throat would move rapidly. When the seizure was done she would sleep for a long time.  The only thing patient had was the Gardasil HPV shot. She still has difficulty with her left arm. She was a healthy 19 year old girl until she had the shot.  Follow-up: In regards to treatments they wanted to put a pacemaker in for her heart rate. She still has seizures and alot of kidney infections which she never had before we are at 5 mths since last seizure. More testing needs to be done on this vaccine.
Age: 13.0
Sex: M
Vaccine: MNQ, VARCEL, MNQ, VARCEL
Symptoms: Migraine, Visual impairment, Vomiting
Clinical narrative: Initial information received on 02 February 2009 from a health care professional. A 14 year old male patient with no reported past medical history received a first time dose of MENACTRA (lot number U238BA) administered in the right arm and VARIVAX (manufacturer Merck, lot number I025U) administered in the left arm on 24 August 2007 at 09:15. On 21 August 2007 the patient received a first time dose of Tdap (manufacturer GSK, lot number AC52B015AA) administered in the right arm. A few hours post vaccination on 24 August 2007, the family reported that the patient developed a migraine headache, vomiting and visual disturbances. The family stated that the patient was treated at that time, details not provided. MRI of the brain was pending. The date of MRI was not provided. The patient complaints of occasional migraines, however the patient was reported as recovered. List of Documents held by Sender: none.  2/20/09 MR received from PCP. Seen 2/2/09 with c/o Migraines. Exam WNL. Impression:  Migraines.
Age: 13.0
Sex: M
Vaccine: MNQ, VARCEL, MNQ, VARCEL
Symptoms: Headache, Migraine, Nuclear magnetic resonance imaging brain, Visual impairment
Clinical narrative: Initial information received on 02 February 2009 from a health care professional. A 14 year old male patient with no reported past medical history received a first time dose of MENACTRA (lot number U238BA) administered in the right arm and VARIVAX (manufacturer Merck, lot number I025U) administered in the left arm on 24 August 2007 at 09:15. On 21 August 2007 the patient received a first time dose of Tdap (manufacturer GSK, lot number AC52B015AA) administered in the right arm. A few hours post vaccination on 24 August 2007, the family reported that the patient developed a migraine headache, vomiting and visual disturbances. The family stated that the patient was treated at that time, details not provided. MRI of the brain was pending. The date of MRI was not provided. The patient complaints of occasional migraines, however the patient was reported as recovered. List of Documents held by Sender: none.  2/20/09 MR received from PCP. Seen 2/2/09 with c/o Migraines. Exam WNL. Impression:  Migraines.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Blood culture, Computerised tomogram normal, Convulsion, Full blood count normal, Metabolic function test normal
Clinical narrative: Initial information received on 02 February 2009 from a health care professional. A 14 year old male patient received MENACTRA (lot number U2824AA) administered in the left deltoid intramuscularly on 31 January 2009 in the morning. On that same day, approximately 12 hours later, the patient experienced a generalized seizure. Details regarding the seizure were not provided. The patient was taken to the emergency room. On 31 January 2009 a CT scan, CBC (complete blood count), and metabolic panel were completed. The results were normal. BC (blood culture) was pending at the time of the report. The patient was awaiting a neurology consult, however the consult had not been scheduled at the time of the report. The patient's recovery status was not reported. No further information was provided. List of Documents held by Sender: none.
Age: 12.0
Sex: F
Vaccine: HPV4, MMR
Symptoms: Computerised tomogram normal, Convulsion, Electroencephalogram normal, Neurological examination normal, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a female patient who on unknown date was vaccinated with the second dose of GARDASIL.  It was reported that after the appointment, possibly on the same day, the patient developed seizures.  She went to the emergency room but was not admitted.  The physician stated that the patient had no problems with the first dose of GARDASIL.  At the time of reporting the patient has completely recovered.  Upon internal review, seizure was considered to be an other important medical event.  Additional information has been requested. 3/16/09-records received-vaccine administered on 8/16/08-. On 12/1/08 sudden onset of seizures-Neurolgoy consultation 1/13/09-PE WNL. Impression seizure episode.   9/11/09 Hospital records received DOS 8/27/09 to 8/29/09. Assessment: Epilepsy.  Patient presents with recent tonic/clonic seizures, decreased school performance. Foggy and distracted. c/o R/L temporal pain. Left frontal lobe lesion / schizencephaly. 10/12/09 Record received for ER date 11/30/08. DX: seizure.  Presenting symptoms: caregiver states pt had episode of generalized tonic/clonic shaking of the arms and legs associated with loss of consciousness for 2 to 3 minutes. Prior to episode, pt felt spinning sensation, fell to the floor and hitting head. Pt states felt normal prior to episode.
Age: 12.0
Sex: F
Vaccine: HPV4, MMR
Symptoms: Abdominal pain upper, Blood glucose normal, Blood test normal, Computerised tomogram normal, Convulsion
Clinical narrative: Information has been received from a physician concerning a female patient who on unknown date was vaccinated with the second dose of GARDASIL.  It was reported that after the appointment, possibly on the same day, the patient developed seizures.  She went to the emergency room but was not admitted.  The physician stated that the patient had no problems with the first dose of GARDASIL.  At the time of reporting the patient has completely recovered.  Upon internal review, seizure was considered to be an other important medical event.  Additional information has been requested. 3/16/09-records received-vaccine administered on 8/16/08-. On 12/1/08 sudden onset of seizures-Neurolgoy consultation 1/13/09-PE WNL. Impression seizure episode.   9/11/09 Hospital records received DOS 8/27/09 to 8/29/09. Assessment: Epilepsy.  Patient presents with recent tonic/clonic seizures, decreased school performance. Foggy and distracted. c/o R/L temporal pain. Left frontal lobe lesion / schizencephaly. 10/12/09 Record received for ER date 11/30/08. DX: seizure.  Presenting symptoms: caregiver states pt had episode of generalized tonic/clonic shaking of the arms and legs associated with loss of consciousness for 2 to 3 minutes. Prior to episode, pt felt spinning sensation, fell to the floor and hitting head. Pt states felt normal prior to episode.
Age: 12.0
Sex: F
Vaccine: HPV4, MMR
Symptoms: Electroencephalogram normal, Headache, No reaction on previous exposure to drug, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a physician concerning a female patient who on unknown date was vaccinated with the second dose of GARDASIL.  It was reported that after the appointment, possibly on the same day, the patient developed seizures.  She went to the emergency room but was not admitted.  The physician stated that the patient had no problems with the first dose of GARDASIL.  At the time of reporting the patient has completely recovered.  Upon internal review, seizure was considered to be an other important medical event.  Additional information has been requested. 3/16/09-records received-vaccine administered on 8/16/08-. On 12/1/08 sudden onset of seizures-Neurolgoy consultation 1/13/09-PE WNL. Impression seizure episode.   9/11/09 Hospital records received DOS 8/27/09 to 8/29/09. Assessment: Epilepsy.  Patient presents with recent tonic/clonic seizures, decreased school performance. Foggy and distracted. c/o R/L temporal pain. Left frontal lobe lesion / schizencephaly. 10/12/09 Record received for ER date 11/30/08. DX: seizure.  Presenting symptoms: caregiver states pt had episode of generalized tonic/clonic shaking of the arms and legs associated with loss of consciousness for 2 to 3 minutes. Prior to episode, pt felt spinning sensation, fell to the floor and hitting head. Pt states felt normal prior to episode.
Sex: F
Vaccine: HPV4
Symptoms: Circulatory collapse, Headache, Migraine
Clinical narrative: Information has been received from a nurse who reported that she received an email from a former employee of theirs, who stated in the email that "a high school student received one or more doses of GARDASIL and after vaccination the patient experienced severe migraines/headaches and then had to hospitalized because the patient also had to have a venous port put in her because her veins kept collapsing". The email did not mention how long the patient was in the hospital or any of the hospital information. Attempts are being made to verify the existence of an identifiable patient. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Meningism, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 14 year old female who was vaccinated with the first dose of GARDASIL. Subsequently the patient went to the emergency room with the symptoms of meningitis, including a high fever. The patient recovered on an unspecified day. The patient did not plan on receiving the second or third doses. The physician considered the symptoms of meningitis, including a high fever was determined to be an other important medical event. No further information is available.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Autism spectrum disorder, Body temperature increased, Pyrexia, Rash
Clinical narrative: Information has been received from a consumer concerning her 5 year old daughter with penicillin allergy who was vaccinated with MMR II (lot number not available) three years ago. There was no concomitant medication. 36-48 hours after vaccination, the patient developed a rash and a fever 104 degrees after receiving the MMR II and recovered 5-6 days after vaccination. She also stated that her daughter was on the autistic spectrum. No further information was provided. The patient sought unspecified medical attention. Upon internal review "autistic spectrum" was considered to be an other important medical event. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash
Clinical narrative: Information has been received from a nurse practitioner and a female consumer with drug hypersensitivity (No otherwise specified) who on unspecified date in 2008 was vaccinated with a dose of ZOSTAVAX (Merck). Subsequently the patient developed an extreme case of shingles and pain. The patient had an allergic reaction to the medication she was given for the pain and spent most of her time in bed. The patient noted that instead of preventing, the vaccine gave her shingles. As of 18-NOV-2008, the adverse events persisted. The reporter felt that extreme case of shingles and pain were related to therapy with ZOSTAVAX (Merck). Follow up information received from the nurse practitioner reported that a 68 years old female patient (weight 136 pounds, height 66 inches) with hypertension, osteopenia, allergic rhinitis, asthma and chronic low back pain, who on 23-MAY-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 659409/0409X) subcutaneously. The patient called the clinic due to painful rash on the right T 10-11 on 30-JUN-2008. The patient was seen on the clinic on 02-JUL-2008, a visual exam was performed, the patient was diagnosed with extensive herpes zoster on the right T 10-11, and this was the first of many visits for extensive herpes zoster on the right T 10-11 distribution. The patient was placed on LYRICA 75 mg twice a day. The herpetic neuralgia persists. It was reported that the patient had a history of chickenpox during childhood. The patient extensive herpes zoster and herpetic neuralgia was considered to be disabling by the nurse practitioner. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia
Clinical narrative: Weakness
Age: 0.6
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site warmth, Pyrexia, Rash
Clinical narrative: Shot given: PENTACEL. persistent fever- 3 days of 100-102 degrees. Red blotch around shot site 3 inches in diameter and beginning to spread to the inside of the child's leg. abnormal shape, similar to the infinity shape. shot site came to a head and was warm to the touch. More than 5 days after the immunization was given the shot site was still warm and came to a head. Rash on the back of the child's head developed, unable to determine whether or not related to shot or not. Rash on the outer side of child's leg and bottom developed but unable to determine whether or not it was related to shot. Both of these occurrences developed 2-3 days after shot was given.
Age: 1.5
Sex: F
Vaccine: DTAP, FLU3, HEPA, MMR, VARCEL
Symptoms: Decreased appetite, Irritability, Mumps, Swelling face
Clinical narrative: Mom States child started becoming grouchy. Appetite decreased. Few days later noticed left side of face/jaw swollen. Went to Doctor-who was sure was mumps from vaccine. Has had no fever-swelling now almost gone-states patient feels fine now.
Age: 0.1
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema normal, Crying, Dehydration, Diarrhoea, Immunology test
Clinical narrative: On 01-26-09 patient presented to Urgent Care with c/o crying, low grade fever, vomiting, diarrhea. Was admitted to hospital with diagnosis of Gastroenteritis/Dehydration. Re-admitted 1/29/09 for IVF. Re-admitted 2/4/09 for projectile vomiting.  3/11/2009 Received hospital medical records for multiple admissions Admit 1/26-1/28/2009. FINAL DX: acute gastroenteritis, secondary to rotavirus; fever; left inguinal hernia Records reveal patient experienced diarrhea x 2 da & vomiting x 1 da along with fever.  Seen in clinic & found to be dehydrated w/hernia.  Tx w/IVF.  Surgical consult done for hernia.  Improved & d/c to home w/PCP f/u.  Admit 1/29-1/30/2009. FINAL DX: vomiting, diarrhea & dehydration.   Patient continued to have symptoms & was readmitted overnight for rehydration.  Improved & d/c to home.  Admit 2/4-2/5/2009. FINAL DX: vomiting Patient developed new nonbilious projectile vomiting.
Age: 0.1
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Immunology test abnormal, Pyrexia, Rotavirus test positive, Vomiting, Vomiting projectile
Clinical narrative: On 01-26-09 patient presented to Urgent Care with c/o crying, low grade fever, vomiting, diarrhea. Was admitted to hospital with diagnosis of Gastroenteritis/Dehydration. Re-admitted 1/29/09 for IVF. Re-admitted 2/4/09 for projectile vomiting.  3/11/2009 Received hospital medical records for multiple admissions Admit 1/26-1/28/2009. FINAL DX: acute gastroenteritis, secondary to rotavirus; fever; left inguinal hernia Records reveal patient experienced diarrhea x 2 da & vomiting x 1 da along with fever.  Seen in clinic & found to be dehydrated w/hernia.  Tx w/IVF.  Surgical consult done for hernia.  Improved & d/c to home w/PCP f/u.  Admit 1/29-1/30/2009. FINAL DX: vomiting, diarrhea & dehydration.   Patient continued to have symptoms & was readmitted overnight for rehydration.  Improved & d/c to home.  Admit 2/4-2/5/2009. FINAL DX: vomiting Patient developed new nonbilious projectile vomiting.
Age: 0.1
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Enema administration, Pyrexia, Rotavirus infection, Rotavirus test positive
Clinical narrative: On 01-26-09 patient presented to Urgent Care with c/o crying, low grade fever, vomiting, diarrhea. Was admitted to hospital with diagnosis of Gastroenteritis/Dehydration. Re-admitted 1/29/09 for IVF. Re-admitted 2/4/09 for projectile vomiting.  3/11/2009 Received hospital medical records for multiple admissions Admit 1/26-1/28/2009. FINAL DX: acute gastroenteritis, secondary to rotavirus; fever; left inguinal hernia Records reveal patient experienced diarrhea x 2 da & vomiting x 1 da along with fever.  Seen in clinic & found to be dehydrated w/hernia.  Tx w/IVF.  Surgical consult done for hernia.  Improved & d/c to home w/PCP f/u.  Admit 1/29-1/30/2009. FINAL DX: vomiting, diarrhea & dehydration.   Patient continued to have symptoms & was readmitted overnight for rehydration.  Improved & d/c to home.  Admit 2/4-2/5/2009. FINAL DX: vomiting Patient developed new nonbilious projectile vomiting.
Age: 0.1
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: On 01-26-09 patient presented to Urgent Care with c/o crying, low grade fever, vomiting, diarrhea. Was admitted to hospital with diagnosis of Gastroenteritis/Dehydration. Re-admitted 1/29/09 for IVF. Re-admitted 2/4/09 for projectile vomiting.  3/11/2009 Received hospital medical records for multiple admissions Admit 1/26-1/28/2009. FINAL DX: acute gastroenteritis, secondary to rotavirus; fever; left inguinal hernia Records reveal patient experienced diarrhea x 2 da & vomiting x 1 da along with fever.  Seen in clinic & found to be dehydrated w/hernia.  Tx w/IVF.  Surgical consult done for hernia.  Improved & d/c to home w/PCP f/u.  Admit 1/29-1/30/2009. FINAL DX: vomiting, diarrhea & dehydration.   Patient continued to have symptoms & was readmitted overnight for rehydration.  Improved & d/c to home.  Admit 2/4-2/5/2009. FINAL DX: vomiting Patient developed new nonbilious projectile vomiting.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Erythema, Nausea, Oedema peripheral, Pain in extremity
Clinical narrative: Mom states child was dizzy, nauseated and right Del red swollen, redness under arm as well and is painful.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient received KINRIX (DTap and IPV) to left medial thigh and Flu to left lateral thigh 2/6/09. Mother noticed itching, redness and swelling at medial left thigh evening of 2/8/09. No hives/other rash or other sx. Measuring 20.5cmx14cm.