chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Adenopathy. Knee pain. Fever. Rash.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Dysphagia, Eye swelling, Rash, Rash macular, Urticaria
Clinical narrative: 1) first few hours - splotches noted on both hands - Inj given @ 5:15 pm 4/22/2008 1) Eye swollen 2) splotches - now hives on chin / both ears/ rash behind both ears, one hive on trunk. 3) C/o difficulty in swallowing 0 fever 0 SOB.
Age: 32.0
Sex: M
Vaccine: TYP
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: Call received 4/20/09 - Pt states itching and feet swelling started next day - took BENADRYL - helped, but is having itching and swelling in feet today - BENADRYL helps itching.
Age: 73.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, tenderness & increased warmth at injection site.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pityriasis rosea, Tinea infection
Clinical narrative: Approximately 1 week after my daughter had her GARDASIL vaccination she broke out into what I though was ringworm- after weeks of battling the ringworm's with OTC meds. I took her back to her Doctor who diagnosed her with pityriasis rosea - They put her on a Medrol dos Pak they cleared up some but then came back worse they put her on Prednisone saw 3 months later she still has it.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pityriasis rosea
Clinical narrative: Approximately 1 week after my daughter had her GARDASIL vaccination she broke out into what I though was ringworm- after weeks of battling the ringworm's with OTC meds. I took her back to her Doctor who diagnosed her with pityriasis rosea - They put her on a Medrol dos Pak they cleared up some but then came back worse they put her on Prednisone saw 3 months later she still has it.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HEPA, HPV4
Symptoms: Abdominal discomfort, Abdominal pain, Activities of daily living impaired, Allergy test, Asthenia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with Attention deficit/hyperactivity disorder beginning in 2006 was vaccinated into the right arm with the first dose of GARDASIL (Lot # 655618/0186U) on 24-MAY-2007, experienced soreness in her arm and headaches but tolerated them. On 01-OCT-2007 the patient was at basketball practice and collapsed on the gym floor with severe abdominal pain and chest pain. The abdominal pains remained. In March 2008 she began vomiting bile and the abdominal pains worsened. They continued to get worse and in June 2008 she had her second shot. Again, her pain increased. She got her third shot of GARDASIL  (Lot #661044/0548X) on 30-SEP-2008 intramuscularly in her left arm. She was at the hospital 4 days after her third shot with abdominal pain, high pulse, low blood pressure, and chest pain. By December patient was beginning to have seizure like episodes of staring and not breathing for 30 to 40 seconds at a time. She was beginning to have lower back pain as well as the abdominal pain and chest pain. She began to complain of burning in her stomach- like was on fire. She had a tingling sensation in her legs and her feet- complaining of them being on fire, but her feet were freezing cold when she would touch them. Patient had a few urinary tract infections and several bouts with dehydration. She also had blood in her stool. She became very weak and had only been to school 4 full days since November 2008. Patient was on numerous types of medicine but nothing seemed to help because of these episodes. Every time she would eat it would make it worse and would be especially more intense during her monthly cycle. She was on a feeding tube for over 3 weeks as well as hospitalized 3 different times. She had been to the ER over 13 times. Labs diagnostics performed included extensive blood work up, lactose intolerance test, allergy testing, CT scans of abdomen and pelvis, upper GI, 3 EKG tests, MRI on her brain, EDG test, colonoscopy, several abdominal ultrasounds, gastro emptying, hyda scan and gallbladder remo. The listing indicated that one or more of the events required emergency room visit, hospitalization, and was considered to be immediately life-threatening. It was also reported that "it was hard to tell which vaccine was the most damaging." No further information is available. 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 and was released. The original reporting source was not provided. The VAERS ID# 342520. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HEPA, HPV4
Symptoms: Back pain, Blood test, Chest pain, Cholecystectomy, Colonoscopy
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with Attention deficit/hyperactivity disorder beginning in 2006 was vaccinated into the right arm with the first dose of GARDASIL (Lot # 655618/0186U) on 24-MAY-2007, experienced soreness in her arm and headaches but tolerated them. On 01-OCT-2007 the patient was at basketball practice and collapsed on the gym floor with severe abdominal pain and chest pain. The abdominal pains remained. In March 2008 she began vomiting bile and the abdominal pains worsened. They continued to get worse and in June 2008 she had her second shot. Again, her pain increased. She got her third shot of GARDASIL  (Lot #661044/0548X) on 30-SEP-2008 intramuscularly in her left arm. She was at the hospital 4 days after her third shot with abdominal pain, high pulse, low blood pressure, and chest pain. By December patient was beginning to have seizure like episodes of staring and not breathing for 30 to 40 seconds at a time. She was beginning to have lower back pain as well as the abdominal pain and chest pain. She began to complain of burning in her stomach- like was on fire. She had a tingling sensation in her legs and her feet- complaining of them being on fire, but her feet were freezing cold when she would touch them. Patient had a few urinary tract infections and several bouts with dehydration. She also had blood in her stool. She became very weak and had only been to school 4 full days since November 2008. Patient was on numerous types of medicine but nothing seemed to help because of these episodes. Every time she would eat it would make it worse and would be especially more intense during her monthly cycle. She was on a feeding tube for over 3 weeks as well as hospitalized 3 different times. She had been to the ER over 13 times. Labs diagnostics performed included extensive blood work up, lactose intolerance test, allergy testing, CT scans of abdomen and pelvis, upper GI, 3 EKG tests, MRI on her brain, EDG test, colonoscopy, several abdominal ultrasounds, gastro emptying, hyda scan and gallbladder remo. The listing indicated that one or more of the events required emergency room visit, hospitalization, and was considered to be immediately life-threatening. It was also reported that "it was hard to tell which vaccine was the most damaging." No further information is available. 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 and was released. The original reporting source was not provided. The VAERS ID# 342520. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HEPA, HPV4
Symptoms: Convulsion, Dehydration, Electrocardiogram, Endoscopic retrograde cholangiopancreatography, Endoscopic ultrasound
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with Attention deficit/hyperactivity disorder beginning in 2006 was vaccinated into the right arm with the first dose of GARDASIL (Lot # 655618/0186U) on 24-MAY-2007, experienced soreness in her arm and headaches but tolerated them. On 01-OCT-2007 the patient was at basketball practice and collapsed on the gym floor with severe abdominal pain and chest pain. The abdominal pains remained. In March 2008 she began vomiting bile and the abdominal pains worsened. They continued to get worse and in June 2008 she had her second shot. Again, her pain increased. She got her third shot of GARDASIL  (Lot #661044/0548X) on 30-SEP-2008 intramuscularly in her left arm. She was at the hospital 4 days after her third shot with abdominal pain, high pulse, low blood pressure, and chest pain. By December patient was beginning to have seizure like episodes of staring and not breathing for 30 to 40 seconds at a time. She was beginning to have lower back pain as well as the abdominal pain and chest pain. She began to complain of burning in her stomach- like was on fire. She had a tingling sensation in her legs and her feet- complaining of them being on fire, but her feet were freezing cold when she would touch them. Patient had a few urinary tract infections and several bouts with dehydration. She also had blood in her stool. She became very weak and had only been to school 4 full days since November 2008. Patient was on numerous types of medicine but nothing seemed to help because of these episodes. Every time she would eat it would make it worse and would be especially more intense during her monthly cycle. She was on a feeding tube for over 3 weeks as well as hospitalized 3 different times. She had been to the ER over 13 times. Labs diagnostics performed included extensive blood work up, lactose intolerance test, allergy testing, CT scans of abdomen and pelvis, upper GI, 3 EKG tests, MRI on her brain, EDG test, colonoscopy, several abdominal ultrasounds, gastro emptying, hyda scan and gallbladder remo. The listing indicated that one or more of the events required emergency room visit, hospitalization, and was considered to be immediately life-threatening. It was also reported that "it was hard to tell which vaccine was the most damaging." No further information is available. 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 and was released. The original reporting source was not provided. The VAERS ID# 342520. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HEPA, HPV4
Symptoms: Gastric emptying study, Gastrointestinal tube insertion, Haematochezia, Headache, Heart rate increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with Attention deficit/hyperactivity disorder beginning in 2006 was vaccinated into the right arm with the first dose of GARDASIL (Lot # 655618/0186U) on 24-MAY-2007, experienced soreness in her arm and headaches but tolerated them. On 01-OCT-2007 the patient was at basketball practice and collapsed on the gym floor with severe abdominal pain and chest pain. The abdominal pains remained. In March 2008 she began vomiting bile and the abdominal pains worsened. They continued to get worse and in June 2008 she had her second shot. Again, her pain increased. She got her third shot of GARDASIL  (Lot #661044/0548X) on 30-SEP-2008 intramuscularly in her left arm. She was at the hospital 4 days after her third shot with abdominal pain, high pulse, low blood pressure, and chest pain. By December patient was beginning to have seizure like episodes of staring and not breathing for 30 to 40 seconds at a time. She was beginning to have lower back pain as well as the abdominal pain and chest pain. She began to complain of burning in her stomach- like was on fire. She had a tingling sensation in her legs and her feet- complaining of them being on fire, but her feet were freezing cold when she would touch them. Patient had a few urinary tract infections and several bouts with dehydration. She also had blood in her stool. She became very weak and had only been to school 4 full days since November 2008. Patient was on numerous types of medicine but nothing seemed to help because of these episodes. Every time she would eat it would make it worse and would be especially more intense during her monthly cycle. She was on a feeding tube for over 3 weeks as well as hospitalized 3 different times. She had been to the ER over 13 times. Labs diagnostics performed included extensive blood work up, lactose intolerance test, allergy testing, CT scans of abdomen and pelvis, upper GI, 3 EKG tests, MRI on her brain, EDG test, colonoscopy, several abdominal ultrasounds, gastro emptying, hyda scan and gallbladder remo. The listing indicated that one or more of the events required emergency room visit, hospitalization, and was considered to be immediately life-threatening. It was also reported that "it was hard to tell which vaccine was the most damaging." No further information is available. 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 and was released. The original reporting source was not provided. The VAERS ID# 342520. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HEPA, HPV4
Symptoms: Hypotension, Lactose tolerance test, Magnetic resonance cholangiopancreatography, Nuclear magnetic resonance imaging brain, Oesophagogastroduodenoscopy
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with Attention deficit/hyperactivity disorder beginning in 2006 was vaccinated into the right arm with the first dose of GARDASIL (Lot # 655618/0186U) on 24-MAY-2007, experienced soreness in her arm and headaches but tolerated them. On 01-OCT-2007 the patient was at basketball practice and collapsed on the gym floor with severe abdominal pain and chest pain. The abdominal pains remained. In March 2008 she began vomiting bile and the abdominal pains worsened. They continued to get worse and in June 2008 she had her second shot. Again, her pain increased. She got her third shot of GARDASIL  (Lot #661044/0548X) on 30-SEP-2008 intramuscularly in her left arm. She was at the hospital 4 days after her third shot with abdominal pain, high pulse, low blood pressure, and chest pain. By December patient was beginning to have seizure like episodes of staring and not breathing for 30 to 40 seconds at a time. She was beginning to have lower back pain as well as the abdominal pain and chest pain. She began to complain of burning in her stomach- like was on fire. She had a tingling sensation in her legs and her feet- complaining of them being on fire, but her feet were freezing cold when she would touch them. Patient had a few urinary tract infections and several bouts with dehydration. She also had blood in her stool. She became very weak and had only been to school 4 full days since November 2008. Patient was on numerous types of medicine but nothing seemed to help because of these episodes. Every time she would eat it would make it worse and would be especially more intense during her monthly cycle. She was on a feeding tube for over 3 weeks as well as hospitalized 3 different times. She had been to the ER over 13 times. Labs diagnostics performed included extensive blood work up, lactose intolerance test, allergy testing, CT scans of abdomen and pelvis, upper GI, 3 EKG tests, MRI on her brain, EDG test, colonoscopy, several abdominal ultrasounds, gastro emptying, hyda scan and gallbladder remo. The listing indicated that one or more of the events required emergency room visit, hospitalization, and was considered to be immediately life-threatening. It was also reported that "it was hard to tell which vaccine was the most damaging." No further information is available. 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 and was released. The original reporting source was not provided. The VAERS ID# 342520. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HEPA, HPV4
Symptoms: Pain in extremity, Pancreatitis, Paraesthesia, Peripheral coldness, Respiratory arrest
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with Attention deficit/hyperactivity disorder beginning in 2006 was vaccinated into the right arm with the first dose of GARDASIL (Lot # 655618/0186U) on 24-MAY-2007, experienced soreness in her arm and headaches but tolerated them. On 01-OCT-2007 the patient was at basketball practice and collapsed on the gym floor with severe abdominal pain and chest pain. The abdominal pains remained. In March 2008 she began vomiting bile and the abdominal pains worsened. They continued to get worse and in June 2008 she had her second shot. Again, her pain increased. She got her third shot of GARDASIL  (Lot #661044/0548X) on 30-SEP-2008 intramuscularly in her left arm. She was at the hospital 4 days after her third shot with abdominal pain, high pulse, low blood pressure, and chest pain. By December patient was beginning to have seizure like episodes of staring and not breathing for 30 to 40 seconds at a time. She was beginning to have lower back pain as well as the abdominal pain and chest pain. She began to complain of burning in her stomach- like was on fire. She had a tingling sensation in her legs and her feet- complaining of them being on fire, but her feet were freezing cold when she would touch them. Patient had a few urinary tract infections and several bouts with dehydration. She also had blood in her stool. She became very weak and had only been to school 4 full days since November 2008. Patient was on numerous types of medicine but nothing seemed to help because of these episodes. Every time she would eat it would make it worse and would be especially more intense during her monthly cycle. She was on a feeding tube for over 3 weeks as well as hospitalized 3 different times. She had been to the ER over 13 times. Labs diagnostics performed included extensive blood work up, lactose intolerance test, allergy testing, CT scans of abdomen and pelvis, upper GI, 3 EKG tests, MRI on her brain, EDG test, colonoscopy, several abdominal ultrasounds, gastro emptying, hyda scan and gallbladder remo. The listing indicated that one or more of the events required emergency room visit, hospitalization, and was considered to be immediately life-threatening. It was also reported that "it was hard to tell which vaccine was the most damaging." No further information is available. 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 and was released. The original reporting source was not provided. The VAERS ID# 342520. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HEPA, HPV4
Symptoms: Similar reaction on previous exposure to drug, Staring, Syncope, Ultrasound abdomen, Urinary tract infection
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with Attention deficit/hyperactivity disorder beginning in 2006 was vaccinated into the right arm with the first dose of GARDASIL (Lot # 655618/0186U) on 24-MAY-2007, experienced soreness in her arm and headaches but tolerated them. On 01-OCT-2007 the patient was at basketball practice and collapsed on the gym floor with severe abdominal pain and chest pain. The abdominal pains remained. In March 2008 she began vomiting bile and the abdominal pains worsened. They continued to get worse and in June 2008 she had her second shot. Again, her pain increased. She got her third shot of GARDASIL  (Lot #661044/0548X) on 30-SEP-2008 intramuscularly in her left arm. She was at the hospital 4 days after her third shot with abdominal pain, high pulse, low blood pressure, and chest pain. By December patient was beginning to have seizure like episodes of staring and not breathing for 30 to 40 seconds at a time. She was beginning to have lower back pain as well as the abdominal pain and chest pain. She began to complain of burning in her stomach- like was on fire. She had a tingling sensation in her legs and her feet- complaining of them being on fire, but her feet were freezing cold when she would touch them. Patient had a few urinary tract infections and several bouts with dehydration. She also had blood in her stool. She became very weak and had only been to school 4 full days since November 2008. Patient was on numerous types of medicine but nothing seemed to help because of these episodes. Every time she would eat it would make it worse and would be especially more intense during her monthly cycle. She was on a feeding tube for over 3 weeks as well as hospitalized 3 different times. She had been to the ER over 13 times. Labs diagnostics performed included extensive blood work up, lactose intolerance test, allergy testing, CT scans of abdomen and pelvis, upper GI, 3 EKG tests, MRI on her brain, EDG test, colonoscopy, several abdominal ultrasounds, gastro emptying, hyda scan and gallbladder remo. The listing indicated that one or more of the events required emergency room visit, hospitalization, and was considered to be immediately life-threatening. It was also reported that "it was hard to tell which vaccine was the most damaging." No further information is available. 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 and was released. The original reporting source was not provided. The VAERS ID# 342520. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HEPA, HPV4
Symptoms: Vomiting, X-ray with contrast upper gastrointestinal tract
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with Attention deficit/hyperactivity disorder beginning in 2006 was vaccinated into the right arm with the first dose of GARDASIL (Lot # 655618/0186U) on 24-MAY-2007, experienced soreness in her arm and headaches but tolerated them. On 01-OCT-2007 the patient was at basketball practice and collapsed on the gym floor with severe abdominal pain and chest pain. The abdominal pains remained. In March 2008 she began vomiting bile and the abdominal pains worsened. They continued to get worse and in June 2008 she had her second shot. Again, her pain increased. She got her third shot of GARDASIL  (Lot #661044/0548X) on 30-SEP-2008 intramuscularly in her left arm. She was at the hospital 4 days after her third shot with abdominal pain, high pulse, low blood pressure, and chest pain. By December patient was beginning to have seizure like episodes of staring and not breathing for 30 to 40 seconds at a time. She was beginning to have lower back pain as well as the abdominal pain and chest pain. She began to complain of burning in her stomach- like was on fire. She had a tingling sensation in her legs and her feet- complaining of them being on fire, but her feet were freezing cold when she would touch them. Patient had a few urinary tract infections and several bouts with dehydration. She also had blood in her stool. She became very weak and had only been to school 4 full days since November 2008. Patient was on numerous types of medicine but nothing seemed to help because of these episodes. Every time she would eat it would make it worse and would be especially more intense during her monthly cycle. She was on a feeding tube for over 3 weeks as well as hospitalized 3 different times. She had been to the ER over 13 times. Labs diagnostics performed included extensive blood work up, lactose intolerance test, allergy testing, CT scans of abdomen and pelvis, upper GI, 3 EKG tests, MRI on her brain, EDG test, colonoscopy, several abdominal ultrasounds, gastro emptying, hyda scan and gallbladder remo. The listing indicated that one or more of the events required emergency room visit, hospitalization, and was considered to be immediately life-threatening. It was also reported that "it was hard to tell which vaccine was the most damaging." No further information is available. 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 and was released. The original reporting source was not provided. The VAERS ID# 342520. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HEPA, HPV4
Symptoms: Back pain, Blood test, Chest pain, Colonoscopy, Computerised tomogram
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with Attention deficit/hyperactivity disorder beginning in 2006 was vaccinated into the right arm with the first dose of GARDASIL (Lot # 655618/0186U) on 24-MAY-2007, experienced soreness in her arm and headaches but tolerated them. On 01-OCT-2007 the patient was at basketball practice and collapsed on the gym floor with severe abdominal pain and chest pain. The abdominal pains remained. In March 2008 she began vomiting bile and the abdominal pains worsened. They continued to get worse and in June 2008 she had her second shot. Again, her pain increased. She got her third shot of GARDASIL  (Lot #661044/0548X) on 30-SEP-2008 intramuscularly in her left arm. She was at the hospital 4 days after her third shot with abdominal pain, high pulse, low blood pressure, and chest pain. By December patient was beginning to have seizure like episodes of staring and not breathing for 30 to 40 seconds at a time. She was beginning to have lower back pain as well as the abdominal pain and chest pain. She began to complain of burning in her stomach- like was on fire. She had a tingling sensation in her legs and her feet- complaining of them being on fire, but her feet were freezing cold when she would touch them. Patient had a few urinary tract infections and several bouts with dehydration. She also had blood in her stool. She became very weak and had only been to school 4 full days since November 2008. Patient was on numerous types of medicine but nothing seemed to help because of these episodes. Every time she would eat it would make it worse and would be especially more intense during her monthly cycle. She was on a feeding tube for over 3 weeks as well as hospitalized 3 different times. She had been to the ER over 13 times. Labs diagnostics performed included extensive blood work up, lactose intolerance test, allergy testing, CT scans of abdomen and pelvis, upper GI, 3 EKG tests, MRI on her brain, EDG test, colonoscopy, several abdominal ultrasounds, gastro emptying, hyda scan and gallbladder remo. The listing indicated that one or more of the events required emergency room visit, hospitalization, and was considered to be immediately life-threatening. It was also reported that "it was hard to tell which vaccine was the most damaging." No further information is available. 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 and was released. The original reporting source was not provided. The VAERS ID# 342520. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HEPA, HPV4
Symptoms: Convulsion, Dehydration, Electrocardiogram, Feeling cold, Gallbladder operation
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with Attention deficit/hyperactivity disorder beginning in 2006 was vaccinated into the right arm with the first dose of GARDASIL (Lot # 655618/0186U) on 24-MAY-2007, experienced soreness in her arm and headaches but tolerated them. On 01-OCT-2007 the patient was at basketball practice and collapsed on the gym floor with severe abdominal pain and chest pain. The abdominal pains remained. In March 2008 she began vomiting bile and the abdominal pains worsened. They continued to get worse and in June 2008 she had her second shot. Again, her pain increased. She got her third shot of GARDASIL  (Lot #661044/0548X) on 30-SEP-2008 intramuscularly in her left arm. She was at the hospital 4 days after her third shot with abdominal pain, high pulse, low blood pressure, and chest pain. By December patient was beginning to have seizure like episodes of staring and not breathing for 30 to 40 seconds at a time. She was beginning to have lower back pain as well as the abdominal pain and chest pain. She began to complain of burning in her stomach- like was on fire. She had a tingling sensation in her legs and her feet- complaining of them being on fire, but her feet were freezing cold when she would touch them. Patient had a few urinary tract infections and several bouts with dehydration. She also had blood in her stool. She became very weak and had only been to school 4 full days since November 2008. Patient was on numerous types of medicine but nothing seemed to help because of these episodes. Every time she would eat it would make it worse and would be especially more intense during her monthly cycle. She was on a feeding tube for over 3 weeks as well as hospitalized 3 different times. She had been to the ER over 13 times. Labs diagnostics performed included extensive blood work up, lactose intolerance test, allergy testing, CT scans of abdomen and pelvis, upper GI, 3 EKG tests, MRI on her brain, EDG test, colonoscopy, several abdominal ultrasounds, gastro emptying, hyda scan and gallbladder remo. The listing indicated that one or more of the events required emergency room visit, hospitalization, and was considered to be immediately life-threatening. It was also reported that "it was hard to tell which vaccine was the most damaging." No further information is available. 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 and was released. The original reporting source was not provided. The VAERS ID# 342520. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HEPA, HPV4
Symptoms: Hypotension, Lactose tolerance test, Nuclear magnetic resonance imaging brain, Oesophagogastroduodenoscopy, Pain in extremity
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with Attention deficit/hyperactivity disorder beginning in 2006 was vaccinated into the right arm with the first dose of GARDASIL (Lot # 655618/0186U) on 24-MAY-2007, experienced soreness in her arm and headaches but tolerated them. On 01-OCT-2007 the patient was at basketball practice and collapsed on the gym floor with severe abdominal pain and chest pain. The abdominal pains remained. In March 2008 she began vomiting bile and the abdominal pains worsened. They continued to get worse and in June 2008 she had her second shot. Again, her pain increased. She got her third shot of GARDASIL  (Lot #661044/0548X) on 30-SEP-2008 intramuscularly in her left arm. She was at the hospital 4 days after her third shot with abdominal pain, high pulse, low blood pressure, and chest pain. By December patient was beginning to have seizure like episodes of staring and not breathing for 30 to 40 seconds at a time. She was beginning to have lower back pain as well as the abdominal pain and chest pain. She began to complain of burning in her stomach- like was on fire. She had a tingling sensation in her legs and her feet- complaining of them being on fire, but her feet were freezing cold when she would touch them. Patient had a few urinary tract infections and several bouts with dehydration. She also had blood in her stool. She became very weak and had only been to school 4 full days since November 2008. Patient was on numerous types of medicine but nothing seemed to help because of these episodes. Every time she would eat it would make it worse and would be especially more intense during her monthly cycle. She was on a feeding tube for over 3 weeks as well as hospitalized 3 different times. She had been to the ER over 13 times. Labs diagnostics performed included extensive blood work up, lactose intolerance test, allergy testing, CT scans of abdomen and pelvis, upper GI, 3 EKG tests, MRI on her brain, EDG test, colonoscopy, several abdominal ultrasounds, gastro emptying, hyda scan and gallbladder remo. The listing indicated that one or more of the events required emergency room visit, hospitalization, and was considered to be immediately life-threatening. It was also reported that "it was hard to tell which vaccine was the most damaging." No further information is available. 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 and was released. The original reporting source was not provided. The VAERS ID# 342520. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HEPA, HPV4
Symptoms: Paraesthesia, Peripheral coldness, Respiratory arrest, Staring, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with Attention deficit/hyperactivity disorder beginning in 2006 was vaccinated into the right arm with the first dose of GARDASIL (Lot # 655618/0186U) on 24-MAY-2007, experienced soreness in her arm and headaches but tolerated them. On 01-OCT-2007 the patient was at basketball practice and collapsed on the gym floor with severe abdominal pain and chest pain. The abdominal pains remained. In March 2008 she began vomiting bile and the abdominal pains worsened. They continued to get worse and in June 2008 she had her second shot. Again, her pain increased. She got her third shot of GARDASIL  (Lot #661044/0548X) on 30-SEP-2008 intramuscularly in her left arm. She was at the hospital 4 days after her third shot with abdominal pain, high pulse, low blood pressure, and chest pain. By December patient was beginning to have seizure like episodes of staring and not breathing for 30 to 40 seconds at a time. She was beginning to have lower back pain as well as the abdominal pain and chest pain. She began to complain of burning in her stomach- like was on fire. She had a tingling sensation in her legs and her feet- complaining of them being on fire, but her feet were freezing cold when she would touch them. Patient had a few urinary tract infections and several bouts with dehydration. She also had blood in her stool. She became very weak and had only been to school 4 full days since November 2008. Patient was on numerous types of medicine but nothing seemed to help because of these episodes. Every time she would eat it would make it worse and would be especially more intense during her monthly cycle. She was on a feeding tube for over 3 weeks as well as hospitalized 3 different times. She had been to the ER over 13 times. Labs diagnostics performed included extensive blood work up, lactose intolerance test, allergy testing, CT scans of abdomen and pelvis, upper GI, 3 EKG tests, MRI on her brain, EDG test, colonoscopy, several abdominal ultrasounds, gastro emptying, hyda scan and gallbladder remo. The listing indicated that one or more of the events required emergency room visit, hospitalization, and was considered to be immediately life-threatening. It was also reported that "it was hard to tell which vaccine was the most damaging." No further information is available. 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 and was released. The original reporting source was not provided. The VAERS ID# 342520. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HEPA, HPV4
Symptoms: Tenderness, Ultrasound abdomen, Urinary tract infection, Vaccine positive rechallenge, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with Attention deficit/hyperactivity disorder beginning in 2006 was vaccinated into the right arm with the first dose of GARDASIL (Lot # 655618/0186U) on 24-MAY-2007, experienced soreness in her arm and headaches but tolerated them. On 01-OCT-2007 the patient was at basketball practice and collapsed on the gym floor with severe abdominal pain and chest pain. The abdominal pains remained. In March 2008 she began vomiting bile and the abdominal pains worsened. They continued to get worse and in June 2008 she had her second shot. Again, her pain increased. She got her third shot of GARDASIL  (Lot #661044/0548X) on 30-SEP-2008 intramuscularly in her left arm. She was at the hospital 4 days after her third shot with abdominal pain, high pulse, low blood pressure, and chest pain. By December patient was beginning to have seizure like episodes of staring and not breathing for 30 to 40 seconds at a time. She was beginning to have lower back pain as well as the abdominal pain and chest pain. She began to complain of burning in her stomach- like was on fire. She had a tingling sensation in her legs and her feet- complaining of them being on fire, but her feet were freezing cold when she would touch them. Patient had a few urinary tract infections and several bouts with dehydration. She also had blood in her stool. She became very weak and had only been to school 4 full days since November 2008. Patient was on numerous types of medicine but nothing seemed to help because of these episodes. Every time she would eat it would make it worse and would be especially more intense during her monthly cycle. She was on a feeding tube for over 3 weeks as well as hospitalized 3 different times. She had been to the ER over 13 times. Labs diagnostics performed included extensive blood work up, lactose intolerance test, allergy testing, CT scans of abdomen and pelvis, upper GI, 3 EKG tests, MRI on her brain, EDG test, colonoscopy, several abdominal ultrasounds, gastro emptying, hyda scan and gallbladder remo. The listing indicated that one or more of the events required emergency room visit, hospitalization, and was considered to be immediately life-threatening. It was also reported that "it was hard to tell which vaccine was the most damaging." No further information is available. 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 and was released. The original reporting source was not provided. The VAERS ID# 342520. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HEPA, HPV4
Symptoms: X-ray with contrast upper gastrointestinal tract
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with Attention deficit/hyperactivity disorder beginning in 2006 was vaccinated into the right arm with the first dose of GARDASIL (Lot # 655618/0186U) on 24-MAY-2007, experienced soreness in her arm and headaches but tolerated them. On 01-OCT-2007 the patient was at basketball practice and collapsed on the gym floor with severe abdominal pain and chest pain. The abdominal pains remained. In March 2008 she began vomiting bile and the abdominal pains worsened. They continued to get worse and in June 2008 she had her second shot. Again, her pain increased. She got her third shot of GARDASIL  (Lot #661044/0548X) on 30-SEP-2008 intramuscularly in her left arm. She was at the hospital 4 days after her third shot with abdominal pain, high pulse, low blood pressure, and chest pain. By December patient was beginning to have seizure like episodes of staring and not breathing for 30 to 40 seconds at a time. She was beginning to have lower back pain as well as the abdominal pain and chest pain. She began to complain of burning in her stomach- like was on fire. She had a tingling sensation in her legs and her feet- complaining of them being on fire, but her feet were freezing cold when she would touch them. Patient had a few urinary tract infections and several bouts with dehydration. She also had blood in her stool. She became very weak and had only been to school 4 full days since November 2008. Patient was on numerous types of medicine but nothing seemed to help because of these episodes. Every time she would eat it would make it worse and would be especially more intense during her monthly cycle. She was on a feeding tube for over 3 weeks as well as hospitalized 3 different times. She had been to the ER over 13 times. Labs diagnostics performed included extensive blood work up, lactose intolerance test, allergy testing, CT scans of abdomen and pelvis, upper GI, 3 EKG tests, MRI on her brain, EDG test, colonoscopy, several abdominal ultrasounds, gastro emptying, hyda scan and gallbladder remo. The listing indicated that one or more of the events required emergency room visit, hospitalization, and was considered to be immediately life-threatening. It was also reported that "it was hard to tell which vaccine was the most damaging." No further information is available. 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 and was released. The original reporting source was not provided. The VAERS ID# 342520. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HEPA, HPV4
Symptoms: Abdominal pain, Abdominal pain upper, Burning sensation, Chest pain, Conversion disorder
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with Attention deficit/hyperactivity disorder beginning in 2006 was vaccinated into the right arm with the first dose of GARDASIL (Lot # 655618/0186U) on 24-MAY-2007, experienced soreness in her arm and headaches but tolerated them. On 01-OCT-2007 the patient was at basketball practice and collapsed on the gym floor with severe abdominal pain and chest pain. The abdominal pains remained. In March 2008 she began vomiting bile and the abdominal pains worsened. They continued to get worse and in June 2008 she had her second shot. Again, her pain increased. She got her third shot of GARDASIL  (Lot #661044/0548X) on 30-SEP-2008 intramuscularly in her left arm. She was at the hospital 4 days after her third shot with abdominal pain, high pulse, low blood pressure, and chest pain. By December patient was beginning to have seizure like episodes of staring and not breathing for 30 to 40 seconds at a time. She was beginning to have lower back pain as well as the abdominal pain and chest pain. She began to complain of burning in her stomach- like was on fire. She had a tingling sensation in her legs and her feet- complaining of them being on fire, but her feet were freezing cold when she would touch them. Patient had a few urinary tract infections and several bouts with dehydration. She also had blood in her stool. She became very weak and had only been to school 4 full days since November 2008. Patient was on numerous types of medicine but nothing seemed to help because of these episodes. Every time she would eat it would make it worse and would be especially more intense during her monthly cycle. She was on a feeding tube for over 3 weeks as well as hospitalized 3 different times. She had been to the ER over 13 times. Labs diagnostics performed included extensive blood work up, lactose intolerance test, allergy testing, CT scans of abdomen and pelvis, upper GI, 3 EKG tests, MRI on her brain, EDG test, colonoscopy, several abdominal ultrasounds, gastro emptying, hyda scan and gallbladder remo. The listing indicated that one or more of the events required emergency room visit, hospitalization, and was considered to be immediately life-threatening. It was also reported that "it was hard to tell which vaccine was the most damaging." No further information is available. 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 and was released. The original reporting source was not provided. The VAERS ID# 342520. No further information is available.