chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HEPA, HPV4
Symptoms: Convulsion, Electroencephalogram normal, Fatigue, Gallbladder operation, Headache
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: Heart rate increased, Hypotension, Inappropriate schedule of drug administration, Nuclear magnetic resonance imaging brain normal, Ovulation pain
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, Peripheral coldness, Syncope, Ultrasound abdomen normal, Ultrasound pelvis normal
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: 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: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: RN gave ZOSTAVAX 0.65cc 4/13/09 to pt.  Pt was seen by Dr & staff.  Pt developed classical (dermatomal) zoster several days post vaccine.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: RN gave ZOSTAVAX 0.65cc 4/13/09 to pt.  Pt was seen by Dr & staff.  Pt developed classical (dermatomal) zoster several days post vaccine.
Age: 3.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL
Symptoms: Chest pain, Urticaria, Wheezing
Clinical narrative: Information has been received from a Registered Nurse (R.N) concerning a 45 month old male patient with history of congenital hydrocephalus and history of shunt and no known drug allergies/drug reactions who on 13-MAR-2009 was vaccinated with the first 0.5 ml dose of MMR II (Lot # 659876/1082X) subcutaneously into his left lower thigh. Secondary suspect therapy on the same date included the first dose of VARIVAX (Oka/Merck) (Lot # 63305/1781X) into his left upper thigh. Concomitant therapy on the same date included a dose of PREVNAR and a dose of HAVRIX. It was reported that on 13-MAR-2009 "40 minutes after vaccination, the patient developed wheezing, facial and neck blotchiness. It was also reported that the patient developed a raised, red welt at the site of injection of MMR II. The patient was treated with oral BENADRYL, albuterol nebulizer, and intramuscular SOLUMEDROL. The patient was monitored in the office and recovered within an hour. There were no laboratory diagnostic tests performed. It was reported that the patient was released to home and had fully recovered on 13-MAR-2009. The reporter determined that respiratory distress, wheezing, facial and neck blotchiness and red welt at the injection site were to be other important medical events and respiratory distress was considered to be immediately life-threatening. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Rash macular, Respiratory distress
Clinical narrative: Information has been received from a Registered Nurse (R.N) concerning a 45 month old male patient with history of congenital hydrocephalus and history of shunt and no known drug allergies/drug reactions who on 13-MAR-2009 was vaccinated with the first 0.5 ml dose of MMR II (Lot # 659876/1082X) subcutaneously into his left lower thigh. Secondary suspect therapy on the same date included the first dose of VARIVAX (Oka/Merck) (Lot # 63305/1781X) into his left upper thigh. Concomitant therapy on the same date included a dose of PREVNAR and a dose of HAVRIX. It was reported that on 13-MAR-2009 "40 minutes after vaccination, the patient developed wheezing, facial and neck blotchiness. It was also reported that the patient developed a raised, red welt at the site of injection of MMR II. The patient was treated with oral BENADRYL, albuterol nebulizer, and intramuscular SOLUMEDROL. The patient was monitored in the office and recovered within an hour. There were no laboratory diagnostic tests performed. It was reported that the patient was released to home and had fully recovered on 13-MAR-2009. The reporter determined that respiratory distress, wheezing, facial and neck blotchiness and red welt at the injection site were to be other important medical events and respiratory distress was considered to be immediately life-threatening. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL
Symptoms: Wheezing
Clinical narrative: Information has been received from a Registered Nurse (R.N) concerning a 45 month old male patient with history of congenital hydrocephalus and history of shunt and no known drug allergies/drug reactions who on 13-MAR-2009 was vaccinated with the first 0.5 ml dose of MMR II (Lot # 659876/1082X) subcutaneously into his left lower thigh. Secondary suspect therapy on the same date included the first dose of VARIVAX (Oka/Merck) (Lot # 63305/1781X) into his left upper thigh. Concomitant therapy on the same date included a dose of PREVNAR and a dose of HAVRIX. It was reported that on 13-MAR-2009 "40 minutes after vaccination, the patient developed wheezing, facial and neck blotchiness. It was also reported that the patient developed a raised, red welt at the site of injection of MMR II. The patient was treated with oral BENADRYL, albuterol nebulizer, and intramuscular SOLUMEDROL. The patient was monitored in the office and recovered within an hour. There were no laboratory diagnostic tests performed. It was reported that the patient was released to home and had fully recovered on 13-MAR-2009. The reporter determined that respiratory distress, wheezing, facial and neck blotchiness and red welt at the injection site were to be other important medical events and respiratory distress was considered to be immediately life-threatening. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Laboratory test, Nuclear magnetic resonance imaging, Scan brain
Clinical narrative: Initial and follow up information has been received from a consumer, a certified medical assistant and medical records concerning the consumer's 18 year old female daughter with no pertinent medical history and no drug reactions or allergies. The patient did not smoke or drink. There was no related family history and no history of seizure disorder in the family. On 02-FEB-2009 she was vaccinated with the first dose of GARDASIL (lot # 661766/0652X) and seemed fine. On 07-APR-2009 the patient was vaccinated with second dose of GARDASIL (lot # 661766/0652X). There was no concomitant medication. On 15-APR-2009 the patient stated that the first thing she remembered before having an apparent seizure witnessed by her parents was waking up feeling that she had a lot of saliva in her mouth, so she went to the bathroom to wash her mouth out and then her parents were in another room and heard a sound. They walked into the bathroom and found her having a tonic/clonic seizure that, in their estimation, lasted 5 minutes. She was foaming at the mouth was unresponsive initially and the seizure resolved on its own. Initially, after the seizure ended, she was quite confused, and gradually, since being brought in by ambulance, she had become less and less confused and was able to converse and now knew the date. She initially only knew the President's name. The patient complained of headache that was mild to moderate. She denied any weakness. She had been getting a workup done recently for dizziness. She had no other associated symptoms. She was slightly nauseous. She was treated with Zofran and morphine. She had an echo, which showed some abnormalities with mitral and tricuspid regurgitation, which seemed mild. An EKG was done, which showed sinus rhythm with a rate of 75. No ischemic changes. CBC showed a positive normal CBC, negative UA, normal comprehensive metabolic panel, negative beta HCG. A urine toxicology screen was only positive for opiates. She was given morphine in the emergency department for her headache. CT of head was negative. MRI showed a probably incidental 7X5X3 mm left ventricular recessed diverticulum superior to the posterior hippocampus. The reporter also mentioned that her daughter was also experiencing stuffy nose and shortness of breath after getting the second dose. At the time of this report, the patient's outcome was unknown. Upon internal review, seizure was determined to be an other important medical event. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood glucose normal, Blood human chorionic gonadotropin negative, Computerised tomogram normal, Confusional state, Dizziness
Clinical narrative: Initial and follow up information has been received from a consumer, a certified medical assistant and medical records concerning the consumer's 18 year old female daughter with no pertinent medical history and no drug reactions or allergies. The patient did not smoke or drink. There was no related family history and no history of seizure disorder in the family. On 02-FEB-2009 she was vaccinated with the first dose of GARDASIL (lot # 661766/0652X) and seemed fine. On 07-APR-2009 the patient was vaccinated with second dose of GARDASIL (lot # 661766/0652X). There was no concomitant medication. On 15-APR-2009 the patient stated that the first thing she remembered before having an apparent seizure witnessed by her parents was waking up feeling that she had a lot of saliva in her mouth, so she went to the bathroom to wash her mouth out and then her parents were in another room and heard a sound. They walked into the bathroom and found her having a tonic/clonic seizure that, in their estimation, lasted 5 minutes. She was foaming at the mouth was unresponsive initially and the seizure resolved on its own. Initially, after the seizure ended, she was quite confused, and gradually, since being brought in by ambulance, she had become less and less confused and was able to converse and now knew the date. She initially only knew the President's name. The patient complained of headache that was mild to moderate. She denied any weakness. She had been getting a workup done recently for dizziness. She had no other associated symptoms. She was slightly nauseous. She was treated with Zofran and morphine. She had an echo, which showed some abnormalities with mitral and tricuspid regurgitation, which seemed mild. An EKG was done, which showed sinus rhythm with a rate of 75. No ischemic changes. CBC showed a positive normal CBC, negative UA, normal comprehensive metabolic panel, negative beta HCG. A urine toxicology screen was only positive for opiates. She was given morphine in the emergency department for her headache. CT of head was negative. MRI showed a probably incidental 7X5X3 mm left ventricular recessed diverticulum superior to the posterior hippocampus. The reporter also mentioned that her daughter was also experiencing stuffy nose and shortness of breath after getting the second dose. At the time of this report, the patient's outcome was unknown. Upon internal review, seizure was determined to be an other important medical event. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspnoea, Electrocardiogram normal, Eosinophil count increased, Eosinophil percentage increased, Foaming at mouth
Clinical narrative: Initial and follow up information has been received from a consumer, a certified medical assistant and medical records concerning the consumer's 18 year old female daughter with no pertinent medical history and no drug reactions or allergies. The patient did not smoke or drink. There was no related family history and no history of seizure disorder in the family. On 02-FEB-2009 she was vaccinated with the first dose of GARDASIL (lot # 661766/0652X) and seemed fine. On 07-APR-2009 the patient was vaccinated with second dose of GARDASIL (lot # 661766/0652X). There was no concomitant medication. On 15-APR-2009 the patient stated that the first thing she remembered before having an apparent seizure witnessed by her parents was waking up feeling that she had a lot of saliva in her mouth, so she went to the bathroom to wash her mouth out and then her parents were in another room and heard a sound. They walked into the bathroom and found her having a tonic/clonic seizure that, in their estimation, lasted 5 minutes. She was foaming at the mouth was unresponsive initially and the seizure resolved on its own. Initially, after the seizure ended, she was quite confused, and gradually, since being brought in by ambulance, she had become less and less confused and was able to converse and now knew the date. She initially only knew the President's name. The patient complained of headache that was mild to moderate. She denied any weakness. She had been getting a workup done recently for dizziness. She had no other associated symptoms. She was slightly nauseous. She was treated with Zofran and morphine. She had an echo, which showed some abnormalities with mitral and tricuspid regurgitation, which seemed mild. An EKG was done, which showed sinus rhythm with a rate of 75. No ischemic changes. CBC showed a positive normal CBC, negative UA, normal comprehensive metabolic panel, negative beta HCG. A urine toxicology screen was only positive for opiates. She was given morphine in the emergency department for her headache. CT of head was negative. MRI showed a probably incidental 7X5X3 mm left ventricular recessed diverticulum superior to the posterior hippocampus. The reporter also mentioned that her daughter was also experiencing stuffy nose and shortness of breath after getting the second dose. At the time of this report, the patient's outcome was unknown. Upon internal review, seizure was determined to be an other important medical event. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Full blood count normal, Grand mal convulsion, Headache, Mean platelet volume decreased, Metabolic function test normal
Clinical narrative: Initial and follow up information has been received from a consumer, a certified medical assistant and medical records concerning the consumer's 18 year old female daughter with no pertinent medical history and no drug reactions or allergies. The patient did not smoke or drink. There was no related family history and no history of seizure disorder in the family. On 02-FEB-2009 she was vaccinated with the first dose of GARDASIL (lot # 661766/0652X) and seemed fine. On 07-APR-2009 the patient was vaccinated with second dose of GARDASIL (lot # 661766/0652X). There was no concomitant medication. On 15-APR-2009 the patient stated that the first thing she remembered before having an apparent seizure witnessed by her parents was waking up feeling that she had a lot of saliva in her mouth, so she went to the bathroom to wash her mouth out and then her parents were in another room and heard a sound. They walked into the bathroom and found her having a tonic/clonic seizure that, in their estimation, lasted 5 minutes. She was foaming at the mouth was unresponsive initially and the seizure resolved on its own. Initially, after the seizure ended, she was quite confused, and gradually, since being brought in by ambulance, she had become less and less confused and was able to converse and now knew the date. She initially only knew the President's name. The patient complained of headache that was mild to moderate. She denied any weakness. She had been getting a workup done recently for dizziness. She had no other associated symptoms. She was slightly nauseous. She was treated with Zofran and morphine. She had an echo, which showed some abnormalities with mitral and tricuspid regurgitation, which seemed mild. An EKG was done, which showed sinus rhythm with a rate of 75. No ischemic changes. CBC showed a positive normal CBC, negative UA, normal comprehensive metabolic panel, negative beta HCG. A urine toxicology screen was only positive for opiates. She was given morphine in the emergency department for her headache. CT of head was negative. MRI showed a probably incidental 7X5X3 mm left ventricular recessed diverticulum superior to the posterior hippocampus. The reporter also mentioned that her daughter was also experiencing stuffy nose and shortness of breath after getting the second dose. At the time of this report, the patient's outcome was unknown. Upon internal review, seizure was determined to be an other important medical event. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Mitral valve incompetence, Nasal congestion, Nausea, Nuclear magnetic resonance imaging brain abnormal, Salivary hypersecretion
Clinical narrative: Initial and follow up information has been received from a consumer, a certified medical assistant and medical records concerning the consumer's 18 year old female daughter with no pertinent medical history and no drug reactions or allergies. The patient did not smoke or drink. There was no related family history and no history of seizure disorder in the family. On 02-FEB-2009 she was vaccinated with the first dose of GARDASIL (lot # 661766/0652X) and seemed fine. On 07-APR-2009 the patient was vaccinated with second dose of GARDASIL (lot # 661766/0652X). There was no concomitant medication. On 15-APR-2009 the patient stated that the first thing she remembered before having an apparent seizure witnessed by her parents was waking up feeling that she had a lot of saliva in her mouth, so she went to the bathroom to wash her mouth out and then her parents were in another room and heard a sound. They walked into the bathroom and found her having a tonic/clonic seizure that, in their estimation, lasted 5 minutes. She was foaming at the mouth was unresponsive initially and the seizure resolved on its own. Initially, after the seizure ended, she was quite confused, and gradually, since being brought in by ambulance, she had become less and less confused and was able to converse and now knew the date. She initially only knew the President's name. The patient complained of headache that was mild to moderate. She denied any weakness. She had been getting a workup done recently for dizziness. She had no other associated symptoms. She was slightly nauseous. She was treated with Zofran and morphine. She had an echo, which showed some abnormalities with mitral and tricuspid regurgitation, which seemed mild. An EKG was done, which showed sinus rhythm with a rate of 75. No ischemic changes. CBC showed a positive normal CBC, negative UA, normal comprehensive metabolic panel, negative beta HCG. A urine toxicology screen was only positive for opiates. She was given morphine in the emergency department for her headache. CT of head was negative. MRI showed a probably incidental 7X5X3 mm left ventricular recessed diverticulum superior to the posterior hippocampus. The reporter also mentioned that her daughter was also experiencing stuffy nose and shortness of breath after getting the second dose. At the time of this report, the patient's outcome was unknown. Upon internal review, seizure was determined to be an other important medical event. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Toxicologic test abnormal, Tricuspid valve incompetence, Unresponsive to stimuli, Urine analysis normal
Clinical narrative: Initial and follow up information has been received from a consumer, a certified medical assistant and medical records concerning the consumer's 18 year old female daughter with no pertinent medical history and no drug reactions or allergies. The patient did not smoke or drink. There was no related family history and no history of seizure disorder in the family. On 02-FEB-2009 she was vaccinated with the first dose of GARDASIL (lot # 661766/0652X) and seemed fine. On 07-APR-2009 the patient was vaccinated with second dose of GARDASIL (lot # 661766/0652X). There was no concomitant medication. On 15-APR-2009 the patient stated that the first thing she remembered before having an apparent seizure witnessed by her parents was waking up feeling that she had a lot of saliva in her mouth, so she went to the bathroom to wash her mouth out and then her parents were in another room and heard a sound. They walked into the bathroom and found her having a tonic/clonic seizure that, in their estimation, lasted 5 minutes. She was foaming at the mouth was unresponsive initially and the seizure resolved on its own. Initially, after the seizure ended, she was quite confused, and gradually, since being brought in by ambulance, she had become less and less confused and was able to converse and now knew the date. She initially only knew the President's name. The patient complained of headache that was mild to moderate. She denied any weakness. She had been getting a workup done recently for dizziness. She had no other associated symptoms. She was slightly nauseous. She was treated with Zofran and morphine. She had an echo, which showed some abnormalities with mitral and tricuspid regurgitation, which seemed mild. An EKG was done, which showed sinus rhythm with a rate of 75. No ischemic changes. CBC showed a positive normal CBC, negative UA, normal comprehensive metabolic panel, negative beta HCG. A urine toxicology screen was only positive for opiates. She was given morphine in the emergency department for her headache. CT of head was negative. MRI showed a probably incidental 7X5X3 mm left ventricular recessed diverticulum superior to the posterior hippocampus. The reporter also mentioned that her daughter was also experiencing stuffy nose and shortness of breath after getting the second dose. At the time of this report, the patient's outcome was unknown. Upon internal review, seizure was determined to be an other important medical event. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Sensation of blood flow, Throat tightness
Clinical narrative: Information has been received from a physician concerning a male patient who was vaccinated, "within the last few days", with ZOSTAVAX (Oka/Merck) (Lot # was not available). The physician reported that "within the last few days", the patient experienced a significant adverse reaction. The patient's throat started to tighten and he had a birthmark on his face and during the reaction, it was noticed that there was blood flowing on the blood vessels on the birthmark on his face. The physician noted that the patient was hospitalized (hospital demographics unspecified) but did not specify if the patient was admitted or not. At the time of the report, the patient was recovering. The patient sought medical attention and saw the physician. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: MEN, YF, YF
Symptoms: Alanine aminotransferase increased, Arthralgia, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Blood culture
Clinical narrative: Initial report received on 15 April 2009 from a pharmacist. A 42 year old female patient, who has no known allergies, a history of hepatitis B infection, and medical conditions of SJOGREN's syndrome, hypothyroidism, and hyperlipidemia, had received on 08 April 2009 in preparation for future travel a first intramuscular injection of YF-VAX (lot number and site of administration unknown), and an intramuscular injection of a meningococcal vaccine (Trade name, manufacturer name and site of administration unknown). The subject was taking ZOCOR, ZANTAC, Levothyroxine and Belladonna (indication not reported) at the time of the vaccinations. Three days post-vaccination, the patient experienced fever with chills and sweating (lasting four days), generalized malaise, nausea, pain in all joints (without erythema or swelling), congestion with slight dry cough, neck pain, facial pain, headache and transaminitis. The patient was subsequently hospitalized (date not reported) for one day and received treatment with intravenous fluids, MOTRIN, ZOFRAN, and Ketorolac. Diagnostic testing included a CAT scan of the head without contrast, CAT scan of the abdomen, chest x-ray, blood cultures, urine cultures, urinalysis and lumbar puncture. The results of the tests were not reported except for the urine culture and chest x-ray which were normal. Diagnostic laboratory data revealed, ALK Phos 204, AST 122, ALT 201, WBC 4.6, neutrophil 84%, lymph 14%, ANC 3.8, ESR 30, and CRP 52. The patient recovered (date not reported). The diagnosis was viral syndrome versus "YF-VAX." Documents held by sender: None.  6/3/09 MR received for DOS 4/15-16/09 with D/C DX:  Fever NOS and ER record 4/14/09 with dx: fever-sinusitis/viral syndrome. Pt initially presented on 4/14/09 with c/o frontal H/A, neck pain, cough, joint pain and vomiting x 3 days. Recent travel to Africa.  Already on abx from PMD for suspected sinus inf. To ER with worsening sx. Tx with IVF and abx and d/c.  Returned next day with abd pain, photophobia, nausea, rigors, chills and mild facial swelling. Febrile and tachy in ER. PE (+) for abd tendernes of RUQ. Admitted for eval and d/c next day. ICD9:3393-Drug induced H/A.  E9493 YF Vax causing adverse effects in therapeutic use. 07999Y Unspecified viral infection.
Age: 42.0
Sex: F
Vaccine: MEN, YF, YF
Symptoms: C-reactive protein increased, Chest X-ray normal, Chills, Cough, Culture urine negative
Clinical narrative: Initial report received on 15 April 2009 from a pharmacist. A 42 year old female patient, who has no known allergies, a history of hepatitis B infection, and medical conditions of SJOGREN's syndrome, hypothyroidism, and hyperlipidemia, had received on 08 April 2009 in preparation for future travel a first intramuscular injection of YF-VAX (lot number and site of administration unknown), and an intramuscular injection of a meningococcal vaccine (Trade name, manufacturer name and site of administration unknown). The subject was taking ZOCOR, ZANTAC, Levothyroxine and Belladonna (indication not reported) at the time of the vaccinations. Three days post-vaccination, the patient experienced fever with chills and sweating (lasting four days), generalized malaise, nausea, pain in all joints (without erythema or swelling), congestion with slight dry cough, neck pain, facial pain, headache and transaminitis. The patient was subsequently hospitalized (date not reported) for one day and received treatment with intravenous fluids, MOTRIN, ZOFRAN, and Ketorolac. Diagnostic testing included a CAT scan of the head without contrast, CAT scan of the abdomen, chest x-ray, blood cultures, urine cultures, urinalysis and lumbar puncture. The results of the tests were not reported except for the urine culture and chest x-ray which were normal. Diagnostic laboratory data revealed, ALK Phos 204, AST 122, ALT 201, WBC 4.6, neutrophil 84%, lymph 14%, ANC 3.8, ESR 30, and CRP 52. The patient recovered (date not reported). The diagnosis was viral syndrome versus "YF-VAX." Documents held by sender: None.  6/3/09 MR received for DOS 4/15-16/09 with D/C DX:  Fever NOS and ER record 4/14/09 with dx: fever-sinusitis/viral syndrome. Pt initially presented on 4/14/09 with c/o frontal H/A, neck pain, cough, joint pain and vomiting x 3 days. Recent travel to Africa.  Already on abx from PMD for suspected sinus inf. To ER with worsening sx. Tx with IVF and abx and d/c.  Returned next day with abd pain, photophobia, nausea, rigors, chills and mild facial swelling. Febrile and tachy in ER. PE (+) for abd tendernes of RUQ. Admitted for eval and d/c next day. ICD9:3393-Drug induced H/A.  E9493 YF Vax causing adverse effects in therapeutic use. 07999Y Unspecified viral infection.
Age: 42.0
Sex: F
Vaccine: MEN, YF, YF
Symptoms: Facial pain, Headache, Hyperhidrosis, Lumbar puncture, Lymphocyte percentage decreased
Clinical narrative: Initial report received on 15 April 2009 from a pharmacist. A 42 year old female patient, who has no known allergies, a history of hepatitis B infection, and medical conditions of SJOGREN's syndrome, hypothyroidism, and hyperlipidemia, had received on 08 April 2009 in preparation for future travel a first intramuscular injection of YF-VAX (lot number and site of administration unknown), and an intramuscular injection of a meningococcal vaccine (Trade name, manufacturer name and site of administration unknown). The subject was taking ZOCOR, ZANTAC, Levothyroxine and Belladonna (indication not reported) at the time of the vaccinations. Three days post-vaccination, the patient experienced fever with chills and sweating (lasting four days), generalized malaise, nausea, pain in all joints (without erythema or swelling), congestion with slight dry cough, neck pain, facial pain, headache and transaminitis. The patient was subsequently hospitalized (date not reported) for one day and received treatment with intravenous fluids, MOTRIN, ZOFRAN, and Ketorolac. Diagnostic testing included a CAT scan of the head without contrast, CAT scan of the abdomen, chest x-ray, blood cultures, urine cultures, urinalysis and lumbar puncture. The results of the tests were not reported except for the urine culture and chest x-ray which were normal. Diagnostic laboratory data revealed, ALK Phos 204, AST 122, ALT 201, WBC 4.6, neutrophil 84%, lymph 14%, ANC 3.8, ESR 30, and CRP 52. The patient recovered (date not reported). The diagnosis was viral syndrome versus "YF-VAX." Documents held by sender: None.  6/3/09 MR received for DOS 4/15-16/09 with D/C DX:  Fever NOS and ER record 4/14/09 with dx: fever-sinusitis/viral syndrome. Pt initially presented on 4/14/09 with c/o frontal H/A, neck pain, cough, joint pain and vomiting x 3 days. Recent travel to Africa.  Already on abx from PMD for suspected sinus inf. To ER with worsening sx. Tx with IVF and abx and d/c.  Returned next day with abd pain, photophobia, nausea, rigors, chills and mild facial swelling. Febrile and tachy in ER. PE (+) for abd tendernes of RUQ. Admitted for eval and d/c next day. ICD9:3393-Drug induced H/A.  E9493 YF Vax causing adverse effects in therapeutic use. 07999Y Unspecified viral infection.
Age: 42.0
Sex: F
Vaccine: MEN, YF, YF
Symptoms: Malaise, Nausea, Neck pain, Neutrophil count, Neutrophil percentage increased
Clinical narrative: Initial report received on 15 April 2009 from a pharmacist. A 42 year old female patient, who has no known allergies, a history of hepatitis B infection, and medical conditions of SJOGREN's syndrome, hypothyroidism, and hyperlipidemia, had received on 08 April 2009 in preparation for future travel a first intramuscular injection of YF-VAX (lot number and site of administration unknown), and an intramuscular injection of a meningococcal vaccine (Trade name, manufacturer name and site of administration unknown). The subject was taking ZOCOR, ZANTAC, Levothyroxine and Belladonna (indication not reported) at the time of the vaccinations. Three days post-vaccination, the patient experienced fever with chills and sweating (lasting four days), generalized malaise, nausea, pain in all joints (without erythema or swelling), congestion with slight dry cough, neck pain, facial pain, headache and transaminitis. The patient was subsequently hospitalized (date not reported) for one day and received treatment with intravenous fluids, MOTRIN, ZOFRAN, and Ketorolac. Diagnostic testing included a CAT scan of the head without contrast, CAT scan of the abdomen, chest x-ray, blood cultures, urine cultures, urinalysis and lumbar puncture. The results of the tests were not reported except for the urine culture and chest x-ray which were normal. Diagnostic laboratory data revealed, ALK Phos 204, AST 122, ALT 201, WBC 4.6, neutrophil 84%, lymph 14%, ANC 3.8, ESR 30, and CRP 52. The patient recovered (date not reported). The diagnosis was viral syndrome versus "YF-VAX." Documents held by sender: None.  6/3/09 MR received for DOS 4/15-16/09 with D/C DX:  Fever NOS and ER record 4/14/09 with dx: fever-sinusitis/viral syndrome. Pt initially presented on 4/14/09 with c/o frontal H/A, neck pain, cough, joint pain and vomiting x 3 days. Recent travel to Africa.  Already on abx from PMD for suspected sinus inf. To ER with worsening sx. Tx with IVF and abx and d/c.  Returned next day with abd pain, photophobia, nausea, rigors, chills and mild facial swelling. Febrile and tachy in ER. PE (+) for abd tendernes of RUQ. Admitted for eval and d/c next day. ICD9:3393-Drug induced H/A.  E9493 YF Vax causing adverse effects in therapeutic use. 07999Y Unspecified viral infection.
Age: 42.0
Sex: F
Vaccine: MEN, YF, YF
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, Respiratory tract congestion, Transaminases increased, Urine analysis
Clinical narrative: Initial report received on 15 April 2009 from a pharmacist. A 42 year old female patient, who has no known allergies, a history of hepatitis B infection, and medical conditions of SJOGREN's syndrome, hypothyroidism, and hyperlipidemia, had received on 08 April 2009 in preparation for future travel a first intramuscular injection of YF-VAX (lot number and site of administration unknown), and an intramuscular injection of a meningococcal vaccine (Trade name, manufacturer name and site of administration unknown). The subject was taking ZOCOR, ZANTAC, Levothyroxine and Belladonna (indication not reported) at the time of the vaccinations. Three days post-vaccination, the patient experienced fever with chills and sweating (lasting four days), generalized malaise, nausea, pain in all joints (without erythema or swelling), congestion with slight dry cough, neck pain, facial pain, headache and transaminitis. The patient was subsequently hospitalized (date not reported) for one day and received treatment with intravenous fluids, MOTRIN, ZOFRAN, and Ketorolac. Diagnostic testing included a CAT scan of the head without contrast, CAT scan of the abdomen, chest x-ray, blood cultures, urine cultures, urinalysis and lumbar puncture. The results of the tests were not reported except for the urine culture and chest x-ray which were normal. Diagnostic laboratory data revealed, ALK Phos 204, AST 122, ALT 201, WBC 4.6, neutrophil 84%, lymph 14%, ANC 3.8, ESR 30, and CRP 52. The patient recovered (date not reported). The diagnosis was viral syndrome versus "YF-VAX." Documents held by sender: None.  6/3/09 MR received for DOS 4/15-16/09 with D/C DX:  Fever NOS and ER record 4/14/09 with dx: fever-sinusitis/viral syndrome. Pt initially presented on 4/14/09 with c/o frontal H/A, neck pain, cough, joint pain and vomiting x 3 days. Recent travel to Africa.  Already on abx from PMD for suspected sinus inf. To ER with worsening sx. Tx with IVF and abx and d/c.  Returned next day with abd pain, photophobia, nausea, rigors, chills and mild facial swelling. Febrile and tachy in ER. PE (+) for abd tendernes of RUQ. Admitted for eval and d/c next day. ICD9:3393-Drug induced H/A.  E9493 YF Vax causing adverse effects in therapeutic use. 07999Y Unspecified viral infection.
Age: 42.0
Sex: F
Vaccine: MEN, YF, YF
Symptoms: Viral infection, White blood cell count decreased
Clinical narrative: Initial report received on 15 April 2009 from a pharmacist. A 42 year old female patient, who has no known allergies, a history of hepatitis B infection, and medical conditions of SJOGREN's syndrome, hypothyroidism, and hyperlipidemia, had received on 08 April 2009 in preparation for future travel a first intramuscular injection of YF-VAX (lot number and site of administration unknown), and an intramuscular injection of a meningococcal vaccine (Trade name, manufacturer name and site of administration unknown). The subject was taking ZOCOR, ZANTAC, Levothyroxine and Belladonna (indication not reported) at the time of the vaccinations. Three days post-vaccination, the patient experienced fever with chills and sweating (lasting four days), generalized malaise, nausea, pain in all joints (without erythema or swelling), congestion with slight dry cough, neck pain, facial pain, headache and transaminitis. The patient was subsequently hospitalized (date not reported) for one day and received treatment with intravenous fluids, MOTRIN, ZOFRAN, and Ketorolac. Diagnostic testing included a CAT scan of the head without contrast, CAT scan of the abdomen, chest x-ray, blood cultures, urine cultures, urinalysis and lumbar puncture. The results of the tests were not reported except for the urine culture and chest x-ray which were normal. Diagnostic laboratory data revealed, ALK Phos 204, AST 122, ALT 201, WBC 4.6, neutrophil 84%, lymph 14%, ANC 3.8, ESR 30, and CRP 52. The patient recovered (date not reported). The diagnosis was viral syndrome versus "YF-VAX." Documents held by sender: None.  6/3/09 MR received for DOS 4/15-16/09 with D/C DX:  Fever NOS and ER record 4/14/09 with dx: fever-sinusitis/viral syndrome. Pt initially presented on 4/14/09 with c/o frontal H/A, neck pain, cough, joint pain and vomiting x 3 days. Recent travel to Africa.  Already on abx from PMD for suspected sinus inf. To ER with worsening sx. Tx with IVF and abx and d/c.  Returned next day with abd pain, photophobia, nausea, rigors, chills and mild facial swelling. Febrile and tachy in ER. PE (+) for abd tendernes of RUQ. Admitted for eval and d/c next day. ICD9:3393-Drug induced H/A.  E9493 YF Vax causing adverse effects in therapeutic use. 07999Y Unspecified viral infection.