chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.43
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC, VARCEL, DTPPHIB, HEPA, MEA, PNC, VARCEL, DTAP, HEPA, HIBV, IPV, MMR, PNC, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC, VARCEL
Symptoms: Motor dysfunction, Pyrexia, Varicella, Varicella post vaccine, Weight decreased
Clinical narrative: Information has been received from a consumer concerning a 17 month old male with intestinal bacteria flora disturbance, coeliac disease, flour sensitivity and allergy to chemicals and a history of oral candidiasis, candidiasis of the intestine, adverse drug reaction (MIRALEX), psychotic disorder, confusion, diarrhoea, bloating, does not detoxify and yeast infection. The patient also experienced some of the same and other adverse events after DTaP vaccine on 16-DEC-2008 (case #A0970857A). The patient was born with thrush in mouth and intestines because mom took antibiotics on and off during pregnancy for tooth abscess. Patient's mom was taking birth control shots every three months when she became pregnant. Mom also took omeprazole (unspecified) for reflux during 3rd trimester. Grandmother reports patient's mom did have prenatal care, however was unaware of pregnancy initially. Grandmother reports he tolerated antibiotics well for 3 months, but didn't have any flora in his system. Patient has sibling that is 6 years of age, without any medical issues, from different father. The older brother has been adopted to another family. The patient on 23-MAR-2010 was vaccinated with VARIVAX (Merck), (dose, route and lot # not reported). Secondary suspect included MMR II (dose, route and lot # not reported), VAQTA, DTaP+IPV+HIB, PREVNAR. Concomitant therapy included nutritional supplements. On approximately 30-MAR-2010 (reported as less than one week) the patient experienced high grade fever up to 105 and loss of appetite. On approximately 06-APR-2010 (reported as 2 to 3 weeks after vaccination) the patient experienced chicken pox. On approximately 23-APR-2010 (reported as about one month after vaccination) the patient experienced weight loss, loss of fine motor skills, non communicative, dysphagia and loss of making eye contact. The reporter said that the subject lost about 50 percent of his weight and 80 percent of his fine motor skills. In approximately June 2010 (reported as about 4 month after vaccination), the patient experienced autism. Subsequently in 2010 the patient experienced diarrhea, increase tantrums and loss of all speech. At the time of the report, the grandmother explained that the subject had recovered to about 90 percent and now attended a school for special education student. At the time of reporting the outcome of the events was unspecified except the autism was considered as improved. The patient also experienced adverse events after HAVRIX (administered on 09-MAR-2012) and experienced some of the same events plus different events (case #A0970857C). Upon internal review, loss of all speech was determined to be as other important medical event. No further information is available.
Age: 1.43
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC, VARCEL, DTPPHIB, HEPA, MEA, PNC, VARCEL, DTAP, HEPA, HIBV, IPV, MMR, PNC, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC, VARCEL
Symptoms: Autism, Communication disorder, Decreased appetite, Decreased eye contact, Dysphagia
Clinical narrative: Information has been received from a consumer concerning a 17 month old male with intestinal bacteria flora disturbance, coeliac disease, flour sensitivity and allergy to chemicals and a history of oral candidiasis, candidiasis of the intestine, adverse drug reaction (MIRALEX), psychotic disorder, confusion, diarrhoea, bloating, does not detoxify and yeast infection. The patient also experienced some of the same and other adverse events after DTaP vaccine on 16-DEC-2008 (case #A0970857A). The patient was born with thrush in mouth and intestines because mom took antibiotics on and off during pregnancy for tooth abscess. Patient's mom was taking birth control shots every three months when she became pregnant. Mom also took omeprazole (unspecified) for reflux during 3rd trimester. Grandmother reports patient's mom did have prenatal care, however was unaware of pregnancy initially. Grandmother reports he tolerated antibiotics well for 3 months, but didn't have any flora in his system. Patient has sibling that is 6 years of age, without any medical issues, from different father. The older brother has been adopted to another family. The patient on 23-MAR-2010 was vaccinated with VARIVAX (Merck), (dose, route and lot # not reported). Secondary suspect included MMR II (dose, route and lot # not reported), VAQTA, DTaP+IPV+HIB, PREVNAR. Concomitant therapy included nutritional supplements. On approximately 30-MAR-2010 (reported as less than one week) the patient experienced high grade fever up to 105 and loss of appetite. On approximately 06-APR-2010 (reported as 2 to 3 weeks after vaccination) the patient experienced chicken pox. On approximately 23-APR-2010 (reported as about one month after vaccination) the patient experienced weight loss, loss of fine motor skills, non communicative, dysphagia and loss of making eye contact. The reporter said that the subject lost about 50 percent of his weight and 80 percent of his fine motor skills. In approximately June 2010 (reported as about 4 month after vaccination), the patient experienced autism. Subsequently in 2010 the patient experienced diarrhea, increase tantrums and loss of all speech. At the time of the report, the grandmother explained that the subject had recovered to about 90 percent and now attended a school for special education student. At the time of reporting the outcome of the events was unspecified except the autism was considered as improved. The patient also experienced adverse events after HAVRIX (administered on 09-MAR-2012) and experienced some of the same events plus different events (case #A0970857C). Upon internal review, loss of all speech was determined to be as other important medical event. No further information is available.
Age: 1.43
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC, VARCEL, DTPPHIB, HEPA, MEA, PNC, VARCEL, DTAP, HEPA, HIBV, IPV, MMR, PNC, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC, VARCEL
Symptoms: Psychomotor skills impaired, Pyrexia, Vaccine positive rechallenge, Varicella post vaccine, Weight decreased
Clinical narrative: Information has been received from a consumer concerning a 17 month old male with intestinal bacteria flora disturbance, coeliac disease, flour sensitivity and allergy to chemicals and a history of oral candidiasis, candidiasis of the intestine, adverse drug reaction (MIRALEX), psychotic disorder, confusion, diarrhoea, bloating, does not detoxify and yeast infection. The patient also experienced some of the same and other adverse events after DTaP vaccine on 16-DEC-2008 (case #A0970857A). The patient was born with thrush in mouth and intestines because mom took antibiotics on and off during pregnancy for tooth abscess. Patient's mom was taking birth control shots every three months when she became pregnant. Mom also took omeprazole (unspecified) for reflux during 3rd trimester. Grandmother reports patient's mom did have prenatal care, however was unaware of pregnancy initially. Grandmother reports he tolerated antibiotics well for 3 months, but didn't have any flora in his system. Patient has sibling that is 6 years of age, without any medical issues, from different father. The older brother has been adopted to another family. The patient on 23-MAR-2010 was vaccinated with VARIVAX (Merck), (dose, route and lot # not reported). Secondary suspect included MMR II (dose, route and lot # not reported), VAQTA, DTaP+IPV+HIB, PREVNAR. Concomitant therapy included nutritional supplements. On approximately 30-MAR-2010 (reported as less than one week) the patient experienced high grade fever up to 105 and loss of appetite. On approximately 06-APR-2010 (reported as 2 to 3 weeks after vaccination) the patient experienced chicken pox. On approximately 23-APR-2010 (reported as about one month after vaccination) the patient experienced weight loss, loss of fine motor skills, non communicative, dysphagia and loss of making eye contact. The reporter said that the subject lost about 50 percent of his weight and 80 percent of his fine motor skills. In approximately June 2010 (reported as about 4 month after vaccination), the patient experienced autism. Subsequently in 2010 the patient experienced diarrhea, increase tantrums and loss of all speech. At the time of the report, the grandmother explained that the subject had recovered to about 90 percent and now attended a school for special education student. At the time of reporting the outcome of the events was unspecified except the autism was considered as improved. The patient also experienced adverse events after HAVRIX (administered on 09-MAR-2012) and experienced some of the same events plus different events (case #A0970857C). Upon internal review, loss of all speech was determined to be as other important medical event. No further information is available.
Age: 1.43
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC, VARCEL, DTPPHIB, HEPA, MEA, PNC, VARCEL, DTAP, HEPA, HIBV, IPV, MMR, PNC, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC, VARCEL
Symptoms: Learning disorder, Motor dysfunction, Pyrexia, Varicella post vaccine, Weight decreased
Clinical narrative: Information has been received from a consumer concerning a 17 month old male with intestinal bacteria flora disturbance, coeliac disease, flour sensitivity and allergy to chemicals and a history of oral candidiasis, candidiasis of the intestine, adverse drug reaction (MIRALEX), psychotic disorder, confusion, diarrhoea, bloating, does not detoxify and yeast infection. The patient also experienced some of the same and other adverse events after DTaP vaccine on 16-DEC-2008 (case #A0970857A). The patient was born with thrush in mouth and intestines because mom took antibiotics on and off during pregnancy for tooth abscess. Patient's mom was taking birth control shots every three months when she became pregnant. Mom also took omeprazole (unspecified) for reflux during 3rd trimester. Grandmother reports patient's mom did have prenatal care, however was unaware of pregnancy initially. Grandmother reports he tolerated antibiotics well for 3 months, but didn't have any flora in his system. Patient has sibling that is 6 years of age, without any medical issues, from different father. The older brother has been adopted to another family. The patient on 23-MAR-2010 was vaccinated with VARIVAX (Merck), (dose, route and lot # not reported). Secondary suspect included MMR II (dose, route and lot # not reported), VAQTA, DTaP+IPV+HIB, PREVNAR. Concomitant therapy included nutritional supplements. On approximately 30-MAR-2010 (reported as less than one week) the patient experienced high grade fever up to 105 and loss of appetite. On approximately 06-APR-2010 (reported as 2 to 3 weeks after vaccination) the patient experienced chicken pox. On approximately 23-APR-2010 (reported as about one month after vaccination) the patient experienced weight loss, loss of fine motor skills, non communicative, dysphagia and loss of making eye contact. The reporter said that the subject lost about 50 percent of his weight and 80 percent of his fine motor skills. In approximately June 2010 (reported as about 4 month after vaccination), the patient experienced autism. Subsequently in 2010 the patient experienced diarrhea, increase tantrums and loss of all speech. At the time of the report, the grandmother explained that the subject had recovered to about 90 percent and now attended a school for special education student. At the time of reporting the outcome of the events was unspecified except the autism was considered as improved. The patient also experienced adverse events after HAVRIX (administered on 09-MAR-2012) and experienced some of the same events plus different events (case #A0970857C). Upon internal review, loss of all speech was determined to be as other important medical event. No further information is available.
Age: 1.43
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC, VARCEL, DTPPHIB, HEPA, MEA, PNC, VARCEL, DTAP, HEPA, HIBV, IPV, MMR, PNC, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC, VARCEL
Symptoms: Liver function test normal, Motor dysfunction, Pyrexia, Varicella post vaccine, Weight decreased
Clinical narrative: Information has been received from a consumer concerning a 17 month old male with intestinal bacteria flora disturbance, coeliac disease, flour sensitivity and allergy to chemicals and a history of oral candidiasis, candidiasis of the intestine, adverse drug reaction (MIRALEX), psychotic disorder, confusion, diarrhoea, bloating, does not detoxify and yeast infection. The patient also experienced some of the same and other adverse events after DTaP vaccine on 16-DEC-2008 (case #A0970857A). The patient was born with thrush in mouth and intestines because mom took antibiotics on and off during pregnancy for tooth abscess. Patient's mom was taking birth control shots every three months when she became pregnant. Mom also took omeprazole (unspecified) for reflux during 3rd trimester. Grandmother reports patient's mom did have prenatal care, however was unaware of pregnancy initially. Grandmother reports he tolerated antibiotics well for 3 months, but didn't have any flora in his system. Patient has sibling that is 6 years of age, without any medical issues, from different father. The older brother has been adopted to another family. The patient on 23-MAR-2010 was vaccinated with VARIVAX (Merck), (dose, route and lot # not reported). Secondary suspect included MMR II (dose, route and lot # not reported), VAQTA, DTaP+IPV+HIB, PREVNAR. Concomitant therapy included nutritional supplements. On approximately 30-MAR-2010 (reported as less than one week) the patient experienced high grade fever up to 105 and loss of appetite. On approximately 06-APR-2010 (reported as 2 to 3 weeks after vaccination) the patient experienced chicken pox. On approximately 23-APR-2010 (reported as about one month after vaccination) the patient experienced weight loss, loss of fine motor skills, non communicative, dysphagia and loss of making eye contact. The reporter said that the subject lost about 50 percent of his weight and 80 percent of his fine motor skills. In approximately June 2010 (reported as about 4 month after vaccination), the patient experienced autism. Subsequently in 2010 the patient experienced diarrhea, increase tantrums and loss of all speech. At the time of the report, the grandmother explained that the subject had recovered to about 90 percent and now attended a school for special education student. At the time of reporting the outcome of the events was unspecified except the autism was considered as improved. The patient also experienced adverse events after HAVRIX (administered on 09-MAR-2012) and experienced some of the same events plus different events (case #A0970857C). Upon internal review, loss of all speech was determined to be as other important medical event. No further information is available.
Age: 1.43
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC, VARCEL, DTPPHIB, HEPA, MEA, PNC, VARCEL, DTAP, HEPA, HIBV, IPV, MMR, PNC, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC, VARCEL
Symptoms: Aggression, Aphasia, Autism, Communication disorder, Decreased appetite
Clinical narrative: Information has been received from a consumer concerning a 17 month old male with intestinal bacteria flora disturbance, coeliac disease, flour sensitivity and allergy to chemicals and a history of oral candidiasis, candidiasis of the intestine, adverse drug reaction (MIRALEX), psychotic disorder, confusion, diarrhoea, bloating, does not detoxify and yeast infection. The patient also experienced some of the same and other adverse events after DTaP vaccine on 16-DEC-2008 (case #A0970857A). The patient was born with thrush in mouth and intestines because mom took antibiotics on and off during pregnancy for tooth abscess. Patient's mom was taking birth control shots every three months when she became pregnant. Mom also took omeprazole (unspecified) for reflux during 3rd trimester. Grandmother reports patient's mom did have prenatal care, however was unaware of pregnancy initially. Grandmother reports he tolerated antibiotics well for 3 months, but didn't have any flora in his system. Patient has sibling that is 6 years of age, without any medical issues, from different father. The older brother has been adopted to another family. The patient on 23-MAR-2010 was vaccinated with VARIVAX (Merck), (dose, route and lot # not reported). Secondary suspect included MMR II (dose, route and lot # not reported), VAQTA, DTaP+IPV+HIB, PREVNAR. Concomitant therapy included nutritional supplements. On approximately 30-MAR-2010 (reported as less than one week) the patient experienced high grade fever up to 105 and loss of appetite. On approximately 06-APR-2010 (reported as 2 to 3 weeks after vaccination) the patient experienced chicken pox. On approximately 23-APR-2010 (reported as about one month after vaccination) the patient experienced weight loss, loss of fine motor skills, non communicative, dysphagia and loss of making eye contact. The reporter said that the subject lost about 50 percent of his weight and 80 percent of his fine motor skills. In approximately June 2010 (reported as about 4 month after vaccination), the patient experienced autism. Subsequently in 2010 the patient experienced diarrhea, increase tantrums and loss of all speech. At the time of the report, the grandmother explained that the subject had recovered to about 90 percent and now attended a school for special education student. At the time of reporting the outcome of the events was unspecified except the autism was considered as improved. The patient also experienced adverse events after HAVRIX (administered on 09-MAR-2012) and experienced some of the same events plus different events (case #A0970857C). Upon internal review, loss of all speech was determined to be as other important medical event. No further information is available.
Age: 1.43
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC, VARCEL, DTPPHIB, HEPA, MEA, PNC, VARCEL, DTAP, HEPA, HIBV, IPV, MMR, PNC, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC, VARCEL
Symptoms: Decreased eye contact, Diarrhoea, Dysphagia, Motor dysfunction, Pyrexia
Clinical narrative: Information has been received from a consumer concerning a 17 month old male with intestinal bacteria flora disturbance, coeliac disease, flour sensitivity and allergy to chemicals and a history of oral candidiasis, candidiasis of the intestine, adverse drug reaction (MIRALEX), psychotic disorder, confusion, diarrhoea, bloating, does not detoxify and yeast infection. The patient also experienced some of the same and other adverse events after DTaP vaccine on 16-DEC-2008 (case #A0970857A). The patient was born with thrush in mouth and intestines because mom took antibiotics on and off during pregnancy for tooth abscess. Patient's mom was taking birth control shots every three months when she became pregnant. Mom also took omeprazole (unspecified) for reflux during 3rd trimester. Grandmother reports patient's mom did have prenatal care, however was unaware of pregnancy initially. Grandmother reports he tolerated antibiotics well for 3 months, but didn't have any flora in his system. Patient has sibling that is 6 years of age, without any medical issues, from different father. The older brother has been adopted to another family. The patient on 23-MAR-2010 was vaccinated with VARIVAX (Merck), (dose, route and lot # not reported). Secondary suspect included MMR II (dose, route and lot # not reported), VAQTA, DTaP+IPV+HIB, PREVNAR. Concomitant therapy included nutritional supplements. On approximately 30-MAR-2010 (reported as less than one week) the patient experienced high grade fever up to 105 and loss of appetite. On approximately 06-APR-2010 (reported as 2 to 3 weeks after vaccination) the patient experienced chicken pox. On approximately 23-APR-2010 (reported as about one month after vaccination) the patient experienced weight loss, loss of fine motor skills, non communicative, dysphagia and loss of making eye contact. The reporter said that the subject lost about 50 percent of his weight and 80 percent of his fine motor skills. In approximately June 2010 (reported as about 4 month after vaccination), the patient experienced autism. Subsequently in 2010 the patient experienced diarrhea, increase tantrums and loss of all speech. At the time of the report, the grandmother explained that the subject had recovered to about 90 percent and now attended a school for special education student. At the time of reporting the outcome of the events was unspecified except the autism was considered as improved. The patient also experienced adverse events after HAVRIX (administered on 09-MAR-2012) and experienced some of the same events plus different events (case #A0970857C). Upon internal review, loss of all speech was determined to be as other important medical event. No further information is available.
Age: 1.43
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC, VARCEL, DTPPHIB, HEPA, MEA, PNC, VARCEL, DTAP, HEPA, HIBV, IPV, MMR, PNC, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC, VARCEL
Symptoms: Varicella post vaccine, Weight decreased
Clinical narrative: Information has been received from a consumer concerning a 17 month old male with intestinal bacteria flora disturbance, coeliac disease, flour sensitivity and allergy to chemicals and a history of oral candidiasis, candidiasis of the intestine, adverse drug reaction (MIRALEX), psychotic disorder, confusion, diarrhoea, bloating, does not detoxify and yeast infection. The patient also experienced some of the same and other adverse events after DTaP vaccine on 16-DEC-2008 (case #A0970857A). The patient was born with thrush in mouth and intestines because mom took antibiotics on and off during pregnancy for tooth abscess. Patient's mom was taking birth control shots every three months when she became pregnant. Mom also took omeprazole (unspecified) for reflux during 3rd trimester. Grandmother reports patient's mom did have prenatal care, however was unaware of pregnancy initially. Grandmother reports he tolerated antibiotics well for 3 months, but didn't have any flora in his system. Patient has sibling that is 6 years of age, without any medical issues, from different father. The older brother has been adopted to another family. The patient on 23-MAR-2010 was vaccinated with VARIVAX (Merck), (dose, route and lot # not reported). Secondary suspect included MMR II (dose, route and lot # not reported), VAQTA, DTaP+IPV+HIB, PREVNAR. Concomitant therapy included nutritional supplements. On approximately 30-MAR-2010 (reported as less than one week) the patient experienced high grade fever up to 105 and loss of appetite. On approximately 06-APR-2010 (reported as 2 to 3 weeks after vaccination) the patient experienced chicken pox. On approximately 23-APR-2010 (reported as about one month after vaccination) the patient experienced weight loss, loss of fine motor skills, non communicative, dysphagia and loss of making eye contact. The reporter said that the subject lost about 50 percent of his weight and 80 percent of his fine motor skills. In approximately June 2010 (reported as about 4 month after vaccination), the patient experienced autism. Subsequently in 2010 the patient experienced diarrhea, increase tantrums and loss of all speech. At the time of the report, the grandmother explained that the subject had recovered to about 90 percent and now attended a school for special education student. At the time of reporting the outcome of the events was unspecified except the autism was considered as improved. The patient also experienced adverse events after HAVRIX (administered on 09-MAR-2012) and experienced some of the same events plus different events (case #A0970857C). Upon internal review, loss of all speech was determined to be as other important medical event. No further information is available.
Age: 0.29
Sex: M
Vaccine: RV5, RV5
Symptoms: Bronchitis, Pyrexia
Clinical narrative: 2 day fever with bronchitis symptoms.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Dyskinesia, Hunger, Nausea, Vomiting
Clinical narrative: This incident happened on 31May2012, @10:40 AM local time. Patient started jerking motion while she was sitting in waiting area after immunization, for approximately 10 seconds. Patient responded nurse after jerking motion and complained of nausea and dizziness, vomited X1, Vital signs @10:42 temp: 98, BP: 96/56, Pulse: 50, SPO2: 99. Placed Pt in supine position, elevated feet. Vital signs @10:47 Temp: 97.9, 110/67, Pulse: 74, SPO2: 97. Vital signs @10:52 are Temp: 98.3, BP 102/62, Pulse: 72, SPO2: 98. Vital sings @10:57 are temp: 98.6, BP: 100/62, Pulse: 80, SPO2: 98.  Patient says she's hungry, and feels better and eats spam rice ball at @11:00. Pt denies dizziness. Vital signs @11:02 are Temp: 98.6, BP: 121/72, Pulse: 69, SPO2:98. Patient talking with mother, and friend. Vital signs @11:17 are temp: 98.4, BP: 118/76, Pulse: 72, SPO2: 98. Patient denies dizziness, nor weakness. Pt was discharged at 11:25.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Dyskinesia, Nausea, Vomiting
Clinical narrative: This incident happened on 31May2012, @10:40 AM local time. Patient started jerking motion while she was sitting in waiting area after immunization, for approximately 10 seconds. Patient responded nurse after jerking motion and complained of nausea and dizziness, vomited X1, Vital signs @10:42 temp: 98, BP: 96/56, Pulse: 50, SPO2: 99. Placed Pt in supine position, elevated feet. Vital signs @10:47 Temp: 97.9, 110/67, Pulse: 74, SPO2: 97. Vital signs @10:52 are Temp: 98.3, BP 102/62, Pulse: 72, SPO2: 98. Vital sings @10:57 are temp: 98.6, BP: 100/62, Pulse: 80, SPO2: 98.  Patient says she's hungry, and feels better and eats spam rice ball at @11:00. Pt denies dizziness. Vital signs @11:02 are Temp: 98.6, BP: 121/72, Pulse: 69, SPO2:98. Patient talking with mother, and friend. Vital signs @11:17 are temp: 98.4, BP: 118/76, Pulse: 72, SPO2: 98. Patient denies dizziness, nor weakness. Pt was discharged at 11:25.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Abasia, Aphasia, Cold sweat, Crying, Decreased eye contact
Clinical narrative: Became ill on the way home in the car. Crying without stopping all night. When he finally slept he slept much longer than normal. Became clammy to the touch, listless, only wanted to sleep. Began to have diarrhea right away also. Was not able to get the diarrhea to stop for two years. As soon as he became physically well enough to get out of the crib, it was apparent he had changed. No eye contact, stopped talking,  didn't walk any more, no longer interested in doing anything but watching a Disney Winnie the Pooh movie over and over and over again.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Decreased interest, Diarrhoea, Hypersomnia, Listless, Malaise
Clinical narrative: Became ill on the way home in the car. Crying without stopping all night. When he finally slept he slept much longer than normal. Became clammy to the touch, listless, only wanted to sleep. Began to have diarrhea right away also. Was not able to get the diarrhea to stop for two years. As soon as he became physically well enough to get out of the crib, it was apparent he had changed. No eye contact, stopped talking,  didn't walk any more, no longer interested in doing anything but watching a Disney Winnie the Pooh movie over and over and over again.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Somnolence
Clinical narrative: Became ill on the way home in the car. Crying without stopping all night. When he finally slept he slept much longer than normal. Became clammy to the touch, listless, only wanted to sleep. Began to have diarrhea right away also. Was not able to get the diarrhea to stop for two years. As soon as he became physically well enough to get out of the crib, it was apparent he had changed. No eye contact, stopped talking,  didn't walk any more, no longer interested in doing anything but watching a Disney Winnie the Pooh movie over and over and over again.
Age: 8.0
Sex: F
Vaccine: MMR
Symptoms: Heat rash, Rash, Rash erythematous, Rash generalised
Clinical narrative: Started with a slight red rash on her forehead.  Noticed small "heat rash" like red marks on her back and chest.  It continually got VERY bad until her entire body had small raised red dots everywhere.  They were not itchy.
Age: 17.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Diarrhoea, Injection site urticaria, Rash erythematous, Rash pruritic
Clinical narrative: Pt presented with 5 days of red pruritic rash, hives to arm at injection site & abdomen. C/O Ab pain & diarrhea 4-5 times/day. Treatment Loperamide/ATARAX/Hydrocortisone cream.
Age: 17.0
Sex: M
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: Pt presented with 5 days of red pruritic rash, hives to arm at injection site & abdomen. C/O Ab pain & diarrhea 4-5 times/day. Treatment Loperamide/ATARAX/Hydrocortisone cream.
Age: 21.0
Sex: M
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Disorientation, Dizziness, Excoriation, Eye swelling, Headache
Clinical narrative: Pt stated he felt dizzy about 5 min after being given 2 vaccines listed above. Doctor stepped out of room to get patient water. Door to room slammed shut within 5-10 seconds. I ran to room. Patient face down on floor, I rolled him over. He was looking at me but unaware of surroundings & shaking. He recovered in about 10 seconds. He had abrasion to right temple & swelling about right eye. He complained of headache & vision changes. Vision changes resolved about 1 hr. He threw up once 2-3 hr after event. He went home after 1 hour of observation.
Age: 21.0
Sex: M
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Tremor, Visual impairment, Vomiting
Clinical narrative: Pt stated he felt dizzy about 5 min after being given 2 vaccines listed above. Doctor stepped out of room to get patient water. Door to room slammed shut within 5-10 seconds. I ran to room. Patient face down on floor, I rolled him over. He was looking at me but unaware of surroundings & shaking. He recovered in about 10 seconds. He had abrasion to right temple & swelling about right eye. He complained of headache & vision changes. Vision changes resolved about 1 hr. He threw up once 2-3 hr after event. He went home after 1 hour of observation.
Age: 21.0
Sex: M
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Disorientation, Dizziness, Excoriation, Headache, Swelling face
Clinical narrative: Pt stated he felt dizzy about 5 min after being given 2 vaccines listed above. Doctor stepped out of room to get patient water. Door to room slammed shut within 5-10 seconds. I ran to room. Patient face down on floor, I rolled him over. He was looking at me but unaware of surroundings & shaking. He recovered in about 10 seconds. He had abrasion to right temple & swelling about right eye. He complained of headache & vision changes. Vision changes resolved about 1 hr. He threw up once 2-3 hr after event. He went home after 1 hour of observation.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Lt arm - red & warm to touch from mid arm down to elbow - 6" long & 4 1/2" around starts below deltoid area down to elbow. No induration (+) soft tissue swelling.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pruritus, Rash, Throat irritation, Urticaria
Clinical narrative: Pt c/o's scratchy throat & itchy - BENADRYL 25mg then hives over eyes EPIPEN Jr - relieved for 20min rash started again EPIPEN Jr & 30mg ORAPRED given.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Swelling, redness, raised, warm Rt upper out arm. Fever, chills, joint pain, fatigue.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Swelling, redness, raised, warm Rt upper out arm. Fever, chills, joint pain, fatigue.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Aura, Back pain, Migraine, Pain, Tunnel vision
Clinical narrative: I received the immun at around 11:00 am - by 12:00 I was feeling pain in my back, at 1:30 I started to get migraine, aura and tunnel vision, pain, for 12 hours. Last migraine at 15 years ago.
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Warmth, erythema, induration 4 cm circle around injection site right thigh.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Laboratory test, Nuclear magnetic resonance imaging brain
Clinical narrative: Time of vaccination 1 hour after injection tongue & lips became numb. Next morning outer right arm became numb then right small toe & outer right foot became numb. It felt like when NOVOCAINE is wearing off after dental work.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Full blood count, Injection site rash, Joint swelling, Laboratory test abnormal
Clinical narrative: Employee received the 1st dose of Merck recomb Hep B vaccine.  The next moring she woke uo with minor swelling at left ebow and scattered rash upper/lower lt. arm (site of injection)..also noted some red spots on right arm.  Not itchy...no other symptoms.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Syncopal episode approximately 2 minutes after last immuniation administered.  Episode lasting only a few seconds, vital signs stable - BP 120/80 & pulse 84, skin warm & dry.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Dry skin, Skin warm, Syncope
Clinical narrative: Syncopal episode approximately 2 minutes after last immuniation administered.  Episode lasting only a few seconds, vital signs stable - BP 120/80 & pulse 84, skin warm & dry.
Age: 16.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Chills, Hyperhidrosis, Injection site pain, Myalgia, Pain
Clinical narrative: Myalgias, rigors, fever 100.2, chills, sweating. localized site tenderness only, no rash noted. Rest, increase fluids, ice to upper arms as needed, ibuprofen 400mg every 6-8 hours for pain/fever.
Age: 16.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Myalgias, rigors, fever 100.2, chills, sweating. localized site tenderness only, no rash noted. Rest, increase fluids, ice to upper arms as needed, ibuprofen 400mg every 6-8 hours for pain/fever.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site pain, Injection site pruritus, Swelling face
Clinical narrative: Child developed injection site itching and pain with facial swelling the evening after recieving the HPV/Gardasil vaccine, dose 2.  No wheezing, shortness of breath or tongue swelling. No history of food, drug or environmental allergies.  Mother administered Tylenol and Benadryl and was seen in the office 5/31/12.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Initial report was received from a healthcare professional on 10 April 2012. The reporter for this case is the same as case number: 2012-03809 and 2012-03810. A 63-year-old female patient received a right deltoid (RD) intramuscular injection (dose one) of ADACEL, sanofi pasteur Ltd., sanofi pasteur Inc. lot number U4308BA, (corresponding sanofi pasteur Ltd. lot number C4063) on 21 March 2012. The patient's past medical history was not reported. The patient had an allergy to "Indomethesone". Illness at time of vaccination was reported as tenosynovitis of finger from cat bite. Other vaccinations within four weeks prior to vaccination were reported as none. Concomitant medications included: pravastatin, lisinopril, allopurinol, Acetylsalicylic Acid (ASA), colchicine, ZIAC, multivitamin, and folic acid. The patient experienced a lump, itching, redness, mild tenderness and warm to touch at injection site on 28 March 2012, which required a doctor visit. The patient as already on an antibiotic, AUGMENTIN. Treatment included the addition of antibiotic BACTRIM. The reporter stated the symptoms resolved. The patient's outcome was reported as recovered on unspecified date. Follow-up information was received from a health care professional on 25 May 2012. Based upon new information provided, this case has been upgraded to serious. The patient was a 75-year-old female. The patient was diagnosed with cellulitis on 28 March 2012 and treated with AUGMENTIN XR 1000/62.5mg 1 tablet by mouth twice daily for 10 days that was started on 23 March 2012 and ended on 30 March 2012. The patient was already taking this medication for the cat bite. The patient's past medical history (PMH) included hyperlipidemia, gout, hypertension and lipoma of face. No date of recovery was obtained. The patient's outcome remained recovered. Documents held by sender: None.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth
Clinical narrative: Initial report was received from a healthcare professional on 10 April 2012. The reporter for this case is the same as case number: 2012-03809 and 2012-03810. A 63-year-old female patient received a right deltoid (RD) intramuscular injection (dose one) of ADACEL, sanofi pasteur Ltd., sanofi pasteur Inc. lot number U4308BA, (corresponding sanofi pasteur Ltd. lot number C4063) on 21 March 2012. The patient's past medical history was not reported. The patient had an allergy to "Indomethesone". Illness at time of vaccination was reported as tenosynovitis of finger from cat bite. Other vaccinations within four weeks prior to vaccination were reported as none. Concomitant medications included: pravastatin, lisinopril, allopurinol, Acetylsalicylic Acid (ASA), colchicine, ZIAC, multivitamin, and folic acid. The patient experienced a lump, itching, redness, mild tenderness and warm to touch at injection site on 28 March 2012, which required a doctor visit. The patient as already on an antibiotic, AUGMENTIN. Treatment included the addition of antibiotic BACTRIM. The reporter stated the symptoms resolved. The patient's outcome was reported as recovered on unspecified date. Follow-up information was received from a health care professional on 25 May 2012. Based upon new information provided, this case has been upgraded to serious. The patient was a 75-year-old female. The patient was diagnosed with cellulitis on 28 March 2012 and treated with AUGMENTIN XR 1000/62.5mg 1 tablet by mouth twice daily for 10 days that was started on 23 March 2012 and ended on 30 March 2012. The patient was already taking this medication for the cat bite. The patient's past medical history (PMH) included hyperlipidemia, gout, hypertension and lipoma of face. No date of recovery was obtained. The patient's outcome remained recovered. Documents held by sender: None.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The reporter for this case is the same as case number: 2012-03809 and 2012-03811. Initial report was received on 10 April 2012 from a health care professional, at which time this case was assessed as non-serious listed. Based upon follow-up information received on 25 May 2012 from a health care professional, it was determined that this case now meets seriousness criteria (OTHER - MEDICALLY SIGNIFICANT) and this case has been upgraded from non-serious to serious. This narrative included information reported on both dates. A 46-year-old female patient had received a dose one intramuscular injection in the left deltoid of ADACEL, lot number C4051AA, on 05 April 2012. The patient presented to the emergency room (ER) on 08 April 2012 and was experiencing redness, warmth and swelling at the injection site. The diagnosis was cellulitis. The patient was treated with KEFLEX 500 mg four times a day for 10 days starting on 08 April 2012 and ending on 18 April 2012 and SEPTRA 800/160mg two tablets by mouth two times daily for 10 days beginning on 08 April 2012 and ending of 18 April 2012. The patient was seen again at a physician's office on 10 April 2012 with the diagnosis continued cellulitis and treated with clindamycin 150mg 2 capsules by mouth 3 times daily for 10 days beginning on 10 April 2012 and ending on 20 April 2012. Concomitant medications included simvastatin, metoprolol and chlothalidone. The patient's past medical history was reported as hypertension, hyperlipidemia and allergy to penicillin. Illness at time of vaccination and other vaccinations within four weeks prior to vaccination date were reported as none. The patient's outcome was not recovered. Documents held by sender: None.
Age: 0.9
Sex: F
Vaccine: HEP
Symptoms: Cyanosis, Death
Clinical narrative: Information has been received from a consumer concerning her 10 month old niece with no known allergies who on 09-MAY-2012 was vaccinated with a dose of RECOMBIVAX HB (dose, route and lot # not provided). The consumer stated that on 09-MAY-2012, the patient received the vaccine during the day and then went to sleep for a few hours and woke up at 7:00 pm that evening without any issues. The patient then went to sleep again at 10 pm followed by the mother discovering the baby later that night deceased at an unspecified time. The baby's skin was blue in color when the mother discovered her indicating that the baby passed away. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Chest discomfort, Hypersensitivity, Paraesthesia oral, Pruritus, Swollen tongue
Clinical narrative: Information has been received from a Medical Assistant concerning a 36 year old female patient with "asthma years ago", allergic reaction to BENADRYL, neomycin, KEFLEX, CIPRO, loratadine and penicillin allergy, who on 24-MAY-2012 was vaccinated with a dose of MMR II (lot#, dose and route not reported). Concomitant therapy included tuberculin purified protein derivative, received on 22-MAY-2012 (reported as "received PPD two days ago"). It was reported that on 24-MAY-2012 after vaccination the patient almost immediately had an allergic reaction to the neomycin component of the vaccine. Reporter stated that the patient began to experience itching and then began breaking out in hives. Her tongue swelled and "it was that thick, dry prickly tongue, and she became heavy chested but not short of breath". The medical assistant reported that the patient received epinephrine 0.4ml immediately and "was sent to the emergency room". At the time of reporting the patient status was unknown. Almost immediately allergic reaction to the neomycin component of the vaccine was considered to be immediately life-threatening and other important medical event. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Tongue disorder, Tongue dry, Urticaria
Clinical narrative: Information has been received from a Medical Assistant concerning a 36 year old female patient with "asthma years ago", allergic reaction to BENADRYL, neomycin, KEFLEX, CIPRO, loratadine and penicillin allergy, who on 24-MAY-2012 was vaccinated with a dose of MMR II (lot#, dose and route not reported). Concomitant therapy included tuberculin purified protein derivative, received on 22-MAY-2012 (reported as "received PPD two days ago"). It was reported that on 24-MAY-2012 after vaccination the patient almost immediately had an allergic reaction to the neomycin component of the vaccine. Reporter stated that the patient began to experience itching and then began breaking out in hives. Her tongue swelled and "it was that thick, dry prickly tongue, and she became heavy chested but not short of breath". The medical assistant reported that the patient received epinephrine 0.4ml immediately and "was sent to the emergency room". At the time of reporting the patient status was unknown. Almost immediately allergic reaction to the neomycin component of the vaccine was considered to be immediately life-threatening and other important medical event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event, Blood mercury abnormal, Life support
Clinical narrative: Information has been received from a pharmacist concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (site, dose and lot# not reported). No other vaccines were administered on the same date. It was reported that the pharmacist heard about this adverse experienced from a mom of a patient who was vaccinated with GARDASIL. She said the mom told her that after her daughter got vaccinated at a physician's office, the daughter had a serious adverse event and ended up in the hospital on life support. They were treating her for extremely high levels of mercury in her blood stream. This happened right after she received the GARDASIL vaccine. Extremely high levels of mercury in her blood stream were considered to be significant disability and life threatening by the reporter. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Arm red, swollen warm treated with KEFLEX 500mg BID.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Gaze palsy, Hallucination, auditory, Musculoskeletal stiffness, Seizure like phenomena
Clinical narrative: Patient had mild seizure like activity eyes rolled back of head, body was stiff. Pt says she heard music episode lasted about 30 mins.
Age: 1.1
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Scab, Skin lesion
Clinical narrative: Mother stated 4 lesions on child's face on 5/26/12 that were raised. Next day they were fluid filled & several new lesions on abdomen. Next day after that 2 lesions found on (L) arm - all lesions progressed similarly - crusted & dried. No other symptoms. Child recovered w/o any further problems.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: Please see attached APF.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Pt. had 1st GARDASIL injection 5/29/12 had itchy rash starting early AM 5/30/12 - seen in office & assessed by Dr as hives - possible reaction to injection.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Vaccination site inflammation
Clinical narrative: Area of vaccination become red and inflamed. Patient reported to pharmacist on Friday 5/25/12 if normal Pharmacist told pt. reaction to vaccine on 5/26/12, Pt. treated by doctor for cellulitis Pharmacist contacted pt. on 5/29 patient doing fine.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Disorientation, Malaise, Muscle rigidity, Pallor
Clinical narrative: Administered MCV4 (R) delt followed by Hep A (L) delt. Pt became disoriented, rigid, ashen x 30-40 seconds. Relaxed, responded then developed same sx x 30-40 sec. EMTs called. Pt remained ashen in color but responsive. Stated he did not feel well. Transported to local ER.
Age: 42.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, pain, swelling, and "knot" left upper arm. Pt instructed to apply ice to site, and return to clinic pm.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Cellulitis
Clinical narrative: Localized cellulitis vs imm reaction pt put on Cephalexin.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dry skin, Injection site erythema, Injection site swelling, Pruritus, Skin warm
Clinical narrative: SWELLING AND REDNESS CONTINUE TO INCREASE IN SIZE PER PATIENT. PATIENT STATES AREA IS ITCHY. REDNESS AND SWELLING NOTED AT SITE OF INJECTION, NO FEVERS. SKIN WARM AND DRY AS TO ADJUNCT SKIN.
Age: 90.0
Sex: F
Vaccine: VARCEL
Symptoms: Phlebitis
Clinical narrative: Phlebitis left arm.
Age: 22.0
Sex: M
Vaccine: YF
Symptoms: Back pain, Mobility decreased
Clinical narrative: Mild lower back pain over the preceding two day dramatically worsened to the point of rendering me nearly immobile. This serious back pain lasted for ~4 days, slowly improving.