chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.01
Sex: F
Vaccine: HEP, HIBV, DTAP, HEP, HIBV, MMR
Symptoms: Hypotonia, Insomnia, Laboratory test abnormal, Mental retardation severity unspecified, Nervous system disorder
Clinical narrative: This case was considered medically important.  Medical records were received from an attorney a female patient who received the fourth dose of Hib-Titer vaccine (haemophilus b conjugate vaccine (diphtheria crm 197 protein conjugate injection) along with the four dose of Tripedia (diphtheria/tetanus toxoid/acellular Pertussis vaccine), the patient developed pervasive development disorder.  MEDICAL HISTORY: The patient's concurrent illness include familial risk factor (father: depression, intermittent explosive disorder, possible seizures), familial risk factor (half-sister) attention deficit disorder, emotional and behavioral problems), familial risk factor (father's brother: seizure in childhood with behavioral problems, brain damage), familial risk factor (father's sister: depression), familial risk factor (paternal grandmother: depression), familial risk factor (mother's brother: depression) and familial risk factor (cousin, mother's nephew: manic depressive illness) with a past history of varicella (at 18 months of age).  PRODUCT DETAILS: Indication for Hib-Titer vaccine was immunization.  Product was administered on 27-Jan-1995.  Dose regimen was 1 time per day.  Additional suspect vaccines included Tripedia (diptheria/tetanus toxoid/accelular Pertussis vaccine), Diphtheria and Tetanus toxoids and Pertussis, Poliovirus vaccine live oral, M-M-R (measles, mumps and rubella vaccine), Hepatitis B vaccine, Recombivax-Hb (hepatitis B vaccine) and Diphtheria/Tetanus toxoid/acellular Pertussis vaccine (diphtheria/tetanus toxoid/acellular Pertussis vaccine).  CONCOMITANT THERAPY: Concomitant medications were not reported.  EVENT DETAILS: On an unspecified date, at the age of 12 months, the patient received the fourth dose of Hib-Titer vaccine along with other childhood vaccines.  On an unspecified date, the patient developed pervasive developmental disorder (autism spectrum disorder).  There were no delays noted in the first year of age.  The child crawled between nine months to one year and did not walk until 18 months of age. At one year of age, the patient said "mama".  At two years, the child said a few words, which were lost at three years.  At the age of two years, the child began to scream for 5 to 10 minutes for no known reason.  At the age of four years, the child made stereotyped clucking sounds, scratched others or herself, had self stimulatory hand waving behaviors, which were made when left to herself, waved her hands in front of her face, could follow simple instructions, and had excellent hand use.  It was unknown if the patient recovered from the event.  TEST RESULTS: blood lead (results: 3 ug/dl) was done on 03-Jul-1996, blood lead (results: 5 ug/dl) and DNA test for fragile X (results: pending) were done on 23-Jan-1998.  No additional information was available at the time of this report. (OMIC)
Age: 1.01
Sex: F
Vaccine: HEP, HIBV, DTAP, HEP, HIBV, MMR
Symptoms: Psychomotor hyperactivity, Screaming, Speech disorder, Staring, Tremor
Clinical narrative: This case was considered medically important.  Medical records were received from an attorney a female patient who received the fourth dose of Hib-Titer vaccine (haemophilus b conjugate vaccine (diphtheria crm 197 protein conjugate injection) along with the four dose of Tripedia (diphtheria/tetanus toxoid/acellular Pertussis vaccine), the patient developed pervasive development disorder.  MEDICAL HISTORY: The patient's concurrent illness include familial risk factor (father: depression, intermittent explosive disorder, possible seizures), familial risk factor (half-sister) attention deficit disorder, emotional and behavioral problems), familial risk factor (father's brother: seizure in childhood with behavioral problems, brain damage), familial risk factor (father's sister: depression), familial risk factor (paternal grandmother: depression), familial risk factor (mother's brother: depression) and familial risk factor (cousin, mother's nephew: manic depressive illness) with a past history of varicella (at 18 months of age).  PRODUCT DETAILS: Indication for Hib-Titer vaccine was immunization.  Product was administered on 27-Jan-1995.  Dose regimen was 1 time per day.  Additional suspect vaccines included Tripedia (diptheria/tetanus toxoid/accelular Pertussis vaccine), Diphtheria and Tetanus toxoids and Pertussis, Poliovirus vaccine live oral, M-M-R (measles, mumps and rubella vaccine), Hepatitis B vaccine, Recombivax-Hb (hepatitis B vaccine) and Diphtheria/Tetanus toxoid/acellular Pertussis vaccine (diphtheria/tetanus toxoid/acellular Pertussis vaccine).  CONCOMITANT THERAPY: Concomitant medications were not reported.  EVENT DETAILS: On an unspecified date, at the age of 12 months, the patient received the fourth dose of Hib-Titer vaccine along with other childhood vaccines.  On an unspecified date, the patient developed pervasive developmental disorder (autism spectrum disorder).  There were no delays noted in the first year of age.  The child crawled between nine months to one year and did not walk until 18 months of age. At one year of age, the patient said "mama".  At two years, the child said a few words, which were lost at three years.  At the age of two years, the child began to scream for 5 to 10 minutes for no known reason.  At the age of four years, the child made stereotyped clucking sounds, scratched others or herself, had self stimulatory hand waving behaviors, which were made when left to herself, waved her hands in front of her face, could follow simple instructions, and had excellent hand use.  It was unknown if the patient recovered from the event.  TEST RESULTS: blood lead (results: 3 ug/dl) was done on 03-Jul-1996, blood lead (results: 5 ug/dl) and DNA test for fragile X (results: pending) were done on 23-Jan-1998.  No additional information was available at the time of this report. (OMIC)
Age: 1.01
Sex: F
Vaccine: HEP, HIBV, DTAP, HEP, HIBV, MMR
Symptoms: Autism
Clinical narrative: This case was considered medically important.  Medical records were received from an attorney a female patient who received the fourth dose of Hib-Titer vaccine (haemophilus b conjugate vaccine (diphtheria crm 197 protein conjugate injection) along with the four dose of Tripedia (diphtheria/tetanus toxoid/acellular Pertussis vaccine), the patient developed pervasive development disorder.  MEDICAL HISTORY: The patient's concurrent illness include familial risk factor (father: depression, intermittent explosive disorder, possible seizures), familial risk factor (half-sister) attention deficit disorder, emotional and behavioral problems), familial risk factor (father's brother: seizure in childhood with behavioral problems, brain damage), familial risk factor (father's sister: depression), familial risk factor (paternal grandmother: depression), familial risk factor (mother's brother: depression) and familial risk factor (cousin, mother's nephew: manic depressive illness) with a past history of varicella (at 18 months of age).  PRODUCT DETAILS: Indication for Hib-Titer vaccine was immunization.  Product was administered on 27-Jan-1995.  Dose regimen was 1 time per day.  Additional suspect vaccines included Tripedia (diptheria/tetanus toxoid/accelular Pertussis vaccine), Diphtheria and Tetanus toxoids and Pertussis, Poliovirus vaccine live oral, M-M-R (measles, mumps and rubella vaccine), Hepatitis B vaccine, Recombivax-Hb (hepatitis B vaccine) and Diphtheria/Tetanus toxoid/acellular Pertussis vaccine (diphtheria/tetanus toxoid/acellular Pertussis vaccine).  CONCOMITANT THERAPY: Concomitant medications were not reported.  EVENT DETAILS: On an unspecified date, at the age of 12 months, the patient received the fourth dose of Hib-Titer vaccine along with other childhood vaccines.  On an unspecified date, the patient developed pervasive developmental disorder (autism spectrum disorder).  There were no delays noted in the first year of age.  The child crawled between nine months to one year and did not walk until 18 months of age. At one year of age, the patient said "mama".  At two years, the child said a few words, which were lost at three years.  At the age of two years, the child began to scream for 5 to 10 minutes for no known reason.  At the age of four years, the child made stereotyped clucking sounds, scratched others or herself, had self stimulatory hand waving behaviors, which were made when left to herself, waved her hands in front of her face, could follow simple instructions, and had excellent hand use.  It was unknown if the patient recovered from the event.  TEST RESULTS: blood lead (results: 3 ug/dl) was done on 03-Jul-1996, blood lead (results: 5 ug/dl) and DNA test for fragile X (results: pending) were done on 23-Jan-1998.  No additional information was available at the time of this report. (OMIC)
Age: 3.0
Sex: M
Vaccine: HEP, HIBV
Symptoms: Abnormal behaviour, Aggression, Anger, Antisocial behaviour, Autism
Clinical narrative: This case was considered medically important (OMIC). Medical records regarding Hib Vaccine (manufacturer unk) were received from an attorney regarding a male pt who received the third dose on 11/2/1995 at 3 years of age. On an unspecified date, the child developed encephalopathy and autism. Relevant medical history was not provided. Indication for Hib was immunization. Product was administered on 11/2/95. Dose regimen was 1 dose 1 time per day. Additional suspect vaccines included DTP. Polio, Hep B and MMR. Concomitant medications were not reported. On 11/2895, the pt received the third dose of Hib. On an unspecified date, the pt experienced encephalopathy characterized by language delays, social interactive impairments, and abnormal symbolic play development. On an unspecified date, the pt was diagnosed with autism. It was unk if the pt recovered from the events. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: HEP, HIBV
Symptoms: Blood pressure increased, Cognitive disorder, Coordination abnormal, Crying, Drug abuser
Clinical narrative: This case was considered medically important (OMIC). Medical records regarding Hib Vaccine (manufacturer unk) were received from an attorney regarding a male pt who received the third dose on 11/2/1995 at 3 years of age. On an unspecified date, the child developed encephalopathy and autism. Relevant medical history was not provided. Indication for Hib was immunization. Product was administered on 11/2/95. Dose regimen was 1 dose 1 time per day. Additional suspect vaccines included DTP. Polio, Hep B and MMR. Concomitant medications were not reported. On 11/2895, the pt received the third dose of Hib. On an unspecified date, the pt experienced encephalopathy characterized by language delays, social interactive impairments, and abnormal symbolic play development. On an unspecified date, the pt was diagnosed with autism. It was unk if the pt recovered from the events. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: HEP, HIBV
Symptoms: Drug toxicity, Electroencephalogram normal, Encephalopathy, Hypokinesia, Insomnia
Clinical narrative: This case was considered medically important (OMIC). Medical records regarding Hib Vaccine (manufacturer unk) were received from an attorney regarding a male pt who received the third dose on 11/2/1995 at 3 years of age. On an unspecified date, the child developed encephalopathy and autism. Relevant medical history was not provided. Indication for Hib was immunization. Product was administered on 11/2/95. Dose regimen was 1 dose 1 time per day. Additional suspect vaccines included DTP. Polio, Hep B and MMR. Concomitant medications were not reported. On 11/2895, the pt received the third dose of Hib. On an unspecified date, the pt experienced encephalopathy characterized by language delays, social interactive impairments, and abnormal symbolic play development. On an unspecified date, the pt was diagnosed with autism. It was unk if the pt recovered from the events. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: HEP, HIBV
Symptoms: Mental impairment, Mental retardation severity unspecified, Nervous system disorder, Nuclear magnetic resonance imaging brain normal, Obsessive-compulsive disorder
Clinical narrative: This case was considered medically important (OMIC). Medical records regarding Hib Vaccine (manufacturer unk) were received from an attorney regarding a male pt who received the third dose on 11/2/1995 at 3 years of age. On an unspecified date, the child developed encephalopathy and autism. Relevant medical history was not provided. Indication for Hib was immunization. Product was administered on 11/2/95. Dose regimen was 1 dose 1 time per day. Additional suspect vaccines included DTP. Polio, Hep B and MMR. Concomitant medications were not reported. On 11/2895, the pt received the third dose of Hib. On an unspecified date, the pt experienced encephalopathy characterized by language delays, social interactive impairments, and abnormal symbolic play development. On an unspecified date, the pt was diagnosed with autism. It was unk if the pt recovered from the events. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: HEP, HIBV
Symptoms: Otitis media, Pollakiuria, Pyrexia, Speech disorder
Clinical narrative: This case was considered medically important (OMIC). Medical records regarding Hib Vaccine (manufacturer unk) were received from an attorney regarding a male pt who received the third dose on 11/2/1995 at 3 years of age. On an unspecified date, the child developed encephalopathy and autism. Relevant medical history was not provided. Indication for Hib was immunization. Product was administered on 11/2/95. Dose regimen was 1 dose 1 time per day. Additional suspect vaccines included DTP. Polio, Hep B and MMR. Concomitant medications were not reported. On 11/2895, the pt received the third dose of Hib. On an unspecified date, the pt experienced encephalopathy characterized by language delays, social interactive impairments, and abnormal symbolic play development. On an unspecified date, the pt was diagnosed with autism. It was unk if the pt recovered from the events. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: HEP, HIBV
Symptoms: Abnormal behaviour, Antisocial behaviour, Autism, Blood pressure increased, Encephalopathy
Clinical narrative: This case was considered medically important (OMIC). Medical records regarding Hib Vaccine (manufacturer unk) were received from an attorney regarding a male pt who received the third dose on 11/2/1995 at 3 years of age. On an unspecified date, the child developed encephalopathy and autism. Relevant medical history was not provided. Indication for Hib was immunization. Product was administered on 11/2/95. Dose regimen was 1 dose 1 time per day. Additional suspect vaccines included DTP. Polio, Hep B and MMR. Concomitant medications were not reported. On 11/2895, the pt received the third dose of Hib. On an unspecified date, the pt experienced encephalopathy characterized by language delays, social interactive impairments, and abnormal symbolic play development. On an unspecified date, the pt was diagnosed with autism. It was unk if the pt recovered from the events. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: HEP, HIBV
Symptoms: Speech disorder
Clinical narrative: This case was considered medically important (OMIC). Medical records regarding Hib Vaccine (manufacturer unk) were received from an attorney regarding a male pt who received the third dose on 11/2/1995 at 3 years of age. On an unspecified date, the child developed encephalopathy and autism. Relevant medical history was not provided. Indication for Hib was immunization. Product was administered on 11/2/95. Dose regimen was 1 dose 1 time per day. Additional suspect vaccines included DTP. Polio, Hep B and MMR. Concomitant medications were not reported. On 11/2895, the pt received the third dose of Hib. On an unspecified date, the pt experienced encephalopathy characterized by language delays, social interactive impairments, and abnormal symbolic play development. On an unspecified date, the pt was diagnosed with autism. It was unk if the pt recovered from the events. No additional information was available at the time of this report.
Age: 1.31
Sex: F
Vaccine: DTAPH, HIBV, OPV, HIBV, MMR
Symptoms: Asthma, Autism, Bronchitis acute, Cellulitis, Conjunctivitis
Clinical narrative: This case was considered medically important (OMIC). Medical records regarding Hib Titer vaccine were received from an attorney regarding a female pt who received the fourth dose on 4/10/1992 along with the first dose of MMR II at 15 months of age. On an unspecified date in 1992, at the age of 18 months, the child was diagnosed with autism. On 11/26/1993, the child was diagnosed with autistic spectrum disorder. On 18/1997, the pt experienced encephalopathy. Mother had a slight fever toward the end of the first trimester while pregnant with pt. The pts concurrent illness included familial risk factor (two brothers, ADHD), familial risk factor (maternal first cousin, high functioning autism), familial risk factor 9maternal aunt, learning difficulties), familial risk factor (older brother, similar regression age 15-18 months, although completely turned around per mother). familial risk factor (paternal great uncle epilepsy) and familial risk factor (paternal great uncle Schizophrenia) with a past history of jaundice (mild at birth, did not require light therapy). The pt previously experienced psychomotor hyperactivity and no therapeutic response while taking Prozac (fluoxetine hydrochloride) and a drug like effect while taking Risperdal (risperidone). Indication for Hib Titer vaccine was immunization. Product was administered on 8/10/1992. Dose regimen was 1 dose 1 time per day (IM). Additional suspect medication included MMR II, Tripedia, DTap, DTap/polio. Concomitant medications were not reported. On 8/10/92, the pt received the fourth dose of Hib Titer along with another vaccine. Between 16 and 18 months of age, the child experienced language regression, did not make gestures, did not respond to commands and showed a disinterest in her older brother and maternal grandmother. On an unspecified date, at 18 months of age, the pt was diagnosed with autism. On 11/26/93, the child wad diagnosed with autistic spectrum disorder characterized by a severe communication disorder with decreased eye contact and social relatedness. On 11/8/97, the pt was diagnosed with encephalopathy characterized by disorder of language, social interactivity, and symbolic play impairment. On 8/28/01, the child was assessed as having autism with significant behavioral difficulties. Behavior included agitation, raging, hitting herself in the head, hurting herself, hyperactivity, distraction, and obsessive compulsive tendencies. Treatment included Geodon (Ziprasidone), which stopped all of her outbursts and aggressive and angry behavior that was hurtful to her. However, the child remained somewhat unstable with significant amounts of distractibility. The physician recommended that the pt have additional treatment with Concerta. It was unk if the pt recovered from the events. No additional information was available at the time of this report.
Age: 1.31
Sex: F
Vaccine: DTAPH, HIBV, OPV, HIBV, MMR
Symptoms: Croup infectious, Dermal cyst, Folliculitis, Gastrointestinal disorder, Oesophageal stenosis
Clinical narrative: This case was considered medically important (OMIC). Medical records regarding Hib Titer vaccine were received from an attorney regarding a female pt who received the fourth dose on 4/10/1992 along with the first dose of MMR II at 15 months of age. On an unspecified date in 1992, at the age of 18 months, the child was diagnosed with autism. On 11/26/1993, the child was diagnosed with autistic spectrum disorder. On 18/1997, the pt experienced encephalopathy. Mother had a slight fever toward the end of the first trimester while pregnant with pt. The pts concurrent illness included familial risk factor (two brothers, ADHD), familial risk factor (maternal first cousin, high functioning autism), familial risk factor 9maternal aunt, learning difficulties), familial risk factor (older brother, similar regression age 15-18 months, although completely turned around per mother). familial risk factor (paternal great uncle epilepsy) and familial risk factor (paternal great uncle Schizophrenia) with a past history of jaundice (mild at birth, did not require light therapy). The pt previously experienced psychomotor hyperactivity and no therapeutic response while taking Prozac (fluoxetine hydrochloride) and a drug like effect while taking Risperdal (risperidone). Indication for Hib Titer vaccine was immunization. Product was administered on 8/10/1992. Dose regimen was 1 dose 1 time per day (IM). Additional suspect medication included MMR II, Tripedia, DTap, DTap/polio. Concomitant medications were not reported. On 8/10/92, the pt received the fourth dose of Hib Titer along with another vaccine. Between 16 and 18 months of age, the child experienced language regression, did not make gestures, did not respond to commands and showed a disinterest in her older brother and maternal grandmother. On an unspecified date, at 18 months of age, the pt was diagnosed with autism. On 11/26/93, the child wad diagnosed with autistic spectrum disorder characterized by a severe communication disorder with decreased eye contact and social relatedness. On 11/8/97, the pt was diagnosed with encephalopathy characterized by disorder of language, social interactivity, and symbolic play impairment. On 8/28/01, the child was assessed as having autism with significant behavioral difficulties. Behavior included agitation, raging, hitting herself in the head, hurting herself, hyperactivity, distraction, and obsessive compulsive tendencies. Treatment included Geodon (Ziprasidone), which stopped all of her outbursts and aggressive and angry behavior that was hurtful to her. However, the child remained somewhat unstable with significant amounts of distractibility. The physician recommended that the pt have additional treatment with Concerta. It was unk if the pt recovered from the events. No additional information was available at the time of this report.
Age: 1.31
Sex: F
Vaccine: DTAPH, HIBV, OPV, HIBV, MMR
Symptoms: Otitis media, Pharyngitis, Rash, Rhinitis, Sensory disturbance
Clinical narrative: This case was considered medically important (OMIC). Medical records regarding Hib Titer vaccine were received from an attorney regarding a female pt who received the fourth dose on 4/10/1992 along with the first dose of MMR II at 15 months of age. On an unspecified date in 1992, at the age of 18 months, the child was diagnosed with autism. On 11/26/1993, the child was diagnosed with autistic spectrum disorder. On 18/1997, the pt experienced encephalopathy. Mother had a slight fever toward the end of the first trimester while pregnant with pt. The pts concurrent illness included familial risk factor (two brothers, ADHD), familial risk factor (maternal first cousin, high functioning autism), familial risk factor 9maternal aunt, learning difficulties), familial risk factor (older brother, similar regression age 15-18 months, although completely turned around per mother). familial risk factor (paternal great uncle epilepsy) and familial risk factor (paternal great uncle Schizophrenia) with a past history of jaundice (mild at birth, did not require light therapy). The pt previously experienced psychomotor hyperactivity and no therapeutic response while taking Prozac (fluoxetine hydrochloride) and a drug like effect while taking Risperdal (risperidone). Indication for Hib Titer vaccine was immunization. Product was administered on 8/10/1992. Dose regimen was 1 dose 1 time per day (IM). Additional suspect medication included MMR II, Tripedia, DTap, DTap/polio. Concomitant medications were not reported. On 8/10/92, the pt received the fourth dose of Hib Titer along with another vaccine. Between 16 and 18 months of age, the child experienced language regression, did not make gestures, did not respond to commands and showed a disinterest in her older brother and maternal grandmother. On an unspecified date, at 18 months of age, the pt was diagnosed with autism. On 11/26/93, the child wad diagnosed with autistic spectrum disorder characterized by a severe communication disorder with decreased eye contact and social relatedness. On 11/8/97, the pt was diagnosed with encephalopathy characterized by disorder of language, social interactivity, and symbolic play impairment. On 8/28/01, the child was assessed as having autism with significant behavioral difficulties. Behavior included agitation, raging, hitting herself in the head, hurting herself, hyperactivity, distraction, and obsessive compulsive tendencies. Treatment included Geodon (Ziprasidone), which stopped all of her outbursts and aggressive and angry behavior that was hurtful to her. However, the child remained somewhat unstable with significant amounts of distractibility. The physician recommended that the pt have additional treatment with Concerta. It was unk if the pt recovered from the events. No additional information was available at the time of this report.
Age: 1.31
Sex: F
Vaccine: DTAPH, HIBV, OPV, HIBV, MMR
Symptoms: Skin ulcer, Upper respiratory tract infection, Vaginal infection, Viral infection
Clinical narrative: This case was considered medically important (OMIC). Medical records regarding Hib Titer vaccine were received from an attorney regarding a female pt who received the fourth dose on 4/10/1992 along with the first dose of MMR II at 15 months of age. On an unspecified date in 1992, at the age of 18 months, the child was diagnosed with autism. On 11/26/1993, the child was diagnosed with autistic spectrum disorder. On 18/1997, the pt experienced encephalopathy. Mother had a slight fever toward the end of the first trimester while pregnant with pt. The pts concurrent illness included familial risk factor (two brothers, ADHD), familial risk factor (maternal first cousin, high functioning autism), familial risk factor 9maternal aunt, learning difficulties), familial risk factor (older brother, similar regression age 15-18 months, although completely turned around per mother). familial risk factor (paternal great uncle epilepsy) and familial risk factor (paternal great uncle Schizophrenia) with a past history of jaundice (mild at birth, did not require light therapy). The pt previously experienced psychomotor hyperactivity and no therapeutic response while taking Prozac (fluoxetine hydrochloride) and a drug like effect while taking Risperdal (risperidone). Indication for Hib Titer vaccine was immunization. Product was administered on 8/10/1992. Dose regimen was 1 dose 1 time per day (IM). Additional suspect medication included MMR II, Tripedia, DTap, DTap/polio. Concomitant medications were not reported. On 8/10/92, the pt received the fourth dose of Hib Titer along with another vaccine. Between 16 and 18 months of age, the child experienced language regression, did not make gestures, did not respond to commands and showed a disinterest in her older brother and maternal grandmother. On an unspecified date, at 18 months of age, the pt was diagnosed with autism. On 11/26/93, the child wad diagnosed with autistic spectrum disorder characterized by a severe communication disorder with decreased eye contact and social relatedness. On 11/8/97, the pt was diagnosed with encephalopathy characterized by disorder of language, social interactivity, and symbolic play impairment. On 8/28/01, the child was assessed as having autism with significant behavioral difficulties. Behavior included agitation, raging, hitting herself in the head, hurting herself, hyperactivity, distraction, and obsessive compulsive tendencies. Treatment included Geodon (Ziprasidone), which stopped all of her outbursts and aggressive and angry behavior that was hurtful to her. However, the child remained somewhat unstable with significant amounts of distractibility. The physician recommended that the pt have additional treatment with Concerta. It was unk if the pt recovered from the events. No additional information was available at the time of this report.
Age: 1.31
Sex: F
Vaccine: DTAPH, HIBV, OPV, HIBV, MMR
Symptoms: Abnormal behaviour, Affect lability, Aggression, Agitation, Anger
Clinical narrative: This case was considered medically important (OMIC). Medical records regarding Hib Titer vaccine were received from an attorney regarding a female pt who received the fourth dose on 4/10/1992 along with the first dose of MMR II at 15 months of age. On an unspecified date in 1992, at the age of 18 months, the child was diagnosed with autism. On 11/26/1993, the child was diagnosed with autistic spectrum disorder. On 18/1997, the pt experienced encephalopathy. Mother had a slight fever toward the end of the first trimester while pregnant with pt. The pts concurrent illness included familial risk factor (two brothers, ADHD), familial risk factor (maternal first cousin, high functioning autism), familial risk factor 9maternal aunt, learning difficulties), familial risk factor (older brother, similar regression age 15-18 months, although completely turned around per mother). familial risk factor (paternal great uncle epilepsy) and familial risk factor (paternal great uncle Schizophrenia) with a past history of jaundice (mild at birth, did not require light therapy). The pt previously experienced psychomotor hyperactivity and no therapeutic response while taking Prozac (fluoxetine hydrochloride) and a drug like effect while taking Risperdal (risperidone). Indication for Hib Titer vaccine was immunization. Product was administered on 8/10/1992. Dose regimen was 1 dose 1 time per day (IM). Additional suspect medication included MMR II, Tripedia, DTap, DTap/polio. Concomitant medications were not reported. On 8/10/92, the pt received the fourth dose of Hib Titer along with another vaccine. Between 16 and 18 months of age, the child experienced language regression, did not make gestures, did not respond to commands and showed a disinterest in her older brother and maternal grandmother. On an unspecified date, at 18 months of age, the pt was diagnosed with autism. On 11/26/93, the child wad diagnosed with autistic spectrum disorder characterized by a severe communication disorder with decreased eye contact and social relatedness. On 11/8/97, the pt was diagnosed with encephalopathy characterized by disorder of language, social interactivity, and symbolic play impairment. On 8/28/01, the child was assessed as having autism with significant behavioral difficulties. Behavior included agitation, raging, hitting herself in the head, hurting herself, hyperactivity, distraction, and obsessive compulsive tendencies. Treatment included Geodon (Ziprasidone), which stopped all of her outbursts and aggressive and angry behavior that was hurtful to her. However, the child remained somewhat unstable with significant amounts of distractibility. The physician recommended that the pt have additional treatment with Concerta. It was unk if the pt recovered from the events. No additional information was available at the time of this report.
Age: 1.31
Sex: F
Vaccine: DTAPH, HIBV, OPV, HIBV, MMR
Symptoms: Antisocial behaviour, Autism, Coma, Encephalopathy, Gaze palsy
Clinical narrative: This case was considered medically important (OMIC). Medical records regarding Hib Titer vaccine were received from an attorney regarding a female pt who received the fourth dose on 4/10/1992 along with the first dose of MMR II at 15 months of age. On an unspecified date in 1992, at the age of 18 months, the child was diagnosed with autism. On 11/26/1993, the child was diagnosed with autistic spectrum disorder. On 18/1997, the pt experienced encephalopathy. Mother had a slight fever toward the end of the first trimester while pregnant with pt. The pts concurrent illness included familial risk factor (two brothers, ADHD), familial risk factor (maternal first cousin, high functioning autism), familial risk factor 9maternal aunt, learning difficulties), familial risk factor (older brother, similar regression age 15-18 months, although completely turned around per mother). familial risk factor (paternal great uncle epilepsy) and familial risk factor (paternal great uncle Schizophrenia) with a past history of jaundice (mild at birth, did not require light therapy). The pt previously experienced psychomotor hyperactivity and no therapeutic response while taking Prozac (fluoxetine hydrochloride) and a drug like effect while taking Risperdal (risperidone). Indication for Hib Titer vaccine was immunization. Product was administered on 8/10/1992. Dose regimen was 1 dose 1 time per day (IM). Additional suspect medication included MMR II, Tripedia, DTap, DTap/polio. Concomitant medications were not reported. On 8/10/92, the pt received the fourth dose of Hib Titer along with another vaccine. Between 16 and 18 months of age, the child experienced language regression, did not make gestures, did not respond to commands and showed a disinterest in her older brother and maternal grandmother. On an unspecified date, at 18 months of age, the pt was diagnosed with autism. On 11/26/93, the child wad diagnosed with autistic spectrum disorder characterized by a severe communication disorder with decreased eye contact and social relatedness. On 11/8/97, the pt was diagnosed with encephalopathy characterized by disorder of language, social interactivity, and symbolic play impairment. On 8/28/01, the child was assessed as having autism with significant behavioral difficulties. Behavior included agitation, raging, hitting herself in the head, hurting herself, hyperactivity, distraction, and obsessive compulsive tendencies. Treatment included Geodon (Ziprasidone), which stopped all of her outbursts and aggressive and angry behavior that was hurtful to her. However, the child remained somewhat unstable with significant amounts of distractibility. The physician recommended that the pt have additional treatment with Concerta. It was unk if the pt recovered from the events. No additional information was available at the time of this report.
Age: 1.31
Sex: F
Vaccine: DTAPH, HIBV, OPV, HIBV, MMR
Symptoms: Obsessive-compulsive disorder, Psychomotor hyperactivity, Speech disorder
Clinical narrative: This case was considered medically important (OMIC). Medical records regarding Hib Titer vaccine were received from an attorney regarding a female pt who received the fourth dose on 4/10/1992 along with the first dose of MMR II at 15 months of age. On an unspecified date in 1992, at the age of 18 months, the child was diagnosed with autism. On 11/26/1993, the child was diagnosed with autistic spectrum disorder. On 18/1997, the pt experienced encephalopathy. Mother had a slight fever toward the end of the first trimester while pregnant with pt. The pts concurrent illness included familial risk factor (two brothers, ADHD), familial risk factor (maternal first cousin, high functioning autism), familial risk factor 9maternal aunt, learning difficulties), familial risk factor (older brother, similar regression age 15-18 months, although completely turned around per mother). familial risk factor (paternal great uncle epilepsy) and familial risk factor (paternal great uncle Schizophrenia) with a past history of jaundice (mild at birth, did not require light therapy). The pt previously experienced psychomotor hyperactivity and no therapeutic response while taking Prozac (fluoxetine hydrochloride) and a drug like effect while taking Risperdal (risperidone). Indication for Hib Titer vaccine was immunization. Product was administered on 8/10/1992. Dose regimen was 1 dose 1 time per day (IM). Additional suspect medication included MMR II, Tripedia, DTap, DTap/polio. Concomitant medications were not reported. On 8/10/92, the pt received the fourth dose of Hib Titer along with another vaccine. Between 16 and 18 months of age, the child experienced language regression, did not make gestures, did not respond to commands and showed a disinterest in her older brother and maternal grandmother. On an unspecified date, at 18 months of age, the pt was diagnosed with autism. On 11/26/93, the child wad diagnosed with autistic spectrum disorder characterized by a severe communication disorder with decreased eye contact and social relatedness. On 11/8/97, the pt was diagnosed with encephalopathy characterized by disorder of language, social interactivity, and symbolic play impairment. On 8/28/01, the child was assessed as having autism with significant behavioral difficulties. Behavior included agitation, raging, hitting herself in the head, hurting herself, hyperactivity, distraction, and obsessive compulsive tendencies. Treatment included Geodon (Ziprasidone), which stopped all of her outbursts and aggressive and angry behavior that was hurtful to her. However, the child remained somewhat unstable with significant amounts of distractibility. The physician recommended that the pt have additional treatment with Concerta. It was unk if the pt recovered from the events. No additional information was available at the time of this report.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a certified medical assistant concerning a 4-year-old female who in approximately 2002 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+0 rubella virus vaccine live.  In approximately 2002, suddenly after the vaccine was given, the patient died.  The child's autopsy was inconclusive.  No other information was available.  There was no product quality complaint.  The event was also considered  to be immediately life-threatening by the reporter.  Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperventilation, Tremor
Clinical narrative: Information has been received from a physician concerning a 70 year old female with Alzheimer's disease who on in  September 2006 was vaccinated with a dose of varicella zoster vaccine live.  The patient experienced tremors and hyperventilated when receiving the vaccine and the patient was taken to the emergency room.  Subsequently the patient recovered.  The physician believed that "the experience was more anxiety related than a reaction to the vaccine.  There was no product quality complaint involved.  The patient's experiences were considered to be an important medical events.  Additional information has been requested. (OMIC)
Sex: M
Vaccine: HIBV
Symptoms: Autism, Convulsion, Mental retardation severity unspecified, Sleep disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib vaccine (manufacturer unk) was received from medical records via an attorney regarding a male pt who experienced development disorder, left temporal lobe seizures and autism. The pt received a dose on an unspecified date. The pts concurrent illness included sleep disorder. Indication for Hib conjugate vaccine injection was immunisation. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. Medical records received from an attorney, alleged that on unspecified dated, the pt experienced pervasive development disorder, left temporal lobe seizures (convulsion) and autism. The pts outcome is unk. No additional information was available at the time of this report.
Age: 83.0
Sex: M
Vaccine: RAB
Symptoms: Syncope
Clinical narrative: Syncopal episode (Syncope). A man, born on 4/22/23, was vaccinated for the 4th time with RabAvert, batch no, unknown, on 10/2/06. He has subsequently been hospitalised for a syncopal episode attributed to his past history of atrial fibrillation. Medical plan included ablation therapy for treatment of arrhythmia and pacemaker placement. Pt still in hospital at time of call 4/4/06. Caller did not feel that the hospitalisation could be attributed to the RabAvert vaccination.
Age: 1.02
Sex: M
Vaccine: FLU3, MMRV, PNC
Symptoms: Lethargy, Listless, Opisthotonus, Pallor, Petechiae
Clinical narrative: Fever listless/lethargic: opisthotonus nuthal rifiche petechiae neck and arm where tourniquet was.  No local reaction to shots.  10/27/06 Received medical records from second hospital which revealed patient was seen in ER on 10/5 & experienced fever (102.2 ax), lethargy & decreased appetite.  Had been seen by PCP on 10/5 & LP was done in office & sent to first hospital. Transferred to second hospital to r/o sepsis. Petecchaie noted on neck & face & initial physician noted opisthotonos & nuchal rigidity.  Final dx: febrile reaction to immunizations. 10/31/06 Received medical records from first hospital which reveal patient admitted 10/5/06 with fever & listlessness.  Presentation was limp, pale, irritable with stiff neck & fever of 101.8ax s/p vax day before. 11/13/06 Received medical record from PCP for office visit 10/4/06 day of vax which revealed patient was healthy with only redundant foreskin noted as health concern & was referred to urologist./ss
Age: 1.02
Sex: M
Vaccine: FLU3, MMRV, PNC
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Fever listless/lethargic: opisthotonus nuthal rifiche petechiae neck and arm where tourniquet was.  No local reaction to shots.  10/27/06 Received medical records from second hospital which revealed patient was seen in ER on 10/5 & experienced fever (102.2 ax), lethargy & decreased appetite.  Had been seen by PCP on 10/5 & LP was done in office & sent to first hospital. Transferred to second hospital to r/o sepsis. Petecchaie noted on neck & face & initial physician noted opisthotonos & nuchal rigidity.  Final dx: febrile reaction to immunizations. 10/31/06 Received medical records from first hospital which reveal patient admitted 10/5/06 with fever & listlessness.  Presentation was limp, pale, irritable with stiff neck & fever of 101.8ax s/p vax day before. 11/13/06 Received medical record from PCP for office visit 10/4/06 day of vax which revealed patient was healthy with only redundant foreskin noted as health concern & was referred to urologist./ss
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Haematochezia, Intestinal ischaemia, Intussusception, Necrosis
Clinical narrative: Initial exam showed bloody stools, intussusception. DC DX: Intussusception. Procedure: exp. lap. with reduction of intussuception and right hemicolectomy. Taken emergently to operating room after water-soluble contrast enema was unable to reduce intussusception. Currant jelly stools starting at 8am on 9/17/06. Mass palpable at the midline of her abdomen.  Hospital course uneventful, developed rash thought to be due to Unasyn, changed to Clindamycin. Surgical pathology report: sections show extensive ischemic necrosis secondary to intussusception. Appendiceal nucosa also shows ischemic necrosis. The amount of lymphoid tissue appears to be increased. Resected margins contain viable tissue.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Haematochezia, Intussusception
Clinical narrative: Initial exam showed bloody stools, intussusception. DC DX: Intussusception. Procedure: exp. lap. with reduction of intussuception and right hemicolectomy. Taken emergently to operating room after water-soluble contrast enema was unable to reduce intussusception. Currant jelly stools starting at 8am on 9/17/06. Mass palpable at the midline of her abdomen.  Hospital course uneventful, developed rash thought to be due to Unasyn, changed to Clindamycin. Surgical pathology report: sections show extensive ischemic necrosis secondary to intussusception. Appendiceal nucosa also shows ischemic necrosis. The amount of lymphoid tissue appears to be increased. Resected margins contain viable tissue.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Haematochezia, Irritability, Screaming
Clinical narrative: Bloody mucousy stools with 7 hours of screaming and fussiness.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Haematochezia
Clinical narrative: Bloody mucousy stools with 7 hours of screaming and fussiness.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Bursitis, Shoulder pain
Clinical narrative: (L) shoulder bursitis; shoulder pain 2 weeks. Pt used Advil and ice.
Age: 28.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Chest pain, Injection site pain, Paraesthesia
Clinical narrative: 9/26/06 client received TWINRIX in right deltoid. Received ADACEL in the left deltoid. Clint complained of "tingling" in right hand and some soreness in right deltoid. Resolution in 5 minutes. 10/9/06, c/o "chest pain" which turned halted 10/6/06. Referred to ER physician for f/u.
Age: 5.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and pain at sight of injection ((L) arm).
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Pt complained that she couldn't lift or use arm the next day. Went to MD and recommended ice and pain pills for a few days and scheduled ultrasound of arm.
Age: 14.0
Sex: F
Vaccine: DTAP, MMR, MNQ
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Medication error, Pain
Clinical narrative: Pain, swelling, redness in left arm around injection site. Pt stated whole arm hurt. Pt given Augmentin 875mg 125mg, Prednisone 20mg x 5 days, and Ibuprofen 600 mg.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Ecchymosis, Erythema, Injection site erythema, Oedema, Yellow skin
Clinical narrative: Right arm no erythema injection site, yellowing skin (ecchymosis). Slight edema distal arm with mild erythema. No further treatment warranted.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Anorexia, Diarrhoea, Pyrexia, Tongue discolouration, Vomiting
Clinical narrative: Given Varicella 9/20/06 on 9/22/06 return to office, with fever, diarrhea, vomiting, streaks on tongue, won't eat or drink. Continues Motrin, advised liquids in small amounts only for 12 hours and call DR if no improvement.
Age: 22.0
Sex: F
Vaccine: TD
Symptoms: Abscess, Injection site abscess, Injection site pain
Clinical narrative: SC abscess at injection site above left deltoid. Incision and drainage performed on 9/29/06 with would culture. Pt started on Keflex 500mg QID #20. Soreness since vaccine administered, white, blood discharge since 9/28/06.
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: Herpes zoster, Unevaluable event, Viral infection
Clinical narrative: None Stated
Age: 1.25
Sex: F
Vaccine: HIBV, PNC, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile convulsion, went to ER