chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Eye pain, Fatigue, Headache, Pain
Clinical narrative: Vaccine given in am and pt developed symptoms that evening of the typical sore arm with some fatigue.  By day 2 she had pain in left shoulder to trapezius and left headache, face and eye pain.  Symptoms persist now for 8 days
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 12 x 9 cm area of induration, heat, redness, pain at injection site.
Age: 10.0
Sex: M
Vaccine: MMRV
Symptoms: Abdominal pain, Anxiety, Cardiomegaly, Diarrhoea, Difficulty in walking
Clinical narrative: 1 hour after vaccine admin pt had stomach cramps and diarrhea and was having difficulty walking. Tenderness in bilateral legs, thighs, knees, and calfs. Pain to touch on thighs and calfs. DC DX: myalgia, improved. Pain enhancement syndrome, improved. Anxiety, stable. Diarrhea, resolved.  PMH: multiple MRSA abscesses.  Presented to ER with C/O constant anterior pelvic pain with inability to walk for about a week. C/O pain on bottom of feet, lets, spinal and neck pain but denies headache, blurred vision, nausea and vomiting. Loose stools for 5 days PTA.
Age: 10.0
Sex: M
Vaccine: MMRV
Symptoms: Myalgia, Pain, Tenderness
Clinical narrative: 1 hour after vaccine admin pt had stomach cramps and diarrhea and was having difficulty walking. Tenderness in bilateral legs, thighs, knees, and calfs. Pain to touch on thighs and calfs. DC DX: myalgia, improved. Pain enhancement syndrome, improved. Anxiety, stable. Diarrhea, resolved.  PMH: multiple MRSA abscesses.  Presented to ER with C/O constant anterior pelvic pain with inability to walk for about a week. C/O pain on bottom of feet, lets, spinal and neck pain but denies headache, blurred vision, nausea and vomiting. Loose stools for 5 days PTA.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Complains of a numbness feeling in her right arm, extending from her elbow down to her right index finger on 7 Nov 05.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Chest discomfort, Dizziness, Dysphonia, Pyrexia
Clinical narrative: Vaccine given on 10/06/06 at 11:45 AM; flu-like symptoms appeared shortly thereafter and are still present (10/10/06); fever peeked at 102.5F, dizziness, chest discomfort, very weak and hoarse. Medical attention was necessary but unavailable because of weakened atate, not able to drive. Vaccine was given as part of a health clinic.
Age: 31.0
Sex: F
Vaccine: FLUN3
Symptoms: Palpitations, Somnolence, Tongue disorder
Clinical narrative: Administered Flumist vaccine at 1245-1300. Pt felt sleepy, tongue heavy and palpitations within 1 hour of administration.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Crying
Clinical narrative: Mom reported (@ 4mo well visit)crying for 48 hours within 24h after receiving 2 month immunizations. Cried > 3h inconsolably. Mom did not call office. Tylenol did not help.
Age: 0.52
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Patient received 6months immunization shot (4 shots) including dTAP at 1030AM 10/9/06. He noted to have clonic-tonic seizure around 1500 10/9/06. He was send to ER and now hospitalized for work up. He had history of 3 days temperature 100.5-100.9 per rectal. Pending for blood/stool/urine and CSF culture. Will also have MRI brain and EEG done. DC DX: post vaccination seizure.  Treated with Recephin No seizures in hospital.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Medication error
Clinical narrative: This case was reported by a pharmacist and described the occurrence of inappropriate schedule of drug administration in a 2 day old male subject who was vaccinated with Hep B vaccine (Engerix B) for prophylaxis. No significant medical history or concurrent conditions were noted in this newborn. Concurrent medications included Vitamin K. On 10/3/2006, one day following delivery, the subject received 1st dose of Engerix B at 10 mcg. The following day, on 10/4/06, the subject inadvertently received a 2nd dose of Engerix B at 10 mcg. This was considered to be an inappropriate schedule of drug administration. The subject was reportedly hospitalized or the hospital stay was extended following birth and the maladmininstration of vaccine. The first and second doses of Engerix B should be separated by one month. No adverse events were indicated at the time of reporting.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Discomfort, Feeling hot, Limb discomfort, Sensation of pressure
Clinical narrative: This case was reported by a pharmacist and described the occurrence of feeling of pressure in legs in a 41 year old male subject who was vaccinated with Fluarix for prophylaxis. The subject had no adverse events following receipt of prior immunizations of Influenza (unspecified manufacturer). On 9/28/06 the subject received a dose of Fluarix in the right arm. On 10/1/06, 3 days after vaccination with Fluarix, the subject experienced feeling of pressure, heat and discomfort from his knees to his feet. The pharmacist considered the events to be clinically significant (or to require intervention) (OMIC). The subject was seen by his physician and referred to a neurologist. At the time of initial reporting, 10/9/06, the event were ongoing.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, HIBV, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia, Urticaria
Clinical narrative: Developed 102 temp lasting 36-48 hours. Developed about 3x2.5 inch red, raised area on right thigh. Also developed hives on right lower leg and abdomen. Hard 1.5 inch diameter area wider red area. Phoned nurse who administered vaccines. Says HIB and Hep A given in right thigh.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Discomfort, Swelling
Clinical narrative: Patient felt discomfort in left arm approximately 2 hours after vaccine. Subdermal bleeding due to Warfarin use with excessive swelling and bruising.
Age: 0.5
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: Given .25cc of Fluvirin vaccine.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMRV, PNC, DTAP, DTP, HIBV, MMRV, PNC
Symptoms: Coordination abnormal, Eye pain, Pain, Pyrexia
Clinical narrative: Fever 103 10/2/06, ataxia, c/o eye hurting, c/o upper thigh pain.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMRV, PNC, DTAP, DTP, HIBV, MMRV, PNC
Symptoms: Balance disorder, Coordination abnormal, Difficulty in walking, Eye pain, Injection site pain
Clinical narrative: Fever 103 10/2/06, ataxia, c/o eye hurting, c/o upper thigh pain.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMRV, PNC, DTAP, DTP, HIBV, MMRV, PNC
Symptoms: Pyrexia, Viral infection
Clinical narrative: Fever 103 10/2/06, ataxia, c/o eye hurting, c/o upper thigh pain.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: She has urticaria only on face 5 minutes after immunization, possibly after Rotateq oral administration. Urticaria resolved 30-35 hours later without any further treatment.
Age: 19.0
Sex: M
Vaccine: TD
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Pt stated severe pain in right upper arm, right arm at injection site warm to touch 6 days post vaccination.
Age: 1.26
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: 10/3/06, Brief exam dx'd with varicella. Erythematous papules with fluid filled centers 50-75 lesions. Rx: Benadryl.
Age: 32.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Amnesia, Encephalitis, Headache
Clinical narrative: High fever, severe headaches, pain, confusion, memory loss, etc.  Acute disseminated encephalomyelitis (ADEM).
Age: 32.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Amnesia, Confusional state, Encephalitis, Headache, Pain
Clinical narrative: High fever, severe headaches, pain, confusion, memory loss, etc.  Acute disseminated encephalomyelitis (ADEM).
Age: 32.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Pyrexia, Viral infection
Clinical narrative: High fever, severe headaches, pain, confusion, memory loss, etc.  Acute disseminated encephalomyelitis (ADEM).
Age: 38.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Malaise, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 33 year old female with a penicillin allergy and an iodine allergy who on 08 Aug 2006 was vaccinated with a 0.5 ml SC dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (lot#652325/0953R).  There was no concomitant medication.  On 09-Aug-2006 the patient developed redness at the site of injection.  According to the patient, there was also a localized swelling and a little.  The patient stated that she felt "little bit of fever", but did not take any temperature measurements. Unspecified medical attention was sought.  No laboratory diagnostic tests were performed.  At the time of the report the patient was recovering.  There was no product quality complaint involved. Additional information has been requested. Additional information is not expected.
Age: 38.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Pyrexia, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a 33 year old female with a penicillin allergy and an iodine allergy who on 08 Aug 2006 was vaccinated with a 0.5 ml SC dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (lot#652325/0953R).  There was no concomitant medication.  On 09-Aug-2006 the patient developed redness at the site of injection.  According to the patient, there was also a localized swelling and a little.  The patient stated that she felt "little bit of fever", but did not take any temperature measurements. Unspecified medical attention was sought.  No laboratory diagnostic tests were performed.  At the time of the report the patient was recovering.  There was no product quality complaint involved. Additional information has been requested. Additional information is not expected.
Age: 1.32
Sex: M
Vaccine: DTPHIB, HEP, IPV, HIBV, MMR
Symptoms: Antisocial behaviour, Autism, Drug toxicity, Inflammation, Laboratory test abnormal
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib Titer vaccine was received from a attorney regarding a 20 month old male pt who experienced pervasive developmental, neuromotor dysfunction, hypotonia, dysmorphism, macrocephaly and autism. The pt received the fourth dose of Hib Titer vaccine on 4/6/1995, along with the first dose if MMR II. The pt has a past history of otitis media and ear tube insertion. Indication for Hib Titer vaccine was immunisation. Product was administered on 4/6/1995. Dose regimen was 1 dose 1 time per day. Additional suspect medication included DPT/hib, DPT, Tripedia, Polio virus vaccine live oral, MMR and Hep B. Concomitant medications were not reported. Medical records received from an attorney, alleged that on several dates in 1995, the pt was diagnosed with pervasive developmental delay (autism spectrum disorder), neuromotor dysfunction, hypotonia, Dysmorphism (facial dysmorphism), macrocephaly, and autism on 12/4/1995. The outcome is unknown. Diagnostic procedure developmental age 8.5 months, DQ of 35. At testing child was 23 months of age, and acoustic stimulation test conducted twice and results were okay, were done in 1995. On 8/24/95 test results were metabolic function test results unk, DNA test for fragile X (results provided 1/2/96 normal male pattern, no evidence of fragile X permutation or full mutation, karyotype analysis results normal, and amino acid level (results negative. Blood lead results <5 mcg/dl, was done on 12/13/95. Repeated blood lead results <5mcg/dl, was done on 12/13/98. No additional information was available at the time of this report.
Age: 1.32
Sex: M
Vaccine: DTPHIB, HEP, IPV, HIBV, MMR
Symptoms: Mental impairment, Mental retardation severity unspecified, Nervous system disorder, Speech disorder, Tooth hypoplasia
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib Titer vaccine was received from a attorney regarding a 20 month old male pt who experienced pervasive developmental, neuromotor dysfunction, hypotonia, dysmorphism, macrocephaly and autism. The pt received the fourth dose of Hib Titer vaccine on 4/6/1995, along with the first dose if MMR II. The pt has a past history of otitis media and ear tube insertion. Indication for Hib Titer vaccine was immunisation. Product was administered on 4/6/1995. Dose regimen was 1 dose 1 time per day. Additional suspect medication included DPT/hib, DPT, Tripedia, Polio virus vaccine live oral, MMR and Hep B. Concomitant medications were not reported. Medical records received from an attorney, alleged that on several dates in 1995, the pt was diagnosed with pervasive developmental delay (autism spectrum disorder), neuromotor dysfunction, hypotonia, Dysmorphism (facial dysmorphism), macrocephaly, and autism on 12/4/1995. The outcome is unknown. Diagnostic procedure developmental age 8.5 months, DQ of 35. At testing child was 23 months of age, and acoustic stimulation test conducted twice and results were okay, were done in 1995. On 8/24/95 test results were metabolic function test results unk, DNA test for fragile X (results provided 1/2/96 normal male pattern, no evidence of fragile X permutation or full mutation, karyotype analysis results normal, and amino acid level (results negative. Blood lead results <5 mcg/dl, was done on 12/13/95. Repeated blood lead results <5mcg/dl, was done on 12/13/98. No additional information was available at the time of this report.
Age: 1.32
Sex: M
Vaccine: DTPHIB, HEP, IPV, HIBV, MMR
Symptoms: Autism, Congenital musculoskeletal anomaly, Hypokinesia, Hypotonia, Multiple congenital abnormalities
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib Titer vaccine was received from a attorney regarding a 20 month old male pt who experienced pervasive developmental, neuromotor dysfunction, hypotonia, dysmorphism, macrocephaly and autism. The pt received the fourth dose of Hib Titer vaccine on 4/6/1995, along with the first dose if MMR II. The pt has a past history of otitis media and ear tube insertion. Indication for Hib Titer vaccine was immunisation. Product was administered on 4/6/1995. Dose regimen was 1 dose 1 time per day. Additional suspect medication included DPT/hib, DPT, Tripedia, Polio virus vaccine live oral, MMR and Hep B. Concomitant medications were not reported. Medical records received from an attorney, alleged that on several dates in 1995, the pt was diagnosed with pervasive developmental delay (autism spectrum disorder), neuromotor dysfunction, hypotonia, Dysmorphism (facial dysmorphism), macrocephaly, and autism on 12/4/1995. The outcome is unknown. Diagnostic procedure developmental age 8.5 months, DQ of 35. At testing child was 23 months of age, and acoustic stimulation test conducted twice and results were okay, were done in 1995. On 8/24/95 test results were metabolic function test results unk, DNA test for fragile X (results provided 1/2/96 normal male pattern, no evidence of fragile X permutation or full mutation, karyotype analysis results normal, and amino acid level (results negative. Blood lead results <5 mcg/dl, was done on 12/13/95. Repeated blood lead results <5mcg/dl, was done on 12/13/98. No additional information was available at the time of this report.
Age: 1.32
Sex: M
Vaccine: DTPHIB, HEP, IPV, HIBV, MMR
Symptoms: Neurodevelopmental disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib Titer vaccine was received from a attorney regarding a 20 month old male pt who experienced pervasive developmental, neuromotor dysfunction, hypotonia, dysmorphism, macrocephaly and autism. The pt received the fourth dose of Hib Titer vaccine on 4/6/1995, along with the first dose if MMR II. The pt has a past history of otitis media and ear tube insertion. Indication for Hib Titer vaccine was immunisation. Product was administered on 4/6/1995. Dose regimen was 1 dose 1 time per day. Additional suspect medication included DPT/hib, DPT, Tripedia, Polio virus vaccine live oral, MMR and Hep B. Concomitant medications were not reported. Medical records received from an attorney, alleged that on several dates in 1995, the pt was diagnosed with pervasive developmental delay (autism spectrum disorder), neuromotor dysfunction, hypotonia, Dysmorphism (facial dysmorphism), macrocephaly, and autism on 12/4/1995. The outcome is unknown. Diagnostic procedure developmental age 8.5 months, DQ of 35. At testing child was 23 months of age, and acoustic stimulation test conducted twice and results were okay, were done in 1995. On 8/24/95 test results were metabolic function test results unk, DNA test for fragile X (results provided 1/2/96 normal male pattern, no evidence of fragile X permutation or full mutation, karyotype analysis results normal, and amino acid level (results negative. Blood lead results <5 mcg/dl, was done on 12/13/95. Repeated blood lead results <5mcg/dl, was done on 12/13/98. No additional information was available at the time of this report.
Age: 1.66
Sex: M
Vaccine: HEP, HIBV, IPV, MMR
Symptoms: Alanine aminotransferase increased, Antisocial behaviour, Blood calcium increased, Clumsiness, Cognitive disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib titer vaccine was received from medical records via an attorney regarding a male pt who experienced developmental delay, minor neuromotor dysfunction with hypotonia, dysmorphism and mental retardation. On 8/1/94 the pt received the fourth dose of Hib Titer, along with the third dose of Polio virus vaccine live oral and the fifth dose of Dtp/DTaP (consisting of 3 doses of DTaP) and 2 dosed of Tripedia. The pts concurrent illness included foot deformity and gastroesophageal reflux disease. Indication for Hib Titer vaccine was immunisation. Product was administered on 8/1/94. Dose regimen was 1 dose 1 time per day. Additional suspect medication included DPT, polio, MMR II, Heptavax B and Varivax. Concomitant medications were not reported. Medical records received via an attorney alleged that his client experienced developmental delay (autism spectrum disorder), minor neuromotor dysfunction with hypotonia (neurological symptom), dysmorphism (facial dysmorphism) and mental retardation (severity unspecified). On 11/21/95, the 3 year old boy was evaluated by a child neurologist who noted developmental delay closer to a 1 1/2 year level. He also noted hypotonia which appears to be on a central basis in view of the intact to brisk deep tendon reflexes. On 7/22/2002, the child was again evaluated by a specialist. Findings were similar to the previous specialist. In addition, borderline to mildly limited cognitive abilities, academic achievement commensurate with cognitive level, pervasive developmental disorder, not otherwise specified. On 9/10/02 an additional consult suggested a diagnosis of developmental delay and a possible velocardiofacial syndrome, but this was not confirmed in the consult. Electroencephalogram results diffuse, non specific abnormalities suggestive of diffuse cerebral disturbance, as well as the possibility of focal disturbance in the right posterior brain regions, was done in 1992. No additional information was available at the time of this report.
Age: 1.66
Sex: M
Vaccine: HEP, HIBV, IPV, MMR
Symptoms: Drug toxicity, Echolalia, Emotional disorder, Facial dysmorphism, Fall
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib titer vaccine was received from medical records via an attorney regarding a male pt who experienced developmental delay, minor neuromotor dysfunction with hypotonia, dysmorphism and mental retardation. On 8/1/94 the pt received the fourth dose of Hib Titer, along with the third dose of Polio virus vaccine live oral and the fifth dose of Dtp/DTaP (consisting of 3 doses of DTaP) and 2 dosed of Tripedia. The pts concurrent illness included foot deformity and gastroesophageal reflux disease. Indication for Hib Titer vaccine was immunisation. Product was administered on 8/1/94. Dose regimen was 1 dose 1 time per day. Additional suspect medication included DPT, polio, MMR II, Heptavax B and Varivax. Concomitant medications were not reported. Medical records received via an attorney alleged that his client experienced developmental delay (autism spectrum disorder), minor neuromotor dysfunction with hypotonia (neurological symptom), dysmorphism (facial dysmorphism) and mental retardation (severity unspecified). On 11/21/95, the 3 year old boy was evaluated by a child neurologist who noted developmental delay closer to a 1 1/2 year level. He also noted hypotonia which appears to be on a central basis in view of the intact to brisk deep tendon reflexes. On 7/22/2002, the child was again evaluated by a specialist. Findings were similar to the previous specialist. In addition, borderline to mildly limited cognitive abilities, academic achievement commensurate with cognitive level, pervasive developmental disorder, not otherwise specified. On 9/10/02 an additional consult suggested a diagnosis of developmental delay and a possible velocardiofacial syndrome, but this was not confirmed in the consult. Electroencephalogram results diffuse, non specific abnormalities suggestive of diffuse cerebral disturbance, as well as the possibility of focal disturbance in the right posterior brain regions, was done in 1992. No additional information was available at the time of this report.
Age: 1.66
Sex: M
Vaccine: HEP, HIBV, IPV, MMR
Symptoms: Gait disturbance, Gastrooesophageal reflux disease, Headache, Hearing impaired, Hypokinesia
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib titer vaccine was received from medical records via an attorney regarding a male pt who experienced developmental delay, minor neuromotor dysfunction with hypotonia, dysmorphism and mental retardation. On 8/1/94 the pt received the fourth dose of Hib Titer, along with the third dose of Polio virus vaccine live oral and the fifth dose of Dtp/DTaP (consisting of 3 doses of DTaP) and 2 dosed of Tripedia. The pts concurrent illness included foot deformity and gastroesophageal reflux disease. Indication for Hib Titer vaccine was immunisation. Product was administered on 8/1/94. Dose regimen was 1 dose 1 time per day. Additional suspect medication included DPT, polio, MMR II, Heptavax B and Varivax. Concomitant medications were not reported. Medical records received via an attorney alleged that his client experienced developmental delay (autism spectrum disorder), minor neuromotor dysfunction with hypotonia (neurological symptom), dysmorphism (facial dysmorphism) and mental retardation (severity unspecified). On 11/21/95, the 3 year old boy was evaluated by a child neurologist who noted developmental delay closer to a 1 1/2 year level. He also noted hypotonia which appears to be on a central basis in view of the intact to brisk deep tendon reflexes. On 7/22/2002, the child was again evaluated by a specialist. Findings were similar to the previous specialist. In addition, borderline to mildly limited cognitive abilities, academic achievement commensurate with cognitive level, pervasive developmental disorder, not otherwise specified. On 9/10/02 an additional consult suggested a diagnosis of developmental delay and a possible velocardiofacial syndrome, but this was not confirmed in the consult. Electroencephalogram results diffuse, non specific abnormalities suggestive of diffuse cerebral disturbance, as well as the possibility of focal disturbance in the right posterior brain regions, was done in 1992. No additional information was available at the time of this report.
Age: 1.66
Sex: M
Vaccine: HEP, HIBV, IPV, MMR
Symptoms: Hypotonia, Mental retardation severity unspecified, Neurodevelopmental disorder, Sensory disturbance, Speech disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib titer vaccine was received from medical records via an attorney regarding a male pt who experienced developmental delay, minor neuromotor dysfunction with hypotonia, dysmorphism and mental retardation. On 8/1/94 the pt received the fourth dose of Hib Titer, along with the third dose of Polio virus vaccine live oral and the fifth dose of Dtp/DTaP (consisting of 3 doses of DTaP) and 2 dosed of Tripedia. The pts concurrent illness included foot deformity and gastroesophageal reflux disease. Indication for Hib Titer vaccine was immunisation. Product was administered on 8/1/94. Dose regimen was 1 dose 1 time per day. Additional suspect medication included DPT, polio, MMR II, Heptavax B and Varivax. Concomitant medications were not reported. Medical records received via an attorney alleged that his client experienced developmental delay (autism spectrum disorder), minor neuromotor dysfunction with hypotonia (neurological symptom), dysmorphism (facial dysmorphism) and mental retardation (severity unspecified). On 11/21/95, the 3 year old boy was evaluated by a child neurologist who noted developmental delay closer to a 1 1/2 year level. He also noted hypotonia which appears to be on a central basis in view of the intact to brisk deep tendon reflexes. On 7/22/2002, the child was again evaluated by a specialist. Findings were similar to the previous specialist. In addition, borderline to mildly limited cognitive abilities, academic achievement commensurate with cognitive level, pervasive developmental disorder, not otherwise specified. On 9/10/02 an additional consult suggested a diagnosis of developmental delay and a possible velocardiofacial syndrome, but this was not confirmed in the consult. Electroencephalogram results diffuse, non specific abnormalities suggestive of diffuse cerebral disturbance, as well as the possibility of focal disturbance in the right posterior brain regions, was done in 1992. No additional information was available at the time of this report.
Age: 1.66
Sex: M
Vaccine: HEP, HIBV, IPV, MMR
Symptoms: Vomiting
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib titer vaccine was received from medical records via an attorney regarding a male pt who experienced developmental delay, minor neuromotor dysfunction with hypotonia, dysmorphism and mental retardation. On 8/1/94 the pt received the fourth dose of Hib Titer, along with the third dose of Polio virus vaccine live oral and the fifth dose of Dtp/DTaP (consisting of 3 doses of DTaP) and 2 dosed of Tripedia. The pts concurrent illness included foot deformity and gastroesophageal reflux disease. Indication for Hib Titer vaccine was immunisation. Product was administered on 8/1/94. Dose regimen was 1 dose 1 time per day. Additional suspect medication included DPT, polio, MMR II, Heptavax B and Varivax. Concomitant medications were not reported. Medical records received via an attorney alleged that his client experienced developmental delay (autism spectrum disorder), minor neuromotor dysfunction with hypotonia (neurological symptom), dysmorphism (facial dysmorphism) and mental retardation (severity unspecified). On 11/21/95, the 3 year old boy was evaluated by a child neurologist who noted developmental delay closer to a 1 1/2 year level. He also noted hypotonia which appears to be on a central basis in view of the intact to brisk deep tendon reflexes. On 7/22/2002, the child was again evaluated by a specialist. Findings were similar to the previous specialist. In addition, borderline to mildly limited cognitive abilities, academic achievement commensurate with cognitive level, pervasive developmental disorder, not otherwise specified. On 9/10/02 an additional consult suggested a diagnosis of developmental delay and a possible velocardiofacial syndrome, but this was not confirmed in the consult. Electroencephalogram results diffuse, non specific abnormalities suggestive of diffuse cerebral disturbance, as well as the possibility of focal disturbance in the right posterior brain regions, was done in 1992. No additional information was available at the time of this report.
Age: 1.66
Sex: M
Vaccine: HEP, HIBV, IPV, MMR
Symptoms: Autism, Cardiac disorder, Cognitive disorder, Facial dysmorphism, Hypokinesia
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib titer vaccine was received from medical records via an attorney regarding a male pt who experienced developmental delay, minor neuromotor dysfunction with hypotonia, dysmorphism and mental retardation. On 8/1/94 the pt received the fourth dose of Hib Titer, along with the third dose of Polio virus vaccine live oral and the fifth dose of Dtp/DTaP (consisting of 3 doses of DTaP) and 2 dosed of Tripedia. The pts concurrent illness included foot deformity and gastroesophageal reflux disease. Indication for Hib Titer vaccine was immunisation. Product was administered on 8/1/94. Dose regimen was 1 dose 1 time per day. Additional suspect medication included DPT, polio, MMR II, Heptavax B and Varivax. Concomitant medications were not reported. Medical records received via an attorney alleged that his client experienced developmental delay (autism spectrum disorder), minor neuromotor dysfunction with hypotonia (neurological symptom), dysmorphism (facial dysmorphism) and mental retardation (severity unspecified). On 11/21/95, the 3 year old boy was evaluated by a child neurologist who noted developmental delay closer to a 1 1/2 year level. He also noted hypotonia which appears to be on a central basis in view of the intact to brisk deep tendon reflexes. On 7/22/2002, the child was again evaluated by a specialist. Findings were similar to the previous specialist. In addition, borderline to mildly limited cognitive abilities, academic achievement commensurate with cognitive level, pervasive developmental disorder, not otherwise specified. On 9/10/02 an additional consult suggested a diagnosis of developmental delay and a possible velocardiofacial syndrome, but this was not confirmed in the consult. Electroencephalogram results diffuse, non specific abnormalities suggestive of diffuse cerebral disturbance, as well as the possibility of focal disturbance in the right posterior brain regions, was done in 1992. No additional information was available at the time of this report.
Age: 1.66
Sex: M
Vaccine: HEP, HIBV, IPV, MMR
Symptoms: Hypotonia, Mental retardation severity unspecified, Nervous system disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib titer vaccine was received from medical records via an attorney regarding a male pt who experienced developmental delay, minor neuromotor dysfunction with hypotonia, dysmorphism and mental retardation. On 8/1/94 the pt received the fourth dose of Hib Titer, along with the third dose of Polio virus vaccine live oral and the fifth dose of Dtp/DTaP (consisting of 3 doses of DTaP) and 2 dosed of Tripedia. The pts concurrent illness included foot deformity and gastroesophageal reflux disease. Indication for Hib Titer vaccine was immunisation. Product was administered on 8/1/94. Dose regimen was 1 dose 1 time per day. Additional suspect medication included DPT, polio, MMR II, Heptavax B and Varivax. Concomitant medications were not reported. Medical records received via an attorney alleged that his client experienced developmental delay (autism spectrum disorder), minor neuromotor dysfunction with hypotonia (neurological symptom), dysmorphism (facial dysmorphism) and mental retardation (severity unspecified). On 11/21/95, the 3 year old boy was evaluated by a child neurologist who noted developmental delay closer to a 1 1/2 year level. He also noted hypotonia which appears to be on a central basis in view of the intact to brisk deep tendon reflexes. On 7/22/2002, the child was again evaluated by a specialist. Findings were similar to the previous specialist. In addition, borderline to mildly limited cognitive abilities, academic achievement commensurate with cognitive level, pervasive developmental disorder, not otherwise specified. On 9/10/02 an additional consult suggested a diagnosis of developmental delay and a possible velocardiofacial syndrome, but this was not confirmed in the consult. Electroencephalogram results diffuse, non specific abnormalities suggestive of diffuse cerebral disturbance, as well as the possibility of focal disturbance in the right posterior brain regions, was done in 1992. No additional information was available at the time of this report.
Sex: F
Vaccine: HEP, HIBV, DTAP, HIBV, MMR
Symptoms: Antisocial behaviour, Autism, Bronchiolitis, Drug toxicity, Headache
Clinical narrative: Initial report received from another manufacturer on 9/27/06, reporter number WAES0502USA01394. Information has been received by this reporter secondary to a case in litigation. Follow up information was received by the manufacturer in the form of medical records. Name and address of the reporter was noted as confidential. A 17 month old female pt had received an injection of ActHib, lot number not reported, on an unspecified date. She also received an injection of Hib conj vaccine, manufacturer unknown, lot number unknown, and Tetramune lot number unk, on 7/25/1994. Additionally, she received a second dose injection of hepatitis B vaccine, manufacturer unknown, lot number unknown, on 8/8/1994 a first dose injection of MMR manufacturer unk lot number not reported, on 8/14/95, 12/9/1996. She had also received an injection of Infanrix lot number not reported, date of administration not reported, and injection of Pediarix lot number not reported, date of administration not reported. Routed and sites of administration not reported. Routes and sites of administration were not reported. Other concomitant therapies were reported as Ritalin, oxygen and Clonidine. It was reported that, at an unspecified time, the pt had experienced toxic mercury exposure secondary to mercury emissions from power plants, the mercury in thimerosal laden products and via food chain. Per the report, minor male suffered serious and permanent neurological damage with associated learning disabilities, disorders and impairments. From information based upon medical records, the pt was hospitalized for bronchiolitis from 11/6/94 to 11/8/94. On 12/1395, a physician has reported that the pt had delays in communication and social interaction. On 2/10/97, it was reported again that the pts communication skills were delayed and that the pt appeared socially distant. On 9/15/97, the physician noted the pt as failure to thrive. On 8/21/98 the physician noted that the pt had two previous hospitalizations. It was noted by a physician that the pt had been treated for the medical diagnosis of ADD since Nov 1998. On 2/15/00, it was noted that the pt received services under the disabling condition of speech and language impairment. On 4/12/00, the pt was diagnosed with Aspergers disorder. On 4/21/00, it was noted the pt had atypical autism which was considered and educational disability. At the time of this report, the pt had not recovered.
Sex: F
Vaccine: HEP, HIBV, DTAP, HIBV, MMR
Symptoms: Neurodevelopmental disorder, Oliguria, Sinusitis, Sleep disorder, Speech disorder
Clinical narrative: Initial report received from another manufacturer on 9/27/06, reporter number WAES0502USA01394. Information has been received by this reporter secondary to a case in litigation. Follow up information was received by the manufacturer in the form of medical records. Name and address of the reporter was noted as confidential. A 17 month old female pt had received an injection of ActHib, lot number not reported, on an unspecified date. She also received an injection of Hib conj vaccine, manufacturer unknown, lot number unknown, and Tetramune lot number unk, on 7/25/1994. Additionally, she received a second dose injection of hepatitis B vaccine, manufacturer unknown, lot number unknown, on 8/8/1994 a first dose injection of MMR manufacturer unk lot number not reported, on 8/14/95, 12/9/1996. She had also received an injection of Infanrix lot number not reported, date of administration not reported, and injection of Pediarix lot number not reported, date of administration not reported. Routed and sites of administration not reported. Routes and sites of administration were not reported. Other concomitant therapies were reported as Ritalin, oxygen and Clonidine. It was reported that, at an unspecified time, the pt had experienced toxic mercury exposure secondary to mercury emissions from power plants, the mercury in thimerosal laden products and via food chain. Per the report, minor male suffered serious and permanent neurological damage with associated learning disabilities, disorders and impairments. From information based upon medical records, the pt was hospitalized for bronchiolitis from 11/6/94 to 11/8/94. On 12/1395, a physician has reported that the pt had delays in communication and social interaction. On 2/10/97, it was reported again that the pts communication skills were delayed and that the pt appeared socially distant. On 9/15/97, the physician noted the pt as failure to thrive. On 8/21/98 the physician noted that the pt had two previous hospitalizations. It was noted by a physician that the pt had been treated for the medical diagnosis of ADD since Nov 1998. On 2/15/00, it was noted that the pt received services under the disabling condition of speech and language impairment. On 4/12/00, the pt was diagnosed with Aspergers disorder. On 4/21/00, it was noted the pt had atypical autism which was considered and educational disability. At the time of this report, the pt had not recovered.
Sex: F
Vaccine: HEP, HIBV, DTAP, HIBV, MMR
Symptoms: Vomiting
Clinical narrative: Initial report received from another manufacturer on 9/27/06, reporter number WAES0502USA01394. Information has been received by this reporter secondary to a case in litigation. Follow up information was received by the manufacturer in the form of medical records. Name and address of the reporter was noted as confidential. A 17 month old female pt had received an injection of ActHib, lot number not reported, on an unspecified date. She also received an injection of Hib conj vaccine, manufacturer unknown, lot number unknown, and Tetramune lot number unk, on 7/25/1994. Additionally, she received a second dose injection of hepatitis B vaccine, manufacturer unknown, lot number unknown, on 8/8/1994 a first dose injection of MMR manufacturer unk lot number not reported, on 8/14/95, 12/9/1996. She had also received an injection of Infanrix lot number not reported, date of administration not reported, and injection of Pediarix lot number not reported, date of administration not reported. Routed and sites of administration not reported. Routes and sites of administration were not reported. Other concomitant therapies were reported as Ritalin, oxygen and Clonidine. It was reported that, at an unspecified time, the pt had experienced toxic mercury exposure secondary to mercury emissions from power plants, the mercury in thimerosal laden products and via food chain. Per the report, minor male suffered serious and permanent neurological damage with associated learning disabilities, disorders and impairments. From information based upon medical records, the pt was hospitalized for bronchiolitis from 11/6/94 to 11/8/94. On 12/1395, a physician has reported that the pt had delays in communication and social interaction. On 2/10/97, it was reported again that the pts communication skills were delayed and that the pt appeared socially distant. On 9/15/97, the physician noted the pt as failure to thrive. On 8/21/98 the physician noted that the pt had two previous hospitalizations. It was noted by a physician that the pt had been treated for the medical diagnosis of ADD since Nov 1998. On 2/15/00, it was noted that the pt received services under the disabling condition of speech and language impairment. On 4/12/00, the pt was diagnosed with Aspergers disorder. On 4/21/00, it was noted the pt had atypical autism which was considered and educational disability. At the time of this report, the pt had not recovered.
Sex: F
Vaccine: HEP, HIBV, DTAP, HIBV, MMR
Symptoms: Anorexia, Antisocial behaviour, Autism, Bronchiolitis, Drug toxicity
Clinical narrative: Initial report received from another manufacturer on 9/27/06, reporter number WAES0502USA01394. Information has been received by this reporter secondary to a case in litigation. Follow up information was received by the manufacturer in the form of medical records. Name and address of the reporter was noted as confidential. A 17 month old female pt had received an injection of ActHib, lot number not reported, on an unspecified date. She also received an injection of Hib conj vaccine, manufacturer unknown, lot number unknown, and Tetramune lot number unk, on 7/25/1994. Additionally, she received a second dose injection of hepatitis B vaccine, manufacturer unknown, lot number unknown, on 8/8/1994 a first dose injection of MMR manufacturer unk lot number not reported, on 8/14/95, 12/9/1996. She had also received an injection of Infanrix lot number not reported, date of administration not reported, and injection of Pediarix lot number not reported, date of administration not reported. Routed and sites of administration not reported. Routes and sites of administration were not reported. Other concomitant therapies were reported as Ritalin, oxygen and Clonidine. It was reported that, at an unspecified time, the pt had experienced toxic mercury exposure secondary to mercury emissions from power plants, the mercury in thimerosal laden products and via food chain. Per the report, minor male suffered serious and permanent neurological damage with associated learning disabilities, disorders and impairments. From information based upon medical records, the pt was hospitalized for bronchiolitis from 11/6/94 to 11/8/94. On 12/1395, a physician has reported that the pt had delays in communication and social interaction. On 2/10/97, it was reported again that the pts communication skills were delayed and that the pt appeared socially distant. On 9/15/97, the physician noted the pt as failure to thrive. On 8/21/98 the physician noted that the pt had two previous hospitalizations. It was noted by a physician that the pt had been treated for the medical diagnosis of ADD since Nov 1998. On 2/15/00, it was noted that the pt received services under the disabling condition of speech and language impairment. On 4/12/00, the pt was diagnosed with Aspergers disorder. On 4/21/00, it was noted the pt had atypical autism which was considered and educational disability. At the time of this report, the pt had not recovered.
Sex: F
Vaccine: HEP, HIBV, DTAP, HIBV, MMR
Symptoms: Nervous system disorder, Speech disorder
Clinical narrative: Initial report received from another manufacturer on 9/27/06, reporter number WAES0502USA01394. Information has been received by this reporter secondary to a case in litigation. Follow up information was received by the manufacturer in the form of medical records. Name and address of the reporter was noted as confidential. A 17 month old female pt had received an injection of ActHib, lot number not reported, on an unspecified date. She also received an injection of Hib conj vaccine, manufacturer unknown, lot number unknown, and Tetramune lot number unk, on 7/25/1994. Additionally, she received a second dose injection of hepatitis B vaccine, manufacturer unknown, lot number unknown, on 8/8/1994 a first dose injection of MMR manufacturer unk lot number not reported, on 8/14/95, 12/9/1996. She had also received an injection of Infanrix lot number not reported, date of administration not reported, and injection of Pediarix lot number not reported, date of administration not reported. Routed and sites of administration not reported. Routes and sites of administration were not reported. Other concomitant therapies were reported as Ritalin, oxygen and Clonidine. It was reported that, at an unspecified time, the pt had experienced toxic mercury exposure secondary to mercury emissions from power plants, the mercury in thimerosal laden products and via food chain. Per the report, minor male suffered serious and permanent neurological damage with associated learning disabilities, disorders and impairments. From information based upon medical records, the pt was hospitalized for bronchiolitis from 11/6/94 to 11/8/94. On 12/1395, a physician has reported that the pt had delays in communication and social interaction. On 2/10/97, it was reported again that the pts communication skills were delayed and that the pt appeared socially distant. On 9/15/97, the physician noted the pt as failure to thrive. On 8/21/98 the physician noted that the pt had two previous hospitalizations. It was noted by a physician that the pt had been treated for the medical diagnosis of ADD since Nov 1998. On 2/15/00, it was noted that the pt received services under the disabling condition of speech and language impairment. On 4/12/00, the pt was diagnosed with Aspergers disorder. On 4/21/00, it was noted the pt had atypical autism which was considered and educational disability. At the time of this report, the pt had not recovered.
Sex: F
Vaccine: HEP, HIBV, DTAP, HIBV, MMR
Symptoms: Abnormal behaviour, Autism, Neurodevelopmental disorder, Sleep disorder
Clinical narrative: Initial report received from another manufacturer on 9/27/06, reporter number WAES0502USA01394. Information has been received by this reporter secondary to a case in litigation. Follow up information was received by the manufacturer in the form of medical records. Name and address of the reporter was noted as confidential. A 17 month old female pt had received an injection of ActHib, lot number not reported, on an unspecified date. She also received an injection of Hib conj vaccine, manufacturer unknown, lot number unknown, and Tetramune lot number unk, on 7/25/1994. Additionally, she received a second dose injection of hepatitis B vaccine, manufacturer unknown, lot number unknown, on 8/8/1994 a first dose injection of MMR manufacturer unk lot number not reported, on 8/14/95, 12/9/1996. She had also received an injection of Infanrix lot number not reported, date of administration not reported, and injection of Pediarix lot number not reported, date of administration not reported. Routed and sites of administration not reported. Routes and sites of administration were not reported. Other concomitant therapies were reported as Ritalin, oxygen and Clonidine. It was reported that, at an unspecified time, the pt had experienced toxic mercury exposure secondary to mercury emissions from power plants, the mercury in thimerosal laden products and via food chain. Per the report, minor male suffered serious and permanent neurological damage with associated learning disabilities, disorders and impairments. From information based upon medical records, the pt was hospitalized for bronchiolitis from 11/6/94 to 11/8/94. On 12/1395, a physician has reported that the pt had delays in communication and social interaction. On 2/10/97, it was reported again that the pts communication skills were delayed and that the pt appeared socially distant. On 9/15/97, the physician noted the pt as failure to thrive. On 8/21/98 the physician noted that the pt had two previous hospitalizations. It was noted by a physician that the pt had been treated for the medical diagnosis of ADD since Nov 1998. On 2/15/00, it was noted that the pt received services under the disabling condition of speech and language impairment. On 4/12/00, the pt was diagnosed with Aspergers disorder. On 4/21/00, it was noted the pt had atypical autism which was considered and educational disability. At the time of this report, the pt had not recovered.