chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Feeling hot, Injection site pain, Injection site swelling, Tremor
Clinical narrative: Information has been received from a registered nurse concerning a 74 year old female with no medical history and allergies to acetaminophen (+) propoxyphene napsylate (DARVOCET-N) and codeine who on 21-SEP-2006 was vaccinated intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot#651399/0486F).  Concomitant therapy included aspirin, loratadine (CLARITIN), Lovastatin (manufacturer unknown), risedronate sodium (ACTONEL), vitamins (unspecified), folic acid and mometasone furoate (NASONEX).  On approximately 21-SEP-2006 within 12 hours after vaccination, the patient experienced hot and cold chills, felt shaky, with pain and swelling in the injection site arm from the axilla.  The patient did not have a fever.  She took aspirin for pain (timeframe undetermined).  The next morning 24 hours after vaccination, the arm was still swollen and painful and the patient still did not feel good.  The patient was not as shaky.  Unspecified medical attention was sought.  No diagnostic studies were performed.  At the time of this report, the patient had not recovered.  No product quality complaint was involved.  Hot and cold chills, felt shaky, pain and swelling in the injection site arm from the axilla were considered to be disabling and other important medical events.  Additional information has been requested. (OMIC)
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Dermatitis bullous, Hepatitis, Immune system disorder, Immunoglobulins decreased, Lymphopenia
Clinical narrative: Information has been received from a physician concerning a 13 month old male who on 8/5/06, at 12 months of age, was vaccinated with a dose of MMR II/Varicella. On 9/1/06 the pt broke out in a papulo-bullous rash which began with persistent fever. On 9/14/06 he was admitted to the hospital PICU in respiratory failure. He had greater than 300 lesions in various stages and persistent fever. He has been found to have profound panhypogammaglobulemia and moderate lymphopenia, mild hepatitis but doses not have significant leukopenia or thrombocytopenia. He dose have a bilateral interstitial hemmorhagic pneumonitis. Skin is + VZ DFA, HSV neg. Skin biopsy viral cultures are pending. Skin cultures were also MRSA+, HIV DNA PCR results were pending and complete immunologic testing is underway. On 9/18/06 the physician reported that the pt was probable immunodeficiency and disseminated vaccine related VZ. The pt very likely has a severe T cell deficiency, confirmatory evaluation was pending. The pt had a lymphocytic evaluation at 2 months of age with a CD4 count of 1%, at which time he was admitted for a severe MRSA skin infection. This test result was not known when he received his MMR II/varicella vaccine. The pt's HIV serology was neg and IgG was low normal at 2 months of age. The pt was enrolled in the Varicella zoster virus identification program to identify if VZV is present and if it is present to identify if it is associated with the wild type WT VZV strain or with the manufacturer vaccine VZV strain. Additional information has been requested.
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Pneumonitis, Pyrexia, Rash papular, Respiratory failure, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 13 month old male who on 8/5/06, at 12 months of age, was vaccinated with a dose of MMR II/Varicella. On 9/1/06 the pt broke out in a papulo-bullous rash which began with persistent fever. On 9/14/06 he was admitted to the hospital PICU in respiratory failure. He had greater than 300 lesions in various stages and persistent fever. He has been found to have profound panhypogammaglobulemia and moderate lymphopenia, mild hepatitis but doses not have significant leukopenia or thrombocytopenia. He dose have a bilateral interstitial hemmorhagic pneumonitis. Skin is + VZ DFA, HSV neg. Skin biopsy viral cultures are pending. Skin cultures were also MRSA+, HIV DNA PCR results were pending and complete immunologic testing is underway. On 9/18/06 the physician reported that the pt was probable immunodeficiency and disseminated vaccine related VZ. The pt very likely has a severe T cell deficiency, confirmatory evaluation was pending. The pt had a lymphocytic evaluation at 2 months of age with a CD4 count of 1%, at which time he was admitted for a severe MRSA skin infection. This test result was not known when he received his MMR II/varicella vaccine. The pt's HIV serology was neg and IgG was low normal at 2 months of age. The pt was enrolled in the Varicella zoster virus identification program to identify if VZV is present and if it is present to identify if it is associated with the wild type WT VZV strain or with the manufacturer vaccine VZV strain. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Information has been received from a physician concerning a 4-year-old female who on 06-SEP-2006 was vaccinate  subcutaneously with a 0.5 ml dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  Concomitant vaccinations included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of poliovirus vaccine.  On 08-SEP-2006 the patient experienced a large local reaction in the right arm (injection site arm).  It was noted that it had the look of red cellulitis.  Unspecified medical attention was sought and the patient was treated with cephalexin (KEFLEX).  Subsequently, the patient recovered on 11-SEP-2006.  No product quality complaint was involved.  The reporting physician considered the patient's experience to be an other important medical event.  Additional information has been requested. (OMIC)
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 4-year-old female who on 06-SEP-2006 was vaccinate  subcutaneously with a 0.5 ml dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  Concomitant vaccinations included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of poliovirus vaccine.  On 08-SEP-2006 the patient experienced a large local reaction in the right arm (injection site arm).  It was noted that it had the look of red cellulitis.  Unspecified medical attention was sought and the patient was treated with cephalexin (KEFLEX).  Subsequently, the patient recovered on 11-SEP-2006.  No product quality complaint was involved.  The reporting physician considered the patient's experience to be an other important medical event.  Additional information has been requested. (OMIC)
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Oedema peripheral, Swelling face
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning an 18 year old female with asthma, polycystic ovaries and no known allergies or adverse drug reactions reported.  On 25-SEP-2006, the patient was vaccinated intramuscularly with a 0.5 ml dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653735/0688F).  Concomitant therapy included bupropion HCL (WELLBUTRIN XL), lithium carbonate and risperidone (RISPERDAL).  That evening, on 25-SEP-2006, the patient developed left arm swelling and difficulty breathing.  It was reported that the difficulty breathing could be due to the patient having a cold and being an asthmatic.  On 26-SEP-2006 the patient developed facial swelling.  The patient sought unspecified medical attention.  It was reported that a nurse practitioner and physician were doing an assessment and consultation. On an unspecified date, the patient had the assessment and consultation and her symptoms were not considered to be serious. At the time of this report, the patient was recovering from th events. The reporter considered the events to be serious as other important medical events (date unknown).  Additional information is not expected.
Age: 0.52
Sex: M
Vaccine: DTAP, HEP
Symptoms: Abnormal behaviour, Aggression, Antisocial behaviour, Anxiety, Coordination abnormal
Clinical narrative: This case was reported by a lawyer and described the occurrence of neurological injury in a male subject who was vaccinated with hepatitis B vaccine (Engerix B) and or unidentified hepatitis B vaccine for prophylaxis. On an unspecified date the subject received unspecified dose of hepatitis B vaccine. According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced neurological damage which was attributed to cumulative mercury toxicity. The following information was received via medical records, the subject was vaccinated with hepatitis B vaccine (unknown manufacturer) on 9/8/95, and with Engerix B on 10/9/95 and 3/14/96. He was also vaccinated with DTaP, OPV, MMR and HIB for prophylaxis. The subject took his first steps before twelve months. At two years of age the subject spoke his first understandable but poorly articulated words, and began speaking in phrases between tow and a half to three years of age. On 8/5/99, the subject was evaluated for complaint so frequent temper tantrums, mood instability, initial insomnia, possible articulation speech deficits, periods of high energy and aggression, and obsessive focus on particular subjects. He was diagnosed with Multicomplex developmental disorder (Pervasive developmental disorder). In Sept 1999, Ritalin therapy was initiated. On 12/14/99 the subject underwent a psychiatric evaluation due to concerns with social development. Problems included high strung and controlling behavior, spinning his body, jumping up and down and windmill arm action, poor eye contact, anxiety, use of repetitive phrases, aggression including biting and head butting, self injury including head banging, occasional daytime enuresis, and temper tantrum during transition periods. The subjects sleep was good except for occasional terror attacks. He was noted to have ADHD (hyper since birth), and oppositional defiant disorder. A mental status examination estimated average to above average intelligence. Diagnosis included anxiety disorder nos, rule out pervasive developmental disorder. In Dec 2000, he presented with complaint of ears stopped up with decreased hearing. At that time, it was noted that the subject had some difficulty staying on task. By 2001 the subject was receiving Paxil for anxiety in addition to continued Ritalin. Tenex therapy was also added. An academic evaluation performed at the time showed no cognitive deficits that would require remediation and he was described as an extremely intelligent and capable young man. Concerns included hyperactivity, atypicality, depression, attention problems, and adaptability. Upper limb coordination was below average, with average visual motor control and upper limb speed and dexterity. Occupational therapy was recommended. This case was assessed to be medically significant by manufacturer (OMIC).
Age: 0.52
Sex: M
Vaccine: DTAP, HEP
Symptoms: Depression, Ear discomfort, Enuresis, Gaze palsy, Hypoacusis
Clinical narrative: This case was reported by a lawyer and described the occurrence of neurological injury in a male subject who was vaccinated with hepatitis B vaccine (Engerix B) and or unidentified hepatitis B vaccine for prophylaxis. On an unspecified date the subject received unspecified dose of hepatitis B vaccine. According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced neurological damage which was attributed to cumulative mercury toxicity. The following information was received via medical records, the subject was vaccinated with hepatitis B vaccine (unknown manufacturer) on 9/8/95, and with Engerix B on 10/9/95 and 3/14/96. He was also vaccinated with DTaP, OPV, MMR and HIB for prophylaxis. The subject took his first steps before twelve months. At two years of age the subject spoke his first understandable but poorly articulated words, and began speaking in phrases between tow and a half to three years of age. On 8/5/99, the subject was evaluated for complaint so frequent temper tantrums, mood instability, initial insomnia, possible articulation speech deficits, periods of high energy and aggression, and obsessive focus on particular subjects. He was diagnosed with Multicomplex developmental disorder (Pervasive developmental disorder). In Sept 1999, Ritalin therapy was initiated. On 12/14/99 the subject underwent a psychiatric evaluation due to concerns with social development. Problems included high strung and controlling behavior, spinning his body, jumping up and down and windmill arm action, poor eye contact, anxiety, use of repetitive phrases, aggression including biting and head butting, self injury including head banging, occasional daytime enuresis, and temper tantrum during transition periods. The subjects sleep was good except for occasional terror attacks. He was noted to have ADHD (hyper since birth), and oppositional defiant disorder. A mental status examination estimated average to above average intelligence. Diagnosis included anxiety disorder nos, rule out pervasive developmental disorder. In Dec 2000, he presented with complaint of ears stopped up with decreased hearing. At that time, it was noted that the subject had some difficulty staying on task. By 2001 the subject was receiving Paxil for anxiety in addition to continued Ritalin. Tenex therapy was also added. An academic evaluation performed at the time showed no cognitive deficits that would require remediation and he was described as an extremely intelligent and capable young man. Concerns included hyperactivity, atypicality, depression, attention problems, and adaptability. Upper limb coordination was below average, with average visual motor control and upper limb speed and dexterity. Occupational therapy was recommended. This case was assessed to be medically significant by manufacturer (OMIC).
Age: 0.52
Sex: M
Vaccine: DTAP, HEP
Symptoms: Injury, Insomnia, Mental retardation severity unspecified, Mood swings, Obsessive-compulsive disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of neurological injury in a male subject who was vaccinated with hepatitis B vaccine (Engerix B) and or unidentified hepatitis B vaccine for prophylaxis. On an unspecified date the subject received unspecified dose of hepatitis B vaccine. According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced neurological damage which was attributed to cumulative mercury toxicity. The following information was received via medical records, the subject was vaccinated with hepatitis B vaccine (unknown manufacturer) on 9/8/95, and with Engerix B on 10/9/95 and 3/14/96. He was also vaccinated with DTaP, OPV, MMR and HIB for prophylaxis. The subject took his first steps before twelve months. At two years of age the subject spoke his first understandable but poorly articulated words, and began speaking in phrases between tow and a half to three years of age. On 8/5/99, the subject was evaluated for complaint so frequent temper tantrums, mood instability, initial insomnia, possible articulation speech deficits, periods of high energy and aggression, and obsessive focus on particular subjects. He was diagnosed with Multicomplex developmental disorder (Pervasive developmental disorder). In Sept 1999, Ritalin therapy was initiated. On 12/14/99 the subject underwent a psychiatric evaluation due to concerns with social development. Problems included high strung and controlling behavior, spinning his body, jumping up and down and windmill arm action, poor eye contact, anxiety, use of repetitive phrases, aggression including biting and head butting, self injury including head banging, occasional daytime enuresis, and temper tantrum during transition periods. The subjects sleep was good except for occasional terror attacks. He was noted to have ADHD (hyper since birth), and oppositional defiant disorder. A mental status examination estimated average to above average intelligence. Diagnosis included anxiety disorder nos, rule out pervasive developmental disorder. In Dec 2000, he presented with complaint of ears stopped up with decreased hearing. At that time, it was noted that the subject had some difficulty staying on task. By 2001 the subject was receiving Paxil for anxiety in addition to continued Ritalin. Tenex therapy was also added. An academic evaluation performed at the time showed no cognitive deficits that would require remediation and he was described as an extremely intelligent and capable young man. Concerns included hyperactivity, atypicality, depression, attention problems, and adaptability. Upper limb coordination was below average, with average visual motor control and upper limb speed and dexterity. Occupational therapy was recommended. This case was assessed to be medically significant by manufacturer (OMIC).
Age: 0.52
Sex: M
Vaccine: DTAP, HEP
Symptoms: Psychomotor hyperactivity, Repetitive speech, Speech disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of neurological injury in a male subject who was vaccinated with hepatitis B vaccine (Engerix B) and or unidentified hepatitis B vaccine for prophylaxis. On an unspecified date the subject received unspecified dose of hepatitis B vaccine. According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced neurological damage which was attributed to cumulative mercury toxicity. The following information was received via medical records, the subject was vaccinated with hepatitis B vaccine (unknown manufacturer) on 9/8/95, and with Engerix B on 10/9/95 and 3/14/96. He was also vaccinated with DTaP, OPV, MMR and HIB for prophylaxis. The subject took his first steps before twelve months. At two years of age the subject spoke his first understandable but poorly articulated words, and began speaking in phrases between tow and a half to three years of age. On 8/5/99, the subject was evaluated for complaint so frequent temper tantrums, mood instability, initial insomnia, possible articulation speech deficits, periods of high energy and aggression, and obsessive focus on particular subjects. He was diagnosed with Multicomplex developmental disorder (Pervasive developmental disorder). In Sept 1999, Ritalin therapy was initiated. On 12/14/99 the subject underwent a psychiatric evaluation due to concerns with social development. Problems included high strung and controlling behavior, spinning his body, jumping up and down and windmill arm action, poor eye contact, anxiety, use of repetitive phrases, aggression including biting and head butting, self injury including head banging, occasional daytime enuresis, and temper tantrum during transition periods. The subjects sleep was good except for occasional terror attacks. He was noted to have ADHD (hyper since birth), and oppositional defiant disorder. A mental status examination estimated average to above average intelligence. Diagnosis included anxiety disorder nos, rule out pervasive developmental disorder. In Dec 2000, he presented with complaint of ears stopped up with decreased hearing. At that time, it was noted that the subject had some difficulty staying on task. By 2001 the subject was receiving Paxil for anxiety in addition to continued Ritalin. Tenex therapy was also added. An academic evaluation performed at the time showed no cognitive deficits that would require remediation and he was described as an extremely intelligent and capable young man. Concerns included hyperactivity, atypicality, depression, attention problems, and adaptability. Upper limb coordination was below average, with average visual motor control and upper limb speed and dexterity. Occupational therapy was recommended. This case was assessed to be medically significant by manufacturer (OMIC).
Age: 0.5
Sex: F
Vaccine: HEP, OPV
Symptoms: Anorexia, Antisocial behaviour, Anxiety, Autism, Emotional disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of neurological injury in a male subject who was vaccinated with hepatitis B vaccine (Engerix B) and or unidentified hepatitis B vaccine for prophylaxis. On an unspecified date the subject received unspecified dose of hepatitis B vaccine. According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced neurological damage which was attributed to cumulative mercury toxicity. The following information was received via medical records. the subject was vaccianted with hepatitis B vaccine (manufacturer unspecified) on 7/11/94, 8/8/94 and 12/8/94. The subject was also vaccinated with Tetramune, OPV, MMR for prophylaxis. The subject was the product of a premature twin delivery. The subject was examined on 5/11/95 due to concerns that the subject was dragging her left leg and delayed motor development compared to her twin sister. On 12/13/95, the subject was evaluated for speech and language delays and social development concerns. At that time, she was assessed to have severe language  comprehension and expression delays. Moderate delays in social and emotional skills were also observed. A language reassessment on 2/10/97 showed continued moderate to severe language impairment, with expressive range skills at the fifteen month level. She was diagnosed with speech language impaired. On 10/6/99, the subject was seen in follow up for attention deficit disorder, and in Feb 2000 Ritalin therapy was initiated. In April 2000 the subject was noted to meet the diagnostic criteria for Aspergers syndrome, and had a diagnosis of ADD, inattentive type. Treatment medications in 2000 and 2001 also include Clonidine, Concerta, and Paxil. By Aug 2000, the subject had been diagnosed with pervasive developmental delay. Additional complaints included recurrent headaches, sleep disturbance, and anxiety. According to physicians notes dated 4/14/03, the subjects problems list included pervasive developmental disorder, anorexia, ADD, chronic sinusitis, sleep disorder, and learning disorder. On 8/23/03 the subject presented with ADD and obsessive compulsive disorder, rule out bipolar disorder, rule out psychiatric disorder. This case was assessed to be medically significant by manufacturer (OMIC).
Age: 0.5
Sex: F
Vaccine: HEP, OPV
Symptoms: Gait disturbance, Headache, Hypokinesia, Nervous system disorder, Sinusitis
Clinical narrative: This case was reported by a lawyer and described the occurrence of neurological injury in a male subject who was vaccinated with hepatitis B vaccine (Engerix B) and or unidentified hepatitis B vaccine for prophylaxis. On an unspecified date the subject received unspecified dose of hepatitis B vaccine. According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced neurological damage which was attributed to cumulative mercury toxicity. The following information was received via medical records. the subject was vaccianted with hepatitis B vaccine (manufacturer unspecified) on 7/11/94, 8/8/94 and 12/8/94. The subject was also vaccinated with Tetramune, OPV, MMR for prophylaxis. The subject was the product of a premature twin delivery. The subject was examined on 5/11/95 due to concerns that the subject was dragging her left leg and delayed motor development compared to her twin sister. On 12/13/95, the subject was evaluated for speech and language delays and social development concerns. At that time, she was assessed to have severe language  comprehension and expression delays. Moderate delays in social and emotional skills were also observed. A language reassessment on 2/10/97 showed continued moderate to severe language impairment, with expressive range skills at the fifteen month level. She was diagnosed with speech language impaired. On 10/6/99, the subject was seen in follow up for attention deficit disorder, and in Feb 2000 Ritalin therapy was initiated. In April 2000 the subject was noted to meet the diagnostic criteria for Aspergers syndrome, and had a diagnosis of ADD, inattentive type. Treatment medications in 2000 and 2001 also include Clonidine, Concerta, and Paxil. By Aug 2000, the subject had been diagnosed with pervasive developmental delay. Additional complaints included recurrent headaches, sleep disturbance, and anxiety. According to physicians notes dated 4/14/03, the subjects problems list included pervasive developmental disorder, anorexia, ADD, chronic sinusitis, sleep disorder, and learning disorder. On 8/23/03 the subject presented with ADD and obsessive compulsive disorder, rule out bipolar disorder, rule out psychiatric disorder. This case was assessed to be medically significant by manufacturer (OMIC).
Age: 0.5
Sex: F
Vaccine: HEP, OPV
Symptoms: Sleep disorder, Speech disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of neurological injury in a male subject who was vaccinated with hepatitis B vaccine (Engerix B) and or unidentified hepatitis B vaccine for prophylaxis. On an unspecified date the subject received unspecified dose of hepatitis B vaccine. According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced neurological damage which was attributed to cumulative mercury toxicity. The following information was received via medical records. the subject was vaccianted with hepatitis B vaccine (manufacturer unspecified) on 7/11/94, 8/8/94 and 12/8/94. The subject was also vaccinated with Tetramune, OPV, MMR for prophylaxis. The subject was the product of a premature twin delivery. The subject was examined on 5/11/95 due to concerns that the subject was dragging her left leg and delayed motor development compared to her twin sister. On 12/13/95, the subject was evaluated for speech and language delays and social development concerns. At that time, she was assessed to have severe language  comprehension and expression delays. Moderate delays in social and emotional skills were also observed. A language reassessment on 2/10/97 showed continued moderate to severe language impairment, with expressive range skills at the fifteen month level. She was diagnosed with speech language impaired. On 10/6/99, the subject was seen in follow up for attention deficit disorder, and in Feb 2000 Ritalin therapy was initiated. In April 2000 the subject was noted to meet the diagnostic criteria for Aspergers syndrome, and had a diagnosis of ADD, inattentive type. Treatment medications in 2000 and 2001 also include Clonidine, Concerta, and Paxil. By Aug 2000, the subject had been diagnosed with pervasive developmental delay. Additional complaints included recurrent headaches, sleep disturbance, and anxiety. According to physicians notes dated 4/14/03, the subjects problems list included pervasive developmental disorder, anorexia, ADD, chronic sinusitis, sleep disorder, and learning disorder. On 8/23/03 the subject presented with ADD and obsessive compulsive disorder, rule out bipolar disorder, rule out psychiatric disorder. This case was assessed to be medically significant by manufacturer (OMIC).
Age: 1.98
Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Abnormal behaviour, Affect lability, Aggression, Antisocial behaviour, Autism
Clinical narrative: This case was reported by a lawyer and described the occurrence of neurological damage in a male subject who was vaccinated with hepatitis B vaccine (Engerix B) and or unidentified hep B vaccine for prophylaxis. On an unspecified date the subject received unspecified dose of hep B vaccine. According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced "neurological damage" which was attributed to "cumulative mercury toxicity". The following information was received via medical records. The subject was vaccinated with hep B vaccine, manufacturer unspecified, on 11/4/1992, 8/11/1993, 7/13/1994. The subject was vaccinated with DPTa manufacturer on 09/25/1992, 2/18/1993, and 7/14/1994, and Dtpa on 5/4/1993. The subject was also vaccinated with live attenuated oral poliomyelitis vaccine, Hib, and MMR for prophylaxis. The subject reportedly developed normally until approx two years of age. IN Aug 1995, the subject was diagnosed with a developmental delay, suspect global delay. He was not speaking at that time, and exhibited frustration by tantrums. In Nov 1995, the subject underwent a comprehensive evaluation and demonstrated behaviors consistent with autism including temper tantrums with routine changes, perseveration on fine motor manipulative, abnormal emotional reactions, and failure to communicate normally. He was diagnosed with autism and mental retardation. He was enrolled in a special education program which included speech therapy. On 2/3/1997 the subject was examined for primary concerns of difficult behavior including hitting, throwing things, tantruming, kicking, hitting, and thrashing his body on the floor. On 12/24/1998, previous treatment with Prozac was replaced with Luvox. Upon examination on 2/19/99, the pt was described as restless, irritable, mute not communicating, and was engaging in attention seeking behavior. No physical abnormalities were noted. An updated psychological examination in March 1999 showed overall cognitive function that remained in the mentally deficient range. He continued to exhibit moderately serious behavior problems and maladaptations, including socially inappropriate behaviors within a school setting. This case was assessed to be medically significant by manufacturer (OMIC).
Age: 1.98
Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Drug toxicity, Irritability, Mental retardation severity unspecified, Nervous system disorder, Restlessness
Clinical narrative: This case was reported by a lawyer and described the occurrence of neurological damage in a male subject who was vaccinated with hepatitis B vaccine (Engerix B) and or unidentified hep B vaccine for prophylaxis. On an unspecified date the subject received unspecified dose of hep B vaccine. According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced "neurological damage" which was attributed to "cumulative mercury toxicity". The following information was received via medical records. The subject was vaccinated with hep B vaccine, manufacturer unspecified, on 11/4/1992, 8/11/1993, 7/13/1994. The subject was vaccinated with DPTa manufacturer on 09/25/1992, 2/18/1993, and 7/14/1994, and Dtpa on 5/4/1993. The subject was also vaccinated with live attenuated oral poliomyelitis vaccine, Hib, and MMR for prophylaxis. The subject reportedly developed normally until approx two years of age. IN Aug 1995, the subject was diagnosed with a developmental delay, suspect global delay. He was not speaking at that time, and exhibited frustration by tantrums. In Nov 1995, the subject underwent a comprehensive evaluation and demonstrated behaviors consistent with autism including temper tantrums with routine changes, perseveration on fine motor manipulative, abnormal emotional reactions, and failure to communicate normally. He was diagnosed with autism and mental retardation. He was enrolled in a special education program which included speech therapy. On 2/3/1997 the subject was examined for primary concerns of difficult behavior including hitting, throwing things, tantruming, kicking, hitting, and thrashing his body on the floor. On 12/24/1998, previous treatment with Prozac was replaced with Luvox. Upon examination on 2/19/99, the pt was described as restless, irritable, mute not communicating, and was engaging in attention seeking behavior. No physical abnormalities were noted. An updated psychological examination in March 1999 showed overall cognitive function that remained in the mentally deficient range. He continued to exhibit moderately serious behavior problems and maladaptations, including socially inappropriate behaviors within a school setting. This case was assessed to be medically significant by manufacturer (OMIC).
Age: 1.98
Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Speech disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of neurological damage in a male subject who was vaccinated with hepatitis B vaccine (Engerix B) and or unidentified hep B vaccine for prophylaxis. On an unspecified date the subject received unspecified dose of hep B vaccine. According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced "neurological damage" which was attributed to "cumulative mercury toxicity". The following information was received via medical records. The subject was vaccinated with hep B vaccine, manufacturer unspecified, on 11/4/1992, 8/11/1993, 7/13/1994. The subject was vaccinated with DPTa manufacturer on 09/25/1992, 2/18/1993, and 7/14/1994, and Dtpa on 5/4/1993. The subject was also vaccinated with live attenuated oral poliomyelitis vaccine, Hib, and MMR for prophylaxis. The subject reportedly developed normally until approx two years of age. IN Aug 1995, the subject was diagnosed with a developmental delay, suspect global delay. He was not speaking at that time, and exhibited frustration by tantrums. In Nov 1995, the subject underwent a comprehensive evaluation and demonstrated behaviors consistent with autism including temper tantrums with routine changes, perseveration on fine motor manipulative, abnormal emotional reactions, and failure to communicate normally. He was diagnosed with autism and mental retardation. He was enrolled in a special education program which included speech therapy. On 2/3/1997 the subject was examined for primary concerns of difficult behavior including hitting, throwing things, tantruming, kicking, hitting, and thrashing his body on the floor. On 12/24/1998, previous treatment with Prozac was replaced with Luvox. Upon examination on 2/19/99, the pt was described as restless, irritable, mute not communicating, and was engaging in attention seeking behavior. No physical abnormalities were noted. An updated psychological examination in March 1999 showed overall cognitive function that remained in the mentally deficient range. He continued to exhibit moderately serious behavior problems and maladaptations, including socially inappropriate behaviors within a school setting. This case was assessed to be medically significant by manufacturer (OMIC).
Age: 40.0
Sex: F
Vaccine: HEPAB
Symptoms: Dysgeusia, Fatigue, Myalgia, Neck pain, Paraesthesia
Clinical narrative: This case was reported by a physician and described the occurrence of fatigue in a 40 year old female subject who was vaccinated with Twinrix for prophylaxis. On 9/13/06, the subject received 1st dose of Twinrix (unk). At an unspecified time after vaccination with Twinrix, on or prior to 9/29/06, the subject experienced fatigue, myalgia, metallic taste, tingling to arm, and pain to neck. The subject required a visit to her doctor as a result of these events. The physician considered the events were clinically significant or requiring intervention) (OMIC). At the time of reporting the outcome of the events were unspecified.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Developed redness and swelling around injection site the next am. Increased in size to 12cm diam by 2pm today (9/27). Moderate tenderness and warmth to touch, T 100.6. 9/28/06 hospitalized for IV antibiotics. Varivax given 8/25/06 DC DX: Right thigh cellulitis. Status post varivax injection for DOS 9/28-9/29/06. 9 year old with 3 day history of right thigh swelling 1 day after receiving varivax vaccine in right thigh. Temp at home 101. Erythema and tenderness soon followed was seen in ER that night and received RX of Keflex. Had 2 doses of Kelfex but erythema and tenderness continued to increase. Returned to ER received 1 dose IV Clinidamycin. Had been afebrile no nausea or vomiting. Admitted and received IV clindamycin. Marked improvement in morning with decreased tenderness/erythema. Remained afebrile. After 2nd day of Clindamycin borders of erythema had receded and erythema had reduced to pink blotches. DC on 10 day course of Clindamycin. No labs or diagnostics tests were ordered.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Tenderness
Clinical narrative: Developed redness and swelling around injection site the next am. Increased in size to 12cm diam by 2pm today (9/27). Moderate tenderness and warmth to touch, T 100.6. 9/28/06 hospitalized for IV antibiotics. Varivax given 8/25/06 DC DX: Right thigh cellulitis. Status post varivax injection for DOS 9/28-9/29/06. 9 year old with 3 day history of right thigh swelling 1 day after receiving varivax vaccine in right thigh. Temp at home 101. Erythema and tenderness soon followed was seen in ER that night and received RX of Keflex. Had 2 doses of Kelfex but erythema and tenderness continued to increase. Returned to ER received 1 dose IV Clinidamycin. Had been afebrile no nausea or vomiting. Admitted and received IV clindamycin. Marked improvement in morning with decreased tenderness/erythema. Remained afebrile. After 2nd day of Clindamycin borders of erythema had receded and erythema had reduced to pink blotches. DC on 10 day course of Clindamycin. No labs or diagnostics tests were ordered.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Hypoaesthesia, Neuropathy peripheral, Paralysis
Clinical narrative: 02/14/06 awoke with peripheral neuropathy, 02/17/06 neuropathy progressed and continued to progress including partial left VI palsy., facial dysplasia, lower leg weakness and numbness, 2/18-3/1 received IV steroids, 3/6-3/9/06 got IVIG recovery gradual over next 2-3 months. DC Summary for DOS 02/18-03/01/06 DX:peripheral mononeuropathy multiplex. Possible subacute bacterial endocarditis. Complained of double vision and facial weakness.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Facial palsy, Hypoaesthesia, Muscular weakness, Neuropathy peripheral, Paralysis
Clinical narrative: 02/14/06 awoke with peripheral neuropathy, 02/17/06 neuropathy progressed and continued to progress including partial left VI palsy., facial dysplasia, lower leg weakness and numbness, 2/18-3/1 received IV steroids, 3/6-3/9/06 got IVIG recovery gradual over next 2-3 months. DC Summary for DOS 02/18-03/01/06 DX:peripheral mononeuropathy multiplex. Possible subacute bacterial endocarditis. Complained of double vision and facial weakness.
Age: 51.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Arthritis, Back pain, Hypertension, Insomnia
Clinical narrative: High blood pressure, Insomnia, vision problems, arthritis, back pain, left knee pain. information received from VAMC"no electronic or paper records of this patient for dates requested."
Age: 51.0
Sex: M
Vaccine: ANTH
Symptoms: Visual disturbance
Clinical narrative: High blood pressure, Insomnia, vision problems, arthritis, back pain, left knee pain. information received from VAMC"no electronic or paper records of this patient for dates requested."
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Anaphylactic reaction, Hypersensitivity, Oedema peripheral, Pruritus, Rash
Clinical narrative: Anaphylaxis, treated with IV Benadryl IV fluid bolus and SC epinephrine. 10/05/06-record received for DOS 9/28/06- PE: WNL-assessment prior to immunization: four year old generally doing well, speech articulation issues, innocent heart murmur. Post vaccine office note for DOS 9/28/06-Family enroute to parking lot, mother noted a diffuse rash and the child was very fussy and digging at her skin. She vomited clear mucousy material two or three times. Mother immediately returned to clinic. At the time of assessment she had a diffuse erythematous rash over most of the surface of the body most prominent was the erythema and mild swelling of both hands and feet. She vomited 3 times shortly after arriving into the clinic treatment room, vomitus completely clear except for some greenish material, no blood in vomitus. Peripheral IV started and RX with 10mg of Benadryl IV, appeared to improve over next 5-10 minutes but continued to have gastrointestinal upset and vomited one to two more times. The rash on her back seemed to get worse. Bolus os IV saline approximately 10ml/kg over 20 minutes. BP 70/38. Appeared as though she was going into anaphylactic shock and Epi Pen Jr. 0.15mg administered in left thigh. Also placed on supplemental oxygen as initial pulse ox was 92%. She complained of difficulty breathing but had no stridor or wheezing. Her rash faded within about 30 minutes of administration of epinephrine.  PMH: Significant but localized reaction to her flu shot last year which involved erythema and swelling of the left upper arm. Examination: No swelling of the tongue, lips or pharynx, TM WNL.  Pulse ox normalized at 99% on room air prior to discharge home.  Observed for 3 hours and discharged home on Benadryl and Orapred and provided with an Epi Pen Jr. Follow up visit 9/29/06-No more rash no itching, no coughing drooling or difficulty swallowing. Follow up with Pediatric Allergist. Follow up visit 10/03/06-allergy skin testing was performed with a normal reaction to the histamine control, positive reaction to MMR/Varicella lot number 9758601 for Merck. She did not react to IPV or DTAP. Recommend RAST testing to gelatin.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Vomiting
Clinical narrative: Anaphylaxis, treated with IV Benadryl IV fluid bolus and SC epinephrine. 10/05/06-record received for DOS 9/28/06- PE: WNL-assessment prior to immunization: four year old generally doing well, speech articulation issues, innocent heart murmur. Post vaccine office note for DOS 9/28/06-Family enroute to parking lot, mother noted a diffuse rash and the child was very fussy and digging at her skin. She vomited clear mucousy material two or three times. Mother immediately returned to clinic. At the time of assessment she had a diffuse erythematous rash over most of the surface of the body most prominent was the erythema and mild swelling of both hands and feet. She vomited 3 times shortly after arriving into the clinic treatment room, vomitus completely clear except for some greenish material, no blood in vomitus. Peripheral IV started and RX with 10mg of Benadryl IV, appeared to improve over next 5-10 minutes but continued to have gastrointestinal upset and vomited one to two more times. The rash on her back seemed to get worse. Bolus os IV saline approximately 10ml/kg over 20 minutes. BP 70/38. Appeared as though she was going into anaphylactic shock and Epi Pen Jr. 0.15mg administered in left thigh. Also placed on supplemental oxygen as initial pulse ox was 92%. She complained of difficulty breathing but had no stridor or wheezing. Her rash faded within about 30 minutes of administration of epinephrine.  PMH: Significant but localized reaction to her flu shot last year which involved erythema and swelling of the left upper arm. Examination: No swelling of the tongue, lips or pharynx, TM WNL.  Pulse ox normalized at 99% on room air prior to discharge home.  Observed for 3 hours and discharged home on Benadryl and Orapred and provided with an Epi Pen Jr. Follow up visit 9/29/06-No more rash no itching, no coughing drooling or difficulty swallowing. Follow up with Pediatric Allergist. Follow up visit 10/03/06-allergy skin testing was performed with a normal reaction to the histamine control, positive reaction to MMR/Varicella lot number 9758601 for Merck. She did not react to IPV or DTAP. Recommend RAST testing to gelatin.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Face oedema, Hypoxia, Nausea, Tongue oedema, Urticaria
Clinical narrative: Anaphylaxis, treated with IV Benadryl IV fluid bolus and SC epinephrine. 10/05/06-record received for DOS 9/28/06- PE: WNL-assessment prior to immunization: four year old generally doing well, speech articulation issues, innocent heart murmur. Post vaccine office note for DOS 9/28/06-Family enroute to parking lot, mother noted a diffuse rash and the child was very fussy and digging at her skin. She vomited clear mucousy material two or three times. Mother immediately returned to clinic. At the time of assessment she had a diffuse erythematous rash over most of the surface of the body most prominent was the erythema and mild swelling of both hands and feet. She vomited 3 times shortly after arriving into the clinic treatment room, vomitus completely clear except for some greenish material, no blood in vomitus. Peripheral IV started and RX with 10mg of Benadryl IV, appeared to improve over next 5-10 minutes but continued to have gastrointestinal upset and vomited one to two more times. The rash on her back seemed to get worse. Bolus os IV saline approximately 10ml/kg over 20 minutes. BP 70/38. Appeared as though she was going into anaphylactic shock and Epi Pen Jr. 0.15mg administered in left thigh. Also placed on supplemental oxygen as initial pulse ox was 92%. She complained of difficulty breathing but had no stridor or wheezing. Her rash faded within about 30 minutes of administration of epinephrine.  PMH: Significant but localized reaction to her flu shot last year which involved erythema and swelling of the left upper arm. Examination: No swelling of the tongue, lips or pharynx, TM WNL.  Pulse ox normalized at 99% on room air prior to discharge home.  Observed for 3 hours and discharged home on Benadryl and Orapred and provided with an Epi Pen Jr. Follow up visit 9/29/06-No more rash no itching, no coughing drooling or difficulty swallowing. Follow up with Pediatric Allergist. Follow up visit 10/03/06-allergy skin testing was performed with a normal reaction to the histamine control, positive reaction to MMR/Varicella lot number 9758601 for Merck. She did not react to IPV or DTAP. Recommend RAST testing to gelatin.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Chest pain, Pain
Clinical narrative: Body pain in the knee, arms, hands and chest. This was reported on 11/2/02. sharp pain in right knee during pt run given pain killers and a chit stating that no pt for 3 weeks. C/O during PT session on 11/02/02 felt a sharp pain on his right knee during the run, also said that during the day kept feeling a continuous pain, reported to sick call on the morning of 11/03/02. Received a profile for no running during the next 3 weeks. Seen in clinic patient states pain localized to knee and running makes the pain worse. Exam revealed ROM intact, no swelling noted. Assessment: right knee pain. Exam on 1/6/03, for follow-up for right retropatellar pain syndrome, some improvement noted, some pain in morning but gets better throughout day. Continue follow-up in clinic.
Age: 1.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Acute respiratory failure, Blister, Blood culture negative, Laboratory test abnormal, Pyrexia
Clinical narrative: Per admission record report developed Varivax induced varicella, remains hospitalized 9/29/06. Admitting DX: acute respiratory failure. Dependent exposure 8/29-9/4/06 (5 days prior to 9/2 the date of isolation.). Progress note 9/4/06-continues to spike temps 102.2, increased vesicular type lesion on chest/neck all blood cultures negative. Note of 9/5/06-remains on ventilator, continues to develop new lesion. Decreased renal function, temp 103. Impression: sepsis syndrome, RDS. RX with Acyclovir.  12/19/06-per facility, no DC summary Per 60 day follow up: dischared from hospital to home, Nov. 6, 2006.