chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.27
Sex: M
Vaccine: HEP, HIBV, MMR
Symptoms: Ear pain, Emotional disorder, Hernia, Hypersensitivity, Hyperventilation
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib vaccine was received from medical records via an attorney regarding a male pt who experienced pervasive developmental disorder. The pt receive a Third dose on 3/11/96, along with a first dose of MMR II. Relevant medical history was not provided. Indication for Hib vaccine was immunisation. Product was administered on 3/11/96. Dose regimen was 1 dose 1 time per day IM. Additional suspect medication included Dtap, Ipol, MMR II, Varicella, Dtap, Polio, Engerix B. concomitant medications were not reported. Medical records received form an attorney, alleged that on an unspecified date, the pt experienced pervasive developmental disorder (autism spectrum disorder). The pts outcome is unknown. No additional information was available at the time of this report.
Age: 1.27
Sex: M
Vaccine: HEP, HIBV, MMR
Symptoms: Insomnia, Mental impairment, Mental retardation severity unspecified, Muscle twitching, Nervous system disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib vaccine was received from medical records via an attorney regarding a male pt who experienced pervasive developmental disorder. The pt receive a Third dose on 3/11/96, along with a first dose of MMR II. Relevant medical history was not provided. Indication for Hib vaccine was immunisation. Product was administered on 3/11/96. Dose regimen was 1 dose 1 time per day IM. Additional suspect medication included Dtap, Ipol, MMR II, Varicella, Dtap, Polio, Engerix B. concomitant medications were not reported. Medical records received form an attorney, alleged that on an unspecified date, the pt experienced pervasive developmental disorder (autism spectrum disorder). The pts outcome is unknown. No additional information was available at the time of this report.
Age: 1.27
Sex: M
Vaccine: HEP, HIBV, MMR
Symptoms: Obsessive-compulsive disorder, Otitis media, Pain, Periorbital oedema, Pharyngitis
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib vaccine was received from medical records via an attorney regarding a male pt who experienced pervasive developmental disorder. The pt receive a Third dose on 3/11/96, along with a first dose of MMR II. Relevant medical history was not provided. Indication for Hib vaccine was immunisation. Product was administered on 3/11/96. Dose regimen was 1 dose 1 time per day IM. Additional suspect medication included Dtap, Ipol, MMR II, Varicella, Dtap, Polio, Engerix B. concomitant medications were not reported. Medical records received form an attorney, alleged that on an unspecified date, the pt experienced pervasive developmental disorder (autism spectrum disorder). The pts outcome is unknown. No additional information was available at the time of this report.
Age: 1.27
Sex: M
Vaccine: HEP, HIBV, MMR
Symptoms: Pharyngolaryngeal pain, Pruritus, Psychomotor hyperactivity, Pyrexia, Rash papular
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib vaccine was received from medical records via an attorney regarding a male pt who experienced pervasive developmental disorder. The pt receive a Third dose on 3/11/96, along with a first dose of MMR II. Relevant medical history was not provided. Indication for Hib vaccine was immunisation. Product was administered on 3/11/96. Dose regimen was 1 dose 1 time per day IM. Additional suspect medication included Dtap, Ipol, MMR II, Varicella, Dtap, Polio, Engerix B. concomitant medications were not reported. Medical records received form an attorney, alleged that on an unspecified date, the pt experienced pervasive developmental disorder (autism spectrum disorder). The pts outcome is unknown. No additional information was available at the time of this report.
Age: 1.27
Sex: M
Vaccine: HEP, HIBV, MMR
Symptoms: Rhinitis allergic, Staring, Tic, Tourette's disorder, Tremor
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib vaccine was received from medical records via an attorney regarding a male pt who experienced pervasive developmental disorder. The pt receive a Third dose on 3/11/96, along with a first dose of MMR II. Relevant medical history was not provided. Indication for Hib vaccine was immunisation. Product was administered on 3/11/96. Dose regimen was 1 dose 1 time per day IM. Additional suspect medication included Dtap, Ipol, MMR II, Varicella, Dtap, Polio, Engerix B. concomitant medications were not reported. Medical records received form an attorney, alleged that on an unspecified date, the pt experienced pervasive developmental disorder (autism spectrum disorder). The pts outcome is unknown. No additional information was available at the time of this report.
Age: 1.27
Sex: M
Vaccine: HEP, HIBV, MMR
Symptoms: Upper respiratory tract infection, Viral infection, Weight increased, Wheezing
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib vaccine was received from medical records via an attorney regarding a male pt who experienced pervasive developmental disorder. The pt receive a Third dose on 3/11/96, along with a first dose of MMR II. Relevant medical history was not provided. Indication for Hib vaccine was immunisation. Product was administered on 3/11/96. Dose regimen was 1 dose 1 time per day IM. Additional suspect medication included Dtap, Ipol, MMR II, Varicella, Dtap, Polio, Engerix B. concomitant medications were not reported. Medical records received form an attorney, alleged that on an unspecified date, the pt experienced pervasive developmental disorder (autism spectrum disorder). The pts outcome is unknown. No additional information was available at the time of this report.
Age: 1.27
Sex: M
Vaccine: HEP, HIBV, MMR
Symptoms: Autism
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib vaccine was received from medical records via an attorney regarding a male pt who experienced pervasive developmental disorder. The pt receive a Third dose on 3/11/96, along with a first dose of MMR II. Relevant medical history was not provided. Indication for Hib vaccine was immunisation. Product was administered on 3/11/96. Dose regimen was 1 dose 1 time per day IM. Additional suspect medication included Dtap, Ipol, MMR II, Varicella, Dtap, Polio, Engerix B. concomitant medications were not reported. Medical records received form an attorney, alleged that on an unspecified date, the pt experienced pervasive developmental disorder (autism spectrum disorder). The pts outcome is unknown. No additional information was available at the time of this report.
Age: 1.51
Sex: M
Vaccine: HEP, HIBV, PNC
Symptoms: Abnormal behaviour, Aggression, Anxiety, Autism, Bipolar disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib titer vaccine was received from an attorney via medical records regarding a male pt who experienced pervasive development disorder, disruptive disorder, separation anxiety disorder and bipolar disorder. The pt received a dose on 10/12/2000. The pt also received a dose of Prevnar on 10/12/2000. History of substance abuse and alcohol dependence on maternal side of family. History of mood disorder (father recently killed himself) on paternal side of family. The pt was exposed to nicotine in utero. Indication for Hib titer vaccine was immunisation. Product was administered on 10/12/00. Dose regimen was 1 dose 1 time per day IM. Additional suspect medication included Dtp/Hib, , Tripacel, Fluzone, Engerix B, Polio, MMR II, Varivax, and Prevnar. Concomitant medications were not reported. On an unspecified date, the pt developed pervasive development disorder (autism spectrum disorder), disruptive disorder (conduct disorder), separation anxiety disorder (mental disorder) and Bipolar disorder. No additional information was available at the time of this report.
Age: 1.51
Sex: M
Vaccine: HEP, HIBV, PNC
Symptoms: Drug toxicity, Encopresis, Enuresis, Lymphadenopathy, Mental retardation severity unspecified
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib titer vaccine was received from an attorney via medical records regarding a male pt who experienced pervasive development disorder, disruptive disorder, separation anxiety disorder and bipolar disorder. The pt received a dose on 10/12/2000. The pt also received a dose of Prevnar on 10/12/2000. History of substance abuse and alcohol dependence on maternal side of family. History of mood disorder (father recently killed himself) on paternal side of family. The pt was exposed to nicotine in utero. Indication for Hib titer vaccine was immunisation. Product was administered on 10/12/00. Dose regimen was 1 dose 1 time per day IM. Additional suspect medication included Dtp/Hib, , Tripacel, Fluzone, Engerix B, Polio, MMR II, Varivax, and Prevnar. Concomitant medications were not reported. On an unspecified date, the pt developed pervasive development disorder (autism spectrum disorder), disruptive disorder (conduct disorder), separation anxiety disorder (mental disorder) and Bipolar disorder. No additional information was available at the time of this report.
Age: 1.51
Sex: M
Vaccine: HEP, HIBV, PNC
Symptoms: Nervous system disorder, Otitis media, Psychomotor hyperactivity, Rash, Speech disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib titer vaccine was received from an attorney via medical records regarding a male pt who experienced pervasive development disorder, disruptive disorder, separation anxiety disorder and bipolar disorder. The pt received a dose on 10/12/2000. The pt also received a dose of Prevnar on 10/12/2000. History of substance abuse and alcohol dependence on maternal side of family. History of mood disorder (father recently killed himself) on paternal side of family. The pt was exposed to nicotine in utero. Indication for Hib titer vaccine was immunisation. Product was administered on 10/12/00. Dose regimen was 1 dose 1 time per day IM. Additional suspect medication included Dtp/Hib, , Tripacel, Fluzone, Engerix B, Polio, MMR II, Varivax, and Prevnar. Concomitant medications were not reported. On an unspecified date, the pt developed pervasive development disorder (autism spectrum disorder), disruptive disorder (conduct disorder), separation anxiety disorder (mental disorder) and Bipolar disorder. No additional information was available at the time of this report.
Age: 1.51
Sex: M
Vaccine: HEP, HIBV, PNC
Symptoms: Upper respiratory tract infection
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib titer vaccine was received from an attorney via medical records regarding a male pt who experienced pervasive development disorder, disruptive disorder, separation anxiety disorder and bipolar disorder. The pt received a dose on 10/12/2000. The pt also received a dose of Prevnar on 10/12/2000. History of substance abuse and alcohol dependence on maternal side of family. History of mood disorder (father recently killed himself) on paternal side of family. The pt was exposed to nicotine in utero. Indication for Hib titer vaccine was immunisation. Product was administered on 10/12/00. Dose regimen was 1 dose 1 time per day IM. Additional suspect medication included Dtp/Hib, , Tripacel, Fluzone, Engerix B, Polio, MMR II, Varivax, and Prevnar. Concomitant medications were not reported. On an unspecified date, the pt developed pervasive development disorder (autism spectrum disorder), disruptive disorder (conduct disorder), separation anxiety disorder (mental disorder) and Bipolar disorder. No additional information was available at the time of this report.
Age: 1.51
Sex: M
Vaccine: HEP, HIBV, PNC
Symptoms: Abnormal behaviour, Anxiety, Autism, Bipolar I disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib titer vaccine was received from an attorney via medical records regarding a male pt who experienced pervasive development disorder, disruptive disorder, separation anxiety disorder and bipolar disorder. The pt received a dose on 10/12/2000. The pt also received a dose of Prevnar on 10/12/2000. History of substance abuse and alcohol dependence on maternal side of family. History of mood disorder (father recently killed himself) on paternal side of family. The pt was exposed to nicotine in utero. Indication for Hib titer vaccine was immunisation. Product was administered on 10/12/00. Dose regimen was 1 dose 1 time per day IM. Additional suspect medication included Dtp/Hib, , Tripacel, Fluzone, Engerix B, Polio, MMR II, Varivax, and Prevnar. Concomitant medications were not reported. On an unspecified date, the pt developed pervasive development disorder (autism spectrum disorder), disruptive disorder (conduct disorder), separation anxiety disorder (mental disorder) and Bipolar disorder. No additional information was available at the time of this report.
Age: 1.69
Sex: M
Vaccine: MMR, HIBV
Symptoms: Abnormal behaviour, Aggression, Antisocial behaviour, Anxiety, Bronchiolitis
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib vaccine was received from medical records via an attorney regarding a male pt who experienced disruptive behavior disorder, borderline mental retardation and pervasive developmental disorder. The pt received the first dose on 8/22/90. The pts concurrent illness include flat feet. Indication for Hib titer vaccine was immunisation. Product was administered on 8/22/90. Dose regimen was 1 dose 1 time per day. Additional suspect medication include Dtp, Polio and MMR. Concomitant medications were not reported. Medical records received from a attorney, alleged that on unspecified dates, the pt having received a dose of Hib vaccine, along with other childhood vaccines, experienced disruptive behavior disorder (conduct disorder), borderline mental retardation, and pervasive developmental disorder (Autism spectrum disorder). The pts outcome was unk. No additional information was available at the time of this report.
Age: 1.69
Sex: M
Vaccine: MMR, HIBV
Symptoms: Depression, Drug toxicity, Flatulence, Hearing impaired, Hypersensitivity
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib vaccine was received from medical records via an attorney regarding a male pt who experienced disruptive behavior disorder, borderline mental retardation and pervasive developmental disorder. The pt received the first dose on 8/22/90. The pts concurrent illness include flat feet. Indication for Hib titer vaccine was immunisation. Product was administered on 8/22/90. Dose regimen was 1 dose 1 time per day. Additional suspect medication include Dtp, Polio and MMR. Concomitant medications were not reported. Medical records received from a attorney, alleged that on unspecified dates, the pt having received a dose of Hib vaccine, along with other childhood vaccines, experienced disruptive behavior disorder (conduct disorder), borderline mental retardation, and pervasive developmental disorder (Autism spectrum disorder). The pts outcome was unk. No additional information was available at the time of this report.
Age: 1.69
Sex: M
Vaccine: MMR, HIBV
Symptoms: Hypokinesia, Mental impairment, Mental retardation severity unspecified, Nervous system disorder, Otitis media
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib vaccine was received from medical records via an attorney regarding a male pt who experienced disruptive behavior disorder, borderline mental retardation and pervasive developmental disorder. The pt received the first dose on 8/22/90. The pts concurrent illness include flat feet. Indication for Hib titer vaccine was immunisation. Product was administered on 8/22/90. Dose regimen was 1 dose 1 time per day. Additional suspect medication include Dtp, Polio and MMR. Concomitant medications were not reported. Medical records received from a attorney, alleged that on unspecified dates, the pt having received a dose of Hib vaccine, along with other childhood vaccines, experienced disruptive behavior disorder (conduct disorder), borderline mental retardation, and pervasive developmental disorder (Autism spectrum disorder). The pts outcome was unk. No additional information was available at the time of this report.
Age: 1.69
Sex: M
Vaccine: MMR, HIBV
Symptoms: Rash, Repetitive speech, Respiratory syncytial virus infection, Speech disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib vaccine was received from medical records via an attorney regarding a male pt who experienced disruptive behavior disorder, borderline mental retardation and pervasive developmental disorder. The pt received the first dose on 8/22/90. The pts concurrent illness include flat feet. Indication for Hib titer vaccine was immunisation. Product was administered on 8/22/90. Dose regimen was 1 dose 1 time per day. Additional suspect medication include Dtp, Polio and MMR. Concomitant medications were not reported. Medical records received from a attorney, alleged that on unspecified dates, the pt having received a dose of Hib vaccine, along with other childhood vaccines, experienced disruptive behavior disorder (conduct disorder), borderline mental retardation, and pervasive developmental disorder (Autism spectrum disorder). The pts outcome was unk. No additional information was available at the time of this report.
Age: 1.69
Sex: M
Vaccine: MMR, HIBV
Symptoms: Abnormal behaviour, Autism, Mental retardation severity unspecified
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib vaccine was received from medical records via an attorney regarding a male pt who experienced disruptive behavior disorder, borderline mental retardation and pervasive developmental disorder. The pt received the first dose on 8/22/90. The pts concurrent illness include flat feet. Indication for Hib titer vaccine was immunisation. Product was administered on 8/22/90. Dose regimen was 1 dose 1 time per day. Additional suspect medication include Dtp, Polio and MMR. Concomitant medications were not reported. Medical records received from a attorney, alleged that on unspecified dates, the pt having received a dose of Hib vaccine, along with other childhood vaccines, experienced disruptive behavior disorder (conduct disorder), borderline mental retardation, and pervasive developmental disorder (Autism spectrum disorder). The pts outcome was unk. No additional information was available at the time of this report.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, HIBV, IPV
Symptoms: Aggression, Antisocial behaviour, Anxiety, Aphasia, Autism
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib titer vaccine was received from an attorney regarding a male pt who received the fourth dose on 11/1/95. The pt also received the fourth dose of Polio on the same day. At the age of 31 months pt was diagnosed with pervasive developmental disorder and moderate mental retardation. At six years of age, the pt was diagnosed with ADHD. Relevant medical history was not provided. Indication for Hib titer vaccine was immunisation. Product was administered on 11/01/95. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Polio, MMR, TD, Hep B and Dtp. Concomitant medications were not reported. On 12/16/1993, as age of 31 months, pt was diagnosed with pervasive developmental disorder (autism spectrum disorder) and moderate mental retardation. Upon exam it was noted that pt appeared health but has some of the features of PDD as well as overall developmental delays in the mental retardation range. On 2/26/98 when pat was 6 years old an additional event of ADHD was also noted. During exam, physician noted that inattention and hyperactivity were extremely high, although for brief periods pt was able to absorb himself in looking at books. Pt was also bouncing up and down.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, HIBV, IPV
Symptoms: Enuresis, Hypertonia, Laboratory test abnormal, Mental retardation severity unspecified, Neurodevelopmental disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib titer vaccine was received from an attorney regarding a male pt who received the fourth dose on 11/1/95. The pt also received the fourth dose of Polio on the same day. At the age of 31 months pt was diagnosed with pervasive developmental disorder and moderate mental retardation. At six years of age, the pt was diagnosed with ADHD. Relevant medical history was not provided. Indication for Hib titer vaccine was immunisation. Product was administered on 11/01/95. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Polio, MMR, TD, Hep B and Dtp. Concomitant medications were not reported. On 12/16/1993, as age of 31 months, pt was diagnosed with pervasive developmental disorder (autism spectrum disorder) and moderate mental retardation. Upon exam it was noted that pt appeared health but has some of the features of PDD as well as overall developmental delays in the mental retardation range. On 2/26/98 when pat was 6 years old an additional event of ADHD was also noted. During exam, physician noted that inattention and hyperactivity were extremely high, although for brief periods pt was able to absorb himself in looking at books. Pt was also bouncing up and down.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, HIBV, IPV
Symptoms: Psychomotor hyperactivity, Tremor
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib titer vaccine was received from an attorney regarding a male pt who received the fourth dose on 11/1/95. The pt also received the fourth dose of Polio on the same day. At the age of 31 months pt was diagnosed with pervasive developmental disorder and moderate mental retardation. At six years of age, the pt was diagnosed with ADHD. Relevant medical history was not provided. Indication for Hib titer vaccine was immunisation. Product was administered on 11/01/95. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Polio, MMR, TD, Hep B and Dtp. Concomitant medications were not reported. On 12/16/1993, as age of 31 months, pt was diagnosed with pervasive developmental disorder (autism spectrum disorder) and moderate mental retardation. Upon exam it was noted that pt appeared health but has some of the features of PDD as well as overall developmental delays in the mental retardation range. On 2/26/98 when pat was 6 years old an additional event of ADHD was also noted. During exam, physician noted that inattention and hyperactivity were extremely high, although for brief periods pt was able to absorb himself in looking at books. Pt was also bouncing up and down.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, HIBV, IPV
Symptoms: Autism, Mental retardation severity unspecified, Psychomotor hyperactivity
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib titer vaccine was received from an attorney regarding a male pt who received the fourth dose on 11/1/95. The pt also received the fourth dose of Polio on the same day. At the age of 31 months pt was diagnosed with pervasive developmental disorder and moderate mental retardation. At six years of age, the pt was diagnosed with ADHD. Relevant medical history was not provided. Indication for Hib titer vaccine was immunisation. Product was administered on 11/01/95. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Polio, MMR, TD, Hep B and Dtp. Concomitant medications were not reported. On 12/16/1993, as age of 31 months, pt was diagnosed with pervasive developmental disorder (autism spectrum disorder) and moderate mental retardation. Upon exam it was noted that pt appeared health but has some of the features of PDD as well as overall developmental delays in the mental retardation range. On 2/26/98 when pat was 6 years old an additional event of ADHD was also noted. During exam, physician noted that inattention and hyperactivity were extremely high, although for brief periods pt was able to absorb himself in looking at books. Pt was also bouncing up and down.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: Swelling at site of injection.  Doctor said possible infection.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Carbon dioxide decreased, Pallor, Vomiting, White blood cell count increased
Clinical narrative: Severe vomiting and pallor.  WBC increase 41, 500 with 54% Neutrophils, 17% bands CO2 low at 15, glucose 154, BUN 8, Creatinine 0.2, symptoms completely resolved following day.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea haemorrhagic
Clinical narrative: Information has been received from a physician concerning an infant who was vaccinated PO with a 2.0 ml dose of rotavirus vaccine. The physician reported that the infant subsequently developed diarrhea. The physician noted that the baby's mother thought she saw blood in the diarrhea, but the pt was not seen in the office. At the time of this report, the outcome was unk. Upon internal review, blood in diarrhea was determined to be an other important medical event (OMIC). Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypersensitivity, Pruritus, Rash pruritic
Clinical narrative: Initial report received on 10/3/06 from a health care professional. A 50 year old female pt, with an allergy to Vicodin and Penicillin, had received a left deltoid dose of Fluzone SV 2006-2007 USP, lot number U2192AA, on 10/3/06. The route of administration was not reported. The pt experienced a sudden onset of itching and rash at the injection site on 10/3/06. She required medical evaluation and was treated with Solu Medrol and Zyrtec. The recovery status of the pt was reported as unk. The reporter for this case is the same as for case 200602586. (OMIC)
Age: 12.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Chest pain, Heart rate increased, Hyperhidrosis, Malaise, Respiratory rate increased
Clinical narrative: Serious post marketed study vase from a Nurse of chest pain considered medically important.  The reporter causality is possible top Flu Mist.  This is a case involving a 12-year-old female patient with unknown medical history who received Flu Mist VACCINATION ON 03oCT06.  Ten minutes after receiving Flu Mist, this patient returned to the clinic complaining of "not feeling right".  According to the nurse who was present at the clinic, the patient exhibited "diaphoresis" and "rapid respiration".  Patient's pulse rate was "over 150" (sitting) and patient began to complain of having "chest pain" (supine).  There were no complaints of shortness of breath, radiation of pain, nausea or vomiting, dizziness, anxiety, or loss of consciousness.  Paramedics were called and the patient's blood pressure ("160/80", no baseline BP available) was taken.  As the patient was waiting for an ambulance, she complained that he "throat felt funny".  After clearing her throat,the patient indicated that the throat symptom had completed dissipated.  The paramedics and the patient's father arrived at the scene five minutes later and the patient was taken to the emergency room.  The reporter denies that the patient was on any medications, including aspririn-containing therapy, prior to Flu Mist vaccination.  The patient's father denies this patient having any allergies or hypersensitivity to eggs or egg products.  According to the reporter, however, there is a history of patient hospitalization "about a year ago for stomach problems".  The patient was "told by the hospital not to eat eggs, corns and wheat".  The outcome of the events is unknown at this time.  A request was made to the reporter to forward all relevant follow up medical documentation's obtained on this patient to Product Safety.  The investigator causality is possible to Flu Mist. (OMIC) Per information from annual follow up: Subject recommende to receive regular counseling therapy-No additional information expected from the reporter. 07-Mar-2008
Age: 12.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Chest pain, Cold sweat, Heart rate increased, Hyperhidrosis, Hypertension
Clinical narrative: Serious post marketed study vase from a Nurse of chest pain considered medically important.  The reporter causality is possible top Flu Mist.  This is a case involving a 12-year-old female patient with unknown medical history who received Flu Mist VACCINATION ON 03oCT06.  Ten minutes after receiving Flu Mist, this patient returned to the clinic complaining of "not feeling right".  According to the nurse who was present at the clinic, the patient exhibited "diaphoresis" and "rapid respiration".  Patient's pulse rate was "over 150" (sitting) and patient began to complain of having "chest pain" (supine).  There were no complaints of shortness of breath, radiation of pain, nausea or vomiting, dizziness, anxiety, or loss of consciousness.  Paramedics were called and the patient's blood pressure ("160/80", no baseline BP available) was taken.  As the patient was waiting for an ambulance, she complained that he "throat felt funny".  After clearing her throat,the patient indicated that the throat symptom had completed dissipated.  The paramedics and the patient's father arrived at the scene five minutes later and the patient was taken to the emergency room.  The reporter denies that the patient was on any medications, including aspririn-containing therapy, prior to Flu Mist vaccination.  The patient's father denies this patient having any allergies or hypersensitivity to eggs or egg products.  According to the reporter, however, there is a history of patient hospitalization "about a year ago for stomach problems".  The patient was "told by the hospital not to eat eggs, corns and wheat".  The outcome of the events is unknown at this time.  A request was made to the reporter to forward all relevant follow up medical documentation's obtained on this patient to Product Safety.  The investigator causality is possible to Flu Mist. (OMIC) Per information from annual follow up: Subject recommende to receive regular counseling therapy-No additional information expected from the reporter. 07-Mar-2008
Age: 12.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Pallor
Clinical narrative: Serious post marketed study vase from a Nurse of chest pain considered medically important.  The reporter causality is possible top Flu Mist.  This is a case involving a 12-year-old female patient with unknown medical history who received Flu Mist VACCINATION ON 03oCT06.  Ten minutes after receiving Flu Mist, this patient returned to the clinic complaining of "not feeling right".  According to the nurse who was present at the clinic, the patient exhibited "diaphoresis" and "rapid respiration".  Patient's pulse rate was "over 150" (sitting) and patient began to complain of having "chest pain" (supine).  There were no complaints of shortness of breath, radiation of pain, nausea or vomiting, dizziness, anxiety, or loss of consciousness.  Paramedics were called and the patient's blood pressure ("160/80", no baseline BP available) was taken.  As the patient was waiting for an ambulance, she complained that he "throat felt funny".  After clearing her throat,the patient indicated that the throat symptom had completed dissipated.  The paramedics and the patient's father arrived at the scene five minutes later and the patient was taken to the emergency room.  The reporter denies that the patient was on any medications, including aspririn-containing therapy, prior to Flu Mist vaccination.  The patient's father denies this patient having any allergies or hypersensitivity to eggs or egg products.  According to the reporter, however, there is a history of patient hospitalization "about a year ago for stomach problems".  The patient was "told by the hospital not to eat eggs, corns and wheat".  The outcome of the events is unknown at this time.  A request was made to the reporter to forward all relevant follow up medical documentation's obtained on this patient to Product Safety.  The investigator causality is possible to Flu Mist. (OMIC) Per information from annual follow up: Subject recommende to receive regular counseling therapy-No additional information expected from the reporter. 07-Mar-2008
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hypokinesia, Pain, Vaccine positive rechallenge
Clinical narrative: Took flu shot Friday and Sunday morning went to mail box and had weakness in legs.  Could not walk so she crawled to her house and up stairs to call her daughter on the phone.  Blood pressure and pulse were normal.  Admitted to hospital for tests.  Doctor stated all tests negative.  She had same symptoms the past two years after flu vaccine but didn't relate these symptoms with the flu shot.  The symptoms have progressively worsened since the first ones 3 years ago.  Medical doctor recommended no further flu shots and reported it to our health department.  Stated after two days her symptoms ceased and she had no further problems.  Still has a little soreness in the thighs, but she can walk without difficulty.  Instructed client I would fill out form and she might be contacted.  Instructed her not to take any further vaccines in future.
Age: 80.0
Sex: F
Vaccine: TD
Symptoms: Blood pressure increased, Dizziness, Headache, Heart rate increased, Hypersensitivity
Clinical narrative: About 5-10 minutes after receiving the vaccine, the pt complained of a slight headache and feeling dizzy. Her BP was 150/70, P 72 (prior to vaccine bp was 140/56, P 68) 5-10 minutes later she reported she was fine. She went and had lunch. About 1 1/2 hours after vaccine she had a syncope spell when driving and had a minor leg injury. She called me about 1 1/2 hour later and was advised to go to the ER, while there, she was given Nuban, which she had a reaction to and was then hospitalized. 10/31/06 Received medical records from hospital which reveal patient admitted 6/10/06-6/12/06.  Presented to ER after syncopal episode involving a minor car accident.  Given Nubain in ER for pain control where she developed AE.   PMH: hypothyroidism; HTN; hx of a fib; GERD; OA; DM; & osteoporosis.  S/P nephrectomy for renal cell ca, 1979.    Final Dx: syncope, no clear etiology. Cardiac arrhythmia cannot be r/o.  loop monitor to be done as outpatient; mild bradycardia; severe reaction to pain med, Nubain, w/N&V; developed rapid a fib s/p IV Nubain, & converted to NSR. Secondary Dx: hypothyroidism; HTN; PAT; GERD; OA; & osteoporosis./ss
Age: 80.0
Sex: F
Vaccine: TD
Symptoms: Injury, Syncope
Clinical narrative: About 5-10 minutes after receiving the vaccine, the pt complained of a slight headache and feeling dizzy. Her BP was 150/70, P 72 (prior to vaccine bp was 140/56, P 68) 5-10 minutes later she reported she was fine. She went and had lunch. About 1 1/2 hours after vaccine she had a syncope spell when driving and had a minor leg injury. She called me about 1 1/2 hour later and was advised to go to the ER, while there, she was given Nuban, which she had a reaction to and was then hospitalized. 10/31/06 Received medical records from hospital which reveal patient admitted 6/10/06-6/12/06.  Presented to ER after syncopal episode involving a minor car accident.  Given Nubain in ER for pain control where she developed AE.   PMH: hypothyroidism; HTN; hx of a fib; GERD; OA; DM; & osteoporosis.  S/P nephrectomy for renal cell ca, 1979.    Final Dx: syncope, no clear etiology. Cardiac arrhythmia cannot be r/o.  loop monitor to be done as outpatient; mild bradycardia; severe reaction to pain med, Nubain, w/N&V; developed rapid a fib s/p IV Nubain, & converted to NSR. Secondary Dx: hypothyroidism; HTN; PAT; GERD; OA; & osteoporosis./ss
Age: 19.0
Sex: M
Vaccine: MEN
Symptoms: Chills, Fatigue, Hypotension, Laboratory test abnormal, Leukopenia
Clinical narrative: 24 hrs after vaccine fatigue, 102 fever, malaise, 48 hrs after vaccine increased fever 103.4 so went to emergency dept of evaluation, 2 low blood pressure readings but of questionable accuracy, normal blood pressure later. 72 hrs after vaccine decreased white blood cells to 1.7 then trending back to normal, physicians thought viral infection not 2 vaccine, 1 week later, entirely back to normal.  10/26/06 Received medical records from hospital which reveal patient admitted 5/29/06 w/leukopenia, thrombocytopenia & history of EBV infection 3/06. Patient had fever, chills & severe malaise. Consults by hematology & infectious disease were done which revealed dx: process possibly secondary to EBV, possible connective tissue disorder & other viral infection including DMV & HIV.  Heme reviewed blood smear & found atypical lymphocytes w/o blastic forms.  Heme thought process related to acute EBV infection recently.  ID recommended rechecking labs. CT was to be scheduled. Patient reported that symptoms from EBV had been improving until received menomune vax 5/26. PMH: exercise induced asthma, acne, mono 3/06.  Hospital Course: temp max 103, decreased appetite.  On doxycycline for several years for acne which was d/c as possible cause of aplastic anemia.  10/27/06 Received t/c from hospital med records dept which stated patient admitted on 5/29/06 & d/c on 5/30./ss 10/26/06 Received medical records from PCP which reveal patient seen 3/10/06 wfever & body aches.  Strep test neg. Dx: mild pharyngitis, mild rash.  Patient not improved by 3/15.  Parent requested mono test on 3/21. 10/30/06 Received note from hematologist that all medical records were part of the hospital records/ss
Age: 19.0
Sex: M
Vaccine: MEN
Symptoms: Malaise, Pyrexia, Viral infection, White blood cell count decreased
Clinical narrative: 24 hrs after vaccine fatigue, 102 fever, malaise, 48 hrs after vaccine increased fever 103.4 so went to emergency dept of evaluation, 2 low blood pressure readings but of questionable accuracy, normal blood pressure later. 72 hrs after vaccine decreased white blood cells to 1.7 then trending back to normal, physicians thought viral infection not 2 vaccine, 1 week later, entirely back to normal.  10/26/06 Received medical records from hospital which reveal patient admitted 5/29/06 w/leukopenia, thrombocytopenia & history of EBV infection 3/06. Patient had fever, chills & severe malaise. Consults by hematology & infectious disease were done which revealed dx: process possibly secondary to EBV, possible connective tissue disorder & other viral infection including DMV & HIV.  Heme reviewed blood smear & found atypical lymphocytes w/o blastic forms.  Heme thought process related to acute EBV infection recently.  ID recommended rechecking labs. CT was to be scheduled. Patient reported that symptoms from EBV had been improving until received menomune vax 5/26. PMH: exercise induced asthma, acne, mono 3/06.  Hospital Course: temp max 103, decreased appetite.  On doxycycline for several years for acne which was d/c as possible cause of aplastic anemia.  10/27/06 Received t/c from hospital med records dept which stated patient admitted on 5/29/06 & d/c on 5/30./ss 10/26/06 Received medical records from PCP which reveal patient seen 3/10/06 wfever & body aches.  Strep test neg. Dx: mild pharyngitis, mild rash.  Patient not improved by 3/15.  Parent requested mono test on 3/21. 10/30/06 Received note from hematologist that all medical records were part of the hospital records/ss
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Hypoaesthesia
Clinical narrative: Pain in joints and numbness in arms and legs.
Age: 51.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Unevaluable event
Clinical narrative: BLANK
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Alopecia, Anger, Anxiety, Arthralgia, Back pain
Clinical narrative: Obesity, impaired fasting glucose, chronic low back, elevated liver function tests, health maintenance, osteoarthrosis, fibromyalgia, acute gastritis, burning sensation (chest), depression, Acid reflux, bone ache, joints ache, loss of concentration, high cholesterol, low hemoglobin, low hematocrit, low MCV, low MCH, low PLT, hair loss, headaches, memory bad, anxious, angry, irritable, pain legs back knee, Charlie horse, insomnia, weight gain, allergies.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Blood cholesterol increased, Bone pain, Chest pain, Depression, Disturbance in attention
Clinical narrative: Obesity, impaired fasting glucose, chronic low back, elevated liver function tests, health maintenance, osteoarthrosis, fibromyalgia, acute gastritis, burning sensation (chest), depression, Acid reflux, bone ache, joints ache, loss of concentration, high cholesterol, low hemoglobin, low hematocrit, low MCV, low MCH, low PLT, hair loss, headaches, memory bad, anxious, angry, irritable, pain legs back knee, Charlie horse, insomnia, weight gain, allergies.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Fibromyalgia, Gastritis, Gastrooesophageal reflux disease, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Obesity, impaired fasting glucose, chronic low back, elevated liver function tests, health maintenance, osteoarthrosis, fibromyalgia, acute gastritis, burning sensation (chest), depression, Acid reflux, bone ache, joints ache, loss of concentration, high cholesterol, low hemoglobin, low hematocrit, low MCV, low MCH, low PLT, hair loss, headaches, memory bad, anxious, angry, irritable, pain legs back knee, Charlie horse, insomnia, weight gain, allergies.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Hypersensitivity, Insomnia, Laboratory test abnormal, Liver function test abnormal
Clinical narrative: Obesity, impaired fasting glucose, chronic low back, elevated liver function tests, health maintenance, osteoarthrosis, fibromyalgia, acute gastritis, burning sensation (chest), depression, Acid reflux, bone ache, joints ache, loss of concentration, high cholesterol, low hemoglobin, low hematocrit, low MCV, low MCH, low PLT, hair loss, headaches, memory bad, anxious, angry, irritable, pain legs back knee, Charlie horse, insomnia, weight gain, allergies.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Memory impairment, Muscle spasms, Obesity, Osteoarthritis, Platelet count decreased
Clinical narrative: Obesity, impaired fasting glucose, chronic low back, elevated liver function tests, health maintenance, osteoarthrosis, fibromyalgia, acute gastritis, burning sensation (chest), depression, Acid reflux, bone ache, joints ache, loss of concentration, high cholesterol, low hemoglobin, low hematocrit, low MCV, low MCH, low PLT, hair loss, headaches, memory bad, anxious, angry, irritable, pain legs back knee, Charlie horse, insomnia, weight gain, allergies.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Weight increased
Clinical narrative: Obesity, impaired fasting glucose, chronic low back, elevated liver function tests, health maintenance, osteoarthrosis, fibromyalgia, acute gastritis, burning sensation (chest), depression, Acid reflux, bone ache, joints ache, loss of concentration, high cholesterol, low hemoglobin, low hematocrit, low MCV, low MCH, low PLT, hair loss, headaches, memory bad, anxious, angry, irritable, pain legs back knee, Charlie horse, insomnia, weight gain, allergies.
Age: 62.0
Sex: M
Vaccine: ANTH
Symptoms: Alopecia, Amnesia, Arthralgia, Depression, Diarrhoea
Clinical narrative: Gastritis, Diarrhea, joint pain, lost hair, memory lost, depression, tendonitis, tinea versicolor, erectile dysfunction, treatment in hospital.   11/16/06 Received medical records from VAMC which reveal patient fell while on active duty in Kuwait in 2002 fracturing both wrists (with resulting intraarticular damage) & left shoulder.  Also has DDD w/disc herniation & bulge at multiple levels with cord compression at C6-7. Other medical history includes cervical disc disease w/myelopathy, left shoulder pain w/paresthesia, polyarthralgia, GERD, hyperlipidemia, major depression w/psychotic features & psych hospital admission(9/03), hearing loss, supraspinatus tendinosis of left shoulder, erectile dysfunction, reflex sympathetic dystrophy of left arm, tinea versicolor, HTN, peripheral neuropathy, hiatal hernia, insomnia, left knee DJD.  Treated for pain with multiple rounds of PT/OT, surgery for release of left trigger finger contracture.  Currently undergoing neurosurg eval for cervical decompression.
Age: 62.0
Sex: M
Vaccine: ANTH
Symptoms: Erectile dysfunction, Fungal infection, Gastritis, Tendonitis
Clinical narrative: Gastritis, Diarrhea, joint pain, lost hair, memory lost, depression, tendonitis, tinea versicolor, erectile dysfunction, treatment in hospital.   11/16/06 Received medical records from VAMC which reveal patient fell while on active duty in Kuwait in 2002 fracturing both wrists (with resulting intraarticular damage) & left shoulder.  Also has DDD w/disc herniation & bulge at multiple levels with cord compression at C6-7. Other medical history includes cervical disc disease w/myelopathy, left shoulder pain w/paresthesia, polyarthralgia, GERD, hyperlipidemia, major depression w/psychotic features & psych hospital admission(9/03), hearing loss, supraspinatus tendinosis of left shoulder, erectile dysfunction, reflex sympathetic dystrophy of left arm, tinea versicolor, HTN, peripheral neuropathy, hiatal hernia, insomnia, left knee DJD.  Treated for pain with multiple rounds of PT/OT, surgery for release of left trigger finger contracture.  Currently undergoing neurosurg eval for cervical decompression.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Neck pain, Pain, Pyrexia
Clinical narrative: 10/09/06 c/o left arm pain since Tdap injection 10/04/06, pain radiates up to neck and scupular region. Day of injection temp 101. Pain is improving. Continuing using Ibuprofen and Benadryl and heat.
Age: 1.09
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC
Symptoms: Erythema, Rash, Rash erythematous
Clinical narrative: Wed 9/27 flat red circular rash head trunk then spread to arms not itchy, 9/30 cleared, Mon 10/2 started no other s/s, 10/03 bright red larger circular slightly raised rash head trunk arms, 1/04 more rash face spread down legs, on palms, sides of feet no other s/s, 10/05 rash head to toe still visible but very light in color, clearing.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper
Clinical narrative: 7/10/06 reported pain to right upper extremity, Went to Dr for treatment. Tdap given in left deltoid.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction
Clinical narrative: Reaction happen about 10 minutes after shot (nickel size per mom). Then later that day the area began to get bigger in size. Pt was seen the next morning (10/10/06).
Age: 1.42
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Erythema multiforme, Oedema, Skin ulcer, Urticaria
Clinical narrative: Developed an urticarial/erythema multiforme type (target lesions) rash on 10/04 with erythema and swelling of knees and elbows and some involvement of wrists. Treated with Atarax, Resolved completely within 3 days.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Colitis ulcerative, Diarrhoea haemorrhagic
Clinical narrative: he developed bloody diarrhea 2 days after vaccine Meningococcal 10/3/06 with ulcerative colitis. 10/27/06 Received medical records from PCP which reveal patient seen 9/9/06 for MCV4 vax.  Seen next 9/22 w/BRB in stool that AM.  C/O diarrhea 3x/day for 1-2 weeks self treating with yogurt & OTC antidiarrheal meds.  No fever.  Continued to have blood & mucous in loose stools 3x/day & was referred to GI specialist for colonoscopy & biopsy. 1/2/07 Received medical records from GI specialist which reveal patient had stool cultures for Shiga toxins & yersinia done 10/4 which were neg.  Colonoscopy done 10/6/06 for rectal bleeding.  It was felt at time of scope that it could be colitis or possibly ulcerative colitis.  Multiple biopsies were taken at that time.  Path report returned dx of acute & chronic inflammation, acute cryptitis, crypt abscesses, surface ulceration & cryt distortion consistent with inflammatory bowel disease throughout the transverse, descending & sigmoid colon & rectum.  Started on Asacol & improved significantly with no further abdominal pain, rectal bleeding or diarrhea.