chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Encephalitis herpes, Facial palsy, Febrile convulsion, Feeding disorder, Hemiparesis
Clinical narrative: Information has been received from the government (VAERS # 271615 concerning a 1 year old male with a history of hives who on 26-DEC-2006 was vaccinated with ProQuad (Oka/Merck upgrade process (LOT 655846/1351F) and secondary suspect Vaqta mfr unknown (unspecified). Seven days after vaccination the patient presented with a fever. On 04-JAN-2007, the patient developed convulsion, dysphagia, encephalitis, encephalitis herpes, facial palsy, febrile convulsion, feeding disorder, hemiparesis and inflammation and was hospitalized. Seizure disorder and encephalitis of unknown etiology (Doctors suspects possible viral though tests were negative were diagnosed 9 days post vaccination. The patient is now severely week on her entire left side and is unable to verbally communicate. Many diagnostics were done including barium swallow abnormal, blood alkaline phosphatase increased, blood test normal, brain scan normal, electroencephalogram abnormal, human herpes virus 6 serology. Two spinal taps showed nothing significant and two MRI showed involvement of both frontal cortexes-white matter disease/inflammation. The patient was hospitalized for 21 days and has not yet recovered. Convulsion, dysphagia, encephalitis, encephalitis herpes, facial palsy, febrile convulsion, feeding disorder, hemiparesis and inflammation were considered to disabling and life threatening as were abnormal barium swallow, blood alkaline phosphatase increased brain scan abnormal and EEG abnormal. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the government and was released. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Herpes simplex serology negative, Inflammation, Laboratory test abnormal, Lumbar puncture, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Information has been received from the government (VAERS # 271615 concerning a 1 year old male with a history of hives who on 26-DEC-2006 was vaccinated with ProQuad (Oka/Merck upgrade process (LOT 655846/1351F) and secondary suspect Vaqta mfr unknown (unspecified). Seven days after vaccination the patient presented with a fever. On 04-JAN-2007, the patient developed convulsion, dysphagia, encephalitis, encephalitis herpes, facial palsy, febrile convulsion, feeding disorder, hemiparesis and inflammation and was hospitalized. Seizure disorder and encephalitis of unknown etiology (Doctors suspects possible viral though tests were negative were diagnosed 9 days post vaccination. The patient is now severely week on her entire left side and is unable to verbally communicate. Many diagnostics were done including barium swallow abnormal, blood alkaline phosphatase increased, blood test normal, brain scan normal, electroencephalogram abnormal, human herpes virus 6 serology. Two spinal taps showed nothing significant and two MRI showed involvement of both frontal cortexes-white matter disease/inflammation. The patient was hospitalized for 21 days and has not yet recovered. Convulsion, dysphagia, encephalitis, encephalitis herpes, facial palsy, febrile convulsion, feeding disorder, hemiparesis and inflammation were considered to disabling and life threatening as were abnormal barium swallow, blood alkaline phosphatase increased brain scan abnormal and EEG abnormal. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the government and was released. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Pyrexia, X-ray
Clinical narrative: Information has been received from the government (VAERS # 271615 concerning a 1 year old male with a history of hives who on 26-DEC-2006 was vaccinated with ProQuad (Oka/Merck upgrade process (LOT 655846/1351F) and secondary suspect Vaqta mfr unknown (unspecified). Seven days after vaccination the patient presented with a fever. On 04-JAN-2007, the patient developed convulsion, dysphagia, encephalitis, encephalitis herpes, facial palsy, febrile convulsion, feeding disorder, hemiparesis and inflammation and was hospitalized. Seizure disorder and encephalitis of unknown etiology (Doctors suspects possible viral though tests were negative were diagnosed 9 days post vaccination. The patient is now severely week on her entire left side and is unable to verbally communicate. Many diagnostics were done including barium swallow abnormal, blood alkaline phosphatase increased, blood test normal, brain scan normal, electroencephalogram abnormal, human herpes virus 6 serology. Two spinal taps showed nothing significant and two MRI showed involvement of both frontal cortexes-white matter disease/inflammation. The patient was hospitalized for 21 days and has not yet recovered. Convulsion, dysphagia, encephalitis, encephalitis herpes, facial palsy, febrile convulsion, feeding disorder, hemiparesis and inflammation were considered to disabling and life threatening as were abnormal barium swallow, blood alkaline phosphatase increased brain scan abnormal and EEG abnormal. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the government and was released. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC
Symptoms: Blood culture negative, Body temperature increased, CSF test normal, Computerised tomogram abnormal, Computerised tomogram head
Clinical narrative: Information has been received from the FDA (VAERS# 277412) through the CDC concerning a 12-month-old male with cold like symptoms and a history of laryngomalacia/stridor in July of 2006, gastrooesophageal reflux disease and apnoea monitor use at times who on 21-MAR-2007 was vaccinated subcutaneously in the left leg with a first dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot# 655846/1351F).  Secondary suspect vaccination included hepatitis A vaccine (inactive) (manufacturer unknown).  Other concomitant vaccinations included PREVNAR.  There were no other known medications given.  It was reported that the patient experienced body temperature increased, convulsion, decreased appetite, dermatitis diaper, diarrhea, intubation, irritability, pyrexia, rash generalised, respiratory distress and sinusitis  and was hospitalized for 4 days.  In the evening of 21-MAR-2007 the child began to run a low grade temperature.  Prior to admission on 23-Mar-2007 he was noted to have a fever of 103 and some staring episodes where he was not responding fully.  In the emergency room he was noted to have tremulous movements.  Spinal tap done then "dev".  Laboratory data included CSF values within normal limits, CSF culture showed no growth, RSV and influenza were negative, blood culture showed no growth, CT scan of the head revealed pansinusitis, WBC 11,6000 with some vacuolated monocyte and reactive lymphs.  The outcome was not reported.  The reporter considered body temperature increased, convulsion, decreased appetite, dermatitis diaper, diarrhea, intubation, irritability, pyrexia, rash generalised, respiratory distress and sinusitis to be immediately life threatening.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question (655846/1351F) were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the agency and was released.  Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC
Symptoms: Convulsion, Decreased appetite, Depressed level of consciousness, Dermatitis diaper, Diarrhoea
Clinical narrative: Information has been received from the FDA (VAERS# 277412) through the CDC concerning a 12-month-old male with cold like symptoms and a history of laryngomalacia/stridor in July of 2006, gastrooesophageal reflux disease and apnoea monitor use at times who on 21-MAR-2007 was vaccinated subcutaneously in the left leg with a first dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot# 655846/1351F).  Secondary suspect vaccination included hepatitis A vaccine (inactive) (manufacturer unknown).  Other concomitant vaccinations included PREVNAR.  There were no other known medications given.  It was reported that the patient experienced body temperature increased, convulsion, decreased appetite, dermatitis diaper, diarrhea, intubation, irritability, pyrexia, rash generalised, respiratory distress and sinusitis  and was hospitalized for 4 days.  In the evening of 21-MAR-2007 the child began to run a low grade temperature.  Prior to admission on 23-Mar-2007 he was noted to have a fever of 103 and some staring episodes where he was not responding fully.  In the emergency room he was noted to have tremulous movements.  Spinal tap done then "dev".  Laboratory data included CSF values within normal limits, CSF culture showed no growth, RSV and influenza were negative, blood culture showed no growth, CT scan of the head revealed pansinusitis, WBC 11,6000 with some vacuolated monocyte and reactive lymphs.  The outcome was not reported.  The reporter considered body temperature increased, convulsion, decreased appetite, dermatitis diaper, diarrhea, intubation, irritability, pyrexia, rash generalised, respiratory distress and sinusitis to be immediately life threatening.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question (655846/1351F) were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the agency and was released.  Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC
Symptoms: Influenza serology negative, Intubation, Irritability, Pyrexia, Rash generalised
Clinical narrative: Information has been received from the FDA (VAERS# 277412) through the CDC concerning a 12-month-old male with cold like symptoms and a history of laryngomalacia/stridor in July of 2006, gastrooesophageal reflux disease and apnoea monitor use at times who on 21-MAR-2007 was vaccinated subcutaneously in the left leg with a first dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot# 655846/1351F).  Secondary suspect vaccination included hepatitis A vaccine (inactive) (manufacturer unknown).  Other concomitant vaccinations included PREVNAR.  There were no other known medications given.  It was reported that the patient experienced body temperature increased, convulsion, decreased appetite, dermatitis diaper, diarrhea, intubation, irritability, pyrexia, rash generalised, respiratory distress and sinusitis  and was hospitalized for 4 days.  In the evening of 21-MAR-2007 the child began to run a low grade temperature.  Prior to admission on 23-Mar-2007 he was noted to have a fever of 103 and some staring episodes where he was not responding fully.  In the emergency room he was noted to have tremulous movements.  Spinal tap done then "dev".  Laboratory data included CSF values within normal limits, CSF culture showed no growth, RSV and influenza were negative, blood culture showed no growth, CT scan of the head revealed pansinusitis, WBC 11,6000 with some vacuolated monocyte and reactive lymphs.  The outcome was not reported.  The reporter considered body temperature increased, convulsion, decreased appetite, dermatitis diaper, diarrhea, intubation, irritability, pyrexia, rash generalised, respiratory distress and sinusitis to be immediately life threatening.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question (655846/1351F) were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the agency and was released.  Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC
Symptoms: Respiratory distress, Sinusitis, Staring, Virus serology test, White blood cell count abnormal
Clinical narrative: Information has been received from the FDA (VAERS# 277412) through the CDC concerning a 12-month-old male with cold like symptoms and a history of laryngomalacia/stridor in July of 2006, gastrooesophageal reflux disease and apnoea monitor use at times who on 21-MAR-2007 was vaccinated subcutaneously in the left leg with a first dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot# 655846/1351F).  Secondary suspect vaccination included hepatitis A vaccine (inactive) (manufacturer unknown).  Other concomitant vaccinations included PREVNAR.  There were no other known medications given.  It was reported that the patient experienced body temperature increased, convulsion, decreased appetite, dermatitis diaper, diarrhea, intubation, irritability, pyrexia, rash generalised, respiratory distress and sinusitis  and was hospitalized for 4 days.  In the evening of 21-MAR-2007 the child began to run a low grade temperature.  Prior to admission on 23-Mar-2007 he was noted to have a fever of 103 and some staring episodes where he was not responding fully.  In the emergency room he was noted to have tremulous movements.  Spinal tap done then "dev".  Laboratory data included CSF values within normal limits, CSF culture showed no growth, RSV and influenza were negative, blood culture showed no growth, CT scan of the head revealed pansinusitis, WBC 11,6000 with some vacuolated monocyte and reactive lymphs.  The outcome was not reported.  The reporter considered body temperature increased, convulsion, decreased appetite, dermatitis diaper, diarrhea, intubation, irritability, pyrexia, rash generalised, respiratory distress and sinusitis to be immediately life threatening.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question (655846/1351F) were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the agency and was released.  Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC
Symptoms: White blood cell count normal
Clinical narrative: Information has been received from the FDA (VAERS# 277412) through the CDC concerning a 12-month-old male with cold like symptoms and a history of laryngomalacia/stridor in July of 2006, gastrooesophageal reflux disease and apnoea monitor use at times who on 21-MAR-2007 was vaccinated subcutaneously in the left leg with a first dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot# 655846/1351F).  Secondary suspect vaccination included hepatitis A vaccine (inactive) (manufacturer unknown).  Other concomitant vaccinations included PREVNAR.  There were no other known medications given.  It was reported that the patient experienced body temperature increased, convulsion, decreased appetite, dermatitis diaper, diarrhea, intubation, irritability, pyrexia, rash generalised, respiratory distress and sinusitis  and was hospitalized for 4 days.  In the evening of 21-MAR-2007 the child began to run a low grade temperature.  Prior to admission on 23-Mar-2007 he was noted to have a fever of 103 and some staring episodes where he was not responding fully.  In the emergency room he was noted to have tremulous movements.  Spinal tap done then "dev".  Laboratory data included CSF values within normal limits, CSF culture showed no growth, RSV and influenza were negative, blood culture showed no growth, CT scan of the head revealed pansinusitis, WBC 11,6000 with some vacuolated monocyte and reactive lymphs.  The outcome was not reported.  The reporter considered body temperature increased, convulsion, decreased appetite, dermatitis diaper, diarrhea, intubation, irritability, pyrexia, rash generalised, respiratory distress and sinusitis to be immediately life threatening.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question (655846/1351F) were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the agency and was released.  Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Blood test, Computerised tomogram
Clinical narrative: The following week after receiving ZOSTAVAX, I started losing the hair on my head. Within six weeks I noticed I was losing all of the hair on my body including eyebrows and eye lashes.  Tests including CT scans, bloodwoork, etc., have been run but cause remains unknown.
Age: 1.22
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Acoustic stimulation tests normal, Autism, Blood heavy metal increased, Depressed level of consciousness, Gene mutation identification test
Clinical narrative: Within a few weeks from the time of the vaccination patient showed a loss in his alertness, attentive, and social interaction.  Soon after he started stemming, and exhibited obsessive compulsive traits.  He continued to regress thereafter.  Follow-up: Autism.  He was seen by a neurologist at 18 months of age and diagnosed with Autism.  Currently non-verbal.  Speech, occupational, developmental therapies.  3/14/08 Reviewed PCP medical records. FINAL DX: autism. Vax records confirm as reported.  Office vs of 6/16/2005 indicates patient on formula & refuses cup or to self feed, poor eater, was irritable, speaking 3-5 words.  7/2005 referred to allergist.  By 9/2005, no words & loss of receptive language.  Dx w/probable PDD & referred.  10/2005 dx w/autism, genetic disorder, egg allergy.  Receiving ST/OT.  7/2007 hyperbaric tx.  12/2007 dx w/Lyme's disease Follow-up: Chronic Diarrhea, Food allergies, No speech. This vaccine cause my sons Autism.
Age: 1.22
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Neurological examination abnormal, Obsessive-compulsive disorder, Regressive behaviour, Social avoidant behaviour, Speech disorder
Clinical narrative: Within a few weeks from the time of the vaccination patient showed a loss in his alertness, attentive, and social interaction.  Soon after he started stemming, and exhibited obsessive compulsive traits.  He continued to regress thereafter.  Follow-up: Autism.  He was seen by a neurologist at 18 months of age and diagnosed with Autism.  Currently non-verbal.  Speech, occupational, developmental therapies.  3/14/08 Reviewed PCP medical records. FINAL DX: autism. Vax records confirm as reported.  Office vs of 6/16/2005 indicates patient on formula & refuses cup or to self feed, poor eater, was irritable, speaking 3-5 words.  7/2005 referred to allergist.  By 9/2005, no words & loss of receptive language.  Dx w/probable PDD & referred.  10/2005 dx w/autism, genetic disorder, egg allergy.  Receiving ST/OT.  7/2007 hyperbaric tx.  12/2007 dx w/Lyme's disease Follow-up: Chronic Diarrhea, Food allergies, No speech. This vaccine cause my sons Autism.
Age: 1.22
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Stereotypy
Clinical narrative: Within a few weeks from the time of the vaccination patient showed a loss in his alertness, attentive, and social interaction.  Soon after he started stemming, and exhibited obsessive compulsive traits.  He continued to regress thereafter.  Follow-up: Autism.  He was seen by a neurologist at 18 months of age and diagnosed with Autism.  Currently non-verbal.  Speech, occupational, developmental therapies.  3/14/08 Reviewed PCP medical records. FINAL DX: autism. Vax records confirm as reported.  Office vs of 6/16/2005 indicates patient on formula & refuses cup or to self feed, poor eater, was irritable, speaking 3-5 words.  7/2005 referred to allergist.  By 9/2005, no words & loss of receptive language.  Dx w/probable PDD & referred.  10/2005 dx w/autism, genetic disorder, egg allergy.  Receiving ST/OT.  7/2007 hyperbaric tx.  12/2007 dx w/Lyme's disease Follow-up: Chronic Diarrhea, Food allergies, No speech. This vaccine cause my sons Autism.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Anorexia, Cellulitis, Confusional state, Depressed level of consciousness, Feeling abnormal
Clinical narrative: About 30 hours after administration of vaccine (2/26), patient complained of pain at the site of injection. Pain worsened over the next 24 hours.  Patient slept almost the entire day, lost his appetite, seemed dazed and somewhat confused. By 9 P.M. it was difficult to rouse patient.  Called 911.  Patient admitted to hospital with cellulitis of the left upper arm and possible pneumonia.  Pneumonia ruled out after 48 hours.  Augmentin therapy started 2/29,  P.M.  Patient released from hospital 3/2.  Still on augmentin therapy.  Still experiencing mild pain.  03/12/2008 MR received for DOS 2/27 to 3/2/08. Pt presented with onset of increased somnolence and lethargy, SOB, sweats, fever, chills, purulent sputum and chest pain. Redness at site of recent Pneumovax. Cellulitis of the L arm and R leg noted on PE, as well as thyromegaly and decreased breath sounds and egophony.   4/17/2008 D/C summary recd with D/C Dx:  Cellulitis of the R leg and Left arm, asthmatic bronchitis, hyperlipidemia, atherosclerotic heart disease s/p bypass, well controlled essential hypertension, hypothyroidism, BPH, use of anti-coagulants, atrial fibrillation and DM Type II-diet controlled
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Somnolence
Clinical narrative: About 30 hours after administration of vaccine (2/26), patient complained of pain at the site of injection. Pain worsened over the next 24 hours.  Patient slept almost the entire day, lost his appetite, seemed dazed and somewhat confused. By 9 P.M. it was difficult to rouse patient.  Called 911.  Patient admitted to hospital with cellulitis of the left upper arm and possible pneumonia.  Pneumonia ruled out after 48 hours.  Augmentin therapy started 2/29,  P.M.  Patient released from hospital 3/2.  Still on augmentin therapy.  Still experiencing mild pain.  03/12/2008 MR received for DOS 2/27 to 3/2/08. Pt presented with onset of increased somnolence and lethargy, SOB, sweats, fever, chills, purulent sputum and chest pain. Redness at site of recent Pneumovax. Cellulitis of the L arm and R leg noted on PE, as well as thyromegaly and decreased breath sounds and egophony.   4/17/2008 D/C summary recd with D/C Dx:  Cellulitis of the R leg and Left arm, asthmatic bronchitis, hyperlipidemia, atherosclerotic heart disease s/p bypass, well controlled essential hypertension, hypothyroidism, BPH, use of anti-coagulants, atrial fibrillation and DM Type II-diet controlled
Sex: F
Vaccine: PNC
Symptoms: Abasia, Blood culture positive, Cough, Diet refusal, Pleural effusion
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a 30-month-old female patient who experienced streptococcal pneumoniae bacteremia and pneumococcal pneumonia with pleural effusion. The patient received the fourth dose on an unspecified date. The patient's concurrent illness includes cough (05-Feb-2008-treated with oral Keflex). Concomitant therapy included Keflex (cefalexin monohydrate). On 07-Feb-2008, the patient was hospitalized with streptococcal pneumoniae bacteremia and pneumococcal pneumonia with pleural effusion after a two-day history of cough. The child was not able to walk and was not drinking. A blood culture was performed which identified Streptococal pneumoniae, serotype unknown. The child was treated with intravenous antibiotics cefixime and Vancomycin and discharged to home on intravenous antibiotic Levofloxacin. The physician noted that the child's parents had reported that the child had been fully immunized, however, no medical records had been forwarded. As of 05-Mar-2008, the patient had recovered. Blood culture was done on 07-Feb-2008. No additional information was available at the time of this report.
Sex: F
Vaccine: PNC
Symptoms: Pneumococcal bacteraemia, Pneumonia pneumococcal, Serology test
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a 30-month-old female patient who experienced streptococcal pneumoniae bacteremia and pneumococcal pneumonia with pleural effusion. The patient received the fourth dose on an unspecified date. The patient's concurrent illness includes cough (05-Feb-2008-treated with oral Keflex). Concomitant therapy included Keflex (cefalexin monohydrate). On 07-Feb-2008, the patient was hospitalized with streptococcal pneumoniae bacteremia and pneumococcal pneumonia with pleural effusion after a two-day history of cough. The child was not able to walk and was not drinking. A blood culture was performed which identified Streptococal pneumoniae, serotype unknown. The child was treated with intravenous antibiotics cefixime and Vancomycin and discharged to home on intravenous antibiotic Levofloxacin. The physician noted that the child's parents had reported that the child had been fully immunized, however, no medical records had been forwarded. As of 05-Mar-2008, the patient had recovered. Blood culture was done on 07-Feb-2008. No additional information was available at the time of this report.
Age: 4.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Anaphylactic reaction, Nonspecific reaction
Clinical narrative: Information has been received from a GlaxoSmithKline (manufacturer # A0710606A) concerning a 4-year-old male with a history of hives with OMNCEF and no other known allergies or drug reactions, who on 25-JAN-2008 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (the patient had at least one previous dose) (lot # 655103/0862F); Suspect therapy that day included a fist dose of varicella virus vaccine live (OKA/Merck) (MSD) (lot # 658287/1173U) and a second 0.5 ml dose of hepatitis A vaccine (inactive) (HAVRIX) administered at 12:00 in the left arm. There was no reaction on previous exposure to vaccines. In approximately January 2008, post vaccination, the patient experienced an anaphylactic reaction and a non-specific reaction. The patient was treated with 2 doses of EPINEPHRINE, BENADRYL, oxygen and prednisone. Once stabilized, the patient was sent to the emergency room for observation but was not admitted. He required no further treatment. The patient had no reaction to the first dose of hepatitis A vaccine (HAVRIX). In approximately January 2008, post vaccination, the patient recovered. The adverse events reported were considered to be life threatening and Other Medically Important Events by the reporter. The reporter was originally reported by a physician (allergist). No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Transfusion
Clinical narrative: Information has been received from a nurse practitioner (NP), via a company representative, concerning a 17 year old female patient, who on 12-SEP-2007 was vaccinated IM, with the first dose, 0.5 ml, of Gardasil (lot # not reported).  On 03-OCT-2007, "3 weeks after vaccine," the patient required a blood transfusion (no details provided).  She was hospitalized for an unknown period of time.  At the time of this report, the patient had recovered from the event (date and duration not reported).  The NP considered the event to be serious as an other important medical event.  Additional information has been requested.  3/25/08 Reviewed hospital medical records of 10/18-10/20/2007. FINAL DX: severe anemia; dizziness/weakness; transfused 3U PRBCs; hematemesis, presumed UGI bleed; melena, improved; pertussis, improving; pulmonary edema, improved. Records reveal patient experienced fatigue, dizziness, weakness, upper abdominal pain.  Seen in student health clinic for pmh on 10/12.  Dx at health clinic: whooping cough.  Tx w/antibiotics.  10/13 post-tussive HA, felt faint, DOE, muscle aches, heart pounding, difficult ambulation.  10/15 developed black hard, tarry stool.  Vomiting again on 10/17, but no blood noted.  Gastric lavage in ER was clear.  Tx w/O2, IVF, antiulcer meds & #U PRBCs.  Improved & d/c to home w/peds GI f/u.  Seen in GI clinic 10/30 & was stable; antiulcer med d/c; hemoccult cards provided to collect; consider enteroscopy for any further GI bleeding.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Cyanosis, Hypotonia, Laboratory test normal, Lethargy, Oxygen supplementation
Clinical narrative: Pt had vaccine in morning. That evening approx 6pm-Mom noted that child became, pale, lethargic with lips "Blue" lasted 6-8 minutes, called 911, EMT arrivesd noted limp infant with blue lips. O2 given. Sent to hospital for eval and observation. Recovered to nl state. Observed for 24 hrs.  3/11/08 Hospital medical records of 2/25-2/26/2008.  FINAL DX: hypotonic-hyporesponsive episode as adverse immunization reaction Records reveal patient experienced unresonsiveness, lips blue, pale, limpness, clamminess lasting 8-10 min several hours s/p vaccination on day of admission.  Similar episode s/p 2 mo vax but accompanied by hysterical screaming then apnea & cyanosis for less than 1 min. Neuro, cardio & ID consults done.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pallor
Clinical narrative: Pt had vaccine in morning. That evening approx 6pm-Mom noted that child became, pale, lethargic with lips "Blue" lasted 6-8 minutes, called 911, EMT arrivesd noted limp infant with blue lips. O2 given. Sent to hospital for eval and observation. Recovered to nl state. Observed for 24 hrs.  3/11/08 Hospital medical records of 2/25-2/26/2008.  FINAL DX: hypotonic-hyporesponsive episode as adverse immunization reaction Records reveal patient experienced unresonsiveness, lips blue, pale, limpness, clamminess lasting 8-10 min several hours s/p vaccination on day of admission.  Similar episode s/p 2 mo vax but accompanied by hysterical screaming then apnea & cyanosis for less than 1 min. Neuro, cardio & ID consults done.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Appendicectomy, Surgery
Clinical narrative: Intussusception surgery and appendectomy 2/22/08.  Doctor thought 1st diagnosis related to Appendicitis.  4/8/08 Reviewed hospital medical records of 2/22-2/25/2008. FINAL DX: Ileocolic intussusception, exp lap w/reduction of IS & appendectomy. Records reveal patient experienced screaming, pain, bloody/mucousy stools, emesis.  Seen at outlying ER where BE c/w IS to transverse colon, not able to reduce.  Transferred to higher level of care for peds surgery.  Progressed well s/p surgery & d/c to home.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Abdominal pain upper, Amnesia, Learning disability
Clinical narrative: Stomache pains learning disability- memory loss/processing. 03/07/2008 Vax record, OT(11/30/07) and speech/language evals (11/5/07)received from parent. Speech/language eval reveals a severe language processing disorder.  Significantly below grade level in written language with decreased short term memory. OT eval (+) for neurological processing defects and difficulty in receptive language. 03/19/2008 Vax record with lot #'s obtained from provider and updated in database.  MR received showing WCC on 6/6/05 with normal vision, hearing and development noted.  2OVs in 8/05 for c/o abdominal pain with dx: pharyngitis/abdominal pain-noted to be resolved by 8/26/05.  Otolaryngology consult 8/19/05 noted speech and language appropriate for age.  Multiple sick visits until 2/2007 including w/u for abd pain which was (-). No further WCCs
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Abdominal pain upper, Aggression, Aphasia, Drooling, Inappropriate schedule of drug administration
Clinical narrative: Rash, hives, stomach pains, drooling, loss of speech, tantrums.  03/07/2008 Vax record and OT (11/7/2007) report received from parent.  Report (+) for language delay, frequent night waking, and delayed social skills as well as temper tantrums, and separation anxiety. Pt receives OT to address these issues. 03/19/2008 Vax record with lot #s received from PCP and updated in database. MR received from PCP.  WCC dated 5/10/2006 with normal development and behavioral health noted. PE WNL except uneven circumcision. Frequent sick visits. 12mon WCC 11/06/06 with normal PE except foreskin adhesions. Development normal. Refered to audiology 2/28/07. Maculopapular rash noted 3/19/07. DX Eczema and diaper dermatitis 3/23/07
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash, Urticaria
Clinical narrative: Rash, hives, stomach pains, drooling, loss of speech, tantrums.  03/07/2008 Vax record and OT (11/7/2007) report received from parent.  Report (+) for language delay, frequent night waking, and delayed social skills as well as temper tantrums, and separation anxiety. Pt receives OT to address these issues. 03/19/2008 Vax record with lot #s received from PCP and updated in database. MR received from PCP.  WCC dated 5/10/2006 with normal development and behavioral health noted. PE WNL except uneven circumcision. Frequent sick visits. 12mon WCC 11/06/06 with normal PE except foreskin adhesions. Development normal. Refered to audiology 2/28/07. Maculopapular rash noted 3/19/07. DX Eczema and diaper dermatitis 3/23/07
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None Stated
Age: 46.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Lip swelling
Clinical narrative: Swollen top and bottom lips, triage, IV & Benadryl for allergy. Took 5 days (antibiotic and Benadryl
Age: 34.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Arthralgia, Laboratory test, Myalgia
Clinical narrative: Description: Joint pain reported by pt. Symptom: Joint Pain, multiple joints Comment: 719.49
Age: 1.4
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Body temperature increased, Convulsion
Clinical narrative: Within hours of administering flu .25 and Dtap pt had a 105 degree temp. And a seizure. Called 911-ambulance to medical center. Observed - Motrin (Tylenol given) Discharged on same day - 02-26-08.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injected limb mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Within 1-3 days following vaccination and continuing to date, shoulder joint pain in the arm receiving the shot. Stiffness, limited mobility and pain in left shoulder. There has been improvement but all symptoms, through less intense, continue. Shoulder is improving slowly.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, HPV4, MNQ
Symptoms: Erythema, Injection site erythema, Injection site rash
Clinical narrative: Red rash like halos around sites of 4 immunizations when removing latex free spot bandaids the next day. Also 1 other red area not near an injection site.
Age: 39.0
Sex: F
Vaccine: HEPAB, TDAP, HEPAB, TD
Symptoms: Arthralgia
Clinical narrative: Diffuse arthralgias after TdAP onset 2/20/08.  (Vaccination was 2/19/08).
Age: 39.0
Sex: F
Vaccine: HEPAB, TDAP, HEPAB, TD
Symptoms: Arthralgia, Erythema, Fatigue, Joint swelling, Pain in extremity
Clinical narrative: Diffuse arthralgias after TdAP onset 2/20/08.  (Vaccination was 2/19/08).
Age: 39.0
Sex: F
Vaccine: HEPAB, TDAP, HEPAB, TD
Symptoms: Sleep disorder
Clinical narrative: Diffuse arthralgias after TdAP onset 2/20/08.  (Vaccination was 2/19/08).
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema
Clinical narrative: 2 days after receiving the vaccines, the patient was seen with a 5x7cm area of redness about 4cm below the site of the vaccines on the upper arm.  This cellulitis disappeared with a course of erythremyacin.
Age: 1.3
Sex: M
Vaccine: DTAP, FLU3, PNC
Symptoms: Erythema, Swelling
Clinical narrative: Area of swelling and erythema appeared on right thigh the evening of vaccination.  Area continues to spread.  Seen once already on 3/6, returning 3/8 due to spreading of site.  Site - right lateral thigh.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Induration, Local reaction
Clinical narrative: Localized reaction with erythema and induration at location of Varicella vaccine.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Insomnia, Screaming
Clinical narrative: 3 hours post vaccine immunization, patient with inconsolable (screaming) - 8 hours off/on screaming and sleeping both intermittent.  Screaming was high pitched.
Age: 31.0
Sex: M
Vaccine: TTOX
Symptoms: Nausea
Clinical narrative: Donor states approximately 1/2 hour after receiving Tetanus Toxoid he became nauseous; no vomiting;  Donor states nauseous lasted approximately 2-3 hours. He did not seek any medical attention
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash developed over the weekend of 3/1/08.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, MMR, PNC, VARCEL
Symptoms: Blister
Clinical narrative: 6 days after vaccine child started getting blisters on thighs, then spread to rest of body.  No fever before outbreak.  Sister with kids in her class with chickenpox.  Physician Asst. gave antihistamine.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Abscess, Erythema, Irritability, Limb discomfort, Pyrexia
Clinical narrative: Patient had a fever following the vaccination.  A red, hot bump was at the spot of the immunization (right arm).  Redness, soreness and bump lasted for about 2 weeks.  Cold ice pack applied to area per doctor's instructions.  Patient was very fussy, still.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Body temperature increased, Fatigue, Rash erythematous, Rash macular, White blood cell count increased
Clinical narrative: 1) Elevated body temperature to 100-101 9 days after vaccine administration.  2) Rash macular, erythematous on face, trunk 12 days after vaccine administered.  3) Fatigue 4) White blood cell count 2.0.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, IPV, MMR
Symptoms: Wrong drug administered
Clinical narrative: DTap, IPV, and MMR ordered. DTap/IPV/HepB IPV and MMR administered
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Pruritus
Clinical narrative: 3-6-08 8:00 pm abd and chest itching, 3-6-08 11pm buttocks itching. 3-7-08 630  red bumps under arms, abd back and buttocks. A little heaviness breathing, but no difficulty breathing.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Fatigue, Malaise, Pain, Pyrexia
Clinical narrative: Patient reported onset of fever, malaise, body aches, fatigue, congestion cough.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Respiratory tract congestion
Clinical narrative: Patient reported onset of fever, malaise, body aches, fatigue, congestion cough.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: (R) deltoid reddened 4 1/2" x 5", blanched dime size at injection site, warm to touch, cold compresses 3-5-08 and 3-6-08 by parents, Tylenol given by parents to be seen after assessment at health department by pediatrician.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Local reaction
Clinical narrative: Localized reaction with erythema and induration at location of Varicella vaccine.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Urticaria 48 hour after vaccine.
Age: 1.02
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Abnormal behaviour, Aphasia, Ear disorder, Erythema, Malaise
Clinical narrative: Screamed for three days, bright red with fever of 104.3 and 104.5.  Sick for eight weeks following.  Then sick off and on, developed ear issues, lost speech, developed behavioral issues.
Age: 1.02
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Screaming
Clinical narrative: Screamed for three days, bright red with fever of 104.3 and 104.5.  Sick for eight weeks following.  Then sick off and on, developed ear issues, lost speech, developed behavioral issues.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Pruritus, Urticaria, Vomiting
Clinical narrative: Patient came to employee health for her Hep B series. She thought that she had completed her series when she worked at a nursing home. Unable to locate dates. Decision made to start series over instead of declining. Received the shot 3/5/08 about 10am and went home early that next morning from working 3rd shift with vomiting/diarrhea/hives and itching. Hospital has had many employees out with nausea, vomiting, and diarrhea.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain
Clinical narrative: TDAP given in left deltoid on 2/17/08. On 2/25/08, patient calls Employee Health and reports that she has persistent pain in her left shoulder. She states, "It hurts when I adduct it or pick up anything." Patient sent to Medical Clinic for further evaluation. Patient was placed on the following restrictions for 2 weeks: 1) No overhead reaching greater than 2 hours, 2) may not lift or carry more than 20 lbs, 3) attend physical therapy 3 times a week for 2 weeks. She is scheduled for reevaluation at 2 weeks.
Age: 1.27
Sex: F
Vaccine: DTAP, PNC
Symptoms: Angioedema, Swelling face, Urticaria
Clinical narrative: Child & parents came to office 2/29/08 for evaluation of "swelling of face after ingesting peanut butter. Child has known allergy to eggs. Exam with diagnosis of angioedema. During exam ~ 10 cm diameter hive in area of right antero-lateral thigh at site of immunization of DTaP & PCV7 on 2/27/08.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal pain, Swelling, X-ray
Clinical narrative: Acute pain to right shoulder and swelling.  Began 2 hours after injection. History of rheumatoid arthritis and bursitis. Demerol and Phenergan given for pain relief. Next day patient reported no relief for 24 hours following.
Sex: U
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Report. One day after receiving his DTaP and hepatitis A immunizations, the patient developed a 10 cm x 7 cm ovoid area of warmth, erythema, and edema around the injection site in the lateral right thigh. He has been ambulating normally and the area is not painful to touch. There is no tenderness to palpation, no induration, no drainage, no Nikolsky sign. In the ED, he was given a dose of diphenhydramine. The parents were advised to apply cool compresses to the area and administer acetaminophen or ibuprofen as needed to control discomfort.
Age: 10.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: My son was given three immunizations on February 20, 2008.  They were Tdap, Hep A, and varicella.  On March 5th he complained his arm was hurting.  One of the injection sites was hot to the touch, red, raised, and a little larger than a 50 cent piece.  The doctor's office said he needed to be seen.  Dr. said it was not a reaction to the immunizations.  She drew a circle around the site and told us to watch it and put him on antibiotics in case there was an infection.  I strongly believe this was a side effect from the immunizations.  He had already had chicken pox but was given the vaccine anyway.  I don't know if this was a good idea.  I am wondering if there is any significance in this reaction and if we should avoid any vaccines in the future.
Age: 1.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Patient given wrong vaccine.  Should of been Varicella.
Age: 1.14
Sex: F
Vaccine: MMRV
Symptoms: Asthma, Conjunctivitis infective, Ear infection, Pneumonia, Rash
Clinical narrative: PATIENT WAS GIVEN THE MMR SHOT ON DECEMBER 10, 2007. SHE WOKE UP ON DECEMBER 21, 2007 WITH A SEVERE RASH AND A SWOLLEN FACE.  SHE ALSO WAS SUFFERING FROM SEVERE RESPIRATORY SYMPTOMS AS WELL AS PINK EYE AND EAR INFECTION.  I TOOK HER BACK TO THE PEDIATRICIAN AND SHE TOLD ME THAT IT WILL NEED TO RUN ITS COURSE.  SHE GAVE ME 3 DIFFERENT PRESCRIPTIONS AND SAID THAT IF IT IS NOT LOOKING ANY BETTER WITHIN 24-48 HRS TO CALL HER BACK.  I WENT TO MY PARENTS HOUSE FOR CHRISTMAS AND CALLED DR ON THE 23RD BECAUSE THE RASH HAD APPEARED TO SPREAD.  I ENDED UP TAKING HER TO THE EMERGENCY ROOM ON THE 23RD. THE ATTENDING PEDIATRIC DOCTOR TOLD ME THAT IT WAS JUST A RASH... NOT TO WORRY.  HE ALSO CHANGED ALL OF HER MEDICATION THAT I HAD GOTTEN FROM HER DOCTOR.  ABOUT 4 DAYS LATER THE RASH HAD GONE AWAY BUT SHE WAS STILL SUFFEREING FROM THE RESPIRATORY SYMPTOMS.  I TOOK HER BACK TO THE DOCTOR ON JANUARY 7 FOR A RE-CHECK, SHE WAS THEN ADMITTED INTO THE HOSPITAL ON JANUARY 8TH AND STAYED UNTIL THE 12TH.  SHE HAD RSV AND PNEUMONIA.  BEFORE SHE HAD THE MMR SHOT SHE WAS VERY HEALTHY.  AFTER SHE GOT THE SHOT SHE WAS SICK CONSTANTLY FOR A MONTH.  03/19/2008 MR received for ID and Pulmonary consults 2/5/08 with Impression:  Post RSV Asthma. Pt presented for eval of multiple episodes of upper and middle airway infections, conjunctivitis, and otitis media since December 2007. Pt developed a respiratory infection which was txd with amoxicillin, and subsequently developed a erythroderma-like rash with facial swelling.  It was initially thought to be an allergic rxn to abx, but also was 1 week following MMR. Pt was hospitalized for RSV Bronchiolitis x5days and subsequently developed pneumonia. 04/21/2008 MR received for DOS 1/8-12/2008 with DX: RSV infection and pneumonia. Sent for admission by PMD for URI sx of intermittant fever, nasal congestion, cough.  PE (+) for grunting respirations. Tx with nebs and Zithromax.
Age: 1.14
Sex: F
Vaccine: MMRV
Symptoms: Respiratory syncytial virus infection, Swelling face
Clinical narrative: PATIENT WAS GIVEN THE MMR SHOT ON DECEMBER 10, 2007. SHE WOKE UP ON DECEMBER 21, 2007 WITH A SEVERE RASH AND A SWOLLEN FACE.  SHE ALSO WAS SUFFERING FROM SEVERE RESPIRATORY SYMPTOMS AS WELL AS PINK EYE AND EAR INFECTION.  I TOOK HER BACK TO THE PEDIATRICIAN AND SHE TOLD ME THAT IT WILL NEED TO RUN ITS COURSE.  SHE GAVE ME 3 DIFFERENT PRESCRIPTIONS AND SAID THAT IF IT IS NOT LOOKING ANY BETTER WITHIN 24-48 HRS TO CALL HER BACK.  I WENT TO MY PARENTS HOUSE FOR CHRISTMAS AND CALLED DR ON THE 23RD BECAUSE THE RASH HAD APPEARED TO SPREAD.  I ENDED UP TAKING HER TO THE EMERGENCY ROOM ON THE 23RD. THE ATTENDING PEDIATRIC DOCTOR TOLD ME THAT IT WAS JUST A RASH... NOT TO WORRY.  HE ALSO CHANGED ALL OF HER MEDICATION THAT I HAD GOTTEN FROM HER DOCTOR.  ABOUT 4 DAYS LATER THE RASH HAD GONE AWAY BUT SHE WAS STILL SUFFEREING FROM THE RESPIRATORY SYMPTOMS.  I TOOK HER BACK TO THE DOCTOR ON JANUARY 7 FOR A RE-CHECK, SHE WAS THEN ADMITTED INTO THE HOSPITAL ON JANUARY 8TH AND STAYED UNTIL THE 12TH.  SHE HAD RSV AND PNEUMONIA.  BEFORE SHE HAD THE MMR SHOT SHE WAS VERY HEALTHY.  AFTER SHE GOT THE SHOT SHE WAS SICK CONSTANTLY FOR A MONTH.  03/19/2008 MR received for ID and Pulmonary consults 2/5/08 with Impression:  Post RSV Asthma. Pt presented for eval of multiple episodes of upper and middle airway infections, conjunctivitis, and otitis media since December 2007. Pt developed a respiratory infection which was txd with amoxicillin, and subsequently developed a erythroderma-like rash with facial swelling.  It was initially thought to be an allergic rxn to abx, but also was 1 week following MMR. Pt was hospitalized for RSV Bronchiolitis x5days and subsequently developed pneumonia. 04/21/2008 MR received for DOS 1/8-12/2008 with DX: RSV infection and pneumonia. Sent for admission by PMD for URI sx of intermittant fever, nasal congestion, cough.  PE (+) for grunting respirations. Tx with nebs and Zithromax.