chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Urinary tract infection, Vomiting, Walking aid user
Clinical narrative: I have completed this form on behalf of the patient. I am a local health department nurse. I have become familiar with the patient, over the past 6 years I have checked her blood pressure on a weekly basis. She received a flu vaccination on 10/14/05 in her right deltoid. On the evening 10/16/05, she states she began chilling and soon thereafter began vomiting. She also experienced diarrhea. She was able to tolerate small amounts of boost yet was unable to tolerate solid foods for five days. On 10/19/05, she saw her family physician with continued nausea and a heaviness in her legs. She was diagnosed with a UTI and treated with antibiotics. She gradually began tolerating solid foods yet remained weak. On 11/10/05, she experienced an episode of extreme numbness to her legs. 911 was called and she was admitted with a lab confirmed case of GBS. She was in the hospital for weeks then to be transferred to another facility. She does have some gross motor movement to her lower extremities and he arms are weak yet some fine motor skills evident. I spoke with one of the associates at the hospital in regards to reporting this case. He was not aware of this reporting system therefore I am reporting the case. Medical record states pain, confusion, CVA, urinary tract infection. Information received from the 60 day follow-up states 3-28-06 Client remains a resident. She is presently in therapy and making progress. She is now walking with the assistance of a walker and supervision. She is able to feed herself without problems. Client and her family feel that with continued therapy she may be able to leave the facility and move in with one of her children with the hope of someday getting back to her apartment.  Follow-up: 4-10-07 patient is able to ambulate with the use of a walker. She has been unable to move back to her home independently. She remains at a nursing home facility.
Age: 0.41
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Agitation, Cough, Ear pain, Pyrexia, Rhinorrhoea
Clinical narrative: Fever, irritable, wet cough, clear and white runny nose, ear pain.  Patient was examined by Dr. in office.  Treated with Motrin and Tylenol.  Auralgan to both ears.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Feeling cold
Clinical narrative: After receiving Hep B#2 mom reported child's skin got very cold and needed to do a skin to skin to warm child.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Pruritus, Rash
Clinical narrative: 1hr and 5min after receiving Td, c/o L arm itching and rash itching.  Small red raised bumps present (rash).  Benadryl 50 mg prescription given.
Age: 13.0
Sex: M
Vaccine: TD
Symptoms: Eye disorder
Clinical narrative: Patient's eyes start swelling 12-24hrs after injection was given.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 57 year old white female (previously reported as 72 year old female) with asthma and no history of adverse drug reactions or allergies. On Dec 14 2005, the patient was vaccinated intramuscularly with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 651318/1006P). Concomitant therapy included levothyroxine (Levoxyl), pirbuterol acetate (Maxair), fluticasone propionate + salmeterol xinafoate (Advair) and bupropion HCL (Wellbutrin). On Dec 15 2005 the patient developed redness, swelling, warmth and pain at injection site. The patient contacted the physician and was recommended to rest. There were no other treatments. The patient did not undergo any lab diagnostic studies. It was reported that the patient was improving without treatment. At the time of this report, the patient was recovering from the events. Follow up information from the physician indicated that on Dec 14 2005 the patient developed a severe local reaction with arm swelling two times normal and a temperature 100C orally. The patient required 1.5 days of bedrest. Subsequently on Dec 17 2005 the patient recovered. The patients events were considered to be disabling by the physician. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Cellulitis, Injection site pain
Clinical narrative: On 12-8-05 Patient informed office that she had been having pain at injection site since 12-4-05.  Dr. diagnosed cellulitis prescribe antibiotics.  By 12-22-05 cellulitis resolved.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Influenza like illness, Nausea, Pain
Clinical narrative: Approximately 5 hrs after receiving the shot patient had bad flu symptoms.  Nausea, cold chills, throwing up and aching all over.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: After DTaP shot arm became "twice the size" of the other arm, red and uncomfortable
Age: 82.0
Sex: F
Vaccine: TTOX
Symptoms: Abdominal distension, Erythema, Feeling hot, Pruritus
Clinical narrative: Patient called with L deltoid swollen x 8 day.  Area red swollen, itching, hot to touch.  Dr prescribed Benadryl and Keflex.  Followed up with patient is doing fine now.
Age: 80.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Left deltoid pain, redness, swollen treated by physician with antibiotics and analgesics.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Swelling, Tenderness
Clinical narrative: L arm and erythema distal to and at site of injection with warmth or tender to touch.  Patient states that 2 o'clock after injection L arm began to be sore and red and progressed through the day and night.  Patient given Allegra 60mg, Medrol Dose Pack-offered pain med-pt declined pain medicine
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Pyrexia, Swelling, Tenderness
Clinical narrative: R upper arm large red area hot and firm 2 days post vaccine and fever.  Rx-Augmentin
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Pharyngeal oedema, Rash
Clinical narrative: Rash, throat swelling.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Fatigue, Muscular weakness
Clinical narrative: The patient described having moderate muscle weakness shortly after injection.  This was mostly reported to occur in hi lower extremity.  He also described fatigue and left work early and he missed work the next day because of this also. His symptoms resoved fully as reported after just over 24 hours.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, CSF test abnormal, Hyperglycaemia, Laboratory test abnormal, Myelitis transverse
Clinical narrative: Developed transverse myelitis following administration of Flu Vaccine in 2003.  Admitted to acute care hospital Nov 2003.  Out of work for 1 month. Discharge summary states parethesia, asthenia. msv
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Developed transverse myelitis following administration of Flu Vaccine in 2003.  Admitted to acute care hospital Nov 2003.  Out of work for 1 month. Discharge summary states parethesia, asthenia. msv
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Medication error
Clinical narrative: Third dose of Hep B vaccine given - Adult dose 1.0cc instead of .5cc.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Medication error
Clinical narrative: Hepatitis b vaccine adult dose given for first series 1.0 cc instead of .5cc.
Age: 1.25
Sex: F
Vaccine: HBHEPB, HIBV, PNC, HBHEPB, PNC
Symptoms: Influenza, Viral infection
Clinical narrative: A comvax and Pedvax were given together. Mother stated that she took daughter to MD two days later for stomach flu.  Mother stated that MD told her "it had nothing to do with vaccines that were given."
Age: 1.25
Sex: F
Vaccine: HBHEPB, HIBV, PNC, HBHEPB, PNC
Symptoms: Medication error, Pyrexia, Rash, Vomiting
Clinical narrative: A comvax and Pedvax were given together. Mother stated that she took daughter to MD two days later for stomach flu.  Mother stated that MD told her "it had nothing to do with vaccines that were given."
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Mother called in today and reports that when pt woke up this AM she, mother, found that pt had a red area the size of a baseball on her lt upper arm. Also states that she had a hard area the size of a silver dollar in the center of the red area. Denies that it was there last night. Also denies any fever. Denies any other illnesses.
Age: 63.0
Sex: M
Vaccine: TYP
Symptoms: Asthenia, Dehydration, Diarrhoea, Pyrexia
Clinical narrative: Fever 99F and diarrhea approx 12 hrs post first dose of oral typhoid(10-12 stools in a 12 hr period. Took Lomitil and took 2nd dose at the appropriate time with same symptoms occuring about 12 hrs later.  Became weak and dehydrated.  No further oral typhoid taken .  Has scheduled a typhoid injection.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Anxiety, Arthralgia, Arthropathy, Bronchitis, Cough
Clinical narrative: 1ST SHOT COLD/COUGH SYMPTOMS W/YELLOW PHLEGM  2ND SHOT SAME WITH STIFF KNEE/SHOULDER JOINTS  3RD SHOT ACUTE COUGH BRONCHITIS WHEEZING  GIVEN SEPTRA FOR SYMPTOMS. 11DEC99 SENT TO EMERGENCY HAD BRONCHITIS 3-MOS AND FULL BLOWN ALLERGIC REACTION NAUSEA, VOMITING RASH ON BACK ARMS NECK AND RISING. 4TH SHOT SEVERE RASH HOT FLASHES SAME. 2/24/06 Received medical records which revealed patient experienced chronic bronchitis, sleep apnea, joint pain, depression/anxiety, migraines, continuous cold s/s with cough, SOB, wheezing intermittently & rash (related to antibiotics? or vaccine?)
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Depression, Hot flush, Hypersensitivity, Laboratory test abnormal, Migraine
Clinical narrative: 1ST SHOT COLD/COUGH SYMPTOMS W/YELLOW PHLEGM  2ND SHOT SAME WITH STIFF KNEE/SHOULDER JOINTS  3RD SHOT ACUTE COUGH BRONCHITIS WHEEZING  GIVEN SEPTRA FOR SYMPTOMS. 11DEC99 SENT TO EMERGENCY HAD BRONCHITIS 3-MOS AND FULL BLOWN ALLERGIC REACTION NAUSEA, VOMITING RASH ON BACK ARMS NECK AND RISING. 4TH SHOT SEVERE RASH HOT FLASHES SAME. 2/24/06 Received medical records which revealed patient experienced chronic bronchitis, sleep apnea, joint pain, depression/anxiety, migraines, continuous cold s/s with cough, SOB, wheezing intermittently & rash (related to antibiotics? or vaccine?)
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Nausea, Rash, Vaccine positive rechallenge, Vomiting, Wheezing
Clinical narrative: 1ST SHOT COLD/COUGH SYMPTOMS W/YELLOW PHLEGM  2ND SHOT SAME WITH STIFF KNEE/SHOULDER JOINTS  3RD SHOT ACUTE COUGH BRONCHITIS WHEEZING  GIVEN SEPTRA FOR SYMPTOMS. 11DEC99 SENT TO EMERGENCY HAD BRONCHITIS 3-MOS AND FULL BLOWN ALLERGIC REACTION NAUSEA, VOMITING RASH ON BACK ARMS NECK AND RISING. 4TH SHOT SEVERE RASH HOT FLASHES SAME. 2/24/06 Received medical records which revealed patient experienced chronic bronchitis, sleep apnea, joint pain, depression/anxiety, migraines, continuous cold s/s with cough, SOB, wheezing intermittently & rash (related to antibiotics? or vaccine?)
Age: 20.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Blood creatine phosphokinase increased, Catheterisation cardiac normal, Chest pain
Clinical narrative: 20 year old male immunized with SPV and typhoid vaccines develops chest pain on the evening of 12/25. Chest pain continues into 12/26 causing patient to go to the hospital. Patient is hospitalized with myocarditis. Symptom: Chest Pain, sub-sternal, Start: 12/25/05 End: 12/26/05. Comment: Described as a sitting on my chest substernal chest pain without dyspnea. Symptom: Nausea without vomiting Start: 12/25/05 End: 12/26/05. Comment: occurred in association with the chest pain. Follow-up Information: 20 y/o male presents for followup of hospitalization for myocarditis. Patient reports he was hospitalized from December 26 through December 29, 2005 in Knoxville, Tennessee. The patient was on leave at his grandmother's house when he developed substernal chest pain starting on Christmas night. He reported the pain was similar to chest pain he had when diagnosed with "myocarditis" at age 17. He denied any SOB or vomiting with the pain. He managed to sleep some from the pain but the pain persisted into the next day. The chest pain was worse by the am of December 26, 2005. He noticed the radiation of pain into both arms and nausea. No vomiting reported, no dyspnea, no shortness of breath on the am of December 26. The patient decided to go to the hospital ER. The patient was seen in the local ER. When the ER doctor noticed the abnormal cardiac chemistries, the patient was transoprted via ambulance to a hospital for further care. The patient was admitted to the hospital on 12/26/05. Patient reports he was hospitalized at age 17 for "myocarditis". He does not remember or know what the etiology was. Review of systems was positive for Chest Pain. The patient also complained of achy joints for one week prior to his chest pain.
Age: 20.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Condition aggravated, Echocardiogram, Electrocardiogram T wave abnormal, Electrocardiogram abnormal, Electrocardiogram repolarisation abnormality
Clinical narrative: 20 year old male immunized with SPV and typhoid vaccines develops chest pain on the evening of 12/25. Chest pain continues into 12/26 causing patient to go to the hospital. Patient is hospitalized with myocarditis. Symptom: Chest Pain, sub-sternal, Start: 12/25/05 End: 12/26/05. Comment: Described as a sitting on my chest substernal chest pain without dyspnea. Symptom: Nausea without vomiting Start: 12/25/05 End: 12/26/05. Comment: occurred in association with the chest pain. Follow-up Information: 20 y/o male presents for followup of hospitalization for myocarditis. Patient reports he was hospitalized from December 26 through December 29, 2005 in Knoxville, Tennessee. The patient was on leave at his grandmother's house when he developed substernal chest pain starting on Christmas night. He reported the pain was similar to chest pain he had when diagnosed with "myocarditis" at age 17. He denied any SOB or vomiting with the pain. He managed to sleep some from the pain but the pain persisted into the next day. The chest pain was worse by the am of December 26, 2005. He noticed the radiation of pain into both arms and nausea. No vomiting reported, no dyspnea, no shortness of breath on the am of December 26. The patient decided to go to the hospital ER. The patient was seen in the local ER. When the ER doctor noticed the abnormal cardiac chemistries, the patient was transoprted via ambulance to a hospital for further care. The patient was admitted to the hospital on 12/26/05. Patient reports he was hospitalized at age 17 for "myocarditis". He does not remember or know what the etiology was. Review of systems was positive for Chest Pain. The patient also complained of achy joints for one week prior to his chest pain.
Age: 20.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Laboratory test abnormal, Myocarditis, Nausea, Pain in extremity, QRS axis abnormal
Clinical narrative: 20 year old male immunized with SPV and typhoid vaccines develops chest pain on the evening of 12/25. Chest pain continues into 12/26 causing patient to go to the hospital. Patient is hospitalized with myocarditis. Symptom: Chest Pain, sub-sternal, Start: 12/25/05 End: 12/26/05. Comment: Described as a sitting on my chest substernal chest pain without dyspnea. Symptom: Nausea without vomiting Start: 12/25/05 End: 12/26/05. Comment: occurred in association with the chest pain. Follow-up Information: 20 y/o male presents for followup of hospitalization for myocarditis. Patient reports he was hospitalized from December 26 through December 29, 2005 in Knoxville, Tennessee. The patient was on leave at his grandmother's house when he developed substernal chest pain starting on Christmas night. He reported the pain was similar to chest pain he had when diagnosed with "myocarditis" at age 17. He denied any SOB or vomiting with the pain. He managed to sleep some from the pain but the pain persisted into the next day. The chest pain was worse by the am of December 26, 2005. He noticed the radiation of pain into both arms and nausea. No vomiting reported, no dyspnea, no shortness of breath on the am of December 26. The patient decided to go to the hospital ER. The patient was seen in the local ER. When the ER doctor noticed the abnormal cardiac chemistries, the patient was transoprted via ambulance to a hospital for further care. The patient was admitted to the hospital on 12/26/05. Patient reports he was hospitalized at age 17 for "myocarditis". He does not remember or know what the etiology was. Review of systems was positive for Chest Pain. The patient also complained of achy joints for one week prior to his chest pain.
Age: 20.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Troponin increased
Clinical narrative: 20 year old male immunized with SPV and typhoid vaccines develops chest pain on the evening of 12/25. Chest pain continues into 12/26 causing patient to go to the hospital. Patient is hospitalized with myocarditis. Symptom: Chest Pain, sub-sternal, Start: 12/25/05 End: 12/26/05. Comment: Described as a sitting on my chest substernal chest pain without dyspnea. Symptom: Nausea without vomiting Start: 12/25/05 End: 12/26/05. Comment: occurred in association with the chest pain. Follow-up Information: 20 y/o male presents for followup of hospitalization for myocarditis. Patient reports he was hospitalized from December 26 through December 29, 2005 in Knoxville, Tennessee. The patient was on leave at his grandmother's house when he developed substernal chest pain starting on Christmas night. He reported the pain was similar to chest pain he had when diagnosed with "myocarditis" at age 17. He denied any SOB or vomiting with the pain. He managed to sleep some from the pain but the pain persisted into the next day. The chest pain was worse by the am of December 26, 2005. He noticed the radiation of pain into both arms and nausea. No vomiting reported, no dyspnea, no shortness of breath on the am of December 26. The patient decided to go to the hospital ER. The patient was seen in the local ER. When the ER doctor noticed the abnormal cardiac chemistries, the patient was transoprted via ambulance to a hospital for further care. The patient was admitted to the hospital on 12/26/05. Patient reports he was hospitalized at age 17 for "myocarditis". He does not remember or know what the etiology was. Review of systems was positive for Chest Pain. The patient also complained of achy joints for one week prior to his chest pain.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Pain, Swelling
Clinical narrative: Mother states patient has been complaining all night and today about his L arm hurting.  Mother states arm is swollen, warm and painful.  None of the following symptoms- shortness of breath, difficulty breathing, hoarseness, wheezing, rash, hives, weakness, paleness, increased heart rate, jerking or starring, crying.  Mother gave patient shower and is cooler.  No Tylenol or ice.  Suggested she give Tylenol and put ice on arm.
Age: 10.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Vaccination failure
Clinical narrative: No symptoms
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: swelling, redness  of outer left upper arm where shot administered.
Age: 1.13
Sex: U
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Rash within 20 min of vaccine administration.  Benadryl prescription rash resolved
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Urticaria
Clinical narrative: A non serious spontaneous case from physician involving hives.  The reporter causality is possible to FluMist.  A physician reported that on 21 Sep 05 a patient experienced hives approximately 12 hours after receiving FluMist vaccine.  The patient was seen at the reporter's office and was given oral hydroxyzine.  The patient had conjunctivitis at the time of vaccine and was being treated with antibiotics.  She has previous history of urticaria unrelated to vaccine administration.  Per the reporter the patient is not allergic to eggs and has received other live vaccines with no problem.  After 4 days, the patient completely recovered from the hives.  The reporter assessed the event as possibly related to FluMist vaccine.
Sex: U
Vaccine: FLUN3, FLUN3
Symptoms: Erythema, Nasal congestion
Clinical narrative: A physician reported that patient received FluMist in 2004 and later in the day experienced nasal congestion and redness around the nose.  The patient completely recovered.  No other information is available. The reporter causality is not provided.
Age: 40.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: Pain at injection sight, and mild edema, resolved in 1hr.  Naproxen 500mg given to patient and patient taken to hospital for evaluation.
Age: 40.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Blood pressure increased, Condition aggravated, Hypertension, Injection site pain, Pruritus
Clinical narrative: Pain at injection sight, and mild edema, resolved in 1hr.  Naproxen 500mg given to patient and patient taken to hospital for evaluation.
Age: 1.06
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: About 3 hours after vaccines (MMR, VZV, Hib, Prevnar, DTaP) had 45 min seizure and fever 102.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Erythema, Feeling hot, Injection site induration
Clinical narrative: 10x10 cms of Erythema on L outer deltoid.  warmth, cellulitis reaction, mild tender induration
Age: 20.0
Sex: M
Vaccine: FLU3, HEPA, IPV, MEN, MMR, TD
Symptoms: Asthma, Chest pain, Cough, Loss of consciousness, Myocarditis
Clinical narrative: The Department of Health informed the HC in May 05 of the death of a medically discharged patient. The patient enlisted in Nov 04, medically discharged in Jan 05, and died on Feb 17th. The following HPI is an account of the events prior to his death as recalled by his mother during an interview in May 05. The service member a 20 year old male, who received his enlistment vaccines on 23 Nov 04. While speaking with his mom on 30 Nov he mentioned that he had a cough, and some chest pain. She state that she encourage him to seek medical attention. She state that a couple of days later, while he was running he 'passed out' and when he went to the doctor he was told it was asthma. Mom reported that while he was at home during Christmas, he reported to his family that he was experiencing some chest pain, and did have bumps on his face that cleared in Jan. Mom was unaware of which vaccines her son received but did remember that her son said that the needle was "funny." Mom does not recall if he had a scar on his arm. She state that he was discharged for stress related issues and complaints of chest pain. Mom is unaware of any other details regarding her son's illness during that time only that the chest pain persisted. When questioned about his past history of asthma, she mentioned that he had it a little in childhood but has not been bothered by it since that time. She did mention that her son felt that his pain was not related to asthma. Mom was also questioned about the waiver for a medical exam upon discharge. She state that he was told that if he requested a workup, it would delay his release and that they may not even discharge him. He received his enlistment vaccines of Hep A-Hep B, Influenza, Meningococcal, MRR, Polio, and Td on 23 Nov 04 and he received his second Hep A-Hep B on 5 Jan 05. Chest pain start 11/30/2004, dyspnea (shortness of breath) start 11/30/2004. 4/3/06 Received Autopsy Report which revealed COD as chronic myocarditis.
Age: 20.0
Sex: M
Vaccine: FLU3, HEPA, IPV, MEN, MMR, TD
Symptoms: Nasal congestion, Oedema
Clinical narrative: The Department of Health informed the HC in May 05 of the death of a medically discharged patient. The patient enlisted in Nov 04, medically discharged in Jan 05, and died on Feb 17th. The following HPI is an account of the events prior to his death as recalled by his mother during an interview in May 05. The service member a 20 year old male, who received his enlistment vaccines on 23 Nov 04. While speaking with his mom on 30 Nov he mentioned that he had a cough, and some chest pain. She state that she encourage him to seek medical attention. She state that a couple of days later, while he was running he 'passed out' and when he went to the doctor he was told it was asthma. Mom reported that while he was at home during Christmas, he reported to his family that he was experiencing some chest pain, and did have bumps on his face that cleared in Jan. Mom was unaware of which vaccines her son received but did remember that her son said that the needle was "funny." Mom does not recall if he had a scar on his arm. She state that he was discharged for stress related issues and complaints of chest pain. Mom is unaware of any other details regarding her son's illness during that time only that the chest pain persisted. When questioned about his past history of asthma, she mentioned that he had it a little in childhood but has not been bothered by it since that time. She did mention that her son felt that his pain was not related to asthma. Mom was also questioned about the waiver for a medical exam upon discharge. She state that he was told that if he requested a workup, it would delay his release and that they may not even discharge him. He received his enlistment vaccines of Hep A-Hep B, Influenza, Meningococcal, MRR, Polio, and Td on 23 Nov 04 and he received his second Hep A-Hep B on 5 Jan 05. Chest pain start 11/30/2004, dyspnea (shortness of breath) start 11/30/2004. 4/3/06 Received Autopsy Report which revealed COD as chronic myocarditis.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood product transfusion, CSF test abnormal, Chest pain, Gout, Guillain-Barre syndrome
Clinical narrative: Numbness and weakness in legs progressed to arms, face about 1 week before presenting to physician 12/27/05. Tx: IVIG. Diagnosed GBS. Discharge summary states decreased reflexes, hypertension, chest pain, gout. msv Annual follow up information indicates patient has not recovered, since injection patient has had electric shock type feelings throughtout his body. Admitted to hospital 5/30/06 with right side weakness & numbness. MRI showed moderate cerebral atrophy with associated periventricule ischemic demyelinization. Admission to hosptial 12-27-05 with extremity numbness & weakness. Per 60 day follow up: GUILLAIN BARRE has resolved except for occassional parethesias.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hypertension, Hypoaesthesia, Hyporeflexia, Laboratory test abnormal, Muscular weakness
Clinical narrative: Numbness and weakness in legs progressed to arms, face about 1 week before presenting to physician 12/27/05. Tx: IVIG. Diagnosed GBS. Discharge summary states decreased reflexes, hypertension, chest pain, gout. msv Annual follow up information indicates patient has not recovered, since injection patient has had electric shock type feelings throughtout his body. Admitted to hospital 5/30/06 with right side weakness & numbness. MRI showed moderate cerebral atrophy with associated periventricule ischemic demyelinization. Admission to hosptial 12-27-05 with extremity numbness & weakness. Per 60 day follow up: GUILLAIN BARRE has resolved except for occassional parethesias.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Paraesthesia
Clinical narrative: Numbness and weakness in legs progressed to arms, face about 1 week before presenting to physician 12/27/05. Tx: IVIG. Diagnosed GBS. Discharge summary states decreased reflexes, hypertension, chest pain, gout. msv Annual follow up information indicates patient has not recovered, since injection patient has had electric shock type feelings throughtout his body. Admitted to hospital 5/30/06 with right side weakness & numbness. MRI showed moderate cerebral atrophy with associated periventricule ischemic demyelinization. Admission to hosptial 12-27-05 with extremity numbness & weakness. Per 60 day follow up: GUILLAIN BARRE has resolved except for occassional parethesias.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Agitation, Autism, Mental retardation severity unspecified, Weight increased
Clinical narrative: None Stated Medical records state agitation, weight gain, retarded development. msv. Information received from the 60 day follow-up states he did get better with medication and alot of hard work, he still has autism and is now in a special school. But with therapy & medication he is better after 4 years
Age: 1.45
Sex: M
Vaccine: PNC
Symptoms: Abasia, Constipation, Coordination abnormal, Dysphagia, Guillain-Barre syndrome
Clinical narrative: Patient had adverse drug reaction of Guillain Barre. Discharge summary states Dysphagia, hypotonia, reflex decreased, constipation, ataxia. msv Follow-up: Cough, runny nose 1 week prior to illness. Progressing to being unable to walk - admitted 12-2-05.
Age: 1.45
Sex: M
Vaccine: PNC
Symptoms: Hyporeflexia, Hypotonia, Laboratory test abnormal
Clinical narrative: Patient had adverse drug reaction of Guillain Barre. Discharge summary states Dysphagia, hypotonia, reflex decreased, constipation, ataxia. msv Follow-up: Cough, runny nose 1 week prior to illness. Progressing to being unable to walk - admitted 12-2-05.
Age: 1.08
Sex: M
Vaccine: FLU3, HIBV, MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous, Rosacea
Clinical narrative: 3-4 day hours of fever followed by outbreak of diffuse rash, erythematous papular rash.  Rosacea vs post vaccine measles/rubella reaction.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Hypokinesia, Injection site vesicles
Clinical narrative: 11/07/2005 Seen in ER and patient stated he had stiffness in left arm on Saturday 11/05/2005 and broke out today, 11/07/2005 with blisters where injection was given.  11/09/2005 no other problems noted.  Small 3mm blister noted on left deltoid.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: On 01/04/2006 received flu vaccine in left deltoid.  Shortly thereafter developed swelling, induration, pain and erythema around injection site which has progressively worsened.  Area involved is size of ping-pong ball.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Medication error
Clinical narrative: Fluzone vaccine administered by accident.  Patient had local reaction at age 19.  She has never had the flu vaccine since.  Patient reacted with redness and itchiness.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Approximately 5 hours after receiving flu vaccine mother noticed a rash on face extending to legs and back.  Also lip itchiness.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Cellulitis, Erythema, Swelling, Tenderness
Clinical narrative: Left arm soft tissue, swelling and redness, tenderness measured 14.5cm x 11cm.  Left arm Cellulitis.
Age: 1.4
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, MMR, VARCEL
Symptoms: Injection site mass
Clinical narrative: Small knot at injection site.  No redness, swelling noted by mother.  Possibility it is from the HIB injection.  Child gets very tense at time of immunizations.
Age: 36.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site pustule, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Pustule approximately 1 inch diameter.  Pain and swelling in lymph nodes under arm.  Low grade fever.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: High fever 103.8 within 24 hours of injection.  Chills, headache.  Resolved in 24 hours.
Age: 21.0
Sex: M
Vaccine: UNK
Symptoms: Nonspecific reaction
Clinical narrative: Innoculation to another person (transferred vaccina virus to close contact).
Age: 15.0
Sex: M
Vaccine: HEP, IPV, VARCEL
Symptoms: Convulsion
Clinical narrative: Patient did not take seizure medication this am but failed to tell me that until after shots were administered.  Patient experienced  a seizure activity 5 minutes after shots were administered.  Fully recovery after seizure.
Age: 1.04
Sex: M
Vaccine: FLU3, HBHEPB, MMR, PNC, VARCEL
Symptoms: Cough, Pyrexia, Rash
Clinical narrative: Rash all over body - started on face and spread down chest and back and to extremities and low grade fever.  Symptomatic treatment for fever and cough.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema
Clinical narrative: Red streaks down arm, red at site.  Keflex.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Rash vesicular
Clinical narrative: Client had varicella like rash (approximately 30 lesions) 20 days after vaccination, 1 on 12/07/2005.  Diagnosed with chickenpox at ER on 12/27/2005.
Age: 6.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Right deltoid pain, swelling, and erythema.
Age: 1.18
Sex: F
Vaccine: HEP, OPV, VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Patient developed blistery red rash 2 days ago.  Seen by physician: diagnosed Varicella
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: 15-20 lesions scattered over trunk, neck and some on forehead.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Vaccination failure
Clinical narrative: None stated
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Pyrexia, Rash
Clinical narrative: Patient broke out with rash 1-4-06 had low grade fever.  Patient stayed home from school per nurse.  Will treat symptoms and return to regular activities when blisters heal.
Age: 1.49
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Febrile reaction 12-7-05 to 12-12-05, temp ranged from 101-105 degrees.
Age: 1.76
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Viral infection
Clinical narrative: Chicken pox like rash started 12-15-05 vaccinated on 12/6/05.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Patient diagnosed with Varicella, received Varivax on 6-16-1997.
Age: 1.26
Sex: F
Vaccine: HIBV, MMR
Symptoms: Vaccination complication
Clinical narrative: 3rd flu dose given in error.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: developed chicken pox 1/5/06
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Difficulty in walking, Dizziness, Injection site hypersensitivity, Injection site pain
Clinical narrative: Immunization given at 8am. School contacted parent. Patient was complaining of dizziness, had difficulty walking, fever of 101.  Slept at home until this AM.  12/22 Seen by provider.  Temp 103 given Tylenol at clinic.  Wheezing (history of asthma) weakness and difficulty walking.  Treatment-Tylenol, Rule out viral infection.  Local injection site sore/red.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Somnolence, Wheezing
Clinical narrative: Immunization given at 8am. School contacted parent. Patient was complaining of dizziness, had difficulty walking, fever of 101.  Slept at home until this AM.  12/22 Seen by provider.  Temp 103 given Tylenol at clinic.  Wheezing (history of asthma) weakness and difficulty walking.  Treatment-Tylenol, Rule out viral infection.  Local injection site sore/red.
Age: 0.34
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: fever 102-103.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Dry skin, Erythema, Rash
Clinical narrative: 2 days after vaccine was given. Began with sunburn like rash on abdomen that evening spread to upper chest and neck.  Next day spread to jaw and right ear.  Today neck and ear dry red and flaky.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Pyrexia, Tremor
Clinical narrative: Patient awoke next AM with sore arm, got shakes and temp over 102.  Pulse 120.  Sick all day Saturday better by Sunday.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Swelling face
Clinical narrative: Patient was given Varicella-SQ on 12/22/05.  Patient has no known allergies of any kind.  12/29/05 mother called to report the patient woke this morning 12/29/05 at 10:30 with swollen lips.  Only symptom patient has.  Patient admitted to consuming salmon prior to going to sleep 12/28/05.  Patient's mother also states that patient has a history of eczema.  Mother states that child had flare up of eczema located on her scalp starting earlier in the week of 12/29/05.
Age: 1.28
Sex: F
Vaccine: DTAP, FLU3, HIBV, MMR, PNC, VARCEL
Symptoms: Viral infection
Clinical narrative: 6-8 chicken pox bumps on buttocks and thighs.
Age: 1.0
Sex: F
Vaccine: HIBV, IPV, MMR
Symptoms: Varicella
Clinical narrative: onset of chicken pox 12-25-05, continued through 1/9/06. Follow up - Vaccines were given at another Peds office.  We don't have this information.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: After immunization on 1/10 began with itching and erythema.  Post immunization noticed erythema, warmth on 1/11.  Went to Emergency Doctor.  Diagnosed in clinic 1/12 with increased erythema and warmth left arm.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Irritability, Swelling, Urticaria
Clinical narrative: 3pm 1/12/06 parent noted hives, L arm swollen.  Took child to ER.  Benadryl ordered by ER.  Extreme irritability noted by parent.  Naps only 10 minutes at nap time.  Did sleep all night.  Does play at short intervals.
Age: 1.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Diarrhoea, Pyrexia, Wrong drug administered
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in 18month old patient who was inadvertently vaccinated with Pediarix.  The reporter is the mother of the patient.  A physician or other health care professional has not verified this report.  The patient had no known drug allergies.  The patient had a history of a low grade fever following receipt of prior immunizations.  On 14 September the subject inadvertently received a dose of Pediarix rather than the intended administration of Prevnar.  On 14 September 2005 the patient was also vaccinated with Haemophiliius influenzae type b conjugate vaccine.  On 14 September, less than one day after vaccination with Pediarix patient experienced a fever of 102 degrees Fahrenheit.  On 15 September 2005 the subject experienced diarrhea.  Patient was treated with Tylenol and Motrin.  The consumer reported that she had, "difficulty getting the fever down."  On 17 September 2005, the fever and diarrhea resolved.
Age: 1.04
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Dyskinesia
Clinical narrative: This case was reported by a consumer and described the occurrence of jerking of head of patient who was vaccinated with Pediarix for prophylaxis.  The reporter is the subject's father.  A physician or other health care professional has not verified this report.  Previous and/or concurrent vaccination included haemophilus influenzae type b vaccine and pneumococcal vaccine given on 26 September 2005.  On 26 September 2005 patient received 1st dose of Pediarix to the left thigh.  Concurrently on the same day, the patient also received injections of haemophilus influenzae type b vaccine, and 7-valent pneumococcal conjugate vaccine. On 28 September 2005, 2 days after vaccination with Pediarix, the subject experienced involuntary jerking movements of her head.  The patient's father stated she was jerking her head from side to side; no signs of fever.  The patient was seen by a physician and was referred to a neurologist.  At the time of reporting the event was worse.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Crying, Tremor
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of shaking in an infant female subject who was vaccinated with Pediarix for prophylaxis.  The healthcare professional is the grandmother of the subject.  The healthcare professional reported that, "three more babies" experienced shaking and crying following receipt of Pediarix, however, subject identifiers were not provided. On an unspecified date on or before 30 September 2005, the subject received a dose of Pediarix.  At an unspecified time after vaccination with Pediarix, on an unspecified date on or before 30 September 2005, the subject experienced shaking and crying.  The outcome of the events was not reported.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Medication error
Clinical narrative: This case was reported by a nurse and subsequently by the subject's mother and described the occurrence of injection site redness in patient who was inadvertently vaccinated with a dose of Pediarix sooner then recommended.  Medical history included "no allergies."  On an unspecified date in either September or October 2005, the subject received the 2nd dose of Pediarix.  "Approximately two weeks later," on October 2005, the subject received the third dose of Pediarix in the right thigh.  This is sooner than the recommended interval of six to eight weeks between the 2nd and 3rd doses of Pediarix.  On October 17, 2005, the subject also was vaccinated withHaemophilus influenzae type b conjugate vaccine and Prevnar in the left thigh.  On 17 October 2005, less than one day after vaccination with Pediarix, the subject experienced injection site redness at the site of administration of Pediarix.  At the time of initial reporting, 18 October 2005, the injection site redness was ongoing.  Follow-up was received from the reporting nurse on 09 November 2005.  The nurse stated that the patient was, "medically well."
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia, White blood cell disorder
Clinical narrative: This case was reported by a physician to a sales representative and described the occurrence of decreased white cell count in a patient who was vaccinated with Pediarix for prophylaxis.  On an unspecified date on or before 19 October 2005, patient received a dose of Pediarix.  At an unspecified time after vaccination with Pediarix, on an unspecified date on or before 19 October 2005, the subject experienced " a white count of 25 and a prolonged fever."  The outcome of the events was not reported.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in patient who was vaccinated with Pediarix for prophylaxis.  The reporter is the mother.  The report was initially received from a consumer and subsequently confirmed by a nurse.  On 30 September 2005 the subject received 2nd dose of Pediarix in the right arm.  On 30 September 2005, less than one day after vaccination with Pediarix, the subject experienced fever and injection site pain.  On 01 October 2005, the events were resolved.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Incorrect dose administered
Clinical narrative: This case was reported by a healthcare professional and described patient who was inadvertently vaccinated with an expired dose of Pediarix for prophylaxis.  On 18 October 2005 the subject received the first dose of Pediarix.  The expiration date for this Pediarix is 15 October 2005.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Asthma, Bronchitis acute, Rhinitis, Vaccination complication
Clinical narrative: This case was reported by a physician and described patient who did not respond to Pediarix for prophylaxis.  The patient's medical history included acute bronchitis, allergic rhinitis and reactive airway disease.  On 05 February, 14 April 2003, and 13 June 2003, patient received three doses of Pediarix immunization  series.  On 10 October 2005, two years after vaccination with Pediarix, a hepatitis B surface antibody titer was negative.  On 05 February 2003, the patient was also vaccinated with Prevnar.  On 14 April 2003, the subject was also vaccinated with Prevnar and PedvaxHIB.  On 13 June 2003, the subject was also vaccinated with Prevnar.  In the reporting physician's opinion, the event was possibly related to vaccination with Pediarix; however, the physician also noted the event could have been associated with the subject's medical history/concurrent illness and/or a lack of effect.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Decreased appetite, Lethargy
Clinical narrative: This case was reported by a nurse and described the occurrence of screaming in patient who was vaccinated with Pediarix for prophylaxis.  On 17 October 2005 the subject received 1st dose of Pediarix.  On 17 October 2005, the subject was also vaccinated with Haemophilus influenzae type b conjugate vaccine and Prevnar. At an unspecified time following receipt of the vaccinations, on 17 October 2005, the subject "screamed for 7 hours and then, (on 17 October 2005,) became lethargic."  On 18 October 2005, the subject experienced a decreased appetite.  Patient was seen at a physician's office, "but not given any treatment."  The screaming resolved on 17 October 2005.  The lethargy and decreased appetite resolved on 18 October 2005. The immunization series with Pediarix was discontinued.  The nurse considered the events to possibly be related to vaccination with Pediarix.
Age: 32.0
Sex: F
Vaccine: RAB
Symptoms: Abortion spontaneous, Multiple pregnancy
Clinical narrative: A 32 year old female patient, born on Sept 1 1973 was vaccinated with 1 ml RabAvert IM on Aug 11, 14, 18, 25 2005 and on Sept 8 2005. On Aug 11 2005 the patient also got HRIG. Patient was bitten by the family dog who was determined to be rabid. On Sept 2 2005 the patient was found to be pregnant with twins. She lost pregnancy and had dilation and curettage on Oct 5 2005. Seriousness criterion: medically significant (OMIC). Causality not related. Drug exposure during pregnancy is expected, abortion is unexpected, after vaccination with RabAvert. On a case level, the case is considered unexpected. No change in benefit risk ratio. No measures necessary.
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Bradycardia, Conjunctivitis, Cyst, Depression
Clinical narrative: ACHE JOINT/MUSCLE, ACID REFLUX, MOOD ANXIETY, ARTHRALGIA, BRADYCARDIA, CONCENTRATION DIFFICULTY, CYST INCREASE SIZE, DEPRESSION, GASTRIC ULCER, GASTRITIS, HEADACHES, PAIN MUSCLES/JOINT, STIFFNESS, SKIN CONDITIONS, SLEEP PROBLEM, CONJUNCTIVITIS (MEDICAL INF. AVAILABLE).
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Disturbance in attention, Gastric ulcer, Gastritis, Gastrooesophageal reflux disease, Headache
Clinical narrative: ACHE JOINT/MUSCLE, ACID REFLUX, MOOD ANXIETY, ARTHRALGIA, BRADYCARDIA, CONCENTRATION DIFFICULTY, CYST INCREASE SIZE, DEPRESSION, GASTRIC ULCER, GASTRITIS, HEADACHES, PAIN MUSCLES/JOINT, STIFFNESS, SKIN CONDITIONS, SLEEP PROBLEM, CONJUNCTIVITIS (MEDICAL INF. AVAILABLE).
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Insomnia, Mood swings, Myalgia
Clinical narrative: ACHE JOINT/MUSCLE, ACID REFLUX, MOOD ANXIETY, ARTHRALGIA, BRADYCARDIA, CONCENTRATION DIFFICULTY, CYST INCREASE SIZE, DEPRESSION, GASTRIC ULCER, GASTRITIS, HEADACHES, PAIN MUSCLES/JOINT, STIFFNESS, SKIN CONDITIONS, SLEEP PROBLEM, CONJUNCTIVITIS (MEDICAL INF. AVAILABLE).
Age: 1.23
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Decreased appetite, Feeling hot, Irritability
Clinical narrative: On 12/29/05 child was irritable, felt warm, had a poor appetite and had "red spots on her with no fluid on her head, diaper area and back. Ended up being worst on Sunday, 1/1/06 with big hard fluid filled red spots that popped open and scabbed over" per mother.  Mother states treated with baths and Tylenol and child recovered.  On 1/13/06 mother called to say that 2 brothers previousily immunized for varicella were also sent home from school with "chickenpox".
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Erythema, Injection site vesicles
Clinical narrative: Red area at right thigh, then 2 papules formed, which almost vesiculated and are now drying up.  These vesicles were at the sight of the varicella injection.  Clinically the child is fine.
Age: 3.0
Sex: U
Vaccine: HEP
Symptoms: Autism
Clinical narrative: This case was reported by a medical assistant and described the occurrence of autism in a 3 year old subject of unspecified gender who was exposed to hepatitis B vaccine recombinant (Engerix-B) in utero. On 25 July 2002 the subject's mother received a dose of Engerix-B (dose number not provided, lot ENG5242A4). On 10 January 2006, the mother of the subject contacted the reporter and reported that she was one month pregnant at the time of the administration of Engerix-B and now her 3 year old child has autism. The outcome of the autism was not reported. Autism was assessed as medically serious by manufacturer. (OMIC)