chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: DTP, HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash papular, Rash vesicular
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old female with no known drug allergies and no past medical history who on 26 SEP 2001 was vaccinated with varicella virus vaccine live. There were no concomitant medications reported. On 30 SEP 2001 the patient developed a rash. The patient sought medical attention and was seen in the office on 02 OCT 2001 with varicella like lesions on her entire body. She was afebrile. Comfort treatment was ordered. Follow up information indicated the patient had labial adhesions at the time of her vaccination. On 26 SEP 2001 the patient was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live (639568/0575L). Other vaccines administered that same day included a first dose of MMR subcutaneously in the right arm (638925/0380L), third dose of HIB conjugate vaccine IM in the right thigh (637877/1413K), a second dose of streptococcus pneumoniae vaccine (PREVNAR) (lot #480894) IM in the right thigh, and a third dose of diphtheria toxoid/pertussis vaccine/tetanus IM in the left thigh (lot #996A2). Other concomitant therapy inclided acetaminophen (TYLENOL) and cough, cold and flu therapies (unspecified) (decongestant). On 30 SEP 2001, the patient started with several bumps with fluid under them, and the patient had a fever and was warm to the touch. On 02 OCT 2001, the patient was seen in the physician's office at 1454H. It was reported she had numerous cervical and "suboccgland" covered with papules and vesicles. The patient was prescribed hydroxyzine (ATARAX). It was reported the patient recovered. On 05 NOV 2001, the patient was checked in the office and there were no pox. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old female with attention deficit hyperactivity disorder who in August 1996, was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included methylphenidate HCl (CONCERTA). On 02 OCT 2001, the patient experienced 20 to 30 lesions, some with blisters and was afebrile. She was seen in the physicians office on 03 OCT 2001 and was diagnosed with varicella. It was reported that no treatment was needed. Subsequently the patient recovered. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Dizziness, Unevaluable event
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old Hispanic male with acne who on 03 OCT 2001 at !0:00 was vaccinated with the first dose of varicella virus vaccine live (lot #635605/1151K) (diluent lot #0422L) in the right upper arm. Concomitant therapy on the same day included the third dose of hepatitis B vaccine, recomb (ENGERIX-B) (lot #ENGS100A2) in the left deltoid and tuberculin purified protein derivative (PPD TINE TEST) (lot #C0835AA) on the left forearm. On 03 OCT 2001, five minutes after the injections, the patient experienced dizziness. The child was laid on a bed and monitored by the nurse and physician. Subsequently fifteen minutes later, the patient recovered from dizziness. Follow up information received from the nurse reported that the patient's vital signs were monitored for 2 hours and remained stable. It was also reported that he was ambulatory, experienced no loss of consciousness, was alert and oriented and complained of no difficulty breathing. No further information is expected.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Pruritus, Rash macular
Clinical narrative: 11 a.m. flu vaccination 7:00 pm 3/4" wide & 4" long macule on medial aspect of arm, pruritic & warm to the touch
Age: 1.0
Sex: M
Vaccine: HBHEPB, IPV, PNC, VARCEL
Symptoms: Blister, Cellulitis, Pyrexia
Clinical narrative: Breakthrough varicella-like papules (6)/vesicles(6); temp = 103; developed cellulitis @ left hip area
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Infection, Skin ulcer
Clinical narrative: 16 vesicular lesions on trunk/scalp/face, dx'd as breakthrough varicella
Age: 2.0
Sex: F
Vaccine: DTAP, MMR, OPV, VARCEL
Symptoms: Bacterial infection, Herpes zoster, Laboratory test abnormal
Clinical narrative: C3 zoster complicated by impetigo
Age: 4.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Herpes zoster, Laboratory test abnormal
Clinical narrative: Zoster 3 1" patches L5
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site induration
Clinical narrative: Left thigh w/ 9 x 13 cm area induration and erythema
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Abdominal pain, Drug ineffective, Infection, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a physician concerning a 6 year old male with no known allergies and no past medical history who on 02/08/1996 was vaccinated IM "lat" with a first dose of varicella vaccine. Concomitant therapy included tuberculin skin test. There were no illnesses at the time of vaccination. On 09/24/2001, the pt developed a sore throat and abdominal pain. On 09/26/2001, the pt developed papular lesions on trunk. The pt was afebrile and the lesions were pruritic. The pt sought unspecified medical attention. The rash was noted to be a mild case of chicken pox. On 09/27/2001, the lesions were on the scalp, face and extremities. The reporter stated that the pt had 20 to 30 spots and they did not scab over. The pt had been exposed two weeks prior to the outbreak and during the week of the outbreak. It was noted that there were other children in the classroom with chickenpox. The pt subsequently recovered. No further info is available.
Age: 62.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a 62 year old white female with hypertension, asthma, and a sulfa allergy who on 10/02/01 was vaccinated with a first dose of varicella virus vaccine live 0.5 ml SC. Concomitant therapy included montelukast sodium, estrogens, conjugated (+) medroxyprogesterone acetate (Prempro) and fluticasone propionate (Flovent). The pt had no known recent varicella exposure, but she had  numerous exposures in the past to varicella. The pt has never came down with a clinical case of chicken pox to her knowledge. Prior to receiving the vaccine, the pt had varicella titers drawn which revealed that she had "some immunity" but her levels were not high enough to be considered immune to varicella. On 10/09/01, the pt began to notice a rash. On 10/10/01, she had about 15-20; lesions. She was seen in the emergency room and sent home On 10/11/01, she had approximately 50 papules on her buttocks, legs, face and back. The pt did not have vesicles. The pt also complained of itching for which she was taking diphenhydramine (Benadryl). She was seen in the ER on 10/12/01 and was diagnosed with chicken pox. On 10/15/01, the nurse reported that the pt was still breaking out in "pox and had about 110 pox on her body". None of the lesions had vesiculated. The nurse stated that the pt just kept breaking out in "little red lesions". she reported that 3 doctors had examined the lesions, and all felt the rash was chicken pox. On 10/16/01, the nurse indicated that the pt was continuing to develop new lesions and had lesions on her stomach, upper arms with no lesions from elbow down and legs down to the ankles, but none on either foot. The pt had discontinued diphenhydramine because the itching was subsiding. The pt was doing "pretty well" with no other signs or symptoms, but the pt's varicella persisted . On 10/18/01, a DNA analysis indicated that VZV DNA and B-globin DNA were not amplified. It was determined that the specimen was inadequate, negative for B-globin and no strain could be identified On 10/29/01, the pt recovered. No additional information is expected.
Age: 4.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Drug ineffective, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 4 year old daughter with noknown medical history who on 09/19/2001 was vaccinated SC in the left arm with a first dose of varicella vacicne. There was no illness at the time of vaccination. Subsequently one week later, the pt developed chicken pox. The chicken pox were all over the child's body and she had a fever. As of 10/22/2001, the pt still had the chicken pox on both legs. It was reported that the pt did not have a fever "this past weekend" on approximately 10/20/2001. Unspecified medical attention was sought. Follow-up info from the health care facility indicated that 5-6 days post vaccination on 09/25/2001, the pt broke out in chicken pox that lasted for 6 weeks. It was reported that she still had chicken pox. The pt also experienced fever which lasted for three days. Her mom was unsure how high it was and treated her for comfort. The pt had a few chicken pox on her face, but the rest of her body was covered. No complications were noted. The pt was seen in the health care facility one time and her mom was told to treat her for comfort. Subsequently in early November 2001, the pt recovered. No further info is available.
Age: 4.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Herpes zoster, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 4 year old daughter with noknown medical history who on 09/19/2001 was vaccinated SC in the left arm with a first dose of varicella vacicne. There was no illness at the time of vaccination. Subsequently one week later, the pt developed chicken pox. The chicken pox were all over the child's body and she had a fever. As of 10/22/2001, the pt still had the chicken pox on both legs. It was reported that the pt did not have a fever "this past weekend" on approximately 10/20/2001. Unspecified medical attention was sought. Follow-up info from the health care facility indicated that 5-6 days post vaccination on 09/25/2001, the pt broke out in chicken pox that lasted for 6 weeks. It was reported that she still had chicken pox. The pt also experienced fever which lasted for three days. Her mom was unsure how high it was and treated her for comfort. The pt had a few chicken pox on her face, but the rest of her body was covered. No complications were noted. The pt was seen in the health care facility one time and her mom was told to treat her for comfort. Subsequently in early November 2001, the pt recovered. No further info is available.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Apnoea, Sudden infant death syndrome
Clinical narrative: A physician reported that a 2 month old male received a 1st dose of Prevnar (pneumococcal 7-valent conjugate vaccine), Infanrix (diphtheria vaccine/pertussis vaccine/tetanus vaccine), Pedvax-HIB (haemophilus influenzae type B polysaccharide), Polio Vaccine (poliomyelitis vaccine inactivated), and 2nd dose of Recombivax-HB (hepatitis B vaccine) vaccines on 19 APR 2002. Medical history includes one previous episode of wheezing. Concurrent illness included mild upper respiratory infection. On 20 APR 2002, at 06:00, the infant was found not breathing. No additional information was available as of the date of this report. A copy of this report has been forwarded to the manufacturer. A 15-day follow up report received 6/19/2002 adds: The assistant medical examiner reportedly felt that the infant had experienced SIDS, which was not related to the immunizations administered the previous day. An autopsy report was not available. No additional info was available as of the date of this report. A copy of this report has been forwarded to Glaxo Smith Kline, Merck Sharp Dome and Aventis Pasteur, manufacturers of the concomitantly administered vaccines. Theh Glaxo Smith Kline manufacturer control number for this case is A0368613A.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: A physician reported that a 2 month old male received a 1st dose of Prevnar (pneumococcal 7-valent conjugate vaccine), Infanrix (diphtheria vaccine/pertussis vaccine/tetanus vaccine), Pedvax-HIB (haemophilus influenzae type B polysaccharide), Polio Vaccine (poliomyelitis vaccine inactivated), and 2nd dose of Recombivax-HB (hepatitis B vaccine) vaccines on 19 APR 2002. Medical history includes one previous episode of wheezing. Concurrent illness included mild upper respiratory infection. On 20 APR 2002, at 06:00, the infant was found not breathing. No additional information was available as of the date of this report. A copy of this report has been forwarded to the manufacturer. A 15-day follow up report received 6/19/2002 adds: The assistant medical examiner reportedly felt that the infant had experienced SIDS, which was not related to the immunizations administered the previous day. An autopsy report was not available. No additional info was available as of the date of this report. A copy of this report has been forwarded to Glaxo Smith Kline, Merck Sharp Dome and Aventis Pasteur, manufacturers of the concomitantly administered vaccines. Theh Glaxo Smith Kline manufacturer control number for this case is A0368613A.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: A physician reported that a 2 month old male received a 1st dose of Prevnar (pneumococcal 7-valent conjugate vaccine), Infanrix (diphtheria vaccine/pertussis vaccine/tetanus vaccine), Pedvax-HIB (haemophilus influenzae type B polysaccharide), Polio Vaccine (poliomyelitis vaccine inactivated), and 2nd dose of Recombivax-HB (hepatitis B vaccine) vaccines on 19 APR 2002. Medical history includes one previous episode of wheezing. Concurrent illness included mild upper respiratory infection. On 20 APR 2002, at 06:00, the infant was found not breathing. No additional information was available as of the date of this report. A copy of this report has been forwarded to the manufacturer. A 15-day follow up report received 6/19/2002 adds: The assistant medical examiner reportedly felt that the infant had experienced SIDS, which was not related to the immunizations administered the previous day. An autopsy report was not available. No additional info was available as of the date of this report. A copy of this report has been forwarded to Glaxo Smith Kline, Merck Sharp Dome and Aventis Pasteur, manufacturers of the concomitantly administered vaccines. Theh Glaxo Smith Kline manufacturer control number for this case is A0368613A.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Sudden infant death syndrome
Clinical narrative: Found in prone position in crib, covered by blanket. Preliminary cause of death is SIDS as per medical examiner.
Age: 19.0
Sex: F
Vaccine: MEN, MEN
Symptoms: Chills, Drug ineffective, Laboratory test abnormal, Nausea, Pain
Clinical narrative: It was reported that a 19 year old female pt was vaccinated in September 2001 with Menomune. The pt was hospitalized on 04/23/2002 with fever of 101 deg. F., chills, nausea, and petechiae. Negative for headache and stiff neck. Initial diagnosis septicemia. No lumbar puncture performed. Blood cultures positive for Neisseria meningitidis sero group C. The pt was treated with Rocephin and discharged on 04/29/2002. Final diagnosis Meningococcaemia. From the additional correspondence received stated that the pt was admitted to the hospital via the emergency roon on 04/23/2002 following a brief illness in which she is experiencing high fever, body aches, and a rash. "She underwent a complete septic work-up, including urine, blood and throat cultures. After 48 hours, the blood cultures returned as Neisseria meninitidis. The following day, type specific was obtained and it was found to be Type C. At the time of admission, she was begun on Rocepin, and defervesced within 24 hrs from the beginning of antibiotics and over the course of her hospitalization, her rash resolved other than the purpura. There were no coomplications. She received no additional therapy and no further consultations were obtained." The pt was discharged on 04/29/2002.
Age: 19.0
Sex: F
Vaccine: MEN, MEN
Symptoms: Petechiae, Pyrexia, Sepsis
Clinical narrative: It was reported that a 19 year old female pt was vaccinated in September 2001 with Menomune. The pt was hospitalized on 04/23/2002 with fever of 101 deg. F., chills, nausea, and petechiae. Negative for headache and stiff neck. Initial diagnosis septicemia. No lumbar puncture performed. Blood cultures positive for Neisseria meningitidis sero group C. The pt was treated with Rocephin and discharged on 04/29/2002. Final diagnosis Meningococcaemia. From the additional correspondence received stated that the pt was admitted to the hospital via the emergency roon on 04/23/2002 following a brief illness in which she is experiencing high fever, body aches, and a rash. "She underwent a complete septic work-up, including urine, blood and throat cultures. After 48 hours, the blood cultures returned as Neisseria meninitidis. The following day, type specific was obtained and it was found to be Type C. At the time of admission, she was begun on Rocepin, and defervesced within 24 hrs from the beginning of antibiotics and over the course of her hospitalization, her rash resolved other than the purpura. There were no coomplications. She received no additional therapy and no further consultations were obtained." The pt was discharged on 04/29/2002.
Age: 19.0
Sex: F
Vaccine: MEN, MEN
Symptoms: Bacterial infection, Dizziness, Drug ineffective, Fatigue, Laboratory test abnormal
Clinical narrative: It was reported that a 19 year old female pt was vaccinated in September 2001 with Menomune. The pt was hospitalized on 04/23/2002 with fever of 101 deg. F., chills, nausea, and petechiae. Negative for headache and stiff neck. Initial diagnosis septicemia. No lumbar puncture performed. Blood cultures positive for Neisseria meningitidis sero group C. The pt was treated with Rocephin and discharged on 04/29/2002. Final diagnosis Meningococcaemia. From the additional correspondence received stated that the pt was admitted to the hospital via the emergency roon on 04/23/2002 following a brief illness in which she is experiencing high fever, body aches, and a rash. "She underwent a complete septic work-up, including urine, blood and throat cultures. After 48 hours, the blood cultures returned as Neisseria meninitidis. The following day, type specific was obtained and it was found to be Type C. At the time of admission, she was begun on Rocepin, and defervesced within 24 hrs from the beginning of antibiotics and over the course of her hospitalization, her rash resolved other than the purpura. There were no coomplications. She received no additional therapy and no further consultations were obtained." The pt was discharged on 04/29/2002.
Age: 19.0
Sex: F
Vaccine: MEN, MEN
Symptoms: Nausea, Purpura, Pyrexia, Rash
Clinical narrative: It was reported that a 19 year old female pt was vaccinated in September 2001 with Menomune. The pt was hospitalized on 04/23/2002 with fever of 101 deg. F., chills, nausea, and petechiae. Negative for headache and stiff neck. Initial diagnosis septicemia. No lumbar puncture performed. Blood cultures positive for Neisseria meningitidis sero group C. The pt was treated with Rocephin and discharged on 04/29/2002. Final diagnosis Meningococcaemia. From the additional correspondence received stated that the pt was admitted to the hospital via the emergency roon on 04/23/2002 following a brief illness in which she is experiencing high fever, body aches, and a rash. "She underwent a complete septic work-up, including urine, blood and throat cultures. After 48 hours, the blood cultures returned as Neisseria meninitidis. The following day, type specific was obtained and it was found to be Type C. At the time of admission, she was begun on Rocepin, and defervesced within 24 hrs from the beginning of antibiotics and over the course of her hospitalization, her rash resolved other than the purpura. There were no coomplications. She received no additional therapy and no further consultations were obtained." The pt was discharged on 04/29/2002.
Age: 22.0
Sex: F
Vaccine: MEN
Symptoms: Aphasia, Dysphagia, Headache, Hemiplegia
Clinical narrative: From correspondence received at manufacturer on 15 MAY 2002 it was reported that a 24 year old female patient received a Menomune A/C/Y/W-135 vaccination on 19 NOV 1995. Reportedly, the patient complained of a headache for approximately 2 days prior to 1 MAR 2000. The patient presented to the hospital complaining of headache, initially sent home. The patient went back to the hospital later that evening. Patient was diagnosed with bleeding brain stem, suffered right side paralysis, was unable to speak or swallow. The patient recovered spending approximately 2 months in rehab center. The follow up received on 5/30/02 states call to RN to verify hospitalization. Pt was in ICU on a ventilator for over a week. AFter hospitalization was transferred to a rehabilitation center. Pt stated she had regained most of her strength back. She had called to ask if there were any other cases similar to hers. She inquired about what preservative is used in this vaccine, and if thimerosal was used. Was planning to discuss this with her neurosurgeon. From additional information, it was reported that the patient's current medical condition is unknown.  From additional information received on 05May2004 from a health care professional, it was reported that there has been no contact with the pt since the event of hemorrhage occurred. No further information is anticipated, this case is considered closed.
Sex: U
Vaccine: MMR, PNC
Symptoms: Erythema
Clinical narrative: An investigator reported that an unidentified pt received Prevnar and MMR vaccines on 05/01/2002, as part of a study. During 04/09/2002 to 05/09/2002, at week 16 of the study, the pt developed erythema that was graded 3. According to protocol, grade 3 reactions were considered serious adverse events. The investigator assessed the erythema as definitely related to Prevnar vaccine administration. The medical monitor assessment is unknown.
Age: 1.2
Sex: F
Vaccine: MMR
Symptoms: Autism, Cognitive disorder
Clinical narrative: Information has been received from a foreign legal firm concerning a female who on 12/12/95 was vaccinated with MMRII. Subsequently, the pt experienced learning problems, autism and language problems. Upon internal review, the pt's learning problems, autism and language problems were considered to be other medical events. No further information is available.
Age: 13.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Abdominal pain, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Nausea
Clinical narrative: Information has been received from a physician concerning a 13 year old female with heavy periods and no known allergies who on 04/25/2002 was vaccinated with a second dose of hep A vaccine. Concomitant therapy included hormonal contraceptives and an unspecified anti-depressant. On 04/26/2002, the pt experienced intractible nausea and vomiting and stomach pain and was hospitalized for 4 days. It was noted that her vomiting was severe and she was unable to keep anything down. Her SGPT and SGOT were elevated at 100 and her bilirubin was 1.8-2.0. She was hydrated and stabilized until the 05/04/2002 when she was discharged. On 05/05/2002, she started vomiting again. Follow-up info indicated that the symptoms of nausea, vomiting and stomach pain have continued. It was reported that a fever had disappeared entirely but the "enzymes that were in the neighborhood of 100 were now 400 and 1000." It was also noted that her bilirubin was increased. It was reported that she was hospitalized on 05/01/2002 due to dehydration. On 05/06/2002, the pt came to the physician's office as was still vomiting. The doctor prescribed Zofran, Compazine and Phenergan. It was reported that the pt's condition continues. The reporter felt the pt's experience was a "temporal coincidence." The reporter felt the pt's vomiting, stomach pain, nausea, increased SGOT and SGPT and increased bilirubin were disabling. Follow up information from a physician indicated that the patient's nausea and vomiting led to dehydration and hospitalization. Her liver enzymes were elevated from May 06, 2002 to Mat 11, 2002. The recovery status was reported as unknown. The reporter felt the patient's vomiting, stomach pain, nausea, increased SGOT, increased SGPT and increased bilirubin were disabling. Additional information has been requested. Additional follow up from a physician indicated that the pt was hospitalized from 5/1/02 to 5/4/02. AFter discharge she had a recurrence of vomiting which resolved with Zofran. Her liver enzymes peaked on 5/11/02 at a 371 and 1103 for her SGOT and SGPT respectively. Susbequently, she felt better. Her last blood work on 5/20/02 showed a normal SGOT and a AGPT of 114. It was noted that she also had a viral stool culture which was negative. It was reported that the pt is improving. The reporter felt the pt's vomiting, stomach pain, nausea, increased SGOT, increased SGPT and increased bilirubin were disabling. On 9/4/02, it was reported that the pt's vomiting and described hepatitis had resolved. Liver enzymes were within normal limits on 5/28/02. All viral cultures and ANA were negative. As of 5/28/02, the pt recovered. No further info is expected.  A 15-day follow up report received 6/19/2002 adds no new info.
Age: 13.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 13 year old female with heavy periods and no known allergies who on 04/25/2002 was vaccinated with a second dose of hep A vaccine. Concomitant therapy included hormonal contraceptives and an unspecified anti-depressant. On 04/26/2002, the pt experienced intractible nausea and vomiting and stomach pain and was hospitalized for 4 days. It was noted that her vomiting was severe and she was unable to keep anything down. Her SGPT and SGOT were elevated at 100 and her bilirubin was 1.8-2.0. She was hydrated and stabilized until the 05/04/2002 when she was discharged. On 05/05/2002, she started vomiting again. Follow-up info indicated that the symptoms of nausea, vomiting and stomach pain have continued. It was reported that a fever had disappeared entirely but the "enzymes that were in the neighborhood of 100 were now 400 and 1000." It was also noted that her bilirubin was increased. It was reported that she was hospitalized on 05/01/2002 due to dehydration. On 05/06/2002, the pt came to the physician's office as was still vomiting. The doctor prescribed Zofran, Compazine and Phenergan. It was reported that the pt's condition continues. The reporter felt the pt's experience was a "temporal coincidence." The reporter felt the pt's vomiting, stomach pain, nausea, increased SGOT and SGPT and increased bilirubin were disabling. Follow up information from a physician indicated that the patient's nausea and vomiting led to dehydration and hospitalization. Her liver enzymes were elevated from May 06, 2002 to Mat 11, 2002. The recovery status was reported as unknown. The reporter felt the patient's vomiting, stomach pain, nausea, increased SGOT, increased SGPT and increased bilirubin were disabling. Additional information has been requested. Additional follow up from a physician indicated that the pt was hospitalized from 5/1/02 to 5/4/02. AFter discharge she had a recurrence of vomiting which resolved with Zofran. Her liver enzymes peaked on 5/11/02 at a 371 and 1103 for her SGOT and SGPT respectively. Susbequently, she felt better. Her last blood work on 5/20/02 showed a normal SGOT and a AGPT of 114. It was noted that she also had a viral stool culture which was negative. It was reported that the pt is improving. The reporter felt the pt's vomiting, stomach pain, nausea, increased SGOT, increased SGPT and increased bilirubin were disabling. On 9/4/02, it was reported that the pt's vomiting and described hepatitis had resolved. Liver enzymes were within normal limits on 5/28/02. All viral cultures and ANA were negative. As of 5/28/02, the pt recovered. No further info is expected.  A 15-day follow up report received 6/19/2002 adds no new info.
Age: 13.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Dehydration, Liver function test abnormal, Vomiting
Clinical narrative: Information has been received from a physician concerning a 13 year old female with heavy periods and no known allergies who on 04/25/2002 was vaccinated with a second dose of hep A vaccine. Concomitant therapy included hormonal contraceptives and an unspecified anti-depressant. On 04/26/2002, the pt experienced intractible nausea and vomiting and stomach pain and was hospitalized for 4 days. It was noted that her vomiting was severe and she was unable to keep anything down. Her SGPT and SGOT were elevated at 100 and her bilirubin was 1.8-2.0. She was hydrated and stabilized until the 05/04/2002 when she was discharged. On 05/05/2002, she started vomiting again. Follow-up info indicated that the symptoms of nausea, vomiting and stomach pain have continued. It was reported that a fever had disappeared entirely but the "enzymes that were in the neighborhood of 100 were now 400 and 1000." It was also noted that her bilirubin was increased. It was reported that she was hospitalized on 05/01/2002 due to dehydration. On 05/06/2002, the pt came to the physician's office as was still vomiting. The doctor prescribed Zofran, Compazine and Phenergan. It was reported that the pt's condition continues. The reporter felt the pt's experience was a "temporal coincidence." The reporter felt the pt's vomiting, stomach pain, nausea, increased SGOT and SGPT and increased bilirubin were disabling. Follow up information from a physician indicated that the patient's nausea and vomiting led to dehydration and hospitalization. Her liver enzymes were elevated from May 06, 2002 to Mat 11, 2002. The recovery status was reported as unknown. The reporter felt the patient's vomiting, stomach pain, nausea, increased SGOT, increased SGPT and increased bilirubin were disabling. Additional information has been requested. Additional follow up from a physician indicated that the pt was hospitalized from 5/1/02 to 5/4/02. AFter discharge she had a recurrence of vomiting which resolved with Zofran. Her liver enzymes peaked on 5/11/02 at a 371 and 1103 for her SGOT and SGPT respectively. Susbequently, she felt better. Her last blood work on 5/20/02 showed a normal SGOT and a AGPT of 114. It was noted that she also had a viral stool culture which was negative. It was reported that the pt is improving. The reporter felt the pt's vomiting, stomach pain, nausea, increased SGOT, increased SGPT and increased bilirubin were disabling. On 9/4/02, it was reported that the pt's vomiting and described hepatitis had resolved. Liver enzymes were within normal limits on 5/28/02. All viral cultures and ANA were negative. As of 5/28/02, the pt recovered. No further info is expected.  A 15-day follow up report received 6/19/2002 adds no new info.
Age: 0.5
Sex: M
Vaccine: HEP
Symptoms: Autism, Personality change
Clinical narrative: Information has been received from a consumer concerning her 18 month old son who was vaccinated with hep B vaccine, prior to six months of age. Concomitant therapy included at least one immunization containing thimerosal at less than six months of age. On approximately 04/14/2002, at 17 months old, medical attention was sought and the pt was diagnosed with autism. The mother reported that she first noticed a "change" in her son at six months and has refused other vaccines since that time due to her concerns about safety. The mother expressed a concern regarding the lot numbers containing heavy metals or preservative. Upon internal review, autism was considered an other important medical event. Additional info has been requested.
Age: 1.2
Sex: M
Vaccine: MMR
Symptoms: Autism, Depression, Disturbance in attention, Psychomotor hyperactivity
Clinical narrative: Information has been received from a consumer concerning a 2 year old son with possible food allergies who in approximately November 1988, between 15-18 months of age, was vaccinated with a dose of MMR vaccine. Prior to two year of age the pt was able to maintain eye contact and was an easy going baby. At two years of age, on approximately 08/27/1989, "it seemed like a light switch was turned off." Her son was diagnosed with AUHD at five years of age and a definitive diagnosis of Asperger Syndrome form of Autism at 12 years of age. His current medications are Ritalin and Wellbutrin. The pt's mother reported that the pt craves peanut butter and milk. The pt also experienced depression and it was reported that the pt had mental health counseling. Upon internal review, the pt's ADHD and Asperger Syndrome were considered to be other important medical events. Additional info has been requested.
Age: 1.4
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Blood iron decreased, Contusion, Epistaxis, Hypovitaminosis, Microcytic anaemia
Clinical narrative: The infant presented in the office with a nosebleed, evolving  bruising and pinpoint petechiae 12 days post MMR. Diagnosed with Thrombocytopenia purpura. Hospitalized for dropping platelet count and administration of IVIG. Eventually flown to another hospital for continued treatment. Secondary diagnosis - microcytic anemia & iron deficiency. Eventual recovery in progress; discharged 5/9/02, presently on Prednisone & iron.
Age: 1.4
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Petechiae, Platelet count decreased, Thrombocytopenic purpura
Clinical narrative: The infant presented in the office with a nosebleed, evolving  bruising and pinpoint petechiae 12 days post MMR. Diagnosed with Thrombocytopenia purpura. Hospitalized for dropping platelet count and administration of IVIG. Eventually flown to another hospital for continued treatment. Secondary diagnosis - microcytic anemia & iron deficiency. Eventual recovery in progress; discharged 5/9/02, presently on Prednisone & iron.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Febrile convulsion, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: The pt developed a low grade fever, complained of right leg pain with mild swelling at injection site. The pt also developed a generalized tonic-clonic seizure lasting approximately 50 minutes with a temp of 103.1 deg. F.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Convulsion, Irritability, Vomiting
Clinical narrative: Two days after immunization, the infant became irritable and had a minor motor seizure. No fever noted and the exams were normal. The pt was observed as inpatient with no problems except for several episodes of vomiting.
Age: 1.2
Sex: M
Vaccine: IPV, MMR, PNC, VARCEL
Symptoms: Face oedema, Parotitis
Clinical narrative: 5/13/02-mother noted right face swollen. Taken to ER. diagnosed right parotitis, prescribed Augmentin in 250 mg PO BID X 7d.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Injection site abscess, Injection site erythema, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Child brought to clinic by mother. Received DTaP, Hib, HPV in LLT on 5/8/02. Site approximately size of 1/2 dollar, swollen, red and tender to touch. Abcess noted at injection site. Parent states child has had fever. Obviously ill today.
Age: 0.3
Sex: F
Vaccine: DTAP, HBPV, IPV, PNC
Symptoms: Irritability, Lethargy, Pyrexia
Clinical narrative: Extreme fussiness, fever 101 F, lethargic. A follow up report received 6/6/2002 adds: Continued 24 hours. Tylenol given.
Age: 0.6
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Crying, Rhinorrhoea, Screaming
Clinical narrative: Nasal discharge, no fever, crying unconsolable, no relief from Tylenol. No erythema of thigh, screaming uncontrollable 5/16. Rule out for UTI-UA/C&S urine. No growth, UA WNL. Motrin of 6 hours ATC.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Erythema, Hypersensitivity, Urticaria
Clinical narrative: Child had hives back of hand, neck red, 1 red spot by left eye and mouth, groin red, Awoke crying, Child had Enfamil with iron, 4 oz 7 pm 5/19/02 instead of Alsoy. -ER, Diagnosed -allergic reaction, No meds given, Treatment-switch back to Alsoy formula.
Age: 1.13
Sex: M
Vaccine: HBHEPB, IPV, MMR, VARCEL
Symptoms: Erythema, Tympanic membrane perforation, Urticaria
Clinical narrative: Went to ER due to reddish/yellow discharge from left ear. Previous ear infection in 01/02. No fever, a few pox on face and body. Put on ear drops and amoxicillin. ER physician said it was a possible reaction to varicella. Had red hiving on external ear. Ear drum burst.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Swelling, redness, tight in arm
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: Swelling, redness, Pain in left upper arm, at site if vaccine injection. 8 hrs post-vaccine adm. Given Benadryl- decreased in redness. At the time of vaccination , left upper arm-red, swollen, sore-9 x 12 cm induration and erythema.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Vaccines on 5/22/02 in left arm-DTaP #5, IPV #4 SQ. 24 hrs later-noticed redness, swelling, pain arm injection site. Seen in office 5/24/02, 81/2 X 7 1/2 cm area redness, swelling, induration. From .2 + (?). Treated with Benadryl and Motrin.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Chills, Pyrexia
Clinical narrative: The pt developed high fever and chills.
Age: 0.8
Sex: M
Vaccine: DTAP, HBPV, OPV
Symptoms: Autism
Clinical narrative: Autism. Did not reach typical milestones. Will repeat words spoken to him. Uses a few scattered words.
Age: 1.3
Sex: F
Vaccine: DTPHIB, HEP, MMR, OPV
Symptoms: Autism, Neurodevelopmental disorder
Clinical narrative: Autism. Did not reach typical milestones. Vocalizes, but does not really use speech as a tool to get what she wants. Follow up reports states  pt  has "PDD- Autism".
Age: 1.59
Sex: M
Vaccine: DTAP, OPV
Symptoms: Autism, Neurodevelopmental disorder
Clinical narrative: The pt developed autism; did not reach typical milestones. The pt does speak now but not age appropriate and has difficulty understanding all said to him.
Age: 15.0
Sex: M
Vaccine: HEP, IPV, MMR, TTOX, VARCEL
Symptoms: Haematuria, Pyrexia, Rash
Clinical narrative: Stepfather reports Khuyen. Oral temperature 104 deg. F, Scattered rash "bumps under left upper arm", Carried into ER . ER report-oral temperature 39.0 C (1022) . Diagnosis- Prexia Febrile, Illness, microscopic, Hematuria medication-oral Tylenol gr X
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling, Pruritus
Clinical narrative: Right thigh red, swollen, itchy. Given prescription for Benadryl and advise cool compress to area. Return to clinic  if swelling doesn't get better.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: At 6pm, he had a quarter sized hard, red spot on right arm that was hot to the touch, sore and hurting On 05/08/02, 7 am, arm swollen from shoulder to elbow-2X the size of the other arm, hot and red. Called dr, Was told to use ice pack and give Advil or Tylenol and watch for high temperature and discomfort. Took him to a nurse practitioner @ 4:00- after armpit was swollen
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Injection site mass, Otitis media
Clinical narrative: About 2 weeks post vaccination-lump appeared at or around site of injection No fever-just cranky. At this visit (5/15/02) also had right AOM . The lesion looks like one varicella. No other lesion seen
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia
Clinical narrative: Vaccine given 4/11/02. On return (5/13/02), pt reported that for 3 days after injection entire left side of body was numb. Not reported to office until 5/13/02.
Age: 1.08
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Pyrexia, Rash papular
Clinical narrative: Fever, red papules over all body
Age: 2.8
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: The pt presented to ER with hives. Arrived at 22:58 on 05/15/2002. Mother stated that the child received vaccination at approximately 11:00 on 05/15/2002 and developed urticaria to trunk and back at approximately 12:00. Child was treated with Benadryl and Prelone syrup.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: The pt developed hives four on left shoulder and axilla 15 mins after Hep A vaccination. No other complaints or symptoms. Given Benadryl and the pt recovered.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Twenty-four hours post DTaP immunization, the pt developed red, and tender to touch area.
Age: 11.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Nausea, Pyrexia, Rash, Rash erythematous
Clinical narrative: On 05/09/2002, the pt developed fatigue for two days and on 05/11/2002, she developed red rash that started on face. On 05/12/2002, she presented a fever of 100 deg F and on 05/13/2002, she felt nausea (tiny red dots, some raised).
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain upper, Anorexia, Diarrhoea, Lethargy, Malaise
Clinical narrative: On 05/06/2002, the pt complained of lethargy, diarrhea, malaise. Symptoms persisted and increased in severity. On 05/07/2002, additional symptoms began "anorexia, nausea, mid upper abdomental tenderness radiating to back and right thoracic area. large "lump" appeared on right hand between middle finger. Acephex and Celebrex were prescribed.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Nausea, Skin nodule
Clinical narrative: On 05/06/2002, the pt complained of lethargy, diarrhea, malaise. Symptoms persisted and increased in severity. On 05/07/2002, additional symptoms began "anorexia, nausea, mid upper abdomental tenderness radiating to back and right thoracic area. large "lump" appeared on right hand between middle finger. Acephex and Celebrex were prescribed.
Age: 1.3
Sex: M
Vaccine: DTAP, HBHEPB, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pyrexia
Clinical narrative: The pt developed red and hot to touch right leg and cold compresses were applied. On 05/01/2002, the pt awoke with swollen right let to three times the size from groin to torso.  Also had fever of 101 deg F and was seen in ER. Blood tests showed no infection but while there, the pt fell and cut mouth so then the pt was placed on antibiotics. Returned home and the pt remained irritable throughout the weekend. The pt recovered on 05/07/2002.
Age: 12.0
Sex: M
Vaccine: IPV, MMR, TD
Symptoms: Balance disorder, Nausea, Nervousness, Pallor
Clinical narrative: Shortly after receiving immunizations, stood up and went to R/S appt. While in the hall, "felt sick" as if going to vomit. Face was pale. Was seated. Denied dizziness or lightheadedness, however, was unsteady on feet until seated. Had not eaten breakfast. Given orange juice and within a few minutes, returned to normal. No longer nauseated. Left to go home. Later in PM, mother called concerned that what happened was a "serum reaction" because his paper said pallor was a symptom to watch for. Son was fine now; riding dirt bike but even though reassurance, offered that son was fine and reaction was probably nervous reaction. She was not convinced.
Age: 3.8
Sex: M
Vaccine: DTAP, HEP
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Post vax, noted pt was very tired and slept all night. Temperature was 102F (R) that evening (5/21/02). Awoke at 08:00 on 5/22/02 and mother noticed upper arm was swollen, hot to touch with a red rash. Saw his pediatrician who found a local erythematous and indurated reaction of upper arm to elbow.
Age: 3.8
Sex: M
Vaccine: DTAP, HEP
Symptoms: Pyrexia, Somnolence
Clinical narrative: Post vax, noted pt was very tired and slept all night. Temperature was 102F (R) that evening (5/21/02). Awoke at 08:00 on 5/22/02 and mother noticed upper arm was swollen, hot to touch with a red rash. Saw his pediatrician who found a local erythematous and indurated reaction of upper arm to elbow.
Age: 0.8
Sex: M
Vaccine: IPV
Symptoms: Heart rate increased, Irritability, Pyrexia, Respiratory rate increased
Clinical narrative: Fever 104.7F; pulse 192; resp 80; fussy.
Age: 17.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Dermatitis
Clinical narrative: Dermatitis to face NOS. No treatment indicated per MD.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, DTAP, HIBV, IPV
Symptoms: Irritability, Lethargy, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Stiffness and extreme fussiness the day of the shot. The next day had a fever and lethargy.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, DTAP, HIBV, IPV
Symptoms: Crying, Lethargy, Pyrexia, Screaming
Clinical narrative: Stiffness and extreme fussiness the day of the shot. The next day had a fever and lethargy.
Age: 1.6
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Client presented with right upper thigh swelling, redness, warm to touch and hard (approx. area of 3" X 3". No fever and no problems walking.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Febrile convulsion, Rash
Clinical narrative: On 5/12/02, low-grade temperature X 2 days. On 5/14/02, temperature increased with a rash on scalp. On 5/15/02, temperature increased and at 04:00, had a seizure and went to ER. Essentially febrile seizure X 2 of classic type. Treatment with Tylenol and Advil. Father had febrile seizures as an infant.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Abasia, Asthenia, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: On 5/17/02, right leg started feeling weak; on 5/18/02, both legs weak and fell 3 different times and noted weakness of hands; on 5/19/02, legs were getting weaker and grip was getting weaker and fell 4 times. On 5/20/02, weakness increased. Saw company physician and was referred to a Neurologist. Saw the Neurologist on 5/22/02 and was dx'd with Guillain-Barre.  Received on 06/11/2003: "Not at this time.  The recipient contines to have weakness in all extremities and the treating physician anticipates the recipient will be at maximum medical improvement in May 2005.  Due to company police (6 months of leave and 6 months of light duty) the recipient has a possibility of losing his job.  He has been with this company for 26 years."
Age: 68.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: States left arm was sore after injection. Everyday it was worse. Complained of left arm being red, swollen and itching from injection site to elbow but denies fever. Went to Urgent Care on 5/20/02 and was given prescriptions for Allegra 1 bid and Cephalexin 500mg 1qid. On 5/21/02, pt states it is much improved.
Age: 42.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Pruritus, Pyrexia, Urticaria
Clinical narrative: On the evening of 4/29/02, pt states a fine, pink rash was beginning on wet areas of body (underarms, groin). It spread to cover all of body. Pt complained of severe pruritus at "welts" with scratching. Pt  took tepid bath and used Calamine lotion. Pt did not see or call PCP. Rash resolved in 3 days. Pt stated she also had "fever" (no temperature taken). No SOB.
Age: 48.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Below site was red, swollen and warm to touch.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Area red and warm at time of bringing in for appt.