chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Pruritus
Clinical narrative: Report A0355776A describes an injection site reaction in a 4 year old male who received Infanrix. Medical history, concurrent conditions, and concurrent medications were not specified. On 11/27/2001, the vaccinee received his first injection of vaccinee received infections of inactivated poliomyelitis virus vaccine and MMR vaccine. On 11/30/2001, three days after receiving Infanrix, he experienced an injection site reaction at the site of Infanrix administration, characterized by a hard, red, itchy lump measuring 1.5 inches in diameter; the area was hot to the touch. The vaccinee provider considered the events to be mild in severity and were related to Infanrix administration. The events resolved on 12/06/2001.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site mass, Injection site reaction, Injection site warmth
Clinical narrative: Report 2001028727-1 describes an injection site reaction in a 4 year old male who received Infanrix. Medical history and concurrent conditions were not described. Concomitant vaccines werre inactivated poliomyelitis virus vaccine, MMR. On 11/19/2001, the vaccinee received his first injection of Infanrix. On 11/21/2001, he experienced an injection site reaction characterized by a red, itchy lump 1.5 inches in diameter which was hot to touch. No medical attention was sought required. As of 11/30/2001, the outcomes of the events had resolved.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pruritus
Clinical narrative: Report 2001028727-1 describes an injection site reaction in a 4 year old male who received Infanrix. Medical history and concurrent conditions were not described. Concomitant vaccines werre inactivated poliomyelitis virus vaccine, MMR. On 11/19/2001, the vaccinee received his first injection of Infanrix. On 11/21/2001, he experienced an injection site reaction characterized by a red, itchy lump 1.5 inches in diameter which was hot to touch. No medical attention was sought required. As of 11/30/2001, the outcomes of the events had resolved.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Report A0355827A describes an injection site reaction in a 4 year old female who received Infanrix. Medical history, concurrent conditions, and concurrent medications were not specified. There was no illness at the time of vaccination. On 11/26/2001, the vaccinee received her first injection of Infanrix. On that date, she also received injection of IPOL and MMR. On 11/28/2001, two days post-immunization, she experienced an injection site reaction painful lump the size of a "half dollar." The vaccinee was seen by the physician, who prescribed Duricef 250 mg twice daily. The vaccine provider considered the events to be mild in intensity and related to Infanrix administration. The events resolved on 12/03/2001.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site reaction, Injection site warmth
Clinical narrative: Report 2001028745-1 describes an injection site reaction in a 4 year old female who received Infanrix. Medical history, concurrent conditions, and concurrent medications were not specified. On 11/26/2001, the vaccinee received her first injection of Infanrix. On that date, she also received injection of IPOL and MMR vaccines. On 11/28/2001, two days post-immunization, she experienced an injection site reaction characterized by a red, four-inch lump that was hot to the touch. No medical attention was needed. The vaccine provider considered the events to be mild in intensity and related to Infanrix administration. As of 12/03/2001, the events had resolved.
Age: 1.08
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site induration, Injection site oedema, Injection site reaction
Clinical narrative: Report A0355895A describes an injection site reaction in a 13 month old male who received Infanrix. Medical history, concurrent conditions, and concurrent medications were not specified. There was no illness at the time of immunization. On 1/27/2001, the vaccinee received an injection of Infanrix into the right thigh; it was not known if he had received previous injections of Infanrix. On that date, he also received injections of MMR, ActHIib, Varivax and Prevnar. On 11/28/2001, one day post-immunization, he experienced an injection site, characterized by a 10cm area of redness and swelling, at the site of Infanrix administration. "Severe" induration was present in the center of this area. The reporter stated that "it looks like cellulitis." The events resolved by 12/01/2001. The physician indicated that the injection site induration was severe in intensity, disabling/incapacitating, and related to Infanrix administration.
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: Report A0355897A describes an injection site reaction in a 4 year old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Medical history, concurrent conditions, and concurrent medications were not specified. There was no illness at the time of immunization. The vaccinee had no adverse experiences following receipt of prior immunizations. On 27 NOV 2001, the vaccinee received an injection of Infanrix (lot DTPA522A2); it was not known if he had received previous injections of Infanrix. He also received an injection of varicella virus vaccine. on 28 NOV 2001, one day post immunization, he experienced an injection site reaction characterized by a 10 cm arean of redness and swelling, at the site of Infanrix administration. Severe induration was present in the center of this area. The reporter stated that it looks like cellulitis. The events resolved on 01 DEC 2001. The physician indicated that the injection site induration was severe in intensity, disabling/incapacitating, and related to Infanrix administration.
Age: 0.7
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site reaction
Clinical narrative: Report 200102882-1 describes an injection site reaction in an 8 or 9 month old male who received Infanrix. Medical history, concurrent conditions, and concurrent medications were not specified. On an unspecified date, the vaccinee received an injection of Infanrix; it was not known if he had received previous injections of Infanrix. Subsequently, he experienced a "much greater reaction" at the injection site characterized by a 10cm area of redness and swelling. Induration was present in the center of this area. The reporter stated that "it looks like cellulitis." As of 12/03/2001, the outcomes of the events were unknown.
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: On an unspecified date, the vaccine received her second injection of Infanrix. "Days later", a knot appeared at the injection site. On 12/12/01, the vaccinee received her third injection of Infanrix. On the same day, in the right leg, she received injections of Prevnar and Recombivax-HB. Within 12 hours post-vaccination, approximately 0.5 inch from the Infanrix injection, a knot appeared. The area was red, it was not swollen, painful to the touch or fluid-filled. A home visit by a registered nurse was required. As of 12/11/01, the outcome of the events were unknown.
Age: 0.2
Sex: F
Vaccine: DTAP, PNC
Symptoms: Pallor, Urticaria
Clinical narrative: On 01/10/2002, the infant received her first injections of Infanrix and Prevnar. Immediately, the infant developed hives on her face and she turned pale. The vaccinee was treated with diphenydramine (Benadryl) and observed for one hour in the physician's office. The event resolved.
Age: 1.25
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: On 01/23/01, the child received her fourth injection of Infanrix. On that date, she also received injections of Varivax and IPOL. On 01/25/02, the vaccinee returned to the physician's office with "severe" swelling at the injection site "The area was very very red, hot and painful." The physician made a diagnosis of cellulitis. The physician stated that the event was moderate in intensity and related to Infanrix administration. The event resolved without medical intervention on 01/26/2002.
Age: 1.25
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site warmth
Clinical narrative: On 01/23/01, the child received her fourth injection of Infanrix. On that date, she also received injections of Varivax and IPOL. On 01/25/02, the vaccinee returned to the physician's office with "severe" swelling at the injection site "The area was very very red, hot and painful." The physician made a diagnosis of cellulitis. The physician stated that the event was moderate in intensity and related to Infanrix administration. The event resolved without medical intervention on 01/26/2002.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: On 01/22/02, the child received his fifth injection of Infanrix. On 01/23/02, he received injections of IPOl and MMR. Subsequently, on 01/25/2002, he experienced "severe" swelling at the injection site. The area was "very, very. red, hot and painful". The mother took the child to the emergency room; the emergency physician prescribed diphenhydramine hydrochloride (Benadryl) and a cephalosporin as if the diagnosis were cellulitis". The physician discontinued antibiotic after 24 hours because it was "obvious" to him that "this was a reaction to the vaccine". The physician stated that the cellulitis was moderate in severity and related to Infanrix administration. The cellulitis resolved on 01/27/02.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site warmth
Clinical narrative: On 01/22/02, the child received his fifth injection of Infanrix. On 01/23/02, he received injections of IPOl and MMR. Subsequently, on 01/25/2002, he experienced "severe" swelling at the injection site. The area was "very, very. red, hot and painful". The mother took the child to the emergency room; the emergency physician prescribed diphenhydramine hydrochloride (Benadryl) and a cephalosporin as if the diagnosis were cellulitis". The physician discontinued antibiotic after 24 hours because it was "obvious" to him that "this was a reaction to the vaccine". The physician stated that the cellulitis was moderate in severity and related to Infanrix administration. The cellulitis resolved on 01/27/02.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Cellulitis, Contusion, Injection site erythema, Injection site reaction
Clinical narrative: Report 20020015431 describes cellulitis in a 5 year old female who received Infanrix. Medical history, concurrent conditions, and concurrent medications were not specified. She had an unspecified reaction to Infanrix and MMR vaccine at the age of 15 months. On 01/21/2002, the vaccinee received her fifth injection of Infanrix and her second injection of MMR. On 01/23/2002, the child's mother noted a "bruise" on the right deltoid. On 01/24/2002, the child was seen by the physician. The physician noted a 2cm x 4cm "dark purple" area on the right deltoid. A firm erythematous area was observed next to the ecchymotic area. The physician made a diagnosis of cellulitis and prescribed amoxicillin clavulanate. The most recent info received on 02/15/2002, indicated the ecchymotic area resolved on 02/01/2002; the outcome of the cellulitis and erythema were not specified.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: ON 01/17/02, the child received her fifth injection of Infanrix. On 01/18/02, she experienced "severe" swelling at the injection site, which was also "very, very, red, hot  and painful". The child was seen by the physician, who made a diagnosis of cellulitis. The adverse events resolved without medical intervention on 01/20/02.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site warmth
Clinical narrative: ON 01/17/02, the child received her fifth injection of Infanrix. On 01/18/02, she experienced "severe" swelling at the injection site, which was also "very, very, red, hot  and painful". The child was seen by the physician, who made a diagnosis of cellulitis. The adverse events resolved without medical intervention on 01/20/02.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Crying, Irritability, Pyrexia
Clinical narrative: On 10/23/02, the infant received his first injections of Infanrix. On that date, he also received his first injections of Hib vaccine, (brand name unknown) and IPOL. Within four hours of immunization, he began  crying inconsolably; this persisted for approximately 2.5 hrs. He also experienced fever and irritability, which were treated with paracetamol (Tylenol). The events resolved on 10/24/01. The Infanrix immunization series was discontinued. The reporter stated that the events were moderate in severity and were possibly related to Infanrix administration.
Sex: U
Vaccine: DTAP
Symptoms: Convulsion
Clinical narrative: On an unspecified date, the child received injections of Infanrix, Prevnar and IPOL. It was not known if the child had received previous injections of these vaccines. An unspecified time post-immunization, the child experienced a seizure. No further information was provided.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: In an unspecified date, the vaccinee received an injection of Infanrix; it was not known if she had received previous injections of Infanrix; Subsequently, she experienced cellulitis at the injection site She was seen in the clinic and unspecified medications was prescribed. As of 02/11/02, the outcome of the event was unknown.
Sex: F
Vaccine: DTAP
Symptoms: Convulsion
Clinical narrative: Report A0361249A describes a seizure in a female infant of unspecified age who received Infanrix. This report was received from the vaccinee's neighbor and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not specified. In June 2001 (exact date not known), the infant received her third injection of Infanrix. Approximately four hours post-immunization, the infant experienced a seizure. The infant was seen by a physician. Treatment and outcome of the event were not provided. Seizure is considered medically serious.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Report A0361508A describes injection site cellulitis in a 4 year old male who received Infanrix. Medical history, concurrent conditions, and concurrent medications were not specified. On an unspecified date, the vaccinee received an injection of Infanrix; it was not known if he had received previous injections of Infanrix. Subsequently, he experienced cellulitis at the injection site. He was seen in the clinic and unspecified medication was prescribed. As of 2/11/2002; the outcome of the event was unknown.
Sex: U
Vaccine: DTAP, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Oedema peripheral
Clinical narrative: Report A0365444A descrbes whole limb swellin gin four vaccinees (ages and genders unspecified) who received Infanrix. Medical history, concurrent conditions, and concurrent medications were not specified. On 03/15/2002, these vaccinees received their fourth injections of Infanrix. On 03/17/2002, two days post-immunization, they expeirenced whole limb swelling. The vaccinees wee seen by a physician. Treatment and outcome were unspecified.
Sex: U
Vaccine: DTAP, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Ascites, Blood bilirubin increased
Clinical narrative: Report A0365444A descrbes whole limb swellin gin four vaccinees (ages and genders unspecified) who received Infanrix. Medical history, concurrent conditions, and concurrent medications were not specified. On 03/15/2002, these vaccinees received their fourth injections of Infanrix. On 03/17/2002, two days post-immunization, they expeirenced whole limb swelling. The vaccinees wee seen by a physician. Treatment and outcome were unspecified.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: On 12-DEC-2000, the infant received his first injections of Infanrix, Prevnar, IPOL and Comvax. He died 11 days later, on 23-DEC-2000. The reported cause of death was sudden infant death syndrome.
Age: 0.88
Sex: M
Vaccine: DTAP, HIBV, OPV
Symptoms: Brain oedema, Influenza like illness, Myocarditis
Clinical narrative: On 05-APR-1999, the pt received vaccination of IPV, OPV and HIB in addition to Infanrix. At an unspecified time thereafter, the pt developed flu-like symptoms. His symptoms worsened and he was transported to the hospital on 11-APR-1999. During transport, the pt "coded" and could not be resuscitated. He was pronounced dead on arrival at the hospital. An autopsy revealed acute viral myocarditis and diffuse brain swelling. Reportedly, post-mortem viral titers were "uninformative". The reporter indicated that he believed that the events were most likely related to the OPV?IPV vaccinations and not to Infanrix.
Age: 0.3
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: On 19-JUL-2000, the infant received her first injections of Infanrix, Prevnar, Hib-Titer and IPOL. On 19-JUL-2000, she also received her second injection of Recombivax-HB. On 27-AUG-2000, the child died due to sudden infant death syndrome, 39 days post-vaccination. The investigator and manufacturer medical monitor considered this event unrelated to vaccine administration. F/U info received on 3/14/01 from autopsy results indicated the child was born 4 weeks premature with respiratory problems. The child was also congested for 72 hours preceding death.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: On 25-APR-2000, the infant received his first injections of Infanrix, Prevnar, Hib-Titer and IPOL. He died on 14-JUN-2000, 50 days post-immunization. Autopsy was performed: cause of death was determined to be sudden infant death syndrome. The investigator and manufacturer medical monitor considered this event to be unrelated to vaccine administration.
Age: 1.0
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Cardiac arrest, Coma, Respiratory arrest
Clinical narrative: On 07-AUG-2000, the child received his third injection of Infanrix, along with his first injection of Prevnar, his second injection of Recombivax-HB and his third injection of Hib-Titer. In the morning of an unspecified date, the child was found in his crib, not breathing and in cardiac arrest. He was taken to the local ER, where a heartbeat was re-established following a long period of cardiopulmonary resuscitation. The child was placed on mechanical ventilation. He was unresponsive to light and painful stimuli. The mechanical ventilation was removed and the child died "due to SIDS-like syndrome" on 11-JAN-2001, five months post immunization. The investigator and manufacturer medical monitor considered this event to be unrelated to vaccination.
Age: 1.04
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Cardiac arrest, Infection, Multi-organ failure, Respiratory arrest, Shock
Clinical narrative: Information has been received from a health care professional concerning a 13 month old female pt with congenital ichthyosis and a history of failure to thrive who was vaccinated with a dose of varicella vaccine. Concomitant vaccination the same day included a dose of MMR vaccine. Subsequenlty the pt developed skin lesions and was hospitalized. It was reported that she was in the pediatric on inotropic support, was intubated and developed renal failure mand elevated liver enzymes. The pt was treated with acyclovir. PCR analyses from teh skin/scab samples were done, however results were not reported. As of 05/06/2002, her inotropic support was stopped. On 05/08/2002 it was reported that she developed a new fungal bloodstream infection with non-albicans Candida species and remained intubated and in moderate renal failure. Her skin lesions have dried up, but with her underlying skin condition there were still many skin care issues. Follow-up from  a Pediatric Infectious Disease Fellow on 05/22/2002 indicated that the pt was extubated and her renal function and hepatic function were back to baseline, however she developed a blood stream infection of methicillin resistant staph aureus and was being treated with antibiotics. The pt's father was concerned about other seirous adverse events in children with congenital ichthyosis or Netherton's syndrome after vaccination with varicella vaccine. The reporter indicated that she also reported the case to VAERS. Additional info has been requested. Follow up info received from a physician stated that the pt had remained hospitalized for 44 days and recovered from the vesicular rash, cardiopulmonary arrest, and multi-organ failure approximately three to four weeks later. The physician noted that the vesicular rash, multi-organ failure, and cardiopulmonary arrest were considered life threatening. Additional info has been requested. Additional info received from an agency stated that on an unspecified date approximately three weeks after her vaccination, the pt had a gastrostomy tube palced. During the procedure massive hepatomegaly was detected. It was ntoed that the pt's growth rate improved with nasogastric feeding. It was also reported that on an unspecified date post-vaccinaiton the pt developed pneumonia respiratory syncytial virus (RSV), bronchiolitis, and pneumonia. Additional info has been requested.
Age: 1.04
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Bacterial infection, Fungal infection, Liver function test abnormal, Renal failure, Skin ulcer
Clinical narrative: Information has been received from a health care professional concerning a 13 month old female pt with congenital ichthyosis and a history of failure to thrive who was vaccinated with a dose of varicella vaccine. Concomitant vaccination the same day included a dose of MMR vaccine. Subsequenlty the pt developed skin lesions and was hospitalized. It was reported that she was in the pediatric on inotropic support, was intubated and developed renal failure mand elevated liver enzymes. The pt was treated with acyclovir. PCR analyses from teh skin/scab samples were done, however results were not reported. As of 05/06/2002, her inotropic support was stopped. On 05/08/2002 it was reported that she developed a new fungal bloodstream infection with non-albicans Candida species and remained intubated and in moderate renal failure. Her skin lesions have dried up, but with her underlying skin condition there were still many skin care issues. Follow-up from  a Pediatric Infectious Disease Fellow on 05/22/2002 indicated that the pt was extubated and her renal function and hepatic function were back to baseline, however she developed a blood stream infection of methicillin resistant staph aureus and was being treated with antibiotics. The pt's father was concerned about other seirous adverse events in children with congenital ichthyosis or Netherton's syndrome after vaccination with varicella vaccine. The reporter indicated that she also reported the case to VAERS. Additional info has been requested. Follow up info received from a physician stated that the pt had remained hospitalized for 44 days and recovered from the vesicular rash, cardiopulmonary arrest, and multi-organ failure approximately three to four weeks later. The physician noted that the vesicular rash, multi-organ failure, and cardiopulmonary arrest were considered life threatening. Additional info has been requested. Additional info received from an agency stated that on an unspecified date approximately three weeks after her vaccination, the pt had a gastrostomy tube palced. During the procedure massive hepatomegaly was detected. It was ntoed that the pt's growth rate improved with nasogastric feeding. It was also reported that on an unspecified date post-vaccinaiton the pt developed pneumonia respiratory syncytial virus (RSV), bronchiolitis, and pneumonia. Additional info has been requested.
Sex: U
Vaccine: DTAP, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Oedema peripheral
Clinical narrative: This report describes aggravation of pre-existing biliary atresia in a 4 month old female who received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. This report was forwarded by a manufacturer, who received it as part of a manufacturer post marketing surveillance study of 7-valent pneumococcal conjugate vaccine. This study permitted the standard administration of childhood vaccines concurrent with Prevnar administration. Concurrent medical conditions included biliary atresia and neonatal hepatitis. Concurrent medications were not provided. The infant received her first injection of Infanrix on 5/24/00. She also received her first injections of Prevnar, Haemophilus B conjugate vaccine, inactivated poliomyelitis virus vaccine, and hepatitis B vaccine on 5/24/00. During the clinic visit, routine lab tests, including bilirubin level, were performed. Bilirubin level was determined to be elevated at 34.1 mg/dL; the infant was hospitalized that evening. On 5/25/00, she underwent Kasai procedure. Post-operatively, she developed massive ascites. She was transferred to a tertiary care facility on 5/27/00 and underwent a liver transplantation. She developed unspecified post-surgical complications and died on 6/8/00. The reporter stated that the infant's death was clearly unrelated to vaccination. Cause of death was not provided.
Sex: U
Vaccine: DTAP, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Ascites, Blood bilirubin increased
Clinical narrative: This report describes aggravation of pre-existing biliary atresia in a 4 month old female who received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. This report was forwarded by a manufacturer, who received it as part of a manufacturer post marketing surveillance study of 7-valent pneumococcal conjugate vaccine. This study permitted the standard administration of childhood vaccines concurrent with Prevnar administration. Concurrent medical conditions included biliary atresia and neonatal hepatitis. Concurrent medications were not provided. The infant received her first injection of Infanrix on 5/24/00. She also received her first injections of Prevnar, Haemophilus B conjugate vaccine, inactivated poliomyelitis virus vaccine, and hepatitis B vaccine on 5/24/00. During the clinic visit, routine lab tests, including bilirubin level, were performed. Bilirubin level was determined to be elevated at 34.1 mg/dL; the infant was hospitalized that evening. On 5/25/00, she underwent Kasai procedure. Post-operatively, she developed massive ascites. She was transferred to a tertiary care facility on 5/27/00 and underwent a liver transplantation. She developed unspecified post-surgical complications and died on 6/8/00. The reporter stated that the infant's death was clearly unrelated to vaccination. Cause of death was not provided.
Age: 0.8
Sex: F
Vaccine: HEP
Symptoms: Autism, Movement disorder, Neurodevelopmental disorder, Psychomotor hyperactivity
Clinical narrative: Information has been received from a health professional concerning a 2 year old female pt with no known drug allergies and no past medical history who on 08/18/1997 was vaccinated with a third dose of hep B vaccine. There was no concomitant medication. It was reported that the pt's mother was concerned about mercury in the vaccine. It was also reported that the mother felt the child had possible autistic symptoms starting 05/27/1999 with repetitive movements, hyperactivity and "shuttering." On 08/11/2000, the child had pacing and mouth movements. On 11/29/2000, he had difficulty with fine motor skills, but his gross motor and speech were okay. In January 2001, he saw a neurologist. At that time he had "shuttering" but a negative exam. On 08/16/2001, the school doctor stated he had a developmental and language delay and special ed classes were recommended. It was reported that the pt's primary physician did not feel the child was autistic. Follow-up info from a nurse indicated that the pt had been seen by a physician a couple of times, but the child has not been diagnosed as austistic. Upon internal review, "possible autistic symptoms" were considered an other important medical event. Additional info has been requested. Follow up info from a doctor's office indicated that the mother was only ding some research on her own and inquiring about the vaccinaitons and "not saying that her child's condition has anything to do with a reaction to the vaccinations." No additional info is expected.
Sex: U
Vaccine: DTAP, HEP, HIBV
Symptoms: Congenital brain damage, Drug toxicity, Gastrointestinal disorder, Nervous system disorder
Clinical narrative: Information has been received from a legal firm regarding a case in litigation concerning a patient who was vaccinated with hepatitis B vaccine recombinant and diphtheria toxoid/pertussis vaccine/teta. It is alleged that the patient had adverse experiences with vaccinations containing mercury-based preservative Thimerasol. It is alleged that the injuries occurred on or about 1995, 1996, and 1997. Through the vaccinations administered, from the patient's birth through 1997, the patient was subjected to very high doses of the mercury contained in Thimerosal added to the vaccines. It is further alleged that as a result of the mercury in the Thimerasol-containing vaccinations that the patient now suffers and in the future will continue to suffer from neurological, emotional and physical effects of mercury poisoning. It is also alleged that the patient developed brain damage, central nervous system damage and gastrointestinal system damage. Upon internal review, the patient's mercury poisoning, brain damage, central nervous system damage and gastrointestinal system damage were considered other important medical events. Additional information has been requested.  Reported on 05/14/2003: "Follow up information received 05/01/2003 reported the patient received injections of vaccines alleged to contain thimerosal on the following dates:  09/07/1995, 10/18/1995, 12/18/19995, 02/15/1996, 08/29/1996, 12/12/1996, 03/03/1997, and 08/24/2000.  No further information is available.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Pyrexia, Swelling
Clinical narrative: This report concerns twin patients that received DTaP, IPV, and MMR vaccines and developed swelling arm from elbow to axilla and fever of 102 deg F. They were admitted to hospital. History of "infections, boils, etc." No other patients experienced this reaction. A follow up report received 6/6/2002 adds: Diagnosis was cellulitis.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Convulsion, Somnolence, Staring, Tremor
Clinical narrative: Seizures began 01/24/2002. Staring; shaking of arms, more sleepy than usual, decreased tone. Referred to neurologist 02/01/02. Began on Phenobarbital 2/1/02; subsequently changed to Topomax.  Annual follow up report states: "Had seizures-still treated by neurologist as well.  Decreasing months for seizures as of 01/03.  EEG normal.  Development seems to be back on track.  Will not give another Pertussis Immunization."
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Diabetes mellitus, Headache, Thirst, Urinary incontinence, Vomiting
Clinical narrative: Headaches during first month after shot; headaches, vomiting, excessive thirst and weight loss during second month (vomited twice, peed in bed during night 3 times, lost 10 lbs); two months after ended in hospital. 8/6/02 Diagnosed with diabetes mellitus per hospital discharge summary. AWB
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Weight decreased
Clinical narrative: Headaches during first month after shot; headaches, vomiting, excessive thirst and weight loss during second month (vomited twice, peed in bed during night 3 times, lost 10 lbs); two months after ended in hospital. 8/6/02 Diagnosed with diabetes mellitus per hospital discharge summary. AWB
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Apnoea, Convulsion, Cyanosis, Febrile convulsion
Clinical narrative: 8-12 hours post vaccination, patient had seizure, apnea, required CPR, ended up recovering.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Local reaction at every site at which child received a vaccine. Mother reports red rash developed next day and worse in two days. Rash red blotches like heat rash On 5/28/02, rash almost gone.
Age: 4.2
Sex: F
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Within 24 hours, pt's mother noticed arm was red and by 1pm next day, left arm was swollen, red and hot to the touch. On 05/16/2002, arm was back to normal. No medication given.
Age: 0.6
Sex: M
Vaccine: DTAP, HBPV, PNC
Symptoms: Irritability, Otitis media, Pharyngitis, Pyrexia, Rhinitis
Clinical narrative: 8 hrs after receiving 3rd DTaP, Hib and pneumococcal vaccine the child developed fever of 102.6, irritability and increased sleepiness. He also developed mild cold symptoms not noticed at physical. lasted 72 hrs.
Age: 0.6
Sex: M
Vaccine: DTAP, HBPV, PNC
Symptoms: Somnolence
Clinical narrative: 8 hrs after receiving 3rd DTaP, Hib and pneumococcal vaccine the child developed fever of 102.6, irritability and increased sleepiness. He also developed mild cold symptoms not noticed at physical. lasted 72 hrs.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Rash
Clinical narrative: Fine exanthemia in trunk anterior and posterior, extending to arms, positive exanthema in palms and soles
Age: 0.25
Sex: M
Vaccine: IPV, PNC
Symptoms: Pyrexia
Clinical narrative: The pt developed temp of 102 deg F. 12 hrs after vaccination.
Age: 4.08
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: The pt developed redness, and swelling at the injection site (right arm). Treated with Benadryl in ER. On 05/03/2002, saw PMD with warm, red, covered entire upper arm to shoulder 1cm below elbow.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Eye movement disorder, Hypotonia, Musculoskeletal stiffness, Pyrexia
Clinical narrative: The pt's father described limpness, eyes rolling up, clenching of hands and feet. Took to doctor and given meds; Naproxene suppositories for fever. On 05/10/2002, afebrile, throat, ears injected active.
Age: 4.0
Sex: F
Vaccine: IPV, MMR, TD
Symptoms: Medication error
Clinical narrative: Administered adult Td o.5cc instead of pediatric DTaP in right deltoid. County Health Department called. Advised that student get a temporary medical waiver from physician to enter school conditionally and get DTaP in 6 months. parents called. Given information.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Contusion, Injection site erythema, Injection site oedema
Clinical narrative: right thigh with 2cm erythematous area around injection site on evening of 4/12/02. On 4/13/02, area spread to approximately 10 cm . Went to ER on 4/13/02 and was started on Keflex. Pt was seen in office on 4/15/2002 for F/U, right thigh 32 cm left thigh 29 cm, no fever, taking fluids well, ambulatory with some pain on 4/13/02, no pain by 4/15/02. On 4/17/02 - swelling down and bruising noted.
Age: 1.0
Sex: F
Vaccine: DTAP, HBHEPB, MMR, DTAP, HBHEPB, MMR
Symptoms: Cough, Lacrimation increased, Pyrexia, Rash
Clinical narrative: 3/25/02 - body rash, high fever, watery eyes, 3/25/02 cough started
Age: 1.0
Sex: F
Vaccine: DTAP, HBHEPB, MMR, DTAP, HBHEPB, MMR
Symptoms: Cough, Insomnia, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: 3/25/02 - body rash, high fever, watery eyes, 3/25/02 cough started
Age: 4.4
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: The pt developed redness and swelling on left thigh (14cm x 14cm) for twodays after DTaP administration.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: 9 x 7 cm erythematous, indurated raised oval lesion. Warm to touch, no fever, started with size of a quarter on day of immunization and progressed. Treatment included warm compresses and Benadryl and Tylenol.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema
Clinical narrative: Within 18 hrs of administration of DTaP, left deltoid and upper and lower arm and chest became red and swollen, non-painful and afebrile.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Erythema, Oedema
Clinical narrative: Within 36 hrs of administration of DTap, left deltoid and upper and lower arm, chest were red and swollen, non-painful and afebrile.
Age: 1.5
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dyskinesia, Electroencephalogram abnormal, Eye movement disorder, Irritability
Clinical narrative: Unusually irritable, occassional abnormal nodding/jerking of head and arms, eye rolling. Upper torso movements increased in daily numbers (7-30 episodes per day). Then decreased over a 2 month period. Have not returned to date. Blood and urine tests, lumbar puncture, MRI of brain and EEG.
Age: 43.0
Sex: M
Vaccine: TYP
Symptoms: Hypersensitivity
Clinical narrative: Approximately 30 minutes after taking the vaccine, my eyes became highly sensitive to light. This lasted approximately 1.5 to 2 hours. After which, my eyes returned to normal.
Age: 1.25
Sex: M
Vaccine: HBPV, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: 10 cm erythematous area on left lateral thigh. No induration, non-tender.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Feeling hot, Injection site erythema, Injection site haemorrhage, Tenderness
Clinical narrative: 6cm x 6cm area of erythema, warmth, tenderness in right anterior thigh. Slight ecchymosis 1.5 x 1.5 cm at injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: Large, red, swollen area--warm, non-tender.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Patient had fever of 104F. The rash resembling measles on chest, back and abdomen.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Hyperhidrosis, Injection site pain, Paraesthesia, Urticaria
Clinical narrative: The pt states that she woke up during the night with sweats, dizziness, entire right arm sore with tingling in fingers, tenderness at injection site. Generalized hives during evening, treated with Benadryl. States was also on an antibiotic, sulfite at the time of adverse reaction.
Age: 35.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: The pt developed red, erythema over entire deltoid area. Hot to touch.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Blood pressure increased, Dizziness, Pyrexia, Tremor
Clinical narrative: The pt developed dizziness, fever of 100.1 deg F, shaky, and elevated blood pressure. Taken to ER and given Tylenol. Blood and urine tested. No bacterial infections. Pt's symptoms resolved.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site warmth, Pruritus
Clinical narrative: The pt's mother noticed on 4th day after vaccination, redness, swelling at area of DTaP vaccination on the left mid thigh. No complaints of pain. She called the office because the red area has increased to 2 1/2 inches, non-tender but feels warm and itches. Not completely sure it is not an insect bite. No fever or any other complaints.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Chills, Feeling hot, Flushing, Hyperhidrosis, Urticaria
Clinical narrative: After first 2 doses, patient reported hives on thighs, arms, that also migrated to his face and scalp. After 3rd dose, these symptoms recurred with more intensity and severity requiring 1 week of Benadryl medication. Also included sweating, warmth, chills and flushing.
Age: 0.5
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: The pt developed local redness and induration on left thigh (2cm in size). Treated with cool compresses and Tylenol.
Age: 79.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Patient presented to health department on 04/17/02 for Td s/p wound. Reported to us on 05/02/02 that he had experienced severe pain and swelling of joints on right arm and right leg. Saw MD who felt it was due to vaccination. (Shot was not given on right arm.)
Age: 5.5
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: The pt developed pain, warm to touch, swelling and itching at injection site from top of shoulder to elbow. On 05/09/2002, redness and swelling went to middle of upper arm to middle of forearm. The pt was put on Keflex.
Age: 5.5
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pruritus
Clinical narrative: The pt developed pain, warm to touch, swelling and itching at injection site from top of shoulder to elbow. On 05/09/2002, redness and swelling went to middle of upper arm to middle of forearm. The pt was put on Keflex.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right leg where vaccination was given was swollen and red 24 hours after administration of vaccine.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Oedema peripheral
Clinical narrative: Approximately 36 hours after administration of vaccines, right arm was swollen and red from shoulder to bottom of bicep. Hot to touch. No meds given.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Within 24 hours, left arm was red from shoulder to top of elbow, swollen, and very hot to the touch for 9 days. Patient was put on Augmentin for 14 days. Arm still slightly red; now gone.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Depressed level of consciousness, Unevaluable event
Clinical narrative: Episode with altered mental status. Without seizure or loss of tone about 8-9 hours after immunization lasting 2 hours at the most. Medical evaluation normal.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Chills, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Chills, fever, nausea and vomiting 3 times, myalgia.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Pyrexia
Clinical narrative: High grade fever for 48 to 72 hours. No other symptoms.
Age: 13.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Hypoaesthesia, Loss of consciousness, Syncope
Clinical narrative: Around 09:30 05/21/2002 for Hep A&B. Not previously eaten. Hep B given in left deltoid; briefly passed out for 30 seconds while sitting in chair. Laid to floor but awake/talking. Hep A then administered in right deltoid. Mom phones at 15:00. States has previously passed out at home complaining of numbness and extreme soreness in left arm and feeling faint. Encouraged to call private doctor. Try heat instead of ice and anti-inflammatory meds previously taken.
Age: 32.0
Sex: M
Vaccine: YF, OPV, YF
Symptoms: Asthenia, Dizziness, Heart rate increased, Insomnia, Vision blurred
Clinical narrative: Within 5 hours of the YF vaccine on 5-9-02, pt experienced blurry peripheral vision.  Pt later went on to experience insomnia, dizziness, heart racing upon exertion, and bliateral limb weakness noted by ID doctor on 5-31-02.
Age: 32.0
Sex: M
Vaccine: YF, OPV, YF
Symptoms: Dizziness, Encephalitis, Headache, Insomnia, Neurological symptom
Clinical narrative: Within 5 hours of the YF vaccine on 5-9-02, pt experienced blurry peripheral vision.  Pt later went on to experience insomnia, dizziness, heart racing upon exertion, and bliateral limb weakness noted by ID doctor on 5-31-02.
Sex: M
Vaccine: HEP
Symptoms: Autism, Medication error
Clinical narrative: Report A0369630A describes autism spectrum disorder in a male vaccinee of unspecified age who received hepatitis B vaccine recombinant. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions were not provided. The vaccinee received vaccine on 26 SEP 1997, 14 NOV 1997, and 16 JUL 1997. The second injection of Engerix B was administered at a shorter than recommended interval from the first injection, and the third injection was administered at a longer than recommended interval from the second injection. The vaccinee's attorney alleged that as a result of the exposure to thimerosal from the above vaccines, vaccinee sustained neurological injuries and a result of those injuries has been diagnosed with autism spectrum disorder. Time to onset from immunization, treatment, and outcome of the autism spectrum disorder were not specified. This report of autism spectrum disorder is considered medically serious.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received on 22 MAY 2002 from a father concerning his child who was vaccinated with a dose of MMR virus vaccine live. Subsequently, the patient developed autism and the father believes that the autism is due to the vaccine. Upon internal review autism was considered to be an other important medical event. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received on 22 MAY 2002 from a father concerning his 5 year old daughter who at 18 months of age was vaccinated approximately 1999 with a dose of MMR virus vaccine live. The child was diagnosed with autism a short time after vaccination. The patient sought unspecified medical attention. Upon internal review autism was considered to be an other important medical event. Additional information has been requested.
Sex: U
Vaccine: DTAP, DTP, HEP, HEP, HIBV, MMR, DTAP, DTP, HEP, HEP, HIBV, MMR
Symptoms: Drug toxicity, Nervous system disorder
Clinical narrative: Information has been received regarding a case in litigation concerning a child who had vaccinations containing the toxic mercury-based preservative thimerosal that included hep B vaccine. Concomitant therapy included MMR vaccine, Tri-Immunol, Hib-TITER, Acel-Immune and Hep B vaccines. The periods of stated exposure were from March 1993 through September 1994 and August 1997 through December 1998. The alleged result of these vaccinations is that the pt suffers from and in the future will continue to suffer the toxic neurological effects of mercury poisoning. Upon internal review, mercury poisoning and neurological disorder were considered to be an other important medical event. No further info is available.