chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC, DTAP, IPV, MMR, PNC, DTP, IPV, MMR, PNC
Symptoms: Injection site reaction
Clinical narrative: A sales representative reported that a 4 year old child received Prevnar, Infanrix, MMR, and IPOL vaccines on 12/17/2001. The pt subsequently developed redness over the body, including the eyes. The child was brought to the hospital but was not admitted. No additional info was available as of the date of this report. Additional info received on 02/04/2002, from the physician via sales representative. On 12/18/2001, the pt developed two injection site reactions characterized by induration, redness and warmth. The area of the reactions measured 5cm x 6cm each and were located on the thighs.  Reported on 06/04/2003: "This report was received at an assigned manufacturer with the control number HQ0475104FEB2001.  This report was originally reported by a physician concerning a Hispanic 4-year-old male patient who on 12/17/2001, in the am, was vaccinated with a dose (Lot # 640964/1096L) of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  ON 12/18/2001 the patient developed an injection site reaction.  It was not reported if the patient sought medical attention.  Follow-up information received from a medical assistant indicated that the patient was also vaccinated on 12/17/2001 with concomitant doses of Streptococcus pneumoniae vaccine (PREVNAR) diphtheria toxoid/pertussis vaccine/tetanus toxoid (manufacturer not reported) and poliovirus vaccine (IPOL).  She reported that she did not know the recovery status of the patient.  No additional information is expected.
Age: 0.2
Sex: F
Vaccine: DTAP, HBPV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Abnormal sleep-related event, Agitation, Coma, Contusion, Oral intake reduced
Clinical narrative: The infant's mother stated that the infant had "low-grade fever most of the time". On 1/22/02, the infant received her 1st injection of Infanrix (lot DTPA524A2; expiry 6/03). On that date, she also received injections of Prevnar, IPOL and Hib. On 1/22/02, an unspecified time post vax, the infant reportedly experienced a temperature of 102.2F. On 1/23/02, the infant reportedly died at home. Additional information, including medical confirmation, has been requested.  Autospy report rec'd 06/04/2002: COD undetermined, manner of death undetermined.
Age: 0.2
Sex: F
Vaccine: DTAP, HBPV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia, Respiratory disorder
Clinical narrative: The infant's mother stated that the infant had "low-grade fever most of the time". On 1/22/02, the infant received her 1st injection of Infanrix (lot DTPA524A2; expiry 6/03). On that date, she also received injections of Prevnar, IPOL and Hib. On 1/22/02, an unspecified time post vax, the infant reportedly experienced a temperature of 102.2F. On 1/23/02, the infant reportedly died at home. Additional information, including medical confirmation, has been requested.  Autospy report rec'd 06/04/2002: COD undetermined, manner of death undetermined.
Age: 0.2
Sex: F
Vaccine: DTAP, HBPV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: The infant's mother stated that the infant had "low-grade fever most of the time". On 1/22/02, the infant received her 1st injection of Infanrix (lot DTPA524A2; expiry 6/03). On that date, she also received injections of Prevnar, IPOL and Hib. On 1/22/02, an unspecified time post vax, the infant reportedly experienced a temperature of 102.2F. On 1/23/02, the infant reportedly died at home. Additional information, including medical confirmation, has been requested.  Autospy report rec'd 06/04/2002: COD undetermined, manner of death undetermined.
Age: 0.08
Sex: M
Vaccine: DTP, HIBV, PNC, DTAP, HIBV, PNC, DTP, HIBV, PNC, DTAP, HIBV, PNC
Symptoms: Gastrointestinal disorder, Pyrexia, Vaccine positive rechallenge, Vomiting
Clinical narrative: A nurse reported that a 6 week old male received a 1st dose of Prevnar vaccine, haemophilus b conjugate vaccine and diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed on 10/24/2001. The pt has a past medical history of "innocent ventricular heart murmur" and fever. On 10/30/2001, the infant devleoped emesis. On 11/27/2001, when the infant was 2 months old, he received a 2nd injection of Engerix B and IPOL. On 11/29/2001, the infant again experienced emesis. He was seen in the physician's office and blood was drawn for unspecified laboratory analyses. The infant continued to experience intermittent emesis, with episodes occurring on 12/15/2001 and 01/03/2002. As of 01/07/2002, the infant was being evaluated for possible malrotation or volvulus of the stomach. As of 01/11/2002, the intermittent emesis was ongoing. The vaccine provider considered it to be moderate in intensity and possibly related to either Engerix-B administration, malrotation, or volvulus of the stomach. Follow-up info received on 02/27/2002 from physician. The pt recovered. On 01/05/2002, the pt was discharged. No discharge summary was available from this physician. On 01/07/2002, the pt was doing well and repeat UGI was normal. On 02/14/2002, the pt was again reported as doing well. Another series of immunizations were given DTaP, HIB, Prevnar and IPV without any adverse event. The mother attributes the previous symptoms as related to a "viral illness." Follow-up info also contained product quality lot number for Prevnar.
Age: 0.08
Sex: M
Vaccine: DTP, HIBV, PNC, DTAP, HIBV, PNC, DTP, HIBV, PNC, DTAP, HIBV, PNC
Symptoms: Viral infection, Vomiting
Clinical narrative: A nurse reported that a 6 week old male received a 1st dose of Prevnar vaccine, haemophilus b conjugate vaccine and diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed on 10/24/2001. The pt has a past medical history of "innocent ventricular heart murmur" and fever. On 10/30/2001, the infant devleoped emesis. On 11/27/2001, when the infant was 2 months old, he received a 2nd injection of Engerix B and IPOL. On 11/29/2001, the infant again experienced emesis. He was seen in the physician's office and blood was drawn for unspecified laboratory analyses. The infant continued to experience intermittent emesis, with episodes occurring on 12/15/2001 and 01/03/2002. As of 01/07/2002, the infant was being evaluated for possible malrotation or volvulus of the stomach. As of 01/11/2002, the intermittent emesis was ongoing. The vaccine provider considered it to be moderate in intensity and possibly related to either Engerix-B administration, malrotation, or volvulus of the stomach. Follow-up info received on 02/27/2002 from physician. The pt recovered. On 01/05/2002, the pt was discharged. No discharge summary was available from this physician. On 01/07/2002, the pt was doing well and repeat UGI was normal. On 02/14/2002, the pt was again reported as doing well. Another series of immunizations were given DTaP, HIB, Prevnar and IPV without any adverse event. The mother attributes the previous symptoms as related to a "viral illness." Follow-up info also contained product quality lot number for Prevnar.
Age: 0.08
Sex: M
Vaccine: DTP, HIBV, PNC, DTAP, HIBV, PNC, DTP, HIBV, PNC, DTAP, HIBV, PNC
Symptoms: Vomiting
Clinical narrative: A nurse reported that a 6 week old male received a 1st dose of Prevnar vaccine, haemophilus b conjugate vaccine and diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed on 10/24/2001. The pt has a past medical history of "innocent ventricular heart murmur" and fever. On 10/30/2001, the infant devleoped emesis. On 11/27/2001, when the infant was 2 months old, he received a 2nd injection of Engerix B and IPOL. On 11/29/2001, the infant again experienced emesis. He was seen in the physician's office and blood was drawn for unspecified laboratory analyses. The infant continued to experience intermittent emesis, with episodes occurring on 12/15/2001 and 01/03/2002. As of 01/07/2002, the infant was being evaluated for possible malrotation or volvulus of the stomach. As of 01/11/2002, the intermittent emesis was ongoing. The vaccine provider considered it to be moderate in intensity and possibly related to either Engerix-B administration, malrotation, or volvulus of the stomach. Follow-up info received on 02/27/2002 from physician. The pt recovered. On 01/05/2002, the pt was discharged. No discharge summary was available from this physician. On 01/07/2002, the pt was doing well and repeat UGI was normal. On 02/14/2002, the pt was again reported as doing well. Another series of immunizations were given DTaP, HIB, Prevnar and IPV without any adverse event. The mother attributes the previous symptoms as related to a "viral illness." Follow-up info also contained product quality lot number for Prevnar.
Age: 0.75
Sex: F
Vaccine: PNC, PNC
Symptoms: Injection site oedema, Urticaria
Clinical narrative: A nurse reported that a 9-month-old female received her third dose of Prevnar on 11-Jan-2002 "About 24 hours" post vaccination, the child developed "hives or a rash". She was examined that day by a physician in an emergency department; she was not admitted. No further information is available at the date of this report.
Age: 0.75
Sex: F
Vaccine: PNC, PNC
Symptoms: Rash
Clinical narrative: A nurse reported that a 9-month-old female received her third dose of Prevnar on 11-Jan-2002 "About 24 hours" post vaccination, the child developed "hives or a rash". She was examined that day by a physician in an emergency department; she was not admitted. No further information is available at the date of this report.
Age: 0.57
Sex: M
Vaccine: DTAP, HBHEPB, HEP, PNC, HBHEPB, HEP, DTAP, HBHEPB, HEP, PNC, DTAP
Symptoms: Drug ineffective, Irritability, Pneumonia, Pyrexia, Sepsis
Clinical narrative: A physician reported that a 7 month old male received his third dose of Prevnar along with Tripedia, Comvax, and Recombivax-HB vaccines on 01/07/2002. On 01/21/2002, the infant was seen by a physician for fever, vomiting and irritability. A blood culture was positive for Streptococcus pneumoniae, serotype 19F. A CBC was performed; however, results were not reported. The infant received unspecified treatment. Streptococcal septicemia is considered medically important. Follow up info received on 02/26/2002 from the physician indicated that results of a CBC showed a WBC count of 17.5 cells per cubic millimeter with neutrophils at 81% and lymphocytes at 13%. The infant recovered.
Age: 0.57
Sex: M
Vaccine: DTAP, HBHEPB, HEP, PNC, HBHEPB, HEP, DTAP, HBHEPB, HEP, PNC, DTAP
Symptoms: Vomiting
Clinical narrative: A physician reported that a 7 month old male received his third dose of Prevnar along with Tripedia, Comvax, and Recombivax-HB vaccines on 01/07/2002. On 01/21/2002, the infant was seen by a physician for fever, vomiting and irritability. A blood culture was positive for Streptococcus pneumoniae, serotype 19F. A CBC was performed; however, results were not reported. The infant received unspecified treatment. Streptococcal septicemia is considered medically important. Follow up info received on 02/26/2002 from the physician indicated that results of a CBC showed a WBC count of 17.5 cells per cubic millimeter with neutrophils at 81% and lymphocytes at 13%. The infant recovered.
Age: 0.57
Sex: M
Vaccine: DTAP, HBHEPB, HEP, PNC, HBHEPB, HEP, DTAP, HBHEPB, HEP, PNC, DTAP
Symptoms: Bacterial infection, Irritability, Pyrexia, Sepsis, Vomiting
Clinical narrative: A physician reported that a 7 month old male received his third dose of Prevnar along with Tripedia, Comvax, and Recombivax-HB vaccines on 01/07/2002. On 01/21/2002, the infant was seen by a physician for fever, vomiting and irritability. A blood culture was positive for Streptococcus pneumoniae, serotype 19F. A CBC was performed; however, results were not reported. The infant received unspecified treatment. Streptococcal septicemia is considered medically important. Follow up info received on 02/26/2002 from the physician indicated that results of a CBC showed a WBC count of 17.5 cells per cubic millimeter with neutrophils at 81% and lymphocytes at 13%. The infant recovered.
Age: 0.57
Sex: M
Vaccine: DTAP, HBHEPB, HEP, PNC, HBHEPB, HEP, DTAP, HBHEPB, HEP, PNC, DTAP
Symptoms: Irritability, Laboratory test abnormal, Pneumonia, Pyrexia, Sepsis
Clinical narrative: A physician reported that a 7 month old male received his third dose of Prevnar along with Tripedia, Comvax, and Recombivax-HB vaccines on 01/07/2002. On 01/21/2002, the infant was seen by a physician for fever, vomiting and irritability. A blood culture was positive for Streptococcus pneumoniae, serotype 19F. A CBC was performed; however, results were not reported. The infant received unspecified treatment. Streptococcal septicemia is considered medically important. Follow up info received on 02/26/2002 from the physician indicated that results of a CBC showed a WBC count of 17.5 cells per cubic millimeter with neutrophils at 81% and lymphocytes at 13%. The infant recovered.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Cardiac arrest, Cardio-respiratory arrest, Cerebrovascular disorder, Coma, Eosinophilia
Clinical narrative: A physician via a company representative reported that a 2 month old male received Prevnar, DTaP, Comvax, and IPV on 02/06/2002. That same day, the pt's mother found the baby cold and rushed him to the hospital where he was pronounced dead. As of the date of this report, no further info was available. Per 7/2/02 F/U: Cancelled: Duplicate to HQ0826221FEB2002.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site inflammation, Injection site nodule, Injection site oedema, Small for dates baby, Strabismus
Clinical narrative: A physician via a company representative reported that a 2 month old male received Prevnar, DTaP, Comvax, and IPV on 02/06/2002. That same day, the pt's mother found the baby cold and rushed him to the hospital where he was pronounced dead. As of the date of this report, no further info was available. Per 7/2/02 F/U: Cancelled: Duplicate to HQ0826221FEB2002.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: A physician via a company representative reported that a 2 month old male received Prevnar, DTaP, Comvax, and IPV on 02/06/2002. That same day, the pt's mother found the baby cold and rushed him to the hospital where he was pronounced dead. As of the date of this report, no further info was available. Per 7/2/02 F/U: Cancelled: Duplicate to HQ0826221FEB2002.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Feeling cold
Clinical narrative: A physician via a company representative reported that a 2 month old male received Prevnar, DTaP, Comvax, and IPV on 02/06/2002. That same day, the pt's mother found the baby cold and rushed him to the hospital where he was pronounced dead. As of the date of this report, no further info was available. Per 7/2/02 F/U: Cancelled: Duplicate to HQ0826221FEB2002.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Cyanosis
Clinical narrative: A physician via a company representative reported that a 2 month old male received Prevnar, DTaP, Comvax, and IPV on 02/06/2002. That same day, the pt's mother found the baby cold and rushed him to the hospital where he was pronounced dead. As of the date of this report, no further info was available. Per 7/2/02 F/U: Cancelled: Duplicate to HQ0826221FEB2002.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Cold sweat
Clinical narrative: A physician via a company representative reported that a 2 month old male received Prevnar, DTaP, Comvax, and IPV on 02/06/2002. That same day, the pt's mother found the baby cold and rushed him to the hospital where he was pronounced dead. As of the date of this report, no further info was available. Per 7/2/02 F/U: Cancelled: Duplicate to HQ0826221FEB2002.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Rigors and fever several hours, post vax. Presented to walk-in clinic after 48 hours with right arm redness, swelling and pain. IV Nafcillin and 7 days of Keflex po.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: Rigors and fever several hours, post vax. Presented to walk-in clinic after 48 hours with right arm redness, swelling and pain. IV Nafcillin and 7 days of Keflex po.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Convulsion, Pyrexia
Clinical narrative: Initial documented seizure on 12/13/2001, associated with fever. Parents later informed us that infant has had a similar episode with fever 102.2 about 12 hrs after his 4 month immunization. Hospital d/c summary for subsequent hospitalization on 1/16/02 states diagnosis of epilepsy with recurrent seizures.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Crying, Dyspnoea
Clinical narrative: The baby received her 1st Hep-B on 2/5/02 at 1 month of age at 19:15. Approx. 3 hours later, the baby awoke from sleep screaming and gasping, flush (no cyanosis). She was taken to ER. No fever, normal CBC, no local shot reaction. She was monitored overnight and did fine. Discharged to home in the AM without evident problem.
Age: 0.25
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Eye movement disorder, Musculoskeletal stiffness
Clinical narrative: Pt was vaccinated on 2/20/02 at approx. 10:15. At approx. 21:30, the pt had a seizure lasting about 90 seconds. Her body stiffened and eyes rolled back. She did not have a fever. On Saturday night (early Sunday morning) she had 2 more seizures and was taken to the ER and hospitalized.
Age: 1.4
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site oedema
Clinical narrative: Right thigh swelling from vaccination site.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Contusion, Skin exfoliation
Clinical narrative: Two areas of bruising, skin peeling (2cm x 1cm areas).
Age: 40.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Myalgia
Clinical narrative: Joint and muscle pain all the time.
Age: 7.0
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Child presented with 10-20 chicken pox lesions on trunk and arms. Symptom began on 03/27/2002. Child received varivax on 08/31/1995.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Severe swelling and redness of left leg.
Age: 1.0
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Diarrhoea, Rash maculo-papular
Clinical narrative: The pt was brought to the office with her mother who stated she was called by the babysitter who stated the pt was developing a rash. The pt also had diarrhea for 1-2 days, eating, drinking well, no vomiting, no fever. The rash was covering her entire body and was maculopapular, also involving the palms, non pruritic. Treatment and monitor.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Tenderness, Urticaria
Clinical narrative: Right deltoid, raised, erythematus, tender lesions 4.5x5cm in diameter. Urticarial wheals all over. Treatment with Cetorax.
Age: 0.5
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Mother stated that in 1 1/2 hr post immunization her infant had less than an hour of "odd breathing." She describes some wheezings "working at breathing."
Age: 4.5
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site reaction, Pruritus
Clinical narrative: Injection site warm, swollen, red and itchy at the right upper arm.
Age: 1.0
Sex: F
Vaccine: MMR, UNK, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Red rash all over the body and temperature lasting 1 week.
Sex: F
Vaccine: MMR
Symptoms: Skin ulcer
Clinical narrative: 20-30 small lesions on trunk, afebrile.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site induration, Pain
Clinical narrative: Erythema, induration, pain developed about 36 hrs after immunizations.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Coma, Convulsion, Dyskinesia, Eye movement disorder, Musculoskeletal stiffness
Clinical narrative: On 03/14/2002 sudden onset of high fever and prolonged 20 minute episode of seizure with extremity stiffness, eyes rolled back, non responsive and intermittent jerking of all extremities. Fevers resolved after 24hrs with no further seizures.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: On 03/14/2002 sudden onset of high fever and prolonged 20 minute episode of seizure with extremity stiffness, eyes rolled back, non responsive and intermittent jerking of all extremities. Fevers resolved after 24hrs with no further seizures.
Age: 1.0
Sex: M
Vaccine: HBHEPB, VARCEL
Symptoms: Crying, Febrile convulsion
Clinical narrative: Hepatitis B and Hib combination vaccine and the Varicella vaccine given 3/20/02 at 1 yr well child physical. 3/22 Awoke very hot. Tylenol given. Jerking X 4-5 mins., arched, crying and upset. Seen at ER
Sex: F
Vaccine: HEP
Symptoms: Crying
Clinical narrative: Following hep b vaccine #1, episodes of crying uncontrollable for up to 2 hours several times over 2 days. Seen at ER and in office.
Age: 0.6
Sex: M
Vaccine: DTAP, DTAP, HIBV, IPV, PNC, HIBV, IPV, DTAP, HIBV, IPV, PNC
Symptoms: Adrenal disorder, Bacterial infection, Cough, Dyspnoea, Epiglottitis
Clinical narrative: This report describes a 7 month old male who died after receiving Infanrix. Medical history, concurrent conditions, and concurrent medicaitons were not specified. On 02/01/2002, the vaccine received an injection of Infanrix. It was not known if he had received previous doses of Infanrix. On an unspecified date post-immunization, the vaccinee died. Per F/U 5/10/02; pt had increased labored respirations and fever of 102.7F. He also had nasal flaring, cough was tachypneic and had a weak cry. He was lethargic. Arrested in ER, medical staff unable to resuscitate. Microscopic report: evidence of viral tracheitis and laryngitis as well as bronchopneumonia. Also has mild lymphocytic epiglottitis. Adrenal gland with increased congestion.
Age: 0.6
Sex: M
Vaccine: DTAP, DTAP, HIBV, IPV, PNC, HIBV, IPV, DTAP, HIBV, IPV, PNC
Symptoms: Laryngitis, Lethargy, Pyrexia, Tachypnoea, Tracheitis
Clinical narrative: This report describes a 7 month old male who died after receiving Infanrix. Medical history, concurrent conditions, and concurrent medicaitons were not specified. On 02/01/2002, the vaccine received an injection of Infanrix. It was not known if he had received previous doses of Infanrix. On an unspecified date post-immunization, the vaccinee died. Per F/U 5/10/02; pt had increased labored respirations and fever of 102.7F. He also had nasal flaring, cough was tachypneic and had a weak cry. He was lethargic. Arrested in ER, medical staff unable to resuscitate. Microscopic report: evidence of viral tracheitis and laryngitis as well as bronchopneumonia. Also has mild lymphocytic epiglottitis. Adrenal gland with increased congestion.
Age: 0.6
Sex: M
Vaccine: DTAP, DTAP, HIBV, IPV, PNC, HIBV, IPV, DTAP, HIBV, IPV, PNC
Symptoms: Epiglottitis, Laryngitis, Lethargy, Pyrexia, Respiratory distress
Clinical narrative: This report describes a 7 month old male who died after receiving Infanrix. Medical history, concurrent conditions, and concurrent medicaitons were not specified. On 02/01/2002, the vaccine received an injection of Infanrix. It was not known if he had received previous doses of Infanrix. On an unspecified date post-immunization, the vaccinee died. Per F/U 5/10/02; pt had increased labored respirations and fever of 102.7F. He also had nasal flaring, cough was tachypneic and had a weak cry. He was lethargic. Arrested in ER, medical staff unable to resuscitate. Microscopic report: evidence of viral tracheitis and laryngitis as well as bronchopneumonia. Also has mild lymphocytic epiglottitis. Adrenal gland with increased congestion.
Age: 0.6
Sex: M
Vaccine: DTAP, DTAP, HIBV, IPV, PNC, HIBV, IPV, DTAP, HIBV, IPV, PNC
Symptoms: Tracheitis
Clinical narrative: This report describes a 7 month old male who died after receiving Infanrix. Medical history, concurrent conditions, and concurrent medicaitons were not specified. On 02/01/2002, the vaccine received an injection of Infanrix. It was not known if he had received previous doses of Infanrix. On an unspecified date post-immunization, the vaccinee died. Per F/U 5/10/02; pt had increased labored respirations and fever of 102.7F. He also had nasal flaring, cough was tachypneic and had a weak cry. He was lethargic. Arrested in ER, medical staff unable to resuscitate. Microscopic report: evidence of viral tracheitis and laryngitis as well as bronchopneumonia. Also has mild lymphocytic epiglottitis. Adrenal gland with increased congestion.
Age: 0.6
Sex: M
Vaccine: DTAP, DTAP, HIBV, IPV, PNC, HIBV, IPV, DTAP, HIBV, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: This report describes a 7 month old male who died after receiving Infanrix. Medical history, concurrent conditions, and concurrent medicaitons were not specified. On 02/01/2002, the vaccine received an injection of Infanrix. It was not known if he had received previous doses of Infanrix. On an unspecified date post-immunization, the vaccinee died. Per F/U 5/10/02; pt had increased labored respirations and fever of 102.7F. He also had nasal flaring, cough was tachypneic and had a weak cry. He was lethargic. Arrested in ER, medical staff unable to resuscitate. Microscopic report: evidence of viral tracheitis and laryngitis as well as bronchopneumonia. Also has mild lymphocytic epiglottitis. Adrenal gland with increased congestion.
Age: 0.6
Sex: M
Vaccine: DTAP, DTAP, HIBV, IPV, PNC, HIBV, IPV, DTAP, HIBV, IPV, PNC
Symptoms: Adrenal disorder, Bacterial infection, Cough, Dyspnoea, Epiglottitis
Clinical narrative: A company representative reported that a 7 month old male received Prevnar IPV, and Act-Hib on 02/01/2002. The reporter indicated that at the time of immunization the infant was diagnosed with an ear infection and prescribed amoxicillin. Four to five days post immunization, the infant died in the ER. The results of an autopsy are pending. No further info was available at the date of this report. Per F/U 7/2/02; brought to ER for respiratory distress and fever of 102.7F. He was lethargic. There was evidence of viral traceitis and laryngitis as well as bronchopneumonia and lymphocytic epiglottitis.
Age: 0.6
Sex: M
Vaccine: DTAP, DTAP, HIBV, IPV, PNC, HIBV, IPV, DTAP, HIBV, IPV, PNC
Symptoms: Laryngitis, Lethargy, Pyrexia, Tachypnoea, Tracheitis
Clinical narrative: A company representative reported that a 7 month old male received Prevnar IPV, and Act-Hib on 02/01/2002. The reporter indicated that at the time of immunization the infant was diagnosed with an ear infection and prescribed amoxicillin. Four to five days post immunization, the infant died in the ER. The results of an autopsy are pending. No further info was available at the date of this report. Per F/U 7/2/02; brought to ER for respiratory distress and fever of 102.7F. He was lethargic. There was evidence of viral traceitis and laryngitis as well as bronchopneumonia and lymphocytic epiglottitis.
Age: 0.6
Sex: M
Vaccine: DTAP, DTAP, HIBV, IPV, PNC, HIBV, IPV, DTAP, HIBV, IPV, PNC
Symptoms: Epiglottitis, Laryngitis, Lethargy, Pyrexia, Respiratory distress
Clinical narrative: A company representative reported that a 7 month old male received Prevnar IPV, and Act-Hib on 02/01/2002. The reporter indicated that at the time of immunization the infant was diagnosed with an ear infection and prescribed amoxicillin. Four to five days post immunization, the infant died in the ER. The results of an autopsy are pending. No further info was available at the date of this report. Per F/U 7/2/02; brought to ER for respiratory distress and fever of 102.7F. He was lethargic. There was evidence of viral traceitis and laryngitis as well as bronchopneumonia and lymphocytic epiglottitis.
Age: 0.6
Sex: M
Vaccine: DTAP, DTAP, HIBV, IPV, PNC, HIBV, IPV, DTAP, HIBV, IPV, PNC
Symptoms: Tracheitis
Clinical narrative: A company representative reported that a 7 month old male received Prevnar IPV, and Act-Hib on 02/01/2002. The reporter indicated that at the time of immunization the infant was diagnosed with an ear infection and prescribed amoxicillin. Four to five days post immunization, the infant died in the ER. The results of an autopsy are pending. No further info was available at the date of this report. Per F/U 7/2/02; brought to ER for respiratory distress and fever of 102.7F. He was lethargic. There was evidence of viral traceitis and laryngitis as well as bronchopneumonia and lymphocytic epiglottitis.
Age: 0.6
Sex: M
Vaccine: DTAP, DTAP, HIBV, IPV, PNC, HIBV, IPV, DTAP, HIBV, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: A company representative reported that a 7 month old male received Prevnar IPV, and Act-Hib on 02/01/2002. The reporter indicated that at the time of immunization the infant was diagnosed with an ear infection and prescribed amoxicillin. Four to five days post immunization, the infant died in the ER. The results of an autopsy are pending. No further info was available at the date of this report. Per F/U 7/2/02; brought to ER for respiratory distress and fever of 102.7F. He was lethargic. There was evidence of viral traceitis and laryngitis as well as bronchopneumonia and lymphocytic epiglottitis.
Sex: M
Vaccine: PNC
Symptoms: Meningitis
Clinical narrative: A pediatrician reported that a male child received his second dose of Prevnar. On 07-JAN-02, at 29-months of age, he developed meningistis due to Streptococcus pneumoniae. No further information was available at the date of the report. Cancelled: Duplicate of HQ0190228JAN2002 which will remain the cse of record.
Sex: M
Vaccine: PNC
Symptoms: Ear disorder, Irritability, Meningitis, Pyrexia, Vomiting
Clinical narrative: A physician reported via a company representative that a male child received his second dose of Prevnar. On 07-JAN-2002, at 28 months of age, the child was diagnosed with meningitis due to Streptococcus pneumoniae. The reporter considered the event to be life-threatening. No further information was availble at the date of this report. Follow-up information received on 27-FEB-2002 from the physician indicated that the child was a 25 month old male who presented to an emergency room on 15-JAN-2002 with a four day history of vomiting, fever, irritability and bilateral ear drainage. That same day he was admitted for hospitalization where he was treated with IV fluids, Tobradex (tobramycin/dexamethasone), vancomycin and ceftriaxone. a head CT was negative for cranial abscess. A CSF culture grew penicillin, meropenem and ceftriaxone reisrtant Streptococcus pneumoniae. a blood culture was also positive for penicillin, meropenem and ceftriaxone resistant Streptococus pneumoniae. On 18-Jan-2002, repeat lumbar puncture results showed clear and colorless fluid with a protein level of 97 mg/dL, glucose of 54 M4 mg/DL and WBC level of 456/mm^3. The child recovered and was discharged on 21-Jan-2002. Additional follow-up information received on 28-FEB-2002 indicated tha t the pneumococcal isolate was identified as serotype 19A. This is 1 of 2 patients from this facility who had an adverse experience following receipt of Prevnar.
Age: 6.0
Sex: M
Vaccine: PNC
Symptoms: Back pain, Chest pain, Cough, Pneumonia, Pyrexia
Clinical narrative: A physician reported that a 6 year old male received Prevnar vaccine on 12/05/2001. He has a past medical history of heart transplant, meningitis, and reactive airway. Concomitant medication included prednisone, Tacrolimus, ranitidine hydrochloride and iron. The child's mother reported that he developed upper respiratory congestion and cough for 5 days; however, in the last 2 days he developed "high" fevers with tachypnea, and back and chest pain. He was evaluated in the ER and found to have a "RUL and retrocardiac infiltrate consistent with a community-acquired pneumonia." The child was admitted to the hospital on 02/04/2002. No additional info was available as of the date of this report. follow-up information received on 02/22/2002 from reporting physician. Pt's medical history and concomitant medication provided. The lot number of Prevnar vaccine was provided.
Age: 6.0
Sex: M
Vaccine: PNC
Symptoms: Tachypnoea, Upper respiratory tract congestion
Clinical narrative: A physician reported that a 6 year old male received Prevnar vaccine on 12/05/2001. He has a past medical history of heart transplant, meningitis, and reactive airway. Concomitant medication included prednisone, Tacrolimus, ranitidine hydrochloride and iron. The child's mother reported that he developed upper respiratory congestion and cough for 5 days; however, in the last 2 days he developed "high" fevers with tachypnea, and back and chest pain. He was evaluated in the ER and found to have a "RUL and retrocardiac infiltrate consistent with a community-acquired pneumonia." The child was admitted to the hospital on 02/04/2002. No additional info was available as of the date of this report. follow-up information received on 02/22/2002 from reporting physician. Pt's medical history and concomitant medication provided. The lot number of Prevnar vaccine was provided.
Age: 0.5
Sex: F
Vaccine: PNC
Symptoms: Drug ineffective, Laboratory test abnormal, Sepsis
Clinical narrative: A physician reported that a 17 month old child received a 3rd dose of Prevnar. On 02/12/2002, the child developed a septic elbow. the organism identified was streptococcus pneumoniae. As of the date of this report the child has not recovered. This case was considered serious since "streptococcus pneumoniae septic elbow" required intervention to prevent a more serious medical event. No additional information was available as of the date of this report. Follow-up info received 3/12/02, from physician. The pt was hospitalized for four days and she recovered. Lab data was included. On 2/9/02, an x-ray was administered with the following results: four views of the left elbow were done and this was compared with four views of the left elbow done 2/8/02. There is again demonstration of slight soft tissue swelling at medial distal arm adjacent to elbow. No bony abnormalities are seen. There is no periosteal reaction and no joint effusion is seen. Impression: There is again demonstration of slight soft tissue prominence and edema or infiltrate subcutaneous fat layer distal medial arm. The elbow is intact. On 2/9/02, a gram stain resulted in many segmented neutrophils, few mononuclear leukocytes, few red blood cells and Gram positive diplococti. On 2/9/02, an anerobe culture of elbow aspirate was negative. On 2/9/02, a blood culture revealed no growth for five days. On 2/10/02, an antimicrobial susceptibility test was sensitive to the following: Ceftriaxone .032 (MIC), S (Int); Glindamycin S (KB); Erythromycin S (KB); Ofloxacin S (KB); Penicillin .032 (MIC), S (Int); Tetracycline and Vencomycin. On 2/10/02, a gram stain resulted in few segmented neutrophils and rate Gram positive diplococoi. On 2/11/02, an aerobe culture of elbow aspirate revealed streptococcus pneumoniae (moderate). In Feb 2002, a mean cell hemoglobin and mean cell volume revealed were WNL. Hematocrit was administered with the following results: 31.8 (2/9/02) to 28.9 (2/18/02). Hemoglobin results were 11.1 (2/9/02) to 9.8 (2/18/02). In Feb 2002, a monocyte count, red blood cell count and mean cell hemoglobin concentration were noraml. Neutrophil count results were as follows: Band Neutrophils 13 (2/9/02) to 2 (2/18/02). Segnented neutrophils 61 (2/9/02) to 18 (2/18/02) and Absolute neutrophil count 25.2 (2/9/02) to 1.9 (2/18/02). White blood cell count results were 34 (2/9/02) to 9.4 (2/18/02). Platelet count results were 450 (2/9/02) to 865 (2/18/02). Lymphocyte count results were 22 (2/9/02) to 71 (2/18/02) and atypical lymphocytes were WNL. Mean cell hemoglobin concentration and blood basophils were normal. Eosinophil count results were 3 (2/12/02) to 4 (2/18/02). C-reactive protein results were 21.2 (2/9/02) to 4 (2/18/02). Follow-up info received from physician. He has not received a hospital discharge summary as of this time. The concern is of either "failure of vaccination or strep pneumo septic elbow due to a subtype not covered by the vaccine." The pt is doing well now. Dates of immunization and lot numbers of Prevnar vaccine were also included.
Age: 3.0
Sex: F
Vaccine: PNC
Symptoms: Drug ineffective, Sepsis
Clinical narrative: A pediatrician reported that a 3 year old female received an injection of Prevnar. A few months later, in Feb. 2002, the child developed invasive pneumococcal disease. Invasive pneumococcal disease is considered medically important. No further info was available at the date of this report. The follow up info was received from the physician on 3/14/02. The child, who had a medical history of acute lymphocytic leukemia, received her first dose of Prevnar on 9/17/02. On 2/13/02, a blood culture was collected; Strep pneumoniae was isolated. A diagnosis of pneumococcal bacteremia without focus was made; she was hospitalized that day. She was discharged from the hospital on 2/16/02.
Age: 1.2
Sex: F
Vaccine: PNC
Symptoms: Arthritis bacterial
Clinical narrative: A pediatrician reported that a 14 month old female received her third dose of Prevnar and subsequently was diagnosed with pneumococcal septic arthritis. The reporter indicated that this case and samples for serotyping were sent to the CDC. No further info was available at the date of this report. This event is considered medically important.
Age: 0.5
Sex: M
Vaccine: DTAP, PNC
Symptoms: Bacterial infection, Sepsis
Clinical narrative: A physician reported that an 11 month-old male received a 3rd dose of Prevnar and Infanrix vaccines on 14-JUN-2001, when he was 6-month-old. On 29-Nov-2001, the infant developed pneumococal bacteremia. Blood tests revealed "bacteremia" (without focus)" No additional information was available as of the date of this report This case was considered serious since septicemia streptococcal and drug ineffective were considered medically important in this case follow up information received 19-DEc-2001. Blood isolate from blood culture was serotype 22F (not a Prevnar vaccine serotype). The  patient was also reported to be "healthy and doing well'. Follow-up information received 04-JAN-2002 from physician. these events required an emergency room/ doctor visit the patient recovered.
Age: 1.5
Sex: U
Vaccine: PNC
Symptoms: Convulsion, Drug ineffective, Pneumonia, Sepsis
Clinical narrative: A physician reported via a sales representative that an 18 month old child received a 4th dose of Prevnar. In 12/01, the child experienced a seizure. The pt was seen in an ER where a blood culture showed Streptococcus pneumonia, serotype unknown. The child was hospitalized and recovered. No further information was available at the date of this report.
Sex: F
Vaccine: PNC
Symptoms: Drug ineffective, Pneumonia, Pyrexia, Sepsis
Clinical narrative: A physician reported that an infant female received her third injection of Prevnar. On 12/09/2001, at 11 months of age, the infant was hospitalized for fever "without a source." A blood culture was positive for Streptococcus pneumoniae. Serotype results are pending. The infant was treated with amoxicillin. As of the date of this report, the infant is "clinically improved." Follow-up info received on  01/18/2002 indicated that the blood culture isolate was identified as serotype 19A.
Age: 0.5
Sex: F
Vaccine: PNC
Symptoms: Constipation, Laboratory test abnormal, Pneumonia, Pyrexia, Vomiting
Clinical narrative: A physician reported via a company representative that a 6 month old female, with a history of a mild protein allergy, received her third dose of Prevnar on 01/02/2002. That same day, the infant developed a fever, constipation, and vomiting. A blood culture collected that day was positive for Streptococcus pneumoniae. On 01/05/2002, a urinalysisi and urine culture were negative. The infant was treated with Rocephin and Ceftin. A repeat blood culture on 01/07/2002 showed no growth. Streptococcal septicemia is considered medically important. FOLLOW-UP information received from the physician on 03/26/02 identified the serotype as group 9. The physician also reported that the infant was seen by a physician and has recovered. Additional follow-up information was received on 04/02/02 via telephone call. The physician on 01/02/02 visit,a blood culture was collected and the preliminary results showed no growth in 12-24 hours. Final results were positive for Streptococcus pneumoniae. Thus, the child was a 4 month old when she received her second dose of Prevnar on 11/05/01. On 01/02/02, at 6 month of age, she was diagnosed with streptococcal bactermia.
Sex: U
Vaccine: PNC
Symptoms: Convulsion
Clinical narrative: A pharmacist reported that an unidentified person received Prevnar vaccine. The pharmacist "thinks" the pt did have a seizure following the injection of Prevnar. This case is considered serious since convulsion was considered medically important in this case. No additional info was available as of the date of this report.
Sex: U
Vaccine: PNC
Symptoms: Rash
Clinical narrative: A nurse reported that a child received an injection of Prevnar. Five to six days post vaccination, the child developed a generalized rash. No further info was available at the date of this report.
Age: 4.0
Sex: M
Vaccine: PNC
Symptoms: Tenderness
Clinical narrative: A pediatrician reported via a company representative that a 4 year old male received a subcutaneous injection of Prevnar on 01/29/2002. The following day, the child developed soreness at the injection site. No further information was available at the date of this report. The recommended route of administration for Prevnar is intramuscular.
Age: 0.2
Sex: F
Vaccine: DTAP, PNC
Symptoms: Pallor, Urticaria
Clinical narrative: A nurse reported that a 2 month old female received a 1st dose of Prevnar and Infanrix on 01/10/2002. Immediately post immunization, the infant developed hives on her face and turned pale. She was treated with dihenhydramine and observed in the physician's office for one hour. She recovered. No additional info was available at the date of this report. F/U 7/2/02: Information received on 3/19/02, from LPN; included pts name and address, lot numbers of the vaccines and the county of vaccine administration.
Sex: U
Vaccine: PNC
Symptoms: Pharyngitis, Rhinitis
Clinical narrative: A company sales representative reported that a child received an injection of Prevnar and the next day, developed a "cold." As of the date of this report, no further info was available.
Sex: F
Vaccine: PNC
Symptoms: Contusion, Petechiae
Clinical narrative: A nurse reported that a female received an injection of Prevnar on 02/14/2002 and a few hours following immunization, developed bruising at the injection site. Later that day, the pt developed petechia on her face. As of the date of this report, no further info was available.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Crying, Injection site oedema, Injection site warmth, Irritability, Pain
Clinical narrative: A consumer reported that her 6-month-old son received a dose of Prevnar, DTaP (manufacturer unknown), and IPV vaccines on 17-DEC-2001. Approximately 1-2 hours later, the child began "rolling his head side to side and had a goofy look in his eyes" The child was cranky and screaming all evening and had developed an injection site reaction described as "hot to touch", swollen, and "very" tender. By the following day, the child had stopped screaming and was no longer cranky. No additional information was available at the date of this report. a copy of this report has been forwarded to the manufacturer of the IPV vaccine
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Screaming, Torticollis
Clinical narrative: A consumer reported that her 6-month-old son received a dose of Prevnar, DTaP (manufacturer unknown), and IPV vaccines on 17-DEC-2001. Approximately 1-2 hours later, the child began "rolling his head side to side and had a goofy look in his eyes" The child was cranky and screaming all evening and had developed an injection site reaction described as "hot to touch", swollen, and "very" tender. By the following day, the child had stopped screaming and was no longer cranky. No additional information was available at the date of this report. a copy of this report has been forwarded to the manufacturer of the IPV vaccine
Sex: M
Vaccine: PNC
Symptoms: Agitation, Anorexia, Pyrexia, Screaming
Clinical narrative: A grandmother reported that her grandson received an injection of Prevnar. Subsequently, the child developed a fever, screaming, and was "not eating." The reporter considered screaming to be an "extreme" reaction. The symptoms resolved "in a couple of days." No further info was available at the date of this report.
Age: 0.3
Sex: F
Vaccine: PNC
Symptoms: Anorexia, Crying, Irritability, Pyrexia
Clinical narrative: A registered nurse reported that a 4 month old female received Prevnar vaccine and subsequently developed a "high" fever, irritability, inconsolable crying and was not eating. No additional info was available as of the date of this report.
Age: 0.2
Sex: F
Vaccine: PNC
Symptoms: Injection site reaction
Clinical narrative: A nurse reported that a 2 month old female received her first dose of Prevnar vaccine on 10/30/2001. Post immunization, the infant developed an injection site reaction characterized by a bump and a brown spot. The brown spot was still present two months later when the infant received her four month old immunization. No further info was available at the date of the report.
Age: 0.3
Sex: F
Vaccine: PNC
Symptoms: Injection site reaction
Clinical narrative: A 4 month old female received her second dose of Prevnar on 01/08/2002. She subsequently developed an injection site reaction characterized by a lump and a brown spot. No further info was available at the date of this report.
Age: 0.2
Sex: M
Vaccine: PNC
Symptoms: Anorexia, Crying, Irritability, Pyrexia
Clinical narrative: A registered nurse reported that a 2 month old male received Prevnar vaccine and subsequently developed fever, irritability, inconsolable crying and was not eating. No additional info was available as of the date of this report.
Age: 0.5
Sex: M
Vaccine: PNC
Symptoms: Anorexia, Crying, Irritability, Pyrexia
Clinical narrative: A registered nurse reported that a 6 month old male received Prevnar vaccine and subsequently developed fever, irritability, inconsolable crying and was not eating. No additional info was available as of the date of this report.
Age: 1.5
Sex: M
Vaccine: PNC
Symptoms: Anorexia, Crying, Irritability, Pyrexia
Clinical narrative: A registered nurse reported that an 18-month old male received Prevnar vaccine (pneumococcal 7-valent conjugate vaccine and subsequently developed fever, irritability, inconsolable  crying and was not eating. This is 1 of 4 patients from this facility who experienced these events following receipt of Prevnar lot # 483-166. One patient (not identified) developed a fever of 104.5 degrees. See Case ID HQ9924616JAN 2002, HQ9924716JAN 2002 and HQ989281JAN2002. No additional information was available as of the date of this request.
Age: 0.6
Sex: U
Vaccine: PNC
Symptoms: Infection
Clinical narrative: A sales representative reported that a 7 month old infant received a second dose of Prevnar vaccine and subsequently devleoped "streptococcus." No further information was available at the date of this report.