chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HEP, IPV, PNC
Symptoms: Neurodevelopmental disorder, Staring
Clinical narrative: A 2 month old male received his 1st doses of Prevnar, Infanrix, Recombivax-HB and IPV vaccines on 7/19/00. On 7/20/00, he began to have episodes of jerking, then jerking and staring, occurring 2 to 3 times a day. The episodes became more frequent over the next several weeks. He was hospitalized for seizure control and a dx of infantile massive spasms was made. He has become developmentally delayed and microcephalic. He was treated with medication; however, his seizures were no controlled as of 5/23/01.
Age: 0.2
Sex: F
Vaccine: HEPA, 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: Dermatitis contact, Rash
Clinical narrative: A physician reported that a 2 month old female child received her 1st dose of Prevnar, one dose of Infanrix, IPV, and Comvax vaccines on 05/17/01. Approximately 4 hours later, the child screamed, went limp and was not arousable. The child's mother put the child in their car and drove to a local ER. The child remained non-arousable for the 10 - 15 minute car ride, but she opened her eyes when transferred to a table within the ER. She was transferred and admitted to another facility where, as of 05/18/01, she remained. The reporter noted that 'the child was eating, drinking, and playing at this time.' Results of an electroencephalogram were pending as of the date of this report. No further information was available as of the date of this report. From follow up correspondence received from Merck (WAES01040208) on 07/05/01 stated: Followup information from a hospital receptionist indicated that the discharge diagnosis was a hyporesponsive spell lasting 10 to 15 minutes after immunization. Etiology was not yet determined. She also reported that the results from the EEG was normal. No further information is available. This case is closed. From follow-up corrspondence received on 01/18/2002, the correct lot number was provided for DTaP product administered. The previous number of doses for all products was also provided. No further information is anticipated for this report.
Age: 0.2
Sex: F
Vaccine: HEPA, 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: Coma, Hypotonia, Screaming, Stupor
Clinical narrative: A physician reported that a 2 month old female child received her 1st dose of Prevnar, one dose of Infanrix, IPV, and Comvax vaccines on 05/17/01. Approximately 4 hours later, the child screamed, went limp and was not arousable. The child's mother put the child in their car and drove to a local ER. The child remained non-arousable for the 10 - 15 minute car ride, but she opened her eyes when transferred to a table within the ER. She was transferred and admitted to another facility where, as of 05/18/01, she remained. The reporter noted that 'the child was eating, drinking, and playing at this time.' Results of an electroencephalogram were pending as of the date of this report. No further information was available as of the date of this report. From follow up correspondence received from Merck (WAES01040208) on 07/05/01 stated: Followup information from a hospital receptionist indicated that the discharge diagnosis was a hyporesponsive spell lasting 10 to 15 minutes after immunization. Etiology was not yet determined. She also reported that the results from the EEG was normal. No further information is available. This case is closed. From follow-up corrspondence received on 01/18/2002, the correct lot number was provided for DTaP product administered. The previous number of doses for all products was also provided. No further information is anticipated for this report.
Age: 0.2
Sex: F
Vaccine: HEPA, 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: Crying, Depressed level of consciousness, Hypotonia, Stupor
Clinical narrative: A physician reported that a 2 month old female child received her 1st dose of Prevnar, one dose of Infanrix, IPV, and Comvax vaccines on 05/17/01. Approximately 4 hours later, the child screamed, went limp and was not arousable. The child's mother put the child in their car and drove to a local ER. The child remained non-arousable for the 10 - 15 minute car ride, but she opened her eyes when transferred to a table within the ER. She was transferred and admitted to another facility where, as of 05/18/01, she remained. The reporter noted that 'the child was eating, drinking, and playing at this time.' Results of an electroencephalogram were pending as of the date of this report. No further information was available as of the date of this report. From follow up correspondence received from Merck (WAES01040208) on 07/05/01 stated: Followup information from a hospital receptionist indicated that the discharge diagnosis was a hyporesponsive spell lasting 10 to 15 minutes after immunization. Etiology was not yet determined. She also reported that the results from the EEG was normal. No further information is available. This case is closed. From follow-up corrspondence received on 01/18/2002, the correct lot number was provided for DTaP product administered. The previous number of doses for all products was also provided. No further information is anticipated for this report.
Age: 0.2
Sex: F
Vaccine: HEPA, 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: Coma, Hypotonia
Clinical narrative: A physician reported that a 2 month old female child received her 1st dose of Prevnar, one dose of Infanrix, IPV, and Comvax vaccines on 05/17/01. Approximately 4 hours later, the child screamed, went limp and was not arousable. The child's mother put the child in their car and drove to a local ER. The child remained non-arousable for the 10 - 15 minute car ride, but she opened her eyes when transferred to a table within the ER. She was transferred and admitted to another facility where, as of 05/18/01, she remained. The reporter noted that 'the child was eating, drinking, and playing at this time.' Results of an electroencephalogram were pending as of the date of this report. No further information was available as of the date of this report. From follow up correspondence received from Merck (WAES01040208) on 07/05/01 stated: Followup information from a hospital receptionist indicated that the discharge diagnosis was a hyporesponsive spell lasting 10 to 15 minutes after immunization. Etiology was not yet determined. She also reported that the results from the EEG was normal. No further information is available. This case is closed. From follow-up corrspondence received on 01/18/2002, the correct lot number was provided for DTaP product administered. The previous number of doses for all products was also provided. No further information is anticipated for this report.
Age: 0.2
Sex: F
Vaccine: HEPA, 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: Hypotonia, Hypoventilation, Screaming, Somnolence
Clinical narrative: A physician reported that a 2 month old female child received her 1st dose of Prevnar, one dose of Infanrix, IPV, and Comvax vaccines on 05/17/01. Approximately 4 hours later, the child screamed, went limp and was not arousable. The child's mother put the child in their car and drove to a local ER. The child remained non-arousable for the 10 - 15 minute car ride, but she opened her eyes when transferred to a table within the ER. She was transferred and admitted to another facility where, as of 05/18/01, she remained. The reporter noted that 'the child was eating, drinking, and playing at this time.' Results of an electroencephalogram were pending as of the date of this report. No further information was available as of the date of this report. From follow up correspondence received from Merck (WAES01040208) on 07/05/01 stated: Followup information from a hospital receptionist indicated that the discharge diagnosis was a hyporesponsive spell lasting 10 to 15 minutes after immunization. Etiology was not yet determined. She also reported that the results from the EEG was normal. No further information is available. This case is closed. From follow-up corrspondence received on 01/18/2002, the correct lot number was provided for DTaP product administered. The previous number of doses for all products was also provided. No further information is anticipated for this report.
Age: 0.2
Sex: F
Vaccine: HEPA, 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: Crying, Hypotonia, Stupor
Clinical narrative: A physician reported that a 2 month old female child received her 1st dose of Prevnar, one dose of Infanrix, IPV, and Comvax vaccines on 05/17/01. Approximately 4 hours later, the child screamed, went limp and was not arousable. The child's mother put the child in their car and drove to a local ER. The child remained non-arousable for the 10 - 15 minute car ride, but she opened her eyes when transferred to a table within the ER. She was transferred and admitted to another facility where, as of 05/18/01, she remained. The reporter noted that 'the child was eating, drinking, and playing at this time.' Results of an electroencephalogram were pending as of the date of this report. No further information was available as of the date of this report. From follow up correspondence received from Merck (WAES01040208) on 07/05/01 stated: Followup information from a hospital receptionist indicated that the discharge diagnosis was a hyporesponsive spell lasting 10 to 15 minutes after immunization. Etiology was not yet determined. She also reported that the results from the EEG was normal. No further information is available. This case is closed. From follow-up corrspondence received on 01/18/2002, the correct lot number was provided for DTaP product administered. The previous number of doses for all products was also provided. No further information is anticipated for this report.
Age: 0.2
Sex: F
Vaccine: HEPA, 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: Coma
Clinical narrative: A physician reported that a 2 month old female child received her 1st dose of Prevnar, one dose of Infanrix, IPV, and Comvax vaccines on 05/17/01. Approximately 4 hours later, the child screamed, went limp and was not arousable. The child's mother put the child in their car and drove to a local ER. The child remained non-arousable for the 10 - 15 minute car ride, but she opened her eyes when transferred to a table within the ER. She was transferred and admitted to another facility where, as of 05/18/01, she remained. The reporter noted that 'the child was eating, drinking, and playing at this time.' Results of an electroencephalogram were pending as of the date of this report. No further information was available as of the date of this report. From follow up correspondence received from Merck (WAES01040208) on 07/05/01 stated: Followup information from a hospital receptionist indicated that the discharge diagnosis was a hyporesponsive spell lasting 10 to 15 minutes after immunization. Etiology was not yet determined. She also reported that the results from the EEG was normal. No further information is available. This case is closed. From follow-up corrspondence received on 01/18/2002, the correct lot number was provided for DTaP product administered. The previous number of doses for all products was also provided. No further information is anticipated for this report.
Age: 0.2
Sex: F
Vaccine: HEPA, 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: Dermatitis contact, Rash
Clinical narrative: On 5/17/01 at 14:15, the infant received an injection of Infanrix; it was not known if she had received previous injections of Infanrix. On that date, she also received her 1st injection of 7-valent pneumococcal conjugate vaccine (Prevnar). On 5/17/01, the infant also received injections of combination Haemophilus influenza type b conjugate/hepatitis B vaccine (Comvax) and inactivated poliomyelitis virus vaccine (IPOL); it was not known if she had received previous injections of these vaccines. Approx. 4 hours, post vax, the infant screamed, went limp and was not arousable. The infant's mother transported her to the local ER by car; the infant remained unarousable during the 10 to 15 minute drive. She opened her eyes when she was transported to an exam table in the ER. The infant was transferred and admitted to another facility, where she remained as of 5/18/01. At that time, the physician reported that the "child was eating, drinking, and playing". Outcome of the screaming, limpness and unarousable state were not specified.
Age: 0.2
Sex: F
Vaccine: HEPA, 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: Coma, Hypotonia, Screaming, Stupor
Clinical narrative: On 5/17/01 at 14:15, the infant received an injection of Infanrix; it was not known if she had received previous injections of Infanrix. On that date, she also received her 1st injection of 7-valent pneumococcal conjugate vaccine (Prevnar). On 5/17/01, the infant also received injections of combination Haemophilus influenza type b conjugate/hepatitis B vaccine (Comvax) and inactivated poliomyelitis virus vaccine (IPOL); it was not known if she had received previous injections of these vaccines. Approx. 4 hours, post vax, the infant screamed, went limp and was not arousable. The infant's mother transported her to the local ER by car; the infant remained unarousable during the 10 to 15 minute drive. She opened her eyes when she was transported to an exam table in the ER. The infant was transferred and admitted to another facility, where she remained as of 5/18/01. At that time, the physician reported that the "child was eating, drinking, and playing". Outcome of the screaming, limpness and unarousable state were not specified.
Age: 0.2
Sex: F
Vaccine: HEPA, 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: Crying, Depressed level of consciousness, Hypotonia, Stupor
Clinical narrative: On 5/17/01 at 14:15, the infant received an injection of Infanrix; it was not known if she had received previous injections of Infanrix. On that date, she also received her 1st injection of 7-valent pneumococcal conjugate vaccine (Prevnar). On 5/17/01, the infant also received injections of combination Haemophilus influenza type b conjugate/hepatitis B vaccine (Comvax) and inactivated poliomyelitis virus vaccine (IPOL); it was not known if she had received previous injections of these vaccines. Approx. 4 hours, post vax, the infant screamed, went limp and was not arousable. The infant's mother transported her to the local ER by car; the infant remained unarousable during the 10 to 15 minute drive. She opened her eyes when she was transported to an exam table in the ER. The infant was transferred and admitted to another facility, where she remained as of 5/18/01. At that time, the physician reported that the "child was eating, drinking, and playing". Outcome of the screaming, limpness and unarousable state were not specified.
Age: 0.2
Sex: F
Vaccine: HEPA, 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: Coma, Hypotonia
Clinical narrative: On 5/17/01 at 14:15, the infant received an injection of Infanrix; it was not known if she had received previous injections of Infanrix. On that date, she also received her 1st injection of 7-valent pneumococcal conjugate vaccine (Prevnar). On 5/17/01, the infant also received injections of combination Haemophilus influenza type b conjugate/hepatitis B vaccine (Comvax) and inactivated poliomyelitis virus vaccine (IPOL); it was not known if she had received previous injections of these vaccines. Approx. 4 hours, post vax, the infant screamed, went limp and was not arousable. The infant's mother transported her to the local ER by car; the infant remained unarousable during the 10 to 15 minute drive. She opened her eyes when she was transported to an exam table in the ER. The infant was transferred and admitted to another facility, where she remained as of 5/18/01. At that time, the physician reported that the "child was eating, drinking, and playing". Outcome of the screaming, limpness and unarousable state were not specified.
Age: 0.2
Sex: F
Vaccine: HEPA, 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: Hypotonia, Hypoventilation, Screaming, Somnolence
Clinical narrative: On 5/17/01 at 14:15, the infant received an injection of Infanrix; it was not known if she had received previous injections of Infanrix. On that date, she also received her 1st injection of 7-valent pneumococcal conjugate vaccine (Prevnar). On 5/17/01, the infant also received injections of combination Haemophilus influenza type b conjugate/hepatitis B vaccine (Comvax) and inactivated poliomyelitis virus vaccine (IPOL); it was not known if she had received previous injections of these vaccines. Approx. 4 hours, post vax, the infant screamed, went limp and was not arousable. The infant's mother transported her to the local ER by car; the infant remained unarousable during the 10 to 15 minute drive. She opened her eyes when she was transported to an exam table in the ER. The infant was transferred and admitted to another facility, where she remained as of 5/18/01. At that time, the physician reported that the "child was eating, drinking, and playing". Outcome of the screaming, limpness and unarousable state were not specified.
Age: 0.2
Sex: F
Vaccine: HEPA, 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: Crying, Hypotonia, Stupor
Clinical narrative: On 5/17/01 at 14:15, the infant received an injection of Infanrix; it was not known if she had received previous injections of Infanrix. On that date, she also received her 1st injection of 7-valent pneumococcal conjugate vaccine (Prevnar). On 5/17/01, the infant also received injections of combination Haemophilus influenza type b conjugate/hepatitis B vaccine (Comvax) and inactivated poliomyelitis virus vaccine (IPOL); it was not known if she had received previous injections of these vaccines. Approx. 4 hours, post vax, the infant screamed, went limp and was not arousable. The infant's mother transported her to the local ER by car; the infant remained unarousable during the 10 to 15 minute drive. She opened her eyes when she was transported to an exam table in the ER. The infant was transferred and admitted to another facility, where she remained as of 5/18/01. At that time, the physician reported that the "child was eating, drinking, and playing". Outcome of the screaming, limpness and unarousable state were not specified.
Age: 0.2
Sex: F
Vaccine: HEPA, 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: Coma
Clinical narrative: On 5/17/01 at 14:15, the infant received an injection of Infanrix; it was not known if she had received previous injections of Infanrix. On that date, she also received her 1st injection of 7-valent pneumococcal conjugate vaccine (Prevnar). On 5/17/01, the infant also received injections of combination Haemophilus influenza type b conjugate/hepatitis B vaccine (Comvax) and inactivated poliomyelitis virus vaccine (IPOL); it was not known if she had received previous injections of these vaccines. Approx. 4 hours, post vax, the infant screamed, went limp and was not arousable. The infant's mother transported her to the local ER by car; the infant remained unarousable during the 10 to 15 minute drive. She opened her eyes when she was transported to an exam table in the ER. The infant was transferred and admitted to another facility, where she remained as of 5/18/01. At that time, the physician reported that the "child was eating, drinking, and playing". Outcome of the screaming, limpness and unarousable state were not specified.
Age: 0.19
Sex: F
Vaccine: DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Convulsion, Dyskinesia, Fatigue, Pyrexia, Somnolence
Clinical narrative: Vaccines given at 17:30 on 6/4/01. At 20:30, the infant began to "shake repeatedly" and stare, not responsive to mom's voice. No cyanosis. Then on the way to the hospital, briefly became cyanotic. Diagnosed with seizure.
Age: 0.19
Sex: F
Vaccine: DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Staring
Clinical narrative: Vaccines given at 17:30 on 6/4/01. At 20:30, the infant began to "shake repeatedly" and stare, not responsive to mom's voice. No cyanosis. Then on the way to the hospital, briefly became cyanotic. Diagnosed with seizure.
Age: 0.19
Sex: F
Vaccine: DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Coma, Convulsion, Cyanosis, Staring, Tremor
Clinical narrative: Vaccines given at 17:30 on 6/4/01. At 20:30, the infant began to "shake repeatedly" and stare, not responsive to mom's voice. No cyanosis. Then on the way to the hospital, briefly became cyanotic. Diagnosed with seizure.
Age: 56.0
Sex: M
Vaccine: HEPA
Symptoms: Balance disorder, Confusional state, Dysarthria, Encephalopathy, Headache
Clinical narrative: Post vax, on 4/1/01 at 06:00, had severe frontal headache and was started on Zithromax. On 4/2/01, had onset of severe bilateral tinnitus. On 4/3/01, saw an ENT doctor. No ear infection but dx'd with cholear nerve infection. Steroids and Augmentin were prescribed for possible sinusitis. On 4/8/01, steroids stopped. On 4/11/01, had onset of extreme lethargy, unable to work. On 4/14/01, had onset of acute CNS changes (confused, disoriented, slurred and thick speech, balance problems, intractable hiccups, headaches, lethargy continues). From 4/14/01 to 4/16/01, had extreme somnolence, difficult to awaken and irritable. On 4/16/01, saw a neurologist, and was dx'd with acute encephalopathy and hospitalized. On 4/18/01, discharged with CNS changes improved. On 4/23/01, balance, disorientation and hiccup problems resolved but still unable to work. San ENT/Tinnitus specialist who felt tinnitus was secondary to an acute bilateral hearing loss, probably would not go away. Prescribed another steroid course and Elavil. On 5/3/01 through 5/12/01, confined to bed secondary to fatigue and lethargy. From 5/12/01 to 5/24/01, fatigue starting to resolve. Current problems: severe, unremitting, bilateral tinnitus; insomnia secondary to tinnitus and fatigue continue to be problems, other CNS problems seem to have returned to baseline. Still unable to work.
Age: 56.0
Sex: M
Vaccine: HEPA
Symptoms: Hiccups, Hypoacusis, Infection, Insomnia, Irritability
Clinical narrative: Post vax, on 4/1/01 at 06:00, had severe frontal headache and was started on Zithromax. On 4/2/01, had onset of severe bilateral tinnitus. On 4/3/01, saw an ENT doctor. No ear infection but dx'd with cholear nerve infection. Steroids and Augmentin were prescribed for possible sinusitis. On 4/8/01, steroids stopped. On 4/11/01, had onset of extreme lethargy, unable to work. On 4/14/01, had onset of acute CNS changes (confused, disoriented, slurred and thick speech, balance problems, intractable hiccups, headaches, lethargy continues). From 4/14/01 to 4/16/01, had extreme somnolence, difficult to awaken and irritable. On 4/16/01, saw a neurologist, and was dx'd with acute encephalopathy and hospitalized. On 4/18/01, discharged with CNS changes improved. On 4/23/01, balance, disorientation and hiccup problems resolved but still unable to work. San ENT/Tinnitus specialist who felt tinnitus was secondary to an acute bilateral hearing loss, probably would not go away. Prescribed another steroid course and Elavil. On 5/3/01 through 5/12/01, confined to bed secondary to fatigue and lethargy. From 5/12/01 to 5/24/01, fatigue starting to resolve. Current problems: severe, unremitting, bilateral tinnitus; insomnia secondary to tinnitus and fatigue continue to be problems, other CNS problems seem to have returned to baseline. Still unable to work.
Age: 56.0
Sex: M
Vaccine: HEPA
Symptoms: Lethargy, Nervous system disorder, Sinusitis, Somnolence, Tinnitus
Clinical narrative: Post vax, on 4/1/01 at 06:00, had severe frontal headache and was started on Zithromax. On 4/2/01, had onset of severe bilateral tinnitus. On 4/3/01, saw an ENT doctor. No ear infection but dx'd with cholear nerve infection. Steroids and Augmentin were prescribed for possible sinusitis. On 4/8/01, steroids stopped. On 4/11/01, had onset of extreme lethargy, unable to work. On 4/14/01, had onset of acute CNS changes (confused, disoriented, slurred and thick speech, balance problems, intractable hiccups, headaches, lethargy continues). From 4/14/01 to 4/16/01, had extreme somnolence, difficult to awaken and irritable. On 4/16/01, saw a neurologist, and was dx'd with acute encephalopathy and hospitalized. On 4/18/01, discharged with CNS changes improved. On 4/23/01, balance, disorientation and hiccup problems resolved but still unable to work. San ENT/Tinnitus specialist who felt tinnitus was secondary to an acute bilateral hearing loss, probably would not go away. Prescribed another steroid course and Elavil. On 5/3/01 through 5/12/01, confined to bed secondary to fatigue and lethargy. From 5/12/01 to 5/24/01, fatigue starting to resolve. Current problems: severe, unremitting, bilateral tinnitus; insomnia secondary to tinnitus and fatigue continue to be problems, other CNS problems seem to have returned to baseline. Still unable to work.
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Aphasia, Confusional state, Headache, Hypoaesthesia, Mental impairment
Clinical narrative: This patient had right arm numbness, left frontal headache, aphasia, mental status altered changes, nausea and vomiting. Sickness occurred over 1 - 2 hour period and progressed to confusion and aphasia with in 6 hours; better in 12 - 15 hours.
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Vomiting
Clinical narrative: This patient had right arm numbness, left frontal headache, aphasia, mental status altered changes, nausea and vomiting. Sickness occurred over 1 - 2 hour period and progressed to confusion and aphasia with in 6 hours; better in 12 - 15 hours.
Age: 0.08
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Coma, Constipation, Convulsion, Faeces pale, Injection site erythema
Clinical narrative: "A mother reported that her son received his 1st doses of DTAP, HIB and IPV and his 2nd dose of HEP-B vaccines in early July, 1998. He reportedly, developed injection site reactions characterized by hard lumps, redness and warmth. He later, experienced a "high" fever. His mother notified the physician. The pt became irritable and inconsolable. He experienced high-pitched screaming for several hours and arching of his back. He became chronically constipated, needing help to pass hard, clay-like lumps, which often made him bleed. Shortly following his immunizations, he experienced a series of "vague seizure activity". His entire body would twitch and he would seem unresponsive. The physician was notified. He experienced a few more episodes and recovered. Convulsions are considered "Medically Important"."
Age: 0.08
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Injection site mass, Injection site warmth, Irritability, Muscle twitching, Opisthotonus
Clinical narrative: "A mother reported that her son received his 1st doses of DTAP, HIB and IPV and his 2nd dose of HEP-B vaccines in early July, 1998. He reportedly, developed injection site reactions characterized by hard lumps, redness and warmth. He later, experienced a "high" fever. His mother notified the physician. The pt became irritable and inconsolable. He experienced high-pitched screaming for several hours and arching of his back. He became chronically constipated, needing help to pass hard, clay-like lumps, which often made him bleed. Shortly following his immunizations, he experienced a series of "vague seizure activity". His entire body would twitch and he would seem unresponsive. The physician was notified. He experienced a few more episodes and recovered. Convulsions are considered "Medically Important"."
Age: 0.08
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Pyrexia, Rectal haemorrhage, Screaming
Clinical narrative: "A mother reported that her son received his 1st doses of DTAP, HIB and IPV and his 2nd dose of HEP-B vaccines in early July, 1998. He reportedly, developed injection site reactions characterized by hard lumps, redness and warmth. He later, experienced a "high" fever. His mother notified the physician. The pt became irritable and inconsolable. He experienced high-pitched screaming for several hours and arching of his back. He became chronically constipated, needing help to pass hard, clay-like lumps, which often made him bleed. Shortly following his immunizations, he experienced a series of "vague seizure activity". His entire body would twitch and he would seem unresponsive. The physician was notified. He experienced a few more episodes and recovered. Convulsions are considered "Medically Important"."
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Febrile convulsion
Clinical narrative: Shortly after pt received Prevnar, pt had febrile seizure, in the car on the way home,  and was brought to local ER with a temperature of 103F. Pt also had 2nd and 3rd febrile seizures on 4/18/01 and 4/19/01. No history of seizure disorder prior to Prevnar.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Alanine aminotransferase increased, Anorexia, Arthralgia, Aspartate aminotransferase increased
Clinical narrative: On 4/19/01 and 5/16/01, the pt received her 1st and 2nd doses of Engerix-B, respectively. On 6/1/01, the pt was seen in the physician's office with nausea, vomiting and fever. She was noted to have an enlarged liver; no jaundice was noted. It is unknown if viral hepatitis serologies were obtained. She was treated with prochlorperazine (Compazine). She subsequently, had a dystonic reaction which resolved (see report 2001013944-2). The nausea, vomiting and fever resolved on an unspecified date. The pt was seen by the physician on 6/6/01 and was found to be jaundiced. However, the vaccinee "looks and feels better". Repeat of 6/6/01, liver enzymes and hepatitis panel were performed; results were pending as of 6/6/01. This report is considered "Medically Serious". As of 6/6/01, the jaundice was ongoing. The outcome of the enlarged liver and elevated liver enzymes was not specified. F/U on 9/14/01, it was reported that the pt was referred to a gastroenterologist. A dx of hepatitis A was made and the pt rec'd unspecified outpatient tx. The reporter stated tat the hepatitis A infection was unrelated to Engerix-B. As of 9/14/01 the outcome of the hepatits A was unknown. Hepatitis A is considered medically serious. Per F/U, On 5/31/01, she developed arthralgias, myalgias and a fever of 103F. The gastroenterologist saw the pt on 6/8/01 and at that time, the pt reported "extreme" fatigue, decreased appetite, diffuse abdominal pain and nausea. She had juandice of skin and mild scleral icterus. Dx was a "Hepatitis of an unknown etiology" and prescribed rest. She was seen by this doctor again on 6/11/01 and was feeling better and was able to eat without nausea or vomiting but remained weak. She was much more jaundiced and had increasing scleral icterus. This same doctor saw the pt again 7/5/01 and she had gained 6lbs. The most recent information received on 10/15/01, the vaccine provider stated "The pt already had hepatitis prior to the shot (of Engerix-B)". She also stated that the Hep-A infection was "not at all related to Engerix-B". Outcome of the Hep-A infection was not specified.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Blood bilirubin increased, Dystonia, Fatigue, Hepatitis A, Hepatomegaly
Clinical narrative: On 4/19/01 and 5/16/01, the pt received her 1st and 2nd doses of Engerix-B, respectively. On 6/1/01, the pt was seen in the physician's office with nausea, vomiting and fever. She was noted to have an enlarged liver; no jaundice was noted. It is unknown if viral hepatitis serologies were obtained. She was treated with prochlorperazine (Compazine). She subsequently, had a dystonic reaction which resolved (see report 2001013944-2). The nausea, vomiting and fever resolved on an unspecified date. The pt was seen by the physician on 6/6/01 and was found to be jaundiced. However, the vaccinee "looks and feels better". Repeat of 6/6/01, liver enzymes and hepatitis panel were performed; results were pending as of 6/6/01. This report is considered "Medically Serious". As of 6/6/01, the jaundice was ongoing. The outcome of the enlarged liver and elevated liver enzymes was not specified. F/U on 9/14/01, it was reported that the pt was referred to a gastroenterologist. A dx of hepatitis A was made and the pt rec'd unspecified outpatient tx. The reporter stated tat the hepatitis A infection was unrelated to Engerix-B. As of 9/14/01 the outcome of the hepatits A was unknown. Hepatitis A is considered medically serious. Per F/U, On 5/31/01, she developed arthralgias, myalgias and a fever of 103F. The gastroenterologist saw the pt on 6/8/01 and at that time, the pt reported "extreme" fatigue, decreased appetite, diffuse abdominal pain and nausea. She had juandice of skin and mild scleral icterus. Dx was a "Hepatitis of an unknown etiology" and prescribed rest. She was seen by this doctor again on 6/11/01 and was feeling better and was able to eat without nausea or vomiting but remained weak. She was much more jaundiced and had increasing scleral icterus. This same doctor saw the pt again 7/5/01 and she had gained 6lbs. The most recent information received on 10/15/01, the vaccine provider stated "The pt already had hepatitis prior to the shot (of Engerix-B)". She also stated that the Hep-A infection was "not at all related to Engerix-B". Outcome of the Hep-A infection was not specified.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Jaundice, Lipase increased, Liver function test abnormal, Myalgia, Nausea
Clinical narrative: On 4/19/01 and 5/16/01, the pt received her 1st and 2nd doses of Engerix-B, respectively. On 6/1/01, the pt was seen in the physician's office with nausea, vomiting and fever. She was noted to have an enlarged liver; no jaundice was noted. It is unknown if viral hepatitis serologies were obtained. She was treated with prochlorperazine (Compazine). She subsequently, had a dystonic reaction which resolved (see report 2001013944-2). The nausea, vomiting and fever resolved on an unspecified date. The pt was seen by the physician on 6/6/01 and was found to be jaundiced. However, the vaccinee "looks and feels better". Repeat of 6/6/01, liver enzymes and hepatitis panel were performed; results were pending as of 6/6/01. This report is considered "Medically Serious". As of 6/6/01, the jaundice was ongoing. The outcome of the enlarged liver and elevated liver enzymes was not specified. F/U on 9/14/01, it was reported that the pt was referred to a gastroenterologist. A dx of hepatitis A was made and the pt rec'd unspecified outpatient tx. The reporter stated tat the hepatitis A infection was unrelated to Engerix-B. As of 9/14/01 the outcome of the hepatits A was unknown. Hepatitis A is considered medically serious. Per F/U, On 5/31/01, she developed arthralgias, myalgias and a fever of 103F. The gastroenterologist saw the pt on 6/8/01 and at that time, the pt reported "extreme" fatigue, decreased appetite, diffuse abdominal pain and nausea. She had juandice of skin and mild scleral icterus. Dx was a "Hepatitis of an unknown etiology" and prescribed rest. She was seen by this doctor again on 6/11/01 and was feeling better and was able to eat without nausea or vomiting but remained weak. She was much more jaundiced and had increasing scleral icterus. This same doctor saw the pt again 7/5/01 and she had gained 6lbs. The most recent information received on 10/15/01, the vaccine provider stated "The pt already had hepatitis prior to the shot (of Engerix-B)". She also stated that the Hep-A infection was "not at all related to Engerix-B". Outcome of the Hep-A infection was not specified.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Vomiting
Clinical narrative: On 4/19/01 and 5/16/01, the pt received her 1st and 2nd doses of Engerix-B, respectively. On 6/1/01, the pt was seen in the physician's office with nausea, vomiting and fever. She was noted to have an enlarged liver; no jaundice was noted. It is unknown if viral hepatitis serologies were obtained. She was treated with prochlorperazine (Compazine). She subsequently, had a dystonic reaction which resolved (see report 2001013944-2). The nausea, vomiting and fever resolved on an unspecified date. The pt was seen by the physician on 6/6/01 and was found to be jaundiced. However, the vaccinee "looks and feels better". Repeat of 6/6/01, liver enzymes and hepatitis panel were performed; results were pending as of 6/6/01. This report is considered "Medically Serious". As of 6/6/01, the jaundice was ongoing. The outcome of the enlarged liver and elevated liver enzymes was not specified. F/U on 9/14/01, it was reported that the pt was referred to a gastroenterologist. A dx of hepatitis A was made and the pt rec'd unspecified outpatient tx. The reporter stated tat the hepatitis A infection was unrelated to Engerix-B. As of 9/14/01 the outcome of the hepatits A was unknown. Hepatitis A is considered medically serious. Per F/U, On 5/31/01, she developed arthralgias, myalgias and a fever of 103F. The gastroenterologist saw the pt on 6/8/01 and at that time, the pt reported "extreme" fatigue, decreased appetite, diffuse abdominal pain and nausea. She had juandice of skin and mild scleral icterus. Dx was a "Hepatitis of an unknown etiology" and prescribed rest. She was seen by this doctor again on 6/11/01 and was feeling better and was able to eat without nausea or vomiting but remained weak. She was much more jaundiced and had increasing scleral icterus. This same doctor saw the pt again 7/5/01 and she had gained 6lbs. The most recent information received on 10/15/01, the vaccine provider stated "The pt already had hepatitis prior to the shot (of Engerix-B)". She also stated that the Hep-A infection was "not at all related to Engerix-B". Outcome of the Hep-A infection was not specified.
Age: 78.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Bone disorder, Eyelid ptosis, Glaucoma
Clinical narrative: 3-4 days, post vax, every joint in body aches. Had eye surgery for glaucoma at the end of 4/99. Knees, elbows and wrists are worse in the mornings. On 5/3/99,  recommended to take anti-inflammatory X 5 days, then call if not improved. Pt cannot sleep or drive. Back of calves and back of knees are severely painful. The pain is worse when lies down. Does not hurt when she walks. On 5/28/99, dx'd with polymyalgia rheumatica. She also has OA of hands and both knees (R>L). I am a little bothered by the ptosis on the left which apparently began a few months ago. I will start her on 15mg prednisone a day and ask her to taper the Motrin as needed.
Age: 78.0
Sex: F
Vaccine: LYME
Symptoms: Insomnia, Polymyalgia rheumatica, Red blood cell sedimentation rate increased
Clinical narrative: 3-4 days, post vax, every joint in body aches. Had eye surgery for glaucoma at the end of 4/99. Knees, elbows and wrists are worse in the mornings. On 5/3/99,  recommended to take anti-inflammatory X 5 days, then call if not improved. Pt cannot sleep or drive. Back of calves and back of knees are severely painful. The pain is worse when lies down. Does not hurt when she walks. On 5/28/99, dx'd with polymyalgia rheumatica. She also has OA of hands and both knees (R>L). I am a little bothered by the ptosis on the left which apparently began a few months ago. I will start her on 15mg prednisone a day and ask her to taper the Motrin as needed.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site erythema, Injection site swelling, Irritability, Pyrexia, Screaming
Clinical narrative: Patient began crying 4 am on the morning after immunization. By 8 am, he was screaming nonstop. Tylenol did not help. Patient was taken to the clinic and told it was a reaction to vaccine and to continue taking Tylenol. Patient continued crying all day for two days. On the third day he was fussy, and by the next day, he was all right. He had a low grade fever of 100.6. He had a red, swollen leg at site of DTAP injection.
Age: 1.0
Sex: M
Vaccine: HEP, PNC
Symptoms: Erythema, Swelling
Clinical narrative: Patient developed redness and swelling of leg.
Age: 2.0
Sex: M
Vaccine: PNC, PNC
Symptoms: Hypersensitivity, Rash
Clinical narrative: Patient developed a pink, fine rash on trunk and arms that was like a sunburn. Patient noted to have an allergic reaction.
Age: 2.0
Sex: M
Vaccine: PNC, PNC
Symptoms: Erythema
Clinical narrative: Patient developed a pink, fine rash on trunk and arms that was like a sunburn. Patient noted to have an allergic reaction.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Patient noted to have a hive at injection site where MMR given. He was immediately given Benadryl and stayed for 1 hour. The hive disappeared.
Age: 0.8
Sex: M
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: Patient developed a temperature of 103 that lasted 24 hours. He recovered without sequelae.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Dyskinesia
Clinical narrative: Approximately 30 minutes after vaccines given, mother reported that patient had an episode of jerking. Mother called on 4/16/01 to report that patient had no more episodes, but she had taken her to the ER, and the ER doctor started patient on anti-seizure medication. Patient was to be seen by a neurologist.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Hypersensitivity, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Within 24 hours, patient developed redness, swelling and warmth to the right thigh where injection was given. Erythema spread. Patient was seen in the clinic 2 days after DTAP vaccine. Site size was 8.5cm x 8.5cm. She was treated for cellulitis with Rocephin and Augmentin. It is not clear if she had an allergic reaction or cellulitis secondary to injection puncture site. It was resolved or very much improved on follow up office visit 6/1/01.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site warmth
Clinical narrative: Within 24 hours, patient developed redness, swelling and warmth to the right thigh where injection was given. Erythema spread. Patient was seen in the clinic 2 days after DTAP vaccine. Site size was 8.5cm x 8.5cm. She was treated for cellulitis with Rocephin and Augmentin. It is not clear if she had an allergic reaction or cellulitis secondary to injection puncture site. It was resolved or very much improved on follow up office visit 6/1/01.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Gait disturbance, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed swelling and redness on front and sides of left thigh extending to knee. The area was warm to the touch. Patient noted to have a slight limp with walking.
Age: 12.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Dizziness, Nausea, Pallor, Vomiting
Clinical narrative: Patient became dizzy, pale and nauseated after shots. He vomited several times. His vital signs were stable and his color returned to normal. He left after 15 minutes.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Arthritis, Asthenia, Herpes zoster, Hyperhidrosis, Joint range of motion decreased
Clinical narrative: Patient developed ache in arm immediately after injection. The next day she was weak and sweaty and her arm was painful. She could hardly move it. On 4/8/01, she went to hospital ER and was diagnosed with shingles under left arm and on chest.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Patient developed ache in arm immediately after injection. The next day she was weak and sweaty and her arm was painful. She could hardly move it. On 4/8/01, she went to hospital ER and was diagnosed with shingles under left arm and on chest.
Age: 11.0
Sex: F
Vaccine: DTAP, HEP, MMR
Symptoms: Injection site erythema, Injection site induration, Skin ulcer
Clinical narrative: Patient developed a 5cm x 5cm annular, erythematous, indurated lesion at injection site.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Hyperhidrosis, Nausea, Pallor, Pruritus, Urticaria
Clinical narrative: Patient developed nausea, diaphoresis, pallor, hives and itching. She was given Benadryl.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Contusion, Injection site erythema, Injection site induration
Clinical narrative: Patient developed 3 inches of marked erythema and induration with slight bruising in left deltoid where DTAP was given.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Urticaria
Clinical narrative: Patient developed a 5cm erythematous and tender annular wheal.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Patient developed a 4cm x 4cm erythematous, indurated lesion at injection site.
Age: 18.0
Sex: F
Vaccine: HEP, MMR, TD
Symptoms: Fatigue, Fungal infection, Malaise, Pain, Somnolence
Clinical narrative: Patient developed muscle aches in arms, shoulders and left leg. Hands were sore to write with. On 6/5/01, patient got a fungus in the mouth and became very tired. She developed a strange illness at school and then slept 2 days. After 5 weeks, she was still very tired and receiving treatment for oral fungus.
Age: 49.0
Sex: M
Vaccine: HEPA, TTOX, TYP
Symptoms: Hyperaemia, Injection site pain, Injection site warmth
Clinical narrative: Approximately 24 hours post injection, patient noted tenderness and hyperemic warmth at site. Local treatment was recommended along with Motrin or Advil.
Age: 4.5
Sex: F
Vaccine: MMR
Symptoms: Cough, Hypersensitivity, Pyrexia
Clinical narrative: Patient developed a fever that lasted about 4 days. She then developed a cough that lasted for over a month. The cough came and went for the next 2 months. Patient was then noted to cough whenever she ate peanuts. She developed a peanut allergy.
Age: 51.0
Sex: F
Vaccine: HEPA, MEN, TD, TYP
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Patient developed diarrhea, nausea and vomiting 3 days post vaccines.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Cold sweat, Dizziness, Mydriasis, Vomiting
Clinical narrative: Five minutes after patient received vaccine, she felt faint and vomited. Pupils were dilated, and she was cold and clammy.
Age: 0.2
Sex: F
Vaccine: DTAP, IPV
Symptoms: Urticaria
Clinical narrative: Patient developed hives over entire body.
Age: 29.0
Sex: F
Vaccine: TD
Symptoms: Headache, Injection site hypersensitivity, Injection site induration, Injection site warmth, Muscle spasms
Clinical narrative: Approximately 17 hours post immunization, the patient developed a large, hardened area where vaccine was administered. About 8 hours later, she felt nauseous. About 10 hours later, she developed a stiff neck, headache and temperature of 101 with chills. Her left arm developed spasms running down her arm which have lasted until the present. On 5/22 she developed a rash at and around the injection site which was warm to the touch.
Age: 29.0
Sex: F
Vaccine: TD
Symptoms: Musculoskeletal stiffness, Nausea, Pyrexia
Clinical narrative: Approximately 17 hours post immunization, the patient developed a large, hardened area where vaccine was administered. About 8 hours later, she felt nauseous. About 10 hours later, she developed a stiff neck, headache and temperature of 101 with chills. Her left arm developed spasms running down her arm which have lasted until the present. On 5/22 she developed a rash at and around the injection site which was warm to the touch.