chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Oral intake reduced, Ultrasound abdomen abnormal, Urinary system X-ray, Vomiting, X-ray abnormal
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 3 month old female who on 18-OCT-2007 was vaccinated orally with her second dose of ROTATEQ (Lot # reported as 657045/1053U). Suspect therapy given IM In the right leg included a second dose of HIB conj vaccine (Lot # reported as 654680/0072U). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (Sanofi Pasteur Lot # C2489AA), pneumococcal vaccine (unspecified) (Wyeth Lot #B08657F) and poliovirus vaccine (Sanofi Pasteur Lot # 202402). On 15-NOV-2007 the patient  experienced enema administration, haematochezia, intussusception, irritability, lethargy, oral intake reduced, ultrasound abdomen abnormal and vomiting and was hospitalized. Intussusception required reduction. Repeat intussusception needing second procedure. 21-DEC-2007 Reviewed vax record which confirms dose and lot #'s as reported. 28-DEC-2007 Reviewed hospital medical records which revealed patient experienced vomiting, bloody stool, reduced oral intake, irritability and lethargy. Admitted 16/17-NOV-2007. Enema successfully reduced IS. Admitted for overnight observation. Did well and was d/c to home. Readmitted 19/20-NOV-2007 for recurrence of vomiting and bloody stools. 2nd abdominal US (+)  for IS and was successfully reduced w/air contrast enema. Kept overnight for observation. Did well and d/c to home. FINAL DX: Recurrent ileocecal intussusception at hepatic flexure, enema reduced X2. Radiological LABS: KUB dilated loops of small bowel. Abdominal US (+) for IS X 2. Air enema reduction X 2. Enema administration, haematochezia, intussusception, irritability, lethargy, oral intake reduced, ultrasound abdomen abnormal and vomiting were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 300448. Lot check has been requested. Standard lot check investigations were performed. All in-process quality checks for the lot numbers in question were satisfactory. In addition, expanded lot check investigations were performed. The testing performed on the batches prior to release met all release specifications. The lots met the requirements and were released. No further information is available.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 4 month old female with a history of gastrooesophageal reflux who on 07-APR-2008 was vaccinated with the second of oral ROTATEQ (Lot # 659917/0117X). Concomitant therapy included the second dose of ACTHIB (SANOFI PASTEUR) (Lot # UF355AA), IM in the left leg, the second dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecific) (+) tetanus toxoid (SANOFI PASTEUR) (Lot # C2953AA), IM in the right leg, the second dose of IPOL (SANOFI PASTEUR) (Lot # A0805), IM in left leg, the second dose of PREVNAR (WYETH) (Lot # C49919), IM in the right leg and AXID. On 22-APR-2008 the patient experienced abdominal tenderness, barium double contrast, diarrhoea, haematochezia, laparoscopy, large intestinal obstruction reduction, rotavirus infection, intussusception, surgery and vomiting and was hospitalized. 06-Jun-2008 MR received for DOS 29-Apr-2008 to 30-Apr-2008 with a discharged diagnosis of intussusception (diagnosed on 28-Apr-2008) and Rotavirus. The patient presented to the local ER with a one week history of diarrhea and recent onset of vomiting as well as irritability and abdominal tenderness. The patient was transferred to current facility due to concern for IS. In the ER, the patient had a bloody stool. An abdominal X-ray was concerning for IS. A Barium Enema was positive for IS. Other labs included positive stool for Rotavirus antigen and a negative stool and urine culture. An abdominal ultrasound confirmed IS and the patient was taken for Air Contrast Barium Enema reduction which was only partially successful times two attempts. The patient was taken to the OR for laparoscopic reduction of IS. The patient was taking PO well post-op and was discharged the next day. Follow-up on 06-May-2008 reported that the patient is doing well with healed incision. Abdominal tenderness, barium double contrast, diarrhoea, haematochezia, intussusception, laparoscopy, large intestinal obstruction reduction, rotavirus infection, surgery and vomiting were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # 311216. A lot check has been requested. Lot check results: A standard lot check investigation was performed. All in-progress quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal X-ray, Abdominal tenderness, Barium double contrast abnormal, Barium enema abnormal, Culture stool negative
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 4 month old female with a history of gastrooesophageal reflux who on 07-APR-2008 was vaccinated with the second of oral ROTATEQ (Lot # 659917/0117X). Concomitant therapy included the second dose of ACTHIB (SANOFI PASTEUR) (Lot # UF355AA), IM in the left leg, the second dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecific) (+) tetanus toxoid (SANOFI PASTEUR) (Lot # C2953AA), IM in the right leg, the second dose of IPOL (SANOFI PASTEUR) (Lot # A0805), IM in left leg, the second dose of PREVNAR (WYETH) (Lot # C49919), IM in the right leg and AXID. On 22-APR-2008 the patient experienced abdominal tenderness, barium double contrast, diarrhoea, haematochezia, laparoscopy, large intestinal obstruction reduction, rotavirus infection, intussusception, surgery and vomiting and was hospitalized. 06-Jun-2008 MR received for DOS 29-Apr-2008 to 30-Apr-2008 with a discharged diagnosis of intussusception (diagnosed on 28-Apr-2008) and Rotavirus. The patient presented to the local ER with a one week history of diarrhea and recent onset of vomiting as well as irritability and abdominal tenderness. The patient was transferred to current facility due to concern for IS. In the ER, the patient had a bloody stool. An abdominal X-ray was concerning for IS. A Barium Enema was positive for IS. Other labs included positive stool for Rotavirus antigen and a negative stool and urine culture. An abdominal ultrasound confirmed IS and the patient was taken for Air Contrast Barium Enema reduction which was only partially successful times two attempts. The patient was taken to the OR for laparoscopic reduction of IS. The patient was taking PO well post-op and was discharged the next day. Follow-up on 06-May-2008 reported that the patient is doing well with healed incision. Abdominal tenderness, barium double contrast, diarrhoea, haematochezia, intussusception, laparoscopy, large intestinal obstruction reduction, rotavirus infection, surgery and vomiting were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # 311216. A lot check has been requested. Lot check results: A standard lot check investigation was performed. All in-progress quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Culture urine negative, Diarrhoea, Haematochezia, Intussusception, Irritability
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 4 month old female with a history of gastrooesophageal reflux who on 07-APR-2008 was vaccinated with the second of oral ROTATEQ (Lot # 659917/0117X). Concomitant therapy included the second dose of ACTHIB (SANOFI PASTEUR) (Lot # UF355AA), IM in the left leg, the second dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecific) (+) tetanus toxoid (SANOFI PASTEUR) (Lot # C2953AA), IM in the right leg, the second dose of IPOL (SANOFI PASTEUR) (Lot # A0805), IM in left leg, the second dose of PREVNAR (WYETH) (Lot # C49919), IM in the right leg and AXID. On 22-APR-2008 the patient experienced abdominal tenderness, barium double contrast, diarrhoea, haematochezia, laparoscopy, large intestinal obstruction reduction, rotavirus infection, intussusception, surgery and vomiting and was hospitalized. 06-Jun-2008 MR received for DOS 29-Apr-2008 to 30-Apr-2008 with a discharged diagnosis of intussusception (diagnosed on 28-Apr-2008) and Rotavirus. The patient presented to the local ER with a one week history of diarrhea and recent onset of vomiting as well as irritability and abdominal tenderness. The patient was transferred to current facility due to concern for IS. In the ER, the patient had a bloody stool. An abdominal X-ray was concerning for IS. A Barium Enema was positive for IS. Other labs included positive stool for Rotavirus antigen and a negative stool and urine culture. An abdominal ultrasound confirmed IS and the patient was taken for Air Contrast Barium Enema reduction which was only partially successful times two attempts. The patient was taken to the OR for laparoscopic reduction of IS. The patient was taking PO well post-op and was discharged the next day. Follow-up on 06-May-2008 reported that the patient is doing well with healed incision. Abdominal tenderness, barium double contrast, diarrhoea, haematochezia, intussusception, laparoscopy, large intestinal obstruction reduction, rotavirus infection, surgery and vomiting were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # 311216. A lot check has been requested. Lot check results: A standard lot check investigation was performed. All in-progress quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Laparoscopy, Large intestinal obstruction reduction, Rotavirus infection, Rotavirus test positive, Surgery
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 4 month old female with a history of gastrooesophageal reflux who on 07-APR-2008 was vaccinated with the second of oral ROTATEQ (Lot # 659917/0117X). Concomitant therapy included the second dose of ACTHIB (SANOFI PASTEUR) (Lot # UF355AA), IM in the left leg, the second dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecific) (+) tetanus toxoid (SANOFI PASTEUR) (Lot # C2953AA), IM in the right leg, the second dose of IPOL (SANOFI PASTEUR) (Lot # A0805), IM in left leg, the second dose of PREVNAR (WYETH) (Lot # C49919), IM in the right leg and AXID. On 22-APR-2008 the patient experienced abdominal tenderness, barium double contrast, diarrhoea, haematochezia, laparoscopy, large intestinal obstruction reduction, rotavirus infection, intussusception, surgery and vomiting and was hospitalized. 06-Jun-2008 MR received for DOS 29-Apr-2008 to 30-Apr-2008 with a discharged diagnosis of intussusception (diagnosed on 28-Apr-2008) and Rotavirus. The patient presented to the local ER with a one week history of diarrhea and recent onset of vomiting as well as irritability and abdominal tenderness. The patient was transferred to current facility due to concern for IS. In the ER, the patient had a bloody stool. An abdominal X-ray was concerning for IS. A Barium Enema was positive for IS. Other labs included positive stool for Rotavirus antigen and a negative stool and urine culture. An abdominal ultrasound confirmed IS and the patient was taken for Air Contrast Barium Enema reduction which was only partially successful times two attempts. The patient was taken to the OR for laparoscopic reduction of IS. The patient was taking PO well post-op and was discharged the next day. Follow-up on 06-May-2008 reported that the patient is doing well with healed incision. Abdominal tenderness, barium double contrast, diarrhoea, haematochezia, intussusception, laparoscopy, large intestinal obstruction reduction, rotavirus infection, surgery and vomiting were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # 311216. A lot check has been requested. Lot check results: A standard lot check investigation was performed. All in-progress quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 4 month old female with a history of gastrooesophageal reflux who on 07-APR-2008 was vaccinated with the second of oral ROTATEQ (Lot # 659917/0117X). Concomitant therapy included the second dose of ACTHIB (SANOFI PASTEUR) (Lot # UF355AA), IM in the left leg, the second dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecific) (+) tetanus toxoid (SANOFI PASTEUR) (Lot # C2953AA), IM in the right leg, the second dose of IPOL (SANOFI PASTEUR) (Lot # A0805), IM in left leg, the second dose of PREVNAR (WYETH) (Lot # C49919), IM in the right leg and AXID. On 22-APR-2008 the patient experienced abdominal tenderness, barium double contrast, diarrhoea, haematochezia, laparoscopy, large intestinal obstruction reduction, rotavirus infection, intussusception, surgery and vomiting and was hospitalized. 06-Jun-2008 MR received for DOS 29-Apr-2008 to 30-Apr-2008 with a discharged diagnosis of intussusception (diagnosed on 28-Apr-2008) and Rotavirus. The patient presented to the local ER with a one week history of diarrhea and recent onset of vomiting as well as irritability and abdominal tenderness. The patient was transferred to current facility due to concern for IS. In the ER, the patient had a bloody stool. An abdominal X-ray was concerning for IS. A Barium Enema was positive for IS. Other labs included positive stool for Rotavirus antigen and a negative stool and urine culture. An abdominal ultrasound confirmed IS and the patient was taken for Air Contrast Barium Enema reduction which was only partially successful times two attempts. The patient was taken to the OR for laparoscopic reduction of IS. The patient was taking PO well post-op and was discharged the next day. Follow-up on 06-May-2008 reported that the patient is doing well with healed incision. Abdominal tenderness, barium double contrast, diarrhoea, haematochezia, intussusception, laparoscopy, large intestinal obstruction reduction, rotavirus infection, surgery and vomiting were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # 311216. A lot check has been requested. Lot check results: A standard lot check investigation was performed. All in-progress quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Activities of daily living impaired, Hypotonia, Pallor, Pyrexia, Sleep disorder
Clinical narrative: "none"
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Staring
Clinical narrative: "none"
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Unevaluable event
Clinical narrative: "none"
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthropathy, Renal disorder, Systemic lupus erythematosus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under an act.  On 14-AUG-2007 as 12 year old female was vaccinated with her first dose of GARDASIL.  On 05-DEC-2007 she was vaccinated with her second dose of GARDASIL (lot # 658556/1060U) IM into the right arm.  Near Christmas 2007 patient developed joint symptoms first.  Then after several months (March 2008) she developed a serious kidney problems and was diagnosed with lupus erythematosus.  She was undergoing intermittent chemo treatment with a Pediatric Rheumatologist.  It was reported that the patient's Pediatric Rheumatologist.  It was reported that the patient's experience was considered to be immediately life-threatening.  The VAERS ID # is 318484.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the center and was released.  No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthropathy, Chemotherapy, Renal disorder, Systemic lupus erythematosus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under an act.  On 14-AUG-2007 as 12 year old female was vaccinated with her first dose of GARDASIL.  On 05-DEC-2007 she was vaccinated with her second dose of GARDASIL (lot # 658556/1060U) IM into the right arm.  Near Christmas 2007 patient developed joint symptoms first.  Then after several months (March 2008) she developed a serious kidney problems and was diagnosed with lupus erythematosus.  She was undergoing intermittent chemo treatment with a Pediatric Rheumatologist.  It was reported that the patient's Pediatric Rheumatologist.  It was reported that the patient's experience was considered to be immediately life-threatening.  The VAERS ID # is 318484.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the center and was released.  No further information is available.
Age: 70.0
Sex: F
Vaccine: PPV, TTOX, PPV, PPV, TD
Symptoms: Autopsy, Death
Clinical narrative: This case was received from a health professional on 05 August 2008.  A 71-year-old female patient, with no reported medical conditions or concomitant medications, received the following vaccinations on 21 July 2008: an intramuscular left arm injection of DECAVAC (lot number U2120BA), and an intramuscular right arm injection of PNEUMOVAX (Merck, lot number 0860U).  According to the reporter, the patient passed away within 24 hours of vaccination.  The adverse event was unknown; an autopsy was scheduled for 24 July 2008. No additional information was provided.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Ejection fraction decreased, Fatigue, Malaise, Nausea, Pyrexia
Clinical narrative: CG Member was immunized for smallpox on 25 July, 2008 with 15 jabs into left arm (ACAM2000  Small pox (Vaccinia) Vaccine, Live Acambis Inc., lot#: VV04-003-A Exp:31Dec09).  "Take" was recorded one week later on 01 August, 2008. A few days later on 05 August the patient presented with a pink maculopapular rash on the trunk, redness, pain and swelling around the vaccination site, fever, chills, and body aches.  He also stated he started having chest pain (6/10) and shortness of breath the night before and has been getting worse throughout the day.  Vitals were 115/70, T 101.1, RR 16, HR 87. An ECG revealed diffuse ST segment elevation.  His heart sounds were normal and no rub was appreciated.  Pericarditis was presumatively diagnosed and he was sent to the local ER.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Vaccinia, Vomiting
Clinical narrative: CG Member was immunized for smallpox on 25 July, 2008 with 15 jabs into left arm (ACAM2000  Small pox (Vaccinia) Vaccine, Live Acambis Inc., lot#: VV04-003-A Exp:31Dec09).  "Take" was recorded one week later on 01 August, 2008. A few days later on 05 August the patient presented with a pink maculopapular rash on the trunk, redness, pain and swelling around the vaccination site, fever, chills, and body aches.  He also stated he started having chest pain (6/10) and shortness of breath the night before and has been getting worse throughout the day.  Vitals were 115/70, T 101.1, RR 16, HR 87. An ECG revealed diffuse ST segment elevation.  His heart sounds were normal and no rub was appreciated.  Pericarditis was presumatively diagnosed and he was sent to the local ER.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Angiogram normal, Blood pressure, Body temperature increased, Cardiac enzymes increased, Chest pain
Clinical narrative: CG Member was immunized for smallpox on 25 July, 2008 with 15 jabs into left arm (ACAM2000  Small pox (Vaccinia) Vaccine, Live Acambis Inc., lot#: VV04-003-A Exp:31Dec09).  "Take" was recorded one week later on 01 August, 2008. A few days later on 05 August the patient presented with a pink maculopapular rash on the trunk, redness, pain and swelling around the vaccination site, fever, chills, and body aches.  He also stated he started having chest pain (6/10) and shortness of breath the night before and has been getting worse throughout the day.  Vitals were 115/70, T 101.1, RR 16, HR 87. An ECG revealed diffuse ST segment elevation.  His heart sounds were normal and no rub was appreciated.  Pericarditis was presumatively diagnosed and he was sent to the local ER.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chills, Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram ST segment elevation
Clinical narrative: CG Member was immunized for smallpox on 25 July, 2008 with 15 jabs into left arm (ACAM2000  Small pox (Vaccinia) Vaccine, Live Acambis Inc., lot#: VV04-003-A Exp:31Dec09).  "Take" was recorded one week later on 01 August, 2008. A few days later on 05 August the patient presented with a pink maculopapular rash on the trunk, redness, pain and swelling around the vaccination site, fever, chills, and body aches.  He also stated he started having chest pain (6/10) and shortness of breath the night before and has been getting worse throughout the day.  Vitals were 115/70, T 101.1, RR 16, HR 87. An ECG revealed diffuse ST segment elevation.  His heart sounds were normal and no rub was appreciated.  Pericarditis was presumatively diagnosed and he was sent to the local ER.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Electrocardiogram abnormal, Heart rate normal, Hypokinesia, Injection site erythema, Injection site pain
Clinical narrative: CG Member was immunized for smallpox on 25 July, 2008 with 15 jabs into left arm (ACAM2000  Small pox (Vaccinia) Vaccine, Live Acambis Inc., lot#: VV04-003-A Exp:31Dec09).  "Take" was recorded one week later on 01 August, 2008. A few days later on 05 August the patient presented with a pink maculopapular rash on the trunk, redness, pain and swelling around the vaccination site, fever, chills, and body aches.  He also stated he started having chest pain (6/10) and shortness of breath the night before and has been getting worse throughout the day.  Vitals were 115/70, T 101.1, RR 16, HR 87. An ECG revealed diffuse ST segment elevation.  His heart sounds were normal and no rub was appreciated.  Pericarditis was presumatively diagnosed and he was sent to the local ER.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Injection site swelling, Pain, Pericarditis, Pyrexia, Rash erythematous
Clinical narrative: CG Member was immunized for smallpox on 25 July, 2008 with 15 jabs into left arm (ACAM2000  Small pox (Vaccinia) Vaccine, Live Acambis Inc., lot#: VV04-003-A Exp:31Dec09).  "Take" was recorded one week later on 01 August, 2008. A few days later on 05 August the patient presented with a pink maculopapular rash on the trunk, redness, pain and swelling around the vaccination site, fever, chills, and body aches.  He also stated he started having chest pain (6/10) and shortness of breath the night before and has been getting worse throughout the day.  Vitals were 115/70, T 101.1, RR 16, HR 87. An ECG revealed diffuse ST segment elevation.  His heart sounds were normal and no rub was appreciated.  Pericarditis was presumatively diagnosed and he was sent to the local ER.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Rash maculo-papular, Respiratory rate, Scan
Clinical narrative: CG Member was immunized for smallpox on 25 July, 2008 with 15 jabs into left arm (ACAM2000  Small pox (Vaccinia) Vaccine, Live Acambis Inc., lot#: VV04-003-A Exp:31Dec09).  "Take" was recorded one week later on 01 August, 2008. A few days later on 05 August the patient presented with a pink maculopapular rash on the trunk, redness, pain and swelling around the vaccination site, fever, chills, and body aches.  He also stated he started having chest pain (6/10) and shortness of breath the night before and has been getting worse throughout the day.  Vitals were 115/70, T 101.1, RR 16, HR 87. An ECG revealed diffuse ST segment elevation.  His heart sounds were normal and no rub was appreciated.  Pericarditis was presumatively diagnosed and he was sent to the local ER.
Age: 0.83
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Redness, swelling and tenderness at injection site also swelling of leg at the level of the knee.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dyskinesia, Dyspnoea, Muscular weakness
Clinical narrative: Initial report received from a health care professional on 29 July 2008.  A 17-year-old female patient had received a dose of MENACTRA (lot number and route/site of administration not reported) on 27 June 2008.  Approximately one month post-vaccination, the patient experienced weakness-paralysis-like symptoms from the knee down and was also having difficulty in trying to inhale deeply.  The patient also reported that her toes were "jumping".  The reporter indicated a concern about Guillain-Barre Syndrome.  The patient underwent evaluation (not specified).  Evaluation findings and patient outcome was not reported.  No additional details were provided.
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a R.N. concerning a male who was vaccinated with MMR II (Lot # 648479/0635P). It was reported that the patient was diagnosed with autism. No product quality complaint. Upon internal review, autism was determined to be an other important medical event. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram abnormal, Dyspnoea, Local swelling, Rash erythematous, Salivary gland enlargement
Clinical narrative: Information has been received from a physician concerning a 26 year old female who on 31-JUL-2008 was vaccinated with the third 0.5 ml dose of GARDASIL. On 31-JUL-2008 the patient began to develop swelling of her face and her neck. The swelling caused the patient have difficulty with both breathing and talking. The patient also developed a red rash on her face and neck. The patient sought was hospitalized on 02-AUG-2008. A computed axial tomography (CT) scan showed enlarged salivary glands. Medical attention was sought via office visit. The patient had been treated with clindamycin and corticosteroids. After starting the clindamycin, the patient developed a rash on her chest. The patient was noted to be recovering. No product quality complaint was involved. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Speech disorder, Swelling face
Clinical narrative: Information has been received from a physician concerning a 26 year old female who on 31-JUL-2008 was vaccinated with the third 0.5 ml dose of GARDASIL. On 31-JUL-2008 the patient began to develop swelling of her face and her neck. The swelling caused the patient have difficulty with both breathing and talking. The patient also developed a red rash on her face and neck. The patient sought was hospitalized on 02-AUG-2008. A computed axial tomography (CT) scan showed enlarged salivary glands. Medical attention was sought via office visit. The patient had been treated with clindamycin and corticosteroids. After starting the clindamycin, the patient developed a rash on her chest. The patient was noted to be recovering. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: "Tingling/numbness" (B) legs. Mostly in pinkie toe.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Autopsy
Clinical narrative: Unexpected death at 4 1/2 months age (current coroner's case Medical Examiner's Office).  9/26 Autopsy report states COD as undetermined in infant w/cocaine in bloodstream.  Manner of death is undetermined.  Report also states: metabolic screening (-); cardiomegaly; hepato/splenomegaly.  Patient placed on back & found face down in adult size bed.  Born precipitously at home & admitted to hospital 16 days prior to death.  Mother tested (+) for cocaine during pregnancy & hair testing of infant at birth (+) for cocaine.  Dx w/Influeza A 5/08 & right OM  7/08.  Tox screen at autopsy (+) for cocaine.  Was not breast fed.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium double contrast
Clinical narrative: Ileocecal intussusception.  8/18/2008 MR received for DOS 08/1-2/2008 with D/C DX:  Acute Ileocolic Intussusception, s/p air contrast enema reduction. Pt presented to ER following an episode of bright red blood per rectum as well as alternating fussiness and lethargy. Air contrast enema dx and reduced the IS. Pt had a couple mucusy stool post-procedure but otherwise did well with progressive po.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Activated partial thromboplastin time, Antinuclear antibody, Echocardiogram, Full blood count, Headache
Clinical narrative: Patient developed left optic nerve neuritis June 29, 2008. Also, chronic headache. 8/12/08-records received  for DOS 7/3-7/8/08-DC DX: Optic neuritis versus pseudotumor. Presented to ED with 3 week history of blurred vision of left eye and headache. One week prior patient saw eye doctor who noted swelling of optic nerve unilaterally and referred for MRI which was normal.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Lumbar puncture, Neurological examination, Ophthalmological examination, Optic neuritis, Prothrombin time
Clinical narrative: Patient developed left optic nerve neuritis June 29, 2008. Also, chronic headache. 8/12/08-records received  for DOS 7/3-7/8/08-DC DX: Optic neuritis versus pseudotumor. Presented to ED with 3 week history of blurred vision of left eye and headache. One week prior patient saw eye doctor who noted swelling of optic nerve unilaterally and referred for MRI which was normal.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rheumatoid factor
Clinical narrative: Patient developed left optic nerve neuritis June 29, 2008. Also, chronic headache. 8/12/08-records received  for DOS 7/3-7/8/08-DC DX: Optic neuritis versus pseudotumor. Presented to ED with 3 week history of blurred vision of left eye and headache. One week prior patient saw eye doctor who noted swelling of optic nerve unilaterally and referred for MRI which was normal.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Within 5 to 10 minutes after administering MMR, left upper deltoid became warm to touch, with erythema.  BENADRYL 50mg P.O. given.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia, Screaming
Clinical narrative: Mom called on 7/31/ to report that patient had high pitched screaming and fever following vaccines yesterday- child seems fine today per mom
Age: 68.0
Sex: F
Vaccine: MMR, TD
Symptoms: Arthralgia
Clinical narrative: Patient developed severe joint pain approximately 2 weeks after vaccines & was placed on a weaning dose of prednisone by her PCP.  She is on a 10mg dose of prednisone today & joint pain has returned.
Age: 0.16
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Erythema, Oedema peripheral, Skin warm, Tenderness
Clinical narrative: (R) thigh red and swollen sl hot to the touch and tender
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site induration
Clinical narrative: 8 x 11 cm of induration in area of injection.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Dizziness, Immediate post-injection reaction
Clinical narrative: Patient given vaccine at approximately 1130AM. Patient reported dizziness immediately following injection and was assisted to supine position. Patient then had witnessed seizure at approximately 1138 AM lasting approximately 30sec; No complaint of hypoxia during event. Patient recovered and was sent by ambulance to ER.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Pruritus, Rash
Clinical narrative: Patient called with c/o skin rash on forearms several days after his receipt of SPV and AVA #2.  8/8/08 Autoinnoculation (active)  Symptoms: Rash, focal, Pruritus
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Child ran a low grade fever for 2 days after immunizations. On 8/1/08. She broke out in a rash. Pink raised bumps all over her body, face, arms, legs and back. At the time of the call, she was not itching, had no fever and was acting fine.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Antinuclear antibody, Blood thyroid stimulating hormone, C-reactive protein, Full blood count, Metabolic function test
Clinical narrative: 6/26/08 - patient complained itching immediately after MMR given patient seen by MD. no findings compatible with reactions; 7/22/08 - patient returned to clinic with complained of muscle aches and pains since 7/2/08 - diagnosed with probable serum sickness
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Myalgia, Pruritus, Serum sickness
Clinical narrative: 6/26/08 - patient complained itching immediately after MMR given patient seen by MD. no findings compatible with reactions; 7/22/08 - patient returned to clinic with complained of muscle aches and pains since 7/2/08 - diagnosed with probable serum sickness
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Blood pressure decreased, Pallor
Clinical narrative: Patient became pale, did not black out. Put patient on floor elevated leg/feet. BP checked initial 92/62, after 5 min 102/68, after 10 min 104/72
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus
Clinical narrative: Around 5 min. after vaccination patient's arm was red and itching around 3in x 3in size.  Applied cold compress then ice pack.  Stayed in waiting room for 15 min. and then advised to give BENADRYL & TYLENOL and call Dr.  Mom phoned back 30 min later had given BENADRYL & ibuprofen.  Stated itching was getting better.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema
Clinical narrative: Localized erythema - Ice pack
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Father reported adverse reaction - Brought child to clinic - Round, red, raised 2"x2" area on lower right thigh; Area slightly warm to touch. This is at MMR injection site. - Father gave child Tylenol per dosing instructions on label
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Contusion, Inappropriate schedule of drug administration, Induration, Injection site haemorrhage, Localised oedema
Clinical narrative: 8/1/08 90 mm diameter area of induration and edema, very tender. Central 10 min area of bruising (bled after the shot). Warm to touch but not erythematous.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Skin warm, Tenderness
Clinical narrative: 8/1/08 90 mm diameter area of induration and edema, very tender. Central 10 min area of bruising (bled after the shot). Warm to touch but not erythematous.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Dysphonia, Pharyngolaryngeal pain, Pulmonary congestion, Pyrexia
Clinical narrative: (1) Heavy legs - (3) Horseness, (2) Sore Throat, (4) Congested chest, (5) Cough, (6) Sinus congestion - All within 24 hrs - Lasted for 3 weeks - congestion like pneumonia - Took Musilex - Fever at onset
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Sensation of heaviness, Sinus congestion
Clinical narrative: (1) Heavy legs - (3) Horseness, (2) Sore Throat, (4) Congested chest, (5) Cough, (6) Sinus congestion - All within 24 hrs - Lasted for 3 weeks - congestion like pneumonia - Took Musilex - Fever at onset
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Dizziness, Pallor
Clinical narrative: 7-31-08 at 1146. Patient fainted leaving office; lasting few seconds, pale, dizzy. States didn't eat breakfast.  Alert, awake, answering questions apppopriately. WNL vital signs.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site irritation, Injection site pruritus, Injection site swelling
Clinical narrative: 8/4/08 Telephone call from patient reports she received vaccine 7/31/08.  8/1/08 & 8/2/08 swelling to L upper arm with redness.  She also reports injection site felt "hard".  She also reports itching, burning at injection site.  Patient reports improvement of symptoms 8/4/08.
Age: 17.0
Sex: M
Vaccine: TD
Symptoms: Abasia, Asthenia, Dizziness, Full blood count normal, Nausea
Clinical narrative: 8/4 generalized weakness, dizziness, nausea and inability to walk. Tetanus administered at provider - no local RX at left deltoid. Admitted to hospital. 9/5/08-records received for DOS 8/4/08-DC DX: Generalized weakness. Possible Guillain-Barre syndrome vs viral syndrome. Hypoxemia probably secondary to Guillain-Barre syndrome. Cellulitis of left foot. Stepped on a nail 2 days prior to admission, received tetanus toxoid in ED. Returned on 8/4/08 with C/O tingling of lower extremities became generalized to involve the entire body, weakness, dizzy, unable to walk, difficulty talking.Transferred to another facility.  9/10/08-records received for DOS 8/4/08-liver profile normal. Taking Keflex. C/O occasional dyspnea, dizziness and headache. PE:normal. Impression:Paresthesias and numbness in lower extremities and upper extremities and some generalized weakness that is completely resolved now. Normal neurological exam. Results of interaction between tetanus and Keflex side effects. Discharged home.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Pts arm became red, warm, and quite swollen
Age: 41.0
Sex: M
Vaccine: ANTH, MNQ, TYP
Symptoms: Bacterial culture, Blood test normal, Body temperature increased, Diarrhoea, Malaise
Clinical narrative: PT received a Typhoid vaccination Monday 4 August 2008 at 0900. Roughly 5 hours later PT began to feel ill and started to have diarrhea and vomiting symptoms with a temperature of 101 about 5 hours after the vaccination. By Wednesday 6 Aug 2008 PT temperature increased to 104. PT went to Hospital in at 1800 the same day 6 AUG 2008 to address the temperature and nausea symptoms. PT received IV therapy and was given pain and nausea medication. PT c/o severe weight loss approx. 10 lbs. PT was discharged from the ER at 2330. PT reports major symptom relief beginning Thrusday 7 Aug 2008.
Age: 41.0
Sex: M
Vaccine: ANTH, MNQ, TYP
Symptoms: Nausea, Urine analysis normal, Vomiting, Weight decreased
Clinical narrative: PT received a Typhoid vaccination Monday 4 August 2008 at 0900. Roughly 5 hours later PT began to feel ill and started to have diarrhea and vomiting symptoms with a temperature of 101 about 5 hours after the vaccination. By Wednesday 6 Aug 2008 PT temperature increased to 104. PT went to Hospital in at 1800 the same day 6 AUG 2008 to address the temperature and nausea symptoms. PT received IV therapy and was given pain and nausea medication. PT c/o severe weight loss approx. 10 lbs. PT was discharged from the ER at 2330. PT reports major symptom relief beginning Thrusday 7 Aug 2008.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Cellulitis, Erythema, Induration, Skin warm
Clinical narrative: VARICELLA GIVEN SQ IN LEFT UPPER ARM 2 DAYS AGO (8/6/08. PRESENTS TODAY WITH 35MMX 55MM RED CIRCLE AND 25MMX35MM INDURATION WITHIN THE CIRCLE. DENIES ITCHING OR SCRATCHING. + WARMTH TO TOUCH. ANTIBIOTIC GIVEN BY PROVIDER FOR CELLULITIS.  KEFLEX 500MG TID X 10 DAYS
Age: 1.0
Sex: M
Vaccine: HEP, MMR, PNC
Symptoms: Blood product transfusion, Contusion, Epistaxis, Full blood count, Petechiae
Clinical narrative: Excessive bruising, nosebleeds, petechia. Platelet Count 11,000 upon entering hospital. After 2 rounds of IVIG, platelet count 4000 - 6000. Oral prednisone therapy started after discharge home. Count rebounded to 28,000 after 14 days of prednisone. Returned to low normal range (150,000) in Feb. of 2008, 12 months after onset.  8/15/08 Reviewed PCP medical records of 1/2007-1/2008. FINAL DX: none provided Records reveal patient adoped from out of country at 8.5 mo.  Patient was in good health on 1/18/07 day of vaccination.  Returned to PCP on 2/24/07 for bruises, nosebleeds & bleeding gums intermittently x 1 week.  At that time, reported cold s/s x 1 mo of congestion & wet cough.  Admitted to hospital based on labs.  Returned to PCP s/p hospitalization 2/27/07.  8/26/08 Reviewed hospital medical records of 2/24-2/26/2007. FINAL DX: idiopathic thrombocytopenic purpura Records reveal patient experienced bruising x 1 week and bleeding, nosebleed & bleeding gums x 1 day.  Had been seen in PCP office on day of admit & noted to have petechiae on cheeks.  Peds hematology consult done.  Tx w/IVIG.  D/C to home to f/u w/PCP next day for serial labs.
Age: 1.0
Sex: M
Vaccine: HEP, MMR, PNC
Symptoms: Platelet count decreased
Clinical narrative: Excessive bruising, nosebleeds, petechia. Platelet Count 11,000 upon entering hospital. After 2 rounds of IVIG, platelet count 4000 - 6000. Oral prednisone therapy started after discharge home. Count rebounded to 28,000 after 14 days of prednisone. Returned to low normal range (150,000) in Feb. of 2008, 12 months after onset.  8/15/08 Reviewed PCP medical records of 1/2007-1/2008. FINAL DX: none provided Records reveal patient adoped from out of country at 8.5 mo.  Patient was in good health on 1/18/07 day of vaccination.  Returned to PCP on 2/24/07 for bruises, nosebleeds & bleeding gums intermittently x 1 week.  At that time, reported cold s/s x 1 mo of congestion & wet cough.  Admitted to hospital based on labs.  Returned to PCP s/p hospitalization 2/27/07.  8/26/08 Reviewed hospital medical records of 2/24-2/26/2007. FINAL DX: idiopathic thrombocytopenic purpura Records reveal patient experienced bruising x 1 week and bleeding, nosebleed & bleeding gums x 1 day.  Had been seen in PCP office on day of admit & noted to have petechiae on cheeks.  Peds hematology consult done.  Tx w/IVIG.  D/C to home to f/u w/PCP next day for serial labs.
Age: 29.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Abdominal pain upper, Back pain, Blood test, Headache, Nephrolithiasis
Clinical narrative: Received #2 dose of Adult Hepatitis A and Adult Hepatitis B vaccine on afternoon of 6-03-08, approx. a day and a half after the shots, started with severe back pain, stomach pain, headache, had fever .  Problems persisted for 2 weeks.  Took tylenol and Ibuprofin.  Saw MD 5-7 days after the shot.  Diagnosis was Kidney Stones, client reports feeling shots brought on Kidney stones requests vaers be reported.
Age: 29.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: Received #2 dose of Adult Hepatitis A and Adult Hepatitis B vaccine on afternoon of 6-03-08, approx. a day and a half after the shots, started with severe back pain, stomach pain, headache, had fever .  Problems persisted for 2 weeks.  Took tylenol and Ibuprofin.  Saw MD 5-7 days after the shot.  Diagnosis was Kidney Stones, client reports feeling shots brought on Kidney stones requests vaers be reported.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: The Order written by the RN was written for DTAP when it should have been written for TDAP. After vaccine was given, TDAP order was written ( but it was after the fact )
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Grand mal convulsion, Loss of consciousness, Tonic clonic movements
Clinical narrative: Patient had a grand mal seizure 2 mos. after receiving the Gardasil shot received at Dr's Office.  The seizure last a full 5 minutes with tonic clonic episode and unconsciousness.  The episode happened at the high school and taken to Hospital on June 6, 2008.  8/11/2008 MR received for ER visit 06/06/2008 with DX: Closed head injury, loss of consciousness <1 hour.  Seizure, generalized. Pt presented to ER after witnessed tonic-clonic seizure at school. (+) vomiting. PE WNL except 2 cm L forehead contusion. D/c to f/u as out pt.  5/22/09 Medical records (neurology consult) received DOS 6/6/08 to 6/12/08. FINAL DIAGNOSIS: Single major convulsive seizure without aura. Presented with major convulsive seizure, tenderness over left eyebrow, bit  tongue - small hemorrhagic area.
Age: 64.0
Sex: M
Vaccine: HEPA, IPV, TYP
Symptoms: Diplopia, Guillain-Barre syndrome, Immunology test, Laboratory test abnormal, Miller Fisher syndrome
Clinical narrative: Within 1 week patient developed Miller Fisher Variant of Guillain-Barre Syndrome. On April 28 patient developed diplopia and significant weakening of body muscles. Became much worse by May 2. Worsening probably due to corticosteroids administered to reduce pain. On April 28 patient had 80 mg near nerve C6 in morning, 80 mg in left shoulder at 4 pm. Diplopia developed over the next hour.
Age: 64.0
Sex: M
Vaccine: HEPA, IPV, TYP
Symptoms: Muscular weakness
Clinical narrative: Within 1 week patient developed Miller Fisher Variant of Guillain-Barre Syndrome. On April 28 patient developed diplopia and significant weakening of body muscles. Became much worse by May 2. Worsening probably due to corticosteroids administered to reduce pain. On April 28 patient had 80 mg near nerve C6 in morning, 80 mg in left shoulder at 4 pm. Diplopia developed over the next hour.
Age: 59.0
Sex: F
Vaccine: HEPAB, TD
Symptoms: Diarrhoea, Hyperhidrosis, Local reaction, Nausea, Swelling
Clinical narrative: localized swelling 12 hours after vaccine.  had diarrhea, sweating, nausea ("lasted 15 minutes").  Client reports these S & S and also stated her MD recommended Benadryl po before and after Twinrix.  (Client called MD.)  Vaccine not given today (8/5/08); client referred back to PMD.
Age: 0.33
Sex: M
Vaccine: DPP, HBHEPB, HEP, IPV, PPV, RVX
Symptoms: Cough, Diarrhoea, Dyskinesia, Faeces discoloured, Laboratory test normal
Clinical narrative: fever diarrhea now dark forest green a week later also sometimes just mucus in pamper only shaking head back and forth he is wheezing coughing constant
Age: 0.33
Sex: M
Vaccine: DPP, HBHEPB, HEP, IPV, PPV, RVX
Symptoms: Pyrexia, Wheezing
Clinical narrative: fever diarrhea now dark forest green a week later also sometimes just mucus in pamper only shaking head back and forth he is wheezing coughing constant