chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Intussusception, Lethargy, Mucous stools, Neutrophil count increased, Platelet count increased
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 5 month old female who on 14-MAR-2008 was po vaccinated with the third dose of ROTATEQ lot # reported as 659775/1664U.  Concomitant therapy included the third IM dose of PREVNAR (lot # reported as C45894) in the right leg and the third IM dose of PEDIARIX (lot # reported as AC21B141AA) in the left leg.  On 23-MAR-2008 records revealed a patient experienced abdominal pain, vomiting, lethargy and blood mucoid stools times one day.  Seen in outlying ER where abdominal x-ray suspicious for intussusception and transferred to a higher level of care.  An air contrast barium enema was unsuccessful at reducing the intussusception.  On 24-MAR-2008 (10 days after receiving ROTATEQ) patient was taken to the OR for exploratory laparotomy which was difficult to reduce.  Patient had to have ileal cecectomy (removed 3 inches of colon) with primary anastomosis.  Recovered well post operatively and discharged to home.  Intussusception, abdominal pain, haematochezia, intestinal ischaemia, lethargy, mucous stools and vomiting were considered to be life threatening.  The original reporting source was not provided.  The VAERS ID # is 311011.  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: 0.42
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Vomiting, White blood cell count increased, X-ray abnormal
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 5 month old female who on 14-MAR-2008 was po vaccinated with the third dose of ROTATEQ lot # reported as 659775/1664U.  Concomitant therapy included the third IM dose of PREVNAR (lot # reported as C45894) in the right leg and the third IM dose of PEDIARIX (lot # reported as AC21B141AA) in the left leg.  On 23-MAR-2008 records revealed a patient experienced abdominal pain, vomiting, lethargy and blood mucoid stools times one day.  Seen in outlying ER where abdominal x-ray suspicious for intussusception and transferred to a higher level of care.  An air contrast barium enema was unsuccessful at reducing the intussusception.  On 24-MAR-2008 (10 days after receiving ROTATEQ) patient was taken to the OR for exploratory laparotomy which was difficult to reduce.  Patient had to have ileal cecectomy (removed 3 inches of colon) with primary anastomosis.  Recovered well post operatively and discharged to home.  Intussusception, abdominal pain, haematochezia, intestinal ischaemia, lethargy, mucous stools and vomiting were considered to be life threatening.  The original reporting source was not provided.  The VAERS ID # is 311011.  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: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 5 month old male who on 11-APR-2008 was vaccinated with the third dose of ROTATEQ (Lot # 660374/0275X).  Concomitant therapy included the third dose of PREVNAR (WYETH) (C57539), IM, the third dose of PEDIARIX (GSK) (AC21B024AA), IM and the third dose of ACTHIB (SANOFI PASTEUR) (UF233AA), IM.  On 18-APR-2008 the patient was diagnosed with intussusception and required surgical reduction and was hospitalized.  Intussusception and surgery were considered to be immediately life-threatening.  A lot check has been requested.  The original reporting source was not provided.  The VAERS ID # is 311702.  Lot check results: 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: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Large intestinal obstruction reduction, Surgery
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 5 month old male who on 11-APR-2008 was vaccinated with the third dose of ROTATEQ (Lot # 660374/0275X).  Concomitant therapy included the third dose of PREVNAR (WYETH) (C57539), IM, the third dose of PEDIARIX (GSK) (AC21B024AA), IM and the third dose of ACTHIB (SANOFI PASTEUR) (UF233AA), IM.  On 18-APR-2008 the patient was diagnosed with intussusception and required surgical reduction and was hospitalized.  Intussusception and surgery were considered to be immediately life-threatening.  A lot check has been requested.  The original reporting source was not provided.  The VAERS ID # is 311702.  Lot check results: 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: 0.25
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Appendicectomy, Intussusception, Surgery, Vomiting
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 3 month old male who on 11-MAR-2008 was vaccinated with ROTATEQ, oral, (Lot # 656838/0968U).  Concomitant therapy included ACTHIB, ("HIBV") (Sanofi Pasteur), IM - right leg, (Lot # UF355AA); DAPTACEL ("DTAP") (Sanofi Pasteur), IM - left leg, (Lot # C2935AA); (IPOL), ("IPV") (Sanofi Pasteur), IM - left leg, (Lot # A0170-2); and (PREVNAR), ("PNC") (Wyeth), IM - right leg, (Lot # B47442H).  On 04-APR-2008, the patient experienced appendicectomy, gastroenteritis, intussusception, surgery and vomiting.  The events were considered to be immediately life-threatening and prolonged hospitalization.  On 04-APR-2008, the patient experienced vomiting with every feed and was initially diagnosed with gastroenteritis.  The patient went to the Emergency Department on 04-APR-2008 and 06-APR-2008, and to an office on 07-APR-2008.  The patient was diagnosed with intussusception on 08-APR-2008.  The intussusception was unable to be reduced by radiology and required surgery.  The patient had surgery for intussusception on 08-APR-2008 and an appendectomy.  Reporting source not provided.  VAERS ID # is 312127.  A lot check has been requested.  Lot check results: 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 available.
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Appendicectomy, Gastroenteritis, Intussusception, Surgery, Vomiting
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 3 month old male who on 11-MAR-2008 was vaccinated with ROTATEQ, oral, (Lot # 656838/0968U).  Concomitant therapy included ACTHIB, ("HIBV") (Sanofi Pasteur), IM - right leg, (Lot # UF355AA); DAPTACEL ("DTAP") (Sanofi Pasteur), IM - left leg, (Lot # C2935AA); (IPOL), ("IPV") (Sanofi Pasteur), IM - left leg, (Lot # A0170-2); and (PREVNAR), ("PNC") (Wyeth), IM - right leg, (Lot # B47442H).  On 04-APR-2008, the patient experienced appendicectomy, gastroenteritis, intussusception, surgery and vomiting.  The events were considered to be immediately life-threatening and prolonged hospitalization.  On 04-APR-2008, the patient experienced vomiting with every feed and was initially diagnosed with gastroenteritis.  The patient went to the Emergency Department on 04-APR-2008 and 06-APR-2008, and to an office on 07-APR-2008.  The patient was diagnosed with intussusception on 08-APR-2008.  The intussusception was unable to be reduced by radiology and required surgery.  The patient had surgery for intussusception on 08-APR-2008 and an appendectomy.  Reporting source not provided.  VAERS ID # is 312127.  A lot check has been requested.  Lot check results: 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 available.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abnormal behaviour, Barium double contrast, Colectomy, Decreased appetite, Dehydration
Clinical narrative: Information has been received on request from the FDA regarding a 2 month old male who on 31-MAR-2008 was vaccinated with ROTATEQ, oral, (Lot # 659686/1839U).  Concomitant therapy included PEDIARIX ("DTAPHE"), IM - right leg (GSK) (Lot # AC21B138BA); PREVNAR ("PNC"), unknown route - left leg (Wyeth) (Lot # CS4763); and ACTHIB ("HIBV") IM - left leg (Sanofi Pasteur) (Lot # UF242AB).  Starting on 26-APR-2008, the patient began experiencing the events of abnormal behavior, colectomy, decreased appetite, dehydration, explorative laparotomy, haematochezia, ileostomy, intussusception, irritability, resuscitation and vomiting and was hospitalized.  The events of abnormal behavior, colectomy, decreased appetite, dehydration, exploratory laparotomy, haematochezia, ileostomy, intussusception, irritability, resuscitation and vomiting were considered to be immediately life-threatening and disabling.  On 26-APR-2008, the patient presented to the ER for fussiness, decreased appetite and acting "strange" for several hours.  The patient passed a large, bloody stool in the ER and a barium enema showed intussusception.  Despite multiple attempts, it could not be reduced.  The patient was flown to a hospital and arrived early on 27-APR-2008.  An exploratory laparotomy, after resuscitation, was performed.  In the OR, the patient had reduction of intussusception with a right hemicolectomy and ileostomy.  Total hospital stay was 10 days and discharge was on 07-MAY-2008.  He was readmitted two days later for vomiting and dehydration.  The patient is now home.  Lab data: Contrast enema - intussusception; then OR with exploratory laparotomy.  Reporting source not provided.  VAERS ID # is 313034.  Lot check has been requested.  Lot check results as follows: 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 available.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Explorative laparotomy, Ileostomy, Intussusception, Irritability, Resuscitation
Clinical narrative: Information has been received on request from the FDA regarding a 2 month old male who on 31-MAR-2008 was vaccinated with ROTATEQ, oral, (Lot # 659686/1839U).  Concomitant therapy included PEDIARIX ("DTAPHE"), IM - right leg (GSK) (Lot # AC21B138BA); PREVNAR ("PNC"), unknown route - left leg (Wyeth) (Lot # CS4763); and ACTHIB ("HIBV") IM - left leg (Sanofi Pasteur) (Lot # UF242AB).  Starting on 26-APR-2008, the patient began experiencing the events of abnormal behavior, colectomy, decreased appetite, dehydration, explorative laparotomy, haematochezia, ileostomy, intussusception, irritability, resuscitation and vomiting and was hospitalized.  The events of abnormal behavior, colectomy, decreased appetite, dehydration, exploratory laparotomy, haematochezia, ileostomy, intussusception, irritability, resuscitation and vomiting were considered to be immediately life-threatening and disabling.  On 26-APR-2008, the patient presented to the ER for fussiness, decreased appetite and acting "strange" for several hours.  The patient passed a large, bloody stool in the ER and a barium enema showed intussusception.  Despite multiple attempts, it could not be reduced.  The patient was flown to a hospital and arrived early on 27-APR-2008.  An exploratory laparotomy, after resuscitation, was performed.  In the OR, the patient had reduction of intussusception with a right hemicolectomy and ileostomy.  Total hospital stay was 10 days and discharge was on 07-MAY-2008.  He was readmitted two days later for vomiting and dehydration.  The patient is now home.  Lab data: Contrast enema - intussusception; then OR with exploratory laparotomy.  Reporting source not provided.  VAERS ID # is 313034.  Lot check has been requested.  Lot check results as follows: 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 available.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received on request from the FDA regarding a 2 month old male who on 31-MAR-2008 was vaccinated with ROTATEQ, oral, (Lot # 659686/1839U).  Concomitant therapy included PEDIARIX ("DTAPHE"), IM - right leg (GSK) (Lot # AC21B138BA); PREVNAR ("PNC"), unknown route - left leg (Wyeth) (Lot # CS4763); and ACTHIB ("HIBV") IM - left leg (Sanofi Pasteur) (Lot # UF242AB).  Starting on 26-APR-2008, the patient began experiencing the events of abnormal behavior, colectomy, decreased appetite, dehydration, explorative laparotomy, haematochezia, ileostomy, intussusception, irritability, resuscitation and vomiting and was hospitalized.  The events of abnormal behavior, colectomy, decreased appetite, dehydration, exploratory laparotomy, haematochezia, ileostomy, intussusception, irritability, resuscitation and vomiting were considered to be immediately life-threatening and disabling.  On 26-APR-2008, the patient presented to the ER for fussiness, decreased appetite and acting "strange" for several hours.  The patient passed a large, bloody stool in the ER and a barium enema showed intussusception.  Despite multiple attempts, it could not be reduced.  The patient was flown to a hospital and arrived early on 27-APR-2008.  An exploratory laparotomy, after resuscitation, was performed.  In the OR, the patient had reduction of intussusception with a right hemicolectomy and ileostomy.  Total hospital stay was 10 days and discharge was on 07-MAY-2008.  He was readmitted two days later for vomiting and dehydration.  The patient is now home.  Lab data: Contrast enema - intussusception; then OR with exploratory laparotomy.  Reporting source not provided.  VAERS ID # is 313034.  Lot check has been requested.  Lot check results as follows: 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 available.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abnormal behaviour, Barium enema abnormal, Colectomy, Decreased appetite, Dehydration
Clinical narrative: Information has been received on request from the FDA regarding a 2 month old male who on 31-MAR-2008 was vaccinated with ROTATEQ, oral, (Lot # 659686/1839U).  Concomitant therapy included PEDIARIX ("DTAPHE"), IM - right leg (GSK) (Lot # AC21B138BA); PREVNAR ("PNC"), unknown route - left leg (Wyeth) (Lot # CS4763); and ACTHIB ("HIBV") IM - left leg (Sanofi Pasteur) (Lot # UF242AB).  Starting on 26-APR-2008, the patient began experiencing the events of abnormal behavior, colectomy, decreased appetite, dehydration, explorative laparotomy, haematochezia, ileostomy, intussusception, irritability, resuscitation and vomiting and was hospitalized.  The events of abnormal behavior, colectomy, decreased appetite, dehydration, exploratory laparotomy, haematochezia, ileostomy, intussusception, irritability, resuscitation and vomiting were considered to be immediately life-threatening and disabling.  On 26-APR-2008, the patient presented to the ER for fussiness, decreased appetite and acting "strange" for several hours.  The patient passed a large, bloody stool in the ER and a barium enema showed intussusception.  Despite multiple attempts, it could not be reduced.  The patient was flown to a hospital and arrived early on 27-APR-2008.  An exploratory laparotomy, after resuscitation, was performed.  In the OR, the patient had reduction of intussusception with a right hemicolectomy and ileostomy.  Total hospital stay was 10 days and discharge was on 07-MAY-2008.  He was readmitted two days later for vomiting and dehydration.  The patient is now home.  Lab data: Contrast enema - intussusception; then OR with exploratory laparotomy.  Reporting source not provided.  VAERS ID # is 313034.  Lot check has been requested.  Lot check results as follows: 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 available.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Enema administration, Explorative laparotomy, Haematochezia, Ileostomy, Intussusception
Clinical narrative: Information has been received on request from the FDA regarding a 2 month old male who on 31-MAR-2008 was vaccinated with ROTATEQ, oral, (Lot # 659686/1839U).  Concomitant therapy included PEDIARIX ("DTAPHE"), IM - right leg (GSK) (Lot # AC21B138BA); PREVNAR ("PNC"), unknown route - left leg (Wyeth) (Lot # CS4763); and ACTHIB ("HIBV") IM - left leg (Sanofi Pasteur) (Lot # UF242AB).  Starting on 26-APR-2008, the patient began experiencing the events of abnormal behavior, colectomy, decreased appetite, dehydration, explorative laparotomy, haematochezia, ileostomy, intussusception, irritability, resuscitation and vomiting and was hospitalized.  The events of abnormal behavior, colectomy, decreased appetite, dehydration, exploratory laparotomy, haematochezia, ileostomy, intussusception, irritability, resuscitation and vomiting were considered to be immediately life-threatening and disabling.  On 26-APR-2008, the patient presented to the ER for fussiness, decreased appetite and acting "strange" for several hours.  The patient passed a large, bloody stool in the ER and a barium enema showed intussusception.  Despite multiple attempts, it could not be reduced.  The patient was flown to a hospital and arrived early on 27-APR-2008.  An exploratory laparotomy, after resuscitation, was performed.  In the OR, the patient had reduction of intussusception with a right hemicolectomy and ileostomy.  Total hospital stay was 10 days and discharge was on 07-MAY-2008.  He was readmitted two days later for vomiting and dehydration.  The patient is now home.  Lab data: Contrast enema - intussusception; then OR with exploratory laparotomy.  Reporting source not provided.  VAERS ID # is 313034.  Lot check has been requested.  Lot check results as follows: 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 available.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Irritability, Resuscitation, Vomiting
Clinical narrative: Information has been received on request from the FDA regarding a 2 month old male who on 31-MAR-2008 was vaccinated with ROTATEQ, oral, (Lot # 659686/1839U).  Concomitant therapy included PEDIARIX ("DTAPHE"), IM - right leg (GSK) (Lot # AC21B138BA); PREVNAR ("PNC"), unknown route - left leg (Wyeth) (Lot # CS4763); and ACTHIB ("HIBV") IM - left leg (Sanofi Pasteur) (Lot # UF242AB).  Starting on 26-APR-2008, the patient began experiencing the events of abnormal behavior, colectomy, decreased appetite, dehydration, explorative laparotomy, haematochezia, ileostomy, intussusception, irritability, resuscitation and vomiting and was hospitalized.  The events of abnormal behavior, colectomy, decreased appetite, dehydration, exploratory laparotomy, haematochezia, ileostomy, intussusception, irritability, resuscitation and vomiting were considered to be immediately life-threatening and disabling.  On 26-APR-2008, the patient presented to the ER for fussiness, decreased appetite and acting "strange" for several hours.  The patient passed a large, bloody stool in the ER and a barium enema showed intussusception.  Despite multiple attempts, it could not be reduced.  The patient was flown to a hospital and arrived early on 27-APR-2008.  An exploratory laparotomy, after resuscitation, was performed.  In the OR, the patient had reduction of intussusception with a right hemicolectomy and ileostomy.  Total hospital stay was 10 days and discharge was on 07-MAY-2008.  He was readmitted two days later for vomiting and dehydration.  The patient is now home.  Lab data: Contrast enema - intussusception; then OR with exploratory laparotomy.  Reporting source not provided.  VAERS ID # is 313034.  Lot check has been requested.  Lot check results as follows: 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 available.
Age: 15.0
Sex: F
Vaccine: MNQ, VARCEL, VARCEL
Symptoms: Hypersensitivity
Clinical narrative: AFTER LEAVING CLINIC AT 12:05PM PATIENT'S MOTHER PHONED CLINIC AT 12:45PM STATING THAT PATIENT MAY BE HAVING AN ALLERGIC REACTION TO THE VARICELLA VACCINE.SHE STATED THAT PATIENT'S EYES WERE SWOLLEN.THE PHONE CALL WAS TRANSFERRED TO DR.THE FATHER STATED TO DR. THAT PATIENT'S EYES WERE SWOLLEN AND SHE WAS HAVING DIFFICULTY BREATHING.DR. INSTRUCTED HIM TO TAKE PATIENT TO THE ER OR RETURN TO CLINIC, WHICHEVER WAS CLOSER.AT 1:07PM PATIENT AND HER PARENTS RETURNED TO CLINIC.PATIENT WAS GIVEN EPINEPHRINE 0.3MG AS PER MD ORDER.INJECTION WAS GIVEN IN LEFT THIGH AND TOLERATED WELL.AFTER APPROX. 5 MINUTES THERE WAS NOTED IMPROVEMENT OF SWELLING AROUND EYES.THERE WAS NO COMPLAINTS OF DIFFICULTY BREATHING.PATIENT REMAINED IN OUR PRESENCE FOR 30 MINUTES AND THERE CONTINUED TO BE NOTED IMPROVEMENT.PATIENT WAS DISMISSED BY DR.
Age: 15.0
Sex: F
Vaccine: MNQ, VARCEL, VARCEL
Symptoms: Dyspnoea, Eye swelling, Hypersensitivity
Clinical narrative: AFTER LEAVING CLINIC AT 12:05PM PATIENT'S MOTHER PHONED CLINIC AT 12:45PM STATING THAT PATIENT MAY BE HAVING AN ALLERGIC REACTION TO THE VARICELLA VACCINE.SHE STATED THAT PATIENT'S EYES WERE SWOLLEN.THE PHONE CALL WAS TRANSFERRED TO DR.THE FATHER STATED TO DR. THAT PATIENT'S EYES WERE SWOLLEN AND SHE WAS HAVING DIFFICULTY BREATHING.DR. INSTRUCTED HIM TO TAKE PATIENT TO THE ER OR RETURN TO CLINIC, WHICHEVER WAS CLOSER.AT 1:07PM PATIENT AND HER PARENTS RETURNED TO CLINIC.PATIENT WAS GIVEN EPINEPHRINE 0.3MG AS PER MD ORDER.INJECTION WAS GIVEN IN LEFT THIGH AND TOLERATED WELL.AFTER APPROX. 5 MINUTES THERE WAS NOTED IMPROVEMENT OF SWELLING AROUND EYES.THERE WAS NO COMPLAINTS OF DIFFICULTY BREATHING.PATIENT REMAINED IN OUR PRESENCE FOR 30 MINUTES AND THERE CONTINUED TO BE NOTED IMPROVEMENT.PATIENT WAS DISMISSED BY DR.
Age: 41.0
Sex: U
Vaccine: ANTH
Symptoms: Activated partial thromboplastin time normal, Activated protein C resistance test, Antithrombin III, Blood fibrinogen normal, Blood homocysteine increased
Clinical narrative: Pt complained of a 3 weeks hx of left calf pain after running.  Pt had also had a cross country flight.  Dx with left LE DVT.  Pt on coumadin and lovenox til 4/20/04.  6/07 pt experienced left calf pain and pain dorsum of left foot for about 5 weeks prior to a flight and a one week cruise.  Upon return the pt went to the hospital and it was determined that he had a left foot superficial venous thrombosis.  3/17/08 pt was treated in ER for palpitations.  Pt had an IV.  Upper Ext Venous Duplex which showed superficial venous thrombosis.  Pt wonders if this is caused by AVA?  Symptoms: Muscle Pain, Muscle Pain, Muscle Pain.
Age: 41.0
Sex: U
Vaccine: ANTH
Symptoms: Cardiolipin antibody negative, Deep vein thrombosis, Diagnostic procedure, International normalised ratio decreased, Laboratory test normal
Clinical narrative: Pt complained of a 3 weeks hx of left calf pain after running.  Pt had also had a cross country flight.  Dx with left LE DVT.  Pt on coumadin and lovenox til 4/20/04.  6/07 pt experienced left calf pain and pain dorsum of left foot for about 5 weeks prior to a flight and a one week cruise.  Upon return the pt went to the hospital and it was determined that he had a left foot superficial venous thrombosis.  3/17/08 pt was treated in ER for palpitations.  Pt had an IV.  Upper Ext Venous Duplex which showed superficial venous thrombosis.  Pt wonders if this is caused by AVA?  Symptoms: Muscle Pain, Muscle Pain, Muscle Pain.
Age: 41.0
Sex: U
Vaccine: ANTH
Symptoms: Myalgia, Pain in extremity, Palpitations, Protein C, Protein S normal
Clinical narrative: Pt complained of a 3 weeks hx of left calf pain after running.  Pt had also had a cross country flight.  Dx with left LE DVT.  Pt on coumadin and lovenox til 4/20/04.  6/07 pt experienced left calf pain and pain dorsum of left foot for about 5 weeks prior to a flight and a one week cruise.  Upon return the pt went to the hospital and it was determined that he had a left foot superficial venous thrombosis.  3/17/08 pt was treated in ER for palpitations.  Pt had an IV.  Upper Ext Venous Duplex which showed superficial venous thrombosis.  Pt wonders if this is caused by AVA?  Symptoms: Muscle Pain, Muscle Pain, Muscle Pain.
Age: 41.0
Sex: U
Vaccine: ANTH
Symptoms: Prothrombin time prolonged, Thrombophlebitis superficial, Ultrasound scan abnormal
Clinical narrative: Pt complained of a 3 weeks hx of left calf pain after running.  Pt had also had a cross country flight.  Dx with left LE DVT.  Pt on coumadin and lovenox til 4/20/04.  6/07 pt experienced left calf pain and pain dorsum of left foot for about 5 weeks prior to a flight and a one week cruise.  Upon return the pt went to the hospital and it was determined that he had a left foot superficial venous thrombosis.  3/17/08 pt was treated in ER for palpitations.  Pt had an IV.  Upper Ext Venous Duplex which showed superficial venous thrombosis.  Pt wonders if this is caused by AVA?  Symptoms: Muscle Pain, Muscle Pain, Muscle Pain.
Sex: F
Vaccine: HPV4
Symptoms: Paralysis
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a third dose of GARDASIL.  The physician reported that a lawyer friend of hers mentioned on 17-JUL-2008 that a girl getting paralyzed after her 3rd shot of GARDASIL.  She is currently still in the hospital (duration unspecified).  There was no product quality complaint.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blindness, Convulsion, Disorientation, Fatigue
Clinical narrative: Information has been received from an unspecified source ("someone who is not part of the clinic") concerning a 15 year old (reported by the source as a 16 year old) female who was vaccinated at the clinic with GARDASIL.  The unspecified source told the Company representative that it was reported on television that the patient experienced "fainting and seizure like movements" after receiving GARDASIL.  The unspecified source recounted the news report stating the patient was supervised in the office after the vaccine was given for about an hour and was released to home.  The patient had "splitting headache" and "fatigue" that persisted for about one week after the fainting incident.  According to the archived television program, the patient was a healthy, athletic 15 year old who in approximately July 2008 was taken to the clinic by her mother for a routine physical.  As part of her exam, she was offered GARDASIL.  When the mother asked about the side effects, she was told only about possible redness and soreness.  Almost immediately after getting the vaccination, something went very wrong.  The patient stood up and couldn't see anything.  She fainted and began having seizure like motions. For several moments, the patient was thrashing on the examining room floor. When she woke up, the patient didn't know where and who she was.  She was very pale.  At first the clinic staff had her sit on the ground, and then eventually had her sit on the table.  The patient then became nauseous.  After more than two hours, the patient was sent home.  Her parents were afraid to let her sleep.  It took five days for the patient to get over the migraine-like headaches and debilitating loss of energy.  The Company representative attempted to contact the clinic for follow up, but was unable to get anyone to verify the incident.  Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Immediate post-injection reaction, Nausea, Pallor, Syncope
Clinical narrative: Information has been received from an unspecified source ("someone who is not part of the clinic") concerning a 15 year old (reported by the source as a 16 year old) female who was vaccinated at the clinic with GARDASIL.  The unspecified source told the Company representative that it was reported on television that the patient experienced "fainting and seizure like movements" after receiving GARDASIL.  The unspecified source recounted the news report stating the patient was supervised in the office after the vaccine was given for about an hour and was released to home.  The patient had "splitting headache" and "fatigue" that persisted for about one week after the fainting incident.  According to the archived television program, the patient was a healthy, athletic 15 year old who in approximately July 2008 was taken to the clinic by her mother for a routine physical.  As part of her exam, she was offered GARDASIL.  When the mother asked about the side effects, she was told only about possible redness and soreness.  Almost immediately after getting the vaccination, something went very wrong.  The patient stood up and couldn't see anything.  She fainted and began having seizure like motions. For several moments, the patient was thrashing on the examining room floor. When she woke up, the patient didn't know where and who she was.  She was very pale.  At first the clinic staff had her sit on the ground, and then eventually had her sit on the table.  The patient then became nauseous.  After more than two hours, the patient was sent home.  Her parents were afraid to let her sleep.  It took five days for the patient to get over the migraine-like headaches and debilitating loss of energy.  The Company representative attempted to contact the clinic for follow up, but was unable to get anyone to verify the incident.  Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Hallucination, auditory, Headache, Nocturnal fear
Clinical narrative: Information has been received from a licensed practical nurse as told to her by the patient's mother concerning a 12 year old female with no known drug allergies and a history of headaches, who on 12-JUN-2008 was vaccinated with the first dose of GARDASIL (lot # 654272/0073X), 0.5 mL, IM into her left deltoid.  On approximately 19-JUN-2008, the patient developed the following behavioral symptoms: increase in the frequency of headaches, auditory hallucinations and fear of sleeping in the dark.  The patient was hospitalized for an unspecified period of time and treated with unspecified medication.  She continued taking medication to relieve the behavioral symptoms.  No other symptoms or treatment reported.  At the time of reporting, the patient was recovering.  Additional information has been requested. 8/28/08-records received for DOS 7/17-7/19/08-DC DX:Anxiety disorder (NOS).  Admitted with C/O having images in her head of people killing her. She was not seeing the them but they were images in her head. Tends to be a worrier. Strong family history of anxiety with panic attacks. Admitted for observation and participation in group therapy.
Sex: F
Vaccine: HPV4
Symptoms: Paralysis
Clinical narrative: Information has been received from a physician who reported that a parent of one of her patient's told her that on 21-JUL-2008 that she heard a news story on a television station geared toward Hispanics, that "about 90" girls were paralyzed on GARDASIL. Upon internal review, paralysis was considered an other important medical event. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Blood test, Drug exposure during pregnancy, Ultrasound scan
Clinical narrative: Information has been received from a consumer for the pregnancy registry for GARDASIL, concerning her 18 year old daughter who in February 2008, was vaccinated with the first dose of GARDASIL 0.5 ml for HPV prophylaxis. Concomitant therapy included nadolol. On an unspecified date, the physician was unaware the patient was pregnant and vaccinated her with the second dose of GARDASIL. The consumer reported that on approximately 23-JUN-2008, her daughter had a miscarriage after getting the second dose of GARDASIL; and had to stay in the hospital for 5 to 6 days. The patient was 4 and a half months pregnant. On an unspecified date, a blood work and ultrasound were done (results not provided). Her LMP was 15-FEB-2008 and EDD was 21-NOV-2008. The patient sought medical attention. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Caesarean section, Drug exposure during pregnancy, Pregnancy induced hypertension
Clinical narrative: Information has been received from a physician for the pregnancy registry for VARIVAX, concerning a 33 year old female with hypertension and a poor obstetrical history with an abruption placenta and a child with cerebral palsy, who on 03-FEB-2007 was vaccinated with a first dose of VARIVAX.  Concomitant therapy included losartan potassium-HCTZ.  The patient received second dose of VARIVAX on 07-MAR-2007 and was subsequently determined to be pregnant with LMP date of 20-MAR-2007.  No problems were reported.  The patient underwent quantitative HCG and progesterone level diagnostic tests (results unknown).  On 07-NOV-2007 at 36 weeks 2 days, the patient delivered a healthy female infant (no defects) who weighed 6 pounds 12 ounces.  The infant's APGARs were 8 and 8.  The patient had a c-section due to pregnancy induced hypertension.  The patient did well post-op.  No other problems were noted during her pregnancy.  A product quality complaint was not involved.  Upon internal review, pregnancy induced hypertension was considered to be an other important medical event.  Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Completed suicide
Clinical narrative: This young man was seen at the clinic where the itinerant Public Health Nurse administered the 2 injections.  Later in the early evening he was found outside hanging by the neck - apparent suicide. 2/4/09-Medical Examiner report: COD Hanging.
Age: 19.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Atrial fibrillation
Clinical narrative: Atrial fib. 08/28/2008 MR received for DOS 7/29-31/2008 with D/C DX:  New onset atrial fibrillation.  Benign hypertension. Pt presented with onset of palpitations with a fast, irregular heartbeat associated with some mild SOB.  PE(+) for irregularly irregular heart rhythm. Unable to revert with meds so was cardioverted sucessfully and started on anti-coagulants.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Blood pressure increased, Blood pressure orthostatic, Breath sounds abnormal, Conjunctival discolouration, Dysphagia
Clinical narrative: Within 30-45 seconds of receiving IM Epinephrine, child started to feel better and was breathing more comfortably, with decrease in itchiness/rash/redness around face and neck and conjunctiva became clear again. Child also was able to swallow and "tongue and fingers of Rt hand felt normal again", per patient. EMS arrived within 5 minutes of being contacted and B.P. measurement repeated with pt. sitting up = 124/90 (post Epinephrine IM). Note: O2 sats = 100% with H.R. = 79/min post Epinephrine IM. Pt. then transported via EMS to ER to be examined for possible admission for observation status. Note: Pt received Epi-Pen Jr. i.e. 0.15 mg dose at our office today. I.M. vs Epi-Pen i.e. 0.30 mg dose. 8/11/08-records received for DOS 7/25/08-presented to ED with C/O reaction to vaccines. Received Benadryl in PCP office, no symptoms on arrival to ED. PE normal. Impression: Acute Allergic Reaction.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Dyspnoea, Erythema, Heart rate, Oxygen saturation, Pruritus
Clinical narrative: Within 30-45 seconds of receiving IM Epinephrine, child started to feel better and was breathing more comfortably, with decrease in itchiness/rash/redness around face and neck and conjunctiva became clear again. Child also was able to swallow and "tongue and fingers of Rt hand felt normal again", per patient. EMS arrived within 5 minutes of being contacted and B.P. measurement repeated with pt. sitting up = 124/90 (post Epinephrine IM). Note: O2 sats = 100% with H.R. = 79/min post Epinephrine IM. Pt. then transported via EMS to ER to be examined for possible admission for observation status. Note: Pt received Epi-Pen Jr. i.e. 0.15 mg dose at our office today. I.M. vs Epi-Pen i.e. 0.30 mg dose. 8/11/08-records received for DOS 7/25/08-presented to ED with C/O reaction to vaccines. Received Benadryl in PCP office, no symptoms on arrival to ED. PE normal. Impression: Acute Allergic Reaction.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Rash, Tongue disorder
Clinical narrative: Within 30-45 seconds of receiving IM Epinephrine, child started to feel better and was breathing more comfortably, with decrease in itchiness/rash/redness around face and neck and conjunctiva became clear again. Child also was able to swallow and "tongue and fingers of Rt hand felt normal again", per patient. EMS arrived within 5 minutes of being contacted and B.P. measurement repeated with pt. sitting up = 124/90 (post Epinephrine IM). Note: O2 sats = 100% with H.R. = 79/min post Epinephrine IM. Pt. then transported via EMS to ER to be examined for possible admission for observation status. Note: Pt received Epi-Pen Jr. i.e. 0.15 mg dose at our office today. I.M. vs Epi-Pen i.e. 0.30 mg dose. 8/11/08-records received for DOS 7/25/08-presented to ED with C/O reaction to vaccines. Received Benadryl in PCP office, no symptoms on arrival to ED. PE normal. Impression: Acute Allergic Reaction.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Cold sweat, Dizziness, Fall, Heart rate decreased
Clinical narrative: After receiving HPV (#1) to L delt., pt walked to reception area & "felt dizzy" & fell to floor.  Skin pale, clammy & cool.  BP 70/40, P 48, faint.  Assisted to supine position x20 mins until fully recovered.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Syncope
Clinical narrative: After receiving HPV (#1) to L delt., pt walked to reception area & "felt dizzy" & fell to floor.  Skin pale, clammy & cool.  BP 70/40, P 48, faint.  Assisted to supine position x20 mins until fully recovered.
Age: 17.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None. No reaction to vaccine - error.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site of varicella vaccination noted to be sl. swollen reddened area approx 4-5cm & warm to touch.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, erythema at injection site (left deltoid -> arm).
Age: 32.0
Sex: M
Vaccine: HEP, MMR, YF
Symptoms: Body temperature increased, Incorrect route of drug administration, Pain
Clinical narrative: 1 dose YF given IM inadvertently thinking it was another vaccine, 1 dose given SQ.  2 days later in checking on him - the company MD reported 101 degrees & very achy.  Follow up call made x3 & at 1wk he was symptom free.
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Started with c/o bilat arm pain, shooting up about 2 wks after injection. Couldn't lift arms due to pain.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Nodule, Rash erythematous
Clinical narrative: Posterior Lt arm pea size nodule with erythema surrounding by a 5x10cm erythematous area.  Treated with KEFLEX for 10 days.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Rash, Rash morbilliform
Clinical narrative: Patient received the hepatitis A (HAVRIX) vaccine the morning of 7/24/08.  Eighteen to twenty-four hours later he broke out in a morbilliform drug-reaction like rash on his chest, abdomen, back, upper arms + upper thighs.
Age: 0.8
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Redness, warmth, swelling R thigh.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Dyspnoea, Fatigue, Headache, Muscular weakness
Clinical narrative: Pt developed HA that evening.  Severe-went to sleep.  Next day while exercising developed extreme fatigue, muscle weakness, SOB, blurred vision & dizziness.  Symptoms are resolving today (7/30/08).  Pt is a collegiate athlete.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vision blurred
Clinical narrative: Pt developed HA that evening.  Severe-went to sleep.  Next day while exercising developed extreme fatigue, muscle weakness, SOB, blurred vision & dizziness.  Symptoms are resolving today (7/30/08).  Pt is a collegiate athlete.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: Pt developed HA that evening.  Severe-went to sleep.  Next day while exercising developed extreme fatigue, muscle weakness, SOB, blurred vision & dizziness.  Symptoms are resolving today (7/30/08).  Pt is a collegiate athlete.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscular weakness, Vision blurred
Clinical narrative: Pt developed HA that evening.  Severe-went to sleep.  Next day while exercising developed extreme fatigue, muscle weakness, SOB, blurred vision & dizziness.  Symptoms are resolving today (7/30/08).  Pt is a collegiate athlete.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Echocardiogram normal, Electrocardiogram, Electrocardiogram ambulatory normal, Electroencephalogram normal
Clinical narrative: The patient experienced syncope/seizures on two occasions.  The first episode occurred on 9/23/07 in the P.M. after stepping out of the shower, resulting in an emergency room visit.  An EKG was performed and the patient was released with no identifiable diagnosis.  Two weeks later, the patient had another syncope/seizure episode.  This episode also occurred in the P.M., while at a party.  Because the patient is away from home in college, she was referred by the Medical Director to a local Neurologist.  The neurologist ordered the following test: 1) MRI Scan, 2) EEG, 3) ECHO and 4) Holter monitor.  All of the test results were benign.  To date, no explainable cause has been identified for the seizures. 11/13/08-records received for DOS 9/23/07-ED visit with C/O possible seizure dy prior. Has been dieting times 1 week. Headache. At ED felt fine. Assessment:Evaluation of seizure.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Syncope
Clinical narrative: The patient experienced syncope/seizures on two occasions.  The first episode occurred on 9/23/07 in the P.M. after stepping out of the shower, resulting in an emergency room visit.  An EKG was performed and the patient was released with no identifiable diagnosis.  Two weeks later, the patient had another syncope/seizure episode.  This episode also occurred in the P.M., while at a party.  Because the patient is away from home in college, she was referred by the Medical Director to a local Neurologist.  The neurologist ordered the following test: 1) MRI Scan, 2) EEG, 3) ECHO and 4) Holter monitor.  All of the test results were benign.  To date, no explainable cause has been identified for the seizures. 11/13/08-records received for DOS 9/23/07-ED visit with C/O possible seizure dy prior. Has been dieting times 1 week. Headache. At ED felt fine. Assessment:Evaluation of seizure.
Age: 1.3
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Urticaria
Clinical narrative: Patient developed severe widespread urticarial reaction 2-3 hours after immunizations.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Erythema, Rash pruritic, Urticaria
Clinical narrative: Mom discovered child had rash when undressed to bath him.  Pruritic skin rash, with redness, hives starting on extremities, but encompassing face by arrival to E.R. at 9:21PM.  Urticaria skin rash involved trunk.  No respiratory involvement, no cough, no fever.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: ~30 hrs after vaccine 6-7 cm raised red area over varicella site - Rx BENADRYL - subsided in 24 hrs.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pruritus, Rash macular
Clinical narrative: Within 24 hrs had raised, red 7cm area at injection site, itching - over next 24 hrs flattened, ~10cm macular erythema.  Resolved by 72 hrs.  Rx diphenhyd. 25mg po q 6 h, ice, TYLENOL.
Age: 6.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Head injury, Loss of consciousness
Clinical narrative: After receiving varicella vac & hepatitis A vaccine left building & passed out in parking lot hit head on car.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Headache, Pain, Swelling
Clinical narrative: Severe pain, headache, swelling, erythema.  TYLENOL used.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Somnolence, Syncope
Clinical narrative: Syncope ~2 minutes after receiving vaccine (VARIVAX).  Pt drowsy & c/o headache ~20 minutes after vaccine.