chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: ANTH, HEP, SMALL, TYP
Symptoms: Nausea, Vision blurred
Clinical narrative: This case was received on 27 November 2008 via a search of the VAERS database (reference number 308950).  It was originally reported to VAERS by another unknown manufacturer.  A 29-year-old female patient received the following vaccinations on 10 March 2008: ACAM2000 (manufacturer Acambis, lot number not reported); TYPHIM VI (lot number not reported); HEPTAVAX (manufacturer Merck, lot number not reported); VAQTA (manufacturer Merck, lot number not reported); Anthrax vaccine (trade name, manufacturer and lot number not reported).  The patient reported that she felt nauseated, lightheaded and had an odd pain in her head which began soon after the vaccinations.  The patient could not focus her eyes on anything slightly bright for longer than a few seconds.  Later that night, her eyesight became blurry and everything looked "gummy" and saw she tracers.  Turning her head too much to either side made the head pain worse.  The next day, the patient went to work and the lights in the office and on her computer made her nauseated and she nearly vomited on several occasions.  The patient wasn't able to eat anything for lunch.  The patient left work early that afternoon and went to the emergency room.  The patient was prescribed Motrin and nausea medication (not specified) and given 24-hour quarters.  The next day, the patient slept most of the day because she felt horrible and it hurt her eyes to watch television.  Everything looked "swirly" and she had trouble with short-term memory loss.  The patient randomly walked across a busy street and was nearly hit by a car.  The patient was afraid to drive while this was affecting her.  The patient reported that things just "looked weird".  The symptoms slowly decreased over the course of the next two weeks.  During that time, the patient felt disoriented and lightheaded, very tired and her eyes were "not normal".  The patient recovered.  Relevant Test/Laboratory Data: Not reported.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Pruritus, Rash vesicular
Clinical narrative: This case was received on 27 November 2008 via a search of the VAERS data base (reference number 311501). It was originally reported to VAERS by another manufacturer (Emergent Biosolutions). A 19 year-old patient received the following vaccines on 16 April 2008: TYPHIM VI (administered intramuscularly, lot number not reported); ACAM2000 (manufacturer Acambis Inc., lot number not reported); Biothrax (manufacturer Emergent Biosolutions, lot number not reported). On 30 April 2008, the patient developed a 3 inch by 4 inch fine vesicular rash on the lower left side of the abdomen. The site was itchy. The rash began to fade in one day. The patient recovered.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Condition aggravated, Crying, Enema administration
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information concerning a 5 month (20 weeks) old male patient who on 17-DEC-2007 was vaccinated with ROTATEQ. Concomitant therapy included PREVNAR (lot no. 854013C), PEDIARIX (lot no. AC21B128AB) and ACTHIB (UF192AA). On 05-MAY-2008 the patient was seen in the ER with worsening abdominal pain for one day. The child would bring knees to his chest and cried inconsolably for up to twenty minutes. AXR showed intussusception and the patient was seen by surgery who successfully performed an air-contrast enema. The patient was admitted to the hospital. On 3-JUN-2008, hospital medical records were reviewed for 5-MAY to 7-MAY-2008. FINAL DX: intussusception, enema reduced. Records reveal patient experienced worsening abdominal pain, crying inconsolably, vomiting, reduced oral intake, lethargy, irritability. He was admitted for observation status post enema reduction of IS. The patient improved and discharged to home. The patient had no previous illnesses during a visit and had been seen at ER two days prior with vomiting, but had resolved before the visit. Follow-up information was received from a physician concerning the now 6 month old patient. It was reported that the patient had no pre-existing physician-diagnosed allergies, birth defects, and medical conditions. The patient required hospitalization for 3 days. The original reporter was not provided. The VAER # ID is 311829-1. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Hypophagia, Intussusception, Irritability, Lethargy, Vomiting
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information concerning a 5 month (20 weeks) old male patient who on 17-DEC-2007 was vaccinated with ROTATEQ. Concomitant therapy included PREVNAR (lot no. 854013C), PEDIARIX (lot no. AC21B128AB) and ACTHIB (UF192AA). On 05-MAY-2008 the patient was seen in the ER with worsening abdominal pain for one day. The child would bring knees to his chest and cried inconsolably for up to twenty minutes. AXR showed intussusception and the patient was seen by surgery who successfully performed an air-contrast enema. The patient was admitted to the hospital. On 3-JUN-2008, hospital medical records were reviewed for 5-MAY to 7-MAY-2008. FINAL DX: intussusception, enema reduced. Records reveal patient experienced worsening abdominal pain, crying inconsolably, vomiting, reduced oral intake, lethargy, irritability. He was admitted for observation status post enema reduction of IS. The patient improved and discharged to home. The patient had no previous illnesses during a visit and had been seen at ER two days prior with vomiting, but had resolved before the visit. Follow-up information was received from a physician concerning the now 6 month old patient. It was reported that the patient had no pre-existing physician-diagnosed allergies, birth defects, and medical conditions. The patient required hospitalization for 3 days. The original reporter was not provided. The VAER # ID is 311829-1. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: X-ray abnormal
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information concerning a 5 month (20 weeks) old male patient who on 17-DEC-2007 was vaccinated with ROTATEQ. Concomitant therapy included PREVNAR (lot no. 854013C), PEDIARIX (lot no. AC21B128AB) and ACTHIB (UF192AA). On 05-MAY-2008 the patient was seen in the ER with worsening abdominal pain for one day. The child would bring knees to his chest and cried inconsolably for up to twenty minutes. AXR showed intussusception and the patient was seen by surgery who successfully performed an air-contrast enema. The patient was admitted to the hospital. On 3-JUN-2008, hospital medical records were reviewed for 5-MAY to 7-MAY-2008. FINAL DX: intussusception, enema reduced. Records reveal patient experienced worsening abdominal pain, crying inconsolably, vomiting, reduced oral intake, lethargy, irritability. He was admitted for observation status post enema reduction of IS. The patient improved and discharged to home. The patient had no previous illnesses during a visit and had been seen at ER two days prior with vomiting, but had resolved before the visit. Follow-up information was received from a physician concerning the now 6 month old patient. It was reported that the patient had no pre-existing physician-diagnosed allergies, birth defects, and medical conditions. The patient required hospitalization for 3 days. The original reporter was not provided. The VAER # ID is 311829-1. Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: C-reactive protein increased, Cardiac monitoring normal, Cardiac stress test abnormal, Chest X-ray normal, Chest discomfort
Clinical narrative: "This case was received on 27 November 2008 via a search of the VAERS database (VAERS ID number:  315324).  It was originally reported to VAERS by another manufacturer."  A 30 year-old male patient had received on 31 March 2008 an intramuscular injection of TYPHIM VI (lot number and site not reported), an injection of ACAM2000 (lot number and site not reported), and a subcutaneous injection of BIOTHRAX (Emergent Solutions, lot number and site not reported).  On 10 April 2008, i.e., ten days post-vaccination, the patient developed a pruritic rash from head to toe (minus palms and soles of feet) and was fatigue.  On 12 April 2008, in addition to the rash the patient's upper lip was swollen, and he was experiencing non-radiating substernal chest pain/discomfort/tightness accompanied by exertional dyspnea, and palpitations.  The rash was treated with BENADRYL and PREDNISONE.  The rash continued to wax and wane, but subsequently resolved.  The chest pain was described as "like laying on my back with 10 guys on top of me."  The pain was constant and worse when lying on either side.  There were no changes in the chest pain with deep breaths.  The patient was treated with MOTRIN and COLCHICINE for the chest pain.  The dyspnea was described as "couldn't get full breath...feel winded" with lightheadedness.  The patient felt a little lightheaded at other times as well.  The patient was evaluated in the emergency room two days later on 13 April 2008 and treated with NSAIDS with some improvement.  The chest tightness, exertional dyspnea, palpitations, vaccinia rash and pruritis lasted four days.  The patient's current level of energy for fatigue is 45% on a scale of 0= bedridden to 100=base line energy level.  Per the reporter, review of medical records and vaccination records for 12 April 2008 through 02 June 2008 revealed the final diagnosis to be pericarditis.  The patient's recovery status was not reported, however the outcome was reported as required intervention to prevent permanent impairment/damage.
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Chest pain, Dizziness, Dyspnoea exertional, Echocardiogram normal, Electrocardiogram abnormal
Clinical narrative: "This case was received on 27 November 2008 via a search of the VAERS database (VAERS ID number:  315324).  It was originally reported to VAERS by another manufacturer."  A 30 year-old male patient had received on 31 March 2008 an intramuscular injection of TYPHIM VI (lot number and site not reported), an injection of ACAM2000 (lot number and site not reported), and a subcutaneous injection of BIOTHRAX (Emergent Solutions, lot number and site not reported).  On 10 April 2008, i.e., ten days post-vaccination, the patient developed a pruritic rash from head to toe (minus palms and soles of feet) and was fatigue.  On 12 April 2008, in addition to the rash the patient's upper lip was swollen, and he was experiencing non-radiating substernal chest pain/discomfort/tightness accompanied by exertional dyspnea, and palpitations.  The rash was treated with BENADRYL and PREDNISONE.  The rash continued to wax and wane, but subsequently resolved.  The chest pain was described as "like laying on my back with 10 guys on top of me."  The pain was constant and worse when lying on either side.  There were no changes in the chest pain with deep breaths.  The patient was treated with MOTRIN and COLCHICINE for the chest pain.  The dyspnea was described as "couldn't get full breath...feel winded" with lightheadedness.  The patient felt a little lightheaded at other times as well.  The patient was evaluated in the emergency room two days later on 13 April 2008 and treated with NSAIDS with some improvement.  The chest tightness, exertional dyspnea, palpitations, vaccinia rash and pruritis lasted four days.  The patient's current level of energy for fatigue is 45% on a scale of 0= bedridden to 100=base line energy level.  Per the reporter, review of medical records and vaccination records for 12 April 2008 through 02 June 2008 revealed the final diagnosis to be pericarditis.  The patient's recovery status was not reported, however the outcome was reported as required intervention to prevent permanent impairment/damage.
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Fatigue, Lip swelling, Nuclear magnetic resonance imaging normal, Palpitations, Pericarditis
Clinical narrative: "This case was received on 27 November 2008 via a search of the VAERS database (VAERS ID number:  315324).  It was originally reported to VAERS by another manufacturer."  A 30 year-old male patient had received on 31 March 2008 an intramuscular injection of TYPHIM VI (lot number and site not reported), an injection of ACAM2000 (lot number and site not reported), and a subcutaneous injection of BIOTHRAX (Emergent Solutions, lot number and site not reported).  On 10 April 2008, i.e., ten days post-vaccination, the patient developed a pruritic rash from head to toe (minus palms and soles of feet) and was fatigue.  On 12 April 2008, in addition to the rash the patient's upper lip was swollen, and he was experiencing non-radiating substernal chest pain/discomfort/tightness accompanied by exertional dyspnea, and palpitations.  The rash was treated with BENADRYL and PREDNISONE.  The rash continued to wax and wane, but subsequently resolved.  The chest pain was described as "like laying on my back with 10 guys on top of me."  The pain was constant and worse when lying on either side.  There were no changes in the chest pain with deep breaths.  The patient was treated with MOTRIN and COLCHICINE for the chest pain.  The dyspnea was described as "couldn't get full breath...feel winded" with lightheadedness.  The patient felt a little lightheaded at other times as well.  The patient was evaluated in the emergency room two days later on 13 April 2008 and treated with NSAIDS with some improvement.  The chest tightness, exertional dyspnea, palpitations, vaccinia rash and pruritis lasted four days.  The patient's current level of energy for fatigue is 45% on a scale of 0= bedridden to 100=base line energy level.  Per the reporter, review of medical records and vaccination records for 12 April 2008 through 02 June 2008 revealed the final diagnosis to be pericarditis.  The patient's recovery status was not reported, however the outcome was reported as required intervention to prevent permanent impairment/damage.
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Pulmonary function test normal, Rash pruritic, Troponin
Clinical narrative: "This case was received on 27 November 2008 via a search of the VAERS database (VAERS ID number:  315324).  It was originally reported to VAERS by another manufacturer."  A 30 year-old male patient had received on 31 March 2008 an intramuscular injection of TYPHIM VI (lot number and site not reported), an injection of ACAM2000 (lot number and site not reported), and a subcutaneous injection of BIOTHRAX (Emergent Solutions, lot number and site not reported).  On 10 April 2008, i.e., ten days post-vaccination, the patient developed a pruritic rash from head to toe (minus palms and soles of feet) and was fatigue.  On 12 April 2008, in addition to the rash the patient's upper lip was swollen, and he was experiencing non-radiating substernal chest pain/discomfort/tightness accompanied by exertional dyspnea, and palpitations.  The rash was treated with BENADRYL and PREDNISONE.  The rash continued to wax and wane, but subsequently resolved.  The chest pain was described as "like laying on my back with 10 guys on top of me."  The pain was constant and worse when lying on either side.  There were no changes in the chest pain with deep breaths.  The patient was treated with MOTRIN and COLCHICINE for the chest pain.  The dyspnea was described as "couldn't get full breath...feel winded" with lightheadedness.  The patient felt a little lightheaded at other times as well.  The patient was evaluated in the emergency room two days later on 13 April 2008 and treated with NSAIDS with some improvement.  The chest tightness, exertional dyspnea, palpitations, vaccinia rash and pruritis lasted four days.  The patient's current level of energy for fatigue is 45% on a scale of 0= bedridden to 100=base line energy level.  Per the reporter, review of medical records and vaccination records for 12 April 2008 through 02 June 2008 revealed the final diagnosis to be pericarditis.  The patient's recovery status was not reported, however the outcome was reported as required intervention to prevent permanent impairment/damage.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Eschar, Malaise, Rash, Rash papular
Clinical narrative: This case was received on 27 November 2008 via a search of the VAERS database (reference number 322052). It was originally reported to VAERS by another manufacturer (Acambia, Inc). A 20 year-old male patient, with no reported history, received the following vaccinations on 30 July 2008: an intramuscular injection of TYPHIM VI (lot number A05222), and an injection of ACAM2000 (smallpox, Acambis, Inc, lot number VV04003A). In addition, the patient also received anthrax vaccine (manufacturer and lot number not reported) on an unreported date. On 09 August 2008, ten days.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood glucose abnormal, Colonoscopy, Dehydration, Diarrhoea, Disorientation
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female patient with no known drug allergies, who on 22-AUG-2007 was vaccinated with the first dose of GARDASIL (lot#657736/0389U) 0.5ml intramuscularly at the health department. In October 2007, the patient started experiencing nausea and vomiting, which required hospitalization twice for dehydration. The patient also experienced episodes of rash, dizziness, disorientation, "problems with blood glucose", and urinary tract infections. Patient sought medical attention by calling the health department. The patient has been evaluated by an unspecified endocrinologist but a diagnosis has not been made at the time of the report. A colonoscopy and other unspecified tests were performed which were negative. Patient received her second and third dose of GARDASIL on unspecified dates. At the time of this report the patient had not yet recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Joint effusion, Rash generalised, Urinary tract infection, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female patient with no known drug allergies, who on 22-AUG-2007 was vaccinated with the first dose of GARDASIL (lot#657736/0389U) 0.5ml intramuscularly at the health department. In October 2007, the patient started experiencing nausea and vomiting, which required hospitalization twice for dehydration. The patient also experienced episodes of rash, dizziness, disorientation, "problems with blood glucose", and urinary tract infections. Patient sought medical attention by calling the health department. The patient has been evaluated by an unspecified endocrinologist but a diagnosis has not been made at the time of the report. A colonoscopy and other unspecified tests were performed which were negative. Patient received her second and third dose of GARDASIL on unspecified dates. At the time of this report the patient had not yet recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Weight decreased
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female patient with no known drug allergies, who on 22-AUG-2007 was vaccinated with the first dose of GARDASIL (lot#657736/0389U) 0.5ml intramuscularly at the health department. In October 2007, the patient started experiencing nausea and vomiting, which required hospitalization twice for dehydration. The patient also experienced episodes of rash, dizziness, disorientation, "problems with blood glucose", and urinary tract infections. Patient sought medical attention by calling the health department. The patient has been evaluated by an unspecified endocrinologist but a diagnosis has not been made at the time of the report. A colonoscopy and other unspecified tests were performed which were negative. Patient received her second and third dose of GARDASIL on unspecified dates. At the time of this report the patient had not yet recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood glucose abnormal, Colonoscopy normal, Dehydration, Disorientation, Dizziness
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female patient with no known drug allergies, who on 22-AUG-2007 was vaccinated with the first dose of GARDASIL (lot#657736/0389U) 0.5ml intramuscularly at the health department. In October 2007, the patient started experiencing nausea and vomiting, which required hospitalization twice for dehydration. The patient also experienced episodes of rash, dizziness, disorientation, "problems with blood glucose", and urinary tract infections. Patient sought medical attention by calling the health department. The patient has been evaluated by an unspecified endocrinologist but a diagnosis has not been made at the time of the report. A colonoscopy and other unspecified tests were performed which were negative. Patient received her second and third dose of GARDASIL on unspecified dates. At the time of this report the patient had not yet recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea, Pathology test, Rash, Urinary tract infection, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female patient with no known drug allergies, who on 22-AUG-2007 was vaccinated with the first dose of GARDASIL (lot#657736/0389U) 0.5ml intramuscularly at the health department. In October 2007, the patient started experiencing nausea and vomiting, which required hospitalization twice for dehydration. The patient also experienced episodes of rash, dizziness, disorientation, "problems with blood glucose", and urinary tract infections. Patient sought medical attention by calling the health department. The patient has been evaluated by an unspecified endocrinologist but a diagnosis has not been made at the time of the report. A colonoscopy and other unspecified tests were performed which were negative. Patient received her second and third dose of GARDASIL on unspecified dates. At the time of this report the patient had not yet recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Capillary nail refill test, Livedo reticularis, Rotavirus test positive
Clinical narrative: T 39, diarrhea, mottled, decreased cap refill required. Suspect mild virus infection. Note: stool sent to office for dsRNA rotavirus genome testing.  2/17/09 Received hospital medical records of 1/26-1/31/2009. FINAL DX: Rotavirus, dehydration resolved Records reveal patient experienced yellow watery diarrhea, fever, irritability, oral intake reduced x 2 days & decreased UOP x 1 days.  Exam revealed mottled skin, delayed cap refill, fever of 39.3 & dry lips.  Tx w/IVF & formula change.  Improved & d/c to home.  Sibling also developed watery diarrhea.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Drug exposure during pregnancy, Premature labour
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female patient who on 03-JUN-2008 was vaccinated with a dose of GARDASIL. Concomitant therapy included MENACTRA. On 14-SEP-2008 the patient delivered at 29 weeks pregnant. The status of the baby is unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Foetal disorder
Clinical narrative: Information has been received for the pregnancy registry for GARDASIL from a 20 year old female patient who was vaccinated with the first dose of GARDASIL (lot# not provided) when she was "around one month pregnant".  Subsequently the baby had some complications and when patient was three months pregnant she terminated the pregnancy due to the complications.  Patient was then referred to another physician (name not provided) who told the patient that the complications she had with the baby were probably related to GARDASIL.  Upon internal review, the termination of the pregnancy was considered an other important medical event.  No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain lower, Activities of daily living impaired, Anxiety, Colonoscopy, Decreased appetite
Clinical narrative: Information has been received from a physician concerning a 10 year old female patient with anterior and posterior endometriosis and SYNAREL allergy and a history of laparoscopic band surgery (2007) who on 08-MAY-2008 was vaccinated with first dose of GARDASIL (Lot # not reported). Concomitant therapy included LUPRON DEPOT on 06-NOV-2008, in December 2008 and January 2009. In June-2008 after administration of vaccine the patient experienced intermittent lower anterior abdominal pain on left and right side. The pain was below umbilicus more midline than lateral. Patient had lower abdominal wall tenderness. She also experienced anxiety, nausea and decrease in appetite. She was hospitalized in June of 2008 for a few days due to dehydration and abdominal pain. She did not experience pain in July and August of 2008. On 03-JUL-2008, the patient was vaccinated with the second dose of GARDASIL (lot # not reported). In September of 2008 abdominal pain returned. She was hospitalized 16-SEP-2008 to 18-SEP-2008 and then again in October of 2008. On 03-NOV-2008, the patient was vaccinated with the third dose of GARDASIL (lot # not reported). On 22-JAN-2009 to 23-JAN-2009 she was hospitalized for dehydration. She was unable to attend college because of her symptoms. She was being treated with PERCOCET and DILAUDID but was not currently taking either medication. In September 2008 laparoscopy was performed (results not reported). Also colonoscopy, computed axial tomography, sonogram and complete blood cell count were performed (results not reported). At the time of the report on 27-JAN-2009 the patient was recovering. The patient sought medical attention office visit. The physician considered intermittent lower anterior abdominal pain on left and right side, anxiety, nausea and decrease in appetite to be disabling. Additional information has been requested.   2/10/09 Received hospital medical records of 9/16-9/18/09. FINAL DX: pelvic pain, endometriosis Records reveal patient experienced lower abdominal pain, cramping since 9/8/08 & had been seen in ER several times since then.  Similar s/s in 6/08 & had been on BCP since 5/09.  Tx w/IVF & pain meds.  Laparoscopy done w/findings of multiple areas of endometriosis.  Tx w/endocoagulation.  Progressed well & d/c to home w/continued GYN f/u
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dehydration, Full blood count, Laparoscopy, Nausea, Tenderness
Clinical narrative: Information has been received from a physician concerning a 10 year old female patient with anterior and posterior endometriosis and SYNAREL allergy and a history of laparoscopic band surgery (2007) who on 08-MAY-2008 was vaccinated with first dose of GARDASIL (Lot # not reported). Concomitant therapy included LUPRON DEPOT on 06-NOV-2008, in December 2008 and January 2009. In June-2008 after administration of vaccine the patient experienced intermittent lower anterior abdominal pain on left and right side. The pain was below umbilicus more midline than lateral. Patient had lower abdominal wall tenderness. She also experienced anxiety, nausea and decrease in appetite. She was hospitalized in June of 2008 for a few days due to dehydration and abdominal pain. She did not experience pain in July and August of 2008. On 03-JUL-2008, the patient was vaccinated with the second dose of GARDASIL (lot # not reported). In September of 2008 abdominal pain returned. She was hospitalized 16-SEP-2008 to 18-SEP-2008 and then again in October of 2008. On 03-NOV-2008, the patient was vaccinated with the third dose of GARDASIL (lot # not reported). On 22-JAN-2009 to 23-JAN-2009 she was hospitalized for dehydration. She was unable to attend college because of her symptoms. She was being treated with PERCOCET and DILAUDID but was not currently taking either medication. In September 2008 laparoscopy was performed (results not reported). Also colonoscopy, computed axial tomography, sonogram and complete blood cell count were performed (results not reported). At the time of the report on 27-JAN-2009 the patient was recovering. The patient sought medical attention office visit. The physician considered intermittent lower anterior abdominal pain on left and right side, anxiety, nausea and decrease in appetite to be disabling. Additional information has been requested.   2/10/09 Received hospital medical records of 9/16-9/18/09. FINAL DX: pelvic pain, endometriosis Records reveal patient experienced lower abdominal pain, cramping since 9/8/08 & had been seen in ER several times since then.  Similar s/s in 6/08 & had been on BCP since 5/09.  Tx w/IVF & pain meds.  Laparoscopy done w/findings of multiple areas of endometriosis.  Tx w/endocoagulation.  Progressed well & d/c to home w/continued GYN f/u
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 10 year old female patient with anterior and posterior endometriosis and SYNAREL allergy and a history of laparoscopic band surgery (2007) who on 08-MAY-2008 was vaccinated with first dose of GARDASIL (Lot # not reported). Concomitant therapy included LUPRON DEPOT on 06-NOV-2008, in December 2008 and January 2009. In June-2008 after administration of vaccine the patient experienced intermittent lower anterior abdominal pain on left and right side. The pain was below umbilicus more midline than lateral. Patient had lower abdominal wall tenderness. She also experienced anxiety, nausea and decrease in appetite. She was hospitalized in June of 2008 for a few days due to dehydration and abdominal pain. She did not experience pain in July and August of 2008. On 03-JUL-2008, the patient was vaccinated with the second dose of GARDASIL (lot # not reported). In September of 2008 abdominal pain returned. She was hospitalized 16-SEP-2008 to 18-SEP-2008 and then again in October of 2008. On 03-NOV-2008, the patient was vaccinated with the third dose of GARDASIL (lot # not reported). On 22-JAN-2009 to 23-JAN-2009 she was hospitalized for dehydration. She was unable to attend college because of her symptoms. She was being treated with PERCOCET and DILAUDID but was not currently taking either medication. In September 2008 laparoscopy was performed (results not reported). Also colonoscopy, computed axial tomography, sonogram and complete blood cell count were performed (results not reported). At the time of the report on 27-JAN-2009 the patient was recovering. The patient sought medical attention office visit. The physician considered intermittent lower anterior abdominal pain on left and right side, anxiety, nausea and decrease in appetite to be disabling. Additional information has been requested.   2/10/09 Received hospital medical records of 9/16-9/18/09. FINAL DX: pelvic pain, endometriosis Records reveal patient experienced lower abdominal pain, cramping since 9/8/08 & had been seen in ER several times since then.  Similar s/s in 6/08 & had been on BCP since 5/09.  Tx w/IVF & pain meds.  Laparoscopy done w/findings of multiple areas of endometriosis.  Tx w/endocoagulation.  Progressed well & d/c to home w/continued GYN f/u
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a physician concerning a child who was vaccinated with a dose of ROTATEQ (lot# not available) orally. Child developed rotavirus after receiving the vaccine and was hospitalized. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a physician concerning a child who was vaccinated with a dose of ROTATEQ (lot# not available) orally.  Child developed rotavirus after receiving the vaccine and was hospitalized.  This is one of two reports from the same source.  Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Deep vein thrombosis, Injection site reaction, Phlebitis, Thrombosis
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a "booster" dose of PNEUMOVAX 23 (Lot # not provided). After patient received PNEUMOVAX 23, the patient experienced blood clots at the injection site and phlebitis of the extremities. This is one of two reports from the same source. Additional information has been received from Health Care worker concerning a 82 year old male patient who was vaccinated with PNEUMOVAX 23 (Lot # not provided). Concomitant therapy included FLUOGEN on 15-NOV-2008. On 15-NOV-2008 he developed deep vein thrombosis in right arm. Patient was hospitalized for 5 days. Additional information is not expected.
Age: 1.3
Sex: U
Vaccine: HIBV
Symptoms: Haemophilus infection, Hypogammaglobulinaemia, Meningitis
Clinical narrative: It was reported in a published article, title as stated above that a 15 month old patient was vaccinated with a first and second dose of PEDVAXHIB at 2 and 6 months of age.  There was no booster dose given, per CDC recommendations during a shortage.  Subsequently, the patient experienced invasive haemophilus type b (Hib) disease.  In January 2008, at 15 months of age the patient had a clinical syndrome of meningitis.  It was noted that the patient survived.  It was also noted that subsequent to Hib infection, the child was diagnosed with hypogammaglobulinemia.  The child was not enrolled in group child care.  At the time of the report, the patient's status was unknown.  Upon internal review, meningitis was considered to be an other important medical event.  No further information is available.  A copy of the published article is attached as further documentation of the patient's experience.
Age: 0.6
Sex: F
Vaccine: RV5, DTAPHEPBIP, FLU3, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Diarrhoea, Oliguria, Pyrexia, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 22 week old female patient who on 06-JAN-2009 was orally vaccinated with the third dose of ROTATEQ (lot # 660881/0310X). It was reported that on 06-JAN-2009 the patient developed diarrhea, persistent vomiting, fever and oliguria since receiving her third dose of ROTATEQ. The patient was seen in the local emergency room and was prescribed unspecified anti-diarrhea medication. The patient was then examined in the office on an unspecified date and was prescribed PEDIALYTE. The parents of the patient called the physician's office today to relay that the symptoms have not improved and were referred to the local pediatric urgent care facility. The nurse considered the patient's diarrhea and persisting vomiting, fever and oliguria to be disabling and immediately life-threatening. A lot check has been requested. Additional information has been requested.
Age: 0.6
Sex: F
Vaccine: RV5, DTAPHEPBIP, FLU3, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Diarrhoea, No reaction on previous exposure to drug, Pyrexia, Urine output decreased, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 22 week old female patient who on 06-JAN-2009 was orally vaccinated with the third dose of ROTATEQ (lot # 660881/0310X). It was reported that on 06-JAN-2009 the patient developed diarrhea, persistent vomiting, fever and oliguria since receiving her third dose of ROTATEQ. The patient was seen in the local emergency room and was prescribed unspecified anti-diarrhea medication. The patient was then examined in the office on an unspecified date and was prescribed PEDIALYTE. The parents of the patient called the physician's office today to relay that the symptoms have not improved and were referred to the local pediatric urgent care facility. The nurse considered the patient's diarrhea and persisting vomiting, fever and oliguria to be disabling and immediately life-threatening. A lot check has been requested. Additional information has been requested.
Age: 0.6
Sex: F
Vaccine: RV5, DTAPHEPBIP, FLU3, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Diarrhoea, Pyrexia, Urine output decreased, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 22 week old female patient who on 06-JAN-2009 was orally vaccinated with the third dose of ROTATEQ (lot # 660881/0310X). It was reported that on 06-JAN-2009 the patient developed diarrhea, persistent vomiting, fever and oliguria since receiving her third dose of ROTATEQ. The patient was seen in the local emergency room and was prescribed unspecified anti-diarrhea medication. The patient was then examined in the office on an unspecified date and was prescribed PEDIALYTE. The parents of the patient called the physician's office today to relay that the symptoms have not improved and were referred to the local pediatric urgent care facility. The nurse considered the patient's diarrhea and persisting vomiting, fever and oliguria to be disabling and immediately life-threatening. A lot check has been requested. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Enema administration, Haematochezia, Intussusception, Vomiting
Clinical narrative: Information has been received from an investigator concerning a 3 month old female who was vaccinated with a first dose of ROTATEQ.  This report was part of a post-marketing surveillance study.  The infant (33 week twin) with 4 days of diarrhea and bloodystool and vomiting for 1 day referred to emergency department to rule out intussusception.  The patient was hospitalized on 30-SEP-2007.  Diagnosis confirmed by first air contrast enema, second air contrast enema successfully reduced ileocolic intussusception.  The patient was discharged home.  Event was 53 days post dose 1 of ROTATEQ.  Intussusception was determined to be an other important medical event.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Foetal disorder
Clinical narrative: Information has been received from a licensed practical nurse for the pregnancy registry for GARDASIL concerning a pregnant female patient with herpes simplex type II who was vaccinated with GARDASIL.  Concomitant therapies included VALTREX and prenatal vitamins (unspecified).  No complications during the pregnancy.  On 24-NOV-2008 the patient's baby was having non reassuring fetal heart tones, and patient delivered her baby via cesarean section.  Infant was born normal, without congenital anomalies 40 weeks from LMP.  Baby is a 6 pounds male with an Apgar score of 7/8.  Upon internal review, non reassuring fetal heart tones and cesarean section was determined to be an other important medical event.  No further information is available.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a nurse and the patient's mother for the pregnancy registry for GARDASIL, concerning a 15 year old female with Amoxicillin allergy and psoriasis who on 21-OCT-2008 was vaccinated with the first dose GARDASIL (Lot not provided). Concomitant therapy included hepatitis A virus vaccine (unspecified). On 23-DEC-2008 the patient received the second dose of GARDASIL (Lot not provided). Subsequently the patient discovered that she was pregnant via pregnancy test (LMP: 08-NOV-2008, EDD: 15-AUG-2009). As of 15-JAN-2009 the patient was fine. Follow up information has been received on 29-JAN-2009 from the patient's mother concerning her 15 year old daughter who on 25-JAN-2009 had a miscarriage. Upon internal review, miscarriage was considered to be an Other Important Medical Event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity, Pneumonia
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female patient who on 16-OCT-2008 was vaccinated with the first dose of GARDASIL (lot# 659184/0843X) 0.5ml intramuscularly.  Subsequently the patient developed sharp, intermittent abdominal pain, which resolved without treatment in an unspecified length of time.  On 18-DEC-2008 the patient received her second dose of GARDASIL (lot# 659184/0843X) 0.5ml intramuscularly.  On 22-DEC-2008 patient developed intense abdominal pain as well as pain in her lower extremities.  Patient's parent sought medical attention by calling the health department.  The nurse is unsure if the pain had resolve at the time of this report.  On 05-JAN-2009 patient was hospitalized with a diagnosis of pneumonia and was discharged on 07-JAN-2009.  This is one of several reports received from the same source.  Additional information has been requested.  3/23/09 Received ER & Clinic medical records of 1/19-2/26/2009. FINAL DX: constipation; chronic abdominal pain Records reveal patient experienced crampy intermittent severe abdominal pain & nausea since 10/08 which had worsened in 12/08 & now included muscle tenderness when seen in ER 1/19/09.  Had been using narcotic pain meds, dx w/constipation, & tx w/laxative.  Had missed several days of school due to pain & the pain would awaken her at night.  Seen in GI clinic 1/19/09.  Tx w/laxative & enema w/resolution of abd pain.  Psych counseling started.  RTC 1/26 dx w/functional dyspepsia & meds adjusted.  RTC 2/4/09 w/right back/shoulder pain, vomiting, HAs, abdominal pain improved, classes 1/2 days & exhaustion when completed.  RTC 2/26 w/20# weight gain, continued missed school although abdominal pain & HA less but continued daily.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Back pain, Full blood count normal, Mononucleosis heterophile test, Neck pain
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female patient who on 16-OCT-2008 was vaccinated with the first dose of GARDASIL (lot# 659184/0843X) 0.5ml intramuscularly.  Subsequently the patient developed sharp, intermittent abdominal pain, which resolved without treatment in an unspecified length of time.  On 18-DEC-2008 the patient received her second dose of GARDASIL (lot# 659184/0843X) 0.5ml intramuscularly.  On 22-DEC-2008 patient developed intense abdominal pain as well as pain in her lower extremities.  Patient's parent sought medical attention by calling the health department.  The nurse is unsure if the pain had resolve at the time of this report.  On 05-JAN-2009 patient was hospitalized with a diagnosis of pneumonia and was discharged on 07-JAN-2009.  This is one of several reports received from the same source.  Additional information has been requested.  3/23/09 Received ER & Clinic medical records of 1/19-2/26/2009. FINAL DX: constipation; chronic abdominal pain Records reveal patient experienced crampy intermittent severe abdominal pain & nausea since 10/08 which had worsened in 12/08 & now included muscle tenderness when seen in ER 1/19/09.  Had been using narcotic pain meds, dx w/constipation, & tx w/laxative.  Had missed several days of school due to pain & the pain would awaken her at night.  Seen in GI clinic 1/19/09.  Tx w/laxative & enema w/resolution of abd pain.  Psych counseling started.  RTC 1/26 dx w/functional dyspepsia & meds adjusted.  RTC 2/4/09 w/right back/shoulder pain, vomiting, HAs, abdominal pain improved, classes 1/2 days & exhaustion when completed.  RTC 2/26 w/20# weight gain, continued missed school although abdominal pain & HA less but continued daily.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity, Pneumonia, Streptococcal identification test negative
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female patient who on 16-OCT-2008 was vaccinated with the first dose of GARDASIL (lot# 659184/0843X) 0.5ml intramuscularly.  Subsequently the patient developed sharp, intermittent abdominal pain, which resolved without treatment in an unspecified length of time.  On 18-DEC-2008 the patient received her second dose of GARDASIL (lot# 659184/0843X) 0.5ml intramuscularly.  On 22-DEC-2008 patient developed intense abdominal pain as well as pain in her lower extremities.  Patient's parent sought medical attention by calling the health department.  The nurse is unsure if the pain had resolve at the time of this report.  On 05-JAN-2009 patient was hospitalized with a diagnosis of pneumonia and was discharged on 07-JAN-2009.  This is one of several reports received from the same source.  Additional information has been requested.  3/23/09 Received ER & Clinic medical records of 1/19-2/26/2009. FINAL DX: constipation; chronic abdominal pain Records reveal patient experienced crampy intermittent severe abdominal pain & nausea since 10/08 which had worsened in 12/08 & now included muscle tenderness when seen in ER 1/19/09.  Had been using narcotic pain meds, dx w/constipation, & tx w/laxative.  Had missed several days of school due to pain & the pain would awaken her at night.  Seen in GI clinic 1/19/09.  Tx w/laxative & enema w/resolution of abd pain.  Psych counseling started.  RTC 1/26 dx w/functional dyspepsia & meds adjusted.  RTC 2/4/09 w/right back/shoulder pain, vomiting, HAs, abdominal pain improved, classes 1/2 days & exhaustion when completed.  RTC 2/26 w/20# weight gain, continued missed school although abdominal pain & HA less but continued daily.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Dizziness, Electrocardiogram normal, Electroencephalogram normal, Headache
Clinical narrative: Information has been received from a healthcare worker concerning a 17 year old female patient with no known drug reactions/allergies and medical history who on 15-OCT-2008 was vaccinated intramuscularly with the first dose 0.5 ml dose of GARDASIL (Lot #660618/0572X), and on 22-DEC-2008 with the second dose of GARDASIL (Lot #661044/0548X). There was no concomitant medication. On 29-DEC-2008 at home the patient experienced syncope and possible seizure. The patient was evaluated at a local emergency room and a CT scan of the brain and Electrocardiogram were normal. Since then, the patient had experienced persistent dizziness, headaches, and nausea. The patient was examined in the office and was prescribed PREVACID. An Electroencephalogram was normal. The stool was positive for occult blood so the patient was referred to an unspecified gastroenterologist. An abdominal ultrasound and endoscopy had been scheduled. The patient sought medical attention. At the time of reporting the patient was not recovered. Upon internal review seizures were considered to be an other important medical event. Additional information has been requested.