chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: RV5, UNK
Symptoms: Heart rate normal, Pyrexia, Respiratory rate increased, Rotavirus infection, Rotavirus test positive
Clinical narrative: This is in follow-up to report(s) previously submitted on 4/15/2008. Information Has been received from a nurse concerning a female who on 30-JUL-2008 was vaccinated live with orally ROTATEQ. Concomitant therapy included all "two month old vaccines" on 30-JUL-2008. The patient was seen in the office on 14-AUG-2008 with decreased appetite, low grade fever 99*F and loose stools. The patient was diagnosed with upper respiratory infection and diarrhea. The patient was seen in the emergency room on 16-AUG-2008 since the infant had vomiting and diarrhea. The patient was given IV fluids in the emergency room and discharged to home. On 18-AUG-2008, the patient was seen in the office for Rotavirus. On 19-AUG-2008, stool came back from hospital positive for rotavirus. It was reported that the patient recovered from the events (date unknown). No product quality complaint involved. Additional information has been received from a physician concerning a 10 week old female with NKDA, no birth defects and no medical history, who on 24-JUL-2008, was vaccinated with the first dose of oral ROTATEQ. Illness at time of vaccination included GERD. Concomitant therapy ZANTAC. On 16-AUG-2008, the patient was brought to the ER with complaints of diarrhea and vomiting. She had diarrhea for the last week, only had 1-2 loose stools a day and she had been vomiting. She was diagnosed with reflux and she had been spitting up. She was seen by her primary care physician earlier in the week and was instructed to continue feeding and to give her Pedialyte as needed. They increased her ZANTAC and switched her to Entamil gentle ease. It was reported that over the last 24 hours she has had about 10-11 watery stools but no fever. She has had a mild runny nose. She had still been waiting diapers, but was eating less. She was not  vomiting but just was not eating as well as her usual. The patient had IV initiated in the ER and was given a fluid bolus. Blood work was obtained. Her white count was 18,00 which is mildly elevated, predominant lymphocyte count rather. Catherized urine sample was negative for any signs of infection, bicarbonate 15 and glucose 117. She was hydrated for several hours. She tolerated a ounces of fluid and did not spit up. She had two small seedy stools one was sent for rotazyme and culture. In the evening of 16-AUG-2008, the stool culture came back positive for rotavirus. The patient's condition improved. She was active and discharged to home. Finial impression was acute vomiting with diarrhea. The pateint's formula was switched to Isomil soy formula to help with the diarrhea. The pateint was to continue with pedialyte and ordered to follow up with pediatrician for reevaluation on Monday. The patient was reported as recovered on 23-AUG-2008. Additional information is not expected.
Age: 0.17
Sex: F
Vaccine: RV5, UNK
Symptoms: Upper respiratory tract infection, Vomiting, White blood cell count increased
Clinical narrative: This is in follow-up to report(s) previously submitted on 4/15/2008. Information Has been received from a nurse concerning a female who on 30-JUL-2008 was vaccinated live with orally ROTATEQ. Concomitant therapy included all "two month old vaccines" on 30-JUL-2008. The patient was seen in the office on 14-AUG-2008 with decreased appetite, low grade fever 99*F and loose stools. The patient was diagnosed with upper respiratory infection and diarrhea. The patient was seen in the emergency room on 16-AUG-2008 since the infant had vomiting and diarrhea. The patient was given IV fluids in the emergency room and discharged to home. On 18-AUG-2008, the patient was seen in the office for Rotavirus. On 19-AUG-2008, stool came back from hospital positive for rotavirus. It was reported that the patient recovered from the events (date unknown). No product quality complaint involved. Additional information has been received from a physician concerning a 10 week old female with NKDA, no birth defects and no medical history, who on 24-JUL-2008, was vaccinated with the first dose of oral ROTATEQ. Illness at time of vaccination included GERD. Concomitant therapy ZANTAC. On 16-AUG-2008, the patient was brought to the ER with complaints of diarrhea and vomiting. She had diarrhea for the last week, only had 1-2 loose stools a day and she had been vomiting. She was diagnosed with reflux and she had been spitting up. She was seen by her primary care physician earlier in the week and was instructed to continue feeding and to give her Pedialyte as needed. They increased her ZANTAC and switched her to Entamil gentle ease. It was reported that over the last 24 hours she has had about 10-11 watery stools but no fever. She has had a mild runny nose. She had still been waiting diapers, but was eating less. She was not  vomiting but just was not eating as well as her usual. The patient had IV initiated in the ER and was given a fluid bolus. Blood work was obtained. Her white count was 18,00 which is mildly elevated, predominant lymphocyte count rather. Catherized urine sample was negative for any signs of infection, bicarbonate 15 and glucose 117. She was hydrated for several hours. She tolerated a ounces of fluid and did not spit up. She had two small seedy stools one was sent for rotazyme and culture. In the evening of 16-AUG-2008, the stool culture came back positive for rotavirus. The patient's condition improved. She was active and discharged to home. Finial impression was acute vomiting with diarrhea. The pateint's formula was switched to Isomil soy formula to help with the diarrhea. The pateint was to continue with pedialyte and ordered to follow up with pediatrician for reevaluation on Monday. The patient was reported as recovered on 23-AUG-2008. Additional information is not expected.
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a registered nurse concerning "some of her patients" who on unspecified dates were vaccinated with ROTATEQ (human-bovine). Subsequently, the patients developed diarrhea after receiving the vaccination. At the time of the report, the patient's status were unknown. There was no product quality complaint involved. Follow-up information received from a registered nurse indicated that there was only one male patient that had diarrhea after receiving ROTATEQ (human-bovine). It was noted that the diarrhea was not related to the vaccine, but to the formula the patient was given. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Regurgitation
Clinical narrative: Information has been received from a nurse concerning patients who were vaccinated with ROTATEQ vaccine live (human-bovine) (dates not reported). It was reported that "some" patients have regurgitated the ROTATEQ vaccine live (human-bovine). It was known not to re-dose. The nurse felt that the reaction of regurgitation was not related to the vaccine and was a natural response. No further information is expected.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 17-week-old male who during June 2008, was vaccinated with the first oral dose of ROTATEQ (human-bovine). It was reported that the patient threw up immediately upon administration of the vaccine. Unspecified medical attention was sought in the doctor's office. No product quality complaint was involved. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 2 month old male with no pertinent medical history or drug allergies, who received his first dose of oral ROTATEQ vaccine live (human-bovine), 1 pouch, one week ago and developed loose stools 2 days after the dose. The loose stools have persisted. No bleeding noted. It is reported that the patient is recovering. There were no diagnostic lab tests performed. Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Infantile spitting up
Clinical narrative: Information was received fro a physician regarding a patient  who on 26-AUG-2008 received one dose of oral ROTATEQ (human-bovine) (lot# not reported), and spit it up. The patient was considered to be recovered on 26-AUG-2008. The patient sought medical attention while in the office. No product quality complaint was involved.  No further information is expected.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Pyrexia, Vomiting
Clinical narrative: Information has been received from a pharmacist concerning a 2 month old male who "about 1 week ago" (approximately 22-AUG-2008) was vaccinated with his first oral dose of ROTATEQ vaccine live (human-bovine). Concomitant therapy included tetanus toxoid and hepatitis B virus vaccine (unspecified). The pharmacist reported that her son vomited about 75% of his first dose of ROTATEQ vaccine live (human-bovine). Later that day, he had a fever of 100.7 degrees F and was given TYLENOL. Subsequently, the patient recovered from vomited about 75% of ROTATEQ vaccine live (human-bovine) and fever of 100.7 degrees F on an unknown date. No medical attention was sought. No product quality complaint. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: Information has been received from a physician concerning a 59 day old female who on 16-JUN-2008 was vaccinated with her first oral dose of ROTATEQ (human-bovine). Concomitant therapy included other routine 2-month old vaccinations. The physician reported that when the patient was vaccinated with her first dose of ROTATEQ (human-bovine) on 16-JUN-2008 vomited the entire contents of their stomach almost immediately after receiving the vaccine. The physician reported that the patient was given a re-dose of ROTATEQ (human-bovine) vaccine on 19-JUN-2008. Unspecified medical attention was sought. No product quality complaint.  Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Culture stool negative, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning an approximately 23 week old male infant who on 07-JUL-2008 was vaccinated orally with a second dose of ROTATEQ (lot # 660600/0281X). The first dose of ROTATEQ (lot # 660376/0019X) was given on 05-MAY-2008. Concomitant vaccinations on the same day as the second dose (07-JUL-2008) included DTaP, PREVNAR, poliovirus vaccine inactivated (unspecified) (manufacturer unknown) and Hib conj vaccine (manufacturer unknown). It was noted that the patient experienced diarrhea, vomiting, and a fever of 102.7 approximately 4-5 days before being admitted to the hospital on 10-AUG-2008. The patient's stool cultures were negative. On 12-AUG-2008, the patient was discharged from the hospital. Subsequently, the patient recovered on an unspecified date. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Faeces discoloured
Clinical narrative: Information has been received from a registered nurse concerning a 2 month old female who on 29-JUL-2008 was vaccinated orally with the first dose of ROTATEQ vaccine live (human-bovine) (lot number: 660679/0407X) and within 24 hours developed grey colored diarrhea that has persisted. The patient is reported to be recovering. Additional information has been requested. Additional information has been received from a physician indicating that the patient developed gray diarrhea within one week of receiving ROTATEQ. The diarrhea continued for one month and then went back to normal color. The patient was not previously exposed to this or related drug. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a health professional concerning an "infant" patient (demographics not provided) who was vaccinated on an unspecified date with the third dose of ROTATEQ vaccine live (human-bovine) (lot# not reported). Subsequently, on an unspecified date, the patient experienced diarrhea. The patient's outcome was not reported. Additional information has been requested.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia, Retching, Vomiting
Clinical narrative: Information has been received from a physician concerning a 2 month old female who on 07-AUG-2008 was vaccinated with her first dose of ROTATEQ vaccine live (human-bovine) (lot number not reported). Concomitant therapy included PREVNAR vaccine (CRM197), diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (PEDIARIX) and study vaccination (unspecified). On 07-AUG-2008 the patient's mother called and stated the child developed a fever and she gave her OTC TYLENOL. The child then started to vomit and that continued into the evening. A follow-up call to the mother on 08-AUG-2008 was made, and the mother said that her child was improving. Additional information has been requested. 12/3/08 This is in follow-up to report(s) previously submitted on 9/15/2008. Information has been received from a physician concerning a 9 week old female with no medical history or allergies who on 07-AUG-2008 was vaccinated with her first dose of ROTATEQ (lot #660599/0208X). Secondary suspect concomitant therapy included PREVNAR (lot #C65934), PEDIARIX (lot #AC21B143AA) and Hib conj vaccine (manufacturer unknown) (lot #UF37AA). On 07-AUG-2008 the patient's mother called and stated the child developed a fever and she gave her OTC TYLENOL and she began vomiting until she dry heaved which continued into the evening. The mother was instructed to keep the child elevated for 20 minutes after feeding with good burping. A follow-up call to the mother on 08-AUG-2008 was made and it was reported the emesis resolved, but the child still had a temperature of 100. The mother was further instructed to continue OTC TYLENOL prn for fever if tolerated by the child and to call the office back if emesis returned or new symptoms appeared. It was reported the child recovered from emesis and fever in one day. Additional information is not expected.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a registered nurse concerning an 18 week old white female infant with no known allergies or pertinent medical history who on 23-JUN-2008 was vaccinated orally in the AM with a second dose of ROTATEQ vaccine live (human-bovine) (lot # 660596/0211X). There was no illness at the time of vaccination or any adverse events following prior vaccination. Subsequently, on the same day of vaccination (in the PM) the patient had loose, watery stools that lasted 4-5 days. There were no lab studies performed. At the time of the report, the patient recovered on approximately 27-JUN-2008. Additional information is not expected.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning an 18-week old male who on 08-AUG-2008 was vaccinated orally with the first dose of ROTATEQ vaccine live (human-bovine) (lot# not reported). No adverse effects were reported and no other information is available at this time. Patient outcome was not reported. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a physician concerning a 4 month old male who on unspecified dates were vaccinated with ROTATEQ vaccine live (human-bovine) at his 2 month and 4 month check up visits. It was noted that at the two month check up visit the patient vomited and was re-dosed. It was also noted that at the four month visit the patient received another dose of ROTATEQ vaccine live (human-bovine) and vomited again, but was not re-dosed. Unspecified medical attention was sought. It was unspecified if lab studies were performed. At the time of the report, the patient's status was unknown. There was no product quality complaint involved. No further information is available.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a certified medical assistant concerning a patient who on 14-AUG-2008 was vaccinated orally with a second 2ml dose of ROTATEQ vaccine live (human-bovine) 11 weeks after first dose. The first dose of ROTATEQ vaccine live (human-bovine) was given on 28-MAY-2008. There were no adverse effects reported. At the time of the report, the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare professional concerning a patient who on 15-AUG-2008 was vaccinated with a second dose of ROTATEQ vaccine live (human-bovine) that was greater than 10 weeks from the previous dose. The first dose of ROTATEQ vaccine live (human-bovine) was administered on 03-JUN-2008. There were no problems reported. At the time of the report, the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 2 month old female patient with no known allergies or pertinent medical history who on 12-AUG-2008 was vaccinated orally with a first 2 ml dose of ROTATEQ vaccine live (human-bovine). There was no concomitant medication. On 14-AUG-2008 the patient experienced watery stools. Medical attention was sought in the office. There were no lab studies performed or treatments reported. At the time of the report, the patient was recovering. It was noted that the patient's stools became more solid on 15-AUG-2008. There were no other symptoms reported. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 09/15/2008. Follow-up information has been received from the physician's office. It was noted that the diarrhea was only for one day after vaccination. It was also noted that the mother did not think the diarrhea was related to the vaccine. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: Information has been received from a medical assistant concerning a patient who on 15-AUG-2008 was vaccinated with a first dose of ROTATEQ vaccine. It was reported that the patient had "thrown up" right after receiving the vaccination. At the time of the report, the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/25/2008. Follow-up information has been received from a medical assistant indicated that the child "simply spit up." At the time of the report the patient's status was unknown.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Inappropriate schedule of drug administration, Regurgitation
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 60 day old female with no medical history or allergies who on 15-AUG-2008 was vaccinated PO with the first 2.0 ml dose of ROTATEQ vaccine live (human-bovine) and on 18-AUG-2008 was vaccinated PO with the second and third 2.0 ml dose of ROTATEQ vaccine live (human-bovine). Concomitant vaccine therapy on 15-AUG-2008 included diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (PEDIARIX), Hib conj vaccine (unspecified carrier) (manufacturer unknown) and pneumococcal vaccine (unspecified) (manufacturer unknown). On 15-AUG-2008, the RN reported that the patient regurgitated the first dose of ROTATEQ vaccine live (human-bovine). On 18-AUG-2008, the ROTATEQ vaccine live (human-bovine) dose was attempted twice and both times the dose was regurgitated. No other adverse symptoms were reported and medical attention was sought at an office visit. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a patient who on 08-APR-2008 and on 18-AUG-2008 was vaccinated with the first and second dose respectively of ROTATEQ vaccine live (human-bovine). No adverse effect were reported. It was unknown if patient sought medical attention. A product quality complaint was not involved. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Anorexia
Clinical narrative: Information has been received from a physician concerning a 4 month old female with a history of premature baby 34 weeks and bronchopulmonary dysplasia who on approximately 11-AUG-2008 was vaccinated PO with the second dose of ROTATEQ vaccine live (human-bovine). The physician reported that on approximately 12-AUG-2008 (the day after vaccine administration) the patient's mother complained the child lost her appetite. Unspecified medical attention was sought. Subsequently, the patient recovered from loss of appetite (date unspecified). A product quality complaint was not involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal behaviour, Anger, Feeling abnormal, Gaze palsy, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old white female with attention deficit/hyperactivity disorder and mental illness who on 03-JAN-2007, at 1230, was vaccinated intramuscularly into left deltoid with the first 0.5 ml dose of GARDASIL vaccine (yeast). (Lot number 654741/1208F). On 26-JAN-2007, the patient was vaccinated intramuscularly into left deltoid with the second dose of GARDASIL vaccine (yeast), (Lot number 654741/1208F). There was no illness at the time of vaccination. Concomitant therapy given on 03-JAN-2007 intramuscularly into right deltoid included the first dose of MENACTRA vaccine (dip toxoid) (Lot number U1808AA). Concomitant therapy also included CONCERTA. The patient's mother reported that on 26-JAN-2007 night, the patient "tripped out". The patient threw things, her eyes rolled into back of head and passes out for 3 minutes. The patient had never had anything like that before. The mother reported that the patient was "like a zombie this weekend". The patient was pale on 29-JAN-2007 and continued with anger outbursts over the weekend. There was no fever and no further episodes. The patient was not evaluated by anyone over the weekend. The mother called to seek medical attention on 29-JAN-2007. The doctor advised her to continue to monitor and to call if increased with concerns. No further call came back regarding symptoms. 3 to 4 days post the onset of the events (approximately 30-JAN-2007) the patient recovered. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old white female with attention deficit/hyperactivity disorder and mental illness who on 03-JAN-2007, at 1230, was vaccinated intramuscularly into left deltoid with the first 0.5 ml dose of GARDASIL vaccine (yeast). (Lot number 654741/1208F). On 26-JAN-2007, the patient was vaccinated intramuscularly into left deltoid with the second dose of GARDASIL vaccine (yeast), (Lot number 654741/1208F). There was no illness at the time of vaccination. Concomitant therapy given on 03-JAN-2007 intramuscularly into right deltoid included the first dose of MENACTRA vaccine (dip toxoid) (Lot number U1808AA). Concomitant therapy also included CONCERTA. The patient's mother reported that on 26-JAN-2007 night, the patient "tripped out". The patient threw things, her eyes rolled into back of head and passes out for 3 minutes. The patient had never had anything like that before. The mother reported that the patient was "like a zombie this weekend". The patient was pale on 29-JAN-2007 and continued with anger outbursts over the weekend. There was no fever and no further episodes. The patient was not evaluated by anyone over the weekend. The mother called to seek medical attention on 29-JAN-2007. The doctor advised her to continue to monitor and to call if increased with concerns. No further call came back regarding symptoms. 3 to 4 days post the onset of the events (approximately 30-JAN-2007) the patient recovered. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information and follow up information has been received for Pregnancy Registry for GARDASIL vaccine (yeast) from a 23 year old Caucasian female consumer with asthma and penicillin allergy who on 18-JUL-2007 was vaccinated IM with a first dose of GARDASIL vaccine (yeast) (Lot # 658100/0525U). Concomitant therapy included albuterol. The consumer reported that "I found out today (10-AUG-2007) that I am pregnant". No adverse reaction was reported. She had a "pregnancy test" done. The patient sought unspecified medical attention. The outcome was unknown. On 15-OCT-2007 the patient had a normal ultrasound. Additional information has been requested. Information was received on 07-APR-2008. A normal female infant was born on 21-MAR-2008 (weeks from LMP = 38 5/7). The baby weighed 6lbs. 11 oz. and had an Apgar score of 9/9. There were no congenital anomalies. The baby did develop some jaundice in the first few days of life. This resolved on it's own and was felt to be physiological. No other information was reported concerning this pregnancy. Follow-up information has been received in the form of medical records. On 23-MAR-2008, all state Department of Health tests screen-negative and no follow-up action was requested. On 24-MAR-2008, the newborn's total serum bilirubin test was 15.3 mg/mL (normal range 2.0 to 12.0). On 25-MAR-2008, the newborn's total serum bilirubin test was 18.4 mg/mL (normal range 2.0 to 12.0). On 26-MAR-2008, the newborn's total serum bilirubin test was 18.1 mg/mL (normal range 2.0 to 12.0). On 27-MAR-2008, the newborn's total serum bilirubin test was 16.3 mg/mL (normal range 2.0 to 12.0). On 10-APR-2008, the patient had a 2 week well child visit and all appeared normal. On 21-MAY-2008, the patient presented for a scheduled 2 months well child visit and baby's mother was concerned about the baby spitting up a lot. The baby "seems to be spitty". The physician found that the baby appeared healthy and gaining weight appropriately, so in that point he did not feel that the "spitting" was of any clinical significance. Physician noted will continue to monitor at future visits. Baby was given routine immunizations. On 21-JUL-2008, baby was at the physician's office for 4 month well child visit. It was noted the baby was still spitting up some, but now on formula  and spitting up less then was. Routine vaccinations were given. No additional information is expected. All medical records will be provided upon request.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Gestational diabetes, Ultrasound scan normal
Clinical narrative: Initial and follow up information has been received from a nurse practitioner concerning an 18 year old white female patient who on 18-JUL-2007, was vaccinated with a first 0.5ml dose of GARDASIL vaccine (yeast) (Lot# 657737/0522U). On 18-AUG-2007 a month later (4 weeks after her last menstrual period), the patient found out she was pregnant. The date of her last menstrual period was reported to be 17-JUN-2007. Her estimated delivery date was reported as 25-MAR-2008. Her pregnancy was confirmed by lab work and an ultrasound. It was reported that the patient had a total of 4 ultrasounds and al were within normal limits (WNL). Prenatal vitamins were reported to be taken during the pregnancy. The patient has not had any previous pregnancies or previous live births. On approximately 30-DEC-2007, 28 weeks from her last menstrual period, the patient developed gestational diabetes. On 14-MAR-2008, the patient gave birth to a liveborn infant male weighing 7 pounds 15 ounces. The infant was reported to be normal. It was unknown if the infant had any congenital anomalies or if there were any complications. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Dyspepsia, Pregnancy induced hypertension, Ultrasound antenatal screen normal
Clinical narrative: Initial follow up information has been received from a certified nurse midwife for the Pregnancy Registry for GARDASIL concerning an 18 year old obese, female who on 18-OCT-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot# and site not reported). Subsequently, the patient found out she was pregnant (LMP approximately 07-OCT-2007). On and unspecified date in December 2007, the patient was prescribed  ranitidine (unspecified) for heartburn. On 31-DEC-2007, 06-FEB-2008, and 03-MAR-2008, the patient had ultrasounds for "routine dating and follow up" which were reported to be within normal limits. On an unspecified date, the patient developed mild pregnancy induced hypertension (not further specified). The patient was induced at 37 weeks gestation. On 21-JUN-2008, the patient gave birth to a normal male infant (7 lb, 4 oz; 48.3 cm). There were no congenital anomalies. The infant had Apgar scores of 7 and 9. No additional information was provided. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Insomnia, Pain
Clinical narrative: Information has been received from a physician's assistant through a  pregnancy registry concerning a 21 year old female who on 08-AUG-2007 was vaccinated with the first dose of GARDASIL. The physician's assistant reported that the patient became pregnant after receiving the first dose of GARDASIL. At the time of the report, the patient had a gestational age of 16 weeks, and no adverse reactions were reported. The patient's last menstrual period was approximately 16-SEP-2007 with an estimated due date of 24-JUN-2008. Follow up information received from the physician's assistant stated that on an unspecified dates during the patient's pregnancy she developed pain (NOS) which was treated with TYLENOL 325 mg, PO, PRN and insomnia which was treated with BENADRYL 25 mg, PO, PRN. The patient's unspecified pain and insomnia were considered to be nonserious events. On 22-JUN-2008 at 40 wk 2 days gestation the patient gave birth to a normal female infant. The baby weighed 7 lbs. 6 oz and had a 9/10 Apgar score. It was also reported that there were no complications with the delivery. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Pregnancy test positive, Ultrasound antenatal screen normal
Clinical narrative: Initial and follow-up information has been received for the Pregnancy Registry for GARDASIL from a health professional concerning a 17 year old female with papilloma viral infection diagnosed in December 2007 history of 2 pregnancies, 1 live birth and a history of an elective termination who on an unspecified date was vaccinated with a first dose of GARDASIL. On 14-MAR-2007 the patient was vaccinated with a second dose of GARDASIL (lot#657006/0188U). Concomitant therapy included prenatal vitamins (CB Complete), iron (unspecified), PHENERGAN and ZOFRAN ODT. The patient's (last menstrual period) LMP date was 17-NOV-2007 and the  (estimated date of delivery) EDD date is 23AUG-2008. The estimated date of conception was 30-NOV-2007. On 23-JAN-2008 a confirmation ultrasound was performed and was within normal limits. On 19-MAR-2008 a maternal serum alpha-fetoprotein test was  performed for sequential screening and was within normal limits. There was no adverse experience was related to this event. Medical attention was sought in the office. The product quality complaint unit was not involved. Follow up information was received which indicated that the patient had one previous pregnancy and on elective termination  (6-8 weeks from LMP). The patient had allergy to sulfa and iron deficiency anemia and a history of Papilloma viral infection (biopsies revealed mild to moderate (cervical) dysplasia) and ankle fracture in motor vehicle accident (in MAY of 2007). It was also reported that the patient was group B Strep carrier during pregnancy. On 20-Feb-2008, the patient underwent sequential screen and the result indicated normal. On 19-AUG-2008 (39 3/7 weeks from LMP) the patient delivered a normal male baby who was 8 LB 1oz with an Apgar score 9/9. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Ear infection, Prophylaxis against Rh isoimmunisation, Rhesus antibodies negative
Clinical narrative: Initial and follow up information has been received for the  pregnancy registry for GARDASIL from a physician and a nurse concerning a 24 year old female with a past history of two previous pregnancies (1 full term delivery and 1 spontaneous abortion in the first trimester) and an allergy to AMOXYXILLIN who on 04-OCT-2007 was intramuscularly vaccinated with her first dose of GARDASIL (lot#658563/1063U). The patient received her second dose of GARDASIL (lot#658563/106U) on 29-NOV-2007. The patient was pregnant with an LMP of 30-Sep-2007, at the time of vaccination. Concomitant therapy included daily prenatal vitamins. No adverse events were reported. The patient sought unspecified medical attention by contacting the physician's office. On 14-Dec-2007 an ultrasound was performed to establish the expected delivery date. The patient is due 05-Aug-2008. On 21-Feb-2008 a MSAFP (alpha fetal) was performed, results were negative. the patient tested rH negative on an unspecified date. On 06-May-2008, the patient was given a single dose of globulin, immune. On an unspecified date, the patient was treated for an ear infection with an unknown dose of azithromycin for an unspecified period of time. The patient delivered a normal female baby on 03Aug2008 (39 weeks 5 days from LMP). The baby had APGAR scores of 6 and 9, weighed 9 lbs 8 oz, 48.3 cm long, and a head circumference of 37.0 cm. the patient had no complications during pregnancy or labor. Additional information is not expected
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound antenatal screen normal
Clinical narrative: Initial and follow up information has been received for the  pregnancy registry for GARDASIL from a physician and a nurse concerning a 24 year old female with a past history of two previous pregnancies (1 full term delivery and 1 spontaneous abortion in the first trimester) and an allergy to AMOXYXILLIN who on 04-OCT-2007 was intramuscularly vaccinated with her first dose of GARDASIL (lot#658563/1063U). The patient received her second dose of GARDASIL (lot#658563/106U) on 29-NOV-2007. The patient was pregnant with an LMP of 30-Sep-2007, at the time of vaccination. Concomitant therapy included daily prenatal vitamins. No adverse events were reported. The patient sought unspecified medical attention by contacting the physician's office. On 14-Dec-2007 an ultrasound was performed to establish the expected delivery date. The patient is due 05-Aug-2008. On 21-Feb-2008 a MSAFP (alpha fetal) was performed, results were negative. the patient tested rH negative on an unspecified date. On 06-May-2008, the patient was given a single dose of globulin, immune. On an unspecified date, the patient was treated for an ear infection with an unknown dose of azithromycin for an unspecified period of time. The patient delivered a normal female baby on 03Aug2008 (39 weeks 5 days from LMP). The baby had APGAR scores of 6 and 9, weighed 9 lbs 8 oz, 48.3 cm long, and a head circumference of 37.0 cm. the patient had no complications during pregnancy or labor. Additional information is not expected
Age: 22.0
Sex: F
Vaccine: HPV4, PPV
Symptoms: Drug exposure during pregnancy, Ultrasound antenatal screen normal, Urine human chorionic gonadotropin, Wrong drug administered
Clinical narrative: Initial and follow up information has been received from a registered nurse and through a Merck Pregnancy Registry concerning a 22 year old Hispanic female, with an obstetrical history of 0 pregnancies and 0 live births, who on 30-JAN-2008 was vaccinated intramuscularly with a dose of GARDASIL vaccine (yeast), (Lot # 0211U) and a dose of pneumococcal vaccine, polyval (MSD). Concomitant therapy include unspecified iron and vitamins. It was reported that the patient inadvertently received one dose of GARDASIL vaccine (yeast). The patient was suppose to get a hepatitis B virus vaccine rHBsAg (yeast), (manufacturer unknown) vaccine. The nurse said that this was not product confusion. The patient had not been notified at the time of the report. No other details were reported. It was reported that the patient was pregnant and last menstrual period (LMP) was 12-OCT-2007, (estimated date of delivery 19-JUL-2008). The patient had a urine pregnancy test, on 05-MAR-2008 an ultrasound was performed to determine the baby's growth, dates and anatomy. On 17-JUL-2008, 39.5 weeks from LMP, the patient delivered a normal, healthy male baby weighing 6 pounds 2 ounces, apgar 9/9. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Ultrasound antenatal screen normal, Wrong drug administered
Clinical narrative: Information has been received for the Pregnancy Registry for GARDASIL vaccine (yeast) from a 35 year old female with no pertinent medical history or drug reactions/allergies who on 16-APR-2008 was vaccinated with the "first dose of three doses" of GARDASIL vaccine (yeast) (lot# 0152X) injection. Concomitant therapy included RHOGAM. On 16-APR-2008 the patient was administered GARDASIL vaccine (yeast) instead of another injection the patient was supposed to be receiving. On an unspecified date an ultrasound was performed. No adverse side effects were reported as a result of this. The patient's gestation was 28 weeks. The date of the last menstrual period (LMP) and the estimated date of delivery (EDD) was unknown. Follow-up information was received from a registered nurse RN. The RN reported that the patient should have received RHOGAM injection for Rh negative on 16-APR-2008 but instead received the GARDASIL vaccine (yeast). The RN stated that the nurse who administered the GARDASIL vaccine (yeast) mistakenly did so. There was no product confusion involved. The patient received the RHOGAM injection after the patient received the GARDASIL vaccine (yeast) on 16-APR-2008. On 16-APR=2008, the patient had an ultrasound which was reported as  normal. Follow-up information was received. The patient had a history of 2 previous pregnancies with full-term deliveries. The patient had a history of macrosomia in both previous pregnancies. The birth weights were 9 pounds and 12 ounces and 10 pounds and 5 ounces. The patient's date of her last menstrual period was 06-OCT-2007, the estimated conception date was 20-OCT-2007 and the estimated date of delivery was 13-JUL-2008. On 05-MAR-2008 the patient had an ultrasound for AMA and it was within normal limits. On 14-MAY-2008 an ultrasound was within normal limits. On 09-JUL-2008 the patient delivered a normal, healthy male baby weighing 9 pounds and 15 ounces. The baby's length was 21.5 inches with apgar score 9. His head circumference was 38.7cm. There were no congenial anomalies and no other complications or abnormalities. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Smear cervix
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female with atypical squamous cells of undetermined significance and no known drug allergies who on 15-MAR-2007 was vaccinated with her first dose of GARDASIL vaccine (yeast) (Lot# not reported). On 17-May-2007, the patient was vaccinated with her second dose of GARDASIL vaccine (yeast) (Lot# not reported) and delivered a baby in April 2008. Unknown medical attention was sought in a clinic. It was reported that a PAP test, ultrasound, amniocentesis and Maternal Serum Alpha-Petoprotein Screening (MSAFP) were performed (no results provided). Follow-up information was received from the registered nurse. The patient only received vaccination with GARDASIL vaccine (yeast) there, not obstetrician care. Telephone call follow-up information was received from a healthcare professional at the obstetrician's office, who reported that the patient was last seen on 30-MAY-2008 for her 6 week postpartum check up. The patient had a full term elective induction, and delivered a healthy and normal baby, weighing 3135 grams, whose Apgar assessments were 8.9 and 9. No additional information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Accidental overdose, Gastroenteritis viral, Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: Information has been received from a physician and a medical assistant concerning an 18 year old patient who on 29-AUG-2007 was vaccinated intramuscularly with the first dose of GARDASIL vaccine (yeast) (Lot # and site not reported). On 02-NOV-2007, the patient was vaccinated intramuscularly with a second dose of GARDASIL vaccine (yeast) (Lot # and site not reported). On 10-MAR-2008, the patient was vaccinated intramuscularly with a third dose of GARDASIL vaccine (yeast) (Lot # and site not reported). On 07-JUN-2008, the patient was "received an inadvertent fourth dose" of GARDASIL vaccine (yeast) intramuscularly (Lot # 660553/0070X site not reported). No adverse effect was reported. The patient outcome was not reported. No additional information was available. Follow-up information was received which reported that on 09-JUN-2008 at 10:30 am, the patient experienced soreness of the injection site arm which lasted for 2 days post-vaccination and was seen a 4 days later for presumed viral gastroenteritis that received on an unspecified date. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy test positive, House dust allergy, Hypersensitivity, Mycotic allergy, Urticaria
Clinical narrative: Information has been received from a physician concerning a 26 year old female who on approximately 01-APR-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) 0.5 ml, IM. On approximately 22-APR-2008, the patient experienced urticaria and nasal allergic reaction 3 weeks after her 1st dose of GARDASIL vaccine (yeast). BENADRYL helped the symptoms. An allergy testing was performed by a specialist which showed she was allergic to dust and mold. The patient was getting ready to get her second dose, but was hesitating based on her allergic reaction. At the time of this report, the patient was recovering. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Condition aggravated
Clinical narrative: Information has been received from a 25 year old female patient with papilloma viral infection, without developed of genital warts before her first vaccination with GARDASIL vaccine (yeast), and no known drug reactions/allergies, who on 20-FEB-2008, was vaccinated with the first dose of GARDASIL vaccine (yeast). On 20-APR-2008, the patient was vaccinated with the second dose of GARDASIL vaccine (yeast), 5 ml. Lot# was not provided. There was no concomitant therapy. The patient reported that in May-2008, after the vaccination she experienced a few lesions. The patient sought unspecified medical attention. At the time of the report the patient was expecting to receive her third dose of GARDASIL vaccine (yeast) on 20-AUG-2008. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Fatigue, Headache
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 12 year old female with no pertinent medical history or allergies who "2 months ago", in approximately June 2008, was vaccinated intramuscularly with 0.5 ml first dose of GARDASIL vaccine (yeast). There was no concomitant medication. In approximately June 2008, after the vaccination, the patient experienced a "stomach ache, fatigue, and a headache". Unspecified Medical attention was sought. No laboratory diagnostics studies were performed. Subsequently, the patient recovered. On 01-AUG-2008 the patient was vaccinated intramuscularly with 0.5 ml second dose of GARDASIL vaccine (yeast) at the office. The patient was instructed to sit and wait 15 minutes post-vaccination and the patient did not have symptoms again. No additional adverse event information was reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter with a drug allergy to an unspecified antibiotic who "2 months ago", on approximately 05-JUN-2008 was vaccinated in the deltoid with a first dose of GARDASIL vaccine (yeast). There was no concomitant medication. On approximately 05-JUN-2008, "immediately after injection", the patient experienced severe pain at the injection site. "48-60 hours after injection", on approximately 08-JUN-2008 the patient recovered from severe pain at the injection site. At the time of the report, the patient was planning on receiving the second dose of GARDASIL vaccine (yeast) "in a few days". The patient sought physician's medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Gastric disorder, Vaccine positive rechallenge
Clinical narrative: Information has been received from an office manager concerning a 16 year old female with irregular menstrual cycles and premenstrual syndrome and no drug reactions  or allergies who on 21-MAR-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast). Concomitant therapy included LOESTRIN. "4 weeks post vaccination", on approximately 18-APR-2008 the patient developed severe upper gastric stomach cramps, which lasted for approximately 5 days. The patient had no fever, no vomiting. After that the patient would get some occasional stomach problem. It was reported that the pain was not associated with the patient's menstrual cycle and in fact the patient's menstrual cycle was "better and lighter". On 19-JUN-2008 the patient was vaccinated with her second dose of GARDASIL vaccine (yeast). "Weeks later", the patient developed the same symptoms but worse. The patient played volleyball and the pain was "so bad she could not run". PEPTO_BISMOL seemed to help relieve the symptoms somewhat. At the time of the report, the patient had not recovered from the events yet. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Weight decreased
Clinical narrative: Information has been received from a physician concerning a female adolescent who on an unspecified date was vaccinated with a dose of GARDASIL vaccine (yeast). It was reported that during her GARDASIL vaccine (yeast) therapy, the patient experienced "significant weight loss (over 20 pounds)". The outcome of the patient was not reported. Unspecified medical attention was sought. Additional information has been requested.