chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: RV5
Symptoms: Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a physician concerning a male (age not reported) who in 2007 was vaccinated with three doses of Rotateq, oral. Following the first and third doses (not the second), the patient experienced "extreme voluminous vomiting". The above reaction followed a similar pattern during each of the above episodes. The patient sought unspecified medical attention. Subsequently on an unspecified date, the patient recovered from extreme voluminous vomiting approximately 28 hours post dose. No product quality complaint was involved. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Culture stool, Gastroenteritis rotavirus
Clinical narrative: Information has been received from a physician concerning a 12 week old female who on 14-NOV-2006 was vaccinated with a dose of Rotateq (lot #655174/0848F), single dose, oral. Concomitant medication was not reported. On 08-DEC-2006, 24 days after administration of Rotateq, the patient developed rotavirus gastroenteritis. On an unspecified date, a stool culture was performed with results not reported. The patient was treated with hyoacyamine sulfate (LEVSIN), diet and oral fluids. The symptoms resolved on 11-DEC-2006 and the patient completely recovered from rotavirus gastroenteritis. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, Unevaluable event
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 20 week old male who on 17-MAY-2007 was vaccinated with Rotateq PO first dose. No adverse reactions were reported. Information has been received from a registered nurse concerning a 20-week-old male who on 17-MAY-2007 was vaccinated PO with the first dose of ROTAVIRUS live. It was unknown if medical attention was sought. No adverse reactions were reported. Follow-up information indicated that the patient was never adminstered a dose of ROTAVIRUS  vaccine live. Therefore, WAES0707USA03131 will be deleted from our files for ROTAVIRUS vaccine live. Additional information is not expected.
Age: 0.42
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a physician concerning an 18 week old patient who on 03-JUL-2007 was vaccinated with ROTATEQ PO first dose. The physician reported that the patient did not experience any adverse event related to this event. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2007.  Information has been received from a physician concerning an 18 week old patient who on 03-JUL-2007 was vaccinated with ROTATEQ PO first dose. The physician reported that the patient did not experience any adverse event related to this event. Additional information has been requested.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 4-month-old patient who was vaccinated PO with a 2mL second dose of Rotateq. Subsequently the patient experienced prolonged diarrhea and vomiting. Subsequently, the patient recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007. Information has been received from a health professional concerning a 10-week-old female with no pre-existing allergies, birth defects, or medical conditions who on 09-MAY-2007 was vaccinated PO with the first (also reported as second) 2mL dose of ROTATEQ (Lot # 656382/0234U). Vomiting and diarrhea were noted to be illness at the time of vaccination. Concomitant therapy that day included a first dose of PEDIARIX (Lot # AC21B097AB) administered IM in the right arm, a first dose of PEDVAXHIB (Lot # 655076/1272F) administered IM in the left thigh, and a first dose of PREVNAR (LOt # B08692H) administered IM in the left thigh. On 09-MAY-2007 the patient experienced prolonged diarrhea and vomiting. On 12-MAY-2007, 4 days later, the patient recovered from prolonged diarrhea and vomiting. There were no relevant diagnostic tests or laboratory data. No additional information is expected.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a licensed practical nurse concerning a 22-week-old patient who on 07-JAN-2007, 19-APR_2007, and 04-JUN-2007 was vaccinated with the first, second, and third doses of Rotateq. There were no adverse symptoms and no other information available. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Accidental exposure, Diarrhoea
Clinical narrative: Information has been received from a registered nurse concerning a female nurse who was evidently not using gloves to administer Rotateq (no lot number provided). Subsequently the patient experienced diarrhea. It was reported that the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus, Inappropriate schedule of drug administration, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 20 week old female with a history of bronchiolitis who on 08-DEC-2006 was vaccinated with Rotateq (Lot # 654489/0941F) PO first dose and then was vaccinated again on 08-FEB-2006 with Rotateq (Lot # 654489/0941F) PO 2nd dose. There was no illness at the time of vaccination. On 05-MAR-2007 the patient developed signs and symptoms of rotavirus. A stool test for rotavirus was positive. The patient subsequently recovered. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Crying, Diarrhoea, Ultrasound abdomen, Vomiting, X-ray
Clinical narrative: Information has been received from a physician concerning a patient who on 17-JUL-2007 was vaccinated PO with a first dose of Rotateq. Subsequently, on 18-JUL-2007, the patient experienced vomiting, diarrhea and crying. The patient was sent to the hospital, but it was unknown is she/he was admitted. An ultrasound and an X-ray were obtained. It was found that the patient did not have intussusception or pyloric stenosis. No further information was provided. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus, Underdose
Clinical narrative: Information has been received from a physician concerning a female who on 26-JUL-2007 was vaccinated with a 2.0ml dose of Rotateq (No lot number was provided) and the patient spit up the vaccine and contracted rotavirus when doing so. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Irritability
Clinical narrative: Information has been received from a physician concerning a male who on 25-JUL-2007 was vaccinated with the first oral dose of Rotateq. On 25-JUL-2007 about 4 hours after vaccination, the patient was extremely irritable and experienced diarrhea. Unspecified medical attention was sought. The patient's recovery status was unknown. There was no product quality complaint. Additional information has been requested.
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Inappropriate schedule of drug administration, Weight decreased
Clinical narrative: Information has been received from a physician concerning a 4 week old patient who on 25-JUL-2007 was vaccinated with the first 2.0ml oral dose of ROTATEQ. On 25-JUL-2007 the patient developed profuse diarrhea with up to 6 to 8 stools daily for a period of time and lost 3 ounces. Unspecified medical attention was sought. No labs or diagnostic studies were performed. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 4-month-old patient who on 27-JUL-2007 was vaccinated PO with a first dose of Rotateq (Lot # 657514/0667U). The patient is not experiencing any known symptoms. No further information is available. There was no product quality complaint. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Ultrasound abdomen normal
Clinical narrative: Initial and follow-up information has been received from a physician and a health professional through the Merck pregnancy registry concerning a 19 year old pregnant female (date of conception: 07-AUG-2006) with asthma and headaches with no drug allergies who on 23-AUG-2006 was vaccinated with a first dose of Gardasil (0.5 ml) (lot # "9725101"), intramuscularly. There was no concomitant medication. There was no adverse event related to this event. On 29-AUG-2006 the patient had a LEAP procedure. On 16-SEP-2006 the patient received medroxyprogesterone acetate (DEPO-PROVERA). The date of LMP was reported to be unknown. On 18-SEP-2006 the patient had a normal ultrasound. The estimated delivery date was 30-APR-2007. It was noted that the patient had one previous pregnancy. There was no birth defect in previous pregnancy. However, infant in previous pregnancy had oligohydrosis. Follow-up reported that the patient gave birth to a normal female infant was born at 39 weeks on 23-APR-2007 weighing 6 pounds 12 ounces, length was 20 inches. The apgar score was 8/9, with a head circumference of 33.7. There were no congenital anomalies, complications nor abnormalities with the infant. There were no infections or illness during the pregnancy. Other medications used during this pregnancy included daily prenatal vitamins, as needed albuterol, and daily ascorbic acid (+) cyanocobalamin (+) ferrous fumarate (+) folic acid (CHROMAGEN FORTE). On 27-APR-2007 the baby developed delay conjugate jaundice unspecified. On 30-APR-2007 during an office visit there was no significant jaundice. On approximately May 2007, the baby's umbilical cord was infected. The baby was given prescription "cream". On 07-MAY-2007 the patient was seen in the doctors office and the umbilical cord "looked better". On 21-MAY-2007 the baby was seen by a physician for abdominal pain generalized and excessive crying. The mom reported that the baby was crying "all the time" and she was "very gassy" and "acts like her belly hurts." It was reported that the symptoms were consistent with colic. At the time of the report, it was unknown the outcome of the infant. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Herpes virus infection, Influenza, Pregnancy, Rhinitis
Clinical narrative: Information has been received from a physician through a Merck Pregnancy Registry concerning a 25 year old white female with concurrent medical conditions reported as "good". She has a history of 3 pregnancies (1 live birth full term at 38 weeks and 4 days, and termination of pregnancy - elective), no birth defects in previous pregnancies, herpes genitalis, abnormal PAP with CIN II on 15-SEP-2006 and she had loop electrosurgical excision procedure (LEEP). No history of drug reactions/allergies. On 08-SEP-2006, the patient was vaccinated with the first dose of Gardasil (lot # 654540/0800F). Concomitant medication reported as none. On 03-NOV-2006, the patient was vaccinated with second dose of Gardasil (lot # 653938/0954F) 0.5 ml intramuscularly while she was pregnant. The patient did not have a reliable last menstrual period (LMP) date. The patent sought medical attention. On 05-DEC-2006, an ultrasound was performed to confirm her estimated date of delivery (EDC). The ultrasound revealed EDC of 14-JUL-2007 and single viable intrauterine pregnancy. At the time of reporting, her gestation time was 8 week (LMP 06-OCT-2006). No adverse experience is related to this event. On 23-JUL-2007, an Outcome Pregnancy Questionnaire provided additional information. There were no complications during the pregnancy or labor/delivery. A diagnostic ultrasound was performed during pregnancy, which was within normal limits (NL). The patient developed influenza B during pregnancy. During pregnancy, the patient was treated with FAMVIR for herpes (September 2006), acyclovir 400 mg, twice daily (BID) for herpes, terbutaline for pre-term contractions (dose, duration, and route not reported), and RYNEZE BID on 15-MAR-2007 for rhinitis (dose and route not reported), BIDEX DM three times daily (TID) and Z-PAC for an upper respiratory infection (dose and route not reported) on 19-FEB-2007; DIFLUCAN for vaginitis, DRETHINE and CELESTONE for pre-term contractions (dose, duration, and route not provided) on 29-MAY-2007. On 29-JUN-2007, 37 weeks and 4 days from last menstrual period (LMP), the patient delivered a normal male infant (8 lbs, 8 oz, 21 in) with an APGAR score of 8/9. There were no congential anomalies, complications, or abnormalities. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan, Upper respiratory tract infection, Vaginal infection
Clinical narrative: Information has been received from a physician through a Merck Pregnancy Registry concerning a 25 year old white female with concurrent medical conditions reported as "good". She has a history of 3 pregnancies (1 live birth full term at 38 weeks and 4 days, and termination of pregnancy - elective), no birth defects in previous pregnancies, herpes genitalis, abnormal PAP with CIN II on 15-SEP-2006 and she had loop electrosurgical excision procedure (LEEP). No history of drug reactions/allergies. On 08-SEP-2006, the patient was vaccinated with the first dose of Gardasil (lot # 654540/0800F). Concomitant medication reported as none. On 03-NOV-2006, the patient was vaccinated with second dose of Gardasil (lot # 653938/0954F) 0.5 ml intramuscularly while she was pregnant. The patient did not have a reliable last menstrual period (LMP) date. The patent sought medical attention. On 05-DEC-2006, an ultrasound was performed to confirm her estimated date of delivery (EDC). The ultrasound revealed EDC of 14-JUL-2007 and single viable intrauterine pregnancy. At the time of reporting, her gestation time was 8 week (LMP 06-OCT-2006). No adverse experience is related to this event. On 23-JUL-2007, an Outcome Pregnancy Questionnaire provided additional information. There were no complications during the pregnancy or labor/delivery. A diagnostic ultrasound was performed during pregnancy, which was within normal limits (NL). The patient developed influenza B during pregnancy. During pregnancy, the patient was treated with FAMVIR for herpes (September 2006), acyclovir 400 mg, twice daily (BID) for herpes, terbutaline for pre-term contractions (dose, duration, and route not reported), and RYNEZE BID on 15-MAR-2007 for rhinitis (dose and route not reported), BIDEX DM three times daily (TID) and Z-PAC for an upper respiratory infection (dose and route not reported) on 19-FEB-2007; DIFLUCAN for vaginitis, DRETHINE and CELESTONE for pre-term contractions (dose, duration, and route not provided) on 29-MAY-2007. On 29-JUN-2007, 37 weeks and 4 days from last menstrual period (LMP), the patient delivered a normal male infant (8 lbs, 8 oz, 21 in) with an APGAR score of 8/9. There were no congential anomalies, complications, or abnormalities. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Inappropriate schedule of drug administration, Laboratory test, Pregnancy test positive, Uterine dilation and curettage
Clinical narrative: Initial and follow-up information has been received from the Merck pregnancy registry from a registered nurse and a physician concerning a 34 year old female with drug hypersensitivity to codeine with a history of dilation and curettage procedure done in February, who on 29-MAR-2007 was vaccinated IM with a first dose of Gardasil (lot # 654885/1424F). On 04-Jun-2007 was vaccinated IM with a second dose of Gardasil (lot # 654885/1424F). Concomitant therapy included NEXIUM, ASTELIN, NASONEX, KLONOPIN, "FECON", and antimicrobial (unspecified). ON 25-JUN-2007 and 26-JUN-2007 the patient reported that the beta-human chorionic gonadotropin test (unspecified) were positive. On 05-JUL-2007 and 09-JUL-2007 the patient came into the office for blood work. The 09-JUL-2007 blood work reported that the patient was four to five week pregnant. The patient's last menstrual period was approximately 31-MAY-2007 and the delivery date was 06-MAR-2008. The physician reported that the baby's heart tunnels are present. Subsequently the patient experienced some bleeding during pregnancy. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow-up information has been received from the Merck pregnancy registry form a registered nurse and a physician concerning a 34 year old female with drug hypersensitivty to codeine with a history of dilation and curettage procedure done in Febraury who on 29-MAR-2007 was vaccinated IM with a first dose of GARDASIL (lot # 654885/1424F). On 04-Jun-2007 was vaccinated IM with a second dose of GARDASIL (lot # 654889/1424F). Concomitant therapy inclued NEXIUM, ASTELIN, NASONEX, KLONOPIN, FECOM, and antimicrobial (unspecified). On 25-JUN-2007 and 26-JUN-2007 the patient reported that the beta-human chorionic gonadotropin test (unspecified) were positive. On 05-JUL-2007 and 09-JUL-2007 the patient came into the office for blood work. The 09-JUL-2007 blood work reported that the patient was four to five weeks pregnant. The patient's last menstural period was approximately 31-MAY-2007 and the delivery date was 06-MAR-2008. The physician reported that the baby's heart tunnels are present. Subsequently the patient experienced some bleeding during pregnancy. Follow up information was received from the nurse on 27-MAR-2008. The patient did not receive her prenatal care at their office. The name of the provider was not available. No additional information was provided.
Age: 34.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal haemorrhage
Clinical narrative: Initial and follow-up information has been received from the Merck pregnancy registry from a registered nurse and a physician concerning a 34 year old female with drug hypersensitivity to codeine with a history of dilation and curettage procedure done in February, who on 29-MAR-2007 was vaccinated IM with a first dose of Gardasil (lot # 654885/1424F). On 04-Jun-2007 was vaccinated IM with a second dose of Gardasil (lot # 654885/1424F). Concomitant therapy included NEXIUM, ASTELIN, NASONEX, KLONOPIN, "FECON", and antimicrobial (unspecified). ON 25-JUN-2007 and 26-JUN-2007 the patient reported that the beta-human chorionic gonadotropin test (unspecified) were positive. On 05-JUL-2007 and 09-JUL-2007 the patient came into the office for blood work. The 09-JUL-2007 blood work reported that the patient was four to five week pregnant. The patient's last menstrual period was approximately 31-MAY-2007 and the delivery date was 06-MAR-2008. The physician reported that the baby's heart tunnels are present. Subsequently the patient experienced some bleeding during pregnancy. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow-up information has been received from the Merck pregnancy registry form a registered nurse and a physician concerning a 34 year old female with drug hypersensitivty to codeine with a history of dilation and curettage procedure done in Febraury who on 29-MAR-2007 was vaccinated IM with a first dose of GARDASIL (lot # 654885/1424F). On 04-Jun-2007 was vaccinated IM with a second dose of GARDASIL (lot # 654889/1424F). Concomitant therapy inclued NEXIUM, ASTELIN, NASONEX, KLONOPIN, FECOM, and antimicrobial (unspecified). On 25-JUN-2007 and 26-JUN-2007 the patient reported that the beta-human chorionic gonadotropin test (unspecified) were positive. On 05-JUL-2007 and 09-JUL-2007 the patient came into the office for blood work. The 09-JUL-2007 blood work reported that the patient was four to five weeks pregnant. The patient's last menstural period was approximately 31-MAY-2007 and the delivery date was 06-MAR-2008. The physician reported that the baby's heart tunnels are present. Subsequently the patient experienced some bleeding during pregnancy. Follow up information was received from the nurse on 27-MAR-2008. The patient did not receive her prenatal care at their office. The name of the provider was not available. No additional information was provided.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Depressed level of consciousness, Lethargy
Clinical narrative: Information has been received from a mother concerning her 15 year old daughter who was student with no known drug allergies or illness at the time of vaccination who on 26-MAR-2007 was vaccinated intramuscularly in the left arm with a first dose of Gardasil (Lot #655617/1447F). On 27-MAR-2007 (also reported as approximately 1 to 2 hours after the injection), the patient was lethargic and difficult to arouse. No laboratory diagnostic studies were performed. On an unknown date, the patient recovered. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Heart rate normal, Hypotension, Syncope
Clinical narrative: Information has been received from a health professional concerning an 18 year old female with no illness at the time of vaccination who on 16-MAR-2007 was vaccinated with a first dose of Gardasil (lot number unknown) with no pertinent medical history or drug/reactions/allergies. On 16-MAR-2007 the patient felt dizzy after the administration of Gardasil. On 17-MAY-2007 the patient was administered the second dose of Gardasil (6566051/0244U) IM in the left deltoid expiry date 27-SEP-2009 at 10:15 AM. Concomitant therapy included fluoxetine HCL (PROZAC), minocycline HCl (MINOCIN) and ethinyl estradiol/norgestimate (TRINESSA). Due to the incident with the first dose the healthcare professional sat the patient down, she had water, a candy bar and sat for 15 minutes. At 10:35 AM at the front desk the patient started to feel dizzy, lowered to the wheelchair and fainted for approximately 30 seconds. The patient was taken to the room, her legs were elevated. Her blood pressure measurement was 90/60 and her total heart was 60. The patient stayed for 45 minutes felt okay and left. The patient recovered on 17-MAY-2007. Further information is not available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female who was vaccinated with Gardasil. Moments later the patient passed out. Unspecified medical attention was sought. Subsequently, the patient recovered from passing out. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Skin lesion, Vaginal disorder
Clinical narrative: Information has been received from a consumer, regarding his 16 year old daughter with no pertinent medical history, who "about 4 months ago" was vaccinated with a dose of Gardasil (Lot # not provided). There was no concomitant medication. Subsequently, (time following vaccination not specified), the patient developed vaginal lesions that "looked like cigarette burns." At the time of this report, the patient had not recovered. The father added that his daughter had not continued with the Gardasil vaccine series. The patient sought unspecified medical attention. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Lymphadenopathy, Malaise
Clinical narrative: Information has been received from a physician, concerning a 23 year old female who was vaccinated on an unspecified date at another facility, with the first dose of Gardasil (Lot # not provided). Ten days after the vaccine was administered, the patient developed redness and swelling at the injection site. She also developed general malaise and dizziness (onset timeframe not specified), and 17 days after the vaccine administration, she developed bilateral lymphadenopathy. At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Menstruation irregular
Clinical narrative: Information has been received from a consumer, concerning her 19 year old daughter, with no pertinent medical history, who on 11-MAY-2007 was vaccinated in the gluteal area with the first dose of Gardasil (lot # not provided). There was no concomitant medication. On 11-MAY-2007 her daughter had an irregular period. At the time of this report, she had recovered (date not specified). The patient sought unspecified medical attention. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 15 year old female patient, who on 28-JUN-2007 was vaccinated IM, with the first dose of Gardasil (Lot #657737/0522U). Concomitant therapy included DTaP and Menactra. On 28-JUN-2007, after the vaccination with Gardasil, the patient "experienced syncope." The physician indicated she "recovered after approximately 1 minute. The patient sought unspecified medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Hypotension, Loss of consciousness
Clinical narrative: Information has been received from a physician, via a company representative, concerning an 18 year old female patient, who on 28-JUN-2007 was vaccination with the third dose of Gardasil (lot # not provided). On 28-JUN-2007, the patient passed out three times. Blood pressure was 90/60mmHg following both the first and second episode. As the staff was taking the second blood pressure reading, she again passed out: her blood pressure following the third episode was 100/60mmHg. The physician considered the patient to be recovered on the same day, 28-JUN-2007. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Loss of consciousness, Pain in extremity, Paraesthesia, Syncope
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow up information has been received from a physician, via a company representative, concerning an 18 year old female patient, who on 26-JUN-2007, at 12:30 pm while sitting in a chair, was vaccinated IM, with the first dose of Gardasil (Lot #653736/0014U). On 26-JUN-2007, "shortly after vaccination" at 12:30 pm, when the patient attempted to stand up, she fainted or "blacked out," and fell to the floor in a sitting position. The physician added that this was possibly a "vaso-vagal spell." The patient "regained consciousness immediately," and complained of pain in her left "distal forearm and elbow, not at the injection site." She stated that before she fainted her "entire body felt tingly." The physician confirmed that the patient had recovered on the same day, and "is fine now." The patient sought unspecified medical attention. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope vasovagal
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow up information has been received from a physician, via a company representative, concerning an 18 year old female patient, who on 26-JUN-2007, at 12:30 pm while sitting in a chair, was vaccinated IM, with the first dose of Gardasil (Lot #653736/0014U). On 26-JUN-2007, "shortly after vaccination" at 12:30 pm, when the patient attempted to stand up, she fainted or "blacked out," and fell to the floor in a sitting position. The physician added that this was possibly a "vaso-vagal spell." The patient "regained consciousness immediately," and complained of pain in her left "distal forearm and elbow, not at the injection site." She stated that before she fainted her "entire body felt tingly." The physician confirmed that the patient had recovered on the same day, and "is fine now." The patient sought unspecified medical attention. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Syncope
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient (age unspecified), who on an unknown date was vaccinated with a dose, 0.5ml, of Gardasil (Lot # not provided). Subsequently "fainted and hit her head on the wall." The physician confirmed the patient had recovered (date unspecified).
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Sinusitis, Tremor, Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a physician concerning a 15 year old female, with no pertinent medical history, who was vaccinated with a first dose of Gardasil on an unspecified date. On 27-FEB-2007 was vaccinated with a second dose of Gardasil. On approximately 03-MAR-2007 the patient became extremely dizzy, with vomiting and shaking. The adverse experienced lasts "for a couple of days and then it goes away and the patient recovers." On 26-JUN-2007 the patient was vaccinated IM with a third dose of Gardasil. Concomitant therapy, in June 2007, included antimicrobial (unspecified) for sinusitis (viral infection). On approximately 29-JUN-2007 the patient became extremely dizzy, with vomiting and shaking. The adverse experience lasts "for a couple of days and then it goes away and the patient recovers." Subsequently, the patient recovered from being extremely dizzy, vomiting and shaking. It was reported that the patient did not experience anything after the first dose of the vaccine. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Joint stiffness, Musculoskeletal pain
Clinical narrative: Information has been received from a registered nurse concerning a female between 19 and 26 years of age, who was vaccinated with a first dose of Gardasil. In June 2007, "a couple of weeks ago", the patient experienced soreness, stiffness in the shoulder after receiving the vaccination and was unable to raise her arm above her head. Unspecified medical attention was sought. The outcome was not reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female who was vaccinated with a first dose of Gardasil. Shortly after receiving the vaccination the patient fainted. Unspecified medical attention was sought. Subsequently, the patient recovered from fainting. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Fall, Head injury, Laboratory test, Neck pain, Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 16-JUN-2007 was vaccinated with a dose of Gardasil. Concomitant therapy included Vaqta also given on 16-JUN-2007. On 16-JUN-2007. On 16-JUN-2007 after being administered the vaccines the patient fainted and fell forward and hit her head. Unspecified medical attention was sought. Unspecified blood and urinary tests were performed, results not reported. At the time of the report her head and neck hurts (its' sore). Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Urine analysis
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 16-JUN-2007 was vaccinated with a dose of Gardasil. Concomitant therapy included Vaqta also given on 16-JUN-2007. On 16-JUN-2007. On 16-JUN-2007 after being administered the vaccines the patient fainted and fell forward and hit her head. Unspecified medical attention was sought. Unspecified blood and urinary tests were performed, results not reported. At the time of the report her head and neck hurts (its' sore). Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion
Clinical narrative: Information has been received via a representative, from a nurse concerning her 13 year old daughter, a "special needs child" (unspecified disability), who in June 2007 ("last week"), was vaccinated IM with the first dose of Gardasil (Lot # not provided). The nurse reported that the nurse who administered the vaccine "bent the needle," then removed it and restuck her daughter with the same needle. The next day, the nurse reported that her daughter had developed two black bruises "about the size of a pencil eraser." At the time of this report, it was not specified if the patient had recovered. Follow up information from a physician, revealed that he had no communication with the patient nor direct knowledge of the event. He added that he "suspects bruise from shot." The patient sought unspecified medical attention. No further information is expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Influenza like illness, Injection site pain, Muscle twitching, Musculoskeletal stiffness
Clinical narrative: Information has been received from a physician concerning a 25 year old female with asthma and pollen allergy who on 13-JUN-2007 was vaccinated IM in the upper outer quadrant of the right buttocks, with a first dose of Gardasil (lot # 657736/0389U). Concomitant therapy included YAZ. On approximately 13-JUN-2007 the patient experienced pain at injection. On approximately 18-JUN-2007, the patient recovered from pain at injection site. On 28-JUN-2007 the patient experienced pain at injection site again with muscle twitching, stiff neck and "flu-like" symptoms. Unspecified medical attention was sought. At the time of the report the patient was recovering from pain at injection site, muscle twitching, stiff neck and "flu-like" symptoms. Unspecified medical attention was sought. The physician noted that the patient was a runner. At the time of this report the outcome of the event was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 01/14/2007.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood follicle stimulating hormone increased, Blood luteinising hormone increased, Blood thyroid stimulating hormone, Blood thyroid stimulating hormone increased, Drug exposure during pregnancy
Clinical narrative: Information has been received through the Merck Pregnancy registry from a nurse practitioner concerning an 18 year old female smoker with no previous pregnancies, with menstruation irregular and amenorrhea who on 25-JAN-2007 was vaccinated with a first dose of Gardasil (lot # 655617/1447F). Concomitant therapy included PROMETRIUM. The patient was diagnosed with polycystic ovary syndrome in March 2007. The symptoms of POCS were hirsutism, elevated blood thyroid-stimulating hormone level and luteinizing hormone/follicle stimulating hormone ratio. Subsequently, the patient became pregnant. Her last menstrual period was 30-NOV-2006. Estimated date of delivery was 17-SEP-2007. No problem in pregnancy other than hydronephrosis that  has corrected itself without treatment. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Haematology test, Hirsutism, Hydronephrosis, Polycystic ovaries
Clinical narrative: Information has been received through the Merck Pregnancy registry from a nurse practitioner concerning an 18 year old female smoker with no previous pregnancies, with menstruation irregular and amenorrhea who on 25-JAN-2007 was vaccinated with a first dose of Gardasil (lot # 655617/1447F). Concomitant therapy included PROMETRIUM. The patient was diagnosed with polycystic ovary syndrome in March 2007. The symptoms of POCS were hirsutism, elevated blood thyroid-stimulating hormone level and luteinizing hormone/follicle stimulating hormone ratio. Subsequently, the patient became pregnant. Her last menstrual period was 30-NOV-2006. Estimated date of delivery was 17-SEP-2007. No problem in pregnancy other than hydronephrosis that  has corrected itself without treatment. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Rash pruritic, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with a first dose of Gardasil. Subsequently the patient developed a small itchy rash, pain. Subsequently, the patient recovered from small itchy rash and pain that lasted 2 days. On an unspecified date the patient was vaccinated with a second dose of Gardasil. Subsequently the patient developed a large itchy painful rash that lasted 2 weeks. Medical attention was sought. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on 29-JUN-2007 was vaccinated with a dose of Gardasil (lot # 653736/0014U) 0.5mL injection. There was no concomitant medication. ON 29-JUN-2007 the patient developed a 101.5 degrees fever for 2 days after being vaccinated with Gardasil. Medical attention was sought. On 30-JUN-2007 the patient recovered from the 101.5 degrees fever. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Infectious mononucleosis, Pain
Clinical narrative: Information has been received from a consumer concerning her granddaughter (age unspecified), who on an unspecified date, was vaccinated with the first dose of Gardasil (Lot # not provided). Following the vaccination, the granddaughter felt dizzy, was exhausted, and had pains in her side; she was diagnosed with mononucleosis. No further details were provided. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse concerning a female between the ages of 11 to 13 who in February 2007, was vaccinated with a first dose of Gardasil (lot # unknown) IM. In February 2007, the patient experienced a missed period for the first dose. On an unspecified date the patient was vaccinated with a second dose of Gardasil IM and experienced a missed period for the second dose. Medical attention was sought. The nurse was not concerned because at this age, many patient's menstrual periods are irregular anyway. The patient does plan, or may have already received her third and last vaccination. No further information was provided. At the time of reporting the patient has recovered on an unspecified date. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on 30-MAY-2007 was vaccinated with Gardasil (lot # unknown). Five minutes after receiving Gardasil the patient got up to go to the bathroom, she became dizzy and passed out. She had full recovery within five minutes. The patient did not require any hospitalization and did not have any complications. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 11 or 12 year old female who was vaccinated on an unspecified date with a first dose of Gardasil (lot # unknown). Concomitant therapy included Menactra given on the same date. The patient developed a rash after receiving the first dose of Gardasil and three days later the patient went back to the physician to have the rash taken care of. Medical attention was sought. The physician gave the patient a topical cream for the rash. It was not known if the rash developed at the injection site and it is unknown if the patient will continue the rest of the Gardasil series. At the time of reporting the patient was recovering. No further adverse event information is available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated IM with a first dose of Gardasil. "A couple of months ago", after receiving a first dose of the vaccine the patient thew up. No medical attention was sought. No diagnostic laboratory studies were performed. On an unknown date, the patient recovered from threw up. It was reported that the patient did not have the same reaction after receiving the second dose. No product quality complaint was involved. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Nerve injury, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 13 year old female, with no pertinent medical history, who on an unspecified date was vaccinated with a first dose of Gardasil. On 03-JUL-2007 was vaccinated IM, in her left arm, with a second dose of Gardasil (lot # 658094/0524U). There was no concomitant medication. On 04-JUL-2007 the patient experienced leg pain from knee to ankle. She went to the emergency room and was released. The emergency room physician thinks she might have experienced nerve damage. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Nausea, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a female who in June 2007, was vaccinated with a dose of Gardasil. Subsequently the patient experienced nausea, soreness on the injection site arm and fever. Subsequently, the patient recovered from nausea, soreness on the injection site arm and fever. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Throat tightness
Clinical narrative: Information has been received from a physician's assistant concerning a 14 year old female who was vaccinated intramuscularly with the first dose of Gardasil. It was reported that "within the same day she received the vaccine, the patient experienced "tightening of airway". The physician's assistant was unsure if this was related to the Gardasil because the patient had played softball on a hot, dusty field the same day she received Gardasil. The patient's mother had given her BENADRYL before contacting the physician. The physician's assistant prescribed for the patient 5 days worth of ALLERGAN. It was reported that after the patient took the prescribed steroids she had recovered. It was reported that the patient's sister had completed the vaccine series for Gardasil without any trouble. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician, via a company representative, concerning a "teenaged" female patient, who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not provided). Concomitant therapy included Menactra. Subsequently, after receiving the first dose of Gardasil, the patient developed hives, that "were most severe on the injection site arm." The physician confirmed that the patient had recovered from the hives (duration and date not provided). The patient sought unspecified medical attention. The physician reported that three additional teenaged female patient also developed hives after vaccination with the first dose of Gardasil (lot # not provided (WAES: 0707USA01121, and 0707USA01122). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test false positive, Ultrasound abdomen normal, Vaginal discharge
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient (age unspecified), who on 13-APR-2007 was vaccinated with the first dose of Gardasil (Lot # not provided). The patient later presented to the office for her second vaccination, however, she reported an irregular vaginal discharge, and the vaccine was not administered. A pregnancy test showed a "false" positive, as an ultrasound then confirmed she was not pregnant. At the time of this report, it was unknown if the patient had recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who was vaccinated with a second dose of Gardasil. On an unspecified date, the patient reported an itchy rash after her second dose. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. It was reported that the patient told the physician that she had a similar reaction after the first dose, but did not report it until after the second occurrence. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pallor
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a second dose of Gardasil. On 26-JUN-2007, the patient was very pale and became a little woozy but she did not faint. Unspecified medical attention was sought. On an unspecified date, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received concerning a patient who was vaccinated with a dose of Gardasil. It was reported that there may be a possible adverse event with the vaccine. The reporter did not have any specifics of the type of reaction or any other information. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal stiffness, Skin burning sensation, Throat tightness, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female with a sulfonamide and NSAID allergy and a history of osteomyelitis who on 17-DEC-2006 was vaccinated with a first dose of Gardasil (lot # 654389/0961F) 0.5mL IM. On 19-FEB-2007 the patient was vaccinated with a second dose of Gardasil (lot # 656049/0187U) 0.5mL IM. Concomitant therapy included hormonal contraceptives (unspecified). On both occasions the patient experienced throat closing sensation, neck stiffness and a burning sensation down her arm. Medical attention was sought. All symptoms lasted several hours and at the time of reporting the patient had recovered on both occasions. The patient has not received the third dose yet. No further information is available. Addition information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dermatitis
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with a first dose of GARDASIL (lot# unknown). In June 2007, the patient was vaccinated with a second dose of GARDASIL. The patient developed "dermatitis all down her arm" right after getting her second dose. Medical attention was sought. At the time of reporting it is unknown if the patient had recovered. No further information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007. Follow-up information was received. On 21-DEC-2006 the patient was vaccinated with a second dose of GARDASIL (lot #653735/0688F). On the same day the patient developed a mild red maculopapular eruption on the injection site arm. On an unspecified date the patient recovered approximately one week after injection. On 25-MAY-2007 the patient was vaccinated with a third dose of GARDASIL (lot# 657737/0522U) IM in the right deltoid. On an unspecified date the patient developed a much worse maculopapular rash on the injected extremity and trunk on that side. On an unspecified date the patient recovered without therapy. Additional information is not expected.