chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy, Colonoscopy normal, Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female patient who on unspecified dates was vaccinated intramuscularly with three 0.5 mL doses of GARDASIL. On an unspecified date, "recently", the patient had an abnormal Papanicolaou (PAP) test that was positive for HPV 16. The physician was questioning vaccine failure. The physician did not know how much time there was between the completion of the series and the abnormal PAP test. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. Follow up information indicated that the approximately 27 year old patient was vaccinated with a first dose of GARDASIL on 07-DEC-2007, a second dose on 07-FEB-2008 and a third dose on 18-JUN-2008. On an unknown date a "PAP test" revealed atypical cells of undetermined significance and could not exclude high grade squamous intraepithelial lesions (SIL). ON 11-AUG-2009 an HPV DNA test returned "high risk 16". On 03-SEP-2009 a colposcopy and a biopsy test revealed no dysplasia or malignancy. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Syncope, Vomiting
Clinical narrative: Information has been received from a physician concerning a 26 year old female patient who on 27-AUG-2009 was vaccinated with a third dose of GARDASIL (lot # not reported). On 27-AUG-2009 after third dose the patient fainted and vomited. No adverse events were reported after first and second dose of GARDASIL. The patient did not seek medical attention. At the time on the report on 27-AUG-2009 the patient had recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the third dose of GARDASIL. A few weeks after the third dose of GARDASIL was given, the patient had a few fainting episodes which did not occur in the office but occurred elsewhere. The reporter felt that having a few fainting episodes was not related to therapy with GARDASIL. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a Nurse Practitioner (N.P) concerning a 26 year old female patient with allergic reaction to bee sting who on 09-APR-2009 was vaccinated with the first dose of GARDASIL. On 12-JUN-2009 the patient received the second dose of GARDASIL. It was reported that the patient developed a low grade of fever, and swelling and itching at the injection site after her second vaccination with GARDASIL. The patient was seen in the office. It was reported that the patient recovered on an unspecified date. Follow up information has been received from a facility indicating that the patient received "the shot" at another facility. No other information was available or provided. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Nausea
Clinical narrative: Information has been received from a female for GARDASIL, a Pregnancy Registry product, concerning herself with a history of intra-uterine contraceptive device insertion and no drug allergy who on 02-JUL-2009 was vaccinated with the third dose of GARDASIL. Concomitant therapy included vitamins (unspecified). Subsequently, she discovered that she was pregnant when the patient was looking for a new clinic to place a new IUD (intrauterine device). At this new clinic, she was tested for pregnancy when she reported having nausea. At the time of the report, the patient was 11 weeks pregnant. Her LMP was about 19-MAY-2009. Expected date of delivery was 23-FEB-2010. She is not having any symptoms, exception for some nausea associated with the pregnancy. Also, she was told that the pregnancy is healthy. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Mood swings, Musculoskeletal pain, Rash macular, Vaginal discharge
Clinical narrative: Information has been received from a medical assistant concerning a 26 year old female with possible peptic ulcer, depression, no drug allergies, and a history of anxiety, "gerd", two "terminations" and one knee surgery who on 23-JUL-2009 was vaccinated with a first dose of GARDASIL (Lot No. 661046/0381X). Concomitant therapy included METROGEL, clonazepam and "birth control". Since the patient received her first dose of GARDASIL her whole arm was blotchy, she had mood swings, shoulder pain, hand numbness, and vaginal irritation and discharge. The office medical assistant stated that on 02-OCT-2009 the patient informed she was not going to receive any more doses of GARDASIL. At the time of the report, the outcome of the patient was unknown. Follow up information was received from the nurse who indicated that the patient with a history of bacterial vaginosis on 23-JUL-2009 was vaccinated with a first dose of GARDASIL (Lot No. 661046/0381X) in her left deltoid. Concomitant therapy included KLONOPIN, YASMIN and PERCOCET. Subsequently the patient developed vagina swollen. She sought medical attention for vaginal irritation and discharge. The patient was not recommended to receive the second and third dose of GARDASIL. The outcome of the patient was not reported. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal swelling, Vulvovaginal discomfort
Clinical narrative: Information has been received from a medical assistant concerning a 26 year old female with possible peptic ulcer, depression, no drug allergies, and a history of anxiety, "gerd", two "terminations" and one knee surgery who on 23-JUL-2009 was vaccinated with a first dose of GARDASIL (Lot No. 661046/0381X). Concomitant therapy included METROGEL, clonazepam and "birth control". Since the patient received her first dose of GARDASIL her whole arm was blotchy, she had mood swings, shoulder pain, hand numbness, and vaginal irritation and discharge. The office medical assistant stated that on 02-OCT-2009 the patient informed she was not going to receive any more doses of GARDASIL. At the time of the report, the outcome of the patient was unknown. Follow up information was received from the nurse who indicated that the patient with a history of bacterial vaginosis on 23-JUL-2009 was vaccinated with a first dose of GARDASIL (Lot No. 661046/0381X) in her left deltoid. Concomitant therapy included KLONOPIN, YASMIN and PERCOCET. Subsequently the patient developed vagina swollen. She sought medical attention for vaginal irritation and discharge. The patient was not recommended to receive the second and third dose of GARDASIL. The outcome of the patient was not reported. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female patient who on an unknown date was vaccinated with a first 0.5 ml dose of GARDASIL (Lot No. not reported). On an unknown date the patient developed rash on the face and neck area. The patient sought unspecified medical attention. On an unknown date the patient recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: C-reactive protein normal, Full blood count normal, Headache, Metabolic function test normal, Migraine
Clinical narrative: Information has been received from a physician concerning a 13 year old female with no previous migraine episode nor drug reactions/allergies who on 10-JUN-2009 was vaccinated IM with the first 0.5ml dose of GARDASIL (Lot#660391/0063X). Concomitant therapy included tretinoin (manufacturer unknown) for the treatment of acne. On 14-JUN-2009 the patient had a migraine attack. The patient had a severe headache, nausea, vomiting and phobia. The patient was at the emergency room at a hospital and responded well to medication. The patient received IV TORADOL for pain and IV ZOFRAN for the nausea and vomiting. Lab diagnostics studies performed: complete blood count, C reactive protein, basic metabolic panel - all unremarkable from the report from the unspecified emergency room physician. On 14-JUN-2009 the patient was recovered. Follow-up information has been received from a physician concerning a 13 year old female student with no pre-existing allergies, birth defect, medical conditions and no illness at time of vaccination who was vaccinated IM in the left deltoid with the first dose of GARDASIL (Lot#660391/0063X) at 15:30 pm in the afternoon on 10-JUN-2009. On 14-JUN-2009 in the morning the patient experienced migraine-like episode with severe headache, photophobia, nausea and vomiting, starting between 3.5 to 4 days after first GARDASIL injection. The patient required intravenous TORADOL and ZOFRAN for relief. The patient had no previous migraine history and none since then. The patient sought medical attention by visiting emergency room. The lab diagnostic tests performed: complete blood cell count, serum C-reactive protein test and metabolic marker test were all normal. The patient recovered on 14-JUN-2009. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain, Phobia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 13 year old female with no previous migraine episode nor drug reactions/allergies who on 10-JUN-2009 was vaccinated IM with the first 0.5ml dose of GARDASIL (Lot#660391/0063X). Concomitant therapy included tretinoin (manufacturer unknown) for the treatment of acne. On 14-JUN-2009 the patient had a migraine attack. The patient had a severe headache, nausea, vomiting and phobia. The patient was at the emergency room at a hospital and responded well to medication. The patient received IV TORADOL for pain and IV ZOFRAN for the nausea and vomiting. Lab diagnostics studies performed: complete blood count, C reactive protein, basic metabolic panel - all unremarkable from the report from the unspecified emergency room physician. On 14-JUN-2009 the patient was recovered. Follow-up information has been received from a physician concerning a 13 year old female student with no pre-existing allergies, birth defect, medical conditions and no illness at time of vaccination who was vaccinated IM in the left deltoid with the first dose of GARDASIL (Lot#660391/0063X) at 15:30 pm in the afternoon on 10-JUN-2009. On 14-JUN-2009 in the morning the patient experienced migraine-like episode with severe headache, photophobia, nausea and vomiting, starting between 3.5 to 4 days after first GARDASIL injection. The patient required intravenous TORADOL and ZOFRAN for relief. The patient had no previous migraine history and none since then. The patient sought medical attention by visiting emergency room. The lab diagnostic tests performed: complete blood cell count, serum C-reactive protein test and metabolic marker test were all normal. The patient recovered on 14-JUN-2009. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Injection site pain, Malaise, Nausea, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a nurse concerning a 24 year old female with an allergy to "laughing gas" who on 03-JUN-2009 was vaccinated IM with the first dose of GARDASIL. On 03-AUG-2009 the patient was vaccinated IM with the second dose of GARDASIL (Lot#662404/0312Y). Concomitant therapy included NUVARING. On 04-AUG-2009 this morning the patient called the office stated that she woke up with stomach ache, nausea, soreness at the injection site and a "generalized feeling of not feeling well". There were no laboratory or diagnostic tests performed. At the time of report the patient's status was recovering. Follow-up information has been received from a registered nurse concerning a 24 year old female patient with allergic to laughing gas and with no illness at time of vaccination who was vaccinated with the second dose of GARDASIL (Lot#662404/0312Y) at left deltoid at 9:00 on 03-AUG-2009. The patient had no adverse event after vaccination with the first dose of GARDASIL. On 04-AUG-2009 at 8:00am the patient had nausea and felt like she wanted to vomit. She described that she was feeling of "not feeling well all". The patient had not sought medical attention. There were no relevant diagnostic tests. On 05-AUG-2009 the patient had recovered. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Urinary tract infection, Vaccine positive rechallenge
Clinical narrative: Information has been received from a medical assistant concerning a 26 year old female with no pertinent medical history and no drug allergies, who on 29-JAN-2009 was vaccinated with the 1st dose of GARDASIL, 0.5ml, IM, and the 2nd dose on 31-MAR-2009, 0.5ml, IM. Concomitant therapy included unspecified birth control pill. Subsequently the patient experienced urinary tract infection (date unknown) after receiving the first and second dose of GARDASIL. The patient was evaluated at an unspecified urgent care facility and was prescribed CIPRO, the patient's symptoms were improving. The patient would be receiving her 3rd dose on 04-AUG-2009. The patient sought unspecified medical attention. At the time of the report, the patient's status was recovering. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Arthritis
Clinical narrative: Information has been received from a physician concerning that her daughter, who is a pharmaceutical representative, was vaccinated with GARDASIL in 2008. Subsequently the patient experienced arthritis in her wrist "a few months ago". It was noted that the patient used the computer a lot. The patient sought medical attention. At the time of the report, the patient recovered without treatment. The Health Care Professional contacted during telephone follow-up refused to give any information pertaining to the patient. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Amniotic fluid index, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Streptococcal infection, Streptococcus test positive
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, A Pregnancy Registry product, concerning a 20 year old female with no pertinent medical history and no drug allergies, who on 22-MAY-2009 was vaccinated with her 1st dose of GARDASIL (LOT# 658271/0558X), IM, 0.5ml, and the 2nd dose on 22-JUL-2009 (LOT#662404/0312Y), IM, 0.5ml. Concomitant therapy included NUVARING. The patient called the office and reported that she was eight weeks pregnant. Labs and diagnostic tests included home pregnancy test. The result was positive. The patient's LMP was 10-JUN-2009, and EDD was 17-MAR-2010. There were no adverse effects reported. The patient had not been in the office for medical attention. At the time of the report, the patient's status was pregnant. Follow-up information was received from a registered nurse who reported that this is a female patient with no previous pregnancies. The patient's LMP was reported as June 2009 (date unknown), estimated date of conception was June or July 2009 with an unknown estimated date of delivery. Follow up information received from a registered nurse indicating that the patient had delivered a normal female baby (weight 7 lbs, 13 oz, length 52.1cm, Apgar score 8/9, head circumference 14 inches) on 08-APR-2010 at 40 weeks 3 days gestation. There are no congenial anomalies and no other complications or abnormalities. The patient had was positive for Group B streptococci. Other medication used during pregnancy were ZOFRAN, iron (unspecified), KEFLEX. Lab test included ultrasound, non-stress test (NST) and Amniotic Fluid Index test (AFI), results not reported. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, A Pregnancy Registry product, concerning a 20 year old female with no pertinent medical history and no drug allergies, who on 22-MAY-2009 was vaccinated with her 1st dose of GARDASIL (LOT# 658271/0558X), IM, 0.5ml, and the 2nd dose on 22-JUL-2009 (LOT#662404/0312Y), IM, 0.5ml. Concomitant therapy included NUVARING. The patient called the office and reported that she was eight weeks pregnant. Labs and diagnostic tests included home pregnancy test. The result was positive. The patient's LMP was 10-JUN-2009, and EDD was 17-MAR-2010. There were no adverse effects reported. The patient had not been in the office for medical attention. At the time of the report, the patient's status was pregnant. Follow-up information was received from a registered nurse who reported that this is a female patient with no previous pregnancies. The patient's LMP was reported as June 2009 (date unknown), estimated date of conception was June or July 2009 with an unknown estimated date of delivery. Follow up information received from a registered nurse indicating that the patient had delivered a normal female baby (weight 7 lbs, 13 oz, length 52.1cm, Apgar score 8/9, head circumference 14 inches) on 08-APR-2010 at 40 weeks 3 days gestation. There are no congenial anomalies and no other complications or abnormalities. The patient had was positive for Group B streptococci. Other medication used during pregnancy were ZOFRAN, iron (unspecified), KEFLEX. Lab test included ultrasound, non-stress test (NST) and Amniotic Fluid Index test (AFI), results not reported. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician's employee concerning a female who on unknown date was vaccinated intramuscularly with the first dose 0.5 mL of GARDASIL (LOT # was not provided). The patient passed out after she was given GARDASIL. The patient recovered from passed out on the same day she got the vaccination. She sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with the second dose of GARDASIL (date, dose, route, lot# not reported). After the patient received the second dose of GARDASIL, she started sweating profusely and became dizzy. After placing the patient in the supine position, she began to feel better after 15 minutes. The nurse was going to follow-up with the patient to check her present status. The patient had no adverse reaction after receiving the first dose of GARDASIL. The patient was in the office while the adverse event happened. 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 on unknown date was vaccinated intramuscularly with the first dose of GARDASIL (LOT # was not provided) and fainted. The patient eventually came to and left the office, however, the physician was unsure if she had recovered. She sought medical attention and was seen in office. Follow-up information has been received from the physician concerning the female patient with no known drug allergies or pertinent medical history. It was reported that there was no illness at the time of vaccination. The physician reported that the patient fainted after vaccination for a few seconds. It was noted that the patient did not have any breakfast that day and was practicing field hockey for one hour prior to coming to the office. There were no laboratory studies performed. Subsequently, the patient recovered. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Cephalo-pelvic disproportion, Drug exposure during pregnancy, Ultrasound antenatal screen normal, Umbilical cord around neck
Clinical narrative: Information has been received from a medical assistant concerning a female fetus whose 24 year old mother with a history of one elective termination (date unspecified) and no known allergies who on 20-APR-2009 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot number 1702X). On 22-JUN-2009 the mother was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot number 0294Y). There was no concomitant medication. On an unspecified date, the mother was determined to be pregnant by urine pregnancy test. The last menstrual period (LMP) was 07-JUN-2009 and the estimated delivery date (EDD) was 15-MAR-2010. Medical attention was sought in the office (date unspecified). On 06-AUG-2009, the mother had an ultrasound to confirmed dating results were reported as within normal limits (WNL). On 02-SEP-2009 an "ultrascreen" was performed in order to rule out early detection of Down syndrome, Trisomy 19/13. The result of the test was within normal limits. On 19-MAR-2010 the mother gave birth via C-section due to cephalo-pelvic disproportion to the patient. The patient weighed 7 pounds 8 ounces, 18 inches long. The Apgar score was 8 at one minute and 9 at five minutes. Medication during pregnancy included prenatal vitamin daily. There was no complication during pregnancy, however, the patient's cord was wrapped around her neck twice. No fetal distress was noted. Neither mom nor baby has been back to the office for follow up care. Their current status was not reported. Upon internal review, C-section was determined to be an other important medical event. The mother's experience has been captured in WAES # 0908USA00845. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: Information has been received from a patient who was placed on therapy with GARDASIL. Subsequently the patient experienced an unspecified adverse event. This patient also experienced an adverse event on lisinopril (WAES# 0907USA046021). Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hypotension, Loss of consciousness, Unresponsive to stimuli, Vomiting
Clinical narrative: Information has been received from a nurse concerning a 15 year old female patient with no pertinent medical history and no known allergies who on 15-JUL-2009 was vaccinated in the right deltoid with the first 0.5 ml dose of GARDADSIL (lot number 661953/1130X). There was no concomitant medication. Approximately 3 minutes post administration, the patient passed out. The patient vomited one time, was dizzy. She was mostly unresponsive and very hypotensive for about 45 minutes. The patient "very slowly" became alert and oriented and the blood pressure "very slowly" returned to normal. The patient fully recovered and finished the remained of the appointment without incident. There were no lab diagnostics studied performed. No further information expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse concerning a female patient who on an unspecified date was vaccinated with the first dose of GARDASIL (lot number not reported). On approximately 06-JUL-2009 the patient experienced soreness around the injection site. Unspecified medical attention was sought. At the time of the report, the patient not recovered. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Dizziness, Malaise, Nausea, Pallor
Clinical narrative: Information has been received from a health professional concerning a 21 year old female patient with psoriasis and Raynaud's syndrome who on an unspecified date was vaccinated I.M. with a dose of GARDASIL (dose unknown). The health professional reported that the patient experienced "nausea and flare-ups of psoriasis and Raynaud's disease after receiving GARDASIL". The patient sought medical attention via an office visit. The outcome was not specified. Follow up information was received from the nurse who reported that the female patient with flare ups of psoriasis once or twice per year was vaccinated at another facility and the events were reported to her by the patient and not by direct observation. On the day the patient was vaccinated with the first dose of GARDASIL the patient experienced nausea, dizziness, was pale, and felt ill. A few days after receiving the injection the patient had itching. A few weeks after the injection the patient developed a flare up of psoriasis, this was more intense and prolonged than previous flare ups. The nurse also stated the patient has had more problems in the past year than before. On an unknown date, the patient recovered. It was unknown if the patient had any illnesses at the time of vaccination. There were no labs or diagnostic studies performed. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Psoriasis
Clinical narrative: Information has been received from a health professional concerning a 21 year old female patient with psoriasis and Raynaud's syndrome who on an unspecified date was vaccinated I.M. with a dose of GARDASIL (dose unknown). The health professional reported that the patient experienced "nausea and flare-ups of psoriasis and Raynaud's disease after receiving GARDASIL". The patient sought medical attention via an office visit. The outcome was not specified. Follow up information was received from the nurse who reported that the female patient with flare ups of psoriasis once or twice per year was vaccinated at another facility and the events were reported to her by the patient and not by direct observation. On the day the patient was vaccinated with the first dose of GARDASIL the patient experienced nausea, dizziness, was pale, and felt ill. A few days after receiving the injection the patient had itching. A few weeks after the injection the patient developed a flare up of psoriasis, this was more intense and prolonged than previous flare ups. The nurse also stated the patient has had more problems in the past year than before. On an unknown date, the patient recovered. It was unknown if the patient had any illnesses at the time of vaccination. There were no labs or diagnostic studies performed. No further information is available.
Age: 8.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Inappropriate schedule of drug administration, Nausea
Clinical narrative: Information has been received from a consumer concerning her 11 year old granddaughter, who in September 2009 was vaccinated with the first dose of GARDASIL (lot # not reported). Subsequently, after she received the vaccine, the patient began to feel dizzy and nauseous. The patient recovered on the same day. The patient sought unspecified medical attention. Follow up information has been received from a consumer who reported that her granddaughter in approximately in October 2009 received her second dose of GARDASIL (lot # not reported). No adverse effects were reported. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling of body temperature change, Nausea
Clinical narrative: Information has been received from a licensed practical nurse concerning a 20 year old female with no medical history or allergies who on 04-AUG-2009 was vaccinated IM with 0.5 ml of GARDASIL (lot # 659182/1757U). Concomitant therapy included sertraline HCl (birth control pill). On 06-AUG-2009 the patient called the office stating she experienced nausea and dizziness. There were no laboratory studies performed. The patient sought unspecified medical attention. At the time of reporting, the patient had not recovered. Follow-up information has been received from the registered nurse concerning the 20 year old female who on 04-AUG-2009 at 13:30 was vaccinated with the first dose of GARDASIL in her left arm. Concomitant therapy also included TCA applied to vulva "same day as GARDASIL given" on 04-AUG-2009. The nurse reported the patient complained of nausea, dizziness and being unsure of temperature. The patient stated that she ran "hot and cold". The patient had recovered. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Injection site pain, Syncope, Vomiting
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter with no medical history or allergies who on 05-JUL-2009 was vaccinated, 0.5 ml, with the first dose of GARDASIL (lot # not reported) injection. The patient experienced lightheaded and injection site pain after getting first dose of GARDASIL and fainted, vomiting and tiredness after getting the second dose of GARDASIL on 06-AUG-2009. There was no concomitant medication. There were no laboratory studies performed. The patient sought unspecified medical attention. At the time of reporting, the patient had not recovered from lightheaded and injection site pain. The patient's outcome of faint, vomiting and tiredness were unknown. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Rash
Clinical narrative: Information has been received from a physician's assistant concerning a 15 year old female who "two months ago" on approximately 05-JUN-2009 was vaccinated with her 1st dose of GARDASIL (lot # not provided). 0.5 ml. Subsequently, the patient developed a "golf ball sized rash which was raised approximately 3/4 of an inch off the skin" after the vaccination "two months ago". The patient also had pain at the injection site for approximately one week after the vaccination. The patient had sought unspecified medical attention. At the time of report, the patient recovered. Follow up information has been received from a physician assistant indicating that the patient did not get the injection from their clinic. The patient declined an injection because of an unpleasant experience where she received her first, and only, injection elsewhere. The reporter asked the patient to sign a release to allow her to obtain the other provider's records, but have not received the signed release. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a nurse concerning a patient who on unknown date was vaccinated with GARDASIL (LOT # was not provided) and passed out. The outcome of the patient was unknown. It was also unknown that the patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Tongue ulceration
Clinical narrative: Information has been received from a Billing Coordinator concerning a her niece who on an unspecified date was vaccinated with a dose of GARDASIL (lot # not reported). Subsequently on an unspecified date the patient developed tongue ulcers and fever. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination/therapy, dose number, lot number, date of event, recovery status, healthcare provider name and contact information. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Pain, Tongue ulceration, Tremor
Clinical narrative: Information has been received from a nurse practitioner concerning her 16 year old "healthy" daughter with no pertinent medical history who on 05-AUG-2009 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL in the morning. The nurse practitioner reported that on 05-AUG-2009 by the afternoon, the patient developed tongue ulcers, trembles and body aches. The patient sought unspecified medical attention. Additional information was received from an operations IT manager and a physician, who is the patient's father. It was reported that the patient received GARDASIL (Lot # 662724/0313Y) and did not receive any concomitant vaccinations. The patient also developed flu-like symptoms. Therapy with human papillomavirus vaccine was discontinued. On an unspecified date, the patient recovered from tongue ulcers, trembles, body aches and flu-like symptoms. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a nurse who is the mother of a 17 year old female who in February 2009, was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (lot no. not reported). Concomitant therapy included hormonal contraceptives (unspecified). In February 2009, one week after vaccination the patient experienced aches and pains in her arms and legs. The patient had not received second dose of GARDASIL and the mother had not yet decided whether to discontinue the series. The patient recovered a few days later. The patient sought unspecified medical attention. No further information is available.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Chest X-ray normal, Electrocardiogram normal, Fall, Syncope
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 12 year old female with no medical history and no illness at time of vaccination who on 06-AUG-2009 was vaccinated with her first dose of GARDASIL, Lot# 661046/0381X into her right arm at PM time. Concomitant therapy included her first dose of VARIVAX Lot# 664719/0804Y into her left arm and her first dose of VAQTA Lot# 663548/1604X into her left arm. On 06-AUG-2009, the patient experienced syncope. The patient dropped to the floor five minutes after vaccination, lasted less than 2 minutes and she was oriented right after she was picked up. The patient required emergency room/doctor visit. Laboratory tests included a chest X-ray and an ECG that were normal. On 06-AUG-2009, the patient recovered from syncope. No further information is available.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site irritation, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on 27-MAY-2009 was vaccinated with the first 0.5ml dose of GARDASIL (Lot# not provided). The patient did receive additional vaccines in the other arm on the same day she received GARDASIL, however there was no information regarding which vaccine the patient received. On 27-MAY-2009 after receiving GARDASIL the patient developed a raised, red, irritated rash at the injection site which was still present as of 10-AUG-2009. The patient had sought unknown medical attention. At the time of report the patient's status was not recovered. The second dose of GARDASIL was scheduled to be given on 10-AUG-2009, but was not given because of the rash. Follow-up information has been received indicated the correct address and the patient was 16 years old. Follow-up information has received from a nurse practitioner concerning the patient with a history of eczema, itchy skin and rashes and hives from ZITHROMAX and BACTRIM and with no illness at time of vaccination. The patient was vaccinated IM with the first dose of GARDASIL (Lot# 661953/1130X) in the right deltoid on 27-MAY-2009. On 27-MAY-2009 the patient also was vaccinated in her left arm with MENACTRA and hepatitis A virus vaccine inactivated (manufacturer unknown). The patient returned on 12-JUN-2009 with itchiness in both arms. The right arm was more severe than the left arm. On 12-AUG-2009 the patient returned stating she had persisted swelling at the injection site of GARDASIL. The patient had 3x2.5 cm red slightly raised firm area in the right deltoid. There were no relevant diagnostic tests performed. At the time of report the patients status was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Pruritus
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on 27-MAY-2009 was vaccinated with the first 0.5ml dose of GARDASIL (Lot# not provided). The patient did receive additional vaccines in the other arm on the same day she received GARDASIL, however there was no information regarding which vaccine the patient received. On 27-MAY-2009 after receiving GARDASIL the patient developed a raised, red, irritated rash at the injection site which was still present as of 10-AUG-2009. The patient had sought unknown medical attention. At the time of report the patient's status was not recovered. The second dose of GARDASIL was scheduled to be given on 10-AUG-2009, but was not given because of the rash. Follow-up information has been received indicated the correct address and the patient was 16 years old. Follow-up information has received from a nurse practitioner concerning the patient with a history of eczema, itchy skin and rashes and hives from ZITHROMAX and BACTRIM and with no illness at time of vaccination. The patient was vaccinated IM with the first dose of GARDASIL (Lot# 661953/1130X) in the right deltoid on 27-MAY-2009. On 27-MAY-2009 the patient also was vaccinated in her left arm with MENACTRA and hepatitis A virus vaccine inactivated (manufacturer unknown). The patient returned on 12-JUN-2009 with itchiness in both arms. The right arm was more severe than the left arm. On 12-AUG-2009 the patient returned stating she had persisted swelling at the injection site of GARDASIL. The patient had 3x2.5 cm red slightly raised firm area in the right deltoid. There were no relevant diagnostic tests performed. At the time of report the patients status was unknown. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Inappropriate schedule of drug administration, Incorrect route of drug administration, Injection site discolouration, Injection site erythema
Clinical narrative: Information has been received from a nurse midwife for GARDASIL, a pregnancy registry product, concerning a 31 year old female who on 05-AUG-2009 was inadvertently vaccinated SC in the left forearm with 0.1cc dose of GARDASIL instead of PPD vaccine. There was no concomitant medication. The patient was 11 1/2 weeks pregnant on 05-AUG-2009. The last menstruation period was 20-MAY-2009 and the estimated delivery date would be 24-FEB-2010. Client was seen for a follow up visit today and nurse stated she was okay. The left forearm had some hyperpigmentation but no ulceration. Client had dating sonogram performed on 29-JUL-2009 and was due on 24-FEB-2010. Follow-up information has been received from a nurse practitioner who indicated that on 04-AUG-2009 (also reported as 05-AUG-2009) the patient was accidentally vaccinated subdermal with GARDASIL (Lot # was not reported) in her arm. The whole dose was not given to the patient just partial dose because the office realized that this patient was not supposed to get the GARDASIL vaccine. Nurse reported that the patient developed redness and half centimeter pigmented skin on the injection site. At the time of report the redness and half centimeter pigmented skin on the injection site was not recovered. Follow-up information has been received from a certified nurse midwife who indicated that the female patient was inadvertently vaccinated intradermally with a 0.1cc dose of GARDASIL on 04-AUG-2009. Concomitant therapies included: vitamins unspecified, VISTARIL, MUCINEX, ferrous sulfate, calcium (unspecified). On 19-AUG-2009 the patient developed a 1/2 cm in diameter erythematous hyperpigmented area at the site of injection. There were no symptoms or signs of ulceration. Follow-up information has been received from a certified nurse midwife who indicated that the female patient had allergy symptoms at time of vaccination and had no pre-existing allergies, birth defects and medical conditions. Follow-up information has been received from another health professional indicated that the female patient with 3 previous pregnancies and 2 full term deliveries who on 24-FEB-2010 delivered a normal health female infant. The weight of infant was 3519 gm, the Apgar score of infant was 9/9, the birth date from LMP was 39.1 weeks. There were no congenital anomalies or other complications with the infant. Additional information is not expected.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Skin hyperpigmentation, Underdose
Clinical narrative: Information has been received from a nurse midwife for GARDASIL, a pregnancy registry product, concerning a 31 year old female who on 05-AUG-2009 was inadvertently vaccinated SC in the left forearm with 0.1cc dose of GARDASIL instead of PPD vaccine. There was no concomitant medication. The patient was 11 1/2 weeks pregnant on 05-AUG-2009. The last menstruation period was 20-MAY-2009 and the estimated delivery date would be 24-FEB-2010. Client was seen for a follow up visit today and nurse stated she was okay. The left forearm had some hyperpigmentation but no ulceration. Client had dating sonogram performed on 29-JUL-2009 and was due on 24-FEB-2010. Follow-up information has been received from a nurse practitioner who indicated that on 04-AUG-2009 (also reported as 05-AUG-2009) the patient was accidentally vaccinated subdermal with GARDASIL (Lot # was not reported) in her arm. The whole dose was not given to the patient just partial dose because the office realized that this patient was not supposed to get the GARDASIL vaccine. Nurse reported that the patient developed redness and half centimeter pigmented skin on the injection site. At the time of report the redness and half centimeter pigmented skin on the injection site was not recovered. Follow-up information has been received from a certified nurse midwife who indicated that the female patient was inadvertently vaccinated intradermally with a 0.1cc dose of GARDASIL on 04-AUG-2009. Concomitant therapies included: vitamins unspecified, VISTARIL, MUCINEX, ferrous sulfate, calcium (unspecified). On 19-AUG-2009 the patient developed a 1/2 cm in diameter erythematous hyperpigmented area at the site of injection. There were no symptoms or signs of ulceration. Follow-up information has been received from a certified nurse midwife who indicated that the female patient had allergy symptoms at time of vaccination and had no pre-existing allergies, birth defects and medical conditions. Follow-up information has been received from another health professional indicated that the female patient with 3 previous pregnancies and 2 full term deliveries who on 24-FEB-2010 delivered a normal health female infant. The weight of infant was 3519 gm, the Apgar score of infant was 9/9, the birth date from LMP was 39.1 weeks. There were no congenital anomalies or other complications with the infant. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Immediate post-injection reaction, Malaise, No reaction on previous exposure to drug, Syncope, Tremor
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of GARDASIL on an unspecified date. Subsequently the patient fainted before the needle was removed from the patient. The reporter felt that fainting before needle removed was not related to therapy with GARDASIL. Follow-up information has been received from a medical assistant concerning a 15 year old female who on 22-JUL-2009 was vaccinated with the third dose of GARDASIL (lot# 661531/1311X). There was no reaction reported after the first two doses of GARDASIL. Concomitant vaccination on the same day included a dose of VARIVAX (MSD, lot# and dose not reported). It was reported that after removing the needle, she talked to the patient for a while and then the patient reported feeling sick, and fainted on 22-JUL-2009. The patient was shaking and she wet herself a little. The doctor came in the room, they waited for a while then administered the VARIVAX (MSD). The medical assistant also reported that the patient's parent did not call back so she assumed that the patient was okay. This is an amended report. VARIVAX was changed from "secondary suspect" therapy to "concomitant" therapy since the AE occurred prior to VARIVAX (MSD) administration. Additional information has been requested. This is one of several reports from the same source.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Urinary incontinence
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of GARDASIL on an unspecified date. Subsequently the patient fainted before the needle was removed from the patient. The reporter felt that fainting before needle removed was not related to therapy with GARDASIL. Follow-up information has been received from a medical assistant concerning a 15 year old female who on 22-JUL-2009 was vaccinated with the third dose of GARDASIL (lot# 661531/1311X). There was no reaction reported after the first two doses of GARDASIL. Concomitant vaccination on the same day included a dose of VARIVAX (MSD, lot# and dose not reported). It was reported that after removing the needle, she talked to the patient for a while and then the patient reported feeling sick, and fainted on 22-JUL-2009. The patient was shaking and she wet herself a little. The doctor came in the room, they waited for a while then administered the VARIVAX (MSD). The medical assistant also reported that the patient's parent did not call back so she assumed that the patient was okay. This is an amended report. VARIVAX was changed from "secondary suspect" therapy to "concomitant" therapy since the AE occurred prior to VARIVAX (MSD) administration. Additional information has been requested. This is one of several reports from the same source.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Headache, Muscle spasms, Muscular weakness, Paraesthesia
Clinical narrative: Information has been received from a consumer concerning his 19 year old daughter with no pertinent medical history and no known drug allergies, who in August 2008, was vaccinated with her first dose of GARDASIL, and the second dose on 05-AUG-2009. There was no concomitant medication. On 07-AUG-2009 after the vaccination the patient experienced weak legs, and a tingling feeling in her back and arms. Her legs were so weak that she fell 4 times. She was examined in the Emergency room on 07-AUG-2009. She was not admitted and left that night. There were no labs and diagnostic tests performed. The patient sought unspecified medical attention. At the time of the report, the patient's status was recovering. Follow-up information has been received from a physician concerning the patient with attention deficit disorder, who was vaccinated with her second dose of GARDASIL (lot # 658222/0927U) in the left arm at 09:00 AM. At 08:00 PM on 07-AUG-2009, the patient felt weak, legs and arms tingled, fainted. She rested briefly, and felt fine. No medical intervention. The patient did not seek medical attention. The patient recovered on 07-AUG-2009. Follow up information has been received from the consumer's aunt stating that "the patient now was also experiencing back spasms and severe headache". It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Sex: F
Vaccine: DTAP, HEPA, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a Registered Nurse concerning a female patient who on 04-AUG-2009 was vaccinated with a dose of GARDASIL (lot # not reported). On the same day on 04-AUG-2009 she received a dose of VAQTA (lot not reported) (manufacturer unknown). Concomitant therapy include DTAP and MENACTRA administered on 04-AUG-2009. On 04-AUG-2009 after received the vaccine the patient fainted. The nurse reported that the patient was able to leave the office. At the time on the report on 10-AUG-2009 the patient had recovered. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Dizziness
Clinical narrative: Information has been received from an office manager concerning a 19 year old female patient who on 08-JUN-2009 was vaccinated with the first and only dose of GARDASIL. On an unknown date after receiving GARDASIL the patient experienced chills and dizziness for three days. It was reported that the patient will not receive further doses of GARDASIL. At the time of reporting the patient had recovered. Additional information has been requested.