chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female who on 05-NOV-2010 was vaccinated IM with the first 0.5 ml (also reported as 0.5 mg) dose of GARDASIL (lot # not provided, expired date 12-NOV-2012). Concomitant therapy included multi-vitamins. On 05-NOV-2010 the patient fainted or passed out for five to ten seconds after her first dose of GARDASIL was administered.  The patient was fine after resting for thirty minutes after the injection. The nurse reported that the physician had not heard from the patient after the procedure and said the patient was fine when she left the healthcare office. It was reported that therapy with GARDASIL was discontinued. The patient sought unspecified medical attention. Follow up information received from the registered nurse indicated that the patient was a female, with drug allergies to hydrocodone and no illness at time of vaccination, who on 04-NOV-2010 (previously reported by the registered nurse was 05-NOV-2010) at 9:00 am was vaccinated IM with the first dose of GARDASIL (lot # 666598/0786Z) at right deltoid. Seconds after administration of GARDASIL patient complained of lightheadedness and was assisted to lay back on table she was sitting on. Patient lost consciousness for approximately 10 seconds. Shortly after, patient stated she "felt fine". Vitals were stable. Patient rested in office approximately 20 minutes. Then she had someone drive her back to work. At the time of reporting, the patient's status was recovered. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Biopsy eyelid, Blepharal papilloma, Smear cervix
Clinical narrative: Information has been received from a consumer concerning her daughter current 22 year old daughter with migraine, asthma, fibroids and pertussis allergy, who in 2007 started therapy with GARDASIL (Lot # not reported). Concomitant therapy included TOPAMAX. Consumer reported that about a month to six weeks after her daughter received the 3rd GARDASIL shot, she started developing papillomas around her eyes. They were removed about this time last year in approximately November 2009 or in the beginning of 2010. Within the last 2 or 3 months, in approximately August 2010 they have come back and been multiplying. There were located just where the eyelash goes into the lid, and now there were some growing on the bottom section of the eye too. Consumer's daughter was never admitted to hospital, she had outpatient surgery. On an unspecified date a biopsy on papillomas and invasive Pap smears were performed (results not provided). At the time of the report the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal heart rate normal, Small for dates baby, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a nurse practitioner (N.P.) concerning a 0 day old baby who was conceived to a 31 year old female with sulfonamide allergy and no medical history who on 14-SEP-2010, was vaccinated intramuscularly the first 0.5 mL dose of GARDASIL (663561/1498Y) in her left arm. Concomitant therapy included vitamins. It was reported that on unknown date, the mother performed the follow lab diagnostics: ultrasound normal (USN); positive fetal heart rate (+FHR); single intrauterine pregnancy (SIUP); size less than dates by LMP. At the time of the report, the outcome was unknown. It was unknown if the patient sought an medical attention. The mother's experience was previously reported in WAES 1009USA03286. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Dyspnoea, Normal newborn, Pregnancy test positive
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.), for GARDASIL, a Pregnancy Registry product, concerning an approximately 24 years old female patient with no drug reactions/allergies and a history of irregular menstrual cycle who on 20-JUL-2010 was vaccinated intramuscularly with her first 0.5mL dose of GARDASIL (lot number 666121/1778Y). Concomitant therapy included prenatal vitamins (therapy unspecified). The medical assistant reported that on 29-AUG-2010, the patient was seen in the emergency room for shortness of breath, while there she was tested for a pregnancy test and was positive. No report from the emergency room on the shortness of breath had been received. At the time of report, the patient's shortness break outcome was unknown. Last menstrual period (LMP), 10-JUN-2010. Her estimated date of delivery (EDD) was 17-MAR-2011. Follow-up information has been received from a registered Nurse via a telephone call, who reported that the patient delivered vaginally a healthy male neonate on 27-MAR-2011. The neonate weight at birth was reported as 6 pounds, 1 ounce. Gestational age was 39 weeks. APGAR scores were 8/9. There were no congenital anomalies noted in the OB/delivery report. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a 26 year old female patient with heart condition and allergic to an unspecified medication who on 28-JUL-2010 was vaccinated with a first dose of GARDASIL (Lot# unknown). Concomitant therapy included lithium and SEASONIQUE. The patient reported that she had the first dose of GARDASIL and on 10-AUG-2010, she had severe hair loss (patchy baldness all over her head). She additionally mentioned that she experienced a loss of around 60% of her hair and had bald spots on the sides and top of her head. She mentioned she was due for her second dose of GARDASIL today on 13-SEP-2010 but she did not take it because she was afraid that she was going to lose more hair. The consumer mentioned she got medical attention and saw a different doctor at every visit. The patient stated that her hair was beginning to grow back in the spots where it was lost. There were no laboratory test or diagnostic studies performed. The patient sought medical attention by a doctor visit (also reported as no). Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy cervix, Cervical dysplasia, Endocervical curettage, Hepatitis B DNA assay, Human papilloma virus test positive
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 25 year old female patient with no pertinent medical history or drug reaction and allergies, who on 11-APR-2008 was vaccinated with the first dose of GARDASIL (Lot # 654490/0133X), (route no reported), on 10-JUN-2008 the patient received the second dose of GARDASIL (Lot # 654490/0122X), (route no reported), and on 07-OCT-2008 was vaccinated with the third dose of GARDASIL (Lot # 659184/0843X) (route no reported). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufactured unknown). The nurse reported that on an unspecified date, the patient tested positive for HPV and developed atypical squamous undetermined origin. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. A PAP smear and HPV DNA test were performed. Follow-up information has been received from a licensed visiting nurse and medical records concerning a 25 year old female patient who on 11-Apr-2008 was vaccinated with the first dose of GARDASIL (Lot # 664490/0133X), left deltoid-IM, on 10-JUN-2008 the patient received the second dose of GARDASIL (Lot # 654490/0133X), right deltoid-IM, and on 07-OCT-2008 was vaccinated with the third dose of GARDASIL (Lot # 659194/0843X) right deltoid-IM. On 20-AUG-2010, the patient's routine PAP showed HPV detected and developed atypical squamous cells undetermined significance. On 30-AUG-2010, the patient's HPV DNA pathology report showed HPV DNA detected, reference range was not detected, general categorization: epithelial cell abnormality and the interpretation and result were atypical squamous cells of undetermined significance. The patient's clinical information listed, intrauterine contraceptive device, last menstrual period 10-AUG-2010 and a previous PAP test in Mar-2009 (no results provided). On 20-OCT-2010 repeat PAP showed atypical squamous cells of undetermined significance. Note stated patient could repeat in three months or undergo colposcopy. On 06-DEC-2010, the repeat PAP and tissue pathology revealed diagnoses of endocervix curettage (benign endocervical mucosa) and cervix biopsy (benign reactive exocervical mucosa and transition zone and endocervix not present). The patient's outcome was not provided. All available medical records will be provide upon request. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 25 year old female patient with no pertinent medical history or drug reaction and allergies, who on 11-APR-2008 was vaccinated with the first dose of GARDASIL (Lot # 654490/0133X), (route no reported), on 10-JUN-2008 the patient received the second dose of GARDASIL (Lot # 654490/0122X), (route no reported), and on 07-OCT-2008 was vaccinated with the third dose of GARDASIL (Lot # 659184/0843X) (route no reported). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufactured unknown). The nurse reported that on an unspecified date, the patient tested positive for HPV and developed atypical squamous undetermined origin. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. A PAP smear and HPV DNA test were performed. Follow-up information has been received from a licensed visiting nurse and medical records concerning a 25 year old female patient who on 11-Apr-2008 was vaccinated with the first dose of GARDASIL (Lot # 664490/0133X), left deltoid-IM, on 10-JUN-2008 the patient received the second dose of GARDASIL (Lot # 654490/0133X), right deltoid-IM, and on 07-OCT-2008 was vaccinated with the third dose of GARDASIL (Lot # 659194/0843X) right deltoid-IM. On 20-AUG-2010, the patient's routine PAP showed HPV detected and developed atypical squamous cells undetermined significance. On 30-AUG-2010, the patient's HPV DNA pathology report showed HPV DNA detected, reference range was not detected, general categorization: epithelial cell abnormality and the interpretation and result were atypical squamous cells of undetermined significance. The patient's clinical information listed, intrauterine contraceptive device, last menstrual period 10-AUG-2010 and a previous PAP test in Mar-2009 (no results provided). On 20-OCT-2010 repeat PAP showed atypical squamous cells of undetermined significance. Note stated patient could repeat in three months or undergo colposcopy. On 06-DEC-2010, the repeat PAP and tissue pathology revealed diagnoses of endocervix curettage (benign endocervical mucosa) and cervix biopsy (benign reactive exocervical mucosa and transition zone and endocervix not present). The patient's outcome was not provided. All available medical records will be provide upon request. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: FLUN3, HPV4
Symptoms: Computerised tomogram head, Computerised tomogram normal, Dizziness, Fall, Head injury
Clinical narrative: Information has been received from a physician concerning a 16 year old male who on 03-SEP-2010 was vaccinated IM with the first dose of GARDASIL (lot# not reported). On 03-SEP-2010 the patient became dizzy and lightheaded. He fainted and fell hitting the wall, and he had cuts and broken skin on the forehead and chin and bleeding on the knee. It was reported that he was taken to the ER for bleeding and got 12 stitches on the face, and he also got a CT scan done (the result not reported). At the time of reporting, the outcomes of the events were unknown. Follow up information has been received which reported that the 16 year old male student with no pre-existing allergies who on 03-SEP-2010 at 11:45 was vaccinated IM with the first dose of GARDASIL into left arm. Concomitant therapy included FLUMIST (Lot number 501013P). 6 minutes after the vaccination, the patient experienced syncope. The patient fell and hit head, being diaphoretic. Patient returned to normal mental status within a few minutes and went to emergency room for laceration on forehead. Head computed axial tomography was negative. On an unknown date, the patient recovered. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: FLUN3, HPV4
Symptoms: Hyperhidrosis, Laceration, Skin haemorrhage, Suture insertion, Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old male who on 03-SEP-2010 was vaccinated IM with the first dose of GARDASIL (lot# not reported). On 03-SEP-2010 the patient became dizzy and lightheaded. He fainted and fell hitting the wall, and he had cuts and broken skin on the forehead and chin and bleeding on the knee. It was reported that he was taken to the ER for bleeding and got 12 stitches on the face, and he also got a CT scan done (the result not reported). At the time of reporting, the outcomes of the events were unknown. Follow up information has been received which reported that the 16 year old male student with no pre-existing allergies who on 03-SEP-2010 at 11:45 was vaccinated IM with the first dose of GARDASIL into left arm. Concomitant therapy included FLUMIST (Lot number 501013P). 6 minutes after the vaccination, the patient experienced syncope. The patient fell and hit head, being diaphoretic. Patient returned to normal mental status within a few minutes and went to emergency room for laceration on forehead. Head computed axial tomography was negative. On an unknown date, the patient recovered. Additional information is not expected.
Sex: M
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a male adolescent who on an unspecified date was vaccinated with a 0.5 ml dose of GARDASIL. Subsequently, on approximately 01-SEP-2010 (reported as "in the last week or 2), the patient started feeling faint but never fully passed out. The patient sought unspecified medical attention. The patient recovered after stopping the therapy (same day as the adverse event). No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Cyst, Drug exposure during pregnancy, Pregnancy test positive, Ultrasound abdomen abnormal
Clinical narrative: Information has been received from a physician for GARDASIL, a Pregnancy Registry Product, concerning a 22 year old female patient with no pertinent medical history and no known drug reactions/allergies, who on 23-FEB-2011 was vaccinated IM with the first dose of GARDASIL (Lot # 667194/1271Z and expire date 12-DEC-2011). On 28-FEB-2011 the patient found out she was pregnant. On an unspecified date a pregnancy test, an ultrasound and a blood work test were performed (results for ultrasound and blood work not provided). The physician reported that the patient was not resuming the GARDASIL series until she would give birth. Patient's last menstrual period was approximately on 24-JAN-2011. Expected date of delivery was on 31-OCT-2011. Follow-up information was received from an initial pregnancy questionnaire from a health professional concerning a patient that worked with no previous pregnancies, no illness at the time of vaccination and no pre-existing allergies, birth defects or medical conditions who on 23-FEB-2011 was vaccinated with the first dose of GARDASIL intramuscularly in the right arm. On 21-MAR-2011, an ultrasound was performed and a cyst was seen (365 x 283). The ultrasound showed an intrauterine pregnancy of approximately 7.6 weeks. The patient did not seek medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Aphasia, Dizziness, Flushing, Pallor
Clinical narrative: Information has been received from a nurse concerning a 14 year old female who recently (in approximately December 2010) was vaccinated with the first dose of GARDASIL (lot # not reported). Concomitant therapy included MENACTRA received at the same office visit. Subsequently the patient became flushed, pale, dizzy and could not talk for a moment while leaving the office. The patient did not wait 15 minutes before attempting to leave the office. The patient recovered immediately before leaving the office (time frame unspecified). Therapy with GARDASIL continued as reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a medical assistant concerning a 14 year old female patient with no known drug allergies or pertinent medical history who on 29-JUL-2010 was vaccinated im with a 0.5 ml first dose of GARDASIL (lot number 665607/1333Y, expiration date June 2012). There was no concomitant medication. The medical assistant reported that the patient fainted immediately after the administration of GARDASIL, on 29-JUL-2010. The patient recovered completely after a few minutes without requiring medical treatment. No laboratory tests were performed. The patient sought unspecified medical attention. Follow up information was received and indicated that there was no adverse reaction seen "yet" as reported. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Sensation of heaviness, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with the third dose of GARDASIL (Lot# not reported). Subsequently, the patient felt heaviness in her arm and she felt weak, so the physician had her lay down. The patient's mother never informed the office that the patient had the same reactions when she got her first and second doses of GARDASIL. It was unknown if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Abdominal pain upper, Dizziness
Clinical narrative: Information has been received from a physician and a licensed practical nurse concerning a 17 year old female who on 01-SEP-2010 was vaccinated with a dose of GARDASIL (unspecified dose in series, lot # 666931/0337Z). Concomitant therapy included a dose of HAVRIX (GSK, Lot number AHAVB453BA). The physician reported that the patient who was in the room and witnessed what happened to her sibling, reported feeling lightheaded following administration of GARDASIL. The patient also left the practice feeling well. The nurse reported that the patient was fine after she received the vaccinations but became "worked-up" after she saw her younger sister's reaction. The older sister stated that her stomach hurt. The patient was placed on the exam table to rest and recovered. The older sister went home with her mother and younger sister. Additional information is not expected. This is one of several reports received from the same source. The patient's younger sister's information was captured in WAES#1009USA00144.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Nausea, Pallor
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with the first dose of GARDASIL on 11-SEP-2010. The patient experienced nausea, headache (HA), was pale after receiving dose. The patient was kept for 20 minutes and was pale and dizzy. Physician did not state any specific treatment other than observation in office. After 20 minutes the physician sent the patient to ER where they subsequently recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure before pregnancy, Neonatal disorder, Premature delivery
Clinical narrative: Information has been received from a female Medical Assistant with no drug reactions/allergies and no medical history who on an unknown date, was vaccinated with GARDASIL, a Pregnancy Registry product. There was no concomitant medication. The medical assistant reported that "after receiving a dose of GARDASIL she became pregnant, she is about 5 months pregnant." No adverse event involved. The patient sought unknown medical attention. Follow up information has been received from the reporting Medical Assistant reported that she delivered vaginally a healthy baby girl on 02-FEB-2011 at 36 weeks gestation. She also reported that the baby weighed in at 6lbs, 10 oz. She reported that the baby was born with a "birth mark on her lip" classified as a "hemangioma". She said her baby's health otherwise was good. No other problems encountered. Based on the deliver date 02-FEB-2011 at 36 weeks, the patient's LMP would be approximately 24-MAY-2010, and the EDD calculated by the system is 28-FEB-2011. The baby's experiences has been captured in WAES# 1009USA03287B1. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a 0.5ml dose of GARDASIL (lot # not reported). On an unspecified date the patient started getting headaches since she was given the vaccine. She saw several doctors regarding this AE. They didn't think that it was related to GARDASIL, but it wasn't completely ruled out. The patient's outcome was unknown. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Oedema peripheral, Urticaria
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter with sulfa/sulfites allergy and a history of reactive lymph node in her neck, who on 23-NOV-2010 was vaccinated with the first dose of GARDASIL (lot number not provided) and on approximately 08-MAR-2011 was vaccinated with the second 0.5ml dose of GARDASIL (lot# 1560Z). Concomitant therapy included ADDERALL TABLETS. The consumer mentioned that the patient did not have a reaction after receiving her first dose of GARDASIL. The consumer reported that her daughter received her second dose and had an allergic reaction. It was reported that 24 hours later, the patient began to have hives on her torso and on her cheeks. The consumer also reported that 48 hour later they had the hives somewhat under control with BENADRYL but all the patient's limbs swelled up. The consumer stated that they had received a steroid packet from the doctor that they had not used yet. The consumer also stated that the patient's swelling had started to go down. It was reported that on an unspecified date the patient visited the doctor. No lab diagnostic studies were performed. At the time of the report the patient was recovering. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Mass
Clinical narrative: Information has been received from a nurse concerning a 26 year old female with no drug allergies and a history of thyroid disorder and anxiety who on 04-JAN-2011 was vaccinated with GARDASIL (662518/0087Y) 0.5ml IM in the right arm. Concomitant therapy included levothyroxine (manufacturer unknown), PROZAC and LOESTRIN. The patient was in the office on 03-MAR-2011 and stated that "a week after vaccination" on approximately 11-JAN-2011 experienced 4-5 big knots at her right jawline under the skin, afebrile, denied sore throat or injection site reaction. There were no labs or diagnostic tests performed. The patient fully recovered 1-2 weeks later. Follow up information has been received from the licensed practical nurse concerning a teacher assistant female patient  with no illness at the time of vaccination who on 04-JAN-2011 at 15:40 was vaccinate with a first dose of GARDASIL intramuscularly in the right deltoid. On approximately 18-JAN-2011 ("2 weeks after receiving injection") (previously reported as 11-JAN-2011) she had "big lumps" under the skin. No other symptoms. The patient did not seek medical attention. At the time of reporting, the patient had recovered. The patient did not report the event until 03-MAR-2011. There was no laboratories diagnostic studies performed. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy to vaccine, Injection site erythema, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female student with allergy to penicillin who on an unspecified date was vaccinated with a dose of GARDASIL (Lot # 658222/0927U and expire date not reported), 0.5 ml. intramuscularly in the left deltoid. Registered nurse stated that on 12-AUG-2007, the patient complained of swelling at GARDASIL injection site that was the size of a 50 cent, red and warm area. Registered nurse mentioned that GARDASIL injection appeared to be given in correct site so, they discontinued the GARDASIL series and said that the patient was allergic to GARDASIL, reported as "allergic urticaria". Registered nurse added that patient's had good mobility in her arm and that the injection site was clean. At the time of the report, the patient recovered. It was unknown if the patient sought medical attention. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: Information has been received from a physician concerning a 15 year old female with no known pertinent medical history or drug reactions/allergies who on 24-AUG-2010 was vaccinated with the first dose of GARDASIL (lot#666163/0664Z). Concomitant therapy included SEASONALE. The physician mentioned that the patient developed soreness, redness, and itching soon after. These symptoms would resolve but return after showers or exercise "up the arm" beyond the injection site. The symptoms returned after receiving the second dose of GARDASIL (lot# 666948/0886Z) on 25-OCT-2010. The patient sought unspecified medical attention. At the time of reporting, the patient was not recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 12 year old female with no pertinent medical history or drug reactions/allergies who on 07-MAR-2011 was vaccinated with the first 0.5ml dose of GARDASIL (lot #666929/0331Z, expiration date in November 2012) intramuscularly in the left arm. Concomitant therapy included MENVEO same site with GARDASIL and HAVRIX in right arm. On 07-MAR-2011, the patient experienced injection site reaction. Injection site reaction was described as a tender, 10mm raised, red area at the injection site on the left arm. On 09-MAR-2011, the patient came to the office complaining of the site reaction. The patient was treated with MOTRIN, ice and BENADRYL. No lab diagnostics studies were performed. Reporter could not determine at the time of the call which vaccine caused the injection site reaction. The current status of the patient was not known at the time of the call. Follow-up information has been received from the registered nurse concerning the 12 year old female with no known drug allergies who on 07-MAR-201 was vaccinated intramuscularly in left deltoid with the first dose of GARDASIL (lot#666929/0331Z). Secondary suspect vaccination administered on the same date included a second dose of VARIVAX (lot # 667237/1357Z) (vaccinated subcutaneously in left deltoid as well). Subsequently the patient experienced local site redness swelling (10 cm in diameter, local treatment (ice packs) BENADRYL etc.). The patient did not seek medical attention. The patient recovered on an unspecified date. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 12 year old female with no pertinent medical history or drug reactions/allergies who on 07-MAR-2011 was vaccinated with the first 0.5ml dose of GARDASIL (lot #666929/0331Z, expiration date in November 2012) intramuscularly in the left arm. Concomitant therapy included MENVEO same site with GARDASIL and HAVRIX in right arm. On 07-MAR-2011, the patient experienced injection site reaction. Injection site reaction was described as a tender, 10mm raised, red area at the injection site on the left arm. On 09-MAR-2011, the patient came to the office complaining of the site reaction. The patient was treated with MOTRIN, ice and BENADRYL. No lab diagnostics studies were performed. Reporter could not determine at the time of the call which vaccine caused the injection site reaction. The current status of the patient was not known at the time of the call. Follow-up information has been received from the registered nurse concerning the 12 year old female with no known drug allergies who on 07-MAR-201 was vaccinated intramuscularly in left deltoid with the first dose of GARDASIL (lot#666929/0331Z). Secondary suspect vaccination administered on the same date included a second dose of VARIVAX (lot # 667237/1357Z) (vaccinated subcutaneously in left deltoid as well). Subsequently the patient experienced local site redness swelling (10 cm in diameter, local treatment (ice packs) BENADRYL etc.). The patient did not seek medical attention. The patient recovered on an unspecified date. Additional information is not expected.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Fall, Loss of consciousness, Tooth fracture
Clinical narrative: Information has been received from a nurse concerning a 14 year old male patient, who in approximately November 2010, "November or December timeframe", was vaccinated with a first dose of GARDASIL (Lot # not reported). The nurse reported that they were watching the patient and "10 or 15" minutes after vaccination, the patient passed out and fell and he happened to break his front tooth at the office. The patient was sent to see a dentist for his tooth. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Gait disturbance, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 13 year old female patient with attention deficit disorder, bipolar disorder and esophageal reflux disease who on 09-MAR-2011, was vaccinated with the first dose of GARDASIL (Lot # 666595/0096Z and expiration on 08-AUG-2012). The physician stated that weekend phone service had a message from the patient complaining of fever and difficulty walking after her first dose of GARDASIL on 09-MAR-2011. The physician recommended the patient visit the emergency room but she never went to the hospital. At the time of reporting the patient's outcome patient was unknown. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Body temperature increased, Nausea, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old patient who on an unknown date was vaccinated with a dose of GARDASIL injection (dose, route and lot number not provided). The nurse reported that after receiving GARDASIL injection, the patient experienced nausea, vomiting and elevated temperature (date unspecified). The patient was seen in the emergency room. At the time of the report the patient's outcome was unknown. This is one of three reports received from the same source. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune thyroiditis, Blood test, Chest pain, Neck pain, Pain
Clinical narrative: Information has been received from a patient's mother concerning her daughter, an 18 year old female with a family history of grandfather's hypothyroidism and no known drug reactions or allergies who received the complete 3 series of GARDASIL (Lot numbers not reported) beginning in August 2010 and completed in January 2011. The caller reported her daughter experienced chest pains and shooting neck pains, and was taken to the ER on 11-FEB-2011. The patient stayed in the ER for 5 hours but was not admitted to the hospital. Blood work was done and ultrasound of thyroid was scheduled. The patient was diagnosed with Hashimoto's disease on 14-FEB-2011 by the physician. Patient's mother felt her daughter's diagnosis was related to having received GARDASIL. At the time of the report, the patient had not recovered from the Hashimoto's disease. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Induration, Local reaction, Pain, Skin lesion, Swelling
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old female patient who on 17-AUG-2010 was vaccinated with the first dose of GARDASIL (Lot #, expire date and route not reported). On 18-OCT-2010, the patient was vaccinated with the second dose of GARDASIL (Lot #, expire date and route not reported) and on 17-FEB-2011, the patient was vaccinated with the third dose of GARDASIL (Lot #, expire date and route not reported). Registered nurse reported that on 17-AUG-2010 (also reported as "soon after" receiving the first dose of GARDASIL, the patient experienced pain, soreness and swelling ("the size of a baseball") that lasted 1-2 months before resolving. Registered nurse mentioned that on 18-OCT-2010 after receiving the second dose of GARDASIL , the pain, soreness and swelling ("the size of a baseball") returned, lasting 1-2 months. No symptoms were seen at the time of the third dose of GARDASIL. No treatment was given to the patient. It was unknown if the patient sought medical attention. In 2010, the patient had recovered. Follow-up information was received from the registered nurse concerning female student with no illness at time of vaccination and no pre-existing allergies, birth defects or medical conditions who on 17-AUG-2010 was vaccinated with the first dose of GARDASIL (Lot # 665547/1318Y, expire date not reported), intramuscularly in the left deltoid. On 18-OCT-2010, the patient was vaccinated with the second dose of GARDASIL (Lot # 665547/1318Y, expire date not reported), intramuscularly in the left deltoid and on 17-FEB-2011, the patient was vaccinated with the third dose of GARDASIL (Lot #, expire date and route not reported). Registered nurse stated that patient's mother reported that on 17-FEB-2011 with the third dose of GARDASIL, the patient had a local reaction that lasted 1-2 months and was the size of a tennis ball/baseball. Registered nurse stated the lesion size was only 1/2 dollar indurated but not near as a ball. There were no laboratory diagnostics studies performed. That patient did not seek medical attention. Registered nurse mentioned that the patient experienced the same events on first and second dose of GARDASIL. At the time of the report, the patient recovered. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old female patient who on 17-AUG-2010 was vaccinated with the first dose of GARDASIL (Lot #, expire date and route not reported). On 18-OCT-2010, the patient was vaccinated with the second dose of GARDASIL (Lot #, expire date and route not reported) and on 17-FEB-2011, the patient was vaccinated with the third dose of GARDASIL (Lot #, expire date and route not reported). Registered nurse reported that on 17-AUG-2010 (also reported as "soon after" receiving the first dose of GARDASIL, the patient experienced pain, soreness and swelling ("the size of a baseball") that lasted 1-2 months before resolving. Registered nurse mentioned that on 18-OCT-2010 after receiving the second dose of GARDASIL , the pain, soreness and swelling ("the size of a baseball") returned, lasting 1-2 months. No symptoms were seen at the time of the third dose of GARDASIL. No treatment was given to the patient. It was unknown if the patient sought medical attention. In 2010, the patient had recovered. Follow-up information was received from the registered nurse concerning female student with no illness at time of vaccination and no pre-existing allergies, birth defects or medical conditions who on 17-AUG-2010 was vaccinated with the first dose of GARDASIL (Lot # 665547/1318Y, expire date not reported), intramuscularly in the left deltoid. On 18-OCT-2010, the patient was vaccinated with the second dose of GARDASIL (Lot # 665547/1318Y, expire date not reported), intramuscularly in the left deltoid and on 17-FEB-2011, the patient was vaccinated with the third dose of GARDASIL (Lot #, expire date and route not reported). Registered nurse stated that patient's mother reported that on 17-FEB-2011 with the third dose of GARDASIL, the patient had a local reaction that lasted 1-2 months and was the size of a tennis ball/baseball. Registered nurse stated the lesion size was only 1/2 dollar indurated but not near as a ball. There were no laboratory diagnostics studies performed. That patient did not seek medical attention. Registered nurse mentioned that the patient experienced the same events on first and second dose of GARDASIL. At the time of the report, the patient recovered. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Facial pain, Swelling face
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter with "braces on teeth" and no drug reactions or allergies who in 2010 was began to vaccinate with GARDASIL (lot # not reported). The third dose of GARDASIL was given on 17-FEB-2011 at 15:30 pm in the right upper arm. There was no concomitant medication. By 17:30 pm on 17-FEB-2011, the patient experienced swelling on the right side of her face between her jaw and ear and it was painful to the touch. The mother contacted the physician, MOTRIN was given to treat the symptoms it did provided some relief. On 18-FEB-2011 morning, symptoms were still present but they did not get any worse. There were no laboratories diagnostic studies performed. The mother stated that child did not experience this with the 2 prior dose of GARDASIL. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse drug reaction
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with GARDASIL (dose, lot number and route not provided). The patient had side effects from GARDASIL but the reporter did not provide any details. It was unspecified if the patient sought medical attention. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Local reaction, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female patient with penicillin allergy, graves' disease and hyperthyroidism who on 28-OCT-2010, was vaccinated in the left upper arm with a dose of GARDASIL (Lot# not reported). Concomitant therapy included "Toposol". The nurse reported that on 01-NOV-2010, the patient told the physician that she had a fever and that the injection site was itchy and swollen. The patient was seen in the office on 03-NOV-2010 by the physician who diagnosed the patient with a mild, local injection site reaction. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pain in extremity, Tremor
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female patient with no pertinent medical history and no drug reactions/allergies, who in November 2008, was vaccinated with a first dose of GARDASIL (Lot # not reported). The patient's arm hurt for the rest of the day after receiving her first dose of GARDASIL (Lot # not reported). On an unspecified date, the patient was vaccinated with a second dose of GARDASIL (Lot # not reported) and experienced pain in her arm, shakiness, and syncope-like feeling within a few minutes of administration. Her symptoms lasted for the rest of the day. There were no lab diagnosis/studies performed. The patient sought unspecified medical attention. At the time of the report, the patient had recovered. Follow up information has been received from the medical assistant who stated that the patient reporter their or adverse reaction. They no have further information to report. No further information is available.
Age: 11.0
Sex: M
Vaccine: HPV4, MEN, PER, VARCEL
Symptoms: Autoimmune disorder, Blood urine present, Epistaxis, Haematoma, Protein urine absent
Clinical narrative: Information has been received from a physician concerning a 11 year old male patient with no pertinent medical history and no drug reactions or allergies who on 23-MAR-2010 was vaccinated with a dose of GARDASIL (Lot # 663453/0249Y, expiration date unspecified). Concomitant therapy included vaccination with a dose of VARIVAX, a dose of meningococcal vaccine (manufacturer unspecified) and a dose of pertussis vaccine (manufacturer unspecified). The physician reported that in May or June 2010, the boy began to experience bleeding in the urine, nasally, and had hematomas. The doctor was a pediatric nephrologist who thought it was an auto-immune reaction. The doctor said the boy had proteinuria 3+ and he will do a biopsy if the bleeding continues. At the time of the report the patient still continued bleeding. An ultrasound was performed (result not provided). The patient sought unspecified medical attention. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MEN, PER, VARCEL
Symptoms: Proteinuria, Ultrasound scan
Clinical narrative: Information has been received from a physician concerning a 11 year old male patient with no pertinent medical history and no drug reactions or allergies who on 23-MAR-2010 was vaccinated with a dose of GARDASIL (Lot # 663453/0249Y, expiration date unspecified). Concomitant therapy included vaccination with a dose of VARIVAX, a dose of meningococcal vaccine (manufacturer unspecified) and a dose of pertussis vaccine (manufacturer unspecified). The physician reported that in May or June 2010, the boy began to experience bleeding in the urine, nasally, and had hematomas. The doctor was a pediatric nephrologist who thought it was an auto-immune reaction. The doctor said the boy had proteinuria 3+ and he will do a biopsy if the bleeding continues. At the time of the report the patient still continued bleeding. An ultrasound was performed (result not provided). The patient sought unspecified medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Rash, Smear cervix
Clinical narrative: Information has been received from a licensed practical nurse concerning a 19 year old female patient with allergy to sulfa drugs and a history of ruptured ovarian cyst, who on 29-OCT-2010 was vaccinated with a first of three doses of GARDASIL (Lot # 666596/0097Z) in the left deltoid IM. Concomitant therapy included SPRINTEC. Nurse reported that between the date of administration and 02-NOV-2010 the patient developed a rash at the injection site that progressed down her left arm, across her chest, onto her right arm and was now on her chin. Patient would use BENADRYL. On an unspecified date, a PAP smear was performed (results not provided). The patient did not seek medical attention. At the time of the report, the patient had not recovered. Follow up information was received from a physician who indicated that that patient was a homemaker female with no pre-existing allergies, birth defects or medical conditions who experienced a rash beginning at site of injection (left deltoid) which spread to the chest and to the other arm. There were no illnesses at the time of vaccination or diagnostic laboratory tests performed. On 07-NOV-2010, the patient recovered. No further information is available.
Age: 37.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a nurse practitioner concerning a 37 year old female with no pertinent medical history who in September 2009, was vaccinated with the second dose of GARDASIL. Nurse practitioner stated the new patient to her practice, was vaccinated with first 2 doses of GARDASIL at another health care facility. In the meantime, patient had tested positive for human papilloma virus (HPV) type unknown. The patient sought unspecified medical attention. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Decreased appetite, Fatigue, Headache, Pyrexia
Clinical narrative: Information has been received from a physician for concerning a 16 year old female patient who on 24-AUG-2010 was intramuscularly vaccinated with a dose of GARDASIL. Concomitant vaccine included MENACTRA and meningococcal vaccine (unspecified) (manufacturer unknown). On 24-AUG-2010, the patient and experienced headaches, fatigue, loss of appetite and fever. Field employee said the patient received a MENACTRA and a meningitis vaccine (manufacturer unknown). The patient sought unspecified medical attention. At the time of reporting, the outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Agitation, Hypotension, Syncope
Clinical narrative: Information has been received from an office manager concerning a female who was vaccinated with GARDASIL. The patient experienced syncope, hypotension and agitation. The patient received unspecified medical attention. At the time of the reporting, the patient's status was unknown. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Neonatal disorder
Clinical narrative: Information has been received from a certified nurse midwife, for GARDASIL, a Pregnancy Registry Product, concerning a patient who was born at 37 weeks and 5 days of gestational age with no congenital anomaly. The birth weight was 4 pounds (lbs). The reporter considered the infant small for gestational age. The patient's mother, a 17 year old female, was vaccinated with the first dose of GARDASIL on 02-FEB-2009, the second dose on 04-MAY-2009 IM 0.5 ML right deltoid (lot#: 0151X). The mother's experience has been captured in WAES# 0905USA02012. Additional information has been requested.