chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure via breast milk, Rash
Clinical narrative: Information has been received regarding a case in litigation concerning a 6 month old female infant whose mother on 25-JUN-2008 was vaccinated with a first dose of GARDASIL. Injection site and route not reported). On 27-AUG-2008 the mother was vaccinated with a second dose of GARDASIL. Injection site and route not reported). The mother reported that she was breastfeeding the baby. The baby developed a rash on her face. The mother took the baby to the pediatrician to see if it was vaccine-related. The outcome of the baby was unspecified. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Musculoskeletal pain
Clinical narrative: Information has been received from a pharmacy student concerning a 15 year old female who was vaccinated with GARDASIL vaccine (yeast). The patient had knee, elbow and shoulder pain since she was given GARDASIL vaccine (yeast). The reporter did not know how many doses the patient was given. The outcome was unknown. It was unknown if the patient sought medical attention or not. The reporter stated that she was only asked to research the information but was no further information on the patient. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Rash
Clinical narrative: Information has been received from a nurse concerning a 22 year old female with sulfonamide allergy and allergic reaction to (CLEOCIN) who on 28-AUG-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL vaccine (yeast) (lot no. 659180/1758U). Concomitant therapy included (ORTHO EVRA) and (ANAPROX DS). On 29-AUG-2008 the patient developed swelling of the first digit of her left hand and the second digit if her right hand. On 30-AUG-2008 the patient developed a rash on her right forearm. The patient self-treated with (ADVIL). On 02-SEP-2008 the patient contacted the office by phone stating that the symptoms had resolved. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Ear discomfort, Nasal congestion, Oropharyngeal pain, Urticaria
Clinical narrative: Information has been received from a physician concerning a 21 year old female with hypothyroidism and hypercholesterolaemia and a history of hives in the past who on 27-AUG-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL vaccine (yeast) (lot no. 659655/1486U). Concomitant therapy included (SYNTHROID), (MSD) and hormonal contraceptives (unspecified). On 30-AUG-2008 the patient developed hives on both upper and lower extremities, stuffy nose, sore throat and "a full feeling" in her ears. The physician stated that the patient was "cleaning out a friend's apartment on 29-AUG-2008 and was exposed to a lot of dust and mold at that time". The patient was examined in the office on 03-SEP-2008 and was prescribed topical steroid cream. At time of this report, the patient's symptoms persisted. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female patient who on unspecified dates was vaccinated with the first and second dose of GARDASIL vaccine (yeast). The nurse reported that each time the patient received a dose of HPV vaccine, she experienced flu like symptoms for 3 to 4 days. At the time of the report, the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who on unspecified dates was vaccinated with 3 doses of GARDASIL vaccine (yeast) at another location. The nurse practitioner reported that her office did not realize that and started her on another series and administered 2 doses of GARDASIL vaccine. The patient received 5 doses of HPV vaccine in total. No adverse event reported. It is unknown if the patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Malaise, Visual impairment
Clinical narrative: Information has been received from an office manager concerning a female who "a very long time ago" was vaccinated with a dose of GARDASIL vaccine (yeast) and "that evening felt very strange, had trouble with vision, and just did not feel well". The father of the patient was concerned and the patient contacted doctor for medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Injection site haematoma, Injection site swelling
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter with no known pertinent medical history or drug reactions/allergies who on 06-AUG-2007 was vaccinated with a first dose of GARDASIL vaccine (yeast) 0.5 ml IM. On unspecified dates the patient received the second and the third doses of GARDASIL vaccine (yeast) 0.5 ml IM. Concomitant therapy included an unspecified vaccine. In March 2008, the patient experienced 50% loss of her hair. The patient also experienced bruising and swelling at the injection site on an unspecified date. The patient's 50% loss of hair persisted. The patient's physician had suggested that she should be tested for "heavy metals". The patient sought unspecified medical attention. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a consumer concerning her daughter who on approximately 06-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). Subsequently the patient experienced diarrhea and vomiting. The outcome of the patient was unknown. The patient did not seek medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Borrelia burgdorferi serology negative, Chest X-ray normal, Cough, Dyspnoea, Lip swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old white female who at 9 am on 29-JUL-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot# 660557/0072X) 0.5 ml IM in her left deltoid. Concomitant therapy included (DESOGEN). At 8 am on 12-AUG-2008 (also reported as 13 to 14th August) the patient noted a pruritic rash beginning on her trunk and extending down her legs and arms. Within 24 hours, her plantar surfaces were swollen and she developed a pruritic rash. Then the patient developed swollen lips and a dry cough with shortness of breath within 48 hours. The patient was prescribed 3 weeks course of Prednisone oral, an unspecified "antihistamine" and an Albuterol inhaler. The patient had a chest x-ray on an unspecified date which was negative. A pulmonary function test was performed on an unspecified date with a normal result. A Lyme disease enzyme-linked immunosorbent assay for "pulmonary edema" and her events were confirmed as an allergic reaction. The patient was recovered from the allergic reaction. The patient sought medical attention in the office. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Pulmonary function test normal, Rash pruritic
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old white female who at 9 am on 29-JUL-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot# 660557/0072X) 0.5 ml IM in her left deltoid. Concomitant therapy included (DESOGEN). At 8 am on 12-AUG-2008 (also reported as 13 to 14th August) the patient noted a pruritic rash beginning on her trunk and extending down her legs and arms. Within 24 hours, her plantar surfaces were swollen and she developed a pruritic rash. Then the patient developed swollen lips and a dry cough with shortness of breath within 48 hours. The patient was prescribed 3 weeks course of Prednisone oral, an unspecified "antihistamine" and an Albuterol inhaler. The patient had a chest x-ray on an unspecified date which was negative. A pulmonary function test was performed on an unspecified date with a normal result. A Lyme disease enzyme-linked immunosorbent assay for "pulmonary edema" and her events were confirmed as an allergic reaction. The patient was recovered from the allergic reaction. The patient sought medical attention in the office. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a female who in August 2007, was vaccinated with the first dose of GARDASIL vaccine (yeast). In November 2007, the patient was vaccinated with the second dose of GARDASIL vaccine (yeast). On 03-SEP-2008, "today", the patient was vaccinated with the third dose of GARDASIL vaccine (yeast). No adverse effect reported. It was unknown if the patient sought medical attention or not. Additional information has been requested.
Age: 0.1
Sex: M
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a consumer concerning her 1 month old infant son who on 03-SEP-2008 was vaccinated with GARDASIL vaccine (yeast) instead of a hepatitis B virus vaccine. It was not product confusion but a nursing error due to location in the refrigerator. No adverse effects noted thus far. Medical attention was sought at office. No product quality complaint was involved. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a nurse for the Pregnancy Registry for HPV vaccine concerning a 23 year old female who on 18-APR-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot#659182/1757U) IM. On 06-JUN-2008, was vaccinated with the second dose of GARDASIL vaccine (yeast) (lot#660389/1968U) IM. In September the patient was now pregnant. She had a positive pregnancy test. The patient's LMP was on 20-JUN-2008 and EDD 29-MAR-2009. No other symptoms were noted. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Complication of pregnancy, Drug exposure during pregnancy, Smear cervix normal, Trisomy 8
Clinical narrative: Information has been received from a physician assistant for the Pregnancy Registry for HPV vaccine concerning a 20 year old female patient with no known drug allergies, who on 01-AUG-2008, was vaccinated with the first dose of GARDASIL vaccine (yeast) (Lot # 660620/0571X) IM. On 03-SEP-2008, the physician reported that the patient was administered her first dose of HPV vaccine and was pregnant. The patient's LMP was on 22-JUL-2008 and EDD 29-APR-2009. No adverse effect was reported. Follow-up information has been received from a physician assistant who reported thath the patient experienced spntaneous abortion on 01-OCT-2009 (appreximately 10 weeks from LMP). It was unknown if the products of conception examined. It was unknown if the fetus normal. Follow-up information has been received from a licensed practical nurse who reported that the patinet had gotten her first GARDISIL injection administered on 01-AUG-2008 at their office. The patient reported to them that her last menstrual period was on 29-JUL-2008 (previously reported as 22-JUL-2008). There was no notation in the patient's chart of any concomitant medications or vaccines. It was noted in the patient's chart that she had a spontaneous abortion. The reporter reported that the patient had an ultrasound on 01-OCT-2008 which diagnosed the spontaneous abortion. The ultrasound results were as follows: irregular gestational sac, no embryonic pole or yolk sac seen. The reporter indicated that the patient underwent a dilation and evacuation (D&C) at a hospital. The products of conception were sent for evaluation but they did not have the results of the study because she was being followed by her OB/Gyn practice. Follow-up information has been received from a office manager of an OB/Gyn who reported that the patient went to the emergency room on 01-OCT-2008 with vaginal bleeding. And ultrasound was performed as stated above. On 05-OCT-2008 the patient was admitted to hospital for D&C as a result of an incomplete spontaneous abortion. The pathology results from the analysis were ; female trisomy %, 8 and 23. The patient was seen a few weeks later for her post operative visit and everything was within normal limits. All of the patient's PAP smears since have been within normal limits as well. Neither office had any record of susquent GARDISIL injections. No further information is available. The patient was seen in Washington hospitalAdditional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan abnormal, Uterine dilation and curettage, Vaginal haemorrhage
Clinical narrative: Information has been received from a physician assistant for the Pregnancy Registry for HPV vaccine concerning a 20 year old female patient with no known drug allergies, who on 01-AUG-2008, was vaccinated with the first dose of GARDASIL vaccine (yeast) (Lot # 660620/0571X) IM. On 03-SEP-2008, the physician reported that the patient was administered her first dose of HPV vaccine and was pregnant. The patient's LMP was on 22-JUL-2008 and EDD 29-APR-2009. No adverse effect was reported. Follow-up information has been received from a physician assistant who reported thath the patient experienced spntaneous abortion on 01-OCT-2009 (appreximately 10 weeks from LMP). It was unknown if the products of conception examined. It was unknown if the fetus normal. Follow-up information has been received from a licensed practical nurse who reported that the patinet had gotten her first GARDISIL injection administered on 01-AUG-2008 at their office. The patient reported to them that her last menstrual period was on 29-JUL-2008 (previously reported as 22-JUL-2008). There was no notation in the patient's chart of any concomitant medications or vaccines. It was noted in the patient's chart that she had a spontaneous abortion. The reporter reported that the patient had an ultrasound on 01-OCT-2008 which diagnosed the spontaneous abortion. The ultrasound results were as follows: irregular gestational sac, no embryonic pole or yolk sac seen. The reporter indicated that the patient underwent a dilation and evacuation (D&C) at a hospital. The products of conception were sent for evaluation but they did not have the results of the study because she was being followed by her OB/Gyn practice. Follow-up information has been received from a office manager of an OB/Gyn who reported that the patient went to the emergency room on 01-OCT-2008 with vaginal bleeding. And ultrasound was performed as stated above. On 05-OCT-2008 the patient was admitted to hospital for D&C as a result of an incomplete spontaneous abortion. The pathology results from the analysis were ; female trisomy %, 8 and 23. The patient was seen a few weeks later for her post operative visit and everything was within normal limits. All of the patient's PAP smears since have been within normal limits as well. Neither office had any record of susquent GARDISIL injections. No further information is available. The patient was seen in Washington hospitalAdditional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with GARDASIL vaccine (yeast). Subsequently the patient experienced a serious adverse event. There were no specifics provided regarding the adverse experience. It was not specified whether the patient sought medical attention. Upon internal review, the "serious" adverse event was considered to be an other important medical event. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEP, HPV4
Symptoms: Abdominal pain, Facial pain, Hypoaesthesia facial, Skin discolouration, Swelling
Clinical narrative: Information has been received from a registered (x-ray) technician (RT) concerning her 11 year old daughter with allergic reaction to AMOXICILLIN (+) (AUGMENTIN) and no other pertinent medical history who on 31-JUL-2008 was vaccinated with the first dose of GARDASIL (yeast) (the lot number was not known). Concomitant therapy included other booster vaccines (unspecified by reporter) and hepatitis B virus vaccine (unspecified) (manufacturer unknown). On 02-SEP-2008 the patient developed intermittent numbness on the right side of her face and swelling and other children at school noticed that her face got purple. The patient described it as "a feeling she got after a shot at the dentist's office". She also stated the area was sore and she experienced abdominal pain. At the time of reporting, the patient did not recover. Medical attention was sought via telephone. No product quality complaint was involved. Additional information has been requested,
Age: 34.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 34 year old female who on approximately 03-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) in another office. In approximately September 2008, the patient had presented to the physician's office for the second dose of GARDASIL vaccine (yeast). No product quality complaint was involved. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse concerning an 18 year old female who in approximately September 2007, also reported as one year ago, was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). On 04-SEP-2008 the patient was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). No adverse reactions were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date, was vaccinated with a dose of GARDASIL vaccine (yeast). The physician reported that the patient fainted and hit her head after receiving the dose of HPV vaccine. The patient sought medical attention at the physician's office. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Information has been received from a physician concerning a 14 year old female with penicillin allergy and allergy to amoxicillin (+) (AUGMENTIN) who on 30-JUN-2008 was vaccinated with a dose of GARDASIL vaccine (yeast) intramuscularly in the arm (lot number not reported). Concomitant therapy included hepatitis A vaccine (inactive) (HAVRIX). Subsequently the patient experienced hives on her arm, at the injection site and also on her leg (left or right unspecified). Unspecified medical attention was sought. These symptoms lasted about one week. Subsequently, the patient recovered from the event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a female who in approximately September 2007, also reported as about one year ago, was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). On 04-SEP-2008 the patient was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). No problems reported. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 15 year old female with drug allergy (she had rash on her body after Amoxicillin at age 1), who on 15-MAR-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) and she had no reaction to this dose. On 06-AUG-2008 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast), Lot # 660612/0229X, 0.5 mL, IM. It was reported that within an hour or 2 after vaccination, the patient had rash on her chest and back. Patient was given (SOLU-MEDROL) and (MEDROL DOSEPACK) and told to start (BENADRYL). The patient's outcome is unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder
Clinical narrative: Information has been received from an office staff member who reported their local health department contacted her concerning a female patient who on an unspecified date, was vaccinated with GARDASIL vaccine (yeast), Lot not provided. It was reported that the patient had an autoimmune disorder from GARDASIL vaccine (yeast). The patient's outcome was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal haemorrhage
Clinical narrative: Information has been received from a physician's assistant concerning a 25 year old female with a history of unspecified pelvic complaints, who on 22-AUG-2008 was vaccinated with her first dose of GARDASIL vaccine (yeast), Lot # 0152X. It was reported that on 26-AUG-2008, the patient had one episode of vaginal blood clots. On 26-AUG-2008, the patient recovered from vaginal blood clots. The patient sought medical attention, by phone. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pruritus generalised
Clinical narrative: Information for the Merck Pregnancy registry for GARDASIL vaccine (yeast) has been received from a 20 year old female with urinary tract infection and not known allergies, who on 26-JUN-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast). Concomitant therapy included medications for urinary tract infection. The patient reported that she did not know that she was pregnant at the time of administration of the vaccine. On 29-JUN-2008, three days after vaccination, the patient experienced "itching all over". Subsequently, the patient recovered from the itching. Laboratory studies were not performed. At the time of reporting, the patient was 2 months and 2 weeks pregnant. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a certified nurse midwife concerning an 18 year old female who on 20-NOV-2006 was vaccinated with her first dose of GARDASIL vaccine (yeast) (Lot#653937/0637F). Concomitant therapy included (PREVACID), acetaminophen (+) (ULTRACET), (MSD), (ZOLOFT), (CLARINEX) and (YASMIN). On 20-NOV-2006, a few minutes later after the vaccination, the patient fainted in the office. The patient was fully recovered from fainting a few minutes later. The patient later completed the series without any other symptoms. The patient seek medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Genital haemorrhage, Metrorrhagia
Clinical narrative: Information has been received from a nurse concerning a teenager female patient who on an unknown date, was vaccinated with a dose of GARDASIL.  The nurse reported that the patient experienced vaginal break through bleeding and spotting after receiving GARDASIL vaccine.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning her daughter, a 19 year old female with no pertinent medical history or drug reactions/allergies, who recently was vaccinated with her second dose of GARDASIL.  On the same days she had a PAP smear which was positive for HPV.  There was no concomitant therapy.  As of 04-SEP-2008 the positive HPV persisted.  The patient sought unspecified medical attention.  Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a certified medical assistant concerning a 14 year old female patient who on 22-FEB-2008, was vaccinated with a dose of GARDASIL.  On 22-FEB-2008, just after being vaccinated, the patient fainted.  The patient recovered shortly after she fainted.  No other symptoms were noted.  The patient sought medical attention in the physician's office.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a 19 year old female with no pertinent medical history or drug reaction/allergies, who on 14-AUG-2008 was vaccinated with the first dose of GARDASIL.  There was no concomitant medication.  The patient found that she was pregnant 2 weeks ago on approximately 31-JUL-2008.  As of 04-SEP-2008 the patient was 7 weeks gestation.  The patient's LMP was 14-JUL-2008 and EDD 21-APR-2009.  She had three pregnancy tests.  The patient saw the physician in the office.  No adverse event reported.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning a female with a history of thyroid cyst who on 17-JUN-2008 was vaccinated with the first dose of GARDASIL.  On approximately 24-JUN-2008, "a week after receiving" the vaccine, the patient developed symptoms of "receding small reactive lymph node in her lower LAC section".  Per physician patient will hold off in getting the succeeding GARDASIL.  The patient sought medical attention.  On an unspecified date, the patient recovered.  Additional information has been requested.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician and the patient's mother concerning a 15 year old female with no pertinent medical history who in approximately 03-AUG-2007, was vaccinated with her first dose of GARDASIL.  Concomitant therapy included unspecified birth control.  On 03-SEP-2007 (1 month after 1st dose) the patient began experiencing episodes of passing out.  These episodes occurred just about every other day.  There were "tons of episodes" which lasted until November 2007.  In approximately 02-OCT-2007, she received her second dose of GARDASIL.  In November 2007, therapy with birth control was discontinued.  There were no other known reactions to the birth control, but it was discontinued since they did not know reason for repeated episodes of passing out.  On 23-NOV-2007, the frequent episodes stopped.  Since November of 2007, the patient has had 5 episodes of passing out.  Patient was due for her third dose of GARDASIL in February, but did not receive it.  The patient has had other test done, however, no cardiac abnormalities, or other causes noted.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site
Clinical narrative: Initial and follow-up information has been received from an official concerning a female who was vaccinated with GARDASIL vaccine (yeast) at the gluteal region. It was stated that the girl was vaccinated this way because there was not enough muscle mass to vaccinate the intended way. No symptoms were noted. It was not specified if the patient sought medical attention or not. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Information has been received from a medical assistant concerning a 15 year old female patient with no known drug allergies or pertinent medical history who on 07-AUG-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast), Lot # 654540/1161F, 0.5 mL, intramuscularly in her left deltoid. Other concomitant medication included unspecified allergy medication. It was reported that the patient developed arm pain at the injection site, after receiving the first injection. The patient took Ibuprofen and applied ice and heat; however, the patient's arm pain worsened and the patient could not lift the arm to use a hair brush. On 21-AUG-2008 the patient was reported to have less pain. No other symptoms or treatment reported. At the time of the report the patient was recovering. The patient sought medical attention at physician's office. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Faecal incontinence, Headache, Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 25 year old female who was vaccinated with the second dose of GARDASIL vaccine (yeast). The patient developed nausea, vomiting and "loss of bowel control" about 19 hours after receiving the vaccination. This was followed by a headache that lasted for 3-5 days. The patient sought unspecified medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a physician concerning a 20 year old female who was vaccinated with her second dose of GARDASIL vaccine (yeast). Subsequently the patient experienced 2 syncope episodes immediately post vaccination. Subsequently, the patient recovered from the 2 syncope episodes. The patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a female with no allergies and no medical history reported, who was vaccinated with the first dose of GARDASIL vaccine (yeast) and two weeks later "broke out in hives". The patient was given a Prednisone Dose Pack. It is not known if the hives resolved. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a nurse who heard from a mother that her daughter was vaccinated with GARDASIL vaccine (yeast) and is now experienced hair loss. The hair loss looked like patches of "bold spots" down to the scalp. The patient's hair loss persisted. The patient sought unspecified medical attention. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Pyrexia, Rash generalised
Clinical narrative: Information has been received from a consumer concerning her 20 year old daughter with no allergies and no medical history reported, who on 25-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) and on 28-AUG-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast). Concomitant therapy included ZYRTEC and DEPO-PROVERA. Within 24 hours after second dose of GARDASIL vaccine (yeast), on 29-AUG-2008, the patient began to experience diarrhea and a rash on the back of her legs. The rash progressed up to the patient's back and to her arms and eventually covered approximately 50 percent of her body. On 04-SEP-2008, the patient developed a fever. Th physician's medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Juvenile arthritis, Pain in extremity
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 21-AUG-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast) (Lot # 659184/0843X) and experienced pain in wrists, hands and arm. The physician diagnosed her with juvenile arthritis. The patient's events persisted. The patient sought physician's medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Bedridden, Fatigue, Pain
Clinical narrative: Information has been received from a physician concerning an approximately 18 year old female who on an unspecified date was vaccinated with the second dose of GARDASIL vaccine (yeast), IM and experienced aches and fatigue. The patient was "in bed for 3 days" due this. It was unknown if the patient sought medical attention. The patient outcome was not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning an approximately 16 year old female with no known drug allergies and no medical history reported, who on an unknown date was vaccinated with the second dose of GARDASIL vaccine (yeast). There was no concomitant medication. On an unspecified date, 2 weeks after vaccination, the patient experienced syncope. The patient was also exercising at the time of adverse event. The patient recovered from syncope. The patient sought medical attention at the office. No further information is available.
Age: 32.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Arthralgia, Inappropriate schedule of drug administration, Laboratory test normal, Menstruation irregular
Clinical narrative: Information has been received from a 32 year old female patient with no pertinent medical history or drug reactions/allergies who on 18-JAN-2007, was vaccinated with the first dose of GARDASIL vaccine (yeast), on 19-MAR-2007 was vaccinated with the second dose of GARDASIL vaccine (yeast) and on 19-JUL-2007 was vaccinated with the third dose of GARDASIL vaccine (yeast) into her buttocks. There was no concomitant medication. In May or June-2007, the patient reported that her hair fell out in clumps, she experienced pain in the lower legs and sore joints (though not constant), after she was getting her second dose of HPV vaccine. Also she stated that her periods have gone from a steady every 28 days to between 28 and 50 days. She has not been on birth control for years. She has had no family history of female hair loss. The patient had also consulted a nutritionist and dermatologists. The blood work performed showed no vitamin or mineral deficiency. The patient's hair fell out in clumps, sore joints, pain in the lower legs and irregular menstrual cycle persisted. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a 32 year old female patient with no pertinent medical history or drug reactions/allergies who on 18-JAN-2007, was vaccinated with the first dose of GARDASIL vaccine (yeast), on 19-MAR-2007 was vaccinated with the second dose of GARDASIL vaccine (yeast) and on 19-JUL-2007 was vaccinated with the third dose of GARDASIL vaccine (yeast) into her buttocks. There was no concomitant medication. In May or June-2007, the patient reported that her hair fell out in clumps, she experienced pain in the lower legs and sore joints (though not constant), after she was getting her second dose of HPV vaccine. Also she stated that her periods have gone from a steady every 28 days to between 28 and 50 days. She has not been on birth control for years. She has had no family history of female hair loss. The patient had also consulted a nutritionist and dermatologists. The blood work performed showed no vitamin or mineral deficiency. The patient's hair fell out in clumps, sore joints, pain in the lower legs and irregular menstrual cycle persisted. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female patient who on an an unspecified date were vaccinated with GARDASIL vaccine (yeast). It was reported that the patient fainted within the 15 minute period following vaccination. No specifics known about the patient. At the time of reporting, the patient had recovered. The patient sought medical attention in office. This is one of several patients received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a health professional certified medical assistant concerning a patient who in February 2007, was vaccinated with the first dose of GARDASIL vaccine (yeast) IM. In September 2007 was vaccinated with the second dose GARDASIL vaccine (yeast) IM. No adverse event was reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a health professional concerning an under 26 year old female patient who was vaccinated with the first dose of GARDASIL vaccine (yeast) initially at another facility, but when she went into the physician's office for the second dose of GARDASIL vaccine, the reporter detected an abnormal PAP at this annual visit. This is one of two cases reported from the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 20 year old female patient who on 27-JUN-2008, was vaccinated with the first dose of GARDASIL vaccine (yeast) IM into left deltoid, on 19-AUG-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast) into left deltoid muscle. On 26-AUG-2008, the patient complained of swelling, itching and redness at the injection site. Nurse stated as far as she knew client recovered. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Oedema peripheral, Paraesthesia, Pruritus, Urticaria
Clinical narrative: Information has been received from a physician concerning a 19 year old female patient who in June 2008, received the first dose of GARDASIL vaccine (yeast) IM. On 23-AUG-2008, the patient received the second dose of GARDASIL vaccine (yeast) IM. There was no concomitant medication. The patient experienced the following symptoms within 2 hours after receiving the second dose of GARDASIL vaccine (yeast): hives, swelling of the hands and redness of the hands, itching, tingling along nail and toe nail beds. Given BENADRYL which helped within 1/2 hour. Then put on CLARITAN for maintenance for 10-15 days. Had been off CLARITIN for 36 hours and all of the symptoms recurred. Symptoms are not severe, but hives and itching, swelling of the hands and redness recurred. Took another CLARITIN and BENADRYL. At time of reporting, the patient's adverse experiences were still being treated. No additional information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Chills, Pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female who in July 2008, was vaccinated with the first dose of GARDASIL vaccine (yeast). In July 2008, two hours after vaccination, the patient experienced fever, chills, aches and joint pain. Subsequently, the patient recovered from fever, chills, aches and joint pain. The registered nurse reported that the patient did not seek any treatment  for the symptoms. The symptoms had resolved within 24 hours. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information Has been received from a nurse concerning a 19-20 year old female patient who around the end of 2007, was vaccinated with the first doe of GARDASIL. The patient had no medication history. The nurse reported that the patient experienced irregular menses after receiving GARDASIL. The patient sought unspecified medical attention.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a nurse concerning a 19-20 year old female patient who around the end of 2007, was vaccinated with the first dose of GARDASIL vaccine (yeast). Concomitant therapy included unspecified birth control. The nurse reported that the patient experienced irregular menses after receiving HPV vaccine. The patient sought unspecified medical attention. This is one of several reports provided by the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Emotional distress, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a 13 year old female with a history of scoliosis (status post surgery) who on 28-AUG-2008 was vaccinated with an unspecified dose of GARDASIL (lot # 660612/0229X) in the left upper arm.  Concomitant therapy included FLUZONE.  At 4:00 PM, the patient went to the lobby after receiving her GARDASIL and FLUZONE  shots, she was standing at the front desk and collapsed.  She was unconscious for a few minutes and then woke up.  Normal mental status when woke up except that she was upset.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash generalised, Urticaria
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 25-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) and she had no reaction after her initial GARDASIL vaccine (yeast). On 03-SEP-2008, the patient was vaccinated with the second dose of GARDASIL vaccine (yeast). Four days post vaccination, on 07-SEP-2008, the patient developed what she described as a "hives". At the time of the report, the patient was "still itching with the hive/rash covering for whole body". She had been prescribed unspecified steroids to treat the reaction. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse concerning her daughter who in August 2008, was vaccinated with the first dose of GARDASIL vaccine (yeast) and it was painful. It was unknown if the patient sought medical attention. The patient's outcome was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female who on 05-AUG-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (therapy route and lot number not reported). Concomitant therapy included oral hormonal contraceptives (unspecified). On 05-AUG-2008 the patient experienced a lump, redness and swelling at the injection site after she received her first dose of GARDASIL vaccine (yeast). The patient's symptoms began immediately after she received the dose. The patient sought unspecified medical attention. The swelling and redness subsided but the lump has persisted and as of 05-SEP-2008 has become larger. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 20 year old female with no pertinent medical history or known drug allergies who on 08-JAN-2008, 11-MAR-2008 and 11-JUL-2008 was vaccinated intramuscularly with her 0.5 ml first, second and third doses of GARDASIL vaccine (yeast) (all the lot numbers are 659180/1758U). Concomitant therapy included Ibuprofen, codeine and penicillin (unspecified). After administration of her third dose of GARDASIL vaccine (yeast), the patient developed a generalized rash intermittently on different parts of her body. The patient sought medical attention via telephone. No laboratory or diagnostics tests were performed. At the time of this report, the event persisted. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Presyncope
Clinical narrative: Information has been received from a physician's assistant concerning a 14 year old female who was vaccinated with GARDASIL vaccine (yeast). The patient was also given Adacel. Subsequently the patient turned white and almost passed out but did not. Subsequently, the patient recovered. No medical attention was needed. Additional information has  been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting, Vomiting
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the first dose of GARDASIL. Subsequently, the patient experienced vomiting and nausea. Subsequently, the patient recovered from vomiting and nausea. No product quality complaint was involved. Additional information has been requested.  This is in follow-up information to report (s) previously submitted on 10/8/2008. Follow-up information on 23-DEC-2008 was received from an other health professional who reported that on 04-AUG-2008, the 17 year old student with allergic reaction to CECLOR and no illness at the time of vaccination was vaccinated with the first dose of GARDASIL vaccine into the left deltoid (lot # 659962/1740U). Immediately after injection, the patient became pale, clammy and nauseated. The patient did have small anti of emesis. The patient's grandmother took her in and had her lay down. When the patient awoke, symptoms resolved. The patient was very anxious about having vaccine. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a nurse concerning an unspecified number of females who were vaccinated with their second or third dose of GARDASIL. Subsequently the patients experienced episodes of prolonged arm pain. At the time of this report, the outcomes were unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in its report. Additional information will be provided if available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 27-AUG-2008 was vaccinated with the second dose of GARDASIL. The patient developed right side "body tingling" of the arm and leg. The symptoms resolved on their own. The patient sought medical attention by phone call. The physician did mention that he received conflicting information from the patient and her mother. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a licensed practicing nurse concerning a 25 year old female who in July 2008, was vaccinated with a first dose of GARDASIL (route and administration site not reported).  On 05-SEP-2008 the patient was vaccinated with a second dose of GARDASIL (route and administration site not reported).  On 07-SEP-2008 the patient developed a pinpoint rash on the neck and chest and a little bit on the arms and legs.  The patient's pinpoint rash persisted.  The patient sought unspecified medical attention.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a certified medical assistant concerning a female who was vaccinated with a second dose of GARDASIL.  "Recently" the patient was found out that she had papilloma viral infection.  At the time of this report, the outcome was unknown.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a registered nurse concerning a female who on 07-JAN-2008 and 13-MAY-2008 was vaccinated with 05 ml first and second dose of GARDASIL (lot #654741/1208F and 659180/1758U), respectively.  Subsequently the patient experienced a raised rash at the injection site.  The rash was raised and looked like a "bull's eye".  It was also noted that the patient experienced pruritus at the injection site.  The patient was seen at the office.  At the time of this report, the events persisted.  Additional information has been requested.