chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injury, Syncope, Tonic clonic movements
Clinical narrative: Information has been received from a registered pharmacist concerning her 17 year old daughter with depression and anxiety who 07-NOV-2006, 28-FEB-2007 and 19-JUN-2007 was vaccinate with first, second and third dose of GARDASIL (lot # not reported respectively). The patient experienced four syncopal episodes with clonic movements on 25-JUN-2007 while she was playing soccer (only time the patient was hospitalized, in October 2008, on 31-DEC-2009 while playing hockey and in February 2011 in another country when she was studying, each episode lasted "a few minutes" according to the registered pharmacist. Patient fell and injured during the 31-DEC-2009 episode. Cardiac tests and EEG were performed, however nothing had revealed a possible cause. At the time of reporting the patient had not recovered from fell and injury, the patient was recently referred to an epilepsy specialist. Also the patient just recently told not to drive. The events not life threatening according to the registered of pharmacist. The health care professional contacted during the telephone follow-up could not supply the following information: lot numbers. Follow information has been received from a registered of pharmacist who reported that her daughter had no previous syncopal/ tonic events (prior to June 2007). She had approximately 1 event per year. Symptoms included fainting and tonic clonic events. After first and second dose of GARDASIL the patient did not experience syncopal or tonic clonic events. This is an amended report. The year for the second dose in therapy screen was changed to 28-FEB-2007. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician's assistant concerning a female patient who in approximately February 2011 ("around two months ago"), was vaccinated with a first 0.5 ml dose of GARDASIL. Subsequently the patient said her arm where the injection was given, it swelled up and she had a lot of pain about 5 days around the injection site. The swelling continued for days as well. She had limited use in her arm because of the swelling. It was reported after 5 days the adverse events improved. The patient did not want to continue the second and third dose. At the time of reporting, the patient was fine. The patient did not seek medical attention. The "arm where the injection was given, swelled up" was considered to be disabling ("She had limited use in her arm because of the swelling"). No further information is available.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pain, Pruritus, Rash, Urticaria
Clinical narrative: Information has been received from a physician concerning a 10 year old female with allergic rhinitis, asthma, allergy to cherries and no known drug allergies/reactions, who was vaccinated with the first and second dose of GARDASIL on 06-AUG-2010 and 01-DEC-2010 respectively (dose, route and lot # unspecified). On 01-DEC-2010, patient also received a dose of MENACTRA and a dose of FLUZONE (manufacturer unknown). Concomitant therapy included ZYRTEC and albuterol. The physician reported that the patient developed a small rash following the first injection with GARDASIL (approximately in August 2010) with no reporting lasting effects. Following these injections: second dose of GARDASIL, a dose of MENACTRA and a dose of FLUZONE (manufacturer unknown), the patient developed full blown urticaria. Patient was given BENADRYL and corticosteroids (manufacturers unspecified). No lab diagnostic studies were performed. Therapy with GARDASIL was discontinued, as patient did not receive the third and final dose as a result of the adverse experience. At the time of the report patient's outcome was not reported. Patient sought unspecified medical attention. Follow up information has been received from a physician concerning a 10 year old female student patient who on 06-AUG-2010, was vaccinated into the right arm with the first dose of GARDASIL (lot # unspecified) and on 01-DEC-2010, was vaccinated intramuscularly into the left arm with the second dose of GARDASIL (Lot# 666597/0768Z, expiration date unspecified). It was also reported that on 01-DEC-2010, the patient was also vaccinated with a dose of ADACEL (Lot#C3476AA) intramuscularly in the right arm, a dose of MENACTRA (lot#U3507AA) intramuscularly in the right arm and a dose of influenza virus split virion 3v vaccine inactivated (FLUZONE (influenza virus split virion 3v vaccine inactivated)) (Lot#U3641AA) intramuscularly in the left arm. The physician reported that "following vaccine on 06-AUG-2010", the patient developed wheals, redness and pain. On approximately 01-DEC-2010, the patient developed generalized itchy wheals. The patient was seen on 02-DEC-2010 and was given BENADRYL and prednisone. Therapy with GARDASIL was discontinued. At the time of the report the patient's outcome was unknown. Generalized itchy wheals was considered to be other important medical event because the patient required medical/surgical intervention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse concerning a 13 year old female patient who on an unspecified date was vaccinated with the first dose of GARDASIL (Lot# not reported) and the patient was "OK". On an unspecified date "a few weeks later", the patient was vaccinated with the second dose of GARDASIL (Lot# not reported) and broke out in hives. Hives were treated with BENADRYL. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. Hives were considered to be an other important medical event by the nurse. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, FLUX, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Abdominal pain, Culture throat negative, Headache, Lymphadenopathy, Neck pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 year old female patient who on 08-DEC-2010 was vaccinated with the first dose of GARDASIL (Lot #, expire date and route not reported). On 21-FEB-2011, the patient was vaccinated with the second dose of GARDASIL (Lot #, expire date and route not reported). Concomitant therapy administered also on 08-DEC-2010 included influenza virus vaccine (unspecified) (manufacturer unknown, lot #, expire date and route not reported), Hep A (unspecified) (manufacturer unknown, lot #, expire date and route not reported), VARIVAX ( lot #, expire date and route not reported), Tdap and MENACTRA. Nurse practitioner stated that on 08-DEC-2010 also an intradermal purified protein derivative (IPPD) test was performed (results not provided). On 08-DEC-2010, very soon after receiving the vaccines, the patient developed a stiff neck on one side and lymphadenopathy without pharyngitis. Nurse practitioner reported that the patient was never assessed by her physician and that on 09-DEC-2010, she went to the school and that her symptoms improved "as the day went on". On 22-FEB-2011 24 hours after receiving the second dose of GARDASIL, the patient developed a sore throat, stomach ache, pain at the injection site and her lymph nodes were palpable. The nurse practitioner reported that the patient's symptoms were worse after the second dose of GARDASIL. The nurse practitioner stated that the patient's throat was red and on an unspecified date, she did a throat swab to test for "strep," which the nurse practitioner reported was negative. It was unknown if the patient sought medical attention. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, FLUX, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Pharyngeal erythema, Pharyngitis, Pyrexia, Streptococcus test, Tonsillar hypertrophy
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 year old female patient who on 08-DEC-2010 was vaccinated with the first dose of GARDASIL (Lot #, expire date and route not reported). On 21-FEB-2011, the patient was vaccinated with the second dose of GARDASIL (Lot #, expire date and route not reported). Concomitant therapy administered also on 08-DEC-2010 included influenza virus vaccine (unspecified) (manufacturer unknown, lot #, expire date and route not reported), Hep A (unspecified) (manufacturer unknown, lot #, expire date and route not reported), VARIVAX ( lot #, expire date and route not reported), Tdap and MENACTRA. Nurse practitioner stated that on 08-DEC-2010 also an intradermal purified protein derivative (IPPD) test was performed (results not provided). On 08-DEC-2010, very soon after receiving the vaccines, the patient developed a stiff neck on one side and lymphadenopathy without pharyngitis. Nurse practitioner reported that the patient was never assessed by her physician and that on 09-DEC-2010, she went to the school and that her symptoms improved "as the day went on". On 22-FEB-2011 24 hours after receiving the second dose of GARDASIL, the patient developed a sore throat, stomach ache, pain at the injection site and her lymph nodes were palpable. The nurse practitioner reported that the patient's symptoms were worse after the second dose of GARDASIL. The nurse practitioner stated that the patient's throat was red and on an unspecified date, she did a throat swab to test for "strep," which the nurse practitioner reported was negative. It was unknown if the patient sought medical attention. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, FLUX, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Abdominal pain upper, Injection site pain, Lymph node palpable, Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 year old female patient who on 08-DEC-2010 was vaccinated with the first dose of GARDASIL (Lot #, expire date and route not reported). On 21-FEB-2011, the patient was vaccinated with the second dose of GARDASIL (Lot #, expire date and route not reported). Concomitant therapy administered also on 08-DEC-2010 included influenza virus vaccine (unspecified) (manufacturer unknown, lot #, expire date and route not reported), Hep A (unspecified) (manufacturer unknown, lot #, expire date and route not reported), VARIVAX ( lot #, expire date and route not reported), Tdap and MENACTRA. Nurse practitioner stated that on 08-DEC-2010 also an intradermal purified protein derivative (IPPD) test was performed (results not provided). On 08-DEC-2010, very soon after receiving the vaccines, the patient developed a stiff neck on one side and lymphadenopathy without pharyngitis. Nurse practitioner reported that the patient was never assessed by her physician and that on 09-DEC-2010, she went to the school and that her symptoms improved "as the day went on". On 22-FEB-2011 24 hours after receiving the second dose of GARDASIL, the patient developed a sore throat, stomach ache, pain at the injection site and her lymph nodes were palpable. The nurse practitioner reported that the patient's symptoms were worse after the second dose of GARDASIL. The nurse practitioner stated that the patient's throat was red and on an unspecified date, she did a throat swab to test for "strep," which the nurse practitioner reported was negative. It was unknown if the patient sought medical attention. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, FLUX, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Oropharyngeal pain, Pharyngeal erythema, Streptococcus test negative
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 year old female patient who on 08-DEC-2010 was vaccinated with the first dose of GARDASIL (Lot #, expire date and route not reported). On 21-FEB-2011, the patient was vaccinated with the second dose of GARDASIL (Lot #, expire date and route not reported). Concomitant therapy administered also on 08-DEC-2010 included influenza virus vaccine (unspecified) (manufacturer unknown, lot #, expire date and route not reported), Hep A (unspecified) (manufacturer unknown, lot #, expire date and route not reported), VARIVAX ( lot #, expire date and route not reported), Tdap and MENACTRA. Nurse practitioner stated that on 08-DEC-2010 also an intradermal purified protein derivative (IPPD) test was performed (results not provided). On 08-DEC-2010, very soon after receiving the vaccines, the patient developed a stiff neck on one side and lymphadenopathy without pharyngitis. Nurse practitioner reported that the patient was never assessed by her physician and that on 09-DEC-2010, she went to the school and that her symptoms improved "as the day went on". On 22-FEB-2011 24 hours after receiving the second dose of GARDASIL, the patient developed a sore throat, stomach ache, pain at the injection site and her lymph nodes were palpable. The nurse practitioner reported that the patient's symptoms were worse after the second dose of GARDASIL. The nurse practitioner stated that the patient's throat was red and on an unspecified date, she did a throat swab to test for "strep," which the nurse practitioner reported was negative. It was unknown if the patient sought medical attention. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Irritability, Swelling
Clinical narrative: This case was reported by a physician and described the occurrence of generalized swelling in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included HIBERIX; GlaxoSmithKline; unknown given on 29 July 2011; PEDIARIX; GlaxoSmithKline; unknown given on 29 July 2011; PREVNAR (non-gsk); Wyeth Labs; unknown given on 29 July 2011. On 29 July 2011 at 12:00 the subject received 2nd dose of ROTARIX (oral). On 30 July 2011, 20 hours after vaccination with ROTARIX, the subject experienced generalized swelling and irritability. The events were reported as a systemic reaction. The physician considered the events were clinically significant (or requiring intervention). The subject sought medical attention at the Emergency Room. At the time of reporting the events were unresolved. The physician considered the events were possibly related to vaccination with ROTARIX.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a 23 year old female pharmacy student, with no pertinent medical history, no drug reactions or allergies, who in August 2010, was vaccinated with the first dose of GARDASIL. There was no concomitant medication. The pharmacy student mentioned that after receiving her second dose of GARDASIL, she experienced minor injection site reaction, the site was red and tender. The pharmacy student mentioned that she received the second dose of GARDASIL only 3 weeks after receiving the first dose. No treatment was given. No lab diagnostics studies were performed. The pharmacy student did not seek medical attention. One or two days after the vaccination, the pharmacy student recovered from minor injection site reaction, site redness and site tenderness. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Dyspnoea, Flushing
Clinical narrative: Information has been received from a physician concerning a 15 year old male patient who on an unspecified date was vaccinated IM with a dose of GARDASIL (lot number unknown). It was reported that the patient was taking GARDASIL and went to school and reported to the school nurse due to difficulty breathing and a flush face. At the time of reporting, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Malaise, Vomiting
Clinical narrative: Information has been received from a consumer concerning her16 year old smoker female friend; who a few days ago was vaccinated with the first dose of GARDASIL (lot number and site of administration not reported). A few days ago, the consumer stated that her friend was "feeling sick", dizzy and was vomiting. The patient was sent home early from school as a result. The patient drank cold water as treatment for the adverse events. The patient did not seek medical attention. At the time of the report, the patient had not recovered. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a physician concerning a female patient who on 01-FEB-2011 was vaccinated with a dose of GARDASIL (Lot # and expiration date not provided) (it was not specified which dose in the series this was). Around 09-FEB-2011 the patient experienced cellulitis at the injection site. The patient received antibiotics as treatment for the adverse event. The patient improved, on therapy. At the time of reporting patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy, Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on an unspecified date was vaccinated with the first "standard" dose of GARDASIL, and the second "standard" dose of GARDASIL on 28-FEB-2011. The patient was tested positive for high risk Human papilloma virus (HPV). The patient went into the office on an unspecified date for a colposcopy and sought medical attention. The result of colposcopy was unspecified. The patient was not given treatment. Upon the time of the report, the patient's present status was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Ultrasound antenatal screen
Clinical narrative: Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning his 25 year old wife with no pertinent medical history and no drug reactions or allergies who on 03-FEB-2011 was vaccinated intramuscularly (left deltoid) for positive genital wart with the first 0.5 mL dose of with GARDASIL (lot # not reported). There was no concomitant medication. Physician mentioned his wife was pregnant with five gestation weeks (last menstrual period was approximately on 10-FEB-2011, EDD is approximately on 17-NOV-2011), 3 pregnancy tests were performed (1st and 2nd test were negative and the 3rd was positive), an ultrasound confirming five weeks gestation, beta quantitative at 6700, and the patient visit the obstetrician. Two or three weeks after receiving GARDASIL the patient experienced pain in the left hip and in the last couple of days she experienced pain in the right wrist. No treatment was given. At the time of reporting the patient's outcome was unknown. The patient sought medical attention visit to obstetrician. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a consumer concerning his 17 year old son who on 29-APR-2011, was vaccinated with the first dose of GARDASIL (route and lot number not reported). On Saturday morning on 30-APR-2011, the son was complaining of nausea. By Saturday afternoon, approximately 24 hours after the administration the son felt better. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Hypoaesthesia, Muscle twitching, Myalgia
Clinical narrative: A consumer posted the information on a website, that reported by a mother concerning her daughter who in 2007 was vaccinated with the first dose of GARDASIL (lot# not reported). She was going in for her boosters and the mother rejected all extra dose of GARDASIL. A few weeks after the first vaccination the mother noticed her daughter's neck twitching sharply to one side randomly. She also complained of numbness in her fingers and toes and complained of joint and muscle pains. The mother researched it online a bit and read a website that said teens may develop a tic in this time in their life but it shouldn't last long. The mother took her daughter to the doctors a few weeks later and all kinds of tests were eventually run. Everything came back normal. The mother found that her daughter twitches started a few weeks after she was injected with the GARDASIL vaccine. Researching the effects of the vaccine and more into this drug she was undoubtedly convinced that this was the culprit. She received the "D lot" (the lot number with letter ender). This lot specifically has problems as stated in a credible website. The mother stated again that daughter only received one shot vaccine. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a third dose of GARDASIL (Lot # not reported). The physician reported that the patient received the complete series of GARDASIL and tested positive for HPV DNA 16 and 18 following cytology testing. The patient sought unspecified 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: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Metrorrhagia
Clinical narrative: A 21 year old female patient posted at internet in November 2007 (two years ago) she was vaccinated with a dose of GARDASIL (lot# not reported). Subsequently the patient was spotting in between periods. The patient had always been extremely regular. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female patient with no known drug allergies with a history of spontaneous abortion (in February 2010) who on 07-SEP-2010, was vaccinated IM with the first 0.5 ml dose of GARDASIL (Lot# 666595/0703Z). On 15-SEP-2010, the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot# 666163/0664Z) and on 02-NOV-2010, the patient was vaccinated IM with the third 0.5 ml dose of GARDASIL (lot# 666595/0703Z). There were no concomitant therapies. It was reported that on 07-SEP-2010, the patient was given the first dose of GARDASIL by error. The nurse stated that "should have been vaccines for children which they did not have in their clinic". On 15-SEP-2010, the patient repeated the "first dose" of GARDASIL at her high school in error since the patient did not report she had already received the vaccine and the staff did not know she received it. The nurse stated that on 02-NOV-2010, the patient received by error the "second dose" of GARDASIL by then due to they should have been vaccinated the patient with vaccines for children program. There was no adverse effect reported. This is one of several reports from the same source. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female with no pertinent medical history and no drug reactions or allergies, who was vaccinated IM with the first and second 0.5 ml doses of GARDASIL, in September 2010 and on 21-JAN-2011 respectively (lot numbers not reported). There was no concomitant medication. The physician reported that patient experienced sore arm after receiving the first dose of GARDASIL in September 2010. At the time of the report the patient's outcome was not reported. Patient sought unspecified medical attention. Follow up information have been received from the physician concerning a 22 year old patient, who was vaccinated IM with the first and second 0.5 ml doses of GARDASIL; in September 2010 and on 21-JAN-2011 respectively (lot numbers not reported). It was reported that the patient was vaccinated late with the second dose of GARDASIL. Physician reported that there were no adverse events. It was also reported that the patient had recovered. Follow-up information was received which reported that the female patient was late for the second injection. On 21-JAN-2011, the patient was vaccinated IM in the left deltoid with the second dose of GARDASIL (lot# 667194/1081Z).  There was no adverse event. It was also reported that in the previous injection there was no complication. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning a 16 year old male with no pertinent medical history and no drug allergies, who on 25-FEB-2011 was vaccinated with the first dose of GARDASIL (lot #1560Z). There was no concomitant therapy. On 25-FEB-2011 immediately after the first dose, the patient developed dizziness and light headiness for 3-5 minutes. The patient was very anxious about the GARDASIL and had low blood pressure prior to and following the vaccination. There were no labs or diagnostic tests performed. The patient sought unspecified medical attention. The patient was given glass of water and laid down for 15 minutes. Subsequently, the patient recovered from dizziness and light headiness on 25-FEB-2011. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Drug exposure during pregnancy, Menstruation delayed, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a nurse, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female with no medical history and no drug reactions/allergies who on 25-FEB-2011 was intramuscularly vaccinated with the first dose of GARDASIL and on an unknown date was intramuscularly vaccinated with the second 0.5 mg dose of GARDASIL (lot # 667930/1561Z, expiration unspecified). The reporter stated that the patient came in to receive influenza virus vaccine (unspecified) and her second dose of GARDASIL and reported her period being two days late on 02-MAY-2011. Nurse gave both vaccines, but another nurse felt the patient's report of her "period being two days late was normal" warranted confirmation, administered a pregnancy test. The post-vaccine pregnancy test was positive. No treatment was given for adverse events. The patient did not seek medical attention. The patient's date of last menstrual period and the estimated delivery date were unknown. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning an 18 year old female patient with no medical history and allergy to amoxicillin and AUGMENTIN who on 07-FEB-2011 was intramuscularly vaccinated with the first dose of 0.5 ml GARDASIL (lot # 667866/1437Z, exp: 25-FEB-2013). There was no concomitant medication. The reporter stated that on 07-FEB-2011 the patient developed hives all over her body and itchy after administration of her first dose of GARDASIL. BENADRYL was given for the event. At the time of reporting, the outcome of the patient was recovering. No lab diagnostics studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Arthralgia, Fatigue, Lymphadenopathy, X-ray
Clinical narrative: Information has been received from a nurse practitioner, concerning a 15 year old male patient, with no pertinent medical history, drug reactions or allergies, who on 17-NOV-2010 was vaccinated with his first dose of GARDASIL (lot #, dose and route not reported), on 10-JAN-2011 was vaccinated with his second dose of GARDASIL (lot #, dose and route not reported), and on 23-MAY-2011 was vaccinated with his third dose of GARDASIL (lot #, dose and route not reported). No concomitant medications were reported. Nurse practitioner reported that on approximately 24-NOV-2010, the patient developed swollen glands in his neck, joint pain and fatigue beginning after his first vaccination with GARDASIL, within one or two weeks of first vaccination. Physical therapy and MOTRIN was given as treatment for the events. Unspecified X-rays were performed (results not provided). The patient sought unspecified medical attention. At the time of the report, the patient's outcome was not recovered. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: HPV4
Symptoms: Genital haemorrhage, Genital pain, Pruritus genital
Clinical narrative: Information has been received from a 29 year old male patient with a history of genital wart signs and abnormal genital cells while on previous therapy with a placebo (WAES1012USA02471) who was contacted at the end of B study in April 2010 for a "complementary" series of GARDASIL, as he was receiving the placebo. In April 2010, he was vaccinated with a dose of GARDASIL (Lot# unknown). A week later he started having genital itching, pain, bleeding, which had continued. It was reported that therapy was discontinued. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a consumer concerning her 19 year old son with penicillin allergy and no other pertinent medical history who on 29-DEC-2010, was vaccinated with the first dose of GARDASIL (lot number, dose and site of administration not reported). The consumer reported that her son never received the second or third dose due to illness not related to GARDASIL. The consumer mentioned that her son's physician did not want to administer any vaccine until he was better. At the time of the report, the patient outcome was unknown. 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 unspecified date was vaccinated with the second dose of GARDASIL (lot number, expiration date and site of administration not reported). On unspecified date, after receiving the second dose, the patient experienced and extremely bad headache and went to a neurologist. When the patient returned to the primary care physician the patient's mother shared that the neurologist recommended against getting the third dose as the headache was borderline migraine. The series of GARDASIL vaccine would be discontinued. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Arthralgia, Rheumatoid arthritis, Rheumatoid factor negative, X-ray limb normal
Clinical narrative: Information has been received from consumer and a medical assistant concerning an approximately 18 year old female with no pertinent medical history or known drug allergies who on 14-JUN-2010 was vaccinated with 1st dose of GARDASIL (lot # 0318Z) and hepatitis A virus vaccine inactivated (manufacturer unknown) and PPD. On 26-AUG-2010 the patient was vaccinated with 2nd dose of GARDASIL (lot # 0765Z) and influenza virus vaccine (unspecified). On 04-JAN-2011 the patient was vaccinated with 3rd dose of GARDASIL (lot # 1231Z). The patient came to office on 25-JAN-2011 with complaints of joint pain in bilateral shoulders, knees and hands. The mother of the patient noted that the joint pain began sometime between the 2nd and 3rd GARDASIL doses. On 31-JAN-2011  rheumatoid factor was drawn, results 52. X-ray of hand was normal. On 16-FEB-2011 the patient was diagnosed with rheumatoid arthritis and was referred to a rheumatologist. The treatment for this AE was change diet. The outcome of the patient was unknown at the time of this report. Rheumatoid arthritis is a condition of special interest. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician's assistant concerning an 18 year old female patient who "five years ago" (in approximately 2006), was vaccinated with the third dose of GARDASIL intramuscularly (lot number not reported). The physician's assistant reported that the patient was sexually naive before the treatment. "Within the last few months" (on an unknown date), the patient recently had a PAP smear after being pregnant and was diagnosed as HPV positive. The physician's assistant had working with the patient to retrieve information from the patient's original gynecologist-obstetrician and her original vaccinating primary care physician. The patient had been currently not pregnant. The patient sought unspecified medical attention. At the time of the report the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: DTAP, HPV4, MEN
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient who on approximately 14-APR-2011 was vaccinated with a dose of GARDASIL (dose, route and lot number not provided). Concomitant therapy included DTaP and meningococcal vaccine (unspecified) administered at the same time. The licensed practical nurse who administered vaccines stated that on approximately 14-APR-2011 (one week ago) the patient passed out after the GARDASIL. The patient was really anxious before the injections. It was unknown if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient who on 15-MAY-2009 was vaccinated with the first dose of GARDASIL and on 27-JUL-2009 was vaccinated with the second dose of GARDASIL (lot # not reported) and then ended up in the ER (name and location of hospital were unknown) on 02-AUG-2009 with lymphadenopathy. The patient discontinued the GARDASIL vaccine series and not reintroduced. The patient was not admitted to the hospital. At the time of reporting, the outcome of the patient was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of GARDASIL (dose, route and lot # not reported). The physician reported that on unspecified date the patient experienced hives and rash after a dose of GARDASIL was given. The patient sought unspecified medical attention. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Vision blurred
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient who on approximately 26-MAY-2011, "about a week ago" was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL (lot #, dose and route not reported). The physician reported that the patient experienced dizziness and blurred vision after her first dose of GARDASIL. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was recovering. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a physician concerning his approximately 23 year old daughter with drug reaction to SEPTRA, allergy to peanut and a history of familial Mediterranean fever who on an unspecified date was vaccinated with the second dose of GARDASIL (route and lot# not reported). Concomitant therapy included ZYRTEC and FLONASE. The patient received the first dose of GARDASIL "here" and the second dose at "student health". This patient did not have any problem after the first dose of GARDASIL. "Next day after the 2nd dose", the patient experienced severe arm pain and swelling for 2 weeks. "2 weeks after 2nd dose of GARDASIL" the patient recovered from severe arm pain and swelling. No diagnostic laboratory tests were performed. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Drug exposure during pregnancy, Laboratory test normal, Normal newborn, Pregnancy test positive
Clinical narrative: Information has been received from a physician for GARDASIL a Pregnancy Registry product, concerning a 26 year old female patient with no pertinent medical history, drug reactions or allergies who on 24-MAY-2010 was vaccinated intramuscularly with a first dose, 0.5ml of GARDASIL (Lot # no reported). On 27-JUL-2010, the patient was vaccinated intramuscularly with the second dose 0.5ml of GARDASIL (Lot # no reported). There was no concomitant medication. The physician reported that after receiving the second dose, the patient did not get her menstrual period. After using a home pregnancy test, the result came back positive. The third dose of GARDASIL was not given. On 13-SEP-2010 8 HGC test was performed (no results provided). The patient last menstrual period (LMP) was on 11-JUL-2010. The estimated delivery date is on 17-APR-2011. Follow up information was received from the physician who reported that the female patient with asthma and a history of 2 previous pregnancies, one live birth at 39 weeks and one spontaneous abortion. There were not birth defects and no infant complications in previous pregnancies. On 24-MAY-2010 was vaccinated intramuscularly with a first dose, of GARDASIL (lot # no reported). On 27-JUL-2010, the patient was vaccinated intramuscularly with the second dose 0.5m of GARDASIL. Concomitant therapy included albuterol, FERRALET 90 and FLINTSTONES MULTIVITAMIN. On 11-OCT-2010 an ultrasound revealed a Crown-rump length (CRL) of 11 weeks and 6 days. On 15-OCT-2010, a sequential screen was negative. On 15-NOV-2010, the patient was placed on therapy with FERRALET 90 for the treatment of anemia. The estimated delivery date is on 26-APR-2011. Follow-up information was received from the physician who reported that the female patient with asthma (mild and intermittent). The patient was a smoker of 2 cigarettes/day and marijuana user but quitted during pregnancy. Concomitant therapy included albuterol and MEDROL DOSEPAK. The physician reported that, the patient experienced anemia and group B strep (GBS) positive during pregnancy. The outcome were unknown. The patient was treated with FLINTSTONES MULTIVITAMIN and FERRALET 90 for anemia. On 20-APR-2011, at 40th gestation week, the patient delivered a normal female baby with no complication or congenital anomalies. The baby's weight was 6 lb 9 oz and the Apgar score was 9/9. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Streptococcus test positive, Ultrasound antenatal screen
Clinical narrative: Information has been received from a physician for GARDASIL a Pregnancy Registry product, concerning a 26 year old female patient with no pertinent medical history, drug reactions or allergies who on 24-MAY-2010 was vaccinated intramuscularly with a first dose, 0.5ml of GARDASIL (Lot # no reported). On 27-JUL-2010, the patient was vaccinated intramuscularly with the second dose 0.5ml of GARDASIL (Lot # no reported). There was no concomitant medication. The physician reported that after receiving the second dose, the patient did not get her menstrual period. After using a home pregnancy test, the result came back positive. The third dose of GARDASIL was not given. On 13-SEP-2010 8 HGC test was performed (no results provided). The patient last menstrual period (LMP) was on 11-JUL-2010. The estimated delivery date is on 17-APR-2011. Follow up information was received from the physician who reported that the female patient with asthma and a history of 2 previous pregnancies, one live birth at 39 weeks and one spontaneous abortion. There were not birth defects and no infant complications in previous pregnancies. On 24-MAY-2010 was vaccinated intramuscularly with a first dose, of GARDASIL (lot # no reported). On 27-JUL-2010, the patient was vaccinated intramuscularly with the second dose 0.5m of GARDASIL. Concomitant therapy included albuterol, FERRALET 90 and FLINTSTONES MULTIVITAMIN. On 11-OCT-2010 an ultrasound revealed a Crown-rump length (CRL) of 11 weeks and 6 days. On 15-OCT-2010, a sequential screen was negative. On 15-NOV-2010, the patient was placed on therapy with FERRALET 90 for the treatment of anemia. The estimated delivery date is on 26-APR-2011. Follow-up information was received from the physician who reported that the female patient with asthma (mild and intermittent). The patient was a smoker of 2 cigarettes/day and marijuana user but quitted during pregnancy. Concomitant therapy included albuterol and MEDROL DOSEPAK. The physician reported that, the patient experienced anemia and group B strep (GBS) positive during pregnancy. The outcome were unknown. The patient was treated with FLINTSTONES MULTIVITAMIN and FERRALET 90 for anemia. On 20-APR-2011, at 40th gestation week, the patient delivered a normal female baby with no complication or congenital anomalies. The baby's weight was 6 lb 9 oz and the Apgar score was 9/9. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a female patient in her 20's who on an unspecified dates was vaccinated with the 3 doses of GARDASIL (Lot # and route not reported). The physician reported that the patient completed the GARDASIL series but on an unspecified date she contracted high risk HPV. The physician also stated that the patient was not sexually active prior to receiving GARDASIL and then had only one partner after completing the series. At the time of the report the outcome of the patient was not reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a consumer concerning her 21 year old daughter with grass allergy who on 02-NOV-2010 was vaccinated with intramuscularly with the first 0.5 ml dose of GARDASIL (Lot # reported as 0565Z, Exp date 12-SEP-2015). The consumer reported that after her daughter received the first dose, on 02-NOV-2010, she experienced a rash that originated at the base of her spine and progressed all over her body. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female patient, who on an unspecified date was vaccinated with a second dose of GARDASIL (Lot # not reported). On 02-NOV-2010 the patient experienced numbness in her left extremity which ran down both the patient's legs from therapy on GARDASIL. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a 9 year old female patient with no pertinent medical history and no drug reactions or allergies who on 10-AUG-2010 was vaccinated IM with 0.5 ml of the first dose of GARDASIL (Lot # 666929/0331Z, expiration date not available) and on 09-NOV-2010 received the second dose of the vaccine (lot $ 666507/0768Z, expiration date not available). There was no concomitant medication. The nurse reported that patient fainted immediately after administration of her first and second dose of GARDASIL injection. The patient recovered after each dose while in the office and did not required medical attention. No lab diagnostics studies were performed. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Gaze palsy, Syncope
Clinical narrative: Information has been received from a physician concerning a 9 year old female patient who on 10-AUG-2010 was vaccinated with the first dose of GARDASIL (Lot # not reported) and fainted right after reported noted that "patient's eyes rolled back" as she fainted. On 09-NOV-2010, the patient received her second dose of GARDASIL (Lot # not reported) and her blood pressure went from 103/64 to 94/64 to 88/53. At the time of the report the patient was being observed in office. The patient's outcome was not reported. Patient did not seek medical attention. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Eye irritation, Headache
Clinical narrative: Information has been received from a licensed practical nurse concerning a 17 year old female patient with no drug reactions/allergies and a history of anaemia who on 08-SEP-2010 was vaccinated IM with her first 0.5 ml dose of GARDASIL (Lot # 666929/0331Z). Concomitant therapy included multivitamin with iron. The nurse stated that on 08-SEP-2010 the patient experienced headache and burning of the eyes. The patient had been in the office for twenty minutes after receiving the dose of GARDASIL and did not experience these symptoms until she got home. The duration of the symptoms were not specified to the office nurse. The patient did not receive the second dose of GARDASIL due to the patient's mother's concerns about the side effects that her daughter experienced with the first dose. On 10-SEP-2010 blood work was performed, results were not provided. The patient did not seek medical attention. At the time of the report the patient's outcome was recovered. Follow up information was received from a licensed practical nurse who indicated that the student with no illness at the time of vaccination and no pre-existing allergies or medical conditions was vaccinated with a dose of GARDASIL in her left arm. The patient went on 09-NOV-2010 to the reporter's office for her 2nd dose, then her mother reported her symptoms. The symptoms were not right away nor did they last long per the patient's mom. The patient's mother refused to receive the 2nd dose to this date. No relevant diagnostic or laboratory studies were performed. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a company employee who heard of someone who saw a female faint after receiving GARDASIL (lot# not reported). It was reported that apparently the female stood up immediately after receiving the injection and that's apparently when she fainted. At the time of this report, the patient's outcome was unknown. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a physician concerning an 11 year old female patient who on 03-NOV-2010 was vaccinated with the first dose (reported as 0.5 mg) of GARDASIL (lot number not reported) IM. The physician reported that on 03-NOV-2010 the patient experienced general numbness all over the body, after being injected with GARDASIL. Therapy with GARDASIL was discontinued. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.