chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a consumer concerning her granddaughter who in February 2009 was vaccinated with the 0.5ml first dose intramuscularly of GARDASIL (Lot # unknown). In April 2009, she was vaccinated with the second dose of GARDASIL (Lot # and route no reported). The consumer reported that the third dose should had been administrated in September 2009, however she stated that when her granddaughter went to get her medical records from school, it stated that she had not gotten the third dose of GARDASIL. It had been listed that she received the influenza virus vaccine (unspecified) (name and manufactured no reported), which the office nurse confirmed. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Aphthous stomatitis, Lymphadenopathy, Oral herpes
Clinical narrative: Information has been received from a physician concerning a 23 year old female patient with penicillin (PCN-rash) and anesthetic (nausea and vomiting) allergies who on 18-AUG-2010 was vaccinated with a second dose of series of 3 of GARDASIL (Lot# unknown). The physician stated that two days after vaccination on 20-AUG-2010, the patient reported having canker sores in her mouth, swollen lymph nodes and cold sores on her lips. The outcome of the patient was not reported. The patient sought unspecified medical attention. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Information has been received from a consumer concerning his son who on 10-DEC-2010 was vaccinated with GARDASIL (lot number not provided). On the same day the patient experienced itching, rash and fever after received GARDASIL. It was unknown if the patient sought medical attention. At time of the report, the patient's outcome was unknown. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Headache, Lymph node pain, Lymphadenopathy, Monocyte count increased
Clinical narrative: Information has been received from a physician via medical records concerning 21 year old female patient who on 09-AUG-2010, in the afternoon, was vaccinated with the first dose of GARDASIL (Lot # 662765/0821Y) into her right deltoid. Concomitant therapy included ACIPHEX and LOESTRIN 24 FE. There were no illnesses at the time of vaccination. It was reported that on 11-AUG-2010, the patient presented with low grade temperature for 48 hours, nausea, headache and temperature of 99 F. On 12-AUG-2010, the patient had temperature of 100 F. The diagnosis of posterior cervix lymphadenopathy. Laboratory diagnostic tests performed included: CBC which showed an increase in monocytes 11.8% (high). It was reported that on 19-AUG-2010, the patient saw a physician of infectious diseases for his evaluation. The patient had a temperature of 97 F on that day, and had soreness in submandibular lymph node which persisted. The physician placed her on CEFTIN. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a physician via medical records concerning 21 year old female patient who on 09-AUG-2010, in the afternoon, was vaccinated with the first dose of GARDASIL (Lot # 662765/0821Y) into her right deltoid. Concomitant therapy included ACIPHEX and LOESTRIN 24 FE. There were no illnesses at the time of vaccination. It was reported that on 11-AUG-2010, the patient presented with low grade temperature for 48 hours, nausea, headache and temperature of 99 F. On 12-AUG-2010, the patient had temperature of 100 F. The diagnosis of posterior cervix lymphadenopathy. Laboratory diagnostic tests performed included: CBC which showed an increase in monocytes 11.8% (high). It was reported that on 19-AUG-2010, the patient saw a physician of infectious diseases for his evaluation. The patient had a temperature of 97 F on that day, and had soreness in submandibular lymph node which persisted. The physician placed her on CEFTIN. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Antibody test, HIV antigen, HIV test
Clinical narrative: Information has been received from a nurse, who works at an AIDS Resource Center, concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot number not provided). The nurse reported that the patient had inconclusive test results for human immunodeficiency virus (HIV). The nurse reported that the patient was vaccinated with GARDASIL sometime prior to the HIV testing. The enzyme-linked immuno-sorbent assay (ELISA) antibody test, western blot test and P24 tests were performed. At the time of the report the outcome of the patient was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who on 10-AUG-2010 was vaccinated with the first dose of GARDASIL (lot number 665607/1333Y, exp date June 2012). On 17-AUG-2010 the patient experienced persistent dizziness. The patient was examined by physician on 30-AUG-2010 but was not treated with any medications. She was not hospitalized. At the time of report the patient's status was unknown. Follow-up information was received from a physician concerning a 15 year old female patient with no illness at time of vaccination, who on 10-AUG-2010 was vaccinated with the first dose of GARDASIL (lot number 665607/1333Y) in the left deltoid. The patient experienced dizziness spells and nausea and recovered on 16-SEP-2010. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperventilation, Nausea, Urticaria
Clinical narrative: Information has been received from a bachelor of science in nursing concerning a 13 year old female patient with no allergies and no medical history, who on 22-NOV-2010 was vaccinated with a first dose of GARDASIL (Lot# not reported), IM, and on 29-DEC-2010 was vaccinated with a second dose of GARDASIL (Lot# 666162/0565Z. Exp date 15-SEP-2010), IM. There was no concomitant medication. The nurse reported that on 29-DEC-2010 the patient experienced nausea and hives on her right forearm after receiving second dose of GARDASIL during 15 minutes post administration observation. The patient's mother also reported that on 29-DEC-2010 the patient had experienced brief period of hyperventilation. It was reported that a cold compress was used for the treatment of these symptoms. There were no laboratories performed. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention at the time of administration. This is one of two reports received from the same source. Follow up information has been received from the nurse concerning the patient, who on 29-DEC-2010 experienced nausea, hyperventilation and hives on her right forearm which resolved after 15 minutes. The patient's mother indicated that same reactions were observed when the patient received blood work. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (Lot number unknown). Subsequently the patient fainted. It was unknown if the patient sought medical attention. At the time of this report the patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a female who on an unknown date was vaccinated with a dose of GARDASIL, 15 minutes after her shot, the patient passed out. At the time of this report, the outcome was unknown. Patient sought unspecified medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Asthenia, Back pain, Diarrhoea, Dizziness
Clinical narrative: Information has been received from a consumer concerning her current 17 year old female daughter with allergy to red dye and stings and no pertinent medical history who on 08-JUN-2010 was vaccinated IM with a 0.5 ml dose of GARDASIL (Lot# unknown). There was no concomitant medication. The consumer reported that her daughter every month when she got her menstrual period cycle since 25-JUN-2010 after the GARDASIL, she experienced severe adverse reactions. They included lots of pain, cold to the touch, burning up, sweating, diarrhea, abdominal pain, pain in her lower back, lightheaded, weakness, nausea and vomiting. There were no laboratory tests or diagnostic studies performed. On 30-AUG-2010, the patient had recovered. The patient did not seek medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dysmenorrhoea, Feeling hot, Hyperhidrosis, Nausea, Peripheral coldness
Clinical narrative: Information has been received from a consumer concerning her current 17 year old female daughter with allergy to red dye and stings and no pertinent medical history who on 08-JUN-2010 was vaccinated IM with a 0.5 ml dose of GARDASIL (Lot# unknown). There was no concomitant medication. The consumer reported that her daughter every month when she got her menstrual period cycle since 25-JUN-2010 after the GARDASIL, she experienced severe adverse reactions. They included lots of pain, cold to the touch, burning up, sweating, diarrhea, abdominal pain, pain in her lower back, lightheaded, weakness, nausea and vomiting. There were no laboratory tests or diagnostic studies performed. On 30-AUG-2010, the patient had recovered. The patient did not seek medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a consumer concerning her current 17 year old female daughter with allergy to red dye and stings and no pertinent medical history who on 08-JUN-2010 was vaccinated IM with a 0.5 ml dose of GARDASIL (Lot# unknown). There was no concomitant medication. The consumer reported that her daughter every month when she got her menstrual period cycle since 25-JUN-2010 after the GARDASIL, she experienced severe adverse reactions. They included lots of pain, cold to the touch, burning up, sweating, diarrhea, abdominal pain, pain in her lower back, lightheaded, weakness, nausea and vomiting. There were no laboratory tests or diagnostic studies performed. On 30-AUG-2010, the patient had recovered. The patient did not seek medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a female patient in her 20's with mild allergy who in March 2010, was vaccinated with her first dose of GARDASIL (lot number unknown) and developed headache and dizziness after received the vaccine. Therapy with GARDASIL was discontinued. The patient did not seek medical attention. At the time of report, the patient's outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Juvenile arthritis
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who on unspecified date was vaccinated with a first dose of GARDASIL (dose, route and Lot# not reported). Concomitant therapy included YAZ, anakinra, folic acid and methotrexate. The physician stated that on unspecified date developed juvenile idiopathic arthritis after administration of her first dose of GARDASIL. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TTOX, VARCEL
Symptoms: Fall, Syncope
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 12 year old male patient who on 24-AUG-2010, was vaccinated IM with the first dose of 0.5 ml GARDASIL (Lot# not reported). Concomitant therapy on 24-AUG-2010 "all these vaccines were administered the same day" included tetanus toxoid vaccine (unspecified), VARIVAX, hepatitis A virus vaccine (unspecified) and MENACTRA. The licensed visiting nurse, stated that the patient got their first dose of GARDASIL and fainted, he fell back. He mentioned that he had not eaten all day. The patient sought unspecified medical attention. At the time of the report, the patient had recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Rash maculo-papular, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 25 year old female patient, with no pertinent medical history, drug reactions or allergies who on 23-AUG-2010 was vaccinated intramuscularly with the first dose of GARDASIL (Lot # reported as 0031Z. This lot# is valid for cancidas I.V., 70 mg exp date 20-NOV-2012). Concomitant therapy included VALTREX. The physician reported that the patient broke out in itch, maculopapular rash over arm and upper trunk. Valacyclovir hydrochloride was discontinued but the patient reported that the rash was on her face and lower body over the next 24 hours. On 26-AUG-2010, patient was placed on hydrocortisone 2.5% cream and BENADRYL. On 27-AUG-2010, patient reported worsening of the rash and was placed on therapy with prednisone. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Inflammation, Mass
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient who on an unspecified date was vaccinated with the third dose of GARDASIL (Lot # 666987/1016Z, expire date 22-NOV-2012), 0.5 ml, intramuscularly. Physician stated that on 08-FEB-2011 after receiving the third dose of GARDASIL, a large lump formed on patient's arm. The large lump formed on patient's arm was red and inflamed. No treatment was given to the patient. The patient did not seek medical attention. Therapy was reported as discontinued on 10-FEB-2011. At the time of the report, patient's outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Chills, Headache, Nausea, Papilloma viral infection
Clinical narrative: Information has been received from a registered practical nurse concerning a 16 year old female patient who on an unspecified date was vaccinated with the first dose of GARDASIL. On an unspecified date the patient experienced headache, nausea and fever. The symptoms were resolved with TYLENOL. The patient sought medical attention by a phone call. Follow-up information was received from a physician's assistant who reported that on 14-JUL-2010, the 17 year old (also reported as 18 year old) female patient with no pertinent medical history and no known drug allergies, received the first dose of GARDASIL (lot # 663551/1495Y) intramuscularly into her left arm at 16:21 hours. It was reported that on 19-JUL-2010, the patient experienced headache and chills. The patient did not need any treatment. On an unspecified date, the patient recovered from headache and chills. There was no pre-existing illness at the time of vaccination. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Smear cervix abnormal
Clinical narrative: Information has been received from a registered practical nurse concerning a 16 year old female patient who on an unspecified date was vaccinated with the first dose of GARDASIL. On an unspecified date the patient experienced headache, nausea and fever. The symptoms were resolved with TYLENOL. The patient sought medical attention by a phone call. Follow-up information was received from a physician's assistant who reported that on 14-JUL-2010, the 17 year old (also reported as 18 year old) female patient with no pertinent medical history and no known drug allergies, received the first dose of GARDASIL (lot # 663551/1495Y) intramuscularly into her left arm at 16:21 hours. It was reported that on 19-JUL-2010, the patient experienced headache and chills. The patient did not need any treatment. On an unspecified date, the patient recovered from headache and chills. There was no pre-existing illness at the time of vaccination. No further information is available.
Age: 16.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Injection site discolouration, Injection site mass, Injection site oedema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female patient who on 08-DEC-2008 was vaccinated with a first 0.5ml dose of GARDASIL (Lot# not reported), IM Left deltoid, and on 09-NOV-2010 was vaccinated with a second 0.5ml dose of GARDASIL (665768/1377Y, Exp date 29-JUN-2012), IM Left deltoid. Concomitant therapy included intranasal FLUMIST. The nurse stated that on approximately 12-NOV-2010 the patient experienced itching, minor swelling and a raised "bump" at injection site. The nurse also stated that the rash and symptoms lasted for a few weeks (no dates reported). There was no treatment given for the events. At the time of the report the patient had recovered. The patient sought unspecified medical attention. Follow-up information has been received from the Advanced Practice Registered Nurse previously reported as nurse practitioner who reported that the student female patient with no pre-existing allergies was vaccinated with a second dose of GARDASIL (665768/1377Y), IM, Right arm (Left deltoid, previously reported), Unknown time on 09-NOV-2010. Concomitant therapy included a first dose of intranasal FLUMIST (Lot# 501047P), IN, Unknown time on 09-NOV-2010. The Advanced Practice Registered Nurse stated that on 12-NOV-2010, unknown time the patient experienced edema and hyper pigmentation at the injection site, Right deltoid. At the time of the report that patient had recovered from these symptoms. The patient did not seek medical attention. Follow-up information has been received from the Advanced Practice Registered Nurse who reported that the patient with no illness at the time of vaccination. The nurse stated that on 12-NOV-2010, unknown time the patient experienced pruritus, swollen area at the injection site, right deltoid. The patient did not seek medical attention. At the time of the report the patient had recovered. No further information is available.
Age: 16.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Pruritus
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female patient who on 08-DEC-2008 was vaccinated with a first 0.5ml dose of GARDASIL (Lot# not reported), IM Left deltoid, and on 09-NOV-2010 was vaccinated with a second 0.5ml dose of GARDASIL (665768/1377Y, Exp date 29-JUN-2012), IM Left deltoid. Concomitant therapy included intranasal FLUMIST. The nurse stated that on approximately 12-NOV-2010 the patient experienced itching, minor swelling and a raised "bump" at injection site. The nurse also stated that the rash and symptoms lasted for a few weeks (no dates reported). There was no treatment given for the events. At the time of the report the patient had recovered. The patient sought unspecified medical attention. Follow-up information has been received from the Advanced Practice Registered Nurse previously reported as nurse practitioner who reported that the student female patient with no pre-existing allergies was vaccinated with a second dose of GARDASIL (665768/1377Y), IM, Right arm (Left deltoid, previously reported), Unknown time on 09-NOV-2010. Concomitant therapy included a first dose of intranasal FLUMIST (Lot# 501047P), IN, Unknown time on 09-NOV-2010. The Advanced Practice Registered Nurse stated that on 12-NOV-2010, unknown time the patient experienced edema and hyper pigmentation at the injection site, Right deltoid. At the time of the report that patient had recovered from these symptoms. The patient did not seek medical attention. Follow-up information has been received from the Advanced Practice Registered Nurse who reported that the patient with no illness at the time of vaccination. The nurse stated that on 12-NOV-2010, unknown time the patient experienced pruritus, swollen area at the injection site, right deltoid. The patient did not seek medical attention. At the time of the report the patient had recovered. No further information is available.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal, Vaginal haemorrhage
Clinical narrative: Information has been received from a female consumer in her 30s, who on an unspecified dates was vaccinated with the 3 doses of GARDASIL (Lot #, routes no reported). The consumer reported that after receiving the 3 doses she had been diagnosed with an abnormal pap smears. The patient also had noticed intermittent vaginal bleeding. She had scheduled a colposcopy. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse practitioner (N.P.) concerning a female patient who on unspecified dates was vaccinated with 3 doses of GARDASIL (Lot# not reported). The patient had an abnormal pap smear on 20-AUG-2010. The pap smear revealed "Atypical squamous cells of undetermined significance (ASCUS) with HPV". The patient sought unspecified medical attention. At the time of reporting, the patient was not recovered. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female patient who in May 2008, was vaccinated with a first 0.5 ml suspension IM dose of GARDASIL. The patient completed her GARDASIL regimen at the following schedule, 0, 2 months (in July 2008), 6 months (in November 2008). The patient had initiated sex in 2007. On approximately 07-FEB-2011 ("about a week ago"), the patient showed positive for (HPV). PAP smear and thin prep DNA were performed (no result provided). It is unknown if the patient sought medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Paraesthesia, Rash generalised
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning an 18 year old female patient with asthma and no drug reactions/allergies who on 25-JUN-2010 was vaccinated IM with 0.5 ML dose of GARDASIL (lot # 0318Z). There was no concomitant medication. In approximately 26-JUN-2010 (reported as "one or two days after vaccination") the patient experienced generalized rash. The generalized rash had disappeared but when she touched something cold such as ocean water or cold soda, her hand began to tingle and turned red. The patient sought unspecified medical attention and no laboratory diagnostic study was performed. At the time of reporting, the patient was recovering. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Antibody test abnormal, HIV test, Immunology test
Clinical narrative: Information has been received from a nurse, who works at an AIDS Resource Center, concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot number not provided). The nurse reported that the patient had inconclusive test results for human immunodeficiency virus (HIV). The nurse reported that the patient was vaccinated with GARDASIL sometime prior to the HIV testing. The enzyme-linked immuno-sorbent assay (ELISA) antibody test, western blot test and P24 tests were performed. At the time of the report the outcome of the patient was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal weight gain
Clinical narrative: Information has been received from a Registered Nurse concerning her daughter, a 12 year old female patient with no pertinent medical history and no known drug allergy who sometime this summer, approximately in June 2010 was vaccinated with the third dose of GARDASIL. There was no concomitant medication. The nurse reported that there were no issues with the first 2 doses, however on the 3rd dose the patient's mother noticed a significant weight gain. The patient was originally 118 lbs prior to the 3rd dose, and after the 3rd dose increased weight to 140 lbs in an unspecified time interval. Apparently, the patient was a very active girl and everyone seemed to have no answers as to why this had occurred. As was told that unspecified lab work was done which the did not have available to her and at this point, everything was still unresolved. The patient sought unspecified medical attention. Follow up information has been received from other health professional concerning a 12 year old female patient with no illness at the time of vaccination who on 18-MAR-2010 was vaccinated with the third dose of GARDASIL (lot  # not reported). Patient's mother stated that her daughter had abnormal weight after since receiving last injection on 18-MAR-2010. The patient was 129 lbs on 10-MAR-2010 and weight gain to 144 lbs when she was seen 13-OCT-2010. The patient did not seek medical attention. Outcome of event was unknown at the time of reporting. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram abnormal, Headache, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 11 year old female with allergy to cephalosporins who on 23-AUG-2010 was vaccinated with the first dose of GARDASIL (lot# 666595/0096Z, exp. 14-OCT-2012) 0.5 ml IM. There was no concomitant medication and lab data. The nurse was reporting the patient has experienced low-grade fever of 100.2F and headache since receiving her first dose of GARDASIL on 20-AUG-2010 (previously reported as 23-AUG-2010). The patient contacted the office by phone and was prescribed over-the-counter antipyretic medication. At the time of the report, the outcome of the patient was unknown. Follow up information has been received via from a healthcare professional medical records concerning an 11 year old female student with allergic reaction to CECLOR ; hives and anaphylaxis and allergy to ENDAL HD; hyperactivity; who on 23-AUG-2010, at 15:46 pm, was vaccinated with the first dose of GARDASIL intramuscularly in the left deltoid. There was no concomitant medication. On 22-AUG-2010 the patient experienced fever for a couple of days and headache for a couple of weeks. On 13-SEP-2010, the patient's sinus CT scan showed a complete opacification of the left maxillary sinus and the left osteomeatal complex is not visualized. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Weight decreased
Clinical narrative: Information has been received from a physician concerning an approximately 17 year old female patient with a history of bulimia who in July 2007, was vaccinated with her first dose of GARDASIL (lot # not reported). Concomitant therapy included DEPO-PROVERA. The physician reported that the patient after receiving her second dose of GARDASIL in September 2007 lost 30-40 pounds. Therapy with GARDASIL was discontinued and not reintroduced. At the time of report, the patient's outcome was unknown. The patient did not seek medical attention. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pruritus
Clinical narrative: Information has been received from a 25 year old female patient with no other known drug allergies who on 13-AUG-2010, was vaccinated with a single 120 mcg dose of GARDASIL. Concomitant therapy included BENADRYL. On 13-AUG-2010, the patient experienced red and itchy on both of her hands. The patient stated the injection site was fine without any pain or redness. She only had the itching and redness on both of her hands without any other symptoms. The reaction did not subside until she took BENADRYL the next day. No lab diagnostics studies were performed. The patient was unsure if she would finish the injection series and would consult with her physician. At the time of reporting, the patient was recovering from itching and redness on both of her hands. The patient did not seek medical attention. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Information has been received from a consumer concerning her 13 year old daughter with no past medical history and no allergies who in June 2010, was vaccinated with the first dose of GARDASIL and on 30-AUG-2010 with the second dose of the vaccine. There was no concomitant medication. The mother reported that the patient developed a rash on her neck, face, torso, chest, arms, thighs and upper back a few days after received her second dose of GARDASIL. The rash was red, raised circle. The mother stated "it looked almost like ringworm if there was not so many of them". The rash had persisted. The patient was seen by the physician and her mother insisted on some type of topical treatment. A cream was prescribed (name unknown) but the patient had not begun treatment at the time of the report. The first dose of GARDASIL was given at the end of June 2010 and no reaction was noted. No lab tests or studies had been performed. The mother was not sure if she will allow her daughter to receive the third injection. Follow up information was received from a consumer which reported that the patient received the second dose of GARDASIL (Lot # 666163/0664Z) intramuscularly into her left arm on 31-AUG-2010 (previously reported as 30-AUG-2010), at 17:20. It was reported that the patient developed hives 3 days after immunization. The mother contacted office and requested Lot number. At the time of the report the outcome of the patient was not reported. The patient did not require an emergency room/doctor visit due to the hives. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Information has been received from a physician's assistant concerning a 23 year old female with "mild aluminum sensitivity as child and had a reaction to Tdap and pertussis" and a history of Lyme disease in the past and attention deficit disorder (ADD) who on 20-JUL-2010 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot #665768/1377Y) into her left arm. Concomitant therapy included unspecified birth control medication. "Two weeks after vaccination" on approximately 03-AUG-2010 the patient felt achy all over, joint pain all over and arm pain. The patient thought she was having a reoccurrence of Lyme disease. There were no laboratory studies performed. The patient sought medical attention by calling and visiting the office. The patient was told to use warm compresses and massage. The full body aches went away 1 month after vaccination on approximately 20-AUG-2010. The arm pain that included soreness and tenderness occurred off and on and had not resolved. Follow-up information has been received from a secretary who pulled the chart and reported that no other vaccines were administered with GARDASIL on 20-Jul-2010. The chart showed the patient's last office visit on 20-SEP-2010, at which time the patient told the physician's assistant she would not be getting any further physician's assistant doses. The patient's status was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning a 13 year old female patient who on unspecified date was vaccinated with a dose of GARDASIL (lot number not provided). The physician reported that the patient developed lymphadenopathy on an unspecified date. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow up information has been received from the physician's office. It was confirmed that there was a patient with lymphadenopathy. Attempts are being made to verify the existence of an identifiable patient. This is one of the several report received from the same source. The person in the office contacted during telephone follow up could not supply the following information: patient's name, date of birth, dates of vaccination, dose number (if applicable), lot number, date of event, recovery status, hospital name (if applicable), healthcare provider name and contact information. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site anaesthesia
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated IM with the third dose of GARDASIL (Lot# not reported) and got numbness at the area of the injection. At the time of the report, the patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Muscle spasms, Oedema peripheral, Rash erythematous, Rash macular
Clinical narrative: Information has been received from a physician concerning a 20 year old female patient who on 04-DEC-2008 was vaccinated intramuscularly with the second dose of GARDASIL (Lot # no reported). Concomitant therapy included NUVARING. On 04-DEC-2008 the patient experienced red spots, swollen hands and achy joints. Also, she experienced cramps while on NUVARING. The physician reported that on 08-DEC-2008 the patient visited the hospital but was not hospitalized. At the time of the report, therapy with GARDASIL was discontinued. The outcome of the patient was no reported. Follow-up information was received from a physician concerning a 20 year old female patient who on 04-DEC-2008 was vaccinated intramuscularly with the second dose of GARDASIL (Lot # 0947X) in the left arm. On 08-DEC-2008 (previously reported as 04-DEC-2008) the patient was seen in ER, and experienced swollen hands, joint aches and red splotches. The patient recovered from these events. No further information is available.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Information has been received from a consumer concerning her son, a 11 year old male with no pertinent medical history, drug reactions or allergies who on 15-SEP-2010 was vaccinated with the first dose of 0.5 ml GARDASIL (lot # 666163/0664Z), concomitantly with a 0.5 ml ADACEL (Lot # C3486AA) and a 0.5 ml MENACTRA (lot # U3443BA). The GARDASIL was given at the same site as one of the other vaccines, but the consumer did not know which one. On approximately 16-SEP-2010 (the Thursday or Friday after the vaccination), the patient developed "what seemed like an unusual amount of redness and swelling at the GARDASIL injection site. The patient said that he saw little water filled blisters at the injection site." Her neighbor was a pediatrician who looked at it and said that "the swelling was from the vaccination." No laboratory diagnostics studies were performed. The therapy was not reintroduced. At the time of reporting, the patient was recovering from events after stopping therapy. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy lymph gland normal
Clinical narrative: Information has been received from a physician concerning a female friend in her 20's who on unspecified dates was vaccinated with the first and the second doses of GARDASIL (lot numbers not provided). Within the last year (in 2009) the patient experienced one lymph node under the arm in which the vaccine was given. The node was removed as an outpatient. A biopsy was performed and the result was benign. The patient fully recovered on an unspecified date. There was no serious criteria. This is one of several reports received from the same source. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Local swelling, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning his 12 year old daughter with eczema and seasonal allergies who on an unspecified date was vaccinated intramuscularly into her arm with a first dose of GARDASIL (Lot# unknown). The physician reported that her daughter was given GARDASIL by a pediatrician and on an unspecified date, she experienced redness and swelling in her arm, up her neck and toward her face. Therapy with GARDASIL was discontinued. At the time of the report, the patient had recovered (date unknown). The patient sought unspecified medical attention. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Abnormal loss of weight, Decreased appetite, Hyperventilation, Respiratory disorder
Clinical narrative: Information has been received from a parent at a soccer game concerning her daughter experienced an adverse event after administration of her second dose of GARDASIL three years ago. She experienced extreme weight loss, decrease in appetite, stomach pain, hyperventilation, and breathing problems. Third dose not administered. No hospitalization or treatment. It was unknown if the patient sought medical attention. At the time of the reporting, the patient's status was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a certified nurse midwife concerning a 17 year old female patient with no pertinent medical history and no drug reactions or allergies who in April 2008, was vaccinated IM with the first dose of GARDASIL (Lot# not reported). In November 2009, the patient was vaccinated IM with the second dose of GARDASIL (Lot# not reported) and on 23-SEP-2010, the patient was vaccinated IM with the third dose of GARDASIL (Lot# not reported). There was not concomitant medication. It was reported that on 18-AUG-2008, the patient had an abnormal pap smear. There was not treatment provided. At the time of the report, the patient's outcome was unknown. The patient sought medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administration error
Clinical narrative: Information has been received from a physician concerning a 13 year old female patient with no pertinent medical history and no drugs reactions or allergies who in 2008 was vaccinated with a dose of GARDASIL (lot # unknown). There was no concomitant medication. The physician reported that the consumer's mother stated that her daughter was given the GARDASIL shot incorrectly. "It was administered incorrectly". At the time of report, the patient outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a consumer concerning her 20 year old son with attention deficit/hyperactivity disorder (ADHD) and no drug reactions or allergies, who prior to receiving the GARDASIL he had swollen glands and did not feel well. On 13-SEP-2010, he was vaccinated with a dose of GARDASIL. Concomitant therapy included FOCALIN and ibuprofen. On 14-SEP-2010, the patient broke out in a rash which spread to his entire body. On 15-SEP-2010, patient went to the emergency room where he received cortisone. His rash resolved on 16-SEP-2010. No lab diagnostics studies were performed. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who on 20-SEP-2010 was vaccinated with the first dose of GARDASIL (lot # and route no reported). On 20-SEP-2010 the patient had fainted when given the GARDASIL. The physician stated the patient had no eaten or had anything to drink prior the injection. The physician reported that the patient was also very petite and the patient stated that she would continue with the injection series. At the time of the report, the patient had recovered. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Erythema, Flushing, Headache, Nausea
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient who on 14-FEB-2011 was vaccinated with the first dose of GARDASIL (Lot# 666929/0331Z) intramuscularly. Concomitant therapy included MENACTRA on the same day. On 14-FEB-2011 the patient felt dizzy, nauseous, complained of a headache, and appeared flushed with red cheeks, shortly after receiving the vaccines. The physician reported that the patient was allowed to rest and observed for 15-20 minutes prior to leaving the practice. On 14-FEB-2011 the patient recovered from the events. The patient sought medical attention in the office. Follow up information was received from a health professional reported that the patient was a female student with seasonal allergy who on 14-FEB-2011 at 2:39 PM was vaccinated with the first dose of GARDASIL, intramuscularly on right deltoid. Concomitant therapy included the first dose of MENACTRA (lot number U3544AA), intramuscularly on left deltoid on the same day at 2:40 PM. Shortly after shot at 2:45 PM, the patient became dizzy then developed headache and nausea, cheek were red a flushed looking. Then the patient was told to lie down and be observed. No diagnostic tests were performed. 30 minutes after, the patient recovered. No further information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy skin abnormal, Eosinophilia, Erythema multiforme
Clinical narrative: Information has been received from a certified medical assistant (C.M.A) concerning a 17 year old female patient with no pertinent medical history and no drugs reactions or allergies who on 14-JUN-2010 was vaccinated intramuscularly into her left deltoid with her first dose of GARDASIL (lot # 663551/1498Y). Concomitant therapy included MIRCETTE. The certified medical assistant reported that on 29-JUL-2010 the patient  presented to the office with erythema multiforme on both knees. This diagnosis was made by the physician based on a skin biopsy that showed features of erythema multiforme and trace eosinophils. On 17-SEP-2010, the patient recovered from erythema multiforme on both knees "there were no new eruptions, just post inflammatory changes". Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Depressed level of consciousness, Headache, Muscle tightness, Syncope
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a 24 year old female patient who on 10-SEP-2010 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (Lot# 666121/1778Y). The nurse reported that on 10-SEP-2010, the patient fainted, her muscles got tight and the patient was hard to arouse. The patient developed a headache that lasted until 14-SEP-2010. At the time of the report, the patient was recovering from fainted, muscles got tight and hard to arouse. The patient did not seek medical attention. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Foetal disorder, Maternal exposure during pregnancy, Oligohydramnios
Clinical narrative: Information has been received from a registered nurse, concerning a male baby whose 35 year old female mother with asthma and penicillin allergy, on 17-AUG-2010 was vaccinated with her first dose of GARDASIL (lot number not reported). There was no concomitant medication. The registered nurse reported that on 01-APR-2011 the mother delivered via vaginal a normal male baby, with no congenital anomalies. The baby's weight 4 pounds 15 ounces. The registered nurse stated the baby was "small for dates" during pregnancy. It was also reported that oligohydramnios was noted. The mother's experiences were captured in WAES1008USA03850. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Information has been received from a licensed visiting nurse for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female patient who on 20-JAN-2011, was vaccinated with a first 0.5ml dose of GARDASIL (Lot#667866/1437Z Exp date unknown), IM. At the time of the report the patient had 19 days of gestation (LMP on 01-JAN-2011; EDD on 08-OCT-2011). Follow-up information has been received from a licensed visiting nurse who stated that the female patient with anemia on 20-JAN-2011, was vaccinated with the first dose of GARDASIL (lot# 667866/1437Z). Concomitant medication included iron prenatal vitamins. It was reported that the patient had 3 previous pregnancies and 3 full term deliveries. The patient did not have any spontaneous abortion, any spontaneous termination and any fetal deaths. It was unknown if the patient had any birth defects and infant complications in previous pregnancies. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Palpitations
Clinical narrative: Information has been received from a physician concerning a 17 year old female with no known medical history and no known drug reactions/allergies who on 24-AUG-2010 was vaccinated with GARDASIL. There was no concomitant medication. On 25-AUG-2010, the patient stated that her heart was racing. No laboratory tests were performed to the patient. The patient did not seek medical attention. At the time of this report, the outcome of the patient was unknown. Follow up information was received from the physician, who reported that further questioning the patient, she admitted that the symptoms began before the dose of GARDASIL. She had been unclear regarding chronology. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of GARDASIL. On an unknown date the patient had pain at the injection site post administration of the vaccine. The outcome of the patient was not reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from an office medical assistant concerning a 17 year old female patient with no pertinent history and no drug reaction or allergies who in 2007 (reported as "3 year ago"), was vaccinated with her three doses of GARDASIL. Concomitant therapy included DEPO. On an unspecified date, the patient came into the doctor's office with genital warts. She received Pap smear to determine if she had HPV, which she did (results not provided). Patient thought that she may had been sexually active prior to GARDASIL injection. It was reported that the adverse event did not improve. At the time of reporting, the patient had not recovered. No information is available.