chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a health professional concerning an 18 year old female who on 26-Oct-2007 was vaccinated intramuscularly in the left deltoid with Gardasil (Lot #655154/1210U).  Concomitant therapy included Depo-Provera.  On 26-Oct-2007 the patient experienced pain during administration.  The patient was given an ice pack to apply to the area.  Subsequently, the patient recovered from pain during administration on 27-Oct-2007.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a health professional concerning a 16 year old female who on 23-Aug-2007 was vaccinated intramuscularly using the pre-filled syringe with her first dose of Gardasil (Lot #655154/1210U).  There was no concomitant medication.  On 14-Nov-2007 the patient was vaccinated with the second dose of Gardasil and subsequently experienced pain at administration.  The patient was given ice packs to apply to the area while in the office.  It is unknown if the patient experienced the same pain with the first dose.  Subsequently, the patient recovered from pain at administration on the same day.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on approximately 05-Oct-2007 was vaccinated with her first dose of Gardasil.  There was no concomitant medication.  Subsequently the patient experienced pain, redness, and swelling at the injection site.  The patient sought unspecified medical treatment.  No further information was available.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a health care professional concerning a 15 year old white female with a peanut allergy, allergy to cats and rabbits, and allergies to Keflex and Cefzil who received her first dose of Gardasil on 03-Jul-2007.  On 02-Nov-2007 was vaccinated with her second dose of Gardasil (Lot #659437/1266U) in the left deltoid.  It was reported the patient experienced "hives (for) one week after the vaccine were given on 02-Nov-2007 and 03-Jul-2007".  The patient was treated with Benadryl and Bactroban.  Additional information has been requested. As per a follow up from the physician, there is no further information. No further infformation is expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Dizziness, Vomiting
Clinical narrative: Information has been received from a consumer concerning her 20 year old daughter.  Concomitant therapy included birth control (therapy unspecified).  The patient has a comprised immune system and allergies to penicillin and Neosporin.  On 16-Nov-2007 the patient was vaccinated with her first dose of Gardasil via injection (Lot number not specified).  On the evening of 16-Nov-2007 the patient experienced dizziness and developed diarrhea and vomiting.  The consumer reported that her daughter was beginning to feel better on 18-Nov-2007, but the vomiting returned on 19-Nov-2007.  The patient sought medical attention and had not recovered.  No further information was provided.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site swelling, Pain
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 21-Sep-2007 was vaccinated with a first dose of Gardasil (lot #658563/1063U) injection.  Concomitant therapy included Advair, Proventil and "clindesse" (therapy unspecified).  On 24-Sep-2007 the patient called the office and on an unspecified date the patient developed swelling at reaction site and pain.  Medical attention was sought.  The patient had a fever of 101 for 2 days and took acetaminophen (Tylenol) for the fever.  The physician also reported that the patient visited the office on 17-Nov-2007 to receive a second dose and reported that the swelling was the size of a golf ball.  The vaccine was not given and it is not known whether the series will be completed.  On an unspecified date that patient had recovered.  Additional information has been requested. Follow-up information was received from the physician. It was also reported that the patient had a large lump where the patient's shot was given. The patient also had redness at the injection site. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 21-Sep-2007 was vaccinated with a first dose of Gardasil (lot #658563/1063U) injection.  Concomitant therapy included Advair, Proventil and "clindesse" (therapy unspecified).  On 24-Sep-2007 the patient called the office and on an unspecified date the patient developed swelling at reaction site and pain.  Medical attention was sought.  The patient had a fever of 101 for 2 days and took acetaminophen (Tylenol) for the fever.  The physician also reported that the patient visited the office on 17-Nov-2007 to receive a second dose and reported that the swelling was the size of a golf ball.  The vaccine was not given and it is not known whether the series will be completed.  On an unspecified date that patient had recovered.  Additional information has been requested. Follow-up information was received from the physician. It was also reported that the patient had a large lump where the patient's shot was given. The patient also had redness at the injection site. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Information has been received from a licensed practical nurse concerning a 16 year old female who on an unspecified date was vaccinated with Gardasil (lot # unknown) injection.  Subsequently, on an unspecified date the patient developed warts on hands after receiving Gardasil.  Medical attention was sought.  The patient's warts on hands persisted.  The patient had received 2 doses of Gardasil.  No further information was provided.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: Information has been received from a physician concerning a female in her "early teens" who on an unspecified date was vaccinated with Gardasil (lot # unknown).  On an unspecified date the patient experienced swelling and redness at the injection site as well as "pain radiating down the injected arm".  Medical attention was sought.  No further information was provided.  At the time of reporting it was unknown if the patient had recovered.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2007. Initial and follow-up information has been received from a physician concerning an 18 year old white female in her "early teens" with no illness at the time of vaccination who on 22-OCT-2007 was vaccinated with GARDASIL (lot# 659435/1265U) in the left deltoid. On 22-OCT-2007 the patient experienced swelling and redness at the injection site as well as "pain radiating down the injected arm" from the shoulder to the elbow for 1 month. The patient developed a mild rash. Medical attention was sought. No further information was provided. At the time of reporting it was unknown if the patient had recovered.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: Information has been received from a licensed practical nurse concerning a 17 year old female with no known allergies and no reported medical history who was vaccinated with 3 doses of Gardasil.  The licensed practical nurse reported that the patient tested high positive for HPV types 16 and 18.  It is unknown what type of test was done because it was done at another office.  All three doses were given by another office.  The patient sought medical attention by coming to the office and as of 19-Nov-2007 had not recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pruritus, Rash, Urticaria
Clinical narrative: Information has been received from a registered nurse, concerning a female patient (age not specified) who in September 2007 was vaccinated IM with the first dose of Gardasil, and on 16-Nov-2007 vaccinated IM with the second dose of Gardasil (lot # not provided).  There was no concomitant medication.  On 17-Nov-2007, "after she was given the second dose," the patient developed a rash and hives, as well as pain and itching in the palms in her hands.  She contacted the department of health.  Treatment included Benadryl.  At the time of this report, the outcome of the events was not recovered.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 19-Jul-2007 was vaccinated intramuscularly with the second dose of Gardasil.  It was reported as on "19-Sep-2007" the patient experienced severe headache and high grade fever about an hour after being vaccinated.  The patient sought unspecified medical treatment by being treated with ibuprofen.  The patient recovered at an unspecified time.  Additional information has been requested. Follow-up received 04/16/2008. Patient is (90 lbs. 58 in.) The patient had a history of a rash when exposed to Cefzil. No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female, aged 18 to 26 years, who on an unspecified date was vaccinated with the first dose , 0.5 ml, of Gardasil (lot # not specified).  Subsequently the patient experienced a "swollen hand at the injection site."  At the time of this report, the patient had not recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Genital rash
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient (age not reported) who on an unspecified date was vaccinated with a dose of Gardasil.  Subsequently the patient developed a vulvar rash.  The patient sought medical attention, though treatment was not specified.  At the time of this report, the patient was recovering from the event.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Autoimmune thyroiditis, Laboratory test, Menstruation delayed, Ovarian failure
Clinical narrative: Information has been received from a physician, concerning an 18 year old, non-pregnant female patient with celiac disease and a penicillin allergy, who on 16-Aug-2007 was vaccinated IM with the first dose, 0.5 ml, of Gardasil, and on 19-Oct-2007 with the second dose of Gardasil (lot # not provided).  There was no concomitant medication.  Following the second vaccination, the patient missed her period (date not specified), and was diagnosed with premature ovarian failure.  Diagnostic tests included hormonal studies and thyroid studies (results not reported).  At the time of this report, the patient had not recovered. 02/12/2010 Initial and follow up information has been received from a physician concerning an 18 year old,  non-pregnant female patient with celiac disease and a penicillin allergy, who on 16-AUG-2007 was vaccinated IM with the first dose, 0.5ml, GARDASIL (lot #657868/0523U) and on 19-OCT-2007 with the second dose of GARDASIL (lot # not provided). There was no concomitant medication. The physician reported that the "patient presented with new onset amenorrhea times 2 months starting concurrent with her first vaccine," however the date of onset was also reported as 24-OCT-2007. She had a workup with labs, which determined that she had premature ovarion filure and Hashinotot's thyroiditis. There was no concomitant medication. At the time of this report, the outcome of the events was not specified. The physician questioned a causal relationship of the events to GARDASIL. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test negative, Thyroid function test
Clinical narrative: Information has been received from a physician, concerning an 18 year old, non-pregnant female patient with celiac disease and a penicillin allergy, who on 16-Aug-2007 was vaccinated IM with the first dose, 0.5 ml, of Gardasil, and on 19-Oct-2007 with the second dose of Gardasil (lot # not provided).  There was no concomitant medication.  Following the second vaccination, the patient missed her period (date not specified), and was diagnosed with premature ovarian failure.  Diagnostic tests included hormonal studies and thyroid studies (results not reported).  At the time of this report, the patient had not recovered. 02/12/2010 Initial and follow up information has been received from a physician concerning an 18 year old,  non-pregnant female patient with celiac disease and a penicillin allergy, who on 16-AUG-2007 was vaccinated IM with the first dose, 0.5ml, GARDASIL (lot #657868/0523U) and on 19-OCT-2007 with the second dose of GARDASIL (lot # not provided). There was no concomitant medication. The physician reported that the "patient presented with new onset amenorrhea times 2 months starting concurrent with her first vaccine," however the date of onset was also reported as 24-OCT-2007. She had a workup with labs, which determined that she had premature ovarion filure and Hashinotot's thyroiditis. There was no concomitant medication. At the time of this report, the outcome of the events was not specified. The physician questioned a causal relationship of the events to GARDASIL. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: Information has been received from a nurse practitioner, concerning a female patient (age not specified), who on an unknown date was vaccinated IM with a dose of Gardasil (lot # not reported).  Subsequently the patient developed a minor injection site reaction that involved redness at the injection site.  The patient was seen by the physician (treatment not specified).  After a few days, the patient recovered.  This is one of two reports received from the same source (0711USA04559).  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a nurse concerning a 19 year old female with a allergy to amoxicillin and a history of vaginal surgical repair from blunt trauma who on 11-May-2007 was vaccinated "into a vein" instead of intramuscularly in the left arm with the 1st 0.5 ml dose of Gardasil (lot #656617/0384U).  The mother and patient claimed that they saw blood back into the syringe after the 1st dosage was given.  On 06-Jul-2007, the patient was vaccinated intramuscularly in the right arm with a 0.5ml 2nd dose of Gardasil (lot #657868/0523U).  Concomitant therapy included ethinyl estradiol/norgestimate (Ortho Tri-Cyclen LO).  The nurse stated, post vaccination, the patient became woozy (unspecified which dose) and was told to lay down until she felt better.  Mother stated that the patient does not do well with needles.  The patient received unspecified medical attention and recovered on 11-May-2007.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil and experienced hives.  The patient sought unspecified medical treatment.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Asthenia, Hyperhidrosis, Loss of consciousness, Nausea, Pallor
Clinical narrative: Information has been received from a nurse concerning a 13 year old female who on 19-Nov-2007 was vaccinated with her first dose of Gardasil (Lot #656371/0181U).  Concomitant therapy included influenza virus vaccine (unspecified).  On 19-Nov-2007 the patient fainted.  Subsequently, the patient recovered from fainting.  Additional information has been requested. Information has been received from a nurse concerning a 13 year old female who on 19-NOV-2007 was vaccinated intramuscularly in the right deltoid with her first dose of HPV (lot # 656371/0181U).  On 19-NOV-2007 the patient fainted within 2 minutes of receiving the HPV vaccine. Follow up information reported that after receiving both immunizations, the patient suddenly said "I can't see" and collapsed to the floor froma standing position. She was unconscious for 5 - 10 seconds and then opened her eyes and asked what happened. The nurse kept her on the floor and gave her soda to drink. The patient was weak, shaky, pale, diaphoretic, and nauseous for approximately 10 -to 15 minuts. On 19-NOV-2007, the patient experienced a full recovery from fainting. And being weak, pale, diaphoretic, shak, and nauseous.
Age: 13.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Syncope, Syncope, Tremor
Clinical narrative: Information has been received from a nurse concerning a 13 year old female who on 19-Nov-2007 was vaccinated with her first dose of Gardasil (Lot #656371/0181U).  Concomitant therapy included influenza virus vaccine (unspecified).  On 19-Nov-2007 the patient fainted.  Subsequently, the patient recovered from fainting.  Additional information has been requested. Information has been received from a nurse concerning a 13 year old female who on 19-NOV-2007 was vaccinated intramuscularly in the right deltoid with her first dose of HPV (lot # 656371/0181U).  On 19-NOV-2007 the patient fainted within 2 minutes of receiving the HPV vaccine. Follow up information reported that after receiving both immunizations, the patient suddenly said "I can't see" and collapsed to the floor froma standing position. She was unconscious for 5 - 10 seconds and then opened her eyes and asked what happened. The nurse kept her on the floor and gave her soda to drink. The patient was weak, shaky, pale, diaphoretic, and nauseous for approximately 10 -to 15 minuts. On 19-NOV-2007, the patient experienced a full recovery from fainting. And being weak, pale, diaphoretic, shak, and nauseous.
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on 14-Nov-2007 was vaccinated with the second dose of Gardasil (lot not reported).  "Within 24 hours" of vaccination, the patient experienced diarrhea.  It was reported that the patient sought unspecified medical attention on 15-Nov-2007.  Subsequently, the patient recovered from diarrhea.  There was no product quality complaint.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2007. Follow up information was received on 18-JAN-2008. The nurse reports that the above incident was most likely related to a question and if this was possible to occur with GARDASIL vaccine. She states that the diarrhea was most likely not related to GARDASIL vaccine. She also does not remember who the patient was and therefore she cannot complete the B form.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle twitching
Clinical narrative: Information has been received from a physician concerning a female patient who on 11-Jun-2007 was vaccinated I.M. with the first dose of Gardasil (Lot #0212U).  On 13-Aug-2007, the patient was vaccinated I.M. with a 0.5 ml second dose of Gardasil (Lot #655503/0012U).  There was no concomitant medication.  In October 2007, the patient experienced twitching in the right upper arm.  The patient's twitching in the right upper arm persisted.  Unknown medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Presyncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient who in approximately October 2007, was vaccinated with the first dose of Gardasil.  Subsequently the patient experienced lightheaded and nearly passed out.  Unknown medical attention was sought.  At an unspecified date the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Haematology test, Menstrual disorder
Clinical narrative: Information has been received from a consumer concerning her daughter (age not reported) with a history of hernia when she was 4 or 5 years old and who on 13-Aug-2007 was vaccinated with the first 0.5 mL dose of Gardasil (lot # not provided).  There was no concomitant medication.  The daughter's mother reported that "since August 2007" her daughter has not received her period.  The daughter's last menstrual cycle was on July 31st and was over on August 7th.  "Caller stated that she is positive her daughter is not having sexual contact."  Laboratory blood work was performed (date unspecified, results not provided).  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Familial risk factor, Vomiting
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 23 year old female patient, who on approximately 20-Oct-2007 ("a month ago") was vaccinated IM with the first dose, 0.5 ml, of Gardasil (lot # not provided).  After an unknown duration of time, the patient experienced stomach pain and vomiting.  Subsequently, the patient recovered from stomach pain and vomiting (duration not specified).  The patient sought unspecified medical attention.  The patient's 17 year old sister also experienced the events as described above, when vaccinated with Gardasil (WAES #0711USA04358).  Further information is not available.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 10-12 year old female with no allergies or reported medical history who was vaccinated with Gardasil via injection.  The physician reported that after the first and second dose of Gardasil the patient had a rash on her face that lasted for about a week.  As of 20-Nov-2007 the patient had recovered and the physician was not sure if they were going to continue with the rest of the series.  Additional information has been requested.
Sex: F
Vaccine: DPP, HPV4, MNQ
Symptoms: Loss of consciousness, Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from an office manager in a physician's office, concerning an unspecified number of female patients, who on unspecified dates were vaccinated IM with the first dose of Gardasil (lot #'s not provided).  Concomitant therapy for some patients included Menactra and/or diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified).  The reporter stated that following the vaccination with Gardasil, "90%" of the patients complained of upper arm pain and tingling in their fingers, and "about 10%" of the patients "pass out in the office."  The patients sought unspecified medical attention.  At the time of this report, the outcome of the events were unknown.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Mood swings
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 year old female patient, who on 05-Oct-2007 was vaccinated with a dose of Gardasil (lot # not provided).  On 15-Nov-2007, she reported an injection site rash, as well as mood swings.  At the time of this report, the outcome of the events was unknown.  The patient sought medical advice from the office (details not specified).  Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2007. Initial follow up information has been received from a licensed practical nurse concerning a 15 year old female student with a drug allergy to AMOXIL, and food allergies to wheat, milk, peanuts and corn syrup. Who on 05-OCT-2007 was vaccinated in the right deltoid with the first dose of GARDASIL vaccine (lot # not provided). On 15-NOV-2007, at 3:15 pm. She reported an injection site rash, as well as mood swings. Follow up information indicated the patient also developed a rash on her belly, and was crying all the time. At the time of this report, the patient had recovered from the events (duration not specified). The patient sought medical advice from the office, but did not require a visit. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning a 17 year old female patient who on an unspecified date was vaccinated at school, with a dose of Gardasil (lot # not provided).  Concomitant therapy included "a number of other vaccines" (therapy unspecified) on the same day.  The nurse reported that the patient had "a significant fainting episode" (details not provided).  After an unknown duration of time, the patient regained consciousness.  At the time of this report, the outcome of the events was unknown.  The patient sought unspecified medical attention.  This is one of two reports received from the same source (0711USA04369).  No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Erythema, Pain, Swelling, Wrong technique in drug usage process
Clinical narrative: Information has been received from a nurse concerning an unknown number of patients who were vaccinated with Gardasil.  Subsequently some of the patients who received the vaccine in the recommended areas such as the deltoid and the thigh, experienced pain, swelling and redness at the injection site.  However, an unknown number of patients also may have received the vaccine IM in the buttocks without experiencing any side effects.  No further details were provided.  Follow up information from a healthcare professional indicated that there were 2 patients who experienced pain, swelling and redness, and no further identifying patient details were available.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP
Symptoms: Fall, Head injury, Headache, Hypersomnia, Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female who was vaccinated (route, site and dosage not reported) with Gardasil (lot # not reported).  Concomitant therapy included Menactra, Flumist and Adacel given on the same day.  Post vaccination, the patient stood up and started talking and subsequently fainted.  The patient fully recovered.  Additional information has been requested. Information has been received from a physician and follow-up information from a nurse concerning a 15 year old female with no relevant  medical hisotry, known drug allergies or illnesses at time of vaccination who in 17-NOV-2007, at 11:00 am was vaccinated intramuscularly in the deltoid muscle of the upper left arm with the first 0.5ml dose of HPV vaccine (lot # 658283/0929U). The patient was concomintantly vaccinated with MENACTRA (Lot #62403AA) given intramuscularly in the deltoid muscle of the lower left arm, FLUMIST (Lot #500489P) given intranansally and ALACEL (lot #C2771AA) given intramuscularly in the deltoid muscle of the right arm. The patient fainted post vaccinations. At 11:10 am the patient stood up walked over to the other side of the room and was talking with her family and fell over, hitting her head on top of a chair. The patient was faced down on the ground for approx 30 seconds. The patient came to and started talking. The CNNP came in to the room immediately and gave the patient some water and ice pack for the red area on her forehead. The patient's mother was instructed to watch patient carefully for 48-72 hours. The reporter stated that if the patient started to vomit, get a severe headache, sleeping too much the patient should go to the emergency rooml. No lab diagnostic test were performed. The patient left the office and was fine. The patient fully recovered. No additional information is expected.
Age: 15.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 15 year old female who was vaccinated (route, site and dosage not reported) with Gardasil (lot # not reported).  Concomitant therapy included Menactra, Flumist and Adacel given on the same day.  Post vaccination, the patient stood up and started talking and subsequently fainted.  The patient fully recovered.  Additional information has been requested. Information has been received from a physician and follow-up information from a nurse concerning a 15 year old female with no relevant  medical hisotry, known drug allergies or illnesses at time of vaccination who in 17-NOV-2007, at 11:00 am was vaccinated intramuscularly in the deltoid muscle of the upper left arm with the first 0.5ml dose of HPV vaccine (lot # 658283/0929U). The patient was concomintantly vaccinated with MENACTRA (Lot #62403AA) given intramuscularly in the deltoid muscle of the lower left arm, FLUMIST (Lot #500489P) given intranansally and ALACEL (lot #C2771AA) given intramuscularly in the deltoid muscle of the right arm. The patient fainted post vaccinations. At 11:10 am the patient stood up walked over to the other side of the room and was talking with her family and fell over, hitting her head on top of a chair. The patient was faced down on the ground for approx 30 seconds. The patient came to and started talking. The CNNP came in to the room immediately and gave the patient some water and ice pack for the red area on her forehead. The patient's mother was instructed to watch patient carefully for 48-72 hours. The reporter stated that if the patient started to vomit, get a severe headache, sleeping too much the patient should go to the emergency rooml. No lab diagnostic test were performed. The patient left the office and was fine. The patient fully recovered. No additional information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Familial risk factor, Vomiting
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 17 year old female patient, who on approximately 20-Oct-2007 ("a month ago") was vaccinated IM with the first dose, 0.5 ml, of Gardasil (lot # not provided).  After an unknown duration of time, the patient experienced stomach pain and vomiting.  Subsequently, the patient recovered from stomach pain and vomiting (duration not specified).  The patient sought unspecified medical attention.  The patient's 23 year old sister also experienced the events as described above, when vaccinated with Gardasil (WAES #0711USA04192).  Further information is not available.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of Gardasil.  Subsequently the patient experienced numbness down her arm immediately after the injection.  It was reported that the numbness went away later that day.  Subsequently, the patient recovered from the numbness down her arm.  Additional information has been requested. This is in follow-up to report (s) previously received on 12/14/2007. Additional information was received from a nurese on 08-JAN-2008. The nurse stated that the doctor received VAERS form to complete, but he does not plan on completing the form. There is no specific patient that the nurse can identify who had numbness down her arrm, although the nurse states many patients complain of burning at the injectionsite.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Cardiac arrest, Cardiac monitoring, Cardioversion
Clinical narrative: Information has been received from a health professional concerning a 21 year old female who was vaccinated with the first dose of Gardasil.  "About two weeks" after receiving the first dose of Gardasil the patient experienced heart defibrillation.  The patient sought unspecified medical attention in the physician's office.  Per the reporter, the patient is going to a cardiologist and is now on a heart monitor.  No further AE information.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Cardiac arrest, Cardioversion
Clinical narrative: Information has been received from a health professional concerning an 18 year old female who was vaccinated with her first dose of Gardasil in another doctor's office.  Subsequently the patient experienced a heart defibulation problem.  The patient was not a patient of the health professional, but she can be contacted for more information.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with the first dose of Gardasil.  Subsequently the patient experienced allergic reaction.  Unknown medical attention was sought.  The patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a female (age not reported) with and unspecified immune system disorder who was vaccinated IM with the second dose of Gardasil vaccine. On an unspecified date the patient experience diarrhea. The outcome was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a nurse practitioner, concerning a female patient (age not specified), who on an unknown date was vaccinated IM with a dose of Gardasil vaccine (lot # not reported). Subsequently, the patient developed a minor injection site reaction that involved redness at the injection site. The patient was seen by the physician (treatment not specified). After a few days, the patient recovered. This is one of two reports received from the same source (0711USA04079). Additional information has been requested.
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Back pain, Ear pain, Immediate post-injection reaction, Injection site pain, Musculoskeletal pain
Clinical narrative: Information has been received from a health professional concerning a "11 or 12 year old" female who in November 2007, was vaccinated with her first dose of Gardasil vaccine. Concomitant therapy included influenza virus vaccine (unspecified). In November 2007, the patient experienced pain at the injection site going from her shoulder to her neck and ear almost immediately after getting the shot. That same night the patient also experienced a fever of 104 Fahrenheit. Subsequently, the patient recovered from pain at the injection site and a fever of 104 Fahrenheit. The patient sought medical attention the next day in the office and the doctor gave her Motrin. Information has been received from a healthcare professional concerning a 12 year old female who on 06-NOV-207, was vaccinated with her first dose of HPV vaccine (lot # 639435/1265U). On 06-NOV-2007, within 2 -3 minutes of receiving HPV vaccine, the patient exprienced pain at the injection site going from her shoulder to her neck and ear almost immediately after getting the shot. That same night the patient also experienced a fever of 104 F with a headache and back pain. Subsequently, the patient  recovered from pain at the injection site and a fever of 104 F. The patient sought medical attention the next day in the office and the doctor gave her (MOTRIN).
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Neck pain, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a "11 or 12 year old" female who in November 2007, was vaccinated with her first dose of Gardasil vaccine. Concomitant therapy included influenza virus vaccine (unspecified). In November 2007, the patient experienced pain at the injection site going from her shoulder to her neck and ear almost immediately after getting the shot. That same night the patient also experienced a fever of 104 Fahrenheit. Subsequently, the patient recovered from pain at the injection site and a fever of 104 Fahrenheit. The patient sought medical attention the next day in the office and the doctor gave her Motrin. Information has been received from a healthcare professional concerning a 12 year old female who on 06-NOV-207, was vaccinated with her first dose of HPV vaccine (lot # 639435/1265U). On 06-NOV-2007, within 2 -3 minutes of receiving HPV vaccine, the patient exprienced pain at the injection site going from her shoulder to her neck and ear almost immediately after getting the shot. That same night the patient also experienced a fever of 104 F with a headache and back pain. Subsequently, the patient  recovered from pain at the injection site and a fever of 104 F. The patient sought medical attention the next day in the office and the doctor gave her (MOTRIN).
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 21-NOV-2007 was vaccinated with her first dose of GARDASIL vaccine (yeast) IM. On 21-NOV-2007 the patient became dizzy and felt faint after receiving the first dose. Subsequently, the patient recovered from being dizzy and feeling faint. The patient sought unspecified medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a female who on approximately 19-NOV-2007 was vaccinated with her first dose of Gardasil vaccine. Approximately 2 days after administration, the patient developed hives. The patient was examined in the office. The patient fully recovered from hives without requiring treatment. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2007. Follow-up information was received from a mother concerning her 20 year old daughter with no pertinent medical history and has a drug allergy to amoxicillin who on 20-NOV-2007 was vaccinated with a first dose of GARDASIL vaccine (lot# unknown). Concomitant therapy on 20-NOV-2007 included a tuberculin test (unspecified). On 20-NOV-2007 * her daughter broke out with hives after receiving her first dose of GARDASIL vaccine. No further information given. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Nausea, Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a health professional concerning a 14 year old female who was vaccinated intramuscularly with her first dose of Gardasil vaccine. Subsequently, the patient experienced flu-like symptoms, fever, vomiting, nausea and body aches for 10 days. The nurse practitioner reported that the patient also experienced flu like symptoms, fever, vomiting, nausea and body aches for about 4-5 days after receiving the second dose of Gardasil vaccine intramuscularly. The patient sought unspecified medical treatment. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a health professional concerning a 14 year old female who was vaccinated intramuscularly with her first dose of Gardasil vaccine. Subsequently, the patient experienced flu-like symptoms, fever, vomiting, nausea and body aches for 10 days. The nurse practitioner reported that the patient also experienced flu like symptoms, fever, vomiting, nausea and body aches for about 4-5 days after receiving the second dose of Gardasil vaccine intramuscularly. The patient sought unspecified medical treatment. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a female patient in her mid 30's who in September 2007 (exact date not reported), was vaccinated (site and route reported) with the 1st dose of Gardasil vaccine (lot # not reported). Subsequently, after the vaccination the patient developed a headache and dizziness. The interval between administration of Gardasil vaccine and the onset of symptoms was not reported. No laboratory test were performed. The patient did receive unspecified medical attention and recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Cough, Epstein-Barr virus antibody positive, Epstein-Barr virus antigen positive, Hypoaesthesia, Mononucleosis syndrome
Clinical narrative: Information has been received from a nurse concerning a (approx) 15 year old female who was vaccinated (date, route and site not reported) with the 1st dose of GARDASIL vaccine (yeast) (lot # not reported). Concomitant therapy included influenza virus vaccine (manufacturer unknown). The patient complained of numbness in her hands and feet after receiving GARDASIL vaccine (yeast). The patient reported that the numbness  was on and off. Patient received unspecified medical attention. At the time of this report,  patient's outcome was unknown. Additional information has been requested. Information has been received from a physician concerning a 15 year old female patient who on 20-NOV-2007, was vaccinated IM in to the left deltoid with a first dose of HPV vaccince. On 21-NOV-2007 one day after the vaccination, the patient experienced intermittent numbness and tingling in her hands and feet. It was reported that it would last a few minutes and it occurred 4 to 5 times per day. The patient then went on to develop a cough and cold. On 26-NOV-2007, the patient was daignosed with mononucleosis. Laboratory disgnostic studies performed included serum Epstein-Barr virus early antigen immunoglobulin M antinbody test and serum Epstein-Barr capsid antigen immunoglobulin G antibody test which were reported as positive. Within 5 days, the patient recovered from intermittent numbness in hands and feet. Subsequently, the patient recovered from mononucleosis, cough and cold. No product quality complaint was involved.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Nasopharyngitis, Paraesthesia
Clinical narrative: Information has been received from a nurse concerning a (approx) 15 year old female who was vaccinated (date, route and site not reported) with the 1st dose of GARDASIL vaccine (yeast) (lot # not reported). Concomitant therapy included influenza virus vaccine (manufacturer unknown). The patient complained of numbness in her hands and feet after receiving GARDASIL vaccine (yeast). The patient reported that the numbness  was on and off. Patient received unspecified medical attention. At the time of this report,  patient's outcome was unknown. Additional information has been requested. Information has been received from a physician concerning a 15 year old female patient who on 20-NOV-2007, was vaccinated IM in to the left deltoid with a first dose of HPV vaccince. On 21-NOV-2007 one day after the vaccination, the patient experienced intermittent numbness and tingling in her hands and feet. It was reported that it would last a few minutes and it occurred 4 to 5 times per day. The patient then went on to develop a cough and cold. On 26-NOV-2007, the patient was daignosed with mononucleosis. Laboratory disgnostic studies performed included serum Epstein-Barr virus early antigen immunoglobulin M antinbody test and serum Epstein-Barr capsid antigen immunoglobulin G antibody test which were reported as positive. Within 5 days, the patient recovered from intermittent numbness in hands and feet. Subsequently, the patient recovered from mononucleosis, cough and cold. No product quality complaint was involved.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Hypokinesia, Pain in extremity
Clinical narrative: Information has been received from a nurse concerning a 25 year old female who on 13-NOV-2007 was vaccinated (site and route not reported) with the 1st dose of the Gardasil vaccine (lot #655154/1210U). Subsequently, after receiving the 1st dose of Gardasil vaccine the patient complained of pain in her arm that lasted for 2 weeks and being unable to raise her arm. The patient did receive unspecified medical attention. At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning her 16 year old daughter who in (approximately) November 2007, was vaccinated (site and route not reported) with Gardasil vaccine (dosage and lot# not reported). Two or three weeks after vaccination with Gardasil vaccine, the patient's injection site was still painful and raised and the patient also had hypo-pigmentation around the injection site. The patient did not received medical attention and the AE did not improve. At the time of this report, the patient had not recovered. This is one of two reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female who on an unspecified date was vaccinated with a first dose of Gardasil vaccine (lot# unknown) IM injection. Subsequently, on an unspecified date after receiving the Gardasil vaccine the patient experienced "flu like symptoms (fever, vomiting, nausea and body aches) for about 5 days. Medical attention was sought. On an unspecified date the patient fully recovered. On an unspecified date the patient received a second dose of Gardasil vaccine but did not experience any AE related symptoms. No further information was provided. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Erythema, Herpes virus infection, Vaginal pain, Vaginal ulceration
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a history of urinary tract infection and no drug allergies, who on approximately 05-NOV-2007 was vaccinated with a first dose of Gardasil vaccine. Concomitant therapy included acyclovir. On 18-NOV-2007, the patient presented to the emergency room with vaginal pain. The patient was prescribed acyclovir and diagnosed with herpes. The patient took some pain medications and stayed home from school for a few days. The patient was re-evaluated and found to be an otherwise health, athletic teenager with her hymenal ring still intact and no history of STD diseases or pertinent medical history. The patient had pain and bilateral erythema at the labia minor and there was a black ulceration observed in that area. The patient's white blood cell count was slightly elevated. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.