chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated intramuscularly with a first dose of Gardasil. Subsequently, the patient developed a "rash all over her body". It was reported that the "rash had subsided within 24 hours". The nurse reported that the contact dermatitis was not related to the vaccination with GARDASIL.  The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a female patient with no allergies who on an unknown date, was vaccinated IM into the hip area with a second dose of Gardasil. It was reported that the vaccine was painful. It was reported that the patient was not experiencing any other known symptoms. No medical attention was sought. At the time of this report, the patient's outcome was unknown. The patient is due for her third dose on 20-AUG-2007. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2007.
Age: 11.0
Sex: F
Vaccine: DTAP, HEPA, HPV4, MEN
Symptoms: Dizziness, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a healthy 11-year-old female who is not on any medication, who on an unspecified date at 2:00 pm was vaccinated with the first dose of Gardasil. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, VAQTA and MENJUGATE. Subsequently, following vaccination, the patient experienced dizziness. No other symptoms were reported. It was reported that the patient did not have anything to eat since late in the morning. It is reported that the patient recovered before she left the office. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: No reaction on previous exposure to drug, Syncope
Clinical narrative: Information has been received from a certified medical assistant (CMA), concerning a 17 year old female patient, who on approximately 12-MAY-2007 ("two months ago") was vaccinated with the first dose of Gardasil with no reactions, and on 12-JUL-2007 was vaccinated IM in the right deltoid, with the second dose of Gardasil (Lot #658100/0525U). Concomitant therapy included vaccinations in the left arm with Menactra and Vaqta. On 12-JUL-2007, after receiving the vaccination with Gardasil, the patient fainted. No further details were provided, and it was unknown if the patient had recovered. The CMA reported that an 18 year old female patient experienced a similar episode after vaccination with Gardasil (lot #655503/0012U) (WAES #0706USA04707). Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site inflammation, Injection site mass, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 26 year old female patient who on 23-APR-2007 was vaccinated with a first dose of GARDASIL vaccine(yeast) ( lot # 656051/0244U). On 23-APR-2007 after getting the injection the patient developed serious injection site reaction that lasted for two weeks. She returned to the office and the injection site appeared red, inflamed, swollen, and there was a lump there. The events improved for two weeks and then returned and lasted for a week. The patient would not receive the second and third doses of Gardasil. Unspecified medical attention was sought by the patient. The patient recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow up information has been received from a Rgistered Nurse (R.N.) concerning a 26 year old female with Crohn's disease for which she took steroids daily, who on 23-APR-2007 was vaccinated IM in to right deltoid at 10:00AM with as first dose of GARDASIL vaccine (yeast) lo# 656051/0244U. On 23-APR-2007 after getting the injection the patient developed serious infection site  reacton that lasted for two weeks. She returned to the office and the injection site appeared  red., inflamed, swollen, and there was a lump there. The events improvedfor two weeks and then returned and lasted for a week. The patient would not receive the second dose and third dose of GARDASIL vaccine(yeast). Unspecified medical attention was sought by the patient.. In follow up the reporter reported that on 23-APR-2007, patient had bleeding with injection and had quarter size lump with ecchymosis for two weeks. On 02-MAY-2007, patient was seen  in the office. She was seen in the office again on 17-MAY-2007 and the site was tender and there was alump at injection site again. In follow up it was noted in the office note that the patient bleeding with the injection and had some echhymosis that was quarter sized. Tha paitient recovered. Additional information is not exptected
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Migraine, Pain, Paraesthesia, Tremor
Clinical narrative: Information has been received from a nurse concerning a 12 year old female with a history of migraine who was vaccinated with a first dose of Gardasil (lot # unknown) 0.5 mL injection. The patient developed a migraine headache, severe shaking, aching and tingling in the fingers and toes approximately a half hour after the vaccination. medical attention was sought. At the time of reporting the patient was recovering. No further information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007.  Follow-up information was received.  At the time of vaccination the patient had a migraine.  It was reported that on 12-JUL-2007 that the arm felt sore.  Around 11PM (previously reported as half hour after the vaccination) the patient got a bad migraine with shaking and sweating.  On 12-JUL-2007 the patient recovered without intervention.  On 01-AUG-2007 the patient had a magnetic resonance imaging of the brain with and without IV contrast performed.  The impression was normal.  Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female, who, on an unspecified date, was vaccinated with a dose of Gardasil. Subsequently, the patient developed urticaria. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Allergy test negative, Rash, Urticaria
Clinical narrative: Initial and follow-up information has been received from a health  professional and a consumer concerning her 21 year old daughter who was a student, with a penicillin allergy and a hypersensitivity to canvas who, on 24-MAY-2007, was vaccinated IM in the deltoid with the first dose of Gardasil (lot # 657622/0388U) via injection. There was no concomitant medication. On 24-MAY-2007, (previously reported as 25-MAY-2007) the patient experienced hives, welts all over after receiving the first injection of Gardasil. The patient had been on CLARITIN and had taken steroids (dose, duration, and route not reported) to alleviate the symptoms. As long as the patient continued the CLARITIN, the symptoms subsided, but as soon as the CLARITIN was discontinued, the hives returned. The patient was referred to a dermatologist to test for environmental allergens which may have caused an "incidental allergic reaction." On an unspecified date an allergy test reported no allergens were identified. As of 13-JUL-2007, the patient had not recovered from the hives and welts all over. Additional information has been requested. The reporting health professional considered hives and rash to be other important medical events. Additional information not expected. At the time of the report the patient had not recoveed from the hives and a rash.  The reporting health professional considered hives and rash to be other important medical events.  Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash, Urticaria
Clinical narrative: Initial and follow-up information has been received from a health  professional and a consumer concerning her 21 year old daughter who was a student, with a penicillin allergy and a hypersensitivity to canvas who, on 24-MAY-2007, was vaccinated IM in the deltoid with the first dose of Gardasil (lot # 657622/0388U) via injection. There was no concomitant medication. On 24-MAY-2007, (previously reported as 25-MAY-2007) the patient experienced hives, welts all over after receiving the first injection of Gardasil. The patient had been on CLARITIN and had taken steroids (dose, duration, and route not reported) to alleviate the symptoms. As long as the patient continued the CLARITIN, the symptoms subsided, but as soon as the CLARITIN was discontinued, the hives returned. The patient was referred to a dermatologist to test for environmental allergens which may have caused an "incidental allergic reaction." On an unspecified date an allergy test reported no allergens were identified. As of 13-JUL-2007, the patient had not recovered from the hives and welts all over. Additional information has been requested. The reporting health professional considered hives and rash to be other important medical events. Additional information not expected. At the time of the report the patient had not recoveed from the hives and a rash.  The reporting health professional considered hives and rash to be other important medical events.  Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Allergy test negative, Rash, Urticaria
Clinical narrative: Information has been received from a Certified Medical Assistant (C.M.A.) concerning a 21 year old female patient who on 25-MAY-2007 was vaccinated with a first dose of Gardasil. On 25-MAY-2007 the CMA reported that patient had hives and rash everyday since she was given the vaccine. No other information was reported. Unspecified medical attention was sought by the patient. The patient had not recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted from a Certified Medical Assistant concerning a 21 year old female student who on 24-May-2007 was vaccinated IM with a first dose of GARDASIL lot # 657622/0388U. On 25-May-2007 the CMA reported that the patient had hives and a rash everday since she was given the vaccine. No other information was reported. In follow up it was reported that the patient had hives ever since she hot the first injection. Dermatologist advised to take CLARITIN. Patient's mother stated that once patient stops CLARITIN the hives returns. The patient had not recovered. The reporter considered the patient's hives to be an important medical event. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a Certified Medical Assistant (C.M.A.) concerning a 21 year old female patient who on 25-MAY-2007 was vaccinated with a first dose of Gardasil. On 25-MAY-2007 the CMA reported that patient had hives and rash everyday since she was given the vaccine. No other information was reported. Unspecified medical attention was sought by the patient. The patient had not recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted from a Certified Medical Assistant concerning a 21 year old female student who on 24-May-2007 was vaccinated IM with a first dose of GARDASIL lot # 657622/0388U. On 25-May-2007 the CMA reported that the patient had hives and a rash everday since she was given the vaccine. No other information was reported. In follow up it was reported that the patient had hives ever since she hot the first injection. Dermatologist advised to take CLARITIN. Patient's mother stated that once patient stops CLARITIN the hives returns. The patient had not recovered. The reporter considered the patient's hives to be an important medical event. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil for the prevention of HPV. The patient received the Gardasil vaccination at her local OB/GYN office. A day after the patient received the vaccination, she had a regular check-up with her family physician, where she informed him of swelling at the site of injection after receiving the Gardasil vaccination. As of 13-JUL-2007, the outcome of the patient's swelling at the site of injection was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with Gardasil. Subsequently, the patient developed a rash after receiving a dose of Gardasil. As of 13-JUL-2007, the outcome of the patient's rash was unknown. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female who was vaccinated with Gardasil. After the patient received Gardasil, on 05-JUL-2007, she developed pain in the injection site on her arm, which she had for more than a week. As of 13-JUL-2007, the patient had not recovered from the pain in the injection site on her arm. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow-up information has been received from a nurse practitioner and a consumer concerning a 24 year old female with hypothyroidism, diabetes, gastrooesophageal reflux disease, psoriasis, syncope and depression, who on 05-JUL-2007 was vaccinated intramuscularly in the left arm with a first dose of GARDASIL (Lot # 658094/0524U). Illness at the time of the vaccine included bacterial vaginosis. Concomitant therapy included SYNTHROID, LANTUS, HUMALOG, DIFLUCAN, FLAGYL and REGLAN. On 13-JUL-2007 (previously reported as 05-JUL-2007) the patient experienced a sore left arm. There was no redness, swelling, warmth, or fever reported. The patient was taking TYLENOL per label and three ibuprofen three times a day for pain. The patient was informed to switch to ALEVE two times a day with food and to continue TYLENOL per the label. At the time of the report, the patient's outcome was unknown. This is a consolidation of two reports concerning the same patient. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female who was vaccinated with Gardasil. After the patient received Gardasil, on 05-JUL-2007, she developed pain in the injection site on her arm, which she had for more than a week. As of 13-JUL-2007, the patient had not recovered from the pain in the injection site on her arm. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow-up information has been received from a nurse practitioner and a consumer concerning a 24 year old female with hypothyroidism, diabetes, gastrooesophageal reflux disease, psoriasis, syncope and depression, who on 05-JUL-2007 was vaccinated intramuscularly in the left arm with a first dose of GARDASIL (Lot # 658094/0524U). Illness at the time of the vaccine included bacterial vaginosis. Concomitant therapy included SYNTHROID, LANTUS, HUMALOG, DIFLUCAN, FLAGYL and REGLAN. On 13-JUL-2007 (previously reported as 05-JUL-2007) the patient experienced a sore left arm. There was no redness, swelling, warmth, or fever reported. The patient was taking TYLENOL per label and three ibuprofen three times a day for pain. The patient was informed to switch to ALEVE two times a day with food and to continue TYLENOL per the label. At the time of the report, the patient's outcome was unknown. This is a consolidation of two reports concerning the same patient. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning a 24 year old female with bacterial vaginosis, hypothyroidism, diabetes, gastroesophageal reflux disease, psoriasis, syncope and depression, who on 05-JUL-2007 was vaccinated intramuscularly in the left arm with a first dose of Gardasil (Lot # 658094/0524U). Concomitant therapy included levothyroxine Na (SYNTHROID), insulin glargine (LANTUS), insulin lispro (HUMALOG), fluconazole (DIFLUCAN), metronidazole (FLAGYL), and metoclopramide hydrochloride (REGLAN). On 13-JUL-2007 the patient experienced a sore left arm. There was no redness, swelling, warmth, or fever reported. The patient was taking acteminophen (TYLENOL) per label and three ibuprofen three times a day for pain. The patient was informed to switch to naproxen sodium (ALEVE) two times a day with food and to continue acetaminophen (TYLENOL) per the label. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a consumer concerning a 24 year old female with bacterial vaginosis, hypothyroidism, diabetes, gastroesophageal reflux disease, psoriasis, syncope and depression, who on 05-JUL-2007 was vaccinated intramuscularly in the left arm with a first dose of Gardasil (Lot # 658094/0524U). Concomitant therapy included levothyroxine Na (SYNTHROID), insulin glargine (LANTUS), insulin lispro (HUMALOG), fluconazole (DIFLUCAN), metronidazole (FLAGYL), and metoclopramide hydrochloride (REGLAN). On 13-JUL-2007 the patient experienced a sore left arm. There was no redness, swelling, warmth, or fever reported. The patient was taking acteminophen (TYLENOL) per label and three ibuprofen three times a day for pain. The patient was informed to switch to naproxen sodium (ALEVE) two times a day with food and to continue acetaminophen (TYLENOL) per the label. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 17 year old female who was vaccinated with the third dose of Gardasil. Subsequently, the patient experienced "numbness and tingling of her extremities, as well as fatigue". The patient told her mother this after receiving all three doses of Gardasil. It was unspecified when the patient started experiencing these conditions. As of 13-JUL-2007, the outcome of the patient's numbness and tingling of her extremities and fatigue was unknown. Additional information has been requested.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a Physician's Assistant concerning a female who was vaccinated IM with Gardasil and within 24 hours developed a rash. The patient's outcome was not reported. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007. Information has been received from a Physician's Assistant concerning a female who was vaccinated IM with a dose of GARDASIL and within 24 hours developed a rash. The patient's outcome was not reported. Additional information is not available.
Sex: F
Vaccine: HPV4
Symptoms: Palpitations
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the first dose of Gardasil. Subsequently the patient experienced cardiac palpitations after receiving the vaccine. The symptoms started on the day of administration and occurred several times per day for the next 2 weeks. The frequency of the palpitations has decreased and now occurs rarely. Medical attention was sought. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning an 18 year old female patient who on 10-JUL-2007 was vaccinated with the first dose of the Gardasil (Lot # 658490/0802U). n 10-JUL-2007, within the ten minutes of the vaccination, the patient fainted. Unspecified medical attention was sought. On 10-JUL-2007, the patient recovered. This report is one of two reports from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on 13-JUL-2007 was vaccinated with Gardasil and then developed a fever, sore throat and severe headache. The patient's outcome was not reported. Medical attention was sought. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a few patients who were vaccinated with Gardasil and fainted. The patients had received other vaccines (unspecified) that day. There were no other problems after they fainted, no hospitalizations. Since the label updated to wait 15 minutes after administration they have been waiting 15-20 minutes. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Facial palsy
Clinical narrative: Information has been received from a physician concerning a 11 to 12 year old female who was vaccinated with Gardasil. One week after vaccination, the patient presented with what appeared to be facial Bell's Palsy of the seventh nerve involvement. The physician was then practicing as an Urgent Care physician and sent the patient to the ER for further help. The physician is now practicing at a pediatrician's office and could not follow up on this experience. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow-up information has been received from a nurse practitioner concerning a 21 year old female Radiologist Aide, with no pertinent medical history, who on an 16-MAR-2007 was vaccinated IM in right deltoid with a first dose of Gardasil. Subsequently, on an unspecified date, the patient developed a rash on her leg. The patient's rash never fully went away. On an unspecified date, the patient was vaccinated IM with a second dose of Gardasil. Subsequently, on an unspecified date, the patient's rash on her leg was "more prominent and longer" then the rash received after her first dose. The nurse practitioner reported that the patient was referred to a dermatologist for an evaluation. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site irritation, Injection site pain
Clinical narrative: Information has been received from a nurse concerning an unknown number of female patients who were vaccinated with the second dose of Gardasil and experienced pain and burning at the injection site. There was no specific information about the patients. There were no adverse experiences reported after receiving the first dose. Medical attention was sought. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dizziness, Headache
Clinical narrative: Information has been received from a physician, concerning a 12 year old female patient, with drug hypersensitivity to CEFZIL, who on 12-JUL-2007 was vaccinated IM, with the first dose, 0.5ml, of Gardasil (Lot #657736/0389U). Concomitant vaccination therapy included BOOSTRIX. On 15-JUL-2007, three days following the vaccination, the patient experienced a headache and dizziness, that worsened during the day, and then began to resolve in the evening. The physician reported that on 16-JUL-2007, the patient was "fine," and confirmed that all symptoms had resolved. The patient sought unspecified medical attention. No further information is expected.
Age: 12.0
Sex: F
Vaccine: HEP, HPV4, TDAP
Symptoms: Loss of consciousness, Nausea
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2007: Initial and follow up information has been received from a physician and a medical assistant, via a company representative, concerning a 12 year old female patient, with no known allergies or medical conditions, who on 13-JUL-2007, at 10:05am, was vaccinated IM in the right deltoid, with the first dose, 0.5ml, of GARDASIL (Lot #655619/1427F). Concomitant vaccine therapy included ADACEL (Lot #C2734AA), administered at 10:00am, IM in the left deltoid, and ENGERIX-B (Lot #AHBVB289CA), administered at 10:03am, IM in the left vastus lateralis. On 13-JUL-2007, at 10:07am, the patient experienced nausea and passed out. She was helped to lie down, had a cool cloth applied to her forehead, was assessed by the physician, and then given soda to help with the nausea. She was observed for a total of 20 minutes. The patient recovered from the events on the same day, 13-JUL-2007. The patient sought unspecified medical attention. No further information is expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a registered nurse, concerning a 20 year old female patient, who on 12-JUL-2007 was vaccinated with the second dose of Gardasil (Lot # not reported). There was no concomitant medication. On 12-JUL-2007, after receiving the vaccination, the patient felt like fainting, though she "did not lose consciousness." The nurse confirmed that the patient recovered on the same day, 12-JUL-2007. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Influenza like illness, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a Nurse Practitioner (N.P.) concerning a 17 year old female patient who on 19-JAN-2007 was vaccinated with a first dose of Gardasil lot #654885/1424F and on an unknown day received the second dose of Gardasil lot #655849/0263U. The reporter indicated that the patient developed flu-like symptoms that were severe after one week later of the first injection and had 103 degree fever. Patient was all right after 10 days. She received her second injection and within 24 hours developed flu-like symptoms again which were less severe and had a fever of 102 and recovered within 5 days. The physician did not give the third injection to the patient which she was suppose to get on 16-JUL-2007. The patient sought unspecified medical attention. The patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Chills, Dizziness, Nausea, Vomiting
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a female patient who was vaccinated with a first dose of Gardasil. The nurse reported "patient developed nausea, vomitting, dizziness, and chills." Unspecified medical attention was sought by the patient. The outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Rash
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who in May 2007 "7 weeks ago", was vaccinated with a first dose of Gardasil (lot number unknown) 0.5 mL injection and immediately broke out into a rash. Medical attention was sought. The physician prescribed CLARITIN and the rash cleared. On an unspecified date the patient reported to the physician that the rash reappears every time she stops the CLARITIN. The mother of the patient wishes to discontinue the series of Gardasil. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with a dose of Gardasil (lot number unknown) and fainted. No additional information was available. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female with a history of tinea versicolour, polycystic ovarian syndrome and amenorrhea who on 24-JAN-2007 was vaccinated IM into left deltoid with the first 0.5 ml dose of Gardasil (Lot # 655619/1427F). Concomitant therapy included clomiphene citrate (CLOMID), metformin HCl (GLUCOPHAGE) and multivitamins (unspecified). On approximately 24-JAN-2007, the patient experienced pain. It was reported that the pain was worse on the second day after vaccination. The went away after a couple of days. On an unspecified date in 2007 the patient was vaccinated IM into left deltoid with the second 0.5 ml dose of Gardasil (Lot # 657006/0188U). Subsequently, in 2007, the patient experienced pain. It was reported that the pain was worse on the second day after vaccination. Subsequently, the pain "went away" after a couple of days. On 09-JUL-2007, the patient was vaccinated IM into left deltoid with the second 0.5 ml dose of Gardasil (Lot # 657622/0388U). On approximately 09-JUL-2007. The patient experience pain. It was reported that the pain was worse on the second day after vaccination. Subsequently, the pain "went away" after a couple of days. At the time of the report, the patient's arm still hurt, was sore, and felt like she "slept on the arm wrong". The arm was not getting better or worse and there was no redness or swelling. The patient was advised to take ibuprofen and apply warmth or heat to the affected area. This is one of two reported received from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Vaginal infection
Clinical narrative: Information has been received from the Merck Pregnancy registry via a health professional concerning a 19 year old female with no pertinent past medical history who on 09-MAY-2007 was vaccinated intramuscularly in the right deltoid with a 0.5 ml dose of Gardasil (lot #). On approximately 21-JUN-2007 the patient developed vaginitis and on 21-JUN-2007 treatment with DIFLUCAN was initiated. Subsequently the patient became pregnant. A urine and serum beta-human-chorionic gonadotropin were positive. The patient's last menstrual period was 08-JUL-2007 and the estimated date of delivery was 13-APR-2008. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Influenza like illness, Nasal congestion, Nausea, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a licensed practical nurse (LPN), concerning a 20 year old female patient, who on 13-JUL-2007, was vaccinated IM, with the first dose, 0.5ml, of Gardasil (Lot # not reported). There was no concomitant medication. On 13-JUL-2007, in the evening following the vaccination, the patient experienced flu-like symptoms, with fever, fatigue and nausea. On 17-JUL-2007, the nurse spoke with the patient, who confirmed the symptoms continued, and also reported she currently had "congestion" (unspecified) and a sore throat. At the time of this report, the patient had not recovered from the events. The patient sought unspecified medical attention. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse (LPN), concerning a 20 year old female patient, who on 13-JUL-2007, was vaccinated IM, with the first dose, 0.5ml, of Gardasil (Lot # not reported). There was no concomitant medication. On 13-JUL-2007, in the evening following the vaccination, the patient experienced flu-like symptoms, with fever, fatigue and nausea. On 17-JUL-2007, the nurse spoke with the patient, who confirmed the symptoms continued, and also reported she currently had "congestion" (unspecified) and a sore throat. At the time of this report, the patient had not recovered from the events. The patient sought unspecified medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a Medical Assistant (M.A.) concerning a 17 year old female patient who on 28-JUN-2007 was vaccinated with a first dose of Gardasil lot #653736/0868F. The MA reported that on 28-JUN-2007 the patient "passed out, momentarily" after receiving her first dose of Gardasil. The patient was evaluated in the emergency room, and discharged. No other information was available at this time. The patient sought unspecified medical attention. The outcome was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a 26 year old female who was vaccinated with a third dose of Gardasil. Concomitant therapy included TRIPHASIL. On approximately 26-JUN-2007 the patient experienced pain at the injection site. On 14-JUL-2007 the patient developed a "bump" at the injection site. Subsequently, the patient recovered. It was reported that the patient had "no problems after the first two shots". Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Information has been received from two physicians concerning a female who was vaccinated with a dose of Gardasil. Subsequently the patient experienced injection site and arm pain for 2-3 weeks after the vaccination. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: Information has been received from a 21 year old female consumer, who on 19-APR-2007 was vaccinated IM with the first dose of Gardasil. Following the vaccination (onset date not specified), she experienced soreness where vaccinated, in her upper arm muscle. On 05-JUL-2007, she was vaccinated subcutaneously, with the second dose of Gardasil. The consumer, who stated her physician told her the vaccination should be given subcutaneously, expressed concern that she would not "develop proper titers." The consumer indicated she would visit the health center at her campus. At the time of this report, the outcome of the arm muscle soreness was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Headache, Influenza like illness, Nausea, Pyrexia
Clinical narrative: Information is in follow-up to report (s) previously submitted on 8/14/2007. Information has been received from a nurse concerning a female who on unspecified dates was vaccinated with a first and second dose of GARDSIL (658094/0524U) 0.5mL. On 16-JUL-2007 the patient was vaccinated with her third dose of GARDASIL (lot# unknown). On 16-JUL-2007, the patient developed a fever over 102 degrees F, nausea, headache and "flu like symptoms". Medical attention was sought. At the time of reporting the patient had not recovered. Additional information has been requested. Follow-up information was received. The onset of the adverse event was also reported as 17-JUL-2007 (previously reported as 16-JUL-2007. The patient also experienced chills. At the time of reporting it was unknown if the patient had recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Metrorrhagia
Clinical narrative: Information has been received from a consumer concerning a female niece who in may 2007, was vaccinated with a first dose of Gardasil (lot# unknown) and is now "spotting". Medical attention was not sought. At the time of reporting it is unknown if the patient has recovered. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Migraine
Clinical narrative: Information has been received from a consumer mother concerning her 24 year old daughter with no pertinent medical history or drug/reactions and allergies who in December 2006, was vaccinated with her first dose of Gardasil (lot# unknown). Concomitant therapy included medication for migraine headaches. In February 2007, the patient was vaccinated with her second dose of Gardasil 0.5mL IM in the deltoid muscle and developed flu like symptoms. Medical attention was not sought. The reporters daughter plans on receiving the third dose. At the time of reporting the patient recovered. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Palpitations, Thyroid function test abnormal
Clinical narrative: Information has been received from a physician concerning a 19 year old female who in March 2007, was vaccinated with a first dose of Gardasil (lot # unknown). In March 2007, immediately post-vaccination the patient experienced increased perspiration and heart palpitations. Medical attention was sought. The symptoms resolved within 10 days of onset. Thyroid function tests were performed and were elevated in March 2007 but were normal in June 2007. No further information was available. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female who on 10-JAN-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil (lot # 655619/1427F). On 15-MAR-2007 the patient was vaccinated with a second dose of Gardasil (lot # 657006/0188U). On 16-JUL-2007 the patient had a beta-human chorionic gonadotropin test (unspecified) and the results were reported as negative. On that same day the patient was vaccinated with a third dose of Gardasil (lot # 658100/0525U). On 16-JUL-2007 the patient experienced dizziness and nausea after the vaccination. Unspecified medical attention was sought. The patient's lightheadedness and nausea persisted. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a third dose of Gardasil. Approximately 6 hours after the vaccination, the patient developed a fever, nausea and muscle aches. Unspecified medical attention was sought. On 17-JUL-2007, the patient recovered from the fever, nausea and muscle aches. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a female medical assistant who on 12-DEC-2006 was vaccinated with a 0.5 ml first dose of Gardasil. On 06-APR-2007 the patient was vaccinated with a 0.5 ml second dose of Gardasil. On 06-APR-2007 the patient developed swelling and a "bubble area" at the injection site. The arm became red and hard. There was no drainage noted. Unspecified medical attention was sought. Subsequently, the patient recovered from swelling and a "bubble area" at the injection site and a red and hard arm. The medical assistant did not experience any difficulties with the first injection. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Induration, Injection site swelling, Oedema peripheral, Vaccine positive rechallenge
Clinical narrative: Information has been received from an office manager, who on 09-FEB-2007 was vaccinated (arm unspecified) with a 0.5mL first dose of Gardasil. Subsequently, the patient experienced swelling at the injection site. The patient mentioned that the reaction was mild and resolved on its own. After the patient was vaccinated (arm unspecified) with a second dose of Gardasil on 06-APR-2007 she developed "a more severe injection site reaction." The arm swelled up with a "big bubble" at the site. The arm was hardened and red, which lasted for a month. No drainage was noted. The symptom resolved on its own. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a medical assistant concerning her 16 year old sister, who on 13-JUL-2007 was vaccinated intramuscularly on the lateral portion of the arm (unspecified arm) with a 0.5mL dose of Gardasil. There was no concomitant medication. On 14-JUL-2007 the patient developed a fever and vomited four times. She continued to experience nausea through 16-JUL-2007. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a nurse, via a company representative, concerning a female patient (age unspecified), who on an unknown date was vaccinated IM, with a dose, 0.5ml, of Gardasil (lot # not provided). The day following the vaccination, the patient experienced dizziness. After an unknown duration of time, the dizziness resolved on it's own. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Gastrointestinal disorder, Urticaria
Clinical narrative: Information has been received from a nurse practitioner (NP), via a company representative, concerning a female patient, who was vaccinated on an unknown date, with a dose of Gardasil (Lot # not provided). Subsequently, the patient developed hives and had gastrointestinal problems (unspecified). The NP instructed the patient to not pursue additional vaccinations with Gardasil. At the time of this report, it was unknown if the patient had recovered from the events. The patient sought unspecified medical attention. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Influenza like illness
Clinical narrative: Information has been received from a physician and a medical assistant concerning a 22 year old female with a history of sinus infection (April 2007) who on 22-JUN-2007 was vaccinated with a dose of Gardasil. There was no concomitant medication. On 27-JUN-2007 the patient experienced abdominal pain and severe flu like symptoms. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no pertinent medical history who on 05-JUL-2007 was vaccinated with her first dose intramuscularly with 0.5 ml of Gardasil. There were no concomitant medications. On 05-JUL-2007, 3-4 hours after vaccination, the patient developed a severe headache. The patient was treated with ibuprofen (MOTRIN). The headache lasted six days. On approximately 11-JUL-2007 the patient recovered. There were no laboratory or diagnostic studies performed. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction, Pharyngeal oedema, Urticaria
Clinical narrative: Information has been received from a physician concerning a female patient (age unknown), who, on an unspecified date, was vaccinated with a dose of Gardasil. Subsequently, approximately five days after the vaccination the patient broke out in hives and her throat swelled up. The patient had to go to the emergency room and was treated as an anaphylactic reaction. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, No reaction on previous exposure to drug, Pallor, Syncope
Clinical narrative: Information has been received from an office manager concerning "a few patients" who were vaccinated with Gardasil. Subsequently the patient experienced dizziness. At the time of the report, the patients outcomes were unknown. No product quality complaint was involved. Additional information has been requested. This is in follow-up to reports previously submitted on 8/14/2007. Initial and follow-up information has been received from an office manager concerning a 12 year old hispanic female stundent with an allergy to amoxicillin, who on 12-JUN-2007 at 14:20 was vaccinated intramusculary in the right arm with a second dose of GARDASIL (lot# 656371/0181U). On 10-APR-2007 the patient was vaccinated with a first dose of GARDASIL (Lot# 656371/0181U). The patient did not experience any problems after the first vaccination. On 12-JUN-2007 at 14:30 the patient slowly became pale and when she tried to get up she slowly went forward and reclined against the wall. The patient experienced syncope that lasted less then a minute (previously reported that the patient experienced dizziness). The patient was treated with oxygen and observed for 45 minutes. On 12-JUN-2007 the patient recovered and left the office walking and well. It was noted that there was no illness at the time of vaccination. No product quality complaint was involved. Additional information is expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site scar
Clinical narrative: Information has been received from a nurse concerning her 22 year old daughter with no medical history, who on 20-MAR-2007 was vaccinated intramuscularly (arm unspecified) with a dose of Gardasil. No concomitant medications. Subsequently, the patient developed a light raised scar at the injection site. It was reported that the area looks like scar tissue. It was mentioned that her daughter has dark skin and the scar appears white or lighter than her skin. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Blister, Erythema, Pruritus, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female, who on 15-MAY-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil (lot# 657617/0384U). Concomitant therapy included CLARITIN as needed. On 16-MAY-2007 the patient developed an itchy, red, raised blisters. The patient stated that one of the blisters appeared on her back. At that time the patient did not think that it was related to the vaccination, so she did not call the office to report this. On 14-JUL-2007 the patient was vaccinated intramuscularly in the left arm with a second dose of Gardasil (Lot# 657617/0384U). On 15-JUL-2007 the patient developed the same type of blisters. The blisters were located on the left axilla, left forearm, right shoulder, and back. The patient was being treated with BENADRYL. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2007. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a 15 year old female who was vaccinated with her first dose of Gardasil. Subsequently the patient fainted within minutes. Unspecified medical attention was sought and no treatment was required. Subsequently, the patient recovered. Additional information has been requested.