chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Culture stool, Full blood count, Headache, Laboratory test, Malaise
Clinical narrative: This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow-up information has been received from a physician concerning a 15 year old female student, with no pertinent medical history, who on 10-APR-2007 at 16:00, was vaccinated IM in the left arm with a first dose of GARDASIL (lot # 657621/0387U). On 22-APR-2007 at 17:00, the patient experienced significant malaise, sore throat, headache, chest pain, weight loss and nausea. The patient sought unspecified medical attention. Lab tests included complete blood cell count, serum antinuclear antibodies test, serum rheumatoid factor test, erythrocyte sedimentation rate, serum C-reactive protein test, total serum thyroxins test, serum thyroid-stimulating hormone test, stool culture test, serum serotonin, stool for ova and parasites, and urine culture (results not reported). At the time of the report, the symptoms were still present despite appropriate therapy- labs. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Oropharyngeal pain, Red blood cell sedimentation rate, Rheumatoid factor, Weight decreased
Clinical narrative: This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow-up information has been received from a physician concerning a 15 year old female student, with no pertinent medical history, who on 10-APR-2007 at 16:00, was vaccinated IM in the left arm with a first dose of GARDASIL (lot # 657621/0387U). On 22-APR-2007 at 17:00, the patient experienced significant malaise, sore throat, headache, chest pain, weight loss and nausea. The patient sought unspecified medical attention. Lab tests included complete blood cell count, serum antinuclear antibodies test, serum rheumatoid factor test, erythrocyte sedimentation rate, serum C-reactive protein test, total serum thyroxins test, serum thyroid-stimulating hormone test, stool culture test, serum serotonin, stool for ova and parasites, and urine culture (results not reported). At the time of the report, the symptoms were still present despite appropriate therapy- labs. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Vomiting
Clinical narrative: This is in follow-up report(s) previously submitted on 6/14/2007.  Initial and follow-up information has been received from a physician concerning two females who were vaccinated with their first dose only of Gardasil.  Subsequently the patients both developed fever and vomiting.  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.  In follow-up, it was reported by the physician's nurse that the patient was 12 years old and was vaccinated with her first dose of GARDASIL.  The nurse was unsure how long the fever and vomiting lasted.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash
Clinical narrative: Information has been received from a health professional concerning a female with sulfonamide allergy who was vaccinated with Gardasil. The nurse reported that the patient experienced a really bad injection site rash. No further information was provided. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/14/2007.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a health professional concerning a female patient who was vaccinated with a first dose of Gardasil.  Subsequently the patient passed out after receiving the vaccine.  Therapy with Gardasil was discontinued.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Initial and follow-up information has been received from a health professional concerning a 16 year old female with Crohn's disease who on 15-MAY-2007 was vaccinated in the right deltoid with Gardasil (lot # 657622/0388U).  Concomitant therapy included PENTASA.  The nurse reported that following vaccination, the patient developed a large, red, swollen, warm and painful area one inch below the injection site.  The area was about 10 centimeters wide.  The patient was given BENADRYL.  The area had improved slightly since BENADRYL was started.  At the time of the report, the patient had not recovered.  The nurse also reported the experience of other patients with Gardasil (WAES #0705USA03739).  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient in her 20's, who on 30-APR-2007 was vaccinated IM in the deltoid, with a 0.5ml dose of Gardasil. On 04-MAY-2007, "four days post vaccination," the patient developed "red, itchy hives at the injection site." At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a licensed visiting nurse, via a company representative, concerning a female student in twelfth grade, who on 14-MAY-2007 was vaccinated at a high school health fair, with the first dose, 0.5ml of Gardasil. Concomitant therapy included MENACTRA. The nurse reported that after receiving the vaccination, the student fainted, and was then taken to her private physician by her parents. The nurse confirmed that the student recovered on the same day, 14-MAY-2007. No further information is expected.
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a licensed visiting nurse, via a company representative, concerning a female student in twelfth grade, who on 14-MAY-2007 was vaccinated at a high school health fair, with the first dose, 0.5ml of Gardasil.  Concomitant therapy included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA).  The nurse reported that after receiving the vaccination, the patient fainted, and later recovered on the same day, 14-MAY-2007.  The patient sought unspecified medical attention.  No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient who in January 2007, was vaccinated IM in the deltoid, with a dose, 0.5ml, of Gardasil. In January 2007, the patient developed a "large circular size welt at the injection site." At the time of this report, it was unknown if the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Hallucination, Headache, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 21 year old female with allergies to amoxicillin and cefaclor and no illness at the time of vaccination who on 16-MAR-2007 was vaccinated intramuscularly with a 0.5 mL first dose of Gardasil (lot 657006/0188U).  During the evening of 16-MAR-2007 the patient developed a fever of 102-103 F, a severe headache, and hallucinations.  The patient was treated with alternating doses of acetaminophen and ibuprofen.  By the morning of 17-MAR-2007, "all issues resolved" and the patient recovered.  Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. No additional information is expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Dizziness, Heart rate, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse and a healthcare professional, concerning a 19 year old white female student, who at 3:15pm on 15-MAY-2007 was vaccinated IM in the left deltoid with the first dose, 0.5ml, of Gardasil (Lot #657736/0389U). There was no concomitant medication, nor illness at the time of vaccination. The nurse originally reported that the patient "passed out" after the vaccination was administered, but the healthcare worker, who also administered the vaccine, confirmed that the patient immediately (at 3:15pm) following the vaccination, became lightheaded, dizzy and pale, and began sweating. The healthcare worker took the patient to a room and gave her a drink and an ice pack; vitals included blood pressure of 98/68, heart rate of 72, and temperature of 98.1F. The patient laid down for 20 minutes and started feeling better. The healthcare worker advised the patient to call for a ride, but she refused; she recovered on the same day, 15-MAY-2007. The patient sought unspecified medical attention. No further information is expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse and a healthcare professional, concerning a 19 year old white female student, who at 3:15pm on 15-MAY-2007 was vaccinated IM in the left deltoid with the first dose, 0.5ml, of Gardasil (Lot #657736/0389U). There was no concomitant medication, nor illness at the time of vaccination. The nurse originally reported that the patient "passed out" after the vaccination was administered, but the healthcare worker, who also administered the vaccine, confirmed that the patient immediately (at 3:15pm) following the vaccination, became lightheaded, dizzy and pale, and began sweating. The healthcare worker took the patient to a room and gave her a drink and an ice pack; vitals included blood pressure of 98/68, heart rate of 72, and temperature of 98.1F. The patient laid down for 20 minutes and started feeling better. The healthcare worker advised the patient to call for a ride, but she refused; she recovered on the same day, 15-MAY-2007. The patient sought unspecified medical attention. No further information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Information has been received from a medical assistant concerning a 17 year old female who on 03-MAY-2007 was vaccinated with first dose of Gardasil (lot # 657622/0388U) IM in the right gluteal muscle. There was no concomitant medication. On 04-MAY-2007, the patient developed redness, a bump, and itchiness at the injection site which was the gluteus muscle. Medical attention was sought. At the time of reporting, the patient recovered. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a medical assistant concerning a 17 year old female with no illness at the time of vaccination and no history of allergies or medical conditions who on 03-MAY-2007 was vaccinated with first dose of GARDASIL (lot # 657622/0388U) IM in the right gluteal muscle at approximately 2 PM. There was no concomitant medication. On 04-MAY-2007, the patient developed redness, a bump, and itchiness at the injection site which was the gluteus muscle. Medical attention was sought. At the time of reporting, the patient had recovered. Additional information was received from a family nurse practitioner who reported that the outcome of the events was unknown (previously stated as recovered). No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Initial and follow-up information has been received from a physician's assistant concerning a female who was vaccinated with Gardasil.  Subsequently the patient fainted.  Unspecified medical attention was sought.  Subsequently, the patient recovered from fainting.  There were no laboratory or diagnostic tests performed.  Additional information is requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 20 year old female patient who on 20-MAR-2007 was vaccinated with her first dose of Gardasil.  Three days after the vaccination the patient passed out and was taken to the ER.  It was not known if she was admitted to the hospital.  Subsequently, the patient recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Chills, Dyspnoea, Hyperhidrosis, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female with asthma who was vaccinated with the first dose of Gardasil "a few weeks ago."  Subsequently, while in the office, the patient developed fever, chills, sweating, difficulty breathing and swelling at the injection site.  The patient sought unspecified medical treatment.  On an unspecified date, the patient recovered.  Additional information has been requested.  This is one of two reports received from the same source.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on 03-MAY-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). On approximately 03-MAY-2007, the injection site became red and swollen and the patient experienced nausea. The patient sought unspecified medical attention. At the time of this report, the patient was not recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 09-MAY-2007 was vaccinated with the first dose of Gardasil. Concomitant medication was not reported. On 09-MAY-2007 after the patient received her first dose of Gardasil, she "passed out". Subsequently on an unspecified date, the patient recovered from "passed out". Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physicians assistant concerning a female who "a couple of weeks ago" was vaccinated with her first dose of Gardasil.  Subsequently the patient experienced shingles 2 or 3 days after vaccination.  Unspecified medical attention was sought.  There were no diagnostic or laboratory tests performed.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Blood pressure, Dizziness, Hyperhidrosis
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.) concerning a 15 year old female student who on 09-MAY-2007 was vaccinated IM in left deltoid with a first dose of Gardasil (lot #654272/0319U).  Concomitant therapy included ADACEL.  On 09-MAY-2007 the patient experienced dizziness and became diaphoretic after getting the injection.  The dizziness last 5-10 minutes and the blood pressure measurement was 80/48.  During the examination time the blood pressure measurement was 110/70.  She was given juice and crackers and 10 minutes later she reported feeling better.  She was released in mother's care and her blood pressure measurement was 80/52.  Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Erythema, Pruritus, Rash
Clinical narrative: Information has been received from a physician concerning a 25 year old female with headache and contraception who on 14-MAY-2007 at 3:30 pm was vaccinated with the first dose of Gardasil, 0.5 mL, IM.  Concomitant therapy included vitamins (unspecified), desogestrel/ethinyl estradiol (KARIVA) and ibuprofen.  On 14-MAY-2007, the patient reported a rash appeared on her abdomen and back around 9 pm and spread overnight to her arms and legs.  The patient had no fever or chills.  The patient did not go to work on 15-MAY-2007.  The patient called the physician's office the next day to report the event.  The patient was instructed to take loratadine (CLARITIN) during the day and diphenhydramine hydrochloride (BENADRYL) during the night.  The patient was also instructed to soak in lukewarm water with baking soda.  On 17-MAY-2007, the patient reported that she continued to have some pruritis but the erythema had resolved.  The patient reported that she continued to have a few "bumps" but claims to be much better.  The patient continued with the loratadine during the day and diphenhydramine hydrochloride at night, and taking the lukewarm soaks with baking soda.  The patient stated that she will continue with the soaks as they offer relief from the itching.  The patient has not missed any more time from work due to this condition.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypertension, Jaw disorder, Lip swelling
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with Gardasil. Subsequently the patient experienced swelling lips, jaw problem and hypertension. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pharyngitis, Streptococcal identification test negative, Viral pharyngitis
Clinical narrative: Information has been received from a medical assistant concerning a 13 year old female patient with an amoxicillin allergy and no medical history, who on 20-OCT-2006 was vaccinated IM into the upper arm with a first dose of Gardasil (Lot# 653978/0955F). Concomitant therapy included montelukast sodium (MSD) and albuterol. It was reported that the patient got off the recommended dosing schedule because she was sick. On 05-JAN-2007 the patient was diagnosed with pharyngitis (likely viral). The patient was told to take zinc and homeopathic medicine called "INFLAMMATION by Heal." On 08-JAN-2007, laboratory diagnostic studies included a strep test and culture that was negative. On 12-JAN-2007, the patient was seen again and was diagnosed with pharyngitis and a possible ear infection and was given a homeopathic medicine called ("EUPHORIM"), a nasal spray. On 01-FEB-2007 the patient came in for a second dose of the vaccine (lot # 654702/0011U). It was reported that the patient no longer had an infection and subsequently recovered. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a Nurse Practitioner (N.P.) concerning a female patient who was vaccinated with a first dose of Gardasil. The patient fainted after 1 1/2 hours receiving the injection. Unspecified medical attention was sought. The patient's outcome was recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received via a company representative, from a healthcare professional (office worker) who was vaccinated (date unspecified) with a dose of Gardasil, and subsequently developed a bump under her skin at the injection site.  At the time of this report, the patient had not recovered.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Muscle twitching, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 14 year old female who was vaccinated with a second dose of Gardasil.  Subsequently the patient experienced tingling in her nose, passed out and little twitching.  Unspecified medical attention was sought.  It was reported that the patient recovered 2 minutes after the vaccine was administered.  There were no diagnostic or laboratory tests performed.  Additional information has been requested. This is in follow-up to reports previously submitted on 6/14/2007. Initial and follow-up information has been received from a physician concerning a 14 year old female stundent with reaction to sulphite, milk allergy, sulfonamide allergy, drug hypersensitivity to CECLOR and polycystic ovarin syndrome who on 01-MAY-2007 was vaccinated, into left arm, with a second dose og GARDASIL. On 01-MAY-2007, within 1 minute, the patient recovered from all symptoms and her heart rate was 68. There were no diagnostic or laboratory test performed. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Paraesthesia
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 26 year old female who was vaccinated with a dose of Gardasil.  Immediately after vaccination, the patient experienced numbness and tingling in the fingers on the hand of the arm the patient was vaccinated.  The numbness and tingling were of "fleeting duration," and subsequently, the patient recovered without sequelae.  No further information is available.  This is one of two reports received from the same reporter. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow-up information has been received from a licensed practical nurse (LPN) concerning a 26 year old female who on 27-DEC-2006 at 16:42 was vaccinated IM in the left arm with the first dose of the GARDASIL (Lot # 653736/0689F). Immediately after vaccination, the patient experienced tingling from the injection site in the left deltoid down to the fingertips for about 60 seconds, which then completely resolved. On 28-FEB-2007 at 14:55, the patient was vaccinated IM in the left arm with the second dose of the GARDASIL (Lot # 653736/0689F). After vaccination, the patient experienced tingling from the injection site in the left deltoid down to the fingertips for about 10 seconds, which then completely resolved. The third dose of the GARDASIL was administered on an unspecified date and the patient experienced no tingling or numbness. The patient recovered without sequelae. No further information is expected.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 26 year old female who was vaccinated with a dose of Gardasil.  Immediately after vaccination, the patient experienced numbness and tingling in the fingers on the hand of the arm the patient was vaccinated.  The numbness and tingling were of "fleeting duration," and subsequently, the patient recovered without sequelae.  No further information is available.  This is one of two reports received from the same reporter. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow-up information has been received from a licensed practical nurse (LPN) concerning a 26 year old female who on 27-DEC-2006 at 16:42 was vaccinated IM in the left arm with the first dose of the GARDASIL (Lot # 653736/0689F). Immediately after vaccination, the patient experienced tingling from the injection site in the left deltoid down to the fingertips for about 60 seconds, which then completely resolved. On 28-FEB-2007 at 14:55, the patient was vaccinated IM in the left arm with the second dose of the GARDASIL (Lot # 653736/0689F). After vaccination, the patient experienced tingling from the injection site in the left deltoid down to the fingertips for about 10 seconds, which then completely resolved. The third dose of the GARDASIL was administered on an unspecified date and the patient experienced no tingling or numbness. The patient recovered without sequelae. No further information is expected.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Paraesthesia
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 26 year old female, who was vaccinated with a dose of Gardasil. Immediately after vaccination, the patient experienced numbness and tingling in the fingers on the hand of the arm the patient was vaccinated. The numbness and tingling were of "fleeting duration," and subsequently, the patient recovered without sequelae. No further is available. This is one of two reports received from the same reporter.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 26 year old female, who was vaccinated with a dose of Gardasil. Immediately after vaccination, the patient experienced numbness and tingling in the fingers on the hand of the arm the patient was vaccinated. The numbness and tingling were of "fleeting duration," and subsequently, the patient recovered without sequelae. No further is available. This is one of two reports received from the same reporter.
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Syncope
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced tingling down in her arm and she fainted shortly thereafter. The healthcare worker also reported on another patient (WAES # 0705USA01651). No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Metrorrhagia
Clinical narrative: Information has been received from a female consumer (age not reported) who on 15-MAY-2007 was vaccinated with the first dose of Gardasil.  Concomitant medication was not reported.  On 16-MAY-2007, the day after the patient received her first Gardasil, she experienced vaginal spotting.  The outcome of the event was not reported.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Drug hypersensitivity, Dyspnoea, Feeling abnormal, Panic attack
Clinical narrative: Information has been received from a mother concerning her 20 year old daughter with a history of allergic reaction to antibiotics (unspecified) who on 30-APR-2007, at 3:00 p.m.  was vaccinated intramuscularly with Gardasil (Lot number 656051/0244U). There was no concomitant medication. On 30-APR-2007, after one half hour after receiving the vaccine, the patient experienced an unbalanced feeling "panic attack", pressure on her chest and difficulty breathing. The mother also mentioned that her 2 other daughters experienced the same reactions with two doses of the vaccine but not as severe. The physician reported that the symptoms were not reported to him until 29-MAY-2007 when he called the patient "to find out." No further details were provided. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a female who in March 2007, was vaccinated with Gardasil.  She had no adverse experience at that time.  On 07-MAY-2007 the patient had her second dose of Gardasil.  On approximately 09-MAY-2007 the patient experienced a "hard swelling" at the injection site.  The patient reported that she sought unspecified medical attention.  The patient's hard swelling at the injection site persisted.  No further details were provided.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/174/2007. Information has been received from a registered nurse and a 24 year olf female (weight 130P, height 60") who on 02-MAR-2007 at 08:45 am was vaccinated with the second dose of GARDASIL vaccine (Lot #656049/0187U), IM. She had no adverse experience at that time. On 07-MAY-2007 at 9 am, the patient had her third dose of GARDASIL vaccine (Lot #657736/0389U), IM. concomitant medications was not reported. On approximately 09-MAY-2007, the patient experienced a "hard swelling" at the injection site. The patient reported that she sought unspecified medical attention and treatment with warm soaks was recommended. On an unspecified date, the patient recovered from the hard swelling at the injection site. No further details were provided. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Injection site pain, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient who was vaccinated IM with Gardasil (Lot # not reported). Concomitant therapy included Varivax, DTaP and Menactra. The patient was administered 4 vaccines and on her way out of the physician's office, she fainted. It was also noted that the patient experienced pain when Gardasil was administered. Additional information has been requested. This is one of several reports received from the same source. Initial and follow-up information has been received from a physician and a healthcare professional, concering a 17 year old (previously reported as 12 year old), female patient, with no significant medical history or known allergies, who was vaccinated IM with the second dose GARDASIL (lot # invalid). Concomitant therapy included VARIVAX, DTap and MENACTRA. There was no illness at the time of vaccination. The physician stated the patient was administered 4 vaccines and on her way out of the physician's office, she fainted. The healthcare professional added that the patient complained that the vaccination burned and hurt, and then 5 to 10 minutes later, she "passed out without complication." No further information is expected. This is one of several reports received from the same source.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Balance disorder, Chest discomfort, Dyspnoea, Feeling abnormal, Panic attack
Clinical narrative: Information has been received from a mother concerning her 16 year old daughter who in February 2007, was vaccinated with Gardasil.  In February 2007, the patient experienced difficulty breathing, unbalanced feeling, "panic attack" and pressure on her chest.  On 30-APR-2007 the patient received her second dose of the vaccine and again experienced unbalanced feeling, "panic attack", pressure on her chest and difficulty breathing.  This is one of three reports received from the mother.  These reactions occurred in less severe form than her sister which was reported in WAES #0705USA03593.  No further details were provided.  Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a mother and a physician concerning her 16 year old daughter who in February 2007, was vaccinated with the first dose of GARDASIL. In February 2007, the patient experienced difficulty breathing, unbalanced feeling, "panic attack" and pressure on her chest. On 30-APR-2007 (also reported as 30-MAR-2007), the patient received her second dose of GARDASIL, (lot #656051/0244U), IM. Again the patient experienced unbalanced feeling, "panic attack", pressure on her chest and difficulty breathing. This is one of three reports received from the mother. These reactions occurred in less severe form than her sister which was reported in WAES #0705USA03593. No further details were provided. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from a mother concerning her 16 year old daughter who in February 2007, was vaccinated with Gardasil.  In February 2007, the patient experienced difficulty breathing, unbalanced feeling, "panic attack" and pressure on her chest.  On 30-APR-2007 the patient received her second dose of the vaccine and again experienced unbalanced feeling, "panic attack", pressure on her chest and difficulty breathing.  This is one of three reports received from the mother.  These reactions occurred in less severe form than her sister which was reported in WAES #0705USA03593.  No further details were provided.  Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a mother and a physician concerning her 16 year old daughter who in February 2007, was vaccinated with the first dose of GARDASIL. In February 2007, the patient experienced difficulty breathing, unbalanced feeling, "panic attack" and pressure on her chest. On 30-APR-2007 (also reported as 30-MAR-2007), the patient received her second dose of GARDASIL, (lot #656051/0244U), IM. Again the patient experienced unbalanced feeling, "panic attack", pressure on her chest and difficulty breathing. This is one of three reports received from the mother. These reactions occurred in less severe form than her sister which was reported in WAES #0705USA03593. No further details were provided. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Dyspnoea, Feeling abnormal, Panic attack, Vaccine positive rechallenge
Clinical narrative: Information has been received from a mother concerning her 16 year old daughter who in February 2007, was vaccinated with Gardasil. In February 2007, the patient experienced difficulty breathing, unbalanced feeling, "panic attack" and pressure on her chest. On 30-APR-2007 the patient received her second dose of the vaccine and again experienced unbalanced feeling, "panic attack" pressure on her chest and difficulty breathing. This is one of three reports received from the mother. These reactions occurred in less severe from than her older sister which was reported in WAES #0705USA03593. No further details were provided. Additional information has been requested. This is in follow-up to report (s) previously sumbitted on 6/14/2007.
Sex: U
Vaccine: HPV4
Symptoms: Injection site irritation, Injection site pain
Clinical narrative: Information has been received from a health professional concerning patients who were vaccinated with Gardasil. The nurse reported that 98 patients that received Gardasil complained that the injection hurt and burned. No further information was available. The nurse also reported the experienced of another patient with Gardasil (WAES #0705USA03112). Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a health professional concerning a 20 year old female, with a "psychological" medical history, who on 28-FEB-2007 was vaccinated with Gardasil.  Concomitant medication included sertraline hydrochloride (Zoloft) and topiramate (Topamax).  She received her second dose of Gardasil on 03-MAY-2007.  Subsequently, the patient had an abnormal pap smear which was positive for Human Papillomavirus.  At the time of this report, the patient had not recovered.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with no known allergies who on 17-MAY-2007 was vaccinated IM with 0.5 ml of Gardasil. That same day, 5 minutes after the injection, she felt nauseous which lasted throughout the night and on 18-MAY-2007 she vomited. The patient sought unspecified medical attention. No further information is available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female patient who was vaccinated with a first 0.5ml dose of Gardasil.  Subsequently, the patient fainted after receiving the vaccine.  Unspecified medical attention was sought.  On an unknown date, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Colonoscopy, Dizziness, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female patient who on 10-MAY-2007 was vaccinated with a dose of Gardasil. On 10-MAY-2007 the patient experienced a rash on her legs and dizziness. The day after she developed a rash on her arms. The patient also had a colonoscopy performed on that day. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Ophthalmological examination, Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who was vaccinated with a 0.5 ml dose of Gardasil.  Subsequently, the patient fainted after receiving the vaccine.  Unspecified medical attention was sought.  Laboratory diagnostic studies included an eye exam.  On an unspecified date, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received via a company representative, from a nurse practitioner, concerning the adolescent daughter of a friend, who was vaccinated (date and dose not specified) with a dose of Gardasil. Following the vaccination, the adolescent experienced a headache which lasted about 2 hours. No further information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness
Clinical narrative: Information has been received from a physician, via a company representative, concerning an 18 year old female patient who was vaccinated with the first dose (date and dose unspecified) of Gardasil. The physician reported her approximately 3 hours after the vaccination was administered, the patient called and stated she had experienced some dizziness. At the time of this report, it was unknown if the patient had recovered. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow up information has been received from a physician, via a company representative, concerning a 17 year old (previously reported as 18 year old) female patient who on 09-MAY-2007, was vaccinated from a pre-filled syringe, with the first dose of GARDASIL (Lot #654540/1161F). Concomitant therapy included SYNTHROID; there were no concomitant vaccines administered. The physician reported that approximately 3 to 4 hours after the vaccination was administered, the patient began to feel weak and dizzy, and had to lie down; she recovered within several hours. The physician clarified that the patient had not consulted the office at the time of the event, but later reported it at a return visit to the office. At the time of this report, it was confirmed that the patient had fully recovered. No further information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female who on 07-MAY-2007 was vaccinated with the 2nd dose in the left deltoid with Gardasil (lot # 657617/0384U). There was no concomitant medication. On 07-MAY-2007 the patient experienced rash and itchiness in the joint areas of the armpits, elbows, knees, and ankles which developed after 24 hours of getting the vaccine. The nurse stated that the patient had developed a similar rash when she ate mangos. Patient sought unspecified medical attention. The patient is being treated with steroid cream and has almost recovered. At the time of the report, the patient's rash and itchiness in the joint areas of the armpits, elbows, knees, and ankles had persisted. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Heart rate, Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 19-MAY-2007 was vaccinated with the 1st dose Gardasil.  There was no concomitant medication nor pertinent medical history.  Subsequently the patient experienced syncopal episode within 5 minutes.  Blood pressure was 110/70 and pulse rate was 72.  Unspecified medical attention was sought and no treatment was required.  Subsequently, the patient recovered from syncopal episode.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Depression
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated IM with a 0.5ml dose of Gardasil.  Subsequently, the patient experienced depression after receiving the vaccine.  Unspecified medical attention was sought.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Headache, Neurological examination
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female patient who on 30-MAR-2007 was vaccinated with a first 0.5ml dose of GARDASIL (Lot# 657006/0188U). On 30-MAR-2007 the patient experienced a severe headache. The patient went to the ER but it was not known if she was admitted. On an unspecified date, the patient recovered. On the morning of 21-MAY-2007 the patient received a second dose of the vaccine (Lot#657737/0522U) and no experience was reported. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/14/2007. Information has been received from a registered nurse concerning a 20 year old female student with a history of migraine, asthma and allergies to acetaminophen, codeine, hydrocodone, sulfa, and VICODIN who on 20-MAR-2007, was vaccinated with a first dose 0.5ml dose of GARDASIL (lOT# 657006/0188u). On 20-MAR-2007 the patient experienced a severe headache. The patient went to the ER the day after receiving her vaccination. She reported feeling unclear during the injection and developed a diffuse headache, worse than a migraine and not relieved with MOTRIN or TORADOL. Laboratory diagnostic studies performed were a neurological exam and a CT scan which were both reported to be normal. The headache improved with DILAUDID. The patient was discharged with instructions to follow up with her primary care physician to continue GARDASIL series. Within on to two days, the patient recovered. On the morning of 21-MAY-2007, the patient received a second dose of the vaccine (Lot#657737/0522U) and no experience was reported. No product quality complaint was involved. It was reported that the patient's headache was most likely a side effect from the vaccine. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Pelvic pain, Ultrasound scan normal, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient who was vaccinated with 0.5ml first and second dose of Gardasil. Subsequently, the patient experienced pelvic pain to the point where she couldn't get out of bed in the morning the day after receiving the vaccine. This happened with both the first and second shots. Unspecified medical attention was sought. Laboratory diagnostic studies included a sonogram. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a licensed visiting nurse concerning a 14 year old female student with no medical history or allergies, who on 01-MAY-2007, was vaccinated IM with a second 0.5ml dose of GARDASIL (Lot# 657617/0384U). On 01-MAY-2007, the patient experienced pelvic pain to the point where she couldn't get out of bed in the morning the day after receiving the vaccine. The patient was seen at her primary physicians office. Laboratory diagnostic studies included a pelvic ultrasound which was normal. On 03-MAY-2007, the patient recovered. It was also reported that the patient experienced pelvic pain after the first dose of GARDASIL. No product quality complaint was involved. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Back pain, Injection site pain, Musculoskeletal pain
Clinical narrative: Information has been received from a physician concerning a 20 year old female patient who on 21-MAY-2007 was vaccinated IM into the upper left deltoid with a third 0.5 ml dose Gardasil (Lot# 0211U).  On 21-MAY-2007, the patient felt faint after receiving the vaccine.  A few hours later, the patient's mother reported that the patient experienced pain that radiated at the injection site up her arm and towards her face.  The physician reported that the patient had pain up into her shoulder, radiating to her elbow and down her back.  The physician stated that this reaction was pretty minor and not serious however, he thought that patient was just scared.  The patient was treated with ice and ibuprofen.  It was noted no follow up was necessary.  Subsequently, the patient was recovering.  No product quality complaint was involved.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient, who on approximately 07-MAY-2007 ("about 2 weeks ago"), was vaccinated IM with a dose, 0.5ml, of Gardasil.  The physician reported that on 07-MAY-2007, "the patient fainted right after receiving Gardasil," and confirmed that the patient had recovered (date unspecified).  The patient sought unspecified medical attention.  No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Breast pain, Dizziness, Dyspnoea
Clinical narrative: Information has been received from a registered nurse (RN), via a company representative, concerning the RN's 13 year old daughter, who in May 2007, was vaccinated IM, with the first dose, 0.5ml, of Gardasil. The nurse reported that her daughter experienced dizziness after receiving the vaccination, and then recovered (duration not specified). The patient sought unspecified medical attention. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 6/14/2007: 7/6/2007. Initial and follow up information has been received from a physician and a registered nurse, concerning the RN's 13 year old daughter, with a one week prior onset of dizziness and shortness of breath and no other medical history, who on 03-May-2007, was vaccinated IM in the left arm, with the first dose, 0.5ml, of GARDASIL (Lot #655618/0186U). The nurse originally reported that her daughter experienced dizziness after receiving the vaccination, and then recovered (duration not specified); however, follow up information clarified that her daughter had been in training for track, and one week prior to the vaccination had been experiencing both dizziness and shortness of breath. The physician noted that the baseline dizziness recurred three days after the vaccine was administered. When her daughter stopped running, the RN reported the dizziness resolved (date not specified). The physician confirmed that no treatment or office visit was required. Follow up information from the nurse indicated that the physician "believed the incident was not related to the vaccine", however, information received directly from the physician noted only that it was "likely not vaccine associated". Additional follow up information received from a healthcare professional at the physician's office indicated that on 06-JUL-2007, the patient was vaccinated in the left arm with the second dose of GARDASIL (Lot #655324/0088U). On 07-JUL-2007, she reported left breast pain. Treatment included unspecified non steroidal anti-inflammatory drugs, and the pain was relieved. On 08-JUL-2007, the patient had recovered. No further information is expected.