chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Throat tightness
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who on an unknown day was vaccinated with a second dose of Gardasil. The physician reported that patient after getting second dose of Gardasil "felt dizzy and felt like throat was closing." Unspecified medical attention was sought by the patient. The patient recovered 'an hour after the dose". Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient develop a bump at an injection site after receiving the vaccine. This is one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female patient between "14 and 16 years old" who in February 2007, was vaccinated into the left arm with a first dose of Gardasil. Concomitant therapy included an unknown vaccination into the right arm. Subsequently, the patient fainted after receiving the vaccinations. It was reported that the patient was fine after sitting for a bit. Unspecified medical attention was sought. On an unspecified date, the patient recovered. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. Additonal information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Presyncope
Clinical narrative: Information has been received from a physician concerning an 11 year old female who was vaccinated with a dose of the Gardasil. Concomitant therapy included hepatitis B vaccine, recomb (MSD), meningococcal vaccine (unspecified) and DTAP-IPV. Subsequently, the patient 'kept walking right into the wall". "got dizzy" and "thought she was going to pass out". The patient sought unspecified medical attention. The patient recovered on an unspecified date. Additional information has been requested. Initial and follow-up information has been received from a physician concerning an 11 year old female who on 19-JUN-2007 was vaccinated with first dose of GARDASIL (lot # 657868/0523U).
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine, No reaction on previous exposure to drug, Pain, Pyrexia
Clinical narrative: This is in follow-up to report(s) previously submitted on 7/16/2007. Information has been received from a medical assistant concerning a 16 year old female patient with no medical history or allergies who on 26-JUN-2007, was vaccinated IM into the left deltoid with a third dose of GARDASIL (Lot# 657868/0523U). On 27-JUN-2007 at 10:17, the patient experienced migraine, fever and a whole body ached and was sore. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. It was reported that the patient was having flu like symptoms and it was not a reaction to the vaccine as her first and second injection were without adverse effects. It was reported that the patient was fine after receiving the first two doses. No product quality complaint was involved. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Joint stiffness
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient with no medical history who in January 2007, was vaccinated IM with a 0.5ml dose of Gardasil. One to two days after receiving her first and second dose, the patient developed pain and weakness to both upper limbs. Then 10 to 14 days later, she developed soreness and stiffness to both elbows. It was reported that this discomfort lasts for about 4 days and then resolves. It was also reported that the patient's mother has multiple sclerosis. Unspecified medical attention was sought. At the time of this report, the patient was recovering from pain and weakness to both upper limbs. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow up information has been received from a physician, concerning a 16 year old (previously reported as 12 year old) female student with no medical history and no illness at the time of vaccination, who on 10-NOV-2006 was vaccinated with the first dose of GARDASIL (lot #653938/0954Y). On the same day (previously reported as 1-2 days later), the patient developed weakness in her arm (previously reported as to both upper limbs). She recovered from the weakness the following day. Then 10 to 14 days later, she developed soreness and stiffness to both elbows that resolved after one day (previously reported as duration of 4 days). It was also reported that the patient's mother has multiple sclerosis. Unspecified medical attention was sought. On 10-JAN-2007 the patient was vaccinated IM with the second dose, 0.5ml, of GARDASIL (lot #655619/1427F). As with the first dose, she developed weakness in her arm that resolved the next day- And again 10 -14 days later, she developed soreness and stiffness to both elbows that resolved after one day. On 10-AUG-2007, the patient was vaccinated with the third dose of GARDASIL (lot # invalid). Following this vaccination, the patient did not experience any symptoms. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Mobility decreased, Myalgia, Neck pain, Pain
Clinical narrative: Information has been received from a physician and the father of a consumer concerning a 19 year old female patient with drug hypersensitivity, seasonal allergy hay fever and allergic to codeine who on 27-JUN-2007 was vaccinated IM with a first dose of Gardasil lot #657621/0387U. Concomitant therapy included unspecified birth control pill. The physician reported that on 27-JUN-2007 the patient developed muscle pain in her neck and the patient experienced neck muscle pain on the left side of her neck. The reporter mentioned that on 27-JUN-2007 his daughter experienced injection site pain at neck. On 28-JUN-2007 the patient awakened with pain on her left side of her body, with difficulty moving left arm and leg, and she could not throw her neck and head. Her doctor was notified and said to take her to the Emergency Room. The patient has not recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who on 26-JUN-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included hepatitis virus vaccine (unspecified). On 26-JUN-2007 the reporter that "the patient fainted immediately after receiving her first dose of Gardasil. She recovered completely quickly. Patient's mother reported that she had a similar episode when she received hepatitis injection a few years ago." Unspecified medical attention was sought by patient. The patient recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a physician concerning a 20 year old female patient who was vaccinated with a third dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). On 26-JUN-2007, the patient developed a rash, itching and redness at the injection site. Unspecified medical attention was sought, At the time of this report, the patient's outcome was unknown. It was reported that the patient did not have this experience with the first and second dose. No product quality complaint was involved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Cyanosis, Heart rate decreased, Musculoskeletal stiffness, Nausea, Pallor
Clinical narrative: Information has been received from a physician concerning a 11 year old female student who on 21-JUN-2007 in AM was vaccinated IM in left arm with a first dose of Gardasil. Concomitant suspect therapy included Varivax, (MSD) and Vaqta (inactive), (MSD). Other concomitant therapy included Adacel and Menactra. On 21-JUN-2007, after receiving the Gardasil injection and two other vaccines the patient fainted, very pale, arms stiffened, blue in face and her heart rate became 50. She took smelling salt. She vomited x1 and felt nausea rest of the day. She was in the office for 5 minutes and her legs were lifted. She recovered without any problems. She tool 24 hours to recover. It was indicated that patient did not eat prior to vaccine administration. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Syncope, Vomiting
Clinical narrative: Information has been received from a physician concerning a 11 year old female student who on 21-JUN-2007 in AM was vaccinated IM in left arm with a first dose of Gardasil. Concomitant suspect therapy included Varivax, (MSD) and Vaqta (inactive), (MSD). Other concomitant therapy included Adacel and Menactra. On 21-JUN-2007, after receiving the Gardasil injection and two other vaccines the patient fainted, very pale, arms stiffened, blue in face and her heart rate became 50. She took smelling salt. She vomited x1 and felt nausea rest of the day. She was in the office for 5 minutes and her legs were lifted. She recovered without any problems. She tool 24 hours to recover. It was indicated that patient did not eat prior to vaccine administration. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a number of patients' who were vaccinated with a dose of Gardasil. Subsequently, the patients developed redness and swelling around injection site area. At the time of this report, the patients' outcome was unknown. No product quality complaint was involved. Additional information has been requested. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Pain
Clinical narrative: This is in follow-up to report(s) previously submitted on 7/16/2007. Information has been received from a consumer concerning her 18 year old daughter with exercise induced asthma who in March 2007, was vaccinated with the first 0.5 ml dose of the Gardasil. On approximately 31-MAY-2007, at the end of May 2007, the patient was vaccinated in the buttocks with the second 0.5 ml dose of the Gardasil. Concomitant therapy included montelukast sodium (MSD) and albuterol. On approximately 31-MAY-2007, after the vaccination, the patient reported that "it was one of the most painful shots she ever had." The pain lasted for 3 days and the patient treated herself with Motrin during that time. No laboratory or diagnostic tests were performed. Subsequently, the patient recovered from the pain. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 19 year old female who was vaccinated with a first dose of the Gardasil on an unspecified date. Subsequently, the patient developed a fever of 102 degrees, was vomiting for 24 hours and did not feel well for three days. At the time of the report, the patient had recovered. It was also reported that the patient received the second dose of the Gardasil on an unspecified date, and "she was feeling fine after receiving the" vaccination. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow-up information has been received from a physician concerning a 19 (also reported as 18) year old female with no pertinent medical history or drug reactions/allergies who on 21-SEP-2006 was vaccinated with a first dose of the GARDASIL (lot # unknown) in the arm at 10:30 AM. On 21-SEP-2006 at 10:00 PM, the patient developed a fever of 102 degrees for 24 hours, was vomiting for 24 hours and overall did not feel well for three days after the injection. At the time of the report, the patient had recovered. It was also reported that the patient received the second dose of the GARDASIL on an unspecified date and "she was feeling fine after receiving the vaccination". Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a 16 year old female patient with no medical history or drug allergies who on 25-JUN-2007, was vaccinated IM with a first 0.5ml dose of GARDASIL (Lot# 658094/0524U). Concomitant therapy included Alesse. On 28-JUN-2007, the patient developed hives. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/16/2007. Subsequently, the patient recovered. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Laceration, Syncope
Clinical narrative: This is in follow-up to report(s) previously submitted on 7/16/2007. Information has been received from a physician concerning an approximately 19 year old female patient who in March 2007, was vaccinated with a first 0.5ml dose of Gardasil. Concomitant therapy included oral contraceptives. Subsequently, the patient fainted at the check out counter and felt to the floor in the doctor's office and cut her lip on the edge of the counter. It was reported that the patient had to go to the emergency room for treatment of the laceration stitches. On an unspecified date, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an approximately 17 year old female who on 04-JUN-2007 was vaccinated with a 0.5 ml second dose of Gardasil (lot# 655205/1426F). Concomitant therapy included Cymbalta, Lamicatal, Synthroid, Ortho-Novum, Claritin and "500 fiber therapy". On 19-JUN-2007 the patient went into the office with redness, swelling and itching "beyond normal" around the injection site. The physician did not administer the first dose and was not aware of a previous similar reaction. At the time of the report the patient was recovering from redness, swelling and itching around the injection site. There were no diagnostic or laboratory test performed. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007.  Initial and follow-up information has been received from a physician concerning a 17 year old female, with a history of depression (2001), irritable bowel syndrome, abdominal pain, hypothyroidism (June 2006), ankle instability, fungal dermatitis, Hashimoto's thyroiditis, allergy to GARDASIL, who on 04-JUN-2007 at 4:51 pm, was vaccinated IM in the left deltoid with a 0.5 ml second dose of GARDASIL (lot # 655205/1426F).  Concomitant therapy included CYMBALTA, LAMICTAL, SYNTHROID, (ORTHO-NOVUM 7/7/7), CLARITIN and "500 fiber therapy".  On 06-JUN-2007 (previously reported as 19-JUN-2007) the patient went into the office with redness, pain, swelling and vesicular itching "beyond normal" around the injection site.  On 18-JUN-2007 the patient had recovered.  The physician did not administer the first dose, and was not aware of a previous similar reaction.  There were no diagnostic or laboratory tests performed.  Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site irritation, Oedema peripheral, Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female, with drug hypersensitivity to Vistaril and no pertinent medical history, who on 29-JAN-2007 was vaccinated subcutaneously with a 0.5 ml first dose of Gardasil (lot # 657737/0522U). Concomitant therapy included vitamins (unspecified). On an unspecified date the patient was vaccinated subcutaneously with a second dose of Gardasil. On 27-JUN-2007 the patient experienced irritation, burning and redness at injection site. The burning traveled down her arm and there was tingling in her fingers. Medical attention was sought ON 28-JUN-2007 there was still swelling and redness at the arm. The patient was instructed by the office to put ice on affected area. The AE's improved and the patient's irritation, burning and redness at injection site, tingling in her fingers, and swelling and redness at the arm persisted at the time of reporting. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Urticaria
Clinical narrative: Information has been received concerning a 14 year old female who on 26-JUN-2007 was vaccinated with a 0.5 ml first dose of Gardasil. On 27-JUN-2007 was vaccinated with a 0.5 ml first dose of Gardasil. On 27-JUN-2007 the patient called the office complaining that her left lung was hurting. On 28-JUN-2007 the patient called the office reporting that she had hives. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a laboratory technician concerning a 15 year old female who on 28-JUN-2007 was vaccinated with a 0.5 ml first dose of Gardasil. On 28-JUN-2007, while still in the physician's office the patient fainted. Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. Additional information has been requested. This is one of two reports from the same source.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Syncope
Clinical narrative: Information has been received from a 25 year old female who in April 2007, was vaccinated with a 0.5 ml second dose of Gardasil. Subsequently in April 2007 the patient fainted and had a moderate amount of injection site pain. Unspecified medical attention. Subsequently that same day, the patient recovered from the fainting and moderate amount of injection site pain. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow-up information has been received from a 25 year old female and the doctors office, who in April 2007, was vaccinated with a 0.5 ml second dose of GARDASIL. Subsequently in April 2007 the patient fainted and had a moderate amount of injection site pain. Unspecified medical attention was sought. Subsequently that same day, the patient recovered from the fainting and moderate amount of injection site pain. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Lip oedema, Neck pain, Urticaria
Clinical narrative: This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow up information has been received from a physician (a pediatrician), concerning a 14 year old, female patient, with an allergy to neomycin, who at 3:00pm, on 26-JUN-2007 (previously reported as 27-JUN-2007), was vaccinated IM in the left arm (also reported as left thigh), with the first dose of Gardasil (lot #657736/0389U). There was no concomitant medication. There was no illness at the time of vaccination. On 27-JUN-2007 ("less than 24 hours after"), the patient experienced left sided pain from her neck with inspiration, that radiated "down to her chest into the base of the lung." Treatment involved Motrin, which relieved the pain. Shortly after the pain had subsided ("within 24 hours" of the injection), she experienced severe generalized urticaria and lip edema. Treatment involved Benadryl and prednisone (manufacturer unspecified), and the patient "was better within 24 hours," with no permanent consequences. The physician confirmed the patient had recovered from the events on 28-JUN-2007. No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Heart rate increased
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who was vaccinated with the second dose of the Gardasil on an unspecified date. Subsequently, the patient experienced " a really fast heartbeat". The patient sought unspecified medical attention. At the time of the report, the patient had recovered from the increased heartbeat. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. Additonal information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fall, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 25-JUN-2007 at 11:00 A.M. was vaccinated in the right deltoid with the first dose of Gardasil (lot # 658094/0524U) which was tolerated well. After two to three minutes, the patient stated that she felt dizzy and then lasted approximately 30-45 seconds. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Eye pain, Eye swelling, Eye swelling, Photophobia, Tenderness
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated with her first dose of Gardasil, and within 24 hours experienced tenderness and swelling around her eyes. The patient saw an eye doctor, however the result of that visit is unknown. The patient's outcome was unknown. Additional information has been requested. Follow up information has been received from the LPN concerning the 20 year old white female student who on 26-JUN-2007 at 17:23 received her first dose of GARDASIL (lot #657872/0515U) in the left deltoid. On the morning of the next day, 17-JUN-2007, the patient woke up with painful eyes "it hurt to open them". The LPN indicated that there was no swelling as previous reported, but that the patient's eyes were sensitive to light. She saw an eye doctor, who "said it was viral". The patient recovered on 27-JUN-2007. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Viral infection
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated with her first dose of Gardasil, and within 24 hours experienced tenderness and swelling around her eyes. The patient saw an eye doctor, however the result of that visit is unknown. The patient's outcome was unknown. Additional information has been requested. Follow up information has been received from the LPN concerning the 20 year old white female student who on 26-JUN-2007 at 17:23 received her first dose of GARDASIL (lot #657872/0515U) in the left deltoid. On the morning of the next day, 17-JUN-2007, the patient woke up with painful eyes "it hurt to open them". The LPN indicated that there was no swelling as previous reported, but that the patient's eyes were sensitive to light. She saw an eye doctor, who "said it was viral". The patient recovered on 27-JUN-2007. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning an 18 year old female student who on 26-MAR-2007 was vaccinated IM with her first dose of Gardasil, lot #657622/0388U. Five minutes after the injection, the patient had an episode of syncope. She had normal vitals and improved after lying flat for approximately 15-20 minutes. The patient recovered and received a second dose of Gardasil on an unspecified date. It was reported that "we made her lie flat after the injection. No syncope on 2nd injection. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope vasovagal, Tremor
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who on 28-JUN-2007 was vaccinated with a dose of Gardasil. There was no concomitant medication. As the injection was being administered, the patient had a syncopal episode and appeared to be shaking. It was also reported that she had a vasovagal reaction immediately upon removal of needle following administration of Gardasil. She recovered immediately with no treatment of medication. The patient was reported to be fine, totally asymptomatic. The reporter believed the patient had a vasovagal reaction to the actual injection, not to product, and had no suspicions other than a young, nervous adolescent. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a Physician's Assistant concerning a female patient who on 26-JUN-2007 was vaccinated IM with her third dose of Gardasil. After the third dose, the patient developed enlarged lymphnodes. The patient had no reaction to the first and second doses. Unspecified medical attention was sought. Her outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who on 24-APR-2007 was vaccinated with her first dose of Gardasil, lot # 657006/0188U. After receiving the first dose, she experienced amenorrhea. Unspecified medical attention was sought. Her outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated with the Gardasil on an unspecified date. Subsequently, the patient developed a rash. The patient unspecified medical attention. The patient's outcome was unknown. This report is one of two reports from the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007. Information has been received from a physician concerning a female patient who was vaccinated with GARDASIL on an unspecified date. Subsequently, the patient developed a rash. The patient sought unspecified medical attention. The patient's outcome was unknown.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Rash
Clinical narrative: Information has been received from the grandmother of an 11 year old female who on 21-JUN-2007, was vaccinated with a first dose of Gardasil. On 28-JUN-2007, the patient developed a rash on her arm and stomach area. On 29-JUN-2007, the patient sought medical attention at the Health Department in which she received the vaccine. 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 7/16/2007. Information has been received from a registered nurse concerning an 11 year old female patient who on 21-JUN-2007 at 15:15 PM, was vaccinated into the right deltoid with a first dose of GARDASIL (Lot# 655849/0263U). Concomitant therapy included a first dose into the left deltoid of BOOSTRIX (Lot# AC528008BA). On 28-JUN-2007, the patient developed a rash on her arm and stomach area. On 29-JUN-2007, the patient sought medical attention at the health department in which she received the vaccine. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hyperhidrosis, Loss of consciousness
Clinical narrative: Information has been received from a physical therapist concerning his 12 year daughter with an allergy to ant bites who on approximately 04-JUN-2007 was vaccinated intramuscularly with the first dose of the Gardasil. There was no concomitant medication. On approximately 04-JUN-2007, post-vaccination, the patient experienced a "headache, became diaphoretic and passed out". Unspecified medical attention was sought. No laboratory or diagnostic tests were performed. The patient recovered from the headache, diaphoresis and loss of consciousness. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician, concerning an 18 year old female student, with no known allergies or medical conditions, who on 29-MAR-2007, at 11:00am, was vaccinated IM in the right deltoid, with the first dose of Gardasil (Lot #656371/0181U). There was no illness at the time of vaccination. On 29-MAR-2007, within 5 minutes of receiving the vaccination, the patient had an episode of syncope. She was helped to lie down flat, and was monitored for 15 minutes; she recovered on her own. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a registered nurse concerning a female patient who, on an unspecified date, was vaccinated intramuscularly with a 0.5 ml dose of the Gardasil. Subsequently, the patient had an "abnormal Pap test and was HPV positive." It was reported that the patient had a normal pap result prior to receiving the Gardasil. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Food allergy, Paraesthesia oral, Rash, Reaction to preservatives
Clinical narrative: Information has been received from a nurse, via a company representative, concerning a female patient (age unspecified), who on 27-JUN-2007 was vaccinated with the first dose, 0.5ml, of Gardasil (invalid lot # provided). On 27-JUN-2007 the patient experienced a rash on her chest and arms, as well as a "tingly tongue sensation." Subsequently, the patient recovered from the events (date and duration not specified). Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow up information has been received from a nurse and a physician, concerning a 22 year old, caucasian female patient with hypersensitivity to thimerosal and shrimp, who on 27-JUN-2007, was vaccinated with the first dose, 0.5ml, of GARDASIL (invalid lot # provided). There was no illness at the time of vaccination. The physician reported that on 27-JUN-2007, five minutes after the vaccination, the patient developed hives (previously reported by as "rash") on her chest and arms, and had slight dizziness. The nurse added that the patient also had a "tingly tongue sensation." The physician confirmed that the patient took BENAFRYL on her own, and the symptoms resolved on the same day. No further information is expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse, via a company representative, concerning a female patient (age unspecified), who on 27-JUN-2007 was vaccinated with the first dose, 0.5ml, of Gardasil (invalid lot # provided). On 27-JUN-2007 the patient experienced a rash on her chest and arms, as well as a "tingly tongue sensation." Subsequently, the patient recovered from the events (date and duration not specified). Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow up information has been received from a nurse and a physician, concerning a 22 year old, caucasian female patient with hypersensitivity to thimerosal and shrimp, who on 27-JUN-2007, was vaccinated with the first dose, 0.5ml, of GARDASIL (invalid lot # provided). There was no illness at the time of vaccination. The physician reported that on 27-JUN-2007, five minutes after the vaccination, the patient developed hives (previously reported by as "rash") on her chest and arms, and had slight dizziness. The nurse added that the patient also had a "tingly tongue sensation." The physician confirmed that the patient took BENAFRYL on her own, and the symptoms resolved on the same day. No further information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Cough, Migraine, Pharyngolaryngeal pain, Rash generalised
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a female patient who on 27-JUN-2007 was vaccinated with a second dose of Gardasil. Concomitant therapy included Menactra. The patient developed a sore throat and generalized rash, after her second injection. Unspecified medical attention was sought by the patient. The outcome was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow up information has been received from a Registered Nurse (RN) concerning a 17 year old white female student with allergice rhinitis, migraines and anxiety who on 27-JUN-2007 was vaccinated IM into right hand with a second dose of GARDASIL . Concomitant therapy included MENACTRA. The patient developed a sore throat and generalized rash, after her second injection. In follow up it was mentioned that patient developed generalized urticarial eruption approximately 2 hours after the injection was given. Within 24 hours patient developed cough, and signs and symptoms of allergy. The patient recovered from hives with 24 hours. The patient recovered. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rhinitis allergic, Urticaria
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a female patient who on 27-JUN-2007 was vaccinated with a second dose of Gardasil. Concomitant therapy included Menactra. The patient developed a sore throat and generalized rash, after her second injection. Unspecified medical attention was sought by the patient. The outcome was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow up information has been received from a Registered Nurse (RN) concerning a 17 year old white female student with allergice rhinitis, migraines and anxiety who on 27-JUN-2007 was vaccinated IM into right hand with a second dose of GARDASIL . Concomitant therapy included MENACTRA. The patient developed a sore throat and generalized rash, after her second injection. In follow up it was mentioned that patient developed generalized urticarial eruption approximately 2 hours after the injection was given. Within 24 hours patient developed cough, and signs and symptoms of allergy. The patient recovered from hives with 24 hours. The patient recovered. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Facial pain, Inappropriate schedule of drug administration, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.) concerning a 17 year old female patient who on 29-NOV-2006 was vaccinated IM with a first dose of Gardasil lot # 653736/0868F and on 10-MAR-2007 with a second dose of GARDASIL lot #654702/0011U. Concomitant therapy included Benzamycin Topical Gel and Nuvaring. On 05-DEC-2006 the patient developed painful redness to her face one week after her first injection and on 13-MAR-2007 she also developed painful redness to her face one week after her second injection. The redness and pain lasted about a week and a half in both cases. The patient sought unspecified medical attention. The patient recovered. Additional information has been requested. In follow up it was reported that patient had facial erythema x 2-3 days after each injection (after dose one and two). It was "Painful, itchy and no treatment was given." In follow up it was reported that physician reported that patient after receiving her first and second dose of GARDASIL developed a rash on her face. The patient recovered on an unknown date. Additional information is not expected. This is in follow-up to report (s) previously submitted on 7/16/2007. Initial and follow up has been received from a licensed Practical Nurse (L.P.N.) and a physician concerning a 18 (previously reported as 17 year old)year old female who on 29-NOV-2006 was vaccinated into arm IM with a first dose of GARDASIL vaccine.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 23 year old female patient with a history of panic attacks who on 19-JAN-2007, was vaccinated into the left deltoid with a first dose of Gardasil (Lot# 658094/0524U). Concomitant therapy included hormonal contraceptives (unspecified). On 26-JAN-2007, the patient experienced dizziness and numbness on the left side of her body. Unspecified medical attention was sought. At the time of this report, the patient has not recovered. No product complaint was involved. Additional information has been requested. 8/1/07-copy of report received includes lot #0524U left deltoid. C/O dizziness, vertigo, numbness left side of body, palpitations, pain in jaw, ongoing intermittent to date.received for DOS 01/25/07-clinical information included pain left groin lymph nodes increasing in size and number, right lower quadrant pain, evaluate for lymphoma. Impression: bilatareal adnexal cystic lesions, improved on right with an increased 2.5 cm left adnexal cyst for which follow up is suggestion. No other records available from facility. This is in follow-up to report(s) previously submitted on 7/16/2007.  Information has been received from a licensed practical nurse concerning a 23 year old female patient with vertigo from oral contraceptives and a history of panic attacks, vestibulitis and pelvic pain who on 19-JUN-2007 at approximately 13:00, was vaccinated IM into the left deltoid with a first dose of GARDASIL (Lot# 658094/0524U).  Concomitant therapy included hormonal contraceptives (unspecified).  On 26-JUN-2007, the patient experienced (dizziness, numbness on the left side of her body, vertigo, palpitations and pain in the jaw.  Unspecified medical attention was sought.  Laboratory diagnotic studies included an electrocardiogram and an magnetic resonance imaging (MRI) which were both reported to be normal.  It was reported that these experiences have been intermittantly ongoing to date.  No product quality complaint was involved.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Information has been received from a registered nurse concerning female patient with no pertinent medical history who on approximately 22-JUN-2007 was vaccinated with a dose of the Gardasil. There was no concomitant medication. Five minutes after receiving the vaccination, the patient became dizzy, nauseous and diaphoretic. The symptoms lasted for 10 minutes. Unspecified medical attention was sought. The patient recovered from the dizziness, nausea and diaphoresis on the same day she received the Gardasil. This report is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Metrorrhagia
Clinical narrative: Information has been received from a Physician's Assistant (P.A.) concerning a female patient who roughly on 29-DEC-2006 was vaccinated with a first dose of Gardasil and on an unknown day was vaccinated with a second dose of Gardasil and on 19-JUN-2007 was vaccinated with a third dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). The reporter reported that the patient developed "breakthrough bleeding and spotting" after both the first and second injection. The patient mentioned this information on 19-JUN-2007 when she came to the office. Unspecified medical attention was sought by the patient. The patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated IM with a dose of Gardasil. The physician reported that the patient developed an "extremely sore arm and that the injection site was very hard". He also mentioned that the patient reported that she was having "great difficulty with her arm". The patient was in the physician's office at time of the events. The outcome was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Nausea, Vomiting
Clinical narrative: Information has been received from a nurse concerning 5 to 8 female "12 year old" patients who on unspecified dates, were vaccinated with first doses of Gardasil. Subsequently, on unspecified dates, the patients experienced flu-like symptoms such as nausea and vomiting. Subsequently, the patients recovered ("symptoms passed quickly"). No product quality complaint was involved. 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.
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning her daughter (age unknown) who on unspecified dates was vaccinated with first, second and third doses of Gardasil. Subsequently the patient developed swelling of the arm after all three doses of Gardasil. At the time of this report, the outcome was unknown. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, MMR, MNQ, TDAP
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, Inappropriate schedule of drug administration, Skin warm
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 12 year old female patient, who on an unknown date was vaccinated with a dose of Gardasil (lot # not provided). Concomitant therapy included Menactra and M-M-R II (MSD). Following vaccination with Gardasil, the patient felt dizzy, had tightness in her throat, felt warm, and "fainted for a second." Subsequently, the patient recovered from the events (duration not specified). The patient sought unspecified medical attention. Additional information has been requested. This is a follow-up to report (s) previously submitted on 7/16/2007. Initial and follow up information has been received from a physician concering a 12 year old female student, with no pre-existing medical conditions, who on 20-Jun-2007 at 2:00 pm, was vaccinated IM in the left deltoid, with the first dose of GARDASIL (lot # 654510/0962F). Secondary suspect therapy included the firse dose, IM in the right deltoid of BOOSTRIX (Lot # AC52B014AA), and the first dose, IM in the right deltoid, of GARDASIL (Lot # AHBVB319AA) (previously reported as including MENECTRA and MMRII. There was no illness at the time of vaccination. At 2:06 pm, "after given shot." the patient felt dizzy, had tightness in her throat, felt warm, and briefly fainted. She felt clammy and was sweating when she awoke 2 - 3 minutes after, and stated she "felt funny" for approximately 5 - 10 minutes. She was evaluated in the clinic for 45 minutes, then denied any symptoms. Additional information is not reported.
Age: 16.0
Sex: F
Vaccine: HPV4, MMR, MNQ, TDAP
Symptoms: Syncope, Throat tightness
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 12 year old female patient, who on an unknown date was vaccinated with a dose of Gardasil (lot # not provided). Concomitant therapy included Menactra and M-M-R II (MSD). Following vaccination with Gardasil, the patient felt dizzy, had tightness in her throat, felt warm, and "fainted for a second." Subsequently, the patient recovered from the events (duration not specified). The patient sought unspecified medical attention. Additional information has been requested. This is a follow-up to report (s) previously submitted on 7/16/2007. Initial and follow up information has been received from a physician concering a 12 year old female student, with no pre-existing medical conditions, who on 20-Jun-2007 at 2:00 pm, was vaccinated IM in the left deltoid, with the first dose of GARDASIL (lot # 654510/0962F). Secondary suspect therapy included the firse dose, IM in the right deltoid of BOOSTRIX (Lot # AC52B014AA), and the first dose, IM in the right deltoid, of GARDASIL (Lot # AHBVB319AA) (previously reported as including MENECTRA and MMRII. There was no illness at the time of vaccination. At 2:06 pm, "after given shot." the patient felt dizzy, had tightness in her throat, felt warm, and briefly fainted. She felt clammy and was sweating when she awoke 2 - 3 minutes after, and stated she "felt funny" for approximately 5 - 10 minutes. She was evaluated in the clinic for 45 minutes, then denied any symptoms. Additional information is not reported.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Syncope, Vomiting
Clinical narrative: Information has been received from a laboratory technician concerning a 16 year old patient who on approximately 14-JUN-2007 was vaccinated with a dose of Gardasil. On approximately 14-JUN-2007, while still in the physician's office the patient fainted and vomited. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Migraine, Nausea, Vomiting
Clinical narrative: This is in follow-up to report(s) previously submitted on 7/16/2007. Information has been received from a physician concerning a 22 year old female who on 21-JUN-2007 was vaccinated with Gardasil (lot # not reported) 0.5 ml injection. There was no concomitant medication. On 21-JUN- 2007, the patient experienced severe dizziness, nausea, vomiting which resulted in a migraine. Medical attention was sought. The experience lasted approximately 12 hours. On 22-JUN-2007, the patient recovered. No additional information is expected.
Sex: U
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with a dose of GARDASIL. Concomitant therapy included a dose of VARIVAX (MSD). Subsequently, the patient experienced a "10 x 8 centimeter of left arm redness, warmth and tender," No medical attention was sought. At the time of this report, the patient's outcome was unknown. Additional information has been requested. This is in folow-up to report (s) previously submitted on 7/16/2007. Information has been received from a health professional concerning a patient who was vaccinated with a dose of VARIVAX vaccine (Merck). additional information has been requested. This report was previously sent to FDA V501.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated with the Gardasil on an unspecified date. Subsequently, the patient developed a rash. The patient sought unspecified medical attention. The patient's outcome was unknown. This report is one of two reports from the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007.  Information has been received from a certified nurse midwife concerning a female patient who was vaccinated with GARDASIL on an unspecified date.  Subsequently, the patient developed a rash.  The patient sought unspecified medical attention.  The patient's outcome was unknown.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a registered nurse concerning a female patient who, on an unspecified date, was vaccinated intramuscularly with a 0.5 ml dose of the Gardasil. Subsequently, the patient had an "abnormal Pap test and was HOV positive." It was reported that the patient had a normal pap result prior to receiving the Gardasil. Unspecified medical attention was sought. The patient's outcome was unknown. This is one of two reports from the same source. Additional information has been requested.