chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 15 year old female, who, on an unspecified date, was vaccinated with a first dose of Gardasil. Subsequently, the patient experienced significant arm pain at the injection site and then full body pain. The patient was taken to the emergency room of the local hospital. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated with a first dose of Gardasil. Subsequently, the patient experienced an acute allergic reaction and had to go to the emergency room. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 10 year old female who was vaccinated with Gardasil. It was reported that the patient fainted shortly after receiving Gardasil. The patient sought unspecified medical attention. No further information was available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a pharmacist concerning his daughter (age unknown), who, on an unspecified date, was vaccinated with a dose of Gardasil. Subsequently, the patient experienced nausea for two days. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female (age unknown) was vaccinated with a dose of Gardasil. Subsequently, after receiving the vaccination the patient fainted. The patient sought unspecified medical attention. At the time of the report, the patient had recovered on an unspecified therapy. No product quality complaint was involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling, Swelling face
Clinical narrative: Initial and follow-up information has been received from a physician concerning a female who in approximately April 2007, was vaccinated IM with the first dose of Gardasil. The day after vaccination, the patient experienced swelling of her lips and a member of the patient's family thought that her face was a little puffy too. The patient's outcome was not reported. Medical attention was sought. The patient was instructed to got to the emergency room. The patient has not followed-up with the office nor returned my telephone messages. The office is unaware if the patient went to the emergency room. The patient's outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submittedon 7/16/2007. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Presyncope, Syncope
Clinical narrative: Information has been received from an office manager concerning a female (age unknown), who, on an unspecified date, was vaccinated with a first dose of Gardasil. Subsequently, the patient experienced syncope. The patient did not pass out but felt like she was going to. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Heart rate increased, Nausea
Clinical narrative: Information has been received from a female health professional who on 19-JUN-2007 was vaccinated IM with a second dose of Gardasil. The registered nurse immediately was nauseous, weak and developed an elevated heart rate. The symptoms lasted a few minutes and the registered nurse recovered from feeling nauseous, weak and the elevated heart rate. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated IM with a second dose of GARDASIL. Shortly after being vaccinated the patient fainted. Unspecified medical attention was sought. Subsequently, the patient recovered from fainting. 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 11 year old female with rhinitis and cough at the time of the vaccination who on 11-JUN-2007 was vaccinated with IM with a second dose of GARDASIL (lot # 655205/1426F). Concomitant therapy on 11-JUN-2007 included, IM first dose of MENACTRA (lot #C2559AA) and subcutaneously a seconde dose of VARIVAX (MED) (lot # "04434"). On 1-JUN-2007 the patient fainted wna collapsed in the hallway while going from the exam room to the waiting room. The patient was taken back to the exam room, evaluated, rested and did fine. On 11-JUN-2007, the patient recovered. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Bone pain, Diarrhoea, Nausea, Pyrexia
Clinical narrative: Initial and follow-up information has been received from a nurse practitioner concerning an approximately 27 year old female veterinarian technician, who on 07-MAY-2007 was vaccinated intramuscularly  with a 0.5 ml first dose of GARDASIL (Lot# 657617/0384U). On 07-MAY-2007 (previously reported as during the next 24 hours), the patient experienced fever, nausea, diarrhea, low back pain, vomiting, her spine ached, and it hurt for her to move. Unspecified medical attention was sought. The patient then recovered within 24 hours from the fever, nausea, diarrhea, low back pain, and vomiting on an unspecified date. Additional information has been requested.  Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Initial and follow-up information has been received from a nurse practitioner concerning an approximately 27 year old female veterinarian technician, who on 07-MAY-2007 was vaccinated intramuscularly  with a 0.5 ml first dose of GARDASIL (Lot# 657617/0384U). On 07-MAY-2007 (previously reported as during the next 24 hours), the patient experienced fever, nausea, diarrhea, low back pain, vomiting, her spine ached, and it hurt for her to move. Unspecified medical attention was sought. The patient then recovered within 24 hours from the fever, nausea, diarrhea, low back pain, and vomiting on an unspecified date. Additional information has been requested.  Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Cervix haemorrhage uterine
Clinical narrative: Information has been received from the mother of a 21 year old female with allergy to corn flour who in August 2006, was vaccinated with her first dose of Gardasil. The patient's second dose was in approximately November 2006 and her third dose was on 02-APR-2007. Concomitant therapy included ethinyl estradiol (+) norelgestromin (ORTHO EVRA). On 18-JUN-2007 the patient experienced cervix bleeding. The patient sought medical attention and no laboratory or diagnostic studies were performed. As of 20-JUN-2007, the patient's cervix bleeding persisted. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Fatigue, Nausea
Clinical narrative: Information has been received from a physician concerning a 16 year old Hispanic female who on 24-MAY-2007 was vaccinated with her first dose of Gardasil. There was no concomitant medication. On 25-MAY-2007 the patient developed nausea, dizziness, weakness and was tired.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who was vaccinated with a dose of Gardasil. It was reported that the dose the patient received was unspecified. On an unspecified date, the patient developed genital wart 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. 10/08/07 This is in follow-up to report(s) previously submitted on 7/16/2007. Information has been received from a nurse practitioner concerning a 22 year old female patient with no medical history or allergies who on 22-FEB-2007 at 13:00, was vaccinated IM into the left deltoid with a first dose of GARDASIL (Lot# 653938/0954F). There was no concomitant medication. On 16-APR-2007, the patient developed diffuse genital warts with no exposure to a new sexual partner. The patient was treated with ALDARA with good resolution. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female, who, on an unspecified date, was vaccinated intramuscularly with a second dose of Gardasil. Subsequently, the patient passed out in the car about 15 minutes post vaccination. The nurse practitioner reported that the patient mentioned that she had cleaned her backroom that morning with Tilex and really had nothing substantial to eat besides popcorn and pineapple that day. The patient ended up going to the emergency room. At the time of the 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, MNQ, TDAP
Symptoms: Dizziness, Fall, Loss of consciousness, Syncope
Clinical narrative: Information has been received from an office manager (also reported as a nurse) concerning a 15 year old female with no medical history or allergies, who on 21-JUN-2007 was vaccinated intramuscularly with a first 0.5mL dose of Gardasil (Lot #357736/0389U). Concomitant vaccinations on 21-JUN-2007 included Menactra and Tdap 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 an office manager (also reported as a nurse) concerning a 15 year old female with no allergies and anxiety, who on 21-JUN-2007 at 18:30 was vaccinated intramuscularly in the right arm with a first 0.5mL dose of GARDASIL (Lot #357736/0389U). Concomitant vaccinations on 21-JUN-2007 at 18:30 included MENACTRA (Lot# U2338AA) and ADACEL (Lot# C2720AA) in the left and right arm, respectively. Subsequently, at 18:30 the patient became lightheaded and passed out (previously reported as the patient fainted) after receiving the three shots that "she did not want". The patient collapsed and fell although she did not lose consciousness. The patient did come to right away. Treatment consisted of a cold cloth to her forehead and after eating and drinking sips of cold soda pop, the patient felt better. No lab diagnostic studies were performed. It was noted that the patient was "very anxious" about the shots. On 21-JUN-2007 the patient recovered. No product quality complaint was involved. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Influenza like illness, Musculoskeletal pain
Clinical narrative: Information has been received from a registered nurse, concerning two patients (gender and age not specified), who were vaccinated (date unspecified) with a dose of Gardasil (Lot # not specified). Following vaccination (duration of time not specified), the patient experienced fatigue, flu-like symptoms, dizziness and musculoskeletal aches. At the time of this report, it was unknown if the patients had recovered from the events. The patient sought unspecified medical attention. The nurse reported that another patient experienced similar symptoms following vaccination with Gardasil (WAES #0706USA04089). 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. This is in follow-up to report (s) previously submitted on 7/16/2007. Attempts were made to obtain additional identification information to distinguish the individual patients mentioned in this report, however the nurse confirmed that no additional patient details were available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional concerning a 21 year old white female with no medical history or allergies, who on 19-MAR-2007 was vaccinated intramuscularly in the right deltoid with a first dose of Gardasil (Lot # 655503/0012U). Concomitant therapy included YAZ and ALLEGRA. Subsequently, the patient experienced syncope. The patient had no illness at the time of the vaccination. It was noted that the patient had not eaten that morning. The patient had recovered on 19-MAR-2007. 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 developed a bump at an injection site after receiving the vaccine. This is one of several reports from the same source.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain
Clinical narrative: Information has been received from a physician concerning a female patients between 20 - 25 years old who was vaccinated IM with Gardasil. Subsequently all the patient experienced abdominal cramping "like premenstrual related symptoms". Subsequently, all the patient  recovered from abdominal cramping "like premenstrual related symptoms". The patient did not seek medical attention. Additional information has been requested. This is one of several reports from the same source. 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 and a health professional concernig a 21 year old female patient who on 15-JUN-2007 was vaccinated IM with GARDASIL (lot # 657617/0384U).  On 15-JUN-2007 15 minutes post vaccination, the patient experienced terrible abdominal pain "like premenstrual related symptoms".  On 15-JUN-2007, the patient recovered.  The patient did not seek medical attention.  Alternative diagnosis was incomplete abortion versus dysfunctional uterine bleeding.  Additional information is not expected.  This is one of several reports from the same source.
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a first dose of Gardasil. Subsequently, the patient experienced chest pains and shortness of breath. 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: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pruritus generalised, Urticaria
Clinical narrative: Information has been received from a physician concerning an 18 year old female with "unremarkable" medical history who in April 2007, was vaccinated with a first dose of Gardasil. Subsequently, the patient experienced welts, itching all over body, and nausea. The patient sought unspecified medical attention. The patient recovered from welts, itching all over body and nausea approximately 3 days after initial injection. The physician did plan on administering further doses of Gardasil to this patient. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Rash generalised, Rash pruritic
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 13 year old, female student, with no known drug or food allergies, who on 14-JUN-2007 was vaccinated IM, with the first dose of GARDASIL (Lot #657617/0384U). There was no concomitant medication. On 21-JUN-2007 (previously reported as 15-JUN-2007), the patient developed a generalized, red, raised, pruritic rash. Treatment included BENADRYL. Subsequently, the patient recovered from the rash (date of recovery unspecified). No further information is expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Injection site erythema, Rash pruritic
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 19 year old female patient with no known allergies who on 19-JUN-2007, was vaccinated with a first dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). On the 20-JUN-2007 at approximately 08:00,  she developed a rash on both arms, neck and chest and redness on the injection site forearm. By the next day, the redness developed into a clustered pin-pricked - but not raised - red, itchy rash.  It was reported that the patient did not have a fever. Unspecified medical attention was sought. On 25-JUN-2007, the patient had recovered from fash on both arms, neck and chest and did not recover from redness on injection site forearm and itchy rash. No product quality complaint was involved. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Infectious mononucleosis, Staphylococcal infection
Clinical narrative: Information has been received from a certified medical assistant concerning a 16 year old female patient who on 21-DEC-2006 was vaccinated IM into the arm with a first 0.5ml dose of Gardasil. On 21-FEB-2007 and 21-JUN-2007 the patient was vaccinated into the arm with a second and third dose, respectively. There was no concomitant medications. On 23-MAY-2007, the patient was diagnosed with mononucleosis and a staph infection on her leg. It was reported that the patient was treated with an unnamed sulfa antibiotic and experienced an "allergic reaction." She was then treated with an unnamed steroid. Laboratory diagnostic studies performed included "unknown lab tests." Subsequently, the patient recovered from staph infection on her leg and the allergic reaction. At the time of this report, the patient was recovering from the mononucleosis. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Infectious mononucleosis
Clinical narrative: information has been received from a consumer concerning her 19 year old female daughter who was vaccinated with a first and second dose of Gardasil. It was reported that prior to getting the scheduled third dose of the vaccine, her daughter was diagnosed with mononucleosis. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a physician concerning an approximately 11 year old female patient who was vaccinated with a first dose of Gardasil. Right after administration, the patient experienced tingling in her fingers. Unspecified medical attention was sought. Subsequently,  the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Headache, Hypotension, Nausea, Pallor
Clinical narrative: Information has been received from a registered nurse herself and via a company representative concerning a 17 year old female patient who on 20-JUN-2007 was vaccinated with the first dose of Gardasil (Lot # 0212U). On 21-JUN-2007, the morning following vaccination, the patient called the office and reported that she was pale, had low blood pressure (value not specified), had nausea, was weak and had a headache. On 22-JUN-2007, the patient had recovered from the events. The patient sought unspecified medical attention. Additional information has been requested. Initial and follow-up information has been received from a licensed visiting nurse, concerning a 17 year old female student with a penicillina allergy and no illness at the time of vaccination, who on 20-JUN-2007 at 3:15pm, was vaccinated IM in the right buttock, with
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Headache, Menstruation irregular, Ultrasound abdomen, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received, via the Merck pregnancy registry, from a registered nurse, concerning her 23 daughter with depression, who on 16-NOV-2006 was vaccinated with the first dose of Gardasil (Lot #654540/0800F), and following vaccination (onset date not specified), experienced a slight headache. Concomitant therapy included LOESTRIN 24 FE and WELLBUTRIN. On 16-JAN-2007, she was vaccinated with the second dose of Gardasil (Lot #657005/0314U), and again following vaccination she experienced a slight headache. The nurse indicated her daughter had unknowingly become pregnant on approximately 04-APR-2007, and on 16-MAY-2007, was administered the third dose of Gardasil (Lot #657005/0314U). Again, following the vaccination, she experienced a headache, though this headache was "stronger." The patient sought treatment for the headache with her primary physician, and a urine pregnancy test at that time (date unspecified) indicated she was pregnant. The nurse confirmed that her daughter had been taking the birth control pills (specified above), and had experienced a light menstrual cycle throughout his time period. On 30-MAY-2007, the patient had an ultrasound that confirmed she was approximately 8 weeks pregnant, and "all looked fine." The estimated date of delivery was 09-JAN-2008. At the time of this report, the outcome of headache was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received, via the Merck pregnancy registry, from a registered nurse, concerning her 23 daughter with depression, who on 16-NOV-2006 was vaccinated with the first dose of Gardasil (Lot #654540/0800F), and following vaccination (onset date not specified), experienced a slight headache. Concomitant therapy included LOESTRIN 24 FE and WELLBUTRIN. On 16-JAN-2007, she was vaccinated with the second dose of Gardasil (Lot #657005/0314U), and again following vaccination she experienced a slight headache. The nurse indicated her daughter had unknowingly become pregnant on approximately 04-APR-2007, and on 16-MAY-2007, was administered the third dose of Gardasil (Lot #657005/0314U). Again, following the vaccination, she experienced a headache, though this headache was "stronger." The patient sought treatment for the headache with her primary physician, and a urine pregnancy test at that time (date unspecified) indicated she was pregnant. The nurse confirmed that her daughter had been taking the birth control pills (specified above), and had experienced a light menstrual cycle throughout his time period. On 30-MAY-2007, the patient had an ultrasound that confirmed she was approximately 8 weeks pregnant, and "all looked fine." The estimated date of delivery was 09-JAN-2008. At the time of this report, the outcome of headache was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 26 year old female who on 31-MAY-2007 was vaccinated with a first dose of Gardasil (Lot number 0210U) expiry date 22-NOV-2009 injection in the right deltoid. Concomitant therapy was reported as none. The physician reported that within 10 minutes of receiving the first dose the patient fainted. It was also reported that, the patient "snapped out of it (time unspecified)" recovered. Medical attention was sought and at the time of reporting additional information was not provided. Follow-up information was received from the physician. The patient is not pregnant, was not hospitalized and medications were not given. The patient was given juice. Additional information is not available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Cold compress therapy, Injection site mass, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on 03-MAY-2007 was vaccinated with a first dose of Gardasil (lot # 657622/0388U) IM in the right arm. Concomitant therapy was not reported. On approximately 04-MAY-2007 or 05-MAY-2007 about 24 to 48 hours after the shot he patient developed an orange sized knot at the injection site. Medical attention was sought. At the time of reporting the patient recovered from the orange sized knot at the injection site and no further adverse event information was available. Follow-up information was received on 27-JUN-2007 via telephone. The physician reported that on 03-MAY-2007 the patient developed a softball-size swelling and a knot at the injection site. The physician advised the patient to use cold compresses and to take ibuprofen (MOTRIN). On approximately 05-MAY-2007 the patient recovered from the softball size swelling and a knot at the injection site but the physician is not sure whether or not to continue with the Gardasil dosing schedule due to the patient's experience. The patient has been previously sensitive to other vaccines. No further information was available.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning two female patients (age not reported) who on approximately 01-JUN-2007 were vaccinated with a first dose of Gardasil (lot number unknown). The females may have been siblings. The one patient may have fainted after watching her sister receive Gardasil. It is unspecified whether patient two received the dose. No additional information was provided. Follow-up information was received via telephone. The clinical manager stated that when the first girl received her shot the sister fainted. Both patient were fine. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning an 13 year old female who on 11-JUN-2007 was vaccinated with a first dose of Gardasil (lot number unknown) injection in the right arm and received concomitant suspect therapy which included Vaqta, injection in the left arm. Concomitant therapy included Menactra on the left arm. The physician reported that patient had a low grade fever on 10-JUN-2007 before receiving Gardasil. On 12-JUN-2007 the patient experienced vomiting. Medical attention was sought. The patient was given a medication to control the vomiting. On an unspecified date the patient had recovered. At the time no further adverse event information is available. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Nausea
Clinical narrative: Information has been received from a nurse concerning a 17 year old female who on 21-JUN-2007 was vaccinated intramuscularly with the first dose of Gardasil. Concomitant therapy included sertraline HCl (ZOLOFT). After the vaccine was administered, the patient said that she felt nauseous and wanted to lay down. The reporter stated that the patient had not been sweating and was given crackers and soda. After about twenty minutes, the patient said that she felt better and was sent home. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4, UNK
Symptoms: Inappropriate schedule of drug administration, Syncope
Clinical narrative: Information has been received from a physician concerning a female who the patient reported to the nurse that she faints whenever she gets any shots, on 20-JUN-2007 was vaccinated with a second dose of Gardasil. Concomitant therapy included a vaccination (unspecified). In the doctors office the patient fainted. Unspecified medical attention was sought. Subsequently, the patient recovered from fainting. It was reported that the patient was over the three month window between the first and second dose. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on approximately December 2006, was vaccinated IM with a first dose of Gardasil. On an unspecified date, the patient was vaccinated with a second dose of Gardasil. "About 2 weeks after the second vaccination" the patient developed "big bump on her upper arm". Unspecified medical attention was sought. Subsequently, after a few days the patient recovered from "big bump on her upper arm". 20-JUN-2007 when the patient came into the office for her third dose. It was at this visit that she notified the doctor of the "big bump on her upper arm" that was felt after receiving her second vaccination. On 20-JUN-2007, the patient was vaccinated with a third dose of Gardasil. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Oedema peripheral, Pruritus, Rash macular, Skin warm
Clinical narrative: Information has been received from an LPN concerning a 21 year old female patient with allergies to sulfa and AMOXIL who on 02-APR-2007 and 12-JUN-2007 was vaccinated IM in upper arm with her first and second doses of Gardasil, lot #653736/0014U for both doses. No other medications or vaccines were administered on these days. After both doses the next morning both hands were hot and itchy, slightly swollen, burning sensation of palms, sensitive to heat, blotchy rash from wrist to middle of the forearm (not hives). This lasted approximately one day and resolved with no treatment on either occasion, however the reporter indicated that medical attention was sought. It was also noted that the blotchy rash resolved within 24 hours. The patient requested the third dose. The HCP will probably pre-medicate with BENADRYL and observe. Follow up information has been received concerning the student who on 2-APR-2007 at 2:30 p.m was vaccinated in left deltoid with her first dose of GARDISIL, lot # 65373G/0014U: and on 12-JUN-2007 at 4:00 p.m was vaccinated in left deltoid with her second dose of GARDISIL, lot # 653736/0014U. The nurse stated that the patient's reactions happened post injection #1 and injection #2, both approximately 24 hours post injection. She also stated that that the patient's reaction after dose 1 started on 03-APR-2007 at 2:30 p.m. The patient requested the third dose. The HCP will probably pre-medicate with BENADRYL and observe. Additonal information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Swelling, Temperature intolerance, Vaccine positive rechallenge
Clinical narrative: Information has been received from an LPN concerning a 21 year old female patient with allergies to sulfa and AMOXIL who on 02-APR-2007 and 12-JUN-2007 was vaccinated IM in upper arm with her first and second doses of Gardasil, lot #653736/0014U for both doses. No other medications or vaccines were administered on these days. After both doses the next morning both hands were hot and itchy, slightly swollen, burning sensation of palms, sensitive to heat, blotchy rash from wrist to middle of the forearm (not hives). This lasted approximately one day and resolved with no treatment on either occasion, however the reporter indicated that medical attention was sought. It was also noted that the blotchy rash resolved within 24 hours. The patient requested the third dose. The HCP will probably pre-medicate with BENADRYL and observe. Follow up information has been received concerning the student who on 2-APR-2007 at 2:30 p.m was vaccinated in left deltoid with her first dose of GARDISIL, lot # 65373G/0014U: and on 12-JUN-2007 at 4:00 p.m was vaccinated in left deltoid with her second dose of GARDISIL, lot # 653736/0014U. The nurse stated that the patient's reactions happened post injection #1 and injection #2, both approximately 24 hours post injection. She also stated that that the patient's reaction after dose 1 started on 03-APR-2007 at 2:30 p.m. The patient requested the third dose. The HCP will probably pre-medicate with BENADRYL and observe. Additonal information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site haematoma, Injection site pain
Clinical narrative: Information has been received from a 22 year old female physician's receptionist, who on approximately 13-JUN-2007 was vaccinated IM with her first dose of Gardasil. On approximately 13-JUN-2007 the patient experienced pain at the injection and a hematoma at injection site (lump). The pain at the injection lasted about 4 to 5 days. The patient's hematoma at injection site (lump) persisted. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Cold compress therapy, Head injury, Syncope
Clinical narrative: This is in follow-up to report(s) previously submitted on 7/17/2007. Initial and follow-up information has been received from a physician and a certified medical assistant concerning a 12 year old female with a history of fainting with injections, who on an unspecified date was vaccinated with the first dose of GARDASIL (lot #658094/0524U). Concomitant vaccination that day included MENACTRA. It was reported that following vaccination, the patient sat down for a few minutes. When she went up to the check out window, she fainted and hit her head. The office staff sat her back down and gave her some ice for her head. Subsequently, the patient recovered. It was reported that the patient's fainting was caused by the injection not therapy with GARDASIL. No further information is expected. The VAERS ID # is 285816.
Age: 45.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Pruritus, Urticaria
Clinical narrative: Initial and follow up information has been received from a physician concerning a 45 (previously reported as 44) year old female patient with latex allergy who in March 2007, was vaccinated IM with a first dose of Gardasil and in 25-MAY-20007 (Previously reported as April 2007), got her second dose of Gardasil into left arm deltoid. On 25-MAY-2007 the patient developed itching and hives all over her body. The physician referred the patient to allergist. The patient has not recovered. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 7/16/2007. In follow up it was reported that patient had hives all over body and itching 3 weeks after the second injection. The physician referred the patient to allergist. In follow up it was reported that the patient recovered on 29-JUN-2007. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Injection site bruising
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient (age and gender unknown), who on 22-JUN-2007 was vaccinated by, a medical assistant in the office, intramuscularly with a 0.5ml dose of Gardasil. A pre-filled syringe was used to vaccinate the patient. It was noted that the needle shield bruised the patient's arm at the injection site, when it deployed. The nurse stated that it may have been user error. The full dose was administered to the patient. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pruritus, Injection site swelling, Injection site warmth, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a registered nurse concerning her daughter, with possible allergy to aluminum. The patient subsequently experienced a knot in arm around injection site and pruritus while on therapy with hepatitis B virus vaccine (manufacturer unknown) (WAES # 0706USA05089). The patient was vaccinated IM with a 0.5 ml second dose of Gardasil. Subsequently the patient experienced "knot in her arm around the injection site." The area was swollen and warm th the touch. Unspecified medical attention was sought. It was reported that the patient had an ultrasound that revealed a knot in muscle. It was reported it took 1 month before her symptoms resolved. Subsequently, the patient recovered from "knot in her arm around the injection site", swollen and warm to the touch. It was reported that the patient did not experience any adverse event after the first dose of the vaccine. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan
Clinical narrative: Information has been received from a registered nurse concerning her daughter, with possible allergy to aluminum. The patient subsequently experienced a knot in arm around injection site and pruritus while on therapy with hepatitis B virus vaccine (manufacturer unknown) (WAES # 0706USA05089). The patient was vaccinated IM with a 0.5 ml second dose of Gardasil. Subsequently the patient experienced "knot in her arm around the injection site." The area was swollen and warm th the touch. Unspecified medical attention was sought. It was reported that the patient had an ultrasound that revealed a knot in muscle. It was reported it took 1 month before her symptoms resolved. Subsequently, the patient recovered from "knot in her arm around the injection site", swollen and warm to the touch. It was reported that the patient did not experience any adverse event after the first dose of the vaccine. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 22-JUN-2007 was vaccinated with a first dose of Gardasil. Immediately following the vaccine, the patient fainted. The patient was laid down and watched for ten to fifteen minutes. After that time, the patient was fine and had recovered from fainting. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from an 18 year old female certified medical assistant, who was vaccinated with her first dose of Gardasil. Subsequently she started getting her menstrual period every two weeks for about a month and a half. Additional information has been requested. This is one of two reports from the same source.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Paraesthesia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a 16 year old female with a history of migraines who on approximately February 2007 was vaccinated with a first dose of Gardasil. Subsequently, the patient experienced tingling in her leg and pain in her leg. Subsequently the patient recovered. on an unspecified day in 2007, the patient received a second dose of Gardasil. Subsequently the patient experienced tingling in her leg and pain in her leg. At the time of the report, the patient was recovering. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female patient with a penicillin allergy and no medical history who on 20-APR-2007, was vaccinated IM into the left arm with a first 0.5ml dose of Gardasil. On 16-JUN-2007, the patient was vaccinated with a second dose of Gardasil (Lot# 657736/0389U). There was no concomitant medication. On 20-JUN-2007, the patient developed a vesicular rash which was described as spreading from the lower lip to surrounding both lips and spreading to cheek and around a naris. The patient showed the rash to the psychiatrist. No 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.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a 22 year old female consumer with a history of mild dysplasia and no drug allergies who on 30-MAY-2007, was vaccinated with a dose of Gardasil. There was no concomitant medication. On 12-JUN-2007, her menstrual cycle was about 11 days late. The consumer stated there was the possibility of being pregnant but it has not been confirmed. No medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning an "approximately 20 year old" female patient who was vaccinated with a dose of Gardasil. The patient fainted after receiving the Gardasil. The patient recovered. The nurse reported that two other patient experienced fainting after receiving the dose of Gardasil. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inflammation, Pain, Tenderness
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on approximately 11-JUN-2007 (2 weeks ago), was vaccinated with a dose of Gardasil (lot number unknown). The physician reported that the patient developed pain to arm, tenderness and inflammation (3 cm) since being vaccinated with Gardasil. The outcome of the events were not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure normal, Electrocardiogram normal, Loss of consciousness
Clinical narrative: Information has been received from a health professional concerning a 16 year old female patient who on 22-JUN-2007 was vaccinated IM with a first dose of Gardasil lot #654535/0960F. The patient while sitting passed out for one minute. She appeared fine and an electrocardiogram and blood pressure were normal. She was observed in the office for an hour. No additional information at this time. The patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immunosuppression
Clinical narrative: Information has been received from a physician concerning a female patient with oral cancer who was vaccinated with a dose of Gardasil. It was reported that the patient may have been immunocompromised because she had oral cancer. 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. Follow up information from the physician stated that he was not aware of any adverse reaction with GARDASIL in his patients. Additional information is not expected.
Age: 29.0
Sex: F
Vaccine: HPV4
Symptoms: Aldolase increased, Autoantibody positive, Blood creatine phosphokinase increased, Haematology test, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 29 year old female with no pertinent medical history or drug reactions/allergies who in October 2006, was vaccinated with a first dose of Gardasil (lot number unknown) and in December 2006 with the second dose of Gardasil. On unspecified date the nodules developed in 2006 "late fall", after vaccination. Both vaccines were administered at another office. Concomitant therapy included naproxen sodium (ALEVE), ethinyl estradiol/norethindrone (OVCON) and vitamins (unspecified). The nurse reported that on 27-APR-2007 the patient was examined in their office and on an unspecified date after receiving the third dose of Gardasil in March 2007 at another office she developed myositis described as nodules that developed on the knucles of both hands. Medical attention was sought. The serum creatine kinase (CPK) test and serum aldolase test were elevated and have continued to climb to present 22-JUN-2007. Complete work up for rheumatology was performed and the results were negative. Hematology laboratory tests unspecified were also performed. At the time of reporting the patient has not recovered and no further information was reported. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. Follow-up information was received from a specialist. On an unspecified date in 2006, the patient reported a dull achy feeling primarily in the morning and sometimes lasting all day.  The patient's rhematologic examination was otherwise unrevealing, an extensive laboratory review showed a serum CPK test of 2096. The values have fluctuated they have never normalized. The patient's serologic review was normal except ant-Jo antibobdy of 135.2. The patient is being treated with low dose prednisone 20mg per day which seems to control her symptomatology. The patient's strength examination seems fine and it is hard to find 1 limb that is weaker than the rest. Additional information is not expected.
Age: 29.0
Sex: F
Vaccine: HPV4
Symptoms: Myositis, Nodule, Pain, Serology normal
Clinical narrative: Information has been received from a registered nurse concerning a 29 year old female with no pertinent medical history or drug reactions/allergies who in October 2006, was vaccinated with a first dose of Gardasil (lot number unknown) and in December 2006 with the second dose of Gardasil. On unspecified date the nodules developed in 2006 "late fall", after vaccination. Both vaccines were administered at another office. Concomitant therapy included naproxen sodium (ALEVE), ethinyl estradiol/norethindrone (OVCON) and vitamins (unspecified). The nurse reported that on 27-APR-2007 the patient was examined in their office and on an unspecified date after receiving the third dose of Gardasil in March 2007 at another office she developed myositis described as nodules that developed on the knucles of both hands. Medical attention was sought. The serum creatine kinase (CPK) test and serum aldolase test were elevated and have continued to climb to present 22-JUN-2007. Complete work up for rheumatology was performed and the results were negative. Hematology laboratory tests unspecified were also performed. At the time of reporting the patient has not recovered and no further information was reported. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. Follow-up information was received from a specialist. On an unspecified date in 2006, the patient reported a dull achy feeling primarily in the morning and sometimes lasting all day.  The patient's rhematologic examination was otherwise unrevealing, an extensive laboratory review showed a serum CPK test of 2096. The values have fluctuated they have never normalized. The patient's serologic review was normal except ant-Jo antibobdy of 135.2. The patient is being treated with low dose prednisone 20mg per day which seems to control her symptomatology. The patient's strength examination seems fine and it is hard to find 1 limb that is weaker than the rest. Additional information is not expected.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a nurse practitioner (NP), with a company representative, concerning a 19 year old male patient, with no pertinent medical history, who was vaccinated on an unspecified date, with a dose, 0.5ml. of Gardasil (Lot # not provided). There was no concomitant medication. Subsequently the patient was diagnosed with an infraclavicular swollen lymph nodes. The NP added that no treatment was required, and the event resolved on it's own (date and duration not specified). No further information is expected.