chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a female who was vaccinated with a first dose of GARDASIL by a different provider. Subsequently the developed hives over her entire body 2 hours after injection. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Arthritis reactive, Biopsy, Biopsy bone, Musculoskeletal disorder
Clinical narrative: Information has been received from a physician concerning his daughter who was vaccinated with first and second dose of GARDASIL. Subsequently she was diagnosed with reactive arthritis. It was unknown if patient sought medical attention. The patient had not recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow up information has been received from a physician concerning his daughter who was vaccinated with first and second dose of GARDASIL lot #653735/0688F. In follow up telephone call the physician indicated that his daughter's arm (same arm as injection site) was worse and was "not functional" at that time. She was evaluated for the possibility of fasciitis and had tissue and bone biopsies on 26-SEP-2007. There was also concern about osteomyelitis. She was reported as chronically ill.  No other information was available. It was reported that patient's chronic illness was so excruciating, that she had to take MORPHINE.  The outcome was unknown. The physician was requesting a lot check for the GARDASIL lot his daughter was given. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. In addition an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research, and was released. Additional information has been requested.  Follow-up information was received which reported a cardiologist and his wife, a rheumatologist, opted to have their 17 year old daughter vaccinated.  It was a desicion they now regret.  Following vaccination, their teenage daughter began showing signs and symptoms of an autoimmune disease.  The cardiologist said:  "She went from being a healthy, active teen running, playing lacrosse and participating on swim team to becoming a chronically ill patient".  Additional information is not available.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Injection site pain, Injection site vesicles, Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter with fruit allergy, penicillin and amoxicillin allergy and sulfonamide (BACTRIM) who in March 2007, was vaccinated with the first dose of GARDASIL (Lot # not provided). Concomitant therapy included hepatitis A virus vaccine inactivated (unspecified, manufacturer not provided) (received on same day, but not on the same arm as GARDASIL). It was reported that the patient developed a sore at injection site hours after taking the first dose of the vaccine. It was also reported that the patient developed a sore at injection site that lasted for one week after receiving the second dose of the vaccine in May 2007. The patient also developed bubbles in the injection site that looked like it contains a liquid inside the bubbles and it lasted for 2 months. Subsequently, the patient recovered from liquid filled bubbles in injection site and sore at injection site. The patient sought unspecified medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Laceration, Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 24-AUG-2007 was vaccinated with the first dose of Gardasil (lot # not reported).  There was no concomitant medication.  On 24-AUG-2007 the patient experienced syncope three to five minutes after vaccination.  She fell and scraped her elbow but did not suffer any serious injuries.  Subsequently, the patient recovered from syncope.  It was reported that the patient sought unspecified medical attention.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Pyrexia
Clinical narrative: Information has been received from a physician's assistant concerning her daughter (age unknown), who, on an unspecified date was vaccinated with a third dose of Gardasil.  Subsequently, "within 24 hours post vaccination" the patient experienced "significant muscle aches and a low grade fever."  The patient did not seek medical attention.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/12/2007. Information has been received from a physician's assistant concenring her 25 year old daughter, who, on an unspecified date was vaccinated with a third dose of HPV vaccine. Subsequent;y, "within 24 hours post vaccination" the patient experienced "significant muscle aches and a low grade fever." The patient did not seek medical attention. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Eye pruritus, Eye swelling, Oedema peripheral, Pruritus
Clinical narrative: Information has been received from a physician concerning a 21 year old female with a history of sulfonamide allergy who on 14-SEP-2007 was vaccinated intramuscularly in the right deltoid (previously reported as the left arm) with Gardasil (lot # 657872/0515U).  Subsequently the patient developed an itchy, swollen left arm post vaccination.  Patient outcome was not reported.  Patient sought unspecified medical attention. It was also reported that on 14-SEP-2007 the patient esxperienced swelling and itching of the left eye about 1 hour after leaving the clinic. Patient was told to take 50mg BENADRYL or 20 mg CLARITIN. Subsequently, the patient recovered from swollen left eye and itching left eye.   Additional information has been requested.  Additional infromation is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: Information has been received from a physician concerning a 21 year old female with a history of sulfonamide allergy who on 14-SEP-2007 was vaccinated intramuscularly in the right deltoid (previously reported as the left arm) with Gardasil (lot # 657872/0515U).  Subsequently the patient developed an itchy, swollen left arm post vaccination.  Patient outcome was not reported.  Patient sought unspecified medical attention. It was also reported that on 14-SEP-2007 the patient esxperienced swelling and itching of the left eye about 1 hour after leaving the clinic. Patient was told to take 50mg BENADRYL or 20 mg CLARITIN. Subsequently, the patient recovered from swollen left eye and itching left eye.   Additional information has been requested.  Additional infromation is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Eye pruritus, Eye swelling, Oedema peripheral, Pruritus
Clinical narrative: Information has been received from a physician concerning a 21 year old female patient who on 14-SEP-2007 was vaccinated intramuscularly in the left arm with Gardasil (0.5 ml) (lot # 657872/0515U).  The patient subsequently developed an itchy, swollen left arm post vaccination.  The patient sought medical attention in the physician's office.  At the time of this report, the outcome of the events was unknown.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: Information has been received from a physician concerning a 21 year old female patient who on 14-SEP-2007 was vaccinated intramuscularly in the left arm with Gardasil (0.5 ml) (lot # 657872/0515U).  The patient subsequently developed an itchy, swollen left arm post vaccination.  The patient sought medical attention in the physician's office.  At the time of this report, the outcome of the events was unknown.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Anorexia, Diarrhoea, Nausea
Clinical narrative: Information has been received from a health professional concerning a 16 year old female (weight 130#, height 63") who on 09-JUL-2007 at 5:15 pm was vaccinated with the first dose of Gardasil (lot #657737/0522U) in the right deltoid.  Concomitant medication was not reported.  On 10-JUL-2007, the patient experienced nausea, diarrhea and loss of appetite which lasted approximately one and one half to two weeks.  Subsequently, the patient recovered from nausea, diarrhea and loss of appetite.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from an administrative assistant concerning more than three female patients, ages 13 and up, who, on an unspecified dates, were vaccinated with a dose of Gardasil.  Subsequently, the patients exhibited signs of becoming lightheaded.  The administrative assistant reported that it would be impossible to determine the number of patients exhibiting these signs and she could not provide a lot number for the vaccine.  The office had decided to start a journal logging the patients affected and lot numbers of the vaccine.  At the time of this report, the outcomes were unknown.  Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with a second dose of Gardasil.  Subsequently the patient experienced pain in the arm radiating into the fingers.  It was an intense pain that could last through the day.  This occurred in three to five girls in the practice.  It was unknown whether medical attention was sought.  The patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Asthenia
Clinical narrative: Information has been received from a nurse concerning a female who in May 2007 was vaccinated with GARDASIL. It was reported that the patient has been experiencing weakness since she was given the vaccine. The patient contacted her physician. At the time of this report, the patient's weakness persisted. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female who in September 2007, was vaccinated with Gardasil.  In September 2007, "within 15 minutes" after receiving vaccination the patient experienced syncope.  Unspecified medical attention was sought.  Subsequently, the patient recovered from the syncope and was reported as being fine.  No further information is expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female with epilepsy and asthma, who on 28-MAR-2007 was vaccinated with a second dose of Gardasil (Lot# 655849/0263U).  Subsequently, the patient passed out after she was given the second dose.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 11 year old female who in approximately 2007 was vaccinated with a first dose of Gardasil.  It was reported that after the patient received her first dose of Gardasil she experienced nausea and vomiting the same day which continued the next day.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea
Clinical narrative: Information has been received from a physician's assistant concerning a female (age unknown), who, on an unspecified date, was vaccinated intramuscularly with a 0.5mL first dose of Gardasil.  Subsequently, the patient experienced a headache and nausea that lasted for one week.  The patient called the doctor's office.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female with no allergies or medical history, and no illness at the time of vaccination, who on 27-AUG-2007 at 10:00, was vaccinated in the left deltoid with a 0.5mL first dose of Gardasil (Lot# 658222/0927U).  On 29-AUG-2007 the patient experienced visible condyloma.  It was noted that the patient had not had intercourse in five months.  The patient was seen at the office.  No laboratory diagnostics were performed.  At the time of the report the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female with an allergy to sulfonamides, who on 09-NOV-2006 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil.  On 08-FEB-2007 the patient was vaccinated with a second dose of Gardasil (Lot# 654885/1424F).  Subsequently, the patient developed an injection site reaction.  On 18-SEP-2007 the patient was vaccinated with a third dose of Gardasil.  On 18-SEP-2007 the nurse practitioner noted an 8mm reddish-brown mark with a central broken capillary at the injection site of the left upper arm, noted by the nurse practitioner to be "lower on the left upper arm, nearer the elbow" that had persisted since the second dose.  It was noted that the reaction was tender to touch.  The patient was examined in the office.  At the time of the report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil.  Subsequently the patient experienced severe headaches.  The patient sought unspecified medical attention.  At the time of the report, it was unknown if the patient recovered.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Gynaecological examination, Human papilloma virus test positive, Smear cervix abnormal, Vaccination failure
Clinical narrative: Initial and follow-up information has been received from a certified medical assistant (CMA) concerning a 15 year old female with no medical history who on 16-FEB-2007 was vaccinated IM in a deltoid (unspecified) with the first 0.5 mL dose of Gardasil (lot #655619/1427F).  On 19-JUN-2007, the patient was vaccinated IM in the right deltoid with a second 0.5 mL dose of Gardasil (lot #657736/0389U).  There was no concomitant medication.  On 29-AUG-2007, a Papanicolaou test (PAP smear) was performed on the patient during a routine gynecological examination.  Subsequently, the PAP smear was positive for human papilloma virus (HPV).  The medical assistant reported the event as a vaccination failure.  The patient's outcome was unknown, although, the medical assistant reported that the physician was monitoring the patient.  Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This in follow-up to report (s) previously submitted on 10/12/2007. Information has been received from a Registered Nurse (R.N.) concerning a female patient who was vaccinated IM with a second dose of GARDASIL.  The nurse mentioned that after the second injection the patient experienced "injection site itchiness and redness that lasted 15 days".  Unspecified medical attention was sought by the patient.  No further information was provided.  The outcome was unknown.  Additional information has been requested. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Sensation of heaviness
Clinical narrative: Information has been received from a registered nurse concerning a female who on an unspecified date was vaccinated with a dose of Gardasil.  Subsequently the patient's arm still feels heavy and has a tingly feeling one month after getting the Gardasil.  Unspecified medical attention was sought.  At the time of the report the patient had not recovered.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional concerning a female who, "a couple of weeks ago," was vaccinated with a dose of Gardasil.  It was reported that after vaccination the patient fainted in the parking lot of the physician's office.  The patient's outcome was unknown.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow-up information has been received from a registered nurse concerning a 13 year old white female with exercise-induced asthma who on 26-JUL-2007, at 9:30, was vaccinated IM in the left arm with a dose of GARDASIL (lot #656372/0243U). It was reported that after vaccination, at 9:45, the patient fainted in the parking lot of the physician's office. The patient's blood pressure was noted to be 98/60. The patient was obseved in the physician's office until asymptomatic. On 26-JUL-2007, the patient was recovered. No additional information is expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a female in her early 20s who in August 2007, was vaccinated in her arm with the first dose of GARDASIL (route and lot # not reported). In August 2007, the patient experienced swelling of her lower extremities. It was reported that the patient sought unspecified medical attention. Patient outcome was not reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient who on 18-JUL-2007 was vaccinated with a first dose of GARDASIL. The physician reported that the patient experienced a fever of less than 101 F within a few days after the injection was given. She was treated with TYLENOL and her fever resolved. No additional information was available at this time. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning her 11 year old daughter with no pertinent medical history who on 13-SEP-2007 was vaccinated intramuscularly with 0.5 ml first dose of GARDASIL. There was no concomitant medication. On 14-SEP-2007 within 24 hours the patient developed an injection site reaction. The site was swollen, painful, warm to the touch, and red. The area was about 4" x 2" in size. There were no laboratory or diagnostic tests performed. A call was made to the office. At the time of the report the patient had recovered fully. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a consumer concerning her 10 year old daughter who on 09-AUG-2007 was vaccinated with a dose of GARDASIL. On 09-AUG-2007 the patient developed a rash on the lower half of her body that ended up spreading to the upper half of her body. It was reported there was no injection site reaction. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. The patient's mother reported that the pediatrician does not believe the reaction was caused by GARDASIL. No further information was provided.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated in the past 3 months with a dose of GARDASIL. Subsequently the patient experienced fainted. Medical attention was sought. The patient's outcome was unknown. Follow up information indicated there were 6 patients who after vaccination with a dose of GARDASIL fainted and none of them needed resuscitation. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 14 year old female who in June 2007, was vaccinated in the arm with GARDASIL (Lot # not available). It was reported that the patient also was vaccinated with varicella virus vaccine live at the same time in the same arm. In June 2007, the patient developed a red swollen area around the injection site. Subsequently, the patient recovered from the red swollen area around the injection site. It was reported that the patient sought unspecified medical attention. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a Nurse Practitioner (N.P.) concerning a 11 year old female patient who was vaccinated with a first dose of GARDASIL. The NP reported that the patient fainted after receiving the first dose of GARDASIL. No further information is available. The outcome was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Acne, Injection site pain
Clinical narrative: Initial and follow-up information has been received from a nurse practitioner concerning a 22 year old female with latex and seaonal allergies who in September 2007, was vaccinated with a first dose of GARDASIL. On approximately 18-SEP-2007 the patient presented to the nurse practitioner with pain at the injection site, (unknown which arm), and acne of the face and opposite arm. The patient does not have a history of acne. At the time of the report the patient's outcome was unknown. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a 25 year old female patient with an allergy to ALLEGRA and CLARITIN who on 03-AUG-2007 was vaccinated in the left arm with a first dose of GARDASIL. Post vaccination immediately the patient experienced extreme pain at the injection site, and felt dizzy. Also some slight swelling at the injections site on the first day. The patient stated she still has pain at the injections site and surrounding area. When she raises her left arm it felt painful in the muscle and when she tried to grab things it hurt and it was worrying her. She stated that her left arm had never been the same since the injection. She called the physician's office. No treatment prescribed by the physician. The patient scheduled to have her second vaccination on 01-Oct-2007, and was unknown whether she will continue. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submittedon 10/12/2007. No additional information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Blood test, Fatigue, Neck pain, Sleep disorder
Clinical narrative: Information has been received from a health professional concerning her 16 year old daughter who on 10-AUG-2007 was vaccinated intramuscularly with GARDASIL (Lot # not reported). There was no concomitant medication. On 30-AUG-2007 the patient developed bilateral joint pain in most joints up to and including her neck. The pain has caused a lack of sleep leading to fatigue. X-rays of her joint were normal. Blood work results are pending. She has been taking Naprosin 500 mg twice daily for pain. The patient's bilateral joint pain in most joints up to and including her neck persisted. The patient sought unspecified medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: X-ray abnormal
Clinical narrative: Information has been received from a health professional concerning her 16 year old daughter who on 10-AUG-2007 was vaccinated intramuscularly with GARDASIL (Lot # not reported). There was no concomitant medication. On 30-AUG-2007 the patient developed bilateral joint pain in most joints up to and including her neck. The pain has caused a lack of sleep leading to fatigue. X-rays of her joint were normal. Blood work results are pending. She has been taking Naprosin 500 mg twice daily for pain. The patient's bilateral joint pain in most joints up to and including her neck persisted. The patient sought unspecified medical attention. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female with irritable bowel syndrome, migraine headaches, and no drug allergies, who on 16-AUG-2007 was vaccinated intramuscularly in the left arm with 0.5mL first dose of GARDASIL (Lot# 0469U). Concomitant therapy included ibuprofen and LEVSIN, reported as "Levicid." Subsequently the patient experienced no outward signs but experienced pain on her entire left arm. She was treated with ibuprofen every 6 hours but the pain did not resolve. The patient called the office. No laboratory diagnostics were performed. The patient had an appointment to be seen on 21-SEP-2007. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated with a dose of GARDASIL. Subsequently, the patient did not feel well 15 minutes after the vaccination. The patient sought medical attention during the time she was in the office. The patient recovered on an unspecified date on the same day as the vaccination. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a 16 year old female who on approximately 20-SEP-2007 was vaccinated IM with the third dose of GARDASIL (Lot#not reported). On approximately 20-SEP-2007 the patient stated that it was a little painful in my legs, but that might have to do with the fact I swim everyday for 3 hours". At the time of this report it was not known if the patient had recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pallor, Presyncope
Clinical narrative: Information has been received from a nurse concerning an approximately 14 year old female who on an unspecified date was vaccinated with the first dose of GARDASIL (Lot # not reported). Concomitant therapy included MENACTRA and other unspecified injections. The nurse reported that a few minutes after receiving the vaccination the patient had no color in her face. The nurse stated that it was a "near fainting episode". The nurse laid her down and gave her apple juice. Subsequently the patient recovered. She stated that she works in a large clinic and they have now made it a policy to observe the patients for 20 to 30 post vaccination. Additional informtion has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Injection site pain
Clinical narrative: Information has been received from a nurse concerning a 17 year old female who on 12-SEP-2007 was vaccinated IM with the third dose of GARDASIL (Lot # and dates of previous doses not reported). On 19-SEP-2007 the patient's mother called the office to report that post vaccination (exact onset not report) the her daughter complained of dizziness and that on 13-SEP-2007 she experienced that her left arm hurt at the injection site (pain reported as a 3 on a 1-5 scale). The nurse in the office instructed the mother to massage the patient's arm and give the patient Tylenol for the pain. Experienced dizziness and left arm hurt at the injection site. At the time of this report it was not known if the patient had recovered from the event. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Information has been received from a nurse concerning a 12 year old female who on 14-MAY-2007 was vaccinated with the first dose of GARDASIL (Lot#653735/0688F). On an unspecified date post vaccination the patient developed plantar warts. The patient's plantar warts perisited. The patient sought unspecified medical attention. At the time of the report she had not recovered from the event. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/12/2007. Initial and follow up information has been received from a nurse concerning a 12 year old female who on 24-MAY-2007 was vaccinated with the first dose of GARDASIL (Lot#651735/0688F). Other vaccinations that day included DTP. On 04-SEP-2007 the patient developed plantar warts. The patient's plantar warts persisted. The patient sought unspecified medical attention. At the time of the report it was not known if she had recovered from the event.
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Injection site pain
Clinical narrative: Information has been received from a physician and medical assistant concerning a female who was vaccinated with a dose of GARDASIL. The physician reported that the patient was vaccinated with GARDASIL and experienced severe injection site pain, and was unable to go to work. The medical assistant reported that the patient will see a specialist for the event. The patient's outcome was unknown. The medical assistant reported that doesn't believe that the severe injection site pain was related to GARDASIL. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Flushing
Clinical narrative: Information has been received from a health professional concerning a 24 year old female who on 15-JUL-2007 was vaccinated IM with a first dose of Gardasil. There was no concomitant medication. On 20-SEP-2007 the patient was vaccinated IM with a 0.5 ml second dose of Gardasil Lot # 658560/1062U). While the patient was in the office she experienced dizziness and flushing shortly after receiving the second vaccination. The patient was told to lay down and within twenty minutes she recovered and was able to leave the office on her own. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/12/2007. Follow-up information was received from the physician's office. The patient stated after that hse watched the needle which caused her to feel dizzy etc. Additional information is not expeceted.
Age: 25.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Information and f/u has been received from a registered nurse concerning a 25 year old female with no known allergies or reported medical conditions who on 18-SEP-2007 was vaccinated IM into the right deltoid with a first dose of Gardasil (Lot # 656371/0181U). Concomitant therapy included MENACTRA intramuscular in the left deltoid. On 18-SEP-2007 shortly after receiving the first vaccination of Gardasil the patient felt lightheaded, and fainted. It was reported that she lost consciousness for five - ten seconds and revived on her own. The patient was laid down on the floor and given soda and cold compresses. A full recovery was made within 20 minutes. The nurse followed up with a phone call on 19-SEP-2007 to her family and she was reported to be fine. Unspecified medical attention was sought. No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who on approximately 13-SEP-2007 was vaccinated with Gardasil (Lot # not reported). Subsequently post vaccination the patient fainted. Subsequently, the patient recovered after about 20 minutes. Unspecified medical attention was sought. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Asthenia, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with drug hypersensitivity to AUGMENTIN. Who on 18-JUL-2007 was vaccinated IM into the right deltoid with a 0.5 ml first dose of Gardasil (Lot # 658222/0927U). Concomitant therapy included MENACTRA given in alternative site. The physician reported that on 19-SEP-2007, the patient developed a fever of 100F-102F, fatigue, headache off and on, mayalgia. malaise and was weak. It was reported that there was no rash or other systemic symptoms. Unspecified medical attention was sought. The patient's fever lasted for four days. Subsequently, the patient recovered from the fatigue, fever, malaise, myalgia and headache off and on and was weak.   Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with drug hypersensitivity to AUGMENTIN. Who on 18-JUL-2007 was vaccinated IM into the right deltoid with a 0.5 ml first dose of Gardasil (Lot # 658222/0927U). Concomitant therapy included MENACTRA given in alternative site. The physician reported that on 19-SEP-2007, the patient developed a fever of 100F-102F, fatigue, headache off and on, mayalgia. malaise and was weak. It was reported that there was no rash or other systemic symptoms. Unspecified medical attention was sought. The patient's fever lasted for four days. Subsequently, the patient recovered from the fatigue, fever, malaise, myalgia and headache off and on and was weak.   Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 22-AUG-2007 was vaccinated intramuscularly with the third, 0.5 mL dose of Gardasil. It was reported that after the patient received her third dose of Gardasil she experienced severe headaches. The lot numbers for all three doses of Gardasil are not known. The date of administration for the first and second dose of Gardasil are not known. The patient sought unspecified medical attention. The patient's parent had contacted the physician. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Apgar score normal, Blood human chorionic gonadotropin positive, Delivery, Drug exposure during pregnancy
Clinical narrative: Information has been received through the Merck pregnancy registry, from a physician, via a company representative, regarding an 18 year old female patient, who on 05-FEB-2007 was vaccinated with the first dose, 0.5 ml, of GARDASIL (lot #653736/0014U), and on 13-JUN-2007 with the second dose of GARDASIL (lot #655165/0137U). On 16-AUG-2007, the patient had her LMP, and was unknowingly pregnant when on 13-SEP-2007 she was vaccinated with the third dose of GARDASIL (lot #657872/0515U). On approximately 15-SEP-2007 (possibly 16-SEP-2007), she visited the ER with abdominal cramps and pain, and had a positive pregnancy test. On 20-SEP-2007 she visited the physician's office, and the abdominal cramps and pain had resolved; a second pregnancy test was performed and was positive. The estimated date of delivery was 22-MAY-2008. This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow up information has been received through the Merck pregnancy registry for GARDASIL and from a physician and a licensed practical nurse regarding an 18 year old female patient, who on 05-FEB-2007 was vaccinated with the first dose, 0.5 ml, of GARDASIL (lot #653736/0014U), and on 13-JUN-2007 with the second dose of GARDASIL (lot #655165/0137U). On 16-AUG-2007, the patient had her LMP, and was unknowingly pregnant when on 13-SEP-2007 she was vaccinated with the third dose of GARDASIL (lot #657872/0515U). On approximately 15-SEP-2007 (possibly 16-SEP-2007), she visited the ER with abdominal cramps and pain, and had a positive pregnancy test. On 20-SEP-2007 she visited the physician's office, and the abdominal cramps and pain had resolved; a second pregnancy test was performed and was positive. On 16-APR-2008 the patient had an ultrasound for assessment at 35 weeks, 4 days with a normal result. On a unspecified date the patient developed gestational diabetes during her pregnancy. The outcome of the gestational diabetes was unknown. On 01-MAY-2008 the patient had a vaginal delivery of a full-term, healthy, and normal female, weight 6 lbs. 11 oz. with an Apgar score of 8/9. The reporter stated that the patient developed gestation diabetes during the pregnancy which "had nothing to do with the vaccine." Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test positive
Clinical narrative: Information has been received through the Merck pregnancy registry, from a physician, via a company representative, regarding an 18 year old female patient, who on 05-FEB-2007 was vaccinated with the first dose, 0.5 ml, of GARDASIL (lot #653736/0014U), and on 13-JUN-2007 with the second dose of GARDASIL (lot #655165/0137U). On 16-AUG-2007, the patient had her LMP, and was unknowingly pregnant when on 13-SEP-2007 she was vaccinated with the third dose of GARDASIL (lot #657872/0515U). On approximately 15-SEP-2007 (possibly 16-SEP-2007), she visited the ER with abdominal cramps and pain, and had a positive pregnancy test. On 20-SEP-2007 she visited the physician's office, and the abdominal cramps and pain had resolved; a second pregnancy test was performed and was positive. The estimated date of delivery was 22-MAY-2008. This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow up information has been received through the Merck pregnancy registry for GARDASIL and from a physician and a licensed practical nurse regarding an 18 year old female patient, who on 05-FEB-2007 was vaccinated with the first dose, 0.5 ml, of GARDASIL (lot #653736/0014U), and on 13-JUN-2007 with the second dose of GARDASIL (lot #655165/0137U). On 16-AUG-2007, the patient had her LMP, and was unknowingly pregnant when on 13-SEP-2007 she was vaccinated with the third dose of GARDASIL (lot #657872/0515U). On approximately 15-SEP-2007 (possibly 16-SEP-2007), she visited the ER with abdominal cramps and pain, and had a positive pregnancy test. On 20-SEP-2007 she visited the physician's office, and the abdominal cramps and pain had resolved; a second pregnancy test was performed and was positive. On 16-APR-2008 the patient had an ultrasound for assessment at 35 weeks, 4 days with a normal result. On a unspecified date the patient developed gestational diabetes during her pregnancy. The outcome of the gestational diabetes was unknown. On 01-MAY-2008 the patient had a vaginal delivery of a full-term, healthy, and normal female, weight 6 lbs. 11 oz. with an Apgar score of 8/9. The reporter stated that the patient developed gestation diabetes during the pregnancy which "had nothing to do with the vaccine." Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Breast discharge, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on an unspecified dated was vaccinated with the second dose of GARDASIL. The physician reported that the patient developed a milky discharged from the nipples after the second dose of GARDASIL, "about a week ago", approximately 13-SEP-2007. The discharge lasted two days and resolved without any intervention. The patient had received the first injection of GARDASIL without a problem (date unspecified). No other information was available. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a nurse concerning an 18 year old female patient who was vaccinated with a second dose of GARDASIL. The nurse mentioned that the patient experienced menstrual changes after receiving her second injection, the nurse said "her period was off for several months". The patient was reported to be fine after her first dose of GARDASIL. The patient sought unspecified medical attention. No further information available. The outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 17 year old female who was vaccinated with a first dose of GARDASIL. Subsequently the patient passed out immediately after receiving the vaccination. The patient remained unconscious for approximately thirty seconds. On approximately 17-SEP-2007 she was vaccinated with a second dose of GARDASIL. On approximately 17-SEP-2007 approximately three minutes after vaccination, the patient called out for her mother, started humming, and then passed out. She remained unconscious for approximately thirty seconds. The patient reported that her experience after the second dose of GARDASIL was "different" from the first dose. The patient was being referred to a neurologist. Unspecified medical attention was sought. At the time of the report the patient had recovered. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Injection site pain
Clinical narrative: Information has been received from Pregnancy Registry from a 19 year old female patient who on 08-MAY-2007 was vaccinated IM with a first dose of GARDASIL and received a second dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). Patient reported that she discovered that she was one month pregnant after getting the second vaccination. She stated that she is "one of the rare people who get their period when they are pregnant. "Patient reported that on 10-JUL-2007 she developed soreness at the injection site. 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 10/12/2007, 1/7/2008.  In follow up it was reported that concomitant therapy included ORTHO TRI-CYCLEN.  Patient reported that she discovered that she was one month pregnant after getting the second vaccination.  She stated that she is "one of the rare people who get their period when they are pregnant."  Patient reported that on 10-JUL-2007 she developed soreness at the injection site.  Unspecified medical attention wsa sought by the patient.  The outcome was unknown.  A follow up telephone call was made to get pregnancy outcome information.  Patient informed that she had not yet returned for "her third shot".  No further information available at this time.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy, Erythema nodosum
Clinical narrative: Information has been received from a physician concerning a 19 year old female with penicillin allergy who was vaccinated with a dose of GARDASIL. Concomitant therapy included YASMIN. On 30-AUG-2007 the patient experienced erythema nodosum which was confirmed by biopsy. Unspecified medical attention was sought. At the time of the report the patient had not recovered. The physician was not certain that the GARDASIL was responsible or involved with the erythema nodosum. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female with no pertinent medical history who on 15-AUG-2007 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (Lot #657617/0384U). Concomitant therapy included MENACTRA, hepatitis A virus vaccine (manufacturer unspecified) and diphtheria toxoid (+) pertussis acellular vaccine (manufacturer unspecified) (+) tetanus toxoid. On 15-AUG-2007 10 minutes after vaccination the patient fainted. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. On 15-AUG-2007 the patient recovered. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old female with no pertinent medical history who on 16-MAY-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (Lot #656050/0245U).  It was unknown if the dose was tolerated.  On 18-JUL-2007 the patient was vaccinated intramuscularly with a 0.5 ml second dose of Gardasil.  There was no concomitant therapy.  On 18-JUL-2007 the
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a pharmacy technician concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil (lot# unknown).  Subsequently the patient complained of pain when receiving the Gardasil injection.  Medical attention was sought.  At the time of reporting it was unknown if the patient had recovered.  The pharmacy technician wanted to know if Gardasil could be warmed a little prior to giving thinking that the temperature of the vaccine could be causing the pain.  No additional information was available at this time.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Syncope
Clinical narrative: Information has been received from a physician concerning a female who on approximately 13-SEP-2007 was vaccinated with Gardasil.  On approximately 13-SEP-2007 the patient fainted and hit head after receiving the vaccination.  Subsequently, per the nurse, the patient is fine and recovered from fainting and hitting her head.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Contusion, Injection site bruising, Open wound
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on 06-AUG-2007 was vaccinated intramuscularly into the left arm with her first dose of Gardasil.  There was no concomitant medication.  On 20-AUG-2007 the patient broke out in bruises on both arms from the elbow to the shoulder.  The bruises in the arm pit areas became open sores.  The patient is recovering.  The patient's mother sought medical attention by calling the doctor's office.  The patient has a drug reaction/allergy to VICODIN.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Contusion
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on 06-AUG-2007 was vaccinated intramuscularly into the left arm with her first dose of Gardasil.  There was no concomitant medication.  On 20-AUG-2007 the patient broke out in bruises on both arms from the elbow to the shoulder.  The bruises in the arm pit areas became open sores.  The patient is recovering.  The patient's mother sought medical attention by calling the doctor's office.  The patient has a drug reaction/allergy to VICODIN.  Additional information has been requested.