chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a 20 year old female who on unspecified dates was vaccinated with the first and second dose of Gardasil (lot#unknown). On 18-JUN-2007 the patient was vaccinated with a third dose of Gardasil (lot # 658490/0802U) IM. Concomitant therapy included hormonal contraceptives (unspecified). On 18-JUN-2007, the patient fainted within minutes of being vaccinated. Medical attention was sought. The patient was taken to the ER. At the time of reporting the patient had recovered. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Tremor
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified day was vaccinated with a first dose of Gardasil (lot # unknown) injection. On an unspecified day the patient was vaccinated with a second dose of Gardasil (lot # unknown) injection. On an unspecified date, "the patient's legs started to shake and she felt dizzy and faint after receiving the second dose of Gardasil. Medical attention was sought. The patient had to stay in the office for an hour to make sure she was alright". At the time of reporting the patient recovered on an unspecified date. No further adverse event information was provided. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient with no medical history and a amoxicillin allergy who on 28-FEB-2007, was vaccinated IM with a first dose of GARDASIL (Lot# 653735/0688F). Concomitant therapy included hormonal contraceptives (unspecified). On 28-FEB-2007 later in the evening, the patient developed hives on her body. The patient took BENADRYL for the hives and the following morning the hives subsided. No laboratory diagnostic studies were performed. On an unknown date, the patient recovered. It was also reported that the patient is late for the second dose as of 24-JUL-2007 and has still not received the second dose. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2007. Initial and follow-up information has been received from a physician concerning a 18 year old female student with mild/intermittent reactive airway disese and a amoxicillin allergy, and a history of a viral illness in early February (2/3 x 1 week), who on 28-FEB-2007 at approximately 15:10, ws vaccinated IM with a first dose of GARADSIL (Lot# 653735/0688F). Concomitant therapy included hormonal contraceptives (unspecified). On 28-FEB-2007 at approximately 17:00, one to two hours after the vaccination (previously reported at later in the evening), the patient developed hives on her body. The patient took a dose of BENADRYL for the hives. On 28-FEB-2007 the patient recovered (previously reported as "the following morning the hives subsided"). No laboratory diagnostic studies were performed. It was also reported that the patient is late for the second dose as of 24-JUL-2007 and has still not received the second dose. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Syncope
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2007. Information has been received from a nurse concerning a female patient who was vaccinated with a 0.5ml dose of GARDASIL. Subsequently, the patient fainted and felt fatigue. Unspecified medical attention was sought. On an unspecified date, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pelvic inflammatory disease, Urinary tract infection
Clinical narrative: Information has been received from a nurse practitioner concerning an approximately 19 year old female patient who was vaccinated with a second dose of Gardasil. Subsequently, the patient developed symptoms of a urinary tract infection and was placed on an antibiotic. The patient was then diagnosed with pelvic inflammatory disease and was treated with FLAGYL. 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.
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Neuropathy peripheral, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the first dose of Gardasil and had tingling in both legs after the vaccination. The physician is doing follow up tests to see if the patient had peripheral neuropathy. Medical attention was sought. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the second dose of Gardasil and then missing her menstrual cycle the following month. Medical attention was sought. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow-up information has been received from a physician and a registered nurse practitioner concerning a 15 year old female student, with no pertinent medical history, who on 10-NOV-2006 at 11:06 am, was vaccinated IM in the right hip with a first dose of GARDASIL (lot # 653736/0868F). On 12-JAN-2007 at 17:35, the patient was vaccinated IM in the left arm with a second dose of GARDASIL (lot # 655165/1425P). On 11-MAY-2007 at 16:07, the patient was vaccinated IM in the right arm with a first dose of GARDASIL (lot # 653726/0868F). Concomitant medication included hormonal contraceptives (unspecified). On 13-JUL-2007, the patient missed her menstrual period (also reported as skipping her menstrual period after the first two vaccines). It was also reported at the same time the patient stopped taking hormonal contraceptives (unspecified). The patients menstrual period resumed the following month. At the time of the report, the status of the patient was unknown. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female who on 17-JUL-2007 was vaccinated with a dose of Gardasil. On 23-JUL-2007 the patient developed a nodule underneath the skin at injection site. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously received from a nurse practioner and a registered nurse concerning a 22 year old white with PENICILLIN allergy who on 17-Jul-2007 was vaccinated intramuscularly in the deltoid with a second dose of GARDASIL (657868/0532U). On 23-Jul-2007 the patient complained of a hard lump at the injection site with soreness and exam revealed a pea sized module underneath the skin at injection site. The patient was treated with warm soaks and resting the arm. The patient reported doing heavy lifting. There were no laboratory or diagnostic testes performed. Unspecified medical attention was sought. Subsequently, the patient recovered. On 01-Oct-2007 there was no new information was reported. Additional information has been requested. This is in follow-up to report(s) previously sumitted on 8/14/2007
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient who was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil. Subsequently the patient became dizzy and passed out. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Information has been received from a health professional concerning her 16 year old daughter who on 15-JUN-2007 was vaccinated with a first dose of Gardasil. on 01-JUL-2007 the patient developed joint pain in her fingers. It was reported that the patient developed joint pain one week after initial dose of vaccination. Staff member stated that her daughter plan on receiving her second injection as per schedule. Unspecified medical attention was sought by the patient. Subsequently, the patient recovered. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a certified medical assistant concerning a 21 year old female with a penicillin allergy who on 16-JAN-2007 was vaccinated with the first dose of Gardasil (lot #655619/1427F), single dose, IM. Concomitant therapy included drospirenone (+) ethinyl estradiol (YASMIN). On 16-JAN-2007, the patient had a pap smear performed and the results indicated "positive high risk HPV". The patient sought unspecified medical attention. On 14-MAR-2007, the patient was vaccinated with the second dose of Gardasil (lot #654702/0011U), single dose, IM. On 16-JUL-2007, the patient was vaccinated with the third dose of Gardasil (lot #657868/0523U), single dose, IM. At the time of reporting, it was unknown whether any symptoms have been reported. The outcome of the event was not reported. No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hypoaesthesia, Pyrexia, Vomiting
Clinical narrative: Information has been received from a nurse concerning a 12 year old female who on an unspecified date was vaccinated with the first dose of Gardasil. Concomitant medication was not reported. Subsequently on an unspecified date, the patient presented with light fever, vomiting, headache and numbness from the neck to the arm after being vaccinated with Gardasil. The patient sought unspecified medical attention. The physician thought that the patient had a virus and that the events were not connected to the Gardasil. It was reported that the patient will continue the vaccination series. Subsequently on an unspecified date, the patient recovered from light fever, vomiting, headache and numbness from neck to the arm. The physician felt that light fever vomiting, headache and numbness from neck to the arm were not related to therapy with Gardasil. NO product quality complaint was involved. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a certified medical assistant concerning a 18 year old patient with no pertinent medical history and drug/reactions/allergies who on 10-JAN-2007 was vaccinated with a first dose of Gardasil (lot# 655619/1427F) IM. Concomitant therapy included NUVARING and ORTHO EVRA. On 12-MAR-2007 the patient was vaccinated with a second dose of Gardasil (lot# 6654702/0011U). On 06-MAY-2007 the patient had a cervical smear and was reported as negative. On 13-JUL-2007 the patient was vaccinated with a third dose of Gardasil (lot# 657868/0523U). On 13-JUL-2007 the patient had a cervical smear and was positive for high risk HPV. It was unknown if any symptoms have been reported. No further information is available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning three female patients who on unspecified dates were vaccinated with first doses of Gardasil (lot # unknown) injection and fainted. Medical attention was sought. On unspecified dates at the time of reporting all three patient's recovered. No additional information was provided. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female who on 18-JUL-2007 was vaccinated with a first dose of Gardasil (lot # 658100/0525U) injection in the upper deltoid. On 19-JUL-2007 the patient woke up with hives generalized over her body. The hives continued to get worse and she sought medical attention at an urgent care facility. At the time of reporting the patient had not recovered from the hives. No further information was given. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Information has been received from a receptionist at a physician's office concerning her 12 year old granddaughter who on 09-JUL-2007 was vaccinated with a first dose of Gardasil (lot# unknown) IM injection. On 11-JUL-2007, 2 days post vaccination the patient had experienced nausea, headache and dizziness. Medical attention was sought. At the time of reporting the patient recovered from nausea, headache and dizziness. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of Gardasil and fainted, but recovered a short time after the vaccination. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Rash
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 10-JAN-2007 was vaccinated with a first dose of Gardasil (lot # 657006/0188U) injection. On 12-MAR-2007 after vaccination with a second dose of Gardasil (lot # unknown). Concomitant therapy included drospirenone (+) ethinyl estradiol (YASMIN). Subsequently the patient experienced flat rashes on both her arms and chest after going out into the sun. Medical attention was sought. On an unspecified date the patient had recovered. The mother of the patient mentioned that she took the patient to a travel clinic for an unrelated cause and was told by a nurse there that patient's receiving the Gardasil vaccination should not have sun exposure for 24 hours. The patient did not have such a reaction after her first dose 10-JAN-2007. On 25-JUL-2007 the patient received her third dose of Gardasil. No additional information was provided. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: DTAP, HPV4, IPV
Symptoms: Pallor, Syncope
Clinical narrative: Information has been received from a physician assistant concerning between a 12 to 14 year old female who on an unspecified date "a couple of weeks ago" was vaccinated with a first dose of Gardasil (lot # 655619/1427F) IM in the left deltoid at 10:35 AM. Concomitant therapy on the same day included DTaP-IPV. On the same day as the injection the patient experienced syncope within 5 minutes of receiving her first dose of Gardasil. Medical attention as sought. The patient recovered quickly and completely and walked out of the office. No additional information was provided. Follow-up information was received. The patient had no previous pertinent medical history, drug reactions/allergies or illness at the time of vaccination. The patient was ambulated to the bathroom after injections. The patient fainted at 10:45 AM while in the bathroom per mom. The patient was taken to the patient room. The patient's feet were elevated, skin was pale, unable to get a blood pressure reading, the patient was alert at 10:55 the patient felt better. The blood pressure measurement was 100/58. At 12:10 PM the patient left with mom, the skin was pink. The patient stated that she feels much better. On 07-SEP-2007, the patient recovered. Additional information has been requested.  Additional infromation is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Abdominal tenderness, Back pain, Computerised tomogram, Culture stool
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 22-DEC-2006 was vaccinated with a first dose of Gardasil (lot# unknown) injection. In February 2007, the patient came to the office complaining of abdominal pain, vomiting, nausea. Medical attention was sought. The physician sent the patient to the emergency room because she felt abdominal tenderness. At the hospital, the patient had a computed axial tomography (CT scan) but no results were reported. On an unspecified date 2 days after the emergency room visit, the patient reported diarrhea. The outcome of the event was not reported. On 14-MAR-2007 the patient received a second dose of Gardasil. In May 2007, the patient reported she experience backpain, tingling in the fingers and felt lightheaded. On an unspecified date the patient had a pelvic ultrasound and a stool culture but no results were reported. On 12-JUL-2007 the patient received a third dose of Gardasil. On 24-JUL-2007 the patient experienced stomach pain but no diarrhea or fever. The patient stated that she has had stomach pain on and off since February. The physician referred the patient to a GI specialist. At the time of reporting the patient has not recovered. No additional information was provided. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Dizziness, Nausea, Paraesthesia, Ultrasound pelvis
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 22-DEC-2006 was vaccinated with a first dose of Gardasil (lot# unknown) injection. In February 2007, the patient came to the office complaining of abdominal pain, vomiting, nausea. Medical attention was sought. The physician sent the patient to the emergency room because she felt abdominal tenderness. At the hospital, the patient had a computed axial tomography (CT scan) but no results were reported. On an unspecified date 2 days after the emergency room visit, the patient reported diarrhea. The outcome of the event was not reported. On 14-MAR-2007 the patient received a second dose of Gardasil. In May 2007, the patient reported she experience backpain, tingling in the fingers and felt lightheaded. On an unspecified date the patient had a pelvic ultrasound and a stool culture but no results were reported. On 12-JUL-2007 the patient received a third dose of Gardasil. On 24-JUL-2007 the patient experienced stomach pain but no diarrhea or fever. The patient stated that she has had stomach pain on and off since February. The physician referred the patient to a GI specialist. At the time of reporting the patient has not recovered. No additional information was provided. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 22-DEC-2006 was vaccinated with a first dose of Gardasil (lot# unknown) injection. In February 2007, the patient came to the office complaining of abdominal pain, vomiting, nausea. Medical attention was sought. The physician sent the patient to the emergency room because she felt abdominal tenderness. At the hospital, the patient had a computed axial tomography (CT scan) but no results were reported. On an unspecified date 2 days after the emergency room visit, the patient reported diarrhea. The outcome of the event was not reported. On 14-MAR-2007 the patient received a second dose of Gardasil. In May 2007, the patient reported she experience backpain, tingling in the fingers and felt lightheaded. On an unspecified date the patient had a pelvic ultrasound and a stool culture but no results were reported. On 12-JUL-2007 the patient received a third dose of Gardasil. On 24-JUL-2007 the patient experienced stomach pain but no diarrhea or fever. The patient stated that she has had stomach pain on and off since February. The physician referred the patient to a GI specialist. At the time of reporting the patient has not recovered. No additional information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Syncope
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with a dose of Gardasil (lot# unknown) 0.5 mL IM. On an unspecified date the patient experienced an anxiety attack and fainted. Medical attention was sought. The patient recovered on the same day as the vaccination was given. No additional adverse event information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007. Follow-up information was received. It was reported that this was a vasovagal reaction to the needle not an adverse reaction to the vaccine. The patient often gets following any procedure. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Rash
Clinical narrative: Information has been received from a pharmacist concerning a female who on 13-JUL-2007 was vaccinated with a second dose of Gardasil. On 14-JUL-2007 the patient developed pink bumps around injection site, and scattered bumps on legs, arms, and torso. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female student with no medical history, who on 23-JUL-2007 was vaccinated intramuscularly with a first dose of Gardasil (Lot# 656051/0244U) at 11:00. Subsequently, at 11:20 the patient fainted in the lobby as she walked out of the office and she lost consciousness for less than one minute. There were no illnesses at the time of the vaccination. The patient sought unspecified medical attention. On 23-JUL-2007 the patient recovered. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated with a first dose of Gardasil. Subsequently, the patient fainted. The patient sought unspecified medical attention. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 15 or 16 year old female with a history of "getting dizzy", who, on an unspecified date, was vaccinated with a 0.5mL dose of Gardasil. On 24-JUL-2007, the patient fainted. The patient sought unspecified medical attention. On 24-JUL-2007, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal haemorrhage
Clinical narrative: Information has been received from a certified medical assistant concerning a 20 year old female, who in May-2007 was vaccinated with a first dose of Gardasil. Subsequently, the patient developed vaginal bleeding for about a month. On 23-JUL-2007 the patient was vaccinated intramuscularly with a 0.5mL second dose of Gardasil. Subsequently, the patient developed vaginal bleeding again. The patient was not due for menses. At the time of the report, the patient's outcome was unknown. The physician felt that the vaginal bleeding was unrelated. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow-up information has been received from a certified medical assistant concerning a 21 year old female, who on 16-MAY-2007 at 11:20 was vaccinated in the left deltoid with a first dose of GARDASIL (Lot# 657736/0389U). On 16-MAY-2007 at 11:20 the patient developed vaginal bleeding for about a month. On 23-JUL-2007 at 11:15 the patient was vaccinated intramuscularly in the left deltoid with a 0.5mL second dose of GARDASIL (Lot# 658222/0927U). On 23-JUL-2007 at 11:15 the patient developed some spotting for 1 week that was not related to her cycle (also reported as vaginal bleeding). The patient was not due for menses. The physician felt that the vaginal bleeding was unrelated. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a physician concerning a 13 year old female who was vaccinated with a dose of Gardasil. The reporter reported that the patient claimed to have been infected by the Gardasil. The nurse who took the report reported that it was her understanding that the patient developed a case of condyloma  and physician wanted to know more information about the Gardasil vaccine to share with the patient's parents. The outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female, who in May 2007, was vaccinated with a first dose of Gardasil. On 26-JUL-2007 the patient received a second dose of Gardasil at 09:50. Subsequently, the patient fainted for 30 seconds. The patient was sitting in a chair in the lobby when she fainted. She did not fall off the chair. The patient left the office around 10:05. The physician reported that the patient did not eat anything before receiving the vaccination and it was also reported that the patient may have been nervous about getting the vaccination. The patient sought unspecified medical attention. On 26-JUL-2007 the patient recovered. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow-up information has been received from a physician concerning a 16 year old whhite female student with no drug allergies, who in May 2007, was vaccinated with a first dose of GARDASIL. On 26-JUL-2007 the patient was vaccinated intramuscularly in the right deltoid with a second dose of GARDASIL (lot# 658094/0524U) at 10:10 (previously reported as 09:50). Subsequently, the patient fainted for 30 seconds. The patient was sitting in a chair in the lobby when she fainted. She did not fall off the chair. The patient left the office around 10:05. The physician reported that the patient did not eat anything before receiving the vaccination and it was also reported that the patient did may have been nervous about getting the vaccination. The patient sought unspecified medical attention. On 26-JUL-2007 the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Brachial plexopathy, Hypoaesthesia, Skin test, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female who on 16-NOV-2006 was vaccinated in the left arm with a first dose of Gardasil. On 16-NOV-2006 the patient experienced left hand numbness. The patient recovered after a couple of minutes. On 24-JAN-2007, the patient was vaccinated in the left arm with a second dose of Gardasil. On 24-JAN-2007 the patient experienced left hand numbness. The patient recovered after a couple of minutes. On On 16-JUL-2007 (previously reported as 20-JUL-2007),  the patient was vaccinated in the left arm with a third dose of Gardasil. On 21-JUL-2007 the patient woke up with the numbness in her left hand. The patient had no ascending numbness, no soreness, no local tenderness nor swelling.  The patient sought unspecified medical attention. A "pen prick test (villianbrea test)" was performed. The patient was diagnosed with brachial plexopathy. The patient's brachial plexopathy persisted. On an unspecified date, the patient recovered.  Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Syncope, Tachycardia
Clinical narrative: Information has been received from a licensed practical nurse and a registered nurse concerning a 13 year old female, with no pertinent medical history, who on 09-JUL-2007, while seated, was vaccinated IM in the left deltoid with a first dose of Gardasil (lot # 656371/0181U). There was no concomitant medication. Two minutes after the vaccination the patient stood up and fainted. She also experienced tachycardia, diaphoresis and felt lightheaded everytime she tried to sit up or stand. The patient laid on the floor with her feet up over a chair, and was monitored for abut 40 minutes post vaccination. Subsequently, the patient recovered from fainting, tachycardia, diaphoresis and lightheadedness. About 1 hour after the vaccination the patient left the office. No laboratory or diagnostic tests were performed. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 8/14/2007. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of Gardasil. Subsequently, the patient developed a lump. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning 5 females (age not reported) who on unspecified dates was vaccinated with a dose of Gardasil (lot# unknown). On unspecified dates the patients fainted. The patients all recovered within half an hour. No further information was provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a patient (age and geneder not identicated) was vaccinated with a dose of GARDASIL vaccine. The physician reported that the patient fainted after receiving the dose of GARDASIL vaccine. No further information about the AE available. The patient recovered "either on 25-JUL-2007 or 26-JUL-2007". This is in follow-up to report (s) previously submitted on 8/14/2007. Initial and follow up information has been received from a physician concerning a 18 year old female patient who on August 2007, was vaccinated IM in the deltoid with a dose of GARDASIL. The patient recovered. The physician reported that one other patient fainted after receiving a dose of GARDASIL vaccine. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a Physician Assistant concerning a 15 year old female with a history of syncope with vaccinations who on 24-JUL-2007 was vaccinated with the first dose of Gardasil (Lot # 657872/0515U). Immediately post vaccination on 24-JUL-2007 the patient experienced syncope. It was reported that the patient completely recovered within 20 minutes. The patient's mother reported to the physician assistant that her daughter had a history of fainting during vaccinations. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Body temperature increased, Headache, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with Gardasil. Subsequently the patient experienced elevated temperature, headache and swollen arm. At the time of the report, the outcome of the patient was unknown. This is one of two reports from the same source.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old female with no pertinent medical history who on 18-JUL-2007 was vaccinated with a first dose of Gardasil. There was no concomitant medication. On 18-JUL-2007 the patient experienced syncope within five minutes of the injection. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site mass
Clinical narrative: Information has been received from a nurse, via a company representative, concerning an unknown number of female patient's, who were vaccinated IM, with a dose of GARDASIL vaccine (yeast) (Lot # not provided). The nurse stated that "on a couple of occasions" a lump formed almost immediately at the injection site. The nurse confirmed that the lumps dissipated within 1 to 2 weeks. The patient sought unspecified medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additinal information will be provided if available. Additional information has been requested. This in follw-up  to report(s) previously submitted on 8/14/2007. Initial and follw information has been recieved from a nurse concerning approximately ten female patients, aged 17 to 19 years., who were vaccinated IM witha 1 to 1.5 gauge needle witha adose of GARDASIL vaccine (yeast) (lot # 657736/0389U). The nurse stated that a lump formed almost immediately
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Laboratory test, Syncope
Clinical narrative: Information has been received from a licensed visiting nurse (LVN), via a company representative, concerning a female patient (age not specified), who on 26-JUL-2007 was vaccinated with the first dose of Gardasil (Lot # not provided). About 15 minutes after the vaccination was administered the patient fainted, and then developed "a big knot on her head." Unspecified blood work was ordered (results not provided). The nurse confirmed that the patient's condition had improved. The patient sought unspecified medical attention. The nurse reported that an additional patient (age and gender not specified) fainted after vaccination with Gardasil (Lot # not provided) (WAES #0707USA05016). Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 05-JUL-2007 was vaccinated with the first dose of Gardasil. (Lot # not provided). Subsequently on 06-JUL-2007 the patient developed a rash behind both ears. The patient was treated at a local  center with Benadryl and an unspecified topical corticosteroid. Subsequently on an unspecified date the patient recovered from the rash. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007
Sex: F
Vaccine: HPV4
Symptoms: Dysgeusia, Nausea, Vomiting
Clinical narrative: Information has been received from a pharmacy technician concerning a female who on 06-JUL-2007 was vaccinated by injection with Gardasil, ("lot unavailable"). On 06-JUL-2007 the patient experienced a metallic taste in mouth, nausea, vomiting and taste remained for a few hours after receiving Gardasil. The patient sought unspecified medical attention. At the time of the report the patient had recovered. No additional information was provided. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Bartholin's cyst, Lymphadenopathy, Pharyngitis streptococcal
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female with penicillin allergy and allergy to erythromycin who on 10-JUL-2007, was vaccinated with Gardasil. Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLEN). It was reported that 10 days after the patient received the second vaccination with Gardasil "they" went to the emergency room on 20-JULY-2007. The patient was treated at another physician's office (name of physician and date of visit unspecified) prior to the emergency room visit, but after vaccination with Gardasil for a sore/strept throat. The patient was  treated with clindamycin 600 mg three times a day. The patient was examined in the emergency room and found to be afebrile, with a Bartholin cyst, strep throat and lymphopathy in groin. The patient was examined in the office 3 days after the emergency room visit. The physician and the office in the case were not the office that administered the Gardasil. No other information was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a female with papilloma viral infection who was vaccinated with Gardasil. Subsequently the patient experienced a worse condition than before of the papilloma virus. At the time of the report, the outcome of the patient was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a licensed practical nurse concerning approximately nine female patients who were vaccinated intramuscularly with a 0.5 ml dose of Gardasil. Subsequently the patients became dizzy. Unspecified medical attention was sought. At the time of this report the patient's outcome was unknown. 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 one of two reports received from the same source.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning an 18 year old female who was vaccinated with a dose of Gardasil. The physician reported that the patient fainted after receiving Gardasil. No further information about the AE available. Unspecified medical attention was sought by the patient. The patient recovered "either on 25-JUL-2007 or 26-JUL-2007". The physician reported that one other patient fainted after receiving a dose of Gardasil. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Urticaria
Clinical narrative: Information has been received from a Nurse Practitioner (N.P.) concerning a 40 year old female patient who was vaccinated with a dose of Gardasil. Subsequently the pateint developed welt on both arms. She was taken to the emergency room (ER). The patient recovered. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: Familial risk factor, Injection site reaction, Lichen sclerosus, Petechiae
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a 36 year (previously reported as 25 year) old female pilot with history of vulvar warts/cervical dysp vulva tissue and with allergy to amoxicillin and ampicillin. On 17-MAY-2007, the patient was vaccinated with a first dose of Gardasil (lot # 0210U) 0.5 ml first dose of Gardasil (lot # 0210U) 0.5 ml IM in the left arm. There was no concomitant therapy. In May 2007, within a couple of days of vaccination, the patient developed petechia from and near her right elbow to and around her shoulder. The patient sought medical attention. No diagnostic tests were performed. The nurse was concerned that the patient is more susceptible because her sister had developed idiopathic thrombocytopenic purpura after getting an MMR II (WAES 0708USA01455). The patient recovered 4 days after developing the petechia. In follow up it was reported that on 21-JUL-2007 patient came to clinic for second injection and had question regarding the vaccine. It was reported that the injection was given in her right arm but it was documented injection was being given in left deltoid. Her diagnosis was reported as LICHEN sclerosis et atrophicus and she recovered. The person from Merck was contacted for patient's question. As per the data base search there was nothing about the reaction or effect in the data base a literature searrch will be done by the Merck person which would take (7-14) days to see if anything comes up. The information was reviewed with patient and it was diecided not give the second injection at that time. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature normal, Cardiac disorder, Chest discomfort, Chest pain, Headache
Clinical narrative: Information has been received from a medical assistant concerning an 18 year old female who on 24-MAY-2007 was vaccinated with a dose of Gardasil (lot #655503/0012U) 0.5 ml injection. Concomitant therapy included "DEPO" therapy unspecified. Subsequently, the patient experienced tingling and numbness in her legs, headaches, chest pressure and heart complications. At the time of reporting, the patient had recovered. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 8/14/2007; 10/8/2007. In follow-up it was reported in Medical records that the patient visited the physician's office on 24-JUL-2007, the patient an 18 year old female who on 24-MAY-2007 was vaccinated intramuscularly into the left deltoid muscle with the first dose of GARDASIL (lot # 655503/0012U) 0.5 ml injection. The patient reported that after the first injection of GARDASIL, the patient complained of numbness and tingling to the lower extremities, sharp chest pain, one week later, approximately on 31-MAY-2007. The patient stated that she received a "DEPO" shot on 03-JUL-2007. One week ago, approximately 17-JUL-2007, the patient complained of numbness to the left arm. The series of GARDASIL was discontinued. The patient stated that she took ADVIL when symptoms occurred with good relief. The patient was informed to go to the Emergency Room if symptoms re-occurred without relief. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a medical assistant concerning an 18 year old female who on 24-MAY-2007 was vaccinated with a dose of Gardasil (lot #655503/0012U) 0.5 ml injection. Concomitant therapy included "DEPO" therapy unspecified. Subsequently, the patient experienced tingling and numbness in her legs, headaches, chest pressure and heart complications. At the time of reporting, the patient had recovered. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 8/14/2007; 10/8/2007. In follow-up it was reported in Medical records that the patient visited the physician's office on 24-JUL-2007, the patient an 18 year old female who on 24-MAY-2007 was vaccinated intramuscularly into the left deltoid muscle with the first dose of GARDASIL (lot # 655503/0012U) 0.5 ml injection. The patient reported that after the first injection of GARDASIL, the patient complained of numbness and tingling to the lower extremities, sharp chest pain, one week later, approximately on 31-MAY-2007. The patient stated that she received a "DEPO" shot on 03-JUL-2007. One week ago, approximately 17-JUL-2007, the patient complained of numbness to the left arm. The series of GARDASIL was discontinued. The patient stated that she took ADVIL when symptoms occurred with good relief. The patient was informed to go to the Emergency Room if symptoms re-occurred without relief. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with a dose of Gardasil (lot # unknown) 0.5 mL injection. After receiving Gardasil the patient experienced swelling from injection site down the length of arm. Medical attention was sought. On an unspecified date the patient recovered. No further information was provided. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Rash maculo-papular
Clinical narrative: Information has been received from the Pregnancy Registry for Gardasil from a physician concerning a 15 year old female with a history of two conizations for severe dysplasia in 2006 with no drug reactions/allergies who on unspecified dates was vaccinated with first and second doses of Gardasil (lot# unknown). Concomitant therapy included Ortho-Tri-Cyclen. On approximately 31-JAN-2007, "end of January 2007", the patient experienced raised red spots on the back of arms, chest and legs. The spots come and go. When they go away, the spots turn white in color. Medical attention was sought. The patient has not recovered. On 16-MAY-2007 the patient received her third dose of Gardasil. The patient subsequently learned that she became pregnant. The date of the last menstrual period was 8-MAY-2007. Medical attention was sought. A beta-human chorionic gonadotropin test (unspecified) was performed and the results were positive for pregnancy. The estimated date of delivery is 12-FEB-2008. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness, Pain
Clinical narrative: Information has been received from a pharmacist concerning her 20 year old daughter with a latex allergy, acne and no pertinent medical history who in the middle of MAY 2007 was vaccinated with a first dose of Gardasil (lot # unknown). Concomitant therapy included acne medication (unspecified) and spironolactone. On 24-JUL-2007 the patient was vaccinated with a second dose of Gardasil and collapsed. Her daughter stated that it hurt going in. Approximately 7 to 10 minutes after the injection and while making an appointment, the patient blacked out. The patient stated to her mother that she felt woozy all night. Medical attention was sought. On 25-JUL-2007 the next day the patient had recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 15 year old female with no pertinent medical history or drug reactions/allergies who on 26-JUL-2007 was vaccinated with a first dose of Gardasil (653735/0688F) 0.5mL IM in the left deltoid muscle. There was no concomitant medication. On 26-JUL-2007 the patient experienced severe pain at the injection site of the left deltoid muscle immediately after administration of her first dose of Gardasil. The pain radiates down the left arm and the patient stated that she os unable to bend arm at the elbow. Medical attention was sought. The physician prescribed ibuprofen hcl and ice compresses. At the time of reporting the patient had not recovered. No further information was available. Additional information has been requested. Follow-up information was received. On 27-JUL-2007, the patient had recovered. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Induration
Clinical narrative: Information has been received from a registered nurse concerning a patient (age and gender not reported) who was vaccinated with the complete Gardasil series (lot # unknown) 0.5 mL midway above the arm by a medical assistant at another facility. The patient developed a hard lump for awhile after the injections (time and dose unspecified). The registered nurse did not have any additional information about this patient as it his not  her patient. The nurse was consulted about the adverse experience from another health care professional. The outcome of this report was not reported. No other details were given. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a female with papilloma viral infection who was vaccinated with Gardasil. Subsequently the patient experienced a worst condition then before of the papilloma virus. At the time of the report, the outcomes of the patient was unknown. This is one of several reports from the same source. Additional information has been requested.