chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Nausea, Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a nurse concerning her 15 year old daughter with no pertinent medical history who in October 2008, was vaccinated with the first dose of GARDASIL. The patient was vaccinated with the second and third dose of GARDASIL in December 2008 and August 2009 separately. There was no lot number reported. Concomitant therapy included YAZ. The patient experienced nausea, vomiting and diarrhea after receiving the second dose and the symptoms were resolved (date unspecified). On approximately 17-AUG-2009, the patient experienced nausea, vomiting and diarrhea after receiving the third dose of vaccine. Unspecified medical attention was sought. There were no lab studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Precancerous cells present, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning her 20 year old daughter with migraine and no drug reactions/allergies who in approximately June 2009 "approximately 3 months ago", was vaccinated with the first 0.5 mL dose of GARDASIL (lot # not reported). There was no concomitant medication. On 05-AUG-2009 the patient had a PAP test done which came back showing precancerous cell growth. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a physician concerning a 11 year old female who on approximately 27-JUL-2009 (also reported as "4 to 5 weeks ago"), was vaccinated with a first dose of GARDASIL (lot  number not reported). 2 weeks after the vaccination, the patient had hair loss. The patient contacted the physician via phone. At the time of the report, the patient's status was unknown. Follow up information was received from the physician concerning a 13 year old (not 11 as previously reported) female with no illness or other medical conditions who on 14-JUL-2009 at 17:00 was vaccinated into the left arm with the first dose of GARDASIL (lot# 659655/1486U). Approximately 4 weeks post the vaccination, on 20-AUG-2009 the patient experienced increased hair loss which lasted about 2 month. There were no laboratory diagnostic studies performed. Two months later, on approximately 04-OCT-2009, the patient recovered from hair loss. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Dizziness, Headache, Loss of consciousness
Clinical narrative: Information has been received from a physician assistant concerning a female with ovarian cyst and kidney stone who in August 2008, was vaccinated with GARDASIL. Concomitant therapy included OCELLA. The physician assistant reported that the patient received the 3rd dose of GARDASIL on 16-JUN-2009. Subsequently the patient and passed out, was dizzy and had a headache. The patient was fine when she left the office and it was unknown when the passing out and dizziness occurred. The patient did complain of a headache the day of visit before the third dose of GARDASIL was given. The patient saw a report on television and called the office to report what happened. The physician did not feel this was related to GARDASIL since the patient had a headache prior to receiving the 3rd dose. The 1st and 2nd doses were given by a different office. Subsequently, the patient recovered from passed out, dizziness, and headache. It was indicated that the patient was referred to see a neurologist. The patient sought medical attention, called and visited a physician on 19-AUG-2009. On an unknown date a CAT Scan was performed which was normal. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse concerning a female who "about 1 year ago", in approximately 2008 was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). The nurse stated that "the patient developed hives after receiving the dose of GARDASIL". The patient sought unspecified medical attention. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL. Following vaccination, the patient experienced syncope. The patient sought a physician for medical attention. The patient recovered from syncope. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Loss of consciousness, Snoring, Tremor
Clinical narrative: Information has been received from a physician concerning an approximate 14 year old female, prone to passing out, who on 28-AUG-2009 was vaccinated with a 0.5 mL dose of GARDASIL, intramuscularly. Approximately a minute after getting GARDASIL, the patient passed out and started snoring and shaking. The patient recovered on 28-AUG-2009. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Feeling hot, Inappropriate schedule of drug administration, Syncope
Clinical narrative: Information has been received from a physician concerning an 18 year old female with no medical history or drugs allergies, who on 04-JAN-2007 was vaccinated with a first dose of GARDASIL. The patient received a second dose of GARDASIL (lot # 662404/0312Y) on 17-AUG-2009. Secondary suspect vaccination given on 17-AUG-2009 included a second dose of VAQTA (manufacturer unknown). Concomitant vaccination given on 17-AUG-2009 included a second dose of MENACTRA. After the vaccination the patient sat for 15 minutes and when she stood up to leave the patient fainted. No laboratories studies performed. The physician reported that the patient recovered on 17-AUG-2009 and was then able to leave. Follow-up information has been received from a licensed vocational nurse regarding the 18 year old female patient who on 17-AUG-2009 at 9:30 a.m. was vaccinated intramuscularly in the left arm with the second dose of GARDASIL. Suspect vaccination on the same day at 9:30 a.m. in the right arm included a second dose of MENACTRA (lot # U2919AA). There was no illness at the time of vaccination and no adverse event following prior vaccination. The licensed vocational nurse reported that the patient fall out after she received the vaccines, GARDASIL and MENACTRA. It was noted that the patient was still conscious but felt hot. The patient's vital signs were re-checked and the patient was evaluated by a physician. On 17-AUG-2009 the patient had recovered. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female with no medical history or drugs allergies, who on 25-JUN-2009 was vaccinated with a 0.5 mL first dose of GARDASIL (lot # 661953/1130X, intramuscularly. There was no concomitant medication. About one week after the patient developed a mild case of hives on both arms. The hives lasted 2-3 days. No laboratories studies performed. The patient sought unspecified medical attention. At the time of this report the patient had recovered. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hypoaesthesia, Nausea
Clinical narrative: Information has been received from a physician concerning a 21 year old female who was vaccinated with a 0.5 mL first dose of GARDASIL. Subsequently the patient experienced headache, nausea and arm numbness (injection arm). The patient did not mention it to the physician until she came back to receive her second dose of GARDASIL, by that time she was already recovered. The physician did not administered the second dose at that time and wanted to check first if that would be safe because of the previous reaction. No laboratories studies performed. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Pruritus, Rash, Urticaria
Clinical narrative: Information has been received from the office manager concerning a 20 year old female with no pertinent medical history and no drug reactions / allergies who on 13-JUL-2009 was vaccinated with the first dose of GARDASIL (lot # 662300/0100Y) 0.5 mL, IM. Concomitant therapy included SEASONIQUE. On 13-JUL-2009, a few hours after vaccination, the patient experienced rash and hives on her chest, abdomen and extremities as well as itching and tingling. The patient was evaluated at a local emergency room and was prescribed BENADRYL and prednisone. The patient called the office on 03-SEP-2009, and relayed that the hives have resolved but the rash is persistent. The patient was referred to an unspecified dermatologist for evaluation. At the time of the reporting, the patient had not recovered from itching and tingling. Follow-up information was received from the office manager who reported that the student patient was vaccinated on 13-JUL-2009, with the first dose of GARDASIL (lot # 662300/0100Y) into the right deltoid. On an unknown date (previously reported as "a few hours after vaccination") the patient experienced rash and hives on chest and abdomen and extremities, tingling and itching. The patient required emergency room/doctor visit and was started on prednisone by emergicenter. No further information is expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose normal, Disorientation, Dyskinesia, Gaze palsy, Hyperhidrosis
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 year old female with no pertinent medical history reported and no known drug allergies who on 03-JUL-2009 was vaccinated intramuscularly with her first 0.5mL dose of GARDASIL (Lot number 659054/0315Y). There was no concomitant medication. On 03-JUL-2009, the patient experienced fainted in the waiting room of the office a few minutes after vaccination. She exhibited jerking movements and her eyes rolled back. The patient was monitored and fully recovered while in the office. It was reported that on 02-SEP-2009, the patient was vaccinated intramuscularly with the second dose 0.5mL of GARDASIL (Lot number 659054/0315Y). As the needle was withdrawn from her arm, she exhibited a blank stare and was unresponsive. She exhibited jerky movements and was diaphoretic. After regaining consciousness, she was pale and disoriented. Her blood pressure was "low", her pulse was 68, and her blood glucose was 98. The patient was monitored and fully recovered within 30 minutes. Follow up information was received from the licensed practical nurse. She reported that the patient did not received any vaccines at the time of the two GARDASIL doses. She reported that the physician did not comment as to whether or not the jerky movements were considered tonic-clonic, or whether or not the patient experienced a seizure. The licensed practical nurse felt that based on the speed and way in which the patient recovered, the patient did not experience a seizure. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Hypotension, Loss of consciousness, Pallor, Staring, Syncope
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 year old female with no pertinent medical history reported and no known drug allergies who on 03-JUL-2009 was vaccinated intramuscularly with her first 0.5mL dose of GARDASIL (Lot number 659054/0315Y). There was no concomitant medication. On 03-JUL-2009, the patient experienced fainted in the waiting room of the office a few minutes after vaccination. She exhibited jerking movements and her eyes rolled back. The patient was monitored and fully recovered while in the office. It was reported that on 02-SEP-2009, the patient was vaccinated intramuscularly with the second dose 0.5mL of GARDASIL (Lot number 659054/0315Y). As the needle was withdrawn from her arm, she exhibited a blank stare and was unresponsive. She exhibited jerky movements and was diaphoretic. After regaining consciousness, she was pale and disoriented. Her blood pressure was "low", her pulse was 68, and her blood glucose was 98. The patient was monitored and fully recovered within 30 minutes. Follow up information was received from the licensed practical nurse. She reported that the patient did not received any vaccines at the time of the two GARDASIL doses. She reported that the physician did not comment as to whether or not the jerky movements were considered tonic-clonic, or whether or not the patient experienced a seizure. The licensed practical nurse felt that based on the speed and way in which the patient recovered, the patient did not experience a seizure. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Unresponsive to stimuli
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 year old female with no pertinent medical history reported and no known drug allergies who on 03-JUL-2009 was vaccinated intramuscularly with her first 0.5mL dose of GARDASIL (Lot number 659054/0315Y). There was no concomitant medication. On 03-JUL-2009, the patient experienced fainted in the waiting room of the office a few minutes after vaccination. She exhibited jerking movements and her eyes rolled back. The patient was monitored and fully recovered while in the office. It was reported that on 02-SEP-2009, the patient was vaccinated intramuscularly with the second dose 0.5mL of GARDASIL (Lot number 659054/0315Y). As the needle was withdrawn from her arm, she exhibited a blank stare and was unresponsive. She exhibited jerky movements and was diaphoretic. After regaining consciousness, she was pale and disoriented. Her blood pressure was "low", her pulse was 68, and her blood glucose was 98. The patient was monitored and fully recovered within 30 minutes. Follow up information was received from the licensed practical nurse. She reported that the patient did not received any vaccines at the time of the two GARDASIL doses. She reported that the physician did not comment as to whether or not the jerky movements were considered tonic-clonic, or whether or not the patient experienced a seizure. The licensed practical nurse felt that based on the speed and way in which the patient recovered, the patient did not experience a seizure. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Fibromyalgia, Migraine, Neurogenic bladder, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a physician's assistant concerning a 22 year old female patient who in January 2009, was vaccinated with the third dose of GARDASIL. In February 2009, the patient experienced neurogenic bladder symptoms and fibromyalgia after receiving the 3rd dose of GARDASIL. On an unspecified date, a magnetic resonance image was performed; results were not reported. The patient sought medical attention with the physician's assistant. At the time of reporting the patient's outcome was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information was received from a physician's assistant who reported that the 23 year old patient (previously reported as 22 year old) had experienced multitudes of symptoms including migraines, syncope, neurogenic bladder and chest pains since GARDASIL. According to the reporter the last vaccine was given in January 2009 and the symptoms began in February 2009. The reporter mentioned that the patient has been seeing many specialist including neurologist and an urologist. The physician's assistant also reported that the patient had been to a university medical center for evaluation. The patient had emergency room visits for above. Patient was found to be vitamin D deficient and at the time of reporting she was taking supplements. The physician's assistant reported as well that GARDASIL was administered by the patient's gynecologist. It was also reported that the experiences were still being treated. The patient's outcome was unknown. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Vitamin D deficiency
Clinical narrative: Information has been received from a physician's assistant concerning a 22 year old female patient who in January 2009, was vaccinated with the third dose of GARDASIL. In February 2009, the patient experienced neurogenic bladder symptoms and fibromyalgia after receiving the 3rd dose of GARDASIL. On an unspecified date, a magnetic resonance image was performed; results were not reported. The patient sought medical attention with the physician's assistant. At the time of reporting the patient's outcome was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information was received from a physician's assistant who reported that the 23 year old patient (previously reported as 22 year old) had experienced multitudes of symptoms including migraines, syncope, neurogenic bladder and chest pains since GARDASIL. According to the reporter the last vaccine was given in January 2009 and the symptoms began in February 2009. The reporter mentioned that the patient has been seeing many specialist including neurologist and an urologist. The physician's assistant also reported that the patient had been to a university medical center for evaluation. The patient had emergency room visits for above. Patient was found to be vitamin D deficient and at the time of reporting she was taking supplements. The physician's assistant reported as well that GARDASIL was administered by the patient's gynecologist. It was also reported that the experiences were still being treated. The patient's outcome was unknown. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site mass, Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a medical assistant concerning a female with penicillin allergy and a history of Papanicolaou smear test abnormal who on 26-AUG-2009 was vaccinated with a 0.5 mL dose of GARDASIL (lot # 659054/0311Y), intramuscularly. There was no concomitant medication. The patient was having pain at the injection site, the area felt hard, and there was a lump. The patient called the office because her arm had been feeling sore. No laboratories studies performed. At the time of this report the patient had not recovered. Follow up information received on 24-SEP-2009 from a medical assistant indicated that the patient was a 23 year old female with no illness at the time of vaccination, who on 26-AUG-2009 (also reported as 16-SEP-2009) at 11:15 was vaccinated with a first dose of GARDASIL (lot # 659054/0311Y), intramuscularly into the right deltoid. On 01-SEP-2009 at 16:10 the patient developed pain at the injection site, the area felt hard, and there was a lump. The patient called the office because her arm had been feeling sore. The patient recovered on 18-SEP-2009. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Asthenia, Dizziness, Hypotension
Clinical narrative: Information has been received from a physician concerning an 11 year old female with a temperature of 101 degrees who was vaccinated with the first dose of GARDASIL, DTAP-IPV (manufacturer unknown) and meningococcal vaccine (unspecified) (manufacturer unknown). The patient experienced dizziness and low blood pressure (BP) after receiving the three vaccinations. Her blood pressure count initially was 123 over 68 and after the three vaccinations it dropped to 86/44. When the patient was released to go home, her blood pressure was 118 over unspecified reading. Lot# was not available for GARDASIL. The patient sought medical attention, saw physician. At the time of report the patient's status was unknown. Follow-up information has been received from the physician concerning the 11 year old female with no known allergies and viral pharyngitis (patient had a complaint of fever that day with sore throat and had a headache the day prior) at the time of vaccination who on 01-SEP-2009 came in the office for a scheduled physical exam and at about 10 am was vaccinated IM in the right arm with the first dose of GARDASIL (lot number 662404/0312Y). Secondary suspect vaccination on the same day included the second dose of VARIVAX (Merck) (MSD) (lot number 664325/0663Y) SC in the left arm. Concomitant therapy included the first dose of ADACEL (lot number C3219AA) IM in the left arm and the first dose of MENACTRA (lot number U3020AA) IM in the right arm. After the shots were given, the patient complained of dizziness and weakness. Her BP dropped from 123/68 to 86/44, and BP after was 108/66. No labs were taken. The patient recovered well within 10 minutes in the office. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy lymph gland normal, Lymph node pain, Lymphadenectomy, Lymphadenopathy
Clinical narrative: Information has been received from a registered nurse concerning a 18 year old female with penicillin allergy and no pertinent medical history who on 26-APR-2007, 25-JUN-2007 and 16-NOV-2007 was vaccinated IM at left deltoid with the first (655503/0012U), second (657622/0388U) and third (658560/1062U) 0.5 ml doses of GARDASIL. Concomitant therapy included NUVARING. The nurse reported that the patient experience tenderness of lymph nodes in axilla and neck after the first dose of GARDASIL. After the second dose of GARDASIL, administered on 25-JUN-2007, the same lymph nodes were painful and swollen. The patient was examined by oncologist and family physician (names not provided). One lymph node was removed by oncologist. The third dose of GARDASIL was administered on 16-NOV-2007. She experienced problems with lymph nodes over a 1.5 year period. The oncologist diagnosed her with benign reactive lymph nodes due to GARDASIL. A lymph node biopsy was performed on 24-JUL-2007, and the result was benign. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Platelet count decreased
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of GARDASIL (dose, route, and lot# not reported). Subsequently the patient experienced low platelets. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Injection site haematoma, Injection site pain
Clinical narrative: Information has been received from a certified medical assistant concerning a 25 year old female patient with no pertinent medical history and no known drug allergies who on 09-FEB-2009 was vaccinated S.Q with a 0.5 mL first dose of GARDASIL (lot # 661952/1129X), on 22-APR-2009 she received IM a second 0.5 mL dose of GARDASIL (lot # 658271/0558X) and on 02-SEP-2009 was administered with a third 0.5 mL dose of GARDASIL (lot # 662229/1497X). There was no concomitant medication. On 09-FEB-2009, after administration of the first dose of GARDASIL, the patient experienced bruising and pain at the site of injection. The patient was seen for office visit. No laboratories or diagnostics studies were performed. At the time of reporting the patient had recovered. The health care professional contacted during telephone follow-up could not supply the following information: dates of vaccination and lot number. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer concerning a 14 year old daughter with no pertinent medical history reported and no known drug allergies, who on 23-AUG-2007, 09-DEC-2008 and 06-FEB-2009 was vaccinated with first, second and third doses of GARDASIL (route and lot numbers not reported). There was no concomitant medication. The consumer stated that her daughter had injection site pain after each injection, lasting for a day. No lab studies were performed. The patient sought unspecified medical attention. Follow up information was received from a Licensed Practical Nurse (L.P.N) concerning a 16 year old (also reported as 14 year old) student patient who on 23-AUG-2007, 09-DEC-2008 and 06-FEB-2009 was vaccinated with the first, second and third doses of GARDASIL (respectively). It was reported that the patient never reported to the office any ill or complaint in regards to this vaccine. It was reported that the patient received two doses through her office and never reported anything. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Chills, Hypersensitivity, Influenza like illness, Pain in extremity
Clinical narrative: Information and follow up information has been received from a bachelor of science in nursing and a registered nurse concerning a 25 year old female patient (109 pounds, 59 inches) with dexamethasone allergy, none known birth defects or medical conditions, none known illness at the time of vaccination and none adverse event following prior vaccination, who on 05-JUN-2009 was vaccinated with the first dose of GARDASIL 0.5 ml intramuscularly. On 11-JUL-2009, the patient was vaccinated in the left deltoid with the second dose of GARDASIL (lot# 663451/0216Y). There was no concomitant medication. The patient was fine when she left the office but later the evening of 31-JUL-2009 (also reported as 11-AUG-2009) the patient started to experience back aches, leg pains, chills and flu like symptoms. Then the next day the patient started to feel a little better and went to work. The patient recovered from back aches, leg pains, chills and flu like symptoms. The patient sought unspecified medical attention. Follow up information was received from the registered nurse who stated that the patient received the second dose of GARDASIL on 31-AUG-2009 (previously reported as 11-JUL-2009) at 7 pm. The nurse reported that the same day the patient's father called at 8:05 pm stating that the patient was having an "allergic reaction" with complaints of chills, lower back pain and leg pain. "Per doctor the patient was to take TYLENOL and BENADRYL. If reaction worsened the patient was to go to the Emergency Room". On 01-SEP-2009 the nurse called patient who was feeling better per her mother. No laboratory diagnostics tests were performed. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: FLUX, HPV4, MNQ, VARCEL
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a medical assistant concerning an about 10 year old female who on 02-SEP-2009 was vaccinated with a dose of GARDASIL, influenza virus vaccine (unspecified), VARIVAX (MSD) and MENACTRA, all at the same time. The nurse reported that the patient experienced lightheadedness or dizziness but she did not pass out after receiving all the 4 vaccinations. At the time of the report, it was reported that the patient recovered "a few weeks ago". The patient sought unspecified medical attention. Follow up information was received from the medical assistant who stated that there really was no adverse experience, that they decided patient also had laboratories done and that first time just got a little nausea. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician's assistant concerning a female who about two weeks ago, on approximately 13-JUL-2009, was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). It was reported that after receiving the vaccine, the patient became lightheaded and had to lie down. The patient sought unspecified medical attention. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a physician concerning a 22 year old female patient who on unknown dates was vaccinated with the first and second dose of GARDASIL. It was reported that the patient experienced syncope immediately following her initial 2 doses of GARDASIL while she was in the physician's office. The patient was treated in the office and fully recovered before leaving. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a 27 year old female patient with arthritis who on 24-Aug-2009 was vaccinated with a 0.5 ml first dose of GARDASIL. Concomitant therapy included HUMIRA. The patient reported that on 25-Aug-2009 she experienced severe joint pain after getting her first dose of GARDASIL. At the time of this report, the patient had not recovered. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Anxiety
Clinical narrative: Information has been received from a licensed practical nurse concerning a female who was vaccinated intramuscularly with a 0.5ml dose of GARDASIL. Subsequently the patient experienced "anxiety". Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a pharmacist who heard from a nurse of the clinic next door that a female who on an unspecified date was vaccinated with a dose of GARDASIL (dose, route and lot number not reported), experienced irregular periods after vaccination. It was not specified if the patient sought medical attention. Attempts to verify the existence of an identifiable patient and reporter have been unsuccessful. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Flushing
Clinical narrative: Information has been received from a consumer concerning his daughter who in November 2008 and on 23-JUL-2009, was vaccinated with first and second doses, respectively of GARDASIL (dose, route and lot number not reported). On 23-JUL-2009, the patient felt hot and flushed all over. After 15 minutes she felt better. It was not specified if the patient sought medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure before pregnancy, Pneumonia, Ultrasound scan normal
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female for GARDASIL, a pregnancy registry product, who on 24-SEP-2008 was vaccinated with a first dose of GARDASIL. The patient received a second dose of GARDASIL, and a third dose of GARDASIL (lot # 662300/0100Y). The nurse did not have a lot number for the first and the second dose. The patient became pregnant after the third dose of GARDASIL. The patient's last menstrual period was on 03-JUL-2009 and her estimated delivery date will be on 09-APR-2010. No adverse reactions reported. The patient sought medical attention through a phone call to the health department. Follow up information received from a registered nurse indicated that the patient was a female with asthma, hypothyroidism and a previous live birth; it was also reported that the patient smokes 10 cigarettes a day not drink alcohol. Concomitant therapy included a second dose of hepatitis A virus vaccine (unspecified) (manufacturer unknown), SYNTHROID, prenatal vitamins, albuterol and ADVAIR. In December 2009 the patient had a normal ultrasound. In February 2010 the patient developed pneumonia, the was treated with antibiotics, the patient was not hospitalized because of the pneumonia. The pneumonia's outcome was unknown. On 18-APR-2010 at 41 weeks from her last menstrual period the patient gave birth to a normal female with no congenital anomalies, who weighed 8 pounds and 2 ounces. The baby's length was 20, *25. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccination site pain
Clinical narrative: Initial and follow-up information has been received from a physician and a 25 year old female consumer with no medical history and no illness at time of vaccination who on 11-MAY-2009 was vaccinated with her first dose of GARDASIL into her left deltoid (Lot # 661953/1130X). The patient mentioned that she skipped her second dose (14-AUG-2009). The patient mentioned she was two months late. The patient stated that the first vaccination was very painful "like a nail". Follow-up information from the physician's office indicated that the patient had reported no adverse effects to the physician's office. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Fall, Head injury, Loss of consciousness, Presyncope, Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 01-SEP-2009 was vaccinated with a dose of GARDASIL. The patient fainted after getting GARDASIL. She "fell and hit her head". She regained consciousness afterwards and was "fine". She was given MENACTRA and ADACEL. The patient seemed very nervous about getting the shot and had not eaten anything that day. On the same day, the patient recovered. The patient sought unspecified medical attention. Follow-up information received from the physician indicated that the patient was a female who on 01-SEP-2009 was vaccinated with her first dose of GARDASIL (Lot # 6599621/1740U), there were no illnesses at time of vaccination. Concomitant therapy included MENACTRA (Lot # U2905) administered on her right arm and ADACEL (Lot # UF457) administered on her left arm, both received on 01-SEP-2009. The physician reported that on 01-SEP-2009 the "child" had a vasovagal/passing out event. According to the physician the patient lied down on a table for 15 minutes and improved. No diagnostic tests were performed. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised, Rash pustular
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 16-JUL-2009 was vaccinated intramuscularly with first 0.5mL dose of GARDASIL (Lot number 659054/0315Y) in the left deltoid. It was noted that "the patient might have been taking SPRINTEC". Within 48 hours after vaccination, on 18-JUL-2009, the patient "experienced diffuse body itching with no rash". The patient sought unspecified medical attention. Follow up information has been received from the physician concerning the patient with egg and plant allergy and with no illness at time of vaccination who on 18-JUL-2009 experienced itching and developed pustular rash after scratching. Subsequently, the patient recovered. This is a consolidation of two reports concerning the same patient. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure systolic decreased, Dizziness, Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient with no pertinent medical history, who "about 2 weeks ago", on approximately 20-AUG-2009 was vaccinated intramuscularly with the first dose of GARDASIL, 0.5ml. The doctor stated that "about 2 weeks ago", on approximately 20-AUG-2009, the patient experienced dizziness, syncope and her systolic blood pressure dropped 20 points. It was reported that "about 2 weeks ago", on approximately 20-AUG-2009, the patient recovered from dizziness, syncope and systolic blood pressure dropped 20 points. The patient sought unspecified medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Haematology test abnormal, Hepatic enzyme increased, Infectious mononucleosis
Clinical narrative: Information has been received from an office medical assistant concerning her approximately 16 year old daughter who on an unknown date was vaccinated with the second dose of GARDASIL. On an unspecified date, after receiving the second dose of GARDASIL the patient learned that she had "mono". The patient was also feeling fatigue so she went to her physician's office and had a blood work done which showed she had elevated liver enzymes. On an unknown date the patient's liver enzymes went back to normal. At the time of reporting the patient had recovered from mononucleosis and elevated liver enzymes. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a pharmacist concerning an unspecified age female with unspecified drug reactions/allergies and medical history, who was vaccinated "3 years ago" with all three doses of GARDASIL (started in approximately in JUL-2006) (dates, routes and lot numbers unspecified). There was no concomitant medication reported. The pharmacist reported that the patient tested positive for Human Papilloma Virus (HPV) on a Pap Test. At the time of the report the outcome of the patient was not reported. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician who reported that he was contacted from another physician's office regarding a patient who on an unspecified date was vaccinated with the first dose of GARDASIL and experienced urticaria 48 hours after the first dose. The physician did not have additional details because he had not seen the patient. The outcome of the patient was not reported. It is unknown if the patient sought medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Information has been received from a medical assistant concerning a 13 year old female patient who on 31-AUG-2009 at 10:00 am was vaccinated with the first dose of GARDASIL (lot number not reported). On 01-SEP-2009, around 01:00 am, the patient woke up and she had shortness of breath. The patient's mother gave the patient BENADRYL and they called the clinic because they were worried. Per medical assistant, she followed up with the patient on 01-SEP-2009 and she learned that the patient had recovered. Follow-up information was received from the medical assistant who reported that the patient is a female with no known drug allergies or medical conditions and on 31-AUG-2009 at around 10:30 (also reported as 10:00 am) in the morning received a first dose of GARDASIL (lot# 663452/0671Y) into her left deltoid. It was reported that the patient's mother called and stated that on 01-SEP-2009 at around 1:00 am, the patient complained of trouble breathing through her nose taking a deep breath and throat feeling tight. The patient took multiple doses of BENADRYL throughout the next day. Symptoms did resolve. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Palpitations, Presyncope, Visual impairment
Clinical narrative: Information has been received from a pharmacist concerning a 21 year old female who in late 2008, was vaccinated with the first dose of GARDASIL. Concomitant therapy included ORTHO-NOVUM. Subsequently, the patient experienced "extreme chest pain, heart pounding, then became vasovagal and slid down her chair" after vaccination. During this adverse experience, the patient could hear people talking, but could not see. The patient was given oxygen at the physician's office. The patient had recovered at the time of the report. Follow-up information has been received from the pharmacist concerning her daughter who had no pertinent medical history and was allergic to papaya. The patient had no blindness involved-only a visual disturbance related to the vasovagal episode. The reporter said the patient told her that the chest pain was so bad that she thought she was having a heart attack. The only treatment was oxygen, and the patient (who never loss consciousness) recovered after about a half hour. Follow-up information has been received from a licensed practical nurse reported that the first and only dose of GARDASIL (lot# 661703/0651X) was given on 08-JAN-2009. The event details on 08-JAN-2009 were confirmed. And the patient received 4L of oxygen as treatment. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Menorrhagia, Myalgia
Clinical narrative: Information has been received from a consumer concerning her 13 year old daughter with a history of eczema and no drug allergies, who was vaccinated with her 1st dose of GARDASIL "3 months ago" on approximately 23-APR-2009. The patient would receive her 2nd dose tomorrow on 24-JUL-2009. There was no concomitant medication. Subsequently, after the vaccination her periods had been heavier than normal. She also experienced abdominal cramping, muscle pain in her legs, fatigue, fever and diarrhea. These symptoms occurred only during her period and then stopped when her period ended. The patient just started having her period 6 months ago. There were no labs and diagnostic tests performed. The patient had called the office to seek medical attention. Follow up information has been received from a registered nurse indicating that the patient is a patient of the practice but the office is unaware of an adverse event and had no further information to add. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 13 year old daughter with a history of eczema and no drug allergies, who was vaccinated with her 1st dose of GARDASIL "3 months ago" on approximately 23-APR-2009. The patient would receive her 2nd dose tomorrow on 24-JUL-2009. There was no concomitant medication. Subsequently, after the vaccination her periods had been heavier than normal. She also experienced abdominal cramping, muscle pain in her legs, fatigue, fever and diarrhea. These symptoms occurred only during her period and then stopped when her period ended. The patient just started having her period 6 months ago. There were no labs and diagnostic tests performed. The patient had called the office to seek medical attention. Follow up information has been received from a registered nurse indicating that the patient is a patient of the practice but the office is unaware of an adverse event and had no further information to add. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Abdominal discomfort
Clinical narrative: Information has been received from a physician concerning a patient's cousin who on an unspecified date was vaccinated with a dose of GARDASIL (lot # not reported) 0.5ml, intramuscularly. On unspecified date after getting the vaccine her/his stomach became "upset". The patient sought unspecified medical attention. The outcome of the stomach became "upset" was unknown. The patient's cousin was not a patient at the doctor's patient. Attempts are being made to verify the existence of an identifiable patient and reporter. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Injection site reaction, Local reaction
Clinical narrative: Information has been received from a medical assistant concerning a her about 13 year old daughter with drug reactions or allergies reported as none who on an unspecified date was vaccinated with a second dose of GARDASIL (lot # not reported) intramuscularly. On an unspecified date the patient experienced a localized reaction at the injection site that included a burning sensation. This experience only occurred after the second dose of GARDASIL. The patient did not seek medical attention. At the time on the report on 27-AUG-2009 the patient had recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female patient who on 27-AUG-2009 was vaccinated with the first of GARDASIL, lot # 0670Y. On 03-SEP-2009 the patient developed a size of a dime insect bite like appearance on the injection site, it was also reported that the injection site was hot and hard to the touch with no swelling; however, the patient had tingling in her hand and her entire arm where she had the injection was achy. Nurse practitioner noted that there was no systemic problem. The patient sought medical attention by calling the nurse practitioner. Follow up information was received from the nurse practitioner indicating that the patient was vaccinated in the left deltoid, intramuscularly, at 2 pm. Concomitant therapy included ORTHO TRI-CYCLEN. Nurse reported that on 03-SEP-2009 the patient presented with complaints of swelling at the injection site, heaty, arm achy with tingling in fingers and left hand. Additionally, nurse reported that the patient was treated with OTC (antiinflammatory) and was given ice to area as tolerated. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female patient who on 27-AUG-2009 was vaccinated with the first of GARDASIL, lot # 0670Y. On 03-SEP-2009 the patient developed a size of a dime insect bite like appearance on the injection site, it was also reported that the injection site was hot and hard to the touch with no swelling; however, the patient had tingling in her hand and her entire arm where she had the injection was achy. Nurse practitioner noted that there was no systemic problem. The patient sought medical attention by calling the nurse practitioner. Follow up information was received from the nurse practitioner indicating that the patient was vaccinated in the left deltoid, intramuscularly, at 2 pm. Concomitant therapy included ORTHO TRI-CYCLEN. Nurse reported that on 03-SEP-2009 the patient presented with complaints of swelling at the injection site, heaty, arm achy with tingling in fingers and left hand. Additionally, nurse reported that the patient was treated with OTC (antiinflammatory) and was given ice to area as tolerated. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient who on an unspecified date was vaccinated IM 0.5ml with a first and second doses respectively of GARDASIL (lot numbers unspecified). The physician reported that the patient was given the first dose of the vaccine and the patient "got a little dizzy" (date unspecified). There was no adverse event after the patient got her second dose of the vaccine. At the time of the report the outcome of the patient was recovered (date unspecified). The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female who was vaccinated with a dose of GARDASIL (lot#, route and site of administration not reported). Subsequently the patient experienced syncope episodes after vaccination. Unspecified medical attention was sought. On an unspecified date the patient recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Electrocardiogram normal, Hypoaesthesia, Laboratory test normal, Palpitations
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with her first dose of GARDASIL and later that day went to work out at the gym and started experiencing numbness in her legs. The patient went to ER where she had different tests (including EKG and other unspecified tests) done and everything came back normal. The next day the patient came to the physician's office for a follow-up visit and was experiencing heart palpitations and was referred to a cardiologist. It was unknown if the patient had recovered. No further information is available.