chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Medical device complication, Product quality issue
Clinical narrative: Information has been received from a medical assistant concerning a patient who was vaccinated with GARDASIL. It was reported that the patient missed a dose of GARDASIL due to quality issue with the prefilled syringe they had in stock. The patient missed the dose yesterday. The patient was already late for the second dose. Follow up information received from the medical assistant reported that the syringe (lot # 1423X) was empty. The MA placed the needle onto the hub and was holding on the trigger fingers and the spring released (user error). No leaking in the tray noted which was sealed. The plunger was all the way down and had no product in it. He reported he never touched the plunger. No product or drops seen in the plunger at all. The MA has been using the safety syringe for the past 3 years and was very familiar with it. All of the other 5 syringes are fine. On 01-JUL-2010 QA examined returned complaint sample and observed that the syringe was not locked into the safety device. In addition vaccine residue was observed on the stopper of the syringe. Therefore the empty code was changed to underfill and the code for assembled incorrectly was added. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient, "one of the office nurses daughters" who on an unspecified date was vaccinated with a dose of GARDASIL (Lot# unknown). The nurse practitioner reported that the patient on an unspecified date had an unspecified adverse reaction. It was unknown if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Influenza like illness, Lethargy, Lip swelling, Myalgia
Clinical narrative: Information has been received from a medical assistant concerning a 17 year old female patient with no medical history, no drug reactions/allergies, who on 22-JUN-2007 was vaccinated intramuscularly in the left deltoid with the first dose 0.5 ml of GARDASIL (Lot # 661952/1129X exp date unknown) and on 20-JUL-2010 with the second dose 0.5 of GARDASIL (Lot # and expiration date unknown). There was no concomitant medication. The medical assistant reported that the mother of the child called the doctor office the other day stating that the child was lethargic, tired and her lips were swelling. At the time of the report, the patient had not recovered. There were not laboratories performed. The patient sought unspecified medical attention. Follow up information has been received from a physician concerning the 17 year old female patient with no pre-existing allergies who on 22-JUN-2007 and 20-JUL-2010 was vaccinated IM in the left deltoid with the first and second doses of GARDASIL (Lot number 661952/1129X). On 20-JUL-2010 the patient developed lip swelling, fatigue, myalgia and flu like illness. Subsequent myalgias and fatigue were persistent and noted on follow-up visit on 11-AUG-2010. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Lymphadenopathy, Nausea, Pain, Pyrexia
Clinical narrative: Information has been received from a physician for GARDASIL, a Pregnancy registry product, concerning a 21 year old female who on 09-AUG-2010 was vaccinated with the first dose of GARDASIL (Lot # 662765/0821Y, Exp date 25-JUN-2011). Concomitant therapy included ACIPHEX and "roresterin". On 09-AUG-2010, after receiving the first dose, the patient experienced headache, fever at 100.4 degrees Fahrenheit (also reported as 100.7 degrees Fahrenheit), body ache, swollen lymph nodes, and nausea. The patient also may be pregnant. The physician sated he was planning to examine the patient and ordered a complete blood count. At the time of the report, the patient outcome was unknown, The last menstrual period and the date of the delivery were unknown. The patient sought medical attention by visiting the physician's office. Follow up information has been received from the physician who stated that the patient was not pregnant and was on birth control when administered GARDASIL. Her last menstrual period date was 01-AUG-2010. No further information is available.
Sex: M
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician who reported that on unspecified date one of two boys may have received GARDASIL (Lot # unknown) instead of polio virus vaccine inactivated (unspecified) (manufactured unknown). One boy was 12 year old and the other was 5 year old. The physician was not sure if either boy received GARDASIL. No adverse event was reported. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Muscle atrophy
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with the first dose of GARDASIL and was fine. However, on an unspecified date, after receiving intramuscularly with the second 0.5 mL dose of GARDASIL (Lot# not reported) the patient experienced muscle atrophy. Concomitant therapy at the same time included an intramuscular injection of steroid (name and manufacturer unspecified). The patient did not want to get the third dose of GARDASIL. Unspecified medical attention was sought. At this time of reporting, the patient's outcome was unknown. As of 02-SEP-2010, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Vulvovaginal pain
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on unspecified date was vaccinated IM with the third dose of GARDASIL. It was reported that the patient got her third dose of GADASIL and began having vaginal pain. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Information has been received from a physician concerning a 13 year old female patient with no pertinent medical history or allergies, who on 18-JUN-2010 was vaccinated with the first dose of GARDASIL (Lot # unknown, route and dose not reported). There was no concomitant medication. The physician stated that the patient's father reported that the next day after receiving the vaccine, on 18-JUN-2010, she developed headache, nausea and dizziness. No fever, rash or swelling were seen. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. Follow up information was received from a physician who indicated that the patient with no illness at the time of vaccination and no pre-existing allergies or medical conditions on 17-JUN-2010 at 11:00 a.m. was vaccinated with a first dose of GARDASIL (lot# 663453/0249Y) in her right deltoid. On 18-JUN-2010 the patient experienced nausea and dizziness for a few days. On 21-JUN-2010 the patient recovered. No laboratory or diagnostic tests were performed. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site urticaria, Nausea, Urticaria
Clinical narrative: Information has been received from a 20 year old female with no pertinent medical history and no drug reactions or allergies who on 10-AUG-2010 was vaccinated in her upper left arm with a 0.5 ml dose of GARDASIL (Lot# unknown). There was no concomitant medication. The patient reported that on 10-AUG-2010, within 1 hour after receiving the GARDASIL, she started getting hives at the injection site. The patient also stated that she called her doctor and was told to take BENADRYL. 24 hours later the itching continued and the hives were still present. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient had not recovered. Follow up information has been received from a medical assistant concerning the 20 year old female student with no illness at the time of vaccination and not pre-existing allergies, birth defects or medical conditions, who on 11-AUG-2010 (previous reported as 10-AUG-2010) at 11:30 am was vaccinated in her left deltoid with the second dose second (also reported first dose) of GARDASIL (Lot # 666929/0331Z). On 11-AUG-2010 (previous reported as 10-AUG-2010) at 12:00 pm the patient developed nausea, hives around injection side and down her left arm. The medical assistant reported that the patient took BENADRYL. On 12-AUG-2010, the patient still had hives. At the time of the report, the patient had not recovered. The medical assistant reported that patient's next injection due on 11-OCT-2010. It was noted that they left it up to the patient if she want to received next two injections. Follow-up information has been received from a medical assistant. On 08-OCT-2010 (also reported as 20-OCT-2010), the patient received the second dose of GARDASIL (lot# unknown). The patient did not have any reactions this time. On unspecified date, the patient recovered. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female patient with no known drug allergies or pertinent medical history who on 13-AUG-2010 was vaccinated with the third dose of GARDASIL (lot number 666163/0664Z). There was no concomitant medication. The nurse reported that over the weekend (approximately on 14-AUG-2010) the patient had been having blackouts and fainting even while sitting down. The nurse stated that the patient did not have adverse effects after her first or second dose of GARDASIL. No laboratory tests were performed. At the time of the report the patient had not recovered. The patient was being seen by the nurse practitioner on 16-AUG-2010. Follow-up has been received from a nurse practitioner, concerning a 17 year old female student with anxiety who on 13-AUG-2010, was vaccinated IM in the left arm with the third dose of GARDASIL (lot# 666163/0664Z) at 15:30 pm. There was not illness at the time of vaccination. on 13-AUG-2010, the patient went to work (lifeguard) and felt weak. On approximately 14-AUG-2010 "mostly on 14th and 15th" was feeling like she would pass out; the patient did not have a syncope episode (she just felt like she was going to). The nurse practitioner spoke to the patient's mother on 17-AUG-2010, and she stated that the patient was feeling much better, but still felt dizzy and weak, once on 16-AUG-2010, while playing soccer and had to rest for several minutes and recovered. The patient made an appointment and was seen in the physician's office. On 16-AUG-2010, a blood pressure and heart rate test were performed. At the time of the report, the patient had recovered. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from an advanced practice nurse also reported as a physician concerning a 21 year old female patient who on an unspecified date, was vaccinated with the first dose of GARDASIL injection (Lot# not reported). Subsequently, the patient experienced a rash on her upper chest. On an unspecified date the patient had recovered. It was unknown if the patient sought medical attention. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 26 year old female patient with eczema and no drug reactions/allergies who on 28-JUL-2010, was vaccinated with a standard first dose of GARDASIL (Lot# not reported). Concomitant medication included birth control pills. No lab diagnostic studies were performed. Subsequently, the patient developed redness, pain, and swelling at the injection site. The redness and swelling disappeared after two weeks. The patient had not recovered from pain. The patient sought unspecified medical attention. Follow-up information has been received from a registered nurse practitioner concerning the 26 year old female patient with eczema, migraines, unspecified allergies and elevated lipids who on 28-JUL-2010 was vaccinated into the left deltoid arm with the first dose of GARDASIL (Lot# not reported). Patient possibly had minus cold at time of injection . It was reported that pain, redness and swelling on left deltoid arm began on 28-JUL-2010 and persisted for one month. The patient required doctor visit (date unspecified). On 24-AUG-2010, it was prescribed MEDROL dose pack (on 30-JUL-2010 was seen by a registered nurse practitioner and told to use TYLENOL). At the time of the report the pain in the left arm persisted. There were no relevant diagnostic tests and laboratory data. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female patient who on an unspecified date, the patient had 2 separate doses of GARDASIL (Lots#: not reported) and on 11-AUG-2010, was vaccinated IM with the third dose of GARDASIL (Lot#: not reported). The nurse practitioner reported that on an unspecified date the patient developed HPV. The patient sought unspecified medical attention. 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: Neuralgia
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with the second dose of GARDASIL (Lot # not reported). One week after receiving the second dose the patient experienced nerve pain in the arm that GARDASIL was given, what specific arm unspecified, and the patient was still experiencing the nerve pain at the reporting time. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from an advanced registered nurse practitioner concerning an 18 year old female patient who on 23-DEC-2010 was vaccinated with a dose of GARDASIL, dose and route unspecified (Lot # 661046/0546X Exp date. 01-DEC-2010). The nurse stated that the patient "passed out" approximately two minutes after receiving the dose of GARDASIL. The nurse also stated that the patient spontaneously regained consciousness, and that when she checked on the patient later the same evening, she reported no additional adverse experiences. The patient sought unspecified medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Information has been received from a pharmacist concerning a 18 year old female patient with no pertinent medical history who was vaccinated with the first and second dose of GARDASIL (lot number 658490/0802U for both doses) in 2008. After receiving her second dose in 2008 she experienced swelling, redness and pain in her left shoulder where she received the vaccination. She had pain when she moved. The patient did not seek medical attention. No treatment required. The patient recovered about 1 week after vaccination. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Adverse drug reaction, Drug hypersensitivity, Herpes zoster
Clinical narrative: Information has been received from a physician concerning current 16 year old female patient who on an unspecified date was vaccinated with a dose of GARDASIL  (dose, route and lot# not reported). Subsequently the patient developed a drug reaction/allergy. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The patient subsequently experienced shingles while on therapy with VARIVAX (Merck) (WAES 1101USA02404). Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (Lot number unknown). Subsequently the patient fainted. It was unknown if the patient sought medical attention. At the time of this report, the patient's outcome was unknown. This one of the several reports received from the same source. Follow-up information has been received which reported that the 15 year old female student with no pre-existing allergies, birth defects or medical conditions on 15-JAN-2010 at 5:00 p.m was vaccinated intramuscularly into the right arm with the second dose (also reported as 1st dose) of GARDASIL (Lot # 663454/0672Y). Secondary suspect therapy included vaccination subcutaneously into the left arm with the second dose of VARIVAX (Merck) (Lot # 665196/1075Y). It was reported that the patient fainted after received the vaccine. The patient's outcome was not reported. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Raynaud's phenomenon
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient, who on 04-OCT-2010 was vaccinated with a first 0.5 ml dose of GARDASIL (route and lot # not reported) and on an unspecified date received her second 0.5 ml dose of GARDASIL. Concomitant  therapy included hormonal contraceptives (unspecified), "oral contraceptive". The physician reported that on 16-DEC-2010, after the second dose of GARDASIL the patient experienced chest pain. The patient saw her Pediatrician and her Pediatrician suggested her to see a Cardiologist. The patient was diagnosed with Raynaud's disease. The patient's Cardiologist strongly suggested not getting the third dose of GARDASIL. At the time of the report, the patient's out come was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, Pain
Clinical narrative: Information has been received from a registered nurse concerning a female who on 10-AUG-2010 was vaccinated with the first dose of GARDASIL which had expired on 10-JUN-2010. Registered nurse also stated the patient felt stinging on the same date when she was vaccinated. The patient sought unspecified medical attention since it happened at the office. This is one of two reports received from the same source. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder
Clinical narrative: Information has been received from a certified medical assistant concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (Lot #, expire date and route not reported). Certified medical assistant stated that on an unspecified date, patient experienced abnormal menstrual bleeding. The patient sought unspecified medical attention. At the time of the report, patient's outcome was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL. Physician reported that the patient experienced fainted after receiving GARDASIL. Follow up information has been received from a Registered Nurse concerning a female patient with no known drug allergies who on 20-MAY-2008 at 2:00 pm was vaccinated intramuscularly into the right arm with the first dose of GARDASIL (Lot # 660391/0063X). Concomitant therapy given on the same day on 20-MAY-2008 at 2:00 pm intramuscularly into the left arm included the first dose of BOOSTRIX (Lot # AC52BO20AA) and a first dose given intramuscularly into the left arm of HAVRIX (Lot # AHAVB233AA). The RN reported that after receiving the 3 vaccines on 20-May-2008, at 2:00 pm the patient fainted. Blood pressure after fainting was 98/50. The patient responded well in few seconds. This is one of several reports received from the same source. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Back pain, Menstrual disorder
Clinical narrative: Information has been received from a consumer concerning her granddaughter who on 01-JUL-2010 was vaccinated with a first dose of GARDASIL (route and lot number unspecified). The consumer stated that her granddaughter had not had a menstrual cycle since she was given the first dose of GARDASIL (approximately in July 2010). She stated that the patient had had normal cycles for 1 year until the vaccine was given. It was reported that the patient also had been experiencing knee and back pain since the GARDASIL was given (approximately in July 2010). At the time of the report the patient was not recovered. The patient did not seek medical attention. Additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of GARDASIL (Lot # and route no reported). The physician reported that few days after receiving her first dose on an unspecified date the patient developed a rash on her neck. The rash persisted for two weeks. It was unknown if the patient sought medical attention. Follow up information has been received from an office staff who reported that the doctor did not recall this adverse event or patient. He was unable to provide additional information. Additional information is not expected.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure during pregnancy, No adverse event, Ultrasound antenatal screen normal, Wrong drug administered
Clinical narrative: Information has been received from a Registered Nurse for GARDASIL, a Pregnancy Registry Product, concerning a 30 year old female patient with no pertinent medical history, or drug reactions/allergies, who on 25-JAN-2011 was vaccinated IM inadvertently with a 0.5ml dose of GARDASIL (lot#666162/0565Z) instead of an unnamed influenza vaccine. Concomitant therapy included prenatal vitamins (unspecified). A vial of the GARDASIL was misplaced in a box with the influenza vaccines. On an unspecified date, a pregnancy test ultrasound was performed. No adverse symptoms were noted. Patient's last menstrual period was 15-NOV-2010. Expected date of delivery was 22-AUG-2011. Follow up information was received from a Registered Nurse (R.N) via pregnancy questionnaire who reported that the 30 year old female patient has a history of 3 pregnancies (2 full term deliveries) and 1 spontaneous abortion of twin fetal demise at 14 weeks in 2010. There was no defect in previous pregnancies. It was reported that on 25-JAN-2011, an ultrasound was performed which was within normal limits. The patient was scheduled for the next anatomical ultrasound on 01-APR-2011. Follow-up information was received from an initial pregnancy questionnaire from the registered nurse indicating that the patient's 2 full term deliveries were at 39 weeks from last menstrual period. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a medical assistant concerning a 20 year old female patient, who on unspecified date was vaccinated with the first and second dose of GARDASIL (route and lot # no reported). The medical assistant stated that the patient who went on 20-AUG-2010 to the office for the third dose of GARDASIL changed her mind prior to vaccination stating that on an unspecified date following the second dose she experienced nausea. At the time of the report, the patient outcome was unknown. It was unknown if the patient sought medical attention. Follow-up information has been received from the medical assistant concerning a female student. The patient had received 2 prior doses at college. The GARDASIL was drawn up from a single dose vial and was taken into the patient's exam room. The patient then decided she didn't want the vaccine because the she became dizzy, lightheaded and nauseous nauseas after her second injection at college and this particular day she had not one to drive her home. So she declined the vaccine. The vaccine had already been drawn up but was not administered. On an unspecified date, the patient recovered. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Accidental exposure, Eye irrigation, Eye pain
Clinical narrative: Information has been received from a medical assistant concerning another medical assistant who on 30-DEC-2010, was administering the second dose of GARDASIL (Lot # not reported) to a patient, when some of the dose splashed in her eyes. She washed her eye for 10 minutes and experienced some eye pain during washing. Her pain had since resolved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose normal, Depression, Fatigue, Haemoglobin normal
Clinical narrative: Information has been received from a certified medical assistant concerning a 14 year old female patient with a history of anaemia and no drug reactions/allergies who on 10-AUG-2010, was vaccinated IM with the 0.5 ml first dose of GARDASIL (Lot#: 666118/1539Y). There was no concomitant medication. On 11-AUG-2010, the patient experienced fatigue and depression. The patient was evaluated in the office on 22-AUG-2010. Blood glucose and hemoglobin levels were normal. There was no treatment prescribed. At the time of the report, the patient had not recovered. Follow up information has been received from the certified medical assistant who stated that after further evaluation fatigue and depression were not a reaction to therapy with GARDASIL. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Dysmenorrhoea, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a female who on an unspecified date was vaccinated with a second dose of GARDASIL (lot # not reported). After receiving the second dose of the vaccine the patient developed painful menstrual periods. The patient will receive the third dose of vaccine. At the time of the report, the patient had not recovered. Follow-up information was received from the registered nurse which reported that there was no adverse reaction and the symptoms were unrelated to GARDASIL. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Abdominal pain, Dizziness, Immediate post-injection reaction, Nausea, Pallor
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 09-AUG-2010 was vaccinated with 0.5 ml GARDASIL (lot # 666118/1539Y). Concomitant vaccination included ADACEL. The patient hadn't eaten when she got the vaccination, and then immediately she began having abdominal pain, she became pale, felt faint and dizzy and nauseous. Within an hour she had recovered (it was also reported that the patient recovered on 16-AUG-2010). Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Hypoaesthesia, Malaise
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date, was vaccinated with three doses of GARDASIL (lot # not reported). After receiving her third dose, the patient experienced a reaction to the vaccine. She felt strange, numb all over and generally felt unwell. The symptoms lasted for around 24 hours. Subsequently, the patient recovered from felt strange, numb all over and generally felt unwell. The patient did not seek medical attention. In follow-up, the physician indicated that the patient had not been there in quite a while and that he was working on it. He had no information at this time. This is one of several reports received from the same source. Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Cryotherapy, Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 30 year old female patient with no pertinent medical history and no drugs reactions or allergies who on 12-JUN-2007 was vaccinated with her first dose of GARDASIL (Lot number unknown). There was no concomitant medication. The physician reported that the patient tested positive under high risk papanicolaou test. All three GARDASIL injections were completed previous to papanicolaou test. The patient sought unspecified medical attention. At the time of report, the patient had not recovered. Follow-up information has been received from a registered nurse concerning a 30 year old female with no known drug allergies who on 07-JUN-2010, was vaccinated with the first dose of GARDASIL (Lot n. 657737/0522U), intramuscularly into the right gluteus at 09:00 AM, on 08-AUG-2007, the patient was vaccinated with the second dose of GARDASIL (Lot n. 657737/0522U), intramuscularly into the left gluteus at 09:15 AM and on 12-DEC-2007, the patient was vaccinated the third dose of GARDASIL (Lot n. 658566/1060U), intramuscularly into the right gluteus at 10:00 AM. Reporter stated that in March 2010, a papanicolaou test was taken and the result was low grade squamous intraepithelial lesion (LGSIL), HPV negative. On 20-MAY-2010, another papanicolaou test was taken and the result was epithelial cell abnormality, low grade squamous intraepithelial lesion (LGSIL), high risk of HPV positive. On 03-SEP-2010, the patient underwent a cryosurgery of cervix. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Local swelling
Clinical narrative: Information has been received from an office manager concerning her 16 year old daughter who was vaccinated with the second dose of GARDASIL. Subsequently the patient experienced localized reaction with severe redness and swelling. Therapy with GARDASIL was discontinued. After stopping therapy, the symptoms improved. On an unknown date, the patient was recovered. The patient went to the doctor's office. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a consumer concerning her 12 year old granddaughter with a history of rash from head to toe when she was child and received some vaccines (unspecified), who on unspecified date was vaccinated with 0.5 ml dose intramuscularly of GARDASIL (lot # unknown). On an unspecified date, the patient was vaccinated with the second dose of GARDASIL (Lot # unknown) (route and dose not reported). The consumer reported that after receiving the second dose, her granddaughter's arm went numb for a couple of days and it came back to itself. It was unknown if the patient sought medical attention. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Hypoaesthesia, Malaise
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with three doses of GARDASIL (lot # not reported). After receiving her third dose, the patient experienced a reaction to the vaccine. She felt strange, numb all over and generally felt unwell. The symptoms lasted for around 24 hours. The patient did not seek medical attention. In follow-up, the physician indicated that the patient had not been there is quite a while and that he was working on it. He had no information at this time. This is one of several reports from the same source. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Asthenia, Condition aggravated, Dysphagia, Fatigue
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with anemia who on 10-AUG-2010, was vaccinated IM with the first dose of GARDASIL (Lot# 666118/1539Y). Subsequently, the patient began to feel weakness, tired and wanted to stay in bed. She found it hard to swallow. The patient was also being treated for anemia. She went in the office on 23-AUG-2010, for medical attention and the patient would not be given the other two doses of GARDASIL. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Dizziness, Fatigue, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter with no medical history and no drug reactions/allergies who on 30-DEC-2010 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot number not reported). There was no concomitant medication. On 02-JAN-2011 the patient was complaining of fever, chills, dizziness and fatigue. The patient did not seek medical attention. The patient's fever and chills and dizziness and fatigue persisted. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Borrelia test, Headache, Injected limb mobility decreased, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on 09-AUG-2010 she was vaccinated with the second dose of GARDASIL (Lot # and route not reported). The nurse reported that the patient developed an injection site reaction including pain and swelling after receiving the second dose. She stated that the patient had pain which traveled up and down the arm. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Follow up information has been received from a registered nurse concerning the 18 year old female trainer with reaction to NAPROX (hives) who on 09-AUG-2010, at 11:15, was vaccinated intramuscularly with the second dose of GARDASIL (lot# 662765/0821Y) into her left deltoid. It was reported that the patient was fine post vaccination. On 24-AUG-2010 the patient developed pain and pain increased and she had trouble moving arm. She also had pain in neck and shoulder, site swollen now. The patient was advised to visit the emergency room to evaluation. In review of emergency room records, the patient did not go. At the time of this report, the patient's outcome was not reported. Follow-up information was received from a registered nurse. The patient had allergy to naproxen and had no illness at the time of vaccination. There were no other signs of illness prior to 24-AUG-2010. The patient has had extensive workup from 24-AUG-2010 to present with the primary care physician, at ENT (ear, nose and throat). The tests revealed that tonsillitis (T3), sinus infection, joint pain, headaches, negative for lupus, lyme ("x24"), negative for other tick-borne illness. They have not seen the patient since the event. It was unknown if illness 2 weeks after injection was related or not. The outcome of the events was reported as not recovered. Follow-up information has been received from the registered nurse. She stated that no information was available, they had not seen the patient since August. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction, Injection site swelling, Laboratory test normal, Pain in extremity, Sinusitis
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on 09-AUG-2010 she was vaccinated with the second dose of GARDASIL (Lot # and route not reported). The nurse reported that the patient developed an injection site reaction including pain and swelling after receiving the second dose. She stated that the patient had pain which traveled up and down the arm. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Follow up information has been received from a registered nurse concerning the 18 year old female trainer with reaction to NAPROX (hives) who on 09-AUG-2010, at 11:15, was vaccinated intramuscularly with the second dose of GARDASIL (lot# 662765/0821Y) into her left deltoid. It was reported that the patient was fine post vaccination. On 24-AUG-2010 the patient developed pain and pain increased and she had trouble moving arm. She also had pain in neck and shoulder, site swollen now. The patient was advised to visit the emergency room to evaluation. In review of emergency room records, the patient did not go. At the time of this report, the patient's outcome was not reported. Follow-up information was received from a registered nurse. The patient had allergy to naproxen and had no illness at the time of vaccination. There were no other signs of illness prior to 24-AUG-2010. The patient has had extensive workup from 24-AUG-2010 to present with the primary care physician, at ENT (ear, nose and throat). The tests revealed that tonsillitis (T3), sinus infection, joint pain, headaches, negative for lupus, lyme ("x24"), negative for other tick-borne illness. They have not seen the patient since the event. It was unknown if illness 2 weeks after injection was related or not. The outcome of the events was reported as not recovered. Follow-up information has been received from the registered nurse. She stated that no information was available, they had not seen the patient since August. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Tonsillitis
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on 09-AUG-2010 she was vaccinated with the second dose of GARDASIL (Lot # and route not reported). The nurse reported that the patient developed an injection site reaction including pain and swelling after receiving the second dose. She stated that the patient had pain which traveled up and down the arm. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Follow up information has been received from a registered nurse concerning the 18 year old female trainer with reaction to NAPROX (hives) who on 09-AUG-2010, at 11:15, was vaccinated intramuscularly with the second dose of GARDASIL (lot# 662765/0821Y) into her left deltoid. It was reported that the patient was fine post vaccination. On 24-AUG-2010 the patient developed pain and pain increased and she had trouble moving arm. She also had pain in neck and shoulder, site swollen now. The patient was advised to visit the emergency room to evaluation. In review of emergency room records, the patient did not go. At the time of this report, the patient's outcome was not reported. Follow-up information was received from a registered nurse. The patient had allergy to naproxen and had no illness at the time of vaccination. There were no other signs of illness prior to 24-AUG-2010. The patient has had extensive workup from 24-AUG-2010 to present with the primary care physician, at ENT (ear, nose and throat). The tests revealed that tonsillitis (T3), sinus infection, joint pain, headaches, negative for lupus, lyme ("x24"), negative for other tick-borne illness. They have not seen the patient since the event. It was unknown if illness 2 weeks after injection was related or not. The outcome of the events was reported as not recovered. Follow-up information has been received from the registered nurse. She stated that no information was available, they had not seen the patient since August. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Axillary pain, Blindness, Dizziness, Headache, Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with a history of seizure and migraines who on 13-AUG-2010 was vaccinated intramuscularly with her 0.5 cc first dose of GARDASIL (Lot # 08872-not valid as reported- and expire date in October 2014). The physician stated that after the first shot the patient fainted and on approximately 20-AUG-2010 "one week later", she noticed a lump above her clavicle and discomfort under her arm. The patient sought unspecified medical attention. At the time of report, the patient was recovering from fainted, lump above her clavicle and discomfort under her arm. Follow-up information was received concerning a current 14 year female with no pre-existing allergies, birth defects or medical conditions and no illness at the time of vaccination who on 13-AUG-2010 at 12:30 PM was vaccinated intramuscularly with her first dose of GARDASIL. On 13-AUG-2010 the patient was feeling OK, she was walking out of room and started feeling faint and seeing black. The patient was taken into room and laid her down legs up. Pulse, blood pressure and temperature measurement were performed with no results provided. Before the patient left the physician discharged her in stable condition. Patient later came back with a lymph gland above left clavicle and sore on the left shoulder. At the time of report, the patient's lymph gland above left clavicle and sore on the left shoulder outcome was unknown. On follow up information received on 14-DEC-2010 the medical assistant reported that the patient was seen at the office on 23-AUG-2010 for her lump above her clavicle and also because she was experiencing headaches. At the time of the report, the patient continued to have headaches so the physician might refer her to a specialist. Follow-up information was received, was reported that on unspecified date experienced regional lymph node reaction and possible migraine headache. At the time of the report the patient had recovered from regional lymph node reaction and possible migraine headache. The patient did not seek medical attention. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal pain, Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with a history of seizure and migraines who on 13-AUG-2010 was vaccinated intramuscularly with her 0.5 cc first dose of GARDASIL (Lot # 08872-not valid as reported- and expire date in October 2014). The physician stated that after the first shot the patient fainted and on approximately 20-AUG-2010 "one week later", she noticed a lump above her clavicle and discomfort under her arm. The patient sought unspecified medical attention. At the time of report, the patient was recovering from fainted, lump above her clavicle and discomfort under her arm. Follow-up information was received concerning a current 14 year female with no pre-existing allergies, birth defects or medical conditions and no illness at the time of vaccination who on 13-AUG-2010 at 12:30 PM was vaccinated intramuscularly with her first dose of GARDASIL. On 13-AUG-2010 the patient was feeling OK, she was walking out of room and started feeling faint and seeing black. The patient was taken into room and laid her down legs up. Pulse, blood pressure and temperature measurement were performed with no results provided. Before the patient left the physician discharged her in stable condition. Patient later came back with a lymph gland above left clavicle and sore on the left shoulder. At the time of report, the patient's lymph gland above left clavicle and sore on the left shoulder outcome was unknown. On follow up information received on 14-DEC-2010 the medical assistant reported that the patient was seen at the office on 23-AUG-2010 for her lump above her clavicle and also because she was experiencing headaches. At the time of the report, the patient continued to have headaches so the physician might refer her to a specialist. Follow-up information was received, was reported that on unspecified date experienced regional lymph node reaction and possible migraine headache. At the time of the report the patient had recovered from regional lymph node reaction and possible migraine headache. The patient did not seek medical attention. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Antibody test, HIV test, Immunology test
Clinical narrative: Information has been received from a nurse, who works at an AIDS Resource Center, concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot number not provided). The nurse reported that the patient had inconclusive test results for human immunodeficiency virus (HIV). The nurse reported that the patient was vaccinated with GARDASIL sometime prior to the HIV testing. The enzyme-linked immuno-sorbent assay (ELISA) antibody test, western blot test and P24 tests were performed. At the time of the report the outcome of the patient was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance
Clinical narrative: Information has been received from a physical therapist concerning a female patient between the ages of 18-20 years old who on an unspecified date was vaccinated with a dose of GARDASIL (lot# not reported). It was reported that on an unspecified date, the patient experienced dysautonomia. At the time of the report, the patient's outcomes was unknown. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot number unknown) and in August 2010 "within the last two weeks", she developed a "high fever" for several days. Patient's family was very concerned and took her to the local emergency room. The patient was not hospitalized. At the time of report, the patient's outcome was unknown. Follow-up information has been received from a physician concerning a 13 year old female who on 09-AUG-2010 AM was vaccinated IM in the left deltoid with the third dose of GARDASIL (lot number 666163/0664Z). On the same day, in the afternoon the patient experienced 102.0 degree fever and headache. The fever and headache were required emergency room/doctor visit. At the time of the report the outcome was not reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Foetal disorder, Human chorionic gonadotropin positive, Maternal exposure during pregnancy, Oligohydramnios
Clinical narrative: Information has been received from a registered nurse (R.N.), for GARDASIL, a Pregnancy Registry product, concerning a 25 years old female patient with asthma and allergy to penicillin who on 17-AUG-2010 was vaccinated with her first dose of GARDASIL (lot # unknown). There was no concomitant medication. The nurse reported that the patient was pregnant when she received GARDASIL. On 25-AUG-2010, the patient took a urine pregnancy test which was positive. Therapy with GARDASIL was discontinued (reported on 25-AUG-2010). Last menstrual period (LMP): 22-JUL-2010. Her estimated date of delivery (EDD) is 28-APR-2011. The patient sought unspecified medical attention. At the time of this report, the patient's outcome was unknown. Follow up information has been received via telephone call from the nurse practitioner, indicating that on 01-APR-2011 the patient delivered a normal healthy 4 pounds 15 ounces male with no congenital anomalies via vaginal delivery. It was reported that the baby was "small for dates" during pregnancy. Also it was stated that oligohydramnios was noted. The baby's experiences were captured in WAES#1008USA03850B1. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a 26 year old female who in May 2010, was vaccinated with the second dose GARDASIL. The patient complained that the second dose hurt more than the first. The patient received GARDASIL in her left arm and still complained of pain at the injection site. The patient did not seek medical attention. This is one of several reports received from the same source. Additional information has been requested.