chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site anaesthesia, Muscle twitching
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female with drug reactions or allergies reported as none and pertinent medical history reported as none who on 15-SEP-2009 was vaccinated with a first dose of GARDASIL (LOT # 661046/0381x), 0.5 mL, intramuscularly into left upper arm. There was no concomitant medication. On 16-SEP-2009, the day after administration the first dose of vaccine the patient experienced "a weird numb feeling" at the injection site. The patient also experienced muscle twitching on and off in the left upper area, lasting for 1 month. The patient sought an unspecified medical attention. At the time on the report the patient's numbness of the lateral aspect of the left upper arm persisted. The patient had elected to discontinue GARDASIL. There were no laboratories diagnostics studies performed. Follow up information has been received from the nurse practitioner who reported that the patient mentioned her event during the second dose reminder call. The nurse practitioner reported that the patient did not seek medical attention, and that the event was not disabled in any way. The patient would not receive the last two doses in the series. At the time of the report, the patient was "slowly recovering". No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Vaccine positive rechallenge
Clinical narrative: Information has been received from a medical assistant concerning an 18 year old female patient who on 13-AUG-2008 was vaccinated with a dose of GARDASIL. On 13-AUG-2008 the patient experienced significant headaches after receiving of GARDASIL. Therapy with GARDASIL was discontinued. At the time of the report, the patient had not yet recovered. Follow-up information has been received from the medical assistant concerning a 17 year old (also reported as 18 year old) student whose headaches at menstrual time was more severe. It was also stated that the patient had experienced headaches after receiving a dose of GARDASIL when she was 16 years old, in approximately 2007. The patient's sibling also experienced headache following vaccination with GARDASIL (MSD WAES# 1004USA00899). Additional information has been requested,
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Haematoma, Injection site discolouration, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female patient with no pertinent medical history who on 21-APR-2009 was vaccinated intramuscularly with the first 0.5 mL dose GARDASIL (lot # 661846/1312X). On 16-JUN-2009 the patient was vaccinated intramuscularly with the second 0.5 mL dose GARDASIL (lot # 658271/0558X). The patient did not have a reaction after the first or the second vaccination. On 27-OCT-2009 the patient was vaccinated intramuscularly with the third 0.5 mL dose GARDASIL (lot # 663454/0672Y) in the left upper arm. There was no concomitant medication. At the end of December 2009 (2 month after the third vaccination), the patient developed a tender nodule at the injection site. The injection site was warm, tender, firm with darkened, scaly skim. The patient also had a hematoma on the left arm above the elbow which the patient attributed to "hitting the arm against a door". The patient sought unspecified medical attention. No laboratory diagnostics studies were performed. At the time of the report, the patient 's status was unknown. This is one of several reports from the same same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction, Injection site warmth, No reaction on previous exposure to drug, Skin exfoliation
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female patient with no pertinent medical history who on 21-APR-2009 was vaccinated intramuscularly with the first 0.5 mL dose GARDASIL (lot # 661846/1312X). On 16-JUN-2009 the patient was vaccinated intramuscularly with the second 0.5 mL dose GARDASIL (lot # 658271/0558X). The patient did not have a reaction after the first or the second vaccination. On 27-OCT-2009 the patient was vaccinated intramuscularly with the third 0.5 mL dose GARDASIL (lot # 663454/0672Y) in the left upper arm. There was no concomitant medication. At the end of December 2009 (2 month after the third vaccination), the patient developed a tender nodule at the injection site. The injection site was warm, tender, firm with darkened, scaly skim. The patient also had a hematoma on the left arm above the elbow which the patient attributed to "hitting the arm against a door". The patient sought unspecified medical attention. No laboratory diagnostics studies were performed. At the time of the report, the patient 's status was unknown. This is one of several reports from the same same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Needle issue, Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer concerning a 19 year old female with no pertinent medical history and no drug allergies, who in August 2009, was vaccinated with the first dose of 0.5 ml GARDASIL . On an unspecified date the patient received the second 0.5 ml dose, and on 04-FEB-2010 the patient received the third dose. There was no concomitant medication. The patient felt "a pain and stinging at the injection site" after the first and second vaccination. Each time the AE "only lasted for a day or so". There were no labs or diagnostic tests performed. The patient did not receive medical attention. The patient had recovered "about a day after it started". On 04-FEB-2010 when the patient received the third dose, the needle was not properly attached to the syringe and the vaccine ran down her arm and under her blouse. She did not experience any pain or stinging when she got this vaccination. The reporter did not know how much the vaccine was injected into her daughter's arm this time. No AE was reported from this injection. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site nodule, Vaccine positive rechallenge
Clinical narrative: Information has been received from a medical assistant concerning a 23 year old female with no pertinent medical history and no drug reactions/allergies who on 25-MAR-2009 and 17-JUN-2009 was vaccinated intramuscularly with the first and second dose of GARDASIL (0.5ml, lot #: dose 1 661952/1129X, dose 2 662229/1497X) in her thigh respectively. Concomitant therapy  included ZYRTEC, Omega-3 vitamins (unspecified), echinacea (unspecified), NUVARING and vitamin B (unspecified). About 20 minutes after vaccination both times, the patient experienced a "knot " at the injection  site. There were no lab diagnostics studies performed. 1 or 2 days after vaccination both times, the patient recovered. The patient mentioned that whenever she received vaccines in her arm she developed a knot at the injection site and had difficult moving her extremity in that arm. Names of vaccines involved were unspecified. Follow up information has been received from a medical assistant concerning a 23 year old (reported as 24 year old) female floor nurse who on 25-MAR-2009 and 17-JUN-2009 was vaccinated with the first and second dose of GARDASIL (lot #: dose 1 661952/1129X, dose 2 injection site after each injection. The Area was sore for a day or two then resolved. The patient did not make the reporter aware of this reaction until she came into office for the 3rd injection. The 3rd injection was not given. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Arthralgia, Myalgia, No reaction on previous exposure to drug, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning his friend's daughter (age not reported), who on unknown dates, was vaccinated with the three doses of GARDASIL (lot number and route not reported). The reporting physician stated that patient received the first injection of GARDASIL without adverse experience. Shortly after receiving the second injection of GARDASIL, the patient complained of muscle and joint pain. The patient continued to complain even more so after receiving the third injection of GARDASIL. Per one of the physicians, the patent is an accomplished athlete, but after receiving the second and third dose of GARDASIL, she has had difficulties running with muscle pains in her legs and leg joints. At the time of reporting, the patient's final outcome was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: This report was received from NOVARTIS and was assigned manufacturer report number S2010USA01949, from a 20 year old female patient reporting on herself, who on 20-JAN-2010 was vaccinated with a dose of GARDASIL. It was reported that on 21-JAN-2010 the patient experienced rash on her neck. The patient could not think of anything else she may have done before rash appeared. The outcome of the patient was not reported. This was originally reported by a consumer. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Allergy test, Injection site rash
Clinical narrative: Information has been received from a physician concerning a female patient who on 05-FEB-2010 was vaccinated with  0.5 ml a first dose of GARDASIL (route and lot number not reported). On 05-FEB-2010 the patient experienced rash around the injection site that traveled down to crease of elbow after receiving the first dose of GARDASIL. The physician administered steroid and after approximately 5 minutes, the rash diminished. It was reported that the physician was checking for latex and yeast allergies. Subsequently, the patient recovered from rash on 08-FEB-2009. The patient did not seek medical attention. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test abnormal, Haematology test, Human papilloma virus test positive, Lipids increased, Papilloma viral infection
Clinical narrative: Information has been received from a Registered Nurse concerning a 21 year old female patient with constipation, hypercholesterlaemia and polycystic ovarian syndrome and no known drug allergies, who on 23-MAY-2007 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (unspecified lot number). On 24-JUL-2007 was vaccinated with the second dose of GARDASIL (unspecified lot number) and on 17-DEC-2007 was vaccinated with the third dose of GARDASIL (lot number 659439/1267U). Concomitant therapy included Glucophage, CELEXA, YASMIN and unspecified stool softeners. The nurse reported that the patient was tested positive for high risk HPV on 01-FEB-2010. A blood work performed on an unspecified date showed lipid levels slightly elevated. At the time of the report HPV positive persisted. It was unknown the outcome of the lipid levels slightly elevated. The patient sought unspecified medical attention. Follow up information has been received from a licensed practical nurse who reported that the patient completed the GARDASIL series on 17-DEC-2007 and was positive for HPV types 16 and 18. The nurse also mentioned that the first two doses of GARDASIL were given at another facility and that the results of previous PAP tests were not available. At the time of the report the patient had not recovered. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Dyspnoea, Pain
Clinical narrative: Information has been received from a physician concerning a 25 year old female patient with no known pertinent medical history or drug reactions and allergies who on unspecified date was vaccinated with a dose of GARDASIL (Lot # not provide). The Physician stated that the patient experienced generalized aches, joint pain, shortness of breath and weakness after getting GARDASIL. Patient sought unspecified medical attention. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Oedema peripheral
Clinical narrative: Information has been received from a consumer concerning her 25 year old female friend with no pertinent medical history, drug reaction or allergies who on 08-FEB-2010 was vaccinated with GARDASIL (dose, route, and lot number not reported). Concomitant therapy included hormonal contraceptives (unspecified). On 09-FEB-2010, consumer reported that his girlfriend received 1 dose of GARDASIL and developed swelling of one finger on her right hand. He said that GARDASIL was not administered in her right arm, instead it was administered on the right side of her back. No diagnostic laboratories were performed. The patient had not recovered from swelling of one finger on her hand. The patient called the physician office. Additional information has been received.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pruritus
Clinical narrative: Information has been received from a physician concerning a 23 year old female patient with no pertinent medical history, drug reactions or allergies reported, who on 02-DEC-2009 was vaccinated with a first dose of GARDASIL, into the left deltoid muscle (intramuscular route, lot # 661953/1130X). Concomitant therapy included birth control pills. On 02-DEC-2009 the patient developed a "pea-size, itchy lump" at the injection site. No lab diagnostic studies performed. The patient sought unspecified medical attention. On 02-JAN-2010, the patient recovered. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Food allergy, Injection site induration, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female patient who was vaccinated with all three doses of GARDASIL when she was 18 years old. After the third dose of the series, the patient developed an allergy to chicken. The reporter also stated that the patient developed muscle getting hard at the injection site, and it was still hard. The patient did not receive GARDASIL at this office and received it in another state. At the time of reporting, the outcome was unknown. The patient sought unspecified medical attention. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a nurse. The nurse reported that she saw in Sunday's (07-FEB-2010) newspaper that a female patient had bad effects after getting GARDASIL. Attempts to verify the existence of an identifiable patient have been unsuccessful. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician's assistant concerning her friend, a 25 year old female who on approximately 03-FEB-2010 was vaccinated with a first dose of GARDASIL. On approximately 04-FEB-2010, the next day of vaccination, the patient experienced rash on her chest and abdomen. The rash went away, and then came back in the same area. She did not develop an injection site reaction. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Syncope
Clinical narrative: Information has been received from a nurse aid concerning a 17 year old female who on 12-AUG-2009 was vaccinated with a dose of GARDASIL (route and lot number not reported). On 14-AUG-2009 the patient experienced dizziness, nausea and fainting. It was unknown if she had any laboratory testing performed. As 22-FEB-2010, it was unknown if the patient would received any more GARDASIL and the dizziness, nausea and fainting had resolved on an unspecified date. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Hepatic enzyme increased, Liver function test abnormal
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL. Subsequently the patient experienced abdominal pain. Lab work showed elevated liver enzyme. The patient was sent to gastroenterologist. Subsequently, the patient recovered from abdominal pain and elevated liver enzyme. Liver enzyme have returned to within normal limits. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Wrong technique in drug usage process
Clinical narrative: Information has been received from a registered nurse concerning her 20 year old daughter with positive for human papillomavirus papilloma viral and back injury. The patient's physician decided that she should get vaccinated anyway because there are many different strains of HPV. The mother filled prescription for GARDASIL for a local pharmacy and she received no appropriate education regarding the proper administration of GARDASIL. On 12-FEB-2010, the mother administered a first dose of GARDASIL (lot# 0250X) IM in the right deltoid to her daughter, but she did not shake it prior to administration. Concomitant therapy included LYRICA. On 12-FEB-2010, the patient experienced right deltoid stinging for about 30 second after the injection and it resolved. It was unknown if there was any relevant laboratory data. As of 12-FEB-2010, it was unknown if the daughter will continue GARDASIL and she was fine at this time. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperaesthesia
Clinical narrative: Information has been received from a physician assistant concerning a 24 year old female with no medical history or concurrent condition who on 21-FEB-2010 developed hyperesthesia after receiving a dose of GARDASIL. Concomitant therapy included VALTREX. Approximately two or three days after receiving the vaccine, she complained of sensitivity to touches. The reporter wasn't sure if this vaccine dose was her second or third dose. The patient sought unspecified medical attention. At the time of report the patient had not recovered. Follow up information was received from a physician assistant on 24-FEB-2010 via telephone. It was reported the patient had received the third dose of GARDASIL at another physician's office. The patient complained of sensitivity to touch over her whole body. The patient was placed on therapy with NEURONTIN, 300 mg, twice a day for pain. The patient had a follow-up appointment with the P.A. in a couple of days. The information if the patient's OB-GYN physician was also provided. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a 24 year old female with no medical history or allergies who in November 2009, was vaccinated IM, 0.5 ml, with her second dose of GARDASIL. The patient received both her first and second dosed of GARDASIL in the same arm. Concomitant therapy included unspecified birth control pills. On 14-JAN-2010 the patient experienced persistent pain at the injection site of the right deltoid muscle since administration of her second dose of GARDASIL. The patient was prescribed non-steroidal anti-inflammatory medication with only slight improvement in symptoms. There were no visible signs of inflammation, including no swelling, redness, warmth, etc. There was no interference with range of motion or strength, and no pain elsewhere in the arm. There were no laboratory studies performed. The patient had an office visit to seek medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: VIIth nerve paralysis
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on 06-OCT-2009 was vaccinated with the second dose of GARDASIL (lot number not reported). "Shortly after", the patient experienced Bell's palsy. The date of the first dose unspecified. Unspecified medical attention was sought. At the time of the report, the outcome of the patient was not reported.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Depression, Fatigue, Inappropriate affect, Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning his daughter, an 18 year old female with a history of attention deficit disorder and no drug reactions/allergies who was vaccinated intramuscularly with 3 doses of GARDASIL on 12-AUG-2009, 12-OCT-2009 and 29-JAN-2010. Concomitant therapy included VYVANSE and hormonal contraceptives (unspecified). The first and second doses of GARDASIL hurt at injection site. The third dose hurt more than usual at the injection site. On 31-JAN-2010 the patient complained of severe stomach pain and not feeling good. In the evening of 01-FEB-2010 the patient had an overwhelming sense of depression and started balling and crying out of the blue. The patient had also been tired. There were no laboratory diagnostic studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Vaccine positive rechallenge
Clinical narrative: Information has been received from a pharmacist concerning his daughter, an 18 year old female with a history of attention deficit disorder and no drug reactions/allergies who was vaccinated intramuscularly with 3 doses of GARDASIL on 12-AUG-2009, 12-OCT-2009 and 29-JAN-2010. Concomitant therapy included VYVANSE and hormonal contraceptives (unspecified). The first and second doses of GARDASIL hurt at injection site. The third dose hurt more than usual at the injection site. On 31-JAN-2010 the patient complained of severe stomach pain and not feeling good. In the evening of 01-FEB-2010 the patient had an overwhelming sense of depression and started balling and crying out of the blue. The patient had also been tired. There were no laboratory diagnostic studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning a female who about a year ago, was vaccinated with a dose of GARDASIL. Three days after the vaccination, the patient developed a swollen lymph node. It was unknown if the patient sought medical attention. It took 3 months to resolve. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Depression, Emotional distress, Nausea, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a 19 year old female with attention deficit disorder and no known drug allergies who on 12-AUG-2009 was vaccinated IM with a first 0.5 ml dose of GARDASIL (lot # not reported). 1 week ago, on approximately 27-JAN-2010. the patient was vaccinated IM with a third dose of GARDASIL. Concomitant therapy included VYVANSE. On 02-FEB-2010 the patient developed nausea, abdominal pain and depression. The patient was away at school and had been referred for evaluation at a local facility. The patient sought unspecified medical attention. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. Follow up information has been received from a healthcare professional concerning a 19 year old female student with no illness at the time of vaccination and no known drug allergies who on 29-JAN-2010, at 10:25am, was vaccinated IM into right deltoid with a third dose of GARDASIL (lot # 662765/0821Y). Within 48 after her third injection of GARDASIL, the patient had nausea, abdominal pain, depression and emotional distress. The adverse events gradually resolved. The patient did not have any reaction after first 2 injections. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a consumer concerning someone she known was vaccinated with a dose of GARDASIL (dose, route, and lot# not reported). On unknown date, the patient had tested positive for GARDASIL despite receiving GARDASIL. At the time of the report, the patient's outcome was unknown. No further information is available. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Eyelid oedema, Lip swelling, Urticaria
Clinical narrative: Information has been received from a company representative concerning her 15 year old daughter with asthma and no drug reactions/allergies who on 02-APR-2009 was vaccinated with the first 0.5ml dose of GARDASIL IM. On 29-DEC-2009 the patient was vaccinated with the third 0.5ml dose of GARDASIL (lot# 663452/0671Y) IM. Concomitant therapy included YAZ. On 29-DEC-2009, 45 minutes after receiving her third dose of vaccination, the patient developed widespread hives, as well as lip and eyelid swelling. There were no respiratory symptoms. The patient was seen by the doctor in the office. No laboratory diagnostic studies were performed. The patient was treated with ATARAX and prednisone in the office and the symptoms resolved within 2 hours. At the time of the report, the patient recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 20 year old female allergic to CECLOR and with mild hypertension who on 06-JUL-2007, on 04-MAR-2008 and on 04-FEB-2010 was vaccinated 0.5 ml IM with the first (657737/0522U), second (659441/1446U) and  third (662304/1013Y) doses of GARDASIL. Concomitant therapy included WELLBUTRIN, clonidine and oral hormonal contraceptives (unspecified). The physician reported that the patient experienced pain with each administration. The patient's pain recovered on the day of injection reintroduction pain reappeared. No lab diagnostics studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a approximately 19 year old female patient who "1 month ago", on approximately 04 JAN-2010 was vaccinated with GARDASIL (lot number not reported). "One month" after vaccination, on approximately 04-FEB-2010 the patient experienced a swollen sore right arm. Unspecified medical attention was sought. The outcome of the patient was not reported. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a female medical assistant who on an unspecified date was vaccinated with a dose of GARDASIL (lot number not reported). Subsequently on an unspecified date the patient's arm became swollen, red and hot for 3 days. It was unknown if medial attention was sought. At the time of the report, the patient had recovered. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Local reaction, Rash papular, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 year old female patient with no pertinent medical history and no known allergies who on 02-FEB-2010 was vaccinated IM with a 0.5 ml dose of GARDASIL (lot number 663573/0969Y) in the left deltoid. Concomitant therapy included birth control therapy (unspecified). The patient was monitored post vaccination and was fine when she left the office. The next morning, on 03-FEB-2010, the patient woke up with hives, rash going down her left arm with small bumps on the end; it was reported as localized reaction. The nurse practitioner states clients "now" (at the time of the report, on 04-FEB-2010) had systemic reaction of hives from head to toe. Unspecified medical attention was sought. There was no lab studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 23 year old female with sulfonamide allergy and cefaclor allergy who on approximately 15-AUG-2008 (18 months ago) was vaccinated with the first dose of GARDASIL. The patient fainted after getting her first dose of GARDASIL and recovered on the same day. On 15-FEB-2010 the patient came to the physician's office to received the second dose of GARDASIL. Unspecified medical attention was sought. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: VIIth nerve paralysis
Clinical narrative: Information has been received from a Licensed Practical Nurse, concerning a female patient, who on an unknown date was vaccinated with a dose of GARDASIL (dose, route and lot not provided). On an unknown date, the patient developed bell's palsy after administration of GARDASIL. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Follow-up information has been received from the Licensed Practical Nurse, concerning an 26 year old patient. The nurse stated that the patient received her dose of GARDASIL at another physician's office. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who on 20-JUL-2009 and 16-NOV-2010 was vaccinated with a first and second dose of GARDASIL respectively (lot # not provided). Physician reported that in 1993 and 1994, the patient finished the series of measles-mumps-rubella vaccine, HIB conj-hepatitis B vaccine, poliovirus vaccine and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, and on 27-JAN-2010 the patient experienced shingles. The patient sought medical attention at the office visit. On unspecified date, the patient recovered from shingles. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a nurse concerning a "13 or 15 year old" female patient who "within the last two weeks", on approximately 28-JAN-2010, was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL (Lot # 663694/1316Y). It was reported, that immediately after receiving the GARDASIL the patient fainted. The patient recovered on the same day. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a female with no known history of needle aversion, who was vaccinated with the first dose of GARDASIL possibly one year ago. Before leaving the office the patient felt dizzy. After lying down for 15 minutes, she went home. The patient fainted upon getting out of the car on arrival at home. It was unknown if the patient sought medical attention. At the time of the report, the patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Haemorrhage, Maternal condition affecting foetus, Premature labour
Clinical narrative: Information has been received from a nurse practitioner, concerning a male baby, who on 01-SEP-2009, was exposed via uterus to a dose of GARDASIL (lot number 659054/0314Y). On the same day, the baby was also exposed to influenza virus vaccine (unspecified) and H1N1. On 21-APR-2010, the baby was born preterm at 36 weeks from mother's last menstrual period due to mother was bleeding. The baby was born healthy, with a weight of 6 lb 4.5 oz and apgar score of 8/9. Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Dyskinesia, Headache, Menorrhagia
Clinical narrative: Information has been received from a 28 year old female patient with allergic reaction to aspirin when take extra strength and no medical history who on an unspecified date was vaccinated with the third dose of GARDASIL. There was no concomitant medication. Shortly after vaccination, the patient started experiencing severe, increased motions with an increase of menstrual flow. She also stated she felt body temperature increased along with getting more headaches. The patient could not give specified dates of when she took the vaccine. She simply stated her last dose was given a couple of years ago before her 26th birthday. No medical attention was sought. At the time of the report, the patient had not recovered. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a Licensed Practical Nurse, concerning her 15 year old daughter, who in August 2009 "six months ago", was vaccinated with the first dose of GARDASIL (route and lot number not reported). On 10-FEB-2010, the patient was vaccinated with the third dose of GARDASIL (route and lot number not reported). Nurse reported that her daughter experienced a injection site reaction after the product was given. The nurse stated that her daughter had a "raised area that was hard and warm to touch and also looked like a bulls eye rash". The nurse stated that the rash was "almost gone" at the time of reporting. No reactions were reported after the first two doses of GARDASIL. Patient sought unspecified medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Eye swelling, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician's assistant concerning a 13 year old female patient who on 08-NOV-2008 was vaccinated with the first 0.5ml dose of GARDASIL (lot # not reported). On 17-FEB-2010 the patient was vaccinated with the second 0.5ml dose of GARDASIL (lot # not reported). On 18-FEB-2010 the patient  developed swelling around the eyes after the second vaccination. It was reported that the patient didn't experience any adverse events after the first vaccination. Unspecified medical attention was sought. At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenopia, Conjunctivitis, Eyelid oedema, Headache, Hypoaesthesia facial
Clinical narrative: Initial and follow-up information has been received from a 21 year old female patient and a physician. The patient had a history of a gall bladder removal in May 2009 and not known allergies. On 04-JUN-2009 was vaccinated in the left arm with the first dose of GARDASIL (route and lot number not provided). On 13-AUG-2009, the patient was vaccinated in the left arm with the second dose of GARDASIL (route and lot number not provided). Concomitant therapy included TRI-SPRINTEC and at the end of Nov 2009, was switched to FEMCON FE. There were no concomitant vaccines. At the end of September 2009, the patient experienced that her left eye was feeling very heavy, very puffy and upper lid swollen. In November 2009, the left side of her face started to get affected, and felt tingly and numb and "stopped at midline". The physician reported that on 25-NOV-2009 the patient came to the office complaining of skin tingling. Nothing was noted on the exam. The tingling and numb feeling would last a couple of hours then went away, then came back again. The feeling on the left side of her face was milder and not as frequent. The left eye was the same. The patient felt like the tingly and numb feeling was going to the right side. The patient has also experienced headaches. On 17-DEC-2009, the patient received in the left arm third dose of GARDASIL (route not provided). On 23-DEC-2009, the patient presented with conjunctivitis. The physician stated that there was no connection to GARDASIL. Physician stated that the patient had consulted with ophthalmology and neurology but no contact information or details provided. A Magnetic Resonance Imaging (MRI) was performed approximately on 05-FEB-2010 "2 weeks ago", and the results were normal. Physician reported that she did not order the MRI as she did not feel one was justified. At the time of reporting, At the time of reporting, the patient had not recovered. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Initial and follow-up information has been received from a 21 year old female patient and a physician. The patient had a history of a gall bladder removal in May 2009 and not known allergies. On 04-JUN-2009 was vaccinated in the left arm with the first dose of GARDASIL (route and lot number not provided). On 13-AUG-2009, the patient was vaccinated in the left arm with the second dose of GARDASIL (route and lot number not provided). Concomitant therapy included TRI-SPRINTEC and at the end of Nov 2009, was switched to FEMCON FE. There were no concomitant vaccines. At the end of September 2009, the patient experienced that her left eye was feeling very heavy, very puffy and upper lid swollen. In November 2009, the left side of her face started to get affected, and felt tingly and numb and "stopped at midline". The physician reported that on 25-NOV-2009 the patient came to the office complaining of skin tingling. Nothing was noted on the exam. The tingling and numb feeling would last a couple of hours then went away, then came back again. The feeling on the left side of her face was milder and not as frequent. The left eye was the same. The patient felt like the tingly and numb feeling was going to the right side. The patient has also experienced headaches. On 17-DEC-2009, the patient received in the left arm third dose of GARDASIL (route not provided). On 23-DEC-2009, the patient presented with conjunctivitis. The physician stated that there was no connection to GARDASIL. Physician stated that the patient had consulted with ophthalmology and neurology but no contact information or details provided. A Magnetic Resonance Imaging (MRI) was performed approximately on 05-FEB-2010 "2 weeks ago", and the results were normal. Physician reported that she did not order the MRI as she did not feel one was justified. At the time of reporting, At the time of reporting, the patient had not recovered. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Fatigue, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a consumer concerning her 22 year old daughter with allergy to iodine and "others unspecified" and a history of migraine who "over 1 year ago" was vaccinated with the first dose of GARDASIL. On an unspecified date the patient was vaccinates with the third dose of GARDASIL. There was no lot number reported. Concomitant therapy included progesterone. "5-6 days after received the vaccine", the patient experienced flu-like symptoms, chills, itching and fatigue. The reporter also stated that the patient developed redness and swelling at the injection site after the third dose of the vaccine. The patient called doctor's office. At the time of the report, the patient had not recovered. Follow-up information has been received from a physician concerning the 22 year old (also reported as 23 year old) female patient with sulfa allergy and no illness at the time of vaccination who on 10-FEB-2010 was vaccinated with the third dose of GARDASIL (lot number 662299/1099Y) into the left deltoid. On 17-FEB-2010 the patient experienced flu-like symptoms, itching and swollen at the injection site. The outcome of the patient was reported as unknown. Additional information has been request.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus
Clinical narrative: Information has been received from a consumer concerning her 22 year old daughter with allergy to iodine and "others unspecified" and a history of migraine who "over 1 year ago" was vaccinated with the first dose of GARDASIL. On an unspecified date the patient was vaccinates with the third dose of GARDASIL. There was no lot number reported. Concomitant therapy included progesterone. "5-6 days after received the vaccine", the patient experienced flu-like symptoms, chills, itching and fatigue. The reporter also stated that the patient developed redness and swelling at the injection site after the third dose of the vaccine. The patient called doctor's office. At the time of the report, the patient had not recovered. Follow-up information has been received from a physician concerning the 22 year old (also reported as 23 year old) female patient with sulfa allergy and no illness at the time of vaccination who on 10-FEB-2010 was vaccinated with the third dose of GARDASIL (lot number 662299/1099Y) into the left deltoid. On 17-FEB-2010 the patient experienced flu-like symptoms, itching and swollen at the injection site. The outcome of the patient was reported as unknown. Additional information has been request.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Lethargy, Myalgia, Paraesthesia
Clinical narrative: Information has been received from a 13 year old female patient who in December 2009, was vaccinated with a dose of GARDASIL. In December 2009, the patient experienced weakness, lethargy, pins and needles in her fingers and toes and muscle pain after receiving the vaccination. The patient visited the doctor and was prescribed NOROXIN but no improvement was seen. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Arthropathy
Clinical narrative: Information has been received from a physician who mentioned that she read an article in the magazine which referenced a female patient who on an unspecified date was vaccinated with unspecified dose of GARDASIL (lot# not reported) and the patient experienced "joint issues" several months after receiving GARDASIL. It was reported in the article that a chiropractor was treating the patient with manipulation. At the time of this report, the patient's outcome was unknown. Attempts are being made to verify the existence of an identifiable patient and reporter. Follow up information has been received from a medical assistant who stated that the physician did not remember the name of the article and stated that the article appeared in the March issue. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from an obstetric technologist concerning a 24 year old female who on 23-JUN-2009 and 17-AUG-2009 was vaccinated with the first and second dose of GARDASIL (0.5ml, lot # 0947X) in her left deltoid respectively. On 18-AUG-2009 the patient experienced hives on chest, upper back and arms. On 22-FEB-2010, the patient did not present with rash, however still experienced transient rashes. The patient had sensitivity to "Tide" detergent. The patient did not intend to receive the third dose of GARDASIL. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Injection site pruritus, Rash, Rash pruritic
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on 04-FEB-2010 was vaccinated with a dose GARDASIL. On 05-FEB-2010 the patient developed itchy rash on her hands and forearms which then spread to her lower legs. The patient also d minor itching at the injection site which resolved in a day or two. At the time of the report, the patient was still experiencing the systemic itching. Follow up information has been received from the nurse practitioner concerning a 22 year old female who on 04-FEB-2010 was vaccinated with her first and only dose of GARDASIL (Lot #0669Y). Follow up information has been received from a registered nurse concerning a 22 year old female student with urinary tract infection, no illness at the time of vaccination and no known drug allergies who on 04-FEB-2010 was intramuscularly vaccinated with the first dose of GARDASIL (Lot 0669Y) in her left deltoid. Concomitant therapy included VYVANCE and NUVARING. On 05-FEB-2010 at 09:00 AM, itchy rash was noticed on the patient's hands and wrists, later on her feet and legs and bruising on her left leg. The patient also experienced slight itching at injection site which lasted 2 days (recovered 07-FEB-2010). The rest of itching lasted about 2 weeks (recovered approximately 19-FEB-2010). No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female with allergic reaction to CECLOR, KEFLEX and BACTRIM allergy and no pertinent medical history who on 26-JAN-2010 was vaccinated intramuscularly with the first dose of GARDASIL (lot # 662300/0100Y). Concomitant therapy included TOPAMAX and NUVARING. On 27-JAN-2010 the patient experienced itchiness all over her body. Only when the patient scratched the area, it turned to "hives". There were no lad diagnostic studies performed. At the time of the report the patient was recovering. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal inflammation
Clinical narrative: Information has been received from a consumer concerning 12 year old daughter with allergies and no drug allergies who on 20-JUL-2009 was vaccinated with a first dose of GARDASIL (lot # not reported). Concomitant therapy included allergy medication (caller did not specify which medication). The caller stated daughter missed the second and third doses of GARDASIL. On 23-JAN-2010 the patient experienced inflammation in the vaginal area (daughter was not sexually active). The patient did not seek medical attention. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEP, HPV4, TDAP
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female patient with no known drug allergies or reactions and no pertinent medical history who in "early October 2009" was vaccinated with her initial dose of GARDASIL at a local health department. Concomitant suspect vaccine therapy included a dose of RECOMBIVAX HB (manufacturer unspecified). Other concomitant vaccine therapy included Tdap. The nurse mentioned that the patient developed hives after administration of the vaccines at that visit. On an unspecified date, the patient recovered. The patient sought medical attention contacting the office. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Epistaxis
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 21-JAN-2010 was vaccinated with the third dose of GARDASIL. The mother called the physician indicating that on 21-JAN-2010 the patient suffered a nose bleed after vaccination. The patient sought unspecified medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration, Injection site rash
Clinical narrative: Information has been received from a physician concerning his/her 12 year old daughter who at 9 year old was vaccinated with the first dose of GARDASIL (route and LOT # not reported). After receiving the vaccine, the patient developed a rash. The rash had cleared but skin hypopigmentation at the area had occurred. The area was 3 to 5 inches in circumference and located at the site of injection. Unspecified medical attention was sought. The patient's skin hypopigmentation was not recovered. She was not going to continue with the series. No further information is available.