chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Rash generalised, Respiratory tract congestion
Clinical narrative: Information has been received from a physician concerning a female patient who on approximately 19-JUL-2010 was vaccinated with the second 0.5 ml dose of GARDASIL. The physician reported that about 24 hours after getting her second dose of the vaccine, on approximately 20-JUL-2010, the patient was given her 2nd injection she was congested and then developed a red and bumpy rash beneath armpits. It move to underneath her breasts, and then spread to all over her body. There was no adverse event after the first shot. At the time of the report the patient was recovering. No lab diagnostics studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female who was vaccinated with a dose of GARDASIL (Lot # unknown). The physician reported that after receiving the dose, the patient fainted. The patient sought unspecified medical attention. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Haematology test normal, Menstruation irregular, Nausea, Pain
Clinical narrative: Information has been received from a physician concerning a 23 year old female patient with no other pertinent medical history and no allergies who on approximately 23-JUN-2010 ("two weeks ago") was vaccinated intramuscularly with the first dose of GARDASIL (lot# not reported). There was no concomitant medication. On approximately 24-JUN-2010 ("the day after receiving her first dose of GARDASIL") the patient experienced fatigue, body aches, nausea, menstrual irregularities and vaginal secretions. The patient had been seen twice in an urgent care center and once in the physician's office. Blood work had been performed but were unremarkable. At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal discharge
Clinical narrative: Information has been received from a physician concerning a 23 year old female patient with no other pertinent medical history and no allergies who on approximately 23-JUN-2010 ("two weeks ago") was vaccinated intramuscularly with the first dose of GARDASIL (lot# not reported). There was no concomitant medication. On approximately 24-JUN-2010 ("the day after receiving her first dose of GARDASIL") the patient experienced fatigue, body aches, nausea, menstrual irregularities and vaginal secretions. The patient had been seen twice in an urgent care center and once in the physician's office. Blood work had been performed but were unremarkable. At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Cough, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: Information has been received from a licensed practical nurse concerning a 14 year old male patient with attention deficit disorder and no drug reactions or allergies, who on 29-JUN-2010 was vaccinated IM with a 0.5 ml first dose of GARDASIL (Lot# unknown). Concomitant therapy included CONCERTA and STRATTERA. The nurse reported that on 30-JUN-2010 the patient developed a fever of 102F. On 01-JUL-2010 the patient developed headache, dizziness and body aches. On 01-JUL-2010 the patient was seen in the office. On exam, the patient was afebrile. A complete blood count was performed and revealed low white blood cell count of 3.2. The patient was advised to take TYLENOL and increase fluid intake. The patient sought medical attention by an office visit. At the time of the report, the patient had not recovered from headache, dizziness and body aches. Follow up information received from licensed practical nurse via medical records indicated that the patient was a male student, with no illness at the time of vaccination, who on 29-JUN-2010 at 11:00 was vaccinated with a first dose of GARDASIL (Lot# 0318Z) intramuscularly in his right arm. On 29-JUN-2010 at 16:00 the patient developed fever, body ache, headache, dizziness, anorexia and slight cough. It was reported that the patient experienced a temperature of 102 (units not reported). The patient was seen at a healthcare office on 01-JUL-2010 where he reported the same symptoms with the addition of fatigue. He was treated with TYLENOL (given at 9:30). His blood pressure was 90/60; pulse 60 and Respiratory rate 16. His physical examination was within normal limits. The patient ate soup, popsicles and pudding. His appetite was reported as OK. On the same date the patient had a low white blood cell count (3.2x10E3/uL); a high serum molybdenum test (10.2 %) and a low mean platelets volume test (6.9 fL). The patient continued on treatment with ibuprofen treatment/ further recommendations given to the patient included push fluids and rest. The patient recovered on 02-JUL-2010. No further information is available.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Laboratory test abnormal, Mean platelet volume decreased, Pain, Pyrexia, White blood cell count decreased
Clinical narrative: Information has been received from a licensed practical nurse concerning a 14 year old male patient with attention deficit disorder and no drug reactions or allergies, who on 29-JUN-2010 was vaccinated IM with a 0.5 ml first dose of GARDASIL (Lot# unknown). Concomitant therapy included CONCERTA and STRATTERA. The nurse reported that on 30-JUN-2010 the patient developed a fever of 102F. On 01-JUL-2010 the patient developed headache, dizziness and body aches. On 01-JUL-2010 the patient was seen in the office. On exam, the patient was afebrile. A complete blood count was performed and revealed low white blood cell count of 3.2. The patient was advised to take TYLENOL and increase fluid intake. The patient sought medical attention by an office visit. At the time of the report, the patient had not recovered from headache, dizziness and body aches. Follow up information received from licensed practical nurse via medical records indicated that the patient was a male student, with no illness at the time of vaccination, who on 29-JUN-2010 at 11:00 was vaccinated with a first dose of GARDASIL (Lot# 0318Z) intramuscularly in his right arm. On 29-JUN-2010 at 16:00 the patient developed fever, body ache, headache, dizziness, anorexia and slight cough. It was reported that the patient experienced a temperature of 102 (units not reported). The patient was seen at a healthcare office on 01-JUL-2010 where he reported the same symptoms with the addition of fatigue. He was treated with TYLENOL (given at 9:30). His blood pressure was 90/60; pulse 60 and Respiratory rate 16. His physical examination was within normal limits. The patient ate soup, popsicles and pudding. His appetite was reported as OK. On the same date the patient had a low white blood cell count (3.2x10E3/uL); a high serum molybdenum test (10.2 %) and a low mean platelets volume test (6.9 fL). The patient continued on treatment with ibuprofen treatment/ further recommendations given to the patient included push fluids and rest. The patient recovered on 02-JUL-2010. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Headache
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with a third dose 0.5 ml  of GARDASIL (Lot#: not reported). The nurse advised that, on an unspecified date the patient completed the series of GARDASIL injections. After the last injection the mother of the patient called into the physician's office and advised that the patient was having a headache and a stomachache. The patient sought unspecified medical attention. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Labia enlarged
Clinical narrative: Information has been received from a nurse practitioner concerning a 21 year old female patient with no pertinent medical history and no drug reactions or allergies, who on 26-APR-2011 was vaccinated with the first dose of GARDASIL (Lot number not reported). Concomitant therapy included NUVARING. The nurse practitioner reported that on 26-APR-2011, after administration of the vaccine, the patient experienced labial swelling. No lab diagnostics studies were performed. Vaseline applied locally was given as a treatment for the experience. On 27-APR-2011 the patient recovered from labial swelling. The patient sought medical attention by calling the nurse practitioner. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 years old female patient, who on 06-JAN-2011 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (Lot # 665607/1333Y). Concomitant therapy included desogestrel/ethinyl estradiol (MSD) for contraception. The nurse reported that after vaccination with GARDASIL, the patient had immediately experienced pain in the arm at the injection site and that the pain continued for over a month and got worse. The patient did not seek medical attention. No treatment was given for the event. At the time of the report, the patient's outcome was not recovered. Follow-up information has been received concerning a 25 years old female patient, with no pre-existing allergies, birth defects or medical conditions reported, who on 06-JAN-2011 at 14:00 was vaccinated in the left deltoid with the first 0.5 ml dose of GARDASIL (Lot # 665607/1333Y). It was reported that patient complained of severe pain in her left arm at the injection site that lasted from the day of the injection 06-JAN-2011, through the follow-up visit on 14-FEB-2011. Patient had not been seen since 14-FEB-2011 to determine if symptoms had resolved. There was no illness at time of vaccination. A physical exam was performed on 14-FEB-2011, the result was normal without neurological, vascular or muscular deficits found. At the time of the report, the patient's outcome was unknown, previously reported as not recovered. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Induration, Musculoskeletal stiffness
Clinical narrative: Information has been received from a physician concerning a 15 year old male with no medical history and no drug reactions/allergies who on 02-JUN-2011 was intramuscularly vaccinated with the first dose of 0.5 ml GARDASIL (lot # not reported) in his left arm. The reporter stated that the patient did not receive any other vaccines on 02-JUN-2011 and on 03-JUN-2011 ("today") the patient had stiffness in the right side of his neck that was hard to touch. The reporter did also note that the patient slept on the couch last night. No treatment was given for this adverse event. No lab diagnostics were performed. At the time of reporting, the patient had not recovered. The patient called the office to seek medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Information has been received from a female consumer, who on an unspecified date was vaccinated with a third dose of GARDASIL (Lot # not reported) SQ. The consumer experienced an injection site reaction consisting of a large local reaction of swelling and redness. There were no Lab diagnosis/studies performed. It was reported that the consumer had not receive treatment for the adverse events. The patient did not seek medical attention. At the time of the report, the consumer had recovered. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a physician concerning a 13 year old female with no pertinent medical history who on 18-APR-2011 was vaccinated with the first dose of GARDASIL (lot # not reported). There was no concomitant medication. On 18-APR-2011 the patient experienced headache that lasted for multiple days. The outcome of headache was unknown. The patient sought unspecified medical attention. The patient was initiated a migraine protocol with unspecified medications. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Dehydration, Headache, Malaise, Pain
Clinical narrative: Information has been received from an office manager concerning her daughter, a 15 year old female patient with photodermatitis started in June 2009 (reported as "one year ago") who was vaccinated with the first 0.5ml dose of GARDASIL (lot # 659054/0311Y) on 05-MAR-2010 and the second 0.5ml dose on 11-MAY-2010. It was reported that the patient received GARDASIL and has since complained of aches and pains in various location of her body, headaches, and generally an ill feeling. The patient did not have injection site problems but still felt ill. The patient went to the emergency room once for dehydration and went to a chiropractor. ESR and blood work were performed, which showed sed was elevated. The patient was seeing a dermatologist in July. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: Information has been received from an office manager concerning her daughter, a 15 year old female patient with photodermatitis started in June 2009 (reported as "one year ago") who was vaccinated with the first 0.5ml dose of GARDASIL (lot # 659054/0311Y) on 05-MAR-2010 and the second 0.5ml dose on 11-MAY-2010. It was reported that the patient received GARDASIL and has since complained of aches and pains in various location of her body, headaches, and generally an ill feeling. The patient did not have injection site problems but still felt ill. The patient went to the emergency room once for dehydration and went to a chiropractor. ESR and blood work were performed, which showed sed was elevated. The patient was seeing a dermatologist in July. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old female patient with no pertinent medical history and penicillin allergy who "4 years ago" in January 2007, was vaccinated with the first dose of GARDASIL (Lot # and expire date not reported), intramuscularly. On 12-OCT-2010, the patient was vaccinated with the second dose of GARDASIL (Lot # 663454/0672Y and expire date 19-SEP-2011), intramuscularly. On 29-DEC-2010, the patient was vaccinated with the third dose of GARDASIL (Lot # and expire date not reported), intramuscularly. Concomitant therapy included "birth control pills". The registered nurse stated that after the second dose on 12-OCT-2010, the patient became pale, sweaty and felt lightheaded. Registered nurse also stated that this resolved after giving the patient a ginger ale and crackers shortly thereafter. There were no laboratory diagnostics studies performed. On 12-OCT-2010, the patient recovered. The patient sought unspecified medical attention. Follow up information received from a registered nurse indicated that the student female patient with no illness at the time of vaccination was vaccinated on 12-OCT-2010 at 14:00 PM, with the second dose of GARDASIL intramuscularly in the left deltoid. It was reported that 10 minutes after vaccination, the patient became lightheaded, pale and sweaty. The patient did not seek medical attention. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a female consumer concerning herself who on approximately 17-JUN-2010 was vaccinated with a dose of GARDASIL (lot # not reported). On 01-JUL-2010 the patient experienced a reaction 2 weeks after getting the vaccine, a red outline on where shot was given. At the time of this report, the patient had not recovered. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Fatigue, Gastrointestinal pain, Nausea
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female patient with no pertinent medical history and no drug reactions or allergies who on the morning of 05-APR-2011, was vaccinated with the second dose GARDASIL, 0.5 milliliters, single dose vaccine, intramuscularly (Lot number not provided). There was no concomitant medication. On 05-APR-2011, the patient called the practice after close of business and left a message complaining of sudden onset of nausea and upper gastric pain. Nurse reported that when she spoke with the patient on the morning of 06-APR-2011, the patient reported she was still feeling nauseous and fatigued. Nurse also reported that multiple unspecified household members of the patient experienced an unspecified gastrointestinal virus over the preceding weekend. No treatment was given for the adverse event. Laboratory diagnostics studies were not performed. At the time of the report the patient had not recovered. Follow up information has been received from the registered nurse who reported that the 24 year old (previously reported as 25 year old) female clerical patient with no pre-existing allergies, birth defects or medical conditions. There was no illness at the time of vaccination. On 05-APR-2011 at 10 AM, was vaccinated with the second dose of GARDASIL intramuscularly on the left deltoid (Lot number 0057AA). On the evening at 17:00 of 05-APR-2011, the physician stated that the patient reported nausea and upper gastrointestinal pain that lasted a couple of hours. On 06-APR-2011, the patient complained of nausea and fatigue. The patient also noted that two members of her family had nausea and vomiting "two days prior". The patient did not seek medical attention. At the time of the report the outcome of the patient was unknown. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a physician concerning a 10 year old male with no medical history or allergies who on 05-AUG-2010 was vaccinated with the first dose of GARDASIL (lot# not reported), 0.5 mL. Concomitant therapy included Tdap (manufacturer unspecified) and MENACTRA. The patient waited around for about 10 minutes and started complaining of dizziness and then experienced syncope. "Pretty quickly after the episode", the patient recovered from dizziness and syncope. No lab diagnostics studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a 25 year old female who in June 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.
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Headache, Rash, Syncope
Clinical narrative: A consumer posted the information on a website that reported by a mother concerning her daughter who on unspecified dates was vaccinated with the first and second dose of GARDASIL. After the first vaccination she fainted and was told by the doctor that this was normal. After the second vaccination the patient had chest pains, severe rashes on her face and headaches. She was going to the hospital for chest pains. The mother was scared to death at what the doctor's might find and she was hoping that it was only stress. No further information is available.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Injection site mass, Injection site nodule
Clinical narrative: Information has been received from a 31 year old female physician with no pertinent medical history and no drug allergies who on 18-OCT-2010 was vaccinated with the first dose of GARDASIL (dose, lot# and route not reported) and on 24-DEC-2010 was subcutaneously versus intramuscularly vaccinated with the second dose of GARDASIL (dose, lot# not reported). There was no concomitant medication. The physician reported that she was 32 years old at the time of vaccination and she felt a bump or nodule at the injection site and that was why she suspected subcutaneous administration of vaccination. No lab diagnostics study was performed. At the time of reporting, the outcomes were unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Gastrooesophageal reflux disease, Maternal exposure during pregnancy, Pregnancy test positive, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a 25 year old (reported as 22 year old in the initial report) female who on 30-MAR-2010 was vaccinated with GARDASIL, a Pregnancy Registry product. The patient stated that she saw the GARDASIL pregnancy registry and called to report she received her third dose of the GARDASIL when she was 4 weeks pregnant, (patient gave her LMP as 28-FEB-2010). She stated that she was vaccinated at the health clinic with her third dose of GARDASIL on 30-MAR-2010, but did not know she was pregnant at that time. She took a home pregnancy test and it was positive, but she did not specify the date. Caller stated she is not having any problems. Based on the LMP, the system estimated the delivery date as 05-Dec-2010. The patient reported her estimated due date as 11-DEC-2010. The patient sought unknown medical attention. Follow up information has been received from an unspecified health care professional concerning the 25 year old female who on 30-MAR-2010 was vaccinated with GARDASIL. On unknown date the patient experienced reflux and on 08-SEP-2010 was treated with ZANTAC. She had no previous pregnancies. Her estimated delivery date was 11-DEC-2010 (previously reported as 05-DEC-2010). On 16-JUN-2010 and 09-JUL-2010 she had routing and dating ultrasound scan which showed simple live intrauterine pregnancy (SLIUP) with positive heart  rate (HR). On 25-JUN-2010 Maternal Serum Alpha-Fetoprotein (MSAFP) was done for birth defects screen. The screen tests were negative. On 04-DEC-2010, 39 weeks from last menstrual period (LMP), the patient delivered a normal, healthy male baby weighing 5.2 pounds. There were no congenital anomalies. There were no other complications or abnormalities. There were no complications during pregnancy or labor/delivery. No further information is available.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, TDAP, VARCEL
Symptoms: Anxiety, Blood test, Drug exposure during pregnancy, Ultrasound scan abnormal, Urine analysis
Clinical narrative: Information has been received from a certified nurse practitioner for GARDASIL and VARIVAX, two Pregnancy Registry products, concerning a 12 year old female patient with no pertinent medical history who on 20-OCT-2010 was vaccinated IM with 0.5 ml GARDASIL (lot number 666595/0096Z, expiration date 14-OCT-2012), subcutaneously with 0.5 ml of VARIVAX, IM with 0.5 ml of Tdap and 0.5ml of FLUZONE. It was reported there was no concomitant medication. On 20-OCT-2010, urinalysis was performed (results not provided). On 27-OCT-2010 bloodwork was performed (results not provided). On 27-DEC-2010 the patient went to the physician's office reporting that she was pregnant. A "sonogram" performed by the physician on the same date confirmed that the patient was pregnant when she received the vaccinations on 20-OCT-2010. At time of the report, the patient's outcome was unknown. The nurse practitioner also mentioned that the patient took one dose of ED-A-HIST DM on 15-OCT-2010 and the patient experienced an anxiety attack, requiring the patient to seek medical treatment at an emergency room. Follow-up information has been received from a completed questionnaire. The lot number of VARIVAX was 669723/0835Z. The patient was vaccinated at private doctor office/hospital. The patient was not tested for varicella antibodies before vaccination with VARIVAX. The date of the patient's last menstrual period was unknown and the estimated delivery date was 05-MAY-2011. No amniocentesis or Maternal Serum Alpha-Fetoprotein Screening (MSAFP) was performed. There was no previous pregnancy. No birth defect, no miscarriage or stillbirth occurred in any previous pregnancy. There was no local reaction at vaccine site. There were no varicella symptoms and no herpes zoster symptoms after vaccination. The patient was used FeSO4/prenatal vitamins daily (start date unknown) and azithromycin 1 gram from 06-JAN-2011. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site hypersensitivity, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a 21 year old female who on 19-AUG-2010 was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (lot # not reported). Shortly after 19-SEP-2010 the patient developed a rash that lasted for one week in which was really sensitive at the injection site. On 22-NOV-2010 therapy with GARDASIL was discontinued. After stopping therapy on 22-NOV-2010, the patient's outcome was recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Groin pain, Lymphadenopathy
Clinical narrative: Information has been received from a Certified Medical Assistant concerning a 16 year old female with physical therapy for hip issues who on 17-AUG-2010 was vaccinated with the first dose of GARDASIL (lot # 663559/1178Y). On 22-AUG-2010 the patient experienced pain in the groin which was diagnosed on 24-AUG-2010 as a swollen lymphoid in the left leg. The patient's swollen lymphoid in the left leg persisted. The patient sought unspecified medical attention. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a medical assistant concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL. There was no concomitant medication. The medical assistant reported that about two weeks after receiving the dose of the vaccine, the patient experienced  a bee size lump at the injection site. No lab diagnostics studies were performed. Patient sought unspecified medical attention. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 7 year old female who on 25-AUG-2010 was mistakenly vaccinated with a dose of GARDASIL instead of VARIVAX (Merck). No adverse effects were reported. Follow up information received from the physician concerning a 7 year old female who on 25-AUG-2010 at 1:02 PM was mistakenly vaccinated with a first dose of GARDASIL (lot # 666162/0664Z, IM) in the left deltoid. No adverse effects were reported. The patient tolerated vaccine. Additional information was not expected.
Age: 15.0
Sex: F
Vaccine: FLUX, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female with no medical history or drug allergies who on 11-NOV-2010 was vaccinated IM with a first 0.5 ml dose of GARDASIL (Lot # 666929/0331Z). Secondary suspect therapy included a dose of VARIVAX (therapy route and lot # not reported) and a dose of flu vaccine (manufacturer unspecified) both given on 11-NOV-2010. Concomitant therapy included MENACTRA, HAVRIX and ADACEL all given on 11-NOV-2010. On 11-NOV-2010 the patient who received Dose 1 of GARDASIL fainted 10 minutes after administration. Patient had received other vaccinations during the same visit. On 11-NOV-2010 the patient recovered. No lab diagnostics studies performed. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (Lot Number: 667866/1437Z). On an unspecified date the patient experienced pain in her arm after receiving the GARDASIL. It was unspecified whether the patient sought medical attention. At the time of the report, the patient's present status was unknown. A lot check has been initiated. This is one of several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Conversion disorder, Cyanosis, Dystonia, Immediate post-injection reaction, Musculoskeletal stiffness
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a first dose of GARDASIL (Lot# unknown). The physician reported that immediately after injection, the patient looked like she was going to faint. Patient was in physician's office at that time she was observed and then released from physician's office. The physician indicated that she did not administer the 2 remaining doses of GARDASIL to her patient and she also indicated that the patient also states that she did not want to receive the 2 remaining doses of GARDASIL. At the time of the report, the patient had recovered (date unknown). It was unknown if the patient sought medical attention. Follow up information has been received from the physician concerning the 14 year old female student patient with no illness at the time of vaccination and no known pre-existing allergies, birth defects or medical conditions, who on 21-JUL-2010 at 11:00 am was vaccinated intramuscularly into the right deltoid with the first dose of GARDASIL (Lot # 666163/0664Z). On the same day, the patient was vaccinated intramuscularly into the left deltoid a dose of VAQTA (Lot # 667869/0560Z) and intramuscularly into the left deltoid with a dose of MENACTRA (Lot #U3080AA). The physician stated that after receiving the vaccines, that patient stepped off the table and sat on a chair, about 30 seconds after, the patient was found with her head turned to right and upwards, cyanotic stiff, eyes dilated and unresponsive. The patient was moved to the table and laid down. The physician stated that the patient awoke approximately 30 to 60 second after she was placed on the supine. No post-ictal phase. The patient stated that it was weird and had no memory of the event. The physician thought that it was a vasovagal episode with pseudoseizures/dystonic component. On 21-JUL-2010, the patient had recovered. No further information is available.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Mydriasis, Posture abnormal, Presyncope, Unresponsive to stimuli
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a first dose of GARDASIL (Lot# unknown). The physician reported that immediately after injection, the patient looked like she was going to faint. Patient was in physician's office at that time she was observed and then released from physician's office. The physician indicated that she did not administer the 2 remaining doses of GARDASIL to her patient and she also indicated that the patient also states that she did not want to receive the 2 remaining doses of GARDASIL. At the time of the report, the patient had recovered (date unknown). It was unknown if the patient sought medical attention. Follow up information has been received from the physician concerning the 14 year old female student patient with no illness at the time of vaccination and no known pre-existing allergies, birth defects or medical conditions, who on 21-JUL-2010 at 11:00 am was vaccinated intramuscularly into the right deltoid with the first dose of GARDASIL (Lot # 666163/0664Z). On the same day, the patient was vaccinated intramuscularly into the left deltoid a dose of VAQTA (Lot # 667869/0560Z) and intramuscularly into the left deltoid with a dose of MENACTRA (Lot #U3080AA). The physician stated that after receiving the vaccines, that patient stepped off the table and sat on a chair, about 30 seconds after, the patient was found with her head turned to right and upwards, cyanotic stiff, eyes dilated and unresponsive. The patient was moved to the table and laid down. The physician stated that the patient awoke approximately 30 to 60 second after she was placed on the supine. No post-ictal phase. The patient stated that it was weird and had no memory of the event. The physician thought that it was a vasovagal episode with pseudoseizures/dystonic component. On 21-JUL-2010, the patient had recovered. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient who on an unspecified date was vaccinated with a 0.5 ml dose of GARDASIL. The physician was unsure if the series was completed, but the patient came in for a Pap test and the test came back abnormal. The physician was not sure if the vaccine did not work or if the patient was previously exposed to HPV. Patient sought medical attention by a visit to the doctor's office. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a consumer's mother concerning her 11 year old daughter with no allergies and no medical history reported, who in October 2010, was vaccinated with a dose of GARDASIL dose unspecified (Lot# not reported). Concomitant therapy included CONCERTA. On 28-DEC-2010, "Three weeks ago" she noticed that her daughter had a swollen gland underneath one of her under arms (Axillary). The patient's mother stated that her daughter had been complaining of this ever since she had GARDASIL in October. There were no laboratories performed. At the time of the report the patient's outcome of the patient was unknown. The patient did not seek medical attention. Follow up information has been received from a physician concerning a 11 year old female who on 19-JAN-2011 at 10:30 A.M. was vaccinated with the second dose of GARDASIL on left arm "LA" (Lot # 666595/0992Z). No illness at the time of vaccination. It was not reported pre-existing allergies, birth defects and medical conditions. On a date unknown, the patient recovered from swollen gland of left axillary. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Headache, Immediate post-injection reaction
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated IM with the first dose of GARDASIL (lot number not provided). The physician reported that immediately after vaccination the patient experienced 24 hours of extreme dizziness, headache and weakness. It was reported that therapy with GARDASIL was discontinued. On an unspecified date, the patient recovered from extreme dizziness, headache and weakness. The patient did not seek medical attention. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dysplasia, Laboratory test abnormal, Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a 21 year old female patient who on unspecified date received three doses of GARDASIL (Lot# not reported), IM. The physician stated that the patient experienced test results that determined the woman to be in high risk for Human Papillomavirus (HPV) with mild dysplasia after being administered GARDASIL. At the time of the report the patient's outcome was unknown. The patient did not seek medical attention. This is one from several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Blood glucose, Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who on 14-JUL-2010 was vaccinated with the first dose of GARDASIL (lot number not provided) and with a dose of VAQTA (manufacturer unknown). The physician reported that shortly after receiving the vaccines the patient had a syncopal reaction at the front desk. The patient came around and she was fine before leaving the office. It was unspecified if the patient sought medical attention. Follow up information has been received from the physician concerning the 15 year old female student patient with no pertinent medical history, drug reactions or allergies, no adverse event following prior vaccination and no illness at time of vaccination who on 14-JUL-2010 at 10:00 was vaccinated intramuscularly into her left arm with the first dose of GARDASIL (Lot# 663454/0672Y). There was no other concomitant medication (previously reported as a dose of VAQTA (manufacturer unknown)). The physician reported that on 14-JUL-2010, in 20 minutes after she experienced syncope, she recovered. On an unspecified date, a blood glucose (BG) test was performed result was 92. The patient did not seek medical attention. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Syncope
Clinical narrative: Information was received from a physician regarding a 14 year old female patient who on an unspecified date was vaccinated with a dose of GARDASIL while sitting on an exam table. The reporting physician stated the patient was not in his practice and he learned of the case through his work with a law office. It was reported that the patient was left in the office unattended by the nurse following the vaccination and subsequently, the patient experienced a syncopal episode and fell off the exam table. The reporting physician stated he was not sure if patient lost consciousness but reported that the patient was brought to the hospital. The physician stated he believed the patient was fine but reiterated that he was not the patient's physician and he did not have the patient's chart. The physician stated that the child's mother was attempting to sue the physician's practice because the child was left unattended in the exam room on the table after receiving the GARDASIL injection. The physician stated that he does not relate this event to the HPV vaccine; he believed the mother was trying to make some money. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dysplasia, Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a 19 year old female patient who on unspecified date received three doses of GARDASIL (Lot# not reported), IM. The physician stated that the patient experienced test results that had determined the woman to be at high risk for Human Papillomavirus (HPV) with mild dysplasia after being administered GARDASIL. At the time of the report the patient's outcome was unknown. The patient did not seek medical attention. This is one from several reports received from the same source. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Dizziness, Fall, Lip injury
Clinical narrative: Information has been received from an office manager concerning a 21 year old female with no pertinent medical history who on 14-JUL-2010 was vaccinated with her first dose of GARDASIL (lot number: 663573/0969Y) (site and route not reported). The office manager reported that on 14-JUL-2010 about 10 minutes after receiving GARDASIL the patient was sitting on the exam table and was feeling dizzy and then fell off the exam table. The office manager reported that the patient had a split lip and bruise on her knee and arm. The office manager reported that the patient was then wheel chaired over to the emergency room (name, address and phone number unspecified) but was not admitted and was released. The patient improved on therapy. The office manager reported that the patient had recovered on an unspecified date. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Cervical dysplasia, Smear cervix abnormal
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who on unspecified dates was vaccinated with the first, second and third doses of GARDASIL. Subsequently on an unspecified date, the patient had ASCUS on Pap which was negative for high risk and low risk HPV. At the time of this report, the patient's outcome was unknown. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site atrophy, Injection site discolouration, Skin depigmentation
Clinical narrative: Information has been received from a physician concerning a 22 year old female with depression, insomnia, herpes simplex type II and no drug allergies who on 15-JUN-2010 was intramuscularly vaccinated with 0.5 ml the first dose of GARDASIL (lot # 665768/1377Y) into left arm. Concomitant therapy included VALTREX, hormonal contraceptives (unspecified) and trazodone HCl. On an unknown date the patient experienced hypopigmentation/depigmentation and dimpling to her left arm at the injection site. At the time of reporting, the patient had not recovered. No lab diagnostics studies were performed. The patient sought medical attention by visiting office. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Fall, Feeling abnormal, Feeling hot, Hyperhidrosis, Lip injury
Clinical narrative: Information has been received from a Certified Medical Assistant (C. M. A.) concerning a 9 year old female patient with no medical history and with allergy to fresh pineapple who on 22-JUL-2010 was vaccinated with 0.5 mL first dose of GARDASIL (Lot # 663559/1178Y) IM into the right upper arm. No concomitant medications were reported. It was reported that 2-3 minutes after the patient received GARDASIL and VARIVAX (Merck) by subcutaneous injection in the left upper arm, she reached for the wall while walking out of the office. The patient then fell to the floor, and bit her lips at some point. It was also reported that the patient felt hot and sweaty, seemed "spacey and out of it". The patient was moved to a treatment room, where she laid down for 10-15 minutes with a cool compress before walking out of the office accompanied by her mother. No laboratory tests were performed to the patient. Follow up information was received from the Certified Medical Assistant concerning the female patient who on 22-JUL-2010 at 14:10 was vaccinated IM with a first dose of GARDASIL  (Lot # 663559/1178Y). The medical assistant reported that within 4 minutes of vaccination at 14:14, the patient was walking out of the examination room, leaned towards the right and fell flat on face, hurt mouth where braces lacerated her top lip. The medical assistant reported a near syncope but she was not sure if the patient totally passed out. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Mouth injury, Presyncope
Clinical narrative: Information has been received from a Certified Medical Assistant (C. M. A.) concerning a 9 year old female patient with no medical history and with allergy to fresh pineapple who on 22-JUL-2010 was vaccinated with 0.5 mL first dose of GARDASIL (Lot # 663559/1178Y) IM into the right upper arm. No concomitant medications were reported. It was reported that 2-3 minutes after the patient received GARDASIL and VARIVAX (Merck) by subcutaneous injection in the left upper arm, she reached for the wall while walking out of the office. The patient then fell to the floor, and bit her lips at some point. It was also reported that the patient felt hot and sweaty, seemed "spacey and out of it". The patient was moved to a treatment room, where she laid down for 10-15 minutes with a cool compress before walking out of the office accompanied by her mother. No laboratory tests were performed to the patient. Follow up information was received from the Certified Medical Assistant concerning the female patient who on 22-JUL-2010 at 14:10 was vaccinated IM with a first dose of GARDASIL  (Lot # 663559/1178Y). The medical assistant reported that within 4 minutes of vaccination at 14:14, the patient was walking out of the examination room, leaned towards the right and fell flat on face, hurt mouth where braces lacerated her top lip. The medical assistant reported a near syncope but she was not sure if the patient totally passed out. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hyperventilation, Muscle spasms, Pallor, Syncope, Tachycardia
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with the second dose of GARDASIL (lot # not reported). Subsequently the patient had fainted, became pale, has spasms, tachycardia and was hyperventilating. The patient was monitored more than 30 minutes after the adverse event occurred. On an unspecified date the patient recovered. the physician would not be giving the third dose to the patient. Additional information has been requested.
Sex: F
Vaccine: HPV4
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 (it's unspecified if it was the first or the second or the third dose) (lot# not reported). It was reported that the patient fainted when she was walking out of the doctor's office. No medical attention was sought. At the time of this report, the patient's condition had improved after stopping therapy. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: HIV infection, HIV test positive
Clinical narrative: Information has been received from a pharmacist who stated that a physician contacted her and reported that a female patient, who on an unspecified date was vaccinated with a dose of GARDASIL (lot number not provided), had a positive HIV test result (date not provided). At the time of the report the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Injection site pain, Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning a female who on an unspecified date was vaccinated with first dose of GARDASIL (dose, route and lot number not reported). 4 weeks after receiving the first dose of GARDASIL, the patient developed headache, pain and tingling at the injection site. It was not specified if the patient sought medical attention. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Human chorionic gonadotropin positive, Maternal exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female pregnant patient (confirmed as of 14-FEB-2009, last menstrual period 22-SEP-2008) with no known drug allergies or pertinent medical history who on 19-MAR-2009 was vaccinated IM with a dose of GARDASIL by mistake instead of being vaccinated with an influenza shot. Concomitant therapy included prenatal vitamins (unspecified) and FIORICET. No known adverse effect was reported. Estimated delivery date is 29-JUN-2009. A pregnancy urine test was performed. The patient sought unspecified medical attention. Follow up information has been received via telephone call from a nurse practitioner indicating that the female patient had a normal vaginal birth on 11-JUN-2009 at 37 weeks from LMP, and delivery a healthy male who weighed 3115 grams, and had 8/9 Apgar at one and five minutes respectively. On 20-JUL-2009, the patient went back to the office for a postpartum visit, and the nurse practitioner stated that the baby did not appear to have any problems at that time either. It was reported that after that, the mother returned for contraception. Additional information is not expected.