chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Epistaxis, Immediate post-injection reaction, Lymphadenopathy
Clinical narrative: Initial and follow-up information has been received from a physician concerning a female with a history of a clotting disorder who was vaccinated intramuscularly with a 0.5 ml third dose of GARDASIL vaccine (yeast). Subsequently, the patient developed a nose bleed one hour after GARDASIL vaccine (yeast) administration. She also later developed swollen glands. The patient called the office. At the time of the report the patient had recovered. Additional information has been requested. This is in follow-up to reort previously submitted on 11/14/2007. Initial and follow-up information has been received from a physician concerning a female with von Willebrand type II B who on 28-SEP-2007 at 8:00 pm was vaccinated intramusculary into the deltoid with a 0.5ml third dose of GARDASIL. On 28-SEP-2007 at 8:00pm the patient developed a heavy nose bleed lasting one hour. She also later developed mild swollen neck glands. No other viral type symptoms were noted. The patient called the office. On 30-SEP-2007 the patient recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil vaccine (dose# unknown). The next day the patient experienced fever and chills, presented to the physician's office not feeling well. Patient outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Pruritus
Clinical narrative: Information has been received from a female who was vaccinated with GARDASIL vaccine (yeast). Subsequently the patient's hair began falling out and she felt very itchy. It is unknown whether the patient sought medial attention. The current status of the patient was not reported. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Anorexia, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a 27 year old female with no known allergies, with papilloma viral infection and a history of appendicitis who on 26-APR-2007 was vaccinated with Gardasil vaccine. Concomitant therapy included Paxil. After receiving her first dose in May 2007, the patient experienced loss of appetite. The patient did not seek medical attention. The patient's loss of appetite persisted. At the time of the report, the patient had received all 3 doses of Gardasil vaccine. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Decreased appetite, Dizziness, Nausea
Clinical narrative: Information has been received from a nurse concerning a 22 year old female who on 19-OCT-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot #658554/0928U), 0.5 ml, injection. Concomitant therapy included varicella virus vaccine live (MSD), hepatitis A virus vaccine inactivated (HAVRIX), and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). On 19-OCT-2007, after receiving four vaccines, one being the first dose of GARDASIL vaccine (yeast) the patient experienced nausea, dizziness and decrease in appetite. The patient also received varicella virus vaccine live (lot# 658589/1274U) that same day. On 22-OCT-2007 the patient recovered from nausea, dizziness and decrease in appetite. Unspecified medical attention was sought. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female (141 lbs) qith no known drug allergies and a history of asthma when younger, who on 05-APR-2007 was vaccinated with the first dose of Gardasil vaccine. The patient was vaccinated in the left deltoid with the third dose of Gardasil (lot# 0530U) on 15-OCT-2007. Concomitant therapy included Ortho Tri-Cyclen. When the patient received the first and second dose of Gardasil vaccine, she experienced minimal pain, what would be expected after getting an injection. On 15-OCT-2007, after the third dose of Gardasil vaccine, the patient experienced pain at the injection site at rest and had a limited range of motion. The patient could not raise her arm higher than shoulder level. There was no illness reported at the time of vaccination. The patient's pain at the injection site at rest and not being raise her arm higher than shoulder level persisted. Additional information has been requested.  Follow up information was received on 27-NOV-2007 from the nurse practitioner who reported that on 25-OCT-2007, the patient consulted with the primary caregiver physician's assistant and the patient used antiinflammatory drug to return full range of motion. On 20-NOV-2007, the patient recovered full range of motion. The patient's soreness persisted and the pain lessened in severity.  Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female (141 lbs) qith no known drug allergies and a history of asthma when younger, who on 05-APR-2007 was vaccinated with the first dose of Gardasil vaccine. The patient was vaccinated in the left deltoid with the third dose of Gardasil (lot# 0530U) on 15-OCT-2007. Concomitant therapy included Ortho Tri-Cyclen. When the patient received the first and second dose of Gardasil vaccine, she experienced minimal pain, what would be expected after getting an injection. On 15-OCT-2007, after the third dose of Gardasil vaccine, the patient experienced pain at the injection site at rest and had a limited range of motion. The patient could not raise her arm higher than shoulder level. There was no illness reported at the time of vaccination. The patient's pain at the injection site at rest and not being raise her arm higher than shoulder level persisted. Additional information has been requested.  Follow up information was received on 27-NOV-2007 from the nurse practitioner who reported that on 25-OCT-2007, the patient consulted with the primary caregiver physician's assistant and the patient used antiinflammatory drug to return full range of motion. On 20-NOV-2007, the patient recovered full range of motion. The patient's soreness persisted and the pain lessened in severity.  Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Information has been received from a nurse concerning a 20 year old female who on approximately 15-OCT-2007 was vaccinated with the third dose of Gardasil vaccine. Subsequently the patient's arm was sore and she couldn't lift it about her shoulder since the vaccination. As of 25-OCT-2007, the patient had not recovered.  Additional information has been requested. Information has been received from a nurse concerning a 20 year old female who on approximately 15-OCT-2007 was vaccinated with the third dose of GARDASIL. Subsequently the patient returned to the office on 25-OCT-2007 complaining of pain at the injection site with limited range of motion. There was no redness or swelling. The patient's outcome was not reported. No further information is expected.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: Information has been received from a nurse concerning a 20 year old female who on approximately 15-OCT-2007 was vaccinated with the third dose of Gardasil vaccine. Subsequently the patient's arm was sore and she couldn't lift it about her shoulder since the vaccination. As of 25-OCT-2007, the patient had not recovered.  Additional information has been requested. Information has been received from a nurse concerning a 20 year old female who on approximately 15-OCT-2007 was vaccinated with the third dose of GARDASIL. Subsequently the patient returned to the office on 25-OCT-2007 complaining of pain at the injection site with limited range of motion. There was no redness or swelling. The patient's outcome was not reported. No further information is expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Nasal congestion, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with GARDASIL vaccine (lot# unknown). On an unspecified date the patient developed a fever and nasal congestion shortly after her vaccination with GARDASIL vaccine. Medical attention was sought, no other symptoms were noted. No other information was available. On an unspecified date the patient had recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007. Initial and follow-up information has been received from a physician concerning a 20 year old female with a history of bladder exstrophy and slight cold at the time of vaccination who on 25-JUN-2007 was vaccinated with a second dose of GARDASIL vaccine (lot# 0469U) in the right arm at 3:50 PM. On 25-JUN-2007, the patient developed a fever and nasal congestion shortly after her vaccination with GARDASIL vaccine. Medical attention was sought. No other symptoms were noted. No other information was available. On an unspecified date the patient had recovered. Additional information is not expected.
Age: 9.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Rash
Clinical narrative: Information has been received from a medical assistant concerning her 9 year old daughter who on an unspecified date was vaccinated with a second dose of GARDASIL vaccine (yeast). Concomitant therapy included "several other vaccines on the same day" (therapy unspecified). Subsequently on an unspecified date, the patient experienced rash on her face and neck after she received her second GARDASIL vaccine (yeast). Unspecified medical attention was sought. No details were provided regarding the rash and any treatment that was required. Subsequently on an unspecified date, the patient fully recovered from rash on her face and neck. No product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a certified medical assistant concerning an 18 year old female who on an unspecified date was vaccinated with Gardasil vaccine (lot# unknown), 0.5 mL injection. Concomitant therapy included Synthroid. On an unspecified date the same day as the vaccination the patient felt dizzy like she may faint, on her way to the car, after receiving Gardasil vaccine. Medical attention was sought. The patient went back to the physician's office to lie down. The office gave the patient something to eat and drink, she was fine. No further information was provided.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a physician concerning a 14 year old female with no pertinent medical history or drug reaction/allergies, who on 27-SEP-2007 was vaccinated with the first dose of Gardasil vaccine (0.5 mL). There was no concomitant medication. On 27-SEP-2007 the patient experienced Guillain-Barre Syndrome and was hospitalized. Hospitalization time was unknown. No further details were provided. The Guillain-Barre Syndrome was considered to be immediately life-threatening and disabling. At the time of this report, the patient was recovering.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling cold, Visual disturbance
Clinical narrative: Information has been received from a physician concerning a 9 year old female who was vaccinated with Gardasil vaccine (lot# not reported) for prophylaxis. On 24-OCT-2007, the patient felt slight dizziness, saw spots and got a little cold. The patient did not "pass out". Subsequently, the patient recovered. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Urticaria
Clinical narrative: Information has been received from a physician concerning an approximately 49 year old female who was vaccinated with a second dose of Gardasil vaccine (Lot# 658563/1063U) in the office of her gynecologist. Subsequently, 36 hours later, the patient developed urticaria and went to her primary care doctor for follow up. She was treated for hives (treatment not specified) and was "okay", she was never hospitalized. Subsequently, the patient recovered from the urticaria. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Limb discomfort
Clinical narrative: Information has been received from a female nursing assistant who was vaccinated with the first dose of Gardasil vaccine in her deltoid. Subsequently, the patient's arm became red and sore for a few days. No lab diagnostic studies were preformed. Subsequently, she recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a third dose of Gardasil vaccine. Subsequently, the patient experienced extreme pain that lasted for 18 days. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Herpes virus infection
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the second dose of Gardasil vaccine and developed herpes. The patient recovered from herpes. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix normal
Clinical narrative: Information has been received from a physician concerning a 16 year old female who in October 2006, was vaccinated IM with the third dose of Gardasil vaccine. Subsequently, the patient was diagnosed with HPV. The specific type of HPV was not reported. The patient had received a pap test shortly after completing the series of vaccines and that test was negative. As of 25-OCT-2007, the patient had not recovered from HPV. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007. Information has been received from a physician concerning a 16 year old female (119 lbs., 64 in.) who on 06-OCT-2006, was vaccinated IM with the first dose of GARDASIL vaccine (Lot #653650/0702F). The patient received the second dose of GARDASIL vaccine  (Lot #653736/0689F) on 07-DEC-2006 and the third dose of GARDASIL vaccine (Lot #656049/0187U) on 09-APR-2007. Subsequently the patient was diagnosed with HPV. The specific type of HPV was no treported. The patient had received a pap test shortly after completing the series of vaccines and that the test was negative. As of 25-OCT-2007, the patient had not recovered from HPV. No additional information is expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Nausea
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on 24-OCT-2007 was vaccinated intramuscularly with the first dose of Gardasil vaccine (0.5 mL). On 24-OCT-2007, immediately after receiving the vaccine, the patient became dizzy and nauseous. The patient was rushed to the emergency room by ambulance. No further details were provided. At the time of this report, the outcome of the events was unknown. The reporter felt that the events were serious for an other important medical event. Additional information has been requested. This is an amended report. The route of intramuscular was added to the report. This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a nurse practitioner concerning a 21 year old female student with anxiety who on 24-OCT-2007 at 1:00 PM was vaccinated intramuscularly in the left deltoid with the first dose of GARDASIL (0.5 ml) (lot # 658490/0802U). There were no illnesses at the time of vaccination and no adverse events following prior vaccinations. On 24-OCT-2007, at 1:15 PM the patient experienced lightheadedness and nausea times one and a half hours. The patient was rushed to the emergency room by ambulance. An EKG in the ER was noted to be normal. The patient subsequently recovered the same day. In follow-up the nurse practitioner did not report the events as other important medical events. No further information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Electrocardiogram normal, Laboratory test normal, Loss of consciousness
Clinical narrative: Information has been received from a company representative concerning a 16 year old female who on 25-OCT-2007 was vaccinated with the second dose of Gardasil vaccine. On 25-OCT-2007 the company representative was at the office and saw the patient pass out after receiving the vaccination. An ambulance came to bring the patient away. The patient was awake when she was carried away on the stretcher. The patient's outcome was not reported. Additional information has been requested. Follow up information obtained on Dec 7, 2007. The physician reported that on Aug 28, 2007 the 16 year old white female patient (weight of 221 lbs. and height of 64 inches) was vaccinated IM with the first dose of Gardasil (yeast) (lot #654539/0742U). On Oct 25, 2007 the patient was vaccinated with the second dose of Gardasil (yeast) (lot #654560/1209J). On Oct 25, 2007 the patient passed out twice within ten minutes after receiving her second dose of Gardasil (yeast). The patient sough unspecified medical attention. Blood tests and an EKG were performed (with normal results). The patient recovered on Oct 25, 2007. The patient had no illnesses at time of vaccination and no pre-existing allergies or medical history. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration
Clinical narrative: Information has been received from a female who on approximately 01-SEP-2007, was vaccinated with the first dose of Gardasil vaccine. On approximately 01-SEP-2007, the patient experienced a white square side effect at the injection site. As of 25-OCT-2007, the  patient had not recovered. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning her 16 year old daughter, who on 12-OCT-2007 was vaccinated in her left arm with a second dose of Gardasil vaccine. Subsequently, the patient developed swollen lymph nodes under her left arm. The patient was seen in the office. The patient was treated with Motrin. The patient recovered on an unspecified date. No product quality complaint was involved. This report is on of two reports from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4, MNQ, VARCEL
Symptoms: Malaise
Clinical narrative: Information has been received from a nurse practitioner concerning an 11 year old female with diabetes and no drug allergies, who on 20-AUG-2007 was vaccinated intramuscularly in the left arm with a first dose of GARDASIL vaccine (yeast) (Lot# 0530U). Concomitant suspect vaccination included varicella virus vaccine live. Other concomitant vaccinations included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). On 21-AUG-2007 the patient felt "under the weather and could not get out of bed." The patient did not seek medical attention. No laboratory diagnostics were performed. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 09-OCT-2007 was vaccinated(route and site not reported) with the 2nd 0.5ml dose of GARDASIL vaccine (yeast) (lot # not reported). On 19-Oct-2007, the doctor was informed that the patient had hives on and off for 1 week. Patient sought unspecified medical attention and no additional information is available at this time. Outcome is unknown at the time of this report. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 16 year old female patient who on 25-OCT-2007 was vaccinated IM with the first dose, 0.5  ml, of GARDASIL vaccine (yeast) (lot # not provided). The patient fainted following the vaccination, and was taken to the emergency room. The outcome of the event was unknown. No further information was available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Information has been received from a physician concerning a 17 year old female with a history of asthma, who on 13-OCT-2007 was vaccinated with her first does of Gardasil vaccine (Lot# 654539/0742U). Concomitant therapy included Colbiocin for acne and inhalers for asthma (therapy unspecified). On 25-OCT-2007, the patient experienced hives and itching behind her knees, her thighs and her elbows. The patient's hives and itching behind her knees and thighs and on her elbows persisted. The patient sought medical attention by calling the office. Patient was advised to see her family physician for evaluation. This is in follow-up to report(s) previously submitted on 11/14/2007. Information (and additional information via a B form) has been received from a physician concerning a 17 year old caucasian female with a history of asthma who on 15-OCT-2007 was vaccinated with her first dose of GARDASIL (Lot# 654539/0742U). Concomitant therapy included Colbiocin. On 24-OC-2007 at 9:00 pm the patient experienced red, raised papules behind her knees and thighs and on her elbows. She stated they were very itchy. The patient took BENADRYL that evening. The patient's red, raised papules and hives and itching behind her knees and thighs and on her elbows went away when she awoke the next morning. The patient sought medical attention by calling the office. Patient was advised to see her family physician for evaluation. As of 26-OCT-2007 the patient had recovered. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DTAP, HEPA, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 11 year old female, who on 24-OCT-2007 was vaccinated intramuscularly with the first dose of Gardasil vaccine (Lot # not reported). Concomitant therapy included Havrix and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 21-OCT-2007, the patient fainted after vaccination. The patient was observed for 1 hour in the physician's office and was fine. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Dizziness, Dizziness, Dyskinesia, Head injury
Clinical narrative: Information has been received from a health professional concerning a 20 year old female with a history of syncope vasovagal, "patient has passed out seven times in her life", who on 17-OCT-2007 was vaccinated with the first dose of Gardasil vaccine. Shortly after the vaccination the patient passed out. The patient remained unconscious for approximately one minute. The same day the patient felt light-headed and she had a decreased in her blood pressure. Unknown medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a health professional concerning a 21 year old female with a history of syncope vasovagal who on 17-OCT-2007 was vaccinated with the first dose of GARDASIL. Shortly after the vaccination the patient became lightheaded and passed out in the mid sentence. Hit her head, became very pale. Started jerking movements as if it was a seizure. She was sweating. Blood pressure went low and very hard to sit and back up again without being dizzy. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Information has been received from a health professional concerning a 20 year old female with a history of syncope vasovagal, "patient has passed out seven times in her life", who on 17-OCT-2007 was vaccinated with the first dose of Gardasil vaccine. Shortly after the vaccination the patient passed out. The patient remained unconscious for approximately one minute. The same day the patient felt light-headed and she had a decreased in her blood pressure. Unknown medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a health professional concerning a 21 year old female with a history of syncope vasovagal who on 17-OCT-2007 was vaccinated with the first dose of GARDASIL. Shortly after the vaccination the patient became lightheaded and passed out in the mid sentence. Hit her head, became very pale. Started jerking movements as if it was a seizure. She was sweating. Blood pressure went low and very hard to sit and back up again without being dizzy. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 16 year old female with a history of smoking one pack of cigarettes per day and drinks coffee, who on 23-OCT-2007 was vaccinated with her first dose of Gardasil vaccine (Lot# 654510/0962F). On 23-OCT-2007, the patient fainted and vomited while she was still in the office. Subsequently, the patient recovered from fainting and vomiting while she was in the office. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Heart rate, Loss of consciousness
Clinical narrative: Information has been received from a health professional concerning a 24 year old female who on 25-OCT-2007 was vaccinated IM with the first dose of GARDASIL vaccine (yeast) (lot # 657872/0515U). Concomitant therapy included Yazz-hormonal contraceptives (unspecified). About five minutes after vaccination the patient passed out. The patient came to and about 45-60 minutes later she passed out again. The patient urinated about 5 minutes before passed out for the second time. The physician took blood pressure and pulse each time the patient fainted. The first blood pressure read 119/75 pulse 52, second blood pressure taken while the patient was still lying down unconscious read 130/71 pulse 55, and the third time when patient came to and the blood pressure was 135/80 pulse 55. The patient had a fainting incident before, when she was 12 and she passed out at the dentist office when she received a shot inside her mouth. Medical attention was not sought. The patient was recovered. No product quality complaint was involved.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea, Neurological examination
Clinical narrative: Information has been received from a physician concerning a 26 year old female with a history of depression, who on 24-OCT-2007 was vaccinated intramuscularly with Gardasil vaccine. Concomitant therapy included Effexor XR. On 21-OCT-2007, about an hour after the vaccination, the patient experienced severe headache and nausea. The patient sought unspecified medical treatment. The patient was treated with Darvocet-N. The patient's severe headache and nausea persisted. Additional information has been requested. Information has been received from a physician concerning a 26 year old female with a history of depression, irritable bowel syndrome, and ulcerative colitis who on 24-OCT-2007 was vaccinated intramuscularly with HPV (lot # 668558/1061U). On 24-OCT-2007, about an hour after the vaccination, the patient experienced dizziness, severe headache, and nasuea. The patient sought unspecified medical treatment. The patient was treated with DARVOCET. A neurological exam was performed. The patient recovered on 26-Oct-2007 from the dizziness, severe headache, and nausea. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a company representative concerning a female with epilepsy, who was vaccinated with the first dose of Gardasil vaccine at approximately 2 PM. Concomitant therapy included Carbatrol and Focalin for epilepsy. Subsequently around 2AM, the patient had an urge to diarrhea and throw up, but never did. Her mom later found her passed out on the floor. No further information provided. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Injection site swelling, Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 26 year old female who on 19-OCT-2007 was vaccinated intramuscularly with her first dose of GARDASIL vaccine (yeast). There was no concomitant medication. Within hours of receiving the vaccination, the patient experienced swelling at the injection site that was about 1/2 inch in diameter. On 25-OCT-2007, the patient experienced nausea, vomiting and body aches, chills and fever (patient did not take her temperature, but felt like she had a fever)The patient recoved on 02-Nov-2007.  No other symptoms were noted. The patient sought unspecified medical treatment by phone. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a health professional concerning an 18 year old female with a history of epilepsy, who on 03MAY-2007 was vaccinated with her first dose of Gardasil vaccine. The patient had an abnormal Pap test before and after her first vaccination. On 09-JUL-2007, the patient was vaccinated with her second dose of Gardasil vaccine. After her second vaccination, the patient tested positive for high risk HPV. Concomitant therapy included Tegretol. The patient's condition persisted. The patient denies sexual activity. The patient sought medical attention with the Physician's Assistant (PA). Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a female patient age 11-12 years old who "in the last 5 months" (in 2007) was vaccinated with GARDASIL vaccine (yeast). Subsequently "in the last 5 months" (in 2007) the patient passed out within in a moment of being vaccinated. Medical attention was sought, in the office. She was treated with cool compresses and rest and her blood pressure was monitored. Subsequently, the patient recovered. She will continue with the vaccination series as scheduled. This is one of four total reports received from the same source. One of the girls received the third dose of GARDASIL vaccine (yeast) and hepatitis A virus vaccine inactivated (HAVRIX). The other girls were receiving the first dose of GARDASIL vaccine (yeast). The reporter did not specify which of the four patients was receiving the third dose. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a female patient age 11-12 years old who "in the last 5 months" (in 2007) was vaccinated with Gardasil vaccine. Subsequently, "in the last 5 months" (in 2007) the patient passed out within a moment of being vaccinated. Medical attention was sought, in the office. She was treated with cool compresses and rest and her blood pressure was monitored. Subsequently, the patient recovered. She will continue with the vaccination series as scheduled. This is one of four total reports received from the same source. One of the girls received the third dose of Gardasil vaccine and Havrix. The other girls were receiving the first dose of Gardasil vaccine. The reporter did not specify which of the four patients was receiving the third dose. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Loss of consciousness
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a female patient age 11-12 years old who "in the last 5 months" (in 2007) was vaccinated with GARDASIL vaccine (yeast). Subsequently "in the last 5 months" (in 2007) the patient passed out within in a moment of being vaccinated. Medical attention was sought, in the office. She was treated with cool compresses and rest and her blood pressure was monitored. Subsequently, the patient recovered. She will continue with the vaccination series as scheduled. This is one of four total reports received from the same source. One of the girls received the third dose of GARDSIL vaccine (yeast) and hepatitis A virus vaccine inactivated (HAVRIX). The other girls were receiving the first dose of GARDASILL vaccine (yeast). The reporter did not specify which of the four patients was receiving the third dose. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning an approximately 16 year old female who on 07OCT-2007 was vaccinated with a dose of Gardasil vaccine. Subsequently the patient experienced "unusual rash at the injection site." At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with a first dose of Gardasil vaccine. Subsequently the patient experienced syncope. Subsequently, the patient recovered. On an unspecified date the patient was vaccinated with the second dose of Gardasil vaccine. Subsequently the patient experienced syncope. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dysphonia, Pain in extremity
Clinical narrative: Information has been received from a mother concerning her 15 (also reported as 16) year old daughter who on approximately 25-OCT-2007 was vaccinated intramuscularly with a dose of GARDASIL vaccine (yeast). On approximately 25-OCT-2007 the patient's voice was different and her arm was sore. The mother was advised to contact the primary medical doctor or consider the emergency department. At the time of the report  the patient's outcome was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a Licensed practical nurse concerning 5 female patients aged 14-15, who were vaccinated with Gardasil vaccine. Subsequently the patients fainted, this "happened at all 3 doses not just one in particular". Unspecified medical attention was sought. All continued with therapy. The patients recovered, "all were ok". This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a Licensed practical nurse concerning 5 female patients aged 14-15 who were vaccinated with GARDASIL vaccine (yeast). Subsequently the patients fainted, this "happened at all 3 doses not just one in particular". Unspecified medical attention was sought. All continued with the therapy. The patients recovered, "all were ok". This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a Licensed practical nurse concerning 5 female patients aged 14-15, who were vaccinated with Gardasil vaccine. Subsequently the patients fainted, this "happened at all 3 doses not just one in particular". Unspecified medical attention was sought. All continued with the therapy. The patients recovered, "all were ok". This is one of several reports received from the same source. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Rash
Clinical narrative: Information has been received from a medical assistant concerning a 10 year old female who approximately 22-OCT-2007 was vaccinated with her first dose of GARDASIL vaccine (yeast). On approximately 22-OCT-2007 the patient experienced a rash from the injection site in the deltoid down to her elbow, on both legs and on her mouth. Subsequently, the patient's mother gave her diphenhydramine hydrochloride (BENADRYL) and she recovered from the rash. The patient sought medical attention by calling the office. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007; 1/7/2008.  Information (and additional information via agency) has been received from a medical assistant concerning a 10 year old female with an amoxicillin allergy who on 27-AUG-2007 was vaccinated intramuscularly in the left deltoid at 10:00 am with her first dose of GARDASIL (lot# 658094/0524U).  On the evening of 27-AUG-2007 the patient experienced a rash from the injection site in the deltoid down to her elbow, on both legs and on her mouth and it was itchy.  Subsequently, the patient's mother gave her BENADRYL and she recovered from the rash.  The patient recovered on approximately 02-SEP-2007.  (a week later).  The patient sought medical attention by calling the office.  Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Information has been received from a consumer concerning her daughter who in August 2007, was vaccinated with her first dose of Gardasil vaccine. The patient experienced dizziness and nausea right after receiving the first 0.5 mL dose. She recovered 10 to 15 minutes after it started. On 22-OCT-2007 the patient received her second dose of Gardasil vaccine. On 28-OCT-2007  the patient developed swelling at the injection site. It was painful to the touch but it is not red and does not look infected. The swelling has gone down since it started. The patient's outcome is unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007. Information has been received from a consumer concerning her daughter who in August 2007, was vaccinated with her first dose of GARDASIL vaccine. The patient experienced dizziness and nausea right after receiving the first 0.5 mL dose. She recovered 10 to 15 minutes after it started. On 22-OCT-2007 the patient received her second dose of GARDASIL vaccine (lot# 659435/1265U). On 29-OCT-2007 the patient developed swelling at the injection site an on 30-OCT-2007 slight redness. It was painful to the touch but it is not red and does not look infected. The swelling has gone down since it started. The patient has recovered. The doctor feels the dizziness was not related to the shot. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a health care provider concerning a female patient who was vaccinated with GARDASIL vaccine (yeast). There was no concomitant medication. Subsequently the patient experienced tingling in her fingers on her injected arm. Lot number was not provided. No further information was available. The patient sought unspecified medical treatment. Additional information has been requested. Information has been received from a health care provider concerning a female patient who on 15-Oct-2007, was intramuscularly vaccinated in the right deltoid, with a first dose of GARDASIL. Concomitant medication included ethinyl estradiol (+) norethindrone 1/35. Subsequently, three days later, the patient reported numbness and tingling in her right fingertips to the first joint on all fingers with the least n/t in the pinky finger. Lot number was not provided. The patient was seen in the office on 29-Oct-2007 with continuation of symptoms. She has not reported any history of carpal tunnel symtoms in the past, but has reported recent use of the computer/typing alot since the injection. The HCP evaluated her and she was diagnosed with paraesthesia of IP joint/palmer side of hand without anatomical diagnosis. 04-NOV-2007 called patient for follow-up and all symptoms are resolved. The NCP lists the recovery date as approximately 05-NOV-2007. Additional information has been reuested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Hot flush
Clinical narrative: Information has been received from a consumer concerning her daughter, a 14 year old female who in August 2007, was vaccinated with her first dose of Gardasil vaccine. The consumer reported that her daughter missed the second dose about a week ago and that her daughter experienced hot flashes after receiving the first dose. No lot number was provided. additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Headache, Laboratory test, Nausea, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female with a history of asthma, attention deficit/hyperactivity disorder, chronic upper respiratory infections, gastroesophageal reflux disease and allergic reaction to Augmentin, who on 28-AUG-2007 was vaccinated with her first dose of Gardasil vaccine IM (lot# 656371/0181U) and Zithromax for an STD. Concomitant therapy included Vyvanse 30mg, Septra as needed, Advair, Proventil Inhaler, Aciphex 20mg and Clarinex. On 28-AUG-2007, the patient experienced vomiting within six hours of receiving Gardasil vaccine. The patient called the office reporting she had nausea and a headache. The patient took Advil and Tylenol. On 05-SEP-2007, the patient was seen in the office with continuing vomiting and nausea and also diarrhea and a fever to 102F. The patient was treated with Phenergan. On 12-OCT-2007, the patient was vaccinated with her second dose of Gardasil vaccine (lot 657868/0523U) and within 24 hours the patient experienced vomiting. On 16-OCT-2007, the patient was seen for a blood test and sedrate was high. The patient is recovering from vomiting, nausea, diarrhea, fever and headache. Therapy was discontinued. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Red blood cell sedimentation rate increased, Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a physician concerning a female with a history of asthma, attention deficit/hyperactivity disorder, chronic upper respiratory infections, gastroesophageal reflux disease and allergic reaction to Augmentin, who on 28-AUG-2007 was vaccinated with her first dose of Gardasil vaccine IM (lot# 656371/0181U) and Zithromax for an STD. Concomitant therapy included Vyvanse 30mg, Septra as needed, Advair, Proventil Inhaler, Aciphex 20mg and Clarinex. On 28-AUG-2007, the patient experienced vomiting within six hours of receiving Gardasil vaccine. The patient called the office reporting she had nausea and a headache. The patient took Advil and Tylenol. On 05-SEP-2007, the patient was seen in the office with continuing vomiting and nausea and also diarrhea and a fever to 102F. The patient was treated with Phenergan. On 12-OCT-2007, the patient was vaccinated with her second dose of Gardasil vaccine (lot 657868/0523U) and within 24 hours the patient experienced vomiting. On 16-OCT-2007, the patient was seen for a blood test and sedrate was high. The patient is recovering from vomiting, nausea, diarrhea, fever and headache. Therapy was discontinued. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Syncope
Clinical narrative: Information was received from a health care provider about her daughter, who was vaccinated intramuscularly from a pre-filled syringe on 16-AUG-2007 with her first dose of Gardasil vaccine. On 16-AUG-2007, the patient fainted and experienced pain at injection site, which lasted until 18-AUG-2007. The patient received her second dose of Gardasil vaccine on 20-OCT-2007 and reported no adverse effects. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a physician concerning an approximately 17 year old female who was vaccinated intramuscularly with the first dose of Gardasil vaccine. At this time, the patient also received Menactra. The patient experienced vomiting the same day. The patient was vaccinated with the second and third doses of Gardasil vaccine and again experienced vomiting. The patient recovered on an unspecified date. The patient sought unspecified medical attention by contacting the physician. Dates for the administration of the vaccine series were not available. No further information provided. Additional information has been requested. Information has been received from a physician concerning an 18 year old female withno medical history who on 02-FEB-2207 and 17-APR-2007 was vaccinated IM with a first and second 0.5ml dose of HPC vaccine (Lot #655617/1447F and 656051/0244U) respectively. It was reported that the patient vomited one time, four hours after each dose. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a health professional concerning a 14 year old female who on 18-OCT-2007 was vaccinated with her first dose of Gardasil vaccine. Concomitant therapy included vaccination with hepatitis A vaccine (inactive) (manufacturer unspecified). On 18-OCT-2007, the patient experienced dizziness. The patient sought unspecified medical treatment by calling the nurse practitioner. The patient's dizziness persisted. Lot number was not available. No further information provided. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy to animal, Rash
Clinical narrative: Information has been received from a health professional concerning a 20 year old female with no prior history or illness at the time of vaccination who on 03-OCT-2007 in the afternoon was vaccinated intramuscularly in the left deltoid with a first dose of GARDASIL vaccine (yeast) (Lot # 654536/0742U). On 11-OCT-2007 at 08:40 the patient complained of a raised rash on arms with a few spots on her chest. The patient had no temperature, flu-like symptoms or shortness of breath. It was noted that the patient had just started a new brand of birth control pills. The patient believed it was due to the vaccine or birth control pills. On 13-OCT-2007, the patient saw her primary care physician and was diagnosed with an allergy to her cats. Medications (unspecified) for the allergy were prescribed by the primary care physician. On 13-OCT-2007, the patient had recovered. No further information is available.