chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Loss of consciousness, Nausea, Syncope, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old white female with no illness at the time of being vaccinated and no history of drug allergies who on 27-JUL-2007 was vaccinated with a first dose of Gardasil (lot # 658100/0525U) 0.5 ml in the right deltoid at 11:15 AM. Also on 27-JUL-2007, the patient was vaccinated with a first dose of meningococcal ACYW conj vaccine (dip toxoid) (lot # U2182AA) in the left deltoid at 11:15 Am. The patient was given meningococcal ACYW conj vaccine (dip toxoid) first and then GARDISIL. On 27-JUL-2007, the patient fainted after being vaccinated with first and only dose of Gardasil.  The nurse gave the patient medical attnetion. The nurse caught the patient from falling to the floor when she lost consciousness. She passed out for about a minute and smelling salt  was used to arouse the patient, when she was awoke, she felt nauseated and started vomiting times 2. The patient was kept at the health center for 45 minutes for observation, and then she went home with her guardian without and incedent. On 27-JUL-2007, the patient recovered. No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Pain
Clinical narrative: Information has been received from a receptionist concerning her daughter who was vaccinated with a first dose of Gardasil.  Concomitant therapy included influenza virus vaccine (manufacturer unknown).  Subsequently on the same day the patient experienced achiness and fatigue.  Subsequently, by the next morning, she had fully recovered.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a medical assistant concerning a 19 year old female with penicillin allergy who on 10-JUL-2007 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (Lot # 658100/0525U). There was no concomitant medication. On 10-JUL-2007 several hours later the patient developed vomiting and diarrhea. The patient contacted the office by phone but no therapy was required. On 10-JUL-2007 the vomiting and diarrhea resolved after a few hours and the patient completely recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/12/2007. Information has been received from a medical assisitant concerning a 19 year old female (151 lbs, 63 in,) with penicillin allergy who on 10-JUL-2007 was vaccinated intramuscularly with a 0.5 ml first dose of HPV vaccine (Lot #655100/0525U). There was no concomitant medication. On 10-JUL-2007 several hours later the patient developed vomiting and diarrhea. The patient contacted the office by phone but no therapy was required. On 10-JUL-2007 the vomiting and diarrhea resolved after a few hours and the patient completely recovered. The patient refused further vaccinations with HPV vaccines. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Eyelid oedema, Eyelids pruritus, Malaise
Clinical narrative: Information has been received from a physician, concerning an 18 year old female who on 23-JUL-2007 was vaccinated IM in the right arm with the first dose of Gardasil (lot #657737/0522U), and with a dose of PPD (manufacturer unspecified).  There was no concomitant medication.  Following the vaccinations, she reported she "didn't feel well," and spent 1 day in bed.  On 24-SEP-2007 the patient was vaccinated IM in the right arm with the second dose of Gardasil (lot #658560/1062U), and within 4 hours her right eyelid became itchy and swollen.  On 26-SEP-2007, she was seen in the office.  Treatment included a nonspecified steroid dosepak, BENADRYL and ice.  At the time of this report, the patient had not recovered from the swollen and itching eyelid.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Injection site erythema
Clinical narrative: Information has been received from a registered nurse concerning her daughter who was vaccinated subcutaneously with a dose of Gardasil.  Subsequently the patient experienced redness at the injection site.  Subsequently, the patient fully recovered without treatment.  Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a consumer concerning an 11 year old female with no pertinent medical history who on an unspecified date was vaccinated with a 0.5 ml first dose of Gardasil.  On 22-SEP-2007 the patient was vaccinated with a second dose of Gardasil.  There was no concomitant medication.  On 22-SEP-2007 the patient fainted.  There was no laboratory or diagnostic tests performed.  Unspecified medical attention was sought.  On 22-SEP-2007 the patient recovered.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a consumer concerning an 11 year old female with no pertinent medical history who on an unspecified date was vaccinated with a 0.5 ml first dose of Gardasil.  On 22-SEP-2007 the patient was vaccinated with a second dose of Gardasil.  There was no concomitant medication.  On 22-SEP-2007 the patient fainted.  There was no laboratory or diagnostic tests performed.  Unspecified medical attention was sought.  On 22-SEP-2007 the patient recovered.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Swelling face
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female who was vaccinated with a dose of GARDASIL (Lot # 654885/1424F). Concomitant vaccination given at the same time included MENACTRA. On 18-FEB-2007 three days after vaccination the patient experienced swelling of the face. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/12/2007.  Initial and follow-up information has been received from a registered nurse concerning a 15 year old female with no pertinent medical history who was vaccinated intramuscularly into the left arm with a first dose of GARDASIL (Lot #654885/1424F).  Concomitant vaccination given at the same time included an intramuscular injection into the right arm with a first dose of MENACTRA (Lot #U2108AA).  On 18-FEB-2007 three days after vaccinatio the patient experienced swelling of the face.  An allergist performed tests that revealed negative for GARDASIL.  Subsequently, the patient recovered.  The patient received the second dose of GARDASIL without problem.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Alanine aminotransferase decreased, Blood albumin decreased, Blood calcium decreased, Blood osmolarity
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient who on 21-JUN-2007 was vaccinated IM with her third dose of GARDASIL. A short while later, the patient experienced severe pain at the injection site. She went to the ER due to the pain. She was not hospitalized. Her treatment and outcome were unknown. Additional information has been requested.  Follow up information has been received from the physiican and from medical records concerning the female student with celiac disease (gluten free x 3 weeks) and chronic abdominal pain "her whole life" who on 21-JUN-2007 at 11:15 a.m. was vaccinated IM in the left arm with her third dose of GARDASIL. Concomitant medication included birth control pills and LAMICTAL. The patient's mother reported that the child's arm hurt very bad hours after vaccine administered. Child waited 15 minutes prior to leaving office. Per mother child was taken to ER ddue to pain. Per medical records the patient presented to ER on 23-JUN-2007 complaining of pain in arms and abdominal cramping. The patient thought the symptoms were a side effect of the injection. She was without fever and positive for nausea and vomiting with mild abdominal cramping with onset the night before. She was positive for muscle pain in arms. Abdomen was soft to palpitation, nontender, nondistended, positive bowel sounds in 4 quadrants. Abdominal pain was diffuse, pain was described as cramping, continuous. On a scale of 0-10 the patient rated pain as 10. A chemistry panel was drawn and revealed low potassium, calcium osmolality, alanine aminotransferase, alkaline phosphate, total protein and albumin (values illegible). She was given IV fluids and 4 mg ZOFRAN given IVP into right hand and 1 mg DILAUDID given IVP into right hand. She was to follow up with PCP and given VICODIN PRN. The patient recovered on an unspecifiied date.  The ER physician suspected the patient's symptoms were secondary to GARDASIL.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood potassium decreased, Gastrointestinal sounds abnormal, Injection site pain, Myalgia, Nausea
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient who on 21-JUN-2007 was vaccinated IM with her third dose of GARDASIL. A short while later, the patient experienced severe pain at the injection site. She went to the ER due to the pain. She was not hospitalized. Her treatment and outcome were unknown. Additional information has been requested.  Follow up information has been received from the physiican and from medical records concerning the female student with celiac disease (gluten free x 3 weeks) and chronic abdominal pain "her whole life" who on 21-JUN-2007 at 11:15 a.m. was vaccinated IM in the left arm with her third dose of GARDASIL. Concomitant medication included birth control pills and LAMICTAL. The patient's mother reported that the child's arm hurt very bad hours after vaccine administered. Child waited 15 minutes prior to leaving office. Per mother child was taken to ER ddue to pain. Per medical records the patient presented to ER on 23-JUN-2007 complaining of pain in arms and abdominal cramping. The patient thought the symptoms were a side effect of the injection. She was without fever and positive for nausea and vomiting with mild abdominal cramping with onset the night before. She was positive for muscle pain in arms. Abdomen was soft to palpitation, nontender, nondistended, positive bowel sounds in 4 quadrants. Abdominal pain was diffuse, pain was described as cramping, continuous. On a scale of 0-10 the patient rated pain as 10. A chemistry panel was drawn and revealed low potassium, calcium osmolality, alanine aminotransferase, alkaline phosphate, total protein and albumin (values illegible). She was given IV fluids and 4 mg ZOFRAN given IVP into right hand and 1 mg DILAUDID given IVP into right hand. She was to follow up with PCP and given VICODIN PRN. The patient recovered on an unspecifiied date.  The ER physician suspected the patient's symptoms were secondary to GARDASIL.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Protein total decreased, Respiratory rate, Vomiting
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient who on 21-JUN-2007 was vaccinated IM with her third dose of GARDASIL. A short while later, the patient experienced severe pain at the injection site. She went to the ER due to the pain. She was not hospitalized. Her treatment and outcome were unknown. Additional information has been requested.  Follow up information has been received from the physiican and from medical records concerning the female student with celiac disease (gluten free x 3 weeks) and chronic abdominal pain "her whole life" who on 21-JUN-2007 at 11:15 a.m. was vaccinated IM in the left arm with her third dose of GARDASIL. Concomitant medication included birth control pills and LAMICTAL. The patient's mother reported that the child's arm hurt very bad hours after vaccine administered. Child waited 15 minutes prior to leaving office. Per mother child was taken to ER ddue to pain. Per medical records the patient presented to ER on 23-JUN-2007 complaining of pain in arms and abdominal cramping. The patient thought the symptoms were a side effect of the injection. She was without fever and positive for nausea and vomiting with mild abdominal cramping with onset the night before. She was positive for muscle pain in arms. Abdomen was soft to palpitation, nontender, nondistended, positive bowel sounds in 4 quadrants. Abdominal pain was diffuse, pain was described as cramping, continuous. On a scale of 0-10 the patient rated pain as 10. A chemistry panel was drawn and revealed low potassium, calcium osmolality, alanine aminotransferase, alkaline phosphate, total protein and albumin (values illegible). She was given IV fluids and 4 mg ZOFRAN given IVP into right hand and 1 mg DILAUDID given IVP into right hand. She was to follow up with PCP and given VICODIN PRN. The patient recovered on an unspecifiied date.  The ER physician suspected the patient's symptoms were secondary to GARDASIL.  Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Blood pressure normal, Dyskinesia, Dyskinesia, Feeling abnormal, Hypotonia
Clinical narrative: Initial and follow up information has been received from Nurse Practitioner and a physician concerning a 16 year old female patient with no prior reactions to previous vaccines and a resolving rash diagnosed as shingles. Who on 14-SEP-2007, at 12:00 p.m. was vaccinated in the right arm, with her second dose of GARDASIL, lot #655620/0171U). Concomitant therapy included a first dose in the left arm of BOOSTRIX (lot# AC528018BA, and HAVRIX (ALTAVRI87AA). The physician stated that almost immediately after vaccination the patient went pale and limp, and had a syncopal episode; the NP stated the patient "zoned out" for 3 to 5 minutes after receiving her second dose of GARDASIL, her complexion was gray and her head jerked. Medical attention was sought. The patient was helped to lie down, and her blood pressure within seconds was 110/72 mmHg. She recovered on the same day. Additional information has been requested.  Additional infromation is not expected.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Pallor, Skin discolouration, Syncope
Clinical narrative: Initial and follow up information has been received from Nurse Practitioner and a physician concerning a 16 year old female patient with no prior reactions to previous vaccines and a resolving rash diagnosed as shingles. Who on 14-SEP-2007, at 12:00 p.m. was vaccinated in the right arm, with her second dose of GARDASIL, lot #655620/0171U). Concomitant therapy included a first dose in the left arm of BOOSTRIX (lot# AC528018BA, and HAVRIX (ALTAVRI87AA). The physician stated that almost immediately after vaccination the patient went pale and limp, and had a syncopal episode; the NP stated the patient "zoned out" for 3 to 5 minutes after receiving her second dose of GARDASIL, her complexion was gray and her head jerked. Medical attention was sought. The patient was helped to lie down, and her blood pressure within seconds was 110/72 mmHg. She recovered on the same day. Additional information has been requested.  Additional infromation is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Beta haemolytic streptococcal infection, Epstein-Barr virus infection, Headache, Infectious mononucleosis
Clinical narrative: Information has been received from an RN concerning a female patient who in June 2007, was vaccinated with her first dose of GARDASIL. On 24-SEP-2007 the patient was vaccinated with her second dose of GARDASIL. The nurse stated that 2 days later after getting her first and second doses, the patient experienced weakness and sick. Medical attention was sought. The patient was diagnosed with mononucleosis. Her outcome was This is in follow-up to report (s) previously submitted on 10/12/2007. Initial and follow-up information has been received from an registered nurse (RN) concerning a 15 year old female patient with a hypersensitivity reaction to penicillin, AMOXIL and erythromycin, who on 30-JUL-2007 (previously reported as in June 2007), was vaccinated in the left deltoid with her first dose of GARDASIL vaccine (lot #658560/1062U). There was no illness at the time of vaccination. There was no concomitant medication. The nurse stated that 2 to 3 days after getting her first vaccination, the patient developed a sore throat, fever, weakness, malaise and generally not feeling good. She also experienced a localized reaction on 08-AUG-2007, she visited the physician's office and was diagnosed with strep throat when a rapid strep test was postive for group A stretococcus, and possible mononucleosis. Treatment included clindamycin. After an unknown duration the patient recovered from the symptoms. On 24-SEP-2007 the patient was vaccinated with the second dose of GARDASIL vaccine (lot # not provided). Two to three days after the vaccinaton, similar symtoms recurred and included headache, sore throat, fever (valve not specified), and localized reaction though they were not as severe as those following the first dose. Follow up information in the form of medical records, revealed that the patient visited her primary care physician for a well check up on 25-OCT-2007, and at that time there were no complaints of headache, sore throat no swollen glands, no inflammation, no abnormalities on tonsils, no fever, no skin lesions, and no mention of cough (no anomilies in lungs). The duration of the symptoms was not specified. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Local reaction, Malaise, Oropharyngeal pain, Pharyngitis streptococcal, Pyrexia
Clinical narrative: Information has been received from an RN concerning a female patient who in June 2007, was vaccinated with her first dose of GARDASIL. On 24-SEP-2007 the patient was vaccinated with her second dose of GARDASIL. The nurse stated that 2 days later after getting her first and second doses, the patient experienced weakness and sick. Medical attention was sought. The patient was diagnosed with mononucleosis. Her outcome was This is in follow-up to report (s) previously submitted on 10/12/2007. Initial and follow-up information has been received from an registered nurse (RN) concerning a 15 year old female patient with a hypersensitivity reaction to penicillin, AMOXIL and erythromycin, who on 30-JUL-2007 (previously reported as in June 2007), was vaccinated in the left deltoid with her first dose of GARDASIL vaccine (lot #658560/1062U). There was no illness at the time of vaccination. There was no concomitant medication. The nurse stated that 2 to 3 days after getting her first vaccination, the patient developed a sore throat, fever, weakness, malaise and generally not feeling good. She also experienced a localized reaction on 08-AUG-2007, she visited the physician's office and was diagnosed with strep throat when a rapid strep test was postive for group A stretococcus, and possible mononucleosis. Treatment included clindamycin. After an unknown duration the patient recovered from the symptoms. On 24-SEP-2007 the patient was vaccinated with the second dose of GARDASIL vaccine (lot # not provided). Two to three days after the vaccinaton, similar symtoms recurred and included headache, sore throat, fever (valve not specified), and localized reaction though they were not as severe as those following the first dose. Follow up information in the form of medical records, revealed that the patient visited her primary care physician for a well check up on 25-OCT-2007, and at that time there were no complaints of headache, sore throat no swollen glands, no inflammation, no abnormalities on tonsils, no fever, no skin lesions, and no mention of cough (no anomilies in lungs). The duration of the symptoms was not specified. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Urticaria
Clinical narrative: This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow up information has been received from physician's assistant, and a consumer concerning her 16 year old daughter with an allergy to CECLOR, who on 24-FEB-2007 was vaccinated with her first dose of GARDASIL. After the first dose the patient experienced nausea. On 28-APR-2007 the patient received her second dose of GARDASIL and on 28-AUG-2007 received her third dose (lot # 658558/1061U); she did not experience nausea after these doses. On 17-SEP-2007 (previously reported as 15-SEP-2007) the patient developed hives. She was brought to the ER three times because the hives kept coming back. The patient received an IV in the ER. Unspecified blood work was performed. At the time of the report, the patient was recovering from hives. Follow up information received from a physician's assistant indicated that the outcome of hives was unknown, and was possibly attributed to tanning lotion and situational stress. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Syncope
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter who had a baby in June 2007 and who on 21-SEP-2007 was vaccinated IM with a dose of GARDASIL. Concomitant therapy included DEPO-PROVERA. On 21-SEP-2007 the patient had a fainting episode and was rushed to the hospital where it was determined that she was pregnant. The patient recovered on 22-SEP-2007 (she was not hospitalized). No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a certified medical assistant, via a company representative, concerning a female patient (age not reported), who on an unknown date was vaccinated with a dose of GARDASIL (lot # not reported). Immediately following the vaccination, the patient fainted. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration
Clinical narrative: Information has been received from a consumer concerning her daughter who was vaccinated with a second dose of GARDASIL. Subsequently, the patient developed a knot at the injection site. No medical attention was sought. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Vision blurred
Clinical narrative: Information has been received from a physician concerning a 27 year old female patient with asthma who on 06-SEP-2007, was vaccinated with a third dose of GARDASIL (Lot# 658560/1062U). Concomitant therapy included SEREVENT, ADVAIR, NUVARING and CELEXA. About one hour after the vaccination, the patient experienced blurred vision and cold sweats. Unspecified medical attention was sought. That same day, the patient recovered. No product quality complaint was involved. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 10/12/2007. Information has been received from a physician concerning a 27 year old female with asthma and depression who on 06-SEP-2007, was vaccinated IM into the left arm with a third dose of GARDASIL (Lot# 658560/1062U). On 06-MAR-2007 and 08-MAY-2007, the patient was vaccinated IM into the left arm with a first and second dose of GARDASIL (Lot # 654702/0011U), respectively. Concomitant therapy included SEREVENT, ADVAIR, NUVARING and CELEXA. On 06-SEP-2007 about one hour after the vaccination, the patient experienced blurred vision and cold sweats which lasted about 10 minutes. Unspecified medical attention was sought. That same day, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site urticaria, Muscular weakness, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Information has been received from a medical assistant concerning a female patient who on approximately 27-AUG-2007 "one month ago", was vaccinated with a first dose of GARDASIL. Concomitant therapy included contrast dye. On approximately 27-SEP-2007 "one month later", the patient presented with a welt at the injection site. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/12/2007. Information has been received from a medical assistant concerning a female patient with history of gastropharesis, panic disorder, recurrent syncope and allergies to pseudoephedrine and IV contrast who on 28-Aug-2007, was vaccinated IM into the left arm with a first dose of GARDASIL (lLot # 658488/0930U). On 25-Sep-2007 one month after injection, the patient presented with one day sudden onset of soreness, swelling, stinging in arm and weakness down arm and a welt at the injection site. Unspecified medical attention was sought. At the time of this report, the patient recovered. No product quality complaint was involved. This is one of two reports form the same source. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a nurse concerning a 15 year old female patient with no medical history who in July 2007 "about 2 months ago" , was vaccinated IM with a first 0.5ml dose of GARDASIL (lot # 658556/1060U). On 15-AUG-2007, the patient also received the first dose of Hepatitis A vaccine (Lot# AHAVB106BA). It was reported within minutes. There was no concomitant medication. It was reported that the patient passed out about 5 to 10 seconds after vaccination. Unspecified medical attention was sought. She was aroused shortly and had no complications. No laboratory diagnostic studies were performed. That same day, the patient recovered. No product quality complaint was involved. Additional information has been requested.  No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow-up information has been received from a certified medical assistant concerning a 22 year old female patient with a history of fainting with injections who on 29-MAY-2007, was vaccinated with a first 0.5 ml dose of Gardasil. On 29-MAY-2007, the patient experienced lightheadedness. On 08-AUG-2007 at 12:57, the patient was vaccinated in the right gluteal with received a second dose of GARDASIL. On 08-AUG-2007 at 12:57 the patient fainted and hit her right upper part of her forehead on the counter top. The patient called her boyfriend to pick her up and laid down on the exam table for an hour before leaving the office. It was offered to the patient to call 911 but the patient refused. The patient also refused to go to the emergency room. A few hours after each injection, the patient recovered from lightheadedness and fainting. No product quality complaint was involved. Additional information is not available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter who on 13-JUL-2007, was vaccinated IM with a first dose of Gardasil. "Almost immediately" after the injection, the patient experienced extreme injection site pain which lasted for about 4 hours. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Anorexia, Headache
Clinical narrative: Information has been received from a consumer regarding her 12 year old daughter with no medical history or allergies who on 07-SEP-2007, was vaccinated with a first 0.5ml dose of Gardasil. There was no concomitant medication. On 08-SEP-2007, the patient experienced a light headache and loss of appetite. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised
Clinical narrative: Information has been received from a physician concerning a female patient who on an unknown date was vaccinated with a second dose of Gardasil. Subsequently, the patient developed widespread itching. The patient contacted the office but no treatment was required. It was reported that the remainder of the vaccine series was discontinued. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a consumer concerning her 10 year old daughter who in March 2007 was vaccinated with the first dose of Gardasil with no reaction, and who on 17-SEP-2007 was vaccinated IM with the second dose, 0.5 ml, of Gardasil (lot # not provided). There was no concomitant medication. On 17-SEP-2007 following the vaccination, her daughter experienced pain at the site of injection. She recovered later on the same day. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site irritation
Clinical narrative: Information has been received from a physician concerning female patients who were vaccinated with a dose of Gardasil. Subsequently all patients are complaining of burning at the injection site. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder, Ultrasound scan
Clinical narrative: Information has been received from a licensed practical nurse concerning a female who in May 2007, was vaccinated with a second dose of GARDASIL. Concomitant therapy included unspecified birth control. Subsequently, the patient experienced "abnormal periods". The patient did not recover. On an unspecified date the patient was vaccinated with the 3rd dose of GARDASIL. Subsequently, the abnormal periods discontinued and the patient recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/12/2007. Initial and follow-up information has been received from a licensed practical nurse concerning a 20 year old female with sulfa and amoxicillin allergies who on 28-MAR-2007, was vaccinated into the right deltoid with with a second dose of GARDASIL vaccine (Lot #65051/0244U). Concomitant therapy included unspecified birth control. In June 2007 the patient started her menstrual cycle. The cycle continued with periods of heavy and light terms. On 30-JUL-2007, the patient was vaccinated into the left deltoid with the 3rd dose of GARDASIL vaccine (Lot #0469U). On 31-JUL-2007, a pelvic ultrasound was performed, results were normal. In September 2007 the patient's menstrual cycles went back to normal. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pigmentation disorder
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female with no medical history, who on 26-FEB-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil (Lot# "02430"). Concomitant therapy included hormonal contraceptives (unspecified). Subsequently, the patient developed deep pigmentation. On 03-MAY-2007 the patient was vaccinated with a second dose of Gardasil (Lot# "02434"). Subsequently, the patient developed more deep pigmentation. On 04-SEP-2007 the patient was vaccinated with a third dose of Gardasil (Lot# 658558/1061U). Subsequently, the patient again developed more deep pigmentation. The patient sought unspecified medical attention. No laboratory diagnostics were performed. At the time of the report, the patient had not recovered. No product quality complaint was involved. This report is 1 of 2 reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Injection site pain, Tremor
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a 12 year old female student who in July 2007, was vaccinated with a 0.5mL first dose of Gardasil. The patient experienced no problems after the first dose. On 26-SEP-2007 the patient was vaccinated in the left arm with a second dose of Gardasil (lot# 658558/1061U). There were no illnesses at the time of the vaccination.  On 27-SEP-2007 the patient experienced pain at the injection site, dizziness, and "wobbly/shakey legs." No fever was reported. The patient was instructed to lie down, rest, and call the office with an update on her condition later in the day on 27-SEP-2007. The patient called the office. The patient recovered on an unspecified date. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Muscle spasms
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated intramuscularly with a dose of Gardasil. Subsequently, about one and a half months after the vaccination the patient experienced muscle cramps in the back of the leg (unknown whether one or both legs). The patient visited the after-hours clinic for unspecified reasons. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Discomfort, Hypoaesthesia, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a female consumer, via a company representative, who in approximately August 2007 ("six to eight weeks ago"), was vaccinated in the upper quadrant of the arm, with a dose of Gardasil (lot # not provided). On the day of vaccination, she experienced numbness and discomfort on her whole right arm, and was not able to use her arm. After two days, she recovered. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Dizziness, Heart rate increased
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female with no medical history or allergies, who on 03-SEP-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). Approximately one week later, the patient experienced a fast heart beat, dizziness and pain in her chest. No medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 10/12/2007. Information has been received from a registered nurse concerning a 15 year old female with no medical history who on 31-AUG-2007 (previously reported as 03-SEP-2007) was vaccinated IM into the left arm with a first dose of GARDASIL (lot# 657737/0522U). Illness at the time of vaccination included genital warts and bacterial vaginosis. Concomitant therapy included ORTHO TRI-CYCLEN LO, metronidazole and calcitonin. On approximately 10-SEP-2007 the patient experienced a fast heart beat, dizziness and pain in her chest. No medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse, via company representative, concerning a female patient (age not specified), who on approximately 14-SEP-2007 ("two weeks ago") was vaccinated IM with the first dose, 0.5 ml, of Gardasil (lot # not specified). There was no concomitant medication. On the day of vaccination, the patient called the physician and stated she had a small rash on her chest, about the size of a quarter. Treatment was not specified. At the time of this report, the outcome of the event was unknown. No further information was available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a female patient who was vaccinated with a dose of Gardasil. The nurse reported that on 27-SEP-2007 the patient experienced heavy menstrual bleeding. The patient's heavy menstrual bleeding persisted. No further information was available. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Dehydration, Injection site erythema, Injection site pain, Nausea
Clinical narrative: Information has been received from a 22 year old female patient with penicillin allergy who in August 2007, was vaccinated with a first dose of Gardasil. On 24-SEP-2007 she received the second dose of Gardasil. Concomitant therapy included ORTHO-NOVUM. The patient called and reported "experiencing redness and severe pain at the injection site, vomiting, nausea, chills, dehydration and fever after receiving her first and second dose of Gardasil. The adverse experiences were more severe after the second dose". No further information was available. The patient had not recovered as of this report day. Additional information will be requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Information has been received from a 22 year old female patient with penicillin allergy who in August 2007, was vaccinated with a first dose of Gardasil. On 24-SEP-2007 she received the second dose of Gardasil. Concomitant therapy included ORTHO-NOVUM. The patient called and reported "experiencing redness and severe pain at the injection site, vomiting, nausea, chills, dehydration and fever after receiving her first and second dose of Gardasil. The adverse experiences were more severe after the second dose". No further information was available. The patient had not recovered as of this report day. Additional information will be requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Information has been received from a health professional concerning a 25 year old female who on 06-SEP-2007 was vaccinated with Gardasil (yeast, lot # 658556/1060U) in her right deltoid. Concomitant therapy included oral contraceptive (therapy unspecified). When the patient received her first dose of Gardasil, she experienced a rash. The rash was described as a red, blotchy area on her chest that covered an area of approximately 3-5 inches. The rash did not itch or spread. Medical attention was sought, the patient called the office. As of 27-SEP-2007 the outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Culture stool negative, Diarrhoea
Clinical narrative: Information has been received from a pharmacist, concerning his 16 year old daughter who on 14-AUG-2007 was vaccinated with the first dose of Gardasil (lot # not provided). There was no concomitant medication. In August 2007, "within the first 14 days" after the vaccination, she experienced diarrhea, that initially occurred up to 6 times daily. A stool culture was done and was negative (date not specified). At the time of this report, his daughter had not recovered, with diarrhea continued at up to 3 episodes daily. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information has been received from a nurse concerning a 15 year old female who on 30-AUG-2007 was vaccinated with Gardasil (Lot # 657617/0384U). The nurse reported that the physician had a patient who developed a 6 inch red, swollen area to her left arm below the injection site, after her first immunization with Gardasil. The site was not painful or warm to the touch. Subsequently, the patient recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/12/2007.  Information has been received from a registered nurse concerning a 15 year old female patient who on 30-AUG-2007 in the PM, was vaccinated into the left arm with a first dose of GARDASIL (Lot # 657617/0384U).  The nurse reported that the physician had a patient who developed a 6 inch red, swollen area to her left arm below the injection site, after her first immunization with GARDASIL.  The site was not painful or warm to the touch.  On 06-SEP-2007, the patient developed small small bruising around the injection site and roughly 10 cm from the injection site.  Distally there was an area of redness 10 cm long.  It was not warm to touch but was mildly swollen.  It was reported that there was mild erythema and tenderness with deep palpation.  On an unknown date, the patient recovered.  No product quality complaint was involved. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female who on 26-JUL-2007 was vaccinated with Gardasil (lot # 0469U). Concomitant therapy included LOESTRIN 21). The nurse reported that a patient experienced generalized achiness for 5 days after administration of her first dose of Gardasil  01/07/2008 This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow-up information has been received from a licensed practical nurse concerning a 19 year old female who on 26-JUL-2007 was vaccinated with a first (lot # 0469U) IM in the left deltoid. Concomitant therapy included LOESTRIN 21. On 08-AUG-2007, approximately 2 weeks later (also reported as 26-JUL-2007), the nurse reported that a patient experienced generalized achiness (bones/joints) for 5 days after administration of her first dose of GARDASIL. The patient treated herself with ADVIL. On 13-AUG-2007 (also reported as 01-AUG-2007), the patient recovered from generalized achiness. The patient did visit the office regarding the adverse experience. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician's assistant, via a company representative, concerning a 16 year old female patient, who on an unspecified date was vaccinated with a dose of Gardasil (lot # not specified), and fainted. No further information was available. This is one of two reports received from the same source (WAES#0710USA00631). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal distension, Decreased appetite, Oedema peripheral, Pitting oedema
Clinical narrative: Information has been received from a physician concerning a female who in July 2007 received her second dose of Gardasil. The physician reported the patient experienced swelling in her feet, legs and abdomen which was characterized as "pitting edema." The physician reported the patient's edema was increasing weekly. The patient also experienced bloating and a decreased appetite. As of 28-SEP-2007, the patient was not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Pharyngeal oedema, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 29-SEP-2007 was vaccinated with her third dose of Gardasil. On 30-SEP-2007, the patient developed a fever, vomiting, throat swelling and arthralgias. The physician indicated that the patient had the same non-severe reaction to the previous two vaccinations (dates unspecified). Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Blood glucose increased, Blood pressure, Condition aggravated, Dizziness, Headache
Clinical narrative: This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow-up information has been received from a physician concerning an 18 year old female with an allergy to sulfa and a history of lightheadedness, nausea, sweating and headache (but, not related to vaccination) and syncope on 21-JUN-2001 with negative MRI, and workup results. There was no illness at the time of vaccination who on 10-SEP-2007 was vaccinated with the first dose of Gardasil (Lot# 658560/1062U) in the left deltoid IM. Concomitant therapy included a first dose of meningococcal vaccine (unspecified) (lot# U22768A) IM and a second dose of tuberculin purified protein derivative (PPD TIME TEST) (lot # C2861A) intraderm. Within a minute of the vaccine, the patient experienced lightheadedness, nausea, sweating and headache. The patient's blood sugar was 101, blood pressure was 110/70 and pulse rate was 64. The patient waited in the office for 20 minutes, felt better and went home recovered on 10-SEP-2007. The patient was seen in the office 2 days later and was fine. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Heart rate normal, Hyperhidrosis, Nausea
Clinical narrative: This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow-up information has been received from a physician concerning an 18 year old female with an allergy to sulfa and a history of lightheadedness, nausea, sweating and headache (but, not related to vaccination) and syncope on 21-JUN-2001 with negative MRI, and workup results. There was no illness at the time of vaccination who on 10-SEP-2007 was vaccinated with the first dose of Gardasil (Lot# 658560/1062U) in the left deltoid IM. Concomitant therapy included a first dose of meningococcal vaccine (unspecified) (lot# U22768A) IM and a second dose of tuberculin purified protein derivative (PPD TIME TEST) (lot # C2861A) intraderm. Within a minute of the vaccine, the patient experienced lightheadedness, nausea, sweating and headache. The patient's blood sugar was 101, blood pressure was 110/70 and pulse rate was 64. The patient waited in the office for 20 minutes, felt better and went home recovered on 10-SEP-2007. The patient was seen in the office 2 days later and was fine. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Acne, Inappropriate schedule of drug administration
Clinical narrative: This is in follow-up to report (s) previously submitted on 10/12/2007. Information has been received from the mother of an 18 year old female who on 21-DEC-2006 was vaccinated with the first dose of GARDASIL, the second dose on 27-FEB-2007, and the third dose on 19-JUL-2007. On 21-AUG-2007 the patient inadvertently received a fourth dose of GARDASIL. After receiving the fourth dose, the patient developed acne on her face. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. Follow up information states she has not yet gotten her period. The mother reported that her daughter never had irregular periods prior to the vaccination. As of 28-SEP-2007 the patient had not recovered. No product qualtity complaint was involved. The patient's twin sister also received 4 doses of GARDASIL and developed acne on her face (WAES0710USA00553). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a licensed practical nurse concerning a "couple" patients who were vaccinated with the Gardasil. Subsequently, the patients said that their arms hut when vaccinated with Gardasil. No additional information regarding these other patients was available. The LPN also provided information regarding another patient's experience with Gardasil (WAES#0709USA01895) and "some" patients' experience with Gardasil (WAES#0710USA00229). Additional information has been requested.