chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Contusion, Injection site bruising, Open wound
Clinical narrative: Information has been received from a registered nurse, concerning a college aged female college student, who on an unknown date was vaccinated with the first dose of Gardasil (lot # not provided).  Two weeks later, she developed "bruising" that appeared on both arms from the elbow to the shoulder, and in the axillary area.  The patient's mother had described the axillary area to be "almost like an open sore."  Treatment included antibiotic cream (unspecified).  At the time of this report the patient had recovered (duration not specified).  Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Contusion
Clinical narrative: Information has been received from a registered nurse, concerning a college aged female college student, who on an unknown date was vaccinated with the first dose of Gardasil (lot # not provided).  Two weeks later, she developed "bruising" that appeared on both arms from the elbow to the shoulder, and in the axillary area.  The patient's mother had described the axillary area to be "almost like an open sore."  Treatment included antibiotic cream (unspecified).  At the time of this report the patient had recovered (duration not specified).  Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 21 year old female who on 26-JUL-2007 was vaccinated with Gardasil.  On 29-JUL-2007 the patient experienced a rash that was about the size of a quarter on her leg.  It spread within 2-3 days to hives throughout her body.  The patient went to the ER where she received IV and oral steroids.  Subsequently, the patient recovered from the rash and hives within 2 days of the ER visit.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood pressure, Muscle rigidity, Oxygen saturation normal, Pallor
Clinical narrative: Information has been received from a Registered Nurse concerning a 13 year old female who on 19-SEP-2007 was vaccinated IM in the left arm with the first dose of Gardasil (Lot #655620/0171U).  About 10 minutes after she was vaccinated, the patient leaned against her mother, drew the right arm to the face, became rigid and fainted.  As the patient was laid to the floor she became alert although weak and pale.  Blood pressure was 110/62 and oxygen saturation was 100%.  The patient was monitored in the physician's office for one hour without further adverse symptoms.  The patient went to school the following day and is fully recovered.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a Registered Nurse concerning a 13 year old female who on 19-SEP-2007 was vaccinated IM in the left arm with the first dose of Gardasil (Lot #655620/0171U).  About 10 minutes after she was vaccinated, the patient leaned against her mother, drew the right arm to the face, became rigid and fainted.  As the patient was laid to the floor she became alert although weak and pale.  Blood pressure was 110/62 and oxygen saturation was 100%.  The patient was monitored in the physician's office for one hour without further adverse symptoms.  The patient went to school the following day and is fully recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a health professional concerning a female who on 13-SEP-2007 was vaccinated with her first dose of Gardasil.  On 16-SEP-2007 the patient developed a rash.  The patient sought medical attention in the office, but the details of the exam and treatment are unknown.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count, Petechiae
Clinical narrative: Information has been received from a certified medical assistant (CMA), via a company representative, concerning a 22 year old female patient, with a history of an abnormal Papanicolaou smear and papilloma viral infection (HPV), who on 24-AUG-2007 was vaccinated IM with the first dose, 0.5 ml, of Gardasil (lot # not provided).  Concomitant therapy included TRINESSA.  On 08-SEP-2007, two weeks after the vaccination, the patient developed petechiae on her legs.  The patient was seen by a physician, though treatment was not specified.  At the time of this report, the patient was recovering.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Blood pressure decreased, Dizziness, Dyspnoea, Heart rate
Clinical narrative: Information has been received from a nurse practitioner concerning a 26 year old female who was vaccinated intramuscularly with a 0.5 ml dose of Gardasil.  Subsequently the patient developed shortness of breath, dizziness, a drop in blood pressure and pulse rate.  The patient reported that she hadn't eaten for about 8 hours.  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 nurse practitioner concerning a 26 year old female who was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL. Subsequently the patient developed shortness of breath, dizziness, a drop in blood pressure and pulse rate. The patient reported that she hadn't eaten for about 8 hours. Subsequently, the patient recovered. Additional information has been requested. In follow-up, she reported stated that there was "no adverse reaction".
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Heart rate decreased
Clinical narrative: Information has been received from a nurse practitioner concerning a 26 year old female who was vaccinated intramuscularly with a 0.5 ml dose of Gardasil.  Subsequently the patient developed shortness of breath, dizziness, a drop in blood pressure and pulse rate.  The patient reported that she hadn't eaten for about 8 hours.  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 nurse practitioner concerning a 26 year old female who was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL. Subsequently the patient developed shortness of breath, dizziness, a drop in blood pressure and pulse rate. The patient reported that she hadn't eaten for about 8 hours. Subsequently, the patient recovered. Additional information has been requested. In follow-up, she reported stated that there was "no adverse reaction".
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness postural
Clinical narrative: Information has been received from an approximately 14 year old female who on approximately 07-SEP-2007 was vaccinated with a 0.5 ml first dose of Gardasil.  Concomitant therapy included Vaqta (inactive) (manufacturer unknown).  On approximately 07-SEP-200 right after vaccination the patient experienced dizziness when she attempted to stand up.  Unspecified medical attention was sought.  On approximately 07-SEP-2007, the patient recovered.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Palpitations, Presyncope
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with no pertinent medical history who on 16-JUL-2007 was vaccinated with a 0.5 ml first dose of Gardasil (Lot #658094/0524U).  There was no concomitant medication.  On 16-JUL-2007 the patient almost fainted.  The patient went home and later that evening, the patient experienced abdominal pain that lasted for one hour.  The patient also experienced 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 16 year old non smoking female with sinusitis and a cough (for 4 weeks) being treated with AUGMENTIN at the time of vaccination  who on 15-JUL-2003 at 6:30 pm was vaccinated intramuscularly into the right upper arm with a 0.5 ml first dose of GARDASIL (Lot #658094/0524U).  On the same day at 6:30 pm, the patient was vaccinated intramuscularly into the left upper arm with a first dose of MENACTRA (Lot #02366A).  On 16-JUL-2007 the patient almost fainted.  The patient's mom called the office and reported that the patient had a reaction to GARDASIL.  At 10:00 pm on the night of vaccination the patient doubled over crying with stomach pain.  She complained of feeling her heart race at the same time.  Teh mother stated that the patient reported her heart felt like it was racing only during the time she was crying (approximately 15-20 minutes) By the time they arrived to the emergency room (ER) the patient had calmed down and the heart rate felt normal.  The patient complained of feeling dizzy and nauseated in the ER.  The abdominal discomfort lasted approximately one hour and then was completely gone.  The mother reported that the ER did nothing except monitor the patient for the short time.  Her blood pressure was 114/64, pulse was 66, pulse oxygenation was 98 percent, respiration was 22 and temperature was 35. 4 celcius.  On 16-JUL-2007, the patient  recovered and was sent her home.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nipple pain, Pain in extremity
Clinical narrative: Information has been received from a 26 year old female with no pertinent medical history who on 20-SEP-2007 was vaccinated with a 0.5 ml first dose of Gardasil.  There was no concomitant medication.  On 20-SEP-2007 in the evening around 8:00 pm the patient reported, "the nipples on my breasts became very sensitive and then actually hurt".  "The arm I received the shot also hurts" and "I have had headaches since getting Gardasil".  There was not laboratory or diagnostic tests performed.  The patient did not seek medical attention.  At the time of the report the patient had not recovered.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a consumer concerning her daughter who sometime in July 2007, was vaccinated with a first dose of Gardasil.  Subsequently, 4 days later, the patient broke out in a rash.  At the time of this report, the patient's outcome was unknown. No product quality complaint was involved.  Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Inappropriate schedule of drug administration, Urticaria
Clinical narrative: Information has been received from a pharmacy student concerning a 46 year old (also reported as greater than 26 years of age although exact age unspecified) female physician with oedema peripheral and acne and who was HPV positive prior to vaccination who on 13-SEP-2007 was vaccinated intramuscularly in the right arm with a 0.5 mL first dose of Gardasil.  Concomitant therapy included ALDACTONE TABLETS and doxycycline.  On 20-SEP-2007 the patient developed large generalized welts on the body.  The patient took diphenhydramine 12.5 mg 3 to 4 times for the reaction and stated that the "rash" was less severe as of "14-SEP-2007."  It was noted that the patient took the Gardasil at the recommendation of the patient's gynecologist.  At the time of this report, the patient was recovering.  No product quality complaint was involved.  Additional information has been requested. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a second dose of Gardasil.  Subsequently, the patient experienced an adverse event.  The physician did not elaborate on the specific of the adverse event.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female who in August 2007 was vaccinated with a first dose of Gardasil.  The patient may have been vaccinated with another unspecified vaccine in the opposite arm.  Subsequently the patient fainted.  Patient was monitored in the office and recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a healthcare professional (HCP), via a company representative, concerning a female patient (age not specified) who was vaccinated on an unknown date with a dose of Gardasil (lot # not specified).  The HCP stated that the father of the patient reported that his daughter had pain around the injection site.  At the time of this report, the outcome of the event was unknown.  No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain upper, Body temperature increased, Dizziness, Headache, Injection site swelling
Clinical narrative: Initial and folow-up information has been received from a health professional concerning her 11 year old black daughter with asthma and seasonal allergies who on 14-SEP-2007 was vaccinated into the right arm with a first dose of Gardasil.  Concomitant vaccination on 14-Sept-2007 included a first dose of MENACTRA into the left arm and a first doese of diptheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL) (lot # c275pAA) into the left arm.  Other concomitant therapy included montelukast sodium (MSD), albuterol and cetirizine hydrochloride (ZYRTEC).  On 14-SEP-2007 the patient experienced swelling at the injection site, stomach ache, sore throat, and fever of 102.5 F with headache.  On 15-SEP-2007 the patient was seen in the emergency room.  Temperature was 101.9, pulse was 114, respiration were 20 and unlabored, pulse oximetry was 98 percent on room air and pain was rated 8/10 in multiple areas.  She was diagnosed with pharyngitis.  The patient was discharged home.  A prescription was written for amoxicillin and caretaker was advised to administer ibuprofen and acetaminophen according to instructions provided.  The patient was advised rest and to drink extra fluids. Subsequently, the patient recovered from the injection site swelling.  The patient's dizziness lasted for four days and headache lasted for five days.  The reporting healtth profession was not sure if the patient's experience was related to the vaccine. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Oropharyngeal pain, Pharyngitis, Pyrexia
Clinical narrative: Initial and folow-up information has been received from a health professional concerning her 11 year old black daughter with asthma and seasonal allergies who on 14-SEP-2007 was vaccinated into the right arm with a first dose of Gardasil.  Concomitant vaccination on 14-Sept-2007 included a first dose of MENACTRA into the left arm and a first doese of diptheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL) (lot # c275pAA) into the left arm.  Other concomitant therapy included montelukast sodium (MSD), albuterol and cetirizine hydrochloride (ZYRTEC).  On 14-SEP-2007 the patient experienced swelling at the injection site, stomach ache, sore throat, and fever of 102.5 F with headache.  On 15-SEP-2007 the patient was seen in the emergency room.  Temperature was 101.9, pulse was 114, respiration were 20 and unlabored, pulse oximetry was 98 percent on room air and pain was rated 8/10 in multiple areas.  She was diagnosed with pharyngitis.  The patient was discharged home.  A prescription was written for amoxicillin and caretaker was advised to administer ibuprofen and acetaminophen according to instructions provided.  The patient was advised rest and to drink extra fluids. Subsequently, the patient recovered from the injection site swelling.  The patient's dizziness lasted for four days and headache lasted for five days.  The reporting healtth profession was not sure if the patient's experience was related to the vaccine. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Aphasia, Depression, Drug exposure during pregnancy, Hypoaesthesia, Hypokinesia
Clinical narrative: Initial and follow-up information has been received from the Merck Pregnancy Registry via a registered nurse concerning a 19 year old female with depression and a history of a normal 40 week full term delivery who on 08-AUG-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (Lot #657617/0384U).  Concomitant therapy included DEPO-PROVERA, fluoxetine HCl and an unspecified sleeping pill.  Subsequently, the patient was pregnant.  The patient had been utilizing DEPO-PROVERA so she did not experience regular menstrual cycles.  The patient's last menstrual period was estimated as 24-JUL-2007 from physical exam and the estimated date of delivery was on 29-APR-2008.  It was mentioned that the patient patient suspected pregnancy due to the developing nausea and vomiting.  It was on 10-SEP-2007 after a visit to hospital a urine pregnancy test was performed, results positive.  Also, the nurse mentioned that patient had a visit to the hospital (no admission) during the first week of September 2007.  The patient experienced numbness on the right side in her hands and lower extremities.  She could not move or talk.  Unspecified bloodwork was taken, results were not disclosed.  The patient's symptoms resolved and she was sent home.  There was no diagnosis or explanation to the reason for the patient's numbness.  Patient's outcome related to pregnancy was unknown.  Additional information has been requested. Follow-up phone call information has been received from a registered nurse who reported that the patient delivered a healthy, normal baby on 19-APR-2008. No additional information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Nausea, Urine human chorionic gonadotropin positive, Vomiting
Clinical narrative: Initial and follow-up information has been received from the Merck Pregnancy Registry via a registered nurse concerning a 19 year old female with depression and a history of a normal 40 week full term delivery who on 08-AUG-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (Lot #657617/0384U).  Concomitant therapy included DEPO-PROVERA, fluoxetine HCl and an unspecified sleeping pill.  Subsequently, the patient was pregnant.  The patient had been utilizing DEPO-PROVERA so she did not experience regular menstrual cycles.  The patient's last menstrual period was estimated as 24-JUL-2007 from physical exam and the estimated date of delivery was on 29-APR-2008.  It was mentioned that the patient patient suspected pregnancy due to the developing nausea and vomiting.  It was on 10-SEP-2007 after a visit to hospital a urine pregnancy test was performed, results positive.  Also, the nurse mentioned that patient had a visit to the hospital (no admission) during the first week of September 2007.  The patient experienced numbness on the right side in her hands and lower extremities.  She could not move or talk.  Unspecified bloodwork was taken, results were not disclosed.  The patient's symptoms resolved and she was sent home.  There was no diagnosis or explanation to the reason for the patient's numbness.  Patient's outcome related to pregnancy was unknown.  Additional information has been requested. Follow-up phone call information has been received from a registered nurse who reported that the patient delivered a healthy, normal baby on 19-APR-2008. No additional information is expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Information has been received from a physician concerning a 23 year old female who on 17-SEP-2007 was vaccinated with a third dose of Gardasil (Lot # 0530U).  There was no concomitant medication.  On 21-SEP-2007 the patient developed a rash and had itchiness over her body.  Unspecified medical attention was sought.  The patient's outcome was unknown.  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 physician concerning a 23 year old female who on 17-SEP-2007 was vaccinated with a third dose of GARDASIL (Lot # 0530U) intramuscularly in the right arm.  There was no concomitant medication.  On 20-SEP-2007 the patient developed raised colorless macules over her arms and chest for three days.  The patient recovered from this adverse event.  On 21-SEP-2007 the patient developed a rash and had itchiness over her body. Unspecified medical attention was sought.  The patient's outcome was unknown.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Muscle tightness
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a female who on 24-SEP-2007 was vaccinated by injection with the second dose of Gardasil.  The nurse reported that "after the patient received the second dose, the patient had experienced burning and muscle tightness.  The burning and muscle tightness lasted for about five minutes and then it went away.  There was no redness or swelling.  The nurse said that they used a different arm from the first injection of Gardasil".  The nurse also reported this same experienced happened to other patients after their second dose.  (WAES # 0710USA00703).  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.  Additional information has been requested. This is in follow-up to report (s) previouisly submitted on 10/12/2007. In follow-up the LPN reported that the patient was 18 years or older. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Injection site pain, Malaise, Mass, Rash
Clinical narrative: This is in follow-up to report(s) previously submitted on 10/12/2007; 1/7/2008; 4/7/2008. Information has been received from a consumer concerning her 19 year old daughter with a sulfonamide and AUGMENTIN allergy, asthma and seasonal allergies and no pertinent medical history who on 02-FEB-2007 was vaccinated with a first dose of GARDASIL (lot# unknown) 0.5mL IM in the left deltoid.  There was no concomitant medication.  On approximately 02-FEB-2007 after the injection the patient developed a headache, injection site pain and felt lousy.  Medical attention was not sought.  On an unspecified date the patient recovered.  On 04-APR-2007 the patient was vaccinated with a second dose of GARDASIL (65376/0014U) 0.5mL IM in the left deltoid.  On approximately 04-APR-2007 after the injection the patient developed a headache, injection site pain and felt lousy. The patient also developed a "hives like rash." On an unspecified date the patient recovered.  On 13-JUN-2007 the patient was vaccinated with a third dose of GARDASIL (lot# 656850/0245U) 0.5mL IM in the left deltoid.  On approximately 13-JUN-2007 after the injection the patient developed a headache, injection site pain and felt lousy. The patient also developed a rash three times. The third rash started in November 2007 and was so severe that the patient missed 2 days of school and was admitted to the hospital. The patient treated intravenously with BENADRYL and cortisone. On an unspecified date the patient recovered from the headache, injection site pain, and feeling lousy. It was reported that the rash had gotten better but had not went away.  Additional information has been requested.  Follow-up information was received from a physician. It was reported that on an unspecified date the patient had a lump under the skin approximately 1 cm by 1 cm with the second or third injection for 2 to 3 months and was tender. Additional information is not expected. Follow-up information was received from the mother of the patient reporting that her daughter on 02-FEB-2007, experienced another rash on her hands and feet which was very painful. On an unspecified date, the patient recovered from the rash on her hands and foot. She said that her daughter had a lot of tests which all came back negative (Tests no reported). Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Tenderness, Urticaria, Vaccine positive rechallenge
Clinical narrative: This is in follow-up to report(s) previously submitted on 10/12/2007; 1/7/2008; 4/7/2008. Information has been received from a consumer concerning her 19 year old daughter with a sulfonamide and AUGMENTIN allergy, asthma and seasonal allergies and no pertinent medical history who on 02-FEB-2007 was vaccinated with a first dose of GARDASIL (lot# unknown) 0.5mL IM in the left deltoid.  There was no concomitant medication.  On approximately 02-FEB-2007 after the injection the patient developed a headache, injection site pain and felt lousy.  Medical attention was not sought.  On an unspecified date the patient recovered.  On 04-APR-2007 the patient was vaccinated with a second dose of GARDASIL (65376/0014U) 0.5mL IM in the left deltoid.  On approximately 04-APR-2007 after the injection the patient developed a headache, injection site pain and felt lousy. The patient also developed a "hives like rash." On an unspecified date the patient recovered.  On 13-JUN-2007 the patient was vaccinated with a third dose of GARDASIL (lot# 656850/0245U) 0.5mL IM in the left deltoid.  On approximately 13-JUN-2007 after the injection the patient developed a headache, injection site pain and felt lousy. The patient also developed a rash three times. The third rash started in November 2007 and was so severe that the patient missed 2 days of school and was admitted to the hospital. The patient treated intravenously with BENADRYL and cortisone. On an unspecified date the patient recovered from the headache, injection site pain, and feeling lousy. It was reported that the rash had gotten better but had not went away.  Additional information has been requested.  Follow-up information was received from a physician. It was reported that on an unspecified date the patient had a lump under the skin approximately 1 cm by 1 cm with the second or third injection for 2 to 3 months and was tender. Additional information is not expected. Follow-up information was received from the mother of the patient reporting that her daughter on 02-FEB-2007, experienced another rash on her hands and feet which was very painful. On an unspecified date, the patient recovered from the rash on her hands and foot. She said that her daughter had a lot of tests which all came back negative (Tests no reported). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist concerning a female who was vaccinated with a dose of Gardasil.  Subsequently the patient developed a rash.  There were no laboratory or diagnostic tests performed.  Unspecified medical attention was sought.  At the time of the report the patient had recovered.
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Nausea, Vomiting
Clinical narrative: Information has been received from a nurse concerning a female (age not reported) with pertinent medical history and drug reactions/allergies reported as none who in July 2007 ("a little over two months ago"), was vaccinated with the first dose of Gardasil, injection, 0.5 ml.  Concomitant medication was not reported.  In July 2007 ("day after vaccination"), the patient experienced stomach flu-like symptoms which included nausea and vomiting for three days after her first dose of Gardasil.  The patient sought unspecified medical attention (phone call).  It was reported that the patient does not wish to continue the series of Gardasil.  Subsequently, the patient recovered from stomach flu-like symptoms, nausea and vomiting three days after stopping therapy with Gardasil.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Eyelid oedema, Hypersensitivity, Myalgia, Nausea
Clinical narrative: Information has been received from a certified medical assistant concerning a 22 year old female with shrimp allergy who on 13-SEP-2007 was vaccinated with the first dose of Gardasil (lot #658488/0930U).  Concomitant therapy included NUVARING and ALLEGRA.  On 14-SEP-2007 the following morning, the patient experienced an "allergic reaction".  The certified medical assistant characterized the reaction as "extreme dizziness", a facial "rash" which spread to her chest and back, swelling of her eyelids, "nausea", "fever" and "muscle aches".  The patient sought unspecified medical attention and was treated with BENADRYL. Subsequently on an unspecified date, the patient recovered from extreme dizziness, facial rash which spread to chest and back, swelling of her eyelids, nausea, fever and muscle aches.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a certified medical assistant concerning a 22 year old female with shrimp allergy who on 13-SEP-2007 was vaccinated with the first dose of Gardasil (lot #658488/0930U).  Concomitant therapy included NUVARING and ALLEGRA.  On 14-SEP-2007 the following morning, the patient experienced an "allergic reaction".  The certified medical assistant characterized the reaction as "extreme dizziness", a facial "rash" which spread to her chest and back, swelling of her eyelids, "nausea", "fever" and "muscle aches".  The patient sought unspecified medical attention and was treated with BENADRYL. Subsequently on an unspecified date, the patient recovered from extreme dizziness, facial rash which spread to chest and back, swelling of her eyelids, nausea, fever and muscle aches.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Back pain, Drug exposure during pregnancy, Ultrasound pelvis, Ultrasound scan vagina
Clinical narrative: This is in follow-up to report(s) previously submitted on 10/12/2007. Information has been received from a licensed practical nurse concerning a 16 year old female with migraine and a history of termination of pregnancy 1 year ago in 2006 who on 31-JUL-2007 was vaccinated intramuscularly in the left deltoid with a 0.5 ml dose of Gardasil (lot 655205/1426F). Concomitant therapy included hormonal contraceptives (unspecified), promethazine and cyproheptadine hydrochloride. On 13-SEP-2007, the patient came into the office complaining of right side pain that was radiating to the back. Pregnancy was confirmed on 13-SEP-2007 by pelvic and transvaginal ultrasound and by HGC level.  Date of LMP was 03-AUG-2007. On ultrasound on 04-OCT-2007 was within normal limits. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Urine human chorionic gonadotropin positive
Clinical narrative: This is in follow-up to report(s) previously submitted on 10/12/2007. Information has been received from a licensed practical nurse concerning a 16 year old female with migraine and a history of termination of pregnancy 1 year ago in 2006 who on 31-JUL-2007 was vaccinated intramuscularly in the left deltoid with a 0.5 ml dose of Gardasil (lot 655205/1426F). Concomitant therapy included hormonal contraceptives (unspecified), promethazine and cyproheptadine hydrochloride. On 13-SEP-2007, the patient came into the office complaining of right side pain that was radiating to the back. Pregnancy was confirmed on 13-SEP-2007 by pelvic and transvaginal ultrasound and by HGC level.  Date of LMP was 03-AUG-2007. On ultrasound on 04-OCT-2007 was within normal limits. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a registered nurse concerning 5 female patients (ages not reported) who on unspecified dates were vaccinated with the first dose of Gardasil.  The registered nurse reported that there was no adverse event involved with the first dose and all patients were administered with Gardasil vial.  On unspecified dates, the patients were vaccinated with the second dose of Gardasil with pre-filled syringe.  Concomitant medications were not reported.  Subsequently on unspecified dates, the patients experienced pain at injection site after receiving the second dose of Gardasil.  Unspecified medical attention was sought.  Subsequently on unspecified dates, the patient recovered from pain at injection site.  Additional information has been requested. Additional information was received from a nurse stating that there have been "NO reported adverse reactions" following the administration of over 250 doses of GARDASIL at this practice. The staff members at this practice have conveyed patients were experiencing increased pain when utilizing the prefilled syringes of the GARDASIL vaccine. After supplying the single dose vials, "only" becauseee this concern was expressed, the complaint of unusal pain has ceased. There are no specific details to submit as this merely was a general statement made during a meeting. No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site rash, Local reaction
Clinical narrative: Information has been received from a physician concerning a female patient who on 20-SEP-2007 was vaccinated IM with a dose of Gardasil.  On 21-SEP-2007 the patient developed a localized red rash at injection site.  No other symptoms were noted.  An office visit was required.  The patient's outcome was not reported.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Loss of consciousness, Paraesthesia
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning an adolescent female patient who on 25-SEP-2007 was vaccinated in to deltoid with a dose of Gardasil.  The nurse reported that immediately post vaccination the injected arm felt numb and tingly, which traveled down the arm to the fingers.  The patient described the reaction as "almost like you could feel the medication traveling".  Patient passed out and it took her a while to regain consciousness.  She also reported that an adverse event occurred with the same lot of Gardasil about 2 weeks ago, arm pain, which was previously reported to VAERS.  The nurse did not provided the lot number.  The outcome was unknown.  No other information was available at this time.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a penicillin allergy and no pertinent medical history who on 16-AUG-2007 was vaccinated with a first dose of Gardasil (lot# 658558/1061U) in the left deltoid IM.  There was no concomitant medication.  On 17-AUG-2007 the patient experienced significant nausea, vomiting and diarrhea.  The events started one day after vaccination.  Medical attention was sought.  The patient was seen by the primary care physician on 24-AUG-2007 for evaluation, secondary to persistent symptoms, was told to keep hydrated.  At the time of reporting it was unknown if the patient recovered.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Confusional state, Dizziness, Nausea
Clinical narrative: Information has been received from a licensed practical nurse, concerning an 11 year old female student with no known drug allergies or illness at the time of vaccination, who on 11-JUL-2007 was vaccinated with the first dose of Gardasil (lot #658100/0525U).  Concomitant vaccine administered at the visit included ADACEL.  The following day, the patient's mother reported that on 11-JUL-2007, the patient had experienced dizziness, and on 12-JUL-2007 she experienced confusion and nausea.  There was no fever and no redness at the site of injection, and no treatment was required.  The nurse noted the duration of each symptom as "2 hours," however, the date of recovery was indicated as 13-JUL-2007.  No further information is expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Dizziness, Headache, Heart rate
Clinical narrative: Information has been received from a licensed practical nurse concerning a 23 year old female with no medical history and no illness at the time of being vaccinated.  On 18-SEP-2007, the patient was vaccinated with a first dose of Gardasil (lot # 654539/0742U) IM in the left deltoid.  There was no concomitant medication.  On 18-SEP-2007, 5 minutes after being vaccinated, the patient experienced dizziness and she needed to lie down.  Her blood pressure was 112/76 after 20 minutes blood pressure was 102/78, pulse 80 and her dizziness resolved.  She experienced a slight headache.  On 18-SEP-2007, the patient recovered from the dizziness and slight headache.  No additional information is expected.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site pain, Mobility decreased, Muscular weakness, Vaccine positive rechallenge
Clinical narrative: Information has been received from a licensed vocational nurse concerning a 28 year old female with no pertinent medical history who on 21-MAY-2007 was vaccinated intramuscularly in the left deltoid with a first dose of Gardasil (Lot #656051/0244U).  Concomitant therapy included ACCUTANE and DEPO-PROVERA.  On 28-MAY-2007 the patient complained of pain at the injection site, limited mobility and severe weakness in the entire arm for six weeks after injection.  On approximately 03-JUL-2007 the complaints had resolved.  On 27-JUL-2007 the patient was vaccinated with a second dose of Gardasil.  On approximately 27-JUL-2007 eight hours after vaccination the patient had pain at the injection site.  The skin was clear, and there were no complaints of limited mobility at that time.  The patient's outcome was unknown.  On 21-SEP-2007 the patient planned on receiving a third dose of Gardasil.  At the time of the report the patient's outcome related to the third dose of Gardasil was unknown.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Oedema peripheral, Rash, Streptococcal identification test positive
Clinical narrative: Information has been received from a nurse concerning a 17 year old female patient who on 07-AUG-2007 was vaccinated IM with a first dose of Gardasil.  The nurse reported that after receiving her first dose of Gardasil she developed swelling and rash with joint pain on her lower extremities.  Laboratory tests showed that she had "Strep" and MEDROL dose pack was prescribed.  No further information was available.  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 nurse concerning a 17 year old female patient who on 23-AUG-2007 (also reported as 07-AUG-2007) was vaccinated with a first dose of GARDASIL vaccine. Follow-up information was received from a medical assistant. On 25-SEP-2007, the patient returned to the office for a follow-up visit. The patient had no further problems and was recovered. The patient did no continue the GARDASIL vaccine series of vaccination. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, No reaction on previous exposure to drug, Oral contraception
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female with no known allergies and no reported medical history, who on 21-JUN-2007 was vaccinated with Gardasil.  Concomitant therapy included YASMIN.  The patient received their second dose of Gardasil (lot # 658554/0928U) on 11-SEP-2007.  After received their second dose, the patient experienced flu like symptoms.  The patient fully recovered on 20-SEP-2007 without requiring treatment.  The nurse practitioner reported that the patient did not experience an adverse reaction after her first dose of Gardasil on 21-JUN-2007.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Injection site rash, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female who on 17-MAY-2007 was vaccinated with GARDASIL. On 17-MAY-2007 the patient experienced arm pain, dizziness and rash from the injection site to her elbow. On an unspecified date the patient recovered from her experiences. On 19-JUL-2007 the patient received her second dose of GARDASIL. On 19-JUL-2007 the patient experienced arm pain, dizziness and rash from the injection site to her elbow. On an unspecified date, the patient recovered from her experiences. The patient did visit the physician's office regarding this experience. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Injection site pain, Injection site rash, Injection site swelling, Rash
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who, "last week" on approximately 18-SEP-2007 was vaccinated with a first dose of Gardasil.  Subsequently, the patient experienced a hypersensitivity/allergic reaction to the aluminum adjuvant in the vaccination.  The patient developed an injection site reaction with pain and swelling.  The next day, a rash began to develop over her whole arm (arm unspecified).  The patient was treated with BENADRYL.  The reaction continued to worsen and her arm "turned colors."  The reaction continued to worsen for 2-3 days after the vaccination and then began to improve.  The patient was seen in the office multiple times.  At the time of the report the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Reaction to preservatives, Skin discolouration
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who, "last week" on approximately 18-SEP-2007 was vaccinated with a first dose of Gardasil.  Subsequently, the patient experienced a hypersensitivity/allergic reaction to the aluminum adjuvant in the vaccination.  The patient developed an injection site reaction with pain and swelling.  The next day, a rash began to develop over her whole arm (arm unspecified).  The patient was treated with BENADRYL.  The reaction continued to worsen and her arm "turned colors."  The reaction continued to worsen for 2-3 days after the vaccination and then began to improve.  The patient was seen in the office multiple times.  At the time of the report the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Viral DNA test positive
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female with no drug allergies, who in March 2007, was vaccinated with a third dose of Gardasil.  In September 2007, the patient's deoxyribonucleic acid test for human papillomavirus was positive.  The nurse practitioner noted that the patient was sexually active.  The patient was seen in the doctor's office.  At the time of the report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Headache, Nausea, Syncope
Clinical narrative: Information has been received from a certified medical assistant concerning a 23 year old female with no drug allergies, who on 21-SEP-2007 was vaccinated with a first dose of Gardasil (lot# 654539/0742U).  Concomitant therapy included LUNESTA and lorazepam.  On 21-SEP-2007 the patient fainted  at 15:40 in the physician's office, at check out desk, and later that night the patient felt nauseous and had a headache.  On 25-SEP-2007 a follow-up phone call was made and the patient reported feeling fine.  The patient's blood pressure was taken and was stable.  No other symptoms were noted.  The patient reported tht this has not happened in a long time. The patient's vital signs were stable and there was no evidence of trauma. On 22-SEP-2007 the patient recovered from the headache and nausea. No product quality complaint was involved.  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 certified medical assistant concerning a 23 year old female with no drug allergies, who on 21-SEP-2007 at 15:30 was vaccinated intramuscularly in the left upper arm with a first dose of GARDASIL vaccine (lot# 654539/0742U). On 21-SEP-2007 the patient recovered from fainting. Additional information is not expected.
Age: 29.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site nodule, Injection site pain
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 licensed practical nurse concerning a 29 year old female (also reported as 28) who on an unspecified date was vaccinated with a first dose of Gardasil 0.5mL injection. On 29-MAY-2007 the patient was vaccinated with a second dose of Gardasil (lot# 658558/1061U) IM in the left deltoid. On 29-MAY-2007 the patient experienced tenderness at the injection site. The patient also had a pea size nodule present at the injection site lasting months after the injection. Medical attention was sought. The patient's tenderness and pea size nodule at injection site persisted. No further information was provided. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Loss of consciousness, Syncope vasovagal
Clinical narrative: Information has been received from a registered nurse, concerning a 13 year old female student, who on 10-AUG-2007 at 11:30 am, was vaccinated in the left arm with the first dose of Gardasil (lot #657868/0523U).  Following the vaccination, the patient "had a vasovagal response to injection;" her blood pressure dropped (value not specified) and she passed out.  Treatment included the administration of oxygen; her vital signs were then
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL. Subsequently, the physician saw a rash on the upper rear arm of the patient's area where she was given the GARDASIL. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil.  After getting the Gardasil, the patient developed Guillain Barre syndrome.  Therapy with human papillomavirus vaccine was discontinued.  As of 26-SEP-2007 the patient was not recovered.  Upon internal review, Guillain Barre syndrome is an Other Important Medical Event.  No further information is available, because it was not the reporting physician's patient.