chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Asthma, Wheezing
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 11-FEB-2008 was vaccinated IM in the arm with her first dose of GARDASIL (lot# not provided).  On 11-FEB-2008 the patient experienced "striders syndrome."  Her specific symptoms were wheezing and asthmatic response.  Subsequently, on an unspecified date, the patient recovered from the "striders syndrome."  The patient sought unspecified medical attention.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/14/2008.  Information has been received from a physician concerning a 14 year old female who on 11-FEB-2008 was vaccinated IM in the right deltoid arm with her first dose of GARDASIL (lot# 659439/1267U).  On 11-FEB-2008 the patient experienced "striders syndrome."  Her specific symptoms were wheezing and asthmatic response.  Subsequently, on an unspecified date, the patient recovered from the the "striders syndrome."  The patient sought unspecified medical attention.  Follow up information received from a health professional stated that on 11-FEB-2008 the patient also received vaccination of hepatitis A virus vaccine inactivated (lot# 657840/0797U) administered in the left deltoid.  It was important that on 15-FEB-2008 the patient experienced a "croup-like syndrome with subjective feeling of mirway closure"  and sought unspecified medical attention at the emergency room.  It was reported that on an unspecified date the patient recovered from croup like syndrome with subjective feeling of airway closure.  No further information was available
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Pallor
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 12 year old female on 18-FEB-2008 was vaccinated with the first dose of GARDASIL (lot # not reported). The patient also received MENACTRA (lot # not reported) and ADACEL (lot # not reported) "at the same time." On 18-FEB-2008, "shortly after receiving GARDASIL", the patient "was pale and felt lightheaded." On 19-FEB-2008, "the day after receiving the vaccines, she blacked out while taking a shower and was still very pale. She did not hurt herself when she blacked out." The patient sought unspecified medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Injection site mass, Injection site pain, Nuclear magnetic resonance imaging, Ultrasound scan abnormal
Clinical narrative: Information has been received from a physician concerning a 17 year old patient who on 21-JAN-2008 was vaccinated intramuscularly with a 0.5 mL third dose of GARDASIL (lot # not reported). Subsequently the patient developed a mass and pain at the injection site. The patient sought unspecified medical attention. An MRI was performed and the results were unspecified. Therapy with human papillomavirus vaccine was discontinued on 21-JAN-2008. Additional information has been requested. This is a follow-up to report(s) previously submitted on 1/14/2008. Information has been received from a physician and health professional concerning a 17 yar old patient who on 21-JAN-2008 was vaccinated intramuscularly with 0.5 mL third dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 558560/1062U). On 06-FEB-2008 the patient developed a lump at the injection site. It was also reported that the patient developed pain at the injection site (onset date unknown). The patient came to the office two weeks after the lump appeared. Diagnostic testing performed on 20-FEB-2008 included a sonogram of the left upper arm indicating a nonspecific mass within the upper left extremity: MRI was recommended, and a complete blood cell count was within normal limits except for red (cell) distribution width-cell volume (RDW-VV) was increased at 15.0% (11.5-14.5). An MRI was performed and the results were unspecified. The patient was treated with cephalexin (KEFLEX) 500MG three times a day for ten days. AT the time of reporting the patient's lump has since improved. No further treatment was needed. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix normal
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female who on 12-JAN-2007 was IM with her 1st dose of GARDASIL (lot#653736/0868F). On 13-MAR-2007 the patient was vaccinated IM with her 2nd dose of GARDASIL (lot# 653736/0014U). On 25-JUL-2007 the patient was vaccinated IM with her 3rd dose of GARDASIL (lot# 657872/0515U). It was reported that the patient received all three vaccinations with a pre-filled syringe prior to being sexually active. Concomitant therapy included administration of meningococcal vaccine (unspecified) on 12-JAN-2007 and hormonal contraceptives (unspecified started therapy in September 2007). It was reported that on 08-FEB-2008 the patient had a normal pap test, but the patient tested positive for high risk HPV. The patient sought unspecified medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Infectious mononucleosis, Laboratory test
Clinical narrative: Information has been received from a healthcare worker concerning a 16 year old female who on 05-NOV-2007 was vaccinated intramuscularly with her first dose of GARDASIL (lot #654540/1209U). There was no concomitant medication. On approximately 20-JAN-2008 the patient developed mononucleosis. The patient's mononucleosis persisted. The healthcare worker did not feel the mononucleosis was related to the use of GARDASIL vaccine. The physician can not be contacted. The patient sought unspecified medical attention by calling the physician.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Gastroenteritis viral, Nausea, No reaction on previous exposure to drug, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 24 year old female who on 13-AUG-2007 was vaccinated with her first dose of GARDASIL. On or about 19-Feb-2008 the patient was intramuscularly vaccinated with her third dose of GARDASIL (Lot # 658556/1060U). Concomitant therapy included hormonal contraceptives (unspecified). On 19-FEB-2008 the patient experienced nausea, vomiting, diarrhea, and fever. The patient went to the emergency room and was given IV fluids and was sent home. The patient was diagnosed with a stomach virus. No adverse reactions were reported on the first or second doses of vaccine. Subsequently, the patient recovered from nausea, vomiting, diarrhea, and fever. Additional information has been requested. Follow up information indicated there was no further information available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a health professional concerning a 24 year old female who on 13-AUG-2007 was vaccinated with her first dose of GARDASIL. On or about 19-Feb-2008 the patient was intramuscularly vaccinated with her third dose of GARDASIL (Lot # 658556/1060U). Concomitant therapy included hormonal contraceptives (unspecified). On 19-FEB-2008 the patient experienced nausea, vomiting, diarrhea, and fever. The patient went to the emergency room and was given IV fluids and was sent home. The patient was diagnosed with a stomach virus. No adverse reactions were reported on the first or second doses of vaccine. Subsequently, the patient recovered from nausea, vomiting, diarrhea, and fever. Additional information has been requested. Follow up information indicated there was no further information available.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Chest pain, Dizziness, Dyspnoea
Clinical narrative: Information has been received from a health professional concerning a 15 year old female with a history of asthma who on 20 february 2008 was vaccinated intramuscularly in the left arm with her first does of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot # 657006/0188U).  Concommitanttherapy included vaccination in the left arm with meningococcal ACYN conj vaccine (dip toxoid) (MENACTRA).  On 20 february 2008 the patient experienced shortness of breath, chest pain and light headedness.  Thepatient sought unspecified medical treatment.  The patient recovered after she laid down and took a puff of her albuterol inhaler.  Subsequently, the patient recovered from shortness of breath, chest pain and light headedness.  No further information is available.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Hypoaesthesia, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 14-16 year old female who was vaccinated with her first dose of GARDASIL. On approximately 13-FEB-2008, one day after receiving the vaccine, the patient experienced bilateral numbness and tingling in hands and feet. The patient's bilateral numbness and tingling in hands and feet persisted. The physician reporting is not the administering physician. The patient sought unspecified medical treatment with an office visit. An unspecified CT scan was performed, results were within normal limits. Also an unspecified MRI was performed, results were within  normal limits. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling, Rash, Urticaria, Wheezing
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female who on 17-JUL-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # 657006/0188U). On 27-AUG-2007, the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot # 657006/0188U). On 20-FEB-2008, the patient was vaccinated intramuscularly with her third dose of GARDASIL (Lot # 659657/1487U). Concomitant therapy included ALLEGRA. On 20-FEB-2008, a few minutes after her third dose, the patient developed hives on her arms, shoulder, neck and some lip swelling. The patient was given BENADRYL in the office and seems to have improved. The patient's father noted that the patient has developed rashes and wheezing several times over the last six months. No further information was provided. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning an 11 year old female who on 02-JUL-2007 was vaccinated with Gardasil (lot # not reported).  Concomitant therapy included MENACTRA.  On 02-JUL-2007 the patient experienced a fever that lasted 24 hours after receiving Gardasil.  Subsequently, the patient recovered from the fever.  The patient sought unspecified medical attention with the physician.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain, Local reaction
Clinical narrative: Information has been received from a physician concerning patients who were vaccinated with GARDASIL (Lot# not provided). Per the reporter, "a couple of her patients experienced localized adverse reaction after the injection of GARDASIL. The patients experienced pain at the injection site." The reporter also mentioned that one of the other physicians in the same practice had a patient with the same adverse reaction. No further information was provided. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DTAPIPV, HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Pyrexia, Syncope
Clinical narrative: Information has been received from a physician concerning a female who on 21-FEB-2008 was vaccinated with Gardasil (lot numbers not reported). Concomitant therapy included Varivax (duration and dose not reported). Other concomitant therapy included MENACTRA (Sanofi Pasteur) and DTAP-IPV (GSK). On 22-FEB-2008 the patient experienced fainted, developed redness at injection site and low grade fever 100.4F). The patient was reported to be recovering. No further information is available. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a office staff member at a physician's office concerning a 23 year old female with no reported medical history who on an unspecified date was vaccinated with a dose of GARDASIL (lot number, injection route and site not reported). The office staff member stated that after receiving the dose, the patient went back to the office on an unspecified date and had a pap smear done, which came back positive for HPV. The patient's outcome is unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 18-FEB-2008 was vaccinated with the first dose Gardasil.  Subsequently, the patient developed "flu like" symptoms such as a fever and chills after receiving the first dose of Gardasil.  No diagnostic laboratory studies were performed.  At the time of this report, the patient's mother did not want the patient to receive the second and third dose.  The outcome of this event was unknown.  No product quality complaint involved.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dyspnoea, Injection site swelling, Pyrexia, Rash
Clinical narrative: Information has been received from a healthcare worker concerning a 12 year old female who was vaccinated with her second dose of Gardasil (lot number not provided).  Concomitant therapy included MENACTRA.  Subsequently the patient experienced swelling at injection site, rash, fever and shortness of breath.  The patient was reported to be recovering.  No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Dizziness
Clinical narrative: Information has been received from a health professional concerning a 20 year old Asian/Caucasian female with no reported medical history who on 21-DEC-2007 was vaccinated with her first dose of GARDASIL and on 19-FEB-2008 was vaccinated with her second dose of GARDASIL (Lot #659962/1740U) intramuscularly in the right deltoid at 1:00 pm. Concomitant therapy included DEPO-PROVERA. Immediately after injection the patient felt light headed and broke out into a cold sweat. She was followed up for 10 minutes. The patient felt better and was able to leave. Her reaction after her first shot was "similar". The patient's outcome after the second shot was unknown. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug interaction, Lip swelling, Pharyngeal oedema, Swelling face
Clinical narrative: Information has been received from a pharmaceutical company as part of a business agreement (manufacturer report number 080118-0000044) and a pharmacist concerning a 19 year old female, who, on an unspecified date, was vaccinated with a dose of Gardasil.  Concomitant suspect therapy included CHEMET.  On 18-JAN-2008 the patient experienced throat swelling, swelling of face, swelling of lips, and a drug interaction.  The duration between the administration of the vaccine and the onset of the symptoms was unknown.  The patient temporarily discontinued CHEMET for 3 to 4 weeks.  When the patient resumed treatment with CHEMET she experienced the same events.  Subsequently, the CHEMET was permanently discontinued.  The Gardasil was considered a co-suspect drug.  The reporter considered the events to be possibly related.  Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, MEN, TTOX
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year old female, who on 16-FEB-2008 was vaccinated with a first dose of Gardasil.  Concomitant vaccinations included tetanus toxoid and meningococcal vaccine (unspecified).  Over the weekend, within 24 hours post vaccination the patient experienced several episodes of dizziness, and one syncopal episode where she actually fainted.  The patient returned to the office and the physician did not see any signs of dizziness at that point.  It was reported that the patient did not require any emergency or prolonged health assistance.  The patient recovered on an unspecified date.  Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Blood pressure increased, Dizziness, Heart rate increased, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a medical assistant concerning a 29-year-old female with an allergy to codeine and a medical history of sinus operation in December of 2007 and, who on 25-MAY-2007 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL. There was no concomitant medication. The medical assistant reported that "the patient had some tightness in her back when she received the first two doses, but they did resolve." On 23-JAN-2008 at 09:00 the patient was intramuscularly vaccinated with the third dose of GARDASIL (Lot # 655327/1287U). On 25-JAN-2008, also reported as "one week after" the patient received her third intramuscular dose of GARDASIL (Lot # 655327/1287U) on 23-Jan-2008, she experienced dizziness, nausea, blurred vision and tightness in her back. On 30-JAN-2008 one week after vaccination the patient experienced tightness in her back. "Today," 25-Feb-2008, in the office her heart rate and blood pressure had also elevated. At the time of this report the patient had not recovered from tightness in her back, elevated heart rate and elevated blood pressure and the outcome of the other events was unknown. No product quality complaint was involved. Additional information has been requested. Follow up information received from a nurse practitioner regarding this patient indicated that she has not heard from the patient. Additional information is not expected.
Age: 29.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal stiffness, Nausea, Vaccine positive rechallenge, Vision blurred
Clinical narrative: Information has been received from a medical assistant concerning a 29-year-old female with an allergy to codeine and a medical history of sinus operation in December of 2007 and, who on 25-MAY-2007 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL. There was no concomitant medication. The medical assistant reported that "the patient had some tightness in her back when she received the first two doses, but they did resolve." On 23-JAN-2008 at 09:00 the patient was intramuscularly vaccinated with the third dose of GARDASIL (Lot # 655327/1287U). On 25-JAN-2008, also reported as "one week after" the patient received her third intramuscular dose of GARDASIL (Lot # 655327/1287U) on 23-Jan-2008, she experienced dizziness, nausea, blurred vision and tightness in her back. On 30-JAN-2008 one week after vaccination the patient experienced tightness in her back. "Today," 25-Feb-2008, in the office her heart rate and blood pressure had also elevated. At the time of this report the patient had not recovered from tightness in her back, elevated heart rate and elevated blood pressure and the outcome of the other events was unknown. No product quality complaint was involved. Additional information has been requested. Follow up information received from a nurse practitioner regarding this patient indicated that she has not heard from the patient. Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dysarthria, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a nurse concerning a 28 year old female who was vaccinated intramuscularly on an unspecified date with her first dose of GARDASIL (lot# not provided).  The day after the vaccination the patient experienced light-headedness and slurred speech.  The patient sought unspecified medical attention and her outcome was not reported.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia
Clinical narrative: Information has been received from a health professional concerning multiple females who were vaccinated with Gardasil (lot# not reported) and experienced heavy menstrual flow.  Subsequently, the patients recovered from heavy menstrual flow.  Additional information is trying to be obtained to determine how many patients.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy test, Hypersensitivity
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter with a fruit allergy who on approximately 30-NOV-2007 was vaccinated with her first dose of Gardasil (lot# not reported). There was no concomitant medication. On approximately 01-JAN-2008 the patient experienced a soy allergy (can be anaphylactic and the patient has an epi pen). The patient's soy allergy persisted. The patient sought unspecified medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 16 year old female who was vaccinated with two doses of Gardasil (lot#'s not reported) and developed hives on her legs after both doses.  Subsequently, the patient recovered from hives on an unspecified date.  Therapy was discontinued.  The patient sought unspecified medical attention.  The patient's first dose was given at another office.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2008. Information has been received from a physician concerning an 18 year old female who was vaccinated intramuscularly in the left deltoid on 07-NOV-2007 with her second dose of GARDASIL the patient experienced bruising/swelling on the anterior aspect of the left Tibia, bumps on her face, neck and scalp/and a rash on her right forearm and hand. Subsequently the patient recovered from bruising/swelling on the anterior aspect of the left deltoid, bumps on her face, neck and scalp and a rash on her right forearm and hand. The patient experienced Erythema Nodosum at the time of vaccination. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 24 year old female who on 11-FEB-2008 was vaccinated with the first dose of GARDASIL (Lot# not provided). Subsequently the patient experienced numbness in feet and toes and tingling in feet and toes. The patient's numbness in feet and toes and tingling in feet and toes persisted. No further information was provided. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Syncope
Clinical narrative: Information has been received from a health professional concerning a 15 year old female who on approximately 09-FEB-2008 was vaccinated with her third dose of GARDASIL and experienced syncope.  Subsequently the patient experienced no previous event after receiving the first or second dose of the series.  The patient sought unspecified medical treatment.  Subsequently, the patient recovered from syncope.  Additional information has been requested. Follow-up received 07/11/2008. The patient was reclined and cold compresses were supplied. Subsequently, the patient recovered from syncope. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with her first dose of GARDASIL. Subsequently the patient experienced swelling on her hand. Unspecified medical attention was given. Lot number was not available and no further information was available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with her first dose of GARDASIL.  Subsequently the patient became dizzy and experienced a sharp pain in her arm.  Subsequently, the patient recovered from feeling dizzy and the sharp pain in arm.  The patient sought unspecified medical treatment.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a health professional concerning a 22 year old female who on 23-FEB-2007 was vaccinated with her second dose of GARDASIL.  Subsequently the patient experienced an abnormal pap at an unknown date.  The patient sought unspecified medical treatment.  The nurse noted that the patient has not returned for her third dose yet.  No other information was provided.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female who on 07-JAN-2008 was vaccinated with the first dose of GARDASIL (lot number not provided) and on 25-FEB-2008 was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot number not provided). Concomitant therapy included ORTHO EVRA. The patient experienced dizziness after receiving her first dose of GARDASIL. The dizziness started 1 hour after vaccination and resolved in 2 hours without requiring treatment. The patient experienced nausea starting 20 minutes after receiving her second dose. The patient vomited twice at home after eating toast. The patient called the office to report the reaction and was advised to increase fluid intake. The nurse practitioner added that the patient, who works in a day care center, had recently been exposed to suspected cases of influenza. Medical attention was sought by phone call to the office. At time of reporting, patient outcome was not recovered. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal symptom
Clinical narrative: Information has been received from a female consumer with a thyroid problem who was vaccinated with her 1st dose of GARDASIL (lot# not provided). Concomitant therapy included YASMIN BAYER and SYNTHROID. Subsequently the patient experienced abdominal problems after receiving her first vaccination. It was reported that the patient was treated with a course of antibiotics for 3 weeks and had some unspecified test done. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a health professional concerning a 16 year old female who on approximately 19-FEB-2008 was IM vaccinated with Gardasil (lot number unspecified).  The physician advised the patient to "sit for about 15 minutes", but the patient got up about 5 minutes after being vaccinated in order to make another appointment.  On approximately 19-FEB-2008 the patient passed out at the appointment desk shortly after administration.  Subsequently, the patient recovered before leaving the office.  No further information was provided.  No lot number was given.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 14 year old female who was IM vaccinated with her first dose of GARDASIL (lot number unspecified).  Concomitant therapy included MENACTRA in a different arm.  On 26-FEB-2008 the patient experienced hives in the area below the injection site.  The patient sought medical attention by contacting the physician.  Subsequently, the patient recovered from hives at an unknown date.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Contraception, Dizziness, Drug exposure during pregnancy, HIV test, Pregnancy test
Clinical narrative: Information has been received from a consumer, for the Pregnancy Registry for Gardasil, concerning her 16 year old daughter who on 04-OCT-2007 was vaccinated with a first dose of Gardasil (lot number not provided).  Concomitant therapy included DEPO-PROVERA.  On 04-OCT-2007, after the first dose, the patient's mother reported that the patient felt like she was going to faint and developed a rash on her arms and hands.  Subsequently, the patient recovered (date not specified) from feeling faint and rash on her arms and hands.  Sometime in December 2007, the patient was vaccinated with a second dose of Gardasil (lot number not provided).  The patient's mother reported that the patient is now "approximately 23 and a half weeks" pregnant (estimated LMP is 13-Sep-2007).  On 27-Feb-2007 the patient had an ultrasound performed, which was negative for fetal anomaly.  Unspecified medical attention was sought.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/14/2008. Follow up information received on 23-Jan-2009 from the physician's office. The reporter stated that the patient delivered a healthy normal baby girl, vaginally, weighing 6 lb .5 oz on 15-Jun-2008. The patient/mother developed a "fever" (Temp. not specified) after the delivery, but it resolved and the patient was discharged at the regular time, her stay was extended. The baby was fine". Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Ultrasound scan normal
Clinical narrative: Information has been received from a consumer, for the Pregnancy Registry for Gardasil, concerning her 16 year old daughter who on 04-OCT-2007 was vaccinated with a first dose of Gardasil (lot number not provided).  Concomitant therapy included DEPO-PROVERA.  On 04-OCT-2007, after the first dose, the patient's mother reported that the patient felt like she was going to faint and developed a rash on her arms and hands.  Subsequently, the patient recovered (date not specified) from feeling faint and rash on her arms and hands.  Sometime in December 2007, the patient was vaccinated with a second dose of Gardasil (lot number not provided).  The patient's mother reported that the patient is now "approximately 23 and a half weeks" pregnant (estimated LMP is 13-Sep-2007).  On 27-Feb-2007 the patient had an ultrasound performed, which was negative for fetal anomaly.  Unspecified medical attention was sought.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/14/2008. Follow up information received on 23-Jan-2009 from the physician's office. The reporter stated that the patient delivered a healthy normal baby girl, vaginally, weighing 6 lb .5 oz on 15-Jun-2008. The patient/mother developed a "fever" (Temp. not specified) after the delivery, but it resolved and the patient was discharged at the regular time, her stay was extended. The baby was fine". Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the first dose GARDASIL (lot# not provided). Per the reporter, after receiving the first dose of GARDASIL the patient experienced dizziness. The patient sought unspecified medical attention. No further information was provided. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site swelling, Oedema peripheral, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 16 year old female who was vaccinated IM (date not provided) with a first dose of Gardasil (lot # not specified).  It was reported that the patient experienced some swelling after the first dose however it was not as severe as after the 2nd dose.  The patient received her 2nd IM dose (date not provided) of Gardasil (lot # not specified) and immediately after "got a little knot/swelling at the injection site" and a couple days later the upper arm and under the arm area was swollen.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female who on 15-FEB-2008 was vaccinated with her second dose of GARDASIL (lot #659653/1448U).  On 22-FEB-2008 the patient experienced 1.5 to 2 cm "firm mass" at the injection site.  The patient sought unspecified medical attention by contacting nurse.  It was reported that the patient was treated with an antibiotic (unspecified).  At the time of this report the outcome was unknown.  No other information was provided.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a health professional concerning a 21 year old female with urinary tract infection who on 16-NOV-2007 was vaccinated with her first dose of Gardasil.  On 22-Feb-2008 the patient was vaccinated with her second dose of Gardasil (Lot # 659657/1487U).  Concomitant therapy included BACTRIM for the urinary tract infection.  On 23-FEB-2008 the patient experienced hives.  She was seen in the office on 24-Feb-2008 and prescribed Benadryl, Zyrtec, and Zantac.  Patient will be seen by dermatologist for possible allergy to Bactrim.  Additional information has been requested. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 23 year old female who on 19-FEB-2008 was vaccinated in the right deltoid with the first dose of GARDASIL (659655/1486U). Concomitant therapy included ADACEL. On 19-FEB-2008 the patient experienced fever, nausea, vomiting and profound fatigue. Treatment included increased fluids and BRAT diet as tolerated. TYLENOL was prescribed for fever as needed. As of 21-FEB-2008, the patient was recovering. Subsequently, the patient recovered on 22-Feb-2008. Additional information has been requested. No further information is expected.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Lip swelling, Oedema peripheral, Rash generalised
Clinical narrative: Information has been received from a physician concerning a female with who was vaccinated with Gardasil (Lot # not provided).  Concomitant therapy included MENACTRA and hepatitis A virus vaccine (unspecified).  Per the reporter, 1 day post-vaccination the patient experienced an entire body rash, swollen lips and swollen feet.  The patient sought unspecified medical attention.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/14/2008. Additional information received from B-form (31-Mar-2008): The patient was vaccinated IM in the right arm with the first dose of GARDASIL vaccine (lot#: reported as 1448U) on 15-FEB-2008. On 17-FEB-2008, the patient experienced hives, swollen hands, feet and lower lip. Additional information has been requested
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a health professional concerning a 15 year old female with a history of penicillin allergy and sulfonamide allergy who on 01-DEC-2007 was vaccinated with the first dose of GARDASIL (Lot # not provided).  Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLEN LO).  On 01-DEC-2007 the patient experienced hives at the injection site.  On 16-FEB-2008 the patient was vaccinated with the second dose of GARDASIL (659657/1487U).  Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLEN LO).  On 16-FEB-2008 the patient experienced a severe case of hives that covered her from the waist up and both arms.  The patient sought unspecified medical attention.  The patient was given diphenhydramine hydrochloride (BENADRYL) and the hives resolved.  No additional information is available.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Gaze palsy, Immediate post-injection reaction, Syncope, Tremor
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 15 year old female who on 14-FEB-2008 was vaccinated IM with the first dose of Gardasil (659962/1740U).  On 14-FEB-2008, about 2 -3 minutes after receiving the vaccine the patient "rolled back her eyes, got pale, fainted and trembled a little bit." The patient was out for approximately 3 - 5 seconds. "About 5 minutes later the patient recovered."  No further information was provided.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Catatonia, Gaze palsy, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 22-DEC-2007 was IM vaccinated with her first dose of GARDASIL (lot number unspecified). On 22-DEC-2007, about 5 minutes after the vaccination, the patient got stiff, her eyes rolled back, she had a catatonic reaction and passed our for about a minute or two. Subsequently, the patient recovered completely on 22-Dec-2007. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed, Pregnancy test negative
Clinical narrative: Information has been received from a physician concerning a 19 year old female with a history of ovarian cysts who sometime in December 2007 was vaccinated with the first dose of Gardasil.  In December the patient's period came approximately 3 weeks late.  A pregnancy test was done and the patient was not pregnant.  The patient sought unspecified medical attention.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Oral herpes
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter with no medical history or allergies reported, who was vaccinated intramuscularly with a second 0.5 ml dose of Gardasil.  There was no concomitant medication reported.  Subsequently, the patient experienced a severe case of fever blisters after receiving the second dose of Gardasil.  The patient was not seen by a physician for the outbreak.  At the time of this report the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Headache, Nuclear magnetic resonance imaging, Physical examination
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter with a seasonal allergies and a medical history of an appendicectomy (date not reported), who on 19-OCT-2007 was vaccinated with the first dose of GARDASIL.  Concomitant therapy included cetirizine hydrochloride (ZYRTEC) and an influenza virus vaccine (unspecified).  Subsequently, in October 2007, within two weeks after receiving her first dose of GARDASIL, the patient began to experience headaches that lasted all day.  The patient went to her pediatrician, whose name was unspecified, and told the patient to get more sleep and become more hydrated.  The patient also went to a chiropractor.  After following the pediatrician's recommendations the headaches still persisted and the patient then sought the medical attention of a neurologist.  The neurologist scheduled an MRI, performed a complete physical and diagnosed the patient with "NDPH, which stands for New Daily Persistent Headache."  The consumer also reported that the neurologist stated, "these headaches could come from a virus."  The consumer contacted the pediatrician to see if the patient had any previous illness, which she had not.  The consumer informed the neurologist that her daughter had the GARDASIL vaccine and a flu shot.  The neurologist was not sure if this could be the cause of the headaches.  The consumer stated that if the headaches keep persisting, she may have to take the patient to the hospital.  At the time of this report the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site anaesthesia, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female with attention deficit/hyperactivity disorder and allergic rhinitis who on 04-FEB-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included MENACTRA, tuberculin purified protein derivative and hormonal contraceptives (unspecified). On 06-FEb-2008 the patient experienced pain, swelling, warmth and numbness at the injection site. The patient sought unspecified medical attention. No diagnostic laboratory studies were performed. The patient was treated with BENADRYL. At the time of this report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a female (age not specified) who was vaccinated with her first dose of GARDASIL on an unspecified date (lot number, route and site of administration were not specified).  Concomitant therapy included MENACTRA on the same visit.  Three days after getting the first dose the patient developed hives in both arms and legs.  Unspecified medical attention was sought.  The patient recovered on an unspecified date.  Additional information has been requested. Initial and follow up information has been received from a physician concerning a 17 year old female with no reported medical history and no illness at the time of vaccination who was vaccinated with her first dose of GARDASIL (lot #658563/10630) in the left arm. Concomitant therapy included MENACTRA (Lot #U2419AA) in the right arm on the same visit. On 12-OCT-2008 the patient developed hives on her legs and swollen hands, which lasted about 24 to 48 hours. Unspecified medical attention was sought. The mother gave her BENADRYL. The patient recovered. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: DTAP, HPV4, MEN
Symptoms: Inappropriate schedule of drug administration, Tonsillar hypertrophy
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 14-AUG-2007 was vaccinated with her first 0.5ml dose of Gardasil (lot# unspecified).  Concomitant therapy included MENACTRA and Tdap.  It was reported that after receiving her first dose of Gardasil the patient had swollen tonsils.  Unspecified medical attention was sought.  The patient's swollen tonsils persisted.  No further information was provided.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome, Upper respiratory tract infection
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on approximately 27-AUG-2007 was vaccinated IM with a 0.5 ml first dose of GARDASIL. On approximately 27-JAN-2008 the patient developed an upper respiratory infection. On approximately 13-FEB-2008 the patient developed Guillain-Barre syndrome and was hospitalized. The patient was discharged from the hospital to a rehabilitation center. At the time of the report, the patient had not recovered. The reporting physician felt that GARDASIL vaccination "has nothing to do with the patient's diagnosis." No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Pain
Clinical narrative: Information has been received from a certified nurse practitioner concerning a 26 year old female with no medical history, who in June 2007, was vaccinated IM with a first dose of GARDASIL (Lot# 658554/0928U). There was no concomitant medication. Subsequently, the patient experienced pain. On an unspecified the patient was vaccinated with a second dose of GARDASIL. Subsequently, the patient experienced pain. On 20-FEB-2008 the patient was vaccinated with a third dose of GARDASIL. Immediately post vaccination the patient experienced extreme pain at the injection site that was much more painful then after the first and second. The patient did not seek medical attentio. Laboratory diagnostics were performed. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody, Arthralgia
Clinical narrative: Information has been received from a physician concerning a 17 year old female, who, on an unspecified date, was vaccinated with a 0.5mL first dose of Gardasil.  Subsequently, the patient experienced severe joint pain.  The patient sought unspecified medical attention.  A serum antinuclear antibodies test was performed.  At the time of the report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Obsessive-compulsive disorder, Paranoia
Clinical narrative: Information has been received from a physician concerning a 14 year old female with no medical history and no drug allergies, who on 13-SEP-2007 was vaccinated with a first dose of GARDASIL. Concomitant therapy included clonazepam for "sleep." Subsequently, post vaccination the patient experienced obsessive compulsive behavior. It was reported that the patient was checking doors and under the bed. The patient began to recover until  the second dose. On 20-NOV-2007 the patient was vaccinated with a second dose of GARDASIL. Subsequently, after the second dose of the patient had a more severe reaction. The patient experienced paranoid behavior. It was also reported that the patient had began her menses after the second dose of GARDASIL. The patient was referred to a psychiatrist and was placed on PROZAC. It was reported that the patient's symptoms had improved. However, the psychiatrist did not believe that the patient had been taking the PROZAC long enough for the improvement to be from the treatment. The patient's mother believed that the patient had improved because time had passed since she had received the second dose GARDASIL. The patient spoke with physician. At the time of the report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cyanosis, Head injury, Loss of consciousness
Clinical narrative: Information has been received from a medical assistant concerning an "approximately 16 to 17 year old" female, who in August 2007, was vaccinated with "either the first or second dose of" GARDASIL. There was no concomitant medication. The patient left the office after the vaccination and passed out in the parking lot and hit her head on the asphalt. The patient's father called the office and one of the medical assistant's came down to the parking lot where the patient passed out. It was reported by the medical assistant that the patient returned to the office on an unspecified date and received "either a second or third dose" of GARDASIL. The office made the patient lie down post vaccination. Subsequently, the patient turned blue. The patient sought unspecified medical attention. No laboratory diagnostics were performed. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information has been requested.