chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 13 year old female who on 15-APR-2008 was vaccinated intramuscularly with a 0.5 mL dose of GARDASIL (lot # not reported). Subsequently, on 16-APR-2008 the patient experienced severe headaches and vomiting. It was reported that the patient sought medical attention in a phone call to the physician. Additional information has been requested. This is in follow-up to report previously submitted on 5/14/2008; 7/8/2008. Information has been received from a physician concerning a 16 year old female previously reported as 13 years old) with nk known drug allergies who on 17-APR-2008 (previously reported as 15-APR-2009 was vaccinated intramusculary in the left deltoid with a 0.5ml first dose of GARDASIL (lot# 660391/0063X). On 17-ARR-2008 (previously reported as 16-APR-2008), at 11:00 am, the patient developed severe headaches, nausea and vomiting that lasted for 1 day. It was reported that there was no local redness or swelling. The patient sought medical attention in a phone call to the physicians and recovered the next day. No further information is expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Exfoliative rash, Injection site rash, Rash, Rash erythematous, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on 08-APR-2008 was vaccinated with her second dose of GARDASIL (lot# not provided).  On 10-APR-2008 the patient experienced a rash at the injection site, rash on her chest and rash on her abdomen.  The rash was a scaly red rash with vesicles.  The patient feels well and was afebrile.  The patient was being seen at the urgent care center.  The patient's rash at the injection site and rash on her chest and rash on her abdomen persisted.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a medical assistant concerning a female (age unknown) who on unknown dates was vaccinated (route unknown) with a first and second dose of GARDASIL (Lot # 's unknown). Subsequently, unspecified dates, the patient experienced mild pain at injection site after 1st dose and severe pain at injection site after 2nd dose. Subsequently, on an unknown date, the patient recovered. Unspecified medical attention was sought at the time of the vaccination. The physician gave the patient TYLENOL in the office after the second dose. No product quality control was involved. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 16 year old female patient with no known allergies who on an unspecified date, was vaccinated with 0.5 ml of a second dose of GARDASIL (lot# 659439/1267U), fainted and was pale post vaccination. Subsequently, the patient receovered from her experienced. No other information available. This is one of several reports from the same source. No further ifnormation available. The physician was not certain if the event occurred after the patient's first or second dose of GARDASIL but knew it was definitely not with administration of the third dose.  Additional information has been requested.  This is one of several reports from the same source.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated intramuscularly with GARDASIL (lot # not reported).  Subsequently, the patient fainted.  The patient sought unspecified medical attention.  This is one of several reports received from the same source.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated intramuscularly with GARDASIL (lot # not reported). Subsequently, the patient fainted. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Medical device complication, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 19 year old female with unknown medical history, who on 04-APR-2008 was vaccinated (route unknown) with a second dose of GARDASIL (Lot # 655604/0052X).  The date and the lot number of the first vaccination were not reported.  The physician reported that the patient was "stuck" twice with two different prefilled syringes, because the first syringe did not function properly and did not release the vaccine.  The patient reported arm pain to the physician.  No laboratory diagnostic studies were performed.  The patient sought unspecified medical attention at the physician's office.  Subsequently, on an unspecified date the patient recovered.  This is one of several reports from the same source.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, IPV, MNQ, HPV4, IPV, MNQ
Symptoms: Anxiety, Conversion disorder, Psychomotor hyperactivity, Syncope, Tremor
Clinical narrative: Information has been received from a physician concerning a 17 year old female who was vaccinated on an unspecified date with GARDASIL (lot# not provided). Concomitant therapy included MENACTRA and poliovirus vaccine. Subsequently the patient fainted after receiving the vaccines. When she came to she had a "conversion reaction" where she was anxious, shaky and hyperactive. The patient was taken to the ER, but was not admitted. Subsequently, the patient recovered from fainting, being anxious, shaky and hyperactive. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, IPV, MNQ, HPV4, IPV, MNQ
Symptoms: Syncope, Syncope vasovagal
Clinical narrative: Information has been received from a physician concerning a 17 year old female who was vaccinated on an unspecified date with GARDASIL (lot# not provided). Concomitant therapy included MENACTRA and poliovirus vaccine. Subsequently the patient fainted after receiving the vaccines. When she came to she had a "conversion reaction" where she was anxious, shaky and hyperactive. The patient was taken to the ER, but was not admitted. Subsequently, the patient recovered from fainting, being anxious, shaky and hyperactive. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated intramuscularly on an unspecified date with GARDASIL (lot# not reported). Subsequently the patient experienced a syncope episode. The patient had also experienced syncope at another patient visit when she received a different vaccine. Her outcome was not reported. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated IM with a third 0.5 ml dose of GARDASIL.  Subsequently the patient experienced abnormal Pap test.  At the time of this report, the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain lower
Clinical narrative: Information has been received from a physician concerning a 13 or 14 year old female who in January 2008, was vaccinated with the first dose of GARDASIL (Lot number not provided).  In January 2008, the patient developed pain in right lower quadrant.  The patient went to the ER but was not admitted.  The series of doses was discontinued.  Patient outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort
Clinical narrative: Information has been received from medical assistant concerning a 19 year old female with no previous medical history and no known drug allergies, who on 08-FEB-2008 was vaccinated IM with the first dose of GARDASIL (Lot # 660387/1967U). There was no concomitant medication. The patient developed chest tightening that started after she left the office the same day she received the dose of vaccination. Unknown medical attention was sought in the office. The patient did not report the event until she arrive for her second dose of GARDASIL, which she did not receive. Patient outcome was recovered on an unknown date. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Dyspnoea, No reaction on previous exposure to drug, Pruritus, Rash
Clinical narrative: Information has been received from a office manager concerning a 17 or 18 year old female with breathing issues and unspecified allergies and no known drug allergies who on 19-FEB-2008 was vaccinated with the first dose of GARDASIL (Lot# 658488/1264U).  On 16-APR-2008, the patient was vaccinated with the second dose of GARDASIL (Lot # 660387/1967U).  There was no concomitant medication.  Twenty four hours after the second dose of the vaccine, the patient was itchy, had a rash on the body and breathing difficulty.  Patient did not experience any problems after the first dose of the vaccine.  Patient outcome was recovered on an unknown date.  Unknown medical attention was sought in the office.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on 17-APR-2008 was vaccinated with a dose of GARDASIL. Concomitant therapy included MOBIC and antifugal (unspecified). On 18-APR-2008 the patient experienced rash on face. Unknown medical attention was sought with the nurse practitioner. Patient outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction, Pallor, Rash papular
Clinical narrative: Information has been received from a nurse concerning a 15 year old female with a history of scarring from a motor vehicle accident and no known drug allergies who on 06-OCT-2007 was vaccinated IM in the left arm with the first dose of GARDASIL.  There was no concomitant medication.  On 06-OCT-2007 the patient experienced injection site reaction described as covering a 2 to 3 inch area around the injection site that was blanched with small pea sized elevations.  The reaction occurred several hours after the injection and lasted for about 2 months.  The rash subsided without any treatment.  The patient reported the reaction about six months after receiving the vaccination.  No other symptoms reported.  Unknown medical attention was sought in the office.  No product quality complaint was involved.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Medical device complication, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 21 or 22 years old female with unknown medical history, who on 04-APR-2008 was vaccinated (route unknown) with a second dose of GARDASIL (Lot # 655604/0052X). The date and lot number of the first vaccination were not reported. The physician reported that the patient was "stuck" twice with two different prefilled syringes, because the first syringe did not function properly and did not release the vaccine. The patient reported arm pain to the physician. No laboratory diagnostic studies were performed. The patient sought unspecified medical attention at the physician's office. Subsequently, on an unspecified date the patient recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Injection site pain, Syncope
Clinical narrative: Information has been received from a mother concerning her 16 year old daughter with a sulfonamide allergy who on approximately 17-DEC-2007 was vaccinated with her first dose of GARDASIL (lot# not reported) and fainted.  She also experienced headaches and injection site pain.  Subsequently, the patient recovered from fainting, headaches and injection site pain after a couple days.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Nausea
Clinical narrative: Information has been received from a 25 year old female who was vaccinated on unspecified dates with the first and second doses of GARDASIL (lot #'s not reported) and experienced nausea, pain and itching at the injection.  About one month later she developed a "knot" at the injection site that lasted for about 2-3 months.  After getting the third dose of GARDASIL (lot # not reported) she did not have any adverse reactions.  The first two doses were given by the same nurse and the third dose was given by another nurse at the same office.  Subsequently, the patient recovered from nausea, pain, itching at the injection site and knot at the injection site.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a health professional from an OB/GYN office concerning a female who on 28-JAN-2008 was vaccinated IM with a 0.5 ml first dose of GARDASIL. On 02-Apr-2008 the patient was vaccinated IM with a 0.5 ml second dose of GARDASIL. On 07-APR-2008 the patient developed rash on her arms and legs. At the time of reporting the patient's rash was spreading. The patient went to primary care physician. At the time of reporting the patient had not recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test normal, Menstruation delayed, Pregnancy test negative
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 30-Nov-2007 was vaccinated IM in the right arm with the first dose (lot# 658490/0802U) and on 30-Jan- 2008, vaccinated IM in the left arm with the second dose of GARDASIL (lot# 658490/0802U). Concomitant therapy included MENACTRA (lot# 42375BA) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (lot# AC52B019AA). After the first dose the patient did not get her period for four months. She was on no medication at that time. Negative labs and negative pregnancy test. On 14-Apr-2008 she had her period. The patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with GARDASIL (lot # not reported). Subsequently the patient experienced severe headaches. The physician reported that he did not believe that this experience was related to therapy with GARDASIL. The patient sought unspecified medical attention. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised
Clinical narrative: Information has been received from a nurse concerning a 15 year old white female student who on 09-APR-2008 at 10 am was vaccinated in the right deltoid with the second dose of GARDASIL (Lot # 659964/1978U).  Concomitant therapy included TRINESSA.  The patient's mother called office indicating that on 11-APR-2008 the patient experienced generalized itching, site not reddened and no rash.  The patient recovered on 14-APR-2008.  No product quality complaint was involved.  Additional information has been requested. This is a follow-up to report (s) previously submitted on 5/14/2008- Initial and followup information has been received from a nurse concerning a 15 year old female student who was vaccinated with the first dose of GARDASIL on 07-JAN-2008.  On 09-APR-2008 at 10 am the patient was vaccinated in the right deltoid with the second dose of GARDASIL (Lot # 659960/1987U).  Concomitant therapy included TRINESSA.  The patient's mother called office indicating that on 11-APR-2008 the patient experienced generalised itching, site not reddened, looks fine, and no rash.  The patient was given ZYRTEC and had some relief. The office recommended BENADRYL and to go in the ER if the reaction worsens. The office called to check on 14-APR-2009 with no response from the patient. The patient recovered on 14-APR-2008.    Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Incorrect route of drug administration, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL IM. On approximately 18-APR-2008 was vaccinated with a second dose of GARDASIL IM. The patient received the first dose of vaccine in her arm and experienced so much pain that for her second dose the physician injected it in her back. The patient experienced the same pain in her back as she did in her arm. The outcome of the event was not reported. No further information is available.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Blood creatine phosphokinase increased, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered  nurse concerning a 28 year old female who in October 2006, was vaccinated  intramuscularly with the third 0.5 mL dose of GARDASIL (Lot # 653650/0702F). The nurse reported that the patient received the three dose series of GARDASIL. Concomitant therapy included influenza virus vaccine (unspecified). In December 2006, the patient experienced swelling around her knuckles. It was reported that she also saw a rheumatologist sometime in 2007. Diagnostic laboratory testing performed included creatine phosphokinase was 2096, glutamic-oxaloacetic transamine, was 59; gultamic-pyruvic transaminase was 55, alkaline phosphatase was 37. At the time of this report the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a registered  nurse concerning a 28 year old female who in October 2006, was vaccinated  intramuscularly with the third 0.5 mL dose of GARDASIL (Lot # 653650/0702F). The nurse reported that the patient received the three dose series of GARDASIL. Concomitant therapy included influenza virus vaccine (unspecified). In December 2006, the patient experienced swelling around her knuckles. It was reported that she also saw a rheumatologist sometime in 2007. Diagnostic laboratory testing performed included creatine phosphokinase was 2096, glutamic-oxaloacetic transamine, was 59; gultamic-pyruvic transaminase was 55, alkaline phosphatase was 37. At the time of this report the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2000. Information has been received from a certified medical assistant concerning a 15 year old female patient with a sulfonamide allergy, who in June 2007, August 2007 and December 2007 was vaccinated intramuscularly with the first, second and third dose 0.5 ml doses of GARDASIL (Lot # first dose 0469U, second dose 0530U and third dose 0530U), respectively. On 29-SEP-2007, after her second dose of GARDASIL, she had an abnormal pap of atypical squamous cells. The patient went to the physicians office for a pap and follow up. She also had a colposcopy that identified HPV types: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. At the time of this report the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. Follow up information received indicated that there was no adverse event. The patient's father thought that by getting the vaccine it would expose his daughter and therefore give a false positive. The certified medica assistant was just seeking additional information. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Somnolence
Clinical narrative: Information has been received from a consumer concerning her 21 year old daughter with no medical history or allergies reported, who on 29-FEB-2008 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. On 29-FEB-2008, after receiving her first dose, the patient became very sleepy and developed a rash across her breast line and under her neck. The patient sought unspecified medical attention with a gynecologist. At the time of this report the patient's outcome was not recovered. No product quality complaint was involved. No further information is available.
Age: 64.0
Sex: F
Vaccine: HPV4
Symptoms: Deafness unilateral, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician's wife concerning a 64 year old female who in November 2007 and February 2008 was vaccinated with the first and second doses of GARDASIL, respectively. There was no concomitant medication. Subsequently, after receiving the second dose, the patient experienced hearing loss in the right ear. The patient sought unspecified medical attention. The patient did not experience any problems after the first dose. The patient's date of birth and vaccine were verified. At the time of this report the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site mass
Clinical narrative: Information has been received from a pharmacist concerning a 30 year old female physician who in April 2008, was vaccinated intramuscularly with the second dose of GARDASIL.  On approximately 08-APR-2008, "about two weeks ago," the patient developed a cyst like lump at the injection site.  The patient sought unspecified medical attention.  At the time of this report the patient not recovered.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a dose of GARDASIL. Subsequently the patient fainted after receiving GARDASIL. On an unspecified date the patient recovered. No product quality complaint was involved. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy test, Urticaria
Clinical narrative: Information has been received from a consumer concerning her 12 year old daughter with a penicillin allergy, who on 22-FEB-2008 was vaccinated with the first dose of GARDASIL (Lot # 654272/0073x). There was no concomitant medication. On 22-FEB-2008, approximately one hour post vaccination, the patient developed hives or her legs. The patient sought unspecified medical attention. Diagnostic testing included testing for yeast allergy with no results reported. On 22-FEB-2008 the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, PPV
Symptoms: Allodynia, Hyperaesthesia
Clinical narrative: Information has been received from a pharmacist concerning her 11 year old daughter with allergic reaction to AUGMENTIN who on 21-APR-2008 was vaccinated into the arm (which arm not specified) with a dose of GARDASIL.  Concomitant suspect therapy included PNEUMOVAX 23 (manufacturer unknown) into the other arm.  The reporter reported that on 22-APR-2008, her daughter experienced allodynia or hyperestesia on the left thigh.  She sought medical attention from her physician father.  The patient had not recovered.  No other details available.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Culture, Urticaria
Clinical narrative: Information has been received from a physicianand a health professional concerning a 170 pound, 64 inch, 24 year old caucasian female pharmacy technician with no pre-existing allergies, birth defects, medical conditions, or illness at time of vaccination who was vaccinated with a dose of GARDASIL. The physician reported that the patient out in hives after she got the dose GARDASIL (lot #654272/0073X). IM to the deltoid on 01-APR-2008, at 5:00PM. It was reported that patient received her injection at a pharmacy and a family member who was a nurse administered the vaccination. The physician and health professional reported that the patient brkoe out in hives, itching, whelps, and a rash on 02-APR-2008 after she got the dose of Gardisil. The patient sought medical attnetion via a doctor visit. A culture of the pus from the welps was taken and was positive for a staph infection. The patient reportedly recovered on 06-APR-2008. No treatment information was provided. A standard lot check investigation was performed. All in-process quality checks for thw lot number in question were satisfactory. Inaddition, an expanded lot check investigation was performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No additional information is expected. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Vaginal discharge
Clinical narrative: Information has been received for Merck Pregnancy Registry for GARDASIL vaccine from a Registered Nurse (R.N.) concerning an 18 year old female patient who had received first and second dose of GARDASIL.  It was reported that the second vaccination was given in January or February, 2008.  The patient was tested positive on a home pregnancy urine test and sought treatment with the obstetrical provider on 22-APR-2008 who reported this report.  It was reported that patient's last menstrual period was on "22-DEC-2008".  She was due to be examined on 25-APR-2008 for vaginal discharge that the patient described as "leaking".  No adverse symptoms were reported.  No other information was available.  Patient's outcome was unknown.  Additional information has been requested.  This is in follow-up to report (s) previously submitted on 5/14/2008.  Follow-up information was received from a health professional. It was reported the patient with no previous pregnancies on 06-MAY-2008 had an ultrasound done for screening and the comments was within normal limits. On 01-OCT-2008 (40 and 3/7 weeks from LMP) the patient delivered a normal healthy female baby whose weight was 7 lbs 10 ounces and the Apgar score was 8/9. No further information was available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count, Lymphadenopathy, Tenderness
Clinical narrative: Information has been received from a physician concerning his 16 year old granddaughter with no medical history and no drug allergies, who, on an unspecified date, was vaccinated with a third dose of GARDASIL. There was no concomitant medication. Subsequently, the patient experienced cervical lymphadenopathy of the left side and the area was tender. The patient was seen by the physician. A complete blood count 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: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Dyspnoea, Eye swelling, Fatigue, Malaise
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter who, on an unspecified date was vaccinated with her second dose of GARDASIL (Lot # and site not reported). Subsequently the patient experienced swelling, pain when being touched or taking a shower, joint pain, muscle weakness, nausea, difficulty breathing, general tiredness, congestion, eye redness, eyes swelling shut. It was reported "the swelling seems to come and go in different places". She has also experienced throat pain, and throat tightness. The mother reports "she hasn't felt well since the second dose  of GARDASIL.The mother also reported that her daughter is still experiencing "hurtful swelling and pain to her arms. She can not stay in school she hurts so bad." No further information was provided. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness, Nausea, Ocular hyperaemia, Pain, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter who, on an unspecified date was vaccinated with her second dose of GARDASIL (Lot # and site not reported). Subsequently the patient experienced swelling, pain when being touched or taking a shower, joint pain, muscle weakness, nausea, difficulty breathing, general tiredness, congestion, eye redness, eyes swelling shut. It was reported "the swelling seems to come and go in different places". She has also experienced throat pain, and throat tightness. The mother reports "she hasn't felt well since the second dose  of GARDASIL.The mother also reported that her daughter is still experiencing "hurtful swelling and pain to her arms. She can not stay in school she hurts so bad." No further information was provided. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Respiratory tract congestion, Swelling, Throat tightness
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter who, on an unspecified date was vaccinated with her second dose of GARDASIL (Lot # and site not reported). Subsequently the patient experienced swelling, pain when being touched or taking a shower, joint pain, muscle weakness, nausea, difficulty breathing, general tiredness, congestion, eye redness, eyes swelling shut. It was reported "the swelling seems to come and go in different places". She has also experienced throat pain, and throat tightness. The mother reports "she hasn't felt well since the second dose  of GARDASIL.The mother also reported that her daughter is still experiencing "hurtful swelling and pain to her arms. She can not stay in school she hurts so bad." No further information was provided. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Muscle contractions involuntary, Pallor, Tremor
Clinical narrative: Information has been received from a physician concerning a 23 year old female who on 23-APR-2008 was vaccinated with the first dose of GARDASIL, (Lot# 0151X), 0.5ml IM to the left deltoid. There was no concomitant medication or other pertinent medical history reported. The physician reported that "3 to 5 seconds post vaccination the client developed trembling of her face muscles which lasted for 6 seconds, and she was pale. This incident occurred just now and the physician observed it happening." The client reported to the physician" she could feel her face muscles shaking." At the tine of the report, the client was resting and being monitored. No product quality complaint was involved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Myalgia, Oral contraception
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female who on 21-APR-2008 was vaccinated with her first dose of GARDASIL (Lot # 660387/1967U).  Concomitant therapy included ORTHO-CYCLEN.  On 21-APR-2008 the patient experienced generalized muscle aches and dizziness.  The patient sought unspecified medical attention by contacting the nurse practitioner.  No further information was provided.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning "a number of patients" (ages not reported), who were vaccinated with GARDASIL (date, dose and route not reported). No concomitant medications or pertinent medical history were specified. "Physician reported that a number of patients stated that it hurt when receiving GARDASIL. The patients reported this after administration while still in the office. The outcome of the event was not reported. No product quality complaint was involved. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Dizziness, Headache, Hypoaesthesia, Neck pain, Pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female who on 03-APR-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # 659182/1757U). Concomitant therapy included MENOMUNE-A/C/Y/W-135). On 05-APR-2007, ("two days after vaccination") the patient experienced sensory changes, headaches, numbness and tingling in her arms and legs. By 19-APR-2008, the patients symptoms related to sensory changes, headaches, numbness and tingling in her arms and legs and numbness and tingling in her arms and legs were resolved. On 15-APR-2008 the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot # 659182/1757U). On 18-APR-2008 was she experienced generalized body aches and a sore throat. By 23-APR-2008 the patient experienced headaches, neck aches, numbness of head, dizziness and body aches. The patient's generalized body aches and sore throat and headaches and neck aches and numbness of head and dizziness and body aches persisted. The patient sought unspecified medical attention with an office visit. No further visit. No further was provided. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 5/14/2008.  Initial and follow-up information has been received from a nurse practitioner and a physician concerning a 17 year old female (218 lbs; 64.75 inches), with allergies to ALLEGRA and LEXAPRO who on 03-APR-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # 659182/1757U).  Concomitant therapy included MENOMUNE-A/C/Y/W-135.  On 05-APR-2007, ("two days after vaccination") the patient experienced sensory changes, headaches, numbness and tingling in her arms and legs.  On 15-APR-2008 the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot # 659182/1757U).  On 16-APR-2008, the patient had trouble thinking clearly, and experienced severe headaches for two weeks.  The patient was treated with 25 mg TOPAMAX at bedtime and "was resolved fairly quickly".  On 18-APR-2008 she experienced generalized body aches and a sore throat.  By 19-APR-2008, the patients symptoms related to sensory changes, headaches, numbness and tingling in her arms and legs and numbness and tingling in her arms and legs were resolved.  By 23-APR-2008 the patient experienced neck aches, numbness of head, dizziness and body aches.  On an unspecified date, the patient had an erythrocyte sedimentation rate performed which was within normal limits.  On an unspecified date in MAY 2008, the patient's trouble thinking clearly and severe headaches were resolved.  The patient's outcome related to the generalized body aches, sore throat, neck aches and numbness of head, and body aches was not reported.  No additional information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Paraesthesia, Pharyngolaryngeal pain, Red blood cell sedimentation rate normal, Sensory disturbance, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female who on 03-APR-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # 659182/1757U). Concomitant therapy included MENOMUNE-A/C/Y/W-135). On 05-APR-2007, ("two days after vaccination") the patient experienced sensory changes, headaches, numbness and tingling in her arms and legs. By 19-APR-2008, the patients symptoms related to sensory changes, headaches, numbness and tingling in her arms and legs and numbness and tingling in her arms and legs were resolved. On 15-APR-2008 the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot # 659182/1757U). On 18-APR-2008 was she experienced generalized body aches and a sore throat. By 23-APR-2008 the patient experienced headaches, neck aches, numbness of head, dizziness and body aches. The patient's generalized body aches and sore throat and headaches and neck aches and numbness of head and dizziness and body aches persisted. The patient sought unspecified medical attention with an office visit. No further visit. No further was provided. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 5/14/2008.  Initial and follow-up information has been received from a nurse practitioner and a physician concerning a 17 year old female (218 lbs; 64.75 inches), with allergies to ALLEGRA and LEXAPRO who on 03-APR-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # 659182/1757U).  Concomitant therapy included MENOMUNE-A/C/Y/W-135.  On 05-APR-2007, ("two days after vaccination") the patient experienced sensory changes, headaches, numbness and tingling in her arms and legs.  On 15-APR-2008 the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot # 659182/1757U).  On 16-APR-2008, the patient had trouble thinking clearly, and experienced severe headaches for two weeks.  The patient was treated with 25 mg TOPAMAX at bedtime and "was resolved fairly quickly".  On 18-APR-2008 she experienced generalized body aches and a sore throat.  By 19-APR-2008, the patients symptoms related to sensory changes, headaches, numbness and tingling in her arms and legs and numbness and tingling in her arms and legs were resolved.  By 23-APR-2008 the patient experienced neck aches, numbness of head, dizziness and body aches.  On an unspecified date, the patient had an erythrocyte sedimentation rate performed which was within normal limits.  On an unspecified date in MAY 2008, the patient's trouble thinking clearly and severe headaches were resolved.  The patient's outcome related to the generalized body aches, sore throat, neck aches and numbness of head, and body aches was not reported.  No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Inflammation, Smear cervix
Clinical narrative: Information has been received from an office manager concerning a female (age not reported), who was vaccinated with the 2nd dose of GARDASIL (Lot# not reported, dose, dates, and routes not reported). Concomitant medication and pertinent medical history were unspecified. On an unspecified date the patient developed "inflammation during a pap smear" right around the time she got her second dose of GARDASIL. Unspecified medical attention was sought. The outcome of the event was unspecified. No product quality complaint was involved. Additional information has been requested
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a health professional concerning a female who was recently vaccinated intramuscularly with her first dose of GARDASIL (lot# 659655/1486U).  Subsequently after the vaccination the patient felt woozy.  The patient sat down for a while in the office and recovered from being woozy.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain lower, Adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 or 15 year old female who on an unspecified date was vaccinated with her second dose of GARDASIL (lot #, route and site not reported). "A couple of days later" the patient developed "symptoms of appendicitis; right lower quadrant pain". The patient went to the emergency room and "was told her symptom was a known adverse event related to GARDASIL". The patient was not hospitalized and on an unspecified date recovered. The patient has been vaccinated with her third dose of GARDASIL and had no other symptoms. No other information was provided. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Contraception, Malaise, Myalgia, Pain, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a female who in December 2007, was vaccinated with her first dose of GARDASIL (lot# not reported).  Concomitant therapy included hormonal contraceptives (unspecified).  In February 2008, the patient was vaccinated with her second dose of GARDASIL (lot# not reported).  Subsequently, the patient experienced a fever of 101F and body aches.  The patient recovered from a fever of 101F and body aches after 2-3 days.  Additional information has been requested.  07/08/2008 This is in follow-up to report(s) previously submitted on 5/14/2008. Information and follow up has been received from a registered nurse concerning a 20 year old female who is allergic to codeine and CECLOR and has asthma who in December 2007, was vaccinated with her first dose of GARDASIL (lot# not reported). Concomitant therapy included hormonal contraceptives (unspecified). On 28-FEB-2008, the patient was vaccinated intramuscularly in the right deltoid with her second dose of GARDASIL (lot# 659435/1265U). Subsequently, the patient experienced a fever of 101F eight hours post injection lasting 24 hours accompanied by generalized malaise and myalgia. The fever, generalized malaise and myalgia spontaneously resolved with no further problems. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female who on 03-APR-2008 was vaccinated intramuscularly with her first dose of GARDASIL (lot# 0151X).  Concomitant therapy included PROZAC, SEROQUEL and YAZ.  On 03-APR-2008 the patient experienced a generalized pruritic erythematous rash.  She called the physician's office and was instructed to take BENADRYL 50 mg and ice the site of injection.  Subsequently, the patient recovered from generalized pruritic  erythematous rash after a few hours.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female who on 03-APR-2008 was vaccinated intramuscularly with her first dose of GARDASIL (lot# 0151X).  Concomitant therapy included PROZAC, SEROQUEL and YAZ.  On 03-APR-2008 the patient experienced a generalized pruritic erythematous rash.  She called the physician's office and was instructed to take BENADRYL 50 mg and ice the site of injection.  Subsequently, the patient recovered from generalized pruritic  erythematous rash after a few hours.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Dizziness
Clinical narrative: Information has been received from a Nurse concerning a 11 year old female who was vaccinated IM with a 0.5 ml first dose of GARDASIL (lot# 659655/1486U).  After the vaccination the patient said she felt anxious and light headed.  Unspecified medical attention was sought in the office.  The patient sat down for a while and recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Injection site pain, Pregnancy test positive, Ultrasound scan
Clinical narrative: Information has been received from a consumer, for the Pregnancy Registry for GARDASIL, concerning herself, a 23 year old female with a history of drug hypersensitivity to PAXIL who in December 2007 was vaccinated with a first dose of GARDASIL (lot# not reported).  On an unspecified date the patient was vaccinated 0.5mL, IM with a second dose of GARDASIL (lot# not reported).  Subsequently the patient became pregnant after her second dose (LMP approximately 12-MAR-2008, "1.5 to 2 months gestation").  On an unspecified date the patient had a pregnancy test and a sonogram.  Also, it was reported that the patient experienced soreness at the injection site after the second vaccination with GARDASIL.  The patient sought unspecified medical attention.  The patient outcome was not reported.  Additional information has been requested. Follow up information received from the registered nurse concerning the 23 year old female with depresion with a history of 1 pregnancy and 1 live birth and a history of anorexia. Concomitant therapy included ZOLOFT 50 mg in May 2008 and in October 2008 dose was swithced to 100 mg daily and prenatal vitamins since 24-APR-2008. The patient experienced preterm labor, left ovarian cyst, bacterial vaginitis (x2)  and GERD (2008). The GERD wsa treated with ZANTAC 150 mg BID, from 05-NOV-2008 to 25-NOV-2008 and PROTONIX 40 mg daily and the bacterial vaginitis was treated with FLAGYL 250 mg TID for 7 days reported on 18-JUN-2008 and 07-OCT-2008. An ultrasound was performed on 04-JUN-2008 for size and dates, the patient denied to perform a MSAFF. The patient had an ultrasound for anatomy scan on 08-AUG-2008 which was normal. On 18-DEC-2008, the patient delivered baby girl, weighing 7 pounds, 3 ounces, 19.5 inches.APGAR scores were 9/9. The patient was 39.1 weeks gestation at the time of delivery. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who was vaccinated with the first dose of GARDASIL (Lot number not reported).  Subsequently the patient developed redness on the injection site.  The patient sought medical attention by speaking with the nurse practitioner.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2008. Initial and follow-up information has been received from a nurse practitioner concerning a female patient who on 12-Mar-2008 was vaccinated with the first dose of GARDASIL vaccine (Lot number 654539/0890F).  Subsequently the patient developed redness, swelling, hives, and warm to the touch at the injection site. The nurse practitioner was unsure if she would be giving the patient a second dose since the patient developed hives. The nurse pratitioner may pre medicate the patient with BENADRYL prior to second dose. The patient sought medical attention by speaking with the nurse practitioner. Additional information has been requested.