chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Liver function test, Mycotic allergy, Paraesthesia oral, Pruritus
Clinical narrative: Information has been received from a physician concerning his 22 year old daughter with an allergy to "Kombuka" who on approximately 28-DEC-2006 was vaccinated with a first dose of Gardasil.  There were no concomitant medications.  On approximately 04-JAN-2007 within a week of vaccination the patient developed an oral food reaction while eating mussels.  Symptoms were described as discomfort at the back of the throat, itchiness, feeling as if the tongue was swelling, and difficulty swallowing.  It was noted that the tongue did not actually swell.  The patient was treated with BENADRYL.  Subsequently the patient recovered.  On 17-AUG-2007 the patient was vaccinated with a third dose of Gardasil.  Subsequently, the patient developed similar symptoms of tightening of the upper throat, discomfort, and flu-like symptoms.  The patient was treated with BENADRYL.  Subsequently, the patient recovered.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007.  Initial and follow-up information has been received from a physician concerning his 22 year old daughter with an allergy ot "Kombuka", unspecified food and pollen who on approximately 28-DEC-2006 was vaccinated with a first dose of GARDASIL.  There were no concomitant medication.  On approximately 04-JAN-2007 within a week of vaccination the patient developed an oral food reaction while eating mussels.  Symptoms were described as discomfort at the back of the throat, itchiness, feeling as if the tongue was swelling, and difficulty swalling.  It was noted that the tongue did not actually swell.  The patient was treated with BENADRYL. Subsequently the patient recovered.  On an unspecified date the patient was vaccinated with a second dose of GARDASIL.  Subsequently, the patient had a milder similar reaction and recovered.  On 17-AUG-2007 the patient was vaccinated with a third dose of GARDASIL.  Subsequenlty, the patient developed similar symptoms of difficulty swallowing, flushing and dizziness.  The episodes were self limited lasting 30-60 minutes occuring approximately 4-5 times over two weeks.  It was unrelated to other counts.  The patient was treated with oral BENADRYL and may have had a positive or negative response.  It was reported that the reactions were milder and similar to the reactions after the first and second doses.  It was thought to be a food allergy but probably wasn't.  The patient had 5 physicians visits:  2 primary care physician (PCP) visits, 2 allergist visits and and 1 ears nose and thoat (ENT) visit.  At the time fo the report the patient's outcome was unknown.  Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Seasonal allergy, Throat irritation, Throat tightness, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning his 22 year old daughter with an allergy to "Kombuka" who on approximately 28-DEC-2006 was vaccinated with a first dose of Gardasil.  There were no concomitant medications.  On approximately 04-JAN-2007 within a week of vaccination the patient developed an oral food reaction while eating mussels.  Symptoms were described as discomfort at the back of the throat, itchiness, feeling as if the tongue was swelling, and difficulty swallowing.  It was noted that the tongue did not actually swell.  The patient was treated with BENADRYL.  Subsequently the patient recovered.  On 17-AUG-2007 the patient was vaccinated with a third dose of Gardasil.  Subsequently, the patient developed similar symptoms of tightening of the upper throat, discomfort, and flu-like symptoms.  The patient was treated with BENADRYL.  Subsequently, the patient recovered.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007.  Initial and follow-up information has been received from a physician concerning his 22 year old daughter with an allergy ot "Kombuka", unspecified food and pollen who on approximately 28-DEC-2006 was vaccinated with a first dose of GARDASIL.  There were no concomitant medication.  On approximately 04-JAN-2007 within a week of vaccination the patient developed an oral food reaction while eating mussels.  Symptoms were described as discomfort at the back of the throat, itchiness, feeling as if the tongue was swelling, and difficulty swalling.  It was noted that the tongue did not actually swell.  The patient was treated with BENADRYL. Subsequently the patient recovered.  On an unspecified date the patient was vaccinated with a second dose of GARDASIL.  Subsequently, the patient had a milder similar reaction and recovered.  On 17-AUG-2007 the patient was vaccinated with a third dose of GARDASIL.  Subsequenlty, the patient developed similar symptoms of difficulty swallowing, flushing and dizziness.  The episodes were self limited lasting 30-60 minutes occuring approximately 4-5 times over two weeks.  It was unrelated to other counts.  The patient was treated with oral BENADRYL and may have had a positive or negative response.  It was reported that the reactions were milder and similar to the reactions after the first and second doses.  It was thought to be a food allergy but probably wasn't.  The patient had 5 physicians visits:  2 primary care physician (PCP) visits, 2 allergist visits and and 1 ears nose and thoat (ENT) visit.  At the time fo the report the patient's outcome was unknown.  Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Insomnia
Clinical narrative: Information has been received from a physician assistant concerning a 14 year old female with penicillin allergy who on 13-AUG-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil.  There was no concomitant medication.  On 13-AUG-2007 the patient experienced insomnia and has had trouble sleeping every night.  The patient took BENADRYL for a couple of nights to help sleep and it did help a little.  The patient has not been consuming caffeine.  There were no laboratory or diagnostic tests performed.  Unspecified medical attention was sought.  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse concerning several female patients who were vaccinated with doses Gardasil.  Subsequently the patients developed injection site pain.  Unspecified medical attention was sought.  At the time of the report the patients' outcomes were unknown.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Presyncope
Clinical narrative: Information has been received from a 25 year old female nurse practitioner with no medical history or allergies, who on 11-JUL-2007 in the morning, was vaccinated IM into the left arm with a third dose of Gardasil (Lot# 653735/0688F).  Concomitant therapy included hormonal contraceptives (unspecified).  Moments after receiving the vaccine, she became very lightheaded and experienced a near syncope episode.  No injury was reported.  She sat down to let the lightheaded feeling pass.  She did not completely pass out, but had a rush come over her to which she was not accustomed.  After one to two minutes the symptoms resolved.  It was reported that she felt fine after the experience was over.  It was reported that she did not have any symptoms with the previous two vaccinations.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Rash
Clinical narrative: Information has been received from a physician concerning a female with no allergies and a history of hirsutism who in June 2007, was vaccinated with 0.5 ml Gardasil intramuscularly.  Concomitant therapy included hormonal contraceptives (unspecified).  In June 2007, one week after administration of her first dose of Gardasil the patient developed a rash at the injection site on her arm which extended to her neck.  The patient did not experience any respiratory distress.  The rash resolved spontaneously without treatment.  The patient phoned the physician and did not undergo any lab studies.  The physician added that the patient also experienced an injection site reaction after she received an unspecified meningococcal vaccine.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a female who during the week of 05-AUG-2007 was vaccinated with 0.5mL Gardasil.  The patient became extremely dizzy after receiving Gardasil.  Subsequently, the patient recovered that same week.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Pyrexia, Throat lesion
Clinical narrative: Information has been received from a physician concerning a female who in June 2007, was vaccinated with her first dose of Gardasil, intramuscularly.  In June 2007, the patient experienced fever, swollen glands and "white platelets in her throat."  Subsequently, the patient recovered from fever, swollen glands and "white platelets in her throat."  The patient did receive her second dose on 12-AUG-2007 and the physician was waiting to hear from the patient to see if the AE reappeared.  The patient planned on completing the series.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pharyngolaryngeal pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 21 year old female who was vaccinated with Gardasil.  Subsequently, after the patient received the first dose of Gardasil (Lot #0522U), the patient experienced a sore throat and a low grade fever.  The patient subsequently recovered.  Following the second vaccination with Gardasil (Lot #0424U), the patient again developed a sore throat and low grade fever.  As of 21-AUG-2007, the patient had not recovered from the sore throat and low grade fever.  The patient sought medical attention for her experience.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Information has been received from a physician concerning a 20 year old female with a possible allergy to penicillin and environmental allergies who on 08-JUN-2007 was vaccinated with GARDASIL (Lot #0623U).  Concomitant therapy included ALLEGRA.  On approximately 15-JUN-2007, the patient experienced a red, hard lump at the injection site.  After two days, the patient recovered from the red, hard lump at the injection site.  The patient sought unspecified medical attention.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Asthma
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of Gardasil.  The physician reported that the patient experienced asthma after vaccination.  The physician also reported that the patient was "fine."  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 unknown date was vaccinated IM into the upper arm with an entire dose of Gardasil.  After vaccination, the patient experienced syncope.  Unspecified medical attention was sought.  On an unknown date, the patient recovered.  No product quality complaint was involved.  This is one of two reports from the same source.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 17 year old female with no pertinent medical history and no drug reactions/allergies who on 17-AUG-2007 was vaccinated with Gardasil.  There was no concomitant medication.  The day after administration of her first dose of Gardasil, on 18-AUG-2007, the patient developed widespread hives.  The patient had not experienced respiratory distress.  The patient presented to the physician's office for evaluation on 21-AUG-2007, but the details of the evaluation and the treatment plan were not provided by the physician.  As of 21-AUG-2007, the patient's widespread hives persisted.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with her second dose of Gardasil.  Subsequently, the patient called the physician to report that she experienced fever and rash on the arm (both considered non-serious by the physician).  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody positive, Rash pruritic
Clinical narrative: This is in follow-up to report (s) previously submitted on 9/17/2007. Information has been received from a Nurse Practitioner concerning a 25 year old female with no allergies and no pertinent medical history who on 26-JUN-2007 was vaccinated with 0.5 ml intramuscularly GARDASIL.  There was no concomitant medication.  On 03-JUL-2007 the patient had a rash that initially itched but did not anymore.  The rash was located on the arms and legs and the patient still had it.  The patient took 7 medications (one of which was a steroid, others were unspecified) to treat the rash.  The patient underwent 7 different blood tests which revealed a positive ANA.  As of 21-AUG-2007 the patient was recovering.  Additional information has been requested. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 17 year old white female student, with no previous medial history and no drug allergies, who on 19-JUN-2007 was vaccinated IM with a first dose of Gardasil.  The patient experienced no reaction after the first dose of Gardasil.  There was no concomitant medication.  On 20-AUG-2007 the patient was vaccinated IM with a second dose of Gardasil (lot # 658094/0524U).  There were no illnesses at the time of vaccination. On 20-AUG-2007 one and a half hours post vaccination, the patient was covered with a red pruitic rash over arms which spread to trunk (previously reported as rash).  Unspecified medical attention was sought.  No laboratory diagnostics were performed.  The patient was given diphenhydramine hydrochloride (BENADRYL).  On 21-AUG-2007, the patient recovered from rash.  Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Breast discharge, Breast infection
Clinical narrative: Information has been received from a nurse, via a company representative, concerning a 12 year old female patient, who on approximately 21-JUN-2007 ("two months ago") was vaccinated in the left arm, with the first dose, 0.5ml, of Gardasil (Lot # not provided).  On approximately 27-JUN-2007 ("six days after her first dose"), she developed "an infection on her left breast with draining, oozing pus."  Treatment included unspecified antibiotics.  The patient recovered from the event (date and duration not specified).  On 25-JUL-2007, the patient was vaccinated with the second dose, 0.5ml, of Gardasil, and had not reported any adverse experience.  The nurse questioned if the patient should received the third dose in the vaccination series.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007 concerning a 12 year old female patinet, who on 18-May-2007 (previously reported as approximately 21-Jun-2007) was vaccinated in the right deltoid (previously reported as left arm), with the first dose. 0.5 ml. GARDASIL (Lot # 657617/0184U). On 25-May-2007 (previoius onset reported as approximately 27-Jun-2007), she was diagnosed with an infection on her left breast with draining, boring pus. Treatment included unspecified antibiotics. The patient recovered from the event (date and duration not specified). On 25-Jul-2007, the patient was vaccinated with the second dose, 0.5ml of GARDASIL, and had not reported any adverse experience. The nurse questioned if the patient should receive the third dose in the vaccination series. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Dry eye, Haematology test, Laboratory test, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her 22 year old daughter with an allergy to AVALOX who in December 2006 and February 2007 was vaccinated with a 0.5 ml first and second dose of Gardasil.  Concomitant therapy included iron (unspecified).  The patient's mother reported that sometime in May 2007, the patient was experiencing pain in her wrist and hand associated with rheumatoid arthritis since receiving Gardasil.  The patient also had been diagnosed with Sjogren's syndrome.  The patient sought unspecified medical attention.  Unspecified blood work and manual tests were performed.  At the time of this report, the patient had not recovered.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007. Additional information has been received from a nurse practioner. The nurse reported that the patient "doing fine". The nurse stated that the patient had signs and symptoms (dry eyes and dry mouth) of SJOGREN's syndrome prior to the vacciantion with GADASIL. The patient was not diagnosed with rheumatoid arthritis. The patient's SED rate was reprotedly high at 69 and the RA factor was less than 20, which was reportedly within normal limits. No additional ifnormation is expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Red blood cell sedimentation rate increased, Rheumatoid arthritis, Rheumatoid factor negative, Sjogren's syndrome
Clinical narrative: Information has been received from a consumer concerning her 22 year old daughter with an allergy to AVALOX who in December 2006 and February 2007 was vaccinated with a 0.5 ml first and second dose of Gardasil.  Concomitant therapy included iron (unspecified).  The patient's mother reported that sometime in May 2007, the patient was experiencing pain in her wrist and hand associated with rheumatoid arthritis since receiving Gardasil.  The patient also had been diagnosed with Sjogren's syndrome.  The patient sought unspecified medical attention.  Unspecified blood work and manual tests were performed.  At the time of this report, the patient had not recovered.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007. Additional information has been received from a nurse practioner. The nurse reported that the patient "doing fine". The nurse stated that the patient had signs and symptoms (dry eyes and dry mouth) of SJOGREN's syndrome prior to the vacciantion with GADASIL. The patient was not diagnosed with rheumatoid arthritis. The patient's SED rate was reprotedly high at 69 and the RA factor was less than 20, which was reportedly within normal limits. No additional ifnormation is expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Alpha 1 foetoprotein increased, Blood urine present, Chlamydial infection, Drug exposure during pregnancy, Laboratory test
Clinical narrative: Information has been received for the Pregnancy Registry for Gardasil from a certified medical assistant concerning a 17 year old female with no birth defects in previous pregnancies and no infant complications in previous pregnancy, no pertinent medical history and no drug reactions/allergies who on 30-JUL-2007 was vaccinated with Gardasil (lot # unknown) at another clinic.  Concomitant therapy included tuberculin test and meningococcal vaccine (unspecified).  The patient's date of last menstrual period was 07-APR-2007 and the patient is pregnant.  On 14-AUG-2007 the patient was given prenatal vitamins (type unspecified) and iron pills for the pregnancy.  On an unspecified date lab tests were performed for an OB panel and a urine collection was performed because the patient was complaining (type of complaint unknown) but blood was found in the urine.  On 22-AUG-2007 the patient was treated with ZITHROMAX 1 gram dose for the chlamydial infection.  The estimated date of delivery is 10-APR-2008.  No further information is available.  Additional information has been requested. 07/08/08 Follow-up information was received from the physician's office. The patient had one full-term delivery. On 30-OCT-2007 the patient had a routine maternal serum alpha-fetoprotein test and was negative. On 27-MAR-2008 the patient delivered a healthy female baby weighing 6 pounds and 11 ounces, 17.21/2 in length and 37 weeks from LMP. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Urine analysis abnormal
Clinical narrative: Information has been received for the Pregnancy Registry for Gardasil from a certified medical assistant concerning a 17 year old female with no birth defects in previous pregnancies and no infant complications in previous pregnancy, no pertinent medical history and no drug reactions/allergies who on 30-JUL-2007 was vaccinated with Gardasil (lot # unknown) at another clinic.  Concomitant therapy included tuberculin test and meningococcal vaccine (unspecified).  The patient's date of last menstrual period was 07-APR-2007 and the patient is pregnant.  On 14-AUG-2007 the patient was given prenatal vitamins (type unspecified) and iron pills for the pregnancy.  On an unspecified date lab tests were performed for an OB panel and a urine collection was performed because the patient was complaining (type of complaint unknown) but blood was found in the urine.  On 22-AUG-2007 the patient was treated with ZITHROMAX 1 gram dose for the chlamydial infection.  The estimated date of delivery is 10-APR-2008.  No further information is available.  Additional information has been requested. 07/08/08 Follow-up information was received from the physician's office. The patient had one full-term delivery. On 30-OCT-2007 the patient had a routine maternal serum alpha-fetoprotein test and was negative. On 27-MAR-2008 the patient delivered a healthy female baby weighing 6 pounds and 11 ounces, 17.21/2 in length and 37 weeks from LMP. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a mother concerning her consumer 15 year old daughter with a history of infectious mononucleosis who on approximately 31-JUL-2007 was vaccinated with a 0.5 ml first dose of Gardasil.  Concomitant vaccination included Tdap. Subsequently the patient developed swollen lymph nodes.  Unspecified laboratory test was performed.  Unspecified medical attention was sought.  At the time of the report the patient was recovering.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a nurse concerning a 23 year old female with an allergic reaction to dapsone and a history of vulval lesion who on 19-JUN-2007 was vaccinated with a first dose of Gardasil (lot# 656050/0245U) 0.5mL IM.  Concomitant therapy included dermatologic (unspecified) therapy for acne.  On 20-AUG-2007 the patient was vaccinated with a second dose of Gardasil (lot# unknown) 0.5mL IM.  On 21-AUG-2007 the patient developed an itchy rash on both arms an abdomen.  Medical attention was sought.  The patient's itchy rash on both arms and abdomen persisted.  No other information was available at this time.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a consumer concerning her daughter who on approximately 21-AUG-2007, was vaccinated with a first dose of Gardasil.  On approximately 21-AUG-2007, the patient developed a rash on her torso.  At the time of this report, the patient's outcome was unknown.  No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Pruritus, Urticaria
Clinical narrative: Information has been received from a certified nurse midwife concerning a 22 year old female with no pertinent medical history or drug reactions/allergies who on 19-JUN-2007 was vaccinated with a first dose of Gardasil "usual dose and recommended route".  Concomitant therapy included YASMIN.  On an unspecified date after receiving the vaccination the patient experienced hives all over her arms and spread over her body.  The symptoms were described as "redness of the site" and "itchy".  Medical attention was sought.  The patient took BENADRYL and the symptoms did not improve.  On 20-JUN-2007 the patient had gone to the emergency room where she was given a MEDROL DOSEPAK.  The patient was not admitted to the hospital.  On an unspecified date the patient had recovered.  At the time of reporting the second dose had not been administered.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, No reaction on previous exposure to drug, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old patient who on an unspecified date was vaccinated with a first dose of Gardasil (lot# unknown).  The first dose had no adverse events.  On an unspecified date the patient was vaccinated with a second dose of Gardasil (lot# unknown).  The patient complained of nausea and threw up after getting home.  The patient also complained of dizziness.  The patient was not hospitalized.  On an unspecified date the patient recovered.  Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 9/17/2007. Follow-up information was received. The nurse reported that on 20-AUG-2007, the patient experienced nausea, vomiting and no fever for 2 days. Not related to the vaccine. On an unspecified date the patient recovered. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 22 year old female with no pertinent medical history who on 21-AUG-2007 was vaccinated with a 0.5 ml first dose of Gardasil.  Concomitant therapy included YASMIN.  On 22-AUG-2007 the patient developed an itchy rash all over her body.  The patient was taking BENADRYL for relief of symptoms.  The patient was going to visit the physician on 22-AUG-2007 at 2:00 pm.  At the time of the report the patient was recovering.  Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Chills, Injection site rash, Malaise
Clinical narrative: Information has been received from a physician concerning a 27 year old female patient who on 27-JUL-2007 was vaccinated IM with a third dose of Gardasil.  Subsequently, the patient experienced shivering, not feeling well and multiple bumps around the injection site area of her right arm.  On 17-AUG-2007, it was reported that the patient was seen for this in an office visit.  Laboratory diagnostic studies included blood work which appeared normal.  It was also reported that the patient had mild side effects like dizziness after having her first and second dose of the vaccine but nothing like the third dose.  At the time of this report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who on 22-AUG-2007, was vaccinated IM with a dose of Gardasil.  After receiving the vaccine, the patient fainted.  It was reported that the physician had taken her blood pressure and had given her water.  At the time of this report, the patient's outcome was unknown.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Dizziness, Nausea
Clinical narrative: Information has been received from a registered nurse concerning her 17 year old niece, who, on an unspecified date, was vaccinated with a first dose of Gardasil.  Subsequently, about an hour and a half post vaccination the patient experienced "stomach aches, nausea and dizziness."  The patient did not seek medical attention.  The patient recovered on an unspecified date within 2 hours after vaccination.  No product quality complaint was involved.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a nurse concerning an 18 year old female patient with no medical history who on 20-AUG-2007, was vaccinated IM with a second 0.5ml dose of Gardasil.  After receiving the vaccine, the patient developed itching and a rash that covered a 3 inch area at the injection site.  The patient was given BENADRYL and the rash was clearing up.  It was reported that the patient did not have a reaction to the first dose. No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning a female patient (age not specified), who on approximately 08-AUG-2007 ("two weeks" ago) was vaccinated with a dose of Gardasil (Lot # not provided).  On approximately 08-AUG-2007 the patient experienced pain and soreness at the injection site, and the nurse indicated it continued, two weeks later.  At the time of this report, the outcome of the event was not recovered.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female with a drug hypersensitivity to amoxicillin who on 21-MAY-2007 was vaccinated IM, into the left arm, with a second dose of Gardasil (Lot # 658094/0524U).  There was no concomitant medication.  While the patient was driving home she developed an itchy rash on her right warm which has since spread to her torso and right knee.  The patient was to be seen by the physician on 22-AUG-2007.  At the time of the report the patient had not recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a first dose of Gardasil.  Subsequently the patient experienced syncope.  Unspecified medical attention was sought.  Subsequently, the patient recovered from syncope.  On an unspecified date the patient was vaccinated with a second dose of Gardasil.  Subsequently the patient experienced syncope.  Unspecified medical attention was sought.  At the time of the report the outcome was unknown.  Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Dizziness, Pallor, Presyncope
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female with diabetes who on 22-AUG-2007 was vaccinated with a first dose of Gardasil (lot # 658558/1061U).  Concomitant suspect vaccination included Varivax.  On 22-AUG-2007, the patient became pale, light-headed and almost fainted.  Unspecified medical attention was sought.  On 22-AUG-2007, the patient recovered from becoming pale, light-headed and almost fainting.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Tremor
Clinical narrative: Information has been received from a physician's assistant concerning a female who on an unspecified date was vaccinated with a dose of Gardasil.  Subsequently the patient fainted. The patient was shaking after she "came to".  Unspecified medical attention was sought.  Subsequently, the patient recovered from fainting and shaking.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Dizziness, Malaise, Nausea, Pallor
Clinical narrative: Initial and follow up information has been received from a registered nurse, concerning a 13 year old female patient, with no known medical conditions or allergies, who on 20-AUG-2007 was vaccinated IM in the right deltoid, with a dose, 0.5ml, of Gardasil (lot #658556/1060U), as well as, with the second dose, SC in the left arm, of Varivax (duration and dose not reported) (MSD) (lot #657754/0782U), with the second dose, IM in the left arm, of Vaqta (lot #AHAVB182AA) (manufacturer unspecified) (duration and dose not specified), and with the first dose, IM in the right arm, of MENACTRA (lot #U1821AA). There was no illness at the time of vaccinations. On 20-AUG-2007, following the vaccinations, and while still in the physician's office, the patient reported not feeling good and was pale, felt faint, dizzy and nauseated. At 4:50pm, her blood pressure (BP) was 100/60 mmHg, and her pulse was 48bpm. The patient had not eaten breakfast and was given crackers and juice and laid flat for 15 minutes. Within 20 minutes, she was feeling better, her BP was "good," and her pulse had increased to 60 bpm (previously reported as 64 bpm). The nurse considered the patient to be recovered and she was discharged to home. Additional information has been requested. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Blood pressure normal, Dizziness, Hyperhidrosis, Pain in extremity
Clinical narrative: Information has been received from a registered nurse, concerning a 15 year old female patient, who on 22-AUG-2007 was vaccinated IM, with the first dose, 0.5ml, GARDASIL (Lot #658556/1060U).  There was no concomitant medication.  Following the vaccination, the patient experienced dizziness, began to sweat, and complained of arm and abdominal pain.  The patient was instructed to lie down flat for 30 minutes, and blood pressure was monitored and found to be within normal limits (value not specified).  No treatment was required, and the patient recovered from the events on the same day.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Loss of consciousness, Loss of consciousness, Pallor
Clinical narrative: Initial and follow up information has been received from a registered nurse, concerning a 14 year old female patient with no known medical conditions or allergies, who on 21-AUG-2007 at 1:30 pm was vaccinated IM in the right deltoid, with the first dose, 0.5ml, of Gardasil (Lot 659556/1060U), and IM in the left deltoid with the first dose of ADACEL  (lot# C2769AA). There was no illness at th etime of vaccination. Following the first vaccination, she was fine, but after the vaccination she "slumped and passed out", and blacked out for a few seconds. She was pale when awake. She was monitored, given juice and crackers, and after 15 minutes had recovered and was discharged to home.   Additional information has been requested.  Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure systolic, Dizziness
Clinical narrative: Information has been received from a physician, concerning a 14 year old female patient with mild asthma and allergic reaction to CECLOR, who on 21-JUL-2007 was vaccinated IM, with a dose, 0.5ml, of Gardasil (Lot #656049/0187U). There was no concomitant medication. Following the vaccination, the patient felt lightheaded. The patient's systolic blood pressure was 80mmHg (diastolic unknown), and her pulse was 68bpm. She was given a drink and monitored, and her blood pressure was 80/60mmHg (duration not specified). The patient recovered on the same day, 21-JUL-2007. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician and concerning a 15 year old caucasian female student, with a history of vagal reactions or "fainting with any phlebotomy," who on 04-MAY-2007 was vaccinated IM, with the first dose of Gardasil (Lot # not specified).  Following the vaccination, the patient fainted, described by the HCP as a "significant vagal reaction". Treatment involved the administration of an ammonia inhalant. She recovered after an unknown duration of time (date not provided).  On 06-JUL-2007, the patient received her second dose of Gardasil (Lot # not specified), and "everything was fine." With no problem noted. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Injection site irritation, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning "about 18 patients", who, on an unspecified date, were vaccinated with a dose of Gardasil.  Subsequently, the patients experienced pain and burning while receiving Gardasil.  At the time of the report, the patients' outcomes were unknown.  No product quality complaint was involved.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007. Initial and follow-up information has been received from a registered nurse concerning about 18 patients who are under 18 years of age, who within the last four months, were vaccinated with a dose of GARDASIL. Subsequently, the patients experienced pain and burning at the injection site while receiving GARDASIL, symptoms last approximately 30 minutes. The nurse reported that "none of the symptoms are sever enough to warrant medical attention. At the time of the report, the patient outcomes were unknown. No product quality complaint was involved. Attempts are being made to obtain additional identifying information to distinquish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure normal, Dizziness, Hyperhidrosis, Hypoaesthesia, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female with no pertinent medical history or drug reactions/allergies who on 22-AUG-2007 was vaccinated with a first dose of Gardasil (lot# 658556/1060U) 0.5 mL IM.  There was no concomitant medication.  On 22-AUG-2007 the patient experienced dizziness, began to sweat, complained of arm pain, tingling and numbness after receiving the vaccination.  Medical attention was sought.  The patient was instructed to lie flat for 30 minutes as the blood pressure was monitored.  The specific blood pressure readings were unspecified but reported to be within normal limits.  There were no other symptoms or treatments were reported.  On 22-AUG-2007 the patient recovered. Further information was not available.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female with no pertinent medical history or drug reactions/allergies who on 22-AUG-2007 was vaccinated with a first dose of Gardasil (lot# 658556/1060U) 0.5 mL IM.  There was no concomitant medication.  On 22-AUG-2007 the patient experienced dizziness, began to sweat, complained of arm pain, tingling and numbness after receiving the vaccination.  Medical attention was sought.  The patient was instructed to lie flat for 30 minutes as the blood pressure was monitored.  The specific blood pressure readings were unspecified but reported to be within normal limits.  There were no other symptoms or treatments were reported.  On 22-AUG-2007 the patient recovered. Further information was not available.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female, who, on an unspecified date, was vaccinated with a first dose of Gardasil (Lot # 655165/1425F or 658488/0930U).  Subsequently the patient fainted after administration (also reported as the patient "did not completely faint, but was close to it").  The patient recovered on an unspecified date.  The patient recovered on an unspecified date without incident after sitting in the office.  She went home without complication.  This is one of 3 reports from the same source.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a medical assistant concerning a 19 year old female with no pertinent medical history and a penicillin allergy who on 15-AUG-2007 was vaccinated with Gardasil (lot# 657872/0515U) 0.5 mL in the left deltoid IM.  There was no concomitant medication.  On an unspecified date the patient developed a rash.  Medical attention was sought.  Specific information about the rash was unknown.  At the time of reporting the outcome of the event was not specified.  No further information was available.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: Information has been received from a physician concerning a female who on 21-AUG-2007 was vaccinated with a 0.5 ml dose of Gardasil.  On 22-AUG-2007 the patient had an unspecified adverse event, that was treated with MOTRIN.  The patient did not seek medical attention.  At the time of the report the patient's outcome was unknown.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a physician concerning female patients who were vaccinated with 0.5 ml doses of Gardasil.  Subsequently the patients "got their periods" a couple of days after receiving Gardasil.  The patients contacted the physician.  At the time of the report the patients' outcomes were unknown.  Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: HPV4
Symptoms: CSF oligoclonal band present, Guillain-Barre syndrome, Intervertebral disc degeneration, Nuclear magnetic resonance imaging abnormal, Sinusitis
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a 0.5 mL dose of Gardasil. Subsequently, after vaccination, the patient developed Guillain-Barre syndrome and was hospitalized. It was reported that the patient "recently had plastic surgery and is now in rehab." The patient's outcome was unknown. Additional information has been requested.  4/1/08 Received only partial medical records of 5/23-6/04/2007. FINAL DX: Guillain Barre syndrome. No d/c summary available.  Records indicate patient experienced 2-3 days of neck & back pain & tingling in his legs followed by weakness which became profound until patient fell & was unable to move either leg, also had weakness of both arms along w/facial numbness.  Had HA, cough, runny nose & sore throat & recent dx of URI tx w/antibiotics.  Had nausea x 1 wk & difficulty voiding & swallowing.  Had brief episode of diarrhea 1 week prior.   Was on business trip from out of state.  Admitted to ICU.  Neuro & pulmonary consults done.  Exam revealed hyporeflexia.  Tx w/plasmapheresis.  Developed N/V.  Feeding tube placed.  Transferred to inpatient rehab w/foley cath.  5/6/08 Received hospital medical records of 6/4-7/11/2007. FINAL DX: Guillain-Barre syndrome; neuropathic pain; debility; asthma; dysphonia.  Also developed URI; UTI; hypersensitivity vasculitis, all resolved. Records reveal patient experienced improvement during this rehab hospitlization.  Improved to be able to ambulate w/walker.  Continued to awaken at night w/leg spasms & have erectile dysfunction.  Transferred to another rehab hospital.  This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow-up Information has been received from two physicians concerning a 56 year old sexually active male homosexual (previously reported as female) with a "questionable" history of illicit substance abuse. At the time of this report, the patient was recovering. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: HPV4
Symptoms: Urinary tract infection
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a 0.5 mL dose of Gardasil. Subsequently, after vaccination, the patient developed Guillain-Barre syndrome and was hospitalized. It was reported that the patient "recently had plastic surgery and is now in rehab." The patient's outcome was unknown. Additional information has been requested.  4/1/08 Received only partial medical records of 5/23-6/04/2007. FINAL DX: Guillain Barre syndrome. No d/c summary available.  Records indicate patient experienced 2-3 days of neck & back pain & tingling in his legs followed by weakness which became profound until patient fell & was unable to move either leg, also had weakness of both arms along w/facial numbness.  Had HA, cough, runny nose & sore throat & recent dx of URI tx w/antibiotics.  Had nausea x 1 wk & difficulty voiding & swallowing.  Had brief episode of diarrhea 1 week prior.   Was on business trip from out of state.  Admitted to ICU.  Neuro & pulmonary consults done.  Exam revealed hyporeflexia.  Tx w/plasmapheresis.  Developed N/V.  Feeding tube placed.  Transferred to inpatient rehab w/foley cath.  5/6/08 Received hospital medical records of 6/4-7/11/2007. FINAL DX: Guillain-Barre syndrome; neuropathic pain; debility; asthma; dysphonia.  Also developed URI; UTI; hypersensitivity vasculitis, all resolved. Records reveal patient experienced improvement during this rehab hospitlization.  Improved to be able to ambulate w/walker.  Continued to awaken at night w/leg spasms & have erectile dysfunction.  Transferred to another rehab hospital.  This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow-up Information has been received from two physicians concerning a 56 year old sexually active male homosexual (previously reported as female) with a "questionable" history of illicit substance abuse. At the time of this report, the patient was recovering. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Electrocardiogram, Loss of consciousness, Syncope, Syncope vasovagal
Clinical narrative: Initial and follow-up information has been received from a physician and registered nurse concerning a 17 year old female with no pertinent medical history and no drug allergies/reactions who on an unspecified date was vaccinated with a first dose of GARDASIL (lot # 656050/0245U) injection . Concomitant therapy also given on the same date included PEDIARIX. After receiving the first dose of Gardasil, the patient experienced syncope which the registered nurse and physician felt was a vasovagal response not related to the vaccine. It was reported that the patient "does not like shots." Medical attention was sought in the physician's office. The patient was treated with oxygen to help her breathe and an electrocardiogram was performed (results not provided). Subsequently, the patient recovered. The physician felt that the event required intervention to previous serious criteria (Other Important Medical Event). Additional information is not expected. Follow up information indicated that approximately 2 to 5 minutes after vaccine administration the patient experienced a brief loss of consciousness (less than one minute) with spontaneous recovery. It was presumed to be a vasovagal reaction to the vaccination. No diagnostic laboratory studies were performed. On 02-AUG-2007, the patient recovered. The physician felt that the event required intervention to previous serious criteria (Other Important Medical Event). Additional information is not expected.