chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Fall, Feeling cold, Hyperhidrosis, Loss of consciousness, Nausea
Clinical narrative: Approximately 5 - 10 minutes after receiving vaccine we were leaving and my son fell into the door frame and then in to me. I lowered him to the floor. He complained of feeling dizzy, nauseated, not being able to see, hard to breathe, and was sweating - although complaining of freezing. His skin was clammy to touch and warm. He never lost consciousness. Clinic staff checked his pulse and put a cool cloth on his head & neck. They told me he "passed out" due to anxiety - although he was NEVER anxious about the vaccine & never passed out completely. After 10 more minutes, I was told to take him home & let him rest. The next day, his left arm from shoulder to elbow was very swollen, dark red, itching, & tender to touch. I gave him benadryl every 6 hours & reported this to his physician. The physician said it sounded like an allergic reaction & continue with benadryl unless he has difficulty breathing & if that occurs, to take him to the ER. The arm remained swollen, red, tender, & itching for 2 more days. Benadryl was given during this time. Time of events were from 06/11/08 until 06/15/08.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Oedema peripheral, Pruritus, Skin warm, Tenderness
Clinical narrative: Approximately 5 - 10 minutes after receiving vaccine we were leaving and my son fell into the door frame and then in to me. I lowered him to the floor. He complained of feeling dizzy, nauseated, not being able to see, hard to breathe, and was sweating - although complaining of freezing. His skin was clammy to touch and warm. He never lost consciousness. Clinic staff checked his pulse and put a cool cloth on his head & neck. They told me he "passed out" due to anxiety - although he was NEVER anxious about the vaccine & never passed out completely. After 10 more minutes, I was told to take him home & let him rest. The next day, his left arm from shoulder to elbow was very swollen, dark red, itching, & tender to touch. I gave him benadryl every 6 hours & reported this to his physician. The physician said it sounded like an allergic reaction & continue with benadryl unless he has difficulty breathing & if that occurs, to take him to the ER. The arm remained swollen, red, tender, & itching for 2 more days. Benadryl was given during this time. Time of events were from 06/11/08 until 06/15/08.
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Cough, Nausea, Pain, Pyrexia
Clinical narrative: Fever, body aches, joint pain, cough, congestion, nausea, vomiting lasting more than 5 days after vaccine administered
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Vomiting
Clinical narrative: Fever, body aches, joint pain, cough, congestion, nausea, vomiting lasting more than 5 days after vaccine administered
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Computerised tomogram normal, Dizziness, Electrocardiogram normal, Fall
Clinical narrative: Patient passed out in doctors office after receiving 3rd dose of HPV Vaccine on 05/20/08. Landed face down on floor and received bump on head from fall. On 05/28/08 began feeling light-headed.  Then started having headaches and experiencing general fatigue.  Was seen by Dr. twice and the local hospital emergency room twice.  Also, went to another Hospital. All blood tests and urine tests came back normal.  EKG was normal.  CT scan of the head with and without contrast was normal.  As of today, 06/16/08 patient still experiencing headaches and general fatigue.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Head injury, Headache, Loss of consciousness, Urine analysis normal
Clinical narrative: Patient passed out in doctors office after receiving 3rd dose of HPV Vaccine on 05/20/08. Landed face down on floor and received bump on head from fall. On 05/28/08 began feeling light-headed.  Then started having headaches and experiencing general fatigue.  Was seen by Dr. twice and the local hospital emergency room twice.  Also, went to another Hospital. All blood tests and urine tests came back normal.  EKG was normal.  CT scan of the head with and without contrast was normal.  As of today, 06/16/08 patient still experiencing headaches and general fatigue.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, PNC
Symptoms: Medication error
Clinical narrative: Patient given Pediarix instead of separate vaccines - DTaP, IPV, HBV
Age: 21.0
Sex: F
Vaccine: HEPA, MNQ, PPV, TYP
Symptoms: Full blood count, Injection site erythema, Injection site pain, Nuclear magnetic resonance imaging, White blood cell count increased
Clinical narrative: patient received meningococcal and pneumococcal vaccines in left UE on 6/12/08 in preparation for travel.  Developed redness and pain at site that rapidly progressed requiring hospital admission.  MRI obtained related to pain out of proportion to exam and could not r/o fasciitis.  Admitted to surgery service on Vancomycin and Zosyn and monitoring for evidence of nec. fasc.  6/24/08 MR received from PCP 6/13/2008 and hospital DOS 6/16-18/2008 with DX: Left Upper Arm Cellulitis. Seen 6/13/08 for sinusitis and vaccinations for travel. Pt presented to ER with 3 day hx of rapidly spreading redness, swelling and pain at left arm injection site. Fever up to 102'F with malaise. Pt also reports onset today of pain in chest which increases with breathing.  PE (+) for painful distress, L upper arm erythema and firmness. ID consult with assessment vaccination reaction  vs soft tissue infection with concern for myositis.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis, Pain
Clinical narrative: Cellulitis 3 days post vaccination.  TX at local Emergency Room Clyndamycin IV and Tyl 325mg PO PRN for Pain
Sex: F
Vaccine: HEPAB
Symptoms: Accidental exposure, No adverse event
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of splashed injectable drug in eye in an adult female subject who was vaccinated with TWINRIX (GlaxoSmithKline).  On 12 June 2008 at 12:00, the subject received an unspecified dose of TWINRIX (intraocular, unknown).  A healthcare professional reported the needle came off of the syringe while a nurse was administering a TWINRIX injection, and the nurse was accidentally sprayed in the face and the eye with the solution.  The affected areas were washed and flushed with water.  No irritation was reported.  It was unknown at the time of this report if the nurse was sent for further medical attention.  No adverse events were reported.  The healthcare professional considered the events were clinically significant (or requiring intervention), and were probably related to the use of TWINRIX.  At the time of reporting, the outcome of the events was unspecified.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Headache, Joint swelling, Musculoskeletal discomfort, Oxygen saturation decreased
Clinical narrative: Pt well.  REceived ZOSTAVAX 5/23 - on 6/1/08 developed multiple joint pain and swelling,  arthralgia, high fever (101.3) and headache.  O2 sat 88% ran air.  06/20/2008 MR received for DOS 06/7-10/2008 with D/C DX: Polyarthragia, arthritis resolving on steroids.  Possible serum sickness reaction to recent varicella zoster vaccine. Fever, headache, neck pain-all resolved.  Bronchospasm, resolved.  Hypertension.  Hypercholerolemia. Anxiety Disorder.  GERD exacerbated by steroid use. Pt developed L thumb and hand swelling 1 week after receiving Zostavax.  Swelling spead to L knee, wrist, ankle and great toe. Joint swelling and tenderness noted on PE.  Pt then developed fever and rash was instructed to be evaluated in ER.  IN ER pt's O2 sat dropped from 98% to 88% and was noted to be wheezing and was admitted.   Improvement of all sx noted with IV steroids.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Pt well.  REceived ZOSTAVAX 5/23 - on 6/1/08 developed multiple joint pain and swelling,  arthralgia, high fever (101.3) and headache.  O2 sat 88% ran air.  06/20/2008 MR received for DOS 06/7-10/2008 with D/C DX: Polyarthragia, arthritis resolving on steroids.  Possible serum sickness reaction to recent varicella zoster vaccine. Fever, headache, neck pain-all resolved.  Bronchospasm, resolved.  Hypertension.  Hypercholerolemia. Anxiety Disorder.  GERD exacerbated by steroid use. Pt developed L thumb and hand swelling 1 week after receiving Zostavax.  Swelling spead to L knee, wrist, ankle and great toe. Joint swelling and tenderness noted on PE.  Pt then developed fever and rash was instructed to be evaluated in ER.  IN ER pt's O2 sat dropped from 98% to 88% and was noted to be wheezing and was admitted.   Improvement of all sx noted with IV steroids.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthritis, Inappropriate schedule of drug administration, Pyrexia, Serum sickness, Wheezing
Clinical narrative: Pt well.  REceived ZOSTAVAX 5/23 - on 6/1/08 developed multiple joint pain and swelling,  arthralgia, high fever (101.3) and headache.  O2 sat 88% ran air.  06/20/2008 MR received for DOS 06/7-10/2008 with D/C DX: Polyarthragia, arthritis resolving on steroids.  Possible serum sickness reaction to recent varicella zoster vaccine. Fever, headache, neck pain-all resolved.  Bronchospasm, resolved.  Hypertension.  Hypercholerolemia. Anxiety Disorder.  GERD exacerbated by steroid use. Pt developed L thumb and hand swelling 1 week after receiving Zostavax.  Swelling spead to L knee, wrist, ankle and great toe. Joint swelling and tenderness noted on PE.  Pt then developed fever and rash was instructed to be evaluated in ER.  IN ER pt's O2 sat dropped from 98% to 88% and was noted to be wheezing and was admitted.   Improvement of all sx noted with IV steroids.
Age: 31.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Client reported rash on evening of 06-13-08 (received vaccines 06-13-08 afternoon) rash presented on right and left shoulder and back-Feels stingy and somewhat itchy per client. Rash remains present on 06-16-08. Client reported she did not apply any treatment. Advised client to go to see M.D. for evaluation.
Age: 18.0
Sex: F
Vaccine: HEP, HPV4, MNQ
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: None-Client was given an adult dose of Hepatitis B-instead of Ped./adol. dose.
Age: 29.0
Sex: F
Vaccine: FLU3, IPV, TYP
Symptoms: Feeling abnormal, Palpitations, Tongue disorder, Tremor
Clinical narrative: 320PM patient complained of thick, fuzzy tongue, speech clear, no shortness of breath, no cough. Patient complained of feeling "weird", shakiness and heart racing. Adult epipen 0.3mg injected into right thigh, 911 called. Patient remained alert, oriented x3, and speaking clearly. Patient departed via ambulance to ER at 3:40PM.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Received vaccine on Tues. June 10, 2008; arm was sore on June 11th; sore with swelling, warmth and redness on June 12th - swelling was golf size; soreness, swelling warmth and redness on June 13 and 14 - racquetball sized; Back to golf ball size June 15 and 16 with less soreness, but still warm and pink
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Rash papular, Urine analysis normal
Clinical narrative: Diffuse papular rash.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rash macular
Clinical narrative: Patient developed a macular rash less than 24 hr after vaccines were given.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blood glucose decreased, Syncope
Clinical narrative: Pt. was faint appox 10 min following inj.  Vitals monitored.  Pt's FsBs was 63 - gave juice & crackers resolved within 30 min.  Pt instructed to eat breakfast, especially prior to visit.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Joint swelling, Pyrexia
Clinical narrative: Multiple joints swollen, half of R foot, fingers, knuckle joints, fever.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Fatigue, Headache, Lethargy, Pyrexia, Rash
Clinical narrative: On 6/11/08 about 4AM patient started complained of really bad headache, very tired, lethargic, fever over 101deg, and vomiting. Symptoms lasted all day. Mom says he slept most of the day. Next day he was much better. Rash showed on back of knees on 6/13/08. Doing fine 6/13/08 PM.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: On 6/11/08 about 4AM patient started complained of really bad headache, very tired, lethargic, fever over 101deg, and vomiting. Symptoms lasted all day. Mom says he slept most of the day. Next day he was much better. Rash showed on back of knees on 6/13/08. Doing fine 6/13/08 PM.
Age: 35.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Arthralgia, Pruritus, Rash
Clinical narrative: Vaccinated in Left arm with Hep B #1 and AVA #1. Noticed 4-5 days later a rash on outside surface of rt elbow extending up to bicep area, rash on outside of left elbow with no extension, rash on 1st and 3rd knuckles of rt hand and 1st knuckle of left hand, and on both outer surfaces of the "knotty bone" on the ankle. Denied swelling but experienced extreme itching. OTC hydrocortisone provided little relief. Went to Dr. and was given ATARAX and stronger HTC cream. Rash lasted 2-3 wks before resolving. He also reported bil knee pain without swelling. Pain described like growing pains and would ease with TYLENOL. Pain intermittent x 2-3 wks, and would last approx 15 min. No other joints painful. He denied fever, headache, N/V. Never had anything like this before. Denies any new substances taken internally or extrernally. Symptoms: Rash, diffuse, Pruritus, Joint Pain, multiple joints.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Had urticarial reaction within 40 hours of vaccines.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Erythema, Skin warm, Tenderness
Clinical narrative: Pt received pneumonia vaccine on 6/6/08 on 6/9/08 was seen by MD for progressive redness, tenderness, warmth, and discomfort that was spreading. Pt on LEVAQUIN, cool compress and antihistamine
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Diarrhoea, Irritability, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, irritable 6/11/08 day after shots - now diarrhea.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: erythematous, once at injectino site resolve with ice packs
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Skin warm, Tenderness, Virus serology test
Clinical narrative: 3 cm induration - red, warm, tender.
Age: 29.0
Sex: M
Vaccine: RAB
Symptoms: Asthenia, Fatigue, Nausea
Clinical narrative: Donor stated that he was very nauseous, weak and exhausted. He had CCl less than 200ml, underdraw D/T severe weather and drank water instead of saline, donor thinks this is why he felt bad after leaving center. 6/12/08
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Hot flush, Pain
Clinical narrative: Information has been received from a physician concerning an 11 year old female with asthma who on 25-MAR-2008 was vaccinated via intramuscular route in her right arm with the first 0.5 mL dose of GARDASIL (lot# 659964/1978U).  Concomitant medication included an unspecified asthma medication.  On 25-MAR-2008, a few hours after the dose, the patient experienced pain and tingling of the right arm and right leg as well as "hot flashes".  On 26-MAR-2008, the next day, the pain and tingling and hot flashes resolved.  The physician reported that on 12-MAY-2008 the patient was seen in the office and had complaints of sore throat, nasal discharge and heart palpitations.  The physician ordered a complete blood count, metabolic panel, thyroid stimulating hormone, echocardiogram, electrocardiogram, and Holter monitor.  The blood work and electrocardiogram were normal but results of the echocardiogram and Holter monitor were pending.  On 14-MAY-2008 the patient was seen in the physician's office due to a transient episode of "heart beating fast" and dizziness while she was at school earlier that day.  Vital signs were normal at the time of the examination.  The physician reported that on 27-MAY-2008, the patient was seen in the office for her second dose of GARDASIL.  Her exam was normal.  The physician noted that the second dose of GARDASIL was deferred until final test results became available.  Additional information has been requested.  This is a consolidation of two reports concerning the same patient.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity, Palpitations, Paraesthesia
Clinical narrative: Information has been received from a physician concerning an 11 year old female with asthma who on 25-MAR-2008 was vaccinated via intramuscular route in her right arm with the first 0.5 mL dose of GARDASIL (lot# 659964/1978U).  Concomitant medication included an unspecified asthma medication.  On 25-MAR-2008, a few hours after the dose, the patient experienced pain and tingling of the right arm and right leg as well as "hot flashes".  On 26-MAR-2008, the next day, the pain and tingling and hot flashes resolved.  The physician reported that on 12-MAY-2008 the patient was seen in the office and had complaints of sore throat, nasal discharge and heart palpitations.  The physician ordered a complete blood count, metabolic panel, thyroid stimulating hormone, echocardiogram, electrocardiogram, and Holter monitor.  The blood work and electrocardiogram were normal but results of the echocardiogram and Holter monitor were pending.  On 14-MAY-2008 the patient was seen in the physician's office due to a transient episode of "heart beating fast" and dizziness while she was at school earlier that day.  Vital signs were normal at the time of the examination.  The physician reported that on 27-MAY-2008, the patient was seen in the office for her second dose of GARDASIL.  Her exam was normal.  The physician noted that the second dose of GARDASIL was deferred until final test results became available.  Additional information has been requested.  This is a consolidation of two reports concerning the same patient.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test normal, Blood thyroid stimulating hormone, Echocardiogram, Electrocardiogram ambulatory, Electrocardiogram normal
Clinical narrative: Information has been received from a physician concerning an 11 year old female with asthma who on 25-MAR-2008 was vaccinated via intramuscular route in her right arm with the first 0.5 mL dose of GARDASIL (lot# 659964/1978U).  Concomitant medication included an unspecified asthma medication.  On 25-MAR-2008, a few hours after the dose, the patient experienced pain and tingling of the right arm and right leg as well as "hot flashes".  On 26-MAR-2008, the next day, the pain and tingling and hot flashes resolved.  The physician reported that on 12-MAY-2008 the patient was seen in the office and had complaints of sore throat, nasal discharge and heart palpitations.  The physician ordered a complete blood count, metabolic panel, thyroid stimulating hormone, echocardiogram, electrocardiogram, and Holter monitor.  The blood work and electrocardiogram were normal but results of the echocardiogram and Holter monitor were pending.  On 14-MAY-2008 the patient was seen in the physician's office due to a transient episode of "heart beating fast" and dizziness while she was at school earlier that day.  Vital signs were normal at the time of the examination.  The physician reported that on 27-MAY-2008, the patient was seen in the office for her second dose of GARDASIL.  Her exam was normal.  The physician noted that the second dose of GARDASIL was deferred until final test results became available.  Additional information has been requested.  This is a consolidation of two reports concerning the same patient.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Full blood count normal, Hot flush, Laboratory test normal, Pain in extremity, Palpitations
Clinical narrative: Information has been received from a physician concerning an 11 year old female with asthma who on 25-MAR-2008 was vaccinated via intramuscular route in her right arm with the first 0.5 mL dose of GARDASIL (lot# 659964/1978U).  Concomitant medication included an unspecified asthma medication.  On 25-MAR-2008, a few hours after the dose, the patient experienced pain and tingling of the right arm and right leg as well as "hot flashes".  On 26-MAR-2008, the next day, the pain and tingling and hot flashes resolved.  The physician reported that on 12-MAY-2008 the patient was seen in the office and had complaints of sore throat, nasal discharge and heart palpitations.  The physician ordered a complete blood count, metabolic panel, thyroid stimulating hormone, echocardiogram, electrocardiogram, and Holter monitor.  The blood work and electrocardiogram were normal but results of the echocardiogram and Holter monitor were pending.  On 14-MAY-2008 the patient was seen in the physician's office due to a transient episode of "heart beating fast" and dizziness while she was at school earlier that day.  Vital signs were normal at the time of the examination.  The physician reported that on 27-MAY-2008, the patient was seen in the office for her second dose of GARDASIL.  Her exam was normal.  The physician noted that the second dose of GARDASIL was deferred until final test results became available.  Additional information has been requested.  This is a consolidation of two reports concerning the same patient.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Paraesthesia, Pharyngolaryngeal pain, Rhinorrhoea
Clinical narrative: Information has been received from a physician concerning an 11 year old female with asthma who on 25-MAR-2008 was vaccinated via intramuscular route in her right arm with the first 0.5 mL dose of GARDASIL (lot# 659964/1978U).  Concomitant medication included an unspecified asthma medication.  On 25-MAR-2008, a few hours after the dose, the patient experienced pain and tingling of the right arm and right leg as well as "hot flashes".  On 26-MAR-2008, the next day, the pain and tingling and hot flashes resolved.  The physician reported that on 12-MAY-2008 the patient was seen in the office and had complaints of sore throat, nasal discharge and heart palpitations.  The physician ordered a complete blood count, metabolic panel, thyroid stimulating hormone, echocardiogram, electrocardiogram, and Holter monitor.  The blood work and electrocardiogram were normal but results of the echocardiogram and Holter monitor were pending.  On 14-MAY-2008 the patient was seen in the physician's office due to a transient episode of "heart beating fast" and dizziness while she was at school earlier that day.  Vital signs were normal at the time of the examination.  The physician reported that on 27-MAY-2008, the patient was seen in the office for her second dose of GARDASIL.  Her exam was normal.  The physician noted that the second dose of GARDASIL was deferred until final test results became available.  Additional information has been requested.  This is a consolidation of two reports concerning the same patient.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a pharmacy student concerning a 17 year old female who on 01-MAY-2008 was vaccinated with her third dose of GARDASIL (Lot #, site and route not reported).  On 01-MAY-2008 the patient experienced an increased level of pain when the third dose of GARDASIL was administered.  The patient noted that pain during administration of the third dose was much greater than the pain associated with the first two doses.  The dates of the prior two doses of GARDASIL were not reported and the onset of pain related to these injections was not reported.  The patient sought unspecified medical attention by contacting the pharmacy.  On an unspecified date, the patient recovered from the increased level of pain during vaccine administration.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fall, Head injury, Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a physician concerning a female who on 10-MAY-2008 was vaccinated with her first dose of GARDASIL (lot number unspecified). On 01-MAY-2008 the patient fainted immediately after receiving the dose. She hit the floor and hit her head and "it wasn't good".  The patient sough unspecified medical treatment in the office. No additional information at this time. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site anaesthesia, Injection site pain
Clinical narrative: Information has been received from a nurse concerning females who were vaccinated on unspecified dates with a dose of GARDASIL (lot#'s not reported). Subsequently the patients experienced injection site pain and numbness. Additional information has been requested. A phone call was placed on 07-MAY-2008 to obtain more information; however the phone call has not been returned.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Information has been received from a health professional concerning a 25 year old Native Hawaiian female with asthma, a history of hydrocephalus, no drug reactions/allergies and no illness at the time of the vaccination who on 22-APR-2008 was vaccinated with GARDASIL (lot # 659964/1978U) in the right deltoid at 2:30 PM. Concomitant therapy included DEPO-PROVERA. On 22-APR-2008 at 2:33 PM the patient developed itching and rash over the entire body from face to feet. The patient was given 10 CC's of BENADRYL. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a health professional concerning a female in her early 20's who was vaccinated on an unspecified date with a dose of GARDASIL.  Subsequently the patient called the office and reported her period was delayed following vaccination.  Subsequently, the patient recovered from a delay in her menstrual period.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a health professional concerning a 15 year old female who was vaccinated on an unspecified date with a dose of GARDASIL (lot# not reported).  The patient's mother called and stated her daughter's menstrual period was delayed following vaccination.  Subsequently, the patient recovered from her menstrual period being delayed.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Asthma, Chest X-ray normal, Dyspnoea, Hypoaesthesia, Liver function test normal
Clinical narrative: Information has been received from a nurse practitioner (N.P.) concerning a 14 year old female with no pertinent medical history or drug reactions/allergies who on 16-MAR-2008 was vaccinated with a first dose of GARDASIL (lot# 659437/1266U) 0.5 mL IM.  There was no concomitant medication.  The N.P. mentioned that after receiving her first dose of GARDASIL on 16-MAR-2008 the patient has been experiencing episodic syncope with shortness of breath, numbness and tingling of the arms and then she passes out.  The patient's teachers have reported that she has limb movement similar to a seizure.  The episodes last about 5 to 10 minutes.  The N.P. mentioned that the patient has had 10 or more of these episodes since 12-APR-2008.  All the episodes have been witnessed at school, the episodes that occur at home have not been witnessed.  On 19-Apr-2008 a spirometry test was performed and demonstrated a mild obstruction consistent with mild asthma.  The patient was then placed on an albuterol inhaler.  Additional laboratory and diagnostic tests were performed the same day.  A chest X-ray, liver enzyme test, a kidney function and thyroid function test were normal.  The patient's blood lymphocyte count was slightly decreased and blood monocyte percent was slightly elevated.  The patient was seen in the emergency room the last week of April 2008 and was diagnosed with panic attacks.  The patient was sent to a cardiologist who stated that there was no cardiac underlying reason for the episodes and he believes that the patient was having panic attacks.  The patient was going to be sent to see a neurologist.  At the time of reporting the patient was recovering from syncope, shortness of breath, numbness of the arm, panic attack, tingling of the arm and tonic-clonic movements and the outcome of asthma was unknown.  No additional information was available.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Lymphocyte count decreased, Monocyte count increased, Panic attack, Paraesthesia
Clinical narrative: Information has been received from a nurse practitioner (N.P.) concerning a 14 year old female with no pertinent medical history or drug reactions/allergies who on 16-MAR-2008 was vaccinated with a first dose of GARDASIL (lot# 659437/1266U) 0.5 mL IM.  There was no concomitant medication.  The N.P. mentioned that after receiving her first dose of GARDASIL on 16-MAR-2008 the patient has been experiencing episodic syncope with shortness of breath, numbness and tingling of the arms and then she passes out.  The patient's teachers have reported that she has limb movement similar to a seizure.  The episodes last about 5 to 10 minutes.  The N.P. mentioned that the patient has had 10 or more of these episodes since 12-APR-2008.  All the episodes have been witnessed at school, the episodes that occur at home have not been witnessed.  On 19-Apr-2008 a spirometry test was performed and demonstrated a mild obstruction consistent with mild asthma.  The patient was then placed on an albuterol inhaler.  Additional laboratory and diagnostic tests were performed the same day.  A chest X-ray, liver enzyme test, a kidney function and thyroid function test were normal.  The patient's blood lymphocyte count was slightly decreased and blood monocyte percent was slightly elevated.  The patient was seen in the emergency room the last week of April 2008 and was diagnosed with panic attacks.  The patient was sent to a cardiologist who stated that there was no cardiac underlying reason for the episodes and he believes that the patient was having panic attacks.  The patient was going to be sent to see a neurologist.  At the time of reporting the patient was recovering from syncope, shortness of breath, numbness of the arm, panic attack, tingling of the arm and tonic-clonic movements and the outcome of asthma was unknown.  No additional information was available.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Renal function test normal, Spirometry abnormal, Syncope, Thyroid function test normal, Tonic clonic movements
Clinical narrative: Information has been received from a nurse practitioner (N.P.) concerning a 14 year old female with no pertinent medical history or drug reactions/allergies who on 16-MAR-2008 was vaccinated with a first dose of GARDASIL (lot# 659437/1266U) 0.5 mL IM.  There was no concomitant medication.  The N.P. mentioned that after receiving her first dose of GARDASIL on 16-MAR-2008 the patient has been experiencing episodic syncope with shortness of breath, numbness and tingling of the arms and then she passes out.  The patient's teachers have reported that she has limb movement similar to a seizure.  The episodes last about 5 to 10 minutes.  The N.P. mentioned that the patient has had 10 or more of these episodes since 12-APR-2008.  All the episodes have been witnessed at school, the episodes that occur at home have not been witnessed.  On 19-Apr-2008 a spirometry test was performed and demonstrated a mild obstruction consistent with mild asthma.  The patient was then placed on an albuterol inhaler.  Additional laboratory and diagnostic tests were performed the same day.  A chest X-ray, liver enzyme test, a kidney function and thyroid function test were normal.  The patient's blood lymphocyte count was slightly decreased and blood monocyte percent was slightly elevated.  The patient was seen in the emergency room the last week of April 2008 and was diagnosed with panic attacks.  The patient was sent to a cardiologist who stated that there was no cardiac underlying reason for the episodes and he believes that the patient was having panic attacks.  The patient was going to be sent to see a neurologist.  At the time of reporting the patient was recovering from syncope, shortness of breath, numbness of the arm, panic attack, tingling of the arm and tonic-clonic movements and the outcome of asthma was unknown.  No additional information was available.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female patient with no medical history and no allergies reported who on 02-MAY-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (Lot # 660387/1967U).  Concomitant therapy included hormonal contraceptives (unspecified).  On 03-MAY-2008, approximately 24 hours after the vaccination, the patient developed a vesicular rash on her lower lip and on the tip of her tongue.  The patient was seen in the office on 05-MAY-2008.  No diagnostic laboratory testing was performed.  At the time of this report, the patient's outcome was not recovered.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/13/2008.  Initial and follow up information has been received from a nurse practitioner concerning a 13 year old female patient with no medical history and no allergies reported who on 03-MAY-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (Lot # 560387/1967U).  Concomitant therapy included hormonal contraceptives (unspecified).  On 03-MAY-2008, approximately 24 hours after the vaccination, the patient awoke with papules and vesicles on the inside of her upper and lower lip and on the tip of her tongue.  No reported difficulty breathing, and no reaction at the vaccination site.  On 05-MAY-2008, two days after the incident.  The patient was seen in the office.  The symptoms were present (papules and vesicles).  The nurse practitioner spoke with department who advised the nurse to advise the patient not to complete the series of vaccinations.  The nurse then advised the patient.  No diagnostic laboratory testing was performed.  At the time of this report, the patient's outcome was recovered.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with two doses of GARDASIL.  On an unspecified date, the patient tested positive for Papilloma viral infection (HPV), type unspecified.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Heart rate increased, Oxygen saturation
Clinical narrative: Information has been received from a nurse practitioner concerning a teenage female with no medical history and no drug allergies, who on 22-APR-2008 was vaccinated IM with a first dose of GARDASIL.  On 25-APR-2008 the patient experienced shortness of breath, elevated pulse, and breathing issues.  The patient was taken to the emergency room but the specifics were unknown.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Amniocentesis, Complication of pregnancy, Diabetes mellitus, Drug exposure during pregnancy
Clinical narrative: Information has been received for the Merck Pregnancy Registry for GARDASIL from a 17 year old female with no drug reactions/allergies who maybe a diabetic who in April 2007 was vaccinated with a first dose of GARDASIL.  There was no concomitant medications.  On 27-JUL-2007 the patient was vaccinated with a second dose of GARDASIL injection and was pregnant.  The gestation period was 7 months.  The patient has had a lot of complications with the pregnancy.  Unspecified medical attention was sought.  On an unspecified date blood work and an ultrasound was performed.  No additional information was provided.  Additional information has been requested.  10/08/08 This is in follow-up to report(s) previously submitted on 6/13/2008. Initial and follow-up information has been received for the Merck Pregnancy Registry for GARDASIL from a 17 year old female with a history of genital herpes, no previous pregnancies or spontaneous abortions and no drug reactions/allergies who maybe a diabetic who in April 2007 was vaccinated with a first dose of GARDASIL. Concomitant therapy included prenatal vitamins. On 27-JUL-2007 the patient was vaccinated with a second dose of GARDASIL injection and was pregnant. The gestation period was 7 months. The patient's date of last menstrual period was in October 2007 and the estimated date of delivery is 28-JUL-2008 by an ultrasound. The estimated date of conception is unknown. The patient has had a lot of complications with the pregnancy. Unspecified medical attention was sought. On an unspecified date blood work was performed. On 07-DEC-2007 and 25-FEB-2008 an ultrasound was performed (results were not reported). On 08-FEB-2008 a maternal serum alpha-fetoprotein test was performed and was normal. On 06-Mar-2008 an amniocentesis was performed and revealed "46, XX choroid plexus". On 12-May-2008 a diagnostic laboratory test was performed and was AHN 1 p.p.: 140mgm. On 18-JUL-2008 the patient had a normal baby girl weighing 2635 grams. The APGAR score was 8/9. During labor/delivery the patient had a non-assuring fetal heart tone. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Ultrasound scan
Clinical narrative: Information has been received for the Merck Pregnancy Registry for GARDASIL from a 17 year old female with no drug reactions/allergies who maybe a diabetic who in April 2007 was vaccinated with a first dose of GARDASIL.  There was no concomitant medications.  On 27-JUL-2007 the patient was vaccinated with a second dose of GARDASIL injection and was pregnant.  The gestation period was 7 months.  The patient has had a lot of complications with the pregnancy.  Unspecified medical attention was sought.  On an unspecified date blood work and an ultrasound was performed.  No additional information was provided.  Additional information has been requested.  10/08/08 This is in follow-up to report(s) previously submitted on 6/13/2008. Initial and follow-up information has been received for the Merck Pregnancy Registry for GARDASIL from a 17 year old female with a history of genital herpes, no previous pregnancies or spontaneous abortions and no drug reactions/allergies who maybe a diabetic who in April 2007 was vaccinated with a first dose of GARDASIL. Concomitant therapy included prenatal vitamins. On 27-JUL-2007 the patient was vaccinated with a second dose of GARDASIL injection and was pregnant. The gestation period was 7 months. The patient's date of last menstrual period was in October 2007 and the estimated date of delivery is 28-JUL-2008 by an ultrasound. The estimated date of conception is unknown. The patient has had a lot of complications with the pregnancy. Unspecified medical attention was sought. On an unspecified date blood work was performed. On 07-DEC-2007 and 25-FEB-2008 an ultrasound was performed (results were not reported). On 08-FEB-2008 a maternal serum alpha-fetoprotein test was performed and was normal. On 06-Mar-2008 an amniocentesis was performed and revealed "46, XX choroid plexus". On 12-May-2008 a diagnostic laboratory test was performed and was AHN 1 p.p.: 140mgm. On 18-JUL-2008 the patient had a normal baby girl weighing 2635 grams. The APGAR score was 8/9. During labor/delivery the patient had a non-assuring fetal heart tone. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Pain
Clinical narrative: Information has been received from a 13 year old female with bipolar disorder and an allergic reaction to azithromycin who on an unspecified date was vaccinated with a first dose of GARDASIL and experienced stinging.  At the time of reporting it was unknown if the patient had recovered from stinging.  There was no concomitant medication.  In December 2007, the patient was vaccinated with a second dose of GARDASIL 0.5mL injection.  "Immediately after receiving the vaccine" the patient experienced numbness.  At the time of reporting the patient recovered "after about a week".  Medical attention was not sought.  No further information was provided.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed, Urine human chorionic gonadotropin negative
Clinical narrative: Initial and follow up information has been received from a medical assistant concerning an 18 year old female who in approximately February 2008 (also reported as 2 months ago), was vaccinated with her first dose of GARDASIL (Lot #, site and route not reported).  On 24-APR-2008 the patient was at the physician's office for her second vaccination with GARDASIL and noted that she was one day late for her menstrual period.  A urine pregnancy test was performed which was negative.  The patient was not pregnant, so the second dose of GARDASIL (Lot #, site and route not reported) was administered.  The patient sought unspecified medical attention when she was seen by the physician.  The patient's outcome was not reported.  No further information was provided.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: Information has been received from the authors of the above entitle published literature article concerning a 16 year old female patient who was vaccinated with a dose of GARDASIL.  It was reported that the patient felt dizzy and had pallor within five minutes of receiving an GARDASIL vaccination.  While being escorted back to an examination room, she fainted, but the physician caught her as she fell.  She was observed for thirty minutes in the clinic and recovered completely.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated on an unspecified date with a dose of GARDASIL (lot# not reported).  The patient developed a fever of 103F and red spots on her body after receiving a dose of GARDASIL.  The patient's mother took her to the ER and she was released.  The patient was recovering from the fever and red spots on her body.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Liver function test, Lymphadenopathy, Neck mass, Red blood cell count, X-ray
Clinical narrative: Information has been received from a mother concerning her daughter who in approximately 2007 was vaccinated with her first dose of GARDASIL (lot# not reported). Concomitant therapy included hormonal contraceptives (unspecified). The patient received the second dose of GARDASIL (lot# not reported) between September 2007 and February 2008. During the week of 14-APR-2008 the patient experienced a lump on the side of her neck. The doctor said it was an enlarged lymph node, cause unknown. She was treated with 2 antibiotics. She also saw a dentist for 2 impacted wisdom teeth but the dentist did not think it was connected with the lymph node. However the 2 impacted teeth were removed on 25-APR-2008 because they may have caused the lymph nodes to become infected. The patient's lump on the side of her neck persisted. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fall, Head injury, Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a physician concerning a female who on approximately 15-APR-2008 was vaccinated intramuscularly with her first dose of GARDASIL (lot# not reported).  Three minutes after vaccination the patient experienced syncope and fell down and hit her head.  An ice pack was used for treatment, after which she was awake, oriented and alert.  Subsequently, the patient recovered from syncope and falling down and hitting her head.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Chest X-ray normal, Foreign travel, Tuberculin test positive, Urticaria
Clinical narrative: Initial information and follow up has been received from a health professional concerning a 21 year old female with allergic rhinitis, gastroesophageal reflux disease and drug reactions/allergy to STRATTRA who on 29-FEB-2008 was vaccinated with her first dose of GARDASIL (lot# not reported). Concomitant therapy included a topical antifungal drug (unspecified) and hormonal contraceptives (unspecified). In the beginning of April 2008, the patient experienced hives. The hives appeared after certain activities such as after taking a shower, and then disappeared. However, the hives appeared again a few days later. The patient was seen by the nurse practitioner and was recovering. The patient was also recently tested for tuberculosis and the PPD test was positive, but the chest x-ray was negative. The patient had recent travel out of the country and recent foot fungus.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a certified medical assistant concerning a 26 year old female patient who on 15-APR-2008 was vaccinated with a first dose of GARDASIL (no lot # provided).  Concomitant therapy included YASMIN.  The patient experienced a hives outbreak 10 days after the first dose was given.  The patient sought medical attention through speaking with the medical assistant.  No further information was available from the medical assistant.  The patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Arthritis, Pain
Clinical narrative: Information has been received from a consumer concerning her daughter, a 17 year old female with a history of drug hypersensitivity to PEDIAZOLE, who sometime in 2007 was vaccinated with all three doses of GARDASIL (lot numbers and dates unspecified) and has been diagnosed with arthritis.  Sometime after receiving the first dose, her daughter developed pain all over her body including ankles, knees, and elbows.  Right before receiving the third dose her symptoms started to improve but still existed.  The consumer is wondering if her daughter's symptoms will worsen after receiving dose #3.  The consumer did not want to provide the physician's information or provider's name.  No other details.  The patient's arthritis and pain all over her body persisted.  No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Crying, Dizziness, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient who on 13-FEB-2008 at 12:45 was vaccinated into the left arm with the first dose of GARDASIL (Lot # 659655/1486U). On 13-FEB-2008, immediately after the shot was administered, the patient developed pain in the left arm. She cried for about seven minutes and began to complain of heaviness in her arm and stinging and aching. She then became dizzy and had to lie supine for fifteen minutes. She left the office in stable condition. Within one to two hours she developed swelling and discoloration of all fingers of the left hand. This lasted twenty-four hours and resolved spontaneously. Additional information has been requested.