chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan
Clinical narrative: Initial and follow-up information has been received from the Merck Pregnancy Registry concerning an 18 year old female with no pertinent medical history who on 05-JUL-2007 was vaccinated with a first dose of Gardasil (Lot # 657868/0523U).  Concomitant therapy included ORTHO TRI-CYCLEN LO.  On 12-JUL-2007 an ultrasound was performed due to pelvic pain and the patient was found to be pregnant.  The patient's last menstrual period was on 06-JUN-2007 and the estimated date of delivery is 12-MAR-2008.  Unspecified medical attention was sought.  At the time of the report the patient's outcome was unknown.  Additional information has been requested. Medical records were received from the physician's office on 03-MAR-2008 the baby was in for a well child visit and was 5 days old. The baby was born full term by spontaneous vaginal delivery, no complications during pregnancy/delivery. The birth weight was 5 pounds 11 ounces, length was 18 inches. The patient had a black spot on the left foor and was diagnosed witht mongolian spots on legs. The baby also experienced newborn jaundice down to the face. On 28-FEB-2008 the baby also tilts head to the left with tightness on the left and was diagnosed with torticollis. The parents were instructed in stretching techniques while feeding, changing diapers and at play. On 28-FEB-2008, the patient was vaccinated with Hepatitis B virus vaccine (manufactiurer unknown). On 13-MAR-2008 the bab was seen and there was no jaundice. Upon internal review, mongplian spots wre considered to be a congenital anomaly. Subsequently the patient experienced adverse events after vaccination with hepatitis B virus vaccine (manufacturer unknown). Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Delivery, Drug exposure during pregnancy, Ultrasound scan normal, Urinary tract infection
Clinical narrative: Initial and follow up information has been received for the Pregnancy Registry for Gardasil from a Registered Nurse (R.N.) concerning a 25 year old female patient with high Human Papilloma Virus (HPV) who on 23-MAR-2007 was vaccinated IM in to right deltoid a dose of with  GARDASIL lot #655618/0186U.  The nurse reported that now she was pregnant after receiving the injection.  Routine prenatal labs were done.  Patient was 19 weeks of gestation at the time of this report.  The patient sought unspecified medical attention.  In follow up information the nurse reported that the patient had Urinary tract infection (UTI) for which she was treated with MACROBID twice a day from 21-MAY-2007 till 31-MAY-2007.  On 18-JUL-2007 she had an ultrasound done which had normal result.  She also had maternal serum alpha-fetoprotein test (MSAFP) with a normal result.  The outcome was unknown.  This is one of the two patient from the same office.  Additional information has been requested.This is in follow-up to report (s) previously submitted on 10/08/2007, 7/8/2008. In follow up telephone call to the physician's office the nurse reported that on 14-DEC-2007 at 39 1/2 weeks gestation, the patient delivered a normal baby boy with no congenital anomalies by repeat cesarean section. His birth weight was 6 pounds 15 ounces, and he was 18.5 inches. The infant's apgar score was 8/9. Other medications taken during prenancy were vitimans (unspecified) and iron (unspecified) 325 mg by mouth three times a day. It was reported that there were no complications for the mother or the baby. This is one of the two patient from the same office. Additional information is not expected. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a health professional concerning a few females who were vaccinated with 0.5 ml Gardasil IM.  Subsequently, they experienced momentary discomfort during Gardasil administration.  The nurse was unable to confirm the actual number of patients or identification of the patients.  No further adverse reactions were reported.  No lab testing was performed.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a company representatives daughter concerning a 16 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL. Subsequently the patient's shot hurt. Subsequently, the patient recovered. On an unspecified date was vaccinated
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site dryness
Clinical narrative: Information has been received from a company representatives daughter concerning a 17 year old female who on an unspecified date was vaccinated with GARDASIL. Subsequently the patient experienced dry patch patch around the injection site. At the time of the report, the outcome was unknown. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Migraine
Clinical narrative: Information has been received from a licensed practical nurse concerning a 13 year old female with no known drug allergies and migraines who on 28-AUG-2007 was vaccinated with a dose of GARDASIL, 0.5ml, intramuscularly, in the right arm (Lot#658556/1060U). Concomitant therapy included MENACTRA, ADACEL and VARIVAX (also in the right arm) on that same date. On 30-AUG-2007, the patient's mother called to report that the child developed a swollen, red area on her right arm. On 31-AUG-2007, the patient's mother called back to report the child's arm at the injection site was hot, swollen, and red with the area about 2 inches by 2 inches. It was treated with compresses. The outcome was not reported. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 10/8/2007.  Follow-up information was received. The patient did not have any illness at the time of vaccination. On 04-SEP-2007 the patient stopped complaining and the mom has not checked the area. The patient recovered on 04-SEP-2007. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a licensed practical nurse concerning a 13 year old female with no known drug allergies and migraines who on 28-AUG-2007 was vaccinated with a dose of GARDASIL, 0.5ml, intramuscularly, in the right arm (Lot#658556/1060U). Concomitant therapy included MENACTRA, ADACEL and VARIVAX (also in the right arm) on that same date. On 30-AUG-2007, the patient's mother called to report that the child developed a swollen, red area on her right arm. On 31-AUG-2007, the patient's mother called back to report the child's arm at the injection site was hot, swollen, and red with the area about 2 inches by 2 inches. It was treated with compresses. The outcome was not reported. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 10/8/2007.  Follow-up information was received. The patient did not have any illness at the time of vaccination. On 04-SEP-2007 the patient stopped complaining and the mom has not checked the area. The patient recovered on 04-SEP-2007. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 14 year old female with asthma, seasonal allergy, penicillin allergy and allergy to erythromycin who on 31-AUG-2007 was vaccinated with her first dose of GARDASIL, 0.5ml IM. There was no concomitant medication. Several hours after receiving the vaccine, on 31-AUG-2007 the patient experienced injection site reaction with redness and swelling at the injection site and fever which lasted for 24 hours. She has been taking TYLENOL, ADVIL, BENADRYL for the symptoms. The patient's injection site reaction and redness at injection site and swelling at injection site persisted. Additional has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Fungal infection, Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a pharmacist concerning a female in her early 20s who was vaccinated with the first two doses of GARDASIL at a different clinic. Subsequently the patient tested positive for HPV. The patient come tot he office for a yeast infection and is currently being prescribed DIFLUCAN. She was tested for HPV at the office visit for the yeast infection. The pharmacist did not know if she was tested for HPV prior to the start of GARDASIL. As of 04-SEP-2007 the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated IM with the second dose GARDASIL. Three days after the vaccination, the patient experienced a rash on her upper back. Subsequently, the patient recovered from rash on her upper back. Medical attention was sought. Additional information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Delivery, Drug exposure during pregnancy, Muscle spasms
Clinical narrative: Information has been received from a 27 year old female who on 28-JUN-2007 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL. The consumer reported that she became pregnant after receiving a dose of GARDASIL. The consumer also reported that "she started cramping", but it is "getting better." She reported that "she does not think that this is related to GARDASIL. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/8/2008. Information has been received from a 17 year old female through the Merck pregnancy registry for GARDASIL who on 28-JUN-2007 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL. The consumer reported that she became pregnant after receiving a dose of GARDASIL (LMP 26-JUL-2007). The consumer also reported that "she started cramping", but it is "getting better." She reported that "she does not think that this is related to GARDASIL. In follow up from the patient's physician's office it was reported that the patient vaginally delivered full term, healthy, normal infant weighing 6 pounds, 6 ounces. It was reported that the patient was treated (unspecified) for preterm labor during the pregnancy, however delivered full-term. The patient was also treated for preterm labor during her first pregnancy. No further information is expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a female believed to be 11 years old with no medical history and no drug allergies, who, "two weeks ago" on approximately 21-AUG-2007, was vaccinated with a dose of GARDASIL. Subsequently, after receiving the vaccination the patient was still at the office and became lightheaded, but did not faint. The patient was observe at the office for 15 minutes and then was "fine" and was sent home. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Diarrhoea, Headache, Lethargy, Pyrexia, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old female, who on 21-AUG-2007 was vaccinated intramuscularly with a 0.5mL first dose of GARDASIL. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 29-AUG-2007 the patient developed a fever of 103F. The patient was lethargic, had diarrhea one time, and a severe headache. On 01-SEP-2007 the patient developed hives all over her body. The patient sought unspecified medical attention. On 02-SEP-2007 the patient's headache and fever resolved and the patient started to feel better. On 04-SEP-2007 the patient recovered and went to school. The nurse reported that she was unsure if the patient would be receiving the second dose of GARDASIL. No product quality complaint was involved. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on approximately 04-JUN-2007 was vaccinated with a 0.5 ml first dose of GARDASIL. On approximately 04-JUN-2007 the patient experienced "a huge amount of redness and swelling that was 4 inches in diameter around the injection site". The "patient was taking MOTRIN" and using "cold compresses" to reduce the swelling. The "patient is not receiving the last two dose in the series". Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Psoriasis
Clinical narrative: Information has been received from a receptionist concerning her daughter who on an unspecified date was vaccinated with a first dose of Gardasil.  Subsequently, two days after the first dose the patient experienced psoriasis.  At the time of the report, the outcome was unknown.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Bursitis, Pain in extremity, Tendonitis
Clinical narrative: Information has been received from a physician concerning a female who on 27-AUG-2007 was vaccinated with a dose of Gardasil injection.  On 30-AUG-2007 the patient experienced pain in her arm which was a little bit of tendonitis and bursitis.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with her first dose of GARDASIL, IM. One week post vaccination, the patient experienced irregular menstrual period (two to three weeks earlier than schedule). Subsequently, the patient recovered from irregular menstrual period. Medical attention was sought. Patient Quality Complaints (PQC) was not involved.
Sex: F
Vaccine: HPV4
Symptoms: Prostatic acid phosphatase abnormal
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the first two doses of the Gardasil series (0.5 ml, intramuscular).  Subsequently the patient experienced a positive prostatic acid phosphatase (PAP) test.  The patient was negative before being vaccinated with Gardasil.  The patient sought medical attention.  The patient's outcome was not reported.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody negative, Full blood count normal, Oedema peripheral, Pain, Radioallergosorbent test negative
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 24-AUG-2007 was vaccinated with a second dose do GARDASIL. There were no concomitant medications. On 29-AUG-2007 the patient experienced facial stinging, generalized rash on trunk, extremities, and buttocks, and hands and feet were swollen. No cervical nodes, no joint swelling, no allergies. The nurse reported that the patient is in good health. The patient is being treated with oral BENADRYL. Laboratory data revealed Complete Blood Count was normal, Antinuclear Antibody test performed the results was negative and RAST test was negative for latex. The nurse reported that the RAST test were performed due to the client played with water balloon. It was unsure if the patient would receive the third dose. Additional information is not available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 24-AUG-2007 was vaccinated with a second dose do GARDASIL. There were no concomitant medications. On 29-AUG-2007 the patient experienced facial stinging, generalized rash on trunk, extremities, and buttocks, and hands and feet were swollen. No cervical nodes, no joint swelling, no allergies. The nurse reported that the patient is in good health. The patient is being treated with oral BENADRYL. Laboratory data revealed Complete Blood Count was normal, Antinuclear Antibody test performed the results was negative and RAST test was negative for latex. The nurse reported that the RAST test were performed due to the client played with water balloon. It was unsure if the patient would receive the third dose. Additional information is not available.
Age: 1.3
Sex: F
Vaccine: HIBV, MMR
Symptoms: Autism, Constipation, Eczema
Clinical narrative: The MMR shot was one of the environmental factors contributing to diagnosis of Autism. Other eczema, chronic constipation are other symptoms.  10/23/2007 MR received for WCC on 2/14/2003 to 3/29/2005.  WCC on 2/14/03 with normal growth & dev however still walking with assistance at age 15 mon.  Child had seen opthomologist for eval of stabismus/pseudostrabismus. 18 mon WCC 5/16/03 shows only saying 4 words otherwise doing well.  Hearing eval 5/03 and myringotomy tubes placed 6/03.  TC with MD 8/27/03 re: autism.  MD advised to watch progression of speech and reassessment of skills now that pt is hearing well 2' to ear tubes.  Speech delay noted at 2yr WCC.  Speaks 3-5 words, no phrases. Receiving speech tx and early intervention. Multiple visits for ear issues-bleeding, drainage, OM. 3 yr check with developmental delay noted.  DX: Autistic Disorder. PDD. Refered to GI for constipation and stool withholding. See also 292954. Per 60 day follow up: Constant eczema, chronic constipation, autistic like characteristics.
Age: 82.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pruritus, Rash generalised, Rash vesicular
Clinical narrative: Presented 10/12/07 complaining of itchy, generalized vesicular rash which started about 2 weeks prior.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Herpes zoster, Musculoskeletal pain
Clinical narrative: Presented to office 10/12/07 complaining of severe left shoulder pain which started around 10/6.  Blisters on arm appeared 10/8 in dermatomal pattern.  Diagnosis:  shingles.  Treated with Valtrex 1000mg tid for 7 days and pain medication.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Sinus headache
Clinical narrative: C/O Pain in frontal sinus onset approximately five (5) minutes after adminstration of FluMist.  Reported the symptoms at 1150 and at this time symptoms at on and off.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Oxygen supplementation, Pharyngeal oedema
Clinical narrative: 5-10 minutes after receiving influenza (Fluzone) vaccine, pt c/o throat swelling. Epi and Benadry administered. O2 administered. Transferred to ED.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Rash at injection site about the size of an orange...rash is all red.  Patient says the injection site is quite sore as well.  Injection was given on Thursday October 11th.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Headache
Clinical narrative: The following day, severe headache, extreme dizziness, achiness, joint pain, nausea, weakness, chills, soreness at injection site.  Day 2, same as day 1, less severe, except for injection site which was more tender, swollen.  Day 3, nausea and injection site swelling and tenderness continues. Treated self with rest, naproxen and heat.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Nausea, Pain
Clinical narrative: The following day, severe headache, extreme dizziness, achiness, joint pain, nausea, weakness, chills, soreness at injection site.  Day 2, same as day 1, less severe, except for injection site which was more tender, swollen.  Day 3, nausea and injection site swelling and tenderness continues. Treated self with rest, naproxen and heat.
Age: 4.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling on her left arm where she received the shot.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever to 99.9  total body ache of muscles from 3 hours following shots of both flu and pneumonia  on 10/11/07 to 5:00 am 10/13/07. Wife who had just flu shot felt none of these sysmptoms.
Age: 1.33
Sex: F
Vaccine: DTAP, FLU3, HEPA, PNC
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: FEVER, REDNESS AND SWELL AT AND BELOW INJECTION SITE
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Oedema peripheral, Pruritus, Urticaria
Clinical narrative: Patient experienced swollen arm and fingers, hives, itching, and numbness in fingertip in the arm in which vaccine was injected. Symptoms were delayed onset and happened in approximately 20 hours after vaccination administration. There were no signs of inflammation at the injection site itself in the deltoid muscle. Patient attended a immediate care facility and received medrol dose pack and diphenhydramine treatment for his symptoms.
Age: 46.0
Sex: F
Vaccine: RUB
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Severe stabbing headaches night of vaccination, sense of brain trauma. Repeated headaches one week late, on 10/10/07, and on subsequent days through today (10/13)/07, with additional symptoms of light-headedness and nausea
Age: 1.17
Sex: F
Vaccine: DTAP, FLU3, HEPA
Symptoms: Contusion, Injection site induration, Skin discolouration
Clinical narrative: LEFT THIGH 1.5CM INDURATION AT SHOT SIGHT,  RED AND PURPLE BRUSE INNER L THIGH
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Pyrexia, Sensation of heaviness, Skin warm
Clinical narrative: ALL DAY SATURDAY RAN 102 FEVER, ALSO ARM SO HEAVY AND HURTING FROM RIGHT ABOVE ELBOW TO UP ON SHOULDER.  ON SUNDAY STILL RUNNING LOW GRADE FEVER OF 99.9 AND ARM STILL SORE AND RADIATING HEAT.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Erythema, Malaise, Nausea, Pain
Clinical narrative: Pt complained of feeling "sick" fever unchecked, dizzy, nausea, and vomiting the night after vaccination that am.  On 23rd had upper resp. symptoms and itching.  On 24th continued symptoms as above.  On 27th developed a fine red rash to trunk, arms and face.  On October 11th began having swelling of the bottoms of feet and fingers with aching soreness.  Pt took benadryl and lasix for swelling per private physician.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Pyrexia, Rash, Swelling, Vomiting
Clinical narrative: Pt complained of feeling "sick" fever unchecked, dizzy, nausea, and vomiting the night after vaccination that am.  On 23rd had upper resp. symptoms and itching.  On 24th continued symptoms as above.  On 27th developed a fine red rash to trunk, arms and face.  On October 11th began having swelling of the bottoms of feet and fingers with aching soreness.  Pt took benadryl and lasix for swelling per private physician.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Pain, X-ray normal
Clinical narrative: The morning after injection pt developed swelling at site that progressed for several days. The pain also continued to progress until severe. Pt seen in the office 7/3/07), evaluated and treated with analgesics.  xrays done at the visit were unremarkable.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Blood electrolytes normal, Cardiac function test normal, Cerebellar infarction, Computerised tomogram normal, Convulsion
Clinical narrative: On 7/25 pt had an episode of loss of conciousness, reported seizure activity (by 8 yo witness). Pt did have a very prolonged recovery phase- consistent with a post ictal period. Pt evaluated in the ER 7/25, admitted to the hospital for observation.  10/18/2007 MR received for DOS 7/25-26/2007 for D/C DX of Confusion.  Hx L frontal lobe spontaneous intracerebral hemorrhage 6/2005.  Hx HTN.  Hx hyperlipidemia.  Hx of tobacco abuse. Pt was found by husband lying on the floor.  Eyes were open however pt was not responding in verbally meaningful way. Pt was confused but was reovering upon arrival to ER. Pt has no recollection of event. Admitted for eval of mental status change.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Electroencephalogram abnormal, Encephalomalacia, Loss of consciousness, Nuclear magnetic resonance imaging abnormal, Postictal state
Clinical narrative: On 7/25 pt had an episode of loss of conciousness, reported seizure activity (by 8 yo witness). Pt did have a very prolonged recovery phase- consistent with a post ictal period. Pt evaluated in the ER 7/25, admitted to the hospital for observation.  10/18/2007 MR received for DOS 7/25-26/2007 for D/C DX of Confusion.  Hx L frontal lobe spontaneous intracerebral hemorrhage 6/2005.  Hx HTN.  Hx hyperlipidemia.  Hx of tobacco abuse. Pt was found by husband lying on the floor.  Eyes were open however pt was not responding in verbally meaningful way. Pt was confused but was reovering upon arrival to ER. Pt has no recollection of event. Admitted for eval of mental status change.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Renal failure chronic, Urticaria
Clinical narrative: ON 9/27/07 1145 RECEIVED VACCINE WHILE AT DAILYSIS CENTER AT 1730 WIFE NOTICED WHELPS DEVELOPED ON PATIENT FACE THAT WORSEN AND THEN GEGAN TO RESOLVE NEAR 2000, RESOLVED ON SKILL NURSE VISIT 9/28/07
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female with no medical history or allergies, who on 18-JUN-2007 was vaccinated IM with a first 0.5 ml dose of Gardasil (lot# 657622/0388U).  There was no concomitant medication.  On 18-JUL-2007, the patient fainted for a few seconds.  The patient was observed in the office for 15 minutes and fully recovered.   Unspecified medical attention was sought.  No diagnostic laboratory studies were performed.  It was reported that the patient was vaccinated with a second dose of the vaccine on 20-AUG-2007 and experienced no events.  No quality complaint was involved.  Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, UNK
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician assistant (P.A.) concerning a 9-week-old female with no pre-existing allergies, birth defects, or medical conditions who on 30-AUG-2007 was vaccinated orally with a first dose 2 ml dose of ROTATEQ vaccine (Lot# *05066"). There was no illness at the time of vaccination. Concomitant therapy that day included a first dose of PEDIARIX (Lot # AC21B115BB) administered IM in the left leg, and a first dose of ACTHIB (Lot # UF163AA administered IM in the right leg, and a first dose of PREVENAR vaccine (Lot # B08679K) adminsitered IM in the right leg. Subsequently, within seven days, the patient experienced vomiting and diarrhea.  The patient was seen in the E.R.  The stools were not tested for rotavirus.  It was reported that the vomiting and diarrhea lasted for 24 hours.  The patient recovered.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/12/2007. Follow up information indicated that on 01-SEP-2007 in the PM, within 72 hours of immnunization, the patient experienced vomiting and diarrhea lasting approximately 24 hours. Subsequently, the patient recovered from vomiting and diarrhea. There were no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations. No additional information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fall, Head injury, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female with no drug reactions or allergies and no pertinent medical attention who on 02-JUL-2007 was vaccinated intramuscularly with the first dose of GARDASIL. On 07-SEP-2007, the patient was vaccinated intramuscularly with the second dose of GARDASIL, (lot # "655766/0038U"). The patient fainted 3 minutes after receiving her second dose. The patient hit her head when she fell, but she refused to be taken to an emergency room. The patient sought unspecified medical attention. The patient recovered on 07-SEP-2007. No other information was available at this time. It was reported by the nurse that three patients fainted after receiving GARDASIL. This patient was the second of the three patients. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female with no drug reactions or allergies and no pertinent medical attention who on 02-JUL-2007 was vaccinated intramuscularly with the first dose of GARDASIL. On 07-SEP-2007, the patient was vaccinated intramuscularly with the second dose of GARDASIL, (lot # "655766/0038U"). The patient fainted 3 minutes after receiving her second dose. The patient hit her head when she fell, but she refused to be taken to an emergency room. The patient sought unspecified medical attention. The patient recovered on 07-SEP-2007. No other information was available at this time. It was reported by the nurse that three patients fainted after receiving GARDASIL. This patient was the second of the three patients. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, DTAP, HPV4, MNQ
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 16 year old female patient, who on 30-AUG-2007 was vaccinated in the right arm with the first dose, 0.5 ml of Gardasil (lot # 657006/0188U).  Concomitant vaccine therapy at the visit included a dose in the left arm of MENACTRA and a dose in the right arm of Tdap; other concomitant therapy included loratadine, DEPAKOTE, SEROQUEL, levothyroxine Na.  On 30-AUG-2007, "right after receiving Gardasil," the patient experienced tingling of her legs and arms, mainly on the right side.  At the time of this report, the outcome of the event was unknown.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, DTAP, HPV4, MNQ
Symptoms: Inappropriate schedule of drug administration, Paraesthesia
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 16 year old female patient, who on 30-AUG-2007 was vaccinated in the right arm with the first dose, 0.5 ml of Gardasil (lot # 657006/0188U).  Concomitant vaccine therapy at the visit included a dose in the left arm of MENACTRA and a dose in the right arm of Tdap; other concomitant therapy included loratadine, DEPAKOTE, SEROQUEL, levothyroxine Na.  On 30-AUG-2007, "right after receiving Gardasil," the patient experienced tingling of her legs and arms, mainly on the right side.  At the time of this report, the outcome of the event was unknown.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Culture stool, Diarrhoea, Laboratory test
Clinical narrative: Information has been received from a physician concerning a 3 month old male who on 14-AUG-2007 was vaccinated with his first oral dose of Rotateq (Lot# 657522/0769U).  Subsequently the patient developed diarrhea occurring about 4 times a day.  Medical attention was sought through a pediatric gastroenterologist.  The patient was treated with PREVACID (TAP) and then switched the patient to NUTRAMIGEN.  The patient's was not recovered.  The was no product quality complaint.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 3 month old male who on 14-AUG-2007 was vaccinated with his first oral dose of Rotateq (Lot# 657522/0769U).  Subsequently the patient developed diarrhea occurring about 4 times a day.  Medical attention was sought through a pediatric gastroenterologist.  The patient was treated with PREVACID (TAP) and then switched the patient to NUTRAMIGEN.  The patient's was not recovered.  The was no product quality complaint.  Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Severe local rxn.
Age: 72.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Local reaction
Clinical narrative: Severe local rxn.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Head injury, Loss of consciousness, Syncope
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 24 year old female with history of Raynaud's syndrome who on 07-MAR-2007 was vaccinated intramuscularly into the deltoid with a 0.5 ml first dose of GARDASIL. On an unspecified date the patient was vaccinated with a second dose of GARDASIL. On 19-SEP-2007 the patient was vaccinated with a third dose of GARDASIL (Lot # "1061U"). Concomitant therapy ORTHO-CYCLEN. On 19-SEP-2007 at 16:45, approximately 15 minutes after vaccination the patient was at the check out desk she had a syncope episode with brief loss of consciousness. She hit her head knocking the phone off the wall. There was no visible injury from the fall. The ambulance responded, The patient declined going to the emergency room. On 19-SEP-2007 after 15-20 minutes of observation, the patient recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fall, Head injury, Loss of consciousness, Syncope
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 24 year old female with history of Raynaud's syndrome who on 07-MAR-2007 was vaccinated intramuscularly into the deltoid with a 0.5 ml first dose of GARDASIL. On an unspecified date the patient was vaccinated with a second dose of GARDASIL. On 19-SEP-2007 the patient was vaccinated with a third dose of GARDASIL (Lot # "1061U"). Concomitant therapy ORTHO-CYCLEN. On 19-SEP-2007 at 16:45, approximately 15 minutes after vaccination the patient was at the check out desk she had a syncope episode with brief loss of consciousness. She hit her head knocking the phone off the wall. There was no visible injury from the fall. The ambulance responded, The patient declined going to the emergency room. On 19-SEP-2007 after 15-20 minutes of observation, the patient recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood pressure, Oxygen saturation, Syncope vasovagal
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female who on 10-SEP-2007 was vaccinated IM in the left deltoid with a dose of GARDASIL (658556/1060U). Concomitant therapy included ketoconazole shampoo and clindamycin gel. The nurse reported that the patient has a vasovagal reaction after vaccination. After the vaccination the patient sat with her parents in the office. Within 5-10 minutes the parents indicated that the patient needed help. A physician and two medical assistants came to her aid. Her parents mentioned that she had uncontrolled hand movements. The patient was taken inside and instructed to place her head between he knees. Also she laid down and her blood pressure plus pulse ox were checked. They both were normal. The nurse reported that the patient was never incoherent and never lost consciousness. After 15 minutes, the patient's symptoms resolved. No product quality complaint was involved. Additional information has been requested. Follow up information was received from the nurse practitioner by a chart  notre which was recorded by a physician concerning the patient who had a penicillin allergy and a history of abnormal pap (06-SEP-20070. On 10-SEP-2007, the patient with penicillin allergy was vaccinated with the first dose of GARDASIL IM in her left deltoid. Concomitant therapy included YAZ and ZYRTEK 10 mg. According to the physician, the patient had a fainting epidsode after GARDASIL. The patient was coherent. Vital signs: BP 120/74, pulse within normal limit. There was no shortness of breath. The patient's mom called the reporter on 21-SEP-2007. The patient had worsening headache since GARDASIL. The patient's mom did have patient headache evaluated, including a CT scan. The physician did not have this report. Subsequently, the patient recovered. On 09-MAY-2008 the now 19 yearold patient visited office for pregnancy. On 02-OCT-2008. Pap smear test showed within normal limit. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood pressure normal, Dyskinesia, Oxygen saturation normal, Syncope vasovagal
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female who on 10-SEP-2007 was vaccinated IM in the left deltoid with a dose of GARDASIL (658556/1060U). Concomitant therapy included ketoconazole shampoo and clindamycin gel. The nurse reported that the patient has a vasovagal reaction after vaccination. After the vaccination the patient sat with her parents in the office. Within 5-10 minutes the parents indicated that the patient needed help. A physician and two medical assistants came to her aid. Her parents mentioned that she had uncontrolled hand movements. The patient was taken inside and instructed to place her head between he knees. Also she laid down and her blood pressure plus pulse ox were checked. They both were normal. The nurse reported that the patient was never incoherent and never lost consciousness. After 15 minutes, the patient's symptoms resolved. No product quality complaint was involved. Additional information has been requested. Follow up information was received from the nurse practitioner by a chart  notre which was recorded by a physician concerning the patient who had a penicillin allergy and a history of abnormal pap (06-SEP-20070. On 10-SEP-2007, the patient with penicillin allergy was vaccinated with the first dose of GARDASIL IM in her left deltoid. Concomitant therapy included YAZ and ZYRTEK 10 mg. According to the physician, the patient had a fainting epidsode after GARDASIL. The patient was coherent. Vital signs: BP 120/74, pulse within normal limit. There was no shortness of breath. The patient's mom called the reporter on 21-SEP-2007. The patient had worsening headache since GARDASIL. The patient's mom did have patient headache evaluated, including a CT scan. The physician did not have this report. Subsequently, the patient recovered. On 09-MAY-2008 the now 19 yearold patient visited office for pregnancy. On 02-OCT-2008. Pap smear test showed within normal limit. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Contusion, Induration, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female with no pertinent medical history and no pertinent medical history and no drug reactions/allergies who on 11-SEP-2007 was vaccinated with the first dose of Gardasil (lot # 658560/1062U) 0.5 ml IM in the left upper deltoid. There was no concomitant medication. On 11-SEP-2007, shortly after receiving the vaccine, the patient experienced pain in her forearm and a bruise on the base of her left thumb. Her left hand was cool to the touch, weak, and painful. There was no reaction at the injection site. Medical attention was sought. She was given BENADRYL and observed for 30-45 minutes. The patient's symptoms improved slightly. She was instructed to take ADVIL for pain and to elevate her hand. The nurse contacted the patient's mother last night (11-SEP-2007) and was informed that the patient had a headache but was currently sleeping. The mother was instructed to contact the office with an update on 12-SEP-2007, but she had not yet contacted the office. At the time of reporting, the outcome of the events was unspecified. The nurse felt that the events "could of been life threatening". Clarification was obtained from the nurse via telephone. The registered nurse confirmed that the events were not life threatening. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Contusion, Pain, Pain in extremity, Peripheral coldness
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female with no pertinent medical history and no pertinent medical history and no drug reactions/allergies who on 11-SEP-2007 was vaccinated with the first dose of Gardasil (lot # 658560/1062U) 0.5 ml IM in the left upper deltoid. There was no concomitant medication. On 11-SEP-2007, shortly after receiving the vaccine, the patient experienced pain in her forearm and a bruise on the base of her left thumb. Her left hand was cool to the touch, weak, and painful. There was no reaction at the injection site. Medical attention was sought. She was given BENADRYL and observed for 30-45 minutes. The patient's symptoms improved slightly. She was instructed to take ADVIL for pain and to elevate her hand. The nurse contacted the patient's mother last night (11-SEP-2007) and was informed that the patient had a headache but was currently sleeping. The mother was instructed to contact the office with an update on 12-SEP-2007, but she had not yet contacted the office. At the time of reporting, the outcome of the events was unspecified. The nurse felt that the events "could of been life threatening". Clarification was obtained from the nurse via telephone. The registered nurse confirmed that the events were not life threatening. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who on 20-SEP-2007 was vaccinated with a first dose of Gardasil.  The physician reported that patient fainted after receiving her injection.  Patient sought unspecified medical attention.  The outcome was unknown.  Additional information has been requested. This is in follow-up to reorts previously submitted from a physician and a rgistered nurse, concerning a 10 year old female child with an allergy to codeine, and a viral upper respiratory infection at the time of vaccination, who on 18-SEPT-2007 (previously reported as 20-SEP-2007), at approximately 3:45 p.m. was vaccnated IM in the left deltoid, with the first dose of GARDASIL (lot #658282/0929U). The physician reported that the patient fainted after receiving her injection, adn the nurse added that she had a "fainting episode" while standing in the hallway, approximately 5 minutes after the vaccination. The child fell to the floor and hit her face and arm. She recovered from the fainting in approximately 1 minute, she was told to sit for ten minutes, and was given something todrink. She recovered the same day. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drug hypersensitivity, Fall, Syncope, Viral upper respiratory tract infection
Clinical narrative: Information has been received from a physician concerning a female patient who on 20-SEP-2007 was vaccinated with a first dose of Gardasil.  The physician reported that patient fainted after receiving her injection.  Patient sought unspecified medical attention.  The outcome was unknown.  Additional information has been requested. This is in follow-up to reorts previously submitted from a physician and a rgistered nurse, concerning a 10 year old female child with an allergy to codeine, and a viral upper respiratory infection at the time of vaccination, who on 18-SEPT-2007 (previously reported as 20-SEP-2007), at approximately 3:45 p.m. was vaccnated IM in the left deltoid, with the first dose of GARDASIL (lot #658282/0929U). The physician reported that the patient fainted after receiving her injection, adn the nurse added that she had a "fainting episode" while standing in the hallway, approximately 5 minutes after the vaccination. The child fell to the floor and hit her face and arm. She recovered from the fainting in approximately 1 minute, she was told to sit for ten minutes, and was given something todrink. She recovered the same day. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: Information has been received from a health professional concerning an 18 year old white female who on 16-JUL-2007 at 14:30 PM was vaccinated IM left arm with a first dose of GARDASIL (Lot # 658222/0927U). Concomitant therapy included an IM dose on right arm of MENACTRA (Lot # U2377BA). On 16-JUL-2007 at 18:00 PM the patient experienced headache, fever and dizziness for 2-3 days. At the time of report the patient recovered. Unspecified medical attention was sought. There were no adverse events following prior vaccination for the patient or her sibling. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Dizziness, Headache, No reaction on previous exposure to drug, Pyrexia
Clinical narrative: Information has been received from a health professional concerning an 18 year old white female who on 16-JUL-2007 at 14:30 PM was vaccinated IM left arm with a first dose of GARDASIL (Lot # 658222/0927U). Concomitant therapy included an IM dose on right arm of MENACTRA (Lot # U2377BA). On 16-JUL-2007 at 18:00 PM the patient experienced headache, fever and dizziness for 2-3 days. At the time of report the patient recovered. Unspecified medical attention was sought. There were no adverse events following prior vaccination for the patient or her sibling. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Dizziness, Tremor
Clinical narrative: Information has been received from a registered nurse concerning a female (age unknown), who, on an unspecified date, was vaccinated intramuscularly with a 0.5mL dose of Gardasil. Subsequently, the patient fainted about 10 minutes after the vaccination. No other symptoms were noted. The patient was seen at the office. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow-up information has been received from a registered nurse concerning a 16 year old female student with a history of orthostatic hypotension, who, on 25-SEP-2007 at 11:28 was vaccinated intramuscularly in the right upper arm with a 0.5mL first dose of GARDASIL (Lot# 657006/0188U). Concomitant vaccinations included a first dose of MENACTRA (Lot# U23557AA), administered intramuscularly into the left upper arm at 11:29. There were no illnesses at the time of the vaccinations. On 25-SEP-2007 (reported as at approximately 9:00), the patient experienced a "dizzy spell" after vaccination. There was no syncope (previously reported as the patient fainted about 10 minutes after the vaccination). No other symptoms were noted. The patient was seen at the office. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.