chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Drug exposure during pregnancy, Heart rate increased, Insomnia, Pregnancy test positive
Clinical narrative: Information has been received through the Merck pregnancy registry from an 18 year old female patient with no known allergies and a medical history of blood clots, who on 18-FEB-2008 was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (Lot # 659441/1446U). There was no concomitant medication. On 18-FEB-2008 when the patient received the vaccination. "her heart was beating really fast, and she couldn't sleep because of sharp pain in stomach." On 25-MAR-2008 the patient stated that a pregnancy test given "today," showed that she was 8.5 weeks pregnant. At the time of this report the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter with a history of "sensitivity to vaccines" who about a month ago on approximately 25-FEB-2008 was vaccinated with her first dose of Gardasil (lot# unspecified, injection site and route not reported).  There was no concomitant medication.  The patient experienced pain at the site of injection and developed arthralgia after receiving her her first dose.  The arthralgia developed about 24 hours after receiving Gardasil and lasted 48 hours.  The patient sought medical attention by speaking with the physician.  The physician's name is "Dr."  No other information about the physician was available.  The patient recovered on an unspecified date.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site anaesthesia
Clinical narrative: Information has been received from a physician concerning a female who on 25-MAR-2008 was vaccinated with her second dose of GARDASIL (lot# not reported).  Immediately after vaccination the patient experienced numbness at the injection site.  It was reported that the numbness was transient, lasting just a few seconds.  The numbness resolved as soon as the patient relaxed her arm after the vaccination.  Additional information has been requested. Follow up was received on 12-MAY-2008 from the nurse. She stated she does think the numbness was related to GARDASIL. She does not have any additional information and does not want to receive any further correspondence. Additional information was received on 20-MAY-2008. No further information to provided. Not a vaccine reaction. Patient tensed arm which cut off blood flow resulting in numbness.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site inflammation, Injection site pain, Musculoskeletal discomfort
Clinical narrative: Information has been received from a nurse practitioner concerning a 21 female who on 13-MAR-2008 was vaccinated with her first dose of 0.5 ml GARDASIL (Lot #659962/1740U) intramuscularly in the deltoid.  The nurse practitioner reported that the patient had pain at the injection site for 2 days (onset date not specified).  The pain began improving but on 24-MAR-2008 the patient reported tightness in the shoulder where the GARDASIL vaccine was given, inflammation, and was tender to the touch.  The patient sought medical attention by speaking with the nurse practitioner on an unspecified date.  The patient was treated with ibuprofen (MOTRIN) and hot/warm compresses.  At the time of reporting the patient's outcome was unknown.  No other information was available from the nurse practitioner.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 21-MAR-2008, was vaccinated with a fourth dose of Gardasil (lot# not reported).  Subsequently, the patient experienced inappropriate schedule of vaccine administered.  On 24-MAR-2008 the patient experienced injection site swelling, injection site redness and injection site soreness.  The patient sought unspecified medical attention.  No additional information was available.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 25-MAR-2008 was vaccinated IM with Gardasil (lot# not reported).  It was unknown if this was the patient's first dose.  On 25-MAR-2008 the patient experienced syncope.  The patient sought unspecified medical attention and it was unknown if the doctor was going to continue with the vaccination series.  Subsequently, the patient recovered from syncope. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, MNQ
Symptoms: Chest pain, Computerised tomogram normal, Electrocardiogram normal, Eye pain, Head injury
Clinical narrative: Information has been received from a medical assistant concerning a 15 year old female who on 11-FEB-2008 was vaccinated IM with the first dose of GARDASIL (Lot # 657622/0388U). Concomitant therapy included MENACTRA. Each day since the vaccinations the patient developed new symptoms such as eye pain/pressure in both eyeballs, chest pain like heart attack, headache, neck pain, both arms tingling and crackling with pain, both legs tingling, ribs on both sides ache, sides hurting, fainting frequently (7 times in one day). Patient then would hit her head when she fainted. Patient trying to get in with a neurologist. Medical attention was sought in the emergency room several times. At the time of reporting the patient had not recovered. No product quality complaint was involved. Additional information has been requested.  6/10/08 Reviewed PCP medical records which consisted of various ER records. 1/15/08 -- Seen in ER for chest pain.  Only records provided are labs which reveal mild anemia. 3/6/08 -- Seen in different ER for chest discomfort, pain in right calf, trouble breathing.  Had been seen earlier in day at clinic for same & received Toradol injection. DX w/chest wall pain & tx w/motrin.   3/11/08 Seen in 3rd ER for syncopal episodes x 2 days, epigastric pain, HA x 2-3 wks, & intermittent chest pain x 2 mos.  States chest pain started after hit w/paint ball 6 wks prior.  Admittted to family stress & frequent parental arguments.  Patient is home schooled entire life.   3/13/08 Seen in 4th ER myalgias, syncope & chest pain x 3 mo  3/14/08 Seen in 5th ER for passing out x 1 week w/eyes rolling back & wakes w/HA or chest pain.  Dx w/benign syncopal episode 3/16/08 Returned to ER #5 w/chest pain, epigastric pain, syncope & leg pains x 6-8 wks.  MSW eval done.  Referred for outpatient neuro consult.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, MNQ
Symptoms: Headache, Neck pain, Pain, Paraesthesia, Syncope
Clinical narrative: Information has been received from a medical assistant concerning a 15 year old female who on 11-FEB-2008 was vaccinated IM with the first dose of GARDASIL (Lot # 657622/0388U). Concomitant therapy included MENACTRA. Each day since the vaccinations the patient developed new symptoms such as eye pain/pressure in both eyeballs, chest pain like heart attack, headache, neck pain, both arms tingling and crackling with pain, both legs tingling, ribs on both sides ache, sides hurting, fainting frequently (7 times in one day). Patient then would hit her head when she fainted. Patient trying to get in with a neurologist. Medical attention was sought in the emergency room several times. At the time of reporting the patient had not recovered. No product quality complaint was involved. Additional information has been requested.  6/10/08 Reviewed PCP medical records which consisted of various ER records. 1/15/08 -- Seen in ER for chest pain.  Only records provided are labs which reveal mild anemia. 3/6/08 -- Seen in different ER for chest discomfort, pain in right calf, trouble breathing.  Had been seen earlier in day at clinic for same & received Toradol injection. DX w/chest wall pain & tx w/motrin.   3/11/08 Seen in 3rd ER for syncopal episodes x 2 days, epigastric pain, HA x 2-3 wks, & intermittent chest pain x 2 mos.  States chest pain started after hit w/paint ball 6 wks prior.  Admittted to family stress & frequent parental arguments.  Patient is home schooled entire life.   3/13/08 Seen in 4th ER myalgias, syncope & chest pain x 3 mo  3/14/08 Seen in 5th ER for passing out x 1 week w/eyes rolling back & wakes w/HA or chest pain.  Dx w/benign syncopal episode 3/16/08 Returned to ER #5 w/chest pain, epigastric pain, syncope & leg pains x 6-8 wks.  MSW eval done.  Referred for outpatient neuro consult.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 15 year old female who on 11-FEB-2008 was vaccinated IM with the first dose of GARDASIL (Lot # 657622/0388U). Concomitant therapy included MENACTRA. Each day since the vaccinations the patient developed new symptoms such as eye pain/pressure in both eyeballs, chest pain like heart attack, headache, neck pain, both arms tingling and crackling with pain, both legs tingling, ribs on both sides ache, sides hurting, fainting frequently (7 times in one day). Patient then would hit her head when she fainted. Patient trying to get in with a neurologist. Medical attention was sought in the emergency room several times. At the time of reporting the patient had not recovered. No product quality complaint was involved. Additional information has been requested.  6/10/08 Reviewed PCP medical records which consisted of various ER records. 1/15/08 -- Seen in ER for chest pain.  Only records provided are labs which reveal mild anemia. 3/6/08 -- Seen in different ER for chest discomfort, pain in right calf, trouble breathing.  Had been seen earlier in day at clinic for same & received Toradol injection. DX w/chest wall pain & tx w/motrin.   3/11/08 Seen in 3rd ER for syncopal episodes x 2 days, epigastric pain, HA x 2-3 wks, & intermittent chest pain x 2 mos.  States chest pain started after hit w/paint ball 6 wks prior.  Admittted to family stress & frequent parental arguments.  Patient is home schooled entire life.   3/13/08 Seen in 4th ER myalgias, syncope & chest pain x 3 mo  3/14/08 Seen in 5th ER for passing out x 1 week w/eyes rolling back & wakes w/HA or chest pain.  Dx w/benign syncopal episode 3/16/08 Returned to ER #5 w/chest pain, epigastric pain, syncope & leg pains x 6-8 wks.  MSW eval done.  Referred for outpatient neuro consult.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, MNQ
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Crying, Dizziness
Clinical narrative: Information has been received from a medical assistant concerning a 15 year old female who on 11-FEB-2008 was vaccinated IM with the first dose of GARDASIL (Lot # 657622/0388U). Concomitant therapy included MENACTRA. Each day since the vaccinations the patient developed new symptoms such as eye pain/pressure in both eyeballs, chest pain like heart attack, headache, neck pain, both arms tingling and crackling with pain, both legs tingling, ribs on both sides ache, sides hurting, fainting frequently (7 times in one day). Patient then would hit her head when she fainted. Patient trying to get in with a neurologist. Medical attention was sought in the emergency room several times. At the time of reporting the patient had not recovered. No product quality complaint was involved. Additional information has been requested.  6/10/08 Reviewed PCP medical records which consisted of various ER records. 1/15/08 -- Seen in ER for chest pain.  Only records provided are labs which reveal mild anemia. 3/6/08 -- Seen in different ER for chest discomfort, pain in right calf, trouble breathing.  Had been seen earlier in day at clinic for same & received Toradol injection. DX w/chest wall pain & tx w/motrin.   3/11/08 Seen in 3rd ER for syncopal episodes x 2 days, epigastric pain, HA x 2-3 wks, & intermittent chest pain x 2 mos.  States chest pain started after hit w/paint ball 6 wks prior.  Admittted to family stress & frequent parental arguments.  Patient is home schooled entire life.   3/13/08 Seen in 4th ER myalgias, syncope & chest pain x 3 mo  3/14/08 Seen in 5th ER for passing out x 1 week w/eyes rolling back & wakes w/HA or chest pain.  Dx w/benign syncopal episode 3/16/08 Returned to ER #5 w/chest pain, epigastric pain, syncope & leg pains x 6-8 wks.  MSW eval done.  Referred for outpatient neuro consult.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, MNQ
Symptoms: Eye movement disorder, Eye pain, Fall, Fatigue, Headache
Clinical narrative: Information has been received from a medical assistant concerning a 15 year old female who on 11-FEB-2008 was vaccinated IM with the first dose of GARDASIL (Lot # 657622/0388U). Concomitant therapy included MENACTRA. Each day since the vaccinations the patient developed new symptoms such as eye pain/pressure in both eyeballs, chest pain like heart attack, headache, neck pain, both arms tingling and crackling with pain, both legs tingling, ribs on both sides ache, sides hurting, fainting frequently (7 times in one day). Patient then would hit her head when she fainted. Patient trying to get in with a neurologist. Medical attention was sought in the emergency room several times. At the time of reporting the patient had not recovered. No product quality complaint was involved. Additional information has been requested.  6/10/08 Reviewed PCP medical records which consisted of various ER records. 1/15/08 -- Seen in ER for chest pain.  Only records provided are labs which reveal mild anemia. 3/6/08 -- Seen in different ER for chest discomfort, pain in right calf, trouble breathing.  Had been seen earlier in day at clinic for same & received Toradol injection. DX w/chest wall pain & tx w/motrin.   3/11/08 Seen in 3rd ER for syncopal episodes x 2 days, epigastric pain, HA x 2-3 wks, & intermittent chest pain x 2 mos.  States chest pain started after hit w/paint ball 6 wks prior.  Admittted to family stress & frequent parental arguments.  Patient is home schooled entire life.   3/13/08 Seen in 4th ER myalgias, syncope & chest pain x 3 mo  3/14/08 Seen in 5th ER for passing out x 1 week w/eyes rolling back & wakes w/HA or chest pain.  Dx w/benign syncopal episode 3/16/08 Returned to ER #5 w/chest pain, epigastric pain, syncope & leg pains x 6-8 wks.  MSW eval done.  Referred for outpatient neuro consult.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, MNQ
Symptoms: Laboratory test normal, Musculoskeletal chest pain, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a medical assistant concerning a 15 year old female who on 11-FEB-2008 was vaccinated IM with the first dose of GARDASIL (Lot # 657622/0388U). Concomitant therapy included MENACTRA. Each day since the vaccinations the patient developed new symptoms such as eye pain/pressure in both eyeballs, chest pain like heart attack, headache, neck pain, both arms tingling and crackling with pain, both legs tingling, ribs on both sides ache, sides hurting, fainting frequently (7 times in one day). Patient then would hit her head when she fainted. Patient trying to get in with a neurologist. Medical attention was sought in the emergency room several times. At the time of reporting the patient had not recovered. No product quality complaint was involved. Additional information has been requested.  6/10/08 Reviewed PCP medical records which consisted of various ER records. 1/15/08 -- Seen in ER for chest pain.  Only records provided are labs which reveal mild anemia. 3/6/08 -- Seen in different ER for chest discomfort, pain in right calf, trouble breathing.  Had been seen earlier in day at clinic for same & received Toradol injection. DX w/chest wall pain & tx w/motrin.   3/11/08 Seen in 3rd ER for syncopal episodes x 2 days, epigastric pain, HA x 2-3 wks, & intermittent chest pain x 2 mos.  States chest pain started after hit w/paint ball 6 wks prior.  Admittted to family stress & frequent parental arguments.  Patient is home schooled entire life.   3/13/08 Seen in 4th ER myalgias, syncope & chest pain x 3 mo  3/14/08 Seen in 5th ER for passing out x 1 week w/eyes rolling back & wakes w/HA or chest pain.  Dx w/benign syncopal episode 3/16/08 Returned to ER #5 w/chest pain, epigastric pain, syncope & leg pains x 6-8 wks.  MSW eval done.  Referred for outpatient neuro consult.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, MNQ
Symptoms: Sensory disturbance, Syncope
Clinical narrative: Information has been received from a medical assistant concerning a 15 year old female who on 11-FEB-2008 was vaccinated IM with the first dose of GARDASIL (Lot # 657622/0388U). Concomitant therapy included MENACTRA. Each day since the vaccinations the patient developed new symptoms such as eye pain/pressure in both eyeballs, chest pain like heart attack, headache, neck pain, both arms tingling and crackling with pain, both legs tingling, ribs on both sides ache, sides hurting, fainting frequently (7 times in one day). Patient then would hit her head when she fainted. Patient trying to get in with a neurologist. Medical attention was sought in the emergency room several times. At the time of reporting the patient had not recovered. No product quality complaint was involved. Additional information has been requested.  6/10/08 Reviewed PCP medical records which consisted of various ER records. 1/15/08 -- Seen in ER for chest pain.  Only records provided are labs which reveal mild anemia. 3/6/08 -- Seen in different ER for chest discomfort, pain in right calf, trouble breathing.  Had been seen earlier in day at clinic for same & received Toradol injection. DX w/chest wall pain & tx w/motrin.   3/11/08 Seen in 3rd ER for syncopal episodes x 2 days, epigastric pain, HA x 2-3 wks, & intermittent chest pain x 2 mos.  States chest pain started after hit w/paint ball 6 wks prior.  Admittted to family stress & frequent parental arguments.  Patient is home schooled entire life.   3/13/08 Seen in 4th ER myalgias, syncope & chest pain x 3 mo  3/14/08 Seen in 5th ER for passing out x 1 week w/eyes rolling back & wakes w/HA or chest pain.  Dx w/benign syncopal episode 3/16/08 Returned to ER #5 w/chest pain, epigastric pain, syncope & leg pains x 6-8 wks.  MSW eval done.  Referred for outpatient neuro consult.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Haemorrhage
Clinical narrative: Information has been received from a nurse for Merck Pregnancy Registry concerning a female who in February 2008, was vaccinated with the second dose of Gardasil while she was pregnant.  Now she is experiencing bleeding.  Unknown medical attention was sought. Patient outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Haemorrhage
Clinical narrative: Information has been received from a physician concerning a female (age unknown) with unknown medical history, who in "September 2007", was vaccinated intramuscularly with a first 0.5 mL dose of GARDASIL (Lot # unknown). Subsequently after the first dose, on an unspecified date, the patient experienced "internal bleeding" after first dose. Outcome unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning her daughter, a female (age unknown) with unknown medical history, who on an unknown date was vaccinated (route unknown) with three doses of GARDASIL (Lot # unknown).  Subsequently, on an unknown, after receiving the third dose the patient experienced redness, tightness, and pain in her arm where she received injection.  The physician reported that "the patient had also experienced this after the first and second dose of the series, but the experience she had with the third dose was more severe".  Subsequently, on an unspecified date, on therapy, the patient recovered from redness, tightness, and pain in arm where received injection.  The patient sought unspecified medical attention.  No product quality control was involved.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Rash
Clinical narrative: Information has been received from a physician who reported that a medical assistant reported to her concerning a 13 year old female who on 03-FEB-2008 was vaccinated with a 1st dose of Gardasil (lot# not reported). Concomitant vaccinations that same day included MENACTRA (lot# not reported). On 04-FEB-2008 the patient developed a rash on her face, arms and a little bit around her chest area. The patient was treated with MEDROL for approximately one week. On an unspecified date, the patient recovered from the rash on her face, arms and chest area. Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Influenza like illness, Mood swings
Clinical narrative: Information has been received from a physician concerning a female who on 02-AUG-2007 was vaccinated 0.5mL, IM with GARDASIL (Lot# not reported). Concomitant therapy included MENACTRA (lot# not reported). Following her vaccination the patient experienced flu like symptoms and mood swings. Subsequently, the patient recovered from flu like symptoms and mood swings. The patient sought unspecified medical attention at her physician's office. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Chest pain, Dizziness, Dysphonia, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 16 year old female with obsessive-complusive disorder, panic attacks, anaemia, scoliosis with fusion (2005), and allergies to cat dander, pollen and grass who on 18-AUG-2007 was vaccinated with her first dose of 0.5 ml GARDASIL (Lot #653735/0688F) intramuscularly in the left arm. Concomitant therapy included NOVO-PAROXETINE and iron tablets (unspecified). These symptoms were reported to the physician during an appointment on 21-FEB-2008. The patient reported to the physician that after her first dose on 18-AUG-2007 she developed wheezing, a hoarse voice, and chest pain in the car after her vaccination. The patient said the chest pain traveled from her arm to her chest, and stopped near her neck. She also reported to the physician being anxious and feeling lightheaded. All symptoms resolved within two minutes. The patient had come to the physician's office on 21-FEB-2008 for a second dose GARDASIL. Due to the symptoms on the first dose, the patient was not given a second dose. Also, the patient had reported that she had a yeast allergy. She stated that she experienced swelling after eating a pizza. On 21-MAR-2008 the patient reported that she was joking about her yeast allergy. She is requesting the second dose of GARDASIL. There was no further information available. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Wheezing
Clinical narrative: Information has been received from a physician concerning a 16 year old female with obsessive-complusive disorder, panic attacks, anaemia, scoliosis with fusion (2005), and allergies to cat dander, pollen and grass who on 18-AUG-2007 was vaccinated with her first dose of 0.5 ml GARDASIL (Lot #653735/0688F) intramuscularly in the left arm. Concomitant therapy included NOVO-PAROXETINE and iron tablets (unspecified). These symptoms were reported to the physician during an appointment on 21-FEB-2008. The patient reported to the physician that after her first dose on 18-AUG-2007 she developed wheezing, a hoarse voice, and chest pain in the car after her vaccination. The patient said the chest pain traveled from her arm to her chest, and stopped near her neck. She also reported to the physician being anxious and feeling lightheaded. All symptoms resolved within two minutes. The patient had come to the physician's office on 21-FEB-2008 for a second dose GARDASIL. Due to the symptoms on the first dose, the patient was not given a second dose. Also, the patient had reported that she had a yeast allergy. She stated that she experienced swelling after eating a pizza. On 21-MAR-2008 the patient reported that she was joking about her yeast allergy. She is requesting the second dose of GARDASIL. There was no further information available. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood pressure normal, Bradycardia, Full blood count, Glucose tolerance test normal, Immediate post-injection reaction
Clinical narrative: Information has been received from a physician concerning a 15 year old female with unknown medial history, who on an unspecified date was vaccinated intramuscularly with a dose of GARDASIL. Subsequently, on an unknown date, immediately after being vaccinated, the patient experienced syncope. The patient was fine before leaving the office. No lab diagnostic studies were performed. Subsequently, on an unknown date, the patient recovered from syncope. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008. Initial and follow up information has been received from a physician concerning a 14 year old female with no pre-existing allergies, birth defects, or medical conditions, who on 20-FEB-2008, in the PM, was vaccinated intramuscularly in the right arm with a first dose of GARDASIL (Lot # reported as "12676"). On the same day, 20-FEB-2008, in the PM, she was also vaccinated intramuscularly in the left arm with a first dose of ADACEL (Lot # C2942AA) and intramuscularly in the right arm with a first dose of MENACTRA. Subsequently, on 20-FEB-2008, immediately after being vaccinated, while obtaining a CBC fingerstick, the patient fainted, pallor noted, bradycardia, with a heart rate 45, and normal BP and DXT. The patient's feet were elevated and laid supine. The patient recovered with in five minutes. Heart rate was normal 70's (lying down) and 90 (standing), and regular rhythm noted. The blood pressure was 126/82 and glucose was 105. The patient was seen by a cardiologist. The patient was fine before leaving the office. No product quality complaint was involved. No illnesses at the time of vaccination were noted. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pallor, Respiratory rate decreased, Syncope, Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female with unknown medial history, who on an unspecified date was vaccinated intramuscularly with a dose of GARDASIL. Subsequently, on an unknown date, immediately after being vaccinated, the patient experienced syncope. The patient was fine before leaving the office. No lab diagnostic studies were performed. Subsequently, on an unknown date, the patient recovered from syncope. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008. Initial and follow up information has been received from a physician concerning a 14 year old female with no pre-existing allergies, birth defects, or medical conditions, who on 20-FEB-2008, in the PM, was vaccinated intramuscularly in the right arm with a first dose of GARDASIL (Lot # reported as "12676"). On the same day, 20-FEB-2008, in the PM, she was also vaccinated intramuscularly in the left arm with a first dose of ADACEL (Lot # C2942AA) and intramuscularly in the right arm with a first dose of MENACTRA. Subsequently, on 20-FEB-2008, immediately after being vaccinated, while obtaining a CBC fingerstick, the patient fainted, pallor noted, bradycardia, with a heart rate 45, and normal BP and DXT. The patient's feet were elevated and laid supine. The patient recovered with in five minutes. Heart rate was normal 70's (lying down) and 90 (standing), and regular rhythm noted. The blood pressure was 126/82 and glucose was 105. The patient was seen by a cardiologist. The patient was fine before leaving the office. No product quality complaint was involved. No illnesses at the time of vaccination were noted. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 22 year old female who on 18-MAR-2008 was vaccinated with her first dose of GARDASIL (lot# not reported). On 18-MAR-2008 the patient fainted 4 hours after receiving the vaccine. Subsequently, the patient recovered from fainting. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a health professional concerning a 15- year old female who was vaccinated IM with 0.5 ml doses of GARDASIL. The patient had received all three doses. After each dose the patient developed weakness, dizziness and fainting. Unknown medical attention was sought. At an unknown date the patient recovered. No PQC involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Syncope
Clinical narrative: Information has been received from a licensed visiting nurse concerning an unspecified number of females (ages unknown), who, on unspecified dates, were vaccinated with doses of GARDASIL. It was reported that "alot of girls are fainting (10%) and complaining that the injection was very painful (100%)." The fainting occurred when the patients were in the waiting room or getting ready to got to the waiting room. At the time of the report, the outcome of the patients were unknown. No product quality complaint was involved. Follow-up information indicated that the n nurse had not kept a record of the specific patients that had experienced these symptoms. It was reported that the nurse felt that the symptoms were common in patients who were receiving multiple vaccinations at the same visit. It was reported that the patients would become panic stricken with the anticipation of multiple injections. Due to the fact that no records of these incidences had been kept, no additional patient details could be provided. This is one of two reports from the same source. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site mass, Pain
Clinical narrative: Information has been received from a health professional concerning a 23 year old white female, with no known drug allergies, who on 11-FEB-2008 was vaccinated with a first dose of GARDASIL in the left deltoid. Secondary suspect therapy included vaccination in the left deltoid with a first dose of MENACTRA. On 06-MAR-2008 the patient developed a knot at in left deltoid and a pain that radiates from knot to elbow up to neck and ear. It was reported that the patient had a cold at the time of vaccination. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Nervousness, Oral herpes
Clinical narrative: Information has been received from a physician concerning an 18 year old female, who on 17-MAR-2008 was vaccinated with a first dose of GARDASIL, the patient was noted to be very nervous. Concomitant therapy included antimicrobials (unspecified) for acne. Subsequently, a couple days post vaccination the patient developed a herpes outbreak around her mouth and claimed that she had never had any outbreaks prior to the vaccination. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Gait disturbance, Labia enlarged, Vulvovaginal pruritus
Clinical narrative: Information has been received from a physician concerning a 16 year old female who was vaccinated with two doses of Gardasil. After the patient received the first dose of Gardasil she developed severe itching and swelling of the labia. After the second dose of Gardasil the second incident was more severe than the first incident. After the second dose the patient missed eight days of school and had difficulty walking. She was placed on steroids for eight days and the symptoms resolved. It was reported that the patient did not have a yeast infection. Unknown medical attention was sought in the office. Patient outcome was recovered. No product quality complaint was involved. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a nurse practitioner concerning a female with asthma, mood disorder nos, fruit allergy, hypersensitivity to vegetables, oil sensitivity, peanut allergy, drug hypersensitivity to DECADRON and PREDNISONE and allergic reaction to antibiotics who on 26-DEC-2007 was vaccinated 0.5mL IM in the right deltoid with a 1st dose of GARDASIL (lot# 659441/1446U). That same day the patient received an IM injection of DEPO-PROVERA in her left deltoid. "A few days later the patient phoned the office to report that she had slight redness and edema at the injection site." Which injection site was not specified. On 05-MAR-2008 the patient was vaccinated 0.5mL IM in the right deltoid with a 2nd dose of GARDASIL (lot# 659964/1978U). Concomitant therapy included DEPO-PROVERA which was given in the left deltoid and vitamins (unspecified). On approximately 07-MAR-2008 (2 to 3 days after vaccination) the patient noticed a rash at the injection site with itching. The patient (on approximately 09-MAR-2008) called her physician's office and was treated with BENADRYL and an unspecified topical antihistamine. It was reported that 36 hours after treatment the patient had recovered from the rash and itching at injection site. The nurse questioned if the patient had possibly confused which arms received which injections. The patient was scheduled to be seen in the office on an unspecified date. Subsequently, the patient recovered from itching rash approximately 36 hours. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female who on 26-FEB-2007 was vaccinated with the first dose Gardasil. On 20-MAR-2008, the patient was vaccinated with the second dose of Gardasil. The patient experienced arm pain at the injection site for one month after the first dose. It is unknown whether medical attention was sought. Patient was recovered from arm pain after a month. No product quality complaint was involved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 23 year old female who on 19-MAR-2008 was vaccinated intramuscularly with her first dose of GARDASIL (lot# 659655/1486U) in the morning. In the evening of 19-MAR-2008 the patient experienced a fever, nausea, vomiting and diarrhea. The patient's mother called the physician's office and she was told to eat a diet of bananas, rice, applesauce and toast in additional to a dietary restriction of milk. The patient's fever, nausea, vomiting and diarrhea persisted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008.  In follow up information it was reported that patient called on 20-MAR-2008 morning and complained of diarrhea, vomiting and nausea throughout the night and into morning of 20-MAR-2008.  She was adviced no milk products, IMMODIUM for diarrhea and to keep hydrated with bananas, rice, (rice cereal), applesause  and toast (B. P. A. T.).  Patient called back to an only  gave of the reaction.  It seemed she was quite confused by the phone.  The outcome was unknown.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who was vaccinated with the first dose of Gardasil (lot# not reported). Subsequently the patient fainted. The patient recovered. There was no product quality control involved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician assistant concerning a 23 year old female with no known medical history or drug reactions/allergies, who on an unspecified date was vaccinated with a first dose of GARDASIL and on 07-FEB-2008 was vaccinated intramuscularly with a 0.5 ml second dose of GARDASIL. Concomitant therapy included TRI-SPRINTEC. Approximately 3 weeks after each dose, the patient experienced a rash. The patient called the physician's assistant for unspecified medical attention. Outcome unknown. No product quality complaint was involved. Additional information has been requested. 2/12/2010 This is a followup to  report(s) previously submitted on 4/14/2008. Initial and follow-up information has been received from a physician assistant concerning a white 23 year old special education female with no known medical history or drug reaction/allergies, who on 28-Sep-2007 was vaccinated intramuscularly in the right deltoid with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) Lot #658560/1062U) and on 07-FEB-2008 was vaccinated intramuscularly in the left deltoid with a 0.5 ml second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot # 659962/1740u). Concomitant therapy included ethinyl estradiol/norgestimate (TRI-Sprintec). There were no illness at the time of vaccination. Approximately 3 weeks after each dose, the patient experienced a rash. The physician's assistant did not see the rash. The patient was seen by another provider the frst time and she called to report the experience after the second dose. The patient called the physician's assistant for unspecified medical attention. The patients out come was unknown. No product quality complaint was involved. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Herpes simplex
Clinical narrative: Information has been received from a physician concerning a female (age unknown) with history of about one outbreak of "herpes simplex" a year, who on 06-FEB-2008 was vaccinated with a first 0.5 mL dose of Gardasil (Lot # unknown). After receiving the vaccination the patient now has outbreaks more frequently. Unspecified medical attention was sought. No product quality complaint was involved. Outcome unknown. Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. Initial and follow up information has been received from a physician concerning a 25 year old female with history of about one outbreak of "herpes simplex" a year, no illnesses at the time of vaccination, who on 06-FEB-2008 at 11:45 am was vaccinated intramuscularly in the left deltoid with a first 0.5 mL dose of GARDASIL (Lot # 655154/1210U). Concomitant therapy included BENADRYL, TYLENOL, REXAN and doxycycline. After receiving the vaccination the patient now has outbreaks of genital herpes more frequently. Unspecified medical attention was sought. No product quality complaint was involved. Subsequently, on an unknown date the patient recovered. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal, Smear cervix abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 18 year old female who on 03-AUG-2007 was vaccinated 0.5mL, IM with a 1st dose of GARDASIL (lot# 655165/1425F). On 18-Oct-2007 the patient was vaccinated 0.5mL, IM with a 2nd dose of GARDASIL (lot# 657621/0387U). There was no concomitant medication. Subsequently the patient had a positive panpanicolaou test on 10-MAR-2008. The patient sought unspecified medical attention in her physician's office. It was reported that the patient had not been sexually active since previous papanicolaou test one year ago. Additional information has bee requested. No further information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Nausea, Paraesthesia, Syncope
Clinical narrative: Initial and follow-up information has been received from a nurse practitioner concerning a 17 year old female with attention deficit disorder who on 20-MAR-2008 was vaccinated "in the arm" (exact time not specified) with Gardasil (659180/1758U). Concomitant therapy included ADDERALL TABLETS and hormonal contraceptives (unspecified). On 20-MAR-2008, at an unspecified time, the patient experienced nausea, tingling in legs, faintness and decreased blood pressure (measurement not provided) and at 2:30 she was being transported to the emergency room, where the patient was hydrated and monitored. At the time of the report it was not known if the patient had recovered from these events. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008.  The patient was not admitted to the hospital. The patient recovered and and was able to attend school the next day. Additional information has been requested.
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated on an unspecified date with her first doe of GARDASIL. Concomitant therapy included VARIVAX, (duration and dose not reported) on the same day. Subsequently the patient became dizzy and very faint. The patient sought unspecified medical attention and her outcome was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Panic attack
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated on an unspecified date with Gardasil (lot# not reported). Subsequently the patient experienced a panic attack after receiving the vaccine. The patient sought unspecified medical attention and her outcome was not provided. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyskinesia, Presyncope
Clinical narrative: Information has been received from a physician concerning a 10 year old female who on 17-MAR-2008 was vaccinated with her first dose of GARDASIL (lot# not reported). After receiving the dose, the patient experienced dizziness, near fainting and jerky movements. She was taken to the ER to be treated. Subsequently, the patient recovered from dizziness, near fainting and jerky movements on an unspecified date. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site irritation, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 24 year old female who was vaccinated with an unspecified date with Gardasil (lot# not reported). Subsequently the patient experienced burning at injection site and pain at injection site that lasted for a couple days. Subsequently, the patient recovered from burning at the injection site and pain at injection site. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Concussion, Drug administered at inappropriate site, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female who on 08-NOV-2007 was vaccinated IM in the gluteal region with 0.5 mL dose of GARDASIL (lot # 659437/1266U). Concomitant therapy included RELPAX as needed and YAZ. On 12-NOV-2007 the patient fainted receiving a concussion. The patient called the office on 20-Mar-2008 to report the fainting and concussion that occurred in November of 2007. The patient did not want to continue the vaccination series. The patient recovered. There was no product quality control involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008. Information has been received from a nurse practitioner concerning a 24 year old female who on 08-NOV-2007 was vaccinated IM in the gluteal region with the first 0.5 mL dose of GARDASIL (lot # 659437/1266U). Concomitant therapy included RELPAX as needed and YAZ, for birth control. Four days post vaccinatin, on 12-NOV-2007, the fainted receiving a concussion. The patient called the office on 20-MAR-2008 to report the fainting and concussion that occurred in November of 2007. The patient did not want to continue the vaccination series. On an unspecified date, the patient recovered. There was no product quality complaint involved. Follow up information has been received from a physician. It was reported tht 4 days after the vaccine was administered, the patient was seen in a emergency room for syncopal episode. There were no illness at time of vaccinationand ther were no known drug allergies reported. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Lethargy, Pharyngolaryngeal pain, Somnolence
Clinical narrative: Information has been received from a physician concerning a 16 year old female with IMITREX allergy who on 17-MAR-2008 was vaccinated with the first dose of Gardasil. The same day of the vaccination, the patient ran a low grade temperature (99 deg F). The patient also developed lethargy, feeling sleepy, and sore throat. Unknown medical attention was sought in the office. At time of reporting the patient was improving but still feeling tired. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Laboratory test
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated on an unspecified date with Gardasil (dose and lot # not reported) at a different facility. Subsequently the patient experienced an autoimmune response. The patient was having unspecified blood work done. The patient outcome was not reported. The patient sought unspecified medical attention at the office. Additional information has been requested. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Information has been received from a consumer concerning her daughter with a history of poison ivy allergy who "6 to 8 weeks ago", was vaccinated 0.5mL with the 1st dose of GARDASIL (lot# not reported). Concomitant therapy included hormonal contraceptives (unspecified). Within a week of receiving the vaccination the patient experienced a marble sized knot under her skin at the injection site and the area is still tender. The patient's marble sized knot under skin at injection site persisted. The patient sought unspecified medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: DTAP, HEPA, HPV4, UNK
Symptoms: Immediate post-injection reaction, Inappropriate schedule of drug administration, Injection site swelling, Injection site vesicles
Clinical narrative: Information has been received from a nurse concerning a 13 year old female who on approximately 11-MAR-2008 was vaccinated IM with a 0.5 ml dose of GARDASIL in the right arm. Concomitant therapy included a dose diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid in the left arm (manufacturer unknown), a dose of hepatitis A virus vaccine (unspecified) in the left arm (manufacturer unknown) and a dose of vaccination (unspecified) in the right arm. The patient experienced an immediate onset of blisters and swelling at the injection site on the left arm. The patient was prescribed BENADRYL. Medical attention was sought via exam in the office. Patient outcome was unknown. No product quality complaint was involved. Additional information has been requested.