chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Blood count, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: Pt called today with c/o headache, generalized achiness and fatigue, decreased appetite, stomach aches, nausea and diarrhea.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Nausea, Pain
Clinical narrative: Pt called today with c/o headache, generalized achiness and fatigue, decreased appetite, stomach aches, nausea and diarrhea.
Age: 1.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 8CM BY 10CM REDNESS AND SWELLING RIGHT THEIGH 2 HRS AFTER SHOT
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose decreased, Blood glucose normal, Cyanosis, Grand mal convulsion, Syncope
Clinical narrative: Immediately after HPV vaccine given.  Pt developed cyanosis, syncope, & tonic clonic seizure lasting about 5 minutes. Pt was started on IV, labs drawn in clinic, EMS called and transported to Hospital Peds ER.  Mother reported pt has had 5-6 episodes of tonic clonic seizures during her life and have not been evaluated. Pt has been referred to Peds neurology at Medical Center.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Skin lesion
Clinical narrative: Erythema and puffiness around injection site.  Two pox lesions on lower trunk.
Age: 41.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Cellulitis, Hypersensitivity, Injection site erythema, Injection site reaction, Local reaction
Clinical narrative: EE developed local reaction at injection site within 24 hours of injection.  Was evaluated in Occ Health clinic on 9/13/07. O: Left shoulder - there is an erythematous area 1.5 x 2.5 cm over the injection site.  No edema.  No subcutaneous mass.  This area is slightly tender.  She complains of pain here with abduction to 100 degrees and flexion to 120 degrees.  A:  Local allergic reaction to Tdap placed on 09/11/2007. P:  Continue ice.  Discontinue Aleve.  Hydrocodone 5/500 one h.s. only p.r.n. moderate pain #15.  She may continue to take Tylenol 1 g up to t.i.d.  She was reminded that she may not take more than eight Tylenol 500 mg, which includes hydrocodone with Tylenol 500 mg in a 24-hour period.  Return to regular work today.  Return to clinic as needed. By Friday 8/14/07 and Sunday 8/16/07, the site got worse and spread.  EE was evaluated at Urgent Care Clinic on 8/14/07 and was diagnosed with cellulitis and started on Keflex.  EE was evalated on 9/17/07, antibiotic was changed to IM Rocefin and Doxycycline.  On 9/19/07 EE's condition improving and discharged back to work.
Age: 41.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pain, Tenderness
Clinical narrative: EE developed local reaction at injection site within 24 hours of injection.  Was evaluated in Occ Health clinic on 9/13/07. O: Left shoulder - there is an erythematous area 1.5 x 2.5 cm over the injection site.  No edema.  No subcutaneous mass.  This area is slightly tender.  She complains of pain here with abduction to 100 degrees and flexion to 120 degrees.  A:  Local allergic reaction to Tdap placed on 09/11/2007. P:  Continue ice.  Discontinue Aleve.  Hydrocodone 5/500 one h.s. only p.r.n. moderate pain #15.  She may continue to take Tylenol 1 g up to t.i.d.  She was reminded that she may not take more than eight Tylenol 500 mg, which includes hydrocodone with Tylenol 500 mg in a 24-hour period.  Return to regular work today.  Return to clinic as needed. By Friday 8/14/07 and Sunday 8/16/07, the site got worse and spread.  EE was evaluated at Urgent Care Clinic on 8/14/07 and was diagnosed with cellulitis and started on Keflex.  EE was evalated on 9/17/07, antibiotic was changed to IM Rocefin and Doxycycline.  On 9/19/07 EE's condition improving and discharged back to work.
Age: 17.0
Sex: F
Vaccine: HPVX, VARCEL
Symptoms: Anaphylactic reaction, Chest discomfort, Throat tightness, Wheezing
Clinical narrative: Patient had anaphylaxis. About 20 to 30 minutes after her immunizations, patient complained of her 'throat closing' and chest tightness. EMS arrived and felt the patient was wheezing, so gave an Albuterol treatment and a dose of Benadryl. When the patient arrived in the ED about 20 minutes later, she no longer had chest pain or difficulty breathing. Her vitals signs were stable, on exam she was not wheezing nor had any rash. We gave her a dose of steriod and H2 blocker and observed her for 6 hours after the event. No further events occured. Patient was discharged on steroids and benadryl.
Age: 17.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Chest pain, Dyspnoea, Pharyngeal oedema
Clinical narrative: Patient experienced throat swelling, difficulty breathing and chest pain on inspiration just after leaving the office where she had received Gardasil and Adacel. Symptoms gradually resolved over 48 hours. She did not pursue any medical treatment until 48hrs later and did not take any medications.
Age: 1.08
Sex: F
Vaccine: MMR, PPV
Symptoms: Blood test normal, Diarrhoea, Irritability, Lacrimation increased, Pyrexia
Clinical narrative: 103 degree fever.  Full body rash.  Watery/runny eyes.  Began evening of day vaccine received and lasted for 2 1/2 days.  Chronic diahrrea began that night and lasted for 10 months.  Weight fell off the charts completely.  Some stomach issues persist to this day.  Loss of language within 3 weeks of vaccine.  Some speech delay as of this date.  Irritability and reflux symptoms within 1 month of vaccine.  Treated as a milk and soy allergy.  Removed dairy and soy protein from diet with no change in symptoms.
Age: 1.08
Sex: F
Vaccine: MMR, PPV
Symptoms: Radioallergosorbent test negative, Rash generalised, Speech disorder
Clinical narrative: 103 degree fever.  Full body rash.  Watery/runny eyes.  Began evening of day vaccine received and lasted for 2 1/2 days.  Chronic diahrrea began that night and lasted for 10 months.  Weight fell off the charts completely.  Some stomach issues persist to this day.  Loss of language within 3 weeks of vaccine.  Some speech delay as of this date.  Irritability and reflux symptoms within 1 month of vaccine.  Treated as a milk and soy allergy.  Removed dairy and soy protein from diet with no change in symptoms.
Age: 0.67
Sex: F
Vaccine: DTAP, HEP, PNC
Symptoms: Cold compress therapy, Induration, Injection site swelling, Pyrexia, Skin warm
Clinical narrative: 09Dtap given on 09/17/07.  Mother called on 9/19/07 to report excessive swelling from hip to knee, slightly warm to the touch and "firm".  Fever x 2days-highest was 100.8 degrees.  Swelling has decreased slightly.  Tried to apply cool compress but baby wouldn't allow it to stay on area.  Denies any changes in behavior, eating or sleeping habits.  Has been taking Tylenol prn.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR, PNC
Symptoms: Pruritus, Rash
Clinical narrative: IN TODAY WITH GRANDMOTHER FOR C/O RASH ON BOTH ARMS, LEGS, AND HIS BACK. RAISED CIRCULAR BUMPS 9APPROX LESS THAN ONE MILLIMETER LOCATED ON BILATERAL ARMS AND LEGS. RIASED BUMPS ALSO NOTED ON BUTTOCKS. NO FACIAL RASH OR BUMPS @ INJECTION SITES. AFEBRILE @ PRESENT. NO ERYTHEMA NOTED @ INJECTION SITES. MILD ITCHING NOTED BY GRANDMOTHER. PLANS TO TAKE CHILD TO PMD NEXT WEEK FOR EVALUATION. DISCUSSED OATMEAL BATH FOR ITCHING.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: broke out in rash/sores, severe itching, looks like the chicken pox, treated with Caladryl, Band-Aid spray for itching, benadryl, got 3 prescriptions from family doctor to fill.
Age: 0.12
Sex: F
Vaccine: DTIPV, HIBV
Symptoms: Apraxia, Autism spectrum disorder, Computerised tomogram, Crying, Demyelination
Clinical narrative: Approximately 45 minutes after injection had shrill unconsolable cry, turned extremely pale then became limp. Was premature so age at time of injection was zero. Phone Dr. who stated he was fine, it was not a live virus. 9/21/07-well baby visit notes for DOS 9/1/05 and 12/2/05-patient did not have adverse reaction in the physican office. No longer treating patient. Per 60 day follow up: Residual symptoms related to adverse evernt are Encephalopathy, Cerebral demyelination, Global developmental delay, sensory integration disorder, Apraxia, and Austistic Spectrum disorder. 1/12/2010 Global developmental delay, cerebral demyelination, sensory integration disorder, dysarthria, Apraxia, dysphagia, toxic enphalopathy, Autistic spectrum disorder.
Age: 0.12
Sex: F
Vaccine: DTIPV, HIBV
Symptoms: Developmental delay, Dysarthria, Dysphagia, Encephalopathy, Gait disturbance
Clinical narrative: Approximately 45 minutes after injection had shrill unconsolable cry, turned extremely pale then became limp. Was premature so age at time of injection was zero. Phone Dr. who stated he was fine, it was not a live virus. 9/21/07-well baby visit notes for DOS 9/1/05 and 12/2/05-patient did not have adverse reaction in the physican office. No longer treating patient. Per 60 day follow up: Residual symptoms related to adverse evernt are Encephalopathy, Cerebral demyelination, Global developmental delay, sensory integration disorder, Apraxia, and Austistic Spectrum disorder. 1/12/2010 Global developmental delay, cerebral demyelination, sensory integration disorder, dysarthria, Apraxia, dysphagia, toxic enphalopathy, Autistic spectrum disorder.
Age: 0.12
Sex: F
Vaccine: DTIPV, HIBV
Symptoms: High-pitched crying, Nuclear magnetic resonance imaging, Pallor, Posture abnormal, Sensory integrative dysfunction
Clinical narrative: Approximately 45 minutes after injection had shrill unconsolable cry, turned extremely pale then became limp. Was premature so age at time of injection was zero. Phone Dr. who stated he was fine, it was not a live virus. 9/21/07-well baby visit notes for DOS 9/1/05 and 12/2/05-patient did not have adverse reaction in the physican office. No longer treating patient. Per 60 day follow up: Residual symptoms related to adverse evernt are Encephalopathy, Cerebral demyelination, Global developmental delay, sensory integration disorder, Apraxia, and Austistic Spectrum disorder. 1/12/2010 Global developmental delay, cerebral demyelination, sensory integration disorder, dysarthria, Apraxia, dysphagia, toxic enphalopathy, Autistic spectrum disorder.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Epistaxis, Pyrexia, Rash
Clinical narrative: Fever 105 Degrees F, Bloody Nose, Rash on chest, Currently day 3 and pt is still suffering from all of the above listed symptoms.
Age: 0.17
Sex: M
Vaccine: DTPHEP, RVX
Symptoms: Chest X-ray, Full blood count, Heart rate increased, Laboratory test, Lethargy
Clinical narrative: High fever of over 102 even with tylenol, high pulse of over 230, moaning and lethargy, emergency room gave fluids and tylenol and said to wait it out.
Age: 0.17
Sex: M
Vaccine: DTPHEP, RVX
Symptoms: Moaning, Pyrexia, Urine analysis
Clinical narrative: High fever of over 102 even with tylenol, high pulse of over 230, moaning and lethargy, emergency room gave fluids and tylenol and said to wait it out.
Age: 62.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site discomfort, Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus
Clinical narrative: A 62 year old, female patient complained of swelling, redness, itching at injection site within 24-48 hours after she received Adacel (lot number C2631AA) intramuscularly in the left arm on 29 May 2007. By 01 June 2007, she had pronounced swelling and more discomfort at the injection site. States she also had swelling in her left underarm. Pain extends to elbow. Marked edema, 60 mm x 70 mm erythema, increased skin temperature and fine raised maculopapular rash noted left deltoid area. It was reported that she recovered. Same reporter as case 2007-02196. Follow-up information received on 27 July 2007. The patient was diagnosed with left arm cellulitis secondary to tetanus reaction. She was prescribed Augmentin. The duration of the event was approximately 2 weeks according to the vaccine recipient. It was reported she did not have any illness at the time of vaccination.
Age: 62.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Rash maculo-papular, Swelling
Clinical narrative: A 62 year old, female patient complained of swelling, redness, itching at injection site within 24-48 hours after she received Adacel (lot number C2631AA) intramuscularly in the left arm on 29 May 2007. By 01 June 2007, she had pronounced swelling and more discomfort at the injection site. States she also had swelling in her left underarm. Pain extends to elbow. Marked edema, 60 mm x 70 mm erythema, increased skin temperature and fine raised maculopapular rash noted left deltoid area. It was reported that she recovered. Same reporter as case 2007-02196. Follow-up information received on 27 July 2007. The patient was diagnosed with left arm cellulitis secondary to tetanus reaction. She was prescribed Augmentin. The duration of the event was approximately 2 weeks according to the vaccine recipient. It was reported she did not have any illness at the time of vaccination.
Age: 62.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Axillary mass, Cellulitis, Injection site discomfort, Injection site erythema, Injection site pruritus
Clinical narrative: A 62 year old, female patient complained of swelling, redness, itching at injection site within 24-48 hours after she received Adacel (lot number C2631AA) intramuscularly in the left arm on 29 May 2007. By 01 June 2007, she had pronounced swelling and more discomfort at the injection site. States she also had swelling in her left underarm. Pain extends to elbow. Marked edema, 60 mm x 70 mm erythema, increased skin temperature and fine raised maculopapular rash noted left deltoid area. It was reported that she recovered. Same reporter as case 2007-02196. Follow-up information received on 27 July 2007. The patient was diagnosed with left arm cellulitis secondary to tetanus reaction. She was prescribed Augmentin. The duration of the event was approximately 2 weeks according to the vaccine recipient. It was reported she did not have any illness at the time of vaccination.
Age: 62.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Oedema
Clinical narrative: A 62 year old, female patient complained of swelling, redness, itching at injection site within 24-48 hours after she received Adacel (lot number C2631AA) intramuscularly in the left arm on 29 May 2007. By 01 June 2007, she had pronounced swelling and more discomfort at the injection site. States she also had swelling in her left underarm. Pain extends to elbow. Marked edema, 60 mm x 70 mm erythema, increased skin temperature and fine raised maculopapular rash noted left deltoid area. It was reported that she recovered. Same reporter as case 2007-02196. Follow-up information received on 27 July 2007. The patient was diagnosed with left arm cellulitis secondary to tetanus reaction. She was prescribed Augmentin. The duration of the event was approximately 2 weeks according to the vaccine recipient. It was reported she did not have any illness at the time of vaccination.
Age: 46.0
Sex: M
Vaccine: TDAP, TYP, TDAP, TYP
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Pain, Rash
Clinical narrative: Initial report received from a health care professional on 18 July 2007. A 46 year old, male patient experienced headache, body aches, a rash on his chest, back and abdomen, stomach cramps and an episode of diarrhea, approximately 2 days after he received Adacel (lot number C2759AA) intramuscularly in the left arm and Typhim VI (lot number A0221) intramuscularly in the left arm, on 10 July 2007. All of the symptoms resolved within 4 days and the patient recovered.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Erythema, Tenderness
Clinical narrative: Information has been received from a health professional concerning a 12 year old female who on 20-JUN-2007 was vaccinated on the left side with a second dose of Gardasil (lot # 657737/0522U). Suspect therapy included on the left side a second dose of Varivax (lot # 657406/0516U). Other concomitant therapy included on the left side a second dose of ADACEL (lot # C73444). On 21-JUN-2007 the patient developed an 8.5 cm x 4.5 cm area of erythema and tenderness. Subsequently on an unspecified date, the patient recovered from the erythema and tenderness. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Oedema peripheral, Pain in extremity
Clinical narrative: Initial and follow up information has been received from a physician concerning a 16 year old female patient who on 23-JUL-2007 was vaccinated IM in to right deltoid with a third dose of Gardasil lot #0469U.  Concomitant therapy included Tdap and hormonal contraceptives (unspecified).  The physician reported that the patient developed post vaccination pain at the injection site that radiated to her elbow after she got her third injection on 23-JUL-2007. In follow up it was reported that the patient indicated that her right arm became sore immediately after Gardisil injection. It remained sore from shoulder to elbow 10 days later. She felt hurt to lift her arm. She also reported that it was swollen. The patient has not recovered as of this report day. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Immediate post-injection reaction, Injection site pain, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Initial and follow up information has been received from a physician concerning a 16 year old female patient who on 23-JUL-2007 was vaccinated IM in to right deltoid with a third dose of Gardasil lot #0469U.  Concomitant therapy included Tdap and hormonal contraceptives (unspecified).  The physician reported that the patient developed post vaccination pain at the injection site that radiated to her elbow after she got her third injection on 23-JUL-2007. In follow up it was reported that the patient indicated that her right arm became sore immediately after Gardisil injection. It remained sore from shoulder to elbow 10 days later. She felt hurt to lift her arm. She also reported that it was swollen. The patient has not recovered as of this report day. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Erythema, Injection site swelling, Pruritus, Rash pruritic
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning a female patient (age not reported), who on 01-AUG-2007 was vaccinated with the first dose, 0.5ml, of Gardasil (Lot # unavailable).  Concomitant and suspect vaccine therapy included VARIVAX (MSD) (lot # not reported), and Vaqta (manufacturer not specified).  On 02-AUG-2007, the patient developed a rash, that broke out on her feet and hands, though there was no rash at the injection site.  The patient was scheduled to see her physician, though at the time of this report, the outcome of the event was unknown.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow-up information has been received from a registered nurse, concerning a 16 year female student, with a sulfa allergy and attention deficit disorder, who on 01-AUG-2007 at 10:30 am, was vaccinated IM in the left arm with the first dose, 0.5ml, of GARDASIL (Lot # 658100/0525U), vaccinated with the second dose, SC in the left arm, of VARIVAX (lot #657718/0778U), and vaccinated with the first dose, IM in the right arm, of HAVRIX (Lot #AHAVB163AB). Concomitant and suspect vaccine therapy included CONCERTA, DUAC, and FOCALIN. There was no illness at the time of vaccination. On 01-AUG-2007 (previously reported as 02-AUG-2007), the patient developed a rash, that broke out on her feet and hands, though there was no rash at the injection site. Treatment included BENADRYL, with some relief of the symptoms. On 02-AUG-2007, the patient returned to the office, and erythema of the feet and hands, with urticaria was noted, as well as a local reaction of swelling "at the (VARIVAX) site," and treatment included ZYRTEC daily, for 3 days. At the time of this report, the patient had recovered from the events (duration not specified). The reporting nurse indicated the physician's impression was that the urticaria and local swelling was related to VARIVAX. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Erythema, Injection site swelling, Rash, Urticaria
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning a female patient (age not reported), who on 01-AUG-2007 was vaccinated with the first dose, 0.5ml, of Gardasil (Lot # unavailable).  Concomitant and suspect vaccine therapy included VARIVAX (MSD) (lot # not reported), and Vaqta (manufacturer not specified).  On 02-AUG-2007, the patient developed a rash, that broke out on her feet and hands, though there was no rash at the injection site.  The patient was scheduled to see her physician, though at the time of this report, the outcome of the event was unknown.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow-up information has been received from a registered nurse, concerning a 16 year female student, with a sulfa allergy and attention deficit disorder, who on 01-AUG-2007 at 10:30 am, was vaccinated IM in the left arm with the first dose, 0.5ml, of GARDASIL (Lot # 658100/0525U), vaccinated with the second dose, SC in the left arm, of VARIVAX (lot #657718/0778U), and vaccinated with the first dose, IM in the right arm, of HAVRIX (Lot #AHAVB163AB). Concomitant and suspect vaccine therapy included CONCERTA, DUAC, and FOCALIN. There was no illness at the time of vaccination. On 01-AUG-2007 (previously reported as 02-AUG-2007), the patient developed a rash, that broke out on her feet and hands, though there was no rash at the injection site. Treatment included BENADRYL, with some relief of the symptoms. On 02-AUG-2007, the patient returned to the office, and erythema of the feet and hands, with urticaria was noted, as well as a local reaction of swelling "at the (VARIVAX) site," and treatment included ZYRTEC daily, for 3 days. At the time of this report, the patient had recovered from the events (duration not specified). The reporting nurse indicated the physician's impression was that the urticaria and local swelling was related to VARIVAX. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Crying, Dyskinesia, Dyspnoea, Gaze palsy, Headache
Clinical narrative: Initial and follow up information has been received from a consumer concerning her 14 year old daughter, with pertinent medical history, who on 29-MAY-2007 was vaccinated with a first dose of Gardasil.  The mother reported that her daughter didn't have any reaction.  On 31-JUL-2007 at 11:15, the patient was vaccination IM in the left arm with a 0.5 ml second dose of Gardasil (lot # 655205/1426F).  There was no concomitant medication.  On 31-JUL-2007 approximately five minutes post vaccination the patient experienced a syncopal episode that resulted in the patient falling back against the wall, sitting in the chair (previously reported that the patient fainted twice but got up but complained about her arms felt rigid and tingling).  The mother reported that the patient's eyes were looking upward when the incident happened and all the reporter could see was the whites on the patient's eye balls.  The patient's hands were in claw like position. The patient became alert in less than 5 seconds bafter amonia inhalent was waved under her nose. At that point the patient was alert, sitting up, and talking when she experienced a second syncopal episode approximately 3 to 5 minutes after the first episode. The patient was lowered to the floor, amonia inhalent was presented again and she became alert within a few seconds. The patient did not experience any dificulty in breathing. The patient's blood pressure was 100/80, pulse 72 and 110/90, pulse 88. The patient was crying and fearful, and complained of numbness and stiffness in hands and jaw. It was suspected that he patient was hyperventillating so she was given a paper bag to breath into. The patient experienced persistent stiffness in her hands and her jaw. EMT's were called and arrived at approximately 11:35. The patient was assesed, was sat up in a chair and examined for any head injuries. The EMT's assessed the patient to have had a vasovagal response to the injection, resulting in a syncopal episode and subsequent hyperventillation. There was no eveidence of head or other physical injury. The doctor agreed with the EMT's assessment of the patient and did not feel the events were an adverse vaccine reaction. The patient was alert and oriented when she walked with the nurse and her mother to the car without difficulty at approximately 12:05. The patient's mother called the office at about 14:00 stating that she took the patient to the doctor and the doctor agreed that the events were a vasovagal response to the injecion (previously reported that the patient was taken to the emergency room and was diagnosed with vasovagal). The mother noted that the patient was fine now and just experienced a mild headache but had recovered totally.  It was reported that the patient recovered "after 24 hours".  Additional information is not expected.   Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypotonia, Joint stiffness, Loss of consciousness, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: Initial and follow up information has been received from a consumer concerning her 14 year old daughter, with pertinent medical history, who on 29-MAY-2007 was vaccinated with a first dose of Gardasil.  The mother reported that her daughter didn't have any reaction.  On 31-JUL-2007 at 11:15, the patient was vaccination IM in the left arm with a 0.5 ml second dose of Gardasil (lot # 655205/1426F).  There was no concomitant medication.  On 31-JUL-2007 approximately five minutes post vaccination the patient experienced a syncopal episode that resulted in the patient falling back against the wall, sitting in the chair (previously reported that the patient fainted twice but got up but complained about her arms felt rigid and tingling).  The mother reported that the patient's eyes were looking upward when the incident happened and all the reporter could see was the whites on the patient's eye balls.  The patient's hands were in claw like position. The patient became alert in less than 5 seconds bafter amonia inhalent was waved under her nose. At that point the patient was alert, sitting up, and talking when she experienced a second syncopal episode approximately 3 to 5 minutes after the first episode. The patient was lowered to the floor, amonia inhalent was presented again and she became alert within a few seconds. The patient did not experience any dificulty in breathing. The patient's blood pressure was 100/80, pulse 72 and 110/90, pulse 88. The patient was crying and fearful, and complained of numbness and stiffness in hands and jaw. It was suspected that he patient was hyperventillating so she was given a paper bag to breath into. The patient experienced persistent stiffness in her hands and her jaw. EMT's were called and arrived at approximately 11:35. The patient was assesed, was sat up in a chair and examined for any head injuries. The EMT's assessed the patient to have had a vasovagal response to the injection, resulting in a syncopal episode and subsequent hyperventillation. There was no eveidence of head or other physical injury. The doctor agreed with the EMT's assessment of the patient and did not feel the events were an adverse vaccine reaction. The patient was alert and oriented when she walked with the nurse and her mother to the car without difficulty at approximately 12:05. The patient's mother called the office at about 14:00 stating that she took the patient to the doctor and the doctor agreed that the events were a vasovagal response to the injecion (previously reported that the patient was taken to the emergency room and was diagnosed with vasovagal). The mother noted that the patient was fine now and just experienced a mild headache but had recovered totally.  It was reported that the patient recovered "after 24 hours".  Additional information is not expected.   Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pyrexia, Syncope, Syncope vasovagal, Tremor
Clinical narrative: Initial and follow up information has been received from a consumer concerning her 14 year old daughter, with pertinent medical history, who on 29-MAY-2007 was vaccinated with a first dose of Gardasil.  The mother reported that her daughter didn't have any reaction.  On 31-JUL-2007 at 11:15, the patient was vaccination IM in the left arm with a 0.5 ml second dose of Gardasil (lot # 655205/1426F).  There was no concomitant medication.  On 31-JUL-2007 approximately five minutes post vaccination the patient experienced a syncopal episode that resulted in the patient falling back against the wall, sitting in the chair (previously reported that the patient fainted twice but got up but complained about her arms felt rigid and tingling).  The mother reported that the patient's eyes were looking upward when the incident happened and all the reporter could see was the whites on the patient's eye balls.  The patient's hands were in claw like position. The patient became alert in less than 5 seconds bafter amonia inhalent was waved under her nose. At that point the patient was alert, sitting up, and talking when she experienced a second syncopal episode approximately 3 to 5 minutes after the first episode. The patient was lowered to the floor, amonia inhalent was presented again and she became alert within a few seconds. The patient did not experience any dificulty in breathing. The patient's blood pressure was 100/80, pulse 72 and 110/90, pulse 88. The patient was crying and fearful, and complained of numbness and stiffness in hands and jaw. It was suspected that he patient was hyperventillating so she was given a paper bag to breath into. The patient experienced persistent stiffness in her hands and her jaw. EMT's were called and arrived at approximately 11:35. The patient was assesed, was sat up in a chair and examined for any head injuries. The EMT's assessed the patient to have had a vasovagal response to the injection, resulting in a syncopal episode and subsequent hyperventillation. There was no eveidence of head or other physical injury. The doctor agreed with the EMT's assessment of the patient and did not feel the events were an adverse vaccine reaction. The patient was alert and oriented when she walked with the nurse and her mother to the car without difficulty at approximately 12:05. The patient's mother called the office at about 14:00 stating that she took the patient to the doctor and the doctor agreed that the events were a vasovagal response to the injecion (previously reported that the patient was taken to the emergency room and was diagnosed with vasovagal). The mother noted that the patient was fine now and just experienced a mild headache but had recovered totally.  It was reported that the patient recovered "after 24 hours".  Additional information is not expected.   Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Gaze palsy, Headache, Syncope vasovagal
Clinical narrative: Initial and follow up information has been received from a consumer concerning her 14 year old daughter, with pertinent medical history, who on 29-MAY-2007 was vaccinated with a first dose of Gardasil.  The mother reported that her daughter didn't have any reaction.  On 31-JUL-2007 at 11:15, the patient was vaccination IM in the left arm with a 0.5 ml second dose of Gardasil (lot # 655205/1426F).  There was no concomitant medication.  On 31-JUL-2007 approximately five minutes post vaccination the patient experienced a syncopal episode that resulted in the patient falling back against the wall, sitting in the chair (previously reported that the patient fainted twice but got up but complained about her arms felt rigid and tingling).  The mother reported that the patient's eyes were looking upward when the incident happened and all the reporter could see was the whites on the patient's eye balls.  The patient's hands were in claw like position. The patient became alert in less than 5 seconds bafter amonia inhalent was waved under her nose. At that point the patient was alert, sitting up, and talking when she experienced a second syncopal episode approximately 3 to 5 minutes after the first episode. The patient was lowered to the floor, amonia inhalent was presented again and she became alert within a few seconds. The patient did not experience any dificulty in breathing. The patient's blood pressure was 100/80, pulse 72 and 110/90, pulse 88. The patient was crying and fearful, and complained of numbness and stiffness in hands and jaw. It was suspected that he patient was hyperventillating so she was given a paper bag to breath into. The patient experienced persistent stiffness in her hands and her jaw. EMT's were called and arrived at approximately 11:35. The patient was assesed, was sat up in a chair and examined for any head injuries. The EMT's assessed the patient to have had a vasovagal response to the injection, resulting in a syncopal episode and subsequent hyperventillation. There was no eveidence of head or other physical injury. The doctor agreed with the EMT's assessment of the patient and did not feel the events were an adverse vaccine reaction. The patient was alert and oriented when she walked with the nurse and her mother to the car without difficulty at approximately 12:05. The patient's mother called the office at about 14:00 stating that she took the patient to the doctor and the doctor agreed that the events were a vasovagal response to the injecion (previously reported that the patient was taken to the emergency room and was diagnosed with vasovagal). The mother noted that the patient was fine now and just experienced a mild headache but had recovered totally.  It was reported that the patient recovered "after 24 hours".  Additional information is not expected.   Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Eye rolling, Muscle spasms, Mydriasis, Nausea, Pallor
Clinical narrative: Information has been received from a health professional and emergency department chart concerning a 17 year old female student, with asthma and a history of Atrial septal defect repair and a Electrocardiogram that was abnormal, who on 03-AUG-2007 at 10:07 am, was vaccinated IM in the right deltoid with a second dose of Gardasil (lot # 657737/0522U). Concomitant therapy included NASONEX 2 sprays daily, albuterol, LUTERA 1 tablet daily, montelukast sodium (MSD) and ZYRTEC daily. On 03-AUG-2007 at 10:07 am, the patient experienced eyes rolling, bilateral upper extremity spasms, syncope and was unresponsive for less than a minute. When the episode was over her pupils were dilated, and developed pallor and nausea. The patient was transported to the emergency department. Lab data revealed at 11:26 am the total heartbeat count 64, and the blood pressure measurement 111/53, at 12:27 pm the total heartbeat count 73 and blood pressure measurement 118/56. The head computed axial tomography was negative. On 03-AUG-2007 the patient was discharged and had recovered from her symptoms. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Unresponsive to stimuli
Clinical narrative: Information has been received from a health professional and emergency department chart concerning a 17 year old female student, with asthma and a history of Atrial septal defect repair and a Electrocardiogram that was abnormal, who on 03-AUG-2007 at 10:07 am, was vaccinated IM in the right deltoid with a second dose of Gardasil (lot # 657737/0522U). Concomitant therapy included NASONEX 2 sprays daily, albuterol, LUTERA 1 tablet daily, montelukast sodium (MSD) and ZYRTEC daily. On 03-AUG-2007 at 10:07 am, the patient experienced eyes rolling, bilateral upper extremity spasms, syncope and was unresponsive for less than a minute. When the episode was over her pupils were dilated, and developed pallor and nausea. The patient was transported to the emergency department. Lab data revealed at 11:26 am the total heartbeat count 64, and the blood pressure measurement 111/53, at 12:27 pm the total heartbeat count 73 and blood pressure measurement 118/56. The head computed axial tomography was negative. On 03-AUG-2007 the patient was discharged and had recovered from her symptoms. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood pressure, Computerised tomogram normal, Eye rolling, Heart rate, Muscle spasms
Clinical narrative: Information has been received from a health professional and emergency department chart concerning a 17 year old female student, with asthma and a history of Atrial septal defect repair and a Electrocardiogram that was abnormal, who on 03-AUG-2007 at 10:07 am, was vaccinated IM in the right deltoid with a second dose of Gardasil (lot # 657737/0522U). Concomitant therapy included NASONEX 2 sprays daily, albuterol, LUTERA 1 tablet daily, montelukast sodium (MSD) and ZYRTEC daily. On 03-AUG-2007 at 10:07 am, the patient experienced eyes rolling, bilateral upper extremity spasms, syncope and was unresponsive for less than a minute. When the episode was over her pupils were dilated, and developed pallor and nausea. The patient was transported to the emergency department. Lab data revealed at 11:26 am the total heartbeat count 64, and the blood pressure measurement 111/53, at 12:27 pm the total heartbeat count 73 and blood pressure measurement 118/56. The head computed axial tomography was negative. On 03-AUG-2007 the patient was discharged and had recovered from her symptoms. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Mydriasis, Nausea, Oxygen saturation, Pallor, Syncope
Clinical narrative: Information has been received from a health professional and emergency department chart concerning a 17 year old female student, with asthma and a history of Atrial septal defect repair and a Electrocardiogram that was abnormal, who on 03-AUG-2007 at 10:07 am, was vaccinated IM in the right deltoid with a second dose of Gardasil (lot # 657737/0522U). Concomitant therapy included NASONEX 2 sprays daily, albuterol, LUTERA 1 tablet daily, montelukast sodium (MSD) and ZYRTEC daily. On 03-AUG-2007 at 10:07 am, the patient experienced eyes rolling, bilateral upper extremity spasms, syncope and was unresponsive for less than a minute. When the episode was over her pupils were dilated, and developed pallor and nausea. The patient was transported to the emergency department. Lab data revealed at 11:26 am the total heartbeat count 64, and the blood pressure measurement 111/53, at 12:27 pm the total heartbeat count 73 and blood pressure measurement 118/56. The head computed axial tomography was negative. On 03-AUG-2007 the patient was discharged and had recovered from her symptoms. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Unresponsive to stimuli, White blood cell count
Clinical narrative: Information has been received from a health professional and emergency department chart concerning a 17 year old female student, with asthma and a history of Atrial septal defect repair and a Electrocardiogram that was abnormal, who on 03-AUG-2007 at 10:07 am, was vaccinated IM in the right deltoid with a second dose of Gardasil (lot # 657737/0522U). Concomitant therapy included NASONEX 2 sprays daily, albuterol, LUTERA 1 tablet daily, montelukast sodium (MSD) and ZYRTEC daily. On 03-AUG-2007 at 10:07 am, the patient experienced eyes rolling, bilateral upper extremity spasms, syncope and was unresponsive for less than a minute. When the episode was over her pupils were dilated, and developed pallor and nausea. The patient was transported to the emergency department. Lab data revealed at 11:26 am the total heartbeat count 64, and the blood pressure measurement 111/53, at 12:27 pm the total heartbeat count 73 and blood pressure measurement 118/56. The head computed axial tomography was negative. On 03-AUG-2007 the patient was discharged and had recovered from her symptoms. Additional information is not expected.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, RV5
Symptoms: Kawasaki's disease, Platelet count increased, Red blood cell sedimentation rate increased
Clinical narrative: Information has been received from a physician concerning a 6 month old female who on 29-NOV-2006, 31-JAN-2007, and 02-APR-2007 was vaccinated with the first, second and third dose of Rotateq, respectively. On approximately 15-JUN-2007, the patient experienced Kawasaki disease and was hospitalized "around 15-JUN-2007". It was also reported that the reason for the hospitalization was unknown. Subsequently, the patient recovered from Kawasaki disease. There was no product quality complaint. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, RV5
Symptoms: Kawasaki's disease
Clinical narrative: Information has been received from a physician concerning a 6 month old female who on 29-NOV-2006, 31-JAN-2007, and 02-APR-2007 was vaccinated with the first, second and third dose of Rotateq, respectively. On approximately 15-JUN-2007, the patient experienced Kawasaki disease and was hospitalized "around 15-JUN-2007". It was also reported that the reason for the hospitalization was unknown. Subsequently, the patient recovered from Kawasaki disease. There was no product quality complaint. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old female with a family history of cardiomyopathy and no drug allergies who on 06-AUG-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (657736/0389U).  There was no concomitant medication.  On 07-AUG-2007 the patient developed hives on her torso and back.  There were no laboratory or diagnostic tests performed.  At the time of report the patient was recovering.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Acne, Pruritus, Rash
Clinical narrative: Initial and follow up information has been received from a certified medical assistant concerning a 12 year old female with no pertinent medical history or drug reactions/allergies who on 29-JUN-2007 was vaccinated with a first dose of Gardasil (lot # 657868/0523U) in the left arm. There was no concomitant medication.   On 30-JUN-2007 the patient developed a pimple on her face, one day after vaccination with Gardasil.  Medical attention was sought.  The next day on 01-JUL-2007 the patient developed a rash resembling the pimple, all over her back. It did not look like hives, the rash was itchy only at night. The patient was not seen by the office and required no treatment.  It was reported that approximatley on 03-JUL-2007 the patient recovered 3 days after vaccination.   Additional information has been requested.  Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Acne, Pruritus, Rash generalised
Clinical narrative: Initial and follow up information has been received from a certified medical assistant concerning a 12 year old female with no pertinent medical history or drug reactions/allergies who on 29-JUN-2007 was vaccinated with a first dose of Gardasil (lot # 657868/0523U) in the left arm. There was no concomitant medication.   On 30-JUN-2007 the patient developed a pimple on her face, one day after vaccination with Gardasil.  Medical attention was sought.  The next day on 01-JUL-2007 the patient developed a rash resembling the pimple, all over her back. It did not look like hives, the rash was itchy only at night. The patient was not seen by the office and required no treatment.  It was reported that approximatley on 03-JUL-2007 the patient recovered 3 days after vaccination.   Additional information has been requested.  Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site pain, Neck pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 21 year old female with no pertinent medical history who on 04-AUG-2007 was vaccinated with a dose of Gardasil (lot #657872/0515U).  There was no concomitant medication.  On 04-AUG-2007, a few hours after vaccination, the patient experienced pain in her left shoulder and neck.  Unspecified medical attention was sought.  The patient's pain in her left shoulder and pain in her neck persisted.  There were no laboratory or diagnostic tests performed.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 21 year old female with no pertinent medical history who on 04-AUG-2007 was vaccinated with a dose of Gardasil (lot #657872/0515U).  There was no concomitant medication.  On 04-AUG-2007, a few hours after vaccination, the patient experienced pain in her left shoulder and neck.  Unspecified medical attention was sought.  The patient's pain in her left shoulder and pain in her neck persisted.  There were no laboratory or diagnostic tests performed.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Syncope, Throat tightness
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 17 year old female with a penicillin, sulfa, and (CECLOR) allergy who on 03-AUG-2007 was vaccinated intramuscularly with a first dose of Gardasil (Lot #658222/0927U).  Concomitant suspect vaccination given on 27-JUL-2007 included a second dose of Varivax (MSD).  Concomitant vaccination on the same day included MENACTRA.  On 03-AUG-2007 the patient fainted.  There were no laboratory or diagnostic tests performed.  Medical attention was sought.  On 03-AUG-2007 the patient recovered.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 17 year old female with a penicillin, sulfa, and (CECLOR) allergy who on 03-AUG-2007 was vaccinated intramuscularly with a first dose of Gardasil (Lot #658222/0927U).  Concomitant suspect vaccination given on 27-JUL-2007 included a second dose of Varivax (MSD).  Concomitant vaccination on the same day included MENACTRA.  On 03-AUG-2007 the patient fainted.  There were no laboratory or diagnostic tests performed.  Medical attention was sought.  On 03-AUG-2007 the patient recovered.  Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4
Symptoms: Facial palsy
Clinical narrative: Information has been received from a physician concerning a 13 year old female with no pertinent history who on 01-AUG-2007 was vaccinated with a 0.5 ml first dose of Gardasil (657872/0515U). Concomitant vaccination included (MENACTRA). On 15-AUG-2007 the patient developed "left sided facial nerve paralysis, diagnosed as Bell Palsy". The physician was thinking about discontinuing Gardasil. Unspecified medical attention was sought. At the time of the report the patient was recovering. Additional information was recovering.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Feeling abnormal, Pharyngeal oedema, Swollen tongue
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female who on 10-AUG-2007 was vaccinated with Gardasil (lot # 657872/0515U) 0.5 ml IM in the left deltoid.  Concomitant therapy included hormonal contraceptives (unspecified).  On 10-AUG-2007, a few minutes after leaving the physician's office, the patient experienced a swollen sensation in her throat and tongue.  She took BENADRYL and slept for one hour.  This relieved her symptom (recovered on 10-AUG-2007).  No further information was provided.  Additional information has been requested.