chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Discomfort, Dizziness, Electroencephalogram abnormal, Fall, Gaze palsy
Clinical narrative: This case was received from another manufacturer (reference number WAES0705USA05077) on 07 June 2007. The following information is verbatim as it appears in the other manufacturer's report: "Information has been received from an agency concerning an 18 year old female with a history of very minimal upper respiratory infection symptoms who on 06-MAR-2007 was vaccinated intramuscularly into the left arm with a first dose of Gardasil (Lot # 654535/0960F). Concomitant therapy included Menactra (Lot # U2115AA) in the right arm. On 07-MAR-2007 at 1:30 the patient experienced backache, headache, dizziness and generalized discomfort in the clinic and the patient was referred to her family practice. At her family practice, the patient developed stridor and nystagmus and was transferred to the facility (reported at 4:30) and was admitted to the ICU. Based on records received from the facility, the patient had fever and altered neurological status. She had a temperature of 101.2 and fell at the clinic. The patient presented to the emergency room with nystagmus with mainly her gaze toward the right. The patient was not speaking and was hyperventilating. It was reported that the patient had a fever a few days ago and had been sick with viral syndrome. Physical exam showed pupils equally round and reactive to light but she had nystagmus frequently every few seconds and 'mainly seemed with a right". The patient required an interpreter but she had no spontaneous speech and carpal pedal spasm. A lumbar puncture was performed in the hospital with the following with the following results: clear fluid, 1 WBC, 0 RBC, Glucose WNL at 56 and protein of 19. Other laboratory tests included: WBC of 16.3, neutrophil of 90%, Influenza A and B negative and an EEG which was mildly abnormal due to excessive presence of beta activity which could be drug related. The patient was discharged on 09-MAR-2007 and diagnosed with diseases/disorders of the nervous system, convulsions, tetany, bronchitis, nystagmus, altered mental status, hyperventilation, headache, lumbago and fever. At the time of this report, the outcome was unknown. The original reporting source was not indicated. No further information is available."
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Headache, Hyperventilation, Influenza serology negative, Lack of spontaneous speech, Lumbar puncture
Clinical narrative: This case was received from another manufacturer (reference number WAES0705USA05077) on 07 June 2007. The following information is verbatim as it appears in the other manufacturer's report: "Information has been received from an agency concerning an 18 year old female with a history of very minimal upper respiratory infection symptoms who on 06-MAR-2007 was vaccinated intramuscularly into the left arm with a first dose of Gardasil (Lot # 654535/0960F). Concomitant therapy included Menactra (Lot # U2115AA) in the right arm. On 07-MAR-2007 at 1:30 the patient experienced backache, headache, dizziness and generalized discomfort in the clinic and the patient was referred to her family practice. At her family practice, the patient developed stridor and nystagmus and was transferred to the facility (reported at 4:30) and was admitted to the ICU. Based on records received from the facility, the patient had fever and altered neurological status. She had a temperature of 101.2 and fell at the clinic. The patient presented to the emergency room with nystagmus with mainly her gaze toward the right. The patient was not speaking and was hyperventilating. It was reported that the patient had a fever a few days ago and had been sick with viral syndrome. Physical exam showed pupils equally round and reactive to light but she had nystagmus frequently every few seconds and 'mainly seemed with a right". The patient required an interpreter but she had no spontaneous speech and carpal pedal spasm. A lumbar puncture was performed in the hospital with the following with the following results: clear fluid, 1 WBC, 0 RBC, Glucose WNL at 56 and protein of 19. Other laboratory tests included: WBC of 16.3, neutrophil of 90%, Influenza A and B negative and an EEG which was mildly abnormal due to excessive presence of beta activity which could be drug related. The patient was discharged on 09-MAR-2007 and diagnosed with diseases/disorders of the nervous system, convulsions, tetany, bronchitis, nystagmus, altered mental status, hyperventilation, headache, lumbago and fever. At the time of this report, the outcome was unknown. The original reporting source was not indicated. No further information is available."
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Mental status changes, Nervous system disorder, Neurological symptom, Neutrophil count increased, Nystagmus
Clinical narrative: This case was received from another manufacturer (reference number WAES0705USA05077) on 07 June 2007. The following information is verbatim as it appears in the other manufacturer's report: "Information has been received from an agency concerning an 18 year old female with a history of very minimal upper respiratory infection symptoms who on 06-MAR-2007 was vaccinated intramuscularly into the left arm with a first dose of Gardasil (Lot # 654535/0960F). Concomitant therapy included Menactra (Lot # U2115AA) in the right arm. On 07-MAR-2007 at 1:30 the patient experienced backache, headache, dizziness and generalized discomfort in the clinic and the patient was referred to her family practice. At her family practice, the patient developed stridor and nystagmus and was transferred to the facility (reported at 4:30) and was admitted to the ICU. Based on records received from the facility, the patient had fever and altered neurological status. She had a temperature of 101.2 and fell at the clinic. The patient presented to the emergency room with nystagmus with mainly her gaze toward the right. The patient was not speaking and was hyperventilating. It was reported that the patient had a fever a few days ago and had been sick with viral syndrome. Physical exam showed pupils equally round and reactive to light but she had nystagmus frequently every few seconds and 'mainly seemed with a right". The patient required an interpreter but she had no spontaneous speech and carpal pedal spasm. A lumbar puncture was performed in the hospital with the following with the following results: clear fluid, 1 WBC, 0 RBC, Glucose WNL at 56 and protein of 19. Other laboratory tests included: WBC of 16.3, neutrophil of 90%, Influenza A and B negative and an EEG which was mildly abnormal due to excessive presence of beta activity which could be drug related. The patient was discharged on 09-MAR-2007 and diagnosed with diseases/disorders of the nervous system, convulsions, tetany, bronchitis, nystagmus, altered mental status, hyperventilation, headache, lumbago and fever. At the time of this report, the outcome was unknown. The original reporting source was not indicated. No further information is available."
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Pyrexia, Speech disorder, Stridor, Syncope, Tetany
Clinical narrative: This case was received from another manufacturer (reference number WAES0705USA05077) on 07 June 2007. The following information is verbatim as it appears in the other manufacturer's report: "Information has been received from an agency concerning an 18 year old female with a history of very minimal upper respiratory infection symptoms who on 06-MAR-2007 was vaccinated intramuscularly into the left arm with a first dose of Gardasil (Lot # 654535/0960F). Concomitant therapy included Menactra (Lot # U2115AA) in the right arm. On 07-MAR-2007 at 1:30 the patient experienced backache, headache, dizziness and generalized discomfort in the clinic and the patient was referred to her family practice. At her family practice, the patient developed stridor and nystagmus and was transferred to the facility (reported at 4:30) and was admitted to the ICU. Based on records received from the facility, the patient had fever and altered neurological status. She had a temperature of 101.2 and fell at the clinic. The patient presented to the emergency room with nystagmus with mainly her gaze toward the right. The patient was not speaking and was hyperventilating. It was reported that the patient had a fever a few days ago and had been sick with viral syndrome. Physical exam showed pupils equally round and reactive to light but she had nystagmus frequently every few seconds and 'mainly seemed with a right". The patient required an interpreter but she had no spontaneous speech and carpal pedal spasm. A lumbar puncture was performed in the hospital with the following with the following results: clear fluid, 1 WBC, 0 RBC, Glucose WNL at 56 and protein of 19. Other laboratory tests included: WBC of 16.3, neutrophil of 90%, Influenza A and B negative and an EEG which was mildly abnormal due to excessive presence of beta activity which could be drug related. The patient was discharged on 09-MAR-2007 and diagnosed with diseases/disorders of the nervous system, convulsions, tetany, bronchitis, nystagmus, altered mental status, hyperventilation, headache, lumbago and fever. At the time of this report, the outcome was unknown. The original reporting source was not indicated. No further information is available."
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Viral infection, White blood cell count increased
Clinical narrative: This case was received from another manufacturer (reference number WAES0705USA05077) on 07 June 2007. The following information is verbatim as it appears in the other manufacturer's report: "Information has been received from an agency concerning an 18 year old female with a history of very minimal upper respiratory infection symptoms who on 06-MAR-2007 was vaccinated intramuscularly into the left arm with a first dose of Gardasil (Lot # 654535/0960F). Concomitant therapy included Menactra (Lot # U2115AA) in the right arm. On 07-MAR-2007 at 1:30 the patient experienced backache, headache, dizziness and generalized discomfort in the clinic and the patient was referred to her family practice. At her family practice, the patient developed stridor and nystagmus and was transferred to the facility (reported at 4:30) and was admitted to the ICU. Based on records received from the facility, the patient had fever and altered neurological status. She had a temperature of 101.2 and fell at the clinic. The patient presented to the emergency room with nystagmus with mainly her gaze toward the right. The patient was not speaking and was hyperventilating. It was reported that the patient had a fever a few days ago and had been sick with viral syndrome. Physical exam showed pupils equally round and reactive to light but she had nystagmus frequently every few seconds and 'mainly seemed with a right". The patient required an interpreter but she had no spontaneous speech and carpal pedal spasm. A lumbar puncture was performed in the hospital with the following with the following results: clear fluid, 1 WBC, 0 RBC, Glucose WNL at 56 and protein of 19. Other laboratory tests included: WBC of 16.3, neutrophil of 90%, Influenza A and B negative and an EEG which was mildly abnormal due to excessive presence of beta activity which could be drug related. The patient was discharged on 09-MAR-2007 and diagnosed with diseases/disorders of the nervous system, convulsions, tetany, bronchitis, nystagmus, altered mental status, hyperventilation, headache, lumbago and fever. At the time of this report, the outcome was unknown. The original reporting source was not indicated. No further information is available."
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Dyspnoea, Flushing, Food allergy, Laboratory test, Seasonal allergy
Clinical narrative: Initial information received on 13 June 2007 from another manufacturer, report# WAES0705USA05515, VAERS# not provided. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report:"Information has been received from a physician and his physician and his office manager concerning a 17 year old female with no known drug allergies who on 25-MAY-2007 was vaccinated with the first 0.5 mL dose of Gardasil (lot# 657737/0522U) and concomitant suspect therapy Menactra (lot# U2278AA). It was reported that the patient left the physician's office feeling fine after the vaccinations, although, approximately one hour later returned to the office with severe shortness of breath. The patient was diagnosed with an anaphylaxis reaction and was treated with one epinephrine (EPI-PEN) injection and unspecified steroids. Subsequently, the patient's breathing returned to normal, and the patient was considered recovered from the anaphylactic reaction. The patient was referred to an allergist, who will evaluate the event and attempt to determine the source of the patient's anaphylactic reaction. The Gardasil vaccination series will be "on hold" until results from the allergist are obtained. Anaphylactic reaction was considered to be disabling, immediately life-threatening and medically significant event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Skin test positive, Throat irritation, Throat tightness
Clinical narrative: Initial information received on 13 June 2007 from another manufacturer, report# WAES0705USA05515, VAERS# not provided. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report:"Information has been received from a physician and his physician and his office manager concerning a 17 year old female with no known drug allergies who on 25-MAY-2007 was vaccinated with the first 0.5 mL dose of Gardasil (lot# 657737/0522U) and concomitant suspect therapy Menactra (lot# U2278AA). It was reported that the patient left the physician's office feeling fine after the vaccinations, although, approximately one hour later returned to the office with severe shortness of breath. The patient was diagnosed with an anaphylaxis reaction and was treated with one epinephrine (EPI-PEN) injection and unspecified steroids. Subsequently, the patient's breathing returned to normal, and the patient was considered recovered from the anaphylactic reaction. The patient was referred to an allergist, who will evaluate the event and attempt to determine the source of the patient's anaphylactic reaction. The Gardasil vaccination series will be "on hold" until results from the allergist are obtained. Anaphylactic reaction was considered to be disabling, immediately life-threatening and medically significant event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: Initial information received on 13 June 2007 from another manufacturer, report# WAES0705USA05515, VAERS# not provided. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report:"Information has been received from a physician and his physician and his office manager concerning a 17 year old female with no known drug allergies who on 25-MAY-2007 was vaccinated with the first 0.5 mL dose of Gardasil (lot# 657737/0522U) and concomitant suspect therapy Menactra (lot# U2278AA). It was reported that the patient left the physician's office feeling fine after the vaccinations, although, approximately one hour later returned to the office with severe shortness of breath. The patient was diagnosed with an anaphylaxis reaction and was treated with one epinephrine (EPI-PEN) injection and unspecified steroids. Subsequently, the patient's breathing returned to normal, and the patient was considered recovered from the anaphylactic reaction. The patient was referred to an allergist, who will evaluate the event and attempt to determine the source of the patient's anaphylactic reaction. The Gardasil vaccination series will be "on hold" until results from the allergist are obtained. Anaphylactic reaction was considered to be disabling, immediately life-threatening and medically significant event. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Computerised tomogram normal, Contraception, Convulsion, Drug screen negative, Full blood count normal
Clinical narrative: Information has been received from a physician concerning a 13 year old female with attention deficit/hyperactivity disorder who on 03-MAY-2007 was vaccinated with a first dose of Gardasil (lot # 655503/0012U; expired 13-JUN-2009) injection. Concomitant therapy included Concerta. On 03-JUN-2007, the patient was found unconscious, "incontinent" in urine, on the floor by her father. She had stopped breathing approximately "2-3 minutes". Medical attention was sought. She was taken to the emergency room where she had a head computed tomography (CT) scan, complete blood cell count (CBC), blood chemistry, urine test, and a urine drug screen performed. All tests came back "normal". The conclusion was that the patient had a seizure. On 03-JUN-2007, the patient recovered. The patient will not receive the second and third doses of Gardasil. Upon internal review, the seizure and respiratory arrest were considered to be Other Important Medical Events. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Laboratory test normal, Loss of consciousness, Mood swings, Pain, Pollakiuria
Clinical narrative: Information has been received from a physician concerning a 13 year old female with attention deficit/hyperactivity disorder who on 03-MAY-2007 was vaccinated with a first dose of Gardasil (lot # 655503/0012U; expired 13-JUN-2009) injection. Concomitant therapy included Concerta. On 03-JUN-2007, the patient was found unconscious, "incontinent" in urine, on the floor by her father. She had stopped breathing approximately "2-3 minutes". Medical attention was sought. She was taken to the emergency room where she had a head computed tomography (CT) scan, complete blood cell count (CBC), blood chemistry, urine test, and a urine drug screen performed. All tests came back "normal". The conclusion was that the patient had a seizure. On 03-JUN-2007, the patient recovered. The patient will not receive the second and third doses of Gardasil. Upon internal review, the seizure and respiratory arrest were considered to be Other Important Medical Events. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Pregnancy test urine negative, Respiratory arrest, Urinary incontinence, Urine analysis normal
Clinical narrative: Information has been received from a physician concerning a 13 year old female with attention deficit/hyperactivity disorder who on 03-MAY-2007 was vaccinated with a first dose of Gardasil (lot # 655503/0012U; expired 13-JUN-2009) injection. Concomitant therapy included Concerta. On 03-JUN-2007, the patient was found unconscious, "incontinent" in urine, on the floor by her father. She had stopped breathing approximately "2-3 minutes". Medical attention was sought. She was taken to the emergency room where she had a head computed tomography (CT) scan, complete blood cell count (CBC), blood chemistry, urine test, and a urine drug screen performed. All tests came back "normal". The conclusion was that the patient had a seizure. On 03-JUN-2007, the patient recovered. The patient will not receive the second and third doses of Gardasil. Upon internal review, the seizure and respiratory arrest were considered to be Other Important Medical Events. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Computerised tomogram normal, Convulsion, Drug screen negative, Full blood count normal, Laboratory test normal
Clinical narrative: Information has been received from a physician concerning a 13 year old female with attention deficit/hyperactivity disorder who on 03-MAY-2007 was vaccinated with a first dose of Gardasil (lot # 655503/0012U; expired 13-JUN-2009) injection. Concomitant therapy included Concerta. On 03-JUN-2007, the patient was found unconscious, "incontinent" in urine, on the floor by her father. She had stopped breathing approximately "2-3 minutes". Medical attention was sought. She was taken to the emergency room where she had a head computed tomography (CT) scan, complete blood cell count (CBC), blood chemistry, urine test, and a urine drug screen performed. All tests came back "normal". The conclusion was that the patient had a seizure. On 03-JUN-2007, the patient recovered. The patient will not receive the second and third doses of Gardasil. Upon internal review, the seizure and respiratory arrest were considered to be Other Important Medical Events. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Loss of consciousness, Respiratory arrest, Urinary incontinence, Urine analysis normal
Clinical narrative: Information has been received from a physician concerning a 13 year old female with attention deficit/hyperactivity disorder who on 03-MAY-2007 was vaccinated with a first dose of Gardasil (lot # 655503/0012U; expired 13-JUN-2009) injection. Concomitant therapy included Concerta. On 03-JUN-2007, the patient was found unconscious, "incontinent" in urine, on the floor by her father. She had stopped breathing approximately "2-3 minutes". Medical attention was sought. She was taken to the emergency room where she had a head computed tomography (CT) scan, complete blood cell count (CBC), blood chemistry, urine test, and a urine drug screen performed. All tests came back "normal". The conclusion was that the patient had a seizure. On 03-JUN-2007, the patient recovered. The patient will not receive the second and third doses of Gardasil. Upon internal review, the seizure and respiratory arrest were considered to be Other Important Medical Events. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Blood test normal, Computerised tomogram normal, Convulsion, Electroencephalogram normal, Tremor
Clinical narrative: Information has been received from a physician concerning a 13 year old female with attention deficit/hyperactivity disorder who on 03-MAY-2007 was vaccinated with a first dose of Gardasil (lot # 655503/0012U; expired 13-JUN-2009) injection. Concomitant therapy included Concerta. On 03-JUN-2007, the patient was found unconscious, "incontinent" in urine, on the floor by her father. She had stopped breathing approximately "2-3 minutes". Medical attention was sought. She was taken to the emergency room where she had a head computed tomography (CT) scan, complete blood cell count (CBC), blood chemistry, urine test, and a urine drug screen performed. All tests came back "normal". The conclusion was that the patient had a seizure. On 03-JUN-2007, the patient recovered. The patient will not receive the second and third doses of Gardasil. Upon internal review, the seizure and respiratory arrest were considered to be Other Important Medical Events. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Urinary incontinence, Urine analysis normal, Wheezing
Clinical narrative: Information has been received from a physician concerning a 13 year old female with attention deficit/hyperactivity disorder who on 03-MAY-2007 was vaccinated with a first dose of Gardasil (lot # 655503/0012U; expired 13-JUN-2009) injection. Concomitant therapy included Concerta. On 03-JUN-2007, the patient was found unconscious, "incontinent" in urine, on the floor by her father. She had stopped breathing approximately "2-3 minutes". Medical attention was sought. She was taken to the emergency room where she had a head computed tomography (CT) scan, complete blood cell count (CBC), blood chemistry, urine test, and a urine drug screen performed. All tests came back "normal". The conclusion was that the patient had a seizure. On 03-JUN-2007, the patient recovered. The patient will not receive the second and third doses of Gardasil. Upon internal review, the seizure and respiratory arrest were considered to be Other Important Medical Events. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Anorexia, Barium double contrast, Barium enema, Diarrhoea, Gastrointestinal disorder
Clinical narrative: Vomit, abdominal distension. Seen at medical center, given Zofran. Seen at office next day 6-6-07 for flu. Still fussy, had some diarrhea. Referred back to his doctor for further examination. Intussusception diagnosed and reduced by air barium contrast on 2nd visit.  7/17/07 Received hospital medical records which reveal patient experienced vomiting x 2 days since received vax.  Seen in ER on 6/5, tx w/IVF & d/c to home.  Continued to vomit & seen by PCP 6/6/07 who sent to ER.   Fussy, pale, squirmy & lethargic.  Intussusception incompletely resolved w/air contrast enema & second air contrast enema done which did resolve IS.  Admitted for observation.  Progressed well & d/c to home 6/7/07.  Developed a fever & returned to ER on 6/8.  WBC in ER was 4.8 & UA was neg.  Abdominal x-rays were WNL.  Dx w/acute febrile illness & d/c to home to f/u in surgery clinic in AM. FINAL DX: Intussusception.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception, Irritability, Vomiting, X-ray
Clinical narrative: Vomit, abdominal distension. Seen at medical center, given Zofran. Seen at office next day 6-6-07 for flu. Still fussy, had some diarrhea. Referred back to his doctor for further examination. Intussusception diagnosed and reduced by air barium contrast on 2nd visit.  7/17/07 Received hospital medical records which reveal patient experienced vomiting x 2 days since received vax.  Seen in ER on 6/5, tx w/IVF & d/c to home.  Continued to vomit & seen by PCP 6/6/07 who sent to ER.   Fussy, pale, squirmy & lethargic.  Intussusception incompletely resolved w/air contrast enema & second air contrast enema done which did resolve IS.  Admitted for observation.  Progressed well & d/c to home 6/7/07.  Developed a fever & returned to ER on 6/8.  WBC in ER was 4.8 & UA was neg.  Abdominal x-rays were WNL.  Dx w/acute febrile illness & d/c to home to f/u in surgery clinic in AM. FINAL DX: Intussusception.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal distension, Barium double contrast, Diarrhoea, Intussusception, Irritability
Clinical narrative: Vomit, abdominal distension. Seen at medical center, given Zofran. Seen at office next day 6-6-07 for flu. Still fussy, had some diarrhea. Referred back to his doctor for further examination. Intussusception diagnosed and reduced by air barium contrast on 2nd visit.  7/17/07 Received hospital medical records which reveal patient experienced vomiting x 2 days since received vax.  Seen in ER on 6/5, tx w/IVF & d/c to home.  Continued to vomit & seen by PCP 6/6/07 who sent to ER.   Fussy, pale, squirmy & lethargic.  Intussusception incompletely resolved w/air contrast enema & second air contrast enema done which did resolve IS.  Admitted for observation.  Progressed well & d/c to home 6/7/07.  Developed a fever & returned to ER on 6/8.  WBC in ER was 4.8 & UA was neg.  Abdominal x-rays were WNL.  Dx w/acute febrile illness & d/c to home to f/u in surgery clinic in AM. FINAL DX: Intussusception.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Vomit, abdominal distension. Seen at medical center, given Zofran. Seen at office next day 6-6-07 for flu. Still fussy, had some diarrhea. Referred back to his doctor for further examination. Intussusception diagnosed and reduced by air barium contrast on 2nd visit.  7/17/07 Received hospital medical records which reveal patient experienced vomiting x 2 days since received vax.  Seen in ER on 6/5, tx w/IVF & d/c to home.  Continued to vomit & seen by PCP 6/6/07 who sent to ER.   Fussy, pale, squirmy & lethargic.  Intussusception incompletely resolved w/air contrast enema & second air contrast enema done which did resolve IS.  Admitted for observation.  Progressed well & d/c to home 6/7/07.  Developed a fever & returned to ER on 6/8.  WBC in ER was 4.8 & UA was neg.  Abdominal x-rays were WNL.  Dx w/acute febrile illness & d/c to home to f/u in surgery clinic in AM. FINAL DX: Intussusception.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dehydration, Drug exposure during pregnancy, Pregnancy test positive, Urinary tract infection, Vomiting
Clinical narrative: Information has been received from a nurse concerning a 17 year old female who on 19-JAN-2007 was vaccinated with IM with a 0.5 ml first dose of Gardasil (654389/0961F). On 10-APR-2007 was vaccinated with IM with a 0.5 ml second dose of Gardasil (657617/0384U). Concomitant therapy included vitamins (unspecified). On 10-MAY-2007 the patient was seen in the emergency department because she experienced vomiting and dehydration. On 10-MAY-2007 serum beta-human chorionic gonadotropin test diagnosed the patient as pregnant. The patient was treated with unspecified intravenous solution and ondansetron hydrochloride (ZOFRAN). Her last menstrual period was 28-MAR-2007. Estimated date of delivery was 02-JAN-2008. On approximately, 13-JUN-2007, the patient developed a urinary tract infection. The patient was treated with nitrofurantoin (MACROBID). The reporting nurse practitioner considered vomiting and dehydration and to be other important medical events. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Talipes, Umbilical cord abnormality
Clinical narrative: Initial and follow-up information has been received through the Merck pregnancy registry from a registered nurse concerning an 18 year old female with 1 previous pregnancy that resulted in miscarriage, who on 27-OCT-2006 was vaccinated with the first dose of Gardasil (lot # 653937/0637F) when she was 17 1/7 weeks pregnant, last menstrual period 29-JUN-2006. Concomitant medication included hormonal contraceptives (unspecified). On 03-DEC-2006 the patient found out she was pregnant via a home beta-human chorionic gonadotropin test (unspecified) and concomitant medication was stopped. A full term baby was born on 25-MAR-2007. Subsequently, the infant was born with a left club foot and two vessel umbilical cord. On 04-MAY-2007 the patient was vaccinated with the second dose of Gardasil (lot # 0210U). There were no other birth defects in the family. The nurse felt that the left club foot and two vessel umbilical cord were other important medical events. This is one of two patients received from the same source. This is an amended report. The terms Medication error and No adverse effect and information regarding the events have been deleted from this report and entered into WAES 0701USA02073.
Sex: F
Vaccine: HPV4, MMR, UNK
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a health professional, for the Pregnancy Registry for Gardasil, concerning a female patient who was vaccinated with a dose of Gardasil. Concomitant suspect therapy included a dose of M-M-R II. Other concomitant therapy included "other unspecified vaccines". The reporter mentioned that the patient was pregnant but miscarried after receiving Gardasil. Unspecified medical attention was sought. No additional information was available. Upon internal review, miscarriage was determined to be an other Important Medical Event. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Fluid replacement, Loss of consciousness, Oxygen supplementation
Clinical narrative: Information has been received from a physician's assistant concerning an 11 year old female who on 01-JUN-2007 was vaccinated with Gardasil (lot # 657736/0389U) (doses # unspecified) injection. Concomitant therapy included "T-Dap", and Menactra both also given on 01-JUN-2007. On 01-JUN-2007, approximately 20 minutes after receiving the Gardasil, the patient passed out in the reception area of the physician's office. Medical attention was sought. The patient was fasting and did not have anything to eat before receiving the vaccine. The patient was treated with oxygen and fluids at the physician's office. She was not taken to the emergency room. On 01-JUN-2007, the patient recovered. The reporting physician's assistant felt that the event was serious because the patient was given oxygen (Other Important Medical Event). Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Kawasaki's disease, Lymphadenopathy, Pyrexia, Streptococcal identification test negative, White blood cell count increased
Clinical narrative: Information has been received from the FDA from a physician concerning a 4 year old female with no preexisting conditions, or current illness, who on 23-FEB-2006 was vaccinated with MMR II (Lot # 649754/0378R). There was no concomitant medication. Within five to seven days after receiving the second dose of MMR II, the patient developed fever, lymphadenopathy and was diagnosed with Kawasaki's disease, and was hospitalized. An ER/doctor visit was noted. It was also noted that "21 days later", 16 MAR 2007, was the "onset date". The results of a rapid strep throat test performed, were negative. The WBC's were increased at 15.3. The patient was considered recovered at the time of reporting. The reported events were considered to be a life threatening illness. A lot check and batch review has been requested for Lot # 649754/0378R. A review of the release testing data revealed that the lot in question conformed to all required testing at the time of product release. The lot complies with the standards and was released. Additional information is not expected.
Sex: F
Vaccine: MMR
Symptoms: Coronary artery aneurysm, Hypokinesia, Kawasaki's disease
Clinical narrative: Information that was reported in a published article (article not provided) has been received from VAERS concerning a female who on an unspecified date was vaccinated with a dose of MMR II. Three weeks after vaccination she developed Kawasaki disease. She was treated vigorously, and received IVIG, but went on to develop a left descending coronary artery aneurysm. The patient was described as having slow motor skills and it was reported that she was in an early intervention program. Hypokinesia was noted. At the time of the report the patient had not recovered. No further information was provided. Upon internal review the patient's left descending coronary artery aneurysm was considered an other important medical event. No further information is available.
Age: 8.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Local reaction, Poor quality drug administered
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old male who on 10-APR-2007 was vaccinated with a 0.5 mL SC dose in the right arm of Varivax (lot # 656281/1504F). Suspect vaccination on the same day included a dose of Recombivax HB (manufacturer unknown). It was reported that the Varivax (lot # 656281/1504F) was exposed to 36 F for 4 hours. On 11-APR-2007 the patient developed signs of cellulitis and began unspecified antibiotic treatment on 13-APR-2007. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information was received from a registered nurse, who reports that cellulitis was ruled out and the reaction was diagnosed as an "intense local reaction". At the time of reporting the outcome was not provided. The event of "intense local reaction" was considered to be an other medically important event (OME) by the reporter. No further information is available.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a 6-month-old female with no medical history or allergies who on 15-SEP-2006 (Lot #655082/0779F), 02-NOV-2006 (Lot #655174/0848F) and 08-JAN-2007 (Lot #655407/1115F) was vaccinated PO with the first, second and third doses, respectively, of ROTATEQ. Concomitant vaccinations administered on that same day included a dose of PREVNAR, a dose of PEDVAXHIB and a dose of PEDIARIX. The physician reported that two and a half weeks after receiving the third dose , on approximately 25-JAN-2007, the patient developed intussusception. Unspecified medical attention was sought and the patient was subsequently hospitalized. While hospitalized, the intussusception was corrected without surgery by a "contrast procedure." The patient was hospitalized for an undetermined length of time and released on 15-MAR-2007. The patient was considered to be recovered. The physician also considered the intussusception to be an other important medical event due to the "contrast procedure." Additional information has been requested.  6/25/07 Received vax record from pcp which confirmed RO dose & lot # as reported.  Also provided additional info on other vax received same date.  VAERS database updated w/same.  7/20/07 Received t/c from reporters office w/MRN & corrected dates of admission which was 3/15-3/17/07.  8/14/07 Received hospital medical records which reveal patient experienced nausea 7 vomiting x 5 days.  no stool x 4 days.  Seen by PCP who noted tarry stool & sent to ER.  Fever in ER.  Admitted 3/15-3/17/07.   FINAL DX: Intussusception, enema reduced; acute gastroenteritis.
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Back pain, Dyspnoea, Muscular weakness, Wheezing
Clinical narrative: Subject received initial Anthrax immunization on June 5, 2007. Approximately 4 days later the subject was admitted to hospital with shortness of breath and weakness. He was kept in ICU overnight. He did not require ventilatory support. The subject's primary complaints are wheezing, pain in hips and back, and weakness in lower extremities. A summary of events, written on June 15, 2007, described the subject as improving slowly with oral steroids and physical therapy but he remains hospitalized. The summary states that on June 14, 2007 his doctor came to the conclusion that this probably was an event related to Anthrax vaccine and has reported the information to VAERS.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever, severe headache, body aches. Administered IV fluids. No redness at injection site.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered
Clinical narrative: Reporting of expiration dates. Gardasil exp date is reported as 06 Feb 10. Nurse confused is this 2/10/06 or 2/6/2010. If 2/10/06, administration would have led to an exp med given to an adolescent. If 2/06/2010 nurse may have improperly disposed of unexpired med. Another way to report the expiration date to a more standardized fashion will decrease confusion associated with exp dates on medications.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Cough, Pulmonary congestion, Urticaria, Virus serology test
Clinical narrative: infant developed chest congestion with cough 05/30/07. Taken to ER for urticaria which started 06/01/07 pm. Infant received 2 injections, on follow up 06/05/07 infant had generalized urticaria. RX oral Benadryl.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Cellulitis, Injection site cellulitis, Injection site pain, Injection site swelling
Clinical narrative: Intense swelling to L del on 5/16/07 painful on 5/17/07 swelling from shoulder to elbow DX Cellulitis from Dtap #5
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: L arm 4-5 inch area of warmth, redness, mildly indurated - non-tender - Non- itchy, developed approximately 24 hours after injections - treated with ice, Ibuprofen.
Age: 6.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered
Clinical narrative: 16 yrs 5 mo male given adult dose of HCP B vaccine
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration, Injection site rash
Clinical narrative: Fine unraised pink rash immediately after Gardasil injection on her right deltoid. Rash resolved in 10 minutes. No other complaints. #3 Gardasil - No prior reactions.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site rash, No reaction on previous exposure to drug
Clinical narrative: Pt developed red unraised rash immediately after vaccine was given on her left deltoid. Rash completely resolved after 10 min. No reaction after first dose. Tested other arm for sensitivity to alcohol without reaction.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Child's R arm is red, swollen and hot to touch from below deltoid to elbow. C/O itching. No temp.
Age: 45.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Hypoaesthesia oral, Similar reaction on previous exposure to drug
Clinical narrative: Numbness on tongue that subsides in a few days, occurred following both doses Hepatitis B, eats bread without symptoms. Same symptoms after using Beano
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Full blood count normal, Hypoaesthesia, Musculoskeletal pain, Pain in extremity
Clinical narrative: pain in RL upper arm, shoulder and Rt leg with numbness in rt leg. These improved in 24 hours and began within a few minutes after vaccination. Dizziness, began soon after vaccination and still persist. Petechia on chest and shoulders. 7/10/07-records received-DOS 6/21/07-reaction to vaccine. Felt dizzy pain in right upper arm right shoulder and right side of chest. Felt numb in reight leg. Improved by next morning except for dizziness and still feels dizzy when she stands up. Spots on right shoulder and upper chest. No fever, chill, vomiting headache or vision problem. PE:small patches tiny petechia around right shoulder and upper chest. Neuro exam normal. CBC normal
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Petechiae, Platelet count normal
Clinical narrative: pain in RL upper arm, shoulder and Rt leg with numbness in rt leg. These improved in 24 hours and began within a few minutes after vaccination. Dizziness, began soon after vaccination and still persist. Petechia on chest and shoulders. 7/10/07-records received-DOS 6/21/07-reaction to vaccine. Felt dizzy pain in right upper arm right shoulder and right side of chest. Felt numb in reight leg. Improved by next morning except for dizziness and still feels dizzy when she stands up. Spots on right shoulder and upper chest. No fever, chill, vomiting headache or vision problem. PE:small patches tiny petechia around right shoulder and upper chest. Neuro exam normal. CBC normal
Age: 34.0
Sex: M
Vaccine: ANTH, HEPA, PPV, SMALL, TD, TYP
Symptoms: Arthralgia, Bone pain, Headache, Myalgia
Clinical narrative: Headache, joint and bone pain, muscle pain
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Agitation, Cough, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Pt seen on 6/20/07 with fever and rash x 3 days. Runny nose and cough. Pt seen on 6/22/07 rash and fever worse. Fussy and vomited x 2 1 day prior to visit.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Vomiting
Clinical narrative: Pt seen on 6/20/07 with fever and rash x 3 days. Runny nose and cough. Pt seen on 6/22/07 rash and fever worse. Fussy and vomited x 2 1 day prior to visit.
Sex: U
Vaccine: ANTH, FLUX, HEP
Symptoms: Arthralgia, Blood cholesterol increased, Blood pressure fluctuation, Depression, Headache
Clinical narrative: Ache - joints and muscles - blood - pressure: high and high cholesterol - blood pressure varies - depression - headache: uncontrollable - problem with skin
Sex: U
Vaccine: ANTH, FLUX, HEP
Symptoms: Hypertension, Myalgia, Skin disorder
Clinical narrative: Ache - joints and muscles - blood - pressure: high and high cholesterol - blood pressure varies - depression - headache: uncontrollable - problem with skin
Age: 52.0
Sex: U
Vaccine: HEPA
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting started 6 hours after Hepatitis A vaccination and continued through the night. The next day she had nausea only that lasted until about 6 PM.
Age: 48.0
Sex: F
Vaccine: RAB
Symptoms: Disturbance in attention, Ear pain, Headache, Nausea, Pharyngolaryngeal pain
Clinical narrative: Nausea, headache, ear pain, sore throat, blurred vision, decreased concentration throughout course of injections 5/18/07-6/15/07
Age: 48.0
Sex: F
Vaccine: RAB
Symptoms: Vision blurred
Clinical narrative: Nausea, headache, ear pain, sore throat, blurred vision, decreased concentration throughout course of injections 5/18/07-6/15/07
Age: 0.8
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying
Clinical narrative: Crying - non stop - for over 6 hours 1 1/2 days after vaccine. Seen at children's medical center. No physical findings.
Age: 5.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Vaccine given 6/9/07 - 6/11/07 had localized redness, (cellulitis) on left thigh Ice, Ataset, Keflex.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Cellulitis, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: R arm swollen, painful and hot after immunizations - dx with cellulitis, treated with Omnicef x 10 days.
Age: 0.8
Sex: F
Vaccine: HEP, IPV
Symptoms: Lethargy, Vomiting
Clinical narrative: Vomiting - Lethargy
Age: 1.33
Sex: F
Vaccine: HEPA, PNC, VARCEL
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction to immunizations at site bilaterally
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Pain in extremity, Skin warm
Clinical narrative: Approximately 4 hours after vaccine noticed large whelp over injection site with redness and soreness. Area continued to swell to approximately 3 inch x 3 inch area with continued redness and hot to touch. Arm is very sore next day.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Swollen, heat, red raised area, and pain
Age: 9.0
Sex: F
Vaccine: UNK
Symptoms: Cellulitis, Erythema, Rash papular
Clinical narrative: The evening following injection developed approx 4 cm redness (asymetric from site). Progressive redness no benefit with Benadryl. Also five papules over face, trunk, legs Dx: cellulitis Tx: Cephalexin x 7-100
Sex: U
Vaccine: ANTH
Symptoms: Throat irritation
Clinical narrative: Mild airway irritation. No difficulty breathing.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Diarrhoea, Pyrexia, Rash
Clinical narrative: Within 18 hours developed explosive diarrhea and rash covering lower back to mid thigh including entire genital area. Also started running fever near 102 deg F
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: 7x7cm edematous, erythematous area over vaccination site-warm/tender to touch
Age: 15.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Cellulitis, Heat therapy
Clinical narrative: Cellulitis (R) arm tx: Augmentin 875mg PO BIDx5-7d. warm compresses
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Cellulitis
Clinical narrative: Cellulitis left thigh post vaccination Keflex 250mg PO TID x 1 week. Tylenol warm compress.
Age: 1.1
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC
Symptoms: Pyrexia, Rash
Clinical narrative: 6-22-07 Mom called in with questions and reports that child has developed "spots" (*5) over his trunk and low grade fever giving Ibuprofen for discomfort - reassurance of support offered. To seek MD if condition worsens.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: 3 x 3" red, swollen, warm arm within 24 hours of getting DTaP and Varivax in that arm. No itching, fever.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: 5 x 5" red, swollen, warm arm within 24 hour of getting DTaP and Varivax in that arm. No fever, itching.