chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: RAB
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Patient received a rabies vaccination 7-27-07 on 7-28-07 in the AM. He noticed a red rash to his right arm and wrist, which later spread to his left arm and there spread to his upper back and had some itching.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Full blood count, Injection site erythema, Injection site induration, Injection site pain, White blood cell count
Clinical narrative: Reddened, hardened, sore to touch area to left outer thigh @ IPV injection site. Irregular area appx 5x4 noted by PA @ ER. Mom TC to Health Dept nurse, recommended ER/Dr visit. PA informed health dept nurse that allergic Rx to vaccine was dx. ATB given prophylactic.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Maculopapular rash scattered.
Age: 0.2
Sex: F
Vaccine: UNK
Symptoms: Faeces discoloured, Irritability, Screaming
Clinical narrative: fussy, screaming, green bowel movements
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Full blood count, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: reddened swelling, sl. tenderness (L) arm site of vaccination to r/o cellulitis
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Red blood cell sedimentation rate
Clinical narrative: reddened swelling, sl. tenderness (L) arm site of vaccination to r/o cellulitis
Age: 1.7
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 19th after patient received DTaP 7/16/07. Markedly swelling and red injection site 14 cm x 5 cm and tender on 7/18/07.
Age: 20.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dizziness
Clinical narrative: pt with c/o lightheadedness/dizziness approximately one minute after injection of Gardasil #1. Pt laid down and stated symptoms resolved after about 10 minutes. Pt also recieved TDAP that day. TDAP given first, then Gardasil. Symptoms occurred after Gardasil given.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hot flush, Tremor
Clinical narrative: Patient received Gardasil #1 on 3-09-07. No c/o at time of injection. patient called office on 3-19-07 with c/o feeling shaky, hot flashes,and headache. No other s/s of illness, s/s resolved that day.
Age: 39.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Dizziness, Dyspnoea, Joint stiffness, Lymphadenopathy, Pain
Clinical narrative: PT C/O OF FEVER 103,BODY ACHES,SOB,STIFFNESS IN JOINTS AND DIZZINES, SWOLLEN GLANDS
Age: 39.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Pyrexia
Clinical narrative: PT C/O OF FEVER 103,BODY ACHES,SOB,STIFFNESS IN JOINTS AND DIZZINES, SWOLLEN GLANDS
Age: 60.0
Sex: M
Vaccine: UNK
Symptoms: Adverse event, Blood test, Urticaria
Clinical narrative: Vacciniation in mid April Zostavax for shingles prevention. Broke out with Hives 10 days later. Hives have developed into chronic hives. They still exist. Some doctors feel that the Zostavax vaccine may have had an adverse reaction on my immune system. Cause is still unknow. But hives are serious.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Dizziness, Loss of consciousness, No reaction on previous exposure to drug, Pallor
Clinical narrative: Pt received first two Gardasil without incident. Gardasil #3 given 6-14-07. Following administration pt lost consciousness and was assisted to laying position on exam table by nurse. Pt was non-responsive, clammy, and had weak thready pulse. LOC resolved after 35-45 seconds. Pt had persisting dizziness and discoloration. Pt was unable to come to standing position after approximately 45 minutes lying. Pt was transported to ER via stretcher (we're located in the hospital) due to persisting dizziness and circumoral pallor. Was given Zofran IV in ER and released home.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pulse pressure decreased, Skin discolouration, Unresponsive to stimuli
Clinical narrative: Pt received first two Gardasil without incident. Gardasil #3 given 6-14-07. Following administration pt lost consciousness and was assisted to laying position on exam table by nurse. Pt was non-responsive, clammy, and had weak thready pulse. LOC resolved after 35-45 seconds. Pt had persisting dizziness and discoloration. Pt was unable to come to standing position after approximately 45 minutes lying. Pt was transported to ER via stretcher (we're located in the hospital) due to persisting dizziness and circumoral pallor. Was given Zofran IV in ER and released home.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blood test normal, Computerised tomogram normal, Confusional state, Headache, Lumbar puncture normal
Clinical narrative: The headache started 7-17-07 PM,  low grade fever started 7-18-07,  confusion started 7-18-07 PM, also minor twitches in arms and legs.   Brought to ER 7-18-07 late PM they did CT scan, blood work - drawn from two soruces, and lumbar puncture. They started IV fluid and antibiotics.  Admitted to hospital. Confusion, headache and fever continued through 7-19-07. By noon 7-20-07 he was feeling better.  He didn't have a fever, headache or confusion.  Released from hospital 7-21-07.and presumed viral meningitis.  8/16/07-Records received for DOS 7/18-7/21/07-DC DX:Viral meningitis. Situs inversus, total.  Admitted through ER with headache, confusion, nuchal rigidity. Began to get ill yesterday morning when he woke up with severe headache. Parents could not understand his gibberish. Fevers 100 to 101.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Muscle twitching, Pyrexia
Clinical narrative: The headache started 7-17-07 PM,  low grade fever started 7-18-07,  confusion started 7-18-07 PM, also minor twitches in arms and legs.   Brought to ER 7-18-07 late PM they did CT scan, blood work - drawn from two soruces, and lumbar puncture. They started IV fluid and antibiotics.  Admitted to hospital. Confusion, headache and fever continued through 7-19-07. By noon 7-20-07 he was feeling better.  He didn't have a fever, headache or confusion.  Released from hospital 7-21-07.and presumed viral meningitis.  8/16/07-Records received for DOS 7/18-7/21/07-DC DX:Viral meningitis. Situs inversus, total.  Admitted through ER with headache, confusion, nuchal rigidity. Began to get ill yesterday morning when he woke up with severe headache. Parents could not understand his gibberish. Fevers 100 to 101.
Sex: U
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Dyspnoea, Hyperhidrosis, Nausea
Clinical narrative: I fainted right after receiving the second dose of the vacine.  Started sweating, couldnt breathe, my arms and legs were temporarily paralyzed. I became instantly thirsty and was terribly dizzy and nautios.  It was the most terrifyng experience of my life.  It happened this morning and I have been feeling lightheaded all day, extremely thirsty and weak.  I deeply regret taking the advice of my doctor to get it.  The vacine should be withdrawn and absotelutely not administered to anyone!
Sex: U
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Paralysis, Syncope, Thirst
Clinical narrative: I fainted right after receiving the second dose of the vacine.  Started sweating, couldnt breathe, my arms and legs were temporarily paralyzed. I became instantly thirsty and was terribly dizzy and nautios.  It was the most terrifyng experience of my life.  It happened this morning and I have been feeling lightheaded all day, extremely thirsty and weak.  I deeply regret taking the advice of my doctor to get it.  The vacine should be withdrawn and absotelutely not administered to anyone!
Age: 7.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Blister, Erythema, Swelling
Clinical narrative: 3.5"x4" area of induration with erythema 2" blisters - opened on its own - healthy tissue. Meds Benadryl/Acyclovir
Age: 7.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Blister, Erythema, Induration
Clinical narrative: 3.5"x4" area of induration with erythema 2" blisters - opened on its own - healthy tissue. Meds Benadryl/Acyclovir
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Blood glucose normal, Dyskinesia, Electrocardiogram normal, Gaze palsy, Heart rate decreased
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with asthma and drug hypersensitivity to erythromycin ethylsuccinate (+) sulfisoxazole acetyl (PEDIAZOLE) who on 20-JUL-2007 was vaccinated intramuscularly, into the right deltoid with a first dose of Gardasil (lot #657868/0523U) concomitantly with a dose of Menactra into the left deltoid. Concomitant therapy included cetirizine hydrochloride (ZYRTEC) and albuterol. On 20-JUL-2007, within minutes of the vaccinations, the patient experienced bradycardia and fainting. Her total heartbeat count was 52-57, blood pressure measurement was 98/53 and her pulse oximetry was 99-100 percent. She was unconscious for 3 to 5 minutes and was clammy and pale. She was "better" within 10 minutes. The patient was observes for 30-40 minutes. When she stool up she became nauseated, pale and fainted again. She regained consciousness within 5 minutes. It was reported that she did not eat breakfast and used albuterol before arriving at the appointment. The patient was given crackers and dextrose (+) electrolytes (unspecified) (PEDIALYTE) to drink. Her glucose was 134 and hemoglobin was 14.0. She was sent to the hospital for an electrocardiogram showed normal sinus rhythm and a normal echocardiography. Subsequently, the patient recovered.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Loss of consciousness, Nausea, Pallor
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with asthma and drug hypersensitivity to erythromycin ethylsuccinate (+) sulfisoxazole acetyl (PEDIAZOLE) who on 20-JUL-2007 was vaccinated intramuscularly, into the right deltoid with a first dose of Gardasil (lot #657868/0523U) concomitantly with a dose of Menactra into the left deltoid. Concomitant therapy included cetirizine hydrochloride (ZYRTEC) and albuterol. On 20-JUL-2007, within minutes of the vaccinations, the patient experienced bradycardia and fainting. Her total heartbeat count was 52-57, blood pressure measurement was 98/53 and her pulse oximetry was 99-100 percent. She was unconscious for 3 to 5 minutes and was clammy and pale. She was "better" within 10 minutes. The patient was observes for 30-40 minutes. When she stool up she became nauseated, pale and fainted again. She regained consciousness within 5 minutes. It was reported that she did not eat breakfast and used albuterol before arriving at the appointment. The patient was given crackers and dextrose (+) electrolytes (unspecified) (PEDIALYTE) to drink. Her glucose was 134 and hemoglobin was 14.0. She was sent to the hospital for an electrocardiogram showed normal sinus rhythm and a normal echocardiography. Subsequently, the patient recovered.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Blood glucose increased, Blood pressure, Bradycardia, Cold sweat, Echocardiogram normal
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with asthma and drug hypersensitivity to erythromycin ethylsuccinate (+) sulfisoxazole acetyl (PEDIAZOLE) who on 20-JUL-2007 was vaccinated intramuscularly, into the right deltoid with a first dose of Gardasil (lot #657868/0523U) concomitantly with a dose of Menactra into the left deltoid. Concomitant therapy included cetirizine hydrochloride (ZYRTEC) and albuterol. On 20-JUL-2007, within minutes of the vaccinations, the patient experienced bradycardia and fainting. Her total heartbeat count was 52-57, blood pressure measurement was 98/53 and her pulse oximetry was 99-100 percent. She was unconscious for 3 to 5 minutes and was clammy and pale. She was "better" within 10 minutes. The patient was observes for 30-40 minutes. When she stool up she became nauseated, pale and fainted again. She regained consciousness within 5 minutes. It was reported that she did not eat breakfast and used albuterol before arriving at the appointment. The patient was given crackers and dextrose (+) electrolytes (unspecified) (PEDIALYTE) to drink. Her glucose was 134 and hemoglobin was 14.0. She was sent to the hospital for an electrocardiogram showed normal sinus rhythm and a normal echocardiography. Subsequently, the patient recovered.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Electrocardiogram normal, Haemoglobin normal, Heart rate decreased, Loss of consciousness, Nausea
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with asthma and drug hypersensitivity to erythromycin ethylsuccinate (+) sulfisoxazole acetyl (PEDIAZOLE) who on 20-JUL-2007 was vaccinated intramuscularly, into the right deltoid with a first dose of Gardasil (lot #657868/0523U) concomitantly with a dose of Menactra into the left deltoid. Concomitant therapy included cetirizine hydrochloride (ZYRTEC) and albuterol. On 20-JUL-2007, within minutes of the vaccinations, the patient experienced bradycardia and fainting. Her total heartbeat count was 52-57, blood pressure measurement was 98/53 and her pulse oximetry was 99-100 percent. She was unconscious for 3 to 5 minutes and was clammy and pale. She was "better" within 10 minutes. The patient was observes for 30-40 minutes. When she stool up she became nauseated, pale and fainted again. She regained consciousness within 5 minutes. It was reported that she did not eat breakfast and used albuterol before arriving at the appointment. The patient was given crackers and dextrose (+) electrolytes (unspecified) (PEDIALYTE) to drink. Her glucose was 134 and hemoglobin was 14.0. She was sent to the hospital for an electrocardiogram showed normal sinus rhythm and a normal echocardiography. Subsequently, the patient recovered.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Oxygen saturation, Oxygen saturation normal, Pallor, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with asthma and drug hypersensitivity to erythromycin ethylsuccinate (+) sulfisoxazole acetyl (PEDIAZOLE) who on 20-JUL-2007 was vaccinated intramuscularly, into the right deltoid with a first dose of Gardasil (lot #657868/0523U) concomitantly with a dose of Menactra into the left deltoid. Concomitant therapy included cetirizine hydrochloride (ZYRTEC) and albuterol. On 20-JUL-2007, within minutes of the vaccinations, the patient experienced bradycardia and fainting. Her total heartbeat count was 52-57, blood pressure measurement was 98/53 and her pulse oximetry was 99-100 percent. She was unconscious for 3 to 5 minutes and was clammy and pale. She was "better" within 10 minutes. The patient was observes for 30-40 minutes. When she stool up she became nauseated, pale and fainted again. She regained consciousness within 5 minutes. It was reported that she did not eat breakfast and used albuterol before arriving at the appointment. The patient was given crackers and dextrose (+) electrolytes (unspecified) (PEDIALYTE) to drink. Her glucose was 134 and hemoglobin was 14.0. She was sent to the hospital for an electrocardiogram showed normal sinus rhythm and a normal echocardiography. Subsequently, the patient recovered.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Cough, Eye swelling, Lip swelling, Urticaria, Wheezing
Clinical narrative: Information has been received from a licensed visiting nurse (L.V.N.) concerning a healthy 3-year-old male with no drug allergies who on 18-JUL-2007 was vaccinated intramuscularly in the left thigh with a 0.5 millimeter dose of VAQTA (lot# 657304/0246U). Concomitant therapy included SINGULAR, PULMICORT and a dose in the right leg of DTaP (the patient  never had a reaction with this vaccination before). In the evening on 18-JUL-2007, the patient experienced erythema multiforme and multiple small welts. The patient was taken to the emergency room because his "airway was closing".  The patient was treated with epinephrine and albuterol. After treatment, the welts came back overnight, were larger than before and itchy. There was one big welt from the patients elbow to wrist. His left eye was also puffy. The patient was seen in the office on 19-Jul-2007 and was given a prescription of oral prednisone and BENADRYL. There were no laboratory diagnostic studies performed. The outcome is reported as not recovered. No product quality complaint was involved. The reporter considered that "airway was closing" a life threatening event. The reporter considered the patient's experiences to be other important medical events. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Erythema multiforme, Eye swelling, No reaction on previous exposure to drug, Obstructive airways disorder, Pruritus
Clinical narrative: Information has been received from a licensed visiting nurse (L.V.N.) concerning a healthy 3-year-old male with no drug allergies who on 18-JUL-2007 was vaccinated intramuscularly in the left thigh with a 0.5 millimeter dose of VAQTA (lot# 657304/0246U). Concomitant therapy included SINGULAR, PULMICORT and a dose in the right leg of DTaP (the patient  never had a reaction with this vaccination before). In the evening on 18-JUL-2007, the patient experienced erythema multiforme and multiple small welts. The patient was taken to the emergency room because his "airway was closing".  The patient was treated with epinephrine and albuterol. After treatment, the welts came back overnight, were larger than before and itchy. There was one big welt from the patients elbow to wrist. His left eye was also puffy. The patient was seen in the office on 19-Jul-2007 and was given a prescription of oral prednisone and BENADRYL. There were no laboratory diagnostic studies performed. The outcome is reported as not recovered. No product quality complaint was involved. The reporter considered that "airway was closing" a life threatening event. The reporter considered the patient's experiences to be other important medical events. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Urticaria
Clinical narrative: Information has been received from a licensed visiting nurse (L.V.N.) concerning a healthy 3-year-old male with no drug allergies who on 18-JUL-2007 was vaccinated intramuscularly in the left thigh with a 0.5 millimeter dose of VAQTA (lot# 657304/0246U). Concomitant therapy included SINGULAR, PULMICORT and a dose in the right leg of DTaP (the patient  never had a reaction with this vaccination before). In the evening on 18-JUL-2007, the patient experienced erythema multiforme and multiple small welts. The patient was taken to the emergency room because his "airway was closing".  The patient was treated with epinephrine and albuterol. After treatment, the welts came back overnight, were larger than before and itchy. There was one big welt from the patients elbow to wrist. His left eye was also puffy. The patient was seen in the office on 19-Jul-2007 and was given a prescription of oral prednisone and BENADRYL. There were no laboratory diagnostic studies performed. The outcome is reported as not recovered. No product quality complaint was involved. The reporter considered that "airway was closing" a life threatening event. The reporter considered the patient's experiences to be other important medical events. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Acute myocardial infarction, Catheterisation cardiac, Chest pain, Electrocardiogram QT prolonged, Electrocardiogram ST segment elevation
Clinical narrative: Patient was developed onset of chest pain 11 days after vaccination, was evaluated and found to have elevated cardiac enzymes and sig EKG changes, patient was transported to Hopital where he underwent coronary catheterization.  Patient ultimately diagnosed with peri-myocarditis, patient hospitalized for three day duration, and was discharged.  He is currently taking indocin and coreg.  He is currently doing well.  08/3/2007 MR received for hospital DOS 7/25-27/2007.  Pt presented initially to MD with onset of substernal chest discomfort, flu-like sx, sore throat, and general body aches.  Pt transfered to Local ER where EKG's and cardiac enzymes appeared to indicate MI. He was then transfered via Airlift to current facility.  PE (+) for ant bites on the ankles and L deltoid smallpox site with swelling and yellow drainage. Otherwise WNL.  Discharge DX: Myocarditis.  Recent Smallpox vaccine.  Anterolateral hypokines by echocardiogram.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Electrocardiogram abnormal, Myocardial infarction, Myocarditis, Troponin increased
Clinical narrative: Patient was developed onset of chest pain 11 days after vaccination, was evaluated and found to have elevated cardiac enzymes and sig EKG changes, patient was transported to Hopital where he underwent coronary catheterization.  Patient ultimately diagnosed with peri-myocarditis, patient hospitalized for three day duration, and was discharged.  He is currently taking indocin and coreg.  He is currently doing well.  08/3/2007 MR received for hospital DOS 7/25-27/2007.  Pt presented initially to MD with onset of substernal chest discomfort, flu-like sx, sore throat, and general body aches.  Pt transfered to Local ER where EKG's and cardiac enzymes appeared to indicate MI. He was then transfered via Airlift to current facility.  PE (+) for ant bites on the ankles and L deltoid smallpox site with swelling and yellow drainage. Otherwise WNL.  Discharge DX: Myocarditis.  Recent Smallpox vaccine.  Anterolateral hypokines by echocardiogram.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Cardiac enzymes increased, Catheterisation cardiac abnormal, Chest pain
Clinical narrative: Patient was developed onset of chest pain 11 days after vaccination, was evaluated and found to have elevated cardiac enzymes and sig EKG changes, patient was transported to Hopital where he underwent coronary catheterization.  Patient ultimately diagnosed with peri-myocarditis, patient hospitalized for three day duration, and was discharged.  He is currently taking indocin and coreg.  He is currently doing well.  08/3/2007 MR received for hospital DOS 7/25-27/2007.  Pt presented initially to MD with onset of substernal chest discomfort, flu-like sx, sore throat, and general body aches.  Pt transfered to Local ER where EKG's and cardiac enzymes appeared to indicate MI. He was then transfered via Airlift to current facility.  PE (+) for ant bites on the ankles and L deltoid smallpox site with swelling and yellow drainage. Otherwise WNL.  Discharge DX: Myocarditis.  Recent Smallpox vaccine.  Anterolateral hypokines by echocardiogram.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram change, Hypokinesia, Myocarditis
Clinical narrative: Patient was developed onset of chest pain 11 days after vaccination, was evaluated and found to have elevated cardiac enzymes and sig EKG changes, patient was transported to Hopital where he underwent coronary catheterization.  Patient ultimately diagnosed with peri-myocarditis, patient hospitalized for three day duration, and was discharged.  He is currently taking indocin and coreg.  He is currently doing well.  08/3/2007 MR received for hospital DOS 7/25-27/2007.  Pt presented initially to MD with onset of substernal chest discomfort, flu-like sx, sore throat, and general body aches.  Pt transfered to Local ER where EKG's and cardiac enzymes appeared to indicate MI. He was then transfered via Airlift to current facility.  PE (+) for ant bites on the ankles and L deltoid smallpox site with swelling and yellow drainage. Otherwise WNL.  Discharge DX: Myocarditis.  Recent Smallpox vaccine.  Anterolateral hypokines by echocardiogram.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Myopericarditis, Troponin increased
Clinical narrative: Patient was developed onset of chest pain 11 days after vaccination, was evaluated and found to have elevated cardiac enzymes and sig EKG changes, patient was transported to Hopital where he underwent coronary catheterization.  Patient ultimately diagnosed with peri-myocarditis, patient hospitalized for three day duration, and was discharged.  He is currently taking indocin and coreg.  He is currently doing well.  08/3/2007 MR received for hospital DOS 7/25-27/2007.  Pt presented initially to MD with onset of substernal chest discomfort, flu-like sx, sore throat, and general body aches.  Pt transfered to Local ER where EKG's and cardiac enzymes appeared to indicate MI. He was then transfered via Airlift to current facility.  PE (+) for ant bites on the ankles and L deltoid smallpox site with swelling and yellow drainage. Otherwise WNL.  Discharge DX: Myocarditis.  Recent Smallpox vaccine.  Anterolateral hypokines by echocardiogram.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Burning sensation, Cough, Crying, Dyspnoea, Oral discomfort
Clinical narrative: Information has been received from a certified medical assistant concerning a 4 year old male, with no pertinent medical history, drug reactions or allergies, who on 23-JUL-2007 was vaccinated subcutaneously with varicella virus vaccine live (Lot # 656566/1511F) and MMR (Lot # 656612/0282U0. Other concomitant therapy that same day included poliovirus vaccine, PREVNAR, HAVRIX and DTAP-IPV. Within minutes of receiving the vaccines the patient began to cough and said that the roof of his mouth was burning. The patient and his mother left the physician's office, but returned due to the fact the patient's cough had increased. Upon examination it was noted that the patient was wheezing and the coughing was getting worse. The patient was administered epinephrine and given albuterol nebulizer treatment. The patient recovered shortly after the treatment, and left the office with his mother. The patient was considered recovered on 23 JUL 2007. No lab diagnostics studies were performed. There was no product complaint. The events were considered to be other medically important events due to the intervention to prevent serious criteria. A lot check has been requested. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Stomatitis, Wheezing
Clinical narrative: Information has been received from a certified medical assistant concerning a 4 year old male, with no pertinent medical history, drug reactions or allergies, who on 23-JUL-2007 was vaccinated subcutaneously with varicella virus vaccine live (Lot # 656566/1511F) and MMR (Lot # 656612/0282U0. Other concomitant therapy that same day included poliovirus vaccine, PREVNAR, HAVRIX and DTAP-IPV. Within minutes of receiving the vaccines the patient began to cough and said that the roof of his mouth was burning. The patient and his mother left the physician's office, but returned due to the fact the patient's cough had increased. Upon examination it was noted that the patient was wheezing and the coughing was getting worse. The patient was administered epinephrine and given albuterol nebulizer treatment. The patient recovered shortly after the treatment, and left the office with his mother. The patient was considered recovered on 23 JUL 2007. No lab diagnostics studies were performed. There was no product complaint. The events were considered to be other medically important events due to the intervention to prevent serious criteria. A lot check has been requested. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Cough, Oral discomfort, Wheezing
Clinical narrative: Information has been received from a certified medical assistant concerning a 4 year old male, with no pertinent medical history, drug reactions or allergies, who on 23-JUL-2007 was vaccinated subcutaneously with varicella virus vaccine live (Lot # 656566/1511F) and MMR (Lot # 656612/0282U0. Other concomitant therapy that same day included poliovirus vaccine, PREVNAR, HAVRIX and DTAP-IPV. Within minutes of receiving the vaccines the patient began to cough and said that the roof of his mouth was burning. The patient and his mother left the physician's office, but returned due to the fact the patient's cough had increased. Upon examination it was noted that the patient was wheezing and the coughing was getting worse. The patient was administered epinephrine and given albuterol nebulizer treatment. The patient recovered shortly after the treatment, and left the office with his mother. The patient was considered recovered on 23 JUL 2007. No lab diagnostics studies were performed. There was no product complaint. The events were considered to be other medically important events due to the intervention to prevent serious criteria. A lot check has been requested. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Cough, Immediate post-injection reaction, Oral discomfort, Wheezing
Clinical narrative: Information has been received from a certified medical assistant concerning a 4 year old male, with no pertinent medical history, drug reactions or allergies, who on 23-JUL-2007 was vaccinated subcutaneously with varicella virus vaccine live (Lot # 656566/1511F) and MMR (Lot # 656612/0282U0. Other concomitant therapy that same day included poliovirus vaccine, PREVNAR, HAVRIX and DTAP-IPV. Within minutes of receiving the vaccines the patient began to cough and said that the roof of his mouth was burning. The patient and his mother left the physician's office, but returned due to the fact the patient's cough had increased. Upon examination it was noted that the patient was wheezing and the coughing was getting worse. The patient was administered epinephrine and given albuterol nebulizer treatment. The patient recovered shortly after the treatment, and left the office with his mother. The patient was considered recovered on 23 JUL 2007. No lab diagnostics studies were performed. There was no product complaint. The events were considered to be other medically important events due to the intervention to prevent serious criteria. A lot check has been requested. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Cough, Dyspnoea, Stomatitis, Wheezing
Clinical narrative: Information has been received from a certified medical assistant concerning a 4 year old male, with no pertinent medical history, drug reactions or allergies, who on 23-JUL-2007 was vaccinated subcutaneously with varicella virus vaccine live (Lot # 656566/1511F) and MMR (Lot # 656612/0282U0. Other concomitant therapy that same day included poliovirus vaccine, PREVNAR, HAVRIX and DTAP-IPV. Within minutes of receiving the vaccines the patient began to cough and said that the roof of his mouth was burning. The patient and his mother left the physician's office, but returned due to the fact the patient's cough had increased. Upon examination it was noted that the patient was wheezing and the coughing was getting worse. The patient was administered epinephrine and given albuterol nebulizer treatment. The patient recovered shortly after the treatment, and left the office with his mother. The patient was considered recovered on 23 JUL 2007. No lab diagnostics studies were performed. There was no product complaint. The events were considered to be other medically important events due to the intervention to prevent serious criteria. A lot check has been requested. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Cough, Crying, Dyspnoea, No reaction on previous exposure to drug, Oral discomfort
Clinical narrative: Information has been received from a certified medical assistant concerning a 4 year old male, with no pertinent medical history, drug reactions or allergies, who on 23-JUL-2007 was vaccinated subcutaneously with varicella virus vaccine live (Lot # 656566/1511F) and MMR (Lot # 656612/0282U0. Other concomitant therapy that same day included poliovirus vaccine, PREVNAR, HAVRIX and DTAP-IPV. Within minutes of receiving the vaccines the patient began to cough and said that the roof of his mouth was burning. The patient and his mother left the physician's office, but returned due to the fact the patient's cough had increased. Upon examination it was noted that the patient was wheezing and the coughing was getting worse. The patient was administered epinephrine and given albuterol nebulizer treatment. The patient recovered shortly after the treatment, and left the office with his mother. The patient was considered recovered on 23 JUL 2007. No lab diagnostics studies were performed. There was no product complaint. The events were considered to be other medically important events due to the intervention to prevent serious criteria. A lot check has been requested. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Wheezing
Clinical narrative: Information has been received from a certified medical assistant concerning a 4 year old male, with no pertinent medical history, drug reactions or allergies, who on 23-JUL-2007 was vaccinated subcutaneously with varicella virus vaccine live (Lot # 656566/1511F) and MMR (Lot # 656612/0282U0. Other concomitant therapy that same day included poliovirus vaccine, PREVNAR, HAVRIX and DTAP-IPV. Within minutes of receiving the vaccines the patient began to cough and said that the roof of his mouth was burning. The patient and his mother left the physician's office, but returned due to the fact the patient's cough had increased. Upon examination it was noted that the patient was wheezing and the coughing was getting worse. The patient was administered epinephrine and given albuterol nebulizer treatment. The patient recovered shortly after the treatment, and left the office with his mother. The patient was considered recovered on 23 JUL 2007. No lab diagnostics studies were performed. There was no product complaint. The events were considered to be other medically important events due to the intervention to prevent serious criteria. A lot check has been requested. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abortion spontaneous, Endocervical curettage, Pregnancy test positive, Ultrasound uterus, Uterine dilation and curettage
Clinical narrative: Initial and follow-up information has been received via the Merck pregnancy registry, from a nurse practitioner (NP) and a mother concerning her daughter, a 17 year old female, who on 29-MAY-2007 was vaccinated IM, with the first dose, 0.5ml, of Gardasil (Lot #0211U). On approximately 15-JUN-2007 ("2 1/2 weeks later"), the patient became pregnant. An ultrasound test (date not reported), confirmed the pregnancy duration as 6 weeks and 4 days, and provided an estimated date of delivery of 01-MAR-2008. On 19-JUL-2007 the patient went for an ultrasound that reported the baby's heart beat had stopped. On an unspecified date the patient tested for positive for human papilloma virus. Upon internal review, abortion was considered to be other important medical event. Conflicting information has been received from the patients mother. In was reported that the patient was vaccinated with the first dose of Gardasil on 18-JUN-2007 and the patient was two and a half months pregnant at the time of the vaccination. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abortion, Drug exposure during pregnancy, Foetal heart rate abnormal, Papilloma viral infection, Ultrasound scan
Clinical narrative: Initial and follow-up information has been received via the Merck pregnancy registry, from a nurse practitioner (NP) and a mother concerning her daughter, a 17 year old female, who on 29-MAY-2007 was vaccinated IM, with the first dose, 0.5ml, of Gardasil (Lot #0211U). On approximately 15-JUN-2007 ("2 1/2 weeks later"), the patient became pregnant. An ultrasound test (date not reported), confirmed the pregnancy duration as 6 weeks and 4 days, and provided an estimated date of delivery of 01-MAR-2008. On 19-JUL-2007 the patient went for an ultrasound that reported the baby's heart beat had stopped. On an unspecified date the patient tested for positive for human papilloma virus. Upon internal review, abortion was considered to be other important medical event. Conflicting information has been received from the patients mother. In was reported that the patient was vaccinated with the first dose of Gardasil on 18-JUN-2007 and the patient was two and a half months pregnant at the time of the vaccination. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B, Hepatitis B test negative, Liver transplant, Seroconversion test negative
Clinical narrative: Information has been received from a registered nurse concerning "whole wards" of children who were vaccinated with Recombivax HB. These children developed hepatitis B after vaccination with Recombivax HB. Additional information has been requested. Follow-up information received from a nurse stated that another patient's mother told her that while her child was hospitalized at the hospital for a liver transplant (WAES # 0707USA00679), there were other patients who had received hepatitis B vaccine (manufacturer unknown) that failed to seroconvert and had a "similar situation" like her son. The nurse could not provide any additional information since she did not take care of these patients.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Muscle spasms, Pain, X-ray normal
Clinical narrative: Information has been received from a nurse concerning her 20 year old daughter with a history of sulfonamide allergies rash only, who, on an unspecified date, was vaccinated in the right arm with a dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). Both parents of the patient reported that she was vaccinated very high up in the deltoid area, almost right at the joint at the top of the arm, almost posterior. The father who is an anesthetist nurse is concerned that this may have been an intraarticular injection. Subsequently, three weeks after the vaccination the patient has experienced increased pain at the injection site, throbbing pain down the arm, and her fingers of the right hand cramp. She is being treated with Motrin over the counter 600mg three times daily. The patient was seen at the doctor's office who states that it may be tissue necrosis, but is unsure. The patient was also seen by the orthopedic office and an A-P Plane X Ray was performed, nothing conclusive. The patient is scheduled for an MRI. The reporter indicated, the patient experienced significant disability or incapacity. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Computerised tomogram normal, Drug screen negative, Electroencephalogram abnormal, Grand mal convulsion, Headache
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female who on 13-JUL-2007 was vaccinated with a first dose of Gardasil (lot# unknown) IM at 2:30PM. Concomitant therapy also given on 13-JUL-2007 included Vaqta (duration and dose not reported) and Menactra. Other concomitant therapy included cetirizine hydrochloride (+) pseudoephedrine hydrochloride (ZYRTEC-D). On 14-JUL-2007 at 11:30 PM the patient experienced a generalized tonic-clonic seizure at which time she was admitted to the ER. Several tests were performed including a magnetic resonance imaging (MRI) and a computed axial tomography (CT) test and drug test which were negative. An electroencephalography (EEG) test was also performed which showed minimal abnormalities. There was no family history of seizures and the patient herself had never had a seizure. The patient also had a headache that rated 7 out of 10 . The patient was treated with lorazepam (ATIVAN), which they believe aborted another possible seizure. It was also reported that the patient was on vacation one week before vaccination on a cruise in the Caribbean. At the time of reporting the patient was recovering. Upon internal review generalized clonic-tonic seizure is considered to be an other important medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female who on 13-JUL-2007 was vaccinated with a first dose of Gardasil (lot# unknown) IM at 2:30PM. Concomitant therapy also given on 13-JUL-2007 included Vaqta (duration and dose not reported) and Menactra. Other concomitant therapy included cetirizine hydrochloride (+) pseudoephedrine hydrochloride (ZYRTEC-D). On 14-JUL-2007 at 11:30 PM the patient experienced a generalized tonic-clonic seizure at which time she was admitted to the ER. Several tests were performed including a magnetic resonance imaging (MRI) and a computed axial tomography (CT) test and drug test which were negative. An electroencephalography (EEG) test was also performed which showed minimal abnormalities. There was no family history of seizures and the patient herself had never had a seizure. The patient also had a headache that rated 7 out of 10 . The patient was treated with lorazepam (ATIVAN), which they believe aborted another possible seizure. It was also reported that the patient was on vacation one week before vaccination on a cruise in the Caribbean. At the time of reporting the patient was recovering. Upon internal review generalized clonic-tonic seizure is considered to be an other important medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Computerised tomogram normal, Electroencephalogram abnormal, Grand mal convulsion, Headache, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female who on 13-JUL-2007 was vaccinated with a first dose of Gardasil (lot# unknown) IM at 2:30PM. Concomitant therapy also given on 13-JUL-2007 included Vaqta (duration and dose not reported) and Menactra. Other concomitant therapy included cetirizine hydrochloride (+) pseudoephedrine hydrochloride (ZYRTEC-D). On 14-JUL-2007 at 11:30 PM the patient experienced a generalized tonic-clonic seizure at which time she was admitted to the ER. Several tests were performed including a magnetic resonance imaging (MRI) and a computed axial tomography (CT) test and drug test which were negative. An electroencephalography (EEG) test was also performed which showed minimal abnormalities. There was no family history of seizures and the patient herself had never had a seizure. The patient also had a headache that rated 7 out of 10 . The patient was treated with lorazepam (ATIVAN), which they believe aborted another possible seizure. It was also reported that the patient was on vacation one week before vaccination on a cruise in the Caribbean. At the time of reporting the patient was recovering. Upon internal review generalized clonic-tonic seizure is considered to be an other important medical event. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Laboratory test normal
Clinical narrative: Information has been received from a physician concerning a 22-week-old female who on 14-MAR-2007 and 21-MAY-2007 was vaccinated PO with the first and second 2.0 mL doses, respectively, of Rotateq (Lot numbers not available). The physician reported that on 10-JUN-2007 the patient developed intussusception. Unspecified medical attention was sought and the patient was subsequently hospitalized (duration unknown). An "intussusception" test was noted to be negative, however, an Emergency Room (ER) physician believed that the intussusception had a spontaneous resolution without the need for surgery. The patient subsequently recovered. Additional information has been requested. 9/20/07-records received for DOS-6/10-6/11/07- DC DX: Vomiting. Acute onset of emesis ranging from dark green to coffee ground in color, decreased energy, perioral cyanosis with one episode.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, Intussusception, Vomiting
Clinical narrative: Information has been received from a physician concerning a 15 week old male who on 31-MAY-2007 was vaccinated with Rotateq (Lot# 656833/0407U). Concomitant therapy included Pediarix, Hib conj vaccine (unspecified carrier) and Prevnar. The physician reported that the child was vomiting profusely on the morning of 09-JUL-2007 and was taken to the hospital. The physician reported the child was transferred to another hospital. The child was found to have an intussusception. The physician reported that the patient sought medical attention to prevent serious criteria and was hospitalized because of the experience. Additional information has been requested. 8/8/07-records received from transferring facility for DOS 7/9/07-C/O vomiting.  8/24/07-records received for DOS 7/10-7/20/07-DX: Intussusception. Pyelonephritis. E.coli sepsis/bacteremia. Small bowel-small bowel intussuception noted not reducible by hydrostatic enema. Small bowel resection with anastomosis and incidental appendectomy. Post operative day 2 high fevers noted and urinalysis revealed urinary tract infection. 8/8/07-records received from transferring facility for DOS 7/9/07-C/O vomiting. HX reflux. 8/24/07-records received for DOS 7/10-7/20/07-DX: Intussusception. Pyelonephritis. E.coli sepsis/bacteremia. Gastrographin enema: intussusception. Small bowel-small bowel intussuception noted not reducible by hydrostatic enema. Small bowel resection with anastomosis and incidental appendectomy. Post operative day 2 high fevers noted
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Barium enema, Enema administration, Intussusception, Surgery, X-ray
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with the first, second, and third doses of Rotateq (Lot #'s not provided). Subsequently the patient experienced intussusception and was hospitalized. The patient received an enema, but then had to be opened up to have a small piece of bowel removed. The length of the hospitalized was not provided. Subsequently, the patient recovered from intussusception. No additional information was provided. There was no product quality complaint. Additional information has been requested.    09/14/2007 MR received for hospital DOS 6/5-9/2007 for D/C DX of Intussusception S/P small bowel resection. Infant presented with 1 day hx of emesis and bloody mucus from the rectum. Pt fussy/irritable with intermittant lethagy. (+) dehydration on exam.  Sausage shaped mass palpated in LLQ. Contrast enema unsuccessful in reducing IS.  Taken to OR for Exploratory Lap with reduction of intussusception, ileocectomy, and primary anastomosis. D/C on POD #4. Surgical note reports pt doing well post-op following small and large bowel resection for an unreducible intussusception.