chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Discomfort, Dyspnoea, Laboratory test abnormal, Palpitations
Clinical narrative: CC: Received Smallpox vaccination August 26, 2004, approximately 10-14 days later developed shortness of breath, palpitations, and diagnosed with myopericarditis following September 2004 admission.   History of Present Illness:    Immunization: Smallpox  Vaccine Date: August 26, 2004 Onset date: September 5, 2004 Symptoms: This healthy 21 year old received his first Smallpox vaccination on August 26, 2004.  Approximately day 7 he began to notice some midsternal chest pain 3-4/10 scale with shortness of breath at rest. By day 10-14 his discomfort had worsened and he sought medical attention with a medical physician at base clinic. He stated his pain worsened when lying flat easing sitting up and forward. He was placed on 50 mg Indocin and light duty and referred to a cardiologist.  The doctor consulted another doctor who gave a differential diagnosis of "suspected pericarditis". He was subsequently admitted to a hospital. According to this service member, an echocardiogram confirmed a diagnosis of "myopericarditis". His records indicate a normal EKG and a sonosite limited echo as normal with IRBB (QRS 110) and 2 degree type 1 AVB. His labs showed elevation of CK at 1384, MB 298 --> 14 within 6-8 hours. (records unavailable). He was released one week later on Indocin to light duty for 6-8 weeks being transferred from warehouse work to a desk job typing and driving. His follow up exam with the doctor about week nine included a repeat echocardiogram, stress test and labs that showed no further evidence of myopericarditis and he was cleared for full duty two weeks later. As of this interview (May 5, 2005) he continues to complain of periodic "sharp aches" occurring 4-5 times a week lasting for a few seconds with spontaneous resolution since his return in February 2005. He denies any other complaints including no shortness of breath, nausea, vomiting, radiating pain, weakness, cough or recent illness. He was seen by a doctor on May 5, 2005 for this discomfort after voicing concerns to his supervisor. The doctor referred him to cardiology with an EKG showing NSR with first degree AV Block. His echocardiogram on May 5, 2005 was normal.  He is scheduled for a six weeks cruise the end of May and then deployment.   His initial referral contact with the Vaccine Healthcare Center was from physicians in theater in September 2004.  Attempts in December 2004 continued to be unsuccessful in contacting this member. As of July 18, 2005 no further contact has been made; nor has he responded to email correspondence.  There are no medical records available at this time pending return of medical release forms.  He was indecisive about participating in this study.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Pericarditis
Clinical narrative: CC: Received Smallpox vaccination August 26, 2004, approximately 10-14 days later developed shortness of breath, palpitations, and diagnosed with myopericarditis following September 2004 admission.   History of Present Illness:    Immunization: Smallpox  Vaccine Date: August 26, 2004 Onset date: September 5, 2004 Symptoms: This healthy 21 year old received his first Smallpox vaccination on August 26, 2004.  Approximately day 7 he began to notice some midsternal chest pain 3-4/10 scale with shortness of breath at rest. By day 10-14 his discomfort had worsened and he sought medical attention with a medical physician at base clinic. He stated his pain worsened when lying flat easing sitting up and forward. He was placed on 50 mg Indocin and light duty and referred to a cardiologist.  The doctor consulted another doctor who gave a differential diagnosis of "suspected pericarditis". He was subsequently admitted to a hospital. According to this service member, an echocardiogram confirmed a diagnosis of "myopericarditis". His records indicate a normal EKG and a sonosite limited echo as normal with IRBB (QRS 110) and 2 degree type 1 AVB. His labs showed elevation of CK at 1384, MB 298 --> 14 within 6-8 hours. (records unavailable). He was released one week later on Indocin to light duty for 6-8 weeks being transferred from warehouse work to a desk job typing and driving. His follow up exam with the doctor about week nine included a repeat echocardiogram, stress test and labs that showed no further evidence of myopericarditis and he was cleared for full duty two weeks later. As of this interview (May 5, 2005) he continues to complain of periodic "sharp aches" occurring 4-5 times a week lasting for a few seconds with spontaneous resolution since his return in February 2005. He denies any other complaints including no shortness of breath, nausea, vomiting, radiating pain, weakness, cough or recent illness. He was seen by a doctor on May 5, 2005 for this discomfort after voicing concerns to his supervisor. The doctor referred him to cardiology with an EKG showing NSR with first degree AV Block. His echocardiogram on May 5, 2005 was normal.  He is scheduled for a six weeks cruise the end of May and then deployment.   His initial referral contact with the Vaccine Healthcare Center was from physicians in theater in September 2004.  Attempts in December 2004 continued to be unsuccessful in contacting this member. As of July 18, 2005 no further contact has been made; nor has he responded to email correspondence.  There are no medical records available at this time pending return of medical release forms.  He was indecisive about participating in this study.
Age: 42.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Amnesia, Arrhythmia, Arthralgia, Asthenia, Back pain
Clinical narrative: First, my sincere apologies for the delay in reporting as I have only just learned of the VAERS program.  This is to report a series of two ANTHRAX innoculations received in 1999 (reported on separate forms), that may be a factor in prolonged and chronic health changes I have experienced since approx May 2001.  Of note, I was also exposed to Tuberculosis in that time frame and exhibited a positive PPD (20mm induration), and subsequently underwent TB preventative treatment with Isoniazid (INH). I have a detailed medical history of monthly visits and lab tests following the INH program and can provide copies.     An immediate and pronounced effect was noticed in May 2001 after the INH program began, most notably exhibited as extreme fatigue, joint pain, arthralgia, loss of range-of-motion, lower back pain, lack of stamina, and loss of strength.  The addition of B-6 to the INH regimen was began in July 2001 and some relief was noted.  Continued problem with joint pain caused me to be seen by the Rheumatology Clinic in Aug 01...no previous history of arthralgia.  After transfer in 2002, began experiencing increased kidney pain (LRQ), fatigue, short-term memory loss, and irregular heartbeat/palpitations.  Echocardiogram performed (negative), thyroid levels checked.  During entire period, Physical Fitness Test (PFT) performance continued to decline and failures were noted.  Generalized chest pain continued into 2004, self-admitted to ER on 17SEP04.  Stress test negative.  Began Prevacid treatment.  Honorably discharged in May 2005 before retirement.     Although the significant decline in health seemed to begin in May 2001 following INH treatment, I have found no linkages between INH side-effects and my experiences.  My concern is that this long-term effect, which persists to this day, is potentially connected with the Anthrax vaccinations received in 1999, and/or interactions between INH and the Anthrax vaccine.
Age: 42.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Fatigue, Joint range of motion decreased, Palpitations
Clinical narrative: First, my sincere apologies for the delay in reporting as I have only just learned of the VAERS program.  This is to report a series of two ANTHRAX innoculations received in 1999 (reported on separate forms), that may be a factor in prolonged and chronic health changes I have experienced since approx May 2001.  Of note, I was also exposed to Tuberculosis in that time frame and exhibited a positive PPD (20mm induration), and subsequently underwent TB preventative treatment with Isoniazid (INH). I have a detailed medical history of monthly visits and lab tests following the INH program and can provide copies.     An immediate and pronounced effect was noticed in May 2001 after the INH program began, most notably exhibited as extreme fatigue, joint pain, arthralgia, loss of range-of-motion, lower back pain, lack of stamina, and loss of strength.  The addition of B-6 to the INH regimen was began in July 2001 and some relief was noted.  Continued problem with joint pain caused me to be seen by the Rheumatology Clinic in Aug 01...no previous history of arthralgia.  After transfer in 2002, began experiencing increased kidney pain (LRQ), fatigue, short-term memory loss, and irregular heartbeat/palpitations.  Echocardiogram performed (negative), thyroid levels checked.  During entire period, Physical Fitness Test (PFT) performance continued to decline and failures were noted.  Generalized chest pain continued into 2004, self-admitted to ER on 17SEP04.  Stress test negative.  Began Prevacid treatment.  Honorably discharged in May 2005 before retirement.     Although the significant decline in health seemed to begin in May 2001 following INH treatment, I have found no linkages between INH side-effects and my experiences.  My concern is that this long-term effect, which persists to this day, is potentially connected with the Anthrax vaccinations received in 1999, and/or interactions between INH and the Anthrax vaccine.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Arrhythmia, Arthralgia, Asthenia, Back pain, Fatigue
Clinical narrative: *THIS IS PART-TWO OF A REPORT SUBMITTED ON 7-18-2005 (E-8759) THAT DESCRIBES THE SECOND IN A SERIES OF ANTHRAX IMMUNIZATIONS RECEIVED IN 1999.  I HAVE INCLUDED THE SAME SYMPTOM DESCRIPTION BELOW THAT WAS SUBMITTED IN THE E-8759 REPORT*  First, my sincere apologies for the delay in reporting as I have only just learned of the VAERS program.  This is to report a series of two ANTHRAX innoculations received in 1999 (reported on separate forms), that may be a factor in prolonged and chronic health changes I have experienced since approx May 2001.  Of note, I was also exposed to Tuberculosis in that timeframe and exhibited a positive PPD (20mm induration), and subsequently underwent TB preventative treatment with Isoniazid (INH). I have a detailed medical history of monthly visits and lab tests following the INH program and can provide copies.     An immediate and pronounced effect was noticed in May 2001 after the INH program began, most notably exhibited as extreme fatigue, joint pain, arthralgia, loss of range-of-motion, lower back pain, lack of stamina, and loss of strength.  The addition of B-6 to the INH regimen was began in July 2001 and some relief was noted.  Continued problem with joint pain caused me to be seen by the Rheumatology Clinic in Aug 01...no previous history of arthralgia.  After transfer in 2002, began experiencing increased kidney pain (LRQ), fatigue, short-term memory loss, and irregular heartbeat/palpitations.  Echocardiogram performed (negative), thyroid levels checked.  During entire period, Physical Fitness Test (PFT) performance continued to decline and failures were noted.  Generalized chest pain continued into 2004, self-admitted to ER on 17SEP04.  Stress test negative.  Began Prevacid treatment.  Honorably discharged in May 2005 before retirement.     Although the significant decline in health seemed to begin in May 2001 following INH treatment, I have found no linkages between INH side-effects and my experiences.  My concern is that this long-term effect, which persists to this day, is potentially connected with the Anthrax vaccinations received in 1999, and/or interactions between INH and the Anthrax vaccine.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Joint range of motion decreased, Palpitations
Clinical narrative: *THIS IS PART-TWO OF A REPORT SUBMITTED ON 7-18-2005 (E-8759) THAT DESCRIBES THE SECOND IN A SERIES OF ANTHRAX IMMUNIZATIONS RECEIVED IN 1999.  I HAVE INCLUDED THE SAME SYMPTOM DESCRIPTION BELOW THAT WAS SUBMITTED IN THE E-8759 REPORT*  First, my sincere apologies for the delay in reporting as I have only just learned of the VAERS program.  This is to report a series of two ANTHRAX innoculations received in 1999 (reported on separate forms), that may be a factor in prolonged and chronic health changes I have experienced since approx May 2001.  Of note, I was also exposed to Tuberculosis in that timeframe and exhibited a positive PPD (20mm induration), and subsequently underwent TB preventative treatment with Isoniazid (INH). I have a detailed medical history of monthly visits and lab tests following the INH program and can provide copies.     An immediate and pronounced effect was noticed in May 2001 after the INH program began, most notably exhibited as extreme fatigue, joint pain, arthralgia, loss of range-of-motion, lower back pain, lack of stamina, and loss of strength.  The addition of B-6 to the INH regimen was began in July 2001 and some relief was noted.  Continued problem with joint pain caused me to be seen by the Rheumatology Clinic in Aug 01...no previous history of arthralgia.  After transfer in 2002, began experiencing increased kidney pain (LRQ), fatigue, short-term memory loss, and irregular heartbeat/palpitations.  Echocardiogram performed (negative), thyroid levels checked.  During entire period, Physical Fitness Test (PFT) performance continued to decline and failures were noted.  Generalized chest pain continued into 2004, self-admitted to ER on 17SEP04.  Stress test negative.  Began Prevacid treatment.  Honorably discharged in May 2005 before retirement.     Although the significant decline in health seemed to begin in May 2001 following INH treatment, I have found no linkages between INH side-effects and my experiences.  My concern is that this long-term effect, which persists to this day, is potentially connected with the Anthrax vaccinations received in 1999, and/or interactions between INH and the Anthrax vaccine.
Age: 32.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Fatigue, Nausea, Pruritus, Pyrexia, Rash macular
Clinical narrative: Employee received Varicella vaccine on 062405 per Employee Health protocols;  On Friday, July 8th began itching on both arms.  Sat 070905 noticed one "welt" on left arm with a fever of 100 F.  By Sunday morning, employee reports macular lesions on abdomen with fever of 99 F.  On Monday morning, 071105, lseions were located on abdomen, a "few on chest and arms, one on back and one on leg and foot".  Employee reported feeling tired, nauseated.  Last lesion appeared on Thursday, 071405 and employees states she felt better.  Monday, 071705  No new lesions and all prior lesions crusted.
Age: 32.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Skin ulcer, Urticaria
Clinical narrative: Employee received Varicella vaccine on 062405 per Employee Health protocols;  On Friday, July 8th began itching on both arms.  Sat 070905 noticed one "welt" on left arm with a fever of 100 F.  By Sunday morning, employee reports macular lesions on abdomen with fever of 99 F.  On Monday morning, 071105, lseions were located on abdomen, a "few on chest and arms, one on back and one on leg and foot".  Employee reported feeling tired, nauseated.  Last lesion appeared on Thursday, 071405 and employees states she felt better.  Monday, 071705  No new lesions and all prior lesions crusted.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Medication error
Clinical narrative: My son was given a shot of HIB instead of his DTP.  This is his 5th shot of HIB.  He was given HiB on the following dates: 6/2/2004, 8/5/2004, 9/29/2004, 4/6/2005 and then again at 10:30am on 7/18/2005.  It is too early to tell if there are any adverse reactions. I have notified the nurse and have called the Center for Disease Control and was told to file this report.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Headache, Heart rate increased, Nausea
Clinical narrative: Patient reports after Hepatitis B vaccination #1, patient experienced racing heartbeat, nausea, fatigue and headache throughout the day. Pt reports symptoms did not occur at the same time and did not last for long. Pt reports felt fine the next day. Pt states she did not feel the symptoms were severe enough to report to the health department or her primary physician. Pt denies difficulty breathing, chest tightness, hives, itching or swelling after Hepatitis B injection.
Age: 25.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Blindness, Coagulation time prolonged, Headache, Hypertension, Myocardial infarction
Clinical narrative: Severe Hypertension causing: loss of vision in left eye and myocardial infarction over a period of approximately 5 years. Hypertension has been moderately controlled by the use of medication and follow-up treatment. Stents were recently placed in 2 arteries of the heart. ***dates below are estimated  9/12/05 D/C summary indicated final diagnoses were new onset hypertension and polycythemia. Symptoms at onset were sudden headache, photophobia, and blurred vision.
Age: 25.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Photophobia, Polycythaemia, Red blood cell abnormality, Vision blurred
Clinical narrative: Severe Hypertension causing: loss of vision in left eye and myocardial infarction over a period of approximately 5 years. Hypertension has been moderately controlled by the use of medication and follow-up treatment. Stents were recently placed in 2 arteries of the heart. ***dates below are estimated  9/12/05 D/C summary indicated final diagnoses were new onset hypertension and polycythemia. Symptoms at onset were sudden headache, photophobia, and blurred vision.
Age: 25.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Abdominal pain, Abnormal clotting factor, Blindness, Cardiac disorder, Coagulopathy
Clinical narrative: Severe Hypertension causing: loss of vision in left eye and myocardial infarction over a period of approximately 5 years. Hypertension has been moderately controlled by the use of medication and follow-up treatment. Stents were recently placed in 2 arteries of the heart. ***dates below are estimated  9/12/05 D/C summary indicated final diagnoses were new onset hypertension and polycythemia. Symptoms at onset were sudden headache, photophobia, and blurred vision.
Age: 25.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Computerised tomogram, Computerised tomogram kidney, Gastrointestinal pain, Headache, Hypertension
Clinical narrative: Severe Hypertension causing: loss of vision in left eye and myocardial infarction over a period of approximately 5 years. Hypertension has been moderately controlled by the use of medication and follow-up treatment. Stents were recently placed in 2 arteries of the heart. ***dates below are estimated  9/12/05 D/C summary indicated final diagnoses were new onset hypertension and polycythemia. Symptoms at onset were sudden headache, photophobia, and blurred vision.
Age: 25.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Job dissatisfaction, Laboratory test abnormal, Macular degeneration, Myocardial infarction, Nuclear magnetic resonance imaging
Clinical narrative: Severe Hypertension causing: loss of vision in left eye and myocardial infarction over a period of approximately 5 years. Hypertension has been moderately controlled by the use of medication and follow-up treatment. Stents were recently placed in 2 arteries of the heart. ***dates below are estimated  9/12/05 D/C summary indicated final diagnoses were new onset hypertension and polycythemia. Symptoms at onset were sudden headache, photophobia, and blurred vision.
Age: 25.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Photophobia, Polycythaemia, Rectal haemorrhage, Red blood cell abnormality, Red blood cell count increased
Clinical narrative: Severe Hypertension causing: loss of vision in left eye and myocardial infarction over a period of approximately 5 years. Hypertension has been moderately controlled by the use of medication and follow-up treatment. Stents were recently placed in 2 arteries of the heart. ***dates below are estimated  9/12/05 D/C summary indicated final diagnoses were new onset hypertension and polycythemia. Symptoms at onset were sudden headache, photophobia, and blurred vision.
Age: 25.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Somnolence, Stent placement, Vision blurred, Visual disturbance, X-ray
Clinical narrative: Severe Hypertension causing: loss of vision in left eye and myocardial infarction over a period of approximately 5 years. Hypertension has been moderately controlled by the use of medication and follow-up treatment. Stents were recently placed in 2 arteries of the heart. ***dates below are estimated  9/12/05 D/C summary indicated final diagnoses were new onset hypertension and polycythemia. Symptoms at onset were sudden headache, photophobia, and blurred vision.
Age: 1.28
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Discomfort, Erythema multiforme, Urticaria
Clinical narrative: otherwise healthy child received fourth Dtap (daptacel) and comvax- hep B/Hib and developed urticarial rash on body within 24 hrs- erythema multiforme. no mucosal involvement. no fever but uncomfortable and a large target lesion surrounding vaccine site as well as throughout body.
Age: 5.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Anorexia, Asthenia, Choking, Cough, Gait disturbance
Clinical narrative: Son was given series of rabies vaccine. Approximately two months later began getting noticibly weak.  Three months later developed guillian-barre syndrome. One of the vaccines given was Rabavert. Per review of d/c summary received 7/28/05, diagnosis of GBS is confirmed. Additional symptoms include pain in extremities, staggering gait, vomiting, anorexia, pallor, cough, headache, decreased visual acuity, diminished DTRs, respiratory distress, choking, and low-grade fever.
Age: 5.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Guillain-Barre syndrome, Headache, Hyporeflexia, Pain, Pallor
Clinical narrative: Son was given series of rabies vaccine. Approximately two months later began getting noticibly weak.  Three months later developed guillian-barre syndrome. One of the vaccines given was Rabavert. Per review of d/c summary received 7/28/05, diagnosis of GBS is confirmed. Additional symptoms include pain in extremities, staggering gait, vomiting, anorexia, pallor, cough, headache, decreased visual acuity, diminished DTRs, respiratory distress, choking, and low-grade fever.
Age: 5.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Pyrexia, Respiratory distress, Visual disturbance, Vomiting
Clinical narrative: Son was given series of rabies vaccine. Approximately two months later began getting noticibly weak.  Three months later developed guillian-barre syndrome. One of the vaccines given was Rabavert. Per review of d/c summary received 7/28/05, diagnosis of GBS is confirmed. Additional symptoms include pain in extremities, staggering gait, vomiting, anorexia, pallor, cough, headache, decreased visual acuity, diminished DTRs, respiratory distress, choking, and low-grade fever.
Sex: F
Vaccine: TTOX
Symptoms: Injection site pain
Clinical narrative: Patient experienced lengthy arm pain, deep muscle soreness at injection site and down arm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pruritus, Swelling
Clinical narrative: Upper arm swollen, itchy, recent vaccine on 07/14/2005.  Appoint in office on 07/16/2005.  Stated went to ER during the night, was given Prednisolone and Benadryl.
Age: 0.32
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Crying, Irritability, Pyrexia
Clinical narrative: Fussy, inconsolable, non-stop crying, low grade fever, legs seemed to hurt to move.
Age: 39.0
Sex: M
Vaccine: HEP, TD
Symptoms: Injection site pain, Rash vesicular
Clinical narrative: Immunization administered subcutaneously left arm on 06/24/2005.  On 07/17/2005 patient developed pain at injection site and varicelliform rash on Torso and abdomen.
Age: 1.5
Sex: M
Vaccine: DTAP, HBHEPB, MMR
Symptoms: Rash, Urticaria
Clinical narrative: Received immunizations on 07/15/2005 at 10:00 that evening Dad said he developed whelps and a rash.  The rash and whelps were gone the next am.
Age: 14.0
Sex: U
Vaccine: MNQ, MNQ
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: In follow-up the following information was obtained regarding extensive limb swelling reported: "Mom reported to me today that all symptoms resolved within 3 weeks of vaccination, so by 6/28/05 no symptoms.  Also Mom said, that when she was seen by the PCP on 6/21/05 there was some discomfort, but there was functionality, but that it was guarded."
Age: 14.0
Sex: U
Vaccine: MNQ, MNQ
Symptoms: Discomfort
Clinical narrative: In follow-up the following information was obtained regarding extensive limb swelling reported: "Mom reported to me today that all symptoms resolved within 3 weeks of vaccination, so by 6/28/05 no symptoms.  Also Mom said, that when she was seen by the PCP on 6/21/05 there was some discomfort, but there was functionality, but that it was guarded."
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: Swollen where the shots were given, redness mainly noted once yearly itchy but not painful
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Erythema, Injection site swelling, Pruritus
Clinical narrative: Swollen where the shots were given, redness mainly noted once yearly itchy but not painful
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Abnormal behaviour, CSF test abnormal, Diarrhoea, Fatigue, Headache
Clinical narrative: An initial report was received in the USA from a health care professional. It was reported that an 18 year old male complained of headache, nausea, vomiting, and diarrhea three days after receiving MENACTRA vaccine lot number U1494BA IM in the left arm. The nausea, vomiting and diarrhea stopped on 7/4/05 but the headache persisted. On 7/4/05, his left arm and entire left side of body went numb. He was hospitalized for three days. Treatment provided was not reported. On 7/8/05 the patient was very fatigued and not yet himself. The patient had no reported medical history.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Hypoaesthesia, Laboratory test abnormal, Myasthenic syndrome, Nausea, Vomiting
Clinical narrative: An initial report was received in the USA from a health care professional. It was reported that an 18 year old male complained of headache, nausea, vomiting, and diarrhea three days after receiving MENACTRA vaccine lot number U1494BA IM in the left arm. The nausea, vomiting and diarrhea stopped on 7/4/05 but the headache persisted. On 7/4/05, his left arm and entire left side of body went numb. He was hospitalized for three days. Treatment provided was not reported. On 7/8/05 the patient was very fatigued and not yet himself. The patient had no reported medical history.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: White blood cell count increased
Clinical narrative: An initial report was received in the USA from a health care professional. It was reported that an 18 year old male complained of headache, nausea, vomiting, and diarrhea three days after receiving MENACTRA vaccine lot number U1494BA IM in the left arm. The nausea, vomiting and diarrhea stopped on 7/4/05 but the headache persisted. On 7/4/05, his left arm and entire left side of body went numb. He was hospitalized for three days. Treatment provided was not reported. On 7/8/05 the patient was very fatigued and not yet himself. The patient had no reported medical history.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: CSF protein increased, Dysarthria, Head deformity, Headache, Hemiparesis
Clinical narrative: An initial report was received in the USA from a health care professional. It was reported that an 18 year old male complained of headache, nausea, vomiting, and diarrhea three days after receiving MENACTRA vaccine lot number U1494BA IM in the left arm. The nausea, vomiting and diarrhea stopped on 7/4/05 but the headache persisted. On 7/4/05, his left arm and entire left side of body went numb. He was hospitalized for three days. Treatment provided was not reported. On 7/8/05 the patient was very fatigued and not yet himself. The patient had no reported medical history.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Hypoaesthesia, White blood cell count normal
Clinical narrative: An initial report was received in the USA from a health care professional. It was reported that an 18 year old male complained of headache, nausea, vomiting, and diarrhea three days after receiving MENACTRA vaccine lot number U1494BA IM in the left arm. The nausea, vomiting and diarrhea stopped on 7/4/05 but the headache persisted. On 7/4/05, his left arm and entire left side of body went numb. He was hospitalized for three days. Treatment provided was not reported. On 7/8/05 the patient was very fatigued and not yet himself. The patient had no reported medical history.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Diarrhoea, Fatigue, Headache, Hypoaesthesia, Nausea
Clinical narrative: An initial report was received in the USA from a health care professional. It was reported that an 18 year old male complained of headache, nausea, vomiting, and diarrhea three days after receiving MENACTRA vaccine lot number U1494BA IM in the left arm. The nausea, vomiting and diarrhea stopped on 7/4/05 but the headache persisted. On 7/4/05, his left arm and entire left side of body went numb. He was hospitalized for three days. Treatment provided was not reported. On 7/8/05 the patient was very fatigued and not yet himself. The patient had no reported medical history.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Vomiting
Clinical narrative: An initial report was received in the USA from a health care professional. It was reported that an 18 year old male complained of headache, nausea, vomiting, and diarrhea three days after receiving MENACTRA vaccine lot number U1494BA IM in the left arm. The nausea, vomiting and diarrhea stopped on 7/4/05 but the headache persisted. On 7/4/05, his left arm and entire left side of body went numb. He was hospitalized for three days. Treatment provided was not reported. On 7/8/05 the patient was very fatigued and not yet himself. The patient had no reported medical history.
Age: 26.0
Sex: F
Vaccine: HEP, HEPA, JEV
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: 07/14/2005 Gave Jap Encephalitis # 2, local reaction with local lymphadenopathy; decreasing local swelling; felt afebrile.
Age: 0.17
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: This subject is a two month old male, who developed a fever while enrolled. The subject received the study vaccine on 7/8/05. The subject developed a fever of 101 degrees F on the same date as the study vaccine was given. The parents took the infant to the emergency room. As per the subject's father, a septic work up was performed and the infant was admitted to the hospital overnight. The father stated that all labs were normal and the infant's temperature went down. Treatment provided was antibiotics for 48 hours. The subject recovered. The fever was reported by the investigator as related to the study vaccine.
Age: 0.34
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Death. Received autopsy report which revealed COD as SIDS.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Swelling
Clinical narrative: Mom reports left arm swollen from elbow to shoulder within 2 days of vaccine administration- lasting for about 5 days, no redness - slightly warm to touch.
Age: 46.0
Sex: M
Vaccine: MMR
Symptoms: Pain
Clinical narrative: MMR given on 06/24/2005 as required by school.  On 06/26/2005 began having severe left arm/shoulder pain.  Seen in clinic on 06/27/2005.  Tender anterior shoulder, pain with abduction.  Instructed to take NSAID he already had at home.
Age: 0.65
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Injection site inflammation, Pain, Pyrexia
Clinical narrative: 09/05/2000 - High grade fever, body aches, large red, hot inflamed spot on leg.  06/13/2005 - Low grade fever, body aches, large red, hot inflamed spot on arm.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Contusion, Injection site erythema, Pyrexia, Swelling
Clinical narrative: Mom called the afternoon of 07/12/2005 24 hours after vaccination.  Had reddened area on right thigh injection area, some bruising, swollen, hard spot, low grade temperature.  No temperature at office.  Told Mom warm baths and advil.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Medication error
Clinical narrative: Baby was administered Pediarix and Hib mixed in the same syringe, instead as two different injections.  No adverse effects noted.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Vomiting
Clinical narrative: Vomited for 5 hours straight.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash erythematous
Clinical narrative: Rash 4mm circular erythematous rash on arms and legs.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Received vaccine about 9AM, 07/12/2004, school entry physical exam.  Awoke 1AM with pain, fever of 101.4 degrees and swelling.  Patient reports tiredness and throbbing arm, despite Ibuprophen 800 mg every 8 hours.  Prescribed cephelexin 500mg 1 a day for 7 days.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Left leg red, swollen, warm to touch, 7 x 7cm in size.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local erythema and swelling of same arm.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Ipsilateral left arm swelling and erythema encompassing from mid-arm to mid-forearm (including elbow joint but with full range of motion), starting 1 day after vaccine administration. Reaction noted at visit today.
Age: 1.86
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister
Clinical narrative: Received Varicella vaccine, now has questionable chicken pox reaction (5 blisters, four on face and one on tongue), as reported by mom, which is starting to scab over. No other serious adverse events. Patient has not seen her pediatrician or other medical provider.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Myalgia, Pharyngolaryngeal pain
Clinical narrative: Pt. states that on 7/15/05 she began to feel generalized muscle pain with increasing intensity since.  She reports today that she cannot drive, open doors, etc, and feels very bad.  She also states that she began with a mild sore throat today.  Patient denies any joint pain, fever, or rashes.  I advised patient to see her PCP ASAP.
Age: 91.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Patient was given Pneumovax on 7/16/05 at 8:00 a.m.  On 7/18/05, it was noted that the patient had red, hot, swollen area resembling cellulitis below the injection site.  Cephalexin 500 mg po qid was started.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Oedema
Clinical narrative: Mother called agency on 7/15/2005 that child received vaccine on 7/11/2005. States whole leg swelled down to ankle and took to ER at local hospital. Was treated with Benadryl and an ointment that began with an "H". Mother did not report exact date of emergency room visit.
Age: 36.0
Sex: F
Vaccine: HEPAB, MEN, TTOX, TYP, YF
Symptoms: Injection site erythema, Injection site warmth, Pain, Pruritus
Clinical narrative: I RECEIVED A YELLOW FEVER VACCINE ON SATURDAY 7/16/2005, AND EVERY SINCE SUNDAY 7/17/2005 THERE HAS BEEN A LARGE FLAT RED SPOT THE SIZE OF AN EGG ON MY LEFT ARM AND ITS VERY PAINFUL,  ITCHY AND WARM.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Convulsion, Loss of consciousness, Syncope
Clinical narrative: Patient had a brief seizure and loss consciousness. Patient was seen by emts and taken to the hospital. Patient fainted again after about 3 hours.
Age: 1.86
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Warm to touch, swollen (10x10cm) left leg.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Patient developed Fever to 102.5 approximately 20 hours after receiving vaccine.
Age: 29.0
Sex: F
Vaccine: TTOX
Symptoms: Back pain, Balance disorder, Coordination abnormal, Encephalitis, Facial palsy
Clinical narrative: I had an accident in the kitchen with a knife and cut my finger on 2/8/05, I recieved stitches and a tetanus shot that same day.  Within 1-2 weeks I had severe back pain.  The back pain was severe enough that I went to an urgent care center and the ER on two seperate occasions.  I also went to the student health center and started going to the Physical therapy department on my college campus as well.  While dealing with the back pain, I began experiencing fatigue, muscle soreness, severe hot and cold flashes, headache, numbness and tingling, poor coordination and balance, I could not lift my head (it felt like there were bricks stacked on top of it), bowel problems, there is a black spot in my line of vision (still), and I also got bells palsy.  I was placed in the hospital for two days and one night for observation and testing.  I was put on vicodin, which did not help at all, and given a shot of demerol in the ER for the back pain.  During the PT the extreme pain in my back got better and then I was left with all of the other symptoms and just a pain in my back that was annoying but not excrutiating.  While in the hospital I was put on a steroid for the bells palsy.  After I was released the doctors basically said that they had no idea what was wrong with me, they hope I continue to get better and it must have been the tetanus shot based on my history.  This happened to me as a child at the age of 12 or so.  I fell and got a bad cut on my head, recieved stitches and a tetanus shot.  At that time my parents were told that I had Encephalitis.  I had to quit school, quit my job and could not care for my family.  I feel better now but that black spot is still in my line of vision and I am "absent minded" much more than normal.  Whether this is something to worry about or not, I will find out when I start school again this coming Fall semester.
Age: 29.0
Sex: F
Vaccine: TTOX
Symptoms: Fatigue, Gastrointestinal disorder, Headache, Hot flush, Hypoaesthesia
Clinical narrative: I had an accident in the kitchen with a knife and cut my finger on 2/8/05, I recieved stitches and a tetanus shot that same day.  Within 1-2 weeks I had severe back pain.  The back pain was severe enough that I went to an urgent care center and the ER on two seperate occasions.  I also went to the student health center and started going to the Physical therapy department on my college campus as well.  While dealing with the back pain, I began experiencing fatigue, muscle soreness, severe hot and cold flashes, headache, numbness and tingling, poor coordination and balance, I could not lift my head (it felt like there were bricks stacked on top of it), bowel problems, there is a black spot in my line of vision (still), and I also got bells palsy.  I was placed in the hospital for two days and one night for observation and testing.  I was put on vicodin, which did not help at all, and given a shot of demerol in the ER for the back pain.  During the PT the extreme pain in my back got better and then I was left with all of the other symptoms and just a pain in my back that was annoying but not excrutiating.  While in the hospital I was put on a steroid for the bells palsy.  After I was released the doctors basically said that they had no idea what was wrong with me, they hope I continue to get better and it must have been the tetanus shot based on my history.  This happened to me as a child at the age of 12 or so.  I fell and got a bad cut on my head, recieved stitches and a tetanus shot.  At that time my parents were told that I had Encephalitis.  I had to quit school, quit my job and could not care for my family.  I feel better now but that black spot is still in my line of vision and I am "absent minded" much more than normal.  Whether this is something to worry about or not, I will find out when I start school again this coming Fall semester.
Age: 29.0
Sex: F
Vaccine: TTOX
Symptoms: Injury, Myalgia, Paraesthesia, Sensation of heaviness, Visual field defect
Clinical narrative: I had an accident in the kitchen with a knife and cut my finger on 2/8/05, I recieved stitches and a tetanus shot that same day.  Within 1-2 weeks I had severe back pain.  The back pain was severe enough that I went to an urgent care center and the ER on two seperate occasions.  I also went to the student health center and started going to the Physical therapy department on my college campus as well.  While dealing with the back pain, I began experiencing fatigue, muscle soreness, severe hot and cold flashes, headache, numbness and tingling, poor coordination and balance, I could not lift my head (it felt like there were bricks stacked on top of it), bowel problems, there is a black spot in my line of vision (still), and I also got bells palsy.  I was placed in the hospital for two days and one night for observation and testing.  I was put on vicodin, which did not help at all, and given a shot of demerol in the ER for the back pain.  During the PT the extreme pain in my back got better and then I was left with all of the other symptoms and just a pain in my back that was annoying but not excrutiating.  While in the hospital I was put on a steroid for the bells palsy.  After I was released the doctors basically said that they had no idea what was wrong with me, they hope I continue to get better and it must have been the tetanus shot based on my history.  This happened to me as a child at the age of 12 or so.  I fell and got a bad cut on my head, recieved stitches and a tetanus shot.  At that time my parents were told that I had Encephalitis.  I had to quit school, quit my job and could not care for my family.  I feel better now but that black spot is still in my line of vision and I am "absent minded" much more than normal.  Whether this is something to worry about or not, I will find out when I start school again this coming Fall semester.
Age: 1.76
Sex: M
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Feeling hot, Rash
Clinical narrative: Did start with chicken pox disease on 7/16/05. Few spots scattered over body. Some crusted, some just starting. "Felt warm" over weekend.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Infantile spasms
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of infantile spasms in an infant male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated polio vaccine combined for prophylaxis. On an unspecified date on or before May 2005, the subject received a dose of Pediatric (dose number and lot number not provided). At an unspecified date on or before 5/05, less than one year after vaccination with Pediarix, the subject experienced infantile spasms. The outcome of the event was not reported. Comment: Infantile spasm was assessed as medically serious (OMIC).
Age: 0.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Eye disorder, Muscle twitching, Tremor
Clinical narrative: Eye twitching, shaking motion for 6 minutes.  rule out seizure.  Fever 102.9
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site reaction, Urticaria
Clinical narrative: 4 inch wheal at DTAP injection site.
Age: 6.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: R arm, deltoid, red, hot, swoolen-the size of baseball. Temperature 99F.
Sex: M
Vaccine: MMR
Symptoms: Erythema, Mucosal inflammation, Rash
Clinical narrative: Red, blanchable, pin-point rash and inflamed mucous membranes.
Age: 67.0
Sex: F
Vaccine: HEPAB, IPV, MNQ
Symptoms: Injection site erythema, Injection site swelling, Medication error
Clinical narrative: Rash on L arm, red, slightly raised approx. 3" in length; 1" wide. Pt states "its getting better". Site of SC polio injection in back of arm.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Cough, Pyrexia, Rash, Viral infection
Clinical narrative: Received MMR/Varivax on 7/8/05. Cough and low-grade fever x 2 days. Viral exanthem.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Blister, Infection
Clinical narrative: Received MMR/Varivax on 7/8/05. Cough and low-grade fever x 2 days. Viral exanthem.
Age: 47.0
Sex: F
Vaccine: TYP, YF
Symptoms: Rash
Clinical narrative: Rash on chest and back.
Age: 19.0
Sex: M
Vaccine: TYP, YF
Symptoms: Dyspnoea, Immediate post-injection reaction, Injection site urticaria, Urticaria
Clinical narrative: An initial report was received in the USA from a health care professional on 7/12/05. A nine year old male received YF-VAX, lot number UE449AA, SC in the right arm, TYPHIM VI, lot number Y0794, IM in the left deltoid on 7/11/05. Reportedly, 45 minutes post immunization, the patient experienced shortness of breath. Two to three hours later he broke out in hives at the YF-VAX injection site and other body areas not specified. He was taken to the emergency room where he received IV steroid and Benadryl. He was discharged with oral steroid and Benadryl prescriptions. Past medical history is significant for asthma and shellfish allergy but he denies egg allergy. Reportedly this patient has recovered. (OMIC) Follow-up information received on 30/Aug/2005 from a health care professional. It was reported that the patient was 19 years old, not nine as previously reported. The duration of the symptoms was several hours and the patient recovered the same day. No further information is expected.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Dysarthria, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Initial report received from a health care professional on 7/14/05. An 18 year old male patient received an IM left deltoid injection of Menactra, lot number U1494AB, and an ID right forearm injection of Tubersol 5 TU., lot number C2116AA, on 6/10/05. 15 days later he experienced intermittent tingling in his feet. He was seen by a physician on 6/26/05 and was admitted to the hospital to rule out Guillain-Barre Syndrome. He was released from the hospital on 6/29/05, but was re-admitted on 7/1/05 with facial weakness and slurred speech. He was diagnosed with Guillain-Barre Syndrome. The patient received treatment with plasmaphoresis and was discharged on 7/8/05. As per the reporter, the patient's recovery status is unknown.