chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: OPV
Symptoms: Brain neoplasm
Clinical narrative: This case was considered medically important (OMIC). Information regarding poliovirus vaccine was received from an attorney regarding a female patient who developed a brain tumor. The patient received vaccine. Relevant medical history was not provided. Indication for poliovirus vaccine was immunization. Product was administered sometime in the 1960's. Dose regimen was not provided. Concomitant medications were not reported. The attorney alleges that the polio vaccine product received by the plaintiff contained a harmful prohibited animal virus known as Simian virus 40. The SV40 contained within the patient's polio vaccine product was a cause of the brain tumor she suffered. No additional information was available at the time of this report.
Age: 39.0
Sex: F
Vaccine: HEPA
Symptoms: Pruritus, Pyrexia, Rash, Rash erythematous
Clinical narrative: On 3/2/04 evening, pt stated getting rash on side of trunk and behind knees - "little red dots"- raised and surrounded by white areas"  - "3/3/04 evening- rash had spread to thighs, stomach, underarms and chest" rash is itchy. Has had low grade fever since yesterday. No other signs and symptoms.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, PNC, VARCEL
Symptoms: Injection site inflammation, Oedema, Rash papular
Clinical narrative: Inflamed area where vaccines were injected, swollen 3-4 cm diam. with 2 papules in center vaccines admin. date 2/20/04. Date inflammation was noted 3/02/04.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Dyspnoea, Oedema, Oral intake reduced
Clinical narrative: Approximately 8 hours after immunizations infant had swelling of the mouth and difficulty breathing was seen in ER that night. Follow up on 3 March 04 at 17:30 infant still eating less but swelling almost gone and breathing well.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Red, raised, feverish area around injection site approximately 12 cm in diameter.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Received 4 years shots on 1-28-04, DTaP, IPV, MMR on 1-30-04. Dad noticed entire leg being swollen and red. It was warm to touch. Motrin as needed pain.
Age: 5.5
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Drug ineffective, Infection, Pyrexia, Rash papular
Clinical narrative: "Lesions all over body starting 3-3-04 fever for 12 hours few days ago" 75-100 red lesions with papules, pustules and scabs- torso, arms, legs.
Age: 5.5
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Skin ulcer
Clinical narrative: "Lesions all over body starting 3-3-04 fever for 12 hours few days ago" 75-100 red lesions with papules, pustules and scabs- torso, arms, legs.
Age: 59.0
Sex: U
Vaccine: TYP
Symptoms: Blood pressure increased, Chest pain
Clinical narrative: Chest pains on left side of chest started after I took the first vaccine pill. They continued for 4 hours every 5 minutes or so. 6 days later I visited my general practitioner doctor and my blood pressure was 134/78. Usually, it is 118/80.
Age: 4.92
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema
Clinical narrative: Mom report left upper arm red/swollen.
Age: 37.0
Sex: F
Vaccine: TTOX
Symptoms: Feeling hot, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: One day after shot was given arm was very sore. Next day (2) arm was very hot and sore. Felt like I was running a fever ache in all muscles, day (3) stayed home, fever felt like I had the flu arm sore.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Varicella infection.  Follow up on 04/21/04: Reporter does not give any more new information.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Acne, Anorexia, Depersonalisation, Erythema, Infection
Clinical narrative: 2/24- 5 minutes after vaccine pt got a blotchy red rash that covered forehead and temples. 2/26- began getting red pimple dots on face, doctor said it was probably due to varicella vaccine; began to show loss of appetite; until date symptoms have not diminish; sleep interrupted 2 times at night; behavior change: cranky and clingy. 2/28-3/4- runny nose; pink eye (Left eye) for 1 day; sensitivity in mouth maybe due to teething, no sores were noticed in mouth. 3/3- Fever of 101 degrees F for 12-15 hours. 3/7- Scalp had red blotches at 8 pm. 3/8- Doctor diagnosed pt with measles. Pt had raised spotty rash on trunk all around behind ears forehead and temples.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Insomnia, Irritability, Ocular hyperaemia, Pyrexia, Rash
Clinical narrative: 2/24- 5 minutes after vaccine pt got a blotchy red rash that covered forehead and temples. 2/26- began getting red pimple dots on face, doctor said it was probably due to varicella vaccine; began to show loss of appetite; until date symptoms have not diminish; sleep interrupted 2 times at night; behavior change: cranky and clingy. 2/28-3/4- runny nose; pink eye (Left eye) for 1 day; sensitivity in mouth maybe due to teething, no sores were noticed in mouth. 3/3- Fever of 101 degrees F for 12-15 hours. 3/7- Scalp had red blotches at 8 pm. 3/8- Doctor diagnosed pt with measles. Pt had raised spotty rash on trunk all around behind ears forehead and temples.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash maculo-papular, Rash morbilliform, Rhinorrhoea, Stomatitis
Clinical narrative: 2/24- 5 minutes after vaccine pt got a blotchy red rash that covered forehead and temples. 2/26- began getting red pimple dots on face, doctor said it was probably due to varicella vaccine; began to show loss of appetite; until date symptoms have not diminish; sleep interrupted 2 times at night; behavior change: cranky and clingy. 2/28-3/4- runny nose; pink eye (Left eye) for 1 day; sensitivity in mouth maybe due to teething, no sores were noticed in mouth. 3/3- Fever of 101 degrees F for 12-15 hours. 3/7- Scalp had red blotches at 8 pm. 3/8- Doctor diagnosed pt with measles. Pt had raised spotty rash on trunk all around behind ears forehead and temples.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Oedema peripheral, Paraesthesia, Rash
Clinical narrative: Rash, swollen feet, hands & feet tingling. Benadryl 1 1/2 tsp, Orapred 2 tsp,  Epi-pen 4.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Erythema, Feeling hot
Clinical narrative: Left deltoid with redness, warm to touch- 4 inch area- advised cool compress 4-5 times daily- Tylenol every 4 hours- to primary care physician if work. Per doctor.
Age: 3.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Swollen, redness, hardness and hot on vaccination site 1 1/2 inches around vaccination site, 24 hours after vaccination.
Age: 1.08
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Maculo-papular vesicular rash on back 5-6, few had scabbed, 1-2 on the arms.
Sex: F
Vaccine: HEP
Symptoms: Cold sweat, Dizziness, Feeling abnormal, Feeling cold, Feeling hot
Clinical narrative: Pt received Heb B #2 vaccine at 10:30 am at 3:05 pm pt. called from work, stating she felt "cold then hot, nervous and nauseous" 3:15 pm pt. felt worse - ie clammy, lightheaded- spoke with RN at her work place B/P 140/20, no shortness of breath, no chest pain.
Sex: F
Vaccine: HEP
Symptoms: Nausea, Tension
Clinical narrative: Pt received Heb B #2 vaccine at 10:30 am at 3:05 pm pt. called from work, stating she felt "cold then hot, nervous and nauseous" 3:15 pm pt. felt worse - ie clammy, lightheaded- spoke with RN at her work place B/P 140/20, no shortness of breath, no chest pain.
Age: 1.0
Sex: M
Vaccine: PNC
Symptoms: Drug ineffective, Infection, Laboratory test abnormal, Pneumonia, Sepsis
Clinical narrative: Child had ER visit 12/26/03, diagnosed with pneumonia, antibiotic prescribed. A routine blood culture obtained at ER visit. On 1/8/04, child had follow-up visit. Had recovered. On review of lab, doctor found blood was positive strep pneumoniae resort and called the immunization program.
Age: 2.0
Sex: M
Vaccine: DTAP, HBHEPB, HEPA
Symptoms: Cellulitis, Erythema, Injection site induration, Pain
Clinical narrative: Received immunization 3/9/04- has reaction to right thigh cellulitis (12 x 8 cm) of induration, red, painful.
Age: 1.42
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Erythema, Infection, Pyrexia
Clinical narrative: Parent believes the child has chicken pox. Got vaccine, has red spots, no blisters or open. Slight temp.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Blood pressure increased, Chills, Disturbance in attention, Fatigue, Fibromyalgia
Clinical narrative: Since having the series of Hep. B vaccinations, I have developed Chronic Fatigue Immune Dysfunction Syndrome and Fibromyalgia.  I received the first injection in either December of 1998 or January of 1999; the last injection was in June of 1999.  My symptoms include:  Migraines, IBS, weakened immune system (always getting infections), abnormal labs(elevated liver enzymes, white cell count, low human growth hormone, vitamin deficiency, EBV, high fibrinogin levels), memory/concentration problems, fatigue, weak/painful muscles, sleep disturbance, frequent chills/hot flashes, high blood pressure, restless leg syndrome, night sweats  Both Agencies have given me different dates for the vaccinations; I don't remember if I got one or more injections from either source.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Gastrointestinal disorder, Hot flush, Immune system disorder, Laboratory test abnormal, Memory impairment
Clinical narrative: Since having the series of Hep. B vaccinations, I have developed Chronic Fatigue Immune Dysfunction Syndrome and Fibromyalgia.  I received the first injection in either December of 1998 or January of 1999; the last injection was in June of 1999.  My symptoms include:  Migraines, IBS, weakened immune system (always getting infections), abnormal labs(elevated liver enzymes, white cell count, low human growth hormone, vitamin deficiency, EBV, high fibrinogin levels), memory/concentration problems, fatigue, weak/painful muscles, sleep disturbance, frequent chills/hot flashes, high blood pressure, restless leg syndrome, night sweats  Both Agencies have given me different dates for the vaccinations; I don't remember if I got one or more injections from either source.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Migraine, Myalgia, Night sweats, Restless legs syndrome, Sleep disorder
Clinical narrative: Since having the series of Hep. B vaccinations, I have developed Chronic Fatigue Immune Dysfunction Syndrome and Fibromyalgia.  I received the first injection in either December of 1998 or January of 1999; the last injection was in June of 1999.  My symptoms include:  Migraines, IBS, weakened immune system (always getting infections), abnormal labs(elevated liver enzymes, white cell count, low human growth hormone, vitamin deficiency, EBV, high fibrinogin levels), memory/concentration problems, fatigue, weak/painful muscles, sleep disturbance, frequent chills/hot flashes, high blood pressure, restless leg syndrome, night sweats  Both Agencies have given me different dates for the vaccinations; I don't remember if I got one or more injections from either source.
Age: 18.0
Sex: M
Vaccine: SMALL
Symptoms: Skin ulcer, Tongue ulceration
Clinical narrative: Received Smallpox vaccination 1/27/04.  Three to four days later noticed acne-like lesion on abdomen.  Within 6-7 hours noticed same type lesions on trunk anteriorly and posteriorly, and thighs (R>L).  Developed ulcer on tongue 13 days after receipt of Smallpox vaccine.  None of these had resolved when patient deployed.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Irritability, Oral intake reduced, Pyrexia, Sleep disorder, Vaccine positive rechallenge
Clinical narrative: PATIENT REC'D PEDIARIX#3 AND HIB#3 TYLENOL GIVEN IMMEDIATELY PRIOR AND EVERY FOUR HOURS AFTER. PATIENT DEVELOPED FEVER UP TO 103F. FEVER LASTED OFF AND ON 3-4 DAYS. IRRITABLE BUT CONSOLABLE 4 DAYS. REFUSED SOLIDS FOR 3 DAYS. INTERRUPTED SLEEP FOR GREATER THAN ONE WEEK.  PREVIOUS DOSES OF PEDIARIX AND HIB AT 2 & 4 MONTHS SAME REACTIONS BUT NOT AS SEVERE AND DURATION SOME WHAT SHORTER. ALSO, PATIENT REC'D ENGERIX-B AT BIRTH. HAS HAD TOTAL OF 4 DOSES OF HEP-B.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Abasia, Arthritis, Gout, Pain, Skin nodule
Clinical narrative: MMr vaccine given on 2/4/04.  On 2/8 patient noticed knots behind ears.  2/14 saw doctor for evaluation of knots, drew blood, was positive for arthritis.  2/14 symptoms got worse with gout pain and swelling.  2/24 saw doctor again; unable to walk started on referred to a arthritis specialist.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Swelling
Clinical narrative: MMr vaccine given on 2/4/04.  On 2/8 patient noticed knots behind ears.  2/14 saw doctor for evaluation of knots, drew blood, was positive for arthritis.  2/14 symptoms got worse with gout pain and swelling.  2/24 saw doctor again; unable to walk started on referred to a arthritis specialist.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: This is a 30-year-old who received his 4th anthrax, in his right upper arm, on 03/08/04. He stated he had had no previous reactions to his previous three (3) anthrax vaccinations. On 03/09/04 he noticed after showering that his right upper arm was red and swollen and painful to touch. He relates that his arm is very itchy. He denies any change in muscle strength or sensation in the affect arm. He presented on 03/10/04 to Medical for evaluation secondary to an increase in the swelling of his arm. The Vaccine Healthcare Center (VHC) was asked to evaluate his adverse reaction to anthrax.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Discomfort, Tenderness
Clinical narrative: UNCONSOLABLE CRYING 3 HOURS AFTER VACCINES LASTED 6-7 HOURS. TYLENOL .8CC Q 4 HOURS AND COOL COMPRESSES RELIEVED SOME DISCOMFORT. CHILD SLEPT THROUGH NIGHT AND WAS STILL A BIT TENDER THE NEXT MORNING.
Age: 27.0
Sex: M
Vaccine: MEN
Symptoms: Medication error
Clinical narrative: Vaccine was diluted incorrectly; subsequently, patient received 10 doses of mcg vaccine instead of one dose.  No adverse clinical signs or symptoms at this time; patient received immunization about one hour ago
Age: 0.0
Sex: M
Vaccine: ANTH
Symptoms: Chest pain, Pain
Clinical narrative: Pt c/o pain down left arm 5-10 seconds after receiving the anthrax vaccine.  4 minutes later the Pt c/o chest pain and pressure in center of chest.  911 contacted, oxygen applied, vital signs monitored, pt given 50mg Benadryl IM per medical provider order. Patient was transported to Hospital for further eval and treatment.  Pt transported by Paramedics.
Age: 40.0
Sex: F
Vaccine: SMALL
Symptoms: Basedow's disease, Bone disorder, Chest pain, Fatigue, Goitre
Clinical narrative: #1)Viral-type illness on day #6 after vaccine given; extreme fatigue/myalgias/sent home on quarters #2)cardiac chest pain 2 months later (Apr 03) #3)thyromegaly-diagnosed with Grave's disease 3 months later (May 03)  Nurse follow up on 06/03/04 states: "Complete."
Age: 40.0
Sex: F
Vaccine: SMALL
Symptoms: Laboratory test abnormal, Myalgia, Viral infection
Clinical narrative: #1)Viral-type illness on day #6 after vaccine given; extreme fatigue/myalgias/sent home on quarters #2)cardiac chest pain 2 months later (Apr 03) #3)thyromegaly-diagnosed with Grave's disease 3 months later (May 03)  Nurse follow up on 06/03/04 states: "Complete."
Age: 38.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Tetanus vaccination on February 24, 2004. Two days following this, he developed redness and the area was warm to touch. This area was from about the shoulder area down to the elbow. He denies any impairment in mobility or interference with his ADLs. He did not have a fever or any other symptoms. His arm did not itch. He went to medical and was given a steroid taper pack. He reports that this was effective in relieving the symptoms. He denies any prior reaction to vaccines. He does not know if his vaccination was due because his medical record was misplaced in April.
Age: 39.0
Sex: M
Vaccine: ANTH, TD
Symptoms: Erythema, Feeling hot, Pruritus, Swelling, Vaccine positive rechallenge
Clinical narrative: Left arm above elbow has a 5 inch in diameter is itchy, swolen,red and warm to the touch. Patient has claimed to have previous reaction with anthrax.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema
Clinical narrative: cELLULITIS  AREA RED 5 OVER 6
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Chest pain, Condition aggravated, Discomfort, Fatigue
Clinical narrative: Patient had been asymptomatic following the myopericarditis, which developed on 3/27/2003, ten days following his smallpox vaccine. On November 18, 2003 he received his influenza vaccine and reports that with in 3 days he began to feel a general "run-down" feeling. At that time he also began to experience a discomfort in the left side of his chest. He describes this as "pressure" and rates the intensity as a 3/10. He reports that it has not been continuous, coming and going.  He initially did not think that the discomfort was related to the influenza vaccine or a repeat of his myopericarditis, due in part to the fact that the discomfort was not as intense as what was experienced on prior occasions. Therefore, he did not seek medical attention for approximately one month after symptoms began. He was seen by a doctor on January 7, 2004 at which time his ECHO was within normal limits with an ejection fraction of 68%.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: CELLULITIS  RED / SWOLLEN 4/4
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site reaction
Clinical narrative: 2 PLUM-SIZED LOCAL REACTIONS TO LEFT THIGH AFTER ADMINISTRATION OF MMR AND VARICELLA VACCINE.
Age: 0.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: This report was received concerning a 3 month old male patient who on 11/28/01 was vaccinated IM in the right leg with a dose of haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant. Concomitant suspect therapy on 11/28/01 included the first dose IM in the left leg of diphtheria toxoid/pertussis vaccine/teta, the first dose SC in the left leg of poliovirus vaccine and the first dose IM in the right leg of streptococcus pneumoniae vaccine. There were no other concomitant therapies. On 12/17/01 at 8:38 AM the patient died of sudden infant death syndrome. The reporter noted that the patient experienced no other post-vaccination adverse events. Autopsy results were pending as of the date of this report was submitted to VAERS. It is unknown if the patient had a past medical history. Follow up information received on 5/2/04 reported that an autopsy was performed however, the patient's autopsy results were not provided. No further information is available. This was originally reported by a health professional.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Cardiac tamponade, Chest pain, Neoplasm malignant, Pericardial effusion
Clinical narrative: Mother reports patient received AVA #1 and developed chest pain that night. The next day, diagnosed with pericardial effusion and subsequently rare malignancy of myocardium . Open heart surgery in November 2003. No medical records received. Unit verifies mom's story of symptom onset. Additional follow up information indicates that on 28AUG2003 he presented to ER with pericardial tamponade. he as hospitalized from 28AUG2003-05SEPTEMBER2003 where his effusion was drained was diagnosed with acute hemorrhagic pericarditis. Work up inlcuded negative cultures, cytology and a chest CT with no evidence of malignancy. the pt was treated with abx. A follow up CT scan on 30SEP2003 showed two soft tissues masses in his heart. A biopsy indicated cardiac sarcoma. The pt underwent surgury, however his condition deteriorated and he died on 25FEB2004. Pathology report received 30JULY2004: Diagnosis of poor differentiated high grade sarcoma consistent iwth synovial sarcoma.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Abdominal pain upper, Hypotension, Rash, Somnolence, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female with no relevant medical history, no known allergies, or previous reactions who in 2004 was vaccinated SC with a dose of MMR (lot # 646740/0822N). On the same day, the patient was concomitantly vaccinated with a dose of diphtheria toxoid (+) pertussis acellular vaccine (+) tetanus toxoid and a dose of poliovirus vaccine inactivated. It was reported that the patient was well at the time of vaccination. Approximately 5 minutes post vaccination, the patient began complaining of stomach pains. The patient's mother took her to the bathroom. Shortly thereafter another nurse noticed that the patient was lying on the bathroom floor. The patient was taken to a treatment room. The patient developed syncope, tachycardia, hypotension, and urticaria. No respiratory distress was noted. She was given 1.5 teaspoonsful of diphenhydramine HCl for the urticaria. After 10 minutes, she was given a dose of epinephrine SC as appropriate for her age. The patient was transported by ambulance to the hospital and was hospitalized overnight. She was released the next day and appeared to be fine. The nurse reported that as far as she knew the patient had recovered. Stomach pains, syncope, tachycardia, hypotensive and urticaria were considered to be immediately life threatening. Additional information has been requested. Stomach pains, synope, tachycardia, hypotensive and urticaria were considered to be immediately life-threatening. Other business partner number 2004-00846. No additional information is expected.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Tachycardia, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female with no relevant medical history, no known allergies, or previous reactions who in 2004 was vaccinated SC with a dose of MMR (lot # 646740/0822N). On the same day, the patient was concomitantly vaccinated with a dose of diphtheria toxoid (+) pertussis acellular vaccine (+) tetanus toxoid and a dose of poliovirus vaccine inactivated. It was reported that the patient was well at the time of vaccination. Approximately 5 minutes post vaccination, the patient began complaining of stomach pains. The patient's mother took her to the bathroom. Shortly thereafter another nurse noticed that the patient was lying on the bathroom floor. The patient was taken to a treatment room. The patient developed syncope, tachycardia, hypotension, and urticaria. No respiratory distress was noted. She was given 1.5 teaspoonsful of diphenhydramine HCl for the urticaria. After 10 minutes, she was given a dose of epinephrine SC as appropriate for her age. The patient was transported by ambulance to the hospital and was hospitalized overnight. She was released the next day and appeared to be fine. The nurse reported that as far as she knew the patient had recovered. Stomach pains, syncope, tachycardia, hypotensive and urticaria were considered to be immediately life threatening. Additional information has been requested. Stomach pains, synope, tachycardia, hypotensive and urticaria were considered to be immediately life-threatening. Other business partner number 2004-00846. No additional information is expected.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Abdominal pain, Hypotension, Syncope, Tachycardia, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female with no relevant medical history, no known allergies, or previous reactions who in 2004 was vaccinated SC with a dose of MMR (lot # 646740/0822N). On the same day, the patient was concomitantly vaccinated with a dose of diphtheria toxoid (+) pertussis acellular vaccine (+) tetanus toxoid and a dose of poliovirus vaccine inactivated. It was reported that the patient was well at the time of vaccination. Approximately 5 minutes post vaccination, the patient began complaining of stomach pains. The patient's mother took her to the bathroom. Shortly thereafter another nurse noticed that the patient was lying on the bathroom floor. The patient was taken to a treatment room. The patient developed syncope, tachycardia, hypotension, and urticaria. No respiratory distress was noted. She was given 1.5 teaspoonsful of diphenhydramine HCl for the urticaria. After 10 minutes, she was given a dose of epinephrine SC as appropriate for her age. The patient was transported by ambulance to the hospital and was hospitalized overnight. She was released the next day and appeared to be fine. The nurse reported that as far as she knew the patient had recovered. Stomach pains, syncope, tachycardia, hypotensive and urticaria were considered to be immediately life threatening. Additional information has been requested. Stomach pains, synope, tachycardia, hypotensive and urticaria were considered to be immediately life-threatening. Other business partner number 2004-00846. No additional information is expected.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Abdominal pain upper, Hypotension, Syncope, Tachycardia, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female with no relevant medical history, no known allergies, or previous reactions who in 2004 was vaccinated SC with a dose of MMR (lot # 646740/0822N). On the same day, the patient was concomitantly vaccinated with a dose of diphtheria toxoid (+) pertussis acellular vaccine (+) tetanus toxoid and a dose of poliovirus vaccine inactivated. It was reported that the patient was well at the time of vaccination. Approximately 5 minutes post vaccination, the patient began complaining of stomach pains. The patient's mother took her to the bathroom. Shortly thereafter another nurse noticed that the patient was lying on the bathroom floor. The patient was taken to a treatment room. The patient developed syncope, tachycardia, hypotension, and urticaria. No respiratory distress was noted. She was given 1.5 teaspoonsful of diphenhydramine HCl for the urticaria. After 10 minutes, she was given a dose of epinephrine SC as appropriate for her age. The patient was transported by ambulance to the hospital and was hospitalized overnight. She was released the next day and appeared to be fine. The nurse reported that as far as she knew the patient had recovered. Stomach pains, syncope, tachycardia, hypotensive and urticaria were considered to be immediately life threatening. Additional information has been requested. Stomach pains, synope, tachycardia, hypotensive and urticaria were considered to be immediately life-threatening. Other business partner number 2004-00846. No additional information is expected.
Sex: F
Vaccine: DTAP, HEP, HIBV, MMR, HIBV
Symptoms: Drug toxicity, Nervous system disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Haemophilus B conjugate vaccine was received from an attorney regarding a female patient who experienced mercury poisoning and neurodevelopmental injuries. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Haemophilus B conjugate vaccine was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Additional suspect medication included diphtheria and tetanus toxoids and pertussis vaccine absorbed vaccine, MMR II vaccine and hepatitis B vaccine. Concomitant medications were not reported. It is alleged that as a result of the cumulative exposure to mercury in the thimerosal containing vaccines, the child developed severe neurodevelopmental injuries of mercury poisoning. No additional information was available at the time of this report.
Sex: M
Vaccine: DTAP, HEP, HIBV, MMR, HIBV
Symptoms: Drug toxicity, Nervous system disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Haemophilus B conjugate vaccine was received from an attorney regarding a male patient who experienced mercury poisoning and neurodevelopmental injuries. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Haemophilus B conjugate vaccine was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Additional suspect medication included diphtheria and tetanus toxoids and pertussis vaccine absorbed vaccine, MMR II vaccine and hepatitis B vaccine. Concomitant medications were not reported. It is alleged that as a result of the cumulative exposure to mercury in the thimerosal containing vaccines, the child developed severe neurodevelopmental injuries of mercury poisoning. No additional information was available at the time of this report.
Sex: M
Vaccine: DTAP, HEP, HIBV, MMR, HIBV
Symptoms: Anxiety, Drug toxicity, Nervous system disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Haemophilus B conjugate vaccine was received from an attorney regarding a male patient who experienced mercury poisoning and neurodevelopmental injuries. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Haemophilus B conjugate vaccine was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Additional suspect medication included diphtheria and tetanus toxoids and pertussis vaccine absorbed vaccine, MMR II vaccine and hepatitis B vaccine. Concomitant medications were not reported. It is alleged that as a result of cumulative exposure to mercury in the thimerosal containing vaccine, the child developed severe neurodevelopmental injuries of mercury poisoning. No additional information was available at the time of this report.
Sex: M
Vaccine: DTAP, HEP, HIBV, MMR, HIBV
Symptoms: Drug toxicity, Nervous system disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Haemophilus B conjugate vaccine was received from an attorney regarding a male patient who experienced mercury poisoning and neurodevelopmental injuries. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Haemophilus B conjugate vaccine was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Additional suspect medication included diphtheria and tetanus toxoids and pertussis vaccine absorbed vaccine, MMR II vaccine and hepatitis B vaccine. Concomitant medications were not reported. It is alleged that as a result of cumulative exposure to mercury in the thimerosal containing vaccine, the child developed severe neurodevelopmental injuries of mercury poisoning. No additional information was available at the time of this report.
Sex: M
Vaccine: DTAP, HEP, HIBV, MMR, HIBV
Symptoms: Anxiety, Drug toxicity, Nervous system disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Haemophilus B conjugate vaccine was received from an attorney regarding a male patient who experienced mercury poisoning and neurodevelopmental injuries. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Haemophilus B conjugate vaccine was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Additional suspect medication included diphtheria and tetanus toxoids and pertussis vaccine absorbed vaccine, MMR II vaccine and hepatitis B vaccine. Concomitant medications were not reported. It is alleged that as a result of the cumulative exposure to mercury in the thimerosal containing vaccines, the child developed severe neurodevelopmental injuries of mercury poisoning. No additional information was available at the time of this report.
Sex: M
Vaccine: DTAP, HEP, HIBV, MMR, HIBV
Symptoms: Anxiety, Drug toxicity, Nervous system disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Haemophilus B conjugate vaccine was received from an attorney regarding a male patient who experienced mercury poisoning and neurodevelopmental injuries. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Haemophilus B conjugate vaccine was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Additional suspect medication included diphtheria and tetanus toxoids and pertussis vaccine absorbed vaccine, MMR II vaccine and hepatitis B vaccine. Concomitant medications were not reported. It is alleged that as a result of cumulative exposure to mercury in the thimerosal containing vaccines, the child developed severe neurodevelopmental injuries of mercury poisoning. No additional information was available at the time of this report.
Sex: M
Vaccine: DTAP, HEP, HIBV, MMR, HIBV
Symptoms: Drug toxicity, Nervous system disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Haemophilus B conjugate vaccine was received from an attorney regarding a male patient who experienced mercury poisoning and neurodevelopmental injuries. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Haemophilus B conjugate vaccine was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Additional suspect medication included diphtheria and tetanus toxoids and pertussis vaccine absorbed vaccine, MMR II vaccine and hepatitis B vaccine. Concomitant medications were not reported. It is alleged that as a result of cumulative exposure to mercury in the thimerosal containing vaccines, the child developed severe neurodevelopmental injuries of mercury poisoning. No additional information was available at the time of this report.
Sex: M
Vaccine: DTAP, HEP, HIBV, MMR, HIBV
Symptoms: Anxiety, Drug toxicity, Nervous system disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Haemophilus B conjugate vaccine was received from an attorney regarding a male patient who experienced mercury poisoning and neurodevelopmental injuries. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Haemophilus B conjugate vaccine was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Additional suspect medication included diphtheria and tetanus toxoids and pertussis vaccine absorbed vaccine, MMR II vaccine and hepatitis B vaccine. Concomitant medications were not reported. It is alleged that as a result of the cumulative exposure to mercury in the thimerosal containing vaccines, the child developed severe neurodevelopmental injures of mercury poisoning. No additional information was available at the time of this report.
Sex: M
Vaccine: DTAP, HEP, HIBV, MMR, HIBV
Symptoms: Drug toxicity, Nervous system disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Haemophilus B conjugate vaccine was received from an attorney regarding a male patient who experienced mercury poisoning and neurodevelopmental injuries. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Haemophilus B conjugate vaccine was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Additional suspect medication included diphtheria and tetanus toxoids and pertussis vaccine absorbed vaccine, MMR II vaccine and hepatitis B vaccine. Concomitant medications were not reported. It is alleged that as a result of the cumulative exposure to mercury in the thimerosal containing vaccines, the child developed severe neurodevelopmental injures of mercury poisoning. No additional information was available at the time of this report.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Cerebrovascular accident, Chills, Diarrhoea, Erythema, Headache
Clinical narrative: Injection was given Saturday morning, 11/2/02. Sunday night around 11 or so, started throwing up, fever diarrhea, chills, headache. He continued getting up, going to the restroom with the vomiting and diarrhea until about 10am Monday morning 11/4/02. He told my mom sometime later that he could not move his legs. I went to their house around 2:30 PM. Upon entering his room, he was laying in bed on top of the covers. I felt his foot and ankle, they were cool to the touch. I felt his back when he was trying to sit up and it was burning hot. His face was red. He was speaking. He wanted my son and I to help him get up. We were unable to lift him. I called a nurse friend of mine at 2:55 PM to have her stop by and take his blood pressure and kind of check him over. While I was on the phone with her, my mom yelled for me to call an ambulance. It took the ambulance about 5-10 minutes to get to their home. Dad was speaking to the paramedics, telling them what all was going on. They loaded him into the ambulance and he was still alert and speaking. Somewhere in the 2-3 minute trip to the emergency room, my dad died. Upon entering the emergency room, they had made it a code blue call and continued working on him. The ER doctor worked on dad until 6:00 PM when he was life flighted to another hospital. He was taken to ICU where we were told by the doctors they did not know if he would make it through the night. He was in ICU for 7 days. The doctors ran several tests. During this time, we learned that he had become paralyzed from the waist down, he had a spinal stroke, a head stroke and they were not sure if any damage had been done when he actually died (lack of oxygen to the brain). After 2 weeks in the hospital, dad was moved to a rehab center, from there to a skilled nursing facility and from there, home. Over the next 8.5 months, dad was in and out of the hospital. The longest time between hospital stays was 35 days. On 7/1/03, dad was taken to the hospital for fever. He had a UTI. He was in the hospital for about 10 days and they could not figure out why he kept running a fever at night. He was transferred to another hospital. He was given an injection and it reacted with the medication they had him on, he went into rigors, had a massive heart attack and died on 8/4/03. The death certificate received on 3/23/04 states pontine stroke and pneumonia.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Myocardial infarction, Paralysis, Peripheral coldness, Pneumonia, Pyrexia
Clinical narrative: Injection was given Saturday morning, 11/2/02. Sunday night around 11 or so, started throwing up, fever diarrhea, chills, headache. He continued getting up, going to the restroom with the vomiting and diarrhea until about 10am Monday morning 11/4/02. He told my mom sometime later that he could not move his legs. I went to their house around 2:30 PM. Upon entering his room, he was laying in bed on top of the covers. I felt his foot and ankle, they were cool to the touch. I felt his back when he was trying to sit up and it was burning hot. His face was red. He was speaking. He wanted my son and I to help him get up. We were unable to lift him. I called a nurse friend of mine at 2:55 PM to have her stop by and take his blood pressure and kind of check him over. While I was on the phone with her, my mom yelled for me to call an ambulance. It took the ambulance about 5-10 minutes to get to their home. Dad was speaking to the paramedics, telling them what all was going on. They loaded him into the ambulance and he was still alert and speaking. Somewhere in the 2-3 minute trip to the emergency room, my dad died. Upon entering the emergency room, they had made it a code blue call and continued working on him. The ER doctor worked on dad until 6:00 PM when he was life flighted to another hospital. He was taken to ICU where we were told by the doctors they did not know if he would make it through the night. He was in ICU for 7 days. The doctors ran several tests. During this time, we learned that he had become paralyzed from the waist down, he had a spinal stroke, a head stroke and they were not sure if any damage had been done when he actually died (lack of oxygen to the brain). After 2 weeks in the hospital, dad was moved to a rehab center, from there to a skilled nursing facility and from there, home. Over the next 8.5 months, dad was in and out of the hospital. The longest time between hospital stays was 35 days. On 7/1/03, dad was taken to the hospital for fever. He had a UTI. He was in the hospital for about 10 days and they could not figure out why he kept running a fever at night. He was transferred to another hospital. He was given an injection and it reacted with the medication they had him on, he went into rigors, had a massive heart attack and died on 8/4/03. The death certificate received on 3/23/04 states pontine stroke and pneumonia.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Urinary tract infection, Vomiting
Clinical narrative: Injection was given Saturday morning, 11/2/02. Sunday night around 11 or so, started throwing up, fever diarrhea, chills, headache. He continued getting up, going to the restroom with the vomiting and diarrhea until about 10am Monday morning 11/4/02. He told my mom sometime later that he could not move his legs. I went to their house around 2:30 PM. Upon entering his room, he was laying in bed on top of the covers. I felt his foot and ankle, they were cool to the touch. I felt his back when he was trying to sit up and it was burning hot. His face was red. He was speaking. He wanted my son and I to help him get up. We were unable to lift him. I called a nurse friend of mine at 2:55 PM to have her stop by and take his blood pressure and kind of check him over. While I was on the phone with her, my mom yelled for me to call an ambulance. It took the ambulance about 5-10 minutes to get to their home. Dad was speaking to the paramedics, telling them what all was going on. They loaded him into the ambulance and he was still alert and speaking. Somewhere in the 2-3 minute trip to the emergency room, my dad died. Upon entering the emergency room, they had made it a code blue call and continued working on him. The ER doctor worked on dad until 6:00 PM when he was life flighted to another hospital. He was taken to ICU where we were told by the doctors they did not know if he would make it through the night. He was in ICU for 7 days. The doctors ran several tests. During this time, we learned that he had become paralyzed from the waist down, he had a spinal stroke, a head stroke and they were not sure if any damage had been done when he actually died (lack of oxygen to the brain). After 2 weeks in the hospital, dad was moved to a rehab center, from there to a skilled nursing facility and from there, home. Over the next 8.5 months, dad was in and out of the hospital. The longest time between hospital stays was 35 days. On 7/1/03, dad was taken to the hospital for fever. He had a UTI. He was in the hospital for about 10 days and they could not figure out why he kept running a fever at night. He was transferred to another hospital. He was given an injection and it reacted with the medication they had him on, he went into rigors, had a massive heart attack and died on 8/4/03. The death certificate received on 3/23/04 states pontine stroke and pneumonia.
Age: 62.0
Sex: M
Vaccine: LYME
Symptoms: Arthritis, Infection, Laboratory test abnormal, Muscle spasms, Myalgia
Clinical narrative: I now have Lyme disease and a permanent arthritic condition because of Lymerix vaccine. All of above started shortly after Lymerix shot. Nurse follow up on 05/19/04 states: polymyalgia rheumatica (MYALGIA), leg cramps (CRAMPS LEG)
Age: 62.0
Sex: M
Vaccine: LYME
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: I now have Lyme disease and a permanent arthritic condition because of Lymerix vaccine. All of above started shortly after Lymerix shot. Nurse follow up on 05/19/04 states: polymyalgia rheumatica (MYALGIA), leg cramps (CRAMPS LEG)
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dysgeusia, Fatigue, Hyperhidrosis, Injection site pain
Clinical narrative: This case reported by a nurse and described the occurrence of dizziness in a 48 year old female pt who received hpe B vaccine. The pt's medical history was notable for Bipolar disorder. Concurrently the pt received lithium. On 1/27/04, the pt received the first dose of Engerix B (5465A6). Immediately following administration of Engerix B, the pt experienced dizziness, nausea, sweating, leg weakness, restlessness, taste disturbance, fatigue, and an injection site reaction characterized by injection site pain. Upon examination, the pt's blood pressure was 98/68 and her pulse was 65. Within twelve hours of the injection, on 1/27/04, the pt experienced a "roseola-like rash." On 1/29/04, the pt developed swollen glands and a rash on her face. The events were considered to jeopardize the pt and required intervention. The events were also associated with a potential product complaint. The vaccination series with Engerix B was discontinued. At the time of reporting, 2/24/04, the fatigue, swollen glands and facial rash were unresolved and all the other events resolved with unspecified sequelae. The nurse considered the events to possibly be related to vaccination with Engerix B.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Injection site reaction, Lymphadenopathy, Muscular weakness, Nausea, Rash
Clinical narrative: This case reported by a nurse and described the occurrence of dizziness in a 48 year old female pt who received hpe B vaccine. The pt's medical history was notable for Bipolar disorder. Concurrently the pt received lithium. On 1/27/04, the pt received the first dose of Engerix B (5465A6). Immediately following administration of Engerix B, the pt experienced dizziness, nausea, sweating, leg weakness, restlessness, taste disturbance, fatigue, and an injection site reaction characterized by injection site pain. Upon examination, the pt's blood pressure was 98/68 and her pulse was 65. Within twelve hours of the injection, on 1/27/04, the pt experienced a "roseola-like rash." On 1/29/04, the pt developed swollen glands and a rash on her face. The events were considered to jeopardize the pt and required intervention. The events were also associated with a potential product complaint. The vaccination series with Engerix B was discontinued. At the time of reporting, 2/24/04, the fatigue, swollen glands and facial rash were unresolved and all the other events resolved with unspecified sequelae. The nurse considered the events to possibly be related to vaccination with Engerix B.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Restlessness
Clinical narrative: This case reported by a nurse and described the occurrence of dizziness in a 48 year old female pt who received hpe B vaccine. The pt's medical history was notable for Bipolar disorder. Concurrently the pt received lithium. On 1/27/04, the pt received the first dose of Engerix B (5465A6). Immediately following administration of Engerix B, the pt experienced dizziness, nausea, sweating, leg weakness, restlessness, taste disturbance, fatigue, and an injection site reaction characterized by injection site pain. Upon examination, the pt's blood pressure was 98/68 and her pulse was 65. Within twelve hours of the injection, on 1/27/04, the pt experienced a "roseola-like rash." On 1/29/04, the pt developed swollen glands and a rash on her face. The events were considered to jeopardize the pt and required intervention. The events were also associated with a potential product complaint. The vaccination series with Engerix B was discontinued. At the time of reporting, 2/24/04, the fatigue, swollen glands and facial rash were unresolved and all the other events resolved with unspecified sequelae. The nurse considered the events to possibly be related to vaccination with Engerix B.