chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.06
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Viral infection
Clinical narrative: Shingles
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Anxiety, Pruritus, Restlessness
Clinical narrative: Patient noted itching and hives approximately 3-4 hours after injection.  Presented at er, no hives noted, diagnoses:  Acute Diffuse Pruritis.  Given Prednisone, Atarax, Prilosec.  Experienced feeling restless, edgy, anxious, represented at ER, given imtramuscular decadron and morphine 4 mg for right upper quadrant pain, and sent home.
Age: 1.36
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular
Clinical narrative: Papular rash on trunk, 06/08/2005
Age: 1.16
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Rash
Clinical narrative: MMR - rash.
Age: 1.3
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Coma, Drooling, Musculoskeletal stiffness
Clinical narrative: Onset of fever 06/15/2005 at 1800, Mom found child unresponsive but breathing at 2200.  Described by Mom as stiff legs and arms with slight drooling.  EMT's called.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Paint and induration at injection site.  Pain extends upper arm and back (shoulder).  Induration 10cm circle around injection site.  Afebrile.  Tyco #3 by mouth for pain.
Age: 1.51
Sex: M
Vaccine: DTAPH
Symptoms: Erythema, Swelling
Clinical narrative: Left deltoid red, swollen, no infection.  Given Augmentin, worsens over weekend.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Influenza like illness, Paraesthesia, Rash macular
Clinical narrative: Tingling sensation in throat after Hepatitis B shot.  No shortness of breath.  Medrol dose pack 1, over the counter Benadryl.  Patient called 06/15/2005 - Blotchy arm, flu like symptoms was advised by RN to follow up in ER.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot
Clinical narrative: 8cm x 7cm red, warm area to right deltoid.  No treatment required.
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Facial palsy
Clinical narrative: Bell's Palsy - Onset 06/05/2005.  Saw physician 06/06/2005.
Age: 17.0
Sex: M
Vaccine: PNC
Symptoms: Medication error
Clinical narrative: Reporting product confusion event. Physician administering TB "vaccine" gave Prevnar by mistake. Physician reported event personally and stated "those bottles all look alike". Prevnar was given SC. Physician stated there was no adverse event.
Age: 29.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Asthenia, Bacterial infection, Cellulitis, Chills, Erythema
Clinical narrative: Patient reports pain and swelling present since day of vaccination. Presented to Emergency Room on 6/17/05 with c/o generalized weakness, vomiting, chills and fever with strong headache, generalized body aches and sweating. L shoulder noted with strong pain per the patient, 4-5cm erythematous area with central zone of necrosis about 1cm. Drainage present. Initial culture results noted gram positive cocci. Blood culture with gram positive cocci resembling staph. Admitted to hospital for IV fluids and antibiotics.
Age: 29.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Headache, Hyperhidrosis, Malaise, Necrosis, Pain
Clinical narrative: Patient reports pain and swelling present since day of vaccination. Presented to Emergency Room on 6/17/05 with c/o generalized weakness, vomiting, chills and fever with strong headache, generalized body aches and sweating. L shoulder noted with strong pain per the patient, 4-5cm erythematous area with central zone of necrosis about 1cm. Drainage present. Initial culture results noted gram positive cocci. Blood culture with gram positive cocci resembling staph. Admitted to hospital for IV fluids and antibiotics.
Age: 29.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pyrexia, Sepsis, Swelling, Vomiting
Clinical narrative: Patient reports pain and swelling present since day of vaccination. Presented to Emergency Room on 6/17/05 with c/o generalized weakness, vomiting, chills and fever with strong headache, generalized body aches and sweating. L shoulder noted with strong pain per the patient, 4-5cm erythematous area with central zone of necrosis about 1cm. Drainage present. Initial culture results noted gram positive cocci. Blood culture with gram positive cocci resembling staph. Admitted to hospital for IV fluids and antibiotics.
Age: 29.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Cellulitis, Malaise, Sepsis, Viral infection, White blood cell disorder
Clinical narrative: Patient reports pain and swelling present since day of vaccination. Presented to Emergency Room on 6/17/05 with c/o generalized weakness, vomiting, chills and fever with strong headache, generalized body aches and sweating. L shoulder noted with strong pain per the patient, 4-5cm erythematous area with central zone of necrosis about 1cm. Drainage present. Initial culture results noted gram positive cocci. Blood culture with gram positive cocci resembling staph. Admitted to hospital for IV fluids and antibiotics.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Pneumonia, Pyrexia, Rash
Clinical narrative: Child developed rash on neck and both arms to wrists day after shot was given (12/17/03) Mom called family Dr. who instructed to give her an antihistamine (over the counter)By next am rash was gone but child had a fever of 103 degrees - mom took child to Dr. on 12/18/03 then back to Dr. on 12/22/03 because still running temp. of 103 degrees. Dr. diagnosed child with pneumonia and treated with Zithromax and Aerosol treatment. no hospitalization required.
Age: 1.36
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: On Sunday 5/22/05 child broke out with a few spots around noon with a fever of 103.  Monday 5/23 around midnight broke out in sweat fever down to 101.  Continues to have fever Tuesday 5/24 - Mother is giving Motrin for the fever.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Eyes red and itchy - slight swelling of eyes all day.  Prescribed Tavist syrup, 2 doses; symptoms resolved completely.
Age: 0.49
Sex: M
Vaccine: DT, HBHEPB, IPV, PNC
Symptoms: Agitation, Pyrexia, Vomiting
Clinical narrative: Child developed fever 101.6, unconsolable crying, vomiting. Child was taken to ER to pediatrician x2. Parents states this lasted a week. Child now fine.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Difficulty in walking, Pain
Clinical narrative: Father called the health department to say that his son has been experiencing the following situation: after the vaccine he played in a baseball game, had no known injury, in the am on 5/26/05 he had extreme pain in his left leg (thigh and shin). Saw family physician twice on Fri. 5/27/05. Dr. ordered lab work and an X-ray, gave Tylenol#3 for pain. All tests came back negative. Saw Dr. again on Tuesday 5/31/05. He was referred to an orthopedic specialist. He suggested a needle Bx, family refused, ordered ibuprofen, no longer taking tylenol#3. over the weekend, dad stated that he walked with crutches and then on Tues 5/31/05 he was in a wheelchair per Dad. He only attended school on June 1, 05 since this began last week. Dr. said he would refer the child to a pediatric orthopedic specialist. later 6/3/05 nurse spoke to dad on phone asking questions to complete VAERS form and he reported that son said that pain is much better when he tried to get out of bed and into the wheelchair today. nurse encouraged dad to follow up with physician.
Age: 1.03
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Dehydration, Diarrhoea, Erythema, Swelling, Vomiting
Clinical narrative: Received call on 3/28/05 at 1pm. Patient's left leg red and swollen. No fever present. Mother states vomiting and diarrhea. Took to ER Dx-dehydration. ER told mom to use cool compresses and Tylenol, I encouraged the same.
Age: 1.26
Sex: M
Vaccine: DT, HIBV, MMR, PNC
Symptoms: Rash, Swelling
Clinical narrative: Pt. had few spots on abdomen and 104 degrees after nap at 2:00pm mother called family MD  - instructed to use tylenol. Today 3/22/05 pt. stomach covered with rash and swelling noted around eyes to ears and around nose. Family MD notified mother instructed to use Benadryl. mother notified us at 9:30 on 3/22/05 to file report per MD.
Age: 1.29
Sex: M
Vaccine: DTAP, MMR, PNC
Symptoms: Anaemia, Bacterial infection, Convulsion, Febrile convulsion, Otitis media
Clinical narrative: Fever and seizure developed on 05/20/05, was hospitalized 5/20-24/05 Discharged- Dx- fever, anemia, increased mononucleocytes, febrile seizures, otitis media, staphcapitis, coag neg. sepsis.
Age: 1.29
Sex: M
Vaccine: DTAP, MMR, PNC
Symptoms: Pyrexia, Sepsis
Clinical narrative: Fever and seizure developed on 05/20/05, was hospitalized 5/20-24/05 Discharged- Dx- fever, anemia, increased mononucleocytes, febrile seizures, otitis media, staphcapitis, coag neg. sepsis.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Body temperature fluctuation, Diarrhoea, Pyrexia, Rash, Viral infection
Clinical narrative: Child was taken to emergency room in pm of 6/7/05 with elevated temperature, was admitted to hospital.  Had testing done by Dr. which Dr. states revealed no evidence of infection.  No sign or symptom of local reaction was noted.   Child's temp was up & down with max. temp of 102.7 F, was discharged from hospital AM of 6/9/05 and still had fluctuating temp. 7/18/05 Review of 16-page medical record confirms fever & rash. Additional symptoms were vomiting & diarrhea. 9/15/05 Review of 6-page medical record confirms fever. 9/15/05 Review of 1-page d/c summary confirms scattered rash & fever. 1/25/06 Review of 7-page d/c summary confirms viral illness & fever. Follow-up: Child Dx with Kawasaki disease on 8/19/05, and heart problems with poor circulation.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Vomiting
Clinical narrative: Child was taken to emergency room in pm of 6/7/05 with elevated temperature, was admitted to hospital.  Had testing done by Dr. which Dr. states revealed no evidence of infection.  No sign or symptom of local reaction was noted.   Child's temp was up & down with max. temp of 102.7 F, was discharged from hospital AM of 6/9/05 and still had fluctuating temp. 7/18/05 Review of 16-page medical record confirms fever & rash. Additional symptoms were vomiting & diarrhea. 9/15/05 Review of 6-page medical record confirms fever. 9/15/05 Review of 1-page d/c summary confirms scattered rash & fever. 1/25/06 Review of 7-page d/c summary confirms viral illness & fever. Follow-up: Child Dx with Kawasaki disease on 8/19/05, and heart problems with poor circulation.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Disturbance in attention, Headache, Hypokinesia, Immune system disorder, Thinking abnormal
Clinical narrative: On 3/7/05, 4 days after injection it all began. Shakiness (akin to Parkinsons or MS). Bad Headaches. Loss of motor skills. In a constant fog, very limited ability to think. Onset of ADD, very limited ability to focus. Weakened immune system. Loss of balance. No treatment so far other than CT Scan, MRI, and EEG to tell me there is nothing wrong with me.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Tremor
Clinical narrative: On 3/7/05, 4 days after injection it all began. Shakiness (akin to Parkinsons or MS). Bad Headaches. Loss of motor skills. In a constant fog, very limited ability to think. Onset of ADD, very limited ability to focus. Weakened immune system. Loss of balance. No treatment so far other than CT Scan, MRI, and EEG to tell me there is nothing wrong with me.
Age: 1.1
Sex: M
Vaccine: HBHEPB, MMR, PNC
Symptoms: Irritability, Pain, Pyrexia, Rash, Rash erythematous
Clinical narrative: Fever to 102 for 3 days post-vaccine.  Rash developed 6 days post-vaccine (slightly raised erythematous maculopapular rash mostly on back, spreading to torso, nonpruritic).  Another fever developed 8 days post-vaccine, to 103.5.  Rash improved but pt became more irritable and seemed to have pain when walking.  Fever lasted 24hr.  Mom concerned that "pt not himself".  By day 11 post-vaccine pt improving with decreased irritability and pain.
Age: 1.1
Sex: M
Vaccine: HBHEPB, MMR, PNC
Symptoms: Rash maculo-papular
Clinical narrative: Fever to 102 for 3 days post-vaccine.  Rash developed 6 days post-vaccine (slightly raised erythematous maculopapular rash mostly on back, spreading to torso, nonpruritic).  Another fever developed 8 days post-vaccine, to 103.5.  Rash improved but pt became more irritable and seemed to have pain when walking.  Fever lasted 24hr.  Mom concerned that "pt not himself".  By day 11 post-vaccine pt improving with decreased irritability and pain.
Age: 52.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Abdominal pain upper, Asthenia, Hyporeflexia, Immune system disorder, Laboratory test abnormal
Clinical narrative: severe right upper extremity pain/weakness/absent reflexes, pt underwent an extensive rheumatology/vascular surgery/neurology consults with no findings on any tests whatsoever to explain his symptoms, nothing on MRI despite his swelling in arm and right chest, negative angiogram/EMG and multiple labs. Per follow up report-Patient continues to complain of right upper extremity and breast pain.  Right had slightly edematous and discolored.  Neurologist suggest idiopathic brochial plexus neuropathy, likely autoimmune mediated.
Age: 52.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Oedema, Pain, Radiculitis brachial, Skin discolouration, Swelling
Clinical narrative: severe right upper extremity pain/weakness/absent reflexes, pt underwent an extensive rheumatology/vascular surgery/neurology consults with no findings on any tests whatsoever to explain his symptoms, nothing on MRI despite his swelling in arm and right chest, negative angiogram/EMG and multiple labs. Per follow up report-Patient continues to complain of right upper extremity and breast pain.  Right had slightly edematous and discolored.  Neurologist suggest idiopathic brochial plexus neuropathy, likely autoimmune mediated.
Age: 52.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Asthenia, Bursitis, Feeling hot, Hyporeflexia, Injection site pain
Clinical narrative: severe right upper extremity pain/weakness/absent reflexes, pt underwent an extensive rheumatology/vascular surgery/neurology consults with no findings on any tests whatsoever to explain his symptoms, nothing on MRI despite his swelling in arm and right chest, negative angiogram/EMG and multiple labs. Per follow up report-Patient continues to complain of right upper extremity and breast pain.  Right had slightly edematous and discolored.  Neurologist suggest idiopathic brochial plexus neuropathy, likely autoimmune mediated.
Age: 52.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Muscle twitching, Oedema, Osteoporosis, Pain, Pyrexia
Clinical narrative: severe right upper extremity pain/weakness/absent reflexes, pt underwent an extensive rheumatology/vascular surgery/neurology consults with no findings on any tests whatsoever to explain his symptoms, nothing on MRI despite his swelling in arm and right chest, negative angiogram/EMG and multiple labs. Per follow up report-Patient continues to complain of right upper extremity and breast pain.  Right had slightly edematous and discolored.  Neurologist suggest idiopathic brochial plexus neuropathy, likely autoimmune mediated.
Age: 52.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Sensory disturbance, Tenderness, Tendonitis
Clinical narrative: severe right upper extremity pain/weakness/absent reflexes, pt underwent an extensive rheumatology/vascular surgery/neurology consults with no findings on any tests whatsoever to explain his symptoms, nothing on MRI despite his swelling in arm and right chest, negative angiogram/EMG and multiple labs. Per follow up report-Patient continues to complain of right upper extremity and breast pain.  Right had slightly edematous and discolored.  Neurologist suggest idiopathic brochial plexus neuropathy, likely autoimmune mediated.
Age: 6.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Thurs. 3/17/05 about 4pm, noted 1/2 inch diameter reddened area at injection site Fri 3/18/05 evening , injection site red 1 inch diam. and painful and warm to touch. mother took her to emergency dept. 8pm for evaluation was advised Motrin and ice compresses and to return if area increased. Sat 3/19/05 7:30am returned to emergency dept. 2inch diam. area, with fever about 102 degrees advised give Benadryl, Motrin and ice compresses. Sun 3/20 afebrile no worsening and less red Mon 3/21 am area much improved afebrile, light pink at site.
Age: 25.0
Sex: F
Vaccine: HEP, TD
Symptoms: Nausea, Pyrexia
Clinical narrative: Client states that at 10:30am she ate breakfast. Shortly thereafter, she became quite nauseated and vomited. Also running a low grade fever. Did go to the ER and was given plenergen States she is still nauseated and will see her PCP 3/8. Went to PCP 3/8 no further nausea. Had Tb test done.
Age: 0.74
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Hypokinesia, Pain, Pyrexia, White blood cell count increased
Clinical narrative: 2/23/05 - temp within 8 hours of vaccination. Left leg not moving that much. Moving with pain. Went to ped doctor in am on 2/24/05 was sent to ER. Blood was performed test results - negative. However, pt had increase white blood count 18,000 sent to hospital the same day. Kept for observation 45 hours, sent home on 2/24/05 for bad shot reaction. Motrin and Tylenol prescribed to be administered ever 6 hours prn alternating the meds, by Sunday 2/27/05, pt had no fever and was doing fine.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Autism, Growth retardation, Hypersensitivity, Laboratory test abnormal, Speech disorder
Clinical narrative: Speech and Language delay noted at one year of age 4/12/2000- started the first words program.  Diagnosed with 25% language delay at 2 years of age 6/27/2001 thru speech pathologist; began language therapy.  Diagnosed with autism at 3 yr 3mos(7-9-2002). Per follow up report-Chronis Dysbiosis, Gluten and Caseine sensitivity, heavy metal toxicity, metabolism problems. 12/31/09 Continues to have slow processing speed, intsteinal dysbiosis easily distracted.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: Left arm red and swollen.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling, Pruritus
Clinical narrative: Developed redness, swelling, and "itchy" at site of injection on left deltoid. Do not have full chart to varify other immunizations the child had in the past.
Age: 63.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Vaccine (Tetanus and Diphtheria Toxoids Adsorbed - Decavac) administered on 06/17/05. Less than 8hrs later, patient states injection site felt very tender, warm to touch, lump noted as well. On 6/20/05, redness and induration is approximately same size of a baseball, very warm to touch and tender. Patient to further observe, to return to clinic in 1-2 days for recheck. If worsens, patient will be given oral antibiotics per PCP.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Diabetes mellitus
Clinical narrative: I was deployed from Nov 2002 through May 2003.  I developed type II diabetes, and severe joint pain in both wrists, left index finger and thumb, right pinkie and middle finger, right knee and left big toe.  I received the last anthrax vaccination Jan 2003 and was hospitalized in June 2003 for the diabetes.  The lot number on the anthrax is FAV064.  The received the vaccinations on the following dates:  3 Dec 2002, 18 Dec 2002, and 2 Jan 2003.
Age: 52.0
Sex: M
Vaccine: TD
Symptoms: Chills, Erythema, Injection site infection, Lymphangitis, Pyrexia
Clinical narrative: Probable infected TD injection site - Responded to Cipro 500mg twice daily.  Had fever, chills, local redness, and lymphangitic spread.
Age: 22.0
Sex: F
Vaccine: DTP
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Site became red, raised and warm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Swelling, Tenderness
Clinical narrative: 06/16/2005 - Received call from Mom.  Child's arm is swollen, warm to touch, tender to touch.  Arm swelling extends to elbow.  Has full range of motion, no T, no drainage.  Told Mom Tylenol for discomfort and cold compresses.  Told Mom to call 06/17/2005 if worse, no phone call.  Spoke with Mom 06/26/2005.  She states arm is fine, returned to normal 06/18/2005.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash on trunk, thigh for 3-4 days.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Swelling
Clinical narrative: Tender swelling left deltoid area day after DTAP shot.
Age: 1.51
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Varicella shot given on 02/11/1997, patient developed rash on 06/12/2005, exposure 14 days prior to SIB with supposed chickenpox.
Age: 1.57
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Viral infection
Clinical narrative: Developed chicken pox
Age: 18.0
Sex: F
Vaccine: HEP, MNQ, TD
Symptoms: Urticaria
Clinical narrative: Hives on legs, buttocks and lower back. Pt treated with antihistamine.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Rash
Clinical narrative: Rash, Benadryl 12.5mg PRN, pt had already at home.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Arthralgia, Fatigue, Injection site pain, Skin nodule, Tenderness
Clinical narrative: Received Menactra 6/13/05, 6/14/05 left upper arm very sore and tender axillary nodes on left joint aches, fatigue.
Sex: F
Vaccine: TD
Symptoms: Petechiae, Syncope
Clinical narrative: Syncope after injection 1 week later had petechial rash on extremities and chest.
Age: 51.0
Sex: F
Vaccine: HEPA, TTOX, TYP, YF
Symptoms: Injection site pain, Neuritis
Clinical narrative: This case was reported by a physician and described the occurrence of brachial neuritis in a 51 year old female pt who had received Hep A vaccine (Havrix). On 12Jan04, the pt received the 1st dose of Havrix (VHA7504 was provided however this is not a valid not number) to her right arm. Concurrently she also received an injection of Yellow fever vaccine to her right arm, tenure toxoid and Typhim Vi to her left arm. At an unspecified time following the administration of Havrix, on 12Jan04, the pt experienced injection site pain. She was seen by a physician. On an unspecified date in Jan 2004, a nerve conduction velocity test revealed brachial neuritis. The immunization series with Havrix was discontinued. The event was ongoing as of 06Jul04. The physician considered the events to be non serious and to possibly be related to vaccination with Havrix.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cyanosis
Clinical narrative: This report was received in response to a Freedom of Information request. It described the fatal congenital heart disease in a 2 month old male patient who received diphtheria and tetanus toxoid and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined. The patient's medical history was notable for birth at 39 weeks gestation following spontaneous rupture of membranes. Attempts to advance the mother's labor with oxytocin resulted in fetal heart rate deceleration; therefore, a cesarian section was performed. A heart murmur was noted on the first day of life. The infant was discharged from the hospital. At 5 days of age, he was referred to a cardiologist at a tertiary care center because of the murmur and an abnormal echocardiogram. During physical examination, the cardiologist noted jaundice, acrocyanosis throughout both arms and legs, and a somewhat small mandible. The cardiologist made a diagnosis of hypoplastic left heart syndrome variant with an unbalanced, right dominant atrioventricular canal defect, subpulmonic stenosis, hypoplastic left ventricle with an outflow tract obstruction, mild to moderate atrioventricular valve regurgitation and hypoplasia of the transverse and descending aorta with coarctation. Renal ultrasound revealed grade I hydronephrosis. At 7 days of age, on 6/4/04, the patient underwent Stage I palliation (modified Norwood procedure) with a 4mm right ventricle to pulmonary artery conduit. Following the surgery, the patient developed left vocal cord paralysis, respiratory failure, renal insufficiency requiring peritoneal dialysis, chylous left pleural effusion, relative adrenal insufficiency, thrombocytopenia, gastroesphageal reflux and a moderate pectus carinatum deformity. The patient was hospitalized from 6/2/04 through 7/2/04. On the day of the vaccinations, 8/4/04, the vaccine provider noted that the patient was cyanotic. Concurrent medications included furosemide, metoclopramide hydrochloride, and ranitidine hydrochloride. On 8/4/04, the patient received the first dose of Pediarix (lot 21918A9). On the same day, the patient also received injections of Haemophilus influenzae type B conjugate vaccine (lot UE168AA) and 7-valent pneumococcal conjugate vaccine (lot A57559A). Approximately one day after receipt of the immunizations, at 12:00 on 8/5/04, the patient died. He was taken to the emergency room where aggressive attempts at resuscitation were unsuccessful. An autopsy confirmed the cause of death as congenital heart disease. As of 5/12/05, the autopsy report had not been forwarded.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Abdominal discomfort, Apnoea, Bacterial infection, Cardiomegaly, Coma
Clinical narrative: This report was received in response to a Freedom of Information request. It described sudden infant death syndrome in a 5 month old male patient who received diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined. The patient had a history of colic. The patient was born full term and reportedly had no history of trauma, recent infections, symptoms of upper respiratory infection, or heart disease. At the time of the events, the patient was not receiving any concurrent medications. On 5/12/04, the patient received the first dose of Pediarix (lot 21881C9). On the same day, the patient also received injections of Haemophilus influenzae type B conjugate (lot UA865AA) and 7-valent pneumococcal conjugate vaccine (lot 493262). On 7/30/04, the patient received the second dose of Pediarix. ON the same day, the patient also received injections of Haemophilus influenzae type B conjugate vaccine and 7 valent pneumococcal conjugate vaccine. Approximately 6 days later, during the night of 8/5/04, the patient felt like he may have had a slight fever. At 10:00 PM, the patient ate oatmeal and a banana and was playful. He fell asleep at 12:00 AM on 8/6/04, after having a bottle. At 3:41 AM, the patient awoke, had another bottle, played for a while, then fell asleep. He started screaming, so his mother picked him up. The patient then slept on his mother's chest until 7:00 AM. At 8:10 AM, the mother left the infant asleep on her bed and went to work. At approximately 11:40 AM on 8/6/04, the patient's father found the infant under the bed covers and noticed that the infant was not breathing and was unresponsive. The father summoned emergency medical personnel. Cardiopulmonary resuscitation and mechanical ventilation were initiated by the paramedics and the patient was transported by ambulance to the emergency room. Upon arrival at the emergency room, the patient's rectal temperature was 102.9 degrees F. After 15 minutes of aggressive resuscitation efforts, it was noted that breath sounds were decreased on the left side of the chest. X-ray confirmed that the endotracheal tube had been inserted into the right mainstem. The tube's position was adjusted. The x-ray also revealed cardiomegaly and gaseous distension of the stomach. Gram positive cocci in chains and gram positive rods were detected on blood smear. Under medical decision making, the emergency room physician listed myocarditis, sudden infant death syndrome, trauma, dysrrhythmia, and sepsis. Resuscitation efforts were unsuccessful and the patient was pronounced dead at 12:15. The following day, blood cultures grew Streptococcus viridans and diphtheroids. An autopsy confirmed the cause of death as sudden infant death syndrome. As of 5/12/05, the autopsy report had not been forwarded.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injury, Myocarditis, Pyrexia, Sepsis, Sudden infant death syndrome
Clinical narrative: This report was received in response to a Freedom of Information request. It described sudden infant death syndrome in a 5 month old male patient who received diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined. The patient had a history of colic. The patient was born full term and reportedly had no history of trauma, recent infections, symptoms of upper respiratory infection, or heart disease. At the time of the events, the patient was not receiving any concurrent medications. On 5/12/04, the patient received the first dose of Pediarix (lot 21881C9). On the same day, the patient also received injections of Haemophilus influenzae type B conjugate (lot UA865AA) and 7-valent pneumococcal conjugate vaccine (lot 493262). On 7/30/04, the patient received the second dose of Pediarix. ON the same day, the patient also received injections of Haemophilus influenzae type B conjugate vaccine and 7 valent pneumococcal conjugate vaccine. Approximately 6 days later, during the night of 8/5/04, the patient felt like he may have had a slight fever. At 10:00 PM, the patient ate oatmeal and a banana and was playful. He fell asleep at 12:00 AM on 8/6/04, after having a bottle. At 3:41 AM, the patient awoke, had another bottle, played for a while, then fell asleep. He started screaming, so his mother picked him up. The patient then slept on his mother's chest until 7:00 AM. At 8:10 AM, the mother left the infant asleep on her bed and went to work. At approximately 11:40 AM on 8/6/04, the patient's father found the infant under the bed covers and noticed that the infant was not breathing and was unresponsive. The father summoned emergency medical personnel. Cardiopulmonary resuscitation and mechanical ventilation were initiated by the paramedics and the patient was transported by ambulance to the emergency room. Upon arrival at the emergency room, the patient's rectal temperature was 102.9 degrees F. After 15 minutes of aggressive resuscitation efforts, it was noted that breath sounds were decreased on the left side of the chest. X-ray confirmed that the endotracheal tube had been inserted into the right mainstem. The tube's position was adjusted. The x-ray also revealed cardiomegaly and gaseous distension of the stomach. Gram positive cocci in chains and gram positive rods were detected on blood smear. Under medical decision making, the emergency room physician listed myocarditis, sudden infant death syndrome, trauma, dysrrhythmia, and sepsis. Resuscitation efforts were unsuccessful and the patient was pronounced dead at 12:15. The following day, blood cultures grew Streptococcus viridans and diphtheroids. An autopsy confirmed the cause of death as sudden infant death syndrome. As of 5/12/05, the autopsy report had not been forwarded.
Age: 31.0
Sex: F
Vaccine: TD, TYP, HEPA, TD, TYP
Symptoms: Fatigue, Hepatitis, Jaundice, Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of jaundice in a 31 yr old female pt who received hep A vaccine inactivated (Havrix). On 1Sept04 the pt received the 1st dose of Hep A vaccine. On that date, she also received injection of typhoid vaccine (Typhim Vi) and tetanus and diphtheria toxoids. Approx 6 days later, on 07Sep04, the pt experienced jaundice, fever, myalgia and fatigue. The outcome of the events is unresolved. The physician considered the events to possibly be related to vaccination with Havrix. Jaundice was assessed as medically serious by manf.
Age: 31.0
Sex: F
Vaccine: TD, TYP, HEPA, TD, TYP
Symptoms: Fatigue, Jaundice, Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of jaundice in a 31 yr old female pt who received hep A vaccine inactivated (Havrix). On 1Sept04 the pt received the 1st dose of Hep A vaccine. On that date, she also received injection of typhoid vaccine (Typhim Vi) and tetanus and diphtheria toxoids. Approx 6 days later, on 07Sep04, the pt experienced jaundice, fever, myalgia and fatigue. The outcome of the events is unresolved. The physician considered the events to possibly be related to vaccination with Havrix. Jaundice was assessed as medically serious by manf.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cardiac arrest, Nasal congestion, Retinal haemorrhage, Sudden infant death syndrome
Clinical narrative: This report was received in response to a Freedom of Information request. It described sudden infant death syndrome in a 5 month old male patient who received diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined. The patient's medical history included bronchiolitis which was diagnosed on 9/9/04. Concurrent medication included albuterol nebulizer solution. On 10/5/04, the vaccine responsible physician noted that the patient was still congested and that the lungs were clear. On the form, URI, bronchiolitis resolved was recorded under illness at the time of vaccination. On 10/5/04, the patient received the first dose of Pediarix. On the same day, the patient also received injections of Haemophilus influenzae type B conjugate vaccine, and 7-valent pneumococcal conjugate vaccine. Approximately two days following the administration of the immunizations, on 10/7/04, the patient experienced asystole and retinal hemorrhages and expired. An autopsy confirmed the cause of death as sudden infant death syndrome. As of 5/12/05, the autopsy report had not been forwarded.
Age: 0.08
Sex: M
Vaccine: HEP, HEP
Symptoms: Cerebral haematoma, Crying, Fracture, Gastrooesophageal reflux disease, Injury
Clinical narrative: Information has been received from a mother concerning her approximately 13 month old son, who was born prematurely, who on 1/18/05 was vaccinated with a dose of hepatitis B virus vaccine (lot # 0607D). There was no concomitant medication. It was reported that, in 2005, the patient started shaking and vomiting. It was noted that the physician thought that the reaction was due to milk, and he switched the milk formula. The mother also stated that the patient experienced swelling of his head and a subdural hematoma. The patient was hospitalized, and he underwent brain surgery. The diagnosis of the physician was shaken baby syndrome which the mother denied. It was noted that the patient is now living with his aunt. No product quality complaint was involved. No other information was provided. The events were considered to be other important medical events by the reporter (OMIC). Additional information has been requested.
Age: 0.08
Sex: M
Vaccine: HEP, HEP
Symptoms: Movement disorder, Screaming, Tremor, Vomiting
Clinical narrative: Information has been received from a mother concerning her approximately 13 month old son, who was born prematurely, who on 1/18/05 was vaccinated with a dose of hepatitis B virus vaccine (lot # 0607D). There was no concomitant medication. It was reported that, in 2005, the patient started shaking and vomiting. It was noted that the physician thought that the reaction was due to milk, and he switched the milk formula. The mother also stated that the patient experienced swelling of his head and a subdural hematoma. The patient was hospitalized, and he underwent brain surgery. The diagnosis of the physician was shaken baby syndrome which the mother denied. It was noted that the patient is now living with his aunt. No product quality complaint was involved. No other information was provided. The events were considered to be other important medical events by the reporter (OMIC). Additional information has been requested.
Age: 0.08
Sex: M
Vaccine: HEP, HEP
Symptoms: Child maltreatment syndrome, Hydrocephalus, Subdural haematoma, Tremor, Vomiting
Clinical narrative: Information has been received from a mother concerning her approximately 13 month old son, who was born prematurely, who on 1/18/05 was vaccinated with a dose of hepatitis B virus vaccine (lot # 0607D). There was no concomitant medication. It was reported that, in 2005, the patient started shaking and vomiting. It was noted that the physician thought that the reaction was due to milk, and he switched the milk formula. The mother also stated that the patient experienced swelling of his head and a subdural hematoma. The patient was hospitalized, and he underwent brain surgery. The diagnosis of the physician was shaken baby syndrome which the mother denied. It was noted that the patient is now living with his aunt. No product quality complaint was involved. No other information was provided. The events were considered to be other important medical events by the reporter (OMIC). Additional information has been requested.
Age: 1.58
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Cellulitis, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Immunization adm 6/17/05. Pt in ER next day with sore, swollen area on left ant thigh with cellulitis. Pt put on antibiotics.
Age: 1.13
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Had break through case of chicken pox after direct exposure 4 yrs after Varivax given.
Age: 0.78
Sex: F
Vaccine: PNC
Symptoms: Agranulocytosis, Apnoea, Cardiac arrest, Corneal opacity, Cyanosis
Clinical narrative: Exact events unk. Pt coded. Unable to resuscitate at hospital. Autopsy not done. Discharge Summary received which stated patient experienced asytole, unresponsive, respiratory arrest, cyanosis and corneal clouding. Medical records from PCP received which revealed patient experienced muscular dystrophy, GERD, apnea, agranulocytosis, prior jaundice & equinovalgus.
Age: 0.78
Sex: F
Vaccine: PNC
Symptoms: Jaundice neonatal, Stupor
Clinical narrative: Exact events unk. Pt coded. Unable to resuscitate at hospital. Autopsy not done. Discharge Summary received which stated patient experienced asytole, unresponsive, respiratory arrest, cyanosis and corneal clouding. Medical records from PCP received which revealed patient experienced muscular dystrophy, GERD, apnea, agranulocytosis, prior jaundice & equinovalgus.
Age: 1.17
Sex: F
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning a 4 year old female with an allergy to penicillin and no pertinent medical history reported who in June 2002 was vaccinated SC with the first dose of MMR (dosage not reported). There were no concomitant medications reported. On an unspecified date in 2002, at 2 years of age the patient developed Asperger's syndrome. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the Asperger's syndrome. Upon internal review, the Asperger's syndrome was considered to be an other important medical event (OMIC). Additional information is not expected.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Arrhythmia, Palpitations
Clinical narrative: Information has been received from a registered nurse concerning a female who is more than 30 years old with asthma and no drug reactions/allergies who on 5/31/05 was vaccinated SC with a 0.5mg dose of varicella virus vaccine live (lot # 649440/0116R). There was no concomitant medication. Subsequently, the patient experienced irregular heartbeat with palpitations and was hospitalized. The patient has since been discharged from the hospital and was returning to work. There was no product quality complaint. Additional information has been requested.
Age: 0.13
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Erythema multiforme, Hypersensitivity, Oedema peripheral, Rash
Clinical narrative: Developed rash (hives) on the face/neck around 4 PM on 6/13; advised oral Benadryl. Rash progressively increased in size/number. Spread to arm, hands, leg, feet, thigh. Swelling and redness noted on dorsum of hands and feet; discrete rounded raised patch with central pallor. Different sizes in 24 hours.  Medical record 06/29/05 states erythema multiforma and allergic reaction.
Age: 0.13
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: Developed rash (hives) on the face/neck around 4 PM on 6/13; advised oral Benadryl. Rash progressively increased in size/number. Spread to arm, hands, leg, feet, thigh. Swelling and redness noted on dorsum of hands and feet; discrete rounded raised patch with central pallor. Different sizes in 24 hours.  Medical record 06/29/05 states erythema multiforma and allergic reaction.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Dysphagia, Erythema, Hypersensitivity, Nausea, Pruritus
Clinical narrative: Given MMR #2, DTaP, IPV. 15 minutes later, body red, very itchy, difficulty swallowing. Had similar reaction in 2003 from Varicella vaccine. Saw allergist. Questioned reaction from Neomycin in Varicella. Told nurse ok to give MMR (contains Neomycin). Given Benadryl, Epi Pen and taken to ER.  Discharge Summary received stated patient experienced nausea.  As per annual follow up report: pt found to be allergic to gelatin and neomycin which are components in several childhood immunizations.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Similar reaction on previous exposure to drug
Clinical narrative: Given MMR #2, DTaP, IPV. 15 minutes later, body red, very itchy, difficulty swallowing. Had similar reaction in 2003 from Varicella vaccine. Saw allergist. Questioned reaction from Neomycin in Varicella. Told nurse ok to give MMR (contains Neomycin). Given Benadryl, Epi Pen and taken to ER.  Discharge Summary received stated patient experienced nausea.  As per annual follow up report: pt found to be allergic to gelatin and neomycin which are components in several childhood immunizations.
Age: 42.0
Sex: F
Vaccine: TTOX
Symptoms: Erythema, Hypersensitivity, Injection site induration, Pain, Pyrexia
Clinical narrative: Arthus hypersensitivity.  Aches all over, sore left arm, fever 101 off and on for 3 days, L deltoid with edema, erythema, tender and induration.
Age: 42.0
Sex: F
Vaccine: TTOX
Symptoms: Swelling, Tenderness, Type III immune complex mediated reaction
Clinical narrative: Arthus hypersensitivity.  Aches all over, sore left arm, fever 101 off and on for 3 days, L deltoid with edema, erythema, tender and induration.
Age: 52.0
Sex: M
Vaccine: TD
Symptoms: Hypokinesia, Myalgia, Pain
Clinical narrative: Extreme muscle soreness / deep, aching pain, traveling down left arm to elbow.  Pain increased with range of motion of arm/shoulder.  Became significant three/four weeks following vaccination. It has resolved some.   Discontinued use of Lippitor thinking soreness was a side effect. Scheduled appointment with Orthopedic surgeon when problem did not complete resolve after being off of Lipitor for three weeks.   Daughter was give tetanus shot for dog bite, literature from doctor described symptons that I was experiencing.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Developed fever and fatigue the evening the shot was given.  Also c/o mild intermittent headache.  Fever was up to 102 and lasted for 5 days.  Self medicated with advil prn.  Patient seen today, (6/21/05) doing better with no fever so far.  No further treatment given.
Age: 0.84
Sex: M
Vaccine: DTAP
Symptoms: Abdominal distension, Chills, Decreased appetite, Erythema, Insomnia
Clinical narrative: Temp up to 104 (day of shot and for 2-3 days after), leg red and swollen(day 2), very fussy/irritable (days 1-3), insomnia (day 1), poor appetite (day 1-2), staring spells(days 3-7). Shivers (days 3-7)
Age: 0.84
Sex: M
Vaccine: DTAP
Symptoms: Irritability, Pyrexia, Staring
Clinical narrative: Temp up to 104 (day of shot and for 2-3 days after), leg red and swollen(day 2), very fussy/irritable (days 1-3), insomnia (day 1), poor appetite (day 1-2), staring spells(days 3-7). Shivers (days 3-7)
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Pt had red spot and itching immediately after injection.  Returned the following day with an 11X 12 cm red swollen area on his ledft deltoid.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: POSITIVE SWELLING REDNESS LEFT DELTOID AND WARMTH SINCE IMMUNIZATION. TREATMENT WAS GIVEN KEFLEX AND BENADRYL.
Age: 19.0
Sex: F
Vaccine: RAB
Symptoms: Fatigue, Nausea, Pallor, Syncope, Vomiting
Clinical narrative: 6/20/05 4:50pm Onset of nausea within 3-4 minutes post vaccination. Felt "tired, droopy". B/P 104/70 P.100 reg,R. 20. No dyspnea, rash or swelling. Slight pallor, alert and oriented. States she had similar reaction (nausea) following shots, but only last 5 minutes. 5:10pm After lying down felt less faint. B/P 115/72 P. 82. R. 22. Nausea unchanged. 5:32pm No longer faint. Less pallor, nausea unchanged. Seen by M.D. ok to drive home. Called in sick 6/21/05. Told supervisor she still didn't feel well. 6/21/05 1:45pm Called employee at home. States she feels much better this afternoon. States she vomited once last night. Felt very dizzy this morning so did not go in to work. Feels much better after sleeping most of morning.
Age: 12.0
Sex: F
Vaccine: HEPA, IPV, TD
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: Subjective fever, generalized myalgia, malaise the following morning/day.
Age: 25.0
Sex: F
Vaccine: RAB
Symptoms: Flushing, Hyperaesthesia, Injection site erythema, Somnolence
Clinical narrative: 6/20/05 4:30pm Employee reported a "sunburn" sensation along the top of her left arm within one minute after receiving first rabies vaccination. Skin was sensitive to light touch as if "sunburned". There was a faint pinkness to the dorsal area of the left arm from the injection site to the wrist. No rash, itching or hives. She also developed a distinct triangular "wing" shaped area of flusing on both sides of her chest just below her clavicle and above her breast area . These were not present prior to vaccination. No hives, dyspnea, itching, or swelling noted. B/P 138/80 p. 88 regular, R. 22.  Alert and oriented. Given 25mg Benadryl Elixir p.o. and observed. 4:45pm - B/P 138/80  P. 74 R. 20. No change in flusing or burning sensation to left arm. Given 25mg Benadryl Elixir p.o. Noted some localized reddening around the injection site. No other symptoms. 5:35pm B/P 138/78 P. 70 R. 20 slightly drowsy, but alert and oriented. Flush over chest resolving. No change in sunburn sensation on left arm. 5:50pm Seen by M.D., examined and discharged to complete her shift at the shelter (15 min.) 6/21/05 Contacted employee at home. States no additional flusing experienced. Left arm is mildly sore when she uses it, "like a tetanus shot". No hives or other reactions developed.
Age: 0.51
Sex: F
Vaccine: DTP, IPV
Symptoms: Abnormal behaviour, Autism, Drug toxicity, Gait disturbance, Hyperacusis
Clinical narrative: My daughter started having "the shakes" after her 6 month vaccinations. We were never made aware of the dangers of vaccinations until recently. Between ages 1-3 she had continous ear and sinus infections. We recently discovered that she has Pervasive Developmental Disorder - not otherwise specified (Autism Spectrum Disorder) along with hearing sensitivity, phonological disorder, and ADHD. She has also been diagnosed as being toxic for heavy metals including, but not limited to Mercury and Lead. She also has vision problems.  Information received from medical redords states, limp, ataxia, agitated.
Age: 0.51
Sex: F
Vaccine: DTP, IPV
Symptoms: Hypotonia, Nervousness, Otitis media, Speech disorder, Tremor
Clinical narrative: My daughter started having "the shakes" after her 6 month vaccinations. We were never made aware of the dangers of vaccinations until recently. Between ages 1-3 she had continous ear and sinus infections. We recently discovered that she has Pervasive Developmental Disorder - not otherwise specified (Autism Spectrum Disorder) along with hearing sensitivity, phonological disorder, and ADHD. She has also been diagnosed as being toxic for heavy metals including, but not limited to Mercury and Lead. She also has vision problems.  Information received from medical redords states, limp, ataxia, agitated.