chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pyrexia, Red blood cell count decreased, Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: 11/02/05 felt mild discomfort, feverish. until 11-12 started achiness in elbow and shoulder. 11-15 all joints were in pain 11-21 excruciating pain joints and muscles, took Fluricet (did not help). 11-25 started Prednisone (didn't help) 12-17 and 12-21 oxycodone 5 & 10 mg (didn't help) 12-9 hydrocodone 10 mg (didn't help) 1-3-06 Penicillin started taking Royal Jelly 12/22/05 until now (seemed to help).
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Immune system disorder, Laboratory test abnormal, Myalgia, Pyrexia
Clinical narrative: 11/02/05 felt mild discomfort, feverish. until 11-12 started achiness in elbow and shoulder. 11-15 all joints were in pain 11-21 excruciating pain joints and muscles, took Fluricet (did not help). 11-25 started Prednisone (didn't help) 12-17 and 12-21 oxycodone 5 & 10 mg (didn't help) 12-9 hydrocodone 10 mg (didn't help) 1-3-06 Penicillin started taking Royal Jelly 12/22/05 until now (seemed to help).
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: 11/02/05 felt mild discomfort, feverish. until 11-12 started achiness in elbow and shoulder. 11-15 all joints were in pain 11-21 excruciating pain joints and muscles, took Fluricet (did not help). 11-25 started Prednisone (didn't help) 12-17 and 12-21 oxycodone 5 & 10 mg (didn't help) 12-9 hydrocodone 10 mg (didn't help) 1-3-06 Penicillin started taking Royal Jelly 12/22/05 until now (seemed to help).
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site induration, Pyrexia, Tenderness
Clinical narrative: Discomfort L arm 2-10-06; Induration and erythema; tenderness; temp 100.  Treatment-Medrol Dose pack and Keflex 500 mg 3 times a day for 7days. 2-13-06 (Patient reports resolving)
Age: 17.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Abdominal pain, Chromatopsia, Dizziness, Visual disturbance, Vomiting
Clinical narrative: 2/9/06 received vaccines at about 1615.  Pt reports at about 2200 starting having sharp abdomen pain and became lightheaded, everything in vision became red in color. Pt reports vomiting next AM 2x's. Then states saw spots in different colors at times in peripheral vision.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Syncope vasovagal
Clinical narrative: It was reported that 15 months after immunization (Tdap) pt. collapsed and was taken to ER. Diagnosed with Vasovagal syncope and released on same day.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site pain, Pruritus, Rash
Clinical narrative: Approx 1 hour after receiving vaccine, patient states L arm and hand numbness, rash-small bumps.  Next day arm itchy, no rash, arm hurt at injection site.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Varicella-like rash face and trunk
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Pain
Clinical narrative: 4.5 cm x 6cm on R upper arm pain rated at 7-8 on 1-10 scale. Applied warm compress for about 15min.
Age: 68.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Swelling
Clinical narrative: Vaccine administered 2/9/06. Exam 2/15/06 increased redness, swelling-warm compresses. 2/16/06 Continued increased redness, decreased swelling-6.5x7cm Keflex initiated 500 mg & PO Qtx10days warm compressed, and ointment.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MM, PNC
Symptoms: Erythema
Clinical narrative: L upper arm 3x5 cm erythema and 3 x 2.5 cm erythema with none scar bruise. R arm upper 7 x 10 cm erythema and swelling no bruising
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Red itchy macular rash anterior thigh near site of injection. Began 2-14.
Age: 1.12
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Cyanosis, Erythema, Hypoxia, Lethargy, Pallor
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) unspec) was received from an allergist regarding a 13 month old female patient who received a dose of Prevnar along with a dose of Varivax (varicella virus vaccine, live) on 6/9/2005. On the same day, the child vomited, developed rash on both sides of face and erythema, and became lethargic, cyanotic and pale. Medical history healthy child. Indication for Prevnar was immunization. Product was administered on 6/9/2005. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Varivax. Concomitant medications were not reported. On 6/9/2005, at 10:00, the patient received a dose of Prevnar. On the same day, at 10:30, the patient vomited. The father of the child was instructed by the physicians office to give the child Pedialyte. At 10:35, the patient developed rash on both sided of face and cyanosis on the lips and legs. it was noted that the child was breathing okay. The child became lethargic and pale. the parents brought the child to the ER for evaluation. The ER reported that the child had erythema, no hives on the back and a normal blood pressure. Treatment included Benadryl, oxygen, epinephrine, and Solu Medrol. The child was not admitted to the hospital and was sent home after one hour in the ER. The patients recovery status for the lethargy, pallor and cyanosis was noted by the reporter as no obvious remaining effects from occurrence. The recovery status of the rash, erythema and vomiting was not specified. Blood pressure, results normal,  was done on 6/9/2005. No additional information was available at the time of the report.
Age: 1.12
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Rash, Vomiting
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) unspec) was received from an allergist regarding a 13 month old female patient who received a dose of Prevnar along with a dose of Varivax (varicella virus vaccine, live) on 6/9/2005. On the same day, the child vomited, developed rash on both sides of face and erythema, and became lethargic, cyanotic and pale. Medical history healthy child. Indication for Prevnar was immunization. Product was administered on 6/9/2005. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Varivax. Concomitant medications were not reported. On 6/9/2005, at 10:00, the patient received a dose of Prevnar. On the same day, at 10:30, the patient vomited. The father of the child was instructed by the physicians office to give the child Pedialyte. At 10:35, the patient developed rash on both sided of face and cyanosis on the lips and legs. it was noted that the child was breathing okay. The child became lethargic and pale. the parents brought the child to the ER for evaluation. The ER reported that the child had erythema, no hives on the back and a normal blood pressure. Treatment included Benadryl, oxygen, epinephrine, and Solu Medrol. The child was not admitted to the hospital and was sent home after one hour in the ER. The patients recovery status for the lethargy, pallor and cyanosis was noted by the reporter as no obvious remaining effects from occurrence. The recovery status of the rash, erythema and vomiting was not specified. Blood pressure, results normal,  was done on 6/9/2005. No additional information was available at the time of the report.
Age: 0.15
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea, Erythema, Movement disorder, Pyrexia, Tongue disorder
Clinical narrative: Patient received DTaP, Prevnar, IPV, and Comvax (2 month regular vaccinations) on 1/18.  Began to have fevers that the mom treated with acetaminophen (dose unknown) every 4 hours.  Continued to have fevers.  On 1/19, had 4 episodes of body stiffening, neck extension, head bobbing, tongue thrusting.  Brought into the hospital.  Determined to have had seizures associated with the fever which are believed to have been caused by the vaccines.
Age: 0.15
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Dyskinesia, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Patient received DTaP, Prevnar, IPV, and Comvax (2 month regular vaccinations) on 1/18.  Began to have fevers that the mom treated with acetaminophen (dose unknown) every 4 hours.  Continued to have fevers.  On 1/19, had 4 episodes of body stiffening, neck extension, head bobbing, tongue thrusting.  Brought into the hospital.  Determined to have had seizures associated with the fever which are believed to have been caused by the vaccines.
Age: 1.57
Sex: M
Vaccine: PNC
Symptoms: Erythema, Injection site induration, Swelling
Clinical narrative: L thigh, erythema, swelling, induration.
Age: 1.51
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Vaccination failure
Clinical narrative: None Stated
Age: 36.0
Sex: M
Vaccine: MNQ, TYP, YF
Symptoms: Tinnitus
Clinical narrative: Tinnitus
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Bacterial infection, Drug ineffective, Pneumonia
Clinical narrative: Information has been received from a physician concerning a 60 year old male, with unknown pertinent medical history and unknown drug reactions, allergies, who in 10/25/2006 or Nov 2005, was vaccinated route unknown with a dose of Pneumococcal 23v polysaccharide vaccine (lot unknown). In January 2006, the patient experienced Streptococcus Pneuomiae and was hospitalized for 0-3 days. It was reported that the patient was treated with antibiotics while in the hospital. The patients present status was reported as recovered. No product quality complaint was involved. The patients experience was considered to be an other important medical event by the physician (OMIC). Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: L upper arm with redness, edema, warm to touch "sore". No shortness of breath.
Age: 57.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Erythema, Feeling hot, Hypoaesthesia, Pruritus, Swelling
Clinical narrative: Received Td in L deltoid on 11-14-05.  On 11-21 arm became itchy, red, warm and swollen and began losing feeling in fingers.  Saw MD on 11-21-05.  Was treated with antibiotics and steroids.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Eye irritation, Headache, Myalgia, Pharyngolaryngeal pain
Clinical narrative: Itching, dry cough, sore throat, headache, sinus congestion, eye redness, myalgia, wheezing inspiratory, tickle in chest, child pruritus.  Symptom started 4 hours after injection. A 36 year old male patient with no known allergies, had received an intramuscular injection in the left deltoid and 4 hours later, he experienced tickle in chest, dry cough, sore throat, injected sclera, myalgia, chills, injection site soreness and rash on his left hand.  It was worth noting that the patient had enlarged tonsils but was not ill at time of the vaccination.  The concomitant treatment was not provided. The patient had already received previous doses of Influenza vaccine. The patient received diphenhydramine hydrochloride (Benadryl) per os as corrective treatment.  The patient recovered on an unspecified date.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Sinus congestion, Wheezing
Clinical narrative: Itching, dry cough, sore throat, headache, sinus congestion, eye redness, myalgia, wheezing inspiratory, tickle in chest, child pruritus.  Symptom started 4 hours after injection. A 36 year old male patient with no known allergies, had received an intramuscular injection in the left deltoid and 4 hours later, he experienced tickle in chest, dry cough, sore throat, injected sclera, myalgia, chills, injection site soreness and rash on his left hand.  It was worth noting that the patient had enlarged tonsils but was not ill at time of the vaccination.  The concomitant treatment was not provided. The patient had already received previous doses of Influenza vaccine. The patient received diphenhydramine hydrochloride (Benadryl) per os as corrective treatment.  The patient recovered on an unspecified date.
Age: 1.45
Sex: M
Vaccine: DTAPHEPBIP, MMR, PNC, VARCEL
Symptoms: Erythema, Feeling hot
Clinical narrative: Pt's right thigh has redness that measures 3x2, that is warm to the touch. Left thigh has redness that measures 3.5x3 that is warm to the touch. Mom noticed this AM when changing clothes. Mom has been giving Tylenol. Pt. showed no signs of distress or discomfort.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature decreased, Cyanosis, Oedema
Clinical narrative: Reflex Sympathetic Dystrophy type findings-cyanosis, edema, lower temperature
Age: 70.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Fatigue, Pyrexia
Clinical narrative: Husband states pt. is very fatigued and has had fever of less than 102 F for five days. Pt now has fever over 102 F. Saw a Dr.  Dr. states probably reaction to vaccines.
Age: 1.16
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: C3-C5 vesicular rash. As Zoster associated with fever and fatigue.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Cervical vertebra 7-vesicular rash, A-Zoster, Rx Acyclovir
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Back pain, Herpes zoster, Pyrexia, Rash vesicular
Clinical narrative: L thigh and vaginal area vesicular rash as with fever and back pain. Zoster, Rx-Tylenol
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea, Herpes zoster, Nausea, Rash vesicular
Clinical narrative: Vesicular rash in L 1 dermatome associated with diarrhea and nausea. Oncology patient Leukemia in remission year 4.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Pruritus, Rash macular, Rash papular
Clinical narrative: Seen in Hospital ER for an itchy maculopapular dermatomal rash T8.
Age: 1.22
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: C5 Vesicular Rash, Rx Tylenol only.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Pt received immunization on 2/8/06. Return to clinic 2/10/06 with arm red, swollen, warm to touch. Diameter ~6 inches.
Age: 1.52
Sex: F
Vaccine: DTAP, HEP, MMR, VARCEL
Symptoms: Vaccination failure
Clinical narrative: NONE STATED
Age: 1.15
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Febrile seizure at 20:00.  Temp 102 (R) in ER. No Febrile seizure prior to this event.
Age: 1.28
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Convulsion, Pyrexia, Vomiting
Clinical narrative: Received DTap, Hib 1-10-06. Fever that night of 103.7. Next AM-vomiting. 1-12-06 had seizure of 10 second duration. 1-12-06 PM temp returned to normal, vomiting stopped.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Malaise, Pyrexia, Rash, Viral infection
Clinical narrative: Pt developed varicella.  Symptoms started on 01/04/06, included fever, malaise, rash.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Malaise, Pyrexia, Rash, Viral infection
Clinical narrative: Pt developed varicella. Symptoms started on 02/06/06, included fever, malaise, rash.
Age: 1.49
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Cough, Eye movement disorder, Febrile convulsion, Hyponatraemia, Lethargy
Clinical narrative: Seizure lasted 1 minute, lethargic for 1hour and 15 minutes. Eyes rolled back, arms were stiff and body shaking during seizure. Seen in ER admitted to hospital. Had temp. spike to 103.0. 3/2/06 Received medical records from ER which revealed patient experienced cough, congestion, rhinitis, fever & was dx: otitis media, hyponatremia, febrile seizure
Age: 1.49
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Musculoskeletal stiffness, Nasal congestion, Otitis media, Pyrexia, Rhinitis
Clinical narrative: Seizure lasted 1 minute, lethargic for 1hour and 15 minutes. Eyes rolled back, arms were stiff and body shaking during seizure. Seen in ER admitted to hospital. Had temp. spike to 103.0. 3/2/06 Received medical records from ER which revealed patient experienced cough, congestion, rhinitis, fever & was dx: otitis media, hyponatremia, febrile seizure
Age: 1.49
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Tremor
Clinical narrative: Seizure lasted 1 minute, lethargic for 1hour and 15 minutes. Eyes rolled back, arms were stiff and body shaking during seizure. Seen in ER admitted to hospital. Had temp. spike to 103.0. 3/2/06 Received medical records from ER which revealed patient experienced cough, congestion, rhinitis, fever & was dx: otitis media, hyponatremia, febrile seizure
Age: 25.0
Sex: F
Vaccine: MMR, TD
Symptoms: Rash, Rash erythematous
Clinical narrative: 6" x 4" raised red multiform rash on inner right arm. Onset of rash 01/08/2006 at 0900.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Abnormal behaviour, Crying, Pyrexia, Somnolence
Clinical narrative: Cried for 3 days, temp 102 degrees, tylenol didn't work, didn't want to be touched, sleeping regular hours, maybe more.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Chromaturia, Delirium, Hyperhidrosis, Pain
Clinical narrative: I received the Adacel vaccine in my right deltoid feb 8th at 5pm.  While driving home my head to my right finger tips ached.  On arriving home I felt miserable and went to bed.  I awoke at midnight in full rigors, chills, and had sweat through the bed sheets.  The shaking continued all night long but the chills stopped with 1000mg of tylenol.  By morning I was weak, aching from head to toes and mildly delerious.  That night (Feb 9), my fever was 102 and the chills, aching, rigors started again.  My urine was bright orange through Feb 11th am.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: I received the Adacel vaccine in my right deltoid feb 8th at 5pm.  While driving home my head to my right finger tips ached.  On arriving home I felt miserable and went to bed.  I awoke at midnight in full rigors, chills, and had sweat through the bed sheets.  The shaking continued all night long but the chills stopped with 1000mg of tylenol.  By morning I was weak, aching from head to toes and mildly delerious.  That night (Feb 9), my fever was 102 and the chills, aching, rigors started again.  My urine was bright orange through Feb 11th am.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Medication error
Clinical narrative: DTAP GIVEN INSTEAD OF TDAP. NO ADVERSE ACTION. NO NEED TO REPEAT PER STATE VFC.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Bronchitis, Dyspnoea, Hypersensitivity, Memory impairment
Clinical narrative: I have trouble breathing when I work hard. I get sick all the time, mostly chest colds that won't go away with out medical attention. I have constant joint pain. I forget alot of things that I needed to do or have. It is very frustrating. I have spring and fall allergies, that I never had before. 3/21/06 Received medical records from PCP which reveal patient seen only one time & diagnosed with bronchitis in January, 2006.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Pharyngitis, Rhinitis
Clinical narrative: I have trouble breathing when I work hard. I get sick all the time, mostly chest colds that won't go away with out medical attention. I have constant joint pain. I forget alot of things that I needed to do or have. It is very frustrating. I have spring and fall allergies, that I never had before. 3/21/06 Received medical records from PCP which reveal patient seen only one time & diagnosed with bronchitis in January, 2006.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Herpes zoster, Pain, Pruritus
Clinical narrative: Developed Shingles Feburary 6th, 2006, all of his doctors have said it is from the vaccine (varicella) that he had recieved in October. He seems to be in extreme pain, and is extremly itchy, it had pus filled blisters, on his left leg, the doctor did a scraping and sent it to the lab, it came back as zoster, first we tried benadryl, calamine lotion, and motrin, oatmeal baths. He still seems to be very itchy and in alot of pain espically at night, they now have him on HYDROXYZINE.
Age: 10.0
Sex: M
Vaccine: FLU3, TD
Symptoms: Convulsion, Malaise
Clinical narrative: Patient received the Td and flu shots on 12/22/05.  That evening, mother reported patient to be feeling ill.  He was then seen to have a tonic clonic seizure by mom that she believes lasted about 3 minutes.  Since she was frantic at the time, it is unk. the exact length of the sz or if he had a fever at the time.  Either way, a neighbor took him to a local ED, where a w/u was done.  No fever was reported, no meds given to stop the sz.  An MRI/EEG/blood work was done that were all negative (BLOOD INCLUDED CBC and Lytes).  Patient was d/c'd from the ED without meds.  Patient has since returned to baseline without any recurrence of seizure activity.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: ONSET OF S/S 02-16-06 0300 AWOKE WITH CHILLS, BODY ACHES, FEVER, HEADACHE. S/S PROGRESSED THROUGH-OUT DAY, BECAME VERY TIRED, NAUSEA AT DINNER. S/S SLIGHTLY IMPROVED ON 2/17/06. OUT OF WORK 2/16/06 AND 2/17/06.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: ONSET OF S/S 02-16-06 0300 AWOKE WITH CHILLS, BODY ACHES, FEVER, HEADACHE. S/S PROGRESSED THROUGH-OUT DAY, BECAME VERY TIRED, NAUSEA AT DINNER. S/S SLIGHTLY IMPROVED ON 2/17/06. OUT OF WORK 2/16/06 AND 2/17/06.
Age: 1.36
Sex: M
Vaccine: HIBV, MMR
Symptoms: Abnormal behaviour, Aggression, Asthma, Autism, Constipation
Clinical narrative: By the end of aprox. 2 weeks after the shots, my son had stopped all communication, social skills, physical skills & developed abusive, personally harmful behavioral problems. All he did was cry as if getting sick & squeal to show the need for things or excitement. He started toe walking, head banging, biting, uncontrollable compulsive behavior & sensory problems, (too many to list). He was later diagnosed with AUTISM. 2/27/06Records received from Dr., dev delay ped, which revealed recurrent ear infections, maternal medication, bleeding & injury during pregnancy which resulted in preterm labor.  Patient's behavior included very ltd speech, tantrums, head banging, rare eye contact, difficulty following simple directions.  DX: static progression of speech & neurobehavior w/significant regression during school breaks consistent w/autism.  Slowly progressed. 2/28/06 Received med records from Dr., wholistic ped.  Hx included: nasal allergies w/freq antibiotic use (30-40 rounds prior to 5yo), frequent constipation, night sweats, eczema, giardia.  Patients Mother w/ADD, mild depression & asthma, maternal family w/5 cases of Lupus. 3/16/06 Received med records from Dr., PCP which revealed also a dx of TCP in 12/02. Allergy testing + for 4 of 8 most common foods.  Child does live in older home w/lead pipes. 5/1/06 Received medical records from ped neurologist which reveal dx/speech delay, ADHD. & mild autism.  Tx w/Adderall & had favorable response but remains w/severe speech delay & autism.
Age: 1.36
Sex: M
Vaccine: HIBV, MMR
Symptoms: Crying, Diarrhoea, Eczema, Gait disturbance, Hypersensitivity
Clinical narrative: By the end of aprox. 2 weeks after the shots, my son had stopped all communication, social skills, physical skills & developed abusive, personally harmful behavioral problems. All he did was cry as if getting sick & squeal to show the need for things or excitement. He started toe walking, head banging, biting, uncontrollable compulsive behavior & sensory problems, (too many to list). He was later diagnosed with AUTISM. 2/27/06Records received from Dr., dev delay ped, which revealed recurrent ear infections, maternal medication, bleeding & injury during pregnancy which resulted in preterm labor.  Patient's behavior included very ltd speech, tantrums, head banging, rare eye contact, difficulty following simple directions.  DX: static progression of speech & neurobehavior w/significant regression during school breaks consistent w/autism.  Slowly progressed. 2/28/06 Received med records from Dr., wholistic ped.  Hx included: nasal allergies w/freq antibiotic use (30-40 rounds prior to 5yo), frequent constipation, night sweats, eczema, giardia.  Patients Mother w/ADD, mild depression & asthma, maternal family w/5 cases of Lupus. 3/16/06 Received med records from Dr., PCP which revealed also a dx of TCP in 12/02. Allergy testing + for 4 of 8 most common foods.  Child does live in older home w/lead pipes. 5/1/06 Received medical records from ped neurologist which reveal dx/speech delay, ADHD. & mild autism.  Tx w/Adderall & had favorable response but remains w/severe speech delay & autism.
Age: 1.36
Sex: M
Vaccine: HIBV, MMR
Symptoms: Speech disorder, Thrombocytopenia
Clinical narrative: By the end of aprox. 2 weeks after the shots, my son had stopped all communication, social skills, physical skills & developed abusive, personally harmful behavioral problems. All he did was cry as if getting sick & squeal to show the need for things or excitement. He started toe walking, head banging, biting, uncontrollable compulsive behavior & sensory problems, (too many to list). He was later diagnosed with AUTISM. 2/27/06Records received from Dr., dev delay ped, which revealed recurrent ear infections, maternal medication, bleeding & injury during pregnancy which resulted in preterm labor.  Patient's behavior included very ltd speech, tantrums, head banging, rare eye contact, difficulty following simple directions.  DX: static progression of speech & neurobehavior w/significant regression during school breaks consistent w/autism.  Slowly progressed. 2/28/06 Received med records from Dr., wholistic ped.  Hx included: nasal allergies w/freq antibiotic use (30-40 rounds prior to 5yo), frequent constipation, night sweats, eczema, giardia.  Patients Mother w/ADD, mild depression & asthma, maternal family w/5 cases of Lupus. 3/16/06 Received med records from Dr., PCP which revealed also a dx of TCP in 12/02. Allergy testing + for 4 of 8 most common foods.  Child does live in older home w/lead pipes. 5/1/06 Received medical records from ped neurologist which reveal dx/speech delay, ADHD. & mild autism.  Tx w/Adderall & had favorable response but remains w/severe speech delay & autism.
Age: 1.01
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Rash papular
Clinical narrative: Papular "pox-like" rash developed on back and face five days after administration of MMR, Varicella, and Hib vaccines.  All lesions appears to be in same stage of healing.  No fever or other symptoms.  No treatment other than Aveeno baths and moisturizers.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Back pain, CSF test abnormal, Guillain-Barre syndrome, Headache, Paraesthesia
Clinical narrative: Diagnoses W/GBS 10/17/05. Middle back pain, tingling sensation on her arms and face, headache.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Back pain, Guillain-Barre syndrome, Headache, Paraesthesia
Clinical narrative: Diagnoses W/GBS 10/17/05. Middle back pain, tingling sensation on her arms and face, headache.
Age: 15.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Guillain-Barre syndrome
Clinical narrative: Diagnosed with "mild" GBS not hospitalized, no weakness.
Age: 15.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: Diagnosed with "mild" GBS not hospitalized, no weakness.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Guillain-Barre syndrome
Clinical narrative: Diagnosed with GBS 11/07/2005
Age: 1.21
Sex: M
Vaccine: FLU3, PNC
Symptoms: Stupor, Vomiting
Clinical narrative: Child one minute later vomited immediately and then became hyporesponsive. Responded well to Epi, O2 and Albuterol treatment. Transported to ER.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Myalgia, Pain, Tremor, Urinary incontinence
Clinical narrative: Pt expressed no pain at time of vaccine. Direct soreness at injection site (but no redness or swelling) which pt says never went away and got worse over next weeks to include neck and right upper arm. Now with electric shock type pain of both upper arms with extreme abduction L>R. Also with bladder incontinence and involuntary upper body tremors-rarely .  Referred by PCP to Urology to Neurology to rule out neurological issues. Pain is only with movement upper arms. All symptoms began same time.
Age: 41.0
Sex: F
Vaccine: DTP, TTOX
Symptoms: Vaccination failure
Clinical narrative: NONE
Age: 1.27
Sex: U
Vaccine: VARCEL
Symptoms: Skin ulcer, Viral infection
Clinical narrative: Varivax 6/23/2000.  Chicken pox illness 2/17/2006. 8 lesions mild illness.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Rash
Clinical narrative: Rash on left anterior thigh.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Upper left arm swollen and reddened.  Increasing redness in past 3 days. Pain with Motrin. No red streaking noted from site. No drainage.
Age: 15.0
Sex: F
Vaccine: MEN
Symptoms: Aphasia, Back pain, Dyskinesia, Dystonia, Eye movement disorder
Clinical narrative: Information obtained form Mom 02/12/2006, vaccine given at 1:30pm, later that afternoon had terrible headache, nausea that evening, patient admits to her mom that she did have a sore throat before she received the vaccine. 02/13/2006 went to school that morning, saw DR that after noon, fever 99, aches and pains in her back and spine, negative influenza test, ordered Levaquin and Lortab, patient is lethargic, sleepy, 02/14/2006 7pm went to hospital ER for itchy rash on neck and face, given Toradol and Compazine, rash resolved during ER visit. 02/15/2006 sleepy all day, at 8pm, eyes cross, tongue sticking out and she can't talk, called 911 and taken to Medical center, given Benadryl and jaw loosened. MD told mom it was dystonia or locked jaw. MD stopped Levaquin and Lortab and ordered Amoxicillin and Tylenol. 02/16/2006 had MRI of head and thinks blood cultures done, will be seeing DR for follow up, nausea comes and goes, headache is continuous ranges from a 5 to a 8, very sleepy doesn't wake up unless someone wakes her, MD instructed MOM to wake her up every 2 hours.
Age: 15.0
Sex: F
Vaccine: MEN
Symptoms: Headache, Lethargy, Nausea, Pain, Pyrexia
Clinical narrative: Information obtained form Mom 02/12/2006, vaccine given at 1:30pm, later that afternoon had terrible headache, nausea that evening, patient admits to her mom that she did have a sore throat before she received the vaccine. 02/13/2006 went to school that morning, saw DR that after noon, fever 99, aches and pains in her back and spine, negative influenza test, ordered Levaquin and Lortab, patient is lethargic, sleepy, 02/14/2006 7pm went to hospital ER for itchy rash on neck and face, given Toradol and Compazine, rash resolved during ER visit. 02/15/2006 sleepy all day, at 8pm, eyes cross, tongue sticking out and she can't talk, called 911 and taken to Medical center, given Benadryl and jaw loosened. MD told mom it was dystonia or locked jaw. MD stopped Levaquin and Lortab and ordered Amoxicillin and Tylenol. 02/16/2006 had MRI of head and thinks blood cultures done, will be seeing DR for follow up, nausea comes and goes, headache is continuous ranges from a 5 to a 8, very sleepy doesn't wake up unless someone wakes her, MD instructed MOM to wake her up every 2 hours.
Age: 15.0
Sex: F
Vaccine: MEN
Symptoms: Rash pruritic, Somnolence
Clinical narrative: Information obtained form Mom 02/12/2006, vaccine given at 1:30pm, later that afternoon had terrible headache, nausea that evening, patient admits to her mom that she did have a sore throat before she received the vaccine. 02/13/2006 went to school that morning, saw DR that after noon, fever 99, aches and pains in her back and spine, negative influenza test, ordered Levaquin and Lortab, patient is lethargic, sleepy, 02/14/2006 7pm went to hospital ER for itchy rash on neck and face, given Toradol and Compazine, rash resolved during ER visit. 02/15/2006 sleepy all day, at 8pm, eyes cross, tongue sticking out and she can't talk, called 911 and taken to Medical center, given Benadryl and jaw loosened. MD told mom it was dystonia or locked jaw. MD stopped Levaquin and Lortab and ordered Amoxicillin and Tylenol. 02/16/2006 had MRI of head and thinks blood cultures done, will be seeing DR for follow up, nausea comes and goes, headache is continuous ranges from a 5 to a 8, very sleepy doesn't wake up unless someone wakes her, MD instructed MOM to wake her up every 2 hours.
Age: 27.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Inappropriate affect
Clinical narrative: At 1:28 pm, one minute after injection started to feel dizzy, lightheaded, weird feeling of being happy, happy gas, like at the dentist office after receiving Novocain, both lasted for 15 minutes.
Age: 0.18
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion
Clinical narrative: Patient received his vaccine on Janjuary 16, 2006. He presented to our local ER on January 19, 2006, with a history of several brief partial seizures. He has perisisted with his seizure activity. He has been evaluated by a Pediatric Neurologist. His CT and MRI of the brain are both normal for age. His initial EEG showed some mild abnormalities, but a repeat was normal. He is not on any medication at this time.
Age: 0.18
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Electroencephalogram abnormal
Clinical narrative: Patient received his vaccine on Janjuary 16, 2006. He presented to our local ER on January 19, 2006, with a history of several brief partial seizures. He has perisisted with his seizure activity. He has been evaluated by a Pediatric Neurologist. His CT and MRI of the brain are both normal for age. His initial EEG showed some mild abnormalities, but a repeat was normal. He is not on any medication at this time.
Age: 0.21
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying
Clinical narrative: Vaccine given at 8:30 or 9AM. At about 2 pm began crying, nonstop until nearly 6pm, then slept.  I examined baby at 7:30pm-about interaction and apparently recovered.
Age: 55.0
Sex: M
Vaccine: TD
Symptoms: Pruritus, Rash
Clinical narrative: Pustules to back, chest, face itching.  Symptoms began 8-9 hours after injection.
Age: 20.0
Sex: F
Vaccine: ANTH
Symptoms: Medication error, Rash, Unintended pregnancy
Clinical narrative: Rash that breaks out every once in while on arms. Was pregnant when recieved the vaccination. Daughter has a really weak immune system. Is always sick. Carries the common cold for long periods of time.
Age: 44.0
Sex: F
Vaccine: DT, FLU3, MMR
Symptoms: Injection site abscess
Clinical narrative: Developed an abscess at site of injection.  Received antibiotics and warm compresses to site which helped relieve abscess.
Age: 84.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient administered Pneumococcal vaccine in upper right arm.  Area of warmth and redness observed.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Redness and swelling to left deltoid 1 day after receiving Dtap vaccine. Temp 104. Cellulitis diagnosed by hospital physician. Antibiotics prescribed.  Redness and swelling still visible 2 days after vaccination but mother reports improvement.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Anaphylactic reaction, Hyperhidrosis, Hypoxia, Injection site erythema, Injection site swelling
Clinical narrative: Anaphylaxis occurred within 5 minutes of administering MMR, IPV, and DTaP.  The leg in which MMR was given was red and swollen.  The patient was tachycardic, diaphoretic, wheezing, and we were unable to obtain a blood pressure.  Epinephrine was administered subcutaneously along with albuterol nebs and oxygen.  Initial oxygen saturation was 67%. 3/2/06 REceived medical records from hospital which revealed patient experienced VPS, hydrocephalus, Chiari malformation & s/p myelomeningocele repair, vocal cord paralysis, left hemiparesis, headaches & abdominal pain.  Shunt last revised 2003.  DX: headache in patient w/VP shunt.  4/4/06 Received medical records from PCP which revealed patient cared for at home by VNA & Mom who works f/t.  Receiving ST/OT/PT.  Failure to gain weight & Mom missed many appointments.  Moved from area & did not return until 2/06.  Mom/nurses do I/O cath qid, G-tube but is able to take oral.  Has trach but is off vent, able to speak & suction herself.  W/C bound.  Received vzx 2/1/06 & had anaphylaxis within 5 min w/resp distress, wheezes, poor air exchange, cyanosis, diaphoresis & tachycardia.  Given epi & nebs, bagged via trach & transported to ER/ss
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Laboratory test abnormal, Tachycardia, Wheezing
Clinical narrative: Anaphylaxis occurred within 5 minutes of administering MMR, IPV, and DTaP.  The leg in which MMR was given was red and swollen.  The patient was tachycardic, diaphoretic, wheezing, and we were unable to obtain a blood pressure.  Epinephrine was administered subcutaneously along with albuterol nebs and oxygen.  Initial oxygen saturation was 67%. 3/2/06 REceived medical records from hospital which revealed patient experienced VPS, hydrocephalus, Chiari malformation & s/p myelomeningocele repair, vocal cord paralysis, left hemiparesis, headaches & abdominal pain.  Shunt last revised 2003.  DX: headache in patient w/VP shunt.  4/4/06 Received medical records from PCP which revealed patient cared for at home by VNA & Mom who works f/t.  Receiving ST/OT/PT.  Failure to gain weight & Mom missed many appointments.  Moved from area & did not return until 2/06.  Mom/nurses do I/O cath qid, G-tube but is able to take oral.  Has trach but is off vent, able to speak & suction herself.  W/C bound.  Received vzx 2/1/06 & had anaphylaxis within 5 min w/resp distress, wheezes, poor air exchange, cyanosis, diaphoresis & tachycardia.  Given epi & nebs, bagged via trach & transported to ER/ss
Age: 1.02
Sex: M
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: Aprox 12 hours later with hives and taken to ED given Benadryl and sent home followed up today still mild diffuse hives flat not raised and faint. Much better per parents.
Age: 33.0
Sex: F
Vaccine: UNK
Symptoms: Feeling hot, Injection site swelling, Myalgia
Clinical narrative: Soreness started day of vaccine-very sore to touch following 3 days. Circular, red raised area about the size of 16 oz foam cup opening. Warm to touch.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Pruritus, Swelling
Clinical narrative: Left upper extremity swelling and pruritus. Chills 1st night after injection 2-14-06. Treatment-warm compress. Increase Left upper extremity- followup with physician. 2/20/06 -"much better swelling down".
Age: 0.34
Sex: F
Vaccine: DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Agitation, Crying, Decreased appetite, Pyrexia
Clinical narrative: Seriousness Criteria: Other Medically Significant (OMIC). Initial report received on 09/Feb/2006 from a physician. A 4 month old female patient with no significant medical history had received an intramuscular injection of Daptacel, lot number C2183AA (site not reported), an administration (route not reported) of IPOL, lot number Y034 (site not reported) and an administration (route not reported) of another manufacturer's Comvax vaccine, lot number 0545 (site note reported) on 29/Nov/2005. One day later, the patient developed a 105 degree Fahrenheit fever that lasted 48 hours and two hours of inconsolable crying. It was not reported if the patient had recovered from these events.
Age: 0.34
Sex: F
Vaccine: DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Agitation, Crying, Pyrexia
Clinical narrative: Seriousness Criteria: Other Medically Significant (OMIC). Initial report received on 09/Feb/2006 from a physician. A 4 month old female patient with no significant medical history had received an intramuscular injection of Daptacel, lot number C2183AA (site not reported), an administration (route not reported) of IPOL, lot number Y034 (site not reported) and an administration (route not reported) of another manufacturer's Comvax vaccine, lot number 0545 (site note reported) on 29/Nov/2005. One day later, the patient developed a 105 degree Fahrenheit fever that lasted 48 hours and two hours of inconsolable crying. It was not reported if the patient had recovered from these events.
Age: 1.01
Sex: M
Vaccine: FLU3, MMR, PNC, VARCEL, FLU3, MMR, PNC, VARCEL
Symptoms: Blood gases abnormal, Candidiasis, Dermatitis bullous, Eye discharge, Haematocrit decreased
Clinical narrative: Initial report received from another manufacturer, report number WAER0511USA00930, on 2/8/2006. Information was received from a physician concerning a 12 month old male patient with an allergy to Augmentin who received, on 10/21/2005, an injection of Fluzone SV 2005-2006, lot number and route and site of administration not reported, an injection of MMR II, lot number and route and site of administration not reported, a first dose, right thigh, injection of Varivax, lot number and route of administration not reported, and an injection of Prevnar, manufacturer, lot number and route and site of administration not reported. Events outlined at the beginning of this report included oral candidiasis, eye discharge and varicella. Eleven days post vaccination, on 11/1/2005, the patient developed fever of 102 degrees F and papulopustular lesions around the injection site of the right thigh. On 11/4/2005, he developed gunky eyes and continued with fever between 102 and 103 degrees F. On 11/6/2005, the patients fever was 105.2 degrees F. He was examined in an ER and started on Zithromax. It was noted that the patient was on Zyrtec as that time. Abnormal laboratory findings included C reactive Protein 12.4 mg dl (HIGH), WBC 20.7 (HIGH), hemoglobin 10.2 (LOW) and hematocrit 29.8 (LOW). A strep screen was negative. The patient was re examined by his physician on 11/7/2005, and at that time, had a cluster of lesions at the injection site of the right thigh (now x one week) and one pustule on his neck (for several days). He also had thrush on the buccal mucosa and on the left tonsil. It was noted that he had been on Augmentin since 10/28/2005. The physical examination showed that his nose/sinus, mouth/teeth, throat and skin were abnormal. The patient was treated with nystatin. Concurrent conditions listed by the reporter included an allergic reaction to antibiotics. There was no mention of hospitalization for these events. However, the patients adverse events were determined to be other important medical events by the physician (OMIC). Per the reporter, the patient had recovered.
Age: 1.01
Sex: M
Vaccine: FLU3, MMR, PNC, VARCEL, FLU3, MMR, PNC, VARCEL
Symptoms: Haemoglobin decreased, Injection site reaction, Laboratory test abnormal, Pyrexia, White blood cell count increased
Clinical narrative: Initial report received from another manufacturer, report number WAER0511USA00930, on 2/8/2006. Information was received from a physician concerning a 12 month old male patient with an allergy to Augmentin who received, on 10/21/2005, an injection of Fluzone SV 2005-2006, lot number and route and site of administration not reported, an injection of MMR II, lot number and route and site of administration not reported, a first dose, right thigh, injection of Varivax, lot number and route of administration not reported, and an injection of Prevnar, manufacturer, lot number and route and site of administration not reported. Events outlined at the beginning of this report included oral candidiasis, eye discharge and varicella. Eleven days post vaccination, on 11/1/2005, the patient developed fever of 102 degrees F and papulopustular lesions around the injection site of the right thigh. On 11/4/2005, he developed gunky eyes and continued with fever between 102 and 103 degrees F. On 11/6/2005, the patients fever was 105.2 degrees F. He was examined in an ER and started on Zithromax. It was noted that the patient was on Zyrtec as that time. Abnormal laboratory findings included C reactive Protein 12.4 mg dl (HIGH), WBC 20.7 (HIGH), hemoglobin 10.2 (LOW) and hematocrit 29.8 (LOW). A strep screen was negative. The patient was re examined by his physician on 11/7/2005, and at that time, had a cluster of lesions at the injection site of the right thigh (now x one week) and one pustule on his neck (for several days). He also had thrush on the buccal mucosa and on the left tonsil. It was noted that he had been on Augmentin since 10/28/2005. The physical examination showed that his nose/sinus, mouth/teeth, throat and skin were abnormal. The patient was treated with nystatin. Concurrent conditions listed by the reporter included an allergic reaction to antibiotics. There was no mention of hospitalization for these events. However, the patients adverse events were determined to be other important medical events by the physician (OMIC). Per the reporter, the patient had recovered.
Age: 1.01
Sex: M
Vaccine: FLU3, MMR, PNC, VARCEL, FLU3, MMR, PNC, VARCEL
Symptoms: Candidiasis, Eye discharge, Haematocrit decreased, Haemoglobin decreased, Hypersensitivity
Clinical narrative: Initial report received from another manufacturer, report number WAER0511USA00930, on 2/8/2006. Information was received from a physician concerning a 12 month old male patient with an allergy to Augmentin who received, on 10/21/2005, an injection of Fluzone SV 2005-2006, lot number and route and site of administration not reported, an injection of MMR II, lot number and route and site of administration not reported, a first dose, right thigh, injection of Varivax, lot number and route of administration not reported, and an injection of Prevnar, manufacturer, lot number and route and site of administration not reported. Events outlined at the beginning of this report included oral candidiasis, eye discharge and varicella. Eleven days post vaccination, on 11/1/2005, the patient developed fever of 102 degrees F and papulopustular lesions around the injection site of the right thigh. On 11/4/2005, he developed gunky eyes and continued with fever between 102 and 103 degrees F. On 11/6/2005, the patients fever was 105.2 degrees F. He was examined in an ER and started on Zithromax. It was noted that the patient was on Zyrtec as that time. Abnormal laboratory findings included C reactive Protein 12.4 mg dl (HIGH), WBC 20.7 (HIGH), hemoglobin 10.2 (LOW) and hematocrit 29.8 (LOW). A strep screen was negative. The patient was re examined by his physician on 11/7/2005, and at that time, had a cluster of lesions at the injection site of the right thigh (now x one week) and one pustule on his neck (for several days). He also had thrush on the buccal mucosa and on the left tonsil. It was noted that he had been on Augmentin since 10/28/2005. The physical examination showed that his nose/sinus, mouth/teeth, throat and skin were abnormal. The patient was treated with nystatin. Concurrent conditions listed by the reporter included an allergic reaction to antibiotics. There was no mention of hospitalization for these events. However, the patients adverse events were determined to be other important medical events by the physician (OMIC). Per the reporter, the patient had recovered.