chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: F
Vaccine: DTAP, PNC
Symptoms: Hypersensitivity, Pyrexia, Swelling
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar was received from a consumer regarding her 18 month old daughter who received doses of Prevnar and Infanrix on 11/16/00, and subsequently experienced swelling, fever, crying, autistic behavior, constipation, diarrhea, yeast overgrowth of gastrointestinal tract and food allergies. The patient's concurrent illnesses include multiple food allergies and drug hypersensitivity. Indication for Prevnar was immunization. Product was administered on 11/16/00. Dose regimen was 1 dose. Concomitant medications were not reported. On 11/16/00, the child received a fourth dose of Infanrix, along with Prevnar. That same day, she experienced swelling, high fever, and crying. Crying and fever resolved on 11/19/00. On an unspecified date in November 2000, the patient developed autistic behavior. On unspecified dates, the patient also developed constipation, diarrhea, yeast overgrowth of the gastrointestinal tract, and multiple food allergies. The child was examined at a physician's office and treated with Nystatin. In August 2001, the child was diagnosed with autism. As of 3/24/04, autism, constipation, diarrhea, yeast overgrowth and food allergies were unresolved. No additional information was available at the time of this report.
Age: 1.6
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Convulsion, Gait disturbance, Laboratory test abnormal, Pyrexia, Rash
Clinical narrative: Developed focal seizure lasting > 35 minutes on 4/17/04. Received 2 doses of Ativan in ER; CT head negative.  Nurse follow up on 06/18/04 states: "ADD: Fever, gait abn, eye deviated, leg/arm shaking, rash."
Age: 1.6
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Strabismus, Tremor
Clinical narrative: Developed focal seizure lasting > 35 minutes on 4/17/04. Received 2 doses of Ativan in ER; CT head negative.  Nurse follow up on 06/18/04 states: "ADD: Fever, gait abn, eye deviated, leg/arm shaking, rash."
Age: 1.25
Sex: M
Vaccine: HEP, HIBV, MMR, PNC, VARCEL
Symptoms: Abdominal pain, Abnormal behaviour, Antisocial behaviour, Autism, Diarrhoea
Clinical narrative: Within one month began severe abdominal pain, abnormal behavior (no eye contact, fecal smearing, lost speech), regression in speech and motor skills. Developed sensory problems. Night waking and screaming. Overactive thyroid and yeast.  Nurse follow up on 08/31/04 states: "PDD-pervasive developmental delay; chronic encephalopathy; chronic diarrhea."
Age: 1.25
Sex: M
Vaccine: HEP, HIBV, MMR, PNC, VARCEL
Symptoms: Encephalopathy, Fungal infection, Laboratory test abnormal, Screaming, Sensory disturbance
Clinical narrative: Within one month began severe abdominal pain, abnormal behavior (no eye contact, fecal smearing, lost speech), regression in speech and motor skills. Developed sensory problems. Night waking and screaming. Overactive thyroid and yeast.  Nurse follow up on 08/31/04 states: "PDD-pervasive developmental delay; chronic encephalopathy; chronic diarrhea."
Age: 1.25
Sex: M
Vaccine: HEP, HIBV, MMR, PNC, VARCEL
Symptoms: Sleep disorder, Speech disorder, Thyroid disorder
Clinical narrative: Within one month began severe abdominal pain, abnormal behavior (no eye contact, fecal smearing, lost speech), regression in speech and motor skills. Developed sensory problems. Night waking and screaming. Overactive thyroid and yeast.  Nurse follow up on 08/31/04 states: "PDD-pervasive developmental delay; chronic encephalopathy; chronic diarrhea."
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Swelling
Clinical narrative: Swelling of left elbow and approx 5 inches below elbow and 6 inches above elbow.
Age: 19.0
Sex: M
Vaccine: ANTH
Symptoms: Carpal tunnel syndrome, Hypoaesthesia, Laboratory test abnormal, Paraesthesia, Swelling
Clinical narrative: Inflammation and swelling of knees, fingers and wrists. Carpal Tunnel Syndrome. Has had surgery. Numbness and tingling in hands.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Swelling, redness, puffy, itching. Size of grapefruit.
Sex: F
Vaccine: DTAP, HIBV, IPV, VARCEL
Symptoms: Blister, Rash, Skin ulcer
Clinical narrative: Rash neck, red tongue, vesicular lesions on head and face.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Thigh red, hot , swollen. Left thigh only. No fever.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Rash papular
Clinical narrative: Left ant thigh with 2x3 cm area of erythema. No induration, no warmth, no pain, superficial papular lesions noted. No discharge. Warm compresses, benadryl prn
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Irritability, Pyrexia
Clinical narrative: Temp 103-105; irritable x 3 days.
Age: 73.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Joint range of motion decreased, Lethargy, Myalgia, Neuralgia
Clinical narrative: Within a couple of days my Jaw got tight, my shoulder joints were sore, my arms got so weak, I couldn't lift heavy. Then, it moved to my knees and muscles and was very painful. Then, gradually went away by time 2 weeks were up, no I have nerve and muscle pain in legs. I am better. I visited an immunization specialist and he wouldn't do any tests. He said the reaction would all be at the injection site.
Age: 73.0
Sex: F
Vaccine: TD
Symptoms: Pain in jaw
Clinical narrative: Within a couple of days my Jaw got tight, my shoulder joints were sore, my arms got so weak, I couldn't lift heavy. Then, it moved to my knees and muscles and was very painful. Then, gradually went away by time 2 weeks were up, no I have nerve and muscle pain in legs. I am better. I visited an immunization specialist and he wouldn't do any tests. He said the reaction would all be at the injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Hypersensitivity
Clinical narrative: 10 cm erythema, elevation histamine release. Given zyrtec
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Ecchymosis, Erythema, Injection site warmth, Swelling
Clinical narrative: Red, swollen hot arm after Pneumovax injection- ecchymotic with pain- resolved on own after Vicodin Rx- pt with residual problem.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site reaction
Clinical narrative: Local immunization reaction. Treated with PO abx-Cephalexin 250/5ml+ tsp po tidx10days
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema
Clinical narrative: Right deltoid area with erythema at 10cmx7cm. No exceolate.
Age: 10.0
Sex: M
Vaccine: RAB
Symptoms: Abdominal pain upper, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: My son has been running a temp after rabies vaccination. The first shot was given on 12/31/2003 and he is still with temp every day is currently seeing an infectious disease doctor to find out what is going on. His first 2 vaccines were involved in the recall. Doctors cannot find out what is causing the temps. He also has had a sore throat off and on along with stomach pains that come and go but there is an every day temp.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Anxiety, Arthralgia, Arthropathy, Back pain, Depression
Clinical narrative: After receiving the anthrax vaccine in 1999, the patient started experiencing myalgias, arthralgias, depression, and panic attacks.    Anthrax #1 7/6/99 States that he had a severe local site reaction with this injection. Anthrax #2   7/20/99 Anthrax #3 8/4/99 8/99-9/99 States that he started feeling depressed and was experiencing panic attacks by the end of August. At that time, he was referred to mental health and started therapy for depression and insomnia.  He has been seeing a psychologist on a monthly basis since that time.  States that he feels like he is on an emotional roller coaster. Anthrax #4 1/4/006/00 Diagnosed with chronic depression, anxiety, and panic attacks.  States that he felt tired all the time but could not sleep.  Felt trapped when he was around people and could not fly on airplanes any more due to phobia.     2/01 Transferred. States that he was happy to transfer but continued to feel depressed.  States that after he transferred to another location he would experience periods of deep dark depression that lasted for approximately 6-10 days.  He would sleep to 1600 and go back to bed at 1930.  States that during these times he feels weak and completely worthless.  States that there is no reason to keep going on.  States that it is a real struggle to keep going.  Nothing helps during these periods.       States that he started experiencing right knee pain during this time frame.  Denies any trauma or strain. States that knee pops and clicks most of the time.  States that the pain is intermittent and when it occurs, describes it as a dull ache, which he rates as a 7 on a pain scale from 0-10. States that when it hurts really bad that it causes him to limp and he cannot bear any weight on it.  Is not aware of what causes the intermittent pain.  3/01 Reports that low back pain started around this time.  States that the pain radiates down the back of both legs to the thighs.  States that his pain is also intermittent and when it occurs he cannot sit or stand for long.  States that Percocet is the only thing that helps during this time.  States that the lumbar MRI only showed degenerative joint disease.  5/01 States that right ankle started hurting.  Denies any trauma or strain.  States that the pain feels like an ice pick jabbing through his ankle. Rates the pain as a 10+ on pain scale 0-10.  Cannot recreate the ankle pain.  States that the pain occurs about every other month and lasts for 1-2 days.  States that the MRI of  the ankle is normal.   Attempted suicide.  States that he took an overdose of medication and just wanted to go to sleep and not wake up.  6/03 States that his left elbow started hurting.  States that this pain is constant.  States that the pain radiates from his elbow to his shoulder and from his elbow down his forearm to his middle finger.  States that sometimes his wrist and knuckles hurt and sometimes he may feel a warm sensation down the middle of his forearm.  Cervical MRI reveals some mild bulging.  4/2/04 Placed on profile for Myositis/Myalgias
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Fatigue, Gait disturbance, Injection site reaction, Insomnia, Myalgia
Clinical narrative: After receiving the anthrax vaccine in 1999, the patient started experiencing myalgias, arthralgias, depression, and panic attacks.    Anthrax #1 7/6/99 States that he had a severe local site reaction with this injection. Anthrax #2   7/20/99 Anthrax #3 8/4/99 8/99-9/99 States that he started feeling depressed and was experiencing panic attacks by the end of August. At that time, he was referred to mental health and started therapy for depression and insomnia.  He has been seeing a psychologist on a monthly basis since that time.  States that he feels like he is on an emotional roller coaster. Anthrax #4 1/4/006/00 Diagnosed with chronic depression, anxiety, and panic attacks.  States that he felt tired all the time but could not sleep.  Felt trapped when he was around people and could not fly on airplanes any more due to phobia.     2/01 Transferred. States that he was happy to transfer but continued to feel depressed.  States that after he transferred to another location he would experience periods of deep dark depression that lasted for approximately 6-10 days.  He would sleep to 1600 and go back to bed at 1930.  States that during these times he feels weak and completely worthless.  States that there is no reason to keep going on.  States that it is a real struggle to keep going.  Nothing helps during these periods.       States that he started experiencing right knee pain during this time frame.  Denies any trauma or strain. States that knee pops and clicks most of the time.  States that the pain is intermittent and when it occurs, describes it as a dull ache, which he rates as a 7 on a pain scale from 0-10. States that when it hurts really bad that it causes him to limp and he cannot bear any weight on it.  Is not aware of what causes the intermittent pain.  3/01 Reports that low back pain started around this time.  States that the pain radiates down the back of both legs to the thighs.  States that his pain is also intermittent and when it occurs he cannot sit or stand for long.  States that Percocet is the only thing that helps during this time.  States that the lumbar MRI only showed degenerative joint disease.  5/01 States that right ankle started hurting.  Denies any trauma or strain.  States that the pain feels like an ice pick jabbing through his ankle. Rates the pain as a 10+ on pain scale 0-10.  Cannot recreate the ankle pain.  States that the pain occurs about every other month and lasts for 1-2 days.  States that the MRI of  the ankle is normal.   Attempted suicide.  States that he took an overdose of medication and just wanted to go to sleep and not wake up.  6/03 States that his left elbow started hurting.  States that this pain is constant.  States that the pain radiates from his elbow to his shoulder and from his elbow down his forearm to his middle finger.  States that sometimes his wrist and knuckles hurt and sometimes he may feel a warm sensation down the middle of his forearm.  Cervical MRI reveals some mild bulging.  4/2/04 Placed on profile for Myositis/Myalgias
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Panic reaction, Proctalgia, Sleep disorder, Suicide attempt
Clinical narrative: After receiving the anthrax vaccine in 1999, the patient started experiencing myalgias, arthralgias, depression, and panic attacks.    Anthrax #1 7/6/99 States that he had a severe local site reaction with this injection. Anthrax #2   7/20/99 Anthrax #3 8/4/99 8/99-9/99 States that he started feeling depressed and was experiencing panic attacks by the end of August. At that time, he was referred to mental health and started therapy for depression and insomnia.  He has been seeing a psychologist on a monthly basis since that time.  States that he feels like he is on an emotional roller coaster. Anthrax #4 1/4/006/00 Diagnosed with chronic depression, anxiety, and panic attacks.  States that he felt tired all the time but could not sleep.  Felt trapped when he was around people and could not fly on airplanes any more due to phobia.     2/01 Transferred. States that he was happy to transfer but continued to feel depressed.  States that after he transferred to another location he would experience periods of deep dark depression that lasted for approximately 6-10 days.  He would sleep to 1600 and go back to bed at 1930.  States that during these times he feels weak and completely worthless.  States that there is no reason to keep going on.  States that it is a real struggle to keep going.  Nothing helps during these periods.       States that he started experiencing right knee pain during this time frame.  Denies any trauma or strain. States that knee pops and clicks most of the time.  States that the pain is intermittent and when it occurs, describes it as a dull ache, which he rates as a 7 on a pain scale from 0-10. States that when it hurts really bad that it causes him to limp and he cannot bear any weight on it.  Is not aware of what causes the intermittent pain.  3/01 Reports that low back pain started around this time.  States that the pain radiates down the back of both legs to the thighs.  States that his pain is also intermittent and when it occurs he cannot sit or stand for long.  States that Percocet is the only thing that helps during this time.  States that the lumbar MRI only showed degenerative joint disease.  5/01 States that right ankle started hurting.  Denies any trauma or strain.  States that the pain feels like an ice pick jabbing through his ankle. Rates the pain as a 10+ on pain scale 0-10.  Cannot recreate the ankle pain.  States that the pain occurs about every other month and lasts for 1-2 days.  States that the MRI of  the ankle is normal.   Attempted suicide.  States that he took an overdose of medication and just wanted to go to sleep and not wake up.  6/03 States that his left elbow started hurting.  States that this pain is constant.  States that the pain radiates from his elbow to his shoulder and from his elbow down his forearm to his middle finger.  States that sometimes his wrist and knuckles hurt and sometimes he may feel a warm sensation down the middle of his forearm.  Cervical MRI reveals some mild bulging.  4/2/04 Placed on profile for Myositis/Myalgias
Age: 21.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Medication error
Clinical narrative: Patient states that she received the following vaccinations and medications during her first trimester of pregnancy.  Referred to VHC for possible hydrocephalus.   Infant is approx 6 months of age today with normal growth and development. Anthrax #1 1/26/03  Smallpox 1/26/03 Hep A 1/29/03 Typhoid  2/10/03 Anthrax #2  2/10/03
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Pharyngolaryngeal pain, Pruritus, Rash
Clinical narrative: MMR was recieved on 4/14/04, on 4/16/04 pt developed a slight sore throat. On 4/17/04 developed bumps on her palms, the next day they spread to her feet and knees. C/o itch.  Saw MD on 4/19/04.  TC on 4/19/04 was normal, CBC unremarkable.  Placed on Zyrtec and Triamcinolone Cream.  Was to have F/U on 4/21/04 but she rescheduled for 4/26/04
Age: 5.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Rash, Rash papular
Clinical narrative: Rash began on patient's face and body on 4/15/04, without other signs or symptoms. Patient was seen by pediatrician on 4/16/04 and only had fine papular rash on her legs, without other symptoms.  No treatment was given.  Doctor thought it was either a viral or a contact rash.
Age: 35.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Pyrexia, Type III immune complex mediated reaction
Clinical narrative: Fever, joint pain, arthralgias
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cough, Hyperaesthesia, Pyrexia, Rash, Vomiting
Clinical narrative: The night the vaccines given child ran 104.1 Ax. temp.  The next day, still running fever he complained of it hurting if you touched him.  Developed a rash on his arms. Temp this day 103.4. He was throwing up some on this day also. Today(4-22-04)he had 102.6 temp--threw up once this a.m. and about 6:30pm 4-21-04 he developed a cough. Followup note: Mom did state in her phone call the child was getting beter, and the rash on both arms was getting better.
Age: 56.0
Sex: F
Vaccine: IPV, MEN, TD, TYP, YF
Symptoms: Dry mouth, Fatigue, Heart rate increased, Palpitations, Tongue oedema
Clinical narrative: Patient developed symptoms of "heart pounding" about 10 minutes after the shots were given.  This persisted and approximately 50 minutes after the vaccines were administerd she continued to have a heart pounding sensation and then developed a "heart racing" sensation and had dry mouth and a sensation that her tongue was "getting puffy."  She did not have any wheezing or trouble breathing.  She called 911 and was taken by ambulance to the ER.  She was given IM Benadryl and symptoms subsided over a time period of about one hour.  She was discharged home in good condition.  She did not have any fever or significant soreness in the arms.  She states that the day after these events she felt tired but otherwise felt fine.
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Chest pain, Disturbance in attention, Dysgeusia, Headache
Clinical narrative: I had the third shot yesterday afternoon at my Doctor's office.  I sat around and read magazines for over an hour after the shot.  I had the shot at around 2 PM.  Outside of a dry, clay taste I didn't have an immediate reaction.  At around 6:30 PM my body started to ache all over.  All my joints hurt.  My hips, knees, and ankles were really painful.  I got cramps in my feet and tingling in both hands.  I couldn't concentrate and was very restless.  Every five minutes or so I felt like I should get off the couch and do somethingvery vague.  Standing up caused the aching in my legs to worsen.  At around 9 PM it occurred to me that I had reached a plateau and things weren't getting any worse.  I went to bed at around 9:30 PM and around 3 AM the aching stopped.  Up to that point I kept tossing and turning.  The aching kept me from finding a comfortable position.  Today my legs and joints are sore.  The kind of "I just ran a mile" sore.  Typing has caused my fingers to ache.  I have not had any cramps in my feet.  I have had some tingling in my hands.  Oddly enough, I feel sort of relaxed and somewhat spacey minded.  NOTE:  1st 2 shots given and similar reactions were reported on 11-03-2003 on paper report to VAERS by doctor who is writing this now. Please contact pt. and discuss reaction and advise if he needs testing for antiHBs to assure immunity.
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Mental impairment, Muscle spasms, Pain, Paraesthesia, Restlessness
Clinical narrative: I had the third shot yesterday afternoon at my Doctor's office.  I sat around and read magazines for over an hour after the shot.  I had the shot at around 2 PM.  Outside of a dry, clay taste I didn't have an immediate reaction.  At around 6:30 PM my body started to ache all over.  All my joints hurt.  My hips, knees, and ankles were really painful.  I got cramps in my feet and tingling in both hands.  I couldn't concentrate and was very restless.  Every five minutes or so I felt like I should get off the couch and do somethingvery vague.  Standing up caused the aching in my legs to worsen.  At around 9 PM it occurred to me that I had reached a plateau and things weren't getting any worse.  I went to bed at around 9:30 PM and around 3 AM the aching stopped.  Up to that point I kept tossing and turning.  The aching kept me from finding a comfortable position.  Today my legs and joints are sore.  The kind of "I just ran a mile" sore.  Typing has caused my fingers to ache.  I have not had any cramps in my feet.  I have had some tingling in my hands.  Oddly enough, I feel sort of relaxed and somewhat spacey minded.  NOTE:  1st 2 shots given and similar reactions were reported on 11-03-2003 on paper report to VAERS by doctor who is writing this now. Please contact pt. and discuss reaction and advise if he needs testing for antiHBs to assure immunity.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR
Symptoms: Cough, Pruritus, Urticaria, Wheezing
Clinical narrative: From initial information received on 3/23/04 from a health care professional regarding an adverse event occurring, it was reported that a four year old male patient received a dose DAPTACEL, lot number C1679AA, administered in the left thigh; a dose of IPOL, lot number X0707, administered in the right outer thigh; a dose of HEPATITIS A VACCINE (lot number 1123N) administered in the left thigh; and a dose of MMR (lot number 0950N) administered in the right outer thigh on 3/5/04 at 1:00 PM. The routes of administration were not reported for any of the products. Immediately after immunization (also reported as within one minute), the patient developed generalized pruritus, generalized hives and wheezing. He was given two doses of epinephrine, Benadryl elixir and oral steroids in the office and the symptoms resolved. The patient's past medical history is significant for transposition of the great artery, which had been corrected and allergies to morphine. His concomitant medications included baby aspirin 81mg daily and Lanoxin .5mg twice a day. Reportedly, the patient recovered from these events. From additional information received on 4/14/04 it was reported that the patient was vaccinated SC with a first dose of MMR vaccine, lot number 646898/0950N and a VAQTA vaccine, lot number 647340/1123N. Subsequently, the patient experienced itching, wheezing and hives (also reported as itchy rash and cough developed within one minute of the vaccine and wheezing developed soon after). Follow up information reported that the child's reaction was considered to be an anaphylactic reaction with an immediate onset after vaccination. The patient was not hospitalized. Unspecified medical attention was sought. The patient was treated with two doses of epinephrine, oral diphenhydramine hydrochloride and an oral steroid prednisolone and was monitored in the office. The patient recovered on 3/5/04. Follow up information reported that the physician thought that the MMR vaccine was the primary suspect drug. The nurse reported they were not sure if any other vaccinations were suspected because the reaction occurred immediately after the MMR vaccine. It was also reported that another male patient experienced an anaphylactic reaction following vaccination with an MMR vaccine. From additional information received on 19Apr04 from the manufacturer, the pt's birth weight, number of siblings and how the vaccine was purchased was reported.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR
Symptoms: Anaphylactic reaction, Pruritus, Urticaria, Wheezing
Clinical narrative: From initial information received on 3/23/04 from a health care professional regarding an adverse event occurring, it was reported that a four year old male patient received a dose DAPTACEL, lot number C1679AA, administered in the left thigh; a dose of IPOL, lot number X0707, administered in the right outer thigh; a dose of HEPATITIS A VACCINE (lot number 1123N) administered in the left thigh; and a dose of MMR (lot number 0950N) administered in the right outer thigh on 3/5/04 at 1:00 PM. The routes of administration were not reported for any of the products. Immediately after immunization (also reported as within one minute), the patient developed generalized pruritus, generalized hives and wheezing. He was given two doses of epinephrine, Benadryl elixir and oral steroids in the office and the symptoms resolved. The patient's past medical history is significant for transposition of the great artery, which had been corrected and allergies to morphine. His concomitant medications included baby aspirin 81mg daily and Lanoxin .5mg twice a day. Reportedly, the patient recovered from these events. From additional information received on 4/14/04 it was reported that the patient was vaccinated SC with a first dose of MMR vaccine, lot number 646898/0950N and a VAQTA vaccine, lot number 647340/1123N. Subsequently, the patient experienced itching, wheezing and hives (also reported as itchy rash and cough developed within one minute of the vaccine and wheezing developed soon after). Follow up information reported that the child's reaction was considered to be an anaphylactic reaction with an immediate onset after vaccination. The patient was not hospitalized. Unspecified medical attention was sought. The patient was treated with two doses of epinephrine, oral diphenhydramine hydrochloride and an oral steroid prednisolone and was monitored in the office. The patient recovered on 3/5/04. Follow up information reported that the physician thought that the MMR vaccine was the primary suspect drug. The nurse reported they were not sure if any other vaccinations were suspected because the reaction occurred immediately after the MMR vaccine. It was also reported that another male patient experienced an anaphylactic reaction following vaccination with an MMR vaccine. From additional information received on 19Apr04 from the manufacturer, the pt's birth weight, number of siblings and how the vaccine was purchased was reported.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR
Symptoms: Anaphylactic reaction, Cough, Pruritus, Urticaria, Wheezing
Clinical narrative: From initial information received on 3/23/04 from a health care professional regarding an adverse event occurring, it was reported that a four year old male patient received a dose DAPTACEL, lot number C1679AA, administered in the left thigh; a dose of IPOL, lot number X0707, administered in the right outer thigh; a dose of HEPATITIS A VACCINE (lot number 1123N) administered in the left thigh; and a dose of MMR (lot number 0950N) administered in the right outer thigh on 3/5/04 at 1:00 PM. The routes of administration were not reported for any of the products. Immediately after immunization (also reported as within one minute), the patient developed generalized pruritus, generalized hives and wheezing. He was given two doses of epinephrine, Benadryl elixir and oral steroids in the office and the symptoms resolved. The patient's past medical history is significant for transposition of the great artery, which had been corrected and allergies to morphine. His concomitant medications included baby aspirin 81mg daily and Lanoxin .5mg twice a day. Reportedly, the patient recovered from these events. From additional information received on 4/14/04 it was reported that the patient was vaccinated SC with a first dose of MMR vaccine, lot number 646898/0950N and a VAQTA vaccine, lot number 647340/1123N. Subsequently, the patient experienced itching, wheezing and hives (also reported as itchy rash and cough developed within one minute of the vaccine and wheezing developed soon after). Follow up information reported that the child's reaction was considered to be an anaphylactic reaction with an immediate onset after vaccination. The patient was not hospitalized. Unspecified medical attention was sought. The patient was treated with two doses of epinephrine, oral diphenhydramine hydrochloride and an oral steroid prednisolone and was monitored in the office. The patient recovered on 3/5/04. Follow up information reported that the physician thought that the MMR vaccine was the primary suspect drug. The nurse reported they were not sure if any other vaccinations were suspected because the reaction occurred immediately after the MMR vaccine. It was also reported that another male patient experienced an anaphylactic reaction following vaccination with an MMR vaccine. From additional information received on 19Apr04 from the manufacturer, the pt's birth weight, number of siblings and how the vaccine was purchased was reported.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Feeling hot, Lacrimation increased, Rash, Rash erythematous, Vomiting
Clinical narrative: From initial information received on 3/23/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 4 year old male patient received a dose of DAPTACEL, lot number C1679AA, administered in the left thigh; a dose of IPOL, lot number X0707, administered in the left outer thigh; and a dose of MMR, lot number 646740/0822N, administered in the right outer thigh, on 3/15/04 at 12:00 PM. The routes of administration were not reported for any of the products. Within five minutes of receiving the vaccines, the patient developed generalized hives, vomiting, watering eyes, wheezing and became faint. It was not reported whether the patient lost consciousness. The symptoms were treated with epinephrine, oral Benadryl, and Xopenex and have resolved. Reportedly, the patient recovered from these events. From additional information received on 4/14/04, it was reported that the DAPTACEL vaccination was given IM, the IPOL vaccination SC and the MMR vaccination SC. The patient also experienced a rash. On follow up it was reported that on 3/15/04 the patient began with watering eyes and faint rash at 12:00 PM and after five minutes the rash was more intense and had spread with warmth to touch, vomiting and wheezing. The patient was not hospitalized, but was seen by the doctor and treated. The patient recovered on 3/15/04. It was also reported on follow up that the patient's reaction was considered to be an anaphylactic reaction with an onset of about 20 minutes after vaccination. Follow up information indicated that the MMR vaccination was considered to be the primary suspect because the rash started at the MMR injection site and spread from there. It was reported that the MMR was the only vaccination given in the child's thigh where the rash started. The other two vaccinations were given in the child's other thigh. It was also reported that another male patient experienced an anaphylactic reaction following vaccination with MMR vaccine. No other information was provided.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Wheezing
Clinical narrative: From initial information received on 3/23/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 4 year old male patient received a dose of DAPTACEL, lot number C1679AA, administered in the left thigh; a dose of IPOL, lot number X0707, administered in the left outer thigh; and a dose of MMR, lot number 646740/0822N, administered in the right outer thigh, on 3/15/04 at 12:00 PM. The routes of administration were not reported for any of the products. Within five minutes of receiving the vaccines, the patient developed generalized hives, vomiting, watering eyes, wheezing and became faint. It was not reported whether the patient lost consciousness. The symptoms were treated with epinephrine, oral Benadryl, and Xopenex and have resolved. Reportedly, the patient recovered from these events. From additional information received on 4/14/04, it was reported that the DAPTACEL vaccination was given IM, the IPOL vaccination SC and the MMR vaccination SC. The patient also experienced a rash. On follow up it was reported that on 3/15/04 the patient began with watering eyes and faint rash at 12:00 PM and after five minutes the rash was more intense and had spread with warmth to touch, vomiting and wheezing. The patient was not hospitalized, but was seen by the doctor and treated. The patient recovered on 3/15/04. It was also reported on follow up that the patient's reaction was considered to be an anaphylactic reaction with an onset of about 20 minutes after vaccination. Follow up information indicated that the MMR vaccination was considered to be the primary suspect because the rash started at the MMR injection site and spread from there. It was reported that the MMR was the only vaccination given in the child's thigh where the rash started. The other two vaccinations were given in the child's other thigh. It was also reported that another male patient experienced an anaphylactic reaction following vaccination with MMR vaccine. No other information was provided.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Anaphylactic reaction, Feeling hot, Injection site rash, Lacrimation increased, Rash
Clinical narrative: From initial information received on 3/23/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 4 year old male patient received a dose of DAPTACEL, lot number C1679AA, administered in the left thigh; a dose of IPOL, lot number X0707, administered in the left outer thigh; and a dose of MMR, lot number 646740/0822N, administered in the right outer thigh, on 3/15/04 at 12:00 PM. The routes of administration were not reported for any of the products. Within five minutes of receiving the vaccines, the patient developed generalized hives, vomiting, watering eyes, wheezing and became faint. It was not reported whether the patient lost consciousness. The symptoms were treated with epinephrine, oral Benadryl, and Xopenex and have resolved. Reportedly, the patient recovered from these events. From additional information received on 4/14/04, it was reported that the DAPTACEL vaccination was given IM, the IPOL vaccination SC and the MMR vaccination SC. The patient also experienced a rash. On follow up it was reported that on 3/15/04 the patient began with watering eyes and faint rash at 12:00 PM and after five minutes the rash was more intense and had spread with warmth to touch, vomiting and wheezing. The patient was not hospitalized, but was seen by the doctor and treated. The patient recovered on 3/15/04. It was also reported on follow up that the patient's reaction was considered to be an anaphylactic reaction with an onset of about 20 minutes after vaccination. Follow up information indicated that the MMR vaccination was considered to be the primary suspect because the rash started at the MMR injection site and spread from there. It was reported that the MMR was the only vaccination given in the child's thigh where the rash started. The other two vaccinations were given in the child's other thigh. It was also reported that another male patient experienced an anaphylactic reaction following vaccination with MMR vaccine. No other information was provided.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Syncope, Urticaria, Vomiting, Wheezing
Clinical narrative: From initial information received on 3/23/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 4 year old male patient received a dose of DAPTACEL, lot number C1679AA, administered in the left thigh; a dose of IPOL, lot number X0707, administered in the left outer thigh; and a dose of MMR, lot number 646740/0822N, administered in the right outer thigh, on 3/15/04 at 12:00 PM. The routes of administration were not reported for any of the products. Within five minutes of receiving the vaccines, the patient developed generalized hives, vomiting, watering eyes, wheezing and became faint. It was not reported whether the patient lost consciousness. The symptoms were treated with epinephrine, oral Benadryl, and Xopenex and have resolved. Reportedly, the patient recovered from these events. From additional information received on 4/14/04, it was reported that the DAPTACEL vaccination was given IM, the IPOL vaccination SC and the MMR vaccination SC. The patient also experienced a rash. On follow up it was reported that on 3/15/04 the patient began with watering eyes and faint rash at 12:00 PM and after five minutes the rash was more intense and had spread with warmth to touch, vomiting and wheezing. The patient was not hospitalized, but was seen by the doctor and treated. The patient recovered on 3/15/04. It was also reported on follow up that the patient's reaction was considered to be an anaphylactic reaction with an onset of about 20 minutes after vaccination. Follow up information indicated that the MMR vaccination was considered to be the primary suspect because the rash started at the MMR injection site and spread from there. It was reported that the MMR was the only vaccination given in the child's thigh where the rash started. The other two vaccinations were given in the child's other thigh. It was also reported that another male patient experienced an anaphylactic reaction following vaccination with MMR vaccine. No other information was provided.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Anaphylactic reaction, Feeling hot, Lacrimation increased, Rash, Syncope
Clinical narrative: From initial information received on 3/23/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 4 year old male patient received a dose of DAPTACEL, lot number C1679AA, administered in the left thigh; a dose of IPOL, lot number X0707, administered in the left outer thigh; and a dose of MMR, lot number 646740/0822N, administered in the right outer thigh, on 3/15/04 at 12:00 PM. The routes of administration were not reported for any of the products. Within five minutes of receiving the vaccines, the patient developed generalized hives, vomiting, watering eyes, wheezing and became faint. It was not reported whether the patient lost consciousness. The symptoms were treated with epinephrine, oral Benadryl, and Xopenex and have resolved. Reportedly, the patient recovered from these events. From additional information received on 4/14/04, it was reported that the DAPTACEL vaccination was given IM, the IPOL vaccination SC and the MMR vaccination SC. The patient also experienced a rash. On follow up it was reported that on 3/15/04 the patient began with watering eyes and faint rash at 12:00 PM and after five minutes the rash was more intense and had spread with warmth to touch, vomiting and wheezing. The patient was not hospitalized, but was seen by the doctor and treated. The patient recovered on 3/15/04. It was also reported on follow up that the patient's reaction was considered to be an anaphylactic reaction with an onset of about 20 minutes after vaccination. Follow up information indicated that the MMR vaccination was considered to be the primary suspect because the rash started at the MMR injection site and spread from there. It was reported that the MMR was the only vaccination given in the child's thigh where the rash started. The other two vaccinations were given in the child's other thigh. It was also reported that another male patient experienced an anaphylactic reaction following vaccination with MMR vaccine. No other information was provided.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Urticaria, Vomiting, Wheezing
Clinical narrative: From initial information received on 3/23/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 4 year old male patient received a dose of DAPTACEL, lot number C1679AA, administered in the left thigh; a dose of IPOL, lot number X0707, administered in the left outer thigh; and a dose of MMR, lot number 646740/0822N, administered in the right outer thigh, on 3/15/04 at 12:00 PM. The routes of administration were not reported for any of the products. Within five minutes of receiving the vaccines, the patient developed generalized hives, vomiting, watering eyes, wheezing and became faint. It was not reported whether the patient lost consciousness. The symptoms were treated with epinephrine, oral Benadryl, and Xopenex and have resolved. Reportedly, the patient recovered from these events. From additional information received on 4/14/04, it was reported that the DAPTACEL vaccination was given IM, the IPOL vaccination SC and the MMR vaccination SC. The patient also experienced a rash. On follow up it was reported that on 3/15/04 the patient began with watering eyes and faint rash at 12:00 PM and after five minutes the rash was more intense and had spread with warmth to touch, vomiting and wheezing. The patient was not hospitalized, but was seen by the doctor and treated. The patient recovered on 3/15/04. It was also reported on follow up that the patient's reaction was considered to be an anaphylactic reaction with an onset of about 20 minutes after vaccination. Follow up information indicated that the MMR vaccination was considered to be the primary suspect because the rash started at the MMR injection site and spread from there. It was reported that the MMR was the only vaccination given in the child's thigh where the rash started. The other two vaccinations were given in the child's other thigh. It was also reported that another male patient experienced an anaphylactic reaction following vaccination with MMR vaccine. No other information was provided.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Anaphylactic reaction, Feeling hot, Lacrimation increased, Rash, Vomiting
Clinical narrative: From initial information received on 3/23/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 4 year old male patient received a dose of DAPTACEL, lot number C1679AA, administered in the left thigh; a dose of IPOL, lot number X0707, administered in the left outer thigh; and a dose of MMR, lot number 646740/0822N, administered in the right outer thigh, on 3/15/04 at 12:00 PM. The routes of administration were not reported for any of the products. Within five minutes of receiving the vaccines, the patient developed generalized hives, vomiting, watering eyes, wheezing and became faint. It was not reported whether the patient lost consciousness. The symptoms were treated with epinephrine, oral Benadryl, and Xopenex and have resolved. Reportedly, the patient recovered from these events. From additional information received on 4/14/04, it was reported that the DAPTACEL vaccination was given IM, the IPOL vaccination SC and the MMR vaccination SC. The patient also experienced a rash. On follow up it was reported that on 3/15/04 the patient began with watering eyes and faint rash at 12:00 PM and after five minutes the rash was more intense and had spread with warmth to touch, vomiting and wheezing. The patient was not hospitalized, but was seen by the doctor and treated. The patient recovered on 3/15/04. It was also reported on follow up that the patient's reaction was considered to be an anaphylactic reaction with an onset of about 20 minutes after vaccination. Follow up information indicated that the MMR vaccination was considered to be the primary suspect because the rash started at the MMR injection site and spread from there. It was reported that the MMR was the only vaccination given in the child's thigh where the rash started. The other two vaccinations were given in the child's other thigh. It was also reported that another male patient experienced an anaphylactic reaction following vaccination with MMR vaccine. No other information was provided.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Myositis, Pain, Paraesthesia, Tendonitis
Clinical narrative: 1/20/04 Complained of shooting pains down right arm, numbness, tingling right fingers x 3 weeks. Tx for RT myositis/bicep tendonitis results not back from MRI (some heat).
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Alopecia, Fatigue, Nasal congestion, Subarachnoid haemorrhage
Clinical narrative: Alopecia, fatigue, chronic nasal congestion, subarachnoid hemorrage after the anthrax vaccine.
Age: 52.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, TYP
Symptoms: Tinnitus
Clinical narrative: Tinnitus 14-16 hours post vaccines bilaterally.
Age: 24.0
Sex: F
Vaccine: ANTH, HEP, HEPA, TYP
Symptoms: Discomfort, Dizziness, Injection site erythema, Nausea, Pruritus
Clinical narrative: Light headed, nausea, rash on face and neck. Red blotching on back and anterior chest. Left arm discomfort and pruritis. Redness around Hep A injection site. Close observation and monitoring of vital signs.
Age: 24.0
Sex: F
Vaccine: ANTH, HEP, HEPA, TYP
Symptoms: Rash, Rash macular
Clinical narrative: Light headed, nausea, rash on face and neck. Red blotching on back and anterior chest. Left arm discomfort and pruritis. Redness around Hep A injection site. Close observation and monitoring of vital signs.
Age: 36.0
Sex: M
Vaccine: SMALL
Symptoms: Cardiac disorder, Cough, Mitral valve incompetence, Upper respiratory tract infection
Clinical narrative: Cough, URI symptoms which persisted when patient evaluated by provider March 2004, noted new murmur and subsequently diagnosed with MVP and moderate MR and borderline LVE
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Injection site discolouration, Injection site erythema, Tenderness
Clinical narrative: Onset with redness around injection site on left thigh, warm to touch night of 4/14/04. 5.5x4 inch erythema blanching to left thigh, slight tenderness to palpation. Benadryl 1-2 times a day. Ibuprofen prn discomfort.
Age: 4.5
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Contusion, Feeling hot, Injection site erythema, Rash erythematous
Clinical narrative: Shot given in left arm. The next night I noticed the area was warm, red and raised with bruising by injection site.
Age: 1.25
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Pruritus, Rash, Skin ulcer
Clinical narrative: 4/12/04 rash on legs itching. Orapred 1 tsp QD(15/5). 4/15/04 multi target lesion clusters on knees, thigh, shin and elbows (orapred 4-5 days). 4/16/2004 Continue eruption -continued Orapred x 2days thru and 1/2 tsp qd. x 2 days. 4/19/2004 still scattered like lesions with many excoriatious from itching. Eucerin cream spray. Finish Orapred.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Swelling, redness at injection site. Subject received a DTAP vaccine the day after the vaccination the child developed redness, swelling, warmth and induration at injection site.  Maximal diameter of redness was 14.2cm, maximal diameter of swelling was 8.5cm. No treatment required, resolution of symptoms was seven days following vaccination.