chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.58
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Oedema, Pain, Pruritus, Pyrexia
Clinical narrative: Local erythema, swelling of whole arm and slight pain and itching fever 100.5 degrees; all these were noted 18 hours after vaccination.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Vomiting
Clinical narrative: He got his shot about 4 pm 3-23-04 and about 10 pm he started vomiting and it last for 2-3 days.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Upper left thigh with 8 x 8 cm area red, warm, swollen, non tender. No other reaction. Reassurance, cool compresses.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Possible cellulitis left thigh localized reaction right thigh.
Age: 0.67
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Depersonalisation, Dizziness exertional, Erythema, Lethargy, Oedema
Clinical narrative: Telephone call from mom 3/18/04 in PM- Child woke up and with red, swollen areas on legs  & 102 temp (R). Mom gave Tylenol with relief- After lunch Pt acted dizzy & lethargic- Temp 103 (R)- "Just not acting right". Advised to take pt to ER for evaluation by doctor. 3/04 Note: Follow-up with mom- Spoke to child's doctor (Peds) advised to give Tylenol for 24 hours & call doctor back if no improvement. Doctor states normal reaction- mom to call health department back if any problems- no return call.
Age: 0.67
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Telephone call from mom 3/18/04 in PM- Child woke up and with red, swollen areas on legs  & 102 temp (R). Mom gave Tylenol with relief- After lunch Pt acted dizzy & lethargic- Temp 103 (R)- "Just not acting right". Advised to take pt to ER for evaluation by doctor. 3/04 Note: Follow-up with mom- Spoke to child's doctor (Peds) advised to give Tylenol for 24 hours & call doctor back if no improvement. Doctor states normal reaction- mom to call health department back if any problems- no return call.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myalgia, Oedema, Rash erythematous
Clinical narrative: Right upper arm sore & red, swollen- after 5 hours progresses to 5 x 3 cm reddened raised area with 8-12 cm non tender are surrounded no wheezing or asthma signs.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Injection site inflammation, Oedema
Clinical narrative: Pt seen in ER the day (evening) 5 immunization for erythema & swelling of left arm. No fever, no systemic symptoms. Treated with antibiotics & resolved within 3 days completely ? inflammatory reaction vs. cellulitis.
Age: 37.0
Sex: M
Vaccine: UNK
Symptoms: Tongue paralysis
Clinical narrative: Tongue numbness.
Age: 46.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Bone pain, Fatigue, Rash
Clinical narrative: PT WAS HAVING JOINT PAIN,BONE ACHE AND RASH (LOCAL SITE REACTION "SIZE OF BASEBALL") ON THE UPPER RIGHT ARM. PT. ALSO EXPERIENCEED EXTREME FATIGUE.  SYMPTOMS ARE CURRENTLY DISTRESSING PT. (EMPHASIS ON FATIGUE)  Per follow-up: Still having right shoulder pain and a white pimple erupted at injectin site. Itching is present on and around the pimple.
Age: 50.0
Sex: F
Vaccine: YF
Symptoms: Headache, Hypersensitivity, Hypoaesthesia, Laboratory test abnormal, Malaise
Clinical narrative: Headache, malaise, numbness, itching at injection site started approximately 36 hours post vaccination.
Age: 50.0
Sex: F
Vaccine: YF
Symptoms: Pruritus
Clinical narrative: Headache, malaise, numbness, itching at injection site started approximately 36 hours post vaccination.
Age: 22.0
Sex: F
Vaccine: IPV, MEN, TD, YF
Symptoms: Erythema, Injection site rash, Rash pruritic
Clinical narrative: Itchy red rash started within 2hrs of vaccine. Started at YF site and spread through elbow and up to shoulder. Rash remained approx. 1 wk. Client used OTC anti-itch creams
Age: 0.8
Sex: F
Vaccine: HEP
Symptoms: Blood alkaline phosphatase increased, CSF test abnormal, Gastrointestinal disorder, Guillain-Barre syndrome, Laboratory test abnormal
Clinical narrative: Infant developed Guillan Barre syndrome 5 days after vaccination  Nurse follow up on 07/21/04 states: "acute gastroenteritis."
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Dizziness, Dysphonia, Fatigue, Malaise, Pharyngolaryngeal pain
Clinical narrative: Mini Fevers,Fatigue Lightheadedness, Dizzy Spells, Sore Throat, Hoarse Voice, Malaise, Lump about the size of Tennis ball did not subside until Wednesday. Treated in Hospital Emergency room Monday 5 Apr 2004 and given 48 hours bed rest at home.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Pyrexia
Clinical narrative: Mini Fevers,Fatigue Lightheadedness, Dizzy Spells, Sore Throat, Hoarse Voice, Malaise, Lump about the size of Tennis ball did not subside until Wednesday. Treated in Hospital Emergency room Monday 5 Apr 2004 and given 48 hours bed rest at home.
Age: 20.0
Sex: F
Vaccine: RAB, TYP
Symptoms: Unevaluable event
Clinical narrative: Client received rabies travel vaccinations for trip on Monday, April 5th, 2004.  The rabies vaccine Imovax Lot # W1419-3 was given.  This lot  was recalled on April 5th. The recall information was received after the vaccination was given.    The client was contacted on Tuesday, April 6th, 2004 and informed of the recall and suggested treatment was discussed.  Client came in for HRIG and Imovax post exposure treatment on Wednesday, April 7, 2004.  No signs or symptoms of any adverse effects were noted on history and physical exam and client signed agreement to receive prophylactic treatment as perscribed.
Age: 1.6
Sex: M
Vaccine: DTAPH, IPV, VARCEL
Symptoms: Blister, Pyrexia, Rash
Clinical narrative: 7 days after injection of DTaP/Hib, and Varivax in left outer thigh- got rash with small vesicles- about 8-10 of them.  low grade fever- felt warm, not measured at home.  no fever in office.  Seen at 9 days after immunizations given.  I told mom this was varivax reaction.  keep covered.  warm compresses.  tylenol as needed.  call if worsenes.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Movement disorder, Visual disturbance
Clinical narrative: request for medical records for client for another program on 3/12/04. Records received 3/30/04. Visit to Dr's office 1/31/04 states abnormal head movements and abnormal visual tracking. Questions adverse reaction to immunizations.
Age: 0.4
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: high fever (102.8F).  Swealing and redness around injection site.  symptoms lasted for 3 days.  Patient was administered motrin and tylenol to reduce fever.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMR
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: swelling and erythema of left arm from shoulder to mid forearm, complaints of itching
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Rash
Clinical narrative: minor lacy skin rash present below the injection site, no fever, nonpainful
Age: 1.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Crying, Pyrexia, Rash
Clinical narrative: Pt. rec'd vaccines 4/5/04 afternoon.  Mom states he began running high fever 4/7/04, doesn't know actually temp measurement (no thermometer).  Still running fever and crying 4/8/04 "as if he is in pain".  No other symptoms other than slight "heat rash" appearance to back on 4/6/04, gone by 4/7/04.  Mother is taking him to clinic today.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Erythema, Pyrexia
Clinical narrative: Redness to Left Upper Bicep, Gastric Pain, Diarrhea, Fever Chills
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Dizziness, Heart rate increased, Nausea, Paraesthesia
Clinical narrative: Immediately after receipt of anthrax vaccine she experienced burning at the injection site, tingling in hands bilaterally, sweating, heart racing, nausea, and dizziness.  Nurse's note indicates BP 84/48 and P 52 supine.  No loss of consciousness.  She was sent to the Clinic when she had not significantly improved an hour later.  EKG showed S-T changes in leads V1  V4.  She was referred for a stress test.  The Exercise Stress Test was equivocal.  She had downsloping of S-T segments in leads V5 and V6 which rapidly returned to normal in recovery. A nuclear stress test was recommended.  She developed bilateral knee pain that she attributed to extra physical training.  The knee pain is effectively relieved with Naprosyn.  She is currently undergoing a taper of the Naprosyn.  She has had a subsequent dose of Hepatitis B without any adverse event.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Thermal burn
Clinical narrative: Immediately after receipt of anthrax vaccine she experienced burning at the injection site, tingling in hands bilaterally, sweating, heart racing, nausea, and dizziness.  Nurse's note indicates BP 84/48 and P 52 supine.  No loss of consciousness.  She was sent to the Clinic when she had not significantly improved an hour later.  EKG showed S-T changes in leads V1  V4.  She was referred for a stress test.  The Exercise Stress Test was equivocal.  She had downsloping of S-T segments in leads V5 and V6 which rapidly returned to normal in recovery. A nuclear stress test was recommended.  She developed bilateral knee pain that she attributed to extra physical training.  The knee pain is effectively relieved with Naprosyn.  She is currently undergoing a taper of the Naprosyn.  She has had a subsequent dose of Hepatitis B without any adverse event.
Age: 28.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Sought emergency room treatment because of swelling, redness, and pain at vaccination site on 04/04/04. Was treated with antibiotics and Benadryl.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling at site of vaccination.  It is warm to the touch, swollen and hard.
Age: 68.0
Sex: F
Vaccine: MMR
Symptoms: Ocular hyperaemia, Oedema peripheral, Pain
Clinical narrative: Pain and swelling in hands, wrists, lower legs and feet.  Red and "tired" eyes. Evaluated by MDs on 3/29 and 3/30 who patient reports diagnosed adverse reaction to MMR.  Treated with increase in dose of diuretics, rest, and analgesics.  Missed 4 days of work and filed WC claim because MMR was required for employment (rubella titre non immune.)  Back to work full-time April 5th.  Still under treatment, but improving, expect recovery in 1-2 weeks.
Age: 1.0
Sex: F
Vaccine: HBHEPB, HEP, MMR, VARCEL, HBHEPB, MMR, VARCEL
Symptoms: Pneumonia, Pyrexia
Clinical narrative: contracted pneumonia 10 days after vaccination.  I am not sure if it is related or not, but pneumonia is listed as a severe problem for the chicken pox vaccination.  She had high fever for 6 days (starting 10th day after vaccination) and lethargy.  I took her to the hospital and Dr. found she had pneumonia.  She was treated with Zithromax antibiotic.  She is still running a fever after 5 days of antibiotics.
Age: 1.0
Sex: F
Vaccine: HBHEPB, HEP, MMR, VARCEL, HBHEPB, MMR, VARCEL
Symptoms: Injection site vesicles, Pneumonia, Pyrexia, Upper respiratory tract infection
Clinical narrative: contracted pneumonia 10 days after vaccination.  I am not sure if it is related or not, but pneumonia is listed as a severe problem for the chicken pox vaccination.  She had high fever for 6 days (starting 10th day after vaccination) and lethargy.  I took her to the hospital and Dr. found she had pneumonia.  She was treated with Zithromax antibiotic.  She is still running a fever after 5 days of antibiotics.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Anaphylactoid reaction, Apnoea, Autism, Blindness, Congenital central nervous system anomaly
Clinical narrative: ANAPHYLAXIS, APNEA, CEREBRAL PALSY, NARCOLEPSY, MENTAL RETARDATION, NON VERBAL, NON ABULATORY, INCONTIENT, CORTICAL BLINDNESS, EPILEPSY (INTRACTIBLE). TOTICOLIS, VERITIGO, PERIPHERAL VISION USAGE (AUTISM?)FAILURE TO THRIVE: G-TUBE FED. 24 HR/7DAY PER WEEK CARE TEN YEARS LATER. HOSPITAL DID NO INTERVENTION IN 1993 IN THE HOUR AFTER VACCINATION AND DURING ANAPHYLAXIS. CHILD LOST SUCKLING ABILTIY AND BEGAN SEIZURE ACTIVITY. i CONTINUED TO HAVE HIM VACCINATED, I BELEIVED IN THE VACCINATION PROGRAM, NOW PERMANENTLY AND COMPLETELY DISABLED.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Convulsion, Faecal incontinence, Growth retardation, Mental retardation severity unspecified, Somnolence
Clinical narrative: ANAPHYLAXIS, APNEA, CEREBRAL PALSY, NARCOLEPSY, MENTAL RETARDATION, NON VERBAL, NON ABULATORY, INCONTIENT, CORTICAL BLINDNESS, EPILEPSY (INTRACTIBLE). TOTICOLIS, VERITIGO, PERIPHERAL VISION USAGE (AUTISM?)FAILURE TO THRIVE: G-TUBE FED. 24 HR/7DAY PER WEEK CARE TEN YEARS LATER. HOSPITAL DID NO INTERVENTION IN 1993 IN THE HOUR AFTER VACCINATION AND DURING ANAPHYLAXIS. CHILD LOST SUCKLING ABILTIY AND BEGAN SEIZURE ACTIVITY. i CONTINUED TO HAVE HIM VACCINATED, I BELEIVED IN THE VACCINATION PROGRAM, NOW PERMANENTLY AND COMPLETELY DISABLED.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Torticollis, Urinary incontinence, Vertigo
Clinical narrative: ANAPHYLAXIS, APNEA, CEREBRAL PALSY, NARCOLEPSY, MENTAL RETARDATION, NON VERBAL, NON ABULATORY, INCONTIENT, CORTICAL BLINDNESS, EPILEPSY (INTRACTIBLE). TOTICOLIS, VERITIGO, PERIPHERAL VISION USAGE (AUTISM?)FAILURE TO THRIVE: G-TUBE FED. 24 HR/7DAY PER WEEK CARE TEN YEARS LATER. HOSPITAL DID NO INTERVENTION IN 1993 IN THE HOUR AFTER VACCINATION AND DURING ANAPHYLAXIS. CHILD LOST SUCKLING ABILTIY AND BEGAN SEIZURE ACTIVITY. i CONTINUED TO HAVE HIM VACCINATED, I BELEIVED IN THE VACCINATION PROGRAM, NOW PERMANENTLY AND COMPLETELY DISABLED.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Asthenia, Chest pain, Chills, Coordination abnormal
Clinical narrative: This is a follow-up report. 4 years and 3 months post anthrax vaccination, I am still experiencing these symptoms: dizziness, balance trouble, cognitive problems, muscle and joint pain, chronic fatigue, tinnitus, shortness of breath. I have been diagnosed with Chronic Fatigue Syndrome and Fibromyalgia. I function at approximately 20% of my normal prevaccination.  On the date of last vaccination (2 Feb 2000) I went to the hospital in an ambulance because of:  near passing out, high pulse (110), high blood pressure (180/100), extreme chills, shortness of breath, chest pains.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Dizziness, Dyspnoea, Hypertension, Myalgia, Tachycardia
Clinical narrative: This is a follow-up report. 4 years and 3 months post anthrax vaccination, I am still experiencing these symptoms: dizziness, balance trouble, cognitive problems, muscle and joint pain, chronic fatigue, tinnitus, shortness of breath. I have been diagnosed with Chronic Fatigue Syndrome and Fibromyalgia. I function at approximately 20% of my normal prevaccination.  On the date of last vaccination (2 Feb 2000) I went to the hospital in an ambulance because of:  near passing out, high pulse (110), high blood pressure (180/100), extreme chills, shortness of breath, chest pains.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Thinking abnormal, Tinnitus
Clinical narrative: This is a follow-up report. 4 years and 3 months post anthrax vaccination, I am still experiencing these symptoms: dizziness, balance trouble, cognitive problems, muscle and joint pain, chronic fatigue, tinnitus, shortness of breath. I have been diagnosed with Chronic Fatigue Syndrome and Fibromyalgia. I function at approximately 20% of my normal prevaccination.  On the date of last vaccination (2 Feb 2000) I went to the hospital in an ambulance because of:  near passing out, high pulse (110), high blood pressure (180/100), extreme chills, shortness of breath, chest pains.
Age: 42.0
Sex: F
Vaccine: ANTH
Symptoms: Chest discomfort, Chest pain, Dizziness, Gait disturbance, Headache
Clinical narrative: Received anthrax and began to feel faint and lightheaded. During the evening, states that her head started hurting over the frontoparietal region.  States that the top of her head "hurt so bad that she felt like her head was going to blow off."  Rates headache on pain scale from 0-10 as a 10.   States that she was not able to function but reports no nausea, vomiting or sensitivity to light or noise.   Does not remember any associated symptoms with headache.  States that she was concerned about completing her mission and the headache was getting in her way.  States that she finally took some Motrin and was somewhat better.  Describes somewhat better as able to function.  States that headache lasted two days.  While in formation, one hour after dinner, started experiencing numbness in left hand and lower arm, which progressively got worse to the point that she began to feel substernal chest tightness and pain and was admitted to the ER.  Denies any nausea, vomiting, dysphasia, or diaphoresis.  While in the ER she was given nitroglycerin and morphine before her chest pain resolved.   Cardiologist felt that the stress echo was suggesting ischemic coronary disease, examined the patient.  At this point the doctor offered a diagnostic cardiac catheterization, which the patient refused to give consent since she had an appointment later that week for cardiology consultation.  A final diagnosis with this admission was atypical chest pain (See narrative summary dated 7 Feb 03). Stress MRI performed. Reports that during a 4-mile walk, started noticing the pain in her left leg.  States that before she got to the 2nd mile, she noticed a dull ache in her left leg from above her hip to her ankle and felt as though her leg "was dragging."  Reports the aching sensation as a 3 on pain scale 0-10.  After being up on the leg for a while reports the pain as a 7-8 and reports limping.  During this episode, she also reports a funny sensation with some numbness on the left side of her head with some left jaw pain in addition to the numbness of left arm.      Referred to neurology clinic by cardiology clinic. Exam benign except for Blepharospasms. Cranial MRI ordered. Cervical MRI ordered.
Age: 42.0
Sex: F
Vaccine: ANTH
Symptoms: Hypoaesthesia, Hypotonia, Muscle twitching, Pain, Syncope
Clinical narrative: Received anthrax and began to feel faint and lightheaded. During the evening, states that her head started hurting over the frontoparietal region.  States that the top of her head "hurt so bad that she felt like her head was going to blow off."  Rates headache on pain scale from 0-10 as a 10.   States that she was not able to function but reports no nausea, vomiting or sensitivity to light or noise.   Does not remember any associated symptoms with headache.  States that she was concerned about completing her mission and the headache was getting in her way.  States that she finally took some Motrin and was somewhat better.  Describes somewhat better as able to function.  States that headache lasted two days.  While in formation, one hour after dinner, started experiencing numbness in left hand and lower arm, which progressively got worse to the point that she began to feel substernal chest tightness and pain and was admitted to the ER.  Denies any nausea, vomiting, dysphasia, or diaphoresis.  While in the ER she was given nitroglycerin and morphine before her chest pain resolved.   Cardiologist felt that the stress echo was suggesting ischemic coronary disease, examined the patient.  At this point the doctor offered a diagnostic cardiac catheterization, which the patient refused to give consent since she had an appointment later that week for cardiology consultation.  A final diagnosis with this admission was atypical chest pain (See narrative summary dated 7 Feb 03). Stress MRI performed. Reports that during a 4-mile walk, started noticing the pain in her left leg.  States that before she got to the 2nd mile, she noticed a dull ache in her left leg from above her hip to her ankle and felt as though her leg "was dragging."  Reports the aching sensation as a 3 on pain scale 0-10.  After being up on the leg for a while reports the pain as a 7-8 and reports limping.  During this episode, she also reports a funny sensation with some numbness on the left side of her head with some left jaw pain in addition to the numbness of left arm.      Referred to neurology clinic by cardiology clinic. Exam benign except for Blepharospasms. Cranial MRI ordered. Cervical MRI ordered.
Age: 42.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Flushing, Injection site rash
Clinical narrative: Flushing of skin, throat felt tight, difficulty breathing. Shot area-itching and lasted 10 minutes.
Age: 42.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Syncope, Throat tightness, Urticaria
Clinical narrative: Flushing of skin, throat felt tight, difficulty breathing. Shot area-itching and lasted 10 minutes.
Age: 42.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Dyspnoea, Flushing, Hypersensitivity, Pruritus, Throat tightness
Clinical narrative: Flushing of skin, throat felt tight, difficulty breathing. Shot area-itching and lasted 10 minutes.
Age: 2.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Skin discolouration, Tremor
Clinical narrative: It was reported that a 2 year old female pt received Imovax Rabies, lot number not reported, administered IM in the deltoid on 3/29/04, as part of a post-exposure series after being bitten by a dog. Within 30 minutes to one hour after being discharged from the ER, the pt experienced weakness, an unspecified "color change" and was shaky. She returned to the ER and was treated with epinephrine and IV fluids (normal saline solution). She was admitted to the hospital; however, no further details were provided. The pt's recovery status was not reported. It was not reported whether the dog had been tested for rabies. A telephone call was placed to the reporting physician on 4/2/04 for the purpose of obtaining additional info. He stated that the pt was bitten by a stray dog and the animal was not captured or tested for rabies. The pt was seen in the ER and was administered a first dose of Imovax Rabies on 3/29/04. The physician did not have the lot number at the time of the telephone call, but stated that he would attempt to obtain it. He also stated that the pt did not receive RIG on 3/29/04 since the hospital did not have any available at that time. The pt received RIG the following day, on 3/30/04. The pt was admitted to the hospital on 3/29/04 and released on 3/31/04. It was not known if she recovered from these events.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Chest pain, Myalgia, Pyrexia
Clinical narrative: Information has been received from an office manager concerning a 41 year old male who on 11/14/02 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. No lot number was available as it was not recorded in the patient's chart. There were no concomitant vaccinations. Several hours after being vaccinated the patient developed a fever, muscle aches, and chest pain. The patient was admitted to the hospital for overnight observation. The reporter was unaware of any treatment the patient may have received while hospitalized. The patient was discharged the following day as he developed no other symptoms and his events had resolved. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning her cousin's child who, on an unknown date, was vaccinated with a dose of MMR (lot number not reported). Subsequently, the patient developed autism. Unspecified medical attention was sought. The patient had not recovered. Autism was determined to be an other important medical event (OMIC). Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Spleen disorder
Clinical narrative: Information has been received from a pharmacist concerning an approximately 61 year old female with a sulfa allergy who in 2000 and 2001 was vaccinated with a first and second dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included Advair 250/50and Allegra. In 2001, after receiving a second dose, the pt developed a site reaction. Unspecified attention was sought and it was reported that the site reaction abated. On 3/25/04 the pharmacist reported that the pt was currently in the hospital for a splenectomy. The reason for the splenectomy was unknown. There was no product quality complaint involved. Information received on 3/25/04 contained the following adverse experiences: spleen disorder. Additional info has been requested. Follow up information from the pharmacist indicated that she called to find out information on revaccination since the patient was in the hospital for the splenectomy. She reported that the physician wanted to reduce the risk of another injection site reaction and wre not sure if they should give another dose this soon. The patient ha since been discharged from the hospital. No further information was available.
Sex: M
Vaccine: MMR
Symptoms: Speech disorder
Clinical narrative: Information has been received from two health professionals the authors of a literature article concerning a male patient who was vaccinated with a dose of MMR (lot # not reported). It was reported that the patient had received all recommended childhood vaccinations except hepatitis B vaccine. Subsequently, the patient had significant speech difficulties. Upon internal review, significant speech difficulties were considered to be other important medical events (OMIC). It was previously reported in a published article that the patient's brother has autism and the patient's mother had a miscarriage. No further information is available.
Age: 1.25
Sex: M
Vaccine: MMR, MMR
Symptoms: Autism, Diarrhoea, Social avoidant behaviour, Speech disorder
Clinical narrative: Information has been received from two health professionals the authors of a literature article concerning a 15 month old male who was vaccinated with MMR (lot number not reported). It was reported that the patient's mother received a dose of MMR  after his birth and was subsequently breast-fed for six months and at first developed normally. He received his MMR at age 15 months. By age 18 months, he developed chronic diarrhea, stopped talking, and became withdrawn. He has been diagnosed with autism, after extensive work up that was otherwise negative, including normal chromosomal studies. The authors also reported that subsequent children of the patient's mother were afflicted with learning disabilities, mental retardation, pervasive developmental disorder, Tourette syndrome, prematurity, hypoplastic left heart syndrome, and a single kidney. Family history was negative for autism and the mother had normal chromosomal studies. No further information is expected. (OMIC)
Age: 1.25
Sex: M
Vaccine: MMR, MMR
Symptoms: Autism, Diarrhoea, Eczema, Insomnia, Irritability
Clinical narrative: Information has been received from two health professionals the authors of a literature article concerning a 15 month old male who was vaccinated with MMR (lot number not reported). It was reported that the patient's mother received a dose of MMR  after his birth and was subsequently breast-fed for six months and at first developed normally. He received his MMR at age 15 months. By age 18 months, he developed chronic diarrhea, stopped talking, and became withdrawn. He has been diagnosed with autism, after extensive work up that was otherwise negative, including normal chromosomal studies. The authors also reported that subsequent children of the patient's mother were afflicted with learning disabilities, mental retardation, pervasive developmental disorder, Tourette syndrome, prematurity, hypoplastic left heart syndrome, and a single kidney. Family history was negative for autism and the mother had normal chromosomal studies. No further information is expected. (OMIC)
Age: 1.25
Sex: M
Vaccine: MMR, MMR
Symptoms: Pyrexia, Social avoidant behaviour, Speech disorder
Clinical narrative: Information has been received from two health professionals the authors of a literature article concerning a 15 month old male who was vaccinated with MMR (lot number not reported). It was reported that the patient's mother received a dose of MMR  after his birth and was subsequently breast-fed for six months and at first developed normally. He received his MMR at age 15 months. By age 18 months, he developed chronic diarrhea, stopped talking, and became withdrawn. He has been diagnosed with autism, after extensive work up that was otherwise negative, including normal chromosomal studies. The authors also reported that subsequent children of the patient's mother were afflicted with learning disabilities, mental retardation, pervasive developmental disorder, Tourette syndrome, prematurity, hypoplastic left heart syndrome, and a single kidney. Family history was negative for autism and the mother had normal chromosomal studies. No further information is expected. (OMIC)
Age: 1.25
Sex: M
Vaccine: MMR, MMR
Symptoms: Autism, Diarrhoea, Social avoidant behaviour, Speech disorder
Clinical narrative: Information has been received from two health professionals the authors of a literature article concerning a 15 month old male with a history who was vaccinated with his first dose of MMR (lot number not reported). The patient's mother was vaccinated with a booster dose of MMR in the post-partum period, the patient was subsequently breast-fed. The boy, who was born at full term and was breast-fed, appeared bright, verbal and sociable during the first year of life. At the age of 15 months, he received his first MMR. He reacted promptly with fever, irritability, and loose stools. Shortly thereafter, he lost previous acquired speech and withdrew from social contact. He currently has persistent diarrhea, sleep difficulties, and extensive eczema. He has been diagnosed with ASD. The authors also reported that the mother became febrile and developed a rash after vaccination with MMR. Upon internal review, autistic disorder was considered to be an other important medical event (OMIC). No further information is expected.
Age: 1.25
Sex: M
Vaccine: MMR, MMR
Symptoms: Autism, Diarrhoea, Eczema, Insomnia, Irritability
Clinical narrative: Information has been received from two health professionals the authors of a literature article concerning a 15 month old male with a history who was vaccinated with his first dose of MMR (lot number not reported). The patient's mother was vaccinated with a booster dose of MMR in the post-partum period, the patient was subsequently breast-fed. The boy, who was born at full term and was breast-fed, appeared bright, verbal and sociable during the first year of life. At the age of 15 months, he received his first MMR. He reacted promptly with fever, irritability, and loose stools. Shortly thereafter, he lost previous acquired speech and withdrew from social contact. He currently has persistent diarrhea, sleep difficulties, and extensive eczema. He has been diagnosed with ASD. The authors also reported that the mother became febrile and developed a rash after vaccination with MMR. Upon internal review, autistic disorder was considered to be an other important medical event (OMIC). No further information is expected.
Age: 1.25
Sex: M
Vaccine: MMR, MMR
Symptoms: Pyrexia, Social avoidant behaviour, Speech disorder
Clinical narrative: Information has been received from two health professionals the authors of a literature article concerning a 15 month old male with a history who was vaccinated with his first dose of MMR (lot number not reported). The patient's mother was vaccinated with a booster dose of MMR in the post-partum period, the patient was subsequently breast-fed. The boy, who was born at full term and was breast-fed, appeared bright, verbal and sociable during the first year of life. At the age of 15 months, he received his first MMR. He reacted promptly with fever, irritability, and loose stools. Shortly thereafter, he lost previous acquired speech and withdrew from social contact. He currently has persistent diarrhea, sleep difficulties, and extensive eczema. He has been diagnosed with ASD. The authors also reported that the mother became febrile and developed a rash after vaccination with MMR. Upon internal review, autistic disorder was considered to be an other important medical event (OMIC). No further information is expected.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Autism, Constipation, Rash, Speech disorder, Thinking abnormal
Clinical narrative: Information has been received from two health professionals the authors of a literature article concerning a 12 month old male who was vaccinated with MMR (lot number not reported). The patient's mother was vaccinated with a dose of MMR in the immediate post-partum period and it was reported that the baby was breast-fed beyond 18 months of age. In the first year of life, he was severely constipated and had three viral illnesses with generalized exanthems. he was immunized on the recommended schedule and received his first MMR  at the age of 12 months. Prior to this time, the boy had appropriate speech and above-average cognitive abilities, but he stopped progressing after his first birthday and then went on to lose previously acquired skills. A developmental evaluation done at a chronological age of 20 months revealed an approximate developmental age of 11-13 months (language, motor, and cognitive). Autistic symptoms are now apparent and a diagnosis of autism is forthcoming. The mother also developed severe arthritis of her knees, ankles, and hips following her own vaccination. Upon internal review, autistic symptoms were considered to be other important medical event (OMIC). No further information is expected.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Viral infection
Clinical narrative: Information has been received from two health professionals the authors of a literature article concerning a 12 month old male who was vaccinated with MMR (lot number not reported). The patient's mother was vaccinated with a dose of MMR in the immediate post-partum period and it was reported that the baby was breast-fed beyond 18 months of age. In the first year of life, he was severely constipated and had three viral illnesses with generalized exanthems. he was immunized on the recommended schedule and received his first MMR  at the age of 12 months. Prior to this time, the boy had appropriate speech and above-average cognitive abilities, but he stopped progressing after his first birthday and then went on to lose previously acquired skills. A developmental evaluation done at a chronological age of 20 months revealed an approximate developmental age of 11-13 months (language, motor, and cognitive). Autistic symptoms are now apparent and a diagnosis of autism is forthcoming. The mother also developed severe arthritis of her knees, ankles, and hips following her own vaccination. Upon internal review, autistic symptoms were considered to be other important medical event (OMIC). No further information is expected.
Sex: F
Vaccine: MMR
Symptoms: Arthritis, Unintended pregnancy
Clinical narrative: Information has been received from two health professionals the authors of a literature article, concerning a female who had measles and rubella as a child, who was found to be rubella susceptible when she was pregnant in 1984, 1986, 1992 and 1998, and who was vaccinated with measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot not reported) in the immediate postpartum period of her last pregnancy. It was also reported that she received no vaccines following the first three pregnancies. Her two older children (a boy, age 16, and a girl, age 13) are healthy. A third infant died at age 2 days from prematurity related complications. Subsequently, the pt developed severe arthritis of her knees, ankles, and hips following her own vaccination. The authors also reported that her baby boy developed autistic symptoms after his vaccination with measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (WAES0404USA00066). Upon internal review, severe arthritis of her knees, ankles, and hips was considered to be an other important medical event (OMIC). Additional information is not expected.
Age: 51.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Arthropathy, Bacterial infection, Delirium, Depression
Clinical narrative: Neuropathies in hands and feet. Neurologic implications throughout body, burning pain. Brain spect abnormal. Severe joint pain, shoulders, hips, and elbows. Symptoms began about 1 year after third shot. All symptoms have progressed since Spring 2002. Informed that problems are permanent. No treatment known. Nurse follow up on 06/28/04 states: "Per review of medical records, please add the following symptoms to Box 7: hyperacusis (HYPERACUSIS), numbness (PARESTHESIA), TMJ (JOINT DIS), tinnitus (TINNITUS), myalgia (MYALGIA), reactive depression (DEPRESSION), weight loss (WEIGHT DEC), sleeping poorly (insomnia), and chronic Lyme disease (INFECT). "
Age: 51.0
Sex: M
Vaccine: LYME
Symptoms: Hyperacusis, Insomnia, Laboratory test abnormal, Myalgia, Nervous system disorder
Clinical narrative: Neuropathies in hands and feet. Neurologic implications throughout body, burning pain. Brain spect abnormal. Severe joint pain, shoulders, hips, and elbows. Symptoms began about 1 year after third shot. All symptoms have progressed since Spring 2002. Informed that problems are permanent. No treatment known. Nurse follow up on 06/28/04 states: "Per review of medical records, please add the following symptoms to Box 7: hyperacusis (HYPERACUSIS), numbness (PARESTHESIA), TMJ (JOINT DIS), tinnitus (TINNITUS), myalgia (MYALGIA), reactive depression (DEPRESSION), weight loss (WEIGHT DEC), sleeping poorly (insomnia), and chronic Lyme disease (INFECT). "
Age: 51.0
Sex: M
Vaccine: LYME
Symptoms: Neuropathy, Paraesthesia, Shoulder pain, Tinnitus, Weight decreased
Clinical narrative: Neuropathies in hands and feet. Neurologic implications throughout body, burning pain. Brain spect abnormal. Severe joint pain, shoulders, hips, and elbows. Symptoms began about 1 year after third shot. All symptoms have progressed since Spring 2002. Informed that problems are permanent. No treatment known. Nurse follow up on 06/28/04 states: "Per review of medical records, please add the following symptoms to Box 7: hyperacusis (HYPERACUSIS), numbness (PARESTHESIA), TMJ (JOINT DIS), tinnitus (TINNITUS), myalgia (MYALGIA), reactive depression (DEPRESSION), weight loss (WEIGHT DEC), sleeping poorly (insomnia), and chronic Lyme disease (INFECT). "
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypoaesthesia, Injection site induration, Paraesthesia, Pruritus
Clinical narrative: Left arm red, hard, tender to touch. Itching, tingly, slight numbness intermittent through arm. 4"x2" area of erythema.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: Left arm red, hard, tender to touch. Itching, tingly, slight numbness intermittent through arm. 4"x2" area of erythema.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Amnesia, Arthralgia, Fatigue, Gastrointestinal disorder, Headache
Clinical narrative: Irritable bowel syndrome, joint and muscle pain, fatigue, tingling in fingers, memory loss, new onset headaches. See clinical summary.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Laboratory test abnormal, Myalgia, Paraesthesia
Clinical narrative: Irritable bowel syndrome, joint and muscle pain, fatigue, tingling in fingers, memory loss, new onset headaches. See clinical summary.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion
Clinical narrative: 3/4/04 Mother called to report "seizure in son at 6pm". See report from hospital ER.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness at site. 6cmx5cm raised area. Dr advised to apply cold and hot compresses and apply Benadryl Cream to site.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot
Clinical narrative: Entire thigh area red and warm to touch.
Age: 4.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Started with small red area late afternoon on 3-9-04. Once pt. awoke on 3-10-04 grandma noted redness with swelling from knee up to top of thigh starting to wrap around thigh. No temperature. Painful if touched. No vomiting.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Convulsion, Otitis media, Pyrexia, Swelling
Clinical narrative: High fever of 103 and possible seizures and swelling per dad phone call.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Left upper arm--cellulitis around site of injection. Tx: Cefzil 180 mg BID po x 5 days
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cough, Respiratory rate decreased, Urticaria, Wheezing
Clinical narrative: Client broke out in hives, began coughing, decreased breath sounds with wheeze. Sent to ED.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Rash, Rash maculo-papular
Clinical narrative: 1 day following MMR and IPV right thigh and DTaP left thigh, pt. developed redness over right anterior thigh; no other symptoms on exam, 6x9 cm red splotchy rash over vaccine zone.
Age: 1.2
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 3/15/04 Imm. Right arm reddened at immunization site 50x40mm - also swollen. Right arm reddened at immunization site deltoid 20x25 mm
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Hypoaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: Client had numbness in jaw and left side of face approximately within 2 hours of Td. By next morning some numbness in jaw only, resolved by the afternoon. That afternoon redness appeared and swelling at site of injection. As of 3-22-04 area still reddened.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site nodule, Irritability, Pain
Clinical narrative: 2x nodules 0.5x1cm each at anterior-lateral thigh at the site of vaccinaiton. Right thigh. Fussy acting like leg hurts since shots.
Age: 41.0
Sex: F
Vaccine: HEP, TD
Symptoms: Myalgia, Pain
Clinical narrative: 2/13 arm soreness started. Constant arm pain until 2/19. Pain worsened from 2/19 through 2/20/04. Presented to doctor on 2/20 who prescribed muscle relaxants, antiinflammatories and acetaminophen.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Tenderness, Urticaria
Clinical narrative: Client called  Health Dept on 1/15/04 around 1:15pm to report that on 1/14/04 around 2pm that her right arm in deltoid region became red, sore and swollen and then began getting hives on right arm. Client called her Drs office around 5pm on 1/14/04 to report symptoms. Was Rx Atarax to take TID for itching. States hives continue on 1/15/04 on right arm down to elbow. Instructed client to call her physician if symptoms worsen if hives increase and/or any difficulty breathing.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Asthma, Dehydration, Pneumonia, Pyrexia, Tonsillitis
Clinical narrative: 12 hours post shot ran fever. Saturday went to ER. Pneumonia and dehydrated. Placed on antibiotics. Had pneumonia again 1yr later (2/03). Developed asthma 10/03. Started with tonsillitis. Child appeared to be healthy until this shot.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Nasal congestion, Pyrexia, Vomiting
Clinical narrative: Temp 99; Vomiting, nasal congestion, vomited several times post immunization. Took 5AM feeding and kept down. Vomited again later in morning. Taking Tylenol for temp (with vomiting). 3/31/04 Talked with child's mother. States child is fine now. Dr. was notified after mother talked to me and was given something for vomiting.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Injection site induration
Clinical narrative: 31.5x7cm area of increased erythema , heat and induration over deltoid surface of left upper arm.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site hypersensitivity, Injection site swelling, Pruritus
Clinical narrative: DTaP to right thigh one day later with swelling and itching to area. Max 4cmx6cm.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Abscess
Clinical narrative: Sterile abcess left arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Swelling and redness about 14.5x9.5cm left thigh.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cough, Erythema, Pruritus, Rash, Wheezing
Clinical narrative: Child received vaccinations listed below, less than 30 minutes later child developed intense erythematous, pruritic rash covering all body severe now.  Also wheezing and paropysm of cough, treated with Decodron 8mg IM, Albuterol Neb 2.5mg and Benadryl with now complete resolution of symtpoms by 1 hour post treatment.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Headache, Injection site erythema, Injection site oedema, Pyrexia, Urticaria
Clinical narrative: Swelling/redness at sight of injection of MMR (right arm).  Hives right side of body.  Headache, low grade fever.
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Marked erythema and induration from shoulder to elbow of right upper arm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Red, hot, swollen, tender, indurated arm.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cellulitis, Irritability
Clinical narrative: Left thigh with 12cm red streak beginning at immunization site.  Non-tender to touch, mom states streak subsiding.  No fever, baby irritable.
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site warmth, Pruritus
Clinical narrative: Pt received DTAP right thigh upper 5cc and IPV lower IM 5cc. on 03/29/04.  Father of child states child had redness, warm to touch, itchy upper thigh on Tuesday 03/30/04 AM.  Father of child came to our office on 04/01/04 to have pt evaluated.
Age: 0.6
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Cyanosis, Hypotonia, Hypoventilation, Pyrexia
Clinical narrative: Night of vaccination (several hours had elapsed), pt had episode of going limp, shallow breathing, circum oral cyanosis.  Slight fever had been noted.  Called paramedics-episode had resolved when they arrived.  Not taken to an ER.
Age: 8.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Myalgia, Pyrexia
Clinical narrative: History of questionable immunodeficiency, recurrent pneumonia given Prevnar 2 years ago.  Received Pneumovax as part of Polysaccharide Antibody workup on 11/10/03 in 24 hours developed pain/swelling at site, fever to 103F, myalgias.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Rash macular
Clinical narrative: Red blotches on bilateral arms from elbows to wrists which started 5 hours after hepatitis B vaccination and IPPD placement.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 9x6 inch hot, erythematous reaction to upper left arm within 48 hours of administration.  Treated with Benadryl 2 tsp every 6 hours.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Varicella in vaccinated pt.  Seen 03/18/2004 in office (Age 5 11/12 when examined to confirm diagnosis).
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Pt developed a red, indurated, tender area around vaccination site antoroluturol right thigh but mother only reported it today.  Today area is dark, red, irregular, indurated, not tender no nodes.  6x5cm.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erytematous, indurated area around site of injection.  Small red spot remains.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Developed varicella rash 04/01/02.
Sex: M
Vaccine: UNK
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: Left deltoid red and warm to touch.