chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 2 days post injection pt. was seen. There was redness at the site measuring 10cm x 6 1/2 cm. Pt. complains of moderate pain. The pt. is being treated with Benadryl.
Age: 48.0
Sex: F
Vaccine: HEPAB, IPV, TYP
Symptoms: Pyrexia
Clinical narrative: Fever 5/1/07 --> 5/5/07 (99.8), large, painful gland base of neck. Treatment: lemon juice. Saw chiropractor - detox treatment, lives meridian bio-resonance therapy. Pain relieved after treatment.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Screaming
Clinical narrative: Baby had high pitched screaming > 3 hours. Temp 98.9 but had given Tylenol every 4 hours.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Pharyngolaryngeal pain
Clinical narrative: Employee received Hep B vaccine (1st shot) in 05/31/07, 0830am complain of sore throat since 430pm 05/31/07. Seem to get worse overnight. No temp increased, no redness or inflammation at injection site. Doctor notified 0830 06/01/07.
Age: 6.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Induration, Swelling
Clinical narrative: Swollen and indurated approximately 6cm.
Age: 0.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: MMR and Varicella vaccinations given at 4 months. No adverse signs or symptoms occurred. No treatment needed.
Age: 10.0
Sex: F
Vaccine: JEV
Symptoms: Cough, Wheezing
Clinical narrative: 24 hours following Japanese Encephalitis vaccine #2 - cough, wheezing
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Eyelid oedema, Headache, Lip swelling, Neck pain, Pyrexia
Clinical narrative: Fever, severe headache, neck pain, swelling of eyelids and lips (and fingertips).
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Dyspnoea, Hypoaesthesia, Nervousness, Vomiting
Clinical narrative: Employee reports dizziness, trouble breathing, nervousness, temp 101.6, numbness right arm for approximately 1 hour all happening evening after injection given. Received injection approximately 345pm 5/31/07. He had vomiting x 1 430am of 6/1/07. He denies swelling, itching, hives or other problems at left arm injection site. He was able to eat breakfast and felt no nausea at 9am 6/1/07. Medical staff notified AM 6/1/07.
Age: 22.0
Sex: M
Vaccine: HEPA
Symptoms: Ear pain, Pharyngolaryngeal pain, Rhinorrhoea, Sinus disorder, Vomiting
Clinical narrative: Sinuses are irritated, runny nose, ear aches, vomiting, coughing, sore throat. Started the next morning after receiving vaccination. Took Tylenol Cold and Sinus day and nighttime, Dayquil and Niquil, sweet oil for earaches.
Age: 5.0
Sex: F
Vaccine: DTAP, MMRV, DTAP, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth, Pain
Clinical narrative: Child presented to HD on 05-31-2007 after receiving injection on 05-29-2007.  Right Tricep area was red, swollen, warm to touch and had several fluid filled bilsters at site.  Mother stated that child had complained with pain the night before.  Mother denied any other complaints. It was determined thru NCIR that this was site of MMRV injection.  Mother was advised on use of motrin and referred to Private Provider.
Age: 5.0
Sex: F
Vaccine: DTAP, MMRV, DTAP, MMRV
Symptoms: Discomfort, Injection site erythema, Injection site rash, Injection site swelling, Injection site vesicles
Clinical narrative: Child presented to HD on 05-31-2007 after receiving injection on 05-29-2007.  Right Tricep area was red, swollen, warm to touch and had several fluid filled bilsters at site.  Mother stated that child had complained with pain the night before.  Mother denied any other complaints. It was determined thru NCIR that this was site of MMRV injection.  Mother was advised on use of motrin and referred to Private Provider.
Age: 5.0
Sex: F
Vaccine: DTAP, MMRV, DTAP, MMRV
Symptoms: Injection site warmth, Scab
Clinical narrative: Child presented to HD on 05-31-2007 after receiving injection on 05-29-2007.  Right Tricep area was red, swollen, warm to touch and had several fluid filled bilsters at site.  Mother stated that child had complained with pain the night before.  Mother denied any other complaints. It was determined thru NCIR that this was site of MMRV injection.  Mother was advised on use of motrin and referred to Private Provider.
Age: 1.17
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Pt received Varicella vaccine in summer of 2006. Contracted varicella (was seen in office and diagnosed by primary care provider) May, 2007.
Age: 0.71
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: No adverse event occurred.  Child received RotaTeq dose #2 at 37 weeks of age which was outside of licensing guidelines.
Age: 29.0
Sex: F
Vaccine: ANTH
Symptoms: Cold sweat, Dermatitis contact, Palpitations, Rash vesicular
Clinical narrative: In 2004 I took the 1st, 2nd, and 3rd (Oct 04) anthrax shot right before it was taken off the market.  After the second and third shot I experience very strong heart palpatations with a cold sweat on four different occasions.  The fourth occasion happened on (Feb 2005) and had someone drive me to the ER.  They documented it in my records as Chest Wall Syndrome, but I know my body and have been VERY healthy my entire life and never experience chest pains before.  I have not experienced anything like that since, but in Jan 05 I developed a very nasty rash on the back of my neck.  Not a typical rash, but actually raised off my skin and it was oozing.  I had never seen anything like it, so I decided to go to the ER to find out exactly what it was.  He said it looked like an allergic reaction and prescribed some sort of steroid.  When I got back it was not completely gone so went to the Doc where he refered me to dermatology.  The dermatologist said it looked like contact dermatitis, possibly from my necklace.  I informed him I had worn the necklace for 10 years and never experienced a rash like that.  He stuck to his guns and stated contact dermatitis in my records.  Currently, my job is making it mandatory to take Anthrax shots again and I know in my reactions listed above have something to do with the shot.  Is there anything I can do to get a waiver of some sort.  I do not want to loose my career, nor do I want to put myself at health risks from the shot.  Any suggestions?
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Low grade fever; moderate swelling of right arm
Age: 31.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Angina pectoris, Aspartate aminotransferase increased, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Catheterisation cardiac abnormal
Clinical narrative: Myopericarditis following smallpox vaccination. Body aches began ~5/26, but were attributed to body armor - took 1000mg Tylenol evening of 5/27; woke up with CP on morning of 5/28. Pt presented at hospital with body aches and chest pain (sharp pain upon inspiration) on morning of 5/28.  Transferred morning of 5/28 by Rural/Metro Ambulance to another Hospital. Treated in route w/ IV, 324 mg baby aspirin and oxygen administered by nasal canula. Presented at hospital with angina.  Hospitalized 5/28-5/30.  06/04/2007 MR received for hospitalization 5/28-30/2007 for initial onset of body aches x 2 days preceding an episode of chest pain on 5/28/2007.  Chest pain was worst lying down and improved upon sitting or standing.  Initially seen at another facility where he was noted to have an ST elevation on EKG and elevated troponin.  Transfered to current facility for eval and tx. DX: Likely small-pox vaccination associated Myopericarditis. 08/03/2007 F/U records received from military.  DX: probable vaccinia related myopericarditis.
Age: 31.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chest pain, Echocardiogram, Electrocardiogram abnormal, Metabolic function test abnormal, Myopericarditis
Clinical narrative: Myopericarditis following smallpox vaccination. Body aches began ~5/26, but were attributed to body armor - took 1000mg Tylenol evening of 5/27; woke up with CP on morning of 5/28. Pt presented at hospital with body aches and chest pain (sharp pain upon inspiration) on morning of 5/28.  Transferred morning of 5/28 by Rural/Metro Ambulance to another Hospital. Treated in route w/ IV, 324 mg baby aspirin and oxygen administered by nasal canula. Presented at hospital with angina.  Hospitalized 5/28-5/30.  06/04/2007 MR received for hospitalization 5/28-30/2007 for initial onset of body aches x 2 days preceding an episode of chest pain on 5/28/2007.  Chest pain was worst lying down and improved upon sitting or standing.  Initially seen at another facility where he was noted to have an ST elevation on EKG and elevated troponin.  Transfered to current facility for eval and tx. DX: Likely small-pox vaccination associated Myopericarditis. 08/03/2007 F/U records received from military.  DX: probable vaccinia related myopericarditis.
Age: 31.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Oxygen supplementation, Pain, Troponin increased
Clinical narrative: Myopericarditis following smallpox vaccination. Body aches began ~5/26, but were attributed to body armor - took 1000mg Tylenol evening of 5/27; woke up with CP on morning of 5/28. Pt presented at hospital with body aches and chest pain (sharp pain upon inspiration) on morning of 5/28.  Transferred morning of 5/28 by Rural/Metro Ambulance to another Hospital. Treated in route w/ IV, 324 mg baby aspirin and oxygen administered by nasal canula. Presented at hospital with angina.  Hospitalized 5/28-5/30.  06/04/2007 MR received for hospitalization 5/28-30/2007 for initial onset of body aches x 2 days preceding an episode of chest pain on 5/28/2007.  Chest pain was worst lying down and improved upon sitting or standing.  Initially seen at another facility where he was noted to have an ST elevation on EKG and elevated troponin.  Transfered to current facility for eval and tx. DX: Likely small-pox vaccination associated Myopericarditis. 08/03/2007 F/U records received from military.  DX: probable vaccinia related myopericarditis.
Age: 0.25
Sex: F
Vaccine: HIBV, PNC
Symptoms: Erythema, Irritability, Swelling
Clinical narrative: Redness, Objective swelling, irritability within a few hours of injection
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Feeling hot, Irritability, Skin warm, Unresponsive to stimuli
Clinical narrative: Patient seen for 4 month well child check on 4/11/2007.  Normal exam.  Received routine vaccines.  That evening, patient noted to be fussy.  Improved by 10pm.  Placed face down in parents bed.  Mother awoke at 5am to find infant hot, unresponsive.  Called EMS.  Patient unable to be resuscitated and expired.  7/31/07 Received autopsy report which states COD as undetermined & manner of death as undetermined.  Patient found unresponsive in prone position while co-sleeping w/parents in adult bed.  Temp in ER was 103.2.  No congenital anomalies or traumatic injuries found at autopsy. Tox & metabolic tests were neg.  Cultures were non contributory.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Eczema, Molluscum contagiosum, Pruritus, Urticaria
Clinical narrative: Within a day began red bump outbreak that was inflamed.  With in two weeks what I thought was excema spread behind her knees.  Within a month it spread up her legs , within a year out of control red whleps and blisters insane itching, totally misdiagnosed during this time, ultiamtely diagnosed with Molluscum and Excema.  I believe she contracted the Molluscum Pox virus from the vaccine for Chicken pox becasue I can pinpoint her symptoms to the vaccine and not before.  She has subsequently missed weeks of school and had very painful treatments to try and rid herslef of this pox virus.  I believe the Chicken Pox vaccine in conjunction with her mild execema prior to the vaccination caused her to get Molluscum.  Her immune system is wrecked as a  result of the ongoing Molluscum and Execma.  I can't help but wonder how many other children with execma have the same thing happen after their chicken pox vaccine?
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Pyrexia, Skin warm, Vomiting
Clinical narrative: Vomiting, fever and a 7 x 4 1/4 cm red,swollen, warm to touch area on the R posterior upper arm. Patient was alreaday on Doxycycline for ear cellulitis.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: mmrv given 2 days ago to rlt. moc noted redness and swollen. pt seen in appointment today. Dr. assessment noted rt lateral thigh with errythematous edematous area 1.5 x 20 cm nontender to palpation.
Age: 46.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Nausea, Pyrexia
Clinical narrative: fever of 104degrees,fever lasted 2-3 days but did not remain 104 degrees. Nausea x 2-3 days redness, swelling, peeling of skin, and hardness @ site(right deltoid.
Age: 46.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Skin exfoliation
Clinical narrative: fever of 104degrees,fever lasted 2-3 days but did not remain 104 degrees. Nausea x 2-3 days redness, swelling, peeling of skin, and hardness @ site(right deltoid.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Rash pruritic
Clinical narrative: Patient called on 06/01/07 to report that he developed a rash on his right lower back on 05/28/07.  The rash is itchy but not painful.  He saw Dr. on 06/01/07 who diagnosed his with Shingles.  Patient was given Valtrex one gram twice a day po.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: Patient called on 06/01/07 to report that he developed a rash on his right lower back on 05/28/07.  The rash is itchy but not painful.  He saw Dr. on 06/01/07 who diagnosed his with Shingles.  Patient was given Valtrex one gram twice a day po.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Discomfort, Herpes zoster, Pruritus, Rash
Clinical narrative: Patient called on 06/01/07 to report that he developed a rash on his right lower back on 05/28/07.  The rash is itchy but not painful.  He saw Dr. on 06/01/07 who diagnosed his with Shingles.  Patient was given Valtrex one gram twice a day po.
Sex: U
Vaccine: HEPA, PNC, TDAP, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: TDAP GIVEN IN ERROR, CHILD SHOULD HAVE RECEIVED DTAP
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Gait disturbance, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt c/o of swollen left leg from mid thigh down below knee. Site is red and warm to touch. Pt was limping.
Age: 63.0
Sex: F
Vaccine: RUB, VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Fever 10 day post vaccination, rash on trunk on 14 days post vaccine.  No other symptoms at this time
Age: 39.0
Sex: M
Vaccine: MMR
Symptoms: Ear pain, Pain in jaw
Clinical narrative: Patient called on 5/31/07 in pm to report that after receiving MMR on 5/15/07 he began having problems with "intense jaw pain" and "pain near his ears." States that the pain started about 48 hrs. after receiving the vaccine. He reported no other symptoms, but stated that the pain has remained persistent and has not seemed to improve. I called our Chief Medical Officer, who didn't feel the problem was vaccine-related, but suggested that I file a VAERS report. Patient stated that he had not yet sought medical treatment. I advised him to contact his primary care physician about pain.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Soreness, stiffness, redness, swelling, induration and tenderness at injection site, developing 24 - 48 hours after injection.
Age: 51.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Induration, Injection site mass, Injection site pruritus
Clinical narrative: Second anthrax vaccine received 24 May 07.  Area of induration and erythema and itching minimum 3 by 4 inches in dimension lasting greater than 9 days.  Site of first vaccination on left arm also continues to itch and with marble sized lump in each site.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Dehydration, Diarrhoea, Occult blood negative, Weight decreased
Clinical narrative: Diarrhea, mild dehydration, weight loss over 1 week
Age: 37.0
Sex: F
Vaccine: ANTH
Symptoms: Headache, Nausea, Paraesthesia, Swelling, Tenderness
Clinical narrative: 5cm Rt bicep tenderness, swelling, tingling distally and also headache and nausea/vomiting x2. No errythenia & No fever/chills.
Age: 37.0
Sex: F
Vaccine: ANTH
Symptoms: Vomiting
Clinical narrative: 5cm Rt bicep tenderness, swelling, tingling distally and also headache and nausea/vomiting x2. No errythenia & No fever/chills.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash rubelliform
Clinical narrative: Information has been received from a physician concerning a 12 month old male with no known allergies or pertinent medical history who on 01-AUG-2003 was vaccinated SC with a 0.5 dose of MMR II (lot # 640728/1376L). The patient was afebrile though illness at the time of vaccination included an ear infection. Concomitant therapy included amoxicillin/clavulanate potassium (AUGMENTIN) for treatment of the ear infection. On 07-AUG-2003 the patient developed a rubella like rash and fever. The patient was seen at the practice again on 09-AUG-2003 and was treated with over the counter acetaminophen (TYLENOL) and diphenhydramine hydrochloride (BENADRYL). There were no labs performed. Subsequently, the patient fully recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL, DTAP, MMR
Symptoms: Agitation, Body temperature increased, Flushing, Oxygen saturation, Pruritus
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 4-year-old male (previously reported as 5) with a cleft lip and no known drug allergies who on 01-SEP-2005 (previously reported as "four to four and a half months ago" in approximately February 2006) was vaccinated with a second dose of MMR II. Suspect vaccination included a fourth dose of DTaP. It was reported that "30 minutes after injection" the patient experienced trouble breathing. The nurse reported that medical treatment was sough and the patient was treated for a anaphylactic reaction. The patient was taken to the hospital but the nurse was unsure if he was admitted. The outcome was reported as recovered. It was noted that the experience was "previously reported on 02-SEP-2005". No product quality complaint was involved. The reporter considered trouble breathing to be an other important medical event. It was reported that the patient had an adverse experience after vaccination with varicella virus vaccine live (Oka/Merck) (MSD) (WAES# 0607USA05677). Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL, DTAP, MMR
Symptoms: Reaction to previous exposure to any vaccine
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 4-year-old male (previously reported as 5) with a cleft lip and no known drug allergies who on 01-SEP-2005 (previously reported as "four to four and a half months ago" in approximately February 2006) was vaccinated with a second dose of MMR II. Suspect vaccination included a fourth dose of DTaP. It was reported that "30 minutes after injection" the patient experienced trouble breathing. The nurse reported that medical treatment was sough and the patient was treated for a anaphylactic reaction. The patient was taken to the hospital but the nurse was unsure if he was admitted. The outcome was reported as recovered. It was noted that the experience was "previously reported on 02-SEP-2005". No product quality complaint was involved. The reporter considered trouble breathing to be an other important medical event. It was reported that the patient had an adverse experience after vaccination with varicella virus vaccine live (Oka/Merck) (MSD) (WAES# 0607USA05677). Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL, DTAP, MMR
Symptoms: Anaphylactic reaction, Dyspnoea, Reaction to previous exposure to any vaccine
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 4-year-old male (previously reported as 5) with a cleft lip and no known drug allergies who on 01-SEP-2005 (previously reported as "four to four and a half months ago" in approximately February 2006) was vaccinated with a second dose of MMR II. Suspect vaccination included a fourth dose of DTaP. It was reported that "30 minutes after injection" the patient experienced trouble breathing. The nurse reported that medical treatment was sough and the patient was treated for a anaphylactic reaction. The patient was taken to the hospital but the nurse was unsure if he was admitted. The outcome was reported as recovered. It was noted that the experience was "previously reported on 02-SEP-2005". No product quality complaint was involved. The reporter considered trouble breathing to be an other important medical event. It was reported that the patient had an adverse experience after vaccination with varicella virus vaccine live (Oka/Merck) (MSD) (WAES# 0607USA05677). Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL, MMR, PNC, VARCEL
Symptoms: Condition aggravated, Febrile convulsion
Clinical narrative: Information has been received Wyeth for Prevnar and was assigned manufacturer report number HQWYE491023MAR06. This was originally reported from a physician concerning a 4-year-old male with a history of febrile seizures who on 07-MAR-2006 was vaccinated SC (also reported as IM) with a second dose of MMR II (Lot # 650099/0582R). Suspect therapy that day included a 0.5mL third dose of Prevnar (Batch # B08643F) administered IM and a first dose of Varivax (Lot # 651052/0562R) administered SC (also reported as IM). Concomitant therapy included a fourth dose of ActHib (Batch # UE036AA) administered IM. On 11-MAR-2006 the patient developed a febrile seizure and was hospitalized for 3 days. On 13-MAR-2006, the patient recovered and was discharged from the hospital. No additional information was available at the time of the report. Follow up information received from a physician indicated that on 10-MAR-2006, the child was admitted to the hospital for 2 days for a febrile seizure. The outcome was reported as recovered. The reporter considered the febrile seizure to be immediately life-threatening. The records of testing prior to release of the lots in question (Lot # 650099/0582R and Lot # 651052/0562R) have been rechecked and found to be satisfactory. The lots met the requirements and were released by the regulatory agency. No additional information is expected.
Age: 4.0
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL, MMR, PNC, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Information has been received Wyeth for Prevnar and was assigned manufacturer report number HQWYE491023MAR06. This was originally reported from a physician concerning a 4-year-old male with a history of febrile seizures who on 07-MAR-2006 was vaccinated SC (also reported as IM) with a second dose of MMR II (Lot # 650099/0582R). Suspect therapy that day included a 0.5mL third dose of Prevnar (Batch # B08643F) administered IM and a first dose of Varivax (Lot # 651052/0562R) administered SC (also reported as IM). Concomitant therapy included a fourth dose of ActHib (Batch # UE036AA) administered IM. On 11-MAR-2006 the patient developed a febrile seizure and was hospitalized for 3 days. On 13-MAR-2006, the patient recovered and was discharged from the hospital. No additional information was available at the time of the report. Follow up information received from a physician indicated that on 10-MAR-2006, the child was admitted to the hospital for 2 days for a febrile seizure. The outcome was reported as recovered. The reporter considered the febrile seizure to be immediately life-threatening. The records of testing prior to release of the lots in question (Lot # 650099/0582R and Lot # 651052/0562R) have been rechecked and found to be satisfactory. The lots met the requirements and were released by the regulatory agency. No additional information is expected.
Age: 64.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Blood cholesterol increased, Blood count normal, Blood sodium decreased, Blood test normal
Clinical narrative: Information has been received from a physician's assistant (PA) concerning a 64-year-old white male with no medical history or allergies and elevated cholesterol and hypertension who on 18-APR-2006, at 1530, was vaccinated SC in the right upper extremity with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3) (Lot #652018/1057R). There was no illness at the time of vaccination. Concomitant therapy included atenolol, atorvastatin Ca (LIPITOR) and clemastine fumarate (TAVIST). The PA reported that on 24-APR-2006, at 2200, the patient developed a fever of 102, a rash on his arms, legs and trunk, a headache and joint(s) pain (aching). On 25-APR-2006, the patient also developed nausea, sore throat and a stiff neck. The patient was evaluated in the Emergency Room (ER). A complete blood count (CBC), blood chemistry (with the exception of a slightly low sodium (134 mEq/L)) and a chest x-ray were all within normal limits. A mumps immunoglobulin M test was negative. The patient was not hospitalized and was treated with doxycycline. On 26-JUN-2006, the patient recovered from the fever, sore throat, stiff neck, headache, joint pain and rash. Additional information is not expected.
Age: 64.0
Sex: M
Vaccine: MMR
Symptoms: Body temperature increased, Chest X-ray normal, Headache, Hypertension, Mumps antibody test negative
Clinical narrative: Information has been received from a physician's assistant (PA) concerning a 64-year-old white male with no medical history or allergies and elevated cholesterol and hypertension who on 18-APR-2006, at 1530, was vaccinated SC in the right upper extremity with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3) (Lot #652018/1057R). There was no illness at the time of vaccination. Concomitant therapy included atenolol, atorvastatin Ca (LIPITOR) and clemastine fumarate (TAVIST). The PA reported that on 24-APR-2006, at 2200, the patient developed a fever of 102, a rash on his arms, legs and trunk, a headache and joint(s) pain (aching). On 25-APR-2006, the patient also developed nausea, sore throat and a stiff neck. The patient was evaluated in the Emergency Room (ER). A complete blood count (CBC), blood chemistry (with the exception of a slightly low sodium (134 mEq/L)) and a chest x-ray were all within normal limits. A mumps immunoglobulin M test was negative. The patient was not hospitalized and was treated with doxycycline. On 26-JUN-2006, the patient recovered from the fever, sore throat, stiff neck, headache, joint pain and rash. Additional information is not expected.
Age: 64.0
Sex: M
Vaccine: MMR
Symptoms: Musculoskeletal stiffness, Nausea, Pharyngolaryngeal pain, Pyrexia, Rash generalised
Clinical narrative: Information has been received from a physician's assistant (PA) concerning a 64-year-old white male with no medical history or allergies and elevated cholesterol and hypertension who on 18-APR-2006, at 1530, was vaccinated SC in the right upper extremity with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3) (Lot #652018/1057R). There was no illness at the time of vaccination. Concomitant therapy included atenolol, atorvastatin Ca (LIPITOR) and clemastine fumarate (TAVIST). The PA reported that on 24-APR-2006, at 2200, the patient developed a fever of 102, a rash on his arms, legs and trunk, a headache and joint(s) pain (aching). On 25-APR-2006, the patient also developed nausea, sore throat and a stiff neck. The patient was evaluated in the Emergency Room (ER). A complete blood count (CBC), blood chemistry (with the exception of a slightly low sodium (134 mEq/L)) and a chest x-ray were all within normal limits. A mumps immunoglobulin M test was negative. The patient was not hospitalized and was treated with doxycycline. On 26-JUN-2006, the patient recovered from the fever, sore throat, stiff neck, headache, joint pain and rash. Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Back pain, Fungal infection, Hypothyroidism, Joint swelling
Clinical narrative: Information has been received from a 55 year old white female, who is a registered nurse, with no known allergies, hypothyroidism and a fungal infection who on 13-APR-2006 was vaccinated SC with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3) (lot# 652321/0093F). Concomitant therapy included levothyroxine sodium and terbinafine (LAMISIL). On 21-APR-2006 the patient developed pain and stiffness in her shoulder, back and hips which was "fairly significant", she was better on 24-APR-2006 and was then okay. On the morning of 27-APR-2006 her right knee was puffy, and then both knees were swollen and "huge". On 28-APR-2006, the patient was seen by her physician who felt that everything was related to vaccination and he advised her not to have another measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3) vaccine. The patient was not treated with anything, and she recovered. The patient thought that all of her symptoms were gone by the middle on May though her physician stated that she could possibly have reccuring episodes. Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Pain
Clinical narrative: Information has been received from a 55 year old white female, who is a registered nurse, with no known allergies, hypothyroidism and a fungal infection who on 13-APR-2006 was vaccinated SC with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3) (lot# 652321/0093F). Concomitant therapy included levothyroxine sodium and terbinafine (LAMISIL). On 21-APR-2006 the patient developed pain and stiffness in her shoulder, back and hips which was "fairly significant", she was better on 24-APR-2006 and was then okay. On the morning of 27-APR-2006 her right knee was puffy, and then both knees were swollen and "huge". On 28-APR-2006, the patient was seen by her physician who felt that everything was related to vaccination and he advised her not to have another measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3) vaccine. The patient was not treated with anything, and she recovered. The patient thought that all of her symptoms were gone by the middle on May though her physician stated that she could possibly have reccuring episodes. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: HEPA, MMR, HEPA, MMR
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a physician concerning a 5-year-old male who on 25-MAY-2006 was vaccinated with a dose of MMR II. Concomitant vaccination on the same day included a dose of HAVRIX. On 25-MAY-2006, the patient had anaphylactic reaction to the vaccine. He was given an epinephrine injection at the physician's office and subsequently recovered. A product quality complaint was not involved. Anaphylactic reaction was considered to be an other important medical event by the reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: HEPA, MMR, HEPA, MMR
Symptoms: Anaphylactic reaction, Cough, No reaction on previous exposure to drug, Pruritus, Rash
Clinical narrative: Information has been received from a physician concerning a 5-year-old male who on 25-MAY-2006 was vaccinated with a dose of MMR II. Concomitant vaccination on the same day included a dose of HAVRIX. On 25-MAY-2006, the patient had anaphylactic reaction to the vaccine. He was given an epinephrine injection at the physician's office and subsequently recovered. A product quality complaint was not involved. Anaphylactic reaction was considered to be an other important medical event by the reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: HEPA, MMR, HEPA, MMR
Symptoms: Respiratory distress, Urticaria, Wheezing
Clinical narrative: Information has been received from a physician concerning a 5-year-old male who on 25-MAY-2006 was vaccinated with a dose of MMR II. Concomitant vaccination on the same day included a dose of HAVRIX. On 25-MAY-2006, the patient had anaphylactic reaction to the vaccine. He was given an epinephrine injection at the physician's office and subsequently recovered. A product quality complaint was not involved. Anaphylactic reaction was considered to be an other important medical event by the reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: HEPA, MMR, HEPA, MMR
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a Registered Nurse and GlaxoSmithKline (assigned manufacturer report number A060782A) concerning a 5 year old male patient with no pre-existing medical conditions, birth defects, or allergies who on 25-MAY-2006 at 12:20 PM was vaccinated SQ in the left arm with his 2nd dose of MMR II (lot #651110/1048R). There was no illness at the time of vaccination. The patient also received a first dose of Havrix (AHAVA305AA) administered IM in the right arm at the same time. There were n o other concomitant medications. On 25-MAY-2006 at 12:30 PM, 10 minutes after vaccination, the nurse reported that the patient developed an anaphylactic reaction with the dose of MMR II (LOT #651110/1048R). While still in the office, the patient developed an itch and cough. His symptoms also developed into wheezing and the development of hives. He was noted to have an acute anaphylactic reaction with respiratory distress and subsequent rash. The patient was treated in the office with SC epinephrine, IV dexamethasone (manufacturer not reported), oral Benadryl, and Xopenex. The patient was seen in the office over a 4 hour period (outcome recovered, unspecified date) and he was referred to an allergist. The vaccination course with Havrix was discontinued. There was no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations of the patient or his siblings. It was reported that the patient received his initial dose of MMR II on 15-MAY-2002 and that he experienced no symptoms at that time. The reporter considered anaphylactic reaction to be immediately life-threatening and an other important medical event. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards and was released. The nurse considered the events to possibly be related to vaccination with Havrix and MMR II. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: HEPA, MMR, HEPA, MMR
Symptoms: Anaphylactic reaction, Cough, No reaction on previous exposure to drug, Pruritus, Rash
Clinical narrative: Information has been received from a Registered Nurse and GlaxoSmithKline (assigned manufacturer report number A060782A) concerning a 5 year old male patient with no pre-existing medical conditions, birth defects, or allergies who on 25-MAY-2006 at 12:20 PM was vaccinated SQ in the left arm with his 2nd dose of MMR II (lot #651110/1048R). There was no illness at the time of vaccination. The patient also received a first dose of Havrix (AHAVA305AA) administered IM in the right arm at the same time. There were n o other concomitant medications. On 25-MAY-2006 at 12:30 PM, 10 minutes after vaccination, the nurse reported that the patient developed an anaphylactic reaction with the dose of MMR II (LOT #651110/1048R). While still in the office, the patient developed an itch and cough. His symptoms also developed into wheezing and the development of hives. He was noted to have an acute anaphylactic reaction with respiratory distress and subsequent rash. The patient was treated in the office with SC epinephrine, IV dexamethasone (manufacturer not reported), oral Benadryl, and Xopenex. The patient was seen in the office over a 4 hour period (outcome recovered, unspecified date) and he was referred to an allergist. The vaccination course with Havrix was discontinued. There was no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations of the patient or his siblings. It was reported that the patient received his initial dose of MMR II on 15-MAY-2002 and that he experienced no symptoms at that time. The reporter considered anaphylactic reaction to be immediately life-threatening and an other important medical event. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards and was released. The nurse considered the events to possibly be related to vaccination with Havrix and MMR II. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: HEPA, MMR, HEPA, MMR
Symptoms: Respiratory distress, Urticaria, Wheezing
Clinical narrative: Information has been received from a Registered Nurse and GlaxoSmithKline (assigned manufacturer report number A060782A) concerning a 5 year old male patient with no pre-existing medical conditions, birth defects, or allergies who on 25-MAY-2006 at 12:20 PM was vaccinated SQ in the left arm with his 2nd dose of MMR II (lot #651110/1048R). There was no illness at the time of vaccination. The patient also received a first dose of Havrix (AHAVA305AA) administered IM in the right arm at the same time. There were n o other concomitant medications. On 25-MAY-2006 at 12:30 PM, 10 minutes after vaccination, the nurse reported that the patient developed an anaphylactic reaction with the dose of MMR II (LOT #651110/1048R). While still in the office, the patient developed an itch and cough. His symptoms also developed into wheezing and the development of hives. He was noted to have an acute anaphylactic reaction with respiratory distress and subsequent rash. The patient was treated in the office with SC epinephrine, IV dexamethasone (manufacturer not reported), oral Benadryl, and Xopenex. The patient was seen in the office over a 4 hour period (outcome recovered, unspecified date) and he was referred to an allergist. The vaccination course with Havrix was discontinued. There was no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations of the patient or his siblings. It was reported that the patient received his initial dose of MMR II on 15-MAY-2002 and that he experienced no symptoms at that time. The reporter considered anaphylactic reaction to be immediately life-threatening and an other important medical event. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards and was released. The nurse considered the events to possibly be related to vaccination with Havrix and MMR II. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Hypersensitivity, Petechiae, Urticaria, Wheezing
Clinical narrative: Information has been received from a registered nurse concerning a 4-year-old male with asthma who on 06-JUN-2006 was vaccinated with a second 0.5mL dose of MMR II (Lot # 653317/0211F). It was noted that the child was vaccinated with the first dose of MMR II at 15-months of age. There was no concomitant medication. On 06-JUN-2006, within 5 minutes of vaccination, the patient experienced wheezing, facial petechiae, and hives on his neck. The child was given a nebulizer treatment, and was transported to the hospital via ambulance. The patient's wheezing and facial petechiae and hives on neck persisted. it was noted that the child was discharged from the hospital with a diagnosis of allergic reaction. He was given IV steroids while hospitalized. The patient was noted to be recovering. The nurse requested a lot check on Lot # 653317/0211F. There was no product quality complaint involved. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of an agency and was released by the regulatory agency. Allergic reaction was considered to be immediately life-threatening. Allergic reaction was considered to be disabling. The reporter considered the events to be other important medical events. Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Culture negative, Erythema, Oedema, Rash
Clinical narrative: Information has been received from a physician concerning a 14 month old white male with gastrooesophageal reflux disease and lactose intolerance (pH) who on 03-JUN-2006 during the day was vaccinated SC in the left thigh with a 0.5 mL first dose of MMR II (lot # 653129/0213F). There was no concomitant medication. There was no illness at the time of vaccination. On 03-JUN-2006, in the evening within 12-24 hours of vaccination, the patient had a "rash with bilateral joint pain (ankles-dorsum, knees, elbows), erythematous, edematous, painful according to patient's history." On 05-JUN-2006 the patient presented to the office with arthralgia. A urinalysis and culture and sensitivity were negative. It was noted that the patient had no fever and no egg allergy. The patient recovered on 08-JUN-2006. There was no product quality complaint involved. Additional information is not expected.
Age: 1.2
Sex: M
Vaccine: MMR
Symptoms: Urine analysis normal
Clinical narrative: Information has been received from a physician concerning a 14 month old white male with gastrooesophageal reflux disease and lactose intolerance (pH) who on 03-JUN-2006 during the day was vaccinated SC in the left thigh with a 0.5 mL first dose of MMR II (lot # 653129/0213F). There was no concomitant medication. There was no illness at the time of vaccination. On 03-JUN-2006, in the evening within 12-24 hours of vaccination, the patient had a "rash with bilateral joint pain (ankles-dorsum, knees, elbows), erythematous, edematous, painful according to patient's history." On 05-JUN-2006 the patient presented to the office with arthralgia. A urinalysis and culture and sensitivity were negative. It was noted that the patient had no fever and no egg allergy. The patient recovered on 08-JUN-2006. There was no product quality complaint involved. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: HEP, MMR, PNC, VARCEL
Symptoms: Body temperature decreased, Body temperature increased, Chest X-ray normal, Measles, Pyrexia
Clinical narrative: Information has been received from a physician and a licensed practical nurse (LPN) concerning a 12-month-old white male who, on the morning of 23-MAY-2006 was vaccinated SQ in the right arm with the second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3) (Lot #649817/0728R). Concomitant vaccinations administered on that same day and time included the first SC dose in the left arm of varicella virus vaccine live (MSD) (Lot #652557/1024R), the third IM dose in the left leg of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (MSD) (Lot #651667/0356R) and the fourth IM dose in the right leg of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (Lot #38633K). There was no illness at the time of vaccination. It was reported that on 23-MAY-2006, the patient developed a fever of 104 F. The patient subsequently developed a case of measles. On 25-MAY-2006, the patient was seen by the physician. At that time, his WBC and chest x-ray was normal. On 26-MAY-2006, the patient's temperature had fallen to 99 F and he was noted to be playful. At that time, the patient was considered to be recovered after receiving therapy (unspecified). Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: HEP, MMR, PNC, VARCEL
Symptoms: White blood cell count normal
Clinical narrative: Information has been received from a physician and a licensed practical nurse (LPN) concerning a 12-month-old white male who, on the morning of 23-MAY-2006 was vaccinated SQ in the right arm with the second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3) (Lot #649817/0728R). Concomitant vaccinations administered on that same day and time included the first SC dose in the left arm of varicella virus vaccine live (MSD) (Lot #652557/1024R), the third IM dose in the left leg of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (MSD) (Lot #651667/0356R) and the fourth IM dose in the right leg of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (Lot #38633K). There was no illness at the time of vaccination. It was reported that on 23-MAY-2006, the patient developed a fever of 104 F. The patient subsequently developed a case of measles. On 25-MAY-2006, the patient was seen by the physician. At that time, his WBC and chest x-ray was normal. On 26-MAY-2006, the patient's temperature had fallen to 99 F and he was noted to be playful. At that time, the patient was considered to be recovered after receiving therapy (unspecified). Additional information is not expected.
Age: 1.01
Sex: F
Vaccine: HIBV, PNC, HIBV, MMRV, PNC
Symptoms: Abnormal behaviour, Irritability, Nuclear magnetic resonance imaging brain normal, Pyrexia, Scan brain
Clinical narrative: fever x 7 - 10 days starting 2 days after vaccination, behavior change (irritability alternating with somnolence) starting 14 days after vaccination.  Patient was admitted for evaluation and observation.  Symptoms resolved by the time of discharge (4 days later) and the child has had normal development since that time.  06/11/2007 MR received for 2 admissions (7/15-19/2006 and 7/23-24/2006). Child initially presented 7/15/07 with c/o mental status changes following a week long febrile viral syndrome.  Changes include uncontrollable screaming, restlessness,  behavior changes, excessive sleepiness with difficulty keeping awake.  Child was seen outpatient and had a head CT showing diffuse cerebral edema and was admitted with a dx of encephalitis vs ADEM.  PE: WNL. Txd with steroids, anti-virals, and antibiotics. Discharge DX: Possible Vaccine Associated Encephalomyelitis 2nd admission 7/23 child presented with low grade fever, vomiting and associated intermittant lethargy. Somnolence was similar to episodes from prior admission.  Discharge DX:  Emesis, Fever from unclear etiology, most likely viral-resolved.  S/P Acute disseminated encephalomyelitis, possibly vaccine related.