chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: DTP, HEPA, HEPA, TDAP, VARCEL
Symptoms: Body temperature increased, Dizziness, Injection site erythema, Injection site swelling, Swelling face
Clinical narrative: Red, raised area around injection site approx. 3cm x 6cm.  Hives on trunk and both arms. Swelling of facial area. Dizziness and blurred vision. Temperature of 101.4. Pulse of 118. Parent gave Benedryl at home and saw little improvement. Pt seen in Emergency Room at 11:00 PM. Physician gave Benedryl and steroid by IV. Pt condition improved.  Discharged to home.
Age: 17.0
Sex: F
Vaccine: DTP, HEPA, HEPA, TDAP, VARCEL
Symptoms: Urticaria, Vision blurred
Clinical narrative: Red, raised area around injection site approx. 3cm x 6cm.  Hives on trunk and both arms. Swelling of facial area. Dizziness and blurred vision. Temperature of 101.4. Pulse of 118. Parent gave Benedryl at home and saw little improvement. Pt seen in Emergency Room at 11:00 PM. Physician gave Benedryl and steroid by IV. Pt condition improved.  Discharged to home.
Age: 17.0
Sex: F
Vaccine: DTP, HEPA, HEPA, TDAP, VARCEL
Symptoms: Chest X-ray normal, Ear, nose and throat examination normal, Hypersensitivity, Injection site urticaria, Pruritus
Clinical narrative: Red, raised area around injection site approx. 3cm x 6cm.  Hives on trunk and both arms. Swelling of facial area. Dizziness and blurred vision. Temperature of 101.4. Pulse of 118. Parent gave Benedryl at home and saw little improvement. Pt seen in Emergency Room at 11:00 PM. Physician gave Benedryl and steroid by IV. Pt condition improved.  Discharged to home.
Age: 17.0
Sex: F
Vaccine: DTP, HEPA, HEPA, TDAP, VARCEL
Symptoms: Somnolence, Urticaria
Clinical narrative: Red, raised area around injection site approx. 3cm x 6cm.  Hives on trunk and both arms. Swelling of facial area. Dizziness and blurred vision. Temperature of 101.4. Pulse of 118. Parent gave Benedryl at home and saw little improvement. Pt seen in Emergency Room at 11:00 PM. Physician gave Benedryl and steroid by IV. Pt condition improved.  Discharged to home.
Age: 17.0
Sex: F
Vaccine: DTP, HEPA, HEPA, TDAP, VARCEL
Symptoms: Body temperature increased, Dizziness, Injection site erythema, Injection site swelling, Swelling face
Clinical narrative: Notes from the ER VISIT:----Apparently, it was one of the things for chicken pox and later at the site of the immunization, she developed a large wheel and flare with hive-like reaction and progressively developed hives over her entire trunk and arms. They were quite itchy. She did take two Benadryl tablets at home, but did not feel they were controlling the itching very well. She came into the emergency room to be evaluated and treated further. She has no known history of allergies, specifically not to immunizations or to eggs. She was not having any breathing difficulty or trouble swallowing. It was simply diffuse hives and itching. Her vital signs were normal and her exam of her ears, nose, and throat was normal and the chest was clear. No wheezing or rhonchi. The patient had a good expiratory phase to respiration as well. The skin was diffusely populated with small hive-like lesions that were causing itching and at the site of the immunization, there was a large, probably 5 cm in diameter confluent hive. The presumptive diagnosis then is allergy to either the vehicle or some component of the immunization.   PLAN: She was given IV Benadryl 50 mg and IV Solu-Medrol 125 mg to try to break up the reaction and relieve her itching. Within a matter of minutes, the itching was improved. She was a bit sleepy after that, but comfortable. We observed her for approximately an hour to an hour and a half in the Emergency Room and she showed no untoward signs of progressing allergic reaction. In fact, she was much improved. She was discharged to the home and use her own supply of Benadryl if she has any recurring itching, but return to the hospital ER if she has trouble with breathing or swallowing. She is also encouraged to discuss further with her doctor what she might have been allergic to in that immunization whether it could have been a preservative or a component of the immunization itself.
Age: 17.0
Sex: F
Vaccine: DTP, HEPA, HEPA, TDAP, VARCEL
Symptoms: Urticaria, Vision blurred
Clinical narrative: Notes from the ER VISIT:----Apparently, it was one of the things for chicken pox and later at the site of the immunization, she developed a large wheel and flare with hive-like reaction and progressively developed hives over her entire trunk and arms. They were quite itchy. She did take two Benadryl tablets at home, but did not feel they were controlling the itching very well. She came into the emergency room to be evaluated and treated further. She has no known history of allergies, specifically not to immunizations or to eggs. She was not having any breathing difficulty or trouble swallowing. It was simply diffuse hives and itching. Her vital signs were normal and her exam of her ears, nose, and throat was normal and the chest was clear. No wheezing or rhonchi. The patient had a good expiratory phase to respiration as well. The skin was diffusely populated with small hive-like lesions that were causing itching and at the site of the immunization, there was a large, probably 5 cm in diameter confluent hive. The presumptive diagnosis then is allergy to either the vehicle or some component of the immunization.   PLAN: She was given IV Benadryl 50 mg and IV Solu-Medrol 125 mg to try to break up the reaction and relieve her itching. Within a matter of minutes, the itching was improved. She was a bit sleepy after that, but comfortable. We observed her for approximately an hour to an hour and a half in the Emergency Room and she showed no untoward signs of progressing allergic reaction. In fact, she was much improved. She was discharged to the home and use her own supply of Benadryl if she has any recurring itching, but return to the hospital ER if she has trouble with breathing or swallowing. She is also encouraged to discuss further with her doctor what she might have been allergic to in that immunization whether it could have been a preservative or a component of the immunization itself.
Age: 17.0
Sex: F
Vaccine: DTP, HEPA, HEPA, TDAP, VARCEL
Symptoms: Chest X-ray normal, Ear, nose and throat examination normal, Hypersensitivity, Injection site urticaria, Pruritus
Clinical narrative: Notes from the ER VISIT:----Apparently, it was one of the things for chicken pox and later at the site of the immunization, she developed a large wheel and flare with hive-like reaction and progressively developed hives over her entire trunk and arms. They were quite itchy. She did take two Benadryl tablets at home, but did not feel they were controlling the itching very well. She came into the emergency room to be evaluated and treated further. She has no known history of allergies, specifically not to immunizations or to eggs. She was not having any breathing difficulty or trouble swallowing. It was simply diffuse hives and itching. Her vital signs were normal and her exam of her ears, nose, and throat was normal and the chest was clear. No wheezing or rhonchi. The patient had a good expiratory phase to respiration as well. The skin was diffusely populated with small hive-like lesions that were causing itching and at the site of the immunization, there was a large, probably 5 cm in diameter confluent hive. The presumptive diagnosis then is allergy to either the vehicle or some component of the immunization.   PLAN: She was given IV Benadryl 50 mg and IV Solu-Medrol 125 mg to try to break up the reaction and relieve her itching. Within a matter of minutes, the itching was improved. She was a bit sleepy after that, but comfortable. We observed her for approximately an hour to an hour and a half in the Emergency Room and she showed no untoward signs of progressing allergic reaction. In fact, she was much improved. She was discharged to the home and use her own supply of Benadryl if she has any recurring itching, but return to the hospital ER if she has trouble with breathing or swallowing. She is also encouraged to discuss further with her doctor what she might have been allergic to in that immunization whether it could have been a preservative or a component of the immunization itself.
Age: 17.0
Sex: F
Vaccine: DTP, HEPA, HEPA, TDAP, VARCEL
Symptoms: Somnolence, Urticaria
Clinical narrative: Notes from the ER VISIT:----Apparently, it was one of the things for chicken pox and later at the site of the immunization, she developed a large wheel and flare with hive-like reaction and progressively developed hives over her entire trunk and arms. They were quite itchy. She did take two Benadryl tablets at home, but did not feel they were controlling the itching very well. She came into the emergency room to be evaluated and treated further. She has no known history of allergies, specifically not to immunizations or to eggs. She was not having any breathing difficulty or trouble swallowing. It was simply diffuse hives and itching. Her vital signs were normal and her exam of her ears, nose, and throat was normal and the chest was clear. No wheezing or rhonchi. The patient had a good expiratory phase to respiration as well. The skin was diffusely populated with small hive-like lesions that were causing itching and at the site of the immunization, there was a large, probably 5 cm in diameter confluent hive. The presumptive diagnosis then is allergy to either the vehicle or some component of the immunization.   PLAN: She was given IV Benadryl 50 mg and IV Solu-Medrol 125 mg to try to break up the reaction and relieve her itching. Within a matter of minutes, the itching was improved. She was a bit sleepy after that, but comfortable. We observed her for approximately an hour to an hour and a half in the Emergency Room and she showed no untoward signs of progressing allergic reaction. In fact, she was much improved. She was discharged to the home and use her own supply of Benadryl if she has any recurring itching, but return to the hospital ER if she has trouble with breathing or swallowing. She is also encouraged to discuss further with her doctor what she might have been allergic to in that immunization whether it could have been a preservative or a component of the immunization itself.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Aspiration biopsy, Biopsy, Biopsy bone marrow abnormal, Chemotherapy, Chest X-ray
Clinical narrative: Vaccination administered 1/16/08, despite argument with PA and LPN about not getting it (and being told I "may already have the virus," so I should get the vaccination; they obviously believed it was a cure instead of preventative) Severe itching appeared a few weeks after the initial vaccine. Injection site itched slightly after the vaccine was administered, and continued to spread to legs, hips, and buttocks). Itching felt as if it were coming from the inside (subcutaneous). Noticed lumps along collarbone (left side) and went to physician. After a number of physicians, received chest x-ray and needle biopsy, followed by an excisional biopsy, which diagnosed me with Hodgkin's Lymphoma, stage 2A. Treatment: Six months of ABVD chemotherapy (treatment occurred Thursdays, every other week from 06/24/08 to 12/04/08). Patient has been free of symptoms since December 2008.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Hodgkin's disease, Injection site pruritus, Laboratory test, Mass, Pruritus
Clinical narrative: Vaccination administered 1/16/08, despite argument with PA and LPN about not getting it (and being told I "may already have the virus," so I should get the vaccination; they obviously believed it was a cure instead of preventative) Severe itching appeared a few weeks after the initial vaccine. Injection site itched slightly after the vaccine was administered, and continued to spread to legs, hips, and buttocks). Itching felt as if it were coming from the inside (subcutaneous). Noticed lumps along collarbone (left side) and went to physician. After a number of physicians, received chest x-ray and needle biopsy, followed by an excisional biopsy, which diagnosed me with Hodgkin's Lymphoma, stage 2A. Treatment: Six months of ABVD chemotherapy (treatment occurred Thursdays, every other week from 06/24/08 to 12/04/08). Patient has been free of symptoms since December 2008.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pulmonary function test
Clinical narrative: Vaccination administered 1/16/08, despite argument with PA and LPN about not getting it (and being told I "may already have the virus," so I should get the vaccination; they obviously believed it was a cure instead of preventative) Severe itching appeared a few weeks after the initial vaccine. Injection site itched slightly after the vaccine was administered, and continued to spread to legs, hips, and buttocks). Itching felt as if it were coming from the inside (subcutaneous). Noticed lumps along collarbone (left side) and went to physician. After a number of physicians, received chest x-ray and needle biopsy, followed by an excisional biopsy, which diagnosed me with Hodgkin's Lymphoma, stage 2A. Treatment: Six months of ABVD chemotherapy (treatment occurred Thursdays, every other week from 06/24/08 to 12/04/08). Patient has been free of symptoms since December 2008.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: (L) deltoid area, warm to touch. 2 1/2" x 2 1/2" erythema, edema, painful to touch.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Infection, Pain, Skin warm
Clinical narrative: Swelling, redness, soreness, hot to touch. By Friday it was worse went to doctor - not sure if from shot or what, allergic reaction, infection or heading into staph infection - given antibiotics, claritin and Ibuprofen - Got better but didn't go away. Noticed on July 22nd it was red again, hot to touch, bumpy and blistering - Went to doctor for the third time and diagnosed as a type of contact infection - given steroid shot and a cortisone-steroid creme to apply to it twice a day. It is now Monday July 16th and it is disappearing, hopefully this time it won't come back.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Swelling, redness, soreness, hot to touch. By Friday it was worse went to doctor - not sure if from shot or what, allergic reaction, infection or heading into staph infection - given antibiotics, claritin and Ibuprofen - Got better but didn't go away. Noticed on July 22nd it was red again, hot to touch, bumpy and blistering - Went to doctor for the third time and diagnosed as a type of contact infection - given steroid shot and a cortisone-steroid creme to apply to it twice a day. It is now Monday July 16th and it is disappearing, hopefully this time it won't come back.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Localized redness, swelling, itching at injection site 5cm X 4cm warm to touch.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Anaphylactic reaction, Flushing, Respiratory distress
Clinical narrative: Anaphaxis response:  flushing,respiratory distress approximately 1 hour after Tdap given. ER: Benadryl and steroids. ER records attached.
Age: 0.5
Sex: M
Vaccine: DPP, MMR, RVX
Symptoms: Crying, Diarrhoea, Diet refusal, Eyes sunken, Inappropriate schedule of drug administration
Clinical narrative: Loose/watery stools.
Age: 0.5
Sex: M
Vaccine: DPP, MMR, RVX
Symptoms: Ocular hyperaemia, Pyrexia, Vomiting
Clinical narrative: Loose/watery stools.
Age: 20.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Cough, Epistaxis
Clinical narrative: Chronic nosebleeds and cough, no treatment for symptoms. Occurs weekely.
Age: 0.22
Sex: M
Vaccine: HIBV
Symptoms: Injection site dermatitis, Upper respiratory tract congestion, Wheezing
Clinical narrative: Wheezing and congestion along with Atopic Dermatitis/eczema around injection site in Left lateral thigh and several patches around left posterior elbow.
Age: 16.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Nasal inflammation, Rash erythematous
Clinical narrative: Several red plaque on the diffuse both arms, both legs, abdomen, and back. Inflammed mucosa and nares.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Condition aggravated, Headache, Pain in extremity, Pyrexia
Clinical narrative: On day following immunization, patient developed extremely sore arm. Then the next day, developed fever of 104 degrees, asthma worsened, and developed headache. Despite around the clock acetaminophen, fever remained above 100 degrees until 4th day after immunization.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Anaphylactic reaction, Lethargy, Pallor, Pharyngeal oedema, Urticaria
Clinical narrative: Anaphylaxis within 10 mins after vaccines developed urticaria, pallor, lethargy, throat swelling and wheezing. Given EPINEPHRINE, PREDNISONE, BENADRYL and Xoprex in office and transferred to ER (another course of epi and had IV SOLUMEDROL).
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Wheezing
Clinical narrative: Anaphylaxis within 10 mins after vaccines developed urticaria, pallor, lethargy, throat swelling and wheezing. Given EPINEPHRINE, PREDNISONE, BENADRYL and Xoprex in office and transferred to ER (another course of epi and had IV SOLUMEDROL).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Erythema, Fatigue, Oedema peripheral, Pain in extremity
Clinical narrative: Received ZOSTAVAX on 7-20-10. Per pt on Wednesday left arm become swollen and red, hot to touch and painful. Thursday temp 100.1 and on Friday c/o fatigue. Better by weekend. But today still c/o being very tired.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Received ZOSTAVAX on 7-20-10. Per pt on Wednesday left arm become swollen and red, hot to touch and painful. Thursday temp 100.1 and on Friday c/o fatigue. Better by weekend. But today still c/o being very tired.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Herpes zoster, Rash papular, Rash pustular
Clinical narrative: Apparent shingles: erythema papules and pustules appeared 07-22-10 around (R) flank and groin.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Flank pain, Premature labour, Uterine contractions during pregnancy
Clinical narrative: Information has been received from a consumer concerning her daughter, a 14 year old female who on 08-AUG-2008 was vaccinated with the first dose of GARDASIL, 0.5 mL, intramuscular, The caller stated that when her daughter received the first dose of vaccination she was 2 months pregnant. On 14-OCT-2008, the patient received the second dose of GARDASIL. Caller did not mention any adverse event. It was unknown if the patient sought medical attention. Additional information has been received from a consumer concerning her daughter, who "delivered really early and the baby died after it was born." The consumer stated her daughter was almost five and a half to six months pregnant and she started having pains in her side, went to the doctor and was told everything was ok and went home. The next week her pains started again and then felt like contractions, and when she went to the doctor she was already dilated around four or more centimeters and they couldn't stop her contractions. The consumer reported that the baby was born and then died (No further details provided). It was reported that the consumer's daughter had good days and bad days. The baby's experience is reported in WAES 0810USA02499B1. Upon internal review, preterm delivery was determined to be an other important medical event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Injection site pain
Clinical narrative: Patient complained of feeling light-headed after receiving her third Gardasil dose, was placed in a supine position and observed for 15 minutes, and felt back to normal and was ambulatory upon leaving the office.  She called back on 7/26/2010 complaining of persistent pain in her left upper arm since receiving the vaccine and stated the pain was not relieved with Tylenol.  She denies erythema or swelling at the injection site, fever, or other complaints.  She was advised to try ibuprofen or Aleve, apply heat to the site, and to follow up if the pain does not resolve.
Age: 0.22
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV, RVX
Symptoms: Convulsion, Dyskinesia, Salivary hypersecretion, Somnolence, Tremor
Clinical narrative: Baby had an approximately one minute seizure with all over shaking/jerking and extra oral secretions.  Episode resolved and baby was sleepy but appeared otherwise fine.  No cyanosis noted or fever at time of event.  Parents presented to my office on Monday after the event on Saturday evening.  At time of office visit, no further episodes and normal exam.  Her immunizations were given at the local health dept.  I have no record of vaccine manufacturer or administration information as not provided via my office.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash pruritic
Clinical narrative: Beginning of itchy rash, increased in intensity. Saw Dr. at 8:30 AM 07/23/2010. Diagnosed with shingles. Prescribed 1GM Valacyclovir and 0.1% Triamcinolone.
Age: 34.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Abdominal pain upper, Diarrhoea, Fatigue, Full blood count
Clinical narrative: Severe diarrhea, abdominal pain, fever, stomach pain that lasted 4 weeks, swollen lymph nodes in the groin, malaise and fatigue still ongoing.
Age: 34.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Malaise, Monocytosis, Pyrexia, White blood cell count increased
Clinical narrative: Severe diarrhea, abdominal pain, fever, stomach pain that lasted 4 weeks, swollen lymph nodes in the groin, malaise and fatigue still ongoing.
Sex: U
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Premature baby
Clinical narrative: Information has been received from a consumer concerning her daughter, who on 08-AUG-2008 was vaccinated with the first dose of GARDASIL, 0.5 mL, intramuscular while she was 2 months pregnant. The consumer stated her daughter was almost five and a half to six months pregnant when she started having pains in her side, went to the doctor and was told everything was ok and went home. The next week her pains started again and then felt like contractions, and when she went to the doctor she was already dilated around four or more centimeters and they couldn't stop her contractions. The consumer reported that the baby was born and then died (No further details provided). The mother's experience is reported in WAES 0810USA02499. Upon internal review, preterm labor was determined to be an other important medical event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Blood count normal, Hot flush, Oedema peripheral, Pain in extremity
Clinical narrative: Hives, rash-welps ,itchy, hot flashes, swollen feet, hands, arms. Sore arms, knees, ankles, knuckles. Treated with Steroid shot: peridsone medication and Benedryl and Zyrtec.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash, Streptococcus test negative, Urticaria, White blood cell count increased
Clinical narrative: Hives, rash-welps ,itchy, hot flashes, swollen feet, hands, arms. Sore arms, knees, ankles, knuckles. Treated with Steroid shot: peridsone medication and Benedryl and Zyrtec.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Pyrexia, Rash
Clinical narrative: Received Tdap in Right arm on 7/16/2010 then had fever and nausea on 7/17/2010 which resolved on 7/19/2010.  Rash on right arm on 7/20/10.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient broke out in a rash on 7/15/2010 of freckle like spots that formed in a line of about 50 spots per arm. Also rash on left side of head and face. Patient also noted pruritis. Patient said the rash and pruritis is resolving. Patient counseled to seek medical attention if exacerbation or persistence of symptoms.
Age: 28.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Malaise, Pallor, Posturing, Syncope
Clinical narrative: PATIENT AND SPOUSED ADVISED PATIENT FAINTS POST-VACCINES. VACCINES ADMINISTERED. 5 MINUTES POST VACCINE ADMINISTRATION, PT. STATED DID NOT FEEL WELL SKIN COLOR PALE THEN FAINTED BILATERAL UPPER EXTREMITIES EXHIBITED POSTURING. PATIENT REGAINED CONSCIOUSNESS WITHIN 20 SECONDS POST ADMINISTRATION OF AMMONIA INHALANT NEAR NOSTRILS.
Sex: U
Vaccine: HPV4
Symptoms: Multiple sclerosis
Clinical narrative: Information has been received from a physician concerning a patient who "4-5 years ago", in approximately 2005 was vaccinated with the last dose of GARDASIL. The physician stated that the patient was given 3 doses of GARDASIL and then developed multiple sclerosis. The outcome of the patient was not reported. It was unknown if the patient sought medical attention. It was reported that there were a lot of "ambiguity" surrounding this patient. Multiple sclerosis was considered to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: FLUX
Symptoms: Ankle fracture, Cholecystectomy, Colon injury, Foot fracture, Gait disturbance
Clinical narrative: Initial case was retrieved from scientific literature on 19 July 2010. A young female patient (age not reported), with medical history not reported, received an injection (date, route and site not provided) of influenza vaccine, lot number not reported. "Within thirty minutes the woman lost consciousness while driving, causing her to lose control of her motor vehicle. She suffered severe injuries and was hospitalized for six weeks. During that time her gallbladder and a kidney were removed. She also suffered a colon injury, a lacerated liver, a fractured arm and multiple left foot and ankle fractures, which left her with a permanent limp. The patient sued and claimed that the loss of consciousness was from a vasovagal reaction to the vaccination. An expert witness stated this type of reaction was "not uncommon" and was a "universally-recognized potential complication." The outcome for the events were not reported. Editor's Comments: Details of this case are missing. The medical staff has an obligation to observe the patient after an injection for a reasonable period of time. In this case, it is hard to imagine that a vasovagal reaction could occur so long (30 minutes) after the injection. Perhaps the expert witness testimony should be scrutinized. Documents held by sender: None.
Sex: F
Vaccine: FLUX
Symptoms: Hypotonia, Impaired driving ability, Injury, Multiple fractures, Nephrectomy
Clinical narrative: Initial case was retrieved from scientific literature on 19 July 2010. A young female patient (age not reported), with medical history not reported, received an injection (date, route and site not provided) of influenza vaccine, lot number not reported. "Within thirty minutes the woman lost consciousness while driving, causing her to lose control of her motor vehicle. She suffered severe injuries and was hospitalized for six weeks. During that time her gallbladder and a kidney were removed. She also suffered a colon injury, a lacerated liver, a fractured arm and multiple left foot and ankle fractures, which left her with a permanent limp. The patient sued and claimed that the loss of consciousness was from a vasovagal reaction to the vaccination. An expert witness stated this type of reaction was "not uncommon" and was a "universally-recognized potential complication." The outcome for the events were not reported. Editor's Comments: Details of this case are missing. The medical staff has an obligation to observe the patient after an injection for a reasonable period of time. In this case, it is hard to imagine that a vasovagal reaction could occur so long (30 minutes) after the injection. Perhaps the expert witness testimony should be scrutinized. Documents held by sender: None.
Sex: F
Vaccine: FLUX
Symptoms: Presyncope, Road traffic accident, Traumatic liver injury, Upper limb fracture
Clinical narrative: Initial case was retrieved from scientific literature on 19 July 2010. A young female patient (age not reported), with medical history not reported, received an injection (date, route and site not provided) of influenza vaccine, lot number not reported. "Within thirty minutes the woman lost consciousness while driving, causing her to lose control of her motor vehicle. She suffered severe injuries and was hospitalized for six weeks. During that time her gallbladder and a kidney were removed. She also suffered a colon injury, a lacerated liver, a fractured arm and multiple left foot and ankle fractures, which left her with a permanent limp. The patient sued and claimed that the loss of consciousness was from a vasovagal reaction to the vaccination. An expert witness stated this type of reaction was "not uncommon" and was a "universally-recognized potential complication." The outcome for the events were not reported. Editor's Comments: Details of this case are missing. The medical staff has an obligation to observe the patient after an injection for a reasonable period of time. In this case, it is hard to imagine that a vasovagal reaction could occur so long (30 minutes) after the injection. Perhaps the expert witness testimony should be scrutinized. Documents held by sender: None.
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Blood creatine phosphokinase MB, Cardiac stress test normal, Echocardiogram abnormal, Electrocardiogram normal, Troponin increased
Clinical narrative: Initial report received on 21 July 2010 from an investigator participating in a trial. A male subject developed possible myocarditis 8 days after receiving a first dose of ACAM2000 and a first dose of concomitant vaccine Anthrax (manufacturer not reported) on 23 June 2010. Medical history and concomitant medications were not reported. On 01 July 2010 the subject had asymptomatic elevated troponin and was referred to the investigator on 06 July 2010. Seven days later, the subject was evaluated by cardiology and had a normal troponin, elevated CK-MB (5.6% ng/mL), normal EKG and was admitted to the hospital. An echo was found to be borderline abnormal, and perfusion stress test was normal. The subject was discharged on day 3 of hospitalization with no diagnosis. The subject was seen for follow-up on 19 July 2010 and prescribed colchicine. The subject has not recovered. According to the investigator, the event was possibly related to the study vaccine and concomitant vaccine. Documents held by sender: None.
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Unevaluable event
Clinical narrative: Initial report received on 21 July 2010 from an investigator participating in a trial. A male subject developed possible myocarditis 8 days after receiving a first dose of ACAM2000 and a first dose of concomitant vaccine Anthrax (manufacturer not reported) on 23 June 2010. Medical history and concomitant medications were not reported. On 01 July 2010 the subject had asymptomatic elevated troponin and was referred to the investigator on 06 July 2010. Seven days later, the subject was evaluated by cardiology and had a normal troponin, elevated CK-MB (5.6% ng/mL), normal EKG and was admitted to the hospital. An echo was found to be borderline abnormal, and perfusion stress test was normal. The subject was discharged on day 3 of hospitalization with no diagnosis. The subject was seen for follow-up on 19 July 2010 and prescribed colchicine. The subject has not recovered. According to the investigator, the event was possibly related to the study vaccine and concomitant vaccine. Documents held by sender: None.
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Blood creatine phosphokinase MB increased, Cardiac stress test normal, Echocardiogram abnormal, Electrocardiogram normal, Troponin increased
Clinical narrative: Initial report received on 21 July 2010 from an investigator participating in a trial. A male subject developed possible myocarditis 8 days after receiving a first dose of ACAM2000 and a first dose of concomitant vaccine Anthrax (manufacturer not reported) on 23 June 2010. Medical history and concomitant medications were not reported. On 01 July 2010 the subject had asymptomatic elevated troponin and was referred to the investigator on 06 July 2010. Seven days later, the subject was evaluated by cardiology and had a normal troponin, elevated CK-MB (5.6% ng/mL), normal EKG and was admitted to the hospital. An echo was found to be borderline abnormal, and perfusion stress test was normal. The subject was discharged on day 3 of hospitalization with no diagnosis. The subject was seen for follow-up on 19 July 2010 and prescribed colchicine. The subject has not recovered. According to the investigator, the event was possibly related to the study vaccine and concomitant vaccine. Documents held by sender: None.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Syncope
Clinical narrative: Fainted.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling
Clinical narrative: Local circumscribed swelling 3 to 4 cm diameter area injection no systemic component.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Chest pain, Hypoaesthesia, Muscular weakness, Rubella antibody test
Clinical narrative: 27 year old female who became symptomatic 30 minutes after receiving MMR vaccine. No previous problems with receiving vaccines as a child. Developed chest pain, numbness, and weakness down right arm. BP 122/76 - Pulse 70; Resp: 18 Temp: 36 O & SAT 99% medicated with BENADRYL 50mg, SOLUMEDROL and FAMOTIDINE - symptoms resolved.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, swelling, itching, pain after 24 hours of administration, warm to touch. 20 mm round appx 7/26/10.
Age: 2.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site inflammation, Injection site warmth
Clinical narrative: Reaction to iummunes (L) thigh medial to injection site is inflamed, warm to touch.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Cellulitis at injection site. Arm red, swollen, warm. Treating with ZITHROMAX.
Age: 1.53
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Body temperature increased, Cyanosis, Febrile convulsion, Hypotonia, Respiratory arrest
Clinical narrative: Febrile Seizure, limp and not breathing.  Lips and face turned blue.  Lasted approx 20-30 seconds.  Checked at ER afterwards.  Temp 100.7 when seized and 103 10 minutes later at the ER.
Age: 34.0
Sex: F
Vaccine: YF
Symptoms: Anxiety, Headache, Laboratory test, Muscular weakness, Tachycardia
Clinical narrative: Yellow fever vaccine administered 6/7/10. On 6/18/10, pt experienced headache, muscle weakness, tachycardia and anxiety. Seen by PMD who examined and did (unknown) blood work. On inquiry, pt failed to reveal hx of malaria, "tick fever", and removal/dissection of benign liver tumor in 9/07. F/u on 6/25/10 sx had abated except residual, mild fatigue.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Rash - went to Dr 7/8/10 and returned on 7/12/10 on PREDNISONE today rash better 7/14/10.
Age: 1.36
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at site. No treatment necessary.
Age: 39.0
Sex: M
Vaccine: MNQ, RAB
Symptoms: Dizziness, Hearing impaired, Inflammation, Injection site pain, Laboratory test normal
Clinical narrative: Combined initial health care professional report received on 20 Jul 2010 and follow up report received on 22 Jul 2010: This patient with medical history of scarlet fever within four weeks before vaccination, received MENVEO (batch number 030011) 0.5 ml intramuscularly into the right arm deltoid muscle on 28 Jun 2010 in the evening. The patient was concomitantly vaccinated with HCD (rabies vaccine) 1ml intramuscularly in the right arm deltoid on 28 Jun 2010 also. On 30 Jun 2010, two days after vaccination with MENVEO, the patient experienced severe local reaction on the right (vaccinated) arm with discoloration and signs of inflammation and pain at injection site (right arm). On an unknown date, three days after vaccination, the patient experienced defective hearing in right ear and dizziness which persisted for one week. On an unknown date, the patient had laboratory test done whose result was normal. The outcome of the event was reported as recovered on day 9 after vaccination. The causality was not reported.
Age: 39.0
Sex: M
Vaccine: MNQ, RAB
Symptoms: Local reaction, Skin discolouration
Clinical narrative: Combined initial health care professional report received on 20 Jul 2010 and follow up report received on 22 Jul 2010: This patient with medical history of scarlet fever within four weeks before vaccination, received MENVEO (batch number 030011) 0.5 ml intramuscularly into the right arm deltoid muscle on 28 Jun 2010 in the evening. The patient was concomitantly vaccinated with HCD (rabies vaccine) 1ml intramuscularly in the right arm deltoid on 28 Jun 2010 also. On 30 Jun 2010, two days after vaccination with MENVEO, the patient experienced severe local reaction on the right (vaccinated) arm with discoloration and signs of inflammation and pain at injection site (right arm). On an unknown date, three days after vaccination, the patient experienced defective hearing in right ear and dizziness which persisted for one week. On an unknown date, the patient had laboratory test done whose result was normal. The outcome of the event was reported as recovered on day 9 after vaccination. The causality was not reported.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Hyperaesthesia, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Redness and swelling around area of injection (of Varicella vaccine #2) followed by pinch-like tenderness at the site of vaccine. Pain is still ongoing to this day and recurs with touching skin over that arm and sometimes rash like redness is still visible. Similar reaction occurred in other arm following MMR vaccine approximately 3 years ago and sensitivity is still present with light touch on that arm. Sensitivity overall improved but not completely recovered.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Similar reaction on previous exposure to drug
Clinical narrative: Redness and swelling around area of injection (of Varicella vaccine #2) followed by pinch-like tenderness at the site of vaccine. Pain is still ongoing to this day and recurs with touching skin over that arm and sometimes rash like redness is still visible. Similar reaction occurred in other arm following MMR vaccine approximately 3 years ago and sensitivity is still present with light touch on that arm. Sensitivity overall improved but not completely recovered.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Fall, Head injury, Heart rate irregular, Pallor, Syncope
Clinical narrative: Client continued to converse/act normally post-vaccination about college plans, vaccination requirements, etc for approximately three minutes. LPN began getting a second set of vitals and as LPN turned around to fill out the immunization card while the machine was taking a 2nd blood pressure (one pre-vaccination), she saw out of the corner of her eye the pt start to fold over and fall off the side of the exam table, hitting her forehead on the wall on the way to the ground. LPN reports the time from vaccination to fainting to be no more than 3 minutes. At that point, she called for help and was assisted by me, RN. By the time I reached the room (<1minute post fainting episode), the pt was coherent and asking worriedly about what happened. LPN was supporting her head and neck and telling her to relax while she obtained another set of vitals. I brought her 2 ice packs to apply to her head and neck and called her mother to tell her what happened. Approximately 3 minutes after calling her mother and describing what happened, I notified EMS services and requested their assistance. <2 minutes later, EMS personnel arrived in our office to evaluate the pt. Pt was still pale and EMS reported a pulse ranging from the 40's to 90's with an irregular heart beat. Approximately 5 minutes after EMS arrived, the pts mother arrived and entered the room with the EMS personnel. EMS continued to monitor pts vital signs and glucose while she was lying on the floor x5 minutes. EMS suggesting heart rhythym monitor, so we moved the pt to the exam table. EMS monitored the heart rhythm and further assessed X15-20minutes. Pt asking for us to call and see if she go straight to her PCP's office from our office. I called and made arrangements for her to go straight to see her PCP, DO. While I was making an appointment for the pt to be seen immediately at her PCP's office (approximately 10minutes) she had signed EMS's refusal to be taken to the hospital and EMS had left, but LPN remained in the room with her monitoring her vital signs. Pt left our office at approximately 2:55pm.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Syncope
Clinical narrative: Client continued to converse/act normally post-vaccination about college plans, vaccination requirements, etc for approximately three minutes. LPN began getting a second set of vitals and as LPN turned around to fill out the immunization card while the machine was taking a 2nd blood pressure (one pre-vaccination), she saw out of the corner of her eye the pt start to fold over and fall off the side of the exam table, hitting her forehead on the wall on the way to the ground. LPN reports the time from vaccination to fainting to be no more than 3 minutes. At that point, she called for help and was assisted by me, RN. By the time I reached the room (<1minute post fainting episode), the pt was coherent and asking worriedly about what happened. LPN was supporting her head and neck and telling her to relax while she obtained another set of vitals. I brought her 2 ice packs to apply to her head and neck and called her mother to tell her what happened. Approximately 3 minutes after calling her mother and describing what happened, I notified EMS services and requested their assistance. <2 minutes later, EMS personnel arrived in our office to evaluate the pt. Pt was still pale and EMS reported a pulse ranging from the 40's to 90's with an irregular heart beat. Approximately 5 minutes after EMS arrived, the pts mother arrived and entered the room with the EMS personnel. EMS continued to monitor pts vital signs and glucose while she was lying on the floor x5 minutes. EMS suggesting heart rhythym monitor, so we moved the pt to the exam table. EMS monitored the heart rhythm and further assessed X15-20minutes. Pt asking for us to call and see if she go straight to her PCP's office from our office. I called and made arrangements for her to go straight to see her PCP, DO. While I was making an appointment for the pt to be seen immediately at her PCP's office (approximately 10minutes) she had signed EMS's refusal to be taken to the hospital and EMS had left, but LPN remained in the room with her monitoring her vital signs. Pt left our office at approximately 2:55pm.
Age: 22.0
Sex: F
Vaccine: PPV, RAB
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt noted redness at injection site - L upper triceps area - size of baseball on 7/1/10 - eve and had low-grade fever, and 7/3/10 - eve had 103 degree temp and outer L arm redness extended to elbow - with swelling and "hot to touch, painful on 7-4-10 went to ER and was admitted to hospital.
Age: 22.0
Sex: F
Vaccine: PPV, RAB
Symptoms: Pyrexia
Clinical narrative: Pt noted redness at injection site - L upper triceps area - size of baseball on 7/1/10 - eve and had low-grade fever, and 7/3/10 - eve had 103 degree temp and outer L arm redness extended to elbow - with swelling and "hot to touch, painful on 7-4-10 went to ER and was admitted to hospital.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Deformity, Immunisation reaction, Pruritus, Rash, Scar
Clinical narrative: Had the Flu and pneumonia shots - the next day had a rash on (R) leg that covered the lower part of his leg - He went to the doctor and he said that it was due to the flu shot. He has had scarring and permanent disfigurement of the skin on the leg - He has been on BENADRYL and top cortisone cream.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal pain, Barium enema, Computerised tomogram abnormal, Haematochezia, Intussusception
Clinical narrative: 6 days after vaccines developed crampy abdominal pain and bloody stools. CT showed ileocecal intussusception. Surgical reduction was performed after barium enema failed.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Small intestinal intussusception reduction
Clinical narrative: 6 days after vaccines developed crampy abdominal pain and bloody stools. CT showed ileocecal intussusception. Surgical reduction was performed after barium enema failed.
Age: 4.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: Pt had a red mound at the site of KINRIX vaccine 24 hours later (4.5cm x 4cm). It was hot swollen and red. Also developed a red macule under (R) eye. 5cm x 5cm.
Age: 0.23
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying, Death, Diarrhoea, Eating disorder, Infantile spitting up
Clinical narrative: High pitch crying, frequently spitting up, direahea, and eating pattern wasn't regular.
Age: 64.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Swelling and redness to arm. Onset estimated.
Age: 0.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Cough, Fontanelle bulging, Grand mal convulsion, Laboratory test, Lethargy
Clinical narrative: The patient was febrile on Sunday 1/31/10 and recently had cough and congestion which became more severe. His fever continued the next day. On Tuesday, feb 2, 2010 he became lethargic. Later that afternoon his mother picked him up from the babysitters at which time he was very lethargic and also had bulging fontanels. He was Taken to the local ER and later transferred to different facility. Upon arrival to the facility the patient had a high fever and developed generalized tonic-clonic seizures.
Age: 0.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Nuclear magnetic resonance imaging, Pyrexia, Respiratory tract congestion, Scan brain
Clinical narrative: The patient was febrile on Sunday 1/31/10 and recently had cough and congestion which became more severe. His fever continued the next day. On Tuesday, feb 2, 2010 he became lethargic. Later that afternoon his mother picked him up from the babysitters at which time he was very lethargic and also had bulging fontanels. He was Taken to the local ER and later transferred to different facility. Upon arrival to the facility the patient had a high fever and developed generalized tonic-clonic seizures.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Body temperature increased, Crying, Faeces discoloured
Clinical narrative: Inconsolable crying for 5 days. Also had T to 99.6dF 5 days after vaccine. Greener bowel movements for last 5 days (also given rotavirus vaccine at same time).
Age: 4.0
Sex: F
Vaccine: DTAP, DTP, IPV, VARCEL
Symptoms: Injection site haematoma, Injection site mass, Injection site swelling, Irritability, Pyrexia
Clinical narrative: High Fever 103.8, Swollen & Lump Bruise Leg at injection site, Lump is still there as of 7/26/2010, Fussiness. Given 2 1/2 tsp of Ibuprofen, every 4 to 6 hrs, had to get child bath in warm water to help bring fever down. Symptoms seems to be getting better, except swollen leg and lump at injection site. As of 7/26/2010.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Dizziness, Fatigue, Injection site swelling, Pyrexia
Clinical narrative: Patient woke up with a 102.2 fever. Patient was very tired, weak and dizzy. Motrin helped symptoms and reduced the fever. Mother noted swelling at the injection site on Left arm.