chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Pain to site (left deltoid). Multiple Fluid filled blisters to left upper arm. swelling, redness and warmth to site.  Edema to to top of spine. Difficulty moving extremities.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Oedema
Clinical narrative: Pain to site (left deltoid). Multiple Fluid filled blisters to left upper arm. swelling, redness and warmth to site.  Edema to to top of spine. Difficulty moving extremities.
Age: 24.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 24 years old male patient. The patient was respectively vaccinated with first, second and third dose of 0.5 ml GARDASIL (lot number unspecified) intramuscularly on 20-JUL-2012, 15-NOV-2012 and 14-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray, Erythema, Hyperhidrosis, Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report as received from an approximately 34 years old female patient refers to herself with asthma and allergic to latex. The patient's medical history included no spleen and fibromyalgia. The patient was vaccinated with the first dose of PNEUMOVAX23 (dose, route and lot# not reported) about 10 years ago, approximately in 2003, two weeks prior to a splenectomy surgery and did not have any problems. The patient was vaccinated with the second dose of PNEUMOVAX23 (dose, route and lot# not reported) on 09-JAN-2013. Concomitant medications included YAZ, SINGULAIR, DULERA, CYMBALTA, OMNARIS, LEVOXYL and phentermine. On 10-JAN-2013, 24 hours after after the second dose of PNEUMOVAX23, the patient was in the emergency room because she experienced tachycardia, diaphoresis, fever of 101 F and the right arm in which the PNEUMOVAX23 was given was red, swollen and painful to the touch. The patient was given BENADRYL and TAMIFLU for the events. There was right arm X-ray and chest X-ray performed (result unknown). At the time of reporting, the outcome of splenectomy surgery was unknown and the outcome of the other events was recovering. Upon internal review, splenectomy surgery was considered to be other medical significant event. This is one of several reports received from the same source. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Tachycardia, X-ray
Clinical narrative: This spontaneous report as received from an approximately 34 years old female patient refers to herself with asthma and allergic to latex. The patient's medical history included no spleen and fibromyalgia. The patient was vaccinated with the first dose of PNEUMOVAX23 (dose, route and lot# not reported) about 10 years ago, approximately in 2003, two weeks prior to a splenectomy surgery and did not have any problems. The patient was vaccinated with the second dose of PNEUMOVAX23 (dose, route and lot# not reported) on 09-JAN-2013. Concomitant medications included YAZ, SINGULAIR, DULERA, CYMBALTA, OMNARIS, LEVOXYL and phentermine. On 10-JAN-2013, 24 hours after after the second dose of PNEUMOVAX23, the patient was in the emergency room because she experienced tachycardia, diaphoresis, fever of 101 F and the right arm in which the PNEUMOVAX23 was given was red, swollen and painful to the touch. The patient was given BENADRYL and TAMIFLU for the events. There was right arm X-ray and chest X-ray performed (result unknown). At the time of reporting, the outcome of splenectomy surgery was unknown and the outcome of the other events was recovering. Upon internal review, splenectomy surgery was considered to be other medical significant event. This is one of several reports received from the same source. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Cerebrovascular accident, Computerised tomogram normal, Echocardiogram, Hemiplegia, Hypoaesthesia
Clinical narrative: 6:45 pm - Numbness began in right arm, moved down his leg, then to the right side of his face. Paralysis experienced on whole right side. Went to medical center - Diagnosed with stroke transferred to hospital.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Ultrasound Doppler normal
Clinical narrative: 6:45 pm - Numbness began in right arm, moved down his leg, then to the right side of his face. Paralysis experienced on whole right side. Went to medical center - Diagnosed with stroke transferred to hospital.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Cardiac stress test normal, Chest discomfort, Chest pain, Dizziness, Echocardiogram normal
Clinical narrative: Rec'd Tdap 1/7/13 at 10 a.m. Ret to work. 12:00 ate lunch. 12:30 - Felt lightheaded, flushed, nauseated "not right". Told to lie down. Sys BP >90. 1255 - felt "throat full & burning". Taken to ER. Also c/o some chest pain. Rx: BENADRYL & SOLU-MEDROL & IV fluid not much change. Approx 3:30 p.m. kept for overnite observation as cont. to complain of fullness & burning in throat. No SOB noted. Some mild chest discomfort.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Electrocardiogram normal, Feeling abnormal, Flushing, Full blood count normal, Metabolic function test normal
Clinical narrative: Rec'd Tdap 1/7/13 at 10 a.m. Ret to work. 12:00 ate lunch. 12:30 - Felt lightheaded, flushed, nauseated "not right". Told to lie down. Sys BP >90. 1255 - felt "throat full & burning". Taken to ER. Also c/o some chest pain. Rx: BENADRYL & SOLU-MEDROL & IV fluid not much change. Approx 3:30 p.m. kept for overnite observation as cont. to complain of fullness & burning in throat. No SOB noted. Some mild chest discomfort.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Neutrophil percentage increased, Throat irritation, Throat tightness
Clinical narrative: Rec'd Tdap 1/7/13 at 10 a.m. Ret to work. 12:00 ate lunch. 12:30 - Felt lightheaded, flushed, nauseated "not right". Told to lie down. Sys BP >90. 1255 - felt "throat full & burning". Taken to ER. Also c/o some chest pain. Rx: BENADRYL & SOLU-MEDROL & IV fluid not much change. Approx 3:30 p.m. kept for overnite observation as cont. to complain of fullness & burning in throat. No SOB noted. Some mild chest discomfort.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Computerised tomogram normal, Convulsion, Diarrhoea, Electroencephalogram, Laboratory test normal
Clinical narrative: Seizure x 2. 1st with palpable fever, 100 degree R in ER, 7 hours after vaccines given. Second seizure 32+ hours after vaccines, with 101 degrees R. Septic work up with L.P. negative. Some diarrhea.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Lumbar puncture normal, Pyrexia
Clinical narrative: Seizure x 2. 1st with palpable fever, 100 degree R in ER, 7 hours after vaccines given. Second seizure 32+ hours after vaccines, with 101 degrees R. Septic work up with L.P. negative. Some diarrhea.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Acute respiratory distress syndrome, Blood gases, Blood test, Computerised tomogram, Cough
Clinical narrative: Within hrs of receiving vaccine, become febrile, body aches, dry cough. Went to Emergency clinic w/in 48 hrs. after symptoms became worse. Over the course of days, diagnosed with pneumonia then ARDS & ventilated in ICU for awhile. Still recovering (lungs) nonsmoker - nonasthma.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Intensive care, Mechanical ventilation, Pain, Pneumonia, Pyrexia
Clinical narrative: Within hrs of receiving vaccine, become febrile, body aches, dry cough. Went to Emergency clinic w/in 48 hrs. after symptoms became worse. Over the course of days, diagnosed with pneumonia then ARDS & ventilated in ICU for awhile. Still recovering (lungs) nonsmoker - nonasthma.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Within hrs of receiving vaccine, become febrile, body aches, dry cough. Went to Emergency clinic w/in 48 hrs. after symptoms became worse. Over the course of days, diagnosed with pneumonia then ARDS & ventilated in ICU for awhile. Still recovering (lungs) nonsmoker - nonasthma.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying, Irritability
Clinical narrative: 2 days after PENTACEL, PREVNAR & ROTATEQ vaccines, roughly, 1 day persistent. Irritability & crying which resolved; TYLENOL some benefit (-) fever.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Dysuria, Myalgia, Pruritus, Stomatitis
Clinical narrative: 1 hour following vaccine reported terrible taste in her mouth, sores in her mouth, tender muscles, burning urination and itching.
Age: 49.0
Sex: M
Vaccine: UNK
Symptoms: Tinnitus, Urticaria, Vertigo
Clinical narrative: Pt experienced hives, vertigo, tinnitus. Sent to ER-pt received orders to take BENADRYL 25 mg po tid for 5 days, and prednisone 60 mg po daily for 4 days. Instructed to go back to ER if symptoms get worse.
Age: 20.0
Sex: F
Vaccine: HEPA, TYP, VARCEL
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Pt called with complaints of redness and nodule at site of varicella.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient became lightheaded and passed out after receiving 2 vaccines.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Inflammation, Injection site injury, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: Patient complained about arm pain and visited MD in Oct. MD saw no reason for pain and sent pt. for MRI. Pt was given a cortisone shot and meloxicam and referred for physical therapy.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Tendonitis
Clinical narrative: Patient complained about arm pain and visited MD in Oct. MD saw no reason for pain and sent pt. for MRI. Pt was given a cortisone shot and meloxicam and referred for physical therapy.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis
Clinical narrative: Clinical cellulitis secondary to vaccination with MMRV.
Age: 26.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Redness / hot on left arm.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: Arms & legs were red, covered in bumps, extreme itch. Flu shot approximately 10:40AM; pt reported sx at approximately 4PM. Advised pt to get an antihistamine.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: FLUZONE intradermal given 1/11/13 came to pharmacy 1/13/13, 4pm arm red, slight swelling & blister formed at shot site told BENADRYL, NEOSPORIN, contact primary doctor.
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Syncope episode after given vaccine passed out for about 5 seconds EMTs checked her over & felt she was ok not to go to hospital, she did not want to go to the hospital.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypoaesthesia, Paraesthesia, Swelling
Clinical narrative: Left arm went sort of numb with pins and needle feeling 2 hours after administration and last for 1 full day. Raised red area that is 4 in x 4 in.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: Positive influenza Type A. After influenza vaccine given on 10/18/12.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Influenza U4547CA 6/30/13 given too early 10/26/12. Influenza U4547CA 6/30/13 given too early 11/27/12.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Nausea, Pyrexia
Clinical narrative: < 2 min after vaccine administration patient felt flushed & nauseated. Monitored pt. for 5 min & mother wanted to take her to ER. Pt. ended up w/ a low grade fever.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Pallor, Pyrexia
Clinical narrative: Notes per office visit on 1/17/13 for R arm pain: [Patient History] Received vaccines in right arm 2 days ago (15th).  Has developed severe pain at sites, unable to move her arm without the use of her other hand (to assist).  Can't care for her 8 month old.  Feels swollen.  Had been having fevers to 103, for which she took ibuprofen, but those have resolved.  Ibuprofen not helping with her arm. [Physical Exam  R arm]  No upper arm erythema, upper arm swollen, deltoid muscle tenderness noted, reduced shoulder abduction, reduced shoulder adduction.  Skin pallor noted in involved area. [Treatment]  Naprosyn 500mg 1 po BID prn pain/fever, # 30;  Tylenol #3, 300-30 mg, 1 or 2 Q4-6 hrs prn w/ food, # 20.  Patient to return prn.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea for 3 days; Vomited on day 3.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Dysgraphia, Gait disturbance, Lumbar puncture, Neurological examination, Nuclear magnetic resonance imaging brain
Clinical narrative: Shuffling while walking. Struggle with writing and his handwriting got smaller and shakier for the past two days.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Localized redness, swelling, hot to touch at (R) Deltoid inj. site, measured approx 2" x 3" when eval. @ HD on 1/17/13. Pt c/o of BP elevation. BP readings 150/100 (R) & (L). Pt reports her first Flu inj. Flu Mist 2 yrs ago. No reaction. Pt thinks she may be allergic to "preservatives" & when counseled says she has no hx of allergy to Thimersol or contact lens solutions.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Cyanosis, Dyspnoea
Clinical narrative: FACIAL CYANOSIS, DIFFICULTY BREATHING.
Age: 1.5
Sex: M
Vaccine: FLUX
Symptoms: Burning sensation, Decreased appetite, Diarrhoea, Herpes zoster, Injection site rash
Clinical narrative: Beginning on 11/21/12 our son began throwing up all solids and liquids given for about 48 hours.  Towards the end of the 48 hours he could keep down some solids and breast milk.  He was seen at the emergency room on 11/22/12, where they gave him an anti-nausea medication and recommended the continued feeding of breast milk.  By 36 hours after the onset of vomiting, he was keeping all foods down, but not eating as much as usual.  By 11/24/12 we noticed that he was having diarrhea which was leaving a bright red rash on his bottom as well as a rash with sores on the inside of his right thigh near his scrotum.  Within a few days the sores began to bubble up to about a half dollar size, with a string of sores continuing from his inner thigh to his right butt cheek.  He was seen again at Emergency on 12/2/12 and diagnosed with Herpes Zoster: shingles.  The doctor also took a look at a string of itchy "bug bites" that I had running from my left abdomen to my left mid-back and believed I had shingles as well.  I do not know which of us first displayed symptoms as I believed that I had bug bites.  Within a week both of us had progressed to dried and scabbed up wounds where the lesions had been with minor itching and burning at the lesion locations.  Neither of us took any medications to get the lesions to clear up or go away.  I had never been vaccinated with the Varicella vaccine, but had the chicken pox around the age of five.  According to my records, my son had the first varicella vaccine on 4/27/2012 and he never received the second dose.  He received the flu vaccine on 10/25/2012.
Age: 1.5
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Rash erythematous, Scab, Skin ulcer, Vomiting
Clinical narrative: Beginning on 11/21/12 our son began throwing up all solids and liquids given for about 48 hours.  Towards the end of the 48 hours he could keep down some solids and breast milk.  He was seen at the emergency room on 11/22/12, where they gave him an anti-nausea medication and recommended the continued feeding of breast milk.  By 36 hours after the onset of vomiting, he was keeping all foods down, but not eating as much as usual.  By 11/24/12 we noticed that he was having diarrhea which was leaving a bright red rash on his bottom as well as a rash with sores on the inside of his right thigh near his scrotum.  Within a few days the sores began to bubble up to about a half dollar size, with a string of sores continuing from his inner thigh to his right butt cheek.  He was seen again at Emergency on 12/2/12 and diagnosed with Herpes Zoster: shingles.  The doctor also took a look at a string of itchy "bug bites" that I had running from my left abdomen to my left mid-back and believed I had shingles as well.  I do not know which of us first displayed symptoms as I believed that I had bug bites.  Within a week both of us had progressed to dried and scabbed up wounds where the lesions had been with minor itching and burning at the lesion locations.  Neither of us took any medications to get the lesions to clear up or go away.  I had never been vaccinated with the Varicella vaccine, but had the chicken pox around the age of five.  According to my records, my son had the first varicella vaccine on 4/27/2012 and he never received the second dose.  He received the flu vaccine on 10/25/2012.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Conjunctivitis infective, Cough, Eye discharge, Eye infection
Clinical narrative: Patient states that she within 5 minutes she felt it in her throat affecting her vocal cords making it difficut for her to talk, headache, cough, mucus, eyes became red and pus like pink eye. Was in bed for 3 days eating ice chips. Did not seek medical care.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Ocular hyperaemia, Speech disorder, Vocal cord disorder
Clinical narrative: Patient states that she within 5 minutes she felt it in her throat affecting her vocal cords making it difficut for her to talk, headache, cough, mucus, eyes became red and pus like pink eye. Was in bed for 3 days eating ice chips. Did not seek medical care.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: No immediate reaction noted by family - only 3 or 4 days ago did mom notice large pink, tender site Rt deltoid 5 x 4 cm. No pustule. No drainage. No axillary node. Father did have MRSA within past several months but now "ok".
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, swollen, tender right deltoid. Pt taking BENADRYL, BENADRYL cream, hydrocortisone cream as needed.
Age: 18.0
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient given FLUMIST on 1-10-13 after already given it on 10-4-12. No adverse reactions noted.
Age: 34.0
Sex: F
Vaccine: FLUN3
Symptoms: Eye irritation, Immediate post-injection reaction, Muscle twitching
Clinical narrative: Immediate burning of eyes at time of FLUMIST admin. then (R) eye has been twitching on & off for few days. Patient continues to have eye twitching but less - gradually getting better.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Cellulitis, Hypersensitivity, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: (R) upper arm 8 x 9 cm hot red area. Fever, 101.6 Dx Cellulitis, allergic reaction given Abx.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Dizziness
Clinical narrative: Within 10 minutes of receiving a flu shot, the patient got lightheaded and allegedly had a seizure.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Patient noticed red dots on foot approximately 48 hrs after influenza vaccination which had spread up to knee and thigh. No itching reported. No swelling.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Infection, Injection site erythema, Injection site pain
Clinical narrative: Patient developed next day redness/soreness at injection site. The pain spread into armpit and became worse. Patient visited physician after the worsening reaction. She was diagnosed with infection and treated with antibiotics.
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain upper, Arthralgia, Herpes zoster, Pain, Pyrexia
Clinical narrative: 2 weeks after Flu shot I had, fever, stomach pain, joint ache and found out I had shingles. Took Prednisone and corticosteroids prescription. After 2 1/2 months still have burning pain on left body.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Haemorrhage, Swelling
Clinical narrative: Injection given in left deltoid, patient bled a little so cotton ball was applied, when cotton removed one inch area was swollen. A few minutes later the swollen area was close to two inches and ice was applied. After ice swelling went down after five minutes to one inch area. Ice continued to be applied.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: Pt said that ever since she got vaccine her arm has been sore and has nerve pain. She said it lasted 3 weeks.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Nausea, Pain, Pyrexia
Clinical narrative: Dizziness, pain & body aches, diarrhea, nausea, vomiting, fever.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Dizziness, pain & body aches, diarrhea, nausea, vomiting, fever.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Oropharyngeal pain
Clinical narrative: Nausea, diarrhea, sore throat.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Neck pain, Tremor
Clinical narrative: Shakes / chills, sore neck at around 7:45PM shot given around 1:40 PM.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Rash
Clinical narrative: Within 48 hours of administration of ZOSTAVAX pt developed a rash & neuropathic pain.
Age: 1.01
Sex: F
Vaccine: HEPA, PNC
Symptoms: Vaccination failure, Varicella post vaccine
Clinical narrative: Varicella rash on 12/7/12 - symptomatic care. Failed vaccine coverage.
Age: 21.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, ANTH, FLUN3, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Myocarditis, Troponin I increased
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor or this study, Sanofi Pasteur. This study case was received from the investigator (MILVAX) on 09 January 2013. A 21-year-old male subject received on 27 October 2012 the following vaccinations: an injection of ACAM2000 (lot number not reported); and concomitant vaccines: INFLUENZA, SEASONAL INJ, (manufacturer unknown, lot number not reported), and an ANTHRAX 1 (other manufacturer, lot number not reported). The subject had no significant medical history. On 12 October 2012, fifteen days post vaccination, the subject was diagnosed with Non-specific myocarditis. Laboratory testing included a Troponin 1 blood test on 10 October 2012 with an abnormal result of highest value of 03.09. On 12 October 2012, an electrocardiogram (ECG) and Echocardiogram were both reported as normal. Treatments were not reported. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional study. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, ANTH, FLUN3, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Lymphadenopathy, Myocarditis, Troponin I increased
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor or this study, Sanofi Pasteur. This study case was received from the investigator (MILVAX) on 09 January 2013. A 21-year-old male subject received on 27 October 2012 the following vaccinations: an injection of ACAM2000 (lot number not reported); and concomitant vaccines: INFLUENZA, SEASONAL INJ, (manufacturer unknown, lot number not reported), and an ANTHRAX 1 (other manufacturer, lot number not reported). The subject had no significant medical history. On 12 October 2012, fifteen days post vaccination, the subject was diagnosed with Non-specific myocarditis. Laboratory testing included a Troponin 1 blood test on 10 October 2012 with an abnormal result of highest value of 03.09. On 12 October 2012, an electrocardiogram (ECG) and Echocardiogram were both reported as normal. Treatments were not reported. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional study. Documents held by sender: None.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, PNC
Symptoms: Vaccination failure, Varicella post vaccine
Clinical narrative: Varicella rash on 12/8/12 - exposed to sibling. Failed vaccine - already had VARIVAX x 2.
Age: 44.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, TDAP
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocardial infarction, Troponin I increased
Clinical narrative: This study case was received from the investigator on 09 January 2013. An 44 year-old male subject whose past medical history included high blood pressure and elevated cholesterol was found to have "subendocardial infarction" 13 days after the subject had received the following vaccines on 04 October 2012: an injection of ACAM2000 (lot number, route and site of administration not reported), Influenza seasonal injectable vaccine (manufacturer, lot number, route and site of administration not reported), Tdap vaccine (manufacturer, lot number, route and site of administration not reported and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I on 13 October 2012 recorded highest value of 00.13, an abnormal ECG on 15 October 2012 and a normal Echocardiogram on 15 October 2012. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Influenza virus test positive
Clinical narrative: Initial report was received on 10 January 2013 from a consumer who is also the patient's daughter. A female patient (date of birth not reported) had received a "standard dose" of Influenza vaccine (manufacturer, lot number, route and site of administration not reported) in "late August or early September". The patient was admitted to the hospital on 10 January 2013 and tested positive for influenza. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Urticaria
Clinical narrative: Hives all over his body.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: R upper arm 9x12 cm area of erythema and induration adjacent to vaccine administration site.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Chills, Erythema, Headache, Injection site erythema, Injection site pain
Clinical narrative: Left Deltoid: 4cmx5cm red raised area warm & painful to the touch (TDAP) Left arm: 3cmxcm pink reddish area warm & tender to the touch (Varicella) Right deltoid: 6cmx10cm red raised area warm & painful to the touch.  C/o of chills & headache; bilateral arms mildly erythemous - no swelling; no raised borders.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Left Deltoid: 4cmx5cm red raised area warm & painful to the touch (TDAP) Left arm: 3cmxcm pink reddish area warm & tender to the touch (Varicella) Right deltoid: 6cmx10cm red raised area warm & painful to the touch.  C/o of chills & headache; bilateral arms mildly erythemous - no swelling; no raised borders.
Age: 0.73
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Body temperature increased, Erythema, Skin warm, Vomiting
Clinical narrative: Child slept periodically after receiving vaccines on 1/9/13 and throughout the day of 1/10/13 child began vomiting at 10 PM on 1/10/13 after each attempt to feed. Parent gave child 2 oz of Sprite on 1/11/13 at 5 AM and child was able to tolerate without emesis. Child's temp on 1/10/13 PM was 100 degrees F. Same on 1/11/13 at 0930. Child has had 3 wet diapers on 1/11/13 from 5 AM - 10 AM. Child's cheeks are reddened- warm 1/10-1/11/13.
Age: 85.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Paraesthesia
Clinical narrative: Arm where pneumonia vaccine was given was sore, some swelling and was red for about one week.  It continues to have intermittent pain, tingling, and itching in an area just below the muscle where shot was given.
Age: 85.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pruritus
Clinical narrative: Arm where pneumonia vaccine was given was sore, some swelling and was red for about one week.  It continues to have intermittent pain, tingling, and itching in an area just below the muscle where shot was given.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Extensive swelling of vaccinated limb, Urticaria
Clinical narrative: Initial report was received from a healthcare professional on 14 January 2013. A 59-year-old male patient, whose medical history, concomitant medication and illness at the time of vaccination and any other vaccinations within 4 weeks of vaccinations were unknown, had received an intradermal dose 1 of FLUZONE ID vaccine, batch number: UT4466AA (site of administration was unknown) on 12 January 2013. On 13 January 2013 i.e. one day after receiving FLUZONE ID vaccine, the patient experienced welt the size of a softball. The corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome was not reported. Follow-up information was received from a healthcare professional on 14 January 2013, which upgraded this to a serious case. According to the reporter, the patient received the FLUZONE intradermal on 12 January 2013, and the reaction actually started several hours later on that same day, originally reported as the next day on 13 January 2013, The patient then experienced swelling extending from the injection site to the entire arm and hand. The patient's outcome remained not reported. Documents held by sender: None.
Age: 40.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Dizziness, Dyskinesia, Loss of consciousness, Muscle rigidity, Posture abnormal
Clinical narrative: C/o being "light headed", slumped over in chair. Appeared to pass out then stiffened with rapid arm and feet movement. Patient easily aroused. BP 100/60.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Flushing, Skin warm, Throat tightness
Clinical narrative: Note:  Time of flu injection and onset of adverse events are approximates -- very close to correct time.  Within a few minutes of receiving intradermal flu vaccine patient stated throat was feeling tight and started coughing.  No itching or rash but stated face was feeling hot. Face slightly flushed.  Lungs clear -- no wheezing. Breathing without difficulty but needed to clear throat.  BP 118/78; Pulse 84.  Given 50mg Benadryl IM at 8:38 AM.  Pt. started noticing less tightness in throat and face felt less hot within minutes.  8:45 AM Coughing much less -- states feels much better.  9:16 AM - BP 110/82; Pulse 72.  No coughing.  States feeling fine -- denies throat tightness or feeling in any way that is not her normal self.
Age: 19.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, ANTH, FLU3, SMALL
Symptoms: Acute myocardial infarction, Cardiomyopathy, Echocardiogram abnormal, Electrocardiogram abnormal, Troponin I increased
Clinical narrative: This study case was received from the investigator on 15 January 2013. A 19-year-old male subject, with a past medical history of high blood pressure, received ACAM2000 (lot number not reported) on an unreported date in 2012. On 26 November 2012, within 30 days post small pox vaccination, the subject had abnormal Troponin I result, with highest value of 0.03 ng/mL. On 26 November 2012, the subject had an electrocardiogram (ECG) with abnormal results, and on same day, was diagnosed with an acute myocardial infarction, unspecified site. An echocardiogram was performed with abnormal results on 27 November 2012. MRI of brain, spinal cord, heart and lumbar puncture studies were not performed. On 29 November 2012, the subject was also diagnosed with other primary cardiomyopathies. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, ANTH, FLU3, SMALL
Symptoms: Barbiturates negative, Blood cholesterol normal, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Blood creatinine increased
Clinical narrative: This study case was received from the investigator on 15 January 2013. A 19-year-old male subject, with a past medical history of high blood pressure, received ACAM2000 (lot number not reported) on an unreported date in 2012. On 26 November 2012, within 30 days post small pox vaccination, the subject had abnormal Troponin I result, with highest value of 0.03 ng/mL. On 26 November 2012, the subject had an electrocardiogram (ECG) with abnormal results, and on same day, was diagnosed with an acute myocardial infarction, unspecified site. An echocardiogram was performed with abnormal results on 27 November 2012. MRI of brain, spinal cord, heart and lumbar puncture studies were not performed. On 29 November 2012, the subject was also diagnosed with other primary cardiomyopathies. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, ANTH, FLU3, SMALL
Symptoms: Blood iron, Blood iron decreased, Blood thyroid stimulating hormone decreased, Blood triglycerides normal, Cardiomyopathy
Clinical narrative: This study case was received from the investigator on 15 January 2013. A 19-year-old male subject, with a past medical history of high blood pressure, received ACAM2000 (lot number not reported) on an unreported date in 2012. On 26 November 2012, within 30 days post small pox vaccination, the subject had abnormal Troponin I result, with highest value of 0.03 ng/mL. On 26 November 2012, the subject had an electrocardiogram (ECG) with abnormal results, and on same day, was diagnosed with an acute myocardial infarction, unspecified site. An echocardiogram was performed with abnormal results on 27 November 2012. MRI of brain, spinal cord, heart and lumbar puncture studies were not performed. On 29 November 2012, the subject was also diagnosed with other primary cardiomyopathies. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, ANTH, FLU3, SMALL
Symptoms: Catheterisation cardiac abnormal, Chest X-ray normal, Chest discomfort, Chest pain, Differential white blood cell count abnormal
Clinical narrative: This study case was received from the investigator on 15 January 2013. A 19-year-old male subject, with a past medical history of high blood pressure, received ACAM2000 (lot number not reported) on an unreported date in 2012. On 26 November 2012, within 30 days post small pox vaccination, the subject had abnormal Troponin I result, with highest value of 0.03 ng/mL. On 26 November 2012, the subject had an electrocardiogram (ECG) with abnormal results, and on same day, was diagnosed with an acute myocardial infarction, unspecified site. An echocardiogram was performed with abnormal results on 27 November 2012. MRI of brain, spinal cord, heart and lumbar puncture studies were not performed. On 29 November 2012, the subject was also diagnosed with other primary cardiomyopathies. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, ANTH, FLU3, SMALL
Symptoms: Dizziness, Drug screen positive, Dyspnoea, Echocardiogram, Echocardiogram abnormal
Clinical narrative: This study case was received from the investigator on 15 January 2013. A 19-year-old male subject, with a past medical history of high blood pressure, received ACAM2000 (lot number not reported) on an unreported date in 2012. On 26 November 2012, within 30 days post small pox vaccination, the subject had abnormal Troponin I result, with highest value of 0.03 ng/mL. On 26 November 2012, the subject had an electrocardiogram (ECG) with abnormal results, and on same day, was diagnosed with an acute myocardial infarction, unspecified site. An echocardiogram was performed with abnormal results on 27 November 2012. MRI of brain, spinal cord, heart and lumbar puncture studies were not performed. On 29 November 2012, the subject was also diagnosed with other primary cardiomyopathies. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, ANTH, FLU3, SMALL
Symptoms: Ejection fraction decreased, Electrocardiogram PR prolongation, Electrocardiogram QRS complex normal, Electrocardiogram QT interval normal, Electrocardiogram ST segment elevation
Clinical narrative: This study case was received from the investigator on 15 January 2013. A 19-year-old male subject, with a past medical history of high blood pressure, received ACAM2000 (lot number not reported) on an unreported date in 2012. On 26 November 2012, within 30 days post small pox vaccination, the subject had abnormal Troponin I result, with highest value of 0.03 ng/mL. On 26 November 2012, the subject had an electrocardiogram (ECG) with abnormal results, and on same day, was diagnosed with an acute myocardial infarction, unspecified site. An echocardiogram was performed with abnormal results on 27 November 2012. MRI of brain, spinal cord, heart and lumbar puncture studies were not performed. On 29 November 2012, the subject was also diagnosed with other primary cardiomyopathies. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, ANTH, FLU3, SMALL
Symptoms: Electrocardiogram T wave abnormal, Full blood count abnormal, High density lipoprotein normal, Hyperhidrosis, Left ventricular dysfunction
Clinical narrative: This study case was received from the investigator on 15 January 2013. A 19-year-old male subject, with a past medical history of high blood pressure, received ACAM2000 (lot number not reported) on an unreported date in 2012. On 26 November 2012, within 30 days post small pox vaccination, the subject had abnormal Troponin I result, with highest value of 0.03 ng/mL. On 26 November 2012, the subject had an electrocardiogram (ECG) with abnormal results, and on same day, was diagnosed with an acute myocardial infarction, unspecified site. An echocardiogram was performed with abnormal results on 27 November 2012. MRI of brain, spinal cord, heart and lumbar puncture studies were not performed. On 29 November 2012, the subject was also diagnosed with other primary cardiomyopathies. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, ANTH, FLU3, SMALL
Symptoms: Left ventricular end-diastolic pressure, Low density lipoprotein decreased, Mitral valve incompetence, Monocyte count increased, Muscle spasms
Clinical narrative: This study case was received from the investigator on 15 January 2013. A 19-year-old male subject, with a past medical history of high blood pressure, received ACAM2000 (lot number not reported) on an unreported date in 2012. On 26 November 2012, within 30 days post small pox vaccination, the subject had abnormal Troponin I result, with highest value of 0.03 ng/mL. On 26 November 2012, the subject had an electrocardiogram (ECG) with abnormal results, and on same day, was diagnosed with an acute myocardial infarction, unspecified site. An echocardiogram was performed with abnormal results on 27 November 2012. MRI of brain, spinal cord, heart and lumbar puncture studies were not performed. On 29 November 2012, the subject was also diagnosed with other primary cardiomyopathies. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, ANTH, FLU3, SMALL
Symptoms: Myocarditis, Nausea, Neutrophil count increased, Neutrophil percentage increased, Opiates negative
Clinical narrative: This study case was received from the investigator on 15 January 2013. A 19-year-old male subject, with a past medical history of high blood pressure, received ACAM2000 (lot number not reported) on an unreported date in 2012. On 26 November 2012, within 30 days post small pox vaccination, the subject had abnormal Troponin I result, with highest value of 0.03 ng/mL. On 26 November 2012, the subject had an electrocardiogram (ECG) with abnormal results, and on same day, was diagnosed with an acute myocardial infarction, unspecified site. An echocardiogram was performed with abnormal results on 27 November 2012. MRI of brain, spinal cord, heart and lumbar puncture studies were not performed. On 29 November 2012, the subject was also diagnosed with other primary cardiomyopathies. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, ANTH, FLU3, SMALL
Symptoms: Palpitations, Pleurisy, Pulmonary valve incompetence, QRS axis abnormal, QRS axis normal
Clinical narrative: This study case was received from the investigator on 15 January 2013. A 19-year-old male subject, with a past medical history of high blood pressure, received ACAM2000 (lot number not reported) on an unreported date in 2012. On 26 November 2012, within 30 days post small pox vaccination, the subject had abnormal Troponin I result, with highest value of 0.03 ng/mL. On 26 November 2012, the subject had an electrocardiogram (ECG) with abnormal results, and on same day, was diagnosed with an acute myocardial infarction, unspecified site. An echocardiogram was performed with abnormal results on 27 November 2012. MRI of brain, spinal cord, heart and lumbar puncture studies were not performed. On 29 November 2012, the subject was also diagnosed with other primary cardiomyopathies. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, ANTH, FLU3, SMALL
Symptoms: Red blood cell count normal, Serum ferritin increased, Sinus arrhythmia, Sinus tachycardia, Thyroxine free normal
Clinical narrative: This study case was received from the investigator on 15 January 2013. A 19-year-old male subject, with a past medical history of high blood pressure, received ACAM2000 (lot number not reported) on an unreported date in 2012. On 26 November 2012, within 30 days post small pox vaccination, the subject had abnormal Troponin I result, with highest value of 0.03 ng/mL. On 26 November 2012, the subject had an electrocardiogram (ECG) with abnormal results, and on same day, was diagnosed with an acute myocardial infarction, unspecified site. An echocardiogram was performed with abnormal results on 27 November 2012. MRI of brain, spinal cord, heart and lumbar puncture studies were not performed. On 29 November 2012, the subject was also diagnosed with other primary cardiomyopathies. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, ANTH, FLU3, SMALL
Symptoms: Total cholesterol/HDL ratio, Troponin I, Troponin T, Troponin T increased, Troponin normal
Clinical narrative: This study case was received from the investigator on 15 January 2013. A 19-year-old male subject, with a past medical history of high blood pressure, received ACAM2000 (lot number not reported) on an unreported date in 2012. On 26 November 2012, within 30 days post small pox vaccination, the subject had abnormal Troponin I result, with highest value of 0.03 ng/mL. On 26 November 2012, the subject had an electrocardiogram (ECG) with abnormal results, and on same day, was diagnosed with an acute myocardial infarction, unspecified site. An echocardiogram was performed with abnormal results on 27 November 2012. MRI of brain, spinal cord, heart and lumbar puncture studies were not performed. On 29 November 2012, the subject was also diagnosed with other primary cardiomyopathies. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, ANTH, FLU3, SMALL
Symptoms: Urine amphetamine negative, Very low density lipoprotein normal
Clinical narrative: This study case was received from the investigator on 15 January 2013. A 19-year-old male subject, with a past medical history of high blood pressure, received ACAM2000 (lot number not reported) on an unreported date in 2012. On 26 November 2012, within 30 days post small pox vaccination, the subject had abnormal Troponin I result, with highest value of 0.03 ng/mL. On 26 November 2012, the subject had an electrocardiogram (ECG) with abnormal results, and on same day, was diagnosed with an acute myocardial infarction, unspecified site. An echocardiogram was performed with abnormal results on 27 November 2012. MRI of brain, spinal cord, heart and lumbar puncture studies were not performed. On 29 November 2012, the subject was also diagnosed with other primary cardiomyopathies. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.