chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Arthralgia, Injection site erythema, Lymphadenitis, Myalgia, Pyrexia
Clinical narrative: 2 days post-immunization pt. developed hand-sized erythema at site if injection, distant seperated urticaria-type patches on bilateral wrists, myalgias, arthralgias, lymphadenitis, and feverof 101.5
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Urticaria
Clinical narrative: 2 days post-immunization pt. developed hand-sized erythema at site if injection, distant seperated urticaria-type patches on bilateral wrists, myalgias, arthralgias, lymphadenitis, and feverof 101.5
Age: 14.0
Sex: M
Vaccine: HEPA, YF
Symptoms: Cough, Eye pruritus, Injection site erythema, Injection site papule, Injection site pruritus
Clinical narrative: 6/6/07: Administered yellow fever vaccine SQ and Hep A vaccine IM in right arm.  Latex free bandaid applied to injection sites.  Approximately 2 minutes later, patient complained of itching at both injection sites.  Bandaids removed.  At yellow fever site, small reddened papule formed which increased in size over the next 5 minutes.  Patient complained of itching becoming worse.  Also complained of itching of eyes and throat.  Developed a cough that was not previously presnt.  Benadryl 1 ml administered IM.  Dr. in health department at the time of event and was called to clinic.  Patient improved within 5 minutes.  At 45 minutes, patient had no itching at injection site, no itching of throat or eyes.  Patient breathing well, cough subsided.  Patient discharged to care of parent.  Vital signs stable. 6/7/07:  Clinic nurse called patient and parent to inquire about symptoms.  No sypmtoms. Patient feeling well.
Age: 14.0
Sex: M
Vaccine: HEPA, YF
Symptoms: Throat irritation
Clinical narrative: 6/6/07: Administered yellow fever vaccine SQ and Hep A vaccine IM in right arm.  Latex free bandaid applied to injection sites.  Approximately 2 minutes later, patient complained of itching at both injection sites.  Bandaids removed.  At yellow fever site, small reddened papule formed which increased in size over the next 5 minutes.  Patient complained of itching becoming worse.  Also complained of itching of eyes and throat.  Developed a cough that was not previously presnt.  Benadryl 1 ml administered IM.  Dr. in health department at the time of event and was called to clinic.  Patient improved within 5 minutes.  At 45 minutes, patient had no itching at injection site, no itching of throat or eyes.  Patient breathing well, cough subsided.  Patient discharged to care of parent.  Vital signs stable. 6/7/07:  Clinic nurse called patient and parent to inquire about symptoms.  No sypmtoms. Patient feeling well.
Sex: M
Vaccine: HEP
Symptoms: Dyspnoea, Pain
Clinical narrative: Pain, difficulty breathing, infant was placed on oxygen for over 2 months
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC
Symptoms: Malaise, Pyrexia, Rash pruritic
Clinical narrative: About a week after vaccinations developed a slight fever with malaise. Three days later, ten days after immunization, developed a pruitic rash on trunk (front and back), chest, upper arms, thighs, and peri-area. No treatment given.
Age: 21.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Erythema, Pyrexia
Clinical narrative: Red spots about 1/4 inch in size, on rright rib cage and stomach. Low grade fever x 3 days,
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 10 x 9cm swelling of left arm near left deltoid (area vaccine administered) area warm to touch and reddened.
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Blood creatine phosphokinase MB, Blood creatine phosphokinase increased, Body temperature increased, Chest pain, Electrocardiogram abnormal
Clinical narrative: Pt received tetanus shot (Tdap) am 5/31/07 when treated by nurse at urgent care. Developed chest pain PM 6/3/07. Seen in ER 6/4/07 PM with elevated CK, CK-MB, Troponin and temp 100. and ECG changes. Cath was normal arteries but left ventricle hypokinesis, EF c/o diagnosed with myocarditis.  6/26/07 Received hospital med recs which reveal patient seen in cardio clinic on 6/11 & in ER on 6/12.  Had been hospitalized at another facility.    Cardio clinic note of 6/11 reveals pt developed chest pain 4 days s/p vax w/low grade fever.  Was doing well on med s/p d/c from hospital w/no chest pain & no sob only fatigue.  Exam revealed ekg changes of  involution & t-wave inversions in a pattern characteristic of evolving ischemia from myocarditis.  Meds were titrated & was scheduled for f/u echocardiogram & f/u.  Patient seen in ER on 6/12 for chest tightness which had made him extremely anxious.  EKG & CXR were unchanged.  Labs includeing cardiac enzymes were WNL.  Repeat echocardiogram was done & showed improvement of ejection fraction but still abnormal LV function.  Started on GI med as was on NSAIDS & released from ER w/continued cardio clinic f/u.  7/17/07 Received 2nd hospital medical records which reveal patient admitted 6/4-6/6/07 after experienced dull, constant, substernal chest pain.  Had been seen in ER 4 days earlier for cut on hand by broken glass &  received tetanus booster at that time.  Transferred for cardiac cath which showed normal coronary arteries but LV dysfunction.  Tx w/meds & d/c to home to f/u w/cardiology & pcp. FINAL DX: acute myocarditis; left ventricular dysfunction, ejection fraction 40%; brief runs of non sustained V-tach, resolved prior to d/c.
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Hypokinesia, Myocarditis, Troponin increased
Clinical narrative: Pt received tetanus shot (Tdap) am 5/31/07 when treated by nurse at urgent care. Developed chest pain PM 6/3/07. Seen in ER 6/4/07 PM with elevated CK, CK-MB, Troponin and temp 100. and ECG changes. Cath was normal arteries but left ventricle hypokinesis, EF c/o diagnosed with myocarditis.  6/26/07 Received hospital med recs which reveal patient seen in cardio clinic on 6/11 & in ER on 6/12.  Had been hospitalized at another facility.    Cardio clinic note of 6/11 reveals pt developed chest pain 4 days s/p vax w/low grade fever.  Was doing well on med s/p d/c from hospital w/no chest pain & no sob only fatigue.  Exam revealed ekg changes of  involution & t-wave inversions in a pattern characteristic of evolving ischemia from myocarditis.  Meds were titrated & was scheduled for f/u echocardiogram & f/u.  Patient seen in ER on 6/12 for chest tightness which had made him extremely anxious.  EKG & CXR were unchanged.  Labs includeing cardiac enzymes were WNL.  Repeat echocardiogram was done & showed improvement of ejection fraction but still abnormal LV function.  Started on GI med as was on NSAIDS & released from ER w/continued cardio clinic f/u.  7/17/07 Received 2nd hospital medical records which reveal patient admitted 6/4-6/6/07 after experienced dull, constant, substernal chest pain.  Had been seen in ER 4 days earlier for cut on hand by broken glass &  received tetanus booster at that time.  Transferred for cardiac cath which showed normal coronary arteries but LV dysfunction.  Tx w/meds & d/c to home to f/u w/cardiology & pcp. FINAL DX: acute myocarditis; left ventricular dysfunction, ejection fraction 40%; brief runs of non sustained V-tach, resolved prior to d/c.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Lip swelling, Nasopharyngitis
Clinical narrative: Received Tdap 5/18/07. 5/22/07 felt catching a cold and took 2 aspirins (525mgs each) 5 hours later lips swelled went to ER at hospital. Told ER probably ASA not the Tdap. Reporting just in case.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose increased, Fatigue, Hyperventilation, Livedo reticularis, Peripheral coldness
Clinical narrative: Patient developed hyperventilation; cold, mottled hands. Normal vital signs normal blood sugar. Halfway through Albuterol treatment, patient looked tired ---> sent to ER via EMS.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, hot swollen arm
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Abscess, Erythema, Induration, Skin warm
Clinical narrative: Alert, NAD 97.8 temp. Upper left arm with a 10cm diameter of induration and warmth and redness - sterile abcess. Supportive care for now.
Age: 18.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: Cellulitis diagnosed 2 days after vaccine given 8 1/2cm red area, warm, swollen. Treated with Augmentin 875mg BID x 10 days.
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Body temperature increased, Fatigue, Muscle twitching, Myalgia
Clinical narrative: Muscle aches, fatigue, generalized body aches and weakness. Temp 99.1. Muscular twitching.
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Muscle aches, fatigue, generalized body aches and weakness. Temp 99.1. Muscular twitching.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Secondary transmission
Clinical narrative: Patient reports that shortly after he received vaccine his 49 year wife developed shingles dx 6-21-07 by her PCP after rash x 10 days.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Pyrexia, Streptococcal identification test negative
Clinical narrative: Fever of 104 with headache
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Local reaction
Clinical narrative: Local site reaction - swelling
Age: 10.0
Sex: F
Vaccine: HPV4, TDAP, UNK, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, heat and mild swelling to left upper arm at injection site. Denies pain.
Age: 18.0
Sex: F
Vaccine: HEP, HPV4
Symptoms: Arthropod bite, Chest X-ray normal, Dyspnoea exertional, Fatigue, Full blood count normal
Clinical narrative: 6/4/07 Eve - felt fatigued, mild achy then 6/5/07 awoke with extreme achiness, mild dyspnea with exertion and swelling of face. 6/4/07 Eve had been outdoors fishing, one bug bite found on her hand. ER Visit attached. Recovered in 1 day.
Age: 18.0
Sex: F
Vaccine: HEP, HPV4
Symptoms: Pain, Streptococcal identification test negative, Swelling face
Clinical narrative: 6/4/07 Eve - felt fatigued, mild achy then 6/5/07 awoke with extreme achiness, mild dyspnea with exertion and swelling of face. 6/4/07 Eve had been outdoors fishing, one bug bite found on her hand. ER Visit attached. Recovered in 1 day.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site vesicles
Clinical narrative: Patient self reported localized clusters of pruritic vesicular at injection site left deltoid, back, right shoulder area. Developed on 6/13/07; resolved over next 7-8 days.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, pain and swelling progressive after VZV vaccine.
Age: 0.2
Sex: F
Vaccine: DTAP, IPV
Symptoms: Agitation, Dyspnoea, Electroencephalogram, Irritability, Musculoskeletal stiffness
Clinical narrative: Fussy, irritable, generalized tonic stiffness, vibratory shaking, gasping breathing patterns each episode lasting > 20 seconds.
Age: 0.2
Sex: F
Vaccine: DTAP, IPV
Symptoms: Scan brain, Tremor
Clinical narrative: Fussy, irritable, generalized tonic stiffness, vibratory shaking, gasping breathing patterns each episode lasting > 20 seconds.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Inflammation, Oedema, Rash, Skin discolouration
Clinical narrative: Red spot left thigh; approximately 10cm diameter pinkish inflammation in left thigh positive mild edema ---> see notes.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Hypersensitivity, Mass, Skin warm
Clinical narrative: 6-21-07 AM mother phoned reporting large knot with redness and warmth to right arm - at that time Benadryl and ice if area became worse and not improved to bring her in later in day. At 6:30pm mom brought child to doctor at our clinic - diagnosed allergic reaction to Varivax --> treatment = Atarax, Augmentin and follow up in AM. 6/22/07 AM condition improved continue treatment: If worse return otherwise follow up in Thursday.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Back pain, Chills, Fatigue, Feeling abnormal
Clinical narrative: Large local reaction AVA #6 site: redness, swelling, induration, pain, bilateral kidney, back and groin pain  o  Feeling terrible o  Having symptoms fatigue, weakness, pain right arm, bilateral flank pain o  Generalized pain left arm/deltoid, axilla and bilateral kidneys w/groin tenderness since Monday evening w/o relief. Tuesday worse w/o increase in discomfort today (Wed) o  Feeling tired or poorly o  Fever o  Chills  o  Neck symptoms c/o stiffnes to neck following tension  o  Genitourinary symptoms bilateral groin pain, no urinary symptoms, denies hesitancy, frequency, no STD exposure  o  Skin symptoms right deltoid red swollen hot to touch   o  Musculoskeletal symptoms
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Flank pain, Groin pain, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Large local reaction AVA #6 site: redness, swelling, induration, pain, bilateral kidney, back and groin pain  o  Feeling terrible o  Having symptoms fatigue, weakness, pain right arm, bilateral flank pain o  Generalized pain left arm/deltoid, axilla and bilateral kidneys w/groin tenderness since Monday evening w/o relief. Tuesday worse w/o increase in discomfort today (Wed) o  Feeling tired or poorly o  Fever o  Chills  o  Neck symptoms c/o stiffnes to neck following tension  o  Genitourinary symptoms bilateral groin pain, no urinary symptoms, denies hesitancy, frequency, no STD exposure  o  Skin symptoms right deltoid red swollen hot to touch   o  Musculoskeletal symptoms
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site swelling, Injection site warmth, Musculoskeletal stiffness, Pyrexia, Renal disorder
Clinical narrative: Large local reaction AVA #6 site: redness, swelling, induration, pain, bilateral kidney, back and groin pain  o  Feeling terrible o  Having symptoms fatigue, weakness, pain right arm, bilateral flank pain o  Generalized pain left arm/deltoid, axilla and bilateral kidneys w/groin tenderness since Monday evening w/o relief. Tuesday worse w/o increase in discomfort today (Wed) o  Feeling tired or poorly o  Fever o  Chills  o  Neck symptoms c/o stiffnes to neck following tension  o  Genitourinary symptoms bilateral groin pain, no urinary symptoms, denies hesitancy, frequency, no STD exposure  o  Skin symptoms right deltoid red swollen hot to touch   o  Musculoskeletal symptoms
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles rash onset 7 days after zostavax
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Lymphadenitis, Lymphangitis, Pain, Swelling
Clinical narrative: SX = sudden onset of pain and swelling on day 8 post small pox vaccination.                                      O = lymphadenitis/ lymphangitis Left upper arm and axillae
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Pyrexia, Rash
Clinical narrative: Developed rash and low grade fever within 12 hrs of vaccine administration.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Fibromyalgia, Injection site erythema, Injection site urticaria
Clinical narrative: Patient (who is also a physician) called 6-22-07 and reported that she did get the delayed response-24 hrs after the injection where she had a 2.5-3" raised red hive at the injection sight.  She also reported that her fibromyalgea flared up at the same time that the hive appeared and lasted about 2 days.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Echocardiogram, Electroencephalogram, Immediate post-injection reaction, Syncope
Clinical narrative: syncopal episode immediately after injection.  patient quickly recovered and felt fine after about 15 seconds.  no nausea, vomiting.
Age: 37.0
Sex: F
Vaccine: MMRV, MMR, MMRV, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: 37 Year old female given MMRV instead of MMR and Varicella.  No adverse reaction to injection.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Urticaria
Clinical narrative: Patient developed severe urticaria 10 minutes after her vaccines.  She was immediately given 20 mg of Benadryl po.  No respiratory distress at any time.  She continued to have urticaria and was given 15 mg sc of epinepherine.  The symptoms subsided and the patient was being transported to the ED.  She then at about 20 minutes post dose developed symptoms again.  911 was called and she was brought to the ED via ambulance.  No wheezing or respiratory distress.
Age: 28.0
Sex: F
Vaccine: MNQ, TYP, YF
Symptoms: Cold sweat, Headache, Pain
Clinical narrative: Patient reports "cold Sweats" headache and body aches.Symptoms began 06/21/07. Patient leaving on boat, states does not have time to come in for check.
Age: 40.0
Sex: F
Vaccine: MNQ
Symptoms: Body temperature increased, Pain
Clinical narrative: Patent states he developed body aches, and low grade temp. a few hours after vaccination. Stated symptoms lasted 3 days, went away and returned 06/22/2007.Patient declined to come in for check today. States may come in tommorrow.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Patient received MMR vaccine on 6/7/07, returned to office on 06/22/07 complaining of rash for 7 days.
Age: 5.0
Sex: M
Vaccine: DPP, IPV, MMR
Symptoms: Body temperature increased
Clinical narrative: Temperature 103.5
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Cough, Lethargy, Pyrexia, Rash morbilliform, Rhinorrhoea
Clinical narrative: Measles like rash primarily on torso, persistent cough, runny nose, lethargy, fever.  Still symptomatic on 6/22/2007. Tested for Strep (negative). Treated with antihistamine (benadryl), antipruritic, and childrens advil.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Streptococcal identification test negative
Clinical narrative: Measles like rash primarily on torso, persistent cough, runny nose, lethargy, fever.  Still symptomatic on 6/22/2007. Tested for Strep (negative). Treated with antihistamine (benadryl), antipruritic, and childrens advil.
Age: 53.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Immediate post-injection reaction, Muscle spasms, Myalgia
Clinical narrative: Immediately after my first of three anthrax shots I had muscle cramps, sore joints and muscles that continue to persist more than a month after the last shot. No treatment.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL, HPV4, MNQ, VARCEL
Symptoms: Asthenia, Blood pressure decreased, Heart rate decreased, Musculoskeletal stiffness, Pallor
Clinical narrative: After 3 minutes of the application, the patient  got paleness, weakness, shakeness, generalized stiffness. She asked then "What happened? The BP went down to 80/60, and heart rate around 50's. The situation resolved in 15 minutes. No aditional treatment was given.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL, HPV4, MNQ, VARCEL
Symptoms: Tremor
Clinical narrative: After 3 minutes of the application, the patient  got paleness, weakness, shakeness, generalized stiffness. She asked then "What happened? The BP went down to 80/60, and heart rate around 50's. The situation resolved in 15 minutes. No aditional treatment was given.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL, HPV4, MNQ, VARCEL
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: After 3 minutes of the application, the patient  got paleness, weakness, shakeness, generalized stiffness. She asked then "What happened? The BP went down to 80/60, and heart rate around 50's. The situation resolved in 15 minutes. No aditional treatment was given.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Hypotension, Malaise, Musculoskeletal stiffness, Pallor, Syncope
Clinical narrative: Patient received Gardasil. Three minutes after the vaccine was given she said: "I don't feel good" Then she went pale, stiff, fainted. She didn't recall what happened. She came back after 5 minutes. Her BP was low, 60/40 and received epi 0.3 mg.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Asthenia, Hypotension, Pallor, Syncope
Clinical narrative: Patient received Gardasil. Three minutes after the vaccine was given she said: "I don't feel good" Then she went pale, stiff, fainted. She didn't recall what happened. She came back after 5 minutes. Her BP was low, 60/40 and received epi 0.3 mg.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Kidney infection, Urinary tract infection
Clinical narrative: Urinary tract infection moved into kidneys and caused kidney infection resulting in hospitalization and IV antibiotics.  7/6/07 Received hospital medical records which reveal patient experienced fever,  back pain & vomiting while away from home on mission trip.  Exam revealed bilat CVA tenderness. Admitted 6/22-6/23/07.  D/C to f/u for outpatient oral antibiotics. FINAL DX: Pyelonephritis, resolving. 8/14/07 Received vax record which confirms HPV dose & lot # as reported.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Acne, Chest pain, Diarrhoea, Dyspnoea, Headache
Clinical narrative: Permanent flu Unexplained head pain  Leg cramp Muscular pain Consistent diarrhea Unexplained seasickness  Chest pain Difficult to breathe  Difficult to loose weight  Uncommon acne on the head 8/27/07 Reviewed VAMC medical records for 6/2005-5/2006 which reveal patient experienced: sleep disturbance, anxiety, depression, fatigue, headaches, muscle pain, chronic low back pain w/radiculopathy, URI, umbilical hernia repair w/postop infection, morning cough, sinusitis, bronchospasm, GERD, allergies LABS: MRI L4L5 bulging annulus.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Influenza, Motion sickness, Muscle spasms, Myalgia, Weight loss poor
Clinical narrative: Permanent flu Unexplained head pain  Leg cramp Muscular pain Consistent diarrhea Unexplained seasickness  Chest pain Difficult to breathe  Difficult to loose weight  Uncommon acne on the head 8/27/07 Reviewed VAMC medical records for 6/2005-5/2006 which reveal patient experienced: sleep disturbance, anxiety, depression, fatigue, headaches, muscle pain, chronic low back pain w/radiculopathy, URI, umbilical hernia repair w/postop infection, morning cough, sinusitis, bronchospasm, GERD, allergies LABS: MRI L4L5 bulging annulus.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Loss of consciousness, Nausea, Vomiting
Clinical narrative: Pt stated he was fine after receiving vaccine. Within 5-10 minutes he was in waiting room and passed out. After 10-15 minutes of observation he left accompanied by his mother. Vomited in the parking lot and continued to c/o nausea couple hrs later. 3 hours past injection Dr did F/L
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Diarrhea, vomitting, fever as high as 101.8
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Abscess, Heat therapy, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Patient recieved Adacel on 6/16/07.  She  complained of mild swelling and pain at injection site, starting 1 day after injection.  She noted that pain and swelling became progressively worse starting on day 4 (06/20/07)post injection through her presentation on day 6 post-injection (06/22/07).  Upon exam of injection site (left arm, deltoid muscle) - pt had a slightly raised, erythematous patch (approximately 4" across by 2 1/2" high), with approximately 1/2" diameter induration under the injection site.  The site was HOT to touch and tender to palpation.  There was no visible exudate. The patients temperature was 98.1, heart rate - 72.  The patient last had DTP in 1987; patient has no medical history, and was taking only oral contraceptive pills for medication.  Diagnosis is sterile abcess. Treatment for patient is Cephalexin 500mg by mouth three times a day for 10 days.  I also reccomended warm compresses at injection site, and tylenol for pain/swelling.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient recieved Adacel on 6/16/07.  She  complained of mild swelling and pain at injection site, starting 1 day after injection.  She noted that pain and swelling became progressively worse starting on day 4 (06/20/07)post injection through her presentation on day 6 post-injection (06/22/07).  Upon exam of injection site (left arm, deltoid muscle) - pt had a slightly raised, erythematous patch (approximately 4" across by 2 1/2" high), with approximately 1/2" diameter induration under the injection site.  The site was HOT to touch and tender to palpation.  There was no visible exudate. The patients temperature was 98.1, heart rate - 72.  The patient last had DTP in 1987; patient has no medical history, and was taking only oral contraceptive pills for medication.  Diagnosis is sterile abcess. Treatment for patient is Cephalexin 500mg by mouth three times a day for 10 days.  I also reccomended warm compresses at injection site, and tylenol for pain/swelling.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: C-reactive protein increased, Echocardiogram abnormal, Immunoglobulins, Kawasaki's disease, Pericardial effusion
Clinical narrative: Information has been received from FDA (VAERS #277823) concerning a 2-month-old female with a history of seborrhoea on the scalp and eczema and no other pre-existing illness who on 19-APR-2007 was vaccinated with a dose of Rotateq (Lot #654422/0607F). Concomitant vaccinations administered on that same day included a dose of Pediarix (Lot # AC21B066AA), a dose of PedvaxHib (654677/1124F) and a dose of Prevnar (Lot #B08691K). On 19-APR-2007, within 12 hours of vaccination, the patient developed high fevers then preceeded in the next 24 hours to develop Kawasaki's syndrome including eye changes, generalized rash and oral changes. This was confirmed by a physician and the patient was treated with IV gammaglobulin. On 23-APR-2007, an echocardiogram revealed apical pericardial effusion. On 24-APR-2007, C-reactive protein was increased at 12.4. At the time of this report, the outcome was unknown. The reporter considered the events to be serious. Additional information was received from a physician who indicated that, as described, the patient would be considered to have incomplete Kawasaki's disease. She noted that the pericardial effusion noted on echocardiography was consistent with the diagnosis as was the elevated C-reactive protein. She also noted that since the etiology of Kawasaki's disease remains unknown, it was not possible to determine an incubation period. The physician felt that it was unlikely that there was any true relationship between the Kawasaki's disease and Rotateq. No further information is available.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia, Rash, Rash generalised
Clinical narrative: Information has been received from FDA (VAERS #277823) concerning a 2-month-old female with a history of seborrhoea on the scalp and eczema and no other pre-existing illness who on 19-APR-2007 was vaccinated with a dose of Rotateq (Lot #654422/0607F). Concomitant vaccinations administered on that same day included a dose of Pediarix (Lot # AC21B066AA), a dose of PedvaxHib (654677/1124F) and a dose of Prevnar (Lot #B08691K). On 19-APR-2007, within 12 hours of vaccination, the patient developed high fevers then preceeded in the next 24 hours to develop Kawasaki's syndrome including eye changes, generalized rash and oral changes. This was confirmed by a physician and the patient was treated with IV gammaglobulin. On 23-APR-2007, an echocardiogram revealed apical pericardial effusion. On 24-APR-2007, C-reactive protein was increased at 12.4. At the time of this report, the outcome was unknown. The reporter considered the events to be serious. Additional information was received from a physician who indicated that, as described, the patient would be considered to have incomplete Kawasaki's disease. She noted that the pericardial effusion noted on echocardiography was consistent with the diagnosis as was the elevated C-reactive protein. She also noted that since the etiology of Kawasaki's disease remains unknown, it was not possible to determine an incubation period. The physician felt that it was unlikely that there was any true relationship between the Kawasaki's disease and Rotateq. No further information is available.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: C-reactive protein increased, Eye disorder, Kawasaki's disease, Pericardial effusion, Pyrexia
Clinical narrative: Information has been received from FDA (VAERS #277823) concerning a 2-month-old female with a history of seborrhoea on the scalp and eczema and no other pre-existing illness who on 19-APR-2007 was vaccinated with a dose of Rotateq (Lot #654422/0607F). Concomitant vaccinations administered on that same day included a dose of Pediarix (Lot # AC21B066AA), a dose of PedvaxHib (654677/1124F) and a dose of Prevnar (Lot #B08691K). On 19-APR-2007, within 12 hours of vaccination, the patient developed high fevers then preceeded in the next 24 hours to develop Kawasaki's syndrome including eye changes, generalized rash and oral changes. This was confirmed by a physician and the patient was treated with IV gammaglobulin. On 23-APR-2007, an echocardiogram revealed apical pericardial effusion. On 24-APR-2007, C-reactive protein was increased at 12.4. At the time of this report, the outcome was unknown. The reporter considered the events to be serious. Additional information was received from a physician who indicated that, as described, the patient would be considered to have incomplete Kawasaki's disease. She noted that the pericardial effusion noted on echocardiography was consistent with the diagnosis as was the elevated C-reactive protein. She also noted that since the etiology of Kawasaki's disease remains unknown, it was not possible to determine an incubation period. The physician felt that it was unlikely that there was any true relationship between the Kawasaki's disease and Rotateq. No further information is available.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rash generalised
Clinical narrative: Information has been received from FDA (VAERS #277823) concerning a 2-month-old female with a history of seborrhoea on the scalp and eczema and no other pre-existing illness who on 19-APR-2007 was vaccinated with a dose of Rotateq (Lot #654422/0607F). Concomitant vaccinations administered on that same day included a dose of Pediarix (Lot # AC21B066AA), a dose of PedvaxHib (654677/1124F) and a dose of Prevnar (Lot #B08691K). On 19-APR-2007, within 12 hours of vaccination, the patient developed high fevers then preceeded in the next 24 hours to develop Kawasaki's syndrome including eye changes, generalized rash and oral changes. This was confirmed by a physician and the patient was treated with IV gammaglobulin. On 23-APR-2007, an echocardiogram revealed apical pericardial effusion. On 24-APR-2007, C-reactive protein was increased at 12.4. At the time of this report, the outcome was unknown. The reporter considered the events to be serious. Additional information was received from a physician who indicated that, as described, the patient would be considered to have incomplete Kawasaki's disease. She noted that the pericardial effusion noted on echocardiography was consistent with the diagnosis as was the elevated C-reactive protein. She also noted that since the etiology of Kawasaki's disease remains unknown, it was not possible to determine an incubation period. The physician felt that it was unlikely that there was any true relationship between the Kawasaki's disease and Rotateq. No further information is available.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, RV5
Symptoms: Abdominal X-ray, Diarrhoea, Enema administration, Intussusception, Pyrexia
Clinical narrative: Information has been received from an agency (VAERS# 278716) concerning a 6 month old male who on 14-MAY-2007 was vaccinated with a third dose Rotateq (656105/1232F). On 15-MAY-2007 the patient experienced intussusception. Procedure: Barium enema. Upon internal review, the intussusception was determined to be an other important medical event. A lot check had been requested. A review of the initial release testing for the lot number in question was found to conform to specifications. The lot complies with the standards of an agency and released. Additional information is not expected.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, RV5
Symptoms: Barium enema, Intussusception
Clinical narrative: Information has been received from an agency (VAERS# 278716) concerning a 6 month old male who on 14-MAY-2007 was vaccinated with a third dose Rotateq (656105/1232F). On 15-MAY-2007 the patient experienced intussusception. Procedure: Barium enema. Upon internal review, the intussusception was determined to be an other important medical event. A lot check had been requested. A review of the initial release testing for the lot number in question was found to conform to specifications. The lot complies with the standards of an agency and released. Additional information is not expected.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal distension, Appendicectomy, Barium enema, Decreased appetite, Diarrhoea
Clinical narrative: Information has been received from an agency concerning a 7 month old male (VAERS# 279290), with an allergy to amoxil medication, who on 09-APR-2007 was vaccinated with a third dose of Rotateq (Lot# 656192/0022U). Concomitant vaccines included a third dose of PEDIARIX (Lot# AC21B097AB), a third dose of ACTHIB (Lot# UF084AA), and a third dose of PREVNAR (Lot# B36258H). On 08-MAY-2007 the patient experienced intussusception. It was reported that the patient had a gut resection. Follow-up information from an agency indicated that on 08-MAY-2007 the patient vomited three times. On 09-MAY-2007 the patient vomited six times and had a poor appetite. PHENEGRAN 0.3 ml was administered for the vomiting. The patient was given PEDIALYTE and GATORADE at home. 48 hours prior to admission to the hospital the patient had progressive abdominal distention, vomiting, and two episodes of bloody stools. The patient was initially admitted to the hospital for feeding difficulties and a fever since the previous night. After admission to the hospital the patient was placed on IV fluids. The patient had one loose stool with a little red color, the day after admission, the patient was distended. An x-ray suggested intussusception and a barium enema confirmed it. Surgery was done shortly after 05-JUN-2007. Records received from the hospital had a diagnosis of intussusception, dehydration, left otitis media, upper respiratory infection, and vomiting. The surgery was exploratory laporatomy with reduction of intussusception and incidental appendectomy. During the course of the hospitalization the patient developed diarrhea, vomiting and abdominal distention. It was reported that the patient recovered. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of an agency was released. Additional information is not expected.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Faeces discoloured, Fluid replacement, Full blood count, Intussusception, Metabolic function test
Clinical narrative: Information has been received from an agency concerning a 7 month old male (VAERS# 279290), with an allergy to amoxil medication, who on 09-APR-2007 was vaccinated with a third dose of Rotateq (Lot# 656192/0022U). Concomitant vaccines included a third dose of PEDIARIX (Lot# AC21B097AB), a third dose of ACTHIB (Lot# UF084AA), and a third dose of PREVNAR (Lot# B36258H). On 08-MAY-2007 the patient experienced intussusception. It was reported that the patient had a gut resection. Follow-up information from an agency indicated that on 08-MAY-2007 the patient vomited three times. On 09-MAY-2007 the patient vomited six times and had a poor appetite. PHENEGRAN 0.3 ml was administered for the vomiting. The patient was given PEDIALYTE and GATORADE at home. 48 hours prior to admission to the hospital the patient had progressive abdominal distention, vomiting, and two episodes of bloody stools. The patient was initially admitted to the hospital for feeding difficulties and a fever since the previous night. After admission to the hospital the patient was placed on IV fluids. The patient had one loose stool with a little red color, the day after admission, the patient was distended. An x-ray suggested intussusception and a barium enema confirmed it. Surgery was done shortly after 05-JUN-2007. Records received from the hospital had a diagnosis of intussusception, dehydration, left otitis media, upper respiratory infection, and vomiting. The surgery was exploratory laporatomy with reduction of intussusception and incidental appendectomy. During the course of the hospitalization the patient developed diarrhea, vomiting and abdominal distention. It was reported that the patient recovered. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of an agency was released. Additional information is not expected.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Occult blood positive, Rotavirus test negative, Surgery, Urine analysis, Vomiting
Clinical narrative: Information has been received from an agency concerning a 7 month old male (VAERS# 279290), with an allergy to amoxil medication, who on 09-APR-2007 was vaccinated with a third dose of Rotateq (Lot# 656192/0022U). Concomitant vaccines included a third dose of PEDIARIX (Lot# AC21B097AB), a third dose of ACTHIB (Lot# UF084AA), and a third dose of PREVNAR (Lot# B36258H). On 08-MAY-2007 the patient experienced intussusception. It was reported that the patient had a gut resection. Follow-up information from an agency indicated that on 08-MAY-2007 the patient vomited three times. On 09-MAY-2007 the patient vomited six times and had a poor appetite. PHENEGRAN 0.3 ml was administered for the vomiting. The patient was given PEDIALYTE and GATORADE at home. 48 hours prior to admission to the hospital the patient had progressive abdominal distention, vomiting, and two episodes of bloody stools. The patient was initially admitted to the hospital for feeding difficulties and a fever since the previous night. After admission to the hospital the patient was placed on IV fluids. The patient had one loose stool with a little red color, the day after admission, the patient was distended. An x-ray suggested intussusception and a barium enema confirmed it. Surgery was done shortly after 05-JUN-2007. Records received from the hospital had a diagnosis of intussusception, dehydration, left otitis media, upper respiratory infection, and vomiting. The surgery was exploratory laporatomy with reduction of intussusception and incidental appendectomy. During the course of the hospitalization the patient developed diarrhea, vomiting and abdominal distention. It was reported that the patient recovered. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of an agency was released. Additional information is not expected.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal distension, Appendicectomy, Barium enema, Decreased appetite, Dehydration
Clinical narrative: Information has been received from an agency concerning a 7 month old male (VAERS# 279290), with an allergy to amoxil medication, who on 09-APR-2007 was vaccinated with a third dose of Rotateq (Lot# 656192/0022U). Concomitant vaccines included a third dose of PEDIARIX (Lot# AC21B097AB), a third dose of ACTHIB (Lot# UF084AA), and a third dose of PREVNAR (Lot# B36258H). On 08-MAY-2007 the patient experienced intussusception. It was reported that the patient had a gut resection. Follow-up information from an agency indicated that on 08-MAY-2007 the patient vomited three times. On 09-MAY-2007 the patient vomited six times and had a poor appetite. PHENEGRAN 0.3 ml was administered for the vomiting. The patient was given PEDIALYTE and GATORADE at home. 48 hours prior to admission to the hospital the patient had progressive abdominal distention, vomiting, and two episodes of bloody stools. The patient was initially admitted to the hospital for feeding difficulties and a fever since the previous night. After admission to the hospital the patient was placed on IV fluids. The patient had one loose stool with a little red color, the day after admission, the patient was distended. An x-ray suggested intussusception and a barium enema confirmed it. Surgery was done shortly after 05-JUN-2007. Records received from the hospital had a diagnosis of intussusception, dehydration, left otitis media, upper respiratory infection, and vomiting. The surgery was exploratory laporatomy with reduction of intussusception and incidental appendectomy. During the course of the hospitalization the patient developed diarrhea, vomiting and abdominal distention. It was reported that the patient recovered. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of an agency was released. Additional information is not expected.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Explorative laparotomy, Feeding disorder of infancy or early childhood, Full blood count normal, Haematochezia
Clinical narrative: Information has been received from an agency concerning a 7 month old male (VAERS# 279290), with an allergy to amoxil medication, who on 09-APR-2007 was vaccinated with a third dose of Rotateq (Lot# 656192/0022U). Concomitant vaccines included a third dose of PEDIARIX (Lot# AC21B097AB), a third dose of ACTHIB (Lot# UF084AA), and a third dose of PREVNAR (Lot# B36258H). On 08-MAY-2007 the patient experienced intussusception. It was reported that the patient had a gut resection. Follow-up information from an agency indicated that on 08-MAY-2007 the patient vomited three times. On 09-MAY-2007 the patient vomited six times and had a poor appetite. PHENEGRAN 0.3 ml was administered for the vomiting. The patient was given PEDIALYTE and GATORADE at home. 48 hours prior to admission to the hospital the patient had progressive abdominal distention, vomiting, and two episodes of bloody stools. The patient was initially admitted to the hospital for feeding difficulties and a fever since the previous night. After admission to the hospital the patient was placed on IV fluids. The patient had one loose stool with a little red color, the day after admission, the patient was distended. An x-ray suggested intussusception and a barium enema confirmed it. Surgery was done shortly after 05-JUN-2007. Records received from the hospital had a diagnosis of intussusception, dehydration, left otitis media, upper respiratory infection, and vomiting. The surgery was exploratory laporatomy with reduction of intussusception and incidental appendectomy. During the course of the hospitalization the patient developed diarrhea, vomiting and abdominal distention. It was reported that the patient recovered. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of an agency was released. Additional information is not expected.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Laparotomy, Otitis media, Pyrexia, Stool analysis normal
Clinical narrative: Information has been received from an agency concerning a 7 month old male (VAERS# 279290), with an allergy to amoxil medication, who on 09-APR-2007 was vaccinated with a third dose of Rotateq (Lot# 656192/0022U). Concomitant vaccines included a third dose of PEDIARIX (Lot# AC21B097AB), a third dose of ACTHIB (Lot# UF084AA), and a third dose of PREVNAR (Lot# B36258H). On 08-MAY-2007 the patient experienced intussusception. It was reported that the patient had a gut resection. Follow-up information from an agency indicated that on 08-MAY-2007 the patient vomited three times. On 09-MAY-2007 the patient vomited six times and had a poor appetite. PHENEGRAN 0.3 ml was administered for the vomiting. The patient was given PEDIALYTE and GATORADE at home. 48 hours prior to admission to the hospital the patient had progressive abdominal distention, vomiting, and two episodes of bloody stools. The patient was initially admitted to the hospital for feeding difficulties and a fever since the previous night. After admission to the hospital the patient was placed on IV fluids. The patient had one loose stool with a little red color, the day after admission, the patient was distended. An x-ray suggested intussusception and a barium enema confirmed it. Surgery was done shortly after 05-JUN-2007. Records received from the hospital had a diagnosis of intussusception, dehydration, left otitis media, upper respiratory infection, and vomiting. The surgery was exploratory laporatomy with reduction of intussusception and incidental appendectomy. During the course of the hospitalization the patient developed diarrhea, vomiting and abdominal distention. It was reported that the patient recovered. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of an agency was released. Additional information is not expected.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Upper respiratory tract infection, Urine analysis, Vomiting
Clinical narrative: Information has been received from an agency concerning a 7 month old male (VAERS# 279290), with an allergy to amoxil medication, who on 09-APR-2007 was vaccinated with a third dose of Rotateq (Lot# 656192/0022U). Concomitant vaccines included a third dose of PEDIARIX (Lot# AC21B097AB), a third dose of ACTHIB (Lot# UF084AA), and a third dose of PREVNAR (Lot# B36258H). On 08-MAY-2007 the patient experienced intussusception. It was reported that the patient had a gut resection. Follow-up information from an agency indicated that on 08-MAY-2007 the patient vomited three times. On 09-MAY-2007 the patient vomited six times and had a poor appetite. PHENEGRAN 0.3 ml was administered for the vomiting. The patient was given PEDIALYTE and GATORADE at home. 48 hours prior to admission to the hospital the patient had progressive abdominal distention, vomiting, and two episodes of bloody stools. The patient was initially admitted to the hospital for feeding difficulties and a fever since the previous night. After admission to the hospital the patient was placed on IV fluids. The patient had one loose stool with a little red color, the day after admission, the patient was distended. An x-ray suggested intussusception and a barium enema confirmed it. Surgery was done shortly after 05-JUN-2007. Records received from the hospital had a diagnosis of intussusception, dehydration, left otitis media, upper respiratory infection, and vomiting. The surgery was exploratory laporatomy with reduction of intussusception and incidental appendectomy. During the course of the hospitalization the patient developed diarrhea, vomiting and abdominal distention. It was reported that the patient recovered. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of an agency was released. Additional information is not expected.