chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.84
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, PNC13
Symptoms: Autopsy, Cardiac arrest, Cardiomegaly, Convulsion, Culture tissue specimen positive
Clinical narrative: This is a spontaneous report from a Pfizer sales representative on behalf of a contactable physician.  A 15-month-old male (at the time of death) received the first dose of PREVNAR 13 on an unknown date in JUL2010 at 0.5ml, and the second dose on an unknown date in Oct2010, to prevent against pneumococcal disease.  Relevant medical history was unknown.  The relevant concomitant medications were unknown.  The infant had only been administered two doses of PREVNAR 13 instead of four doses.  On 11MAR2011, he was taken to the Emergency Room and diagnosed with neural infection.  Treatment was not reported.  On 13MAR2011, the patient was taken to the Emergency Room again, but did not see the doctor came back home.  On 14MAR2011, the patient was taken to the physician's office, where he presented with fever, vomiting, and neural infection, because of which he was hospitalized.  On 14MAR2011, while in the hospital, he had seizures.  An x-ray was performed which revealed an enlarged heart.  The patient then had cardiac arrest.  On 14MAR2011, the patient was transferred to a hospital where they have found viral myocarditis.  Treatments in response to the events were not reported.  On 15MAR2011, the infant died.  An autopsy was performed on brain tissue culture on 15MAR2011, which showed that he died due to pneumococcal meningitis.  The clinical outcome of the reported event of pneumococcal meningitis (per autopsy results) was fatal, and the outcome of the other events was unknown.  Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13.
Age: 0.84
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, PNC13
Symptoms: Death, Meningitis pneumococcal, Neurological infection, Pyrexia, Viral myocarditis
Clinical narrative: This is a spontaneous report from a Pfizer sales representative on behalf of a contactable physician.  A 15-month-old male (at the time of death) received the first dose of PREVNAR 13 on an unknown date in JUL2010 at 0.5ml, and the second dose on an unknown date in Oct2010, to prevent against pneumococcal disease.  Relevant medical history was unknown.  The relevant concomitant medications were unknown.  The infant had only been administered two doses of PREVNAR 13 instead of four doses.  On 11MAR2011, he was taken to the Emergency Room and diagnosed with neural infection.  Treatment was not reported.  On 13MAR2011, the patient was taken to the Emergency Room again, but did not see the doctor came back home.  On 14MAR2011, the patient was taken to the physician's office, where he presented with fever, vomiting, and neural infection, because of which he was hospitalized.  On 14MAR2011, while in the hospital, he had seizures.  An x-ray was performed which revealed an enlarged heart.  The patient then had cardiac arrest.  On 14MAR2011, the patient was transferred to a hospital where they have found viral myocarditis.  Treatments in response to the events were not reported.  On 15MAR2011, the infant died.  An autopsy was performed on brain tissue culture on 15MAR2011, which showed that he died due to pneumococcal meningitis.  The clinical outcome of the reported event of pneumococcal meningitis (per autopsy results) was fatal, and the outcome of the other events was unknown.  Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13.
Age: 0.84
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, PNC13
Symptoms: Vomiting, X-ray abnormal
Clinical narrative: This is a spontaneous report from a Pfizer sales representative on behalf of a contactable physician.  A 15-month-old male (at the time of death) received the first dose of PREVNAR 13 on an unknown date in JUL2010 at 0.5ml, and the second dose on an unknown date in Oct2010, to prevent against pneumococcal disease.  Relevant medical history was unknown.  The relevant concomitant medications were unknown.  The infant had only been administered two doses of PREVNAR 13 instead of four doses.  On 11MAR2011, he was taken to the Emergency Room and diagnosed with neural infection.  Treatment was not reported.  On 13MAR2011, the patient was taken to the Emergency Room again, but did not see the doctor came back home.  On 14MAR2011, the patient was taken to the physician's office, where he presented with fever, vomiting, and neural infection, because of which he was hospitalized.  On 14MAR2011, while in the hospital, he had seizures.  An x-ray was performed which revealed an enlarged heart.  The patient then had cardiac arrest.  On 14MAR2011, the patient was transferred to a hospital where they have found viral myocarditis.  Treatments in response to the events were not reported.  On 15MAR2011, the infant died.  An autopsy was performed on brain tissue culture on 15MAR2011, which showed that he died due to pneumococcal meningitis.  The clinical outcome of the reported event of pneumococcal meningitis (per autopsy results) was fatal, and the outcome of the other events was unknown.  Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13.
Age: 0.84
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, PNC13
Symptoms: Arrhythmia, Autopsy, Cardiac arrest, Cardiomegaly, Convulsion
Clinical narrative: This is a spontaneous report from a Pfizer sales representative on behalf of a contactable physician.  A 15-month-old male (at the time of death) received the first dose of PREVNAR 13 on an unknown date in JUL2010 at 0.5ml, and the second dose on an unknown date in Oct2010, to prevent against pneumococcal disease.  Relevant medical history was unknown.  The relevant concomitant medications were unknown.  The infant had only been administered two doses of PREVNAR 13 instead of four doses.  On 11MAR2011, he was taken to the Emergency Room and diagnosed with neural infection.  Treatment was not reported.  On 13MAR2011, the patient was taken to the Emergency Room again, but did not see the doctor came back home.  On 14MAR2011, the patient was taken to the physician's office, where he presented with fever, vomiting, and neural infection, because of which he was hospitalized.  On 14MAR2011, while in the hospital, he had seizures.  An x-ray was performed which revealed an enlarged heart.  The patient then had cardiac arrest.  On 14MAR2011, the patient was transferred to a hospital where they have found viral myocarditis.  Treatments in response to the events were not reported.  On 15MAR2011, the infant died.  An autopsy was performed on brain tissue culture on 15MAR2011, which showed that he died due to pneumococcal meningitis.  The clinical outcome of the reported event of pneumococcal meningitis (per autopsy results) was fatal, and the outcome of the other events was unknown.  Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13.
Age: 0.84
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, PNC13
Symptoms: Death, Disseminated intravascular coagulation, Ear infection, Meningitis pneumococcal, Organ failure
Clinical narrative: This is a spontaneous report from a Pfizer sales representative on behalf of a contactable physician.  A 15-month-old male (at the time of death) received the first dose of PREVNAR 13 on an unknown date in JUL2010 at 0.5ml, and the second dose on an unknown date in Oct2010, to prevent against pneumococcal disease.  Relevant medical history was unknown.  The relevant concomitant medications were unknown.  The infant had only been administered two doses of PREVNAR 13 instead of four doses.  On 11MAR2011, he was taken to the Emergency Room and diagnosed with neural infection.  Treatment was not reported.  On 13MAR2011, the patient was taken to the Emergency Room again, but did not see the doctor came back home.  On 14MAR2011, the patient was taken to the physician's office, where he presented with fever, vomiting, and neural infection, because of which he was hospitalized.  On 14MAR2011, while in the hospital, he had seizures.  An x-ray was performed which revealed an enlarged heart.  The patient then had cardiac arrest.  On 14MAR2011, the patient was transferred to a hospital where they have found viral myocarditis.  Treatments in response to the events were not reported.  On 15MAR2011, the infant died.  An autopsy was performed on brain tissue culture on 15MAR2011, which showed that he died due to pneumococcal meningitis.  The clinical outcome of the reported event of pneumococcal meningitis (per autopsy results) was fatal, and the outcome of the other events was unknown.  Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13.
Age: 0.84
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, PNC13
Symptoms: Pyrexia, Streptococcus test positive, Vomiting, X-ray abnormal
Clinical narrative: This is a spontaneous report from a Pfizer sales representative on behalf of a contactable physician.  A 15-month-old male (at the time of death) received the first dose of PREVNAR 13 on an unknown date in JUL2010 at 0.5ml, and the second dose on an unknown date in Oct2010, to prevent against pneumococcal disease.  Relevant medical history was unknown.  The relevant concomitant medications were unknown.  The infant had only been administered two doses of PREVNAR 13 instead of four doses.  On 11MAR2011, he was taken to the Emergency Room and diagnosed with neural infection.  Treatment was not reported.  On 13MAR2011, the patient was taken to the Emergency Room again, but did not see the doctor came back home.  On 14MAR2011, the patient was taken to the physician's office, where he presented with fever, vomiting, and neural infection, because of which he was hospitalized.  On 14MAR2011, while in the hospital, he had seizures.  An x-ray was performed which revealed an enlarged heart.  The patient then had cardiac arrest.  On 14MAR2011, the patient was transferred to a hospital where they have found viral myocarditis.  Treatments in response to the events were not reported.  On 15MAR2011, the infant died.  An autopsy was performed on brain tissue culture on 15MAR2011, which showed that he died due to pneumococcal meningitis.  The clinical outcome of the reported event of pneumococcal meningitis (per autopsy results) was fatal, and the outcome of the other events was unknown.  Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphonia, Throat tightness, Urticaria
Clinical narrative: Patient stated she got home & felt okay, all of a sudden she developed hives & was hoarse. She felt her throat tighten. She took some BENADRYL & felt better.
Age: 9.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Condition aggravated, Cough, Dyspnoea, Erythema
Clinical narrative: Almost 10 year girl w/asthma presents 1 day after receiving GARDASIL #1, MENACTRA, and BOOSTRIX. Mom states 3 minutes after arriving home pt's eyes started to swell up and turn red. Her arm also start to swell and turn red. This is the arm where the GARDASIL vaccine was placed (the right arm-- MENACTRA and BOOSTRIX were placed in the left). Mom gave dye free children's BENADRYL 5 ml x 1 and the swelling around the eyes and eyes improved. Overnight Patient started coughing. History of vomiting, abdominal pain, fever. Some SOB. Mom brought patient to clinic 3/30/2011.
Age: 9.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Eye swelling, Ocular hyperaemia, Oedema peripheral, Pyrexia, Vomiting
Clinical narrative: Almost 10 year girl w/asthma presents 1 day after receiving GARDASIL #1, MENACTRA, and BOOSTRIX. Mom states 3 minutes after arriving home pt's eyes started to swell up and turn red. Her arm also start to swell and turn red. This is the arm where the GARDASIL vaccine was placed (the right arm-- MENACTRA and BOOSTRIX were placed in the left). Mom gave dye free children's BENADRYL 5 ml x 1 and the swelling around the eyes and eyes improved. Overnight Patient started coughing. History of vomiting, abdominal pain, fever. Some SOB. Mom brought patient to clinic 3/30/2011.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Hypoaesthesia
Clinical narrative: After receiving GARDASIL vaccine, left arm went numb to touch for approx. 30 minutes.
Age: 65.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: One day after shot, injection site got hard, little bit of pain, but mostly itching, for about 2 days. Then it softened, MD recommended BENADRYL. No fever so MD didn't recommend or prescribe antibiotic.
Age: 39.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Rash maculo-papular, Skin warm
Clinical narrative: Individual received 1st dose of anthrax vaccine on 5Feb11 - left arm. He then rec'd HepA & Typhoid in his right arm on 6Feb11. On 8Feb11 individual noticed "red spots warm to touch on arm, leg, ankle". No fever, no swelling. Raised dime sized bumps multiple.
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Cough, Dyspnoea, Influenza virus test negative, Nasal congestion, Pain
Clinical narrative: pt c/o body aches, sore jaw, nasal congestion, cough, feverish, shortness of breath on 3/30/11
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Pain in jaw, Pyrexia, Streptococcus test negative
Clinical narrative: pt c/o body aches, sore jaw, nasal congestion, cough, feverish, shortness of breath on 3/30/11
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, PNC
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Right thigh red, swollen & tender at vaccine (PROQUAD) site. Pt. previously had separate MMR & Varicella & DTaP & IPV separate.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: Vaccine given 03/21/11 - pt paged on call MD at 5am 3/22/11 - c/o fever 102 -> advised ADVIL - call if still has fever > 101. Seen in office 3/22/11 - T. 101.8 - headache, joint pain. Rx'd with Ibuprofen QID. No swelling, redness at site.
Age: 1.43
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 3/23/11 Fever; hot red firm swelling around injection site (PROQUAD given), itchy, painful site, child irritable. Treated with cold compresses & ADVIL, Topical Antihis.
Age: 1.43
Sex: F
Vaccine: MMRV
Symptoms: Injection site warmth, Irritability, Pyrexia
Clinical narrative: 3/23/11 Fever; hot red firm swelling around injection site (PROQUAD given), itchy, painful site, child irritable. Treated with cold compresses & ADVIL, Topical Antihis.
Age: 44.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Contusion, Myalgia, Skeletal injury
Clinical narrative: Pt c/o recurrent right deltoid muscle pain. Pt. seen by family physician on 20110211 and by clinic physician. Pt. diagnosed with deep tissue/bone bruise. We will continue to follow up with patient.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pregnant patient received preservative free FLUZONE. Reports sore arm after vaccination and is still sore and cannot lift arm above chest levels 16 days after vaccination. Patient aware can take acetaminophen but has not taken any. Referred to MD.
Age: 31.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Apathy, Chills, Decreased appetite, Delusion, Dizziness
Clinical narrative: Cold feet, night sweats, dizziness, lumps in back, flush complexion, lack of motivation, soreness of body internal organs, loss of appetite, chills, shakiness, delusion thought pattern, pinch or swollen kidney low left side.
Age: 31.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Flushing, Infection, Mass, Night sweats, Pain
Clinical narrative: Cold feet, night sweats, dizziness, lumps in back, flush complexion, lack of motivation, soreness of body internal organs, loss of appetite, chills, shakiness, delusion thought pattern, pinch or swollen kidney low left side.
Age: 31.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Peripheral coldness, Pneumonia, Renal disorder, Tremor, X-ray abnormal
Clinical narrative: Cold feet, night sweats, dizziness, lumps in back, flush complexion, lack of motivation, soreness of body internal organs, loss of appetite, chills, shakiness, delusion thought pattern, pinch or swollen kidney low left side.
Age: 3.0
Sex: F
Vaccine: PNC
Symptoms: Emotional distress, Gait disturbance, Pain in extremity
Clinical narrative: Day after PREVNAR vaccine patient inconsolable with complaints of leg pain. Patient limping. No fever, swelling or redness at site. Some improvement after TYLENOL.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Laboratory test, Ultrasound abdomen
Clinical narrative: Abdominal pain (chronic) per mom's report.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Left deltoid warm to touch, erythema, induration. Was started on Cephalexin for possible cellulitis.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Joint range of motion decreased, Pain, Swelling
Clinical narrative: Redness, swelling, pain, decreased range of motion. Secondary pain & swelling.
Age: 22.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Eye swelling, Swelling face
Clinical narrative: (R) facial cheek swelled and slight swelling of eyes. Denies itching, hives, difficulty breathing. Lasted 2-3 days. Took BENADRYL -> initially on "old box" and bought new at pharmacy which he feels helped. Thought he might have slept wrong on it.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Mother notice redness & swelling on 3/30/11 on right arm. Patient is getting treated with antibiotic KEFLEX for cellulitis.
Age: 76.0
Sex: M
Vaccine: BCG
Symptoms: Tuberculin test, Unevaluable event
Clinical narrative: Patient had BCG Vaccine on 3/23/10 and PPD on 3/29/11. When PPD was read on 3/31/11, patient was noted to have a dime-sized red raised area.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Local reaction, Oedema peripheral, Pain in extremity
Clinical narrative: Pain, redness, swelling and numbness limb of injection.  MD dx = local reaction.  Tx = Motrin x 2 wks.  F/u  t/c on 3-31-2011.  Client states sx slowly resolving.
Age: 4.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site pain, Urticaria
Clinical narrative: On 3/29 inch and a half redness in diameter and slight tenderness at site of injection. On 3/30 small hives on lower back noticed at 7:30 pm. At 1:30 am almost her entire back was covered in huge hives. Gave one dose of Benadryl and all hives were gone in the morning.
Age: 35.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Muscular weakness, Pain, Pain in extremity
Clinical narrative: Patient complains of migratory pain moving from deltoid to trapezius area; pain with motion, no nodule, no redness, some arm weakness, pain and soreness reported from MD office to Infection Control Director today, 3/31/11 @ 1:00PM
Age: 35.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Injection site pain, Muscular weakness, Myalgia, Pain, Pain in extremity
Clinical narrative: Patient complains of migratory pain moving from deltoid to trapezius area; pain with motion, no nodule, no redness, some arm weakness, pain and soreness reported from MD office to Infection Control Director today, 3/31/11 @ 1:00PM
Age: 16.0
Sex: F
Vaccine: HPV4, PPV
Symptoms: Body temperature increased, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) delt, baseball sz, swelling, redness, warmth, (102.0, headache, sore throat, achy). Warm compress, TYLENOL, cool compresses.
Age: 16.0
Sex: F
Vaccine: HPV4, PPV
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: (L) delt, baseball sz, swelling, redness, warmth, (102.0, headache, sore throat, achy). Warm compress, TYLENOL, cool compresses.
Age: 23.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration, Oedema peripheral, Pruritus, Pyrexia
Clinical narrative: Father returned with child the day after vaccines administered. Reports child woke up this AM with a red, swollen, itch, warm to touch area on (R) lateral Deltoid the size of a 50 cent piece. Child admitted he had been scratching area because it itched. Father stated area increased in size to the size of a baseball within 2 hours of awakening this AM - child denied pain in area only itching - reddened area noted on (R) arm that measured 3 inches x 3 inches warm and hard to touch. Advised dad to give child MOTRIN every 6 hrs, BENADRYL as needed for itching and keep cold compresses on area - Father called the Health Dept the next morning and reported area is the same size but "weeping" now and child has a fever, advised father to take child to Dr. this AM.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Secretion discharge, Skin warm
Clinical narrative: Father returned with child the day after vaccines administered. Reports child woke up this AM with a red, swollen, itch, warm to touch area on (R) lateral Deltoid the size of a 50 cent piece. Child admitted he had been scratching area because it itched. Father stated area increased in size to the size of a baseball within 2 hours of awakening this AM - child denied pain in area only itching - reddened area noted on (R) arm that measured 3 inches x 3 inches warm and hard to touch. Advised dad to give child MOTRIN every 6 hrs, BENADRYL as needed for itching and keep cold compresses on area - Father called the Health Dept the next morning and reported area is the same size but "weeping" now and child has a fever, advised father to take child to Dr. this AM.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Induration, Injected limb mobility decreased, Injection site pain
Clinical narrative: Received PPSV23 right deltoid 3-28-2011, c/o pain right deltoid that evening with stiffness and difficulty moving right arm at midnight.  3-30-2011 at midnight c/o pain distal to injection site.  Saw a provider the afternoon of 3-30-11 with c/o pain approximately 70 mm distal to the injection site.  At this time the patient had an approximate 70 x 80 mm area of erythema along the inner aspect of the right arm, +/- 70 mm below the injection site.  The injection site was clean.  Area of erythema was warm to touch and painful.  The patient was able to move her arm with c/o pain.  Was diagnosed with cellulitis and Keflex 500mg, 2 po bid, for 10 days and Naprosyn 500mg, 1 po bid prn pain/ fever ordered.  The patient's temp was 97.3 at the OV on the 30th.  There was mild induration at the area of erythema, no LAD in axilla or epitrochlear involvement.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Pain, Skin warm
Clinical narrative: Received PPSV23 right deltoid 3-28-2011, c/o pain right deltoid that evening with stiffness and difficulty moving right arm at midnight.  3-30-2011 at midnight c/o pain distal to injection site.  Saw a provider the afternoon of 3-30-11 with c/o pain approximately 70 mm distal to the injection site.  At this time the patient had an approximate 70 x 80 mm area of erythema along the inner aspect of the right arm, +/- 70 mm below the injection site.  The injection site was clean.  Area of erythema was warm to touch and painful.  The patient was able to move her arm with c/o pain.  Was diagnosed with cellulitis and Keflex 500mg, 2 po bid, for 10 days and Naprosyn 500mg, 1 po bid prn pain/ fever ordered.  The patient's temp was 97.3 at the OV on the 30th.  There was mild induration at the area of erythema, no LAD in axilla or epitrochlear involvement.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Back pain, Chest pain, Neck pain, Pain
Clinical narrative: patient describes left anterior chest, neck, and left back sharp pain, now described as achey 2 days later. Denies SOB. Given Advil as needed.
Age: 20.0
Sex: F
Vaccine: MMR, TDAP, MMR, TDAP
Symptoms: Induration, Inflammation, Injection site nodule, Tenderness
Clinical narrative: Patient reported to Dr's office for follow up.  Presented with nodule at site of injection.  No cellulitis, o heat, tender, inflamed, some induration per Dr. Pt recovery - I am unaware of any improvement or decline since original report.
Age: 20.0
Sex: F
Vaccine: MMR, TDAP, MMR, TDAP
Symptoms: Injection site induration, Injection site inflammation, Injection site nodule, Injection site pain
Clinical narrative: Patient reported to Dr's office for follow up.  Presented with nodule at site of injection.  No cellulitis, o heat, tender, inflamed, some induration per Dr. Pt recovery - I am unaware of any improvement or decline since original report.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Lymphadenopathy, Oedema peripheral
Clinical narrative: Swelling under the arm - Lymphadenopathy  Seen in office 3 days after Tdap given
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: APPROX 5 CM RAISED, RED, HOT AREA WITH MILD SWELLING OF RIGHT DELTOID AT VACCINE SITE
Age: 10.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Chest pain, Crying, Pain
Clinical narrative: Mother reports via phone call that child complained of "whole body really hurts" and moderate to severe chest pain, denies SOB.   Child states chest pain is constant and occurs without regard to activity or rest. States began a couple of hours after receiving vaccines. Mother reports temp of 99.1 F and states there is no apparent redness or rash at the immunization sites.  Child can be heard crying quietly.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site erythema, Pain in extremity
Clinical narrative: My arm remained sore where the shot was given that day.  They told me it would for a while; that was normal.  Well now it's been 7 months and it's worse than ever.  There is even a red spot where the needle went in.  The pain radiates down my arm into my wrist and hand.  Hydrocodone does not relieve the pain.  I've told the doctor about it as well as my rheumatologist.  The doctor just made some kind of excuse I didn't understand but basically said I was stuck with the pain and my rheumatologist didn't say anything but neither one suggested I report it as a side effect.  I didn't know others had the same problem until I researched it on the internet.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Autoimmune thyroiditis, Skin hyperpigmentation, Vitiligo
Clinical narrative: NOTICED NON-PIGMENTED AREAS ON HIPS
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Nausea, Pain, Pyrexia, Tremor
Clinical narrative: Pt. woke at 3/30/11 2:00 AM with chills & shaking, nauseous. 4:15 AM achy, shaking, vomiting x 5. 7:30 AM temp at 100.8 deg. Pt. took TYLENOL to decrease temp. Pt. came in office & started on 0.9% Sodium Chloride IV drip. Subject received 1 liter IV fluid and discharged at 15:30. No further vomiting. Temp. decreased to 98.4 following TYLENOL & fluids. BP 108/62 at release. Pt. discharged to home. F/U this morning at 11:00 AM 3/31/11, pt. reports no more fever, vomiting, shaking and chills.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Pt. woke at 3/30/11 2:00 AM with chills & shaking, nauseous. 4:15 AM achy, shaking, vomiting x 5. 7:30 AM temp at 100.8 deg. Pt. took TYLENOL to decrease temp. Pt. came in office & started on 0.9% Sodium Chloride IV drip. Subject received 1 liter IV fluid and discharged at 15:30. No further vomiting. Temp. decreased to 98.4 following TYLENOL & fluids. BP 108/62 at release. Pt. discharged to home. F/U this morning at 11:00 AM 3/31/11, pt. reports no more fever, vomiting, shaking and chills.
Age: 3.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt. c/o swelling, pain at injection site. Seen in office, 4" circle erythema, warm, tender told to monitor and call if sx change, worsen.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swollen, hot to touch.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right thigh red/swollen. 3-9-11 ER (AUGMENTIN). 3-10-11 Dr- Cool pack, BENADRYL.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Erythema
Clinical narrative: Red, hot temp 102 degrees, (L) arm 5-6 inches in diameter. On 3/31/10 - called to check on pt & stated almost back to normal.
Age: 34.0
Sex: M
Vaccine: HEPAB
Symptoms: Pain in extremity
Clinical narrative: During return appt 3/29/11 c/o ache (R) forearm 1 week after admin of TWINRIX (R) deltoid.  Pain not resolved. Referred to clinic for f.u. & eval.  Vaccine given at STD clinic.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: (R) deltoid fever, erythematous and inflamed at the touch - Cephalexin treatment course given.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: (L) deltoid swelling, redness and purplish hue, low-grade fever 100.1, otherwise fine.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Abdominal discomfort, Burning sensation, Chills, Musculoskeletal pain
Clinical narrative: 3/29/11 complained that he felt like "he was burning up". Extreme shoulder pain. 3/30/11 stomach upset, chills & extreme shoulder pain. Dr. recommended Ibuprofen.
Age: 39.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Asthenia, Bone pain, Disturbance in attention, Dizziness, Fatigue
Clinical narrative: My first symptom started within about 5 min of getting my series of shots. I became very light-headed, but I just chalked it up to being too nervous for these stupid shots to begin with. I work across the parking lot from the facility that gave me the injections so it took me just a few moments to walk back to work and by the time I got back I was told I was very pale and I also felt very light-headed. My work day ends at 4:30 which is only about 30 min after I got my vaccines and within 10 min of my drive home it honestly became very dangerous for me to drive! The only way that I can describe it was being so dizzy, light-headed, and being in a massive fog all at the same time almost like being "buzzed" from drinking? From the bottom of my heart I was scared to death and it took all of my focus and energy to finish the 5 min left of my drive home. By 5:00 I was so weak all over my body I had a hard time even walking to try and change out of my dress clothes and into my sweats and t-shirt. I called the 24-hour nurse hotline at 5:35pm to see what the heck was going on and if I need to go to the ER. The nurse said that flu-like symptoms do occur but she was worried about how severe my head was then asked if I was alone or if I had someone home with. The nurse said that if my breathing becomes an issue or if I had any seizures to have my husband rush me in ASAP. The very horrible thing that scared me the most was about 6:00 when I tried to get off the sofa to go to the bathroom I noticed that the muscles in my entire body had weakened significantly and by the time I did get to the bathroom I was absolutely exhausted! My spine hurt so badly it felt like it was hot and the pain radiated up to my head and it felt like a "ball" of pain where my head connects to my spinal column. My focus and attention span was affected immensely along with my muscle strength. I stayed home the next day because by the time I got done showering in the morning I had no strength left to do anything. I went back to work on Wednesday which was two days after my injections and I had such a difficult time focusing on my computer screen, but the crazy thing was I needed to highlight a patient's file and I could not take the cap off my stupid pen! I had to go to another one of our front office ladies and ask them to do it for me. Today is 03/31/11 and it is 15:37pm and my strength is much better my head is feeling more focused but I am maybe 75% of what I am usually for strength. I have no idea what on earth happened but I will NEVER be getting another vaccination. My fellow coworkers seen what happened now unfortunately they are afraid to get them as well. Could you please respond to this so I can understand what on earth happened to me please?
Age: 39.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Fear, Feeling drunk, Feeling hot, Gait disturbance, Headache
Clinical narrative: My first symptom started within about 5 min of getting my series of shots. I became very light-headed, but I just chalked it up to being too nervous for these stupid shots to begin with. I work across the parking lot from the facility that gave me the injections so it took me just a few moments to walk back to work and by the time I got back I was told I was very pale and I also felt very light-headed. My work day ends at 4:30 which is only about 30 min after I got my vaccines and within 10 min of my drive home it honestly became very dangerous for me to drive! The only way that I can describe it was being so dizzy, light-headed, and being in a massive fog all at the same time almost like being "buzzed" from drinking? From the bottom of my heart I was scared to death and it took all of my focus and energy to finish the 5 min left of my drive home. By 5:00 I was so weak all over my body I had a hard time even walking to try and change out of my dress clothes and into my sweats and t-shirt. I called the 24-hour nurse hotline at 5:35pm to see what the heck was going on and if I need to go to the ER. The nurse said that flu-like symptoms do occur but she was worried about how severe my head was then asked if I was alone or if I had someone home with. The nurse said that if my breathing becomes an issue or if I had any seizures to have my husband rush me in ASAP. The very horrible thing that scared me the most was about 6:00 when I tried to get off the sofa to go to the bathroom I noticed that the muscles in my entire body had weakened significantly and by the time I did get to the bathroom I was absolutely exhausted! My spine hurt so badly it felt like it was hot and the pain radiated up to my head and it felt like a "ball" of pain where my head connects to my spinal column. My focus and attention span was affected immensely along with my muscle strength. I stayed home the next day because by the time I got done showering in the morning I had no strength left to do anything. I went back to work on Wednesday which was two days after my injections and I had such a difficult time focusing on my computer screen, but the crazy thing was I needed to highlight a patient's file and I could not take the cap off my stupid pen! I had to go to another one of our front office ladies and ask them to do it for me. Today is 03/31/11 and it is 15:37pm and my strength is much better my head is feeling more focused but I am maybe 75% of what I am usually for strength. I have no idea what on earth happened but I will NEVER be getting another vaccination. My fellow coworkers seen what happened now unfortunately they are afraid to get them as well. Could you please respond to this so I can understand what on earth happened to me please?
Age: 39.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Impaired driving ability, Muscular weakness, Pallor, Vision blurred
Clinical narrative: My first symptom started within about 5 min of getting my series of shots. I became very light-headed, but I just chalked it up to being too nervous for these stupid shots to begin with. I work across the parking lot from the facility that gave me the injections so it took me just a few moments to walk back to work and by the time I got back I was told I was very pale and I also felt very light-headed. My work day ends at 4:30 which is only about 30 min after I got my vaccines and within 10 min of my drive home it honestly became very dangerous for me to drive! The only way that I can describe it was being so dizzy, light-headed, and being in a massive fog all at the same time almost like being "buzzed" from drinking? From the bottom of my heart I was scared to death and it took all of my focus and energy to finish the 5 min left of my drive home. By 5:00 I was so weak all over my body I had a hard time even walking to try and change out of my dress clothes and into my sweats and t-shirt. I called the 24-hour nurse hotline at 5:35pm to see what the heck was going on and if I need to go to the ER. The nurse said that flu-like symptoms do occur but she was worried about how severe my head was then asked if I was alone or if I had someone home with. The nurse said that if my breathing becomes an issue or if I had any seizures to have my husband rush me in ASAP. The very horrible thing that scared me the most was about 6:00 when I tried to get off the sofa to go to the bathroom I noticed that the muscles in my entire body had weakened significantly and by the time I did get to the bathroom I was absolutely exhausted! My spine hurt so badly it felt like it was hot and the pain radiated up to my head and it felt like a "ball" of pain where my head connects to my spinal column. My focus and attention span was affected immensely along with my muscle strength. I stayed home the next day because by the time I got done showering in the morning I had no strength left to do anything. I went back to work on Wednesday which was two days after my injections and I had such a difficult time focusing on my computer screen, but the crazy thing was I needed to highlight a patient's file and I could not take the cap off my stupid pen! I had to go to another one of our front office ladies and ask them to do it for me. Today is 03/31/11 and it is 15:37pm and my strength is much better my head is feeling more focused but I am maybe 75% of what I am usually for strength. I have no idea what on earth happened but I will NEVER be getting another vaccination. My fellow coworkers seen what happened now unfortunately they are afraid to get them as well. Could you please respond to this so I can understand what on earth happened to me please?
Age: 1.44
Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) leg red, swollen, warm to touch. Advised to monitor, call if worse.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Body temperature increased, Irritability
Clinical narrative: T-100.3 1 day after imms., fussy, TYLENOL, cool compresses, monitor, call if change/worse.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Body temperature increased, Irritability
Clinical narrative: T-100.8 day after vaccines. Baby fussy, cool compresses, TYLENOL as needed. Monitor and call if sx change/worse.
Age: 0.8
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: 1 week after injection, lump, redness at injection site. Cool compress, TYLENOL. Call if sx. change/worse.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Body temperature increased
Clinical narrative: T- 101.3 after imms. observe, TYLENOL as needed. Call if sx. change/worsen.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: 1/2 hour after injection c/o arm sore tingly, hurts to move arm. Also recently had tattoo in same arm. Advised Ibuprofen, cool compresses, call if change/worse.
Age: 1.02
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives approx. 3 hrs after vaccination-ORAPRED & BENADRYL.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Body temperature increased, Cough, Irritability, Nasal congestion, Retching
Clinical narrative: Per mom infant developed increased cough and gagging. The following day, with increased nasal congestion and wheezing. Congestion can last for 4 weeks. Per mom has noted to occur with prior immunization at 4 mo visit. (has nasal congestion last time). This time increased fussiness, temp of 100.1.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Wheezing
Clinical narrative: Per mom infant developed increased cough and gagging. The following day, with increased nasal congestion and wheezing. Congestion can last for 4 weeks. Per mom has noted to occur with prior immunization at 4 mo visit. (has nasal congestion last time). This time increased fussiness, temp of 100.1.
Age: 40.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain
Clinical narrative: PNEUMOVAX at 0830. Itchy & red at injection site with tender axillary lymph node approx 9 hr. after admin. Rx with BENADRYL, ice, ibu. Progressed to myalgias, chills, feverish that evening. Improved during day so stopped Rx. Symptoms recurred next night & injection site more swollen & red with return of myalgias.
Age: 40.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Myalgia, Pyrexia
Clinical narrative: PNEUMOVAX at 0830. Itchy & red at injection site with tender axillary lymph node approx 9 hr. after admin. Rx with BENADRYL, ice, ibu. Progressed to myalgias, chills, feverish that evening. Improved during day so stopped Rx. Symptoms recurred next night & injection site more swollen & red with return of myalgias.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Immunizations given 3/28. Some redness 3/28 pm. By 3/29 - 1/2 dollar size. By 3/30 - redness size of baseball in am. 3/30 afternoon 10cmx12cm red, warm, tender area (R) thigh.
Age: 0.35
Sex: F
Vaccine: HIBV
Symptoms: Crying, Feeling abnormal, Irritability, Vaccine positive rechallenge, Vomiting projectile
Clinical narrative: Initial report received on 22 July 2010 from a consumer, who is the patient's parent. A 4 month old female patient, with no medical history, received a second dose of ACTHIB (lot number UF976AA, which corresponds to sanofi pasteur SA lot number E0318-1) on 03 May 2010. Two to three hours post-vaccination, the patient began crying a high-pitched continuous cry for 1.5 hours. Afterward, the patient slept for six to seven hours and when she woke, she was dazed and cranky for the remainder of the day. The patient recovered. Of note, as captured in case 2010-03964, this patient previously experienced high-pitched crying, sleeping for six to seven hours, waking up dazed and cranky, and had projectile vomiting twice after receiving the first dose of ACTHIB and a dose of DAPTACEL on 25 February 2010.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cyanosis, Refusal of treatment by relative
Clinical narrative: Initial report received from a health care professional on 02 June 2010. A 6-month-old infant, with no reported medical history, received an injection (route and site not provided) on 02 December 2009 of ACTHIB, sanofi pasteur SA lot number D0395-1 and sanofi pasteur Inc. lot number UF673AA, an injection of PEDIARIX (lot number GSKAC21B187AA) and PREVNAR (lot number D1920) and turned blue in bed the same day the patient had the immunization. The event was not reported at the time. The patient's mother reported the event at the infants 12 month visit and refused all immunizations for the patient due to this event. Documents held by sender: None.
Age: 34.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Biopsy site unspecified abnormal, Blood test abnormal, Chest X-ray abnormal, Computerised tomogram abnormal, Cough
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 07-MAY-2007, a 34 year old female patient with hyperlipidaemia, recurrent pyelonephritis, a 3 mm LLL (lower left lobe) lung nodule noted of incidental finding on a CT performed on 23-APR-2007, and rhinorrhoea and a history of right ovarian cyst, fibrocystic breast disease, bartholin's cyst, urinary tract infection and no known drug allergies was vaccinated SQ with the first dose of GARDASIL (Lot # 657005/0314U) into her right arm at Obstetrician's visit. The patient had several Obstetricians' visits for unrelated complaints. Primary care physician's records indicated that on 12-JUN-2007, the patient complained of signs and symptoms of cold for 5 weeks, chest pain with palpation, sinus pressure, sinus headache (HA), cough. A repeat CT was done.  On 30-JUL-2007, the patient was diagnosed with migraine, nausea, Gastroesophageal reflux disease (GERD), Urinary tract infection (UTI) and possible endometriosis. On an unspecified date, the patient was diagnosed with allergic rhinitis, and cough. The patient's ears were stuffed and she had facial pain. On the patient's second visit, (date not provided) she complained of acid reflux. On 01-DEC-2007, approximately "one year later", the patient developed a terrible cough that would not go away. The patient thought it was allergies; she also noticed that her lymph nodes were swollen. Subsequently, the patient became pregnant; she could not have any tests done to see what was going on. The patient gave birth to her son in November 2008 and immediately had a chest X-ray, which let to a PET scan and biopsy. The results confirmed the diagnosis of Hodgkin's lymphoma. Diagnostic laboratory tests included: Blood work (results not provided) and H/H 11.1/33 (L). The events of terrible cough, lymph nodes swollen, Hodkins lymphoma, chest pain with palpation, sinus pressure, sinus headache, migraine, nausea, GERD, allergic rhinitis, ears stuffed, face pain and complained of cold were considered to be life threatening events. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Research Center and was released. The original reporting source was not provided. The VAERS ID # was 415775.