chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Pneumonia, Pneumonia aspiration, Respiratory disorder, Respiratory failure, Tracheostomy
Clinical narrative: Patient is a 59 yrs old male with no significant PMH who initially presented to the ER with two days of progressive numbness and tingling which started in his hands and spread to his legs and then unable to get out of bed due to weakness of extremities. Patient was admitted to the hospital. His CT of head was negative. He was seen by neurology and LP studies showed evidence of Guillain-Barre Syndrome. He was started on IVIG. His EMG and nerve conduction was consistent with axonal varient GBS which has poor prognosis. During the hospitalization, he continued to have progressive weakness including his swallowing and respiratory status. He went into respiratory failure with COPD retention and was transferred to ICU. He was intubated. He was started for antibiotics for possible aspiration pneumonia vs hospital-acquired pneumonia. He had bronchoscopy with thick secretions. He had tracheostomy placement on 3/19/12. 3/24: Continues with vent and nebs. Completed all antibiotics. 3/25: Passed swallow evaluation and started on puree diet with nectar thick liquids. 3/26 failed repeat swallow evaluation, NPO. Resumed on tube feeds was placed on TC. 3/27 overnight, placed back on ventilator. States he couldn't breathe. Doing OK. No complaints. Placed on TC this morning.
Age: 28.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Patient specifies that he has varicella.
Age: 31.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Muscle spasticity, Neuropathy peripheral
Clinical narrative: Case number PHHY2012IT023240 is an initial spontaneous report received a consumer via health authority (reference number 161184) on 15 Mar 2012. This report refers to a 31-year-old female patient whose medical history, past drugs, current conditions and concomitant medications were not reported. She was vaccinated with influenza vaccine (manufacturer and batch number unknown) on 05 Nov 2009. On 30 Nov 2009 she developed neuropathy (not specified further) and spasticity at upper and lower limbs. After vaccination, she did not receive any further vaccination. The final outcome was reported as condition unchanged. Seriousness criteria for the events was reported as disability. The causality of the events was reported as suspected.
Age: 8.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Rash papular
Clinical narrative: Red, raised bump. Circle in shape. Area was sore x 2 days and becoming better on lt arm where flu shot given. PPD admin same arm.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Crying, Irritability
Clinical narrative: Very irritable & crying for >3 hours post imm without fever -> sent to ER for eval because infant wouldn't settle with comfort & TYLENOL.
Age: 29.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Bronchitis, Erythema, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever, swelling, redness x 3 days. Clinical exam on 2/16/12 -> local redness & swelling at injection site. (+) Bronchitis.
Age: 29.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: Fever, swelling, redness x 3 days. Clinical exam on 2/16/12 -> local redness & swelling at injection site. (+) Bronchitis.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncope about 2 minutes after administration of vaccines.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: 4" welt on back side of right arm swelling and red at varicella site SC. Instructed to use cool compress dose of BENADRYL. If symptoms do not improve call for appt. Mom called Dr. office 3-19-12.
Sex: F
Vaccine: RAB
Symptoms: Diarrhoea, Injection site pain, Nausea
Clinical narrative: Nausea 3-4 days, diarrhea 1 day, soreness at site. Patient received 2nd & 3rd doses with less problem.
Age: 13.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Anxiety, Dyspnoea, Fear of needles, Loss of consciousness, Paraesthesia
Clinical narrative: Mother called and states that after leaving health unit approximately 30 minutes after shots, daughter had SOB, tingling and passed out for a few seconds while in the car drive home.  Mother called her doctor who told her that it was probably anxiety because she is fearful of needles.  Mom states child is doing fine now.
Age: 12.0
Sex: M
Vaccine: HPVX
Symptoms: Abdominal pain upper, Anger, Depression, Headache, Mood altered
Clinical narrative: My son had the HPV series starting almost 2 years ago. It was pushed hard at the doctors office. Ever since then he has had stomach aches, headaches, psychiatric symptoms, periods of rages, periods of depression, etc. He has NEVER experienced any of this before the vaccines. After each vaccine he was very sore and very moody for a week or so after, the last one was the worst. I am disgusted that our society is pushing these vaccines onto CHILDREN and even the HPV to BOYS. I should have known better. This vaccine should be taken off the market.
Age: 12.0
Sex: M
Vaccine: HPVX
Symptoms: Pain, Psychiatric symptom
Clinical narrative: My son had the HPV series starting almost 2 years ago. It was pushed hard at the doctors office. Ever since then he has had stomach aches, headaches, psychiatric symptoms, periods of rages, periods of depression, etc. He has NEVER experienced any of this before the vaccines. After each vaccine he was very sore and very moody for a week or so after, the last one was the worst. I am disgusted that our society is pushing these vaccines onto CHILDREN and even the HPV to BOYS. I should have known better. This vaccine should be taken off the market.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Local reaction - redness, swelling and soreness at injection site in right deltoid.  Seen in Emergency Center and sent home on OTC Benadryl and Motrin.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Convulsion, Respiratory disorder, Respiratory rate increased, Tremor
Clinical narrative: Seizure (tremors in arms, legs and chest/shoulders). Rapid, irregular breathing.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Mild swelling of the Left arm, redness and mild itching.
Age: 1.72
Sex: M
Vaccine: DTAP, HEP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness of right upper thigh.
Age: 1.26
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site rash, Papule, Rash, Rash erythematous, Rash papular
Clinical narrative: Sporadic papules noted to Right arm mostly located over elbow. Distinct satellite patern noted to upper arm. Rash was non-pruritic, erythematous, monomorphic papules with occasional papulovesicles noted on extensor surfaces of bilateral arms. By Feb 2, 2012 rash spread from Right arm to upper left arm, elbow and extensor surface of arm. Rash continued to spread to bilateral lower extremities and Right side of trunk underneath Right arm. We took him to a dermatologist who prescribed Hydrocortisone ointment for rash. Rash has lasted greater than 10 weeks.
Age: 5.0
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Accidental exposure, Nausea
Clinical narrative: Child was inappropriately given an HPV vaccine inadvertently. Child is 5 years old.  When parent was notified the following day, mom reported that child complained of nausea.  No further treatment was needed.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Patient was vaccinated with Pneumococcal pneumonia vaccine at 10:51 AM, patient developed selling and redness in the left upper arm (vaccination site).
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient was vaccinated with Pneumococcal pneumonia vaccine at 10:51 AM, patient developed selling and redness in the left upper arm (vaccination site).
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt received vaccines, Saturday 3/24/12, received call from mom stating that child woke up Sunday morning with right arm swollen from shoulder to elbow & warm. No fever. Evaluated in clinic on Mon 3/26/12. Positive warmth, erythema to mid-arm. Recommend ibuprofen & monitoring.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Pt broke out in rash. Mother is taking pt to be treated.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Rash at injection site after administration.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Knot at injection site with redness noted, knot decreased but still notable by time of visit.
Age: 51.0
Sex: M
Vaccine: HEPAB
Symptoms: Blister, Pruritus, Rash erythematous
Clinical narrative: Red rash changing to blisters w/i 24 hour of vaccine administration started on back of neck, (L) side of neck, then (B) arms below elbows only. Takes a couple of weeks to resolve, (+) itching. Occured after 1st & 2nd doses of TWINRIX, but didn't report it. Increased rxn after each shot. Has used hydrocortisone prior. Prednisone 5d now.
Sex: U
Vaccine: PNC13, VARCEL
Symptoms: Rash generalised, Rash papular, Vaccination complication
Clinical narrative: Red papular rash scatter all over body 3-13-12.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Eye oedema, Pruritus, Rhinorrhoea, Sneezing
Clinical narrative: Pt had edema of the eyes, clear rhinorrhea, itchy skin with no rash, sneezing.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Dysphonia
Clinical narrative: Pt had hoarseness of voice at night after given called on call dr. was told to give BENADRYL & contact us. Child was hoarse next am and fine by afternoon.
Age: 1.0
Sex: F
Vaccine: FLUX
Symptoms: Incorrect dose administered
Clinical narrative: A father brought his 1-year-old daughter in for a flu shot to the health dept. Through the interpreter, it was determined this was a booster shot and father assured us it had been at least 30 days since original shot. The father had given the birth date as one date and the correct date was 4 month earlier. Other countries use this way of writing dates. This was a third flu shot the child was given this year.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Malaise, Pallor, Pyrexia
Clinical narrative: Pt presented to ED with symptoms of serum sickness 2 days after receiving PNEUMOVAX 23 in a local physician's office (eg. had malaise, chills, blanching, joint pain, low grade fever).
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Serum sickness
Clinical narrative: Pt presented to ED with symptoms of serum sickness 2 days after receiving PNEUMOVAX 23 in a local physician's office (eg. had malaise, chills, blanching, joint pain, low grade fever).
Age: 1.22
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Respiratory arrest
Clinical narrative: Per parent, patient acting appropriately yesterday afternoon and last night - playful. Parent woke up around 4:15 am and child not breathing.
Age: 1.26
Sex: F
Vaccine: DTAP, HEP, HIBV
Symptoms: Injection site erythema, Injection site rash, Rash erythematous
Clinical narrative: Developed rash on belly, diaper area, upper thighs.  Dime sized, confluent, red, slightly raised.  Spread to face, eyes, arms, between fingers and toes.  Not itchy. Rx: Zyrtec.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mother reported that left arm swollen from shoulder to elbow, red and hot to touch.  Taken to see his PCP 3-28-12.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Blood culture negative, Culture urine negative, Pyrexia, Rhinorrhoea, Tuberculin test negative
Clinical narrative: Pt came to clinic with temp 104.5, mild runny nose and no other symptoms, exam was WNL and fever attributed to vaccines. Pt went to ED 3/14 again with high fever and was admitted for 10 days with intermittent high fever, no other symptoms, extensive work up for infection was negative. Vitals were always stable and pt appeared clinically well except for high fevers.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: X-ray normal
Clinical narrative: Pt came to clinic with temp 104.5, mild runny nose and no other symptoms, exam was WNL and fever attributed to vaccines. Pt went to ED 3/14 again with high fever and was admitted for 10 days with intermittent high fever, no other symptoms, extensive work up for infection was negative. Vitals were always stable and pt appeared clinically well except for high fevers.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: I am the physician assistant who saw patient on 3/27/12 for a rash that could be varicella.  She has reported that her daughter had varicella vaccine and other vaccinations one week ago.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Pyrexia, Rash, Urine analysis normal
Clinical narrative: Fever 101.7 initially. Seen in clinic next day. Fever 103.2 T. Fever lasted for 3 days. Had rash to legs only from 03/23/2012 continuing through 3/27/2012.
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Muscular weakness, Myalgia
Clinical narrative: Pain, swelling and redness at the injection site involving the whole upper deltoid of the right arm.  On March 26, 2012 the colleague reported muscle pain and weakness in the whole right arm.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: Colleague states she felt whole body fatigue and achiness for 3 days following the injection.  States left upper arm was extremely sore that entire time as well.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Back pain, Blood creatine phosphokinase normal, Full blood count normal
Clinical narrative: At first arm sore, then on 11/08/2010 began having pain, numbness, and weakness radiating down her lt arm into her fingers and up into her upper back and side of her neck. Tingling bilat feet. Lightheaded, nausea, vomiting, fatigue, feeling out of sorts, head feels pressure. Seen by physiatrist on 11/09/2010. Seen by another work comp MD on 11/11/10. Treated with skelaxin for h/a. Labs all normal. No dx of rabdo. Not Guillain-Barre, neurologically intact. may be "muscular response to even slight trauma and this will most likely self resolve. However, one is not unable to completely rule out brachial neuritis" given oral steroids one week. Light duty at work. Work comp claim denied. Last seen by WC Dr on 11/17/10. Seen by her private physician and returned to work w/o restiction 12/2/2010.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Laboratory test, Muscular weakness, Neck pain
Clinical narrative: At first arm sore, then on 11/08/2010 began having pain, numbness, and weakness radiating down her lt arm into her fingers and up into her upper back and side of her neck. Tingling bilat feet. Lightheaded, nausea, vomiting, fatigue, feeling out of sorts, head feels pressure. Seen by physiatrist on 11/09/2010. Seen by another work comp MD on 11/11/10. Treated with skelaxin for h/a. Labs all normal. No dx of rabdo. Not Guillain-Barre, neurologically intact. may be "muscular response to even slight trauma and this will most likely self resolve. However, one is not unable to completely rule out brachial neuritis" given oral steroids one week. Light duty at work. Work comp claim denied. Last seen by WC Dr on 11/17/10. Seen by her private physician and returned to work w/o restiction 12/2/2010.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia, Specific gravity urine normal, Urine analysis normal
Clinical narrative: At first arm sore, then on 11/08/2010 began having pain, numbness, and weakness radiating down her lt arm into her fingers and up into her upper back and side of her neck. Tingling bilat feet. Lightheaded, nausea, vomiting, fatigue, feeling out of sorts, head feels pressure. Seen by physiatrist on 11/09/2010. Seen by another work comp MD on 11/11/10. Treated with skelaxin for h/a. Labs all normal. No dx of rabdo. Not Guillain-Barre, neurologically intact. may be "muscular response to even slight trauma and this will most likely self resolve. However, one is not unable to completely rule out brachial neuritis" given oral steroids one week. Light duty at work. Work comp claim denied. Last seen by WC Dr on 11/17/10. Seen by her private physician and returned to work w/o restiction 12/2/2010.
Age: 35.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Injection site irritation, Injection site pruritus, Injection site reaction
Clinical narrative: Yesterday, client noticed an itchy, rash on her right arm, where Varicella vaccine was placed on 3/26/2012. It an intact raised reddened round area 40mm X 50mm in diameter.  She complains of discomfort and itching sensation. When asked, she denied any respiratory symptoms and did not notice the skin irritation right away.  When she looked at it in the mirror, she was surprised how large it was.
Age: 35.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Injection site swelling, Rash pruritic
Clinical narrative: Yesterday, client noticed an itchy, rash on her right arm, where Varicella vaccine was placed on 3/26/2012. It an intact raised reddened round area 40mm X 50mm in diameter.  She complains of discomfort and itching sensation. When asked, she denied any respiratory symptoms and did not notice the skin irritation right away.  When she looked at it in the mirror, she was surprised how large it was.
Age: 11.0
Sex: M
Vaccine: HPV4, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Patient came in stated that his left arm was in pain. Nurse noted that the IM location was not red or swollen but the SQ was a little red. At 4:35 PM patient came in stating that his arms were in pain nurse noted that both left and right SQ sides are warm at the touch and swollen. Patient was given Motrin and advised to ice areas.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chest pain, Dizziness, Dyspnoea, Dysuria
Clinical narrative: (I took Benadryl and ibuprofen prior to vaccine administration because of previous sensitivity to flu shot), but still had palpitations and heart racing and chest tightness/pain--extreme for first 14-16 hrs, intense for another 24 hrs. Resolved completely after 5 days. Pulse irregularity,  shortness of breath, face & arms were flushed but cold, extremities were cold/tingling sensation (& other Raynaud's syndrome symptoms) fatigue and muscle ache, light headedness, nausea, unable to void for almost 36 hrs. Everything resolved about 5 1/2 days later.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Flushing, Heart rate irregular, Myalgia, Nausea
Clinical narrative: (I took Benadryl and ibuprofen prior to vaccine administration because of previous sensitivity to flu shot), but still had palpitations and heart racing and chest tightness/pain--extreme for first 14-16 hrs, intense for another 24 hrs. Resolved completely after 5 days. Pulse irregularity,  shortness of breath, face & arms were flushed but cold, extremities were cold/tingling sensation (& other Raynaud's syndrome symptoms) fatigue and muscle ache, light headedness, nausea, unable to void for almost 36 hrs. Everything resolved about 5 1/2 days later.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations, Paraesthesia, Peripheral coldness, Raynaud's phenomenon
Clinical narrative: (I took Benadryl and ibuprofen prior to vaccine administration because of previous sensitivity to flu shot), but still had palpitations and heart racing and chest tightness/pain--extreme for first 14-16 hrs, intense for another 24 hrs. Resolved completely after 5 days. Pulse irregularity,  shortness of breath, face & arms were flushed but cold, extremities were cold/tingling sensation (& other Raynaud's syndrome symptoms) fatigue and muscle ache, light headedness, nausea, unable to void for almost 36 hrs. Everything resolved about 5 1/2 days later.
Age: 1.9
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Acne, Papule, Rash pustular, Scab, Skin lesion
Clinical narrative: Started with pimples and then open areas on anterior neck by 3/25-26. new lesion on right eyelid and 3/27 on upper chest. 3/28 in office with eroded quality to neck lesions, crusted pustule on right eyelid; small pustule on: left upper chest, left axilla, right chest-lateral and small papules/early pustules on upper inner arms and on chest wall. Patient is not scratching. Mupirocin for eroded lesions. Home care and contageon prevention counseling to father who brought son in.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Induration, Joint swelling, Mass, Oedema peripheral
Clinical narrative: Large, red, hard lumps covering both legs on shins and calves with a few on upper thighs and forearm. Swelling of shins, calves, and ankles.
Age: 1.82
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV, PNC13
Symptoms: Convulsion, Disorientation, Muscle twitching, Pyrexia
Clinical narrative: Fever to 101 and 6 brief seizures with twitching and disorientation over about half hour.
Age: 0.73
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Blood culture, Blood gases, Blood lactic acid, Culture urine, Endotracheal intubation
Clinical narrative: FEVER 102.5 R STATUS GRAND MAL SEIZURE ACTIVITY WITH SUBSEQUENT ORAL ENTUBATION, SEIZURE CESSATION WITH VALIUM RECATL/IV; CRITICAL CARE ADMISSION TO PICU
Age: 0.73
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Full blood count, Grand mal convulsion, Influenza virus test, Intensive care, Laboratory test
Clinical narrative: FEVER 102.5 R STATUS GRAND MAL SEIZURE ACTIVITY WITH SUBSEQUENT ORAL ENTUBATION, SEIZURE CESSATION WITH VALIUM RECATL/IV; CRITICAL CARE ADMISSION TO PICU
Age: 0.73
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Pyrexia, Respiratory syncytial virus test, Urine analysis
Clinical narrative: FEVER 102.5 R STATUS GRAND MAL SEIZURE ACTIVITY WITH SUBSEQUENT ORAL ENTUBATION, SEIZURE CESSATION WITH VALIUM RECATL/IV; CRITICAL CARE ADMISSION TO PICU
Age: 54.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Rash, Rash papular
Clinical narrative: Patient developed bilateral upper extremity papular rash s/p receiving hepatitis B vaccine to (L) arm & influenza vaccine to (R) arm. No other symptoms.
Age: 0.74
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Ear infection, Lethargy, Pyrexia
Clinical narrative: Baby's mother called the clinic on 3/26/12 stating child had fever since receiving imms 3/22/12. Temp was 102 on 3-25-12 & 101.7 on 3-26-12. Also stated child was lethargic.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Malaise, Myalgia, Nausea
Clinical narrative: Headache, malaise, myalgias, nausea, vomiting and swelling and redness and pain at the site of the vaccine. Began 3/19/12. All symptoms except swelling and pain at site have resolved except swelling & pain at site.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site pain, Vaccination site swelling, Vomiting
Clinical narrative: Headache, malaise, myalgias, nausea, vomiting and swelling and redness and pain at the site of the vaccine. Began 3/19/12. All symptoms except swelling and pain at site have resolved except swelling & pain at site.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling
Clinical narrative: Child received immunizations on 3/23/12, booster shots for pre-school. Father came in 3/27/12 to report child had increased temp, 102 & redness & swelling (L) arm x2 days. He made appt to see PCP for 3/29/12. Tx: cool compress/warm compress, TYLENOL or MOTRIN. F/u PCP apt. 3/29/12.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt vaccinated in (L) arm on 3/24/12. On 3/25/12 received call from mom stating (L) arm was swollen from shoulder to elbow and was red & warm - no fever. Evaluated in clinic on 3/26/12 - and arm erythematous swollen to mid arm/no fever - Recommended observation & ibuprofen.
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Oropharyngeal pain, Pyrexia, Urticaria
Clinical narrative: 26 y/o F received rabies vaccine 3/21 with hives/sore throat/feverish sensation noted AM of 3/22. Hives progressed, pt sought care in ED 3/25 & given ZYRTEC/BENADRYL/Prednisone with improvement.
Age: 61.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Sixty one yrs old female presented to foreign travel clinic at local health dept. Client requesting Hepatitis A and Typhoid vaccine. Client was given a 1.0 cc dose of typhoid vi vaccine and a 1.0cc dose of hep A vaccine. Error noted immediately after administering the extra dose of typhoid. Client was given Typhoid vi lot number Lot number G1121-1 in rt deltoid muscle. Failed to recheck dosage amount and recheck name of vaccine being administered. Typhoid iv was provided in multi dose vial. Client # XXXXXX is doing well. Steps to prevent future error slow down and follow rechecking steps with administer any vaccines.
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Adult Pt was given DTaP by mistake when Tdap was ordered. Pt denies any adverse effects. Nurse and MA double checked vaccine but neither are familiar with vaccines and do not have a vast experience with them. Staff will be instructed by both myself and the local Public Health Nurse in the hopes of educating new staff and preventing further errors.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Case number PHHY2011US113885 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS: 434567) website on 30 Dec 2011 with the follow-up received from Quality assurance department (reference number: 140398) on 06 Jan 2012 with a follow up report received on 16 Mar 2012. This report refers to 41 year old female patient. The patient's medical history included allergy to penicillin and DILANTIN. The patient was vaccinated with FLUVIRIN (batch number: 1100401) intramuscularly in the left arm on 11 Sep 2011. On 11 Sep 2011, the patient experienced cellulitis around injection site. Treatment with Doxycycline 100 mg twice daily was started 2 days later. The outcome of event was reported as condition unchanged as of 15 Sep 2011. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 1100401 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality assurance department on 06 Jan 2012: Updated Quality complaint number (sentry record number: 140398). Follow up received from the quality assurance department (reference number: 140398) on 16 Mar 2012. Batch review report updated.
Age: 53.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Case number PHHY2011US113994 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 438680) website on 30 Dec 2011 with a follow-up received from the quality assurance department (reference number: 140960) on 11 Jan 2012 with a follow up report received on 16 Mar 2012: This report refers to a 53-year-old male patient. His medical history included stroke, coronary artery disease and accelerated hypertension and concomitant medications were clonidine, eszopiclone, aspirin, hydralazine, lisinopril and metoprolol. He was vaccinated with FLUVIRIN (batch number: 104) intramuscularly on unspecified site and pneumococcal polysaccharide vaccine (other manufacturer, batch number: 1011AA) through unspecified route and site on 02 Oct 2011. On an unspecified date, the patient experienced cellulitis. The patient did not visit doctor. The final outcome was reported as complete recovery. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 104 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow-up received from the quality assurance department (reference number: 140960) on 11 Jan 2012: Updated reference number. Follow up received from the quality assurance department (reference number: 140960) on 16 Mar 2012. Batch review report updated.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Laboratory test abnormal
Clinical narrative: Case number PHHY2011US114403 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 439226) website on 30 Dec 2011 with a follow-up received from the quality assurance department (reference number: 140855) on 11 Jan 2012 and a follow up report received on 16 Mar 2012: This report refers to a 51-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number: 11034P) into the right arm on 04 Oct 2011. It was reported that site below the injection site became red and swollen, warm to touch on 05 Oct 2011. The patient's family doctor observed the site. Laboratory diagnostic test revealed cellulitis. The patient was prescribed Cephalexin 500 mg thrice daily. A week later, swelling was down, redness was gone. The patient recovered completely on unspecified date. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 11034P was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow-up received from the quality assurance department (reference number: 140855) on 11 Jan 2012: Updated reference number. Follow up received from the quality assurance department (reference number: 140855) on 16 Mar 2012. Batch review report updated.
Age: 14.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Case number PHHY2012US010520 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 444799) website on 07 Feb 2012 with a follow up received from the quality assurance department (reference number: 146675) on 20 Feb 2012 and a follow up received on 16 Mar 2012. This report refers to a 14-year-old female patient. Her medical history was not reported and concomitant medications included ZOLOFT. She was vaccinated with MENVEO (batch number: A10054) intramuscularly on to right arm, FLUN vaccine (other manufacturer, batch number: YL2069) through intranasal route and human papilloma virus quadrivalent vaccine (other manufacturer, batch number: 1317AA) intramuscularly on to left arm on 29 Nov 2011. On 30 Nov 2011, she experienced right upper arm redness, itchiness, hot to touch induration 10-12 cm, cellulitis and local reaction. Ice was applied for 15 to 20 minutes TID. She was given BENADRYL and KEFLEX. The outcome of the events was reported as complete recovery as of 01 Dec 2011. The quality assurance department opened a complaint for this case with reference number 146675. Based on the documents review, it was stated that the concerned MENVEO batch number M10054A was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from the quality assurance department (reference number: 146675) on 20 Feb 2012: Updated reference number. Follow up received from the quality assurance department (reference number: 146675) on 16 Mar 2012. Batch review report updated.
Age: 14.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ
Symptoms: Local reaction
Clinical narrative: Case number PHHY2012US010520 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 444799) website on 07 Feb 2012 with a follow up received from the quality assurance department (reference number: 146675) on 20 Feb 2012 and a follow up received on 16 Mar 2012. This report refers to a 14-year-old female patient. Her medical history was not reported and concomitant medications included ZOLOFT. She was vaccinated with MENVEO (batch number: A10054) intramuscularly on to right arm, FLUN vaccine (other manufacturer, batch number: YL2069) through intranasal route and human papilloma virus quadrivalent vaccine (other manufacturer, batch number: 1317AA) intramuscularly on to left arm on 29 Nov 2011. On 30 Nov 2011, she experienced right upper arm redness, itchiness, hot to touch induration 10-12 cm, cellulitis and local reaction. Ice was applied for 15 to 20 minutes TID. She was given BENADRYL and KEFLEX. The outcome of the events was reported as complete recovery as of 01 Dec 2011. The quality assurance department opened a complaint for this case with reference number 146675. Based on the documents review, it was stated that the concerned MENVEO batch number M10054A was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from the quality assurance department (reference number: 146675) on 20 Feb 2012: Updated reference number. Follow up received from the quality assurance department (reference number: 146675) on 16 Mar 2012. Batch review report updated.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Case number PHHY2012US010523 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 444816) website on 07 Feb 2012 and with a follow up received from the Quality assurance department on 21 Feb 2012 with the follow-up received from Quality assurance department on 16 Mar 2012. This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A10054) intramuscularly on to right arm and DTaP (other manufacturer, batch number: C3828AA) intramuscularly on to left arm on 29 Nov 2011. On 30 Nov 2011, he experienced in his right upper arm; redness, warm to touch, itching, induration 8cm x 6.8 cm, cellulitis and local reaction. He applied ice for 15-20 minutes TID. He took BENADRYL and KEFLEX. The outcome of the events was reported as complete recovery as of 01 Dec 2011. A quality complaint for batch review was recorded with reference number 146926. Batch review report concluded that, based on the documents review, it was stated that the concerned MENVEO (batch number: A10054) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow up received from the quality assurance department on 21 Feb 2012: Updated only the quality reference number. Follow-up received from Quality assurance department on 16 Mar 2012: Updated batch review report.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Local reaction
Clinical narrative: Case number PHHY2012US010523 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 444816) website on 07 Feb 2012 and with a follow up received from the Quality assurance department on 21 Feb 2012 with the follow-up received from Quality assurance department on 16 Mar 2012. This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A10054) intramuscularly on to right arm and DTaP (other manufacturer, batch number: C3828AA) intramuscularly on to left arm on 29 Nov 2011. On 30 Nov 2011, he experienced in his right upper arm; redness, warm to touch, itching, induration 8cm x 6.8 cm, cellulitis and local reaction. He applied ice for 15-20 minutes TID. He took BENADRYL and KEFLEX. The outcome of the events was reported as complete recovery as of 01 Dec 2011. A quality complaint for batch review was recorded with reference number 146926. Batch review report concluded that, based on the documents review, it was stated that the concerned MENVEO (batch number: A10054) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow up received from the quality assurance department on 21 Feb 2012: Updated only the quality reference number. Follow-up received from Quality assurance department on 16 Mar 2012: Updated batch review report.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Fatigue, Hemiparesis, Mobility decreased
Clinical narrative: Initial report received from a healthcare professional, who also submitted report to Vaccine Adverse Event Reporting System (VAERS), on 22 March 2012. A 60-year-old female patient received a left arm intramuscular injection of FLUZONE, sanofi pasteur Inc., lot number UT440AA, on 05 September 2011. The patient's medical history and any concomitant medications were not reported. Illness at time of vaccination was reported as none, but the patient had a sore throat two weeks earlier. On 12 September 2011, about a week after injection, the patient experienced extreme muscle fatigue, weakness and paralysis, and overall fatigue, which has lasted three months. At three months, patient was showing slight improvement over the last three weeks, but could not perform normal daily function. Since then the patient has gotten progressively worse, as she is now in a wheelchair due to she can not really use the left side of her body, left arm and left leg, which are very weak and hard to lift. Her husband has to help her take a bath. She has lost her job, and this has been debilitating. The patient's outcome is not recovered. Documents held by sender: None.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle fatigue, Paralysis, Wheelchair user
Clinical narrative: Initial report received from a healthcare professional, who also submitted report to Vaccine Adverse Event Reporting System (VAERS), on 22 March 2012. A 60-year-old female patient received a left arm intramuscular injection of FLUZONE, sanofi pasteur Inc., lot number UT440AA, on 05 September 2011. The patient's medical history and any concomitant medications were not reported. Illness at time of vaccination was reported as none, but the patient had a sore throat two weeks earlier. On 12 September 2011, about a week after injection, the patient experienced extreme muscle fatigue, weakness and paralysis, and overall fatigue, which has lasted three months. At three months, patient was showing slight improvement over the last three weeks, but could not perform normal daily function. Since then the patient has gotten progressively worse, as she is now in a wheelchair due to she can not really use the left side of her body, left arm and left leg, which are very weak and hard to lift. Her husband has to help her take a bath. She has lost her job, and this has been debilitating. The patient's outcome is not recovered. Documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, TYP, JEV1, ANTH, JEVX, SMALL, TYP
Symptoms: Chest pain, Electrocardiogram abnormal, Myocarditis, Pericarditis, Troponin increased
Clinical narrative: The following information was available on the VAERS homepage on 14 Mar 2012. A 22 year old male received a first dose of IXIARO (batch number JEV10F53F) on 14 Oct 2011. Eleven days later, on 25 Oct 2011, approximately at 10 a.m., substernal chest pain, with radiation to left arm, occurred at rest. Vaccinee was examined by a physician two hours later (vital signs and physical examination) and was taken to a hospital, where ECG was consistent with pericarditis. Lab tests showed elevated troponins (7.8), indicating myocarditis. The vaccinee was hospitalized for four days; he recovered.
Age: 22.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, TYP, JEV1, ANTH, JEVX, SMALL, TYP
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Troponin I increased
Clinical narrative: The following information was available on the VAERS homepage on 14 Mar 2012. A 22 year old male received a first dose of IXIARO (batch number JEV10F53F) on 14 Oct 2011. Eleven days later, on 25 Oct 2011, approximately at 10 a.m., substernal chest pain, with radiation to left arm, occurred at rest. Vaccinee was examined by a physician two hours later (vital signs and physical examination) and was taken to a hospital, where ECG was consistent with pericarditis. Lab tests showed elevated troponins (7.8), indicating myocarditis. The vaccinee was hospitalized for four days; he recovered.
Age: 46.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Hypoaesthesia, Lumbar puncture abnormal, Muscular weakness, Myelitis transverse, Nuclear magnetic resonance imaging spinal cord abnormal
Clinical narrative: Stiffness in legs heavy and numb legs hard time walking felt like I had no balance.
Age: 46.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Pleocytosis, Spinal cord disorder, Urinary retention
Clinical narrative: Stiffness in legs heavy and numb legs hard time walking felt like I had no balance.
Age: 46.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Balance disorder, Gait disturbance, Hypoaesthesia, Musculoskeletal stiffness, Sensation of heaviness
Clinical narrative: Stiffness in legs heavy and numb legs hard time walking felt like I had no balance.
Age: 1.27
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: C-reactive protein increased, Decreased appetite, Immunoglobulin therapy, Irritability, Joint swelling
Clinical narrative: Rash/hives 2/17/12 - present high fever (> 101) 2/18/12 - 2/28/12 swollen joint 2/21/12 - present lack of appetite 2/18/12 - 3/2/12 irritability 2/22/12 - present. IVIG treatment (for possible incomplete Kawasaki Disease) 2/26/12 Naproxen 4mL 2xday (for possible systemic JIA vs. Kawasaki Disease) 3/2/12 - present [aspirin (for possible Kawasaki Disease)] 2/26/12 - 3/1/12.
Age: 1.27
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Laboratory test, Platelet count increased, Pyrexia, Rash, Red blood cell sedimentation rate increased
Clinical narrative: Rash/hives 2/17/12 - present high fever (> 101) 2/18/12 - 2/28/12 swollen joint 2/21/12 - present lack of appetite 2/18/12 - 3/2/12 irritability 2/22/12 - present. IVIG treatment (for possible incomplete Kawasaki Disease) 2/26/12 Naproxen 4mL 2xday (for possible systemic JIA vs. Kawasaki Disease) 3/2/12 - present [aspirin (for possible Kawasaki Disease)] 2/26/12 - 3/1/12.
Age: 1.27
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Urticaria, White blood cell count increased
Clinical narrative: Rash/hives 2/17/12 - present high fever (> 101) 2/18/12 - 2/28/12 swollen joint 2/21/12 - present lack of appetite 2/18/12 - 3/2/12 irritability 2/22/12 - present. IVIG treatment (for possible incomplete Kawasaki Disease) 2/26/12 Naproxen 4mL 2xday (for possible systemic JIA vs. Kawasaki Disease) 3/2/12 - present [aspirin (for possible Kawasaki Disease)] 2/26/12 - 3/1/12.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Syncope
Clinical narrative: Feeling faint.
Age: 1.7
Sex: M
Vaccine: FLU3
Symptoms: Abnormal behaviour, Decreased eye contact, Decreased interest, Frustration, Head banging
Clinical narrative: Initial report received from a consumer, who is also the patient's parent, on 23 March 2012. The event was reported during the course of a vaccine brand usage survey being conducted by a national sampling organization on behalf of sanofi pasteur. A 20-month-old male patient had received an injection of INFLUENZA VACCINE (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later "stopped talking, acted funny, lost interest in everything and everybody, had no eye contact and would bang his head on the floor like he was frustrated." The patient received speech and occupational therapy. The patient "slowly pulled out of it with a lot of help." The patient "still gets speech therapy and is in kindergarten." No further information was available at the time of the report. The patient's outcome not reported. Documents held by sender: None.
Age: 1.7
Sex: M
Vaccine: FLU3
Symptoms: Speech disorder
Clinical narrative: Initial report received from a consumer, who is also the patient's parent, on 23 March 2012. The event was reported during the course of a vaccine brand usage survey being conducted by a national sampling organization on behalf of sanofi pasteur. A 20-month-old male patient had received an injection of INFLUENZA VACCINE (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later "stopped talking, acted funny, lost interest in everything and everybody, had no eye contact and would bang his head on the floor like he was frustrated." The patient received speech and occupational therapy. The patient "slowly pulled out of it with a lot of help." The patient "still gets speech therapy and is in kindergarten." No further information was available at the time of the report. The patient's outcome not reported. Documents held by sender: None.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Arthus or arthus-like localized reaction around site of injection with swelling, erythema, edema, pain & heat within 12 hours after injection.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Type III immune complex mediated reaction
Clinical narrative: Arthus or arthus-like localized reaction around site of injection with swelling, erythema, edema, pain & heat within 12 hours after injection.