chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: RAB
Symptoms: Visual acuity reduced, Visual disturbance
Clinical narrative: A 51 year old female pt experienced spots before her eyes, faintness, near blindness, and aches pains and tingling in her legs after receiving RabAvert for a stray cat bite. RabAvert was received IM on 13Sep04, 16Sep04, 21Sep04 and 28Sep04. Medical history included high blood pressure and type two diabetes. Concomitant medication included metformin, Toprol XL, Captopril, Risperdal, and Zoloft. A stray cat bit the pt on 11Sep04. On 13Sep04 she received her first injection of RabAvert in her hip and another medication (type unspecified) in the other hip. On 16Sep04 she received her second dose of RabAvert with no adverse events. On 21Sep04 she received her third dose. Immediately after receiving the injections she experienced spots before her eyes and nearly fainted. She also experienced aches, pains and tingling of the legs. The hospital staff had her sit down and the events resolved within 5 minutes without treatment. On 28Sep04 she received her fourth dose and experienced near blindness while driving home from the hospital. She did not stop driving, and the event resolved within 5 minutes with no treatment. She again experienced aches, pains and tingling in her legs, which she treated with oral ibuprofen orally and felt that the events were resolved. She stated she had never experienced any of these events before. Her physician told her that as her white count was fine, she probably has fibromyalgia.
Age: 26.0
Sex: M
Vaccine: RAB, TTOX
Symptoms: Ageusia, Anxiety, Asthenia, Coordination abnormal, Decreased appetite
Clinical narrative: A 26 year old male pt experienced malaise, nausea, fatigue, eye swelling, dizziness, pruritic rash, lethargy, somnolence, blurred vision, an episode of paralysis, anxiety, dysarthria, weakness, feeling abnormal, decreased attention, ageusia, decreased appetite, and incoordination while receiving RabAvert. The pt had received a post exposure prophylaxis regimen of RabAvert beginning sometime after 27Aug04 with completion of the fifth injection on 27Sep04. Past medical history was not provided except to say the pt did not have a history of alcohol abuse. Concomitant medications consisted of Advil, Allegra, Tylenol. On 27Aug04 the pt was bitten by a bat on his right scapula. He presented to a local hospital and was treated with the first injection of RabAvert, Tetanus toxoid and Human Rabies Immuno Globulin (HRIG). Shortly after the vaccination the pt felt bad described as a drunken drugged feeling, wanted to die, slowed down, and miserable. A similar reaction occurred with each of the two subsequent RabAvert injections. After the fourth dose of RabAvert, he developed nausea, fatigue, a swollen right eye, he felt dizzy and had an itchy rash on his face, left shoulder and chest. Treatment was initiated with Benadryl and a tapering dose Medrol pack by a physician at the local health dept with resolution of the rash. On 27Sep04 the pt was premedicated with Benadryl for the final dose of RabAvert. Three days later the pt awoke with extreme fatigue, lethargy, diffuculty awakening but went to work and began to feel worse, complaining of dizziness, blurred vision, nausea and feeling faint (no syncope). He went to a local emergency dept and was observed for three to four hours and there experienced a 20 minute episode of inability to move his extremities, felt like he was going to die and had slurred speech, diagnosed as a panic attack. The pt was discharged from the ER and was dizzy while driving home with continued lethargy and dizziness. On 30Sep04 a neurologist evaluated the pt ordering an MRI EEG and LP, advising admission but the pt walked out of the hospital stating he did not want an invasive procedure. The neurologist stated that he doubled the pt had encephalitis or meningitis and was probably having a reaction to the vaccine. Ever since, the pt has continued lethargy, blurred vision, intermittent slurred speech, lack of muscle strength, blankness of mind, decreased attention span, decreased taste and appetite and incoordination, per the pt and his mother.
Age: 26.0
Sex: M
Vaccine: RAB, TTOX
Symptoms: Disturbance in attention, Dizziness, Dysarthria, Eye oedema, Fatigue
Clinical narrative: A 26 year old male pt experienced malaise, nausea, fatigue, eye swelling, dizziness, pruritic rash, lethargy, somnolence, blurred vision, an episode of paralysis, anxiety, dysarthria, weakness, feeling abnormal, decreased attention, ageusia, decreased appetite, and incoordination while receiving RabAvert. The pt had received a post exposure prophylaxis regimen of RabAvert beginning sometime after 27Aug04 with completion of the fifth injection on 27Sep04. Past medical history was not provided except to say the pt did not have a history of alcohol abuse. Concomitant medications consisted of Advil, Allegra, Tylenol. On 27Aug04 the pt was bitten by a bat on his right scapula. He presented to a local hospital and was treated with the first injection of RabAvert, Tetanus toxoid and Human Rabies Immuno Globulin (HRIG). Shortly after the vaccination the pt felt bad described as a drunken drugged feeling, wanted to die, slowed down, and miserable. A similar reaction occurred with each of the two subsequent RabAvert injections. After the fourth dose of RabAvert, he developed nausea, fatigue, a swollen right eye, he felt dizzy and had an itchy rash on his face, left shoulder and chest. Treatment was initiated with Benadryl and a tapering dose Medrol pack by a physician at the local health dept with resolution of the rash. On 27Sep04 the pt was premedicated with Benadryl for the final dose of RabAvert. Three days later the pt awoke with extreme fatigue, lethargy, diffuculty awakening but went to work and began to feel worse, complaining of dizziness, blurred vision, nausea and feeling faint (no syncope). He went to a local emergency dept and was observed for three to four hours and there experienced a 20 minute episode of inability to move his extremities, felt like he was going to die and had slurred speech, diagnosed as a panic attack. The pt was discharged from the ER and was dizzy while driving home with continued lethargy and dizziness. On 30Sep04 a neurologist evaluated the pt ordering an MRI EEG and LP, advising admission but the pt walked out of the hospital stating he did not want an invasive procedure. The neurologist stated that he doubled the pt had encephalitis or meningitis and was probably having a reaction to the vaccine. Ever since, the pt has continued lethargy, blurred vision, intermittent slurred speech, lack of muscle strength, blankness of mind, decreased attention span, decreased taste and appetite and incoordination, per the pt and his mother.
Age: 26.0
Sex: M
Vaccine: RAB, TTOX
Symptoms: Lethargy, Malaise, Nausea, Paralysis, Rash pruritic
Clinical narrative: A 26 year old male pt experienced malaise, nausea, fatigue, eye swelling, dizziness, pruritic rash, lethargy, somnolence, blurred vision, an episode of paralysis, anxiety, dysarthria, weakness, feeling abnormal, decreased attention, ageusia, decreased appetite, and incoordination while receiving RabAvert. The pt had received a post exposure prophylaxis regimen of RabAvert beginning sometime after 27Aug04 with completion of the fifth injection on 27Sep04. Past medical history was not provided except to say the pt did not have a history of alcohol abuse. Concomitant medications consisted of Advil, Allegra, Tylenol. On 27Aug04 the pt was bitten by a bat on his right scapula. He presented to a local hospital and was treated with the first injection of RabAvert, Tetanus toxoid and Human Rabies Immuno Globulin (HRIG). Shortly after the vaccination the pt felt bad described as a drunken drugged feeling, wanted to die, slowed down, and miserable. A similar reaction occurred with each of the two subsequent RabAvert injections. After the fourth dose of RabAvert, he developed nausea, fatigue, a swollen right eye, he felt dizzy and had an itchy rash on his face, left shoulder and chest. Treatment was initiated with Benadryl and a tapering dose Medrol pack by a physician at the local health dept with resolution of the rash. On 27Sep04 the pt was premedicated with Benadryl for the final dose of RabAvert. Three days later the pt awoke with extreme fatigue, lethargy, diffuculty awakening but went to work and began to feel worse, complaining of dizziness, blurred vision, nausea and feeling faint (no syncope). He went to a local emergency dept and was observed for three to four hours and there experienced a 20 minute episode of inability to move his extremities, felt like he was going to die and had slurred speech, diagnosed as a panic attack. The pt was discharged from the ER and was dizzy while driving home with continued lethargy and dizziness. On 30Sep04 a neurologist evaluated the pt ordering an MRI EEG and LP, advising admission but the pt walked out of the hospital stating he did not want an invasive procedure. The neurologist stated that he doubled the pt had encephalitis or meningitis and was probably having a reaction to the vaccine. Ever since, the pt has continued lethargy, blurred vision, intermittent slurred speech, lack of muscle strength, blankness of mind, decreased attention span, decreased taste and appetite and incoordination, per the pt and his mother.
Age: 26.0
Sex: M
Vaccine: RAB, TTOX
Symptoms: Somnolence, Vision blurred
Clinical narrative: A 26 year old male pt experienced malaise, nausea, fatigue, eye swelling, dizziness, pruritic rash, lethargy, somnolence, blurred vision, an episode of paralysis, anxiety, dysarthria, weakness, feeling abnormal, decreased attention, ageusia, decreased appetite, and incoordination while receiving RabAvert. The pt had received a post exposure prophylaxis regimen of RabAvert beginning sometime after 27Aug04 with completion of the fifth injection on 27Sep04. Past medical history was not provided except to say the pt did not have a history of alcohol abuse. Concomitant medications consisted of Advil, Allegra, Tylenol. On 27Aug04 the pt was bitten by a bat on his right scapula. He presented to a local hospital and was treated with the first injection of RabAvert, Tetanus toxoid and Human Rabies Immuno Globulin (HRIG). Shortly after the vaccination the pt felt bad described as a drunken drugged feeling, wanted to die, slowed down, and miserable. A similar reaction occurred with each of the two subsequent RabAvert injections. After the fourth dose of RabAvert, he developed nausea, fatigue, a swollen right eye, he felt dizzy and had an itchy rash on his face, left shoulder and chest. Treatment was initiated with Benadryl and a tapering dose Medrol pack by a physician at the local health dept with resolution of the rash. On 27Sep04 the pt was premedicated with Benadryl for the final dose of RabAvert. Three days later the pt awoke with extreme fatigue, lethargy, diffuculty awakening but went to work and began to feel worse, complaining of dizziness, blurred vision, nausea and feeling faint (no syncope). He went to a local emergency dept and was observed for three to four hours and there experienced a 20 minute episode of inability to move his extremities, felt like he was going to die and had slurred speech, diagnosed as a panic attack. The pt was discharged from the ER and was dizzy while driving home with continued lethargy and dizziness. On 30Sep04 a neurologist evaluated the pt ordering an MRI EEG and LP, advising admission but the pt walked out of the hospital stating he did not want an invasive procedure. The neurologist stated that he doubled the pt had encephalitis or meningitis and was probably having a reaction to the vaccine. Ever since, the pt has continued lethargy, blurred vision, intermittent slurred speech, lack of muscle strength, blankness of mind, decreased attention span, decreased taste and appetite and incoordination, per the pt and his mother.
Age: 35.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain, Asthenia, Dysphonia, Fatigue, Headache
Clinical narrative: A 34 year old female patient experienced nausea, abdominal cramps, sore throat, hoarseness, fatigue, muscle soreness, weakness and headache after receiving RabAvert (lot number 336011, expiration date 03/07) for pre exposure prophylaxis. RabAvert 1ml was received via intramuscular injection in the deltoid on 09/16/04 and 09/23/04. The patient had no past medical history, was on no concomitant medication and had no known allergies. The patient had no adverse reactions to her first dose of RabAvert on 09/24/04, the day after her second dose, she experienced nausea, abdominal cramps, sore throat, hoarseness, fatigue, muscle soreness, weakness and headache. Her physician treated her with oral prednisone. She was cleared by the occupational health clinic to return to work on 10/07/04. She was seen again in the clinic on 10/14/04 and the events were completely resolved. The patients' third dose of RabAvert, due between 10/07/04 and 10/14/04, was held until further occupational health assessment, scheduled for 10/28/04.
Age: 35.0
Sex: F
Vaccine: RAB
Symptoms: Myalgia, Nausea, Pharyngolaryngeal pain
Clinical narrative: A 34 year old female patient experienced nausea, abdominal cramps, sore throat, hoarseness, fatigue, muscle soreness, weakness and headache after receiving RabAvert (lot number 336011, expiration date 03/07) for pre exposure prophylaxis. RabAvert 1ml was received via intramuscular injection in the deltoid on 09/16/04 and 09/23/04. The patient had no past medical history, was on no concomitant medication and had no known allergies. The patient had no adverse reactions to her first dose of RabAvert on 09/24/04, the day after her second dose, she experienced nausea, abdominal cramps, sore throat, hoarseness, fatigue, muscle soreness, weakness and headache. Her physician treated her with oral prednisone. She was cleared by the occupational health clinic to return to work on 10/07/04. She was seen again in the clinic on 10/14/04 and the events were completely resolved. The patients' third dose of RabAvert, due between 10/07/04 and 10/14/04, was held until further occupational health assessment, scheduled for 10/28/04.
Age: 2.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Coordination abnormal, Injury, Palpitations, Somnolence, Tremor
Clinical narrative: A 2 year old female patient experienced increased tremors, uncoordinated movements, drowsiness and a strong heart beat after receiving RabAvert for post exposure prophylaxis. The patient received RabAvert intramuscularly, 1 ml in the left thigh. Medical history included intermittent mild tremors of th hands upon awakening. Family history included mild epilepsy and benign tumors in the mother. Concomitant medication included Poly-Vi-Sol with iron and Zantac. The patient received a flu vaccination on 10/06/04. On 10/08/04 her mother reported "something grey flew out of the bushes at the stroller", and that upon arriving home noted the patient had scratches on her lower extremities; later that day the patient received RabAvert and human immunoglobulin (IGG). Subsequently the mother noticed that the patient was trembling prior to going to sleep. The next day she was still trembling, had uncoordinated movements, was drowsy and her heart was "going really strongly." The events were all resolved without treatment on 10/11/04. She was seen in the pediatrician's office for the second dose of RabAvert, which was not given. On 10/14/04 the patient was seen by another pediatrician and a neurologist, who stated the patient was "perfectly healthy and just had a day of involuntary movement."
Age: 44.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Hypoaesthesia, Paraesthesia
Clinical narrative: A 43 year old female patient experienced a tingling sensation and numbness after receiving her first dose of RabAvert for post exposure prophylaxis. She received 1 ml RabAvert rabies vaccine intramuscularly in her right arm on the 10/12/04. She has no past medical history apart from being allergic penicillin. There were no concomitant medications. Approximately two hours later she experienced the same symptoms in her left arm, then later in her right leg above the kneecap. The symptoms were persistent and did not improve or worsen. Although the sensation was not painful it gave her discomfort for which she took Benadryl, which did not help. At 2:00am on 10/03/04, she went to the emergency room and was seen by a neurologist. Following up was scheduled for the 10/14/04. The sensation in her arms had improved on the 10/14/04, however her legs still felt weak. She was not planning on continuing with RabAvert vaccinations. Follow up received 10/22/04: The patient received RabAvert in her right arm for post exposure prophylaxis after waking up on 10/12/04 with two spots near her ear that looked like bites. As a caution she went to a health clinic and received a RabAvert injection. On follow up, the patient stated she felt much better. Her neurologist told her he had never seen a reaction to RabAvert like this before. The symptoms in her legs disappeared after a day and her arms were almost completely recovered as well. She confirmed that she did not have any more RabAvert injections.
Sex: F
Vaccine: RAB
Symptoms: Lymphadenitis
Clinical narrative: A female patient developed lymph node swelling in her armpit following treatment with RabAvert for post exposure therapy. The physician started the series in a patient who received the second dose three days ago (date not given). Within 48 hours of the second dose, she developed lymph node swelling in the armpit of the deltoid used for immunization. There were no other associated localized or systemic symptoms. There were also no symptoms of hypersensitivity, allergy or neurologic complications. The physician assessed the event as possibly realted to the RabAvert therapy.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Injection site erythema, Injection site pain, Myalgia, Pyrexia
Clinical narrative: A 22 year old female patient developed fever, muscle aches, headache, localized tenderness at the the injection site and localized redness at the injection site following RabAvert therapy. A nurse at an outpatient clinic reported a female patient who is a worker in an animal shelter where there had been a dog nearby that was later determined to have rabies. The patient was offered HRIG and post exposure series but refused. She later accepted the pre exposure series. The patient took the first vaccination to RabAvert intramuscularly, on day 0, and the second on day 7. The lot number for these doses was 323011. On day 10 she developed fever (101 by the patient's report), muscle aches, headache, and localized redness and tenderness at the injection site. The reporter assessed the events as possibly related to RabAvert. Follow up information received 02/24/04: Past medical history included migraine headaches. The onset date of the fever, migraine headache and myalgia was 01/25/04. The patient received a total of three RabAvert doses given intramuscular that were 1cc each. They were given on 10/15/04, 01/22/04, and 02/05/04. No tests were required; the signs and symptoms resolved within a few days and were probably viral in nature. The patient had a complete recovery.
Age: 1.04
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Pyrexia, Viral infection
Clinical narrative: ON 1/8/2005 PRESENTED IN THE OFFICE WITH SPOTS - FEVER BEGAN 3 DAYS BEFORE - EXPOSED TO CHICKEN POX 2 WEEKS BEFORE  DX: MILD CHICKEN POX STATUS POST VACCINE
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Acidosis, Anaphylactic reaction, Anaphylactic shock, Hypotension, Hypoxia
Clinical narrative: Patient with sneezing, diffuse hives, hypotension and hypoxia 30 minutes after receiving vaccines.  Treated with epinephrine and benadryl and observed in hospital overnight. Discharge Summary received on 1/26/2005 states pt experience anaphylaxis and acidosis. Follow up 02/04/05: anaphylactic shock with metabolic acidosis.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Metabolic acidosis, Sneezing, Urticaria
Clinical narrative: Patient with sneezing, diffuse hives, hypotension and hypoxia 30 minutes after receiving vaccines.  Treated with epinephrine and benadryl and observed in hospital overnight. Discharge Summary received on 1/26/2005 states pt experience anaphylaxis and acidosis. Follow up 02/04/05: anaphylactic shock with metabolic acidosis.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Lung disorder, Malaise, Pneumonia, Pyrexia
Clinical narrative: PT Received Vaccination on Tues October 12th, On Saturday Oct 16 PT complained of feeling sick, Pt was admitted on Monday. PT was diagnosed with Pneumonia, and Septic Shock. Pt was in ARDS and never recovered. Pt was under other doctors care for bronchitis. PT deceased on 12/24/2004. Discharge summary from hospital received which revealed pt had multiple respiratory allergies, heavy smoker had SOB, fever, back & chest pain.  CXR consistent w/multilobar pneumonia & COPD.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory distress, Sepsis
Clinical narrative: PT Received Vaccination on Tues October 12th, On Saturday Oct 16 PT complained of feeling sick, Pt was admitted on Monday. PT was diagnosed with Pneumonia, and Septic Shock. Pt was in ARDS and never recovered. Pt was under other doctors care for bronchitis. PT deceased on 12/24/2004. Discharge summary from hospital received which revealed pt had multiple respiratory allergies, heavy smoker had SOB, fever, back & chest pain.  CXR consistent w/multilobar pneumonia & COPD.
Age: 23.0
Sex: M
Vaccine: FLUN3
Symptoms: Photophobia, Visual field defect
Clinical narrative: PT administered Flu-Mist at 1050 and started c/o of loss of perpherial vision at 1100.  Pt examined by doctor and Field of Vision test performed.  Both test were WNL.  Pt c/o of minor photophobia and HA.  Neuro exam was normal.  After 30 min., symptoms decreased expect for HA.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Arthralgia, Cough, Diarrhoea, Muscle spasms
Clinical narrative: 1) Severe muscle cramping/pain in right shoulder/neck area 24 hours after injection.  Shot injected in right arm. 2) Severe gastrointestinal cramping and diarrhea 60 hours after injection. 3) Burning chest & dry cough 7 days from injection 4) 100 degree fever 9 days after injection w/muscle & joint aches and pains.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Neck pain, Pyrexia, Shoulder pain
Clinical narrative: 1) Severe muscle cramping/pain in right shoulder/neck area 24 hours after injection.  Shot injected in right arm. 2) Severe gastrointestinal cramping and diarrhea 60 hours after injection. 3) Burning chest & dry cough 7 days from injection 4) 100 degree fever 9 days after injection w/muscle & joint aches and pains.
Age: 3.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Lymphadenopathy, Petechiae
Clinical narrative: Petechial rash on trunk/buttocks. Seen by diagnosed by MD. Also very swollen lymph gland in neck.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Herpes zoster, Pain, Viral infection
Clinical narrative: Within 2 days of vaccination, blisters appeared on the face, neck, front torso, legs.  Pain in the back of the right leg with burning sensation, currently spreading to the buttock area.  Sores being treated with ointment prescribed my Dermatologist, and tylenol for the pain in the leg...INSUFFICIENT.  Diagnosed by 3 physicians as chicken pox & possible shingles.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Hypersensitivity, Infection, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: DtaP, Varicella received right arm 1/12/05. 1/14/05 patient brought to clinic with erythema, swelling, tenderness and rash at site of injection.  Night time fever reported by caregiver.  Symptoms reported to have started the evening of the 13th.  Diagnosed by physician as allergic reaction to vaccination with potentially superimposed infection.  Treatment included Benadryl and Augmentin for 5 days.  Kenalog cream to rash BID until clear.  Caregiver talked to on 1/24/05 - she reported child's arm resolved without problem.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: DtaP, Varicella received right arm 1/12/05. 1/14/05 patient brought to clinic with erythema, swelling, tenderness and rash at site of injection.  Night time fever reported by caregiver.  Symptoms reported to have started the evening of the 13th.  Diagnosed by physician as allergic reaction to vaccination with potentially superimposed infection.  Treatment included Benadryl and Augmentin for 5 days.  Kenalog cream to rash BID until clear.  Caregiver talked to on 1/24/05 - she reported child's arm resolved without problem.
Age: 1.4
Sex: M
Vaccine: DTAPH, FLU3, PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Skin ulcer
Clinical narrative: THE LESION IS .25 CM IN SIZE. SHAPE IS ROUND. VESICLE ARRANGEMENT IS GROUPED, AND HAS A FOCAL DISTRIBUTION.  ADDITIONAL SURROUNDING ERYTHEMA, INDURATION, AND WARMTH, NOT SPREADING.  START BACTROBAN NOW, BENADRYL IF NEEDED, DURACEF IF WORSENS, AFFECTED SITE OUTLINED.
Age: 0.35
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Information regarding Prevnar was received from an investigator regarding a 5 month old male participant in a study who experienced SIDS. The participant received the first dose on 12/4/01. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 12/4/01. Dose regimen was 1 dose. Concomitant therapy included Hib-Titer, Infanrix, Engerix B, and IPV. The patient died on 1/15/02. The coroner's office reported the cause of death as SIDS. An autopsy was performed and material has been requested. The investigator and medical monitor considered sudden infant death syndrome not related to the study product. This report of a serious, labeled, not related event is being submitted in a 15-day time frame as requested by FDA. Autopsy report received which revealed COD as SIDS in 7-week preemie.
Age: 0.16
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Information regarding Prevnar was received from an investigator regarding a 2 month old female participant in a study who experienced SIDS. The participant received the first dose on 4/4/01. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 4/4/01. Dose regimen was 1 dose. Concomitant therapy included Hib-Titer, Recombivax-HB, IPV, and Infanrix. The patient died due to SIDS on 4/9/01. The cause of death was reported as sudden infant death syndrome. The investigator considered sudden infant death syndrome remotely related to the study product. The medical monitor considered this event not related to study product. This report of a serious, labeled, non related event is being submitted in a 15-day time frame as requested by FDA. Autopsy report received which revealed COD as SIDS.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with MMR. Subsequently, the patient developed autism. The physician reported that a mother wanted to delay the vaccination of her younger child with MMR because her older child had autism. The physician stated that he does not believe there was any connection between the older child receiving MMR and then developing autism. However, the mother believes if she waits until younger child is a little older, it will be safer for her child. Unspecified medical attention was sought. No product quality complaint involved. Upon internal review, autism was considered an important medical event (OMIC). Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Discomfort, Hypertrophy, Injection site pain, Laboratory test abnormal, Myositis
Clinical narrative: From follow up information received on 1/14/05 the seriousness of this case was upgraded from non-serious to serious, as based upon medical judgement. From initial information received on 11/1/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 51 year old male patient received a dose of FLUZONE vaccine, lot number U106888, administered in the right deltoid on 10/17/03. Four days later, on 10/21/04, the patient developed lingering shoulder pain at the right deltoid site. The patient has seen an orthopedic shoulder specialist and has been through physical therapy. He also used non-steroidal anti-inflammatories with no beneficial effect. The orthopedic shoulder specialist thought that the patient may have developed some sort of myositis. Patient's pre-existing medical conditions include high cholesterol. He has no known allergies. He did not have any illnesses at the time of vaccination. Concomitant medications at the time of vaccination included ASA and Zocor. The patient previously received four doses of influenza vaccine with no reactions reported. Reportedly, the discomfort, although it has waxed and waned somewhat, has not diminished significantly over the last several months. The patient has not recovered from these events. From additional information received on 1/14/05, from a physician, it was reported that the patient received a 0.5ml dose of FLUZONE, administered IM in the right deltoid. Reportedly, the patient had no illnesses at the time of vaccination. An MRI of the patient's right shoulder was completed on 10/22/04 due to right shoulder pain. The MRI showed marked AC joint hypertrophy, labrum intact and minor glenoid changes. Per the reporter, the patient's shoulder pain was somewhat improved as of the patient's office visit on 12/23/04. The physician stated that he does not consider the adverse events to be a significant or permanent disability, but it was a cause of significant pain. Reportedly, the patient retained strength, range of motion and function of his shoulder. Contact information for the patient's orthopedic specialist was provided. The adverse event coding for injection site pain was upgraded to shoulder pain.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Shoulder pain
Clinical narrative: From follow up information received on 1/14/05 the seriousness of this case was upgraded from non-serious to serious, as based upon medical judgement. From initial information received on 11/1/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 51 year old male patient received a dose of FLUZONE vaccine, lot number U106888, administered in the right deltoid on 10/17/03. Four days later, on 10/21/04, the patient developed lingering shoulder pain at the right deltoid site. The patient has seen an orthopedic shoulder specialist and has been through physical therapy. He also used non-steroidal anti-inflammatories with no beneficial effect. The orthopedic shoulder specialist thought that the patient may have developed some sort of myositis. Patient's pre-existing medical conditions include high cholesterol. He has no known allergies. He did not have any illnesses at the time of vaccination. Concomitant medications at the time of vaccination included ASA and Zocor. The patient previously received four doses of influenza vaccine with no reactions reported. Reportedly, the discomfort, although it has waxed and waned somewhat, has not diminished significantly over the last several months. The patient has not recovered from these events. From additional information received on 1/14/05, from a physician, it was reported that the patient received a 0.5ml dose of FLUZONE, administered IM in the right deltoid. Reportedly, the patient had no illnesses at the time of vaccination. An MRI of the patient's right shoulder was completed on 10/22/04 due to right shoulder pain. The MRI showed marked AC joint hypertrophy, labrum intact and minor glenoid changes. Per the reporter, the patient's shoulder pain was somewhat improved as of the patient's office visit on 12/23/04. The physician stated that he does not consider the adverse events to be a significant or permanent disability, but it was a cause of significant pain. Reportedly, the patient retained strength, range of motion and function of his shoulder. Contact information for the patient's orthopedic specialist was provided. The adverse event coding for injection site pain was upgraded to shoulder pain.
Age: 24.0
Sex: M
Vaccine: JEV, PPV
Symptoms: Chest discomfort, Insomnia
Clinical narrative: From initial information received on 1/18/05 from a health clinic regarding an adverse event, it was reported that a 24 year old male patient received his first dose of JE-VAX, lot number EJN213A, administered in the left deltoid, and his first dose of PNEUMOVAX, lot number 0513P, on 1/11/05 at 10:00 AM. The route of administration was not reported for either product. Twelve hours after receiving the vaccines, the patient developed chest tightness and was unable to sleep. The events lasted 20 minutes and then resolved. The patient was hospitalized and recovered from these events.
Age: 0.4
Sex: U
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: CSF test abnormal, Convulsion, Feeling hot
Clinical narrative: Felt warm per paramedics, ER at hospital. Seizure Activity 11/25/04 6:00am S2 at home.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Hypokinesia, Injection site pain
Clinical narrative: Received flu shot on left deltoid on 11/10/2004 at senior center, flu clinic organized by Board of Health. Information based on pt; she felt pain and couldn't pick up the left arm 2 hours after the shot. She experienced numbness down to the wrist. She was seen by Dr the same day. She continued to experience pain and difficult of movement on the left arm. She is under PT until now.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperaemia
Clinical narrative: Left deltoid area/hyperemia 60mm x 30mm
Age: 0.64
Sex: M
Vaccine: FLU3, PNC
Symptoms: Asthenia, Injection site pain, Myalgia
Clinical narrative: Right leg pain (weakness). Information from medical records states myalgia. msv
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site erythema, Injection site swelling
Clinical narrative: Client described next day injection site, redened and swollen.  Slightly itchy.  Seen in Clinic 12/23 Arm at injection site remgins redened to about 4 cms.  Bruised at injection site and edges of redness.
Age: 1.0
Sex: M
Vaccine: FLU3, HBHEPB, MMR, VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: MMR, Comvax (ABV/HIB), Varicella, Flu shots given on 12/17/04. Had Febrile Sz on 12/19/2004 associated with fever.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: C/O flu like symptoms next day, fatigue, nausea, and HA x 4days. Reports HA went away for couple days and then returned. HA reported as constant, everyday all day. Reports high BP also as a new diagnosis, scheduled for tests on coratid arteries.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Dizziness, Feeling cold, Insomnia
Clinical narrative: Chills, fever, weakness, dizziness, nausea, couldn't sleep, too cold.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pyrexia
Clinical narrative: Chills, fever, weakness, dizziness, nausea, couldn't sleep, too cold.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV
Symptoms: Erythema, Feeling hot, Swelling, Tenderness
Clinical narrative: 1" needle used Left shoulder - 5 cm red area. - warm to touch. - swollen, firm, tender.  01/21/2005 Keflex 2 tsp po 250 mg/5cc 2x/day x10 days.
Age: 0.11
Sex: M
Vaccine: DTAP, HEP
Symptoms: Crying, Pyrexia, Screaming
Clinical narrative: Fever up to 103 within 6 hrs, crying, screaming x 6-8 hrs inconsolable
Age: 1.51
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Dermatitis bullous, Pruritus
Clinical narrative: 1/4/05: Patient has had a rash for two days. Patient is a 1 1/2 year old female brought in by her father today with complaints of a rash which appears like chickenpox for the last two days. Patient has had no fever, runny nose or cough. She was last seen here on 12/27/04, for a well child visit and received Varivax #1 at that time. The rash is itchy. The patient has rash on her scalp, trunk and extremities. She has been eating and drinking well, is active and alert otherwise. Patient was given some Benadryl syrup for itching for the rash. Impression: Varicella like rash.
Age: 1.51
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Dermatitis bullous, Heart rate irregular
Clinical narrative: 1/4/05: Patient has had a rash for two days. Patient is a 1 1/2 year old female brought in by her father today with complaints of a rash which appears like chickenpox for the last two days. Patient has had no fever, runny nose or cough. She was last seen here on 12/27/04, for a well child visit and received Varivax #1 at that time. The rash is itchy. The patient has rash on her scalp, trunk and extremities. She has been eating and drinking well, is active and alert otherwise. Patient was given some Benadryl syrup for itching for the rash. Impression: Varicella like rash.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC, VARCEL
Symptoms: Cellulitis
Clinical narrative: Child received injections in each arm on 01/11/05, DTaP, IM ,Left arm; Varicella, SQ, left arm: Prevnar, IM, left arm, IPV, IM, right arm; MMR, SQ, right arm. The next day she had cellulitis of both arms. The patient was treated with Keflex 250mg, warm soaks or ice as needed and Tylenol or Ibuprofen.
Age: 66.0
Sex: M
Vaccine: TD
Symptoms: Oedema peripheral, Pain, Pruritus
Clinical narrative: Next morning after receiving Td, client experienced some swelling and soreness in upper left arm, which lasted for 3 days. Today, 01/18/05, the patient only complains of slight itching where the swelling occurred.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient mother states she has no history of reaction to prior immunizations. Mother noticed a redness and swelling to child's left arm last night while giving her a bath on 01/05/05. On 1/06/05 mother brought patient into health department and patient's left shoulder area was warm, red swollen and had a raised area of about 4 inches in diameter. Mother was advised to seek medical attention from PCP. Since patient had no local PCP, her mother stated she would take her to the ED. Patient was given Benadryl on 01/05/05 by her mother, but she stated it had no effect.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Pruritus
Clinical narrative: 01/05/05, Mom called to report right left hot and itchy in AM. Nurse Practitioner instructed her to given Tylenol and put an ice pack on his leg for 20 minutes and to call back after lunch. At 3:15 PM, mom called to report his leg is still bothersome and the redness seemed to be spreading to the back of his leg. Mom was instructed to start Benadryl and use ice pack for 5 minutes each hour. If not better in the AM, mom is to take to the doctor on 01/06/05. 1/07/05, Mom called at 3:15 PM to say patient is better, the Benadryl helped. She did not have to take him to the doctor.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Staring
Clinical narrative: Per parent child had staring episode several hours after vaccine, lasting a few seconds. Taken to ER for evaluation.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: 48 hours after vaccination given, patient brought to clinic with redness to left upper arm, erythema with mild induration. No fever and normal movement.
Age: 4.0
Sex: F
Vaccine: DTAP, HBHEPB, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Large red swollen area immediately after injection was given. Began to subside 15 to 20 minutes after injection. 01/07/05, arm is sore and slight swelling remains.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Erythema, Injection site mass
Clinical narrative: 1 cm knot and redness left anterior thigh 3 mm knot right thigh
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Injection site induration
Clinical narrative: Patient return to office on 01/13/2005. Mother c/o patient having red area on his left thigh for 2 days. Patient had vaccination given on 01/11/2005. Nurse observed 3.5 cc induration on left thigh near area of where vaccination was given.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Chest pain, Neck pain
Clinical narrative: 5 minutes after injection pain in neck and across low back, 10 minutes - low retrosternal pain, 15 - 20 minutes - pain resolved
Age: 0.18
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Coma, Skin discolouration, Somnolence, Staring
Clinical narrative: Patient had increase in sleep day after immunizations afebrile upon awakening. Mother noted infant to be gray in color, glossy eyed and poorly responsive for several minutes same day as shots
Age: 3.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Erythema, Eye swelling, Nasal oedema, Ocular hyperaemia, Pruritus
Clinical narrative: 1:45  PM Child given DTAP and MMR. No allergy to eggs-eats eggs everyday, mom explained. 2:15 PM Child and Mom at checkout, child eyes red and swollen, no wheezing. Mom wants to give child his Zyrtec medication. 2:30 PM Child's nose reddened and swelling with increase of redness on chest and face. No wheezing. Itching and scratching skin. To Pikeville Medical Center emergency room. B/P 90/60, Wt. 38 , P 110 , R 29 at Health Department
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Localized swelling, redness, within 24 hrs after receiving Dtap 5 and IPV 4.  Given Ibuprofen with prescription to take med for pain; also recommended compresses to area (arm) and elevation. Monitor for progression; RTC prn
Age: 1.27
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme, Tx: Orapred 15/5 3/4 tsp bid x 5 day; Atarax 10/5 1/2 tsp qid 2 day; Zyrtec 5/5 1/2 tsp qid x 30 days.
Age: 0.54
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Crying, Screaming
Clinical narrative: Incessant crying after immunization for 12hours
Age: 1.31
Sex: M
Vaccine: PNC
Symptoms: Apnoea, Cardiac arrest, Convulsion, Loss of consciousness, Pyrexia
Clinical narrative: Pt presents to clinic for ER F/U. Pt per mother had a seizure last night after receiving 4th pneumococcal vaccine yesterday in clinic. Pt was having fevers relived within Motrin. Mom states that pt lost consciousness and she had to perform CPR. Pt was taken to med ctr and evaluated and released. Only abdominal lab was CBC. Pt feeling well this AM. No other problems.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: 1" needle, Left shoulder swelling, redness, pain, 2.3cm x 6cm tender, not firm. Keflex (250mg 15ml) 1 1/2 tsp po 3x 1day x 10 days ice
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 1' needle,  left deltoid area 2-3 cm circle of swelling, tenderness, hot to touch and red. Treated with Keflex 1 tsp po twice a day x 10 days. Improving
Age: 1.76
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Cellulitis, Rash erythematous, Swelling
Clinical narrative: Patient received DTaP to left thigh on 01/17/05. Patient returned on 01/19/05, with 9 cm red, swollen warm rash that was non tender. The patient was afebrile and able to walk. He was treated with ice and Benadryl. Mom went to ER for second opinion, he was diagnosed with cellulitis and treated with Omnicef.
Age: 33.0
Sex: F
Vaccine: HEP, TD
Symptoms: Abdominal pain, Lymphadenitis, Malaise, Myalgia
Clinical narrative: Patient had axillary lymph node swelling on side of injection, also malaise, myalgia, and abdominal pain. Lymph node swelling resolving at time of follow up visit. Labs ordered to rule out other etiology.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash papular
Clinical narrative: Multiple papules to the scalp, thorax and extremities.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Entire left arm swollen, red, painful.
Age: 22.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort, Nausea
Clinical narrative: Abdominal discomfort and nausea approximately 5-6 hours after taking the vaccine.  There are 4 pills:  the first had the worst reaction, the second was much milder, the third and fourth had no reaction.  No treatment other than rest.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Hypokinesia, Injection site erythema, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Swelling, redness, pain, around elbow area, evening 9/15/04.  Seen at local ER. MD gave pt pain meds, returned to hospital within 1-2 weeks- was given physical therapy, saw local nurse practioner. Dr talked with another doctor on Dec/04; still having problems.  Doctor was seeing pt for ? pneumonia, did not address issue with arm.  Seen by several MD's at hospital- told that "shot" given to low and "you need to have something done before you loose your arm".  Still has pain, more at night-limited ability to lift, ROM causes pain Rt. arm. 1/25/05 Spoke with patient, continues to c/o of pain in rt arm "difficult to sleep at night, can only carry light groceries, but anything heavey "will pay for it later".  Has mobility of are, can feed self.  Is right handed.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Joint range of motion decreased, Pain, Pneumonia
Clinical narrative: Swelling, redness, pain, around elbow area, evening 9/15/04.  Seen at local ER. MD gave pt pain meds, returned to hospital within 1-2 weeks- was given physical therapy, saw local nurse practioner. Dr talked with another doctor on Dec/04; still having problems.  Doctor was seeing pt for ? pneumonia, did not address issue with arm.  Seen by several MD's at hospital- told that "shot" given to low and "you need to have something done before you loose your arm".  Still has pain, more at night-limited ability to lift, ROM causes pain Rt. arm. 1/25/05 Spoke with patient, continues to c/o of pain in rt arm "difficult to sleep at night, can only carry light groceries, but anything heavey "will pay for it later".  Has mobility of are, can feed self.  Is right handed.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Hypoaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: Mother called at 10:00am shortly after Hep B #3 given.  Reports child has quarter size red/swollen area with numbness in arem (lt).  Advised to apply cold compress and call PMD for evaluation.  Denies other symptom.  Advised to call HD to report further tx/problems.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Rash, Swelling
Clinical narrative: Swelling, local rash of Lt lower leg 5-6 hours after injection.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Heart rate increased, Paraesthesia
Clinical narrative: About 1 hour after receiving vaccine, felt light headed, & prickly sensation on neck, back and chest.  Felt like heart rate increased.  No visible hives.  Took 50mg PO Benadryl at home.  Relief obtained in about 1 hour.  did not seek medical help, even though advised to do so.
Age: 1.06
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Rash over face, trunk, back and legs, rash off & on for 3 days.
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Gait disturbance, Injection site reaction, Pyrexia
Clinical narrative: Patient presented to ER at 8:24 pm on 1/21/05 with fever and leg swelling in right thigh.  Child had received Pneumovax vaccine yesterday (1/20/05) in right thigh.  On 1/21/05 in the am patient had minimal swelling, redness and tenderness present.  Redness, pain, and swelling increased throughout the day and fever developed.   Patient now walks with limp due to pain.  Admitted to hospital and was treated with Acetaminophen for the pain and cefazolin for the infection. Was on cefazolin IV for 2.5 days.  Over weekend patient clinically improved with redness and swelling decreasing.  He was discharged on 1/24/05 with a prescription for 7 days of oral cephalexin. Medical records received on 4/20/2005 states cellulitis and injection site reaction.