chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza like illness, Laboratory test abnormal, Oedema peripheral
Clinical narrative: Patient administered FLUMIST vaccine and one week post vaccine, patient developed flulike syndrome, followed by fatigue and shortness of breath that worsened over 6 weeks before being referred to local cardiologist presenting with severe cardiomyopathy and associated congestive heart failure. 12/22/06 Received medical records from hospital which reveal patient admitted 11/10/06-11/14/06 after having flu like s/s of fever, malaise & body aches for approx 1 week after received the FluMist vax, followed by SOB & fatigue that continued to worsen over approx 6 wk period before presented to cardiologist office profoundly symptomatic.  Exam revealed JVD & est CVP of 10-12; summation gallop; small amount of ascites; trace bipedal edema Final DX: Congestive heart failure, compensated; cardiomyopathy, severe & presumably post-viral.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Eye oedema, Pain, Pharyngolaryngeal pain
Clinical narrative: sore throat, achiness, and edema bil eyes.
Age: 78.0
Sex: F
Vaccine: FLUX
Symptoms: Anxiety, Chills, Depression, Ear pain, Pharyngolaryngeal pain
Clinical narrative: I received the vaccine on 11/13/06 at 11:15 AM. About 8 hours later I began to feel a slight sore throat and earache.  However, at about midnight I developed a severe anxiety attack and depression, which lasted for about 7 hours.  It was accompanied by a very low (96.8) temperature and chills. All of the symptoms subsided by about 8:00PM on November 14.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Jaundice, Myalgia, Night sweats, Pruritus
Clinical narrative: Patient recieved flu shot on 10/21/06 and started having flu symptoms (myalgias and night sweats) shortly afterward on 10/28/06. The patient also developed severe itching all over his body (which was not relieved by Benadryl) shortly after recieving the vaccine. By 10/30/06, the flu symptoms had gone away, but he still had itching all over his body. He was seen by his primary care physician on 10/30/06 and had jaundice of the skin and eyes.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Cough, Dyspnoea, Fatigue, Nasal congestion
Clinical narrative: sore throat, cough, nasal congestion, runny nose, weakness, fatigue, slight difficulty breathing, very slight wheezing, soreness
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pharyngolaryngeal pain, Rhinorrhoea, Wheezing
Clinical narrative: sore throat, cough, nasal congestion, runny nose, weakness, fatigue, slight difficulty breathing, very slight wheezing, soreness
Age: 2.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Unevaluable event
Clinical narrative: none known
Age: 85.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient stated that right arm (pneumonia given in) somewhat pink in color and swollen where injections was given.  It was recommended for them to apply ice....if temp. or difficulty in breathing notify physician
Age: 10.0
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Skin rash on chest, legs and arms
Age: 85.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: Pain in Rt. arm this was arm flu shot was given in...We suggested that he elevate arm.....took tylenol.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Client complained of redness, swelling and pain  to right arm.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Warm and redness around injection site
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Urticaria
Clinical narrative: Hives on arm,neck, stomach and face.  Pain in arm
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, redness and pain in arm from shoulder to elbow including axillary area.
Age: 1.5
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Medication error
Clinical narrative: Vaccine date on lot expired. no adverse S&S. Vaccine to be repeated in one month.
Age: 1.5
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Medication error
Clinical narrative: expired vaccine administered.  will be re-administered in 1 month.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Cough, Eye discharge, Pain
Clinical narrative: Continuous thick yellow discharge from eyes, deep cough, fever 101, body aches and weakness, cold shivers. Fever, shivers, eye discharge lasted 24 hours. Body aches, weakness, and cough lasted 8 days. Advil only treatment.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Continuous thick yellow discharge from eyes, deep cough, fever 101, body aches and weakness, cold shivers. Fever, shivers, eye discharge lasted 24 hours. Body aches, weakness, and cough lasted 8 days. Advil only treatment.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Mom calls 11/16/06 to say arm at site if immunization is red, warm swollen, sore to touch, and has low grade fever.  Treatment recommended: ibuprofen,warm moist packs to site
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rashes on forehead.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC
Symptoms: Herpes zoster, Viral infection
Clinical narrative: Patient has shingles today, Varivax was given 5/06
Age: 1.01
Sex: M
Vaccine: FLU3, HIBV, MMRV, PNC
Symptoms: Erythema
Clinical narrative: 1.5 INCH X 1.5 INCH RED BLOTCH NOTED TO RT LEG.
Age: 1.02
Sex: F
Vaccine: FLU3, HEPA, HIBV, MMRV, PNC
Symptoms: Erythema
Clinical narrative: 1.5 IN x 1.5 IN RED BLOTCH TO UPPER RT THIGH.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Breakthrough chickenpox.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Chills, Depressed level of consciousness, Dizziness, Dyspnoea
Clinical narrative: felt fine day flu was administered. on 11/7/2006 didn't feel good. stated heart rate was up (100) bp was 115/62. had difficulty breathing was dizzy,having chills and felt "wacky" was hallucinating and balance was off. Felt like she had decrease in consciousness. Felt ok the second day, but symptoms returned on the third day for five more days. Today her legs are still jerky and her balance is still off.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Hallucination, Heart rate increased, Muscle spasms
Clinical narrative: felt fine day flu was administered. on 11/7/2006 didn't feel good. stated heart rate was up (100) bp was 115/62. had difficulty breathing was dizzy,having chills and felt "wacky" was hallucinating and balance was off. Felt like she had decrease in consciousness. Felt ok the second day, but symptoms returned on the third day for five more days. Today her legs are still jerky and her balance is still off.
Age: 0.64
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Eye oedema, Rash
Clinical narrative: rashes, swelling lower eyes
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Headache, Injection site warmth, Oedema peripheral, Pyrexia
Clinical narrative: Fever, headache x2 days, Right upper extremity redness and swelling on the lower half of the upper arm (proximal to the elbow), hot and tender to palpation.  All per patient report.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Tenderness
Clinical narrative: Fever, headache x2 days, Right upper extremity redness and swelling on the lower half of the upper arm (proximal to the elbow), hot and tender to palpation.  All per patient report.
Age: 32.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Aphasia, Coma, Encephalitis, Hemiparesis, Paralysis
Clinical narrative: Two days following second dose of rabies vaccine, admitted to hospital w/ left side weakness, progressing rapidly to full paralysis and aphasia. Pts neurologic status has continued to decline. On November 16, quadrapoligic, unresponsive; intubated in Neural Intensive Care Unit.   3/15/07 Received medical records from hospital which reveal patient admitted 11/11/06-11/17/06.  Received rabies vax on 11/1 & 11/8. Stated to ID consult that she received rabies vax every 3 yrs routinely while employed at vet office. Developed bronchitis on 11/4-5 & treated w/antibiotics beginning 11/6.  Awoke w/hemiparesis (initially left then became bilateral), fever, HA, neck pain, photophobia, speech impairment, right leg tremors & N/V when sat up on 11/10.  Seen at outlying hospital, admitted, treated w/steroids & IV antibiotics, then transferred on 11/11.  Consults by neuro, neurosurg, ID, ICU & gen surg.  Admitted to neuro ICU.  Approx 4 hrs s/p admit, developed aphasia.  Condition declined over next few days & began Cheyne-Stokes respiration & was intubated.  Continued tx w/plasmapheresis, high dose steroids, dilantin, mannitol & Diamox.  Severe hypotension tx w/pressors.  Condition continued to deteriorate despite aggressive tx & pt expired on 11/17/06 s/p brain herniation.   3/15/2007 Received Autopsy Report forwarded via fax from CDC which reveals COD as ADEM s/p rabies vaccine.
Age: 32.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Quadriplegia
Clinical narrative: Two days following second dose of rabies vaccine, admitted to hospital w/ left side weakness, progressing rapidly to full paralysis and aphasia. Pts neurologic status has continued to decline. On November 16, quadrapoligic, unresponsive; intubated in Neural Intensive Care Unit.   3/15/07 Received medical records from hospital which reveal patient admitted 11/11/06-11/17/06.  Received rabies vax on 11/1 & 11/8. Stated to ID consult that she received rabies vax every 3 yrs routinely while employed at vet office. Developed bronchitis on 11/4-5 & treated w/antibiotics beginning 11/6.  Awoke w/hemiparesis (initially left then became bilateral), fever, HA, neck pain, photophobia, speech impairment, right leg tremors & N/V when sat up on 11/10.  Seen at outlying hospital, admitted, treated w/steroids & IV antibiotics, then transferred on 11/11.  Consults by neuro, neurosurg, ID, ICU & gen surg.  Admitted to neuro ICU.  Approx 4 hrs s/p admit, developed aphasia.  Condition declined over next few days & began Cheyne-Stokes respiration & was intubated.  Continued tx w/plasmapheresis, high dose steroids, dilantin, mannitol & Diamox.  Severe hypotension tx w/pressors.  Condition continued to deteriorate despite aggressive tx & pt expired on 11/17/06 s/p brain herniation.   3/15/2007 Received Autopsy Report forwarded via fax from CDC which reveals COD as ADEM s/p rabies vaccine.
Age: 32.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Aphasia, Depressed level of consciousness, Hypersensitivity, Hypoxia, Immune system disorder
Clinical narrative: Two days following second dose of rabies vaccine, admitted to hospital w/ left side weakness, progressing rapidly to full paralysis and aphasia. Pts neurologic status has continued to decline. On November 16, quadrapoligic, unresponsive; intubated in Neural Intensive Care Unit.   3/15/07 Received medical records from hospital which reveal patient admitted 11/11/06-11/17/06.  Received rabies vax on 11/1 & 11/8. Stated to ID consult that she received rabies vax every 3 yrs routinely while employed at vet office. Developed bronchitis on 11/4-5 & treated w/antibiotics beginning 11/6.  Awoke w/hemiparesis (initially left then became bilateral), fever, HA, neck pain, photophobia, speech impairment, right leg tremors & N/V when sat up on 11/10.  Seen at outlying hospital, admitted, treated w/steroids & IV antibiotics, then transferred on 11/11.  Consults by neuro, neurosurg, ID, ICU & gen surg.  Admitted to neuro ICU.  Approx 4 hrs s/p admit, developed aphasia.  Condition declined over next few days & began Cheyne-Stokes respiration & was intubated.  Continued tx w/plasmapheresis, high dose steroids, dilantin, mannitol & Diamox.  Severe hypotension tx w/pressors.  Condition continued to deteriorate despite aggressive tx & pt expired on 11/17/06 s/p brain herniation.   3/15/2007 Received Autopsy Report forwarded via fax from CDC which reveals COD as ADEM s/p rabies vaccine.
Age: 32.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Nervous system disorder, Respiratory disorder, Sensation of heaviness
Clinical narrative: Two days following second dose of rabies vaccine, admitted to hospital w/ left side weakness, progressing rapidly to full paralysis and aphasia. Pts neurologic status has continued to decline. On November 16, quadrapoligic, unresponsive; intubated in Neural Intensive Care Unit.   3/15/07 Received medical records from hospital which reveal patient admitted 11/11/06-11/17/06.  Received rabies vax on 11/1 & 11/8. Stated to ID consult that she received rabies vax every 3 yrs routinely while employed at vet office. Developed bronchitis on 11/4-5 & treated w/antibiotics beginning 11/6.  Awoke w/hemiparesis (initially left then became bilateral), fever, HA, neck pain, photophobia, speech impairment, right leg tremors & N/V when sat up on 11/10.  Seen at outlying hospital, admitted, treated w/steroids & IV antibiotics, then transferred on 11/11.  Consults by neuro, neurosurg, ID, ICU & gen surg.  Admitted to neuro ICU.  Approx 4 hrs s/p admit, developed aphasia.  Condition declined over next few days & began Cheyne-Stokes respiration & was intubated.  Continued tx w/plasmapheresis, high dose steroids, dilantin, mannitol & Diamox.  Severe hypotension tx w/pressors.  Condition continued to deteriorate despite aggressive tx & pt expired on 11/17/06 s/p brain herniation.   3/15/2007 Received Autopsy Report forwarded via fax from CDC which reveals COD as ADEM s/p rabies vaccine.
Age: 32.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Aphasia, Coma, Demyelination, Encephalitis, Headache
Clinical narrative: Two days following second dose of rabies vaccine, admitted to hospital w/ left side weakness, progressing rapidly to full paralysis and aphasia. Pts neurologic status has continued to decline. On November 16, quadrapoligic, unresponsive; intubated in Neural Intensive Care Unit.   3/15/07 Received medical records from hospital which reveal patient admitted 11/11/06-11/17/06.  Received rabies vax on 11/1 & 11/8. Stated to ID consult that she received rabies vax every 3 yrs routinely while employed at vet office. Developed bronchitis on 11/4-5 & treated w/antibiotics beginning 11/6.  Awoke w/hemiparesis (initially left then became bilateral), fever, HA, neck pain, photophobia, speech impairment, right leg tremors & N/V when sat up on 11/10.  Seen at outlying hospital, admitted, treated w/steroids & IV antibiotics, then transferred on 11/11.  Consults by neuro, neurosurg, ID, ICU & gen surg.  Admitted to neuro ICU.  Approx 4 hrs s/p admit, developed aphasia.  Condition declined over next few days & began Cheyne-Stokes respiration & was intubated.  Continued tx w/plasmapheresis, high dose steroids, dilantin, mannitol & Diamox.  Severe hypotension tx w/pressors.  Condition continued to deteriorate despite aggressive tx & pt expired on 11/17/06 s/p brain herniation.   3/15/2007 Received Autopsy Report forwarded via fax from CDC which reveals COD as ADEM s/p rabies vaccine.
Age: 32.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Hemiparesis, Laboratory test abnormal, Myelitis transverse, Nervous system disorder, Quadriplegia
Clinical narrative: Two days following second dose of rabies vaccine, admitted to hospital w/ left side weakness, progressing rapidly to full paralysis and aphasia. Pts neurologic status has continued to decline. On November 16, quadrapoligic, unresponsive; intubated in Neural Intensive Care Unit.   3/15/07 Received medical records from hospital which reveal patient admitted 11/11/06-11/17/06.  Received rabies vax on 11/1 & 11/8. Stated to ID consult that she received rabies vax every 3 yrs routinely while employed at vet office. Developed bronchitis on 11/4-5 & treated w/antibiotics beginning 11/6.  Awoke w/hemiparesis (initially left then became bilateral), fever, HA, neck pain, photophobia, speech impairment, right leg tremors & N/V when sat up on 11/10.  Seen at outlying hospital, admitted, treated w/steroids & IV antibiotics, then transferred on 11/11.  Consults by neuro, neurosurg, ID, ICU & gen surg.  Admitted to neuro ICU.  Approx 4 hrs s/p admit, developed aphasia.  Condition declined over next few days & began Cheyne-Stokes respiration & was intubated.  Continued tx w/plasmapheresis, high dose steroids, dilantin, mannitol & Diamox.  Severe hypotension tx w/pressors.  Condition continued to deteriorate despite aggressive tx & pt expired on 11/17/06 s/p brain herniation.   3/15/2007 Received Autopsy Report forwarded via fax from CDC which reveals COD as ADEM s/p rabies vaccine.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site warmth, Pruritus, Swelling
Clinical narrative: Within 24 hours arm was itching, 48 hours post vaccination arm was hot to touch, swollen and red.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Similar reaction on previous exposure to drug, Urticaria
Clinical narrative: urticaria/myalgias beginning 12 hrs post injection. urticaria lasted 3 days, myalgias continued for 10-14 days.  symptomatic with acetoaminphen.  note: patient had similar, but milder reaction to flu vaccine in 1998-no vaccine in 1999/2000, but has had annually since 2001 without problem until now.
Age: 0.42
Sex: M
Vaccine: DPP, HIBV, PNC, UNK
Symptoms: Crying, Injection site erythema, Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: HIGH FEVER (104 DEGREES ONE HOUR AFTER TYLENOL WAS ADMINISTERED,) LARGE RED RASH AT INJECTION SITE, HARD SWELLING OF INJECTION AREA, PERSISTANT CRYING, PERMANENT SETBACK OF DEVELOPMENTAL SKILLS.
Age: 0.42
Sex: M
Vaccine: DPP, HIBV, PNC, UNK
Symptoms: Neurodevelopmental disorder, Pyrexia
Clinical narrative: HIGH FEVER (104 DEGREES ONE HOUR AFTER TYLENOL WAS ADMINISTERED,) LARGE RED RASH AT INJECTION SITE, HARD SWELLING OF INJECTION AREA, PERSISTANT CRYING, PERMANENT SETBACK OF DEVELOPMENTAL SKILLS.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Facial palsy, Hypoaesthesia, Pain, Paralysis
Clinical narrative: INfluenza vaccine and Human Papilloma VIrus vaccines  given November  10 about 11:45 AM. Patient woke up with numbness on right side of face on November  11.  Presented to Emergency Room on November 12 with Bells Palsy of  right side of face. Unable  to move right side of face.  Unable to close right eye.  Previously healthy, no symptoms on day of vaccine administration.  Received MR from pediatrician revealing a healthy 12 year old in for well-child exam. 24 hours after Flu and Gardasil vax. child developed numbness, pain, and inability to move the right side of face. Assessment:  Facial Nerve Palsy-unclear etiology. Child was sent by car to Minneapolis Children's ER to be evaluated. ER report received:  DX: Bell's Palsy
Age: 19.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Heart rate increased, Muscle disorder, Muscle spasms, Paralysis
Clinical narrative: This case was reported by a consumer and described the occurrence of paralysis in a 19 year old female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified) for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. The subjects medical history included primary immune deficiency. Concurrent medications included antibiotics. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On an unspecified date in Nov 2005 the subject received a dose of Influenza virus vaccine. Approx nine hours later, on an unspecified date in Nov 2005, the subject experienced tiredness. During that night following receipt of influenza virus vaccine, the subject experienced muscle spasm at night, heart racing and a fluttering feeling in her muscles, such that she could not move. The subject went to the doctor the day after these events for IV immunoglobulin (for primary immune deficiency) not because of the reaction she had during the night. The doctor checked her out and she seemed fine. The events were considered disabling. At the time of reporting the events were resolved.
Sex: F
Vaccine: FLUX
Symptoms: Chills, Injection site anaesthesia, Nausea, Pain
Clinical narrative: Felt achy, chills. Went to bed early. Next day was numb on vaccine site, aches, pain, nausea, fever. Talked to the nurse who recommended Tylenol for pain but because of nausea was unable to keep it down. Nausea and aches are gradually going away, feels better today.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Eye discharge, Swelling face, Throat tightness
Clinical narrative: Patient phoned stating she was treated in ER for yellow drainage from eyes, tightness in throat, lips swelling and increased blood pressure
Age: 5.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: Severe pain at injection site
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Medication error
Clinical narrative: Nurse gave patient 0.1 ml intra dermal injection of flu instead of 0.1 ml of PPD intra dermal. PPD vaccine 11/17/06 red, slightly warm to touch at side of influenza injection site.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Confusional state, Crying, Depression, Headache, Pain
Clinical narrative: Patient developed extreme pain in both feet, progressing up both legs, extreme headache, depression, episodes of crying,mental confusion, states symptoms lasted 1 week began to subside 11/16/06. Reported symptoms to MD, was seen 11/16/06 referred to neurologist, but did not keep appointment. Patient reported symptoms to family pediatrician, will attempt to/ heal of flu vaccine.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Rash macular, Rash maculo-papular
Clinical narrative: Macular, maculopapular rash all over.  Started on face and went down intermittently.  Started 24 hours after flu shot.  Also flushing of face noted along with it.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Dry eye, Dry mouth, Dyspnoea, Eye swelling, Musculoskeletal stiffness
Clinical narrative: Patient received injection afternoon of 11/16/06. By 8:30pm eyes were swollen, shortness of breath, stiffness and pain neck and shoulders, nausea, dry mouth and eyes. Patient starting drink more water, used eye drops and inhaler. Eyes are still swollen and some lung irritation on 11/17/06.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain
Clinical narrative: Patient received injection afternoon of 11/16/06. By 8:30pm eyes were swollen, shortness of breath, stiffness and pain neck and shoulders, nausea, dry mouth and eyes. Patient starting drink more water, used eye drops and inhaler. Eyes are still swollen and some lung irritation on 11/17/06.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Syncope
Clinical narrative: Fainted.  15 minutes later had explosive diarrhea.  Felt weak and went to bed.  On 11/16 had little diarrhea and today feels fine.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Facial palsy
Clinical narrative: Bell's Palsy right occurred 24 hours after injection of Gardasil. Previously healthy. MR received revealing an 18 yr. old in for well-woman exam with only c/o some discomfort in the mastoid area behind her right ear x2 days. The following day she presented with right-sided facial droop. HPI: Pt awoke morning following Gardasil vax. and had difficulty with spitting out her toothpaste. No pain or visual loss. No extremity weakness or paresthesias. Most obvious upon smiling.  Able to wrinkle forehead and puff cheeks. Good sensation. Txd with Famvir, Solu-medrol and Refresh Tears.  Assessment:  Bell's Palsy.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Tachycardia
Clinical narrative: Heart rate 150 at rest 16 hours after vaccines administered. Right arm red, slight induration at site of administration.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Lymphadenopathy, Nasal congestion, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Received flu shot  10/30/06. On 10/31/06 patient stated about 6 hours after the flu shot his head "filled up" and "had nasal congestion" and was "stuffed up" and had a sore throat. Stated his temp was 101F, took aspirin and rested. Stated his glands on both sides of his throat are swollen and edema has now gone down with only residual tenderness. No other adverse symptoms. States injection site without redness or swelling. Decline offer of throat culture. On 11/1/06, states he is doing better and that he had a throat culture done which was normal.  Stated sore throat was gone and lymph nodes no longer sore.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Rash, Rash pruritic
Clinical narrative: Flu shot placed 10/26/06. She called on 11/6/2006 to report development of a rash 2-3 days later (10/27 or 10/28) at injection site, which reports was red & pruiritic. States 1 week later, she ate eggs and the rash and pruritis got worse. Developed rash on arms, L abdomen and L back and left upper thigh. General achiness. Not on new meds and is not immunosuppresed. On 11/6/06 rash resolving. "Rash" appears as nonfluid  filled red circles (largest size=size of a pencil eraser). Denied fever. Per infection control -informed to seek medical care. Not sure if patient has seen a doctor yet.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Blister
Clinical narrative: Received flu vaccine 11/1/06 at Employee Health Flu Clinic. Informed Employee Health nurse on 11/6/06 that she noticed a blister on her R upper anterior thigh and some slight redness around it. Reported blister fluid filled. Denied pain, pruitis or any other symptoms. On 11/6/06 patient saw doctor and doctor not concerned. 11/8/06 developed 2 more blisters on her wrists.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 11/14/06 830AM Zostavax SQ LA. Approximately 24 hours later, injection site was firm 1"x1" oblong, tender. 11/15/06 Noticed tender and firmarca at injection site. 11/16/06 5PM Injection site measures 60mmx20mm - red, hot to touch, firmarca 30mmx18mm and darker red. ? Blister.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pain, Swelling
Clinical narrative: Painful, swollen - hot to touch.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash
Clinical narrative: Child developed rash to face and chest approximately 5 minutes after vaccine. No lethargy or difficulty breathing noted. VSS Pt sent to emergency room for evaluation.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Pain
Clinical narrative: Mom noticed in PM of 11/16/06 injection site red, warm to touch. Approximate size of egg - lump formed. Child complained of pain; treated with Benadryl/Tylenol.
Age: 58.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Injection site induration, Sensation of heaviness
Clinical narrative: Immediately after administrating the shot, the patient's arm developed a hardening around the injection site. Her skin also had red spots in a circular pattern around the injection site. She said her arm felt heavy.
Age: 24.0
Sex: F
Vaccine: RUB
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a licensed practical nurse concerning a 24-year-old postpartum female with no pertinent medical history and no drug reactions / allergies who in approximately April 2005 was vaccinated with a dose of MERUVAX II. There was no concomitant medication. On 04-OCT-2005 a rubella titer was negative. Unspecified medical attention was sought. The outcome was not recovered. There was no product quality complaint. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: RUB
Symptoms: Arthralgia, Joint swelling, Lymphadenopathy, Oedema peripheral, Rash
Clinical narrative: Information has been received from a 52-year-old female with allergies to penicillin, sulfa, phenylephrin HCL, ibuprofen; dystonic reaction to "phenothiazines"; increased heart rate and a sensation of bugs crawling on her skin after pseudoephedrine, "TCAs" and "phenoprophyline"; omeprazole (PRILOSEC) gave her a low grade headache and made her dizzy. On 10-DEC-2005 the patient was vaccinated with a 0.5 ml dose of MERUVAX II. There was no concomitant medication. On 19-DEC-2005 the patient developed swollen glands and rash. Unspecified medical attention was sought and no diagnostic laboratory tests were performed. It was reported that the patient recovered from the swollen glands and rash. On 25-DEC-2005 the patient developed painful and swollen knees, wrists and hands. At the time of the report, the swelling had gone down, but did not disappear completely. The patient is recovering from the painful and swollen knees, wrists and hands. No product quality complaint was involved. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: RUB
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 29 year old female with no known medical history or allergies who "two years ago," in 2004, "after giving birth" was vaccinated with a dose of MERUVAX II. A "recent" antibody test was negative, in approximately January 2006. The nurse reported that the patient was not pregnant at the time of the vaccination, but "is now." Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site rash, Urticaria
Clinical narrative: Typical soreness at injection site.  Approx 1 hours later rash appeared at injection site and arm. By evening it spread and worsened.  By next day the hives were all over upper body (arms, chest, back, stomach). On Sunday called doctor's office told to take Benadryl and come in morning.  Treatment from Primary Care Physician on Monday was prescription for Methylprednisolone tablets.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Anxiety, Blood glucose increased, Carbon dioxide decreased, Dizziness, Hypokalaemia
Clinical narrative: WENT TACHYCARDIC, DIZZY AND ALMOST FAINTED, WHICH PRODUCED AND ANXIETY ATTACH. HR 180 BPM, WAS GIVEN 6 ML PUSH ENDOCARD, DID NOT WORK.  THEN WAS GIVEN 12 ML PUSH ENDOCARD WHICH SLIGHTLY HELPED HEARTRATE STABALIZE.  WAS BROUGHT TO ER FOR EKG BLOODWORK AND FURTHER OBSERVATION.  MR received revealing ER visit for anxiety attack and SVT on same day as flu shot. PE WNL except tachycardia and anxiety. Treated with Adenosine in ambulance which converted pt. from SVT to Sinus Tach. In ER given Ativan, Zofran, and KCl. Discharged after several hours. Impression: Anxiety attack, tachycardia, nausea, hypokalemia.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Supraventricular tachycardia, Tachycardia, White blood cell count increased
Clinical narrative: WENT TACHYCARDIC, DIZZY AND ALMOST FAINTED, WHICH PRODUCED AND ANXIETY ATTACH. HR 180 BPM, WAS GIVEN 6 ML PUSH ENDOCARD, DID NOT WORK.  THEN WAS GIVEN 12 ML PUSH ENDOCARD WHICH SLIGHTLY HELPED HEARTRATE STABALIZE.  WAS BROUGHT TO ER FOR EKG BLOODWORK AND FURTHER OBSERVATION.  MR received revealing ER visit for anxiety attack and SVT on same day as flu shot. PE WNL except tachycardia and anxiety. Treated with Adenosine in ambulance which converted pt. from SVT to Sinus Tach. In ER given Ativan, Zofran, and KCl. Discharged after several hours. Impression: Anxiety attack, tachycardia, nausea, hypokalemia.
Age: 0.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Chest pain, Ear pain, Pain, Pyrexia
Clinical narrative: Patient states she had a severe reaction starting 2 days after the flu vaccine(given 11-4-06). Patient states having fever of 100.9 , severe pain, shooting pains all over her body including right leg, left arm, chest , head and ear. Patient reports a diagnosis of cellulitis in elbow with Keflex given by 1 of the 2 doctors she saw. Patient is still undergoing treatment at this time.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Oedema peripheral, Pruritus
Clinical narrative: I (patient) broke out in itchy hives, extremities became swollen, experienced dizziness, feverish, had diarrhea, experienced slight difficulty breathing.  I took Claritin, but that didn't help.  I then took Benedryl and that did help.  However, my work took one look at me and told me to go to the doctor.  She took a swab for strep (she said it could be scarlet fever - even though I didn't have any white dots in my throat nor did I have a high fever), but that test came back negative.  The hives have gone away (48 hrs later) and now I'm just left feeling dizzy, nauseated, diarrhea, and have a rash.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: I (patient) broke out in itchy hives, extremities became swollen, experienced dizziness, feverish, had diarrhea, experienced slight difficulty breathing.  I took Claritin, but that didn't help.  I then took Benedryl and that did help.  However, my work took one look at me and told me to go to the doctor.  She took a swab for strep (she said it could be scarlet fever - even though I didn't have any white dots in my throat nor did I have a high fever), but that test came back negative.  The hives have gone away (48 hrs later) and now I'm just left feeling dizzy, nauseated, diarrhea, and have a rash.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Headache, Injection site reaction, Joint range of motion decreased, Myalgia
Clinical narrative: Hives around site of injection.  Urgent care visit resulted in a diagnosis of Cellulitis.  Additionally, I experienced a fever of 102, had a lot of muscle aches, headache, and could not lift my arm for a full 24 hours.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives around site of injection.  Urgent care visit resulted in a diagnosis of Cellulitis.  Additionally, I experienced a fever of 102, had a lot of muscle aches, headache, and could not lift my arm for a full 24 hours.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Blood pressure increased, Heart rate increased, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: 102.5 Degr Fever  Blood Pressure 148 over 102 Heart Rate 100 for appr. 14 Hours Extreme Pain in left Arm where Vaccine was administered, Arm severely swollen.  Pain slowly subsiding after about 18 hours but still sensitive to the touch after three Days. Swelling started to subside after about 48 Hours.  MR received from vax. provider which reveals a pre-op eval on  Nov. 15 2006.  Spoke with patient/reporter-no treatment sought for AE.
Age: 7.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Asthenia, Dizziness, Dyspnoea, Erythema, Face oedema
Clinical narrative: serious allergic reaction, fever, hives, itching of feet and hands, reddening of skin, swelling of eyes, face and ears, tiredness, weakness, dizziness, paleness, shortness of breath.
Age: 7.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Fatigue, Hypersensitivity, Pallor, Pruritus, Pyrexia
Clinical narrative: serious allergic reaction, fever, hives, itching of feet and hands, reddening of skin, swelling of eyes, face and ears, tiredness, weakness, dizziness, paleness, shortness of breath.
Age: 7.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Urticaria
Clinical narrative: serious allergic reaction, fever, hives, itching of feet and hands, reddening of skin, swelling of eyes, face and ears, tiredness, weakness, dizziness, paleness, shortness of breath.
Age: 7.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Decreased appetite, Dizziness, Erythema, Fatigue, Skin ulcer
Clinical narrative: serious allergic reaction, fever, hives, itching of feet and hands, reddening of skin, swelling of eyes, face and ears, tiredness, weakness, dizziness, paleness, shortness of breath.
Age: 37.0
Sex: M
Vaccine: FLUN3
Symptoms: Diarrhoea, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: High fever 2 days Severe headache 2 days Diarrhea 1 day Nauseous 2 day Vomiting 2 days
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Hyperhidrosis, Hypokinesia
Clinical narrative: Within 6 hours of the injection, chills and shivering, sweats, general weakness and inability to stand.  Stayed in bed for the entire day after the injection.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Epistaxis, Petechiae, Platelet count decreased, Thrombosis
Clinical narrative: ITP: petechial rash all over body, including over site of vaccine administration; blood clot in mouth, epistaxis, platelet count of 1100, events started 18 hours after administration of influenza vaccine (fluarix); symptoms improved with administration of steroids and IVIG in hospital, patient was discharged 6 days after admission with increased platelet count to 70,000 after treatment and had no further bleeding/petechiae after administration to hospital and treatment.  1/9/07 Received medical records from hospital which reveal patient admitted 10/31/06-11/6/06 with bleeding.  Had red bumps on legs, arms, trunk & back for 2 days prior to admit after received flu shot on day bumps began.  Also had a bloody nose & saw PCP who obtained labs which revealed plts of 1100 & patient sent for admit.  Exam in ER revealed positive blood clot in left buccal mucosa, positive petechiae in upper palate, under tongue, bilateral extremities & back.  Slight tender cervical LAD.  Received steroids & IVIG in ER after heme consult.  Slowly improved & d/c to home on tapering steroids & heme clinic follow up.  FINAL DX: Idiopathic thrombocytopenia.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Hypokinesia, Paraesthesia, Shoulder pain
Clinical narrative: I had a flu shot Oct. 2, after that for the next couple of weeks, I experienced numbing and tingling in my left arms from my fingertips to my shoulderblade, I dismissed it as an 'aftereffect' of the shot. Week three went by, I went to the PCP, described the problems, She put me on Naprosyn and Neurontin, which only masked the problems, as the numbing and tingling were still there. Week four, I started having motor problems, dropping cups and plates, etc. I went to an orthopedic, everything was normal, including xray of my neck. So, onto neurologist who did a nerve conductivity test that turned out normal. . Week 5 included PAIN, and increasing into the shoulder blade. I had a full exam with the neurologist (week 6) . He has ordered Brain MRA's and C-Spine MRI tests, which are scheduled for this wed (nov.  22ndth) I have a physical therapy evaluation Tomorrow (Monday , Nov. 20th..   The neurologist seems to think the symptoms are MS- like and conclude it was probably from the flu shot.   I took blood tests today, Including SED Rate, ANA, C React Protein, and an RA test.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Dizzyness for 45 minutes to an hour. Almost blacked out.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Blood glucose increased, Diabetes mellitus, Increased appetite, Thirst, Urinary retention
Clinical narrative: A five year old male pt, with a history of allergy to Amoxicillin and Augmentin, and who was taking Poly Vi Flor tablets, had received a injection of Infanrix, lot number AC14B036AA, and a first 0.5ml dose, right arm, SC injection of ProQuad, lot number 652681/1134R, on 7/27/06. The pt was diagnosed with Diabetes Mellitus 42 days post immunization, on 9/7/06. On 9/7/06, the pt was seen in a physicians office with symptoms of weight loss, increased thirst, increased appetite, and increased urination for two to three days. A urinalysis was positive for glucose that was too high to get a reading. The pt was diagnosed with diabetes, and was admitted to the hospital where he was followed by an endocrinologist. The pt was hospitalized for three to four days. The pt has not recovered. The reporter considered the diabetes to be an other important medical event (OMIC), and was life threatening because if the condition was left untreated the pt could go into a diabetic coma. The reporter considered the pts disorder to be disabling. The reporter also noted that the pts twin sister, age five years old, had an adverse experience following vaccination with ProQuad of abdominal pain, erythema, swelling face, flushing, and pruritis. That case, was reported in the other manufactures report number, WAES0609USA02038. The records of testing prior to release of the other manufactures lot in question, have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. The other manufacturer had requested additional information.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Weight decreased
Clinical narrative: A five year old male pt, with a history of allergy to Amoxicillin and Augmentin, and who was taking Poly Vi Flor tablets, had received a injection of Infanrix, lot number AC14B036AA, and a first 0.5ml dose, right arm, SC injection of ProQuad, lot number 652681/1134R, on 7/27/06. The pt was diagnosed with Diabetes Mellitus 42 days post immunization, on 9/7/06. On 9/7/06, the pt was seen in a physicians office with symptoms of weight loss, increased thirst, increased appetite, and increased urination for two to three days. A urinalysis was positive for glucose that was too high to get a reading. The pt was diagnosed with diabetes, and was admitted to the hospital where he was followed by an endocrinologist. The pt was hospitalized for three to four days. The pt has not recovered. The reporter considered the diabetes to be an other important medical event (OMIC), and was life threatening because if the condition was left untreated the pt could go into a diabetic coma. The reporter considered the pts disorder to be disabling. The reporter also noted that the pts twin sister, age five years old, had an adverse experience following vaccination with ProQuad of abdominal pain, erythema, swelling face, flushing, and pruritis. That case, was reported in the other manufactures report number, WAES0609USA02038. The records of testing prior to release of the other manufactures lot in question, have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. The other manufacturer had requested additional information.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Blood glucose increased, Diabetes mellitus, Urine analysis abnormal
Clinical narrative: A five year old male pt, with a history of allergy to Amoxicillin and Augmentin, and who was taking Poly Vi Flor tablets, had received a injection of Infanrix, lot number AC14B036AA, and a first 0.5ml dose, right arm, SC injection of ProQuad, lot number 652681/1134R, on 7/27/06. The pt was diagnosed with Diabetes Mellitus 42 days post immunization, on 9/7/06. On 9/7/06, the pt was seen in a physicians office with symptoms of weight loss, increased thirst, increased appetite, and increased urination for two to three days. A urinalysis was positive for glucose that was too high to get a reading. The pt was diagnosed with diabetes, and was admitted to the hospital where he was followed by an endocrinologist. The pt was hospitalized for three to four days. The pt has not recovered. The reporter considered the diabetes to be an other important medical event (OMIC), and was life threatening because if the condition was left untreated the pt could go into a diabetic coma. The reporter considered the pts disorder to be disabling. The reporter also noted that the pts twin sister, age five years old, had an adverse experience following vaccination with ProQuad of abdominal pain, erythema, swelling face, flushing, and pruritis. That case, was reported in the other manufactures report number, WAES0609USA02038. The records of testing prior to release of the other manufactures lot in question, have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. The other manufacturer had requested additional information.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Blood glucose increased, Diabetes mellitus, Increased appetite, Pollakiuria, Thirst
Clinical narrative: A five year old male pt, with a history of allergy to Amoxicillin and Augmentin, and who was taking Poly Vi Flor tablets, had received a injection of Infanrix, lot number AC14B036AA, and a first 0.5ml dose, right arm, SC injection of ProQuad, lot number 652681/1134R, on 7/27/06. The pt was diagnosed with Diabetes Mellitus 42 days post immunization, on 9/7/06. On 9/7/06, the pt was seen in a physicians office with symptoms of weight loss, increased thirst, increased appetite, and increased urination for two to three days. A urinalysis was positive for glucose that was too high to get a reading. The pt was diagnosed with diabetes, and was admitted to the hospital where he was followed by an endocrinologist. The pt was hospitalized for three to four days. The pt has not recovered. The reporter considered the diabetes to be an other important medical event (OMIC), and was life threatening because if the condition was left untreated the pt could go into a diabetic coma. The reporter considered the pts disorder to be disabling. The reporter also noted that the pts twin sister, age five years old, had an adverse experience following vaccination with ProQuad of abdominal pain, erythema, swelling face, flushing, and pruritis. That case, was reported in the other manufactures report number, WAES0609USA02038. The records of testing prior to release of the other manufactures lot in question, have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. The other manufacturer had requested additional information.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Haematochezia, Intestinal ischaemia, Intussusception, Necrosis
Clinical narrative: Information has been received concerning a 20 week old female, with no medical history and no allergies, who on 9/1/06 was vaccinated with a second dose of Rotavirus vaccine (lot 653754/0139F). Concomitant vaccines administered on the same day included a second dose in the left thigh of Tripedia (lot U1397AB), a second dose in the left thigh of ActHib (lot UE930AA, a second dose in the right thigh of Ipol (Lot X1166) and a second dose of Prevnar (lot B08683E). There was no illness at the time of vaccination. On 9/17/06, at 8:34am, the pts initial exam showed blood stools and intussusception, and was hospitalized for 5 days. The pt received a water soluble contrast enema. It was reported that the pt recovered. Additional information is not expected. A lot check was requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Haematochezia, Intussusception
Clinical narrative: Information has been received concerning a 20 week old female, with no medical history and no allergies, who on 9/1/06 was vaccinated with a second dose of Rotavirus vaccine (lot 653754/0139F). Concomitant vaccines administered on the same day included a second dose in the left thigh of Tripedia (lot U1397AB), a second dose in the left thigh of ActHib (lot UE930AA, a second dose in the right thigh of Ipol (Lot X1166) and a second dose of Prevnar (lot B08683E). There was no illness at the time of vaccination. On 9/17/06, at 8:34am, the pts initial exam showed blood stools and intussusception, and was hospitalized for 5 days. The pt received a water soluble contrast enema. It was reported that the pt recovered. Additional information is not expected. A lot check was requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released.