chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: MNQ, MNQ, TD
Symptoms: Tinea versicolour
Clinical narrative: 8/30/2007 from patient's mother 2 hours after shot HA, bluish around mouth, legs and warm shot was given took to ER, achy all over. MD saw said flu-like symptoms, sent home ignored everything she tried to tell him. O2 level was okay, B/P increase 100/60 to normal for prior his eye. C/O  tired, achy, bluish legs when increase left arm very painful bluish, no fever, chills, no difficulty breathe, no appetite encouraged fluids, Tylenol for pain. 8/31/07 Took to ER for blood work, with cyanosis, no H/A, achy, fatigue sent home negative 8/30/07. Today no HA, left arm / -- painful. He is less achy, no H/A, continue tired, sleepy, bluish at times.
Age: 11.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Cold compress therapy, Hyperaemia, Oedema, Skin warm
Clinical narrative: 3 3/4" X 4 1/2" area of edema and hyperemia, hot to touch. (left arm) Instructed to take Benadryl 50 mg QID, cool compresses, decrease activity left arm
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Severe diarrhea with 101 fever after Rotateq immunization, starting on 9/5/07 for 3-4 days.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient given Zostavax vaccine prior to the age of 60 years old.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Hypoaesthesia, Pain in extremity, Skin disorder
Clinical narrative: I received the shingles vaccine and within 3 hours developed pain in both legs including burning, numbness sensitive to touch. Went to ER 4 days later, treated with Vicodin for pain. Still feel nite pain 11 days later but less.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Hypoaesthesia, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: I received the shingles vaccine and within 3 hours developed pain in both legs including burning, numbness sensitive to touch. Went to ER 4 days later, treated with Vicodin for pain. Still feel nite pain 11 days later but less.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: I received the shingles vaccine and within 3 hours developed pain in both legs including burning, numbness sensitive to touch. Went to ER 4 days later, treated with Vicodin for pain. Still feel nite pain 11 days later but less.
Age: 35.0
Sex: F
Vaccine: TTOX, UNK
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Erythema/pain at injection site diameter 6 cm.
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Blister, Body temperature increased, Chills, Erythema, Mass
Clinical narrative: Erythema/warmth spreading over upper arm, fever and chills, T= 100.5, knot area this developed blisters
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia, Skin warm
Clinical narrative: Erythema/warmth spreading over upper arm, fever and chills, T= 100.5, knot area this developed blisters
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Heat therapy, Oedema peripheral
Clinical narrative: Day after vaccine administered mom notified leg red and swollen, no fever. Treatment - Supportive care ----> war, compresses, Tylenol PRN.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itching at injection site.
Age: 59.0
Sex: M
Vaccine: HEP
Symptoms: Facial palsy
Clinical narrative: Bells palsy
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Area noted on right arm 9cm x 10cm in size.
Age: 21.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: Severe pain left deltoid - was given Tylenol 3 by doctor. 9-14-07 Telephone pain completely gone.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Injected limb mobility decreased, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Temp 48 hours after inj 99-100 8/21/07 - severe pain in left arm and shoulder un-able to raise above her head - saw Orthopedic doctor with MRI to follow. Not resolved as of 10/12/2007.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site induration, Pruritus
Clinical narrative: 5 1/2 x 7cm induration began 24 hours after administration at site of DTaP #4 mild pruritus. No systemic sx otherwise.
Age: 26.0
Sex: U
Vaccine: TD, TD
Symptoms: Asthenia, Fatigue, Laboratory test normal, Local swelling, Myalgia
Clinical narrative: Local swelling, fatigue, muscle aches, myalgia, weakness, an extensive laboratory work up was negative. Follow-up: Vaccine was administered 7/24/07. She was seen for her first office visit complaining of fatigue on 8/1/07.
Age: 26.0
Sex: U
Vaccine: TD, TD
Symptoms: Asthenia, Disorientation, Fatigue, Loss of consciousness, Myalgia
Clinical narrative: Local swelling, fatigue, muscle aches, myalgia, weakness, an extensive laboratory work up was negative. Follow-up: Vaccine was administered 7/24/07. She was seen for her first office visit complaining of fatigue on 8/1/07.
Age: 26.0
Sex: U
Vaccine: TD, TD
Symptoms: Pyrexia, Swelling
Clinical narrative: Local swelling, fatigue, muscle aches, myalgia, weakness, an extensive laboratory work up was negative. Follow-up: Vaccine was administered 7/24/07. She was seen for her first office visit complaining of fatigue on 8/1/07.
Age: 38.0
Sex: F
Vaccine: JEV
Symptoms: Oedema mouth, Swollen tongue, Urticaria
Clinical narrative: Last night 9/12 1 1/2 hours after dinner started with hives, tongue and mouth swollen, throat tightens, went to ER was given Solumedrol IV, Prednisone 50mg, x 5 days, tsp PCN.
Age: 1.2
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC
Symptoms: Rash generalised
Clinical narrative: Father and mother of child presents to clinic stating that they were referred to the nurse to eval generalized rash all over body, legs, arms and trunk for possible reactions to vaccine received 8/14/07. Child received the following vaccine on 8/14/07 Pediarix, MMR, Hib, Hep A, Prevnar. Child was seen by Community meds.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Client seen for vaccines. Mom stated child develop rash appearance on face back and shoulder 2 days later. She telephone her MD just was waiting on appointment to see. She telephoned the clinic 1 week later. She states rash has improved. She denied fever, or itching. Client never saw pediatrician.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Varicella
Clinical narrative: Client received vaccine 6/07. Client mother called Health Department this AM c/o child with bumps on back. Slight temperature. Instructed mom to take child to Pediatrician. Received phone call from doctor office with child diagnosed with chickenpox. This was child's second vaccine no complaints with earlier vaccine at 1 year old.
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever 105
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain
Clinical narrative: Patient showed local inflammation at site of Anthrax vaccine associated redness, swelling, induration, tenderness extending concentrically around site from just below shoulder to elbow postercally. Dx: local reaction vs cellulitis.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Local reaction
Clinical narrative: Patient showed local inflammation at site of Anthrax vaccine associated redness, swelling, induration, tenderness extending concentrically around site from just below shoulder to elbow postercally. Dx: local reaction vs cellulitis.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: On 9-6-07 at 12:00 Pneumo vaccine given at about 11:00pm warm to touch, tender. Today right upper arm red, swelling, some itching, T 98.8, PAC notified and examined patient ice packs, Alleve, call nurse on Monday.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: On 9-6-07 at 12:00 Pneumo vaccine given at about 11:00pm warm to touch, tender. Today right upper arm red, swelling, some itching, T 98.8, PAC notified and examined patient ice packs, Alleve, call nurse on Monday.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Patient received Pneumovax in left deltoid on 9-6-07 at 2:30 on 9-7-07 AM left arm warm to touch, red, swollen, painful, fever. Doctor notified and examined patient T 98.5, ice pack, move arm, Motrin (fever, pain).
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Erythema, Heat therapy, Induration, Injection site swelling, Tenderness
Clinical narrative: Extensive swelling left arm - red/tender and indurated. Rx: Pain meds and warm compress
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Rash generalised, Rash macular
Clinical narrative: MMR administered on 8/29/07. Mother states that on 9/8/07, patient broke out in a total body rash. Child has red/macular rash (total body).
Age: 1.0
Sex: F
Vaccine: HIBV, PNC
Symptoms: Pyrexia, Rash macular, Roseola
Clinical narrative: Fever over 101 for 3 days - fever broke and a fine macular rash on trunk seen. Dx as Roseola by doctor - parents felt the reaction was from immunization given on 8/24/07 Prevnar and Hib.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: 8/29/07 Rash started and continued for about 1 week. Rash all over patients body. Appeared to be itchy. No other symptoms.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Blood pressure decreased, Headache, Pallor, Stomach discomfort
Clinical narrative: sick stomach, headache, sudden severe drop in blood pressure, ashen skin color. BP went to 70/50. took 40 minutes to regain strength and pressure
Age: 15.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, Pain, and Heat below injection site - Left arm 4.5" x 5"
Age: 25.0
Sex: F
Vaccine: TTOX
Symptoms: Pain, Pain in extremity
Clinical narrative: Very very severe pain in arm where vaccine was injected.  I can barely move my arm- feels like there a golf ball stuck in my arm and the pain is shooting down to my fingers!  It's really unbareable
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Local reaction, Pain, Swelling
Clinical narrative: Pt received Varicella vaccine at check up appt on 9-10-2007 with no reaction noted after 20 minute wait time. Pt developed a large local reaction to left arm site on 9-12-2007 including a 7x6 cm area of erythema, soreness, swelling. Instructed per Dr to use warm compresses and anti-inflammatory meds. Spoke with mom on   9-14-2007 - states pt much better - swelling and redness decreased - pt doing fine.
Age: 20.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient recieved Varicella on 08/16/2007 right leg SQ, ON 08/27/2007 Patient called office 08/27/2007 c/o redness and swelling at sight
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, MMR
Symptoms: Erythema, Injection site pain, Injection site reaction, Pruritus, Pyrexia
Clinical narrative: grandmother reports mild fever in first 48 hours, typical soreness at site.  Day 2 after immunization itching and redness increased.  Seen 9/14/07 1100,  at clinic, 4 days after immz , Left arm redness with warmth.  Redness from deltoid area to elbow on frontal aspect.  Received Pediarix in L deltoid at 1600 9/10/07.  No treatment, monitor, increased site reaction.  Consider benadryl prior to future immunz.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, MMR
Symptoms: Skin warm
Clinical narrative: grandmother reports mild fever in first 48 hours, typical soreness at site.  Day 2 after immunization itching and redness increased.  Seen 9/14/07 1100,  at clinic, 4 days after immz , Left arm redness with warmth.  Redness from deltoid area to elbow on frontal aspect.  Received Pediarix in L deltoid at 1600 9/10/07.  No treatment, monitor, increased site reaction.  Consider benadryl prior to future immunz.
Age: 11.0
Sex: M
Vaccine: DTAP, HEPA, MNQ, VARCEL
Symptoms: Heat therapy, Injection site mass, Injection site rash
Clinical narrative: He has a knot under vaccine site and it has a rash around it. I gave him a warm compress, tylenol and benadryl.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis
Clinical narrative: Left Deltoid cellulitis developed over two days.  Patient examined and placed on Keflex (200 mg tid x 7 days).
Age: 30.0
Sex: F
Vaccine: ANTH
Symptoms: Urticaria
Clinical narrative: Developed hives approx 48 hours after dose 6 anthrax vaccine administration.  patient with hx of episodic hives prior to more acute episode.
Age: 0.75
Sex: F
Vaccine: PNC
Symptoms: Floppy infant, Miosis, Pyrexia, Vomiting
Clinical narrative: Per ER report: "Parents respond child has been like a "floopy doll" and unable to support her body weight when sitting up. Emesis X2 this afternoon, pupils were noted to be pin point. Has maintained low-grade fever (T 100R).         CT head w/o contrast (negative), basic metabolic panel
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Flushing, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Patient received a DTAP and Mantoux on 09-06-2007 at approximately 1:30 p.m. Within 1 hour she states that she became dizzy, her hands began to sweat, her face was flushed. Within 1 1/2 hour she began to vomit, 4 times over next 3 hours. She was nauseated through the night, but was fine by morning.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: 15 month old male brought by mother with redness and moderate swelling at the site of DTap injection in the left thigh given yesterday. There was no fever or rash and pt has been playing as if without pain. 9x9 cm area of redness and swelling without lymphangitic streaks in the anterior aspect of the left upper thigh with a 1x1 cm non-tender induration around the puncture site
Age: 35.0
Sex: M
Vaccine: SMALL
Symptoms: Areflexia, Audiogram abnormal, Deafness neurosensory, Dizziness, Drug effect decreased
Clinical narrative: 35 y/o healthy male received Anthrax vaccine #1 and Typhoid vaccine on 16 AUG 07 without significant side effects.  On 03 SEP 07 received Small pox vaccine in left deltoid (no prior history of small pox vaccination or exposure).  On 07 SEP 07 patient experienced sudden, profound left sided sensorineural hearing loss and vertigo which has been persistent and unresponsive to high dose oral prednisone and anti-virals.  12/10/2007 MR received for OVs and audiometric testing beginning 09/03/2007 to 11/27/2007. Medical screening 9/3/07 with pt "feeling fine, no symptoms".  Smallpox vax received. Pt reported back on 9/7/07 with c/o sudden onset L sided hearing loss. No other sx other than fullness in L ear.  DX: Sensorineural Hearing Loss Asymmetrical Initially txd with prednisone and anti-virals. Seen again 9/12/07. Pt now c/o imbalance and feeling like inebriated. Meclizine Rxd for vertigo. DX as above with Sudden Hearing Loss of Unknown Etiology. OV 9/13/07 with c/o severe dizziness, nausea, vomiting, and poor po intake. OV 9/17/07 with (+) nystagmus and falls with tandem Romberg. Pt had Intra-tympanic steroid injection 9/20/07. OV 11/27/07 Pt reports hearing chirping like sounds in the L ear.  No further vertigo or dizziness  Per 60 day follow up: Persistent 100% sensorineural hearing loss L ear. 1/12/2010 Complete deafness (sensor neural hearing loss and absent vestibular functions) has persisted and appears permanent.
Age: 35.0
Sex: M
Vaccine: SMALL
Symptoms: Fall, Nuclear magnetic resonance imaging brain normal, Sudden hearing loss, Vertigo
Clinical narrative: 35 y/o healthy male received Anthrax vaccine #1 and Typhoid vaccine on 16 AUG 07 without significant side effects.  On 03 SEP 07 received Small pox vaccine in left deltoid (no prior history of small pox vaccination or exposure).  On 07 SEP 07 patient experienced sudden, profound left sided sensorineural hearing loss and vertigo which has been persistent and unresponsive to high dose oral prednisone and anti-virals.  12/10/2007 MR received for OVs and audiometric testing beginning 09/03/2007 to 11/27/2007. Medical screening 9/3/07 with pt "feeling fine, no symptoms".  Smallpox vax received. Pt reported back on 9/7/07 with c/o sudden onset L sided hearing loss. No other sx other than fullness in L ear.  DX: Sensorineural Hearing Loss Asymmetrical Initially txd with prednisone and anti-virals. Seen again 9/12/07. Pt now c/o imbalance and feeling like inebriated. Meclizine Rxd for vertigo. DX as above with Sudden Hearing Loss of Unknown Etiology. OV 9/13/07 with c/o severe dizziness, nausea, vomiting, and poor po intake. OV 9/17/07 with (+) nystagmus and falls with tandem Romberg. Pt had Intra-tympanic steroid injection 9/20/07. OV 11/27/07 Pt reports hearing chirping like sounds in the L ear.  No further vertigo or dizziness  Per 60 day follow up: Persistent 100% sensorineural hearing loss L ear. 1/12/2010 Complete deafness (sensor neural hearing loss and absent vestibular functions) has persisted and appears permanent.
Age: 21.0
Sex: U
Vaccine: TD
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Muscle spasms
Clinical narrative: I received the shot on Friday and had some soreness in my left arm that night and a lot of tenderness the next day, I couldnt even lean on my arm without feeling pain.  On Sunday, I woke up feeling like every muscle in my body hurt and had a fever by that night, I also have had diarrhea, chills, a rash, tiredness, and head ache.  On Monday my fever was up to 102.  It is now over a week later (Saturday September 15th, 2007) and I still have not gotten rid of cramping and diarrhea.  I was perfectly healthy before I got the shot.  I had to leave work early on Monday because I was still too miserable to handle it.
Age: 21.0
Sex: U
Vaccine: TD
Symptoms: Myalgia, Pain in extremity, Pyrexia, Rash, Tenderness
Clinical narrative: I received the shot on Friday and had some soreness in my left arm that night and a lot of tenderness the next day, I couldnt even lean on my arm without feeling pain.  On Sunday, I woke up feeling like every muscle in my body hurt and had a fever by that night, I also have had diarrhea, chills, a rash, tiredness, and head ache.  On Monday my fever was up to 102.  It is now over a week later (Saturday September 15th, 2007) and I still have not gotten rid of cramping and diarrhea.  I was perfectly healthy before I got the shot.  I had to leave work early on Monday because I was still too miserable to handle it.
Age: 11.0
Sex: F
Vaccine: HPVX, TDAP, VARCEL
Symptoms: Asthenia, Dyskinesia, Dysphonia, Fall, Headache
Clinical narrative: Nurse had my daughter sitting on the edge of the exam table.  She administered HPV and my daughter fainted, fell off exam table head first and had a mild jerking episode.  She was pale and had a headache when she woke up.  She was hoarse and weak and couldn't speak easily.
Age: 11.0
Sex: F
Vaccine: HPVX, TDAP, VARCEL
Symptoms: Pallor, Speech disorder, Syncope
Clinical narrative: Nurse had my daughter sitting on the edge of the exam table.  She administered HPV and my daughter fainted, fell off exam table head first and had a mild jerking episode.  She was pale and had a headache when she woke up.  She was hoarse and weak and couldn't speak easily.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Hypokinesia, Injection site swelling, Paraesthesia, Skin warm
Clinical narrative: SWELLING BELOW THE INJECTION SITE THAT IS APPROX 120 MM IN CIRCUMFRANCE, HOT TO THE TOUCH AND CAUSES A DULL PAIN EVEN IF NOT COMPRESSED.  SWELLING LIMITS MOVEMENT.  PT STATES HE FEELS TINGLING IN FINGERS ON RIGHT HAND.  PT IS DEPLOYING AND HIS SYMPTOMS HAVE NOT GONE AWAY YET SO I WILL MARK NO FOR THE ANSWER TO PATIENT RECOVERED. BIOPORT CORP WAS THE MANUFACTURER.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Autoimmune disorder, Erythema, Fatigue, Hypoaesthesia, Inflammation
Clinical narrative: numbness 2 days after shot started in foot, then became general numbness, fatigue, pain, blurred vision, ringing ears, severe vertigo, redness all over body (inflammation) been almost 2 years, all symptoms have gotten worse (autoimmune) numbness started in left foot 2 days after vaccine, then over next week generalized malaise/fatigue, pain in left leg and hip, then after 1 month vision went blurry and ears started ringing and vertigo. Has been almost 2 years and all symptoms have worsened. Redness all over body, numbness all over body including head and face. Inflammation of the inner ear which is causing severe vertigo. Been to many doctors can not find anything wrong, MRI test of brain and other test all normal. This vaccines has changed my life, hopefully I will recover. Some day, doctors test did confirm I had inflammation of the inner ear.  9/18/07 Received medical records from ENT which reveals patient seen from 4/2006 through 10/2006.  Patient had received Td in 12/2005 s/p cut on arm from rusty nail.  Records reveal patient initially 4/25/06 for acute onset of dizziness which had now become daily w/variable intensity.  Had already been evaluated by 3 other doctors for problem which had begun in January, 2006. Testing revealed elevated reflex thresholds bilaterally, unequal acoustic reflexes, type A tympanograms bilaterally, COG testing revealed posterior abnormal pattern.Tx w/steroids both orally & injectable, antifungal.  Was hospitalized 5/12-5/18/2006 for w/u.  Meds were adjusted on 5/22/06 W/some improvement by 6/2/06 visit but w/low grade fever.  On 6/23/06 visit had continued low grade fever & HA.  MEds were adjusted through July, 06.  Patient underwent chelation from another MD which intially exacerated s/s & treated w/additional injectable steroids. PMH: chancre sores, genital herpes, anxiety disorder.  EBV.  Herpes zoster.  sleep disorder.   FINAL DX: post herpetic polyneuropathy; dizziness; visual disturbance; imbalance; labyrinthine hypofunction bilaterally; fatigue; anxiety; candidiasis; possible heavy metal burden; & dysautonomia.   9/25/07 Medical records from internist for 11/06 through 9/07 which reveal patient experienced vertigo, body numbness, muscle pain & blurred vision after received vax in 2005 s/p rusty nail puncture.  Symptoms seen to have worsened but MD notes are very difficult to read & unable to determine if an actual diagnosis was given.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Malaise, Pain, Tinnitus, Vertigo, Vision blurred
Clinical narrative: numbness 2 days after shot started in foot, then became general numbness, fatigue, pain, blurred vision, ringing ears, severe vertigo, redness all over body (inflammation) been almost 2 years, all symptoms have gotten worse (autoimmune) numbness started in left foot 2 days after vaccine, then over next week generalized malaise/fatigue, pain in left leg and hip, then after 1 month vision went blurry and ears started ringing and vertigo. Has been almost 2 years and all symptoms have worsened. Redness all over body, numbness all over body including head and face. Inflammation of the inner ear which is causing severe vertigo. Been to many doctors can not find anything wrong, MRI test of brain and other test all normal. This vaccines has changed my life, hopefully I will recover. Some day, doctors test did confirm I had inflammation of the inner ear.  9/18/07 Received medical records from ENT which reveals patient seen from 4/2006 through 10/2006.  Patient had received Td in 12/2005 s/p cut on arm from rusty nail.  Records reveal patient initially 4/25/06 for acute onset of dizziness which had now become daily w/variable intensity.  Had already been evaluated by 3 other doctors for problem which had begun in January, 2006. Testing revealed elevated reflex thresholds bilaterally, unequal acoustic reflexes, type A tympanograms bilaterally, COG testing revealed posterior abnormal pattern.Tx w/steroids both orally & injectable, antifungal.  Was hospitalized 5/12-5/18/2006 for w/u.  Meds were adjusted on 5/22/06 W/some improvement by 6/2/06 visit but w/low grade fever.  On 6/23/06 visit had continued low grade fever & HA.  MEds were adjusted through July, 06.  Patient underwent chelation from another MD which intially exacerated s/s & treated w/additional injectable steroids. PMH: chancre sores, genital herpes, anxiety disorder.  EBV.  Herpes zoster.  sleep disorder.   FINAL DX: post herpetic polyneuropathy; dizziness; visual disturbance; imbalance; labyrinthine hypofunction bilaterally; fatigue; anxiety; candidiasis; possible heavy metal burden; & dysautonomia.   9/25/07 Medical records from internist for 11/06 through 9/07 which reveal patient experienced vertigo, body numbness, muscle pain & blurred vision after received vax in 2005 s/p rusty nail puncture.  Symptoms seen to have worsened but MD notes are very difficult to read & unable to determine if an actual diagnosis was given.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Haematuria, Henoch-Schonlein purpura
Clinical narrative: This case was received on 05 September 2007 from another manufacturer under reference number WAES0705USA05091. The following is verbatim from that report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female with no past medical history and no illnesses treated on 20-MAR-2007 with Gardasil, first dose, intramuscularly in the left arm hepatitis A virus vaccine (unspecified), intramuscularly in the left arm, second dose (lot # AHAVB129AA) and meningococcal ACYW conj vaccine (dip toxoid), first dose intramuscularly in the right arm (lot # 42159AA) experienced Henoch-Schonlein purpura on 06-APR-2007. It was also reported that the patient had mild hematuria which subsequently resolved. The listing indicated the event required hospitalization. No further information is available." "In follow-up, identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act revealed no new information." "This is an amended report, the lot # (AGAVB129AA) was changed in the narrative to (AHAVB129AA)."
Age: 47.0
Sex: F
Vaccine: TDAP, TYP, YF, TDAP, TYP, YF, TDAP, TYP, YF
Symptoms: Gait disturbance, Guillain-Barre syndrome, Paraesthesia, Paraesthesia oral
Clinical narrative: Initial report received on 07 September 2007 from the Centers for Disease Control and Prevention as noted in the Yellow Fever Working Group Meeting Agenda dated 10 September 2007, VAERS# 288086. A 47-year-old female patient had received an injection of YF-Vax, lot number not reported; an injection of Adacel, lot number not reported; and an injection of Typhim VI, lot number not reported; on 04 June 2007. Routes and sites of administration were not reported. Sixteen days post-vaccination, the patient experienced difficulty walking, and tingling in the hands, feet, and tongue. She was subsequently hospitalized for 60 days with the diagnosis of Guillain Barre Syndrome. The patient was being followed by the Clinical Immunization Safety Network (CISA). Recovery status was not reported.
Age: 53.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Guillain-Barre syndrome
Clinical narrative: Pt. presented to ER with hx of LBP, tingling in feet / progressing to numbnesS. Dx with GBS, admitted -Rx immunoglobulin therapy. Discharged 9/10, to follow with neurology/P.T.
Age: 53.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Computerised tomogram, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture, Nuclear magnetic resonance imaging normal
Clinical narrative: Pt. presented to ER with hx of LBP, tingling in feet / progressing to numbnesS. Dx with GBS, admitted -Rx immunoglobulin therapy. Discharged 9/10, to follow with neurology/P.T.
Age: 53.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Paraesthesia, Unevaluable event
Clinical narrative: Pt. presented to ER with hx of LBP, tingling in feet / progressing to numbnesS. Dx with GBS, admitted -Rx immunoglobulin therapy. Discharged 9/10, to follow with neurology/P.T.
Age: 53.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Back pain, Computerised tomogram normal, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulins
Clinical narrative: Pt. presented to ER with hx of LBP, tingling in feet / progressing to numbnesS. Dx with GBS, admitted -Rx immunoglobulin therapy. Discharged 9/10, to follow with neurology/P.T.
Age: 53.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Pt. presented to ER with hx of LBP, tingling in feet / progressing to numbnesS. Dx with GBS, admitted -Rx immunoglobulin therapy. Discharged 9/10, to follow with neurology/P.T.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Bacteraemia, Escherichia infection, Pyrexia, Urinary tract infection
Clinical narrative: Fever up to 104-105 F for 2 days.  9/17/07 Case closed with hospital D/C summary that accompanied report.  Summary reveals patient experienced fever, vomiting, diarrhea, decreased oral intake, dehydration, anemia, irritability, increased sleepiness, & bulging fontanelle.  Admitted 8/30-9/10/2007.  Extensive w/u done & tx w/IV antibiotics.  Improved & D/C to home w/PICC line for continued IV antibiotics & additional renal w/u. FINAL DX: E.coli  UTI, pyelonephritis, bacteremia; presumed meningitis secondary to clinical diagnosis.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had a localized adverse tissue reaction to immunizations. He had redness and swelling of (R) thigh that involved 6 inches just around the injection site. Area was warm to the touch with no edema. Dr recommended Motrin and compress. Rx given for Claritin daily.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Cerebral palsy, Cough, Flushing, Hyperhidrosis, Lip swelling
Clinical narrative: Patient reports case of cerebral palsy, lower lip swelling, flushed face, + cough, nausea and fever, diaphoretic, no SOB, tachycardic, felt sick. Transferred home. Received Zyrtec and Benadryl stat.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Malaise, Nausea, Pyrexia, Tachycardia
Clinical narrative: Patient reports case of cerebral palsy, lower lip swelling, flushed face, + cough, nausea and fever, diaphoretic, no SOB, tachycardic, felt sick. Transferred home. Received Zyrtec and Benadryl stat.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Apnoea, Body temperature decreased, Cyanosis, Death, Hypothermia
Clinical narrative: This is a 7-day report. This case was unblinded, the patient received Prevnar. Information regarding Prevnar was received from an investigator regarding a 2-month-old male participant in a study who experienced death. The participant received the first dose on 30-AUG-2007. On 11-Sep-2007, the patient was found in the crib at Day Care on his back, unresponsive, blue and not breathing. Day Care workers initiated cardiopulmonary resuscitation and contacted 911 emergency response. Upon emergency medical response arrival , the child was noted to be apneic and pulseless. The patient was intubated without difficulty and cardiopulmonary resuscitation was continued. An intraosseous line was placed in the left lower extremity that was infusing well. A total of 4 doses of epinephrine were given without any response. The child remained apneic and pulseless. Upon arrival to the emergency room the child had blood pooling on the posterior back and neck area. On physical examination pupils were fixed at approximately 2-3 mm. bilaterally and no pulse was noted. The physician also noted hypothermia and stiffness. The patient was pronounced dead at 12:42 in the afternoon at the hospital. The cause of death was reported as unknown. The parents reported the child had been completely healthy up to this point. No additional information was available at the time of this report. The investigator(s) considered death possibly related to the study product. The medical monitor(s) considered death not related to the study product because temporal relationship 12 days after vaccination does not suggest causal relationship.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Musculoskeletal stiffness, Pulse absent, Pupil fixed, Resuscitation, Unresponsive to stimuli
Clinical narrative: This is a 7-day report. This case was unblinded, the patient received Prevnar. Information regarding Prevnar was received from an investigator regarding a 2-month-old male participant in a study who experienced death. The participant received the first dose on 30-AUG-2007. On 11-Sep-2007, the patient was found in the crib at Day Care on his back, unresponsive, blue and not breathing. Day Care workers initiated cardiopulmonary resuscitation and contacted 911 emergency response. Upon emergency medical response arrival , the child was noted to be apneic and pulseless. The patient was intubated without difficulty and cardiopulmonary resuscitation was continued. An intraosseous line was placed in the left lower extremity that was infusing well. A total of 4 doses of epinephrine were given without any response. The child remained apneic and pulseless. Upon arrival to the emergency room the child had blood pooling on the posterior back and neck area. On physical examination pupils were fixed at approximately 2-3 mm. bilaterally and no pulse was noted. The physician also noted hypothermia and stiffness. The patient was pronounced dead at 12:42 in the afternoon at the hospital. The cause of death was reported as unknown. The parents reported the child had been completely healthy up to this point. No additional information was available at the time of this report. The investigator(s) considered death possibly related to the study product. The medical monitor(s) considered death not related to the study product because temporal relationship 12 days after vaccination does not suggest causal relationship.
Sex: F
Vaccine: PNC
Symptoms: Deafness, Pneumococcal infection
Clinical narrative: Information regarding Prevnar was received from a  physician regarding a female patient (under 2 years of age) who experienced invasive pneumococcal disease resulting in hearing loss. The patient received a dose on an unknown date in 2007. The patient experienced invasive pneumococcal disease resulting in hearing loss on an unknown date in 2007. The serotype was unknown. The patient was hospitalized. Laboratory test results and treatments were not reported. The outcome for pneumococcal disease and hearing loss was not recovered. The events resulted in a persistent or significant disability. No additional information was available at the time of this report.
Age: 0.51
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a 6 month old female who on 27-AUG-2007 was vaccinated with her third dose of Rotateq. On 04-SEP-2007 the patient had been admitted to a local hospital for a suspected intussusception. On 05-SEP-2007 was sent to a hospital. Medical attention was sought via hospital admission. There was no product quality complaint. No further information is available.  9/18/007 Received patient demographics from CDC. 9/18/07 Received ER medical records which reveal patient experienced abdominal pain, vomiting, bloody diarrahea, lethargy w/palpable mass in left mid abdomen.  Had additional bloody diarrhea in ER.  Transferred to higher level of care. ER Dx: Intussusception.  9/27/07 Linked w/291340. 10/19/07 Reviewed vaccination record from pcp.  VAERS database updated w/same.  Records faxed to CDC. 11/2/07 Received hospital medical records which reveal patient experienced bloody stools & fever.  Admitted 9/5-9/12/2007.  IS not reducible by BE in ER & was taken to surgery for laparoscopic reduction & exp laparotomy.  Ileocecectomy performed to remove ischemic segment of cecum.  ID consult done. Did well postoperatively & d/c to home FINAL DX: Intussusception, surgically reduced.  Records faxed to CDC.
Age: 0.51
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Barium double contrast, Enema administration, Explorative laparotomy, Haematochezia
Clinical narrative: Information has been received from a physician concerning a 6 month old female who on 27-AUG-2007 was vaccinated with her third dose of Rotateq. On 04-SEP-2007 the patient had been admitted to a local hospital for a suspected intussusception. On 05-SEP-2007 was sent to a hospital. Medical attention was sought via hospital admission. There was no product quality complaint. No further information is available.  9/18/007 Received patient demographics from CDC. 9/18/07 Received ER medical records which reveal patient experienced abdominal pain, vomiting, bloody diarrahea, lethargy w/palpable mass in left mid abdomen.  Had additional bloody diarrhea in ER.  Transferred to higher level of care. ER Dx: Intussusception.  9/27/07 Linked w/291340. 10/19/07 Reviewed vaccination record from pcp.  VAERS database updated w/same.  Records faxed to CDC. 11/2/07 Received hospital medical records which reveal patient experienced bloody stools & fever.  Admitted 9/5-9/12/2007.  IS not reducible by BE in ER & was taken to surgery for laparoscopic reduction & exp laparotomy.  Ileocecectomy performed to remove ischemic segment of cecum.  ID consult done. Did well postoperatively & d/c to home FINAL DX: Intussusception, surgically reduced.  Records faxed to CDC.
Age: 0.51
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5
Symptoms: Intussusception, Surgery, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Information has been received from a physician concerning a 6 month old female who on 27-AUG-2007 was vaccinated with her third dose of Rotateq. On 04-SEP-2007 the patient had been admitted to a local hospital for a suspected intussusception. On 05-SEP-2007 was sent to a hospital. Medical attention was sought via hospital admission. There was no product quality complaint. No further information is available.  9/18/007 Received patient demographics from CDC. 9/18/07 Received ER medical records which reveal patient experienced abdominal pain, vomiting, bloody diarrahea, lethargy w/palpable mass in left mid abdomen.  Had additional bloody diarrhea in ER.  Transferred to higher level of care. ER Dx: Intussusception.  9/27/07 Linked w/291340. 10/19/07 Reviewed vaccination record from pcp.  VAERS database updated w/same.  Records faxed to CDC. 11/2/07 Received hospital medical records which reveal patient experienced bloody stools & fever.  Admitted 9/5-9/12/2007.  IS not reducible by BE in ER & was taken to surgery for laparoscopic reduction & exp laparotomy.  Ileocecectomy performed to remove ischemic segment of cecum.  ID consult done. Did well postoperatively & d/c to home FINAL DX: Intussusception, surgically reduced.  Records faxed to CDC.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Drug screen positive, Laboratory test, Smear cervix, Substance abuse
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female with a history of drug abuse who on 07-AUG-2006 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (Lot #653937/0637F). On 11-OCT-2006 the patient was vaccinated with a second dose of Gardasil. On 16-APR-2007 the patient was vaccinated with a third dose of Gardasil. Concomitant therapy included prenatal vitamins (unspecified). Subsequently the patient became pregnant. The patient's last menstrual period was on 11-JUN-2007 and the estimated date of delivery was 17-MAR-2008. On unspecified dates a urine drug screen, ultrasound, pap test, and a prenatal screen was performed. The patient contacted the physician by telephone. On 09-JUL-2007 the patient was hospitalized for substance abuse. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female with a history of drug abuse who on 07-AUG-2006 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (Lot #653937/0637F). On 11-OCT-2006 the patient was vaccinated with a second dose of Gardasil. On 16-APR-2007 the patient was vaccinated with a third dose of Gardasil. Concomitant therapy included prenatal vitamins (unspecified). Subsequently the patient became pregnant. The patient's last menstrual period was on 11-JUN-2007 and the estimated date of delivery was 17-MAR-2008. On unspecified dates a urine drug screen, ultrasound, pap test, and a prenatal screen was performed. The patient contacted the physician by telephone. On 09-JUL-2007 the patient was hospitalized for substance abuse. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Antinuclear antibody, Blood creatine phosphokinase increased, Computerised tomogram, Dysarthria, Dysphagia
Clinical narrative: Initial report received on 23 April 2007 from an investigator participating in the above-mentioned trial in the United States under the reference number FIM05. An 83-year-old male subject developed myasthenia gravis approximately one month after he had received a first, intramuscular, left deltoid dose of study vaccine FLUZONE (lot number not reported), on 14 October 2006. The subject had relevant past medical history of fatigue (2005) and ocular hypertension. Sometime in November 2006, approximately one month post-vaccination, the subject began having bilateral facial weakness, difficulty swallowing both liquids and solids, and difficulty articulating his words. He was diagnosed with myasthenia gravis. The subject had a radiographic swallowing study that was normal. An MRI of the brain on 30 November 2006 showed normal brain with mild atrophic changes commensurate with age, thickening of the transverse ligament compatible with inflammatory arthropathies, and no flattening of the cervical medullary junction. On 02 December 2006 and MRI of the cervical spine showed diffuse degenerative disc and vertebral disease changes at the cervical spine with mild central stenosis involving C3-4 through C6-7 levels. There was multilevel asymetric foraminal narrowing and abundant pannus formation about the dens. An Esophagram on 15 December 2006 was normal. On 20 December 2006 EMG and nerve conduction studies showed abnormalities that were not specific for nerve, neuromuscular junction, or muscle disease. Diagnostic laboratory data on 02 January 2007 showed creatine kinase level of 36 (normal range 24-26), and elevated acetylcholine receptor antibody levels of 8.4 (normal range 0.00-0.24). On 18 January 2007, the subject was evaluated by neurology and started on Mestinon. A CAT scan of the chest was ordered along with thyroid panel, serum B12, methylmalonics acid, and ANA (results not reported). The subject continues to progress "well" and is being followed by neurology. The subject did not recovered, but has continued in the study trial. According to the investigator, the event of myasthenia gravis is related to the study vaccine, but not to the concomitant medications. Document held by sender: Neurology doctor notes, EMG and nerve conduction study results. Unblinding information received on 31 August 2007. The subject received Fluzone.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Electromyogram abnormal, Facial paresis, Laboratory test, Laboratory test abnormal, Myasthenia gravis
Clinical narrative: Initial report received on 23 April 2007 from an investigator participating in the above-mentioned trial in the United States under the reference number FIM05. An 83-year-old male subject developed myasthenia gravis approximately one month after he had received a first, intramuscular, left deltoid dose of study vaccine FLUZONE (lot number not reported), on 14 October 2006. The subject had relevant past medical history of fatigue (2005) and ocular hypertension. Sometime in November 2006, approximately one month post-vaccination, the subject began having bilateral facial weakness, difficulty swallowing both liquids and solids, and difficulty articulating his words. He was diagnosed with myasthenia gravis. The subject had a radiographic swallowing study that was normal. An MRI of the brain on 30 November 2006 showed normal brain with mild atrophic changes commensurate with age, thickening of the transverse ligament compatible with inflammatory arthropathies, and no flattening of the cervical medullary junction. On 02 December 2006 and MRI of the cervical spine showed diffuse degenerative disc and vertebral disease changes at the cervical spine with mild central stenosis involving C3-4 through C6-7 levels. There was multilevel asymetric foraminal narrowing and abundant pannus formation about the dens. An Esophagram on 15 December 2006 was normal. On 20 December 2006 EMG and nerve conduction studies showed abnormalities that were not specific for nerve, neuromuscular junction, or muscle disease. Diagnostic laboratory data on 02 January 2007 showed creatine kinase level of 36 (normal range 24-26), and elevated acetylcholine receptor antibody levels of 8.4 (normal range 0.00-0.24). On 18 January 2007, the subject was evaluated by neurology and started on Mestinon. A CAT scan of the chest was ordered along with thyroid panel, serum B12, methylmalonics acid, and ANA (results not reported). The subject continues to progress "well" and is being followed by neurology. The subject did not recovered, but has continued in the study trial. According to the investigator, the event of myasthenia gravis is related to the study vaccine, but not to the concomitant medications. Document held by sender: Neurology doctor notes, EMG and nerve conduction study results. Unblinding information received on 31 August 2007. The subject received Fluzone.