chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site irritation, Injection site pain, Musculoskeletal pain, Nausea, Neck pain
Clinical narrative: This 41 year old reported receipt of first Anthrax vaccine 26 Nov 2002 with complaints of burning, sore to his left arm, and site redness that lasted a couple of days.  His second AVA vaccine was given 23 Dec 2002 had similar complaints of site redness, soreness, however he experienced an acute onset of chest heaviness and shortness of breath while driving in traffic. He stated he had to pull off the road and calm himself down. He admitted to some nausea with radiating left arm, neck, jaw and substernal-left shoulder chest pain 5-6/10 pain scale. He described as a sharp pain 2 hours post vaccination with lasting 20+ minutes changing to a dull pain for next several hours. He remembers touching his AVA site noting increasing pain to chest so assumed it was radiating pain and not cardiac related. Position did not affect chest pain, but movement aggravated. No medical care was sought.  He received his third AVA vaccination 13 Jan 2003 with similar site burning, but worsening site redness and tenderness. Approximately 1-2 hours later he experienced reoccurring midsternal chest pain with shortness of breath 3/10 pain scale that was sharp and lasted about 30 -120 minutes. Position did not affect his pain, but rest did help resolve. Again, since he'd had similar chest pain with previous AVA, he again assumed vaccine related and non-cardiac in origin.  He did not seek medical care.  He received his fourth AVA vaccination 24 Nov 2003 with complaints of increasing site redness and tenderness (worse than previous 3 vaccinations) localized to deltoid region of left arm. He did not experience any chest pain.  He received his fifth AVA 01 Nov 2006 again to the left deltoid with immediate site burning, soreness, redness, and now immediate chest pain with shortness of breath. His appearance changed as patient asked if he was okay. He admitted to chest pain with shortness of breath but told patient he was fine as this had happened after previous AVA vaccines. He sat in the clinic for approximately 20 minutes until symptoms resolved. He quantified the pain on a 5/10 scale similar to initial chest pain following AVA #2 with radiating symptoms to neck, jaw, left arm, nausea w/o vomiting and mildly diaphoretic. No medical care was sought and no reoccurrence of symptoms since.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Pain in extremity, Pain in jaw
Clinical narrative: This 41 year old reported receipt of first Anthrax vaccine 26 Nov 2002 with complaints of burning, sore to his left arm, and site redness that lasted a couple of days.  His second AVA vaccine was given 23 Dec 2002 had similar complaints of site redness, soreness, however he experienced an acute onset of chest heaviness and shortness of breath while driving in traffic. He stated he had to pull off the road and calm himself down. He admitted to some nausea with radiating left arm, neck, jaw and substernal-left shoulder chest pain 5-6/10 pain scale. He described as a sharp pain 2 hours post vaccination with lasting 20+ minutes changing to a dull pain for next several hours. He remembers touching his AVA site noting increasing pain to chest so assumed it was radiating pain and not cardiac related. Position did not affect chest pain, but movement aggravated. No medical care was sought.  He received his third AVA vaccination 13 Jan 2003 with similar site burning, but worsening site redness and tenderness. Approximately 1-2 hours later he experienced reoccurring midsternal chest pain with shortness of breath 3/10 pain scale that was sharp and lasted about 30 -120 minutes. Position did not affect his pain, but rest did help resolve. Again, since he'd had similar chest pain with previous AVA, he again assumed vaccine related and non-cardiac in origin.  He did not seek medical care.  He received his fourth AVA vaccination 24 Nov 2003 with complaints of increasing site redness and tenderness (worse than previous 3 vaccinations) localized to deltoid region of left arm. He did not experience any chest pain.  He received his fifth AVA 01 Nov 2006 again to the left deltoid with immediate site burning, soreness, redness, and now immediate chest pain with shortness of breath. His appearance changed as patient asked if he was okay. He admitted to chest pain with shortness of breath but told patient he was fine as this had happened after previous AVA vaccines. He sat in the clinic for approximately 20 minutes until symptoms resolved. He quantified the pain on a 5/10 scale similar to initial chest pain following AVA #2 with radiating symptoms to neck, jaw, left arm, nausea w/o vomiting and mildly diaphoretic. No medical care was sought and no reoccurrence of symptoms since.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Balance disorder, CSF protein increased, Diplopia, Dizziness
Clinical narrative: Patient present to ECC with 2 day history of diplopia, dysequilibrium, headache, bad taste in mouth, upper extremity paresthesias and weakness, vertigo/dizziness.  Determined to have acute diffuse ocular motor palsy.  Over several days/weeks his ataxia an paresthesias worsen. Progression to worsening weakness, unable to open eyes, difficulty swallowing, descending paralysis. Many differential diagnosis ruled out via consult, lab work, imaging and physical exam.  Determined to have the Miller-Fisher variant of Guillain-Barre. Treated with plasmapheresis x6 treatments. Symptoms improve but patient continued to have issues with vision, speech, swallowing and weakness. Send to rehab for intensive physical, occupational and speech therapy. Patient continued to improve and was sent home to continue outpatient rehab. 1/15/08-records received for DOS 11/5-11/23/07-DC DX: Miller Fisher syndrome with ophthalmoplegia/ataxia/dysphagia. Presented to ED on 11/2/07 with C/P diplopia and ataxia.  Flu shot 10 days prior to onset of symptomalogy. After admission symptoms worsened and developed ophthalmopelgia, difficulty swallowing and clearing his secretions.  PEG placed.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Dysgeusia, Dysphagia, Eye movement disorder, Headache, IIIrd nerve paralysis
Clinical narrative: Patient present to ECC with 2 day history of diplopia, dysequilibrium, headache, bad taste in mouth, upper extremity paresthesias and weakness, vertigo/dizziness.  Determined to have acute diffuse ocular motor palsy.  Over several days/weeks his ataxia an paresthesias worsen. Progression to worsening weakness, unable to open eyes, difficulty swallowing, descending paralysis. Many differential diagnosis ruled out via consult, lab work, imaging and physical exam.  Determined to have the Miller-Fisher variant of Guillain-Barre. Treated with plasmapheresis x6 treatments. Symptoms improve but patient continued to have issues with vision, speech, swallowing and weakness. Send to rehab for intensive physical, occupational and speech therapy. Patient continued to improve and was sent home to continue outpatient rehab. 1/15/08-records received for DOS 11/5-11/23/07-DC DX: Miller Fisher syndrome with ophthalmoplegia/ataxia/dysphagia. Presented to ED on 11/2/07 with C/P diplopia and ataxia.  Flu shot 10 days prior to onset of symptomalogy. After admission symptoms worsened and developed ophthalmopelgia, difficulty swallowing and clearing his secretions.  PEG placed.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test, Lumbar puncture abnormal, Miller Fisher syndrome, Paraesthesia, Paralysis
Clinical narrative: Patient present to ECC with 2 day history of diplopia, dysequilibrium, headache, bad taste in mouth, upper extremity paresthesias and weakness, vertigo/dizziness.  Determined to have acute diffuse ocular motor palsy.  Over several days/weeks his ataxia an paresthesias worsen. Progression to worsening weakness, unable to open eyes, difficulty swallowing, descending paralysis. Many differential diagnosis ruled out via consult, lab work, imaging and physical exam.  Determined to have the Miller-Fisher variant of Guillain-Barre. Treated with plasmapheresis x6 treatments. Symptoms improve but patient continued to have issues with vision, speech, swallowing and weakness. Send to rehab for intensive physical, occupational and speech therapy. Patient continued to improve and was sent home to continue outpatient rehab. 1/15/08-records received for DOS 11/5-11/23/07-DC DX: Miller Fisher syndrome with ophthalmoplegia/ataxia/dysphagia. Presented to ED on 11/2/07 with C/P diplopia and ataxia.  Flu shot 10 days prior to onset of symptomalogy. After admission symptoms worsened and developed ophthalmopelgia, difficulty swallowing and clearing his secretions.  PEG placed.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Physical examination, Speech disorder, Vertigo
Clinical narrative: Patient present to ECC with 2 day history of diplopia, dysequilibrium, headache, bad taste in mouth, upper extremity paresthesias and weakness, vertigo/dizziness.  Determined to have acute diffuse ocular motor palsy.  Over several days/weeks his ataxia an paresthesias worsen. Progression to worsening weakness, unable to open eyes, difficulty swallowing, descending paralysis. Many differential diagnosis ruled out via consult, lab work, imaging and physical exam.  Determined to have the Miller-Fisher variant of Guillain-Barre. Treated with plasmapheresis x6 treatments. Symptoms improve but patient continued to have issues with vision, speech, swallowing and weakness. Send to rehab for intensive physical, occupational and speech therapy. Patient continued to improve and was sent home to continue outpatient rehab. 1/15/08-records received for DOS 11/5-11/23/07-DC DX: Miller Fisher syndrome with ophthalmoplegia/ataxia/dysphagia. Presented to ED on 11/2/07 with C/P diplopia and ataxia.  Flu shot 10 days prior to onset of symptomalogy. After admission symptoms worsened and developed ophthalmopelgia, difficulty swallowing and clearing his secretions.  PEG placed.
Age: 1.67
Sex: F
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Cellulitis, Erythema, Injection site rash, Pyrexia, Skin warm
Clinical narrative: Pt was given Pediarix and Hep A vaccinations on 1/7/08; were given in her right thigh.  Redness and warmth to the touch began thereafter; pt re-examined on 1/9/08 and at that point, she had a normal temperature in our office and a 2-3 inch (diameter) erythematous, slightly raised, rash localized circumferentially around the injection sites.  Pt was diagnosed with Cellulitis of Leg and Immunization Reaction--told to use warm or cool compresses, Tylenol for pain.  Advised that this reaction was not uncommon with Pediarix.  Advised to follow-up with any high fever/streaking/spreading of the rash.
Age: 1.67
Sex: F
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Urticaria
Clinical narrative: Pt was given Pediarix and Hep A vaccinations on 1/7/08; were given in her right thigh.  Redness and warmth to the touch began thereafter; pt re-examined on 1/9/08 and at that point, she had a normal temperature in our office and a 2-3 inch (diameter) erythematous, slightly raised, rash localized circumferentially around the injection sites.  Pt was diagnosed with Cellulitis of Leg and Immunization Reaction--told to use warm or cool compresses, Tylenol for pain.  Advised that this reaction was not uncommon with Pediarix.  Advised to follow-up with any high fever/streaking/spreading of the rash.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Dysphagia, Flushing, Injection site pruritus
Clinical narrative: Patient states on 12//17/07 approximately 8:30 AM the injection site began to itch and swell.  By 6:00 PM, she felt flushed from her chest to her neck, weak, dizzy and had difficulty swallowing.  She took 50 mg Benadryl and called the paramedics who advised ER visit.  She was seen at hospital, given Claritin and Prednisone but still symptomatic
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Patient states on 12//17/07 approximately 8:30 AM the injection site began to itch and swell.  By 6:00 PM, she felt flushed from her chest to her neck, weak, dizzy and had difficulty swallowing.  She took 50 mg Benadryl and called the paramedics who advised ER visit.  She was seen at hospital, given Claritin and Prednisone but still symptomatic
Age: 9.0
Sex: M
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Onset redness at sight of SQ varicella inj (warm to touch) - 12/28/07.  Cont.  redness increasing in size with swelling approx size 11.5 cm x 14.5 cm.  Seen by Dr. on 12/31/07.  Placed on Keflex 500 tid.  1/1/08 symptoms resolving per patient mom.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: Shaky Malaise Swelling/erythema/induration at site ( 6x8 cm) Lymph node swelling/tenderness ( 2 cm) brachial/axillary
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Malaise, Tremor
Clinical narrative: Shaky Malaise Swelling/erythema/induration at site ( 6x8 cm) Lymph node swelling/tenderness ( 2 cm) brachial/axillary
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Crying, Muscle spasms
Clinical narrative: 120 mins after vaccination now returned to clinic. Patient has been crying at daycare. Patient was crying (very hard) and seemed to be having rotating spasms of calf. Very dramatic. It came in waves, with apprehension. Ice packs seemed to help. Refer -> local ER
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Varicella Zostr (L) U.E.
Age: 0.6
Sex: M
Vaccine: DTAP, FLU3, HIBV, IPV, PNC
Symptoms: Injection site induration, Injection site rash
Clinical narrative: Rash and hard bump on left thigh
Age: 1.4
Sex: M
Vaccine: FLU3, HIBV, MMR, PNC, VARCEL
Symptoms: Blister, Food allergy, Rash
Clinical narrative: Rash around mouth and trunk.  Rash on right leg with blistering x approx. 3 days.  Pt had egg allergy causing allergic rash.  Prescribed Benadryl 6 mg by mouth every 6 hours and hydrocortisone 1% cream twice a day as needed.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient received varicella vaccine: 1) 12/11/04; 2) 11/29/07; 3) 1/14/08
Age: 0.8
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: Rotateq vaccine inappropriately administered at 40 weeks of age.  100.4 fever reporter by mom the day after vaccine administration.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hypotension, Syncope
Clinical narrative: Patient fainted in waiting room while checking out after receiving first guardasil vaccination.  Treated with observation and remaining supine with monitoring of vital signs - was alert/oriented and vital signs stable - observed about 45 min to one hour as she was dizzy also up until about 45 minutes after the event.  Mildly hypotensive.
Age: 10.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, VARCEL
Symptoms: Induration, Skin warm, Tenderness
Clinical narrative: 2 inch x 3 inch red indurated area back of right arm.  Warm & tender.  Treatment ice, Benadryl 25 mg orally at bedtime, Benadryl gel topically during school.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Blood pressure, Heart rate, Lethargy
Clinical narrative: Vaccines administered to client on 11/27/07 at 11:30 am.  Client appeared lethargic but was responsive.  Ammonia inhalant administered with immediate response from client.  BP & pulse taken.  911 phoned.  Fire dept. assessed client.  Client appeared okay and left the clinic walking and talking.  Mom states client did not eat breakfast.  (never unconscious)
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Pharyngolaryngeal pain, Respiratory tract congestion
Clinical narrative: C/O sore throat, congestion, and cough - Improved but still with cough.  No fever.
Age: 16.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Auricular swelling, Blister, Dizziness, Rash generalised, Swelling face
Clinical narrative: 11/7/07-had wheezing after vaccine after leaving clinic.  11/13/07-face & ears swollen with blisters, rash over body, wheezing, dizziness, blurred vision, mom took to ER.  11/15/07-wheezing, face swollen, back to ER.  Back to school 11/19/07.
Age: 16.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Vision blurred, Wheezing
Clinical narrative: 11/7/07-had wheezing after vaccine after leaving clinic.  11/13/07-face & ears swollen with blisters, rash over body, wheezing, dizziness, blurred vision, mom took to ER.  11/15/07-wheezing, face swollen, back to ER.  Back to school 11/19/07.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Pruritus
Clinical narrative: Redness around injection site, rash developed.  Client c/o itching without relief after taking Benadryl.  Saw MD 11-15-07, gave him a shot for itching and a Rx for Motrin & Benadryl.
Age: 1.0
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Injection site rash
Clinical narrative: RASH and BUMPS AROUND SITE; no Temperature
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Blister, Rash
Clinical narrative: On 1-2-08 woke up with rash & got worse throughout the day.  Rash was small red spots/blisters.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Varicella
Clinical narrative: Rash
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Red, raised area the size of fifty cent piece, to right upper arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Pain, Pruritus, Skin warm
Clinical narrative: 9cmx9cm area erythema with itching, hot, painful
Age: 1.1
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Fever, red bump on thigh
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Erythema, Influenza like illness, Malaise, Rash
Clinical narrative: Patient's mother reports that she noticed "Non-Raised" Red Rash Started on patient's Torso, with patient feeling general malaise, flu-like symptoms - took child to their Pediatrician no other treatment given
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: 1 day after Gardasil injection, fever of 104.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Inflammation, Oedema peripheral, Pain, Skin warm
Clinical narrative: Patient complained of increasing pain after vaccine. Waited 2 days and pain continued to increase. By third day, she noticed swelling of right arm, tender to touch, erythema: area was hot/inflamed. Treatment: Rocephin 1 gram left buttock; Augmentin 875mg twice a day for 7 days
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: Patient complained of increasing pain after vaccine. Waited 2 days and pain continued to increase. By third day, she noticed swelling of right arm, tender to touch, erythema: area was hot/inflamed. Treatment: Rocephin 1 gram left buttock; Augmentin 875mg twice a day for 7 days
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Swelling
Clinical narrative: Swelling and pain (Left axillary) ice - Motrin 600 mg 6-8 hours for 3-4 days.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Rash macular
Clinical narrative: Rash on neck and upper back, started 1-3-08 after Tdap vaccination.  Flat macules on upper chest/back.  Rash not pruritic, no histaminic flushing of cheeks.  Rash does not appear to be urticarial.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Headache, Nausea, Stomach discomfort
Clinical narrative: Patient reports headache, nausea stomach upset along with weakness seen at "medical center" 11/19/07 - Reports M.D. said unsure if reaction from flu and patient was released; 12/20/07 F/U all made and patient fully recovered.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Physical examination
Clinical narrative: Developed genital warts for 2 weeks.  Rx: Aldara 5% cream 3 times a week for 6 weeks.  Dermatologic.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: My right arm was sore I could Raised up to put my clothing on. I had put hot towels on it for three days, and take pain pills
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema
Clinical narrative: Redness to (R) arm - approx. 4cm
Sex: U
Vaccine: UNK
Symptoms: Dysphonia, Ear discomfort, Laryngitis, Malaise, Pharyngolaryngeal pain
Clinical narrative: This was Oct. 9. I got very sick. Sore throat, fever, laryngitis. I was sick a month. My ear is still stopped up, and I am still hoarse -and I don't get sick. Haven't had a flu in 15 years or so.
Sex: U
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: This was Oct. 9. I got very sick. Sore throat, fever, laryngitis. I was sick a month. My ear is still stopped up, and I am still hoarse -and I don't get sick. Haven't had a flu in 15 years or so.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Client received Influenza vaccine 10/29/07.  Reported to HD 11/7/07 after office visit with MD.  Stated she started with rash on her abdomen 11/2/07 that looks like small mosquito bites.  Continued to spread.  Hives type rash noted on abdomen and pelvic area today with itching.  Was put on Medical Doze Pack by MD.  Denies allergies to eggs.  Client to discuss with her allergist prior to next flu shot.
Age: 21.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Tetanus injection site red, swollen, warm to touch, Donor went to her Doctor - Antibiotic prescribed
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Hives on body began in evening after vaccine given in the afternoon. Hives persist as of 1/7/08.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia, Induration, Injected limb mobility decreased, Pain in extremity, Skin warm
Clinical narrative: (R) arm painful/numb. Hot, hard lump. Unable to lift arm.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Impetigo, Varicella
Clinical narrative: Patient received varicella vaccine 12/6/07, seen 12/26/07 and diagnosed with varicella head to toe lesions. Seen again 12/28/07 and treated for Impetigo.
Age: 67.0
Sex: F
Vaccine: TD
Symptoms: Oedema peripheral, Pain
Clinical narrative: Injection given left upper arm 10/9/07. Area developed large painful lump, arm swollen and remains swollen and painful with residual lump still present 12/10/07. Pt ordered for arm physical therapy.
Age: 33.0
Sex: M
Vaccine: HEPA
Symptoms: Medication error
Clinical narrative: Nurse administered hepatitis A intra-nasal when should have been given intra-muscular.  The patient was to receive a flu mist vaccine that is given intra-nasal.
Age: 45.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect route of drug administration
Clinical narrative: RN administered hepatitis A intra-nasal when should have been given intra-muscular. The patient was to receive a FluMist vaccine that is given intra-nasal.
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect route of drug administration, Rhinalgia
Clinical narrative: RN administered hepatitis A intranasal when should have been given intra-muscular.  The patient was to receive a FluMist vaccine that is given intra-nasal.  Patient states that her nose is sore but is not having any other problems.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Body temperature increased
Clinical narrative: Temp 104 F - axillary. No further pertussis vaccine.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Body temperature increased, Diarrhoea, Vomiting
Clinical narrative: Day after vaccine, had 6 days have low-grade temp (max 99.1), vomiting, diarrhea, epigastric pain.
Age: 17.0
Sex: F
Vaccine: HPVX
Symptoms: Contusion, Platelet count decreased, Platelet transfusion, Thrombocytopenia
Clinical narrative: 1-2-08-Diag. with thrombocytopenia, platelet count dropped to 8000.  Plt transfusion x2.  Easy bruising began Nov. 07. 1/16/08-records received for DOS 1/4/08-consultation for C/O headache since 1/3/08 now improved-admitted on 1/3/08-with easy bruising and platelet count of 7000. No other systemic symptoms. While receiving treatment with IV gamma globulin, C/O severe headache, throbbing with sensitive to bright lights and some nausea. Saw spots in her eyes. Denies neck stiffness, but has some mild neck discomfort.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 2 mos old infant received 1st Hib vaccine at 930 AM 1/10/08. Pt present 5 hours later, crying, inconsolable with 5x5cm area of swelling, redness, increased warmth around injection site. Treated with ice and Tylenol.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Febrile convulsion
Clinical narrative: Patient developed febrile seizure about 11 hours after administration of immunization and was brought to medical center.
Age: 1.3
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Blood test, Chest X-ray, Culture urine, Febrile convulsion, Pyrexia
Clinical narrative: Febrile seizure - fever 103
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: 11-9-07 AM shot for flu - at injection felt as if given a double dose. Got sore that day. Next morn could not raise arm to side up. Back to doctor, given large dose of pain med. Didn't stop pain. Arm still in pain. As of 1-2-08 Arm still sore small amt of pain, but arm still not able to raise up to side or back without pain.
Age: 1.3
Sex: F
Vaccine: DTAP, FLU3, IPV
Symptoms: Blood test normal, Chest X-ray normal, Cough, Pyrexia, X-ray normal
Clinical narrative: Fever/cough (mother insist symptoms were from flu shot)
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Syncope
Clinical narrative: Client states she felt "very hot" after vaccination and then fainted.  Client felt fine within several minutes.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Rash vesicular
Clinical narrative: Within 6 hours, pt had "chicken pox" like lesions on (L) arm - 2x3" area around needle site. In the AM - the rash had moved  to elbow. Needle site redness was quarter size reddened area and very tender. Today, a small redness still appears.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Abdominal pain, Barium double contrast, Blood albumin decreased, Blood creatinine normal, Blood glucose increased
Clinical narrative: A serious report of Henoch-Schonlein purpura and intussusception, status post reduction was received from a study investigator concerning a four-year-old male, who is enrolled in a trial. The patient had a medical history that consisted of episodes of bright red blood in the stool which occurred on 18-Oct-2007; bilateral pedal edema and macular rash over the lower extremities and buttocks for which he was seen in the emergency room on 25-Nov-2007. Concomitant medications were not reported. The subject received FluMist intranasally on 10-Nov-2007 for influenza immunization. On 25-Nov-2007, the subject was seen in the emergency room for bilateral foot swelling/pain with a rash that spread from feet to groin. Physical examination confirmed bilateral pedal edema and macular rash over his lower extremities and buttocks. Laboratory evaluation which consisted of sedimentation rate, complete blood count (CBC) with differential, liver function enzymes, blood urea nitrogen (BUN), urine analysis were within normal values. Impression was that of hypersensitivity vasculitis. A diagnosis of Henoch-Schonlein purpura was made on 26-Nov-2007 when he was re-evaluated for his rash. From 01-Dec-2007 to 02-Dec-2007, he was hospitalized for abdominal pain and vomiting secondary to Henoch-Schonlein purpura. Ultrasound and gastrografin enema were negative for intussusception and other pathology. His laboratory results were normal except for his white blood cells (WBC) count of 13.7 and a 4+ ketones in his urine on admission. His discharge diagnoses were : Henoch-Schonlein purpura, and abdominal pain and dehydration. He was re-hospitalized from 08-Dec-2007 to 10-Dec-2007 because of blood in the stools, severe abdominal pain and bilious emesis. An air enema revealed intussusception in the upper part of the ascending colon which resolved during the procedure. Abnormal laboratory results include : WBC= 22.1; red blood cell (RBC) count = 6.01; hemoglobin = 14.9; hematocrit; platelet = 508; granulocyte = 851; lymphocyte; serum glucose = 140; serum creatinine = 0.11; serum sodium = 131; serum potassium = 5.6; serum albumin = 3.5; urinalysis showed protein = 30, 1+ blood. RBC = 3.9, ccasional mucous and amorphous crystals. He was observed for three days without complications except for one episode of painless bloody stool. His discharge diagnoses were Henoch-Schonlein purpura and intussusception, reduced. The subject was discharged home on prednisolone 15 mg twice daily for three days followed by a tapering regimen over six days, and lansoprazole 15 mg daily. The subject recovered from both events. The subject did not experience a rechallenge while receiving the study vaccine. The investigator assessed causality for the events as not related to FluMist.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Blood potassium increased, Blood sodium decreased, Blood urea normal, Blood urine present, Dehydration
Clinical narrative: A serious report of Henoch-Schonlein purpura and intussusception, status post reduction was received from a study investigator concerning a four-year-old male, who is enrolled in a trial. The patient had a medical history that consisted of episodes of bright red blood in the stool which occurred on 18-Oct-2007; bilateral pedal edema and macular rash over the lower extremities and buttocks for which he was seen in the emergency room on 25-Nov-2007. Concomitant medications were not reported. The subject received FluMist intranasally on 10-Nov-2007 for influenza immunization. On 25-Nov-2007, the subject was seen in the emergency room for bilateral foot swelling/pain with a rash that spread from feet to groin. Physical examination confirmed bilateral pedal edema and macular rash over his lower extremities and buttocks. Laboratory evaluation which consisted of sedimentation rate, complete blood count (CBC) with differential, liver function enzymes, blood urea nitrogen (BUN), urine analysis were within normal values. Impression was that of hypersensitivity vasculitis. A diagnosis of Henoch-Schonlein purpura was made on 26-Nov-2007 when he was re-evaluated for his rash. From 01-Dec-2007 to 02-Dec-2007, he was hospitalized for abdominal pain and vomiting secondary to Henoch-Schonlein purpura. Ultrasound and gastrografin enema were negative for intussusception and other pathology. His laboratory results were normal except for his white blood cells (WBC) count of 13.7 and a 4+ ketones in his urine on admission. His discharge diagnoses were : Henoch-Schonlein purpura, and abdominal pain and dehydration. He was re-hospitalized from 08-Dec-2007 to 10-Dec-2007 because of blood in the stools, severe abdominal pain and bilious emesis. An air enema revealed intussusception in the upper part of the ascending colon which resolved during the procedure. Abnormal laboratory results include : WBC= 22.1; red blood cell (RBC) count = 6.01; hemoglobin = 14.9; hematocrit; platelet = 508; granulocyte = 851; lymphocyte; serum glucose = 140; serum creatinine = 0.11; serum sodium = 131; serum potassium = 5.6; serum albumin = 3.5; urinalysis showed protein = 30, 1+ blood. RBC = 3.9, ccasional mucous and amorphous crystals. He was observed for three days without complications except for one episode of painless bloody stool. His discharge diagnoses were Henoch-Schonlein purpura and intussusception, reduced. The subject was discharged home on prednisolone 15 mg twice daily for three days followed by a tapering regimen over six days, and lansoprazole 15 mg daily. The subject recovered from both events. The subject did not experience a rechallenge while receiving the study vaccine. The investigator assessed causality for the events as not related to FluMist.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Differential white blood cell count normal, Full blood count normal, Haematochezia, Haematocrit increased, Haemoglobin increased
Clinical narrative: A serious report of Henoch-Schonlein purpura and intussusception, status post reduction was received from a study investigator concerning a four-year-old male, who is enrolled in a trial. The patient had a medical history that consisted of episodes of bright red blood in the stool which occurred on 18-Oct-2007; bilateral pedal edema and macular rash over the lower extremities and buttocks for which he was seen in the emergency room on 25-Nov-2007. Concomitant medications were not reported. The subject received FluMist intranasally on 10-Nov-2007 for influenza immunization. On 25-Nov-2007, the subject was seen in the emergency room for bilateral foot swelling/pain with a rash that spread from feet to groin. Physical examination confirmed bilateral pedal edema and macular rash over his lower extremities and buttocks. Laboratory evaluation which consisted of sedimentation rate, complete blood count (CBC) with differential, liver function enzymes, blood urea nitrogen (BUN), urine analysis were within normal values. Impression was that of hypersensitivity vasculitis. A diagnosis of Henoch-Schonlein purpura was made on 26-Nov-2007 when he was re-evaluated for his rash. From 01-Dec-2007 to 02-Dec-2007, he was hospitalized for abdominal pain and vomiting secondary to Henoch-Schonlein purpura. Ultrasound and gastrografin enema were negative for intussusception and other pathology. His laboratory results were normal except for his white blood cells (WBC) count of 13.7 and a 4+ ketones in his urine on admission. His discharge diagnoses were : Henoch-Schonlein purpura, and abdominal pain and dehydration. He was re-hospitalized from 08-Dec-2007 to 10-Dec-2007 because of blood in the stools, severe abdominal pain and bilious emesis. An air enema revealed intussusception in the upper part of the ascending colon which resolved during the procedure. Abnormal laboratory results include : WBC= 22.1; red blood cell (RBC) count = 6.01; hemoglobin = 14.9; hematocrit; platelet = 508; granulocyte = 851; lymphocyte; serum glucose = 140; serum creatinine = 0.11; serum sodium = 131; serum potassium = 5.6; serum albumin = 3.5; urinalysis showed protein = 30, 1+ blood. RBC = 3.9, ccasional mucous and amorphous crystals. He was observed for three days without complications except for one episode of painless bloody stool. His discharge diagnoses were Henoch-Schonlein purpura and intussusception, reduced. The subject was discharged home on prednisolone 15 mg twice daily for three days followed by a tapering regimen over six days, and lansoprazole 15 mg daily. The subject recovered from both events. The subject did not experience a rechallenge while receiving the study vaccine. The investigator assessed causality for the events as not related to FluMist.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Henoch-Schonlein purpura, Intussusception, Leukocytoclastic vasculitis, Liver function test normal, Lymphocyte percentage decreased
Clinical narrative: A serious report of Henoch-Schonlein purpura and intussusception, status post reduction was received from a study investigator concerning a four-year-old male, who is enrolled in a trial. The patient had a medical history that consisted of episodes of bright red blood in the stool which occurred on 18-Oct-2007; bilateral pedal edema and macular rash over the lower extremities and buttocks for which he was seen in the emergency room on 25-Nov-2007. Concomitant medications were not reported. The subject received FluMist intranasally on 10-Nov-2007 for influenza immunization. On 25-Nov-2007, the subject was seen in the emergency room for bilateral foot swelling/pain with a rash that spread from feet to groin. Physical examination confirmed bilateral pedal edema and macular rash over his lower extremities and buttocks. Laboratory evaluation which consisted of sedimentation rate, complete blood count (CBC) with differential, liver function enzymes, blood urea nitrogen (BUN), urine analysis were within normal values. Impression was that of hypersensitivity vasculitis. A diagnosis of Henoch-Schonlein purpura was made on 26-Nov-2007 when he was re-evaluated for his rash. From 01-Dec-2007 to 02-Dec-2007, he was hospitalized for abdominal pain and vomiting secondary to Henoch-Schonlein purpura. Ultrasound and gastrografin enema were negative for intussusception and other pathology. His laboratory results were normal except for his white blood cells (WBC) count of 13.7 and a 4+ ketones in his urine on admission. His discharge diagnoses were : Henoch-Schonlein purpura, and abdominal pain and dehydration. He was re-hospitalized from 08-Dec-2007 to 10-Dec-2007 because of blood in the stools, severe abdominal pain and bilious emesis. An air enema revealed intussusception in the upper part of the ascending colon which resolved during the procedure. Abnormal laboratory results include : WBC= 22.1; red blood cell (RBC) count = 6.01; hemoglobin = 14.9; hematocrit; platelet = 508; granulocyte = 851; lymphocyte; serum glucose = 140; serum creatinine = 0.11; serum sodium = 131; serum potassium = 5.6; serum albumin = 3.5; urinalysis showed protein = 30, 1+ blood. RBC = 3.9, ccasional mucous and amorphous crystals. He was observed for three days without complications except for one episode of painless bloody stool. His discharge diagnoses were Henoch-Schonlein purpura and intussusception, reduced. The subject was discharged home on prednisolone 15 mg twice daily for three days followed by a tapering regimen over six days, and lansoprazole 15 mg daily. The subject recovered from both events. The subject did not experience a rechallenge while receiving the study vaccine. The investigator assessed causality for the events as not related to FluMist.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Mean cell haemoglobin decreased, Mean cell volume abnormal, Monocyte count decreased, Oedema peripheral, Pain in extremity
Clinical narrative: A serious report of Henoch-Schonlein purpura and intussusception, status post reduction was received from a study investigator concerning a four-year-old male, who is enrolled in a trial. The patient had a medical history that consisted of episodes of bright red blood in the stool which occurred on 18-Oct-2007; bilateral pedal edema and macular rash over the lower extremities and buttocks for which he was seen in the emergency room on 25-Nov-2007. Concomitant medications were not reported. The subject received FluMist intranasally on 10-Nov-2007 for influenza immunization. On 25-Nov-2007, the subject was seen in the emergency room for bilateral foot swelling/pain with a rash that spread from feet to groin. Physical examination confirmed bilateral pedal edema and macular rash over his lower extremities and buttocks. Laboratory evaluation which consisted of sedimentation rate, complete blood count (CBC) with differential, liver function enzymes, blood urea nitrogen (BUN), urine analysis were within normal values. Impression was that of hypersensitivity vasculitis. A diagnosis of Henoch-Schonlein purpura was made on 26-Nov-2007 when he was re-evaluated for his rash. From 01-Dec-2007 to 02-Dec-2007, he was hospitalized for abdominal pain and vomiting secondary to Henoch-Schonlein purpura. Ultrasound and gastrografin enema were negative for intussusception and other pathology. His laboratory results were normal except for his white blood cells (WBC) count of 13.7 and a 4+ ketones in his urine on admission. His discharge diagnoses were : Henoch-Schonlein purpura, and abdominal pain and dehydration. He was re-hospitalized from 08-Dec-2007 to 10-Dec-2007 because of blood in the stools, severe abdominal pain and bilious emesis. An air enema revealed intussusception in the upper part of the ascending colon which resolved during the procedure. Abnormal laboratory results include : WBC= 22.1; red blood cell (RBC) count = 6.01; hemoglobin = 14.9; hematocrit; platelet = 508; granulocyte = 851; lymphocyte; serum glucose = 140; serum creatinine = 0.11; serum sodium = 131; serum potassium = 5.6; serum albumin = 3.5; urinalysis showed protein = 30, 1+ blood. RBC = 3.9, ccasional mucous and amorphous crystals. He was observed for three days without complications except for one episode of painless bloody stool. His discharge diagnoses were Henoch-Schonlein purpura and intussusception, reduced. The subject was discharged home on prednisolone 15 mg twice daily for three days followed by a tapering regimen over six days, and lansoprazole 15 mg daily. The subject recovered from both events. The subject did not experience a rechallenge while receiving the study vaccine. The investigator assessed causality for the events as not related to FluMist.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Platelet count increased, Rash macular, Red blood cell count increased, Red blood cell sedimentation rate normal, Ultrasound scan normal
Clinical narrative: A serious report of Henoch-Schonlein purpura and intussusception, status post reduction was received from a study investigator concerning a four-year-old male, who is enrolled in a trial. The patient had a medical history that consisted of episodes of bright red blood in the stool which occurred on 18-Oct-2007; bilateral pedal edema and macular rash over the lower extremities and buttocks for which he was seen in the emergency room on 25-Nov-2007. Concomitant medications were not reported. The subject received FluMist intranasally on 10-Nov-2007 for influenza immunization. On 25-Nov-2007, the subject was seen in the emergency room for bilateral foot swelling/pain with a rash that spread from feet to groin. Physical examination confirmed bilateral pedal edema and macular rash over his lower extremities and buttocks. Laboratory evaluation which consisted of sedimentation rate, complete blood count (CBC) with differential, liver function enzymes, blood urea nitrogen (BUN), urine analysis were within normal values. Impression was that of hypersensitivity vasculitis. A diagnosis of Henoch-Schonlein purpura was made on 26-Nov-2007 when he was re-evaluated for his rash. From 01-Dec-2007 to 02-Dec-2007, he was hospitalized for abdominal pain and vomiting secondary to Henoch-Schonlein purpura. Ultrasound and gastrografin enema were negative for intussusception and other pathology. His laboratory results were normal except for his white blood cells (WBC) count of 13.7 and a 4+ ketones in his urine on admission. His discharge diagnoses were : Henoch-Schonlein purpura, and abdominal pain and dehydration. He was re-hospitalized from 08-Dec-2007 to 10-Dec-2007 because of blood in the stools, severe abdominal pain and bilious emesis. An air enema revealed intussusception in the upper part of the ascending colon which resolved during the procedure. Abnormal laboratory results include : WBC= 22.1; red blood cell (RBC) count = 6.01; hemoglobin = 14.9; hematocrit; platelet = 508; granulocyte = 851; lymphocyte; serum glucose = 140; serum creatinine = 0.11; serum sodium = 131; serum potassium = 5.6; serum albumin = 3.5; urinalysis showed protein = 30, 1+ blood. RBC = 3.9, ccasional mucous and amorphous crystals. He was observed for three days without complications except for one episode of painless bloody stool. His discharge diagnoses were Henoch-Schonlein purpura and intussusception, reduced. The subject was discharged home on prednisolone 15 mg twice daily for three days followed by a tapering regimen over six days, and lansoprazole 15 mg daily. The subject recovered from both events. The subject did not experience a rechallenge while receiving the study vaccine. The investigator assessed causality for the events as not related to FluMist.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Urine analysis normal, Urine ketone body present, Vomiting, White blood cell count increased
Clinical narrative: A serious report of Henoch-Schonlein purpura and intussusception, status post reduction was received from a study investigator concerning a four-year-old male, who is enrolled in a trial. The patient had a medical history that consisted of episodes of bright red blood in the stool which occurred on 18-Oct-2007; bilateral pedal edema and macular rash over the lower extremities and buttocks for which he was seen in the emergency room on 25-Nov-2007. Concomitant medications were not reported. The subject received FluMist intranasally on 10-Nov-2007 for influenza immunization. On 25-Nov-2007, the subject was seen in the emergency room for bilateral foot swelling/pain with a rash that spread from feet to groin. Physical examination confirmed bilateral pedal edema and macular rash over his lower extremities and buttocks. Laboratory evaluation which consisted of sedimentation rate, complete blood count (CBC) with differential, liver function enzymes, blood urea nitrogen (BUN), urine analysis were within normal values. Impression was that of hypersensitivity vasculitis. A diagnosis of Henoch-Schonlein purpura was made on 26-Nov-2007 when he was re-evaluated for his rash. From 01-Dec-2007 to 02-Dec-2007, he was hospitalized for abdominal pain and vomiting secondary to Henoch-Schonlein purpura. Ultrasound and gastrografin enema were negative for intussusception and other pathology. His laboratory results were normal except for his white blood cells (WBC) count of 13.7 and a 4+ ketones in his urine on admission. His discharge diagnoses were : Henoch-Schonlein purpura, and abdominal pain and dehydration. He was re-hospitalized from 08-Dec-2007 to 10-Dec-2007 because of blood in the stools, severe abdominal pain and bilious emesis. An air enema revealed intussusception in the upper part of the ascending colon which resolved during the procedure. Abnormal laboratory results include : WBC= 22.1; red blood cell (RBC) count = 6.01; hemoglobin = 14.9; hematocrit; platelet = 508; granulocyte = 851; lymphocyte; serum glucose = 140; serum creatinine = 0.11; serum sodium = 131; serum potassium = 5.6; serum albumin = 3.5; urinalysis showed protein = 30, 1+ blood. RBC = 3.9, ccasional mucous and amorphous crystals. He was observed for three days without complications except for one episode of painless bloody stool. His discharge diagnoses were Henoch-Schonlein purpura and intussusception, reduced. The subject was discharged home on prednisolone 15 mg twice daily for three days followed by a tapering regimen over six days, and lansoprazole 15 mg daily. The subject recovered from both events. The subject did not experience a rechallenge while receiving the study vaccine. The investigator assessed causality for the events as not related to FluMist.
Age: 36.0
Sex: M
Vaccine: FLUN3
Symptoms: Decreased appetite, Lip swelling, Night sweats, Productive cough, Respiratory tract congestion
Clinical narrative: A nonserious report of chest congestion, coughing with phlegm, night sweats, nasal congestion, lip swollen, and poor appetite has been received from a consumer concerning her son, a three-year-old male. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age Flumist. No medical history nor concomitant medication were provided. The patient received Flumist on 07-Dec-2007. On 08-Dec-2007, the child experienced chest congestion, coughing with phlegm, night sweats, nasal congestion, lip swollen, and poor appetite. No outcome for the events was provided by the reporter; although the symptoms were reported to be somewhat better. The patient did not experience a rechallenge while receiving the suspect product. The reporter provided no causality assessment for the events. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to MEDI-0006289, a report for the patient's mother.