chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Injection site pruritus, Post herpetic neuralgia
Clinical narrative: This spontaneous report was received from a current 72 year old male patient with sulfa allergy and post herpetic neuralgia pain after got shingles approximately in 2006 (approximately 7-8 years ago). About one year and three months ago, approximately in November 2012, the patient was vaccinated with a dose of ZOSTAVAX (total dose, route, lot number and expiration date not provided). The patient had no any co-suspect therapy or concomitant medications. It was reported that after receiving the ZOSTAVAX, his preexisting post-hermetic neuralgia pain, which manifested itself in his right hip, radiating to his right buttocks, right back and right leg cleared up almost immediately (within 3-5 days or receiving the ZOSTAVAX). 7-8 years ago when he was diagnosed with the shingles, the patient was prescribed VALTREX for two weeks during the acute stage of the disease and prescribed 1/2 of the VALTREX daily as prophylaxis. The patient stated that his post-herpetic neuralgia pain continued to be so sad despite taking the VALTREX, that he discontinued taking it about two years ago, at which time he visited a pain clinic for the post-herpetic neuralgia pain. The patient reported that he refused to take any pain medication. The patient stated that although the injection site of the ZOSTAVAX itched a little (approximately in November 2012), his post-herpetic neuralgia pain subsided. The patient noted that this discomfort was completely gone despite his pain had been so bad that his physician suggested a pain clinic. The patient also reported that he was now (approximately in February 2014) beginning to feel a bit discomfort in this area again, like a little bundle of sore nerves. At the time of the report, the patient's injection site itchy outcome was unknown, and patient had not recovered from a discomfort in the area like a little bundle of sore nerves. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Dizziness, Headache, Injection site erythema
Clinical narrative: Pain where shot was given, redness & swelling where shot was given, fever over 101F, headache, chills, body aches, weakness, dizziness.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Pain where shot was given, redness & swelling where shot was given, fever over 101F, headache, chills, body aches, weakness, dizziness.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Chest pain, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: After receiving my flu shot, I had normal pain at the injection shot. Although the pain never stopped and continued to increase drastically, to the point of not being capable of using my left arm.  I can not lift my arm without having severe pain. The pain began in my left shoulder and has progressively moved done my arm to my elbow and then to my wrist. The pain is excruciating and has not subsided. I need help showering, washing/styling my hair and getting dressed. Went to emergency room 12/01/13, pain started shooting from my left arm across the front and back of my chest.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, X-ray limb
Clinical narrative: After receiving my flu shot, I had normal pain at the injection shot. Although the pain never stopped and continued to increase drastically, to the point of not being capable of using my left arm.  I can not lift my arm without having severe pain. The pain began in my left shoulder and has progressively moved done my arm to my elbow and then to my wrist. The pain is excruciating and has not subsided. I need help showering, washing/styling my hair and getting dressed. Went to emergency room 12/01/13, pain started shooting from my left arm across the front and back of my chest.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Convulsion, Electroencephalogram normal, Fatigue, Feeling abnormal
Clinical narrative: ON THE 24TH OF OCTOBER PATIENT HAD AN EPISODE OF FAINT/WEAK AND STRANGE FEELINGS.  ER VISIT DIAGNOSED AS PANIC ATTACK AND PRESCRIBED XANAX.  SHE SEEMED OK UNTIL 2 WEEKS LATER BEGAN HAVING SEIZURES, NON RESPONSIVE EPISODES, NERVE TWITCHES, CONSTANT FATIGUE, OFTEN WEAK AND LEGS DESCRIBED AS A FUNNY FEELING AS THEY ARENT THERE.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Muscle twitching, Panic attack, Syncope, Unresponsive to stimuli
Clinical narrative: ON THE 24TH OF OCTOBER PATIENT HAD AN EPISODE OF FAINT/WEAK AND STRANGE FEELINGS.  ER VISIT DIAGNOSED AS PANIC ATTACK AND PRESCRIBED XANAX.  SHE SEEMED OK UNTIL 2 WEEKS LATER BEGAN HAVING SEIZURES, NON RESPONSIVE EPISODES, NERVE TWITCHES, CONSTANT FATIGUE, OFTEN WEAK AND LEGS DESCRIBED AS A FUNNY FEELING AS THEY ARENT THERE.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Abasia, Aphasia, Blood pressure fluctuation, Blood test, Computerised tomogram
Clinical narrative: GBS, numbness, unable to swallow, unable to walk or speak, move, paralysis, pain, unstable blood pressure, complication from ventilation tube, on ventilator two times, multiple tests, rehabilitation in hospital, physical therapy, lumbar puncture, cat scan, MRI, EMG, lab, blood work.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Dysphagia, Electromyogram, Guillain-Barre syndrome, Hypoaesthesia, Laboratory test
Clinical narrative: GBS, numbness, unable to swallow, unable to walk or speak, move, paralysis, pain, unstable blood pressure, complication from ventilation tube, on ventilator two times, multiple tests, rehabilitation in hospital, physical therapy, lumbar puncture, cat scan, MRI, EMG, lab, blood work.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Lumbar puncture, Mechanical ventilation complication, Mobility decreased, Nuclear magnetic resonance imaging, Pain
Clinical narrative: GBS, numbness, unable to swallow, unable to walk or speak, move, paralysis, pain, unstable blood pressure, complication from ventilation tube, on ventilator two times, multiple tests, rehabilitation in hospital, physical therapy, lumbar puncture, cat scan, MRI, EMG, lab, blood work.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Paralysis
Clinical narrative: GBS, numbness, unable to swallow, unable to walk or speak, move, paralysis, pain, unstable blood pressure, complication from ventilation tube, on ventilator two times, multiple tests, rehabilitation in hospital, physical therapy, lumbar puncture, cat scan, MRI, EMG, lab, blood work.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Abasia, Aphasia, Blood pressure abnormal, Blood test, Computerised tomogram
Clinical narrative: GBS, numbness, unable to swallow, unable to walk or speak, move, paralysis, pain, unstable blood pressure, complication from ventilation tube, on ventilator two times, multiple tests, rehabilitation in hospital, physical therapy, lumbar puncture, cat scan, MRI, EMG, lab, blood work.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Lumbar puncture, Mechanical ventilation, Mechanical ventilation complication, Mobility decreased, Nuclear magnetic resonance imaging
Clinical narrative: GBS, numbness, unable to swallow, unable to walk or speak, move, paralysis, pain, unstable blood pressure, complication from ventilation tube, on ventilator two times, multiple tests, rehabilitation in hospital, physical therapy, lumbar puncture, cat scan, MRI, EMG, lab, blood work.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain, Paralysis
Clinical narrative: GBS, numbness, unable to swallow, unable to walk or speak, move, paralysis, pain, unstable blood pressure, complication from ventilation tube, on ventilator two times, multiple tests, rehabilitation in hospital, physical therapy, lumbar puncture, cat scan, MRI, EMG, lab, blood work.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Gingival bleeding, Petechiae, Platelet count decreased, Thrombocytopenia
Clinical narrative: Gum bleeding, petechiae. Diagnosed with thrombocytopenia 2/7/14.
Age: 0.42
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Incorrect vaccine given.  Pt received Kinrix when she should have received Infanrix.
Age: 31.0
Sex: M
Vaccine: ANTH, JEV1
Symptoms: Injection site erythema, Injection site haemorrhage
Clinical narrative: Redness at injection site with ecchymosis. Greater than 120mm following the right deltoid throughout. Neg lymphadenopathy or seq.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Urticaria
Clinical narrative: Pt. was vaccinated w/varicella and MMR on 2/11/14.  Per mom, left arm became swollen, red, and tender to touch in am on 2/12/14.  Pt. also developed hives starting on 2/12 in am. Varicella was administered in left arm.  Pt. followed up with HCP and Benadryl given by mom.
Age: 61.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Fever of 101 - 102 that lasted for 48 hours.  I had no other symptoms and took only Advil for treatment.
Age: 1.35
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Injection site discolouration, Injection site erythema, Injection site haemorrhage, Injection site nodule, Injection site pain
Clinical narrative: ~4-6 hours after the vaccine, injection site (R anterior thigh) became erythematous with a dime-sized area of swelling. Over the next week developed significant ecchymosis. Was seen in office 8/14/13. At that time still had a 'knot' per Mom that was tender with pressure. On exam he had ~1.5x3/4" bluish ecchymosis on his R thigh with a palpable firm well-circumscribed pea-sized subcutaneous nodule, tender with pressure. He was seen again on 9/18/13. At that time he had a residual nickel-sized area of faint hyperpigmentation. Subcutaneous nodule was relatively unchanged. Was most recently seen 2/11/14. Still has ~1 cm faint hyperpigmentation with a 2-3mm firm subcutaneous round nodule. Never got a fever or rash.
Age: 1.35
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Injection site swelling
Clinical narrative: ~4-6 hours after the vaccine, injection site (R anterior thigh) became erythematous with a dime-sized area of swelling. Over the next week developed significant ecchymosis. Was seen in office 8/14/13. At that time still had a 'knot' per Mom that was tender with pressure. On exam he had ~1.5x3/4" bluish ecchymosis on his R thigh with a palpable firm well-circumscribed pea-sized subcutaneous nodule, tender with pressure. He was seen again on 9/18/13. At that time he had a residual nickel-sized area of faint hyperpigmentation. Subcutaneous nodule was relatively unchanged. Was most recently seen 2/11/14. Still has ~1 cm faint hyperpigmentation with a 2-3mm firm subcutaneous round nodule. Never got a fever or rash.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Immunodeficiency, Lethargy, Muscular weakness, Nausea
Clinical narrative: 102 fever x 3 days, lethargic with leg weakness bilaterally, within one week of receiving had upper respiratory infection, severy back pain and nausea and vomiting, symptoms are continuing, feels this vaccine compromised her immune system.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Upper respiratory tract infection, Vomiting
Clinical narrative: 102 fever x 3 days, lethargic with leg weakness bilaterally, within one week of receiving had upper respiratory infection, severy back pain and nausea and vomiting, symptoms are continuing, feels this vaccine compromised her immune system.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Eyelid oedema, Hot flush, Paraesthesia, Paraesthesia oral
Clinical narrative: At 1:15 pt started having: Hot face; Tingling lips, face; Swollen eye lids.
Age: 1.24
Sex: M
Vaccine: HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Rash generalised
Clinical narrative: RASH ON FACE ARMS TORSO LEGS PELVIC REGION SO FAR  ON DAY 2 OF ONSET OF EVENT.
Age: 2.0
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Full blood count normal, Vasculitis
Clinical narrative: Vasculitis - waist down lower extremities 2/10/14 spread to arms by 2/11/14 pm.
Age: 39.0
Sex: M
Vaccine: MNQ
Symptoms: Back pain, Cold sweat, Dyspnoea, Hyperhidrosis, Muscular weakness
Clinical narrative: Vaccinated 1-27-14, symptoms occurred after 2/7/14 -> hot/cold sweats, fever on/off (not measured), neck/back pain, consistent weakness on all limbs, especially left arm. Stiff neck, (some) difficulty breathing (SOB). White of eyes changed to slight blue, excess thirst, tingling joints, clammy feeling.
Age: 39.0
Sex: M
Vaccine: MNQ
Symptoms: Musculoskeletal stiffness, Neck pain, Paraesthesia, Pyrexia, Scleral discolouration
Clinical narrative: Vaccinated 1-27-14, symptoms occurred after 2/7/14 -> hot/cold sweats, fever on/off (not measured), neck/back pain, consistent weakness on all limbs, especially left arm. Stiff neck, (some) difficulty breathing (SOB). White of eyes changed to slight blue, excess thirst, tingling joints, clammy feeling.
Age: 39.0
Sex: M
Vaccine: MNQ
Symptoms: Thirst
Clinical narrative: Vaccinated 1-27-14, symptoms occurred after 2/7/14 -> hot/cold sweats, fever on/off (not measured), neck/back pain, consistent weakness on all limbs, especially left arm. Stiff neck, (some) difficulty breathing (SOB). White of eyes changed to slight blue, excess thirst, tingling joints, clammy feeling.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: Pt received immunization on afternoon of 2/4, that evening noticed numbness in 4th-5th digits (L) hand w/ weakness, called in to clinic 2/12 and was seen at clinic on 2/12 for s/s of (L) hand numbness, advised rest, ice per provider, expected to resolve spontaneously.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: URTICARIA ON THE ANTERIOR AND POSTERIOR AREA OF HER ABD WHICH LATER SPREAD TO THE ANTERIOR PORTION OF HER RIGHT ARM, INNER THIGHS, AND BEHIND HER RIGHT AND LEFT KNEE. SHE RECEIVED RX FOR PREDNISONE PO X 6 DAYS WHICH HELPED RESOLVE THE URTICARIA.
Age: 0.32
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema, Immediate post-injection reaction
Clinical narrative: Immediately after shots administered, he turned red in limbs and face. Lasted about 10 minutes then resolved. This reaction did not happen with last set of shots.
Age: 1.68
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Muscle spasms, Pyrexia
Clinical narrative: Parent of child reported child developed a high fever 12 hrs after getting vaccines (DTaP, Hib, PCV). Parent gave child a fever reducer medication. Fever continued to raise. Child experienced a muscle spasm of all extremities. Parent called 9-1-1. Child taken to Hosp ER. Observed and released back home the same evening.
Age: 39.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Anion gap, Asthenia, Blood chloride, Blood creatinine, Blood urea
Clinical narrative: Headache and weakness, dyspnea.
Age: 39.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Dyspnoea, Headache
Clinical narrative: Headache and weakness, dyspnea.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Blood glucose normal, C-reactive protein increased, Chest X-ray normal, Chest pain
Clinical narrative: Given Pneumovax injection 2/11/14. Had appt w/ Dr 2/12/14- reported that evening/night after Vaccine given rt arm became reddened, painful over rt arm injection site- felt weak. Reported had some chest pain during the night. After 2/12/14 appt- late afternoon went to ER for c/o chest pain- stated d/c same day and got home around 1830. RN called pt 2/13/14 - pt reported arm conts to be "somewhat reddened, stiff and sore". Was instructed by MD at ER may use either Ibuprofen or Tylenol po. Note:  pt had previous Pneumovax vaccine at age 60 pt reported; this vaccine given > 5 years later as vet turning at 66 this month.  Reports that after 1st Pheumo vaccine "did not feel well". Also note that pt received Flu vaccine 2/11/14 to lt deltoid; Pneumo was given in rt deltoid.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Electrocardiogram normal, Injection site erythema, Injection site pain, Lymphocyte percentage decreased, Monocyte percentage increased
Clinical narrative: Given Pneumovax injection 2/11/14. Had appt w/ Dr 2/12/14- reported that evening/night after Vaccine given rt arm became reddened, painful over rt arm injection site- felt weak. Reported had some chest pain during the night. After 2/12/14 appt- late afternoon went to ER for c/o chest pain- stated d/c same day and got home around 1830. RN called pt 2/13/14 - pt reported arm conts to be "somewhat reddened, stiff and sore". Was instructed by MD at ER may use either Ibuprofen or Tylenol po. Note:  pt had previous Pneumovax vaccine at age 60 pt reported; this vaccine given > 5 years later as vet turning at 66 this month.  Reports that after 1st Pheumo vaccine "did not feel well". Also note that pt received Flu vaccine 2/11/14 to lt deltoid; Pneumo was given in rt deltoid.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal stiffness, Neutrophil percentage increased
Clinical narrative: Given Pneumovax injection 2/11/14. Had appt w/ Dr 2/12/14- reported that evening/night after Vaccine given rt arm became reddened, painful over rt arm injection site- felt weak. Reported had some chest pain during the night. After 2/12/14 appt- late afternoon went to ER for c/o chest pain- stated d/c same day and got home around 1830. RN called pt 2/13/14 - pt reported arm conts to be "somewhat reddened, stiff and sore". Was instructed by MD at ER may use either Ibuprofen or Tylenol po. Note:  pt had previous Pneumovax vaccine at age 60 pt reported; this vaccine given > 5 years later as vet turning at 66 this month.  Reports that after 1st Pheumo vaccine "did not feel well". Also note that pt received Flu vaccine 2/11/14 to lt deltoid; Pneumo was given in rt deltoid.
Age: 16.0
Sex: M
Vaccine: HEP, IPV, TD, VARCEL
Symptoms: Asthenia, Hypotension, Lethargy, Pallor, Pulse pressure decreased
Clinical narrative: Patient became unresponsive in chair color poor, skin cool and dry. Faint pulse and low BP. S/sx lasted 90 seconds. Patient lethargic and weak. EMS called. Color remained poor patient gradually became more alert. Patient returned to baseline after 45mins. Color good VSS.  Declined transport to ER and went home with mother.
Age: 16.0
Sex: M
Vaccine: HEP, IPV, TD, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient became unresponsive in chair color poor, skin cool and dry. Faint pulse and low BP. S/sx lasted 90 seconds. Patient lethargic and weak. EMS called. Color remained poor patient gradually became more alert. Patient returned to baseline after 45mins. Color good VSS.  Declined transport to ER and went home with mother.
Age: 45.0
Sex: M
Vaccine: JEV1
Symptoms: Hot flush, Rash generalised
Clinical narrative: Patient started to experiance heat flashes, generalized rashing over entire body. Patient took Benadryl at 1345 and experienced relief in 20 minutes.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Hives over torso, arms.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Blood creatine phosphokinase normal, CSF culture negative, CSF glucose normal, CSF protein increased, CSF white blood cell count negative
Clinical narrative: This is a 25-year-old otherwise healthy female banker who flew to see her fiance on Saturday and today 2/3/14 at 9 a.m. after taking some Dramamine for a whale watching trip, had the sudden onset of bilateral arm numbness. She presented to our emergency room here at approximately 11 a.m. and soon after had numbness in all extremities. This numbness was not associated with dysesthesias, paresthesias, skin changes, or other symptoms, but by mid afternoon was associated with flaccid quadriparesis of all extremities. She began to have her minimum inspiratory and expiratory pressures monitored in the emergency room and they were never less than 60. In terms of the associated symptoms, she denies any headaches or vision changes, or hearing changes, dysphagia, odynophagia, neck stiffness, fevers, chills, nausea, vomiting, diarrhea, or recent illness. Specifically, she has not had a cold or flu symptoms this entire winter season. She has recently received the last course of her HPV vaccine, the third dose in January 2014. Although she did take ibuprofen 200 mg x1 shortly before the onset of symptoms, she has not been taking any other analgesics and she has no possible exposures to Botox or botulinum toxin. She denies any recent immunizations other than she finished up in January the vaccine to prevent the HPV. The patient reported that symptoms all came on rather quickly within an hour of presentation. The patient reports no history of known vasculitis, no history of previous stroke, and no history of multiple sclerosis. The patient is unclear as to what exactly precipitated this at this time. Patient treated for Guillain Barre with plasmapheresis.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug screen negative, Dysaesthesia, Electrocardiogram normal, Guillain-Barre syndrome, Haemoglobin normal
Clinical narrative: This is a 25-year-old otherwise healthy female banker who flew to see her fiance on Saturday and today 2/3/14 at 9 a.m. after taking some Dramamine for a whale watching trip, had the sudden onset of bilateral arm numbness. She presented to our emergency room here at approximately 11 a.m. and soon after had numbness in all extremities. This numbness was not associated with dysesthesias, paresthesias, skin changes, or other symptoms, but by mid afternoon was associated with flaccid quadriparesis of all extremities. She began to have her minimum inspiratory and expiratory pressures monitored in the emergency room and they were never less than 60. In terms of the associated symptoms, she denies any headaches or vision changes, or hearing changes, dysphagia, odynophagia, neck stiffness, fevers, chills, nausea, vomiting, diarrhea, or recent illness. Specifically, she has not had a cold or flu symptoms this entire winter season. She has recently received the last course of her HPV vaccine, the third dose in January 2014. Although she did take ibuprofen 200 mg x1 shortly before the onset of symptoms, she has not been taking any other analgesics and she has no possible exposures to Botox or botulinum toxin. She denies any recent immunizations other than she finished up in January the vaccine to prevent the HPV. The patient reported that symptoms all came on rather quickly within an hour of presentation. The patient reports no history of known vasculitis, no history of previous stroke, and no history of multiple sclerosis. The patient is unclear as to what exactly precipitated this at this time. Patient treated for Guillain Barre with plasmapheresis.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Hypotonia, Liver function test normal, Metabolic function test normal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: This is a 25-year-old otherwise healthy female banker who flew to see her fiance on Saturday and today 2/3/14 at 9 a.m. after taking some Dramamine for a whale watching trip, had the sudden onset of bilateral arm numbness. She presented to our emergency room here at approximately 11 a.m. and soon after had numbness in all extremities. This numbness was not associated with dysesthesias, paresthesias, skin changes, or other symptoms, but by mid afternoon was associated with flaccid quadriparesis of all extremities. She began to have her minimum inspiratory and expiratory pressures monitored in the emergency room and they were never less than 60. In terms of the associated symptoms, she denies any headaches or vision changes, or hearing changes, dysphagia, odynophagia, neck stiffness, fevers, chills, nausea, vomiting, diarrhea, or recent illness. Specifically, she has not had a cold or flu symptoms this entire winter season. She has recently received the last course of her HPV vaccine, the third dose in January 2014. Although she did take ibuprofen 200 mg x1 shortly before the onset of symptoms, she has not been taking any other analgesics and she has no possible exposures to Botox or botulinum toxin. She denies any recent immunizations other than she finished up in January the vaccine to prevent the HPV. The patient reported that symptoms all came on rather quickly within an hour of presentation. The patient reports no history of known vasculitis, no history of previous stroke, and no history of multiple sclerosis. The patient is unclear as to what exactly precipitated this at this time. Patient treated for Guillain Barre with plasmapheresis.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging spinal normal, Paraesthesia, Plasmapheresis, Platelet count normal, Quadriparesis
Clinical narrative: This is a 25-year-old otherwise healthy female banker who flew to see her fiance on Saturday and today 2/3/14 at 9 a.m. after taking some Dramamine for a whale watching trip, had the sudden onset of bilateral arm numbness. She presented to our emergency room here at approximately 11 a.m. and soon after had numbness in all extremities. This numbness was not associated with dysesthesias, paresthesias, skin changes, or other symptoms, but by mid afternoon was associated with flaccid quadriparesis of all extremities. She began to have her minimum inspiratory and expiratory pressures monitored in the emergency room and they were never less than 60. In terms of the associated symptoms, she denies any headaches or vision changes, or hearing changes, dysphagia, odynophagia, neck stiffness, fevers, chills, nausea, vomiting, diarrhea, or recent illness. Specifically, she has not had a cold or flu symptoms this entire winter season. She has recently received the last course of her HPV vaccine, the third dose in January 2014. Although she did take ibuprofen 200 mg x1 shortly before the onset of symptoms, she has not been taking any other analgesics and she has no possible exposures to Botox or botulinum toxin. She denies any recent immunizations other than she finished up in January the vaccine to prevent the HPV. The patient reported that symptoms all came on rather quickly within an hour of presentation. The patient reports no history of known vasculitis, no history of previous stroke, and no history of multiple sclerosis. The patient is unclear as to what exactly precipitated this at this time. Patient treated for Guillain Barre with plasmapheresis.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Red blood cell sedimentation rate normal, Respiration abnormal, Skin disorder, White blood cell count normal
Clinical narrative: This is a 25-year-old otherwise healthy female banker who flew to see her fiance on Saturday and today 2/3/14 at 9 a.m. after taking some Dramamine for a whale watching trip, had the sudden onset of bilateral arm numbness. She presented to our emergency room here at approximately 11 a.m. and soon after had numbness in all extremities. This numbness was not associated with dysesthesias, paresthesias, skin changes, or other symptoms, but by mid afternoon was associated with flaccid quadriparesis of all extremities. She began to have her minimum inspiratory and expiratory pressures monitored in the emergency room and they were never less than 60. In terms of the associated symptoms, she denies any headaches or vision changes, or hearing changes, dysphagia, odynophagia, neck stiffness, fevers, chills, nausea, vomiting, diarrhea, or recent illness. Specifically, she has not had a cold or flu symptoms this entire winter season. She has recently received the last course of her HPV vaccine, the third dose in January 2014. Although she did take ibuprofen 200 mg x1 shortly before the onset of symptoms, she has not been taking any other analgesics and she has no possible exposures to Botox or botulinum toxin. She denies any recent immunizations other than she finished up in January the vaccine to prevent the HPV. The patient reported that symptoms all came on rather quickly within an hour of presentation. The patient reports no history of known vasculitis, no history of previous stroke, and no history of multiple sclerosis. The patient is unclear as to what exactly precipitated this at this time. Patient treated for Guillain Barre with plasmapheresis.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient is a 4 year old male who presents with: Immunization - pt had a reaction to the vaccines given in his L leg. He was given Dtap and IPV in left leg 2/10/2014. The reaction is near the Dtap site. Skin: brisk capillary refill, good skin turgor and 10 cm x 8 cm area of erythema, warmth and mild induration at left upper anterior leg, no fluctuance or punctum.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Asthma, Condition aggravated, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Increased asthma and very itchy red rash which continues to spread on scalp, entire back & sides, shoulders, and continuing to present.   Administered 40 mg. Kenalog 2/10/14, with no improvement.  Increased doses of prednisone.
Age: 0.5
Sex: F
Vaccine: FLU3, HIBV, PNC13, RV5
Symptoms: Diet refusal, Enema administration, Haematochezia, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Started vomiting hourly and refused to eat. Was submitted to ER at 1:00 PM where symptoms continued until she passed a bloody stool. Was moved to another hospital where an ultrasound confirmed an intussusception. A enema was performed and monitored via x-ray to correct the intestine at 2:00 AM the following morning. Treatment was successful and x-ray confirmed correction.
Age: 0.5
Sex: F
Vaccine: FLU3, HIBV, PNC13, RV5
Symptoms: Vomiting, X-ray gastrointestinal tract abnormal
Clinical narrative: Started vomiting hourly and refused to eat. Was submitted to ER at 1:00 PM where symptoms continued until she passed a bloody stool. Was moved to another hospital where an ultrasound confirmed an intussusception. A enema was performed and monitored via x-ray to correct the intestine at 2:00 AM the following morning. Treatment was successful and x-ray confirmed correction.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Rash, Skin plaque
Clinical narrative: 4 days after injection patient developed photodistributed rash: face, neck, hands, red plaques.
Sex: F
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 10-FEB-2014 the patient was vaccinated with RECOMBIVAX HB INJ 2.5/0.5 thimerosal status unknown (route, dosage and dose number unknown; lot number reported as1047AA EXP 15-DEC-2013). No adverse symptoms were reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient said arm was really red at injection site about 4 inches in diameter. She said it hurt or was sore also. Patient stopped by on 2-6-14 to show me. She also said it was a little swollen.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Granuloma, Injection site mass, Injection site oedema, Seroma, Surgery
Clinical narrative: 15 mo. imm. given on 07-09-13 at WCE. First report of s/s by parents to office on 8-15-13. S/S = (Rt) thigh edema; 'moderate' size soft lump without warmth, redness, tenderness. (No VAERS report sent - mgr. not informed). Developed granuloma; now with 2.8 x 3.7 cm seroma req. sx drainage and POCS excision on 02-18-14.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Therapeutic procedure, Ultrasound scan
Clinical narrative: 15 mo. imm. given on 07-09-13 at WCE. First report of s/s by parents to office on 8-15-13. S/S = (Rt) thigh edema; 'moderate' size soft lump without warmth, redness, tenderness. (No VAERS report sent - mgr. not informed). Developed granuloma; now with 2.8 x 3.7 cm seroma req. sx drainage and POCS excision on 02-18-14.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Pt was given HPV vaccine and within a few seconds fainted. Vital signs were taken shortly after and were normal. Pt was monitored for 15 mins and sent home.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cellulitis, Injection site streaking, Injection site vesicles, Local swelling, Lymphangitis
Clinical narrative: Pt presented 48 hours after given (R) deltoid GARDASIL IZ. The area involved (R) forearm with swelling, warmth, large bullous and red streaking up posterior of upper arm pt sent to ER for eval of cellulitis and presumed lymphangitis.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Skin warm
Clinical narrative: Pt presented 48 hours after given (R) deltoid GARDASIL IZ. The area involved (R) forearm with swelling, warmth, large bullous and red streaking up posterior of upper arm pt sent to ER for eval of cellulitis and presumed lymphangitis.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blister, Injected limb mobility decreased, Local swelling
Clinical narrative: Pt presented 48 hours after given (R) deltoid GARDASIL IZ. The area involved (R) forearm with swelling, warmth, large bullous and red streaking up posterior of upper arm pt sent to ER for eval of cellulitis and presumed lymphangitis.
Age: 68.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site erythema, Skin warm
Clinical narrative: Patients wants this documented and placed on file. Red blotch around injection site measuring about 2 inches in diameter. Hot to touch.
Age: 0.18
Sex: M
Vaccine: HEPA, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to an unknown age female patient. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and lot # were not reported). Concomitant medication was not reported. On an unknown date, the patient experienced bruising and swelling of her arm at the injection site after receiving ZOSTAVAX. The patient sought medical attention at the pharmacy. On an unknown date, the bruising and swelling of her arm at the injection site resolved within 1 or 2 days. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to an unspecified number of patients and unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (dose, lot number and expiration date not reported) subcutaneous. There was no concomitant medication reported. Pharmacist mentioned other unspecified pharmacist stated that they have given ZOSTAVAX subcutaneous in the bicep area of the arm on an unknown date. No adverse effects reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Local swelling
Clinical narrative: This medically confirmed report (initial receipt 11-Dec-2013) concerns a 66 year old male patient. Medical history included penicillin allergy and concomitant medications included blood pressure medications. On the 08-Nov-2013, the patient received a flu shot (manufacturer and batch number not provided). On the same day, the patient also received his first dose of PNEUMOVAX 23 (H013581) 0.5 mL via the intramuscular route, 3rd time. On the 09-Nov-2013, one day after receiving his first dose of PNEUMOVAX, the patient experienced severe swelling of the hand and arm. The patient was seen at a hospital emergency room but was not admitted. On 10-Nov-2013, the patient developed cellulitis. Treatment included Sulfamethoxazole/trimethoprim and cephalexin. Outcome was reported as recovered. Follow up (20-Jan-2014) Vaccine administration, PNEUMOVAX batch number, PNEUMOVAX administration details, AE onset date. Case correction (06-Feb-2014) Overall case unlisted.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood thyroid stimulating hormone decreased, Hyperthyroidism, Thyroxine normal
Clinical narrative: Case received from a healthcare professional on 04-Feb-2014. A 57-year-old male patient, with no illness at the time of the vaccination but a reported pre-existing health conditions, had received his dose of FLUZONE (batch number UH900AB, route and anatomical site of administration not reported) on 26-Dec-2013. The patient had a medical history of high BP (blood pressure), hypercholesterolemia, gout and impaired fasting glucose. On an unspecified date post-vaccination, the patient presented with exhibiting symptoms of hyperthyroidism, which required a doctor visit. The patient's symptoms were not resolved at the time of the report. No other information was provided.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hyperthyroidism
Clinical narrative: Case received from a healthcare professional on 04-Feb-2014. A 57-year-old male patient, with no illness at the time of the vaccination but a reported pre-existing health conditions, had received his dose of FLUZONE (batch number UH900AB, route and anatomical site of administration not reported) on 26-Dec-2013. The patient had a medical history of high BP (blood pressure), hypercholesterolemia, gout and impaired fasting glucose. On an unspecified date post-vaccination, the patient presented with exhibiting symptoms of hyperthyroidism, which required a doctor visit. The patient's symptoms were not resolved at the time of the report. No other information was provided.
Age: 70.0
Sex: F
Vaccine: PER
Symptoms: Convulsion, Fall, Incoherent, Loss of consciousness, Malaise
Clinical narrative: She began to feel ill and went to the bathroom. I heard her talking to herself about being ill, then I heard a thump. She had fallen off the toilet and was complaining of feeling very ill. She was incoherent for apx 4 min. She then passed out and had a seizure for about 30 sec. She then came to and asked to lie down. I called 911 but she said she wanted to lie down. She is now sleeping.
Age: 70.0
Sex: F
Vaccine: PER
Symptoms: Somnolence
Clinical narrative: She began to feel ill and went to the bathroom. I heard her talking to herself about being ill, then I heard a thump. She had fallen off the toilet and was complaining of feeling very ill. She was incoherent for apx 4 min. She then passed out and had a seizure for about 30 sec. She then came to and asked to lie down. I called 911 but she said she wanted to lie down. She is now sleeping.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from clinical medical assistant refers to a patient of unknown age and gender. On 01-AUG-2013, the patient was vaccinated with GARDASIL first dose (dose unit, route, lot# and expiry date unknown). On 11-FEB-2014 today, patient visited office to receive the second dose (dose unit, route, lot number and expiry date unknown). the outcome of in the office today (11-FEB-2014) to receive the second dose was unknown. No other information to report. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old patient of unknown gender. On 19-SEP-2013 the patient was vaccinated intramuscularly with a first dose of PNEUMOVAX23 0.5 ml, (lot # not reported). On 12-DEC-2013 the patient received inadvertently second dose of PNEUMOVAX23 0.5 ml, intramuscularly, lot # J004080, expiry date 22-AUG-2014. No adverse effects were reported. The patient sought medical attention by contacting the pharmacist. Follow up information has been received from the pharmacist reported the 66 year old female patient with allergy to penicillin (PCN). On 12-DEC-2013 at 15:45 the patient was vaccinated intramuscularly in deltoid with second dose of PNEUMOVAX23. It was reported that the patient did not report any adverse reaction but the primary care doctor called the pharmacy. The doctor reported that she already received the vaccine last year and did not need another dose. The doctor did have any adverse reaction to report about the patient. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a currently 67 year old female patient with osteoarthritis and psoriatic arthritis and a history of unspecified reaction to SULFA. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot #, dose, route and site of administration not reported). Concomitant therapies included ENBREL 50 mg, calcium, PRILOSEC, SYNTHROID, WELLBUTRIN and etodolac. It was reported that the patient received ZOSTAVAX developed an unspecified reaction (dates not provided). It was unknown if the patient sought medical attention. The outcome of unspecified reaction is unknown. Causality was not provided. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Adverse reaction, Full blood count, Haematocrit normal, Haemoglobin normal, Mean cell haemoglobin concentration normal
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a currently 67 year old female patient with osteoarthritis and psoriatic arthritis and a history of unspecified reaction to SULFA. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot #, dose, route and site of administration not reported). Concomitant therapies included ENBREL 50 mg, calcium, PRILOSEC, SYNTHROID, WELLBUTRIN and etodolac. It was reported that the patient received ZOSTAVAX developed an unspecified reaction (dates not provided). It was unknown if the patient sought medical attention. The outcome of unspecified reaction is unknown. Causality was not provided. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, Platelet count normal, Red blood cell count decreased, Red cell distribution width normal
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a currently 67 year old female patient with osteoarthritis and psoriatic arthritis and a history of unspecified reaction to SULFA. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot #, dose, route and site of administration not reported). Concomitant therapies included ENBREL 50 mg, calcium, PRILOSEC, SYNTHROID, WELLBUTRIN and etodolac. It was reported that the patient received ZOSTAVAX developed an unspecified reaction (dates not provided). It was unknown if the patient sought medical attention. The outcome of unspecified reaction is unknown. Causality was not provided. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Synovitis, White blood cell count normal
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a currently 67 year old female patient with osteoarthritis and psoriatic arthritis and a history of unspecified reaction to SULFA. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot #, dose, route and site of administration not reported). Concomitant therapies included ENBREL 50 mg, calcium, PRILOSEC, SYNTHROID, WELLBUTRIN and etodolac. It was reported that the patient received ZOSTAVAX developed an unspecified reaction (dates not provided). It was unknown if the patient sought medical attention. The outcome of unspecified reaction is unknown. Causality was not provided. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: HPV4
Symptoms: Blood test, Chest X-ray, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a physician via a field employee refers to a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. On an unknown date within a few dates after receiving GARDASIL the patient experienced cervical lymphadenopathy. The cervical lymphadenopathy occurred on the same side as injection site for GARDASIL. The patient had chest X-ray and unspecified blood work. The outcome of cervical lymphadenopathy was reported as resolved in 2 week (reported as dissipated in 2 weeks). The case is linked to 1402USA007016 (same reporter link). Additional information has been requested.
Age: 1.2
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a health professional via company representative refers to a 14 month old patient. On 30-JAN-2014, the patient was vaccinated with a dose of PROQUAD (Merck) (lot # J007862, Exp date: 28-DEC-2014) (dose and route unspecified) and a dose of VARIVAX (Merck) (lot #, dose and route unspecified). No PQC, and no adverse effects reported. No product confusion discovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Blood test, Chest X-ray, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a physician via a field employee refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. On an unknown date within a few dates after receiving GARDASIL the patient experienced cervical lymphadenopathy. The cervical lymphadenopathy occurred on the same side as injection site for GARDASIL. The patient had chest X-ray and unspecified blood work. The outcome of cervical lymphadenopathy was reported as resolved in 2 week (reported as dissipated in 2 weeks). This case is linked to 1402USA004625 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients. On an unknown date unspecified patients were vaccinated with doses of GARDASIL (lot #, expiration date and dose unspecified), in the gluteal muscle. No adverse effect reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site rash, Nausea, Pain in extremity
Clinical narrative: This spontaneous report as received from a physician (D.O.) via a representative refers to a 60 year old female patient. On 04-FEB-2014 the patient was vaccinated with a dose of ZOSTAVAX, one single injection, lot # J011338, expiry date 19-DEC-2104, injection route. On 06-FEB-2014, the patient developed a sore arm with a red rash like patch at the injection site after receiving ZOSTAVAX vaccine. This red rash like patch at the injection site was one inch in size. The patient also experienced headache, nausea and vomiting after receiving the ZOSTAVAX vaccine. The patient saw the physician. The physician administered 80 mg of DEPO-MEDROL (frequency and manufacturer unknown) for treatment of the nausea. At the time of reporting, the patient was recovering from the adverse events. The causality between ZOSTAVAX and adverse events was not provided. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a physician (D.O.) via a representative refers to a 60 year old female patient. On 04-FEB-2014 the patient was vaccinated with a dose of ZOSTAVAX, one single injection, lot # J011338, expiry date 19-DEC-2104, injection route. On 06-FEB-2014, the patient developed a sore arm with a red rash like patch at the injection site after receiving ZOSTAVAX vaccine. This red rash like patch at the injection site was one inch in size. The patient also experienced headache, nausea and vomiting after receiving the ZOSTAVAX vaccine. The patient saw the physician. The physician administered 80 mg of DEPO-MEDROL (frequency and manufacturer unknown) for treatment of the nausea. At the time of reporting, the patient was recovering from the adverse events. The causality between ZOSTAVAX and adverse events was not provided. Additional information is not expected.