chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Local reaction, Skin warm
Clinical narrative: Swelling soreness at upper arm injection site. 6-9 am swelling from shoulder to elbow with decrease use of RUE. Ice, MOTRIN. Appt 6-9 localized reaction for warmth & redness. 6-10- worse swelling, redness, hot ER Dx cellulitis given KEFLEX.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Pain (R) arm.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Blood pressure abnormal, Head injury, Nausea, Pallor, Syncope
Clinical narrative: Patient waited approximately 5 minutes after administration to get up to leave the office. He fainted before leaving. He hit his head on the wall. Skin was pasty and very pale. He was nauseated. Cold compresses. Patient lay down for about 15 minutes before blood pressure returned to normal.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chest pain, Electrocardiogram normal, Headache, Wheezing
Clinical narrative: 12 hours after HPV #1 given, patient developed chest pain, wheezing and headache.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMR
Symptoms: Injection site swelling
Clinical narrative: Mother advised child taken to ER & they treated child for (Rt) leg swelling. Child was prescribed antibiotic.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash pruritic
Clinical narrative: Pt came in on 6-12-12 had itchy rash total body ached soon after inj.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Rash
Clinical narrative: Rash. Erythema.
Age: 27.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Tinnitus, Vision blurred
Clinical narrative: Patient experienced dizziness, ringing in the ears, and blurred vision. Symptoms started within 30 seconds and resolved within 5 minutes. No treatment.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Pyrexia, Streptococcus test negative
Clinical narrative: Mother described onset of 104 degrees F fever within 24 hrs. of vaccination. Fever persisted for 4 days, decreasing to below 101 degrees F on day 4. Pt taken to pediatrician where source of fever was not identified. Neg. strep, neg ear infection.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Contusion, Epistaxis, Full blood count abnormal, Idiopathic thrombocytopenic purpura, Petechiae
Clinical narrative: Epistaxis and bruising - petechiae clinical hx., exam, CBC results consistent with ITP sent to hospital for eval by heme.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Urticaria
Clinical narrative: Large bullseye hive located near injection site. Red and hard in center of hive. Patient discovered hive the day after vaccination. Patient was given prednisone by physician.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Burning,itching, swelling, painful, hot to touch started a couple of hours after injection & continued to get worse til today -> 2 1/2 days post injection.
Age: 2.0
Sex: F
Vaccine: HIBV, IPV
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Whole body urticarial rash with 2-4 mm wheals & surrounding flare. Very itchy.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Hypoaesthesia oral, Injection site swelling
Clinical narrative: Pt noticed difficulty swallowing. Numbness throughout her mouth w/ swelling at injection site. Lasted 2-3 days. Pt only expressed this 3 weeks later at her next appt.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin warm, Tenderness
Clinical narrative: Edema, itching, erythema, hot to touch, tenderness of entire arm of injection lasting for 3-4 days.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Local swelling, Swelling
Clinical narrative: Swelling under (R) arm & (R) side of neck.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: - (L) arm site is red with induration (3 in width x 4 in ht). - Painful to touch. - Warm to touch. - Tx with ibuprofen for pain, BENADRYL et ice (cool) compress.
Age: 55.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Laboratory test normal, Loss of consciousness, Malaise, Somnolence, Syncope
Clinical narrative: Within 10 minutes of receiving the vaccines, she fainted for 1-2 minute - loss of consciousness. Placed on the floor. For 40 minutes continued to not feel well and remained groggy. 911 summoned and took her to hospital ER. Given IV hydration over 2 hours and was discharged home in good condition. No sequelae since the incident. (called patient on several occasions).
Age: 18.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Electroencephalogram, Narcolepsy, Sleep study, Somnolence
Clinical narrative: Excessive sleepiness. Was diagnosed with narcolepsy by a neurologist. Treatment has included amantadine, NUVIGIL, ADDERALL XL.
Age: 15.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Fatigue, Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report (initial receipt 05-Jun-2012) concerns a 15-year-old female patient, who had a medical history of type 1 diabetes mellitus and a reaction to Thimerosal in prior vaccination (type uncertain) which resulted in rash. Concomitant medication included NOVOLOG insulin via a pump. On 20-Feb-2012 the patient received INFLUENZA vaccination in her right deltoid (manufacturer and batch no. were not provided) and PNEUMOVAX 23 0.5 ml intramuscularly in her left deltoid. On 21-Feb-2012 the patient experienced left upper arm cellulitis, left arm pain and fatigue. Most of the patient's left upper outer arm became erythematous, warm and very tender. She developed a fever of 100.7F. She was treated with oral AUGMENTIN and intramuscular (IM) ROCEPHIN. The next day the redness in upper arm improved but new redness and swelling developed in her clavicle and lower arm near elbow. The fever resolved. New areas of erythema would begin in the arm as other areas resolved. AUGMENTIN was stopped and OMNICEF was started. The erythema stopped spreading. Clindamycin was provided for methicillin-resistant staphylococcal aureus (MRSA) coverage. By 29-Feb-2012 the erythema and warmth had resolved. The pain persisted for another month or so. The outcome for the events was recovered. The patient was no longer receiving treatment. On 29-May-2012, the reporter provided PNEUMOVAX 23 as a suspect drug and INFLUENZA vaccination as a concomitant medication.
Age: 15.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Oedema peripheral, Pain in extremity, Pyrexia, Swelling
Clinical narrative: This spontaneous report (initial receipt 05-Jun-2012) concerns a 15-year-old female patient, who had a medical history of type 1 diabetes mellitus and a reaction to Thimerosal in prior vaccination (type uncertain) which resulted in rash. Concomitant medication included NOVOLOG insulin via a pump. On 20-Feb-2012 the patient received INFLUENZA vaccination in her right deltoid (manufacturer and batch no. were not provided) and PNEUMOVAX 23 0.5 ml intramuscularly in her left deltoid. On 21-Feb-2012 the patient experienced left upper arm cellulitis, left arm pain and fatigue. Most of the patient's left upper outer arm became erythematous, warm and very tender. She developed a fever of 100.7F. She was treated with oral AUGMENTIN and intramuscular (IM) ROCEPHIN. The next day the redness in upper arm improved but new redness and swelling developed in her clavicle and lower arm near elbow. The fever resolved. New areas of erythema would begin in the arm as other areas resolved. AUGMENTIN was stopped and OMNICEF was started. The erythema stopped spreading. Clindamycin was provided for methicillin-resistant staphylococcal aureus (MRSA) coverage. By 29-Feb-2012 the erythema and warmth had resolved. The pain persisted for another month or so. The outcome for the events was recovered. The patient was no longer receiving treatment. On 29-May-2012, the reporter provided PNEUMOVAX 23 as a suspect drug and INFLUENZA vaccination as a concomitant medication.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Redness to the right thigh.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Allergy test negative, Blood immunoglobulin E, Body temperature increased, Erythema, Fatigue
Clinical narrative: On 10/24/05 the pt received AFLURIA (CSL U1771AA). Approximately, 3 hours later a colleague noted that the pt's face was red. The pt felt warm and "fatigued". He reported to medical and when he removed his shirt it was noted that he had red raised "blotches" on his chest, neck, arms, waist and groin. The pt recalls that his temp was 102. He denied pruritus, facial/lip swelling, difficulty swallowing, N,V, increase in diarrhea, SOB, cough. The pt recalls that an IV was started and that he was treated with MOTRIN. He thinks that he was given IV antibiotics but is not sure. The pt was released after several hours. He was seen in follow-up the next day with improvements of his fever and rash but not resolution. He does not recall when his temperature returned to normal but it did take about 3 days for the rash to resolve. There is on documentation of this event in the pt's medical record (paper copy or ER). Of note, the EMR indicates that the pt received an H1N1 vaccination on 1/29/12 and an INFLUENZA vaccination on 11/6/12. These vaccinations are not recorded in the pt's medical record (paper copy) and the pt is certain that he did not receive these vaccinations as he was told in 2005 that he should not receive further INFLUENZA vaccinations.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Radioallergosorbent test positive, Rash macular
Clinical narrative: On 10/24/05 the pt received AFLURIA (CSL U1771AA). Approximately, 3 hours later a colleague noted that the pt's face was red. The pt felt warm and "fatigued". He reported to medical and when he removed his shirt it was noted that he had red raised "blotches" on his chest, neck, arms, waist and groin. The pt recalls that his temp was 102. He denied pruritus, facial/lip swelling, difficulty swallowing, N,V, increase in diarrhea, SOB, cough. The pt recalls that an IV was started and that he was treated with MOTRIN. He thinks that he was given IV antibiotics but is not sure. The pt was released after several hours. He was seen in follow-up the next day with improvements of his fever and rash but not resolution. He does not recall when his temperature returned to normal but it did take about 3 days for the rash to resolve. There is on documentation of this event in the pt's medical record (paper copy or ER). Of note, the EMR indicates that the pt received an H1N1 vaccination on 1/29/12 and an INFLUENZA vaccination on 11/6/12. These vaccinations are not recorded in the pt's medical record (paper copy) and the pt is certain that he did not receive these vaccinations as he was told in 2005 that he should not receive further INFLUENZA vaccinations.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Computerised tomogram head, Dyskinesia, Electrocardiogram, Full blood count, Headache
Clinical narrative: Patient had a sudden onset of pressure in her head four days later pt feeling vision closed it and darken. Pt lost consciousness & collapsed to the floor. Generalized jerking while unconscious.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Loss of consciousness, Metabolic function test, Syncope, Urine analysis, Visual impairment
Clinical narrative: Patient had a sudden onset of pressure in her head four days later pt feeling vision closed it and darken. Pt lost consciousness & collapsed to the floor. Generalized jerking while unconscious.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Patient had a sudden onset of pressure in her head four days later pt feeling vision closed it and darken. Pt lost consciousness & collapsed to the floor. Generalized jerking while unconscious.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Decreased appetite, Full blood count, Irritability, Platelet count normal, Pyrexia
Clinical narrative: 06.07.12 - MMR given. 06.14.12 - rash, irritability, poor eating, fever. 06.15.12 - recovered. 6.20.12 rash irritability still with symptoms.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, White blood cell count, White blood cell count normal
Clinical narrative: 06.07.12 - MMR given. 06.14.12 - rash, irritability, poor eating, fever. 06.15.12 - recovered. 6.20.12 rash irritability still with symptoms.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Abscess, Cellulitis, Injection site erythema, Injection site rash
Clinical narrative: Red bumps on (L) upper arm area.
Age: 1.11
Sex: M
Vaccine: FLU3, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Crying, Erythema, Local swelling, Petechiae
Clinical narrative: Infant crying hard during and after injections, within 2-3 minutes of getting vaccines, red, raised areas developed on face and head, approx 10 total. No other signs of reaction.  Discussed with mother going to ER, she was in agreement. Seen by ER physician who dx it as petechial rash, but said he had never seen such a reaction before. No treatment, told to follow up with family physician.
Age: 1.36
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Headache, Irritability, Nasal congestion, Pyrexia
Clinical narrative: Fussy after shots, parent reports fever but no temperature taken.  Reports Tylenol given but no relief.  Will take to Emergency Room for evaluation.  Also reports headache and stuffy nose.  Parent reports will call back with update.  6/18:  parent did not return call.   Unable to reach for more info.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Convulsion, Loss of consciousness
Clinical narrative: Lost consciousness, seizure noted approximately 30 seconds.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Leukocytosis, White blood cell count increased
Clinical narrative: Cellulitis at injection site. Leukocytosis.
Age: 22.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Skin discolouration, Swelling
Clinical narrative: Patient present mild redness to back of L arm measuring from 7" L x 3.5 " W.  Top point of measurement is dark in coloration till the last 1" of measurement if red and arm to touch.  Patient states she noticed the increase of redness and swelling on Friday night into Saturday morning and she thought maybe it is because it was from graduation and everyone hugging her.  Then she states it felt better on Sunday; still with some mild redness & swelling; reports feeling better today; instructed patient to take IBU as directed and apply ice to area for 15-20 min several times a day.  F/U if no improvement by 1-2 days is recommended, sooner if symptoms worsen.  to RTC Urgent care for re-evaluation.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Blood creatine phosphokinase MB normal, Blood creatine phosphokinase normal, C-reactive protein increased, Chest X-ray normal, Dyspnoea
Clinical narrative: 23 year-old M, primary SPV vaccinee who received his SPV on 4 June, with no other vaccines, reported intermittent episodes of shortness of breath during the period between 12 and 14 June (8-10 days post-vaccine receipt). Patient denies any chest pain or pressure. Denies palpitations. He describes the shortness of breath like "being at 7,000 feet altitude". No other accompanying symptoms except felt "crumby" - tired, achy. Symptoms not severe enough to seek medical evaluation at the time and also said "he was too busy with work". Patient noted dyspnea when walking, but reports there were times during this period when he exerted himself and did not experience dyspnea. He was unable to identify factors making symptoms worse or that made them better. Symptoms have not recurred since 14 June. Patient did not self treat. He denies any recent infections or exposures. He denies any chronic illnesses, especially DM, HTN and hyperlipidemia. He reports asthma during elementary school, but not since then. He takes no medications on a routine basis. Patient smokes about 1/4 ppd x 3 years. He has not family history of premature CAD, but mother had CVA around age 57. Patient routinely runs and lifts weights. Reports running 2 miles this morning without experiencing any symptoms. No hx of any previous vaccine adverse events.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram normal, Fatigue, Full blood count normal, Metabolic function test normal, Pain
Clinical narrative: 23 year-old M, primary SPV vaccinee who received his SPV on 4 June, with no other vaccines, reported intermittent episodes of shortness of breath during the period between 12 and 14 June (8-10 days post-vaccine receipt). Patient denies any chest pain or pressure. Denies palpitations. He describes the shortness of breath like "being at 7,000 feet altitude". No other accompanying symptoms except felt "crumby" - tired, achy. Symptoms not severe enough to seek medical evaluation at the time and also said "he was too busy with work". Patient noted dyspnea when walking, but reports there were times during this period when he exerted himself and did not experience dyspnea. He was unable to identify factors making symptoms worse or that made them better. Symptoms have not recurred since 14 June. Patient did not self treat. He denies any recent infections or exposures. He denies any chronic illnesses, especially DM, HTN and hyperlipidemia. He reports asthma during elementary school, but not since then. He takes no medications on a routine basis. Patient smokes about 1/4 ppd x 3 years. He has not family history of premature CAD, but mother had CVA around age 57. Patient routinely runs and lifts weights. Reports running 2 miles this morning without experiencing any symptoms. No hx of any previous vaccine adverse events.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Red blood cell sedimentation rate normal, Troponin I
Clinical narrative: 23 year-old M, primary SPV vaccinee who received his SPV on 4 June, with no other vaccines, reported intermittent episodes of shortness of breath during the period between 12 and 14 June (8-10 days post-vaccine receipt). Patient denies any chest pain or pressure. Denies palpitations. He describes the shortness of breath like "being at 7,000 feet altitude". No other accompanying symptoms except felt "crumby" - tired, achy. Symptoms not severe enough to seek medical evaluation at the time and also said "he was too busy with work". Patient noted dyspnea when walking, but reports there were times during this period when he exerted himself and did not experience dyspnea. He was unable to identify factors making symptoms worse or that made them better. Symptoms have not recurred since 14 June. Patient did not self treat. He denies any recent infections or exposures. He denies any chronic illnesses, especially DM, HTN and hyperlipidemia. He reports asthma during elementary school, but not since then. He takes no medications on a routine basis. Patient smokes about 1/4 ppd x 3 years. He has not family history of premature CAD, but mother had CVA around age 57. Patient routinely runs and lifts weights. Reports running 2 miles this morning without experiencing any symptoms. No hx of any previous vaccine adverse events.
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Blood test, Body temperature, Chills, Fatigue, Influenza virus test
Clinical narrative: Fatigue, chills, temp, vomiting. ER admitted fluids meds. 5hr duration.
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Urine analysis, Vomiting
Clinical narrative: Fatigue, chills, temp, vomiting. ER admitted fluids meds. 5hr duration.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Narcolepsy, Somnolence
Clinical narrative: Onset of severe daytime sleepiness.  Saw sleep doctor who diagnosed pt with narcolepsy and informed parents that it may have been due to the flu/H1N1 vaccine.
Age: 17.0
Sex: M
Vaccine: HEP, HEPA, HPV4, MNQ, HEP, HEPA, HPV4, MNQ
Symptoms: Blood glucose, Dizziness, Pallor, Tremor, Vomiting
Clinical narrative: While vaccines were being administered by medical assistant she noted that the patient turned pale and started having mild upper body shaking.  Lasted around 5 seconds.  Patient then started to vomit.  When questioned patient reports that he felt lightheaded and the next thing he noticed was "everyone" in the room.  Patient was taken to a room to lie down.  VS taken and blood sugar.  Blood was drawn as well before vaccines were adminstered.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: One swollen, hard, painful lymph node at 12:45 PM 06/19/2012. Cluster of at least 3 swollen, hard, painful lymph nodes upon awakening at 11:00 AM 06/20/2012.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash macular, Rash pruritic
Clinical narrative: Pt received KINRIX, MMR & Varicella yesterday. Today has red, itchy blotches on back of neck armpits trunk. None on arms/legs. No fever. Adv BENADRYL and to contact office if symptoms worsen or change.
Age: 0.13
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Diarrhea - Surely non bloody stool with each feeding starting 24 hour after Rotavirus.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Chills, Injection site swelling, Lethargy
Clinical narrative: Per email from Pt: After shift I began to feel weak, sore and lethargic. This continued throughout the day (I took 2 naps on the 14th totaling 6 hours). Throughout the night I had cold chills and pretty severe joint pain. Upon waking up on the am of the 15th, most of my symptoms had gone away however I noticed that the injection site had severe swelling. It looked like someone had cut half an apple and placed it on my arm. After consulting with my family physician, he requested I come to either him or urgent care. I proceeded to Urgent care & spoke with the on duty Dr. His diagnosis was that the injection may have 1 of 2 things, either a blood vessel to burst & this resulted in a hematoma (although the doctor hadn't seen swelling like this before) or a possible infection in the muscle secondary to the injection. Because of the possibility of the infection he prescribed me an antibiotic.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Per email from Pt: After shift I began to feel weak, sore and lethargic. This continued throughout the day (I took 2 naps on the 14th totaling 6 hours). Throughout the night I had cold chills and pretty severe joint pain. Upon waking up on the am of the 15th, most of my symptoms had gone away however I noticed that the injection site had severe swelling. It looked like someone had cut half an apple and placed it on my arm. After consulting with my family physician, he requested I come to either him or urgent care. I proceeded to Urgent care & spoke with the on duty Dr. His diagnosis was that the injection may have 1 of 2 things, either a blood vessel to burst & this resulted in a hematoma (although the doctor hadn't seen swelling like this before) or a possible infection in the muscle secondary to the injection. Because of the possibility of the infection he prescribed me an antibiotic.
Age: 60.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: SEVERE RASH.
Sex: M
Vaccine: HEP
Symptoms: Developmental delay
Clinical narrative: Severe Developmental Delays.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: 11 x 13 mm area of erythema and swelling.
Age: 1.21
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Condition aggravated, Eczema, Injection site eczema, Injection site mass, Pruritus
Clinical narrative: Patient woke up with a golf ball sized lump at injection site that lasted four weeks and a very aggravated eczema patch at injection site that lasted six weeks. Ever since, she has had severe eczema all over her body, requiring long-term use of corticosteroids to control itching. She has scratched her skin off several times and constantly has scratches on her body where she has scratched so hard she bleeds.
Age: 1.21
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Scratch, Skin haemorrhage
Clinical narrative: Patient woke up with a golf ball sized lump at injection site that lasted four weeks and a very aggravated eczema patch at injection site that lasted six weeks. Ever since, she has had severe eczema all over her body, requiring long-term use of corticosteroids to control itching. She has scratched her skin off several times and constantly has scratches on her body where she has scratched so hard she bleeds.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Epistaxis, Nasal cavity packing
Clinical narrative: Stated approx. 2 hrs after receiving vaccines. Had a profuse nose bleed. Went to ER she stated her BP was 195/105 and they couldn't stop the bleeding so they had to pack the nares.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Urticaria.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Fainting.
Sex: M
Vaccine: HEP
Symptoms: Eczema, Urticaria
Clinical narrative: Hives head to toe hours after vaccine given. Vaccine was also given against parents will. Child's hives got increasingly worse over 24 hours after injection. Child started with severe eczema within weeks that was felt to be related to vaccine by all doctors.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Injection site pain, Nausea
Clinical narrative: Fever (subjective), nausea, vomiting, redness, tenderness, swelling, pain to injection site with redness spreading to majority of upper arm. Unable to raise affected arm past 90 degrees.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Swelling, Tenderness, Vomiting
Clinical narrative: Fever (subjective), nausea, vomiting, redness, tenderness, swelling, pain to injection site with redness spreading to majority of upper arm. Unable to raise affected arm past 90 degrees.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, OPV, PPV, RVX
Symptoms: Abnormal behaviour, Chills, Confusional state, Crying, Dehydration
Clinical narrative: Severe fevers, chills, constant diarrhea, nursing constantly for 2.5 days, no sleep in 2.5 days, confusion (not recognizing parents), aches and pains, possible loss of sight (no reaction to light changes, movement, etc.), inconsolable crying, needing to be held non-stop, serious sweating and dehydration, slight writhing of limbs.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, OPV, PPV, RVX
Symptoms: Diarrhoea, Hyperhidrosis, Increased appetite, Insomnia, Pain
Clinical narrative: Severe fevers, chills, constant diarrhea, nursing constantly for 2.5 days, no sleep in 2.5 days, confusion (not recognizing parents), aches and pains, possible loss of sight (no reaction to light changes, movement, etc.), inconsolable crying, needing to be held non-stop, serious sweating and dehydration, slight writhing of limbs.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, OPV, PPV, RVX
Symptoms: Pyrexia, Unresponsive to stimuli
Clinical narrative: Severe fevers, chills, constant diarrhea, nursing constantly for 2.5 days, no sleep in 2.5 days, confusion (not recognizing parents), aches and pains, possible loss of sight (no reaction to light changes, movement, etc.), inconsolable crying, needing to be held non-stop, serious sweating and dehydration, slight writhing of limbs.
Age: 0.21
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Decreased appetite, Diarrhoea, Malaise, Pyrexia, Vomiting
Clinical narrative: Diarrhea, watery not associated with vomiting. He had low grade fever, slightly decreased appetite. Activity unchanged. Voiding well. He had 4-5 large watery and 3-4 moderate amount of mushy stools. Physical exam today showed a happy, smiling and cooing baby, temp. of 100.4 (R) Weight=12# 15oz (weight yesterday=13#), moist mucous membranes. Rest of P E unremarkable. Mom Started feeling sick yesterday and today she is having diarrhea also. Rx: Continue breastfeeding.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Lethargy, Ocular hyperaemia, Pyrexia, Rash
Clinical narrative: She develop Red eye, lethergy and sleepy (06/17/12) that night has has Fever 103-104F for 8-12 hrs then dropped as Tylenol given, cough then runny nose start with rash from 19 Jun 2012.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Rhinorrhoea, Somnolence
Clinical narrative: She develop Red eye, lethergy and sleepy (06/17/12) that night has has Fever 103-104F for 8-12 hrs then dropped as Tylenol given, cough then runny nose start with rash from 19 Jun 2012.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient complained of red, itchy arm at the area of injection site. This persisted for about 1 week. She didn't use any treatment.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Dyskinesia
Clinical narrative: After patient received vaccines patient slumped in the waiting room chair and began having jerking motions. Patient was transferred via wheelchair to stretcher. Placed with legs above heart. Medical doctor and RN called to the scene and monitored vital signs. Discharged after vital signs normal and lightheadedness and dizziness resolved.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Patient diagnosed with shingles at dr's office 6-20-12 started on VALTREX. No previous dx of chickenpox. Did receive two doses of Varicella vaccine, one at 12 mo of age and one at 11 years.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site induration, Injection site pain
Clinical narrative: Complains of left upper arm pain of decreased movement secondary to pain two week after injection. Left tricep feels more firm and is tender touch.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: MMR (Rt leg) & Varicella (Lt leg) given child fine no severe reaction (was observed approx 45 min). Other than injection sites slightly red. Mother called next day (6-12-12) stating right leg (where MMR given) was red the entire leg. Advised to go to ER. Mother states gave BENADRYL and redness went away.
Age: 1.51
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Accidental exposure
Clinical narrative: None.
Age: 1.51
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Muscle strain, Pain, Pain in extremity, Rash
Clinical narrative: Information has been received from a 71 year old male patient reporting on himself with a history of fever blister on lips and neuralgia who on 17-MAY-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number: 670755/0622AA) (dose and site of administration were not reported). Concomitant therapy included ADVAIR, ezetimibe, AVODART and timolol (manufacturer unspecified). On 22-MAY-2012, the patient began to experience a tingling and burning in his left thigh and thought it was neuralgia that the patient had experienced before. On 23-MAY-2012, the patient went to ER and was given SKELAXIN a muscle relaxer but the patient got worse. The patient had what was called lightening bolt pain, a shooting pain. On 27-MAY-2012, the patient was worse and went back to the same hospital ER and saw the same doctor who apologized for not diagnosing the patient with shingles the first time. The patient's symptoms were muscle pain, pain between knee and upper thigh on the left side and around the patient's abdomen and up under the patient's left armpit. The patient had a rash in these places as well. The patient was told to not take the SKELAXIN any more and was prescribed VICODIN and VALTREX. A yearly blood work was performed (results not provided). At the time of the report, the patient was recovering. Follow up information has been received from the consumer who reported that he was still suffering. The patient reported that he received 2 allergy shots in his left arm on 21-MAY-2012. These injection were for allergies to weed and pollen. It was reported that VICODIN was not relieving his pain. Follow up information has been received from a physician concerning a retired patient with a history of chickenpox. It was reported that the patient received ZOSTAVAX (Merck) at drug store and 3 days later, on 19-MAY-2012, he developed extensive Herpes zoster eruptions on same side of body - back thigh. It was reported that rash occurred. Other systemic symptoms included malaise. Pain was 9 on 10-grade scale. Maximum temperature was 99. There was no recent exposure to chickenpox or Herpes zoster. No direct fluorescent antibody was done. No photo was taken. At the time of report the patient was recovering (also reported that the duration of Herpes zoster was 10 days). Reported adverse events were considered to be disabling and other important medical events by the physician. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Axillary pain, Blood test, Burning sensation, Herpes zoster
Clinical narrative: Information has been received from a 71 year old male patient reporting on himself with a history of fever blister on lips and neuralgia who on 17-MAY-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number: 670755/0622AA) (dose and site of administration were not reported). Concomitant therapy included ADVAIR, ezetimibe, AVODART and timolol (manufacturer unspecified). On 22-MAY-2012, the patient began to experience a tingling and burning in his left thigh and thought it was neuralgia that the patient had experienced before. On 23-MAY-2012, the patient went to ER and was given SKELAXIN a muscle relaxer but the patient got worse. The patient had what was called lightening bolt pain, a shooting pain. On 27-MAY-2012, the patient was worse and went back to the same hospital ER and saw the same doctor who apologized for not diagnosing the patient with shingles the first time. The patient's symptoms were muscle pain, pain between knee and upper thigh on the left side and around the patient's abdomen and up under the patient's left armpit. The patient had a rash in these places as well. The patient was told to not take the SKELAXIN any more and was prescribed VICODIN and VALTREX. A yearly blood work was performed (results not provided). At the time of the report, the patient was recovering. Follow up information has been received from the consumer who reported that he was still suffering. The patient reported that he received 2 allergy shots in his left arm on 21-MAY-2012. These injection were for allergies to weed and pollen. It was reported that VICODIN was not relieving his pain. Follow up information has been received from a physician concerning a retired patient with a history of chickenpox. It was reported that the patient received ZOSTAVAX (Merck) at drug store and 3 days later, on 19-MAY-2012, he developed extensive Herpes zoster eruptions on same side of body - back thigh. It was reported that rash occurred. Other systemic symptoms included malaise. Pain was 9 on 10-grade scale. Maximum temperature was 99. There was no recent exposure to chickenpox or Herpes zoster. No direct fluorescent antibody was done. No photo was taken. At the time of report the patient was recovering (also reported that the duration of Herpes zoster was 10 days). Reported adverse events were considered to be disabling and other important medical events by the physician. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Myalgia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a 71 year old male patient reporting on himself with a history of fever blister on lips and neuralgia who on 17-MAY-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number: 670755/0622AA) (dose and site of administration were not reported). Concomitant therapy included ADVAIR, ezetimibe, AVODART and timolol (manufacturer unspecified). On 22-MAY-2012, the patient began to experience a tingling and burning in his left thigh and thought it was neuralgia that the patient had experienced before. On 23-MAY-2012, the patient went to ER and was given SKELAXIN a muscle relaxer but the patient got worse. The patient had what was called lightening bolt pain, a shooting pain. On 27-MAY-2012, the patient was worse and went back to the same hospital ER and saw the same doctor who apologized for not diagnosing the patient with shingles the first time. The patient's symptoms were muscle pain, pain between knee and upper thigh on the left side and around the patient's abdomen and up under the patient's left armpit. The patient had a rash in these places as well. The patient was told to not take the SKELAXIN any more and was prescribed VICODIN and VALTREX. A yearly blood work was performed (results not provided). At the time of the report, the patient was recovering. Follow up information has been received from the consumer who reported that he was still suffering. The patient reported that he received 2 allergy shots in his left arm on 21-MAY-2012. These injection were for allergies to weed and pollen. It was reported that VICODIN was not relieving his pain. Follow up information has been received from a physician concerning a retired patient with a history of chickenpox. It was reported that the patient received ZOSTAVAX (Merck) at drug store and 3 days later, on 19-MAY-2012, he developed extensive Herpes zoster eruptions on same side of body - back thigh. It was reported that rash occurred. Other systemic symptoms included malaise. Pain was 9 on 10-grade scale. Maximum temperature was 99. There was no recent exposure to chickenpox or Herpes zoster. No direct fluorescent antibody was done. No photo was taken. At the time of report the patient was recovering (also reported that the duration of Herpes zoster was 10 days). Reported adverse events were considered to be disabling and other important medical events by the physician. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a 71 year old male patient reporting on himself with a history of fever blister on lips and neuralgia who on 17-MAY-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number: 670755/0622AA) (dose and site of administration were not reported). Concomitant therapy included ADVAIR, ezetimibe, AVODART and timolol (manufacturer unspecified). On 22-MAY-2012, the patient began to experience a tingling and burning in his left thigh and thought it was neuralgia that the patient had experienced before. On 23-MAY-2012, the patient went to ER and was given SKELAXIN a muscle relaxer but the patient got worse. The patient had what was called lightening bolt pain, a shooting pain. On 27-MAY-2012, the patient was worse and went back to the same hospital ER and saw the same doctor who apologized for not diagnosing the patient with shingles the first time. The patient's symptoms were muscle pain, pain between knee and upper thigh on the left side and around the patient's abdomen and up under the patient's left armpit. The patient had a rash in these places as well. The patient was told to not take the SKELAXIN any more and was prescribed VICODIN and VALTREX. A yearly blood work was performed (results not provided). At the time of the report, the patient was recovering. Follow up information has been received from the consumer who reported that he was still suffering. The patient reported that he received 2 allergy shots in his left arm on 21-MAY-2012. These injection were for allergies to weed and pollen. It was reported that VICODIN was not relieving his pain. Follow up information has been received from a physician concerning a retired patient with a history of chickenpox. It was reported that the patient received ZOSTAVAX (Merck) at drug store and 3 days later, on 19-MAY-2012, he developed extensive Herpes zoster eruptions on same side of body - back thigh. It was reported that rash occurred. Other systemic symptoms included malaise. Pain was 9 on 10-grade scale. Maximum temperature was 99. There was no recent exposure to chickenpox or Herpes zoster. No direct fluorescent antibody was done. No photo was taken. At the time of report the patient was recovering (also reported that the duration of Herpes zoster was 10 days). Reported adverse events were considered to be disabling and other important medical events by the physician. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Abdominal pain upper, Chills, Pyrexia, Tenderness
Clinical narrative: Fever, chills, tender right arm, following day complaints of stomach pain.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Injection site swelling, Injection site warmth, Paraesthesia
Clinical narrative: Day 1 swelling from shoulder to injection site - hot to touch. Day 2 swelling continued to elbow. Day 3 tingling feeling across back of fingers (numb). 6/11 mentioned tingling from nose to temple. MD diagnosed as mild case of shingles.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Initial report was received from a health care professional on 14 June 2012. This is a cluster of two patients who received DAPTACEL and IPOL and developed cellulitis. The other patient was captured in case number 2012-06188. A four-year-old female patient had received the following vaccinations on 11 June 2012: a dose five intramuscular injection in the left thigh of DAPTACEL, sanofi pasteur Ltd., lot number C3944AA, a dose four intramuscular injection in the right thigh of IPOL, sanofi pasteur SA, lot number H1305, an injection of MMR II, Merck (lot number, route and site not reported) and an injection of VARIVAX, Merck (lot number, route and site not reported). On 13 June 2012, the patient experienced a site reaction on the left thigh of redness and swelling. The doctor diagnosed the patient with cellulitis and prescribed "cefeloxin" 250mg/5ml. Illness at the time of vaccination and past medical history were reported as none. The patient's outcome was unknown. Documents held by sender: None.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site haematoma, Injection site pain, Injection site swelling
Clinical narrative: Swelling, pain, some bruising in site left deltoid area. Redness, size of orange. Prednisone ordered by Dr.
Age: 40.0
Sex: M
Vaccine: MMR
Symptoms: Condition aggravated, Convulsion, Joint injury, Neck injury
Clinical narrative: On the light rail went into seizure a few hours after receiving MMR-actually felt this one coming on. My last seizure was last year in November. "My elbows and neck are injured as a rash" took a while"" ER I don't know how I got there.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Rash, Swelling
Clinical narrative: Swelling, redness, soreness, itching, slight bumps - remaining and increasing in intensity to this time on 06/21/2012.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Respiratory arrest, Syncope
Clinical narrative: At about 9:51 right after the second vaccination (Hepatitis A) given the client fainted completely.  The ARNP was called into the room.  The client stopped breathing for about 15 seconds.  Cold compresses were applied.  BP=98/64.  Client came to after several minutes and requested to lay down.  She was assisted to a lying position from the chair where immunization was administered.  Chocolate and soda were given.  The client admitted to having eaten nothing for breakfast.  The mother said that a similar reaction occured before when the client's ears were pierced.  BP on recheck was 118/72.  Client rested for about 20 minutes and then was assisted up slowly and sat up for several minutes and then was able to walk out of the clinic.  Client's mother has the VIS forms.  She was instructed to have the client lie down next time a shot is given and to discuss with the provider.  The first shot administered was the Menactra.  I discussed hepatitis A after that and the second shot given about 5 minutes later.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Injection site pruritus, Injection site swelling, Rash erythematous
Clinical narrative: Pt developed red rash, itching and swelling at injection site.
Age: 1.04
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 10.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Fainting, convulsions. Put child's feet up, gave water, blood pressure normal.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: The next day ran fever up to 102.1. Treated with ibuprofen 600mg tid. Fever resolved by 6-10-12.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling, Tenderness
Clinical narrative: Redness, sore to the touch, itching, swelling.
Age: 33.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: CSF protein increased, CSF white blood cell count negative, Demyelinating polyneuropathy, Electromyogram abnormal, Guillain-Barre syndrome
Clinical narrative: Hospitalized for Guillain Barre Syndrome on 4/4/12.
Age: 33.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal cord abnormal, Spinal osteoarthritis
Clinical narrative: Hospitalized for Guillain Barre Syndrome on 4/4/12.
Age: 24.0
Sex: F
Vaccine: HPV4, PPV
Symptoms: Abortion spontaneous, Human chorionic gonadotropin positive, Maternal exposure during pregnancy, Pneumonia
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female patient who was on ALESSE therapy (unspecified when it was discontinued) and with urinary tract infection, genital herpes and no drug reactions or allergies. On 27-JUL-2011, the patient were vaccinated with the first dose of GARDASIL (lot number: 669308/0636AA, expiration date 11-AUG-2013), 0.5 mL, intramuscularly. Secondary suspect vaccine included a dose of PNEUMOVAX 23 (lot number: 668009/1174Z, expiration date: 10-MAR-2012) (dose and site of administration not reported). Concomitant vaccine included a dose of ADACEL while pregnant. No symptoms were reported. The patient sought unspecified medical attention. No treatment was given for the adverse event. On unspecified date, urine pregnancy test were performed. It was reported that the LMP was on 22-JUN-2011 and EDD was on 28-MAR-2012. Follow-up information was received from a nurse who stated that the patient had a spontaneous abortion; however the exact date was not recorded. The nurse stated the the patient's due date was 28-MAR-2012, and after 28-JUL-2011 (adverse event initial report), the patient never went for her late September 2011 "OB" visit (patient canceled). In January 2012, the patient was reportedly hospitalized for pneumonia, and was seen by the office practice physicians for post hospitalization follow-up in February 2012, but there was no mentioned of an ongoing pregnancy in her record. It was also reported that the patient was pregnant as of May 2012 (approximately 4 weeks), after vaccination with GARDASIL and PNEUMOVAX 23 (MSD, WAES1206USA02290). No further information is available.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Headache, Pruritus, Skin warm, Swelling
Clinical narrative: Starting itching post injection. Swelling started that night. Headache, returned to clinic. Site: left arm posterior raised 12cm x 11cm, pruritic, red, warm to touch. Seen by physician at clinic 6/21. Acetaminophen 500mg tab every six hours prescribed.
Age: 16.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Antibiotic resistant Staphylococcus test positive, Culture wound positive, Injection site vesicles, Pain, Polymerase chain reaction
Clinical narrative: One day after Varicella vaccine administered in right arm, patient developed a vesicular patch on that upper arm. The rash spread across right side of chest & neck. The rash was painful. Clinically, it appeared like shingles. It also grew a small amount of methicillin-sensitive staph aureus. The rash was (+) for varicella on PCR.
Age: 16.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Rash, Varicella virus test positive
Clinical narrative: One day after Varicella vaccine administered in right arm, patient developed a vesicular patch on that upper arm. The rash spread across right side of chest & neck. The rash was painful. Clinically, it appeared like shingles. It also grew a small amount of methicillin-sensitive staph aureus. The rash was (+) for varicella on PCR.