chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.21
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Cyanosis, Electrocardiogram normal, Electroencephalogram normal, Full blood count normal, Grand mal convulsion
Clinical narrative: Patient had her vaccines and went down to the lab for blood draw. She started crying just before the blood draw and held her breath turning blue. Her mother blew on her face and she took a breath and turned pink. Started crying again and agin held her breath but this time she had a generalized tonic clonic seizure lasting 15 minutes. Required Diastat and oxygen.
Age: 1.21
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: Patient had her vaccines and went down to the lab for blood draw. She started crying just before the blood draw and held her breath turning blue. Her mother blew on her face and she took a breath and turned pink. Started crying again and agin held her breath but this time she had a generalized tonic clonic seizure lasting 15 minutes. Required Diastat and oxygen.
Age: 1.02
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Agitation, Pyrexia, Rash, Roseola
Clinical narrative: Patient became agitated. Began running fever. Fever 102.1 Thursday, Friday high as 104, Saturday high of 103, Sunday 102. Treated with infant acetaminophen during day and ibuprofen at night.  Temp normal on 10/07/13, rash started. Saw doctor 10/07/13 and was diagnosed with Roseola.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose decreased, Fatigue, Hypersensitivity, Influenza, Injection site pain
Clinical narrative: On 10/2/13 approximately 9:00 AM patient complained of body aches, soreness at injection site, feeling feverish, and fatigue. Patient was sitting in chair at work station and didn't appear to be in severe distress. Nurse stated to this writer "two nurses were called to the patient's floor with an emergency cart. We offered to check patient. Patient declined services." Patient's supervisor notified this writer patient left work about 2:00 PM. At approximately 2:30 PM this writer contacted patient via phone. Patient stated she was being driven by her mother to her doctor's office as she was a type 1 diabetic and had recent problems with her insulin pump. She didn't think the flu shot caused her any untoward reactions. This writer gave client info about the flu shot including vaccine type, manufacture, route, site, and recommended her physician check with the CDC web site and/or call this writer for additional information. Patient verbalizes understanding to call this writer after the patient felt better for follow up. Patient given this writer's contact information. On 10/8/13 this writer contacted patient via phone call. The patient stated the following: "patient vomited 3-4 times and her BS was in the 50's. Her endocrinologist decreased the patient's insulin via insulin pump. Her endocrinologist said the fourth strain in the influenza vaccine was too strong for the patient and affected the patient's BS. Her endocrinologist recommended Ibuprofen 3-4 by mouth every day until pain decreased. The patient contacted Workman's Compensation on 10/3/13 and was sent to Workman's Compensation provider. Patient states the Workman's Compensation provider stated the following: "Patient had allergic reaction to the influenza shot, had an upper respiratory infection (URI), and the flu. Patient filled a prescription for an oral antibiotic she's to take three times a day which she is taking at present.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia, Upper respiratory tract infection, Vomiting
Clinical narrative: On 10/2/13 approximately 9:00 AM patient complained of body aches, soreness at injection site, feeling feverish, and fatigue. Patient was sitting in chair at work station and didn't appear to be in severe distress. Nurse stated to this writer "two nurses were called to the patient's floor with an emergency cart. We offered to check patient. Patient declined services." Patient's supervisor notified this writer patient left work about 2:00 PM. At approximately 2:30 PM this writer contacted patient via phone. Patient stated she was being driven by her mother to her doctor's office as she was a type 1 diabetic and had recent problems with her insulin pump. She didn't think the flu shot caused her any untoward reactions. This writer gave client info about the flu shot including vaccine type, manufacture, route, site, and recommended her physician check with the CDC web site and/or call this writer for additional information. Patient verbalizes understanding to call this writer after the patient felt better for follow up. Patient given this writer's contact information. On 10/8/13 this writer contacted patient via phone call. The patient stated the following: "patient vomited 3-4 times and her BS was in the 50's. Her endocrinologist decreased the patient's insulin via insulin pump. Her endocrinologist said the fourth strain in the influenza vaccine was too strong for the patient and affected the patient's BS. Her endocrinologist recommended Ibuprofen 3-4 by mouth every day until pain decreased. The patient contacted Workman's Compensation on 10/3/13 and was sent to Workman's Compensation provider. Patient states the Workman's Compensation provider stated the following: "Patient had allergic reaction to the influenza shot, had an upper respiratory infection (URI), and the flu. Patient filled a prescription for an oral antibiotic she's to take three times a day which she is taking at present.
Age: 61.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Bedridden, Rash erythematous, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Red rash, raised spreading four inches down from vaccination site. Patient reported bedridden starting five hours post vaccination. Two days later arm is still red, no longer raised feeling better. Required doctors visit.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose increased, Chest discomfort, Dizziness, Feeling jittery, Flushing
Clinical narrative: Patient received flu shot 10/1/13 at 9:45 AM without complaint. On 10/1/13 at approximately 10:30 AM patient complained of chest pressure, dizziness, soreness at injection site, feeling jittery and flushed; and nausea. Patient appeared to be in moderate distress. Was given comfort measures-carbonated drink for nausea, cool moist towel to back of neck, and ice pack. An emergency cart and personnel was brought to patient's office. Blood sugar was assessed via finger stick and was in the 200's. Patient verbalized understanding from this writer of the following: if symptoms become worse and /or if patient developed shortness of breath, difficulty breathing, severe chest pain to call 911 and/or go to the nearest emergency center immediately. Call private provider as soon as possible and explain events of today. Call this writer after the patient felt better for follow up. Patient given this writer's contact information. Patient was driven home by patient's spouse. On 10/8/13 this writer contacted patient via phone call. The patient stated the following: "on 10/2/13 patient went home and symptoms decreased but still had mild body aches, headache, and felt jittery. On 10/3/13 patient went to her provider who said patient had a moderate reaction to receiving the flu shot. On 10/3/13 that evening the patient spoke with Workman's Compensation nurse who advised patient to call nurse if patient needed to see a Workman's Compensation provider. Patient filled prescriptions for an Albuterol inhaler to be used twice a day for three days, and then as needed; and oral Prednisone which she is taking at present.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site pain, Nausea, Pain, Pregnancy test urine negative
Clinical narrative: Patient received flu shot 10/1/13 at 9:45 AM without complaint. On 10/1/13 at approximately 10:30 AM patient complained of chest pressure, dizziness, soreness at injection site, feeling jittery and flushed; and nausea. Patient appeared to be in moderate distress. Was given comfort measures-carbonated drink for nausea, cool moist towel to back of neck, and ice pack. An emergency cart and personnel was brought to patient's office. Blood sugar was assessed via finger stick and was in the 200's. Patient verbalized understanding from this writer of the following: if symptoms become worse and /or if patient developed shortness of breath, difficulty breathing, severe chest pain to call 911 and/or go to the nearest emergency center immediately. Call private provider as soon as possible and explain events of today. Call this writer after the patient felt better for follow up. Patient given this writer's contact information. Patient was driven home by patient's spouse. On 10/8/13 this writer contacted patient via phone call. The patient stated the following: "on 10/2/13 patient went home and symptoms decreased but still had mild body aches, headache, and felt jittery. On 10/3/13 patient went to her provider who said patient had a moderate reaction to receiving the flu shot. On 10/3/13 that evening the patient spoke with Workman's Compensation nurse who advised patient to call nurse if patient needed to see a Workman's Compensation provider. Patient filled prescriptions for an Albuterol inhaler to be used twice a day for three days, and then as needed; and oral Prednisone which she is taking at present.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination complication
Clinical narrative: Patient received flu shot 10/1/13 at 9:45 AM without complaint. On 10/1/13 at approximately 10:30 AM patient complained of chest pressure, dizziness, soreness at injection site, feeling jittery and flushed; and nausea. Patient appeared to be in moderate distress. Was given comfort measures-carbonated drink for nausea, cool moist towel to back of neck, and ice pack. An emergency cart and personnel was brought to patient's office. Blood sugar was assessed via finger stick and was in the 200's. Patient verbalized understanding from this writer of the following: if symptoms become worse and /or if patient developed shortness of breath, difficulty breathing, severe chest pain to call 911 and/or go to the nearest emergency center immediately. Call private provider as soon as possible and explain events of today. Call this writer after the patient felt better for follow up. Patient given this writer's contact information. Patient was driven home by patient's spouse. On 10/8/13 this writer contacted patient via phone call. The patient stated the following: "on 10/2/13 patient went home and symptoms decreased but still had mild body aches, headache, and felt jittery. On 10/3/13 patient went to her provider who said patient had a moderate reaction to receiving the flu shot. On 10/3/13 that evening the patient spoke with Workman's Compensation nurse who advised patient to call nurse if patient needed to see a Workman's Compensation provider. Patient filled prescriptions for an Albuterol inhaler to be used twice a day for three days, and then as needed; and oral Prednisone which she is taking at present.
Age: 62.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Joint stiffness, Joint swelling
Clinical narrative: 3" diameter red and raised area at site of injection. Swollen stiff right knee since injection though it has improved somewhat.
Age: 39.0
Sex: M
Vaccine: FLUN4
Symptoms: Allergy test, Asthma, Chills, Cold sweat, Condition aggravated
Clinical narrative: Pt experienced NVD, extreme cold sweats and chills, loose stools, loss of apetite and inability to keep food down, SOB, post nanal drip, body aches and fever for two days after recieving influenza nasal mist. Patient was admitted to the hospital for 3 days due to ashtma exacerbation.
Age: 39.0
Sex: M
Vaccine: FLUN4
Symptoms: Decreased appetite, Diarrhoea, Dyspnoea, Food intolerance, Gastroenteritis
Clinical narrative: Pt experienced NVD, extreme cold sweats and chills, loose stools, loss of apetite and inability to keep food down, SOB, post nanal drip, body aches and fever for two days after recieving influenza nasal mist. Patient was admitted to the hospital for 3 days due to ashtma exacerbation.
Age: 39.0
Sex: M
Vaccine: FLUN4
Symptoms: Influenza virus test, Nausea, Pain, Pyrexia, Upper-airway cough syndrome
Clinical narrative: Pt experienced NVD, extreme cold sweats and chills, loose stools, loss of apetite and inability to keep food down, SOB, post nanal drip, body aches and fever for two days after recieving influenza nasal mist. Patient was admitted to the hospital for 3 days due to ashtma exacerbation.
Age: 39.0
Sex: M
Vaccine: FLUN4
Symptoms: Vomiting
Clinical narrative: Pt experienced NVD, extreme cold sweats and chills, loose stools, loss of apetite and inability to keep food down, SOB, post nanal drip, body aches and fever for two days after recieving influenza nasal mist. Patient was admitted to the hospital for 3 days due to ashtma exacerbation.
Age: 4.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Abdominal pain upper, Erythema, Pruritus, Rash macular, Swelling face
Clinical narrative: My son said his stomach hurt, and he vomited. Then his face turned red and blotchy. His nose became dark red and swelled. Also, his ears were red, and he started scratching his face and ears, saying they were itchy.
Age: 4.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Vomiting
Clinical narrative: My son said his stomach hurt, and he vomited. Then his face turned red and blotchy. His nose became dark red and swelled. Also, his ears were red, and he started scratching his face and ears, saying they were itchy.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Dyspnoea
Clinical narrative: Within 1-2 minutes of patient receiving flu shot, husband returned to pharmacy asking for pharmacist help with his wife. Upon arrival patient was having trouble breathing despite being on oxygen. Per guest request I called 911 and advised pt to take slow deep breaths per 911 agent.  Per patient/husband, she has has flu shot in past with no reaction. Her husband said she has been battling attacks like these for years for COPD/anxiety and he thought she was having another COPD attack, not a reaction to flu shot.  Pharmacist stayed with patient until paramedics arrived and took over.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: Immediately I was not able to lift my arm, which continued for several days. The pain became more intense and unbearable. I also felt tingling and numbness. This has lasted for several weeks. The arm continues to be painful.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphonia, Headache, Lacrimation increased, Middle insomnia
Clinical narrative: About an hour after the vaccine I started getting a headache.  Appr. 3 hours later, had a constant tickle in my throat causing me to cough excessively, so that I was hoarse within an hour.  Woke up during the night from a fever. (I did not get up and take my temp) Woke up in the morning with a HUGE headache, eyes watering, a slight fever. Had a headache throughout the day on Oct. 9th. On Oct. 10, felt better, very slight headache remained, and small sore throat.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pyrexia, Throat irritation
Clinical narrative: About an hour after the vaccine I started getting a headache.  Appr. 3 hours later, had a constant tickle in my throat causing me to cough excessively, so that I was hoarse within an hour.  Woke up during the night from a fever. (I did not get up and take my temp) Woke up in the morning with a HUGE headache, eyes watering, a slight fever. Had a headache throughout the day on Oct. 9th. On Oct. 10, felt better, very slight headache remained, and small sore throat.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Swelling
Clinical narrative: Started with a small area of redness and expanded to a larger area of redness and swelling (4 inch by 3 inch approx).
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Visual impairment
Clinical narrative: Patient states that he had blank spots in his vision and was having trouble dictating a letter at work.  This occurred about 2 hours after receiving the shot and went away shortly after.  He feels 100% 24 hours later.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Headache, Nausea, Pain, Pyrexia
Clinical narrative: I felt weak, nauseated, severe headache and body aches. I also had a fever of 102.3. Today is 10/10/2013 and I am still symptomatic!!!
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Corneal graft rejection, Vision blurred
Clinical narrative: Haziness in R eye corneal transplant. Seen by Dr at eye clinic on 10/10/13 and diagnosed with corneal rejection. Started on Medrol dose pack and hourly pred forte eye drops. F/U appt on 10/21/13.
Age: 1.42
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Convulsion, Cyanosis, Febrile convulsion, Gaze palsy, Grand mal convulsion
Clinical narrative: Several days after pt had vaccines- was within 2 weeks, she quit breathing and had seizures. Mother informed clinic of this at w/c appt.
Age: 1.42
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Hypotonia, Pyrexia, Rash, Rash papular, Respiratory arrest
Clinical narrative: Several days after pt had vaccines- was within 2 weeks, she quit breathing and had seizures. Mother informed clinic of this at w/c appt.
Age: 1.42
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Varicella post vaccine, Vomiting
Clinical narrative: Several days after pt had vaccines- was within 2 weeks, she quit breathing and had seizures. Mother informed clinic of this at w/c appt.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt received FLUZONE HD on right deltoid area. PNEUMOVAX 23 shot on left deltoid area. Left deltoid (hand) area, swelling, warm to touch, itching and started spreading by the office. Note: Pt received flu shot only every year in past without adverse effect.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Agitation
Clinical narrative: Agitation.
Age: 53.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Hyperhidrosis, Injection site pruritus, Local swelling, Malaise
Clinical narrative: Day after vaccines "sick as a dog" w/ a little nausea, fever/chills/aches/pallor/profuse diaphoresis, arm swelling, itching at injection site, malaise. No treatment sought.
Age: 53.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Nausea, Pain, Pallor, Pyrexia
Clinical narrative: Day after vaccines "sick as a dog" w/ a little nausea, fever/chills/aches/pallor/profuse diaphoresis, arm swelling, itching at injection site, malaise. No treatment sought.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Dyspnoea, Lymphadenopathy, Pyrexia
Clinical narrative: 2 hours after Fluzone was administered pt complained of tight chest, swollen glands, swollen tongue, difficulty breathing. Fever and chills. Patient took an antihistamine.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Swollen tongue
Clinical narrative: 2 hours after Fluzone was administered pt complained of tight chest, swollen glands, swollen tongue, difficulty breathing. Fever and chills. Patient took an antihistamine.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Intensive care, Pulmonary oedema
Clinical narrative: Lungs filled up with water and ended up in ICU per patient.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Localized reddened area 50mm in circumference, warm to touch. No other symptoms. May or not see PCP. As of 10/10/13, no further communication with patient.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: C/O pain at site, hot, red, and the size of her fist 10/9/13. Today has increased in size to the size of her palm. Self medicating with OTC meds. Her husband is an internist and they are monitoring site together.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Axillary mass, Pain in extremity
Clinical narrative: Telephone call from client that since receiving vaccine she has been having pain in left arm, difficulties with bathing and getting stressed now. She feels a lump in her armpit area. She states she has increased pain when moving her arm and states she has a difficult day at work because of the pain in her L arm. Denies swelling, numbness or tingling of fingers. Instructed and encouraged exercising left arm and to go to PMD, Emergency care immediately.
Age: 32.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Local swelling, Pain, Pain in extremity, Pyrexia
Clinical narrative: L arm swelling, redness, pain, body ache, fever.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Tenderness and oval erythematous skin rash (L) lateral deltoid.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Skin warm, Swelling
Clinical narrative: 3 in x 3 in raised, swollen and hot area. Patient unable to sleep. Ordered BENADRYL 25mg q6h x 24h ZANTAC 75mg q12h x 2.
Age: 0.38
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Crying, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness and swelling in both thighs, fever started at 8PM with 102 degree F. Non stop cry, shrill, high pitched for 2-3 hrs. Given Tylenol at 4:45 PM and give Q 4 hrs throughout night. No tolerate cool clothes or bath to cool legs.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site anaesthesia, Injection site pain, Injection site reaction, Muscular weakness, Paraesthesia
Clinical narrative: Pain/weakness/numbness/tingling on arm where vaccine was given (Tdap).
Age: 0.51
Sex: M
Vaccine: DTAP, FLU3, HEP, IPV, PNC13, RV5
Symptoms: Chest X-ray, Crying, Foaming at mouth, Pyrexia, Tremor
Clinical narrative: At 900PM patient was crying and fever was 102.1. Child started shaking all over and some foaming at the corner of mouth that was less than a minute patient followed up in our office on 10/4/2013 seen Dr. and was referred to a neurologist.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Electrocardiogram ambulatory abnormal, Fatigue, Palpitations, Supraventricular extrasystoles, Ventricular extrasystoles
Clinical narrative: The patient is a 57-year-old female with a history of coronary artery disease, hypertension, dyslipidemia and menopause who presents to discuss palpitations. In the beginning of August she had a 2 week period of significant palpitations which has improved since then. About 5 days prior to the initiation of her symptoms she had a vaccination for the shingles virus. She describes the palpitations as a flip-flopping in her chest and associated with symptoms of fatigue. She denies any significant caffeine intake. She did note that with exertion the symptoms improved. She denies any syncopal episodes. Holter monitor worn for 48 hours from September 4, 2012 showed close to 20,000 ventricular ectopic beats with some being in bigeminy and trigeminy. She also had supraventricular beats but only 23 with no significant pauses or runs of SVT.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion, Erythema, Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Patient received Pneumonia vaccination and experienced swelling at injection site, redness and bruising down entire arm. (Right arm only). When she came to pharmacy, everything subsided other than some bruising.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Pt experienced a round red rash around suspected flu shot site (it looks like a spider bite, not 100% if it was the site of the shot). Red circle 1/2 inch in diameter. Used hydrocortisone cream it went away in a few days once he told us about it.
Age: 36.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Local swelling, Pain
Clinical narrative: Left arm swelled to 1 and 1/2 times normal size. Our pharmacy was closed so he went to an open pharmacy and was advised to take Ibuprofen and diphenhydramine and ice the arm. He didn't call us to report event until 10/7/13 at 5:16PM, by then swelling was down but not completely and he still had pain. Pain was also on Rt side and lower rib cage. Phoned pt again for PCP info. He finally returned call 10/10/13 at 5:35P. His arm is no longer swollen and all pain has resolved.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Patient had a tightness in the chest, after about 10 minutes then shortness of breath, the nurse at the school where a flu clinic was given administered EPIPEN and she was taken to the E.R.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Sensation of foreign body, Swelling face
Clinical narrative: Swollen face, blood - shot eyes, "lump" in throat.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Blindness unilateral, Eye pruritus, Eye swelling
Clinical narrative: 4 hours exactly after vaccine itchiing swelling right eye lasted 2 1/2 days, could not see from eye - patient used OTC Thera Tears.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Pruritus, Urticaria
Clinical narrative: Noted itching on trunk and swelling at site of injection - lasted 4 or 5 days. Symptoms: Urticaria Pruritus.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed a red, raised bubble at injection site.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site rash
Clinical narrative: Redness, bumps and hard lump at injection site.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Hypoaesthesia, Paraesthesia
Clinical narrative: Woke during night with numbness lt. arm, tingling in hand and chest discomfort similar to that 10 years ago - "Dr thought flu virus settled around heart" - ADVIL helped nurse at Dr's office suggested nerve possibly touched by needle and to take TYLENOL prn - Client agreed and has no other complaints.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site bruising, Vaccination site inflammation, Vaccination site ulcer
Clinical narrative: Patient came into the pharmacy today and showed me the vaccination site. Was a 3" x 3" inflamed site that looked slightly ulcerated. She said it was a slight bruise on 10/9, progressed to current status fairly rapidly.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia, X-ray limb normal
Clinical narrative: Information per Dr.'s dictation. Flu shot given on 9/24/2013 - felt pain severe when she was given the injection and the pain kind of shot down her arm into her fingers. Stated sore for a few days, but it persisted and she became concerned when pain did not go away. She states that she does get intermittent numbness and tinling in arm. Denies chills, fever, nausea or vomiting no redness swelling after shot. Taking Ibuprofen and will f/u with ortho if needed.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Urticaria
Clinical narrative: One and a half hrs after inj pt states chest pain, SOB then hives pt treated self with BENADRYL, hive gone 1 day later. Pt calling 2 days after these symptoms began.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Vaccination site red - hot to touch - slight swelling - and tenderness. Prescription for BACTRIM DS 1/1 BID x 7 days.
Age: 0.74
Sex: F
Vaccine: FLU3
Symptoms: Grand mal convulsion
Clinical narrative: Patient experienced 2 seizures (generalized tonic clonic) 1st lasted for 1 min. 2nd lasted for 3 mins on the day she received flu shot, did not have fever at the time of seizures.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Arthralgia.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: It was of a higher severity than I ever had experienced before, and I get my flu shot each year. Raised warm tender area at site of injection with malaise.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal
Clinical narrative: "Brain fog". No treatment.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin reaction
Clinical narrative: Skin reaction to ZOSTAVAX inj. 10-1-13. Went to doctor for other issues, doctor prescribed KEFLEX 500 mg (1 TIX x 7D) for skin infection site of ZOSTAVAX injection.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity
Clinical narrative: She had the flu shot on 9/18/13. She started having left arm and neck pain on 9/29/13. By 10/4/13, the pain is less and not gone.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: (L) thigh edema - ice, ibuprofen. Redness, very enlarged limb to knee w/ possible effusion at knee. Similar rxn with dose in 2012.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Induration, Local swelling
Clinical narrative: Shoulder to mid arm above elbow - very swollen/hard. Then bruising appeared 1 day after. Arm is still swollen/bruised 10 days after.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 9 x 9.5 cm red area to left deltoid area warm, mildly tender. Cool compresses and BENADRYL recommended.
Age: 15.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Pt complains of moderate pain. Pain is a 5 on scale 1-10. Pain described as sharp and throbbing. Pain is localized to (R) hip. Pain radiates to (R) thigh. Pain began 3 days ago pain worsens with ambulation and weight bearing. Pain improves with rest. No swelling or stiffness.
Age: 22.0
Sex: F
Vaccine: TTOX
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Shot given 45 seconds later reported feeling faint. Lost consciousness for less than 10 seconds, immediately felt better. Has hx of fear of needles. Stated this has never happened before. Reported not eating before plasma donation and vaccination.
Age: 52.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Erythema, Joint range of motion decreased, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Local area on arm is red, hot, swollen and hurts. Range of motion very limited.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Inflammation
Clinical narrative: Inflammed red area about 3"x4" slightly hard to the thouch. "Patient was instructed to see doctor."
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Urticaria over entire body. Tx - BENADRYL liquid.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Pain, Skin warm, Swelling
Clinical narrative: Redness, swelling (painful), area hot to touch, had chills/shakes for about 45 minutes then those passed, all of this occurred about at elbow under injection site not around or near.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: Redness, swelling (painful), area hot to touch, had chills/shakes for about 45 minutes then those passed, all of this occurred about at elbow under injection site not around or near.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Malaise, Pyrexia
Clinical narrative: Flu-like symptoms including high fever and malaise.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash morbilliform, Rash vesicular
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a 68-year-old male patient with no pertinent medical history. On 27-SEP-2013 the patient was vaccinated with 0.65 milliliter (ml) ZOSTAVAX (lot#, and expiration date was not reported), subcutaneously. Concomitant therapies included COREG. Approximately on 03-OCT-2013 (reported as "about six days later") the patient experienced a dry rash that was not itchy or painful over his entire stomach and chest area which was "similar to measles or chickenpox". Treatment was not rendered for the events. No laboratory or diagnostic studies were performed. The outcome of rash was unknown. Causality was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous pregnancy report as received from a Licensed Practical Nurse refers to a 15 year old female patient with no drug reactions or allergies. On 16-AUG-2013 the patient was vaccinated with a 0.5 ml dose of GARDASIL (lot # 673256/0629AE, exp date 16-DEC-2014) intramuscular. There was no concomitant medication. The patient learned that she was pregnancy on 22-AUG-2013 (LMP of 22-AUG-2013 and EDD of 29-MAY-2014). It was reported that the patient was in 6 weeks, 4 days gestation. The patient saw an unspecified Obstetrician/Gynecologist (OB-GYN) physician for her pregnancy. No treatment was given for the event. The pregnancy outcome was unknown. No adverse effect reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: This spontaneous report as received from a 11 year old female patient concerning herself. On approximately 01-AUG-2013 the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscularly. On 31-AUG-2013, 30 days after onset of therapy the patient experienced headache. The outcome of headache was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a consumer refers to a male patient of unknown age. On an unknown date in 2013 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date dose, route, indication not reported). On 10-SEP-2013 the patient experienced arm hurt for a couple of days after he got his ZOSTAVAX injection. The outcome of the event was unknown. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: RV5
Symptoms: Accidental exposure to product, Drug administered to patient of inappropriate age, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 15 months old female patient. On an unknown date the patient completed the oral ROTATEQ series in a timely fashion. There was no concomitant medication reported. On an unknown date the patient received a 4th dose of oral ROTATEQ at age 15 months. No adverse effect reported. The physician also reported that the patient also ate 1 bead of silica from a dessicant pack on the same date that she received the 4th dose. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Rash, Urticaria
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a female patient in her 60's. In April 2013(about 6 months ago) the patient was vaccinated with ZOSTAVAX (lot#, dose and route not reported). In April 2013 (about 6 months ago) the patient developed hives and a rash immediately after administration of ZOSTAVAX reported by the nurse. On an unknown date, the patient was recovered. The patient had sought medical attention by unknown type. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Seen in office for rash 10-4-13. Dx - Varicella. Had been sully immunized for varicella. VARIVAX vaccines 9-4-09, 11-27-12.
Age: 36.0
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Wrong drug administered
Clinical narrative: INFANRIX given to adult in place of Tdap.
Age: 44.0
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Wrong drug administered
Clinical narrative: INFANRIX given to adult in place of Tdap.
Age: 51.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Infanrix given to adult ini place of TDap.
Age: 21.0
Sex: F
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: INFANRIX given to adult in place of Tdap.
Age: 33.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Wrong drug administered
Clinical narrative: INFANRIX given to adult in place of tdap.
Age: 29.0
Sex: F
Vaccine: MMR, TDAP, VARCEL, MMR, TDAP, VARCEL, MMR, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse practitioner refers to a 29 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. On 29-JUL-2013 the patient was vaccinated with VARIVAX (dose, route and lot number were not reported), and MMR (manufacturer unknown (dose, route and lot number were not reported), when patient was 7 weeks pregnant. Concomitant medications were not reported. No adverse effects reported. The patient became pregnant with an approximated last menstrual period (LMP) on 10-JUN-2013 and estimated date of delivery (EDD) of 28-MAR-2014. The pregnancy outcome was not reported. Patient did not receive any treatment. Patient went to nurse practitioner for first obstetrics appointment. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: MMR, TDAP, VARCEL, MMR, TDAP, VARCEL, MMR, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse practitioner refers to a 29 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. On 29-JUL-2013 the patient was vaccinated with VARIVAX (dose, route and lot number were not reported), and MMR (manufacturer unknown (dose, route and lot number were not reported), when patient was 7 weeks pregnant. Concomitant medications were not reported. No adverse effects reported. The patient became pregnant with an approximated last menstrual period (LMP) on 10-JUN-2013 and estimated date of delivery (EDD) of 28-MAR-2014. The pregnancy outcome was not reported. Patient did not receive any treatment. Patient went to nurse practitioner for first obstetrics appointment. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: Arm is painful at injection site. The area is sore when she flexes arm or sits for prolonged time, feels like a dull ache.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site pain
Clinical narrative: Arm is painful at injection site. The area is sore when she flexes arm or sits for prolonged time, feels like a dull ache.
Age: 5.0
Sex: M
Vaccine: RV5, RV5
Symptoms: Exposure during pregnancy, Rash, Skin irritation, Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a 5 year-old male patient with penicillin allergy, who, on 08-OCT-2013, was administered his first dose of ROTATEQ orally (dose, and lot # not provided). Nurse had meant to administer oral polio vaccine and accidentally administered ROTATEQ. It was reported that, on an unspecified date in October 2013, the patient developed rash on his legs as well as being irritable. No treatment was provided for the patient. At the time of the report, the patient did not recover from rash and being irritable. Relatedness for rash and being irritable was not reported for ROTATEQ. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: RV5, RV5
Symptoms: Irritability, Rash, Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a 5 year-old male patient with penicillin allergy, who, on 08-OCT-2013, was administered his first dose of ROTATEQ orally (dose, and lot # not provided). Nurse had meant to administer oral polio vaccine and accidentally administered ROTATEQ. It was reported that, on an unspecified date in October 2013, the patient developed rash on his legs as well as being irritable. No treatment was provided for the patient. At the time of the report, the patient did not recover from rash and being irritable. Relatedness for rash and being irritable was not reported for ROTATEQ. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Lip pain, Lip swelling, Oedema mouth, Oral pain, Vaccine positive rechallenge
Clinical narrative: Upper and lower lip edema began on Wed 10/09/13 in the evening. Patient had similar occurrence last year/10-10-13 began treatment: Prednisone 20 mg tab taper over 18 days.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Lip oedema
Clinical narrative: Upper and lower lip edema began on Wed 10/09/13 in the evening. Patient had similar occurrence last year/10-10-13 began treatment: Prednisone 20 mg tab taper over 18 days.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Lip oedema, Vaccine positive rechallenge
Clinical narrative: Upper and lower lip edema began on Wed 10/09/13 in the evening. Patient had similar occurrence last year/10-10-13 began treatment: Prednisone 20 mg tab taper over 18 days.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Lip pain, Lip swelling, Oedema mouth, Oral pain, Vaccine positive rechallenge
Clinical narrative: UPPER AND LOWER LIP EDEMA BEGAN 10/08/13 EVENING TREATMENT: PREDNISONE TAPER 20MG OVER 18 DAYS BEGAN ON 10/10/13.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Lip oedema
Clinical narrative: UPPER AND LOWER LIP EDEMA BEGAN 10/08/13 EVENING TREATMENT: PREDNISONE TAPER 20MG OVER 18 DAYS BEGAN ON 10/10/13.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Lip oedema, Vaccine positive rechallenge
Clinical narrative: UPPER AND LOWER LIP EDEMA BEGAN 10/08/13 EVENING TREATMENT: PREDNISONE TAPER 20MG OVER 18 DAYS BEGAN ON 10/10/13.
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Balance disorder, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Headache, muscle cramps, dizziness, problem breathing, could not sleep, weak, out of balance, tired and slept a lot when I got to sleep.
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Initial insomnia, Muscle spasms
Clinical narrative: Headache, muscle cramps, dizziness, problem breathing, could not sleep, weak, out of balance, tired and slept a lot when I got to sleep.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: High fever, chills, achiness.
Age: 5.0
Sex: F
Vaccine: HIBV, MMR
Symptoms: Pyrexia, Skin warm
Clinical narrative: High fever, limbs and extremities very hot to touch. IBP was given and shift of acetaminophen every 4 hours.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysphagia, Electrocardiogram normal, Eye pruritus, Feeling hot
Clinical narrative: Felt warm, dizzy, nauseated, unable to swallow, bilat eyes itching, left arm (site of flu shot) itching.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Nausea
Clinical narrative: Felt warm, dizzy, nauseated, unable to swallow, bilat eyes itching, left arm (site of flu shot) itching.
Age: 1.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Antibody test positive, Exposure to communicable disease, Immunoglobulin therapy, Polymerase chain reaction, Rash vesicular
Clinical narrative: This literature marketed report from author (physician) refers to a 12 year old male patient with stage IIA Hodgkin disease. On an unknown date, the patient developed vesicular lesions on his trunk and left shoulder. He had been diagnosed with Hodgkin disease 3 months before the current episode. As for all new cancer patients, a history was obtained, which revealed that the patient was vaccinated with a single dose of VARIVAX (Merck) at age 1 and confirmed a positive varicella zoster virus (VZV)-IgG antibody titer of >0.90 on an unknown date, before administering chemotherapy or any blood products. Within 3 months, the patient had completed 4 cycles of chemotherapy, as well as radiation therapy. The patient's father, who was the sole caregiver, had contracted varicella 9 days before the patient's rash was evident. The father had no history of varicella of vaccination. The father was given a prescription for oral acyclovir after diagnosis. When the father's varicella diagnosis was reported to the patient's physician, the patient was given a single infusion of intravenous (IV) immunoglobulin (400 mg/kg), owing to the close exposure to a family member. Nevertheless on an unknown date, the patient presented with varicella 4 days later. Considering that VZV was transmissible for 2 days before the onset of rash, the incubation period between father and son was at least 11 days. The patient was admitted to the hospital and was given IV acyclovir (45 mg/kg/day). His lesions quickly crusted and he was discharged on oral acyclovir after completing a 5-day course of IV acyclovir. On day 8, however, the patient developed new vesicles on his trunk, and subsequently was readmitted and restarted on IV acyclovir. He was discharged with a prescription for oral valacyclovir (1000-mg tablet every 8 hours) for 1 month. On an unknown date, the event varicella was resolved. His symptoms resolved without a recurrence of varicella. A VZV-specific polymerase chain reaction amplification test performed on a peripheral blood sample obtained on day 8 was positive for open reading frame (ORF) 62 sequences resembling those found in wild-type VZV DNA and negative for those found in vaccine VZV DNA. The author assessed the event as related to VARIVAX (Merck). The author concluded that protection after varicella vaccination especially after a single varicella vaccination is not life long. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Scab, Varicella, Varicella virus test positive
Clinical narrative: This literature marketed report from author (physician) refers to a 12 year old male patient with stage IIA Hodgkin disease. On an unknown date, the patient developed vesicular lesions on his trunk and left shoulder. He had been diagnosed with Hodgkin disease 3 months before the current episode. As for all new cancer patients, a history was obtained, which revealed that the patient was vaccinated with a single dose of VARIVAX (Merck) at age 1 and confirmed a positive varicella zoster virus (VZV)-IgG antibody titer of >0.90 on an unknown date, before administering chemotherapy or any blood products. Within 3 months, the patient had completed 4 cycles of chemotherapy, as well as radiation therapy. The patient's father, who was the sole caregiver, had contracted varicella 9 days before the patient's rash was evident. The father had no history of varicella of vaccination. The father was given a prescription for oral acyclovir after diagnosis. When the father's varicella diagnosis was reported to the patient's physician, the patient was given a single infusion of intravenous (IV) immunoglobulin (400 mg/kg), owing to the close exposure to a family member. Nevertheless on an unknown date, the patient presented with varicella 4 days later. Considering that VZV was transmissible for 2 days before the onset of rash, the incubation period between father and son was at least 11 days. The patient was admitted to the hospital and was given IV acyclovir (45 mg/kg/day). His lesions quickly crusted and he was discharged on oral acyclovir after completing a 5-day course of IV acyclovir. On day 8, however, the patient developed new vesicles on his trunk, and subsequently was readmitted and restarted on IV acyclovir. He was discharged with a prescription for oral valacyclovir (1000-mg tablet every 8 hours) for 1 month. On an unknown date, the event varicella was resolved. His symptoms resolved without a recurrence of varicella. A VZV-specific polymerase chain reaction amplification test performed on a peripheral blood sample obtained on day 8 was positive for open reading frame (ORF) 62 sequences resembling those found in wild-type VZV DNA and negative for those found in vaccine VZV DNA. The author assessed the event as related to VARIVAX (Merck). The author concluded that protection after varicella vaccination especially after a single varicella vaccination is not life long. Additional information has been requested.