chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Abnormal behaviour, Computerised tomogram normal, Convulsion, Dyspnoea, Fatigue
Clinical narrative: Per phone call with dad, on 10/21/12013 AT 1000. Patient was given the MCV4 vaccine on 10/10/2013 in the p.m. She then came home for supper around 1830 and was feeling tired and not acting like herself so she went to bed early. By 2300 she woke up and came out by her dad with a swollen face, racing heart, and said "something is wrong". She then fainted. Dad, called 911 and then drove her to the emergency room. They gave her muscle relaxants, did a cat scan (which was normal) and then sent her home with some pills. While at home she didn't improve and her breathing seemed to get worse. Dad again took her in to the emergency room on 10/11/2013 and she convulsed in the car. They did another CT scan (which was normal), gave her an injection to stop the convulsions and transferred her to hospital by ambulance. She apparently continued to have convulsions in the ambulance as well as breathing problems. She was admitted to the ICU. During the convulsions, dad reports her eyes roll back in her head, her legs get stiff and then he would run out to the nurse's station and get the nurse to give her VERSED. The convulsions were 2 hours apart and then gradually became more infrequent such that by day 5 she had gone 36 hours without any convulsions. On the 5th or 6th day a different neurologist told patient she needed to get up and start walking. She got up to walk and then had 2 convulsions 20 minutes apart. She again was given VERSED to get them to stop. Her last convulsions were on 10/17/2013 at approximately 1800-1900. She was discharged on 10/20/2013 and has not had any convulsions since discharge. Dad was given a nasal form of VERSED to give immediately if she had another convulsion. There are still tests pending at hospital. She is on BACLOFEN and cyclobenzaprine at home.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Gaze palsy, Intensive care, Laboratory test, Musculoskeletal stiffness, Palpitations
Clinical narrative: Per phone call with dad, on 10/21/12013 AT 1000. Patient was given the MCV4 vaccine on 10/10/2013 in the p.m. She then came home for supper around 1830 and was feeling tired and not acting like herself so she went to bed early. By 2300 she woke up and came out by her dad with a swollen face, racing heart, and said "something is wrong". She then fainted. Dad, called 911 and then drove her to the emergency room. They gave her muscle relaxants, did a cat scan (which was normal) and then sent her home with some pills. While at home she didn't improve and her breathing seemed to get worse. Dad again took her in to the emergency room on 10/11/2013 and she convulsed in the car. They did another CT scan (which was normal), gave her an injection to stop the convulsions and transferred her to hospital by ambulance. She apparently continued to have convulsions in the ambulance as well as breathing problems. She was admitted to the ICU. During the convulsions, dad reports her eyes roll back in her head, her legs get stiff and then he would run out to the nurse's station and get the nurse to give her VERSED. The convulsions were 2 hours apart and then gradually became more infrequent such that by day 5 she had gone 36 hours without any convulsions. On the 5th or 6th day a different neurologist told patient she needed to get up and start walking. She got up to walk and then had 2 convulsions 20 minutes apart. She again was given VERSED to get them to stop. Her last convulsions were on 10/17/2013 at approximately 1800-1900. She was discharged on 10/20/2013 and has not had any convulsions since discharge. Dad was given a nasal form of VERSED to give immediately if she had another convulsion. There are still tests pending at hospital. She is on BACLOFEN and cyclobenzaprine at home.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Swelling face, Syncope
Clinical narrative: Per phone call with dad, on 10/21/12013 AT 1000. Patient was given the MCV4 vaccine on 10/10/2013 in the p.m. She then came home for supper around 1830 and was feeling tired and not acting like herself so she went to bed early. By 2300 she woke up and came out by her dad with a swollen face, racing heart, and said "something is wrong". She then fainted. Dad, called 911 and then drove her to the emergency room. They gave her muscle relaxants, did a cat scan (which was normal) and then sent her home with some pills. While at home she didn't improve and her breathing seemed to get worse. Dad again took her in to the emergency room on 10/11/2013 and she convulsed in the car. They did another CT scan (which was normal), gave her an injection to stop the convulsions and transferred her to hospital by ambulance. She apparently continued to have convulsions in the ambulance as well as breathing problems. She was admitted to the ICU. During the convulsions, dad reports her eyes roll back in her head, her legs get stiff and then he would run out to the nurse's station and get the nurse to give her VERSED. The convulsions were 2 hours apart and then gradually became more infrequent such that by day 5 she had gone 36 hours without any convulsions. On the 5th or 6th day a different neurologist told patient she needed to get up and start walking. She got up to walk and then had 2 convulsions 20 minutes apart. She again was given VERSED to get them to stop. Her last convulsions were on 10/17/2013 at approximately 1800-1900. She was discharged on 10/20/2013 and has not had any convulsions since discharge. Dad was given a nasal form of VERSED to give immediately if she had another convulsion. There are still tests pending at hospital. She is on BACLOFEN and cyclobenzaprine at home.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Anti-GAD antibody, Antibody test, Blood creatine phosphokinase, Borrelia test, Computerised tomogram
Clinical narrative: Per phone call with dad, on 10/21/12013 AT 1000. Patient was given the MCV4 vaccine on 10/10/2013 in the p.m. She then came home for supper around 1830 and was feeling tired and not acting like herself so she went to bed early. By 2300 she woke up and came out by her dad with a swollen face, racing heart, and said "something is wrong". She then fainted. Dad, called 911 and then drove her to the emergency room. They gave her muscle relaxants, did a cat scan (which was normal) and then sent her home with some pills. While at home she didn't improve and her breathing seemed to get worse. Dad again took her in to the emergency room on 10/11/2013 and she convulsed in the car. They did another CT scan (which was normal), gave her an injection to stop the convulsions and transferred her to hospital by ambulance. She apparently continued to have convulsions in the ambulance as well as breathing problems. She was admitted to the ICU. During the convulsions, dad reports her eyes roll back in her head, her legs get stiff and then he would run out to the nurse's station and get the nurse to give her VERSED. The convulsions were 2 hours apart and then gradually became more infrequent such that by day 5 she had gone 36 hours without any convulsions. On the 5th or 6th day a different neurologist told patient she needed to get up and start walking. She got up to walk and then had 2 convulsions 20 minutes apart. She again was given VERSED to get them to stop. Her last convulsions were on 10/17/2013 at approximately 1800-1900. She was discharged on 10/20/2013 and has not had any convulsions since discharge. Dad was given a nasal form of VERSED to give immediately if she had another convulsion. There are still tests pending at hospital. She is on BACLOFEN and cyclobenzaprine at home.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Dystonia, Herpes simplex serology, Laboratory test, Muscle spasms, Nuclear magnetic resonance imaging
Clinical narrative: Per phone call with dad, on 10/21/12013 AT 1000. Patient was given the MCV4 vaccine on 10/10/2013 in the p.m. She then came home for supper around 1830 and was feeling tired and not acting like herself so she went to bed early. By 2300 she woke up and came out by her dad with a swollen face, racing heart, and said "something is wrong". She then fainted. Dad, called 911 and then drove her to the emergency room. They gave her muscle relaxants, did a cat scan (which was normal) and then sent her home with some pills. While at home she didn't improve and her breathing seemed to get worse. Dad again took her in to the emergency room on 10/11/2013 and she convulsed in the car. They did another CT scan (which was normal), gave her an injection to stop the convulsions and transferred her to hospital by ambulance. She apparently continued to have convulsions in the ambulance as well as breathing problems. She was admitted to the ICU. During the convulsions, dad reports her eyes roll back in her head, her legs get stiff and then he would run out to the nurse's station and get the nurse to give her VERSED. The convulsions were 2 hours apart and then gradually became more infrequent such that by day 5 she had gone 36 hours without any convulsions. On the 5th or 6th day a different neurologist told patient she needed to get up and start walking. She got up to walk and then had 2 convulsions 20 minutes apart. She again was given VERSED to get them to stop. Her last convulsions were on 10/17/2013 at approximately 1800-1900. She was discharged on 10/20/2013 and has not had any convulsions since discharge. Dad was given a nasal form of VERSED to give immediately if she had another convulsion. There are still tests pending at hospital. She is on BACLOFEN and cyclobenzaprine at home.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Opisthotonus, Streptococcus test, Thyroid function test, X-ray
Clinical narrative: Per phone call with dad, on 10/21/12013 AT 1000. Patient was given the MCV4 vaccine on 10/10/2013 in the p.m. She then came home for supper around 1830 and was feeling tired and not acting like herself so she went to bed early. By 2300 she woke up and came out by her dad with a swollen face, racing heart, and said "something is wrong". She then fainted. Dad, called 911 and then drove her to the emergency room. They gave her muscle relaxants, did a cat scan (which was normal) and then sent her home with some pills. While at home she didn't improve and her breathing seemed to get worse. Dad again took her in to the emergency room on 10/11/2013 and she convulsed in the car. They did another CT scan (which was normal), gave her an injection to stop the convulsions and transferred her to hospital by ambulance. She apparently continued to have convulsions in the ambulance as well as breathing problems. She was admitted to the ICU. During the convulsions, dad reports her eyes roll back in her head, her legs get stiff and then he would run out to the nurse's station and get the nurse to give her VERSED. The convulsions were 2 hours apart and then gradually became more infrequent such that by day 5 she had gone 36 hours without any convulsions. On the 5th or 6th day a different neurologist told patient she needed to get up and start walking. She got up to walk and then had 2 convulsions 20 minutes apart. She again was given VERSED to get them to stop. Her last convulsions were on 10/17/2013 at approximately 1800-1900. She was discharged on 10/20/2013 and has not had any convulsions since discharge. Dad was given a nasal form of VERSED to give immediately if she had another convulsion. There are still tests pending at hospital. She is on BACLOFEN and cyclobenzaprine at home.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis
Clinical narrative: Pt presented to office with cellulitis of left arm where vaccine was administered.  Pt was placed on antibiotics.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Mobility decreased
Clinical narrative: PATIENT'S ARM SWELLED AND REPORTED BEING UNABLE TO LIFT.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Papule, Rash pustular, Rash vesicular
Clinical narrative: Wide spread papules, pustules and vesicular eruption concentrated on upper trunk, ear, neck, and upper arms.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Headache, Myalgia, Neck pain, Odynophagia
Clinical narrative: Terrible soreness of muscle on side of neck (trapezius), base of head and back. Hurt when swallowing. Hurts when head is rotated to left, right and back.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Terrible soreness of muscle on side of neck (trapezius), base of head and back. Hurt when swallowing. Hurts when head is rotated to left, right and back.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: LEFT SHOULDER PAIN - INCREASING ON ACTIVE RANGE OF MOTION OF ARM FORWARD AND ABOVE HEAD.  THIS PAIN STARTED AFTER INJECTION AND HAS PROGRESSIVELY GOTTEN WORSE.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Atypical shoulder pain following administration of flu vaccine. Limited range of motion within a few hours and has lingered for weeks.  Feel as though shot was given too high on shoulder.
Age: 53.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis
Clinical narrative: Pt presented to office 2 days after administration of vaccination with cellulitis of arm.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Headache, Nausea
Clinical narrative: Chest tightness in the center of my chest, hard to breathe, shortness of breath, and severe nausea and headache.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Heart rate irregular, Productive cough
Clinical narrative: Wet cough followed next day with highly irregular heart beat. I have some experience with premature ventricular contractions. Generally quite rare and moderate.  This has been incessant all day.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Urticaria
Clinical narrative: Hives around neck. No SOB, no throat or tongue swelling. Then today 10/21/13 started diarrhea. O/w well.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Migraine, Myalgia, Nausea, Vomiting
Clinical narrative: Nausea, vomit, muscle ache, migraine (migraine medicine didn't help and it usually does).
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Eye swelling, Ocular hyperaemia, Pharyngeal oedema, Swelling face
Clinical narrative: Pt became SOB, had facial and eye swelling, vomiting, red eyes throat swelling. After recieving flu vaccine. Epi IM given, Benadryl 50 mg IV and Solumedrol 125mg IV.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Pt became SOB, had facial and eye swelling, vomiting, red eyes throat swelling. After recieving flu vaccine. Epi IM given, Benadryl 50 mg IV and Solumedrol 125mg IV.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Injection site getting very sore.
Age: 5.0
Sex: F
Vaccine: DTPIPV, MMRV
Symptoms: Cough, Pyrexia, Rash, Vomiting
Clinical narrative: Fever between 101-103, Vomiting, Cough, Rash on face and neck. Lasted on and off for a week.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Back pain, Dry mouth, Dyspnoea, Hypoaesthesia
Clinical narrative: Patient states she got her flu shot on Friday when she was in for a routine follow up appointment. She says she was doing well until late Saturday-around 8pm. Numbness and tingling of the L arm, shortness of breath, anxiety, shaking, tachycardia, dryness of the mouth, and low back pain, this lasted for 1hour. Patient states that she took a soda and a tea to relax she says she feels better but the anxiety continues.  Per MD patient was called notifying her this was possible a reaction from the flu shot though it could have been something else. MD charted reaction to patient's chart and have her NOT get it again. Next season we can re-think about patient getting the shot again.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Tachycardia, Tremor
Clinical narrative: Patient states she got her flu shot on Friday when she was in for a routine follow up appointment. She says she was doing well until late Saturday-around 8pm. Numbness and tingling of the L arm, shortness of breath, anxiety, shaking, tachycardia, dryness of the mouth, and low back pain, this lasted for 1hour. Patient states that she took a soda and a tea to relax she says she feels better but the anxiety continues.  Per MD patient was called notifying her this was possible a reaction from the flu shot though it could have been something else. MD charted reaction to patient's chart and have her NOT get it again. Next season we can re-think about patient getting the shot again.
Age: 1.05
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Aggression, Aphasia, Autism, Crying, Decreased eye contact
Clinical narrative: Screaming/crying, raging temper tantrums, no eye contact, all speech lost.
Age: 1.05
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Screaming
Clinical narrative: Screaming/crying, raging temper tantrums, no eye contact, all speech lost.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Anosmia, Colour blindness acquired, Colour vision tests abnormal, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Quick onset of blurred vision in both eyes. Identification of color noted to be incorrect 4 days later. Loss of color perception a week later. Loss of the ability to smell.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Vision blurred
Clinical narrative: Quick onset of blurred vision in both eyes. Identification of color noted to be incorrect 4 days later. Loss of color perception a week later. Loss of the ability to smell.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Cough, Eye discharge, Eye swelling, Eyelid margin crusting
Clinical narrative: Deep chest cough that hurt in the chest and resulted in sore throat. Eyes turned red and swollen and secreting mucus. Cough lasted approximately 5 hours. Eyes were crusted the next morning and still swollen. Eyes not swollen after 3 days. Stuffy for 4 days turning into drainage on the 5th day.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Deep chest cough that hurt in the chest and resulted in sore throat. Eyes turned red and swollen and secreting mucus. Cough lasted approximately 5 hours. Eyes were crusted the next morning and still swollen. Eyes not swollen after 3 days. Stuffy for 4 days turning into drainage on the 5th day.
Age: 17.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Dyspnoea, Hypoaesthesia, Wheezing
Clinical narrative: 10 minutes after vaccine was given she had trouble breathing, wheezing, coughing, and numbness in the face and neck.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Eye swelling, Injection site reaction, Lip swelling, Neck pain
Clinical narrative: Within a few minutes after flu vaccine developed neck, chest pain lasting a few minutes. Then tingling of face, hands and left arm (injection site). Later that day swelling of lips, eyes and skin rash.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Rash
Clinical narrative: Within a few minutes after flu vaccine developed neck, chest pain lasting a few minutes. Then tingling of face, hands and left arm (injection site). Later that day swelling of lips, eyes and skin rash.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Hypoaesthesia, Musculoskeletal discomfort, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Onset of back discomfort/ache evening of flu vaccination; pain in back and thighs all through evening; Fri am reports back stiff; thighs feel stiff; denies numbness and tingling-"feels a little better; Sat am "felt fine"-Sx resolved never took TYLENOL or ibuprofen.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Onset of back discomfort/ache evening of flu vaccination; pain in back and thighs all through evening; Fri am reports back stiff; thighs feel stiff; denies numbness and tingling-"feels a little better; Sat am "felt fine"-Sx resolved never took TYLENOL or ibuprofen.
Age: 34.0
Sex: M
Vaccine: FLU3, HEP, TD
Symptoms: Pruritus, Rash
Clinical narrative: Rash, itching, used Aveeno anti-itch topically. Rash/itching on trunk, legs, arms, face. PHN observed rash. Referred to Urgent Care. Denies swelling, SOB or redness at site.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via publicist representative refers to a female patient in her 60's. On an unknown date, the patient was vaccinated with ZOSTAVAX 0.65 ml, one time, subcutaneous. On an unknown date, the patient experienced redness and swelling at the injection site in an unspecified arm shortly after receiving ZOSTAVAX. The redness lasted more than a few days. The outcome of injection site redness and injection site swelling was reported as not recovered/not resolved. Additional information has been requested.
Age: 1.05
Sex: F
Vaccine: FLU3, MMR, PNC13
Symptoms: Blood culture, Convulsion, Crying, Drooling, Full blood count
Clinical narrative: Received MMR, Flu #1, PREVNAR at about 930AM 10-18-13. Had been fussy for about 1 day before drooling, tongue in mouth. Given TYLENOL 3/4 tsp about 6P.M. 10/18/13. Around 10P.M. mom heard a cry, went to child bedroom and she was having a seizure, drooling, eyes rolled back and tonic clonic arm and leg movement. Taken to ER.
Age: 1.05
Sex: F
Vaccine: FLU3, MMR, PNC13
Symptoms: Gaze palsy, Tonic clonic movements, Urine analysis
Clinical narrative: Received MMR, Flu #1, PREVNAR at about 930AM 10-18-13. Had been fussy for about 1 day before drooling, tongue in mouth. Given TYLENOL 3/4 tsp about 6P.M. 10/18/13. Around 10P.M. mom heard a cry, went to child bedroom and she was having a seizure, drooling, eyes rolled back and tonic clonic arm and leg movement. Taken to ER.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product packaging quantity issue
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. The reporter stated that the diluent vial was completely empty(PQC filed) and they could not reconstitute a dose of with ZOSTAVAX for the patient. The patient did not receive their dose of ZOSTAVAX and the patient will have to come back at another time to receive with ZOSTAVAX. No adverse effects reported. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 01-OCT-2013 the patient was vaccinated with M-M-R II (lot # J002502, expiration date 28-FEB-2015). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for the 15 minutes, 17-SEP-2013 for 35 minutes, on 19-SEP-2013 for 1 hour and 35 minutes, on 20-SEP-2013 for 40 minutes, on 25-SEP-2013 for 45 minutes, on 26-SEP-2013 for 2 hours and 30 minutes and on 01-OCT-2013 for 4 hours. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter linked).
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 25-SEPT-2013 the patient was vaccinated with M-M-R II (lot # J002502, expiration date 28-FEB-2015). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes, 17-SEP-2013 for 35 minutes, on 19-SEP-2013 for 1 hour and 35 minutes, on 20-SEP-2013 for 40 minutes and on 25-SEP-2013 for 45 minutes. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 131USA008373, 1310USA008373, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008405, 1310USA008406, and 1310USA008407 (same reporter linked). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 25-SEPT-2013 the patient was vaccinated with M-M-R II (lot # J002502, expiration date 28-FEB-2015). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes, 17-SEP-2013 for 35 minutes, on 19-SEP-2013 for 1 hour and 35 minutes, on 20-SEP-2013 for 40 minutes and on 25-SEP-2013 for 45 minutes. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 131USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008405, 1310USA008406, and 1310USA008407 (same reporter linked). Additional information has been requested
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 25-SEPT-2013 the patient was vaccinated with M-M-R II (lot # J002502, expiration date 28-FEB-2015). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes, 17-SEP-2013 for 35 minutes, on 19-SEP-2013 for 1 hour and 35 minutes, on 20-SEP-2013 for 40 minutes and on 25-SEP-2013 for 45 minutes. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008372, 131USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008405, 1310USA008406, and 1310USA008407 (same reporter linked). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 25-SEP-2013 the patient was vaccinated with M-M-R II (lot # J002502, expiration date 28-FEB-2015). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes, 17-SEP-2013 for 35 minutes, on 19-SEP-2013 for 1 hour and 35 minutes, on 20-SEP-2013 for 40 minutes and on 25-SEP-2013 for 45 minutes. No known adverse effects. This case is linked to case 131USA001610, 131USA008360, 131USA008361, 131USA008362, 131USA008363, 131USA008364, 131USA008365, 1310USA008366, 1310USA008367,  1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399,1310USA008400,  1310USA008401, 1310USA008402, 1310USA008403,1310USA008404,  1310USA008405, 1310USA008406 and 1310USA008407 (same reporter linked). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 24-SEP-2013 the patient was vaccinated with M-M-R II (lot # J002502, expiration date 28-FEB-2015). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for the 15 minutes, 17-SEP-2013 for 35 minutes, on 19-SEP-2013 for 1 hour and 35 minutes, on 20-SEP-2013 for 40 minutes and on 25-SEP-2013 for 45 minutes. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375,  1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter linked). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to an unspecified number of unspecified patients. On an unknown date, the patients were vaccinated with a dose of ZOSTAVAX (lot#, route and dose were not reported). The nurse reported that an unspecified number of ZOSTAVAX diluent vials might have gone through an unsupported temperature excursion and could had been used to reconstitute ZOSTAVAX and administered to an unspecified number of patients. This occurred over a 13 year period. No adverse effects reported. It was unspecified if the patient sough medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 24-SEP-2013 the patient was vaccinated with M-M-R II (lot # J002502, expiration date 28-FEB-2015). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for the 15 minutes, 17-SEP-2013 for 35 minutes, on 19-SEP-2013 for 1 hour and 35 minutes and on 20-SEP-2013 for 40 minutes. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter linked). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Injection site urticaria, Injection site vesicles
Clinical narrative: This spontaneous report as received from a female nurse of unknown age via a field employee refers to herself. On 10-OCT-2013 the patient was vaccinated with one dose of ZOSTAVAX (dose, route and lot# not specified) in the physician office. On 11-OCT-2013, the patient called and notified the physician office that she was experiencing swelling, a blistering rash and welts around the injection site. The patient treated site with BENADRYL upon self diagnosis. The outcome of all events was unknown. Action taken with ZOSTAVAX due to events was not reported and the patient was not reintroduced. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 85 year old female patient. On 06-NOV-2006 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml/once. Concomitant therapies included gabapentin (it was reported that the patient was taking gabapentin (unspecified dose/frequency and manufacturer) at the time of the report, but it was unknown if she was using the medication at the time of administration ZOSTAVAX). On 03-SEP-2013, the patient developed shingles after administration of ZOSTAVAX. The outcome of shingles was not reported. The patient sought medical attention by an office visit on an unspecified date. The causal relationship between ZOSTAVAX and shingles was not reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Redding and inflammation at site of injection (right upper arm)
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Pyrexia, Urticaria
Clinical narrative: 10/17 4:30 PM MMR vaccine given. 6:00 PM patient felt feverish. 10/18 1:30 AM broke out in hives - took 75mg BENADRYL. 7:00 AM took more BENADRYL - hives continues. 1:40 PM went to PCP and saw NP - continue BENADRYL. 10/21 - hives diminished but still itching.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a consumer, via company representative, refers to a 11 year old male patient. On approximately 2003 (reported as "at the age of two"), the patient was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Concomitant medications included a Attention Deficit Disorder (ADD) medication. Reporter stated that on 10-OCT-2013, the patient was diagnosed with chicken pox. The patient had 13 pox marks at the time of call on his back and arms. The outcome of chicken pox was reported as not recovered/not resolved. Patient sought medical attention: call the physician. The relationship between VARIVAX (Merck) and the events was not reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 02-JUL-2008, patient received the first dose of GARDASIL (dose, route and lot number were not reported). On 13-AUG-2013 the patient was vaccinated with the second dose of GARDASIL (dose, route and lot number were not reported), which was late. The patient then, on 14-OCT-2013, received the third dose of GARDASIL (dose, route and lot number were not reported). Concomitant medications were not reported. No symptoms reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report as received from a physician refers to patients of unknown age and gender. The physician reported that he has an unspecified colleague in another state who had patients that on an unknown date, were vaccinated with MMR II (dose, duration, indication, route and lot were not reported). On an unknown date, patients were not showing as immune to mumps when titers are drawn. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report as received from a physician refers to many patients of unknown age and gender. On an unknown date, many patients were vaccinated with M-M-R II (dose, duration, indication, route and lot were not reported). On an unknown date, many patients were not showing as immune to mumps when titers are drawn. This is one of several reports from same source. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Allergy test, Urticaria
Clinical narrative: This spontaneous report refers to a 53 year old male patient reporting on himself. The patient's medical history included two prior cases of hives in 1995 (date unspecified) and June of 2005, and in both cases the hives went away after about 3 weeks following treatment with unspecified steroids (approximately in 1995 and in July 2005 respectively). None drug allergies were reported. In October 2012, the patient was vaccinated with ZOSTAVAX (concentration, dose, lot number and expiration date were not reported). Concomitant therapies included lisinopril(manufacturer unspecified). In December 2012, the patient developed hives after vaccination with ZOSTAVAX. Patient sought medical attention, he contacted his physician. There were performed unspecified allergy tests but results were not reported. Patient received treatment with oral steroids (manufacturer unspecified). The hives have not resolved despite repeated courses of steroids (manufacturer unspecified). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 19-JUL-2013, the patient was vaccinated with an expired PNEUMOVAX23 (lot number 672057/1417AA, expiration date: 22-JUN-2013)(dose and route were not reported). No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU3, HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: S/P redness and swelling of (L) thigh 3 inches by 3.5 inches today - resolving was larger per patient.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Injection site erythema, Injection site warmth, Myalgia, Pain
Clinical narrative: Pain in muscle, initially; redness and heat at injection site. Improved by 10/15; then pain in bone reported 10/18. 10/21 still reporting some pain/swelling. Has MD appt on 10/24. Has been alternating cold/hot compress every 15 min up to 12 times daily.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Pain in muscle, initially; redness and heat at injection site. Improved by 10/15; then pain in bone reported 10/18. 10/21 still reporting some pain/swelling. Has MD appt on 10/24. Has been alternating cold/hot compress every 15 min up to 12 times daily.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Injection site became red and swollen close to FLUVIRIN site approx 8 hours after injection. Swelling and rash became better after day 3 and continued to improve. No treatment required except cold packs used by patient.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt had redness and swelling at site of injection of ZOSTAVAX.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Headache, Ocular hyperaemia, Throat tightness
Clinical narrative: Patient was on antibiotic therapy for a sinus infection that was cleared up but was not sick. The physician prescribing want patient to continue BACTRIM therapy. Post immunization pt complained of slight throat closing, red eyes and face and headache. All side effects cleared up by the next morning.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Dyspnoea, Pyrexia
Clinical narrative: Pt's complain chills, cough, fever, difficult breathing.
Age: 67.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Local swelling, Pain in extremity
Clinical narrative: Swelling and pain across top right of foot onset one day after and continues. Recommended f/u w Dr.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Cellulitis, Erythema, Local swelling, Skin warm, Swelling
Clinical narrative: MCV4 vaccine was administered on 10/16/13 by medical assistant. Pt came on 10/17/13 with redness, swelling that started after vaccine was given. No fever. On exam right arm erythema, swelling, warmth, tenderness 2 cm below injection site. Given KEFLEX. Pt seen for f/u on 10/21/13 and cellulitis resolved.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Tenderness
Clinical narrative: MCV4 vaccine was administered on 10/16/13 by medical assistant. Pt came on 10/17/13 with redness, swelling that started after vaccine was given. No fever. On exam right arm erythema, swelling, warmth, tenderness 2 cm below injection site. Given KEFLEX. Pt seen for f/u on 10/21/13 and cellulitis resolved.
Age: 12.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Injection site erythema, Local swelling, Vaccination complication
Clinical narrative: Mother reported that patient had reaction to vaccines when in office with sibling. Patient's right arm swelled and lasted 4 days. His left arm was swollen with red circle around injection site and lasted 3 days. Patient's arms currently have no rash or redness. Physician notified.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: Swelling of the left arm. Red and swollen for 2 days. No relief w/ BENADRYL and Ibuprofen and cold compresses.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Photophobia
Clinical narrative: Several hours later pt. experienced a sudden onset of light-headed, dizziness and nausea. She was sensitive to light. She had not eaten yet that day and was working on her feet. She gradually felt stronger and by 10/15/13 felt normal. May have been AE.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Injection site urticaria, Injection site warmth, Malaise
Clinical narrative: Per patient report on 10/21/13: c/o left deltoid swelling, "hive", hot to touch, fever of 102, general malaise. Patient treated herself with PO BENADRYL and rest. Symptoms cleared by 10/21/13.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Right after flu shot given, immediate local swelling just at injection site occurred (right upper arm). The area was a soft swelling and became about as big as a golf ball (no bleeding at all). Pt was in no distress or discomfort. Ice pack applied. Pt was called this AM to see how he was doing and he states it is resolved and had no further problem.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Aldolase normal, Blood creatine phosphokinase normal, Blood thyroid stimulating hormone normal, C-reactive protein normal, Hypoaesthesia
Clinical narrative: Patient reports immediately after the shot he did have some numbness in (L) arm and chest. Then he started having bilateral leg pain and leg weakness. His legs feel like they are locking up. And pain is worse when he stands or walks. It does improve with running but did not go away.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Metabolic function test normal, Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: Patient reports immediately after the shot he did have some numbness in (L) arm and chest. Then he started having bilateral leg pain and leg weakness. His legs feel like they are locking up. And pain is worse when he stands or walks. It does improve with running but did not go away.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: Patient reports immediately after the shot he did have some numbness in (L) arm and chest. Then he started having bilateral leg pain and leg weakness. His legs feel like they are locking up. And pain is worse when he stands or walks. It does improve with running but did not go away.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Injection site induration, Injection site swelling, Malaise
Clinical narrative: Hardness at inj site, considerable swelling, pt indicated her discomfort and malaise incapacitated her for two days. Largely resolved when reported on 10-21-13.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Cyanosis
Clinical narrative: Dark-bluish spot about 6" x 2" close to injection site.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Nausea. Soreness, redness around injection site, swollen.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Mass, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Day of shot no symptoms, pain 10/16/13 bruise started 10/17/13 bruise grew to 3-4" and painful lump appeared, 10/18/132 felt achy and back of neck stiff. This lasted only until the end of day and may not be related. 10/21/13 knot went away. Arm no longer painful and bruise is lightening.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: After administering AFLURIA influenza vaccine in right deltoid, a rash on right arm and itching began about 10 minutes later.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling
Clinical narrative: Swelling of the feet - per staff from Dr. office.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: Shot administered on 10/16/13 at noon. Red rash appeared around 5pm that same day. Not itchy, not raised, "looks like a sunburn" but no heat associated w/ the rash. Rash on both sides of neck and upper chest area Pt called 10/18/13 at pm.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Fever, headache, nausea, fatigue, decreased appetite, vomiting, diarrhea.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, headache, nausea, fatigue, decreased appetite, vomiting, diarrhea.
Age: 93.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Rash and red bumps around the injection site.