chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Body temperature increased, Fall, Febrile convulsion
Clinical narrative: Grandmother reported that mother monitored child's temperature throughout the day.  He was afebrile up to 5 hours p vaccinations. At about 1600, mother reported his temperature was 101 F. At approximately 1630 on 11/12/2013, the same day of the patient's visit to the clinic for vaccinations, he was playing with a family pet and fell to the ground with a seizure.  Patient was brought to a local hospital.  Medical records indicate he suffered a febrile seizure.  Patient was given OTC fever-reducing medications and observed for approximately two hours, then released.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Feeling abnormal
Clinical narrative: Started having uncontrollable chills and shaking.  Put on 3 blankets.  It lasted for 1 1/2 hours before finally subsiding.  My body felt like it was burning up to the touch but I was too sick to get a thermometer.  I then started to get dry heaves and felt like I was going to pass out.  Had difficulty walking from room to bathroom.  Was weak, dizzy and felt generally horrible for all of next day.  Have slept almost non stop until now.  Had no desire to eat anything.  I have had the regular flu shot for 11 years and never had any kind of reaction.  This high dose vaccine that they gave me really made me feel awful and symptoms were bad.  I will not take the high dose vaccine again.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Hypersomnia, Malaise, Retching, Skin warm
Clinical narrative: Started having uncontrollable chills and shaking.  Put on 3 blankets.  It lasted for 1 1/2 hours before finally subsiding.  My body felt like it was burning up to the touch but I was too sick to get a thermometer.  I then started to get dry heaves and felt like I was going to pass out.  Had difficulty walking from room to bathroom.  Was weak, dizzy and felt generally horrible for all of next day.  Have slept almost non stop until now.  Had no desire to eat anything.  I have had the regular flu shot for 11 years and never had any kind of reaction.  This high dose vaccine that they gave me really made me feel awful and symptoms were bad.  I will not take the high dose vaccine again.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Started having uncontrollable chills and shaking.  Put on 3 blankets.  It lasted for 1 1/2 hours before finally subsiding.  My body felt like it was burning up to the touch but I was too sick to get a thermometer.  I then started to get dry heaves and felt like I was going to pass out.  Had difficulty walking from room to bathroom.  Was weak, dizzy and felt generally horrible for all of next day.  Have slept almost non stop until now.  Had no desire to eat anything.  I have had the regular flu shot for 11 years and never had any kind of reaction.  This high dose vaccine that they gave me really made me feel awful and symptoms were bad.  I will not take the high dose vaccine again.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Altered state of consciousness, Blood glucose normal, Hypotonia, Pallor
Clinical narrative: Patient began to complain of stomach pain. She became pale and limp. She was sleepy. All vital signs including heart rate, blood pressure, and blood sugar were within normal limits. She was give Gatorade to drink. It took about 30 minutes for her to regain normal consciousness.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Somnolence
Clinical narrative: Patient began to complain of stomach pain. She became pale and limp. She was sleepy. All vital signs including heart rate, blood pressure, and blood sugar were within normal limits. She was give Gatorade to drink. It took about 30 minutes for her to regain normal consciousness.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Axillary pain, Lymphadenopathy, Ultrasound scan
Clinical narrative: Swelling soreness in left axillary.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Aphagia, Back pain, Chest discomfort, Chest pain, Dizziness
Clinical narrative: I got the flu shot around 10:00 at employee health. Around 12:00 I noticed I was feeling tired and my heart was racing. I took my pulse it was 100 which I usually run around 70. Then I just started feeling nausea and my back started hurting. Anyhow at 5 I had to go to this class for my job. During the class I started sweating and tingling all over and felt like I was going to vomit or pass out so I got up and went down to clinic and laid down on the floor. The other nurses I work with took my vitals my BP was normal but my pulse was 116. I felt like my back hurt so bad and my chest and I felt like I couldn't breathe. So I just laid there with the lights off for like 20 min. but everytime I tried to sit up I got all sweaty again. So one of the other nurses I work with drove me home. I was very sick that night, I had a pounding heading. My lower back hurt so bad. I felt like I could breathe my chest felt tight. The next day I had to call into work. I couldn't eat anything. My head still hurt but was better. I was extremely fatigued I just laid on the couch the whole day. It was horrible. I will never ever get another flu shot for the rest of my life!
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Fatigue, Headache, Hyperhidrosis, Malaise
Clinical narrative: I got the flu shot around 10:00 at employee health. Around 12:00 I noticed I was feeling tired and my heart was racing. I took my pulse it was 100 which I usually run around 70. Then I just started feeling nausea and my back started hurting. Anyhow at 5 I had to go to this class for my job. During the class I started sweating and tingling all over and felt like I was going to vomit or pass out so I got up and went down to clinic and laid down on the floor. The other nurses I work with took my vitals my BP was normal but my pulse was 116. I felt like my back hurt so bad and my chest and I felt like I couldn't breathe. So I just laid there with the lights off for like 20 min. but everytime I tried to sit up I got all sweaty again. So one of the other nurses I work with drove me home. I was very sick that night, I had a pounding heading. My lower back hurt so bad. I felt like I could breathe my chest felt tight. The next day I had to call into work. I couldn't eat anything. My head still hurt but was better. I was extremely fatigued I just laid on the couch the whole day. It was horrible. I will never ever get another flu shot for the rest of my life!
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Palpitations, Paraesthesia
Clinical narrative: I got the flu shot around 10:00 at employee health. Around 12:00 I noticed I was feeling tired and my heart was racing. I took my pulse it was 100 which I usually run around 70. Then I just started feeling nausea and my back started hurting. Anyhow at 5 I had to go to this class for my job. During the class I started sweating and tingling all over and felt like I was going to vomit or pass out so I got up and went down to clinic and laid down on the floor. The other nurses I work with took my vitals my BP was normal but my pulse was 116. I felt like my back hurt so bad and my chest and I felt like I couldn't breathe. So I just laid there with the lights off for like 20 min. but everytime I tried to sit up I got all sweaty again. So one of the other nurses I work with drove me home. I was very sick that night, I had a pounding heading. My lower back hurt so bad. I felt like I could breathe my chest felt tight. The next day I had to call into work. I couldn't eat anything. My head still hurt but was better. I was extremely fatigued I just laid on the couch the whole day. It was horrible. I will never ever get another flu shot for the rest of my life!
Age: 35.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Eye injury, Fall, Syncope
Clinical narrative: Shots given in RT deltoid muscle; Self care after immunizations. Patient verbalized understanding. Patient fainted, someone assisted me  with the patient. He was strong, slipped out of our arms. Head hit the floor. Deep gash over right eye. Pressure applied. Dr. assisted in checking the patient. Someone also assisted in care of patient B/P vital signs and stabilizing patient, 911 was called and responded.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site nodule, Injection site warmth
Clinical narrative: Patient reports a hard large knot at injection site which was also hot to touch.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Vaccination complication
Clinical narrative: Received meningitis shot on 11/11, started having reaction overnight but was small, then yesterday midday started getting bigger, called mom abut 4:30.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 20-APR-2012 the patient was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscular, Lot number was not provided. No concomitant medications were reported. The healthcare worker reported that the patient received his first dose of GARDASIL on 20-APR-2012, the second dose on 04-SEP-2013 and the third on 06-NOV-2013. No adverse effects reported. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician concerning a 55 year old male patient with hypercholesterolemia and hyperglycemia and no drug reactions or allergies. On 09-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J000783; expiration date 30-APR-2014), 0.65 ml, subcutaneous. Concomitant therapies included omeprazole (manufacturer unknown). The physician reported that after the patient received ZOSTAVAX on 19-OCT-2013, he developed shingles. The physician saw the patient on 25-OCT-2103 and diagnosed him with shingles. The patient reported to the physician that he had been using VALTREX for several days. The physician instructed the patient to continue to use the VALTREX but at and increased dose. No laboratory tests were performed. The patient sought medical attention. Patient outcomes was reported as not recovered/not resolved. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Significant pain in vaccination arm from elbow to shoulder and some pain down to wrist. Also, pain and difficulty lifting arm.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Paraesthesia
Clinical narrative: Pt has tingling in left arm 11 days after immunization. States that there is now pain in the shoulder area.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Sensation of foreign body, Throat irritation, Throat tightness
Clinical narrative: Experienced burning to throat and lungs. Coughing and forceful. Felt like there was something caught in my throat. Almost constricted like sensation.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Hypotension, Nausea, Presyncope
Clinical narrative: Fever, chills, fatigue, nausea, near fainting, feeling of low blood pressure, all night of vaccination. Sept 20, 2013 at 3 pm 3 days of fatigue and nausea.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Fever, chills, fatigue, nausea, near fainting, feeling of low blood pressure, all night of vaccination. Sept 20, 2013 at 3 pm 3 days of fatigue and nausea.
Age: 75.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Actual injection was painful. Nine days later still very sore. Unable to move arm first thing in morning because of soreness.
Sex: M
Vaccine: FLU3
Symptoms: Cerebrovascular accident, Computerised tomogram, Laboratory test, Nuclear magnetic resonance imaging, VIIth nerve paralysis
Clinical narrative: Initial onset were symptomatic of CVA. Patient seen at emergency department and diagnosed with Bells Palsy. Patient continues to c/o symptoms consistent with Bells Palsy.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Diarrhoea, Dizziness, Pain, Vomiting
Clinical narrative: Severe chills - vomiting - aches and pains diarrhea - light headed.
Age: 34.0
Sex: M
Vaccine: UNK
Symptoms: Dizziness
Clinical narrative: Lightheadedness/dizziness two days later.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Local swelling, Malaise, Tenderness
Clinical narrative: The patient received the vaccine 10-30-13 around 11:30am. The patient was asked to remain in the store for approximately 15 min and reported no reaction at that time. She called 11-5-13 and said she hasn't felt well the past few days and has had headaches. This morning her arm is swollen from shoulder to fingers and injection site is very red. Arm is tender. I told her to contact her physician.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Lacrimation increased, Wheezing
Clinical narrative: Pt received AFLURIA vaccine approximately 610pm 11/12/13 approx 730 pm (11/12/13) pt experienced shortness of breath, watering eyes, wheezing. Symptoms/signs worsened by 9 pm 11/12/13. Pt self administered dose of albuterol MDI at 9 pm. By 9 am, 11/13/13 s and sx were starting to clear. Pt took a 25 mg dose of diphenhydramine at 10 am s and sx gone by 6 pm 11/13/13.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect drug dosage form administered, No adverse event, Product reconstitution issue
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (19400 PFU) (dose, route and lot number was not reported). No concomitant medications were reported. On an unknown date, the pharmacist injected the sterile diluent into a vial of ZOSTAVAX to reconstitute the product and the ZOSTAVAX did not dissolve right away. The pharmacist proceeded to administer the ZOSTAVAX even though it didn't appear to be properly reconstituted. No adverse symptoms reported. PQC involved. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: FLUN4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever and vomiting started.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Myalgia, Paraesthesia
Clinical narrative: Pt reports muscle ache and have tingling in left arm following shot which then spread towards collar bone and neck. Had some chest tightness 2 days after shot. Arm pain and tingling has persisted since 10-27-13 (treated with MOTRIN and ice). Pt was referred to MD.
Sex: U
Vaccine: FLU3, PNC13
Symptoms: Arthralgia, Chills, Hyperhidrosis, Myalgia
Clinical narrative: 11-5-13 received vaccine midmorning by that evening she had myalgias, joint pain chills and sweating resolving as of 11-7-13.
Age: 31.0
Sex: F
Vaccine: FLUN4
Symptoms: Blood test, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness/tingling in extremities, was seen by PMP. Prednisone helped lessen symptom severity. It is ongoing on day 5.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Erythema, Local swelling
Clinical narrative: Redness and swelling of (L) arm beginning approximately 16 hrs after vaccine. Redness measured 19 x 22 cm. Arm circumference bigger on (L) by 1 1/2 inches.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chest discomfort, Cough, Diarrhoea, Dizziness
Clinical narrative: Within 3 hrs of receiving the vac, I experienced chest tightness, urge to cough, sensation of something in my throat, severe sore, red throat, red eyes, projectile vomiting, with blood, diarrhea, excessive sweating, weakness, dizzy, burned vision, body aches, mouth soreness, including tongue and gums.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Gingival pain, Glossodynia, Haematemesis, Hyperhidrosis, Ocular hyperaemia
Clinical narrative: Within 3 hrs of receiving the vac, I experienced chest tightness, urge to cough, sensation of something in my throat, severe sore, red throat, red eyes, projectile vomiting, with blood, diarrhea, excessive sweating, weakness, dizzy, burned vision, body aches, mouth soreness, including tongue and gums.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Oral pain, Oropharyngeal pain, Pain, Pharyngeal erythema, Sensation of foreign body
Clinical narrative: Within 3 hrs of receiving the vac, I experienced chest tightness, urge to cough, sensation of something in my throat, severe sore, red throat, red eyes, projectile vomiting, with blood, diarrhea, excessive sweating, weakness, dizzy, burned vision, body aches, mouth soreness, including tongue and gums.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred, Vomiting projectile
Clinical narrative: Within 3 hrs of receiving the vac, I experienced chest tightness, urge to cough, sensation of something in my throat, severe sore, red throat, red eyes, projectile vomiting, with blood, diarrhea, excessive sweating, weakness, dizzy, burned vision, body aches, mouth soreness, including tongue and gums.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient called next day with redness and swelling at injection site. Was instructed to use cool compress and pain management. Two days later she went to physician to check and Dr. said it was improving and to continue OTC treatment.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Myalgia, Pain, Pain in extremity
Clinical narrative: Employee had flu vaccine in right deltoid and had muscle soreness and ache and weakness first week - lasting days - today arm is "2" out of 1-10 pain scale. Getting better but never had reaction before.
Age: 77.0
Sex: M
Vaccine: UNK
Symptoms: Hyperaesthesia, Pain
Clinical narrative: Very bad pain over whole body - the slightest touch to the body brought pain.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Gastrooesophageal reflux disease, Injection site rash, Pain, Rash erythematous
Clinical narrative: 1 day later, developed rash around injection site. Rash is red, itchy, painful, burns. Visited MD, they gave an Rx for reflux.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: 1 day later, developed rash around injection site. Rash is red, itchy, painful, burns. Visited MD, they gave an Rx for reflux.
Age: 87.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Breast pain, Pain in extremity
Clinical narrative: My pain started a few days after the shot it was in the upper arm and a few days later into my back and into my breast - had to take TYLENOL extra strength to sleep. Im still in some pain today. No fever.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Within 24 hours of administration, quarter sized redness at site of vaccination - warm and raised. Normal soreness following vaccination.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Gaze palsy, Nausea, Pain, Vision blurred
Clinical narrative: Pt started having extreme fatigue, nausea and body aches day after MENACTRA #2 vaccine. 2 days after seemed "unfocused" and left eye wandered inward. Sent to ER.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Rash, Throat tightness
Clinical narrative: I received the vaccine 11/12/13 took BENADRYL and 2 MOTRIN prior because I told my employer I had prior reaction but felt like I really needed (required) to take shot - I couldn't commit to wearing a mask all flu season - within the 1st hr throat felt like closing - headache also 11/12/13 - Then 11/13/13 rash appeared, saw Dr. saw me 11/15/13 for rash.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 74 year old male patient with diabetes type II. The patient's medical history included shingles at the age of 72 years old. ON 28-SEP-2012 the patient was vaccinated with ZOSTAVAX lot # 0365AE, 0.65 ml, subcutaneous . On 04-NOV-2013, 403 days after onset of therapy the patient developed shingles and experienced pain. The patient sought medical attention and was prescribed valtrex and prednisone as treatment. The outcome of developed shingles and pain was reported as not recovered/not resolved. No action taken with ZOSTAVAX was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a multiple patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (dose, strength, route and site of administration not reported). On unknown dates the patients experienced side effects (not specified). The outcome of side effects was unknown. The relatedness between ZOSTAVAX and side effects was not reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 1.26
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Fatigue, Gait disturbance, Irritability, Poor quality sleep, Pyrexia
Clinical narrative: Fever (39.8 degrees C) 11/8/13 with irritability. Refused to walk without Ibuprofen 11/9 - 11/11/13. Poor sleep, overtired. Snapped out of it 11/13/13.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Heart rate increased, Injection site rash, Local swelling, Pyrexia, Rash
Clinical narrative: Rash on upper left arm in AM on 10/28/13, rash also on R thigh and R arm on Nov. 1 in Am. Rash and swelling moving to entire left arm and hand on Nov. 4th advised by nurse to take Allegra and use calamine lotion. Developed fever on Nov. 13. Nurse advised to go to ER. Blood drawn and WBC was elevated. I was given Benadryl and corticosteroid. Also give 1 liter NaCl via IV, for elevated HR.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: White blood cell count
Clinical narrative: Rash on upper left arm in AM on 10/28/13, rash also on R thigh and R arm on Nov. 1 in Am. Rash and swelling moving to entire left arm and hand on Nov. 4th advised by nurse to take Allegra and use calamine lotion. Developed fever on Nov. 13. Nurse advised to go to ER. Blood drawn and WBC was elevated. I was given Benadryl and corticosteroid. Also give 1 liter NaCl via IV, for elevated HR.
Age: 34.0
Sex: F
Vaccine: FLU3, HIBV, PPV
Symptoms: Chills, Computerised tomogram thorax, Culture, Echocardiogram, Erythema
Clinical narrative: 10/3/13- Given injection in AM, by PM left arm very sore  10/4/13- Saw PCM at Clinic- are swollen and sore, low grade fever by PM  10/5/13- Arm very sore, chills, fever over 102.5 very uncontrolled, red area formed on arm, went to ER, admitted, Ultrasound, pain meds, IV antibiotics started, discharged 10/9/13  Not completely improved for 30 days
Age: 34.0
Sex: F
Vaccine: FLU3, HIBV, PPV
Symptoms: Laboratory test, Local swelling, Pain, Pain in extremity, Pyrexia
Clinical narrative: 10/3/13- Given injection in AM, by PM left arm very sore  10/4/13- Saw PCM at Clinic- are swollen and sore, low grade fever by PM  10/5/13- Arm very sore, chills, fever over 102.5 very uncontrolled, red area formed on arm, went to ER, admitted, Ultrasound, pain meds, IV antibiotics started, discharged 10/9/13  Not completely improved for 30 days
Age: 34.0
Sex: F
Vaccine: FLU3, HIBV, PPV
Symptoms: Ultrasound Doppler, Ultrasound scan
Clinical narrative: 10/3/13- Given injection in AM, by PM left arm very sore  10/4/13- Saw PCM at Clinic- are swollen and sore, low grade fever by PM  10/5/13- Arm very sore, chills, fever over 102.5 very uncontrolled, red area formed on arm, went to ER, admitted, Ultrasound, pain meds, IV antibiotics started, discharged 10/9/13  Not completely improved for 30 days
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Movement disorder, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: Terrible arm muscle pain, limited movement, weakness in arm.  Unable to lift arm beyond shoulder.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Pain in extremity
Clinical narrative: The patient reports adverse reaction to the influenza vaccine that she received on 10/16/2013. She reports that she had left arm pain that was severe and weakness that lasted approximately 2 weeks. The patient did not report this until following visit Nov. 6, 2013.
Age: 29.0
Sex: F
Vaccine: TD
Symptoms: Chills, Injection site pain, Injection site warmth, Pain, Swelling
Clinical narrative: Extreme tenderness to site (L deltoid) and warmth, body aches, chills, swelling.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient reports that she immediately felt pain at the injection site. Patient continued to feel pain/stiffness in arm to date. Patient stated that she needs to take ALEVE for pain management.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist via sales representative regarding a 54 year old male patient. There was no pertinent medical history, drug reactions or allergies. On 19-OCT-2013, the patient was vaccinated with a subcutaneous dose of ZOSTAVAX, (dose and lot number were not provided). Concomitantly on the same day, the patient received FLUVIRIN (unspecified dose/frequency and manufacturer) in the opposite arm. On 19-OCT-2013, immediately after administration with ZOSTAVAX, the patient complained of burning at the injection site, and his arm was red and swollen from the deltoid region down to the elbow. The representative stated "the swelling of the arm looked like it was retaining fluid." The patient was treated with BENADRYL (unspecified dose, frequency and  manufacturer) and patient was advised to apply ice to the swelling. The patient sought medical attention, telephone call to the pharmacist on 21-OCT-2013. Laboratory test was not performed. At the time of the report, the patient had not recovered from the adverse events. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash erythematous, Skin warm
Clinical narrative: Patient came to pharmacy 11 AM 11-15-13 ZOSTAVAX left arm 11-14-13 but on right wrist has red rash. Patient states red, hot, itchy - patient to see her doctor 11-15-13 at 1 PM.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site pain
Clinical narrative: Site of vaccination still sore 26 days after administration.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Contusion, Injected limb mobility decreased, Myalgia, Pain
Clinical narrative: 10/25/13 about 0800 received 2014 flu vaccination in left deltoid IM. During night while asleep 10/25/13 awoke with "inability to lift arm (Left) without excruciating muscle pain." Unable to rotate arm in and out without pain normal ADLs affected. Completed incident report at work 10/28/13 at 0900. Sent to hospital for evaluation/treatment. Seen at hospital 10/29/13 for left shoulder contusion since influenza injection. Returned to regular duty on 10/29/13. Follow-up visits on 10/31/13 and 11/5/13 no abnormal findings on left shoulder exam. Returned to regular duty and released 11/5/13. Patient still has tenderness.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: 10/25/13 about 0800 received 2014 flu vaccination in left deltoid IM. During night while asleep 10/25/13 awoke with "inability to lift arm (Left) without excruciating muscle pain." Unable to rotate arm in and out without pain normal ADLs affected. Completed incident report at work 10/28/13 at 0900. Sent to hospital for evaluation/treatment. Seen at hospital 10/29/13 for left shoulder contusion since influenza injection. Returned to regular duty on 10/29/13. Follow-up visits on 10/31/13 and 11/5/13 no abnormal findings on left shoulder exam. Returned to regular duty and released 11/5/13. Patient still has tenderness.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: At 9:35am returned to Clinic c/o itching and burning. "Felt like area was on fire: Left upper deltoid area hot, dark red approximately 3 inch perimeter around injection site. Diphenhydramine oral suspension 25 mg administered. Ice pack to left deltoid. No difficulty breathing, soreness itching or tightness in throat. Talking without difficulty. BP 140/90 P. 76. Remained at clinic 10:51 pm direct observation. Notified PCP for further orders: Given 2nd dose Diphenhydramine 25 mg. Released to supervision.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: Urticaria  (hives) - next morning. Received CLARITIN.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia
Clinical narrative: Got shot Monday 11/11/2013; Tuesday had muscle pain from arm to neck on one side and headache - told us Thurs 11/14/13.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Tremor
Clinical narrative: FLUZONE vaccine received at 0900 hour on 10-21-13. Abruptly at 2015 hour on 10-21-13 employee begin to have chills and shaking. Abruptly at 0830 hour on 10/22/13 chills and shaking resolved. No other symptoms noted. No fever noted on 10-22-13 0800 hour hrs.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pruritus, Pyrexia
Clinical narrative: Redness in administration site. Fever. Itching in administration site.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal pain, Appendicectomy, Barium enema, Blood test, Dehydration
Clinical narrative: Vaccines given 9/12/13. Abdominal pain, projectile vomiting, screaming, pulling legs to chest - started 10/4/13. No fever. No diarrhea. Took her to Urgent Care - was told "she has a virus" and sent home. No diagnostics performed. 10/6/13 - took her to hospital. Extremely dehydrated, basically non-responsive. Admitted for bowel obstruction caused by intussusception. Ultrasound, X-ray and barium performed. Had surgery 10/7/13 at 4 AM to remove section of intestine and appendix. Released from hospital 10/12/13.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Intestinal obstruction, Intestinal resection, Intussusception, Screaming, Surgery
Clinical narrative: Vaccines given 9/12/13. Abdominal pain, projectile vomiting, screaming, pulling legs to chest - started 10/4/13. No fever. No diarrhea. Took her to Urgent Care - was told "she has a virus" and sent home. No diagnostics performed. 10/6/13 - took her to hospital. Extremely dehydrated, basically non-responsive. Admitted for bowel obstruction caused by intussusception. Ultrasound, X-ray and barium performed. Had surgery 10/7/13 at 4 AM to remove section of intestine and appendix. Released from hospital 10/12/13.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Ultrasound scan, Unresponsive to stimuli, Urine analysis, Viral infection, Vomiting projectile
Clinical narrative: Vaccines given 9/12/13. Abdominal pain, projectile vomiting, screaming, pulling legs to chest - started 10/4/13. No fever. No diarrhea. Took her to Urgent Care - was told "she has a virus" and sent home. No diagnostics performed. 10/6/13 - took her to hospital. Extremely dehydrated, basically non-responsive. Admitted for bowel obstruction caused by intussusception. Ultrasound, X-ray and barium performed. Had surgery 10/7/13 at 4 AM to remove section of intestine and appendix. Released from hospital 10/12/13.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: X-ray
Clinical narrative: Vaccines given 9/12/13. Abdominal pain, projectile vomiting, screaming, pulling legs to chest - started 10/4/13. No fever. No diarrhea. Took her to Urgent Care - was told "she has a virus" and sent home. No diagnostics performed. 10/6/13 - took her to hospital. Extremely dehydrated, basically non-responsive. Admitted for bowel obstruction caused by intussusception. Ultrasound, X-ray and barium performed. Had surgery 10/7/13 at 4 AM to remove section of intestine and appendix. Released from hospital 10/12/13.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: Patient experienced redness and swelling at the injection site. He was seen in the ED, where he reported that there was no pain, but he was feeling some numbness and was having difficuly moving his arm. He did not have a fever. After being discharged, the swelling continued to spread outsde of previous borders and the patient was seen in clinic he next day. He had swelling from shoulder to ebow and was unable to lift his arm. He was treated with diphenhydramine, cetirizine, and cold compresses.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Axillary pain, Cough, Limb discomfort
Clinical narrative: "Uncomfortable feeling" in right armpit area. Hurts with coughing, laying on side, and reaching.
Age: 65.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Injection site inflammation, Pyrexia, Sepsis, Vomiting, Wrong technique in drug usage process
Clinical narrative: A public health client is complaining that her provider mixed Td and PNV23 vaccines in the same syringe and administered them together in her arm. She developed inflammation at the injection site that lingered for 2 weeks. Pt went to the emergency room the evening of the immunization with fever and vomiting and was hospitalized.  No mention of the immunization was in the medical records.  She was diagnosed with sepsis.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Dysgeusia, Dysphagia, Retching
Clinical narrative: Burning in kidney area initially, then developed dry heaves, difficulty swallowing and a metallic taste in her mouth.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood creatine phosphokinase, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient called complaining of significant left upper arm pain with swelling stating that she had a flu shot and pneumonia shot in the same arm yesterday. Scheduled patient for nurse visit same morning. Observed patient holding left arm stating that her arm was heavy. Noted swelling at injection sites in left deltoid that continued down halfway of upper arm. The area was warm to touch and patient indicated the pain was a 9 on scale 1-10. Patient was afebrile and denied difficulty breathing, however, did complain of itching on same upper arm. Patient advised that she tried ice pack last night, but without relief. Dr. was consulted and patient evaluation by provider was performed. Labs were ordered and patient was prescribed Benadryl and Medrol Dose Pack.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Metabolic function test, Sensation of heaviness
Clinical narrative: Patient called complaining of significant left upper arm pain with swelling stating that she had a flu shot and pneumonia shot in the same arm yesterday. Scheduled patient for nurse visit same morning. Observed patient holding left arm stating that her arm was heavy. Noted swelling at injection sites in left deltoid that continued down halfway of upper arm. The area was warm to touch and patient indicated the pain was a 9 on scale 1-10. Patient was afebrile and denied difficulty breathing, however, did complain of itching on same upper arm. Patient advised that she tried ice pack last night, but without relief. Dr. was consulted and patient evaluation by provider was performed. Labs were ordered and patient was prescribed Benadryl and Medrol Dose Pack.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Headache, Hypotension, Laboratory test normal, Nausea
Clinical narrative: Fever, headache, rigors, nausea, vomiting, hypotension.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, headache, rigors, nausea, vomiting, hypotension.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Blood creatine phosphokinase, Differential white blood cell count, Full blood count, Injection site pain, Injection site swelling
Clinical narrative: Spouse advises on 11/14/2013 at approximately 5 pm that patient was in this morning to see Dr. and received a Pneumonia shot and now the area at the injection site is swollen the size of a grapefruit, warm to touch and is very painful.  Patient denies rash, shortness of breath, difficulty breathing, or chest pain.  Instructed spouse to have patient elevate arm, apply cold compress to swollen area and suggested Ibuprofen as needed confirming that patient can take Ibuprofen.  Also instructed spouse to have patient evaluated at local urgent care or ED if symptoms worsen or new symptoms develop especially difficulty breathing or chest pain.  Encouraged patient call back in the morning with status.  Called patient on 11/15/2013 and requested nurse visit to evaluate reaction. Patient was seen by provider and it was noted swelling in left upper arm and warm to touch.  Patient advises that his left arm was less swollen than yesterday evening.  No other complaints.  Patient instructed to take on hand Benadryl and prescribed Prednisone. Patient may use cool pack to affected area as needed.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Spouse advises on 11/14/2013 at approximately 5 pm that patient was in this morning to see Dr. and received a Pneumonia shot and now the area at the injection site is swollen the size of a grapefruit, warm to touch and is very painful.  Patient denies rash, shortness of breath, difficulty breathing, or chest pain.  Instructed spouse to have patient elevate arm, apply cold compress to swollen area and suggested Ibuprofen as needed confirming that patient can take Ibuprofen.  Also instructed spouse to have patient evaluated at local urgent care or ED if symptoms worsen or new symptoms develop especially difficulty breathing or chest pain.  Encouraged patient call back in the morning with status.  Called patient on 11/15/2013 and requested nurse visit to evaluate reaction. Patient was seen by provider and it was noted swelling in left upper arm and warm to touch.  Patient advises that his left arm was less swollen than yesterday evening.  No other complaints.  Patient instructed to take on hand Benadryl and prescribed Prednisone. Patient may use cool pack to affected area as needed.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Hypoaesthesia, Pharyngeal oedema, Pruritus, Urticaria
Clinical narrative: Itching, hives on left side of neck under left ear. Hives in front of neck and redness on front of neck. Slight numbness feeling in left lower portion of face near mouth for a half an hour. Sensation of fullness in throat, but could breathe all right.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Dyspnoea
Clinical narrative: Difficulty breathing, chills.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Fatigue
Clinical narrative: Fatigue, chills.
Age: 0.59
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, RV5
Symptoms: Erythema, Local swelling, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, local erythema and swelling.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Fatigue, Inflammation, Injection site erythema, Pruritus, Rash
Clinical narrative: Redness at injection site (left arm), minor inflammation, fatigue, followed by itchiness and a rash-like, red and bumpy area about 3-4 inches in diameter (within 48 hours). Used Aquaphor to help soothe the area.
Age: 25.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Arm pain, swelling, fevers and chills.
Age: 1.36
Sex: M
Vaccine: DTAP
Symptoms: Eczema, Pruritus, Skin injury
Clinical narrative: Eczema onset after vaccine. None present before shot. Continues to this day with persistent itching to point of breaking skin.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Lethargy, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat, fever, chills, lethargy.
Age: 17.0
Sex: M
Vaccine: FLUN4
Symptoms: Abnormal sensation in eye, Cough, Decreased appetite, Eye pain, Headache
Clinical narrative: Very red sore eyes without discharge x 6 days, pressure in eyes, headache, fever 101F, cough, muscle aches, malaise, loss of appetite, nausea.
Age: 17.0
Sex: M
Vaccine: FLUN4
Symptoms: Malaise, Myalgia, Nausea, Ocular hyperaemia, Pyrexia
Clinical narrative: Very red sore eyes without discharge x 6 days, pressure in eyes, headache, fever 101F, cough, muscle aches, malaise, loss of appetite, nausea.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reports unilateral erythema, swelling, and itching in her left deltoid region that began 1-2 days post injection. Patient was advised to use cold compress and diphenhydramine.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Inflammation
Clinical narrative: Inflammation, redness.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus
Clinical narrative: Immediate itching (pruritic) then erythematous from injection site extending down to the left elbow.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Head injury
Clinical narrative: Patient received Fluvirin '13-'14 and had a seizure at 8:55 PM for about 5 seconds. I moved objects on the table away from him. He banged  his head on the table a few times before reviving.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity, X-ray normal
Clinical narrative: Arm pain, decrease range of motion started happening day after vaccine. Has had imaging. No signs of damage. Starting physical therapy.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Inflammation, Pain, Skin warm
Clinical narrative: Redness, inflammation, hot to touch, pain 48 hours after shot.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Dyspnoea, Rash generalised, Throat irritation
Clinical narrative: Mother states that within 15 min of receiving flu shot, on way home, pt started "clearing her throat" and asking for water. Wouldn't eat dinner, only sipped tea - difficulty breathing in the night. Parents gave DECADRON and 45 min later breathing was better. Rash noted in AM over chest, arms, face, neck, and arms. Taking BENADRYL every 6 hours.
Age: 72.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site anaesthesia, Injection site rash, Injection site swelling, Mobility decreased
Clinical narrative: Swelling, rash and numbness at injection site. Patient had trouble moving his arm.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient's left deltoid was painful immediately after vaccination and has continued to be painful to this point, 3 weeks later. She has lot range of motion of her arm (it was not bruised after vaccination).
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Pain in left arm at bed time day of flu shot. In AM could not move arm w/o pain. Pain subsided somewhat but now, 2 weeks after injection can not raise arm more than 45 degrees without pain and can not put pressure on arm.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 2 x 2 cm sized red, hard, hot area on left thigh.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Pain, Pyrexia, Sensation of heaviness
Clinical narrative: Developed fever of 102 the day after immunization. Fever lasted 2 day, c/o body aches and  joint pain. Soreness at injection site but no redness or swelling. Arm felt heavy for 1 day. Patient's sx's resolved after 5 days.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU3, FLU3
Symptoms: Incorrect dose administered, No adverse event, Off label use
Clinical narrative: Pt. received 2 doses infant influenza vac. and 1 adult dose influenza vaccine at the same visit, in error. No known adverse reaction at this time.
Age: 1.2
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Convulsion, Febrile convulsion, Postictal state, Pyrexia, Tachycardia
Clinical narrative: Patient had a fever 11-8-13. Later in day had a 5 minute seizure at dinner. EMS called, went to ED. Vomited once, febrile 39.3, tachycardic given 150 mg TYLENOL, observed. Short post-ictal period. No further seizure, dx: Febrile seizure, time of admit to ED 18:02, time of discharge to home 20:56.
Age: 1.2
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Patient had a fever 11-8-13. Later in day had a 5 minute seizure at dinner. EMS called, went to ED. Vomited once, febrile 39.3, tachycardic given 150 mg TYLENOL, observed. Short post-ictal period. No further seizure, dx: Febrile seizure, time of admit to ED 18:02, time of discharge to home 20:56.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Pt's arm was red and warm to the touch. She took benadryl and it subsided some.
Age: 21.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Blood pressure decreased, Dyskinesia, Hyperhidrosis, Pallor, Unresponsive to stimuli
Clinical narrative: Gave flu 1st, GARDASIL 2nd and MENACTRA 3rd. A few seconds after vaccines, pt became unresponsive, pale and started with generalized jerking movements for a few seconds (15-30)/ Aroused with ammonia ampule. BP 92/38, diaphoretic, no incontinence. Kept pt. for 1 hr. lying down BP improved. Father drove home.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Joint range of motion decreased, Mobility decreased, Muscular weakness
Clinical narrative: Pt had flu vaccine IM injection (R) upper deltoid on 10/16/13 felt burning during injection and sore. 24 hours later decrease mobility and ROJM and arm weakness which has persisted for 28 days.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Pain in extremity, Tenderness
Clinical narrative: C/o severe headache on the following morning woke up with headache which lasted 4 - 5 hrs. Took 2 TYLENOL tablets. Painful and tender left arm which lasted 3 days.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Back pain, Burning sensation, Hypoaesthesia, Laboratory test, Muscular weakness
Clinical narrative: Concerns seen on 11/1 for severe back pain/burning and numbness in legs. Dad sts provider cracked her back and she was rx'd a muscle relaxer. Back pain resolved, but still w/ weakness in right leg and numbness in left leg. Had a f/u appt at ortho on 11/7 and they did xray, labs, and MRI. Notes from visit in patient does. Thought it could potentially be Guillain Barre syndrome. Has been getting stronger w/ more feeling in legs. No known recent falls or injuries. Afebrile, no other cold sx's. Received FLUMIST on 10/25/13. Here w/dad.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Concerns seen on 11/1 for severe back pain/burning and numbness in legs. Dad sts provider cracked her back and she was rx'd a muscle relaxer. Back pain resolved, but still w/ weakness in right leg and numbness in left leg. Had a f/u appt at ortho on 11/7 and they did xray, labs, and MRI. Notes from visit in patient does. Thought it could potentially be Guillain Barre syndrome. Has been getting stronger w/ more feeling in legs. No known recent falls or injuries. Afebrile, no other cold sx's. Received FLUMIST on 10/25/13. Here w/dad.