chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Diarrhoea, Fatigue, Headache
Clinical narrative: Had shingrix vaccine in the morning yesterday.  Was feeling fine before the shot with no complaints. Increased fatigue noted at bedtime last night with anorexia and nausea, no vomiting.   Headache started overnight last night.  Some blurring of vision intermittently noted overnight but vision has normalized this AM.  + photophobia overnight, better this AM.  + diaphoresis noted overnight.  + chills.  No cough, some throat pain noted overnight but better today.  Took tylenol before bed and again this AM 500mg x 1.  No fevers measured.  Drinking water well.   Diffuse aching noted of L arm where shot was given, but this discomfort is also improving.  No vomiting.  Some loose stools overnight without blood.  No dysuria.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injection site pain, Nausea, Photophobia, Vision blurred
Clinical narrative: Had shingrix vaccine in the morning yesterday.  Was feeling fine before the shot with no complaints. Increased fatigue noted at bedtime last night with anorexia and nausea, no vomiting.   Headache started overnight last night.  Some blurring of vision intermittently noted overnight but vision has normalized this AM.  + photophobia overnight, better this AM.  + diaphoresis noted overnight.  + chills.  No cough, some throat pain noted overnight but better today.  Took tylenol before bed and again this AM 500mg x 1.  No fevers measured.  Drinking water well.   Diffuse aching noted of L arm where shot was given, but this discomfort is also improving.  No vomiting.  Some loose stools overnight without blood.  No dysuria.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Fall
Clinical narrative: Fluzone was administered. Patient stood up by shot booth to wait for his sister to receive her shot. About 3 minutes later he fell into the shot booth and the pharmacist and grandmother caught him and lowered him to the ground. He never lost contentiousness and was revived very quickly. He sat up, BP was 111/86 and patient stated he "felt fine". His grandmother stated he had a similar occurrence at a doctors office.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: She has redness, tenderness and local temperature elevation at the site of injection. - notice today.  Treatment - Ice, Bendryl, Ibuprofen and monitor.  Will be monitored closely to see if that speads.
Age: 68.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Hypersensitivity, Swelling
Clinical narrative: Per MD very swollen and thinks allergic rxn per Pt very swollen, took Benadryl for 1 week. Vacines give in left deltoid
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Oropharyngeal pain
Clinical narrative: Received second Guardasil shot yesterday and complaining of nausea and sore throat today
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Nausea, Pain, Pyrexia, Vaccination complication
Clinical narrative: Poor reaction to Flulaval Influenza vaccine - chills, fever, body aches, nausea.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Nausea, Pain, Pyrexia, Vaccination complication
Clinical narrative: Poor reaction to Flulaval Influenza vaccine - chills, fever, body aches, nausea.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Chills, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Patient returned with chills, nausea/vomiting, bodyaches. No fever on vaccination day but guardian reports patient had low grade fever of unknown temp for 48 hours past vaccination. Patient return to school on 10/10/19. Symptoms resolved.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Increase pain/erythema/swelling at injection site (right deltoid) starting next day and continuing to spread 3 days later: approximate 8cm x 8cm, warm. Site outline. Pt to return in 3 days for follow up. No anaphylactic symptoms. Pt did have new sore throat 10-4-19 along with rhinitis but sx started prior to vaccine. Appears to be local site reaction.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Oropharyngeal pain, Rhinitis, Streptococcus test negative
Clinical narrative: Increase pain/erythema/swelling at injection site (right deltoid) starting next day and continuing to spread 3 days later: approximate 8cm x 8cm, warm. Site outline. Pt to return in 3 days for follow up. No anaphylactic symptoms. Pt did have new sore throat 10-4-19 along with rhinitis but sx started prior to vaccine. Appears to be local site reaction.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Pyrexia
Clinical narrative: High fever 104' - fever for 6 hours even after Tylenol & Motrin given Headache - for an hour
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Incisional drainage, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Developed redness, swelling, soreness on her (L) deltoid - progressed and reported only on 9/30/19 - referred to ER and 10/1/19 admitted to hospital for treatment. Seen by Infectious Disease, placed on IV antibiotics, had Incision & drainage. Discharged home 10/8/19. To be followed up.
Age: 0.33
Sex: U
Vaccine: HEPA, PNC13
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: no adverse effect; four month old patient was inadvertantly administered a dose of VAQTA; four month old patient was inadvertantly administered a dose of VAQTA; This spontaneous report was received from a nurse and refers to a 4-month-old patient of an unknown gender. The patient's past medical history, concomitant medications and drug reaction or allergies were not provided.  On 18-SEP-2019, the patient was inadvertently vaccinated with hepatitis a vaccine, inactivated (VAQTA) (strength, dose, formulation, route of administration were not reported; lot # S007770 with expiration date 24-JUL-2020) of for prophylaxis. The nurse reported that the patient was supposed to be administered a dose of pneumococcal 13v conj vaccine (crm197)(PREVNAR 13). No adverse effects were reported. The outcome of product administered to patient of inappropriate age, no adverse event and wrong vaccine administered were not reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: An improperly stored dose of PEDVAX was administered to the patient; No adverse effects; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) for prophylaxis, lot # N024570 and expiration date 01-MAY-2020 (strength, dose, frequency and route of administration were not reported). No adverse effects were reported.   The temperature of excursion was reported as below 36°F to 32.1°F during a time frame of 8 hours. There was no previous temperature of excursion reported.   A Digital Data Logger was involved.
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Patient recieved an improperly stored dose of PEDVAX; This spontaneous report was received from a medical assistant regarding a 18 months male patient. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On 03-OCT-2019, the patient received an improperly stored dose (product storage error) of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot number R036177, expiration date 08-OCT-2021 for prophylaxis (strength, dose, and route of administration was not provided). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 46.5 degrees Fahrenheit (°F) for 5 minutes. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA006415: US-009507513-1910USA006414: US-009507513-1910USA006562: US-009507513-1910USA006576: US-009507513-1910USA006584:
Age: 12.0
Sex: F
Vaccine: HPV4, MENB, MNQ, TDAP
Symptoms: Rash, Rash papular
Clinical narrative: Rash / Rash on the face and body/ rash on arm neck; Rash is pimply; This case was reported by a nurse via sales rep and described the occurrence of rash in a 12-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA12AZ, expiry date 28th February 2021) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (dTpa vaccine) (batch number C5609AA, expiry date 4th April 2021) for prophylaxis, MENACTRA (batch number U5869AB, expiry date 26th January 2021) for prophylaxis and GARDASIL (batch number RO24271, expiry date 8th May 2021) for prophylaxis.   On 5th August 2019, the patient received the 1st dose of Bexsero (intramuscular) .5 ml. On an unknown date, the patient received dTpa vaccine, the 1st dose of MENACTRA and the 1st dose of GARDASIL. In August 2019, less than a week after receiving Bexsero and dTpa vaccine, the patient experienced rash and papular rash. On an unknown date, the outcome of the rash and papular rash were unknown.   It was unknown if the reporter considered the rash and papular rash to be related to Bexsero and dTpa vaccine.  Additional case details were reported as follows: The vaccine lot number and expiry date was unknown. The nurse reported to a field representative that a patient reported a rash within 2 days of Bexsero administration.  The patient developed a rash after having Bexsero, not itchy, on the face and body. The rash was pimply in appearance on face, arms, and neck. No other information was available. It was unknown how long the rashes lasted and if they were treated because reporter only called in to report the adverse event. The reporter consented to follow up. This is 1 of the 4 linked cases reported by the same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th January 2019, the patient received the 1st dose of Shingrix. On 25th January 2019, 9 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received dose 1 of Shingrix and developed shingles 13 days later.  The patient reported that various food items smell differently than before dose 2. This did not occur after dose 1. The reporter did not consent to follow-up. This case has been linked with US2019AMR177867 having same patient (dose 2)
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Pyrexia, Somnolence
Clinical narrative: fever/ fever was 102; pain at injection site; fatigue; slept all day; chills; This case was reported by a consumer via call center representative and described the occurrence of chills in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th April 2019, the patient received the 1st dose of Shingrix. On 11th April 2019, less than a day after receiving Shingrix, the patient experienced chills, fever, injection site pain, fatigue and sleepiness. On an unknown date, the outcome of the chills, fever, injection site pain and fatigue were recovered/resolved and the outcome of the sleepiness was unknown.   It was unknown if the reporter considered the chills, fever, injection site pain, fatigue and sleepiness to be related to Shingrix.  Additional details were provided as follows The patient received his first dose on and that same day he experienced all the adverse reactions. The fatigue was described as exhausted and slept all day. The fever was 102. The pain at the injection site lasted 2-3 days and all other symptoms lasted a day and a half. Consented to follow up. No phone number and address available. The reporter also mentioned his wife had adverse reactions too. Her experience was reported in separate report. This case has been linked with US2019177136 having same reporter.
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Arthralgia, Chest discomfort, Chills, Cough, Dyspnoea
Clinical narrative: My first symptoms were labored breathing and coughing. I felt like I had a weight on my chest. During the night I had a  fever of 102, chills, all over joint pain, nerve pain and muscle pain. Mild to moderate nausea. The following my symptoms were overall muscle weakness and fatigue.
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Fatigue, Muscular weakness, Myalgia, Nausea, Neuralgia
Clinical narrative: My first symptoms were labored breathing and coughing. I felt like I had a weight on my chest. During the night I had a  fever of 102, chills, all over joint pain, nerve pain and muscle pain. Mild to moderate nausea. The following my symptoms were overall muscle weakness and fatigue.
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pyrexia
Clinical narrative: My first symptoms were labored breathing and coughing. I felt like I had a weight on my chest. During the night I had a  fever of 102, chills, all over joint pain, nerve pain and muscle pain. Mild to moderate nausea. The following my symptoms were overall muscle weakness and fatigue.
Age: 60.0
Sex: F
Vaccine: FLU4, UNK, UNK
Symptoms: Chills, Erythema, Eye pain, Headache, Mobility decreased
Clinical narrative: I was given the FLu shot, tetanus and Shingles shot all in my right arm.  During the day I started to have pain in my arm. It was very difficult to bring arm up. Then slight headaches and pain in my eyes. Join and pain in my entire body accompany by chills and fever (100 degrees). It lasted 24 hours. Next morning after shot my arm was red and swollen and itchy. My arm is still  red and somewhat itchy on the side of the shots.
Age: 60.0
Sex: F
Vaccine: FLU4, UNK, UNK
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: I was given the FLu shot, tetanus and Shingles shot all in my right arm.  During the day I started to have pain in my arm. It was very difficult to bring arm up. Then slight headaches and pain in my eyes. Join and pain in my entire body accompany by chills and fever (100 degrees). It lasted 24 hours. Next morning after shot my arm was red and swollen and itchy. My arm is still  red and somewhat itchy on the side of the shots.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Systemic Pruritus and  Hives Treatment :  Claritin 10mg @ 10:30am                               Prednisone 5mg , 6tabs @ 1:45pm (taper dose  days)
Age: 87.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Fatigue, Injection site pain
Clinical narrative: Pain at injection site, tired and weak, shivering, fever, Upset stomach and throwing up
Age: 87.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Pain at injection site, tired and weak, shivering, fever, Upset stomach and throwing up
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Impaired work ability, Insomnia, Malaise, Mobility decreased, Pain
Clinical narrative: 1 hour after vaccine I couldn?t lift or move arm. Pain was from a 8 to 10. Was sick, and throwing up  Was started on prednisone after 7 days. It helped about 30 %. Still have very limited movement,  terrible pain, pain keeps me up half of the night. .went to general practitioner today and received a cortisone shot to see if that will help.  Cannot do day to day work. I?m a rancher/ horses trainer.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: 1 hour after vaccine I couldn?t lift or move arm. Pain was from a 8 to 10. Was sick, and throwing up  Was started on prednisone after 7 days. It helped about 30 %. Still have very limited movement,  terrible pain, pain keeps me up half of the night. .went to general practitioner today and received a cortisone shot to see if that will help.  Cannot do day to day work. I?m a rancher/ horses trainer.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: RED, WARM  WELT ABOUT THE SIZE OF ADULT HAND, NO FEVER, NO PAIN, NO ITCHING
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Headache, Nasal congestion, Pain, Rhinorrhoea
Clinical narrative: Tired, fatigue, stuffy nose, runny nose, headache, aches
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Child was given Quadracel instead of Pentacel. Child showed no adverse reaction at the time of the vaccine.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is only 64 years old but was given High Dose for 65 and older.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Cerebral infarction
Clinical narrative: Cerebral infarction (stroke) two days later.
Age: 4.0
Sex: M
Vaccine: FLU4, IPV, MMRV
Symptoms: Chest discomfort, Cough, Petechiae, Urticaria, Wheezing
Clinical narrative: petechia rash on face,urticaria scalp and neck,. bilateral wheezing and cough with chest tightness. mom states symptoms started about 2 hours after immuniztions. Blood pressure and pulse stable Albuterol  for wheezing and chest tightness, improved breathing after treatment. Patient was discharged home with oral steroids
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Diarrhoea, Epistaxis, Fall, Influenza
Clinical narrative: Severe flu symptoms, diarrhea, shock, fainting--mild symptoms began about 6 hours after vaccination and became severe 10 hours after vaccination. Fainting resulted in facial bruising and smashed nose--bleeding.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Shock, Syncope
Clinical narrative: Severe flu symptoms, diarrhea, shock, fainting--mild symptoms began about 6 hours after vaccination and became severe 10 hours after vaccination. Fainting resulted in facial bruising and smashed nose--bleeding.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling, Ultrasound Doppler
Clinical narrative: Redness, Swelling, hot to touch
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Inflammation, Injection site induration, Injection site nodule, Injection site reaction
Clinical narrative: Immediately after injecting the vaccine the patient had an inflammatory reaction. At the site of the insertion there was a bump that formed, which was nodule-like and hard to the touch. It was about the size of a quarter, it did not hurt the patient, nor was it red or hot.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Gait disturbance, Injection site pain, Pyrexia
Clinical narrative: R thigh and knee with pain, fever, and limp.
Age: 89.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Back pain, Muscle tightness, Musculoskeletal pain
Clinical narrative: After receiving vaccines, patient felt pain/tightness in her buttocks/lower back.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Localized swelling, erythema, and tenderness. Instructed pt to continue with cool compresses, Tylenol/ibuprofen, start antihistamines, and RTC is worsening or no improvement within the next 24-48 hours.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Mobility decreased, Musculoskeletal pain
Clinical narrative: About 45 minutes after receiving vaccination, I had extreme pain in my shoulder and could not lift my arm.  This lasted for about 24 hours.  I had difficulty sleeping because of the pain.  I took ibuprofen every 4 hours for the next 24 hours.  The pain gradually subsided.  I still have pain with certain positions of my shoulder.  I believe the injection was given too high on my arm and too close to my shoulder joint.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Pain, Pyrexia
Clinical narrative: Patient developed erythema, pain, and fever after vaccine administration. Doctor triaged phone call from parent. Advised to come in following day for follow-up. Did not make an appointment for follow up.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: pain, redness, swelling below deltoid where shot was given -bicep area to elbow. When to urgent care2-4 days after receiving the injection and then followed up at our office because she was still red and swollen. Was getting better after using Ibuprofen and ice recommended at urgent care.
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Asthenia, Dizziness, Feeding disorder, Hypokinesia, Nausea
Clinical narrative: Fever, dizzy, nausea, vomiting, weakness, worsening in the morning (from around 9:30, could hardly move until about 3:30, now just feeling weak, feverish, unable to eat.
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, dizzy, nausea, vomiting, weakness, worsening in the morning (from around 9:30, could hardly move until about 3:30, now just feeling weak, feverish, unable to eat.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Pt w/confirmed pregnancy with known last menstrual cycle of 7/25/19.  Vaccine given 8/1/19
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Blood culture, Body temperature increased, Computerised tomogram head, Culture stool, Diarrhoea
Clinical narrative: Received Flu Vaccine at 1pm on 10/1/19. By 3pm that day, states she had a low-grade fever.  That evening she felt worse and temperature elevated to 103f.  She went to the Emergency room and while there she began to have vomiting and diarrhea.  She also had blurred vision 2 days after the shot.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Full blood count, Pyrexia, Vision blurred, Vomiting
Clinical narrative: Received Flu Vaccine at 1pm on 10/1/19. By 3pm that day, states she had a low-grade fever.  That evening she felt worse and temperature elevated to 103f.  She went to the Emergency room and while there she began to have vomiting and diarrhea.  She also had blurred vision 2 days after the shot.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Mobility decreased, Pain, Pyrexia, Vomiting
Clinical narrative: Severe body aches, fever, headache, vomiting, inability to get out of bed, x 5 days!
Age: 1.42
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient experienced redness and swelling at injection site. Mother reached out to doctor via phone and sent pictures.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt presented 2 days after vaccine received for c/o fatigue, headache, and pain, erythema and warmth over injection site as well as right axillary lymph node swelling, worsening. She was placed on Prednisone x3-5 days and advised to f/up the following day for re-evaluation. Pending f/up and results at this time.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: Pt presented 2 days after vaccine received for c/o fatigue, headache, and pain, erythema and warmth over injection site as well as right axillary lymph node swelling, worsening. She was placed on Prednisone x3-5 days and advised to f/up the following day for re-evaluation. Pending f/up and results at this time.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: swelling and itching after receiving injection, next day no itching. swollen and red and hot bicep to elbow. Started Keflex 500mg bid x10d and medrol dose pak.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Muscle swelling
Clinical narrative: bicep red and swollen
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Redness noted around injection site. Parent messaged doctor and sent picture. Treatment with ice and to return to office if it does not improve in 1-2 days
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash papular
Clinical narrative: flagellate rash anterior/posterior trunk. papular rash left leg, papular rash both arms, rash both palms.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Hypotonia, Local reaction, Vaccination complication
Clinical narrative: Patient with limp, normal reflexes, able to bear weight after dtap and hib were given in left leg one day ago. Likely local vaccine reaction and no signs of joint disease or more severe vaccine reaction at this time. Gave motrin in office and discussed using ice and motrin for next 24 hours around the clock, then as needed. If persisting in 2 days, please return or call.  If unable to bear weight or any other concerning changes, call/go to ED.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Insomnia, Pain in extremity
Clinical narrative: Pharmacist gave flu shot on 10/02/19.  As soon as shot was given patient felt pain all the way down arm. Never happened before to patient.  Patient stated it should not feel that way and Pharmacist  told her it was " because she was tense, & you will be fine". Pt. states unable to sleep from pain & worry & does not know yet of long term effects &/or damage to her body, concerned about unnecessary pain & suffering.
Age: 53.0
Sex: U
Vaccine: VARZOS
Symptoms: Chest pain, Chills, Discomfort, Fatigue, Headache
Clinical narrative: On 10/02/2019, received Shingrix vaccination; 10//03/2019, noticed irritation under left arm pit, left arm was tender/sore around the injection sight; 10/04/2019, small rash appeared under left arm pit and rash appeared on back; 10/05/2019, noticed rash was getting larger on back, under left arm pit and small rash was starting to form on left breast and onto the breast/chest cavity, severe/sharp headaches in back of head behind left ear, chills, fever, fatigue and chest pains; on 10/06/2019 sharp severe headaches was occuring every 45 seconds - 1 minute apart, along with chest pains and the rashes had started to spread and grew larger in size, went to the Emergency Room due to the severe discomfort,
Age: 53.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia, Rash, Skin irritation
Clinical narrative: On 10/02/2019, received Shingrix vaccination; 10//03/2019, noticed irritation under left arm pit, left arm was tender/sore around the injection sight; 10/04/2019, small rash appeared under left arm pit and rash appeared on back; 10/05/2019, noticed rash was getting larger on back, under left arm pit and small rash was starting to form on left breast and onto the breast/chest cavity, severe/sharp headaches in back of head behind left ear, chills, fever, fatigue and chest pains; on 10/06/2019 sharp severe headaches was occuring every 45 seconds - 1 minute apart, along with chest pains and the rashes had started to spread and grew larger in size, went to the Emergency Room due to the severe discomfort,
Age: 0.25
Sex: F
Vaccine: IPV, PNC13
Symptoms: Crying, Diet refusal, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Stiffening body, crying inconsolably for 45 min, refusing to nurse, fever 102 that lasted and hour and a half. Crying when we picked her up or touched her.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Pain
Clinical narrative: Severe pain in shoulder joint  continuous for 24+ hours. Ibuprofen not particularly effective. Until 600 mg taken together which stopped constant pain, but still severe pain with arm movement.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Localized induration with erythema and increased local temperature on site of injection and surrounding skin,  the extent of the induration and redness is affecting the anterior aspect of the entire medial and part of the lower third of the  left thigh, irregularly shaped , looking like a large hive on some areas.  Probably child scratched the area.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Rash, Swelling
Clinical narrative: My left arm between my elbow and shoulder aches like a muscle ache but I haven't done anything to strain muscle.  I spoke with the pharmacist and with a medical doctor and they have not heard of a reaction as such from this vaccine.  I have no idea what caused it so checking.  It started just where the injections was given and has spread to that entire area.  The swelling a rash are gone but now have this soreness.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: an unspecified patient received GARDASIL 9 while being pregnant; This spontaneous report was received from a physician concerning a pregnant patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not reported. The patient's last menstrual period or any information regarding her pregnancy or its outcome, was not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose number, route of administration, anatomical site of vaccination, lot number or expiration date were not provided) for prophylaxis, while being pregnant (exposure during pregnancy).
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue
Clinical narrative: his father complained of unspecified tiredness which has improved but not resolved; This spontaneous report was received from a consumer, referring to his father, a 82 year old male patient. The patient did not have any concomitant therapies or medical history. The patient's drug allergy/reaction included penicillin.  On 25-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported).  On 28-SEP-2019, the patient complained of unspecified tiredness (fatigue). The patient did not seek medical attention and diagnostic laboratories were not performed.  At the time of reporting, the outcome of fatigue was reported as improved but not resolved (resolving)  (also reported as "not recovered"). The causality assessment was not provided.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Feeling abnormal
Clinical narrative: pressure; pain; soreness; weakness; headache; nausea; fever; chills; sweats; arm pain; felt like she was in a vice grip; This case was reported by a consumer via call center representative and described the occurrence of back pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fibromyalgia, arthritis and gastric disorder.   On 5th July 2019, the patient received the 1st dose of Shingrix 50 µg. In July 2019, 12 hrs after receiving Shingrix, the patient experienced back pain, hip discomfort, joint pain, weakness, headache, nausea, fever, chills, sweating, pain in arm and feeling abnormal. On an unknown date, the outcome of the back pain, hip discomfort, joint pain, weakness, headache, nausea, fever, chills, sweating and pain in arm were recovering/resolving and the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the back pain, hip discomfort, joint pain, weakness, headache, nausea, fever, chills, sweating, pain in arm and feeling abnormal to be related to Shingrix.  Additional information received were as follows: At noon, the patient received Shingrix on left arm. By midnight, the patient was having lower back and hip pressure, that felt like she was in a vice grip. The patient also noted joint pain in her elbow, knees, fingers and feet.  The patient had headache, nausea, chills and fever, along with weakness that kept her in bed till Monday. The patient noted all were still present but improving at the reporting date. The patient called the physician office and was told by the nurse to call back if symptoms worsened. The patient stated that she also reported it back to the pharmacy where she received the vaccine. The patient noted it was like affecting her in her weak spots, meaning she had a history of arthritis and fibromyalgia. Less than a week after receiving Shingrix, the patient also noted arm soreness.  The reporter consented to follow up. There was discrepancy between the outcome reported in the structured field (recovering/resolving) and the outcome reported in the source document (fatal). Retained as per the structural field of system.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Musculoskeletal discomfort, Nausea, Pain in extremity
Clinical narrative: pressure; pain; soreness; weakness; headache; nausea; fever; chills; sweats; arm pain; felt like she was in a vice grip; This case was reported by a consumer via call center representative and described the occurrence of back pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fibromyalgia, arthritis and gastric disorder.   On 5th July 2019, the patient received the 1st dose of Shingrix 50 µg. In July 2019, 12 hrs after receiving Shingrix, the patient experienced back pain, hip discomfort, joint pain, weakness, headache, nausea, fever, chills, sweating, pain in arm and feeling abnormal. On an unknown date, the outcome of the back pain, hip discomfort, joint pain, weakness, headache, nausea, fever, chills, sweating and pain in arm were recovering/resolving and the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the back pain, hip discomfort, joint pain, weakness, headache, nausea, fever, chills, sweating, pain in arm and feeling abnormal to be related to Shingrix.  Additional information received were as follows: At noon, the patient received Shingrix on left arm. By midnight, the patient was having lower back and hip pressure, that felt like she was in a vice grip. The patient also noted joint pain in her elbow, knees, fingers and feet.  The patient had headache, nausea, chills and fever, along with weakness that kept her in bed till Monday. The patient noted all were still present but improving at the reporting date. The patient called the physician office and was told by the nurse to call back if symptoms worsened. The patient stated that she also reported it back to the pharmacy where she received the vaccine. The patient noted it was like affecting her in her weak spots, meaning she had a history of arthritis and fibromyalgia. Less than a week after receiving Shingrix, the patient also noted arm soreness.  The reporter consented to follow up. There was discrepancy between the outcome reported in the structured field (recovering/resolving) and the outcome reported in the source document (fatal). Retained as per the structural field of system.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: pressure; pain; soreness; weakness; headache; nausea; fever; chills; sweats; arm pain; felt like she was in a vice grip; This case was reported by a consumer via call center representative and described the occurrence of back pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fibromyalgia, arthritis and gastric disorder.   On 5th July 2019, the patient received the 1st dose of Shingrix 50 µg. In July 2019, 12 hrs after receiving Shingrix, the patient experienced back pain, hip discomfort, joint pain, weakness, headache, nausea, fever, chills, sweating, pain in arm and feeling abnormal. On an unknown date, the outcome of the back pain, hip discomfort, joint pain, weakness, headache, nausea, fever, chills, sweating and pain in arm were recovering/resolving and the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the back pain, hip discomfort, joint pain, weakness, headache, nausea, fever, chills, sweating, pain in arm and feeling abnormal to be related to Shingrix.  Additional information received were as follows: At noon, the patient received Shingrix on left arm. By midnight, the patient was having lower back and hip pressure, that felt like she was in a vice grip. The patient also noted joint pain in her elbow, knees, fingers and feet.  The patient had headache, nausea, chills and fever, along with weakness that kept her in bed till Monday. The patient noted all were still present but improving at the reporting date. The patient called the physician office and was told by the nurse to call back if symptoms worsened. The patient stated that she also reported it back to the pharmacy where she received the vaccine. The patient noted it was like affecting her in her weak spots, meaning she had a history of arthritis and fibromyalgia. Less than a week after receiving Shingrix, the patient also noted arm soreness.  The reporter consented to follow up. There was discrepancy between the outcome reported in the structured field (recovering/resolving) and the outcome reported in the source document (fatal). Retained as per the structural field of system.
Sex: U
Vaccine: VARZOS
Symptoms: Seizure, Syncope
Clinical narrative: Syncope; Seizure; This case was reported by a physician via call center representative and described the occurrence of syncope in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 1 day after receiving Shingrix, the patient experienced syncope (serious criteria GSK medically significant) and seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the syncope and seizure were unknown.   It was unknown if the reporter considered the syncope and seizure to be related to Shingrix.  Additional information was reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The reporter asked that, if syncope and seizures one day after Shingrix had been reported. No further information provided and unable to clarify any information. The reporter did not consent to follow-up.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Neuralgia, Pain in extremity, Paraesthesia, Swelling
Clinical narrative: Patient said she had shakiness,tingly in her hands,arms, and around her eyes later on in the evening after her shot. She had swelling on the left sides of her face which was swelled out to her jaw line, neck and shoulder. Her swelling went away in 48 hours. Sharp nerve pain in big right toe. Her left pointer finger she had sharp pain and also her back.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face, Tremor
Clinical narrative: Patient said she had shakiness,tingly in her hands,arms, and around her eyes later on in the evening after her shot. She had swelling on the left sides of her face which was swelled out to her jaw line, neck and shoulder. Her swelling went away in 48 hours. Sharp nerve pain in big right toe. Her left pointer finger she had sharp pain and also her back.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT NOTICED SYMPTOMS AROUND 7-8PM DURING THE EVENING TIME.  SHE EXPERIENCED REDNESS,SWELLING,SORE ARM, AND FEELING HOT AT THE INJECTION SITE.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Erythema, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Itching of right arm and red, blotchy, burning areas around injection site and down right arm; Oral Benadryl at beginning of symptoms
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash macular
Clinical narrative: Itching of right arm and red, blotchy, burning areas around injection site and down right arm; Oral Benadryl at beginning of symptoms
Age: 1.5
Sex: M
Vaccine: DTAP, FLU4, HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: R lateral thigh 3x9cm swelling/redness; suspect DTap; counseled ice pack, motrin prn; discussed with mom still ok for future DTaP per schedule; will file report on VARES
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: itchy hives on injection area. using benydryl on spot
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Pain, edema, and erythema began the evening of the vaccination on the inside of right arm, from the bottom of the deltoid to the elbow.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Myalgia, Paraesthesia, Peripheral swelling
Clinical narrative: Severe myalgias, fatigue, malaise, and local arm swelling for approximately 5 days. Generalized parasthesias. Patient called after resolution of symptoms and declined appointment.
Age: 27.0
Sex: U
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash generalized
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm is hot , swollen, and painful.
Age: 70.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Patient presented to urgent care with redness and swelling on her left arm 48 hours after receiving Fluad and Shingrix.  Her provider diagnosed her with cellulitis and prescribed doxycycline 100mg tablet. Take one tablet by mouth twice daily for 10 days.
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: Employee presented with redness, edema, induration, warmth and itching around injection site right upper arm Denies fever
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: pt reported 4  day of pain around the site, itching locally around the L arm (site of vaccine).  she didn't notify me (provider) until 2 weeks later and by then the symptoms had completely resolved on their own.
Age: 10.0
Sex: M
Vaccine: UNK
Symptoms: Migraine, Pyrexia
Clinical narrative: Severe migraine headache  and low-grade temp (100)
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Rash
Clinical narrative: She received Tdap on 10/2/19 and developed significant arm pain same day that has been persistent.  Rash developed 2 days ago and it's spreading.  No fevers, doesn't feel ill.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Insomnia
Clinical narrative: about 8 hrs after shot being  administered, started shivering, shaking violently, feverish, nausau, headache, muscle aches and fatigue. slept very little that first night.  got up at 9:30am. exhausted, dizzy and had most of the issues i had the prior day. the next day (today) still had feverish feeling, dizziness, muscle aches and headache.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia, Tremor
Clinical narrative: about 8 hrs after shot being  administered, started shivering, shaking violently, feverish, nausau, headache, muscle aches and fatigue. slept very little that first night.  got up at 9:30am. exhausted, dizzy and had most of the issues i had the prior day. the next day (today) still had feverish feeling, dizziness, muscle aches and headache.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal distension, Asthenia, Diarrhoea, Dizziness, Erythema
Clinical narrative: Arm swollen, red & hot from injection site to below elbow, headache, nausea,  weakness, body aches, dizziness,  GI cramping  & very loose stools. I'm on day 9 & still have weakness, dizziness, GI cramping & very loose stools.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Gastrointestinal pain, Headache, Injection site erythema, Injection site warmth, Nausea
Clinical narrative: Arm swollen, red & hot from injection site to below elbow, headache, nausea,  weakness, body aches, dizziness,  GI cramping  & very loose stools. I'm on day 9 & still have weakness, dizziness, GI cramping & very loose stools.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Peripheral swelling, Skin warm
Clinical narrative: Arm swollen, red & hot from injection site to below elbow, headache, nausea,  weakness, body aches, dizziness,  GI cramping  & very loose stools. I'm on day 9 & still have weakness, dizziness, GI cramping & very loose stools.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pruritus, Swelling face
Clinical narrative: About 36 hours after injection my face started itching and tingling and during the course of the day it swelled up.  I called my doctor to see if I could take Benadryl and he approved that.  Benadryl did not take effect and I went to the ER at Hospital on Thursday evening after my eyes became slits.  ER doc prescribed steroid (Prednisone 50 mg) for 5 days and continue Benadryl.  After a week everything is back to normal.  I am just curious if I should have the second Shingles shot in a few months time.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported that her arm got very large and noticed 2 hours after administration when she took the bandage off that it was swollen and painful. Patient called on 10/10/2019, 2 days after getting the vaccine that she has noticed that it has gone done but is still swollen and red.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal discomfort, Asthenia, Fatigue, Headache, Loss of personal independence in daily activities
Clinical narrative: Body aches, head ache, fatigue -- lasted several days, and kept me from my normal activities. After a few days, I was back to usual activities except for exercising. But I haven't felt well the vaccine then and it has been over 1 week. I don't have the same energy level as before and my stomach is slightly upset. I am thirstier than usual.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Malaise, Pain, Thirst
Clinical narrative: Body aches, head ache, fatigue -- lasted several days, and kept me from my normal activities. After a few days, I was back to usual activities except for exercising. But I haven't felt well the vaccine then and it has been over 1 week. I don't have the same energy level as before and my stomach is slightly upset. I am thirstier than usual.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: sore and swollen arm
Age: 90.0
Sex: M
Vaccine: FLUA3
Symptoms: Chronic obstructive pulmonary disease, Disorientation, Fall, Immobile, Mental status changes
Clinical narrative: The County Health Department was on-site at Senior Living Community for a scheduled FLU Clinic on Wednesday, October 9, 2019. The event started at 10:00 a.m., but  we had been asked to visit the homes of two immobile patients in the community to administer their FLU shots. We learned that patient had a fall the previous day. which we believed was the cause of his immobility. I received a call from Hospice to report heightened disorientation which she noticed today (10/10/2019) from her patient in Hospice care for COPD. She said she was aware there may be no connection to the vaccine, but she wanted to report it since she had seen changes in mental status of both of her Hospice patients who had Flu vaccine at yesterday's off-site Clinic. Hospice said she had given the patient Roxenal to settle him down. When our Nurse was there to administer the vaccine, she noticed the patient seemed tired but was able to answer all her questions. His wife signed the Consent because he asked her to since he was so tired from having just gotten up to go to the bathroom.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Diplegia
Clinical narrative: BILATERAL LOWER EXTREMITY PARALYSIS
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Musculoskeletal pain
Clinical narrative: Shoulder pain Level 8 of 10--overall malaise
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: PATIENT RECEIVED PNEUMOVAX 23 IN LEFT ARM, PT STATED 2 HOURS AFTER RECEIVING IMZ HIS ARM SWELLED AND WAS HOT TO TOUCH.  HE SAID HE TOOK BENADRYL AND IBUPROFEN. HE WENT TO URGENT CARE ON 10/10/19