chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician refers to a 19 year old female patient. On 22-AUG-2013 the patient was vaccinated with a dose of GARDASIL (Lot number J006587, expiration date 04-DEC-2015, dose was not reported). On 22-AUG-2013, the physician mentioned the patient developed syncope following the administration of GARDASIL. The patient visited doctor's office. Action taken with  GARDASIL was unknown. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a registered nurse refers to 2 unspecified patients. On an unknown date the patients were vaccinated with GARDASIL (lot #, expiration, dose, route unspecified). On an unknown date the patients experienced dizziness after received GARDASIL. The event outcome was unknown. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Discomfort, Feeding disorder of infancy or early childhood, Haematochezia, Intussusception, Irritability
Clinical narrative: 8/17/13 poor feeding, uncomfortable, fussy (+) blood in stool vomited x1. He was referred to hospital, he was diagnosed and treated for intussusception.
Age: 0.34
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Ultrasound scan abnormal, Vomiting
Clinical narrative: 8/17/13 poor feeding, uncomfortable, fussy (+) blood in stool vomited x1. He was referred to hospital, he was diagnosed and treated for intussusception.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 30 years old female patient. The patient had no pertinent medical history and drug reactions/allergies. On 05-AUG-2013 the patient was vaccinated with a dose of M-M-R II (lot # unspecified) dose, route and location unspecified for vaccination by an unspecified physician. No concomitant therapy was reported. The patient was found to be pregnant with LMP of an unspecified date the first week of July. ON 22-AUG-2013 the patient received a positive pregnancy test. Date of conception was calculated by LMP plus two weeks as the third week of July. Trimester(s) of exposure was the first. No adverse effect reported. The patient had sought medical attention via office visit. No treatment was given for the events. At the time of this report, the pregnancy outcome was unknown. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Pain
Clinical narrative: This spontaneous report as received from a consumer refers to a 64 year old male patient with penicillin allergy. On 14-AUG-2013 the patient was vaccinated with ZOSTAVAX, dose and frequency were unknown. On 14-AUG-2013, 1 day after onset of therapy the patient experienced aches and pains, and stated they felt like they were getting a cold. During this AE report, the patient stated that they missed a dose of BENICAR (unspecified manufacturer/dose/frequency) on 14-AUG-2013, because they were going to receive ZOSTAVAX. No treatment was given for the AE. The patient did not seek medication attention. Routine blood work was performed without result provided. At time of report the patient was not recovered/not resolved. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure during pregnancy, Herpes zoster, Immunodeficiency
Clinical narrative: Information has been received from a registered nurse for ZOSTAVAX a Pregnancy Registry product refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number, dose, route and indication were not reported). The patient that may have received ZOSTAVAX on an unspecified date may have had a case of shingles on an unspecified date while pregnant. Nurse could not confirm whether patient had a possible history of ZOSTAVAX administration. The LMP and EDD were not known. The pregnancy outcome and the outcome of adverse event were not provided. It was noted that the patient also who was immunocompromised and pregnant again may also had a diagnosis of shingles in 16-AUG-2013 (MARRS number 1308USA008620). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure during pregnancy, Herpes zoster
Clinical narrative: Information has been received from a registered nurse for ZOSTAVAX a Pregnancy Registry product refers to a female patient of unknown age. It was noted that the nurse could not confirm whether patient had a possible history of ZOSTAVAX administration (lot number, dose, route and indication were not reported). On an unspecified date may have had a prior case of shingles on an unspecified date while pregnant (MARRS 1308USA012075). On an unknown date the patient was vaccinated with ZOSTAVAX (lot number, dose, route and indication were not reported). This patient who was presently immunocompromised and pregnant may also have a diagnosis of shingles on 16-AUG-2013. The LMP and ED were not known. The pregnancy outcome and the outcome of adverse event were not provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, route and lot number not provided). Subsequently, on an unknown date, the patient developed HPV disease. The outcome of the event was unknown. The causal relationship was not reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule
Clinical narrative: This spontaneous report as received from a 75 year old female patient with high blood pressure, high cholesterol, arthritis and no known drug reactions/allergies. The patient's medical history included shingles. In July 2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided) for shingles vaccination. The patient got the ZOSTAVAX after she had the shingles. Concomitant therapies included CELBREX and unspecified triglyceride. In July 2013 the patient developed a small knot around the injection site. No treatment was given for the adverse event. No lab diagnostic tests were performed. The patient sought the physician for medical attention. The outcome of the event was reported as recovered (approximate date 2013). The causal relationship was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (LPN) refers to a patient of unknown age and gender. On 14-MAR-2013 the patient was vaccinated with the first dose of GARDASIL (Lot # not reported) (dose and route not reported). On 22-AUG-2013 the patient was vaccinated with the second dose of GARDASIL (Lot # 0692AA, exp date 13-AUG-2013) (dose and route not reported). Concomitant therapy was not reported. It was reported that on 22-AUG-2013 the patient received a second dose of GARDASIL that was expired (exp date. 13-AUG-2013). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an office manager refers to an unspecified number of patients of unknown demographics. On an unknown date the patients were vaccinated with RECOMBIVAX HB (lot #, expiration date, dose and route were unknown) that underwent unsupported temperature excursions and no adverse effects reported. Follow up information was received from the office manager who reported that on 01-AUG-2013 one patient was vaccinated with RECOMBIVAX HB (lot # 1106AA, expiration date 05-APR-2014). This is one of the several reports from the same source. Additional information is not expected.
Age: 40.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Catheterisation cardiac normal, Chest pain, Dyspnoea, Electrocardiogram abnormal, Hyperhidrosis
Clinical narrative: This study case was received from the investigator in a trial on 20 August 2013. An 40 year-old male subject who had no significant past medical history was found to have other chest pain 11 days after receiving on 12 June 2013 the following vaccines: an injection of ACAM2000 (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I on 23 June 2013 recorded highest value of 01.54 and an abnormal ECG on 23 June 2013. An Echocardiogram, lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 40.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 20 August 2013. An 40 year-old male subject who had no significant past medical history was found to have other chest pain 11 days after receiving on 12 June 2013 the following vaccines: an injection of ACAM2000 (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I on 23 June 2013 recorded highest value of 01.54 and an abnormal ECG on 23 June 2013. An Echocardiogram, lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 40.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Chest pain, Electrocardiogram abnormal, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 20 August 2013. An 40 year-old male subject who had no significant past medical history was found to have other chest pain 11 days after receiving on 12 June 2013 the following vaccines: an injection of ACAM2000 (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I on 23 June 2013 recorded highest value of 01.54 and an abnormal ECG on 23 June 2013. An Echocardiogram, lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Alopecia, Blister, Erythema, Headache, Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with no drug allergies. On 28-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot # J001729, exp 20-OCT-2013, 0.65 ml, subcutaneous). The pharmacist reported that a patient developed a headache and "red itchy blisters" around the injection site on an unspecified time after receiving ZOSTAVAX. The pharmacist also reported that on 10-AUG-2013, the patient developed 5 blisters on an unspecified legs on the top 3 blisters on an unspecified arm, and "at least" 6 blister of her back that the patient reported to the pharmacist as "itchy and bubbly". The pharmacist stated that the patient had also lost "about 1/3" of her hair since receiving ZOSTAVAX. The patient saw an unspecified dermatologist on an unspecified date. No treatment was given for the adverse events. No lab diagnostics studies was performed. The outcome of the adverse events was reported as not recovered/not resolved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site vesicles, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with no drug allergies. On 28-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot # J001729, exp 20-OCT-2013, 0.65 ml, subcutaneous). The pharmacist reported that a patient developed a headache and "red itchy blisters" around the injection site on an unspecified time after receiving ZOSTAVAX. The pharmacist also reported that on 10-AUG-2013, the patient developed 5 blisters on an unspecified legs on the top 3 blisters on an unspecified arm, and "at least" 6 blister of her back that the patient reported to the pharmacist as "itchy and bubbly". The pharmacist stated that the patient had also lost "about 1/3" of her hair since receiving ZOSTAVAX. The patient saw an unspecified dermatologist on an unspecified date. No treatment was given for the adverse events. No lab diagnostics studies was performed. The outcome of the adverse events was reported as not recovered/not resolved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Alopecia, Blister, Erythema, Headache, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with no drug allergies. On 28-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot # J001729, exp 20-OCT-2013, 0.65 ml, subcutaneous). The pharmacist reported that a patient developed a headache and "red itchy blisters" around the injection site on an unspecified time after receiving ZOSTAVAX. The pharmacist also reported that on 10-AUG-2013, the patient developed 5 blisters on an unspecified legs on the top 3 blisters on an unspecified arm, and "at least" 6 blister of her back that the patient reported to the pharmacist as "itchy and bubbly". The pharmacist stated that the patient had also lost "about 1/3" of her hair since receiving ZOSTAVAX. The patient saw an unspecified dermatologist on an unspecified date. No treatment was given for the adverse events. No lab diagnostics studies was performed. The outcome of the adverse events was reported as not recovered/not resolved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Alopecia, Back pain, Blood test, Emotional distress, Headache
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with no drug allergies. On 28-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot # J001729, exp 20-OCT-2013, 0.65 ml, subcutaneous). The pharmacist reported that a patient developed a headache and "red itchy blisters" around the injection site on an unspecified time after receiving ZOSTAVAX. The pharmacist also reported that on 10-AUG-2013, the patient developed 5 blisters on an unspecified legs on the top 3 blisters on an unspecified arm, and "at least" 6 blister of her back that the patient reported to the pharmacist as "itchy and bubbly". The pharmacist stated that the patient had also lost "about 1/3" of her hair since receiving ZOSTAVAX. The patient saw an unspecified dermatologist on an unspecified date. No treatment was given for the adverse events. No lab diagnostics studies was performed. The outcome of the adverse events was reported as not recovered/not resolved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash, Sciatica
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with no drug allergies. On 28-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot # J001729, exp 20-OCT-2013, 0.65 ml, subcutaneous). The pharmacist reported that a patient developed a headache and "red itchy blisters" around the injection site on an unspecified time after receiving ZOSTAVAX. The pharmacist also reported that on 10-AUG-2013, the patient developed 5 blisters on an unspecified legs on the top 3 blisters on an unspecified arm, and "at least" 6 blister of her back that the patient reported to the pharmacist as "itchy and bubbly". The pharmacist stated that the patient had also lost "about 1/3" of her hair since receiving ZOSTAVAX. The patient saw an unspecified dermatologist on an unspecified date. No treatment was given for the adverse events. No lab diagnostics studies was performed. The outcome of the adverse events was reported as not recovered/not resolved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Localized reaction around injection site (redness and swelling) improved with Benadryl.
Age: 3.0
Sex: M
Vaccine: VARCEL, VARCEL, MMR
Symptoms: Erythema, Skin mass, Swelling, Tenderness
Clinical narrative: One swollen, red, raised lump in the top middle chest area. It was painful to the touch, not itchy. My son received his first Varicella vaccine today at 3:15 p.m. Second time this happened. the first was after my son had the MMR shot. Same kind of swollen, red, raised lump in the same spot. Painful then too with my son crying in pain. Went to the locL emergent care.
Age: 3.0
Sex: M
Vaccine: VARCEL, VARCEL, MMR
Symptoms: Erythema, Mass, Pain
Clinical narrative: One swollen, red, raised lump in the top middle chest area. It was painful to the touch, not itchy. My son received his first Varicella vaccine today at 3:15 p.m. Second time this happened. the first was after my son had the MMR shot. Same kind of swollen, red, raised lump in the same spot. Painful then too with my son crying in pain. Went to the locL emergent care.
Age: 3.0
Sex: M
Vaccine: VARCEL, VARCEL, MMR
Symptoms: Mass
Clinical narrative: One swollen, red, raised lump in the top middle chest area. It was painful to the touch, not itchy. My son received his first Varicella vaccine today at 3:15 p.m. Second time this happened. the first was after my son had the MMR shot. Same kind of swollen, red, raised lump in the same spot. Painful then too with my son crying in pain. Went to the locL emergent care.
Age: 24.0
Sex: F
Vaccine: MEN, TD
Symptoms: Diarrhoea, Vomiting projectile
Clinical narrative: Severe gastrointestinal purging (projectile vomiting and diarrhea) for about 8 hours. Unable to keep even saltines down until 8pm (18.5 hours). Others in family had eaten exact same meals all day - only difference was vaccines.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site rash, Injection site reaction, Local reaction, Pyrexia, Rash
Clinical narrative: 8/12/13 Vaccine administered. 8/13/13 Localized rxn injection site rash and welt right thigh. 8/15/13 Fever 102F. Few spots vesicular on trunk and face. 8/21/13 Fever and vesicles inc.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Rash vesicular, Urticaria, Varicella virus test
Clinical narrative: 8/12/13 Vaccine administered. 8/13/13 Localized rxn injection site rash and welt right thigh. 8/15/13 Fever 102F. Few spots vesicular on trunk and face. 8/21/13 Fever and vesicles inc.
Age: 24.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Echocardiogram, Electrocardiogram, Pericardial disease, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 20 August 2013. A 24 year-old male subject with no significant past medical history was found to have unspecified disease of pericardium 15 days after the subject had received the following vaccines on 11 July 2013: an injection of ACAM2000 (lot number, route and site of administration not reported) and TYPHIM VI (lot number, route and site of administration not reported). Troponin I, ECG, and echocardiogram were not available. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Inappropriate schedule of drug administration, Metrorrhagia, Smear cervix abnormal
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician refers to a 22 year old female patient with penicillin (unspecified) allergy and percocet (unspecified) allergy. The patient's medical history included depression, suicide attempts and high risk HPV on PAP smears. On 08-AUG-2013, the patient was vaccinated with GARDASIL (lot # reported as H02108, expiry: 13-AUG-2015) dose 2, 0.5 ml, intramuscular route prior to learning of pregnancy. The patient received the first dose of GARDASIL on 12-AUG-2012. Patient was seen in unspecified emergency room for spotting on 16-AUG-2013 and then was seen in physician's office 20-AUG-2013 for pregnancy. The patient became pregnant with LMP on 01-JUL-2013 and EDD of 07-APR-2014. The pregnancy outcome was outcome pending. On an unknown date the patient experienced seen in physician office on 20-AUG-2013 for pregnancy. No treatment was given for spotting. The outcome of spotting was unknown. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: RAB
Symptoms: Local swelling, Nausea, Pain in extremity, Paraesthesia
Clinical narrative: On 8/6/2013 pt recv'd a Rabies vaccine. On 8/14/13 pt. started to experience tingling in left leg and nausea. Right arm was very sore and swollen as well.
Age: 43.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Site is swollen to the size of a tennis ball, red, warm to the touch, itchy and sore.
Age: 14.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Back pain, Musculoskeletal pain, Oedema peripheral, Pain in extremity, Paraesthesia
Clinical narrative: After vaccine given and Pt sitting for 15 min c/o blurred vision and foot pain and tingling. Pt laying down, Vitals monitored.  Pt given fruit snacks and water. Vision and tingling cleared after 35 min Foot pain continued. Pt was rechecked in office at 11:00 8/28/2013 for bilateral leg pain Pain worse in right leg. C/o pain in back, shoulders legs and feet. Right foot swelling in AM noted by pt/ mother. Treating with Advil or Aleve prn.
Age: 14.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Vision blurred
Clinical narrative: After vaccine given and Pt sitting for 15 min c/o blurred vision and foot pain and tingling. Pt laying down, Vitals monitored.  Pt given fruit snacks and water. Vision and tingling cleared after 35 min Foot pain continued. Pt was rechecked in office at 11:00 8/28/2013 for bilateral leg pain Pain worse in right leg. C/o pain in back, shoulders legs and feet. Right foot swelling in AM noted by pt/ mother. Treating with Advil or Aleve prn.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Tremor
Clinical narrative: Tremors. Lasted approximately 30 seconds. Continue to have tremors about 1 time per week that is noticed.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Convulsion, Fall
Clinical narrative: She dropped to the floor and had a 15 second seizure.
Age: 15.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: CLIENT HAS FEVER & RASH.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Blister, Erythema, Pain
Clinical narrative: Reddened area on the posterior and side of right arm with a quarter size blister. Pt c/o soreness and pain.
Age: 16.0
Sex: M
Vaccine: MEN, PPV
Symptoms: Chills, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: High grade fever, diarrhea, vomiting, chills. 7 day course, Motrin and Advil.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient (employee) stated she starting having redness and swelling to vaccination site the evening of 8-26-13 when administered. Reported to Employee Health on 8-27-13 L upper extremity noted to be red and slightly warm to touch at vaccination site. Patient afebrile. No complaint of n/v voiced. Respers easy and unlabored. Patient stated with first vaccine of MMR series she had pain for a couple of days after vaccination but no other reactions. Patient does have medication allergies to PCN, Codeine, Benadryl and sulfa. Patient was educated to apply ice every 4 hours times 20 minutes and take OTC Ibuprofen 400mg for pain/inflammation and to return to employee health if symptoms worsened or did not improve. Patient was seen in business health services on 8-28-13 to be evaluated by physician. Physician prescribed ATB therapy for adverse reaction. Will continue to follow patient.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cough, Drooling, Respiratory rate increased
Clinical narrative: Noticed reaction when leaving office visit after vaccines. Coughing, drooling saliva, rapid breathing were symptoms noticed by mother when they arrived home. As per mother nothing esle was ingested.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Groin pain, Infection
Clinical narrative: Upon awakening the morning following the vaccination, patient c/o pain and aching in the groin bilaterally. The patient was evaluated by his physician and treated for an infection of unknown cause with prescribed antibiotics.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain and redness in upper thighs, hot to touch, and swollen.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Client called with complaint of left arm pain with movement above a 45 degree angle, and with back reaching movement on 8/29/13.  Denies redness, fever, infection, just pain.  Encouraged to see her physician.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: WORSENED SWELLING AND ITCHING AT INJECTION SITE.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Injection site urticaria
Clinical narrative: WORSENED SWELLING AND ITCHING AT INJECTION SITE.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Nausea, Pyrexia
Clinical narrative: Father states patient had a fever, 100, and is nauseous. Stayed home from school. (Father also stated that he "became nauseous from making his son receive the shot.")
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal pain upper, Contusion, Dizziness, Immediate post-injection reaction, Joint swelling
Clinical narrative: Patient fainted immediately after receiving MCV-4 vaccine. Client was laid down to avoid injury and until she responsed. She left the clinic with her mother after a few minutes. Patient notice in the vehicle her ankle was bruised and beginning to swell. Patient continue to feel light headed, dizzy and had a stomach ache. She ate some food when she got home. Her mother took her to the walk-in clinic for her bruised ankle. Patient continued to feel light headed and had a stomach ache.  The doctor at the clinic assessed her throat, heart and ankle (diagnosised as a sprain). He did not feel any allergic reaction had taken place. Patient ate a light dinner, but continued to feel light headed and dizzy when upright. She stayed home from school the following day. Mother reported no fever, no redness at the injection site or hives. Patient returned to school 08/28/13 and felt normal. Mother called the public health clinic on 08/28/13 to report the event. Mother was called on 08/29/13 to follow up on patient's symptoms, which were resolved.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Ligament sprain, Syncope
Clinical narrative: Patient fainted immediately after receiving MCV-4 vaccine. Client was laid down to avoid injury and until she responsed. She left the clinic with her mother after a few minutes. Patient notice in the vehicle her ankle was bruised and beginning to swell. Patient continue to feel light headed, dizzy and had a stomach ache. She ate some food when she got home. Her mother took her to the walk-in clinic for her bruised ankle. Patient continued to feel light headed and had a stomach ache.  The doctor at the clinic assessed her throat, heart and ankle (diagnosised as a sprain). He did not feel any allergic reaction had taken place. Patient ate a light dinner, but continued to feel light headed and dizzy when upright. She stayed home from school the following day. Mother reported no fever, no redness at the injection site or hives. Patient returned to school 08/28/13 and felt normal. Mother called the public health clinic on 08/28/13 to report the event. Mother was called on 08/29/13 to follow up on patient's symptoms, which were resolved.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Inflammation, Local swelling, Pain in extremity, Pyrexia
Clinical narrative: Red, raised, hot to touch, non-painful, circle of inflammation on left anterior thigh. Approximate size is 1 3/4 inch in diameter. Fever in the morning of 101.2 degrees F. Child complains that his "leg hurts." Encouraged mom to continue Tylenol as needed. Mark with a pen the edge of redness. If symptoms worsens or any new symptoms occur to contact pediatrician.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Skin warm
Clinical narrative: Red, raised, hot to touch, non-painful, circle of inflammation on left anterior thigh. Approximate size is 1 3/4 inch in diameter. Fever in the morning of 101.2 degrees F. Child complains that his "leg hurts." Encouraged mom to continue Tylenol as needed. Mark with a pen the edge of redness. If symptoms worsens or any new symptoms occur to contact pediatrician.
Age: 1.01
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Unsure of actual onset but noticed the issue the following day and it remained for approximately a week after. There was a red circle with raised bumps around the injection site.
Age: 1.19
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Aphasia, Autism spectrum disorder, Communication disorder, Febrile convulsion, Laboratory test abnormal
Clinical narrative: On the day of the vaccinations, my son developed an extremely high fever. Early the next morning (03/30/12 at approximately 7:00am), he was rushed to the hospital because of febrile seizures. Prior to the vaccinations on that day, my son was developing normally and speaking several words. After that time, he was no longer speaking. By age 2, I noticed his language still wasn't developing. I took him to his doctor and was referred to a program for speech therapy. After several evaluations, it has been determined that my son is on the spectrum for Autism. We have just begun the evaluation process. He is still non-verbal and has many red flags.
Age: 1.19
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Sensory disturbance, Speech disorder developmental
Clinical narrative: On the day of the vaccinations, my son developed an extremely high fever. Early the next morning (03/30/12 at approximately 7:00am), he was rushed to the hospital because of febrile seizures. Prior to the vaccinations on that day, my son was developing normally and speaking several words. After that time, he was no longer speaking. By age 2, I noticed his language still wasn't developing. I took him to his doctor and was referred to a program for speech therapy. After several evaluations, it has been determined that my son is on the spectrum for Autism. We have just begun the evaluation process. He is still non-verbal and has many red flags.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site rash
Clinical narrative: Rash at injection site.
Age: 33.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Heart rate increased, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Woke up with a fever of 101.6, sore throat, headache, achyness, and felt like heart was beating hard.  Went to dr in the morning and tested positive for strep.  Prescribed amoxicillin.
Age: 33.0
Sex: F
Vaccine: DTAP
Symptoms: Streptococcus test positive
Clinical narrative: Woke up with a fever of 101.6, sore throat, headache, achyness, and felt like heart was beating hard.  Went to dr in the morning and tested positive for strep.  Prescribed amoxicillin.
Age: 0.18
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, RVX
Symptoms: Irritability, Pallor, Vomiting
Clinical narrative: Vomiting, paleness, fussiness.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Erythema, Fatigue, Heart rate increased
Clinical narrative: Pain, redness, swelling in arm, mild fever, tiredness, nausea, muscle aches, dizziness, rapid heart beat, weakness.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Local swelling, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Pain, redness, swelling in arm, mild fever, tiredness, nausea, muscle aches, dizziness, rapid heart beat, weakness.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Pruritus, Skin warm
Clinical narrative: ITCHING, WARMTH AND RED INDURATED AREA 9 X 14 CM.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Cough, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: Very red, painful sore throat, headache, sneezing, malaise, myalgia, coughing, profuse perspiration, blowing large amount of mucus from nose, temperature between 99.4 and 100.4. Moderate soreness and itching at injection site.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus, Malaise, Myalgia, Nasopharyngitis
Clinical narrative: Very red, painful sore throat, headache, sneezing, malaise, myalgia, coughing, profuse perspiration, blowing large amount of mucus from nose, temperature between 99.4 and 100.4. Moderate soreness and itching at injection site.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pharyngeal erythema, Rhinorrhoea, Sneezing
Clinical narrative: Very red, painful sore throat, headache, sneezing, malaise, myalgia, coughing, profuse perspiration, blowing large amount of mucus from nose, temperature between 99.4 and 100.4. Moderate soreness and itching at injection site.
Age: 9.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Hepatic encephalopathy, Liver transplant
Clinical narrative: As per hospital the child develop hepatic encephalopathy 2-3 weeks after given the FLUMIST and he had liver transplant after that.
Age: 9.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Acute hepatic failure, Liver transplant, Vaccination complication
Clinical narrative: As per hospital the child develop hepatic encephalopathy 2-3 weeks after given the FLUMIST and he had liver transplant after that.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a 69 year old female patient with no pertinent medical history. Current conditions of the patient included penicillin allergy, cephalosporins (unspecified) allergy and MACRODANTIN allergy. On 23-AUG-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date reported as H012577 and 28-SEP-2013 respectively), subcutaneously. There were no concomitant medications. On 24-AUG-2013, the patient developed redness, swelling, warmth, periodic itchiness and 2 to 3 dots/bumps in an area about the size of a baseball around the injection site. The patient sought medical attention (came to pharmacy). No lab tests were performed. No treatment was given. However, the pharmacist informed the patient that if the symptoms become bothersome then to use a hydrocortisone cream (manufacturer unknown) for the itchiness and a cool wash cloth for the warmth, redness and swelling. VZVIP packed was faxed. The patient was not recovered from all the adverse events at the time of reporting. The relatedness for all the adverse events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Pyrexia
Clinical narrative: Headache and fever up to 101.4 axillary that last 1 1/2 days.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Tenderness
Clinical narrative: Patient called 08/23/13 to report to the pharmacist that during the night of 8/22/13 her leg started hurting to the touch. By the morning of 8/23/13 she was experiencing a non-painful rash on her buttock and down her leg.  She called her doctor who asked her to observe the area until Monday and to come in and be seen if symptoms persist. By Monday 08/26/13 she was seen in the doctor's office where the patient was diagnosed with an active case of shingles and prescribed an antiviral.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Rash over entire body. Fever. Pt was seen by Dr at American Falls Clinic.  Mother instructed to begin giving her Benadryl and Dr consulted with Allergy Specialist.  She was referred to Allergist for further testing to determine what caused rash.
Age: 34.0
Sex: M
Vaccine: TYP
Symptoms: Tinnitus
Clinical narrative: Started having tinnitus & thought it was related to shot. Went to PCP-no treatment given.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Dizziness, Fall
Clinical narrative: Patient stated she felt dizzy and then fell over and had a seizure. Seizure lasted 3-4 minutes. Vitals were monitored and EMS was called to take the patient to the ER.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fall, Seizure like phenomena, Syncope, Urinary incontinence
Clinical narrative: Patient stated she felt dizzy and then fell over and had a seizure. Seizure lasted 3-4 minutes. Vitals were monitored and EMS was called to take the patient to the ER.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Old version of vaccine received.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: Old flu vaccine administered.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Erythema, tenderness, pain and warmth to left anterior thigh with induration present. Approximately 8cm x 11cm in size.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site induration, Injection site pain, Injection site swelling, Pain
Clinical narrative: High fever of more than 102, chills and body ache and site of injection swollen and hard to touch and painful. Patient did not take Tylenol for fever and pain as instructed and did not apply cool massage over the site.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: High fever of more than 102, chills and body ache and site of injection swollen and hard to touch and painful. Patient did not take Tylenol for fever and pain as instructed and did not apply cool massage over the site.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Pyrexia, Weight decreased
Clinical narrative: 2 hours after receiving vaccines, developed fever, abd. pain, dizziness, and diarrhea lasting 4 days.  5th day felt better but stomach hurt, no diarrhea. Lost nine pounds. Sent to ED received saline bolus.  Dizziness and abd. pain relieved, discharged to home.  Alleges to have had similar symptoms though milder when given dose of HPV one year prior (unreported).
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Injection site erythema
Clinical narrative: The onset was within two days, the patient presented with an expanding redness on left deltoid. The primary care provider had marked it on Tuesday and by Wednesday it had expanded to twice the size. There were no other symptoms reported.
Age: 4.0
Sex: M
Vaccine: DT
Symptoms: Chills, Discomfort, Feeling cold, Irritability, Pruritus generalised
Clinical narrative: Daughter complaining of whole body itching since event onset date.  Irritability has escalated to all day whining and feelings of discomfort.   She has been complaining constantly of feeling cold and has noticeable chills without a fever for 4 days.  Onset of fever began on 8/29/13.
Age: 4.0
Sex: M
Vaccine: DT
Symptoms: Pyrexia
Clinical narrative: Daughter complaining of whole body itching since event onset date.  Irritability has escalated to all day whining and feelings of discomfort.   She has been complaining constantly of feeling cold and has noticeable chills without a fever for 4 days.  Onset of fever began on 8/29/13.
Age: 11.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Body temperature increased, Deafness, Deafness unilateral, Headache, Immediate post-injection reaction
Clinical narrative: FAINTING, PALENESS, THROAT CLOSING, LOSS OF HEARING IN 1 EAR, IMMEDIATE HEADACHE, 103 DEGREE TEMP ABOUT 1.5 HOURS LATER WITH STIFF NECK AND WEAK PAINFUL LEGS AND ACHES AND PAINS.
Age: 11.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Muscular weakness, Musculoskeletal stiffness, Pain, Pain in extremity, Pallor
Clinical narrative: FAINTING, PALENESS, THROAT CLOSING, LOSS OF HEARING IN 1 EAR, IMMEDIATE HEADACHE, 103 DEGREE TEMP ABOUT 1.5 HOURS LATER WITH STIFF NECK AND WEAK PAINFUL LEGS AND ACHES AND PAINS.
Age: 11.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Syncope, Throat tightness
Clinical narrative: FAINTING, PALENESS, THROAT CLOSING, LOSS OF HEARING IN 1 EAR, IMMEDIATE HEADACHE, 103 DEGREE TEMP ABOUT 1.5 HOURS LATER WITH STIFF NECK AND WEAK PAINFUL LEGS AND ACHES AND PAINS.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: Redness, induration, pain over vaccine site.
Age: 11.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Local swelling
Clinical narrative: Patient arm red/swollen. Told to give BENADRYL q 6 hrs.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a 17 year old female patient with no pertinent medical history or drug reactions/allergies. On 19-JUL-2013 the patient was vaccinated with the first dose of 0.5 ml GARDASIL (lot # J003727, expiration 07-NOV-2015), intramuscular. There was no concomitant medication. On 24-JUL-2013, the patient had an acute onset of dizziness, slight fever and headache. No lab diagnostics studies performed. The patient sought medical attention via called physician's office. No treatment was given. These adverse symptoms went away on an unspecified date and the patient was completely recovered on 23-AUG-2013. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to a patient of unknown age. On 23-AUG-2013 the patient was vaccinated with M-M-R II (rHA, lot # 670080/0402AA, expiration date on 01-MAR-2013) (subcutaneous, 0.5 ml, strength not reported). No adverse effects were reported. It was unspecified whether the patient sought for medial attention. The outcome was unknown. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Dyskinesia, Loss of consciousness, Syncope, Urinary incontinence
Clinical narrative: Syncope 5 minutes post GARDASIL administration. Jerking movements, urinated during LOC. Entire incident lasted 8-10min. MD was called and attended to patient. Patient was observed for 30 min post incident and sent home.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Blister, Injection site reaction, Rash, Skin lesion, Urticaria
Clinical narrative: 8/12/13 DTap administered. 8/14/13 Welt 3 inch on injection site; also bumps on left face/cheek. 8/20/13 vesicles started on hands eventually went away; facial lesions L face/cheek stayed on.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a physician for VARIVAX, a Pregnancy Registry product, refers to a 29 year old female patient. On an unknown date the patient was vaccinated with VARIVAX (Merck). The patient was 13 weeks gestation. The patient became pregnant with LMP of 20-MAY-2013 and EDD of 24-FEB-2014. Physician reported that patient received a varicella vaccination, which may have been VARIVAX (Merck) in the "early stages of pregnancy". The patient sought medical attention for pregnancy. No adverse effect reported. The pregnancy outcome was outcome pending. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a female patient of unknown age with no medical history referred to herself. On an unknown date the patient was vaccinated with ZOSTAVAX (injection, strength, lot#, dose/frequency, route and duration were unspecified). There was no concomitant therapy. On an unknown date the patient experienced pain and redness at the injection site after receiving the ZOSTAVAX vaccine. Patient did not seek medical attention. No treatment was given for the events. The outcome was reported as recovering. Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: HEPAB, MNQ, PPV
Symptoms: Dysarthria, Muscular weakness
Clinical narrative: Patient's wife called complaining that her husband was having muscle weakness and slurred speech and wasn't sure if it was related to the vaccines he received.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Expired vaccine given.
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Expired vaccine given.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Pain
Clinical narrative: Patient called complaining of body aches, pain in back. Called me to ask about Guillain-Barre Syndrome. He was not experiencing these symptoms. Patient visited with doctor who did not agree w/Guillain-Barre Syndrome diagnosis patient given rx for prednisone and FLEXERIL. Event reported to me on 8/22/13.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Lip swelling, Pain, Rash
Clinical narrative: Following day after vaccine given, pt states to have body aches and swollen lip; went to hospital after taking Bayer Back and Body. After two weeks after taking allergy med's she went back to ER due to a rash.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Blood glucose increased, Condition aggravated, Diabetes mellitus, Pain in extremity
Clinical narrative: Very sore arm. Pt is diabetic and blood sugar rose significantly.
Age: 11.0
Sex: F
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Condition aggravated, Syncope
Clinical narrative: Pt was sitting in mom's lap while receiving Tdap and MCV4. Fainted after 2nd injection. Roused immediately, placed in supine position with cold compress to inj. sites and given popsicle. Recovered without incident. Mom stated pt. had previously fainted at the sight of blood.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling, Injection site vesicles
Clinical narrative: Approximately 3 1/2 inch diameter knot around injection site (red, swollen, hard to the touch) with approximately 2 inch diameter area with small blisters in the center. Patient had been putting alcohol on it. Recommended hydrocortisone cream and BENADRYL.
Age: 0.05
Sex: M
Vaccine: HEP
Symptoms: Crying
Clinical narrative: Pt mother refused Hep B at hospital on birth, was educated in office about immunizations decided to get hep B 8-26-13 mom states baby has cried non stop when put down.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Arthralgia, Borrelia test negative, Erythema multiforme, Laboratory test normal, Mycoplasma test
Clinical narrative: Joint pain. Rash - Erythema multiforme. Oral lesions. Pruritus --> ATARAX.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Oral disorder, Pruritus, Rash
Clinical narrative: Joint pain. Rash - Erythema multiforme. Oral lesions. Pruritus --> ATARAX.