chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: M
Vaccine: PNC13
Symptoms: Fall, Fatigue, Feeling abnormal, Gait disturbance, Hypoacusis
Clinical narrative: This is a spontaneous report from a contactable consumer that reporter for his father and from the contactable wife's consumer. A 87 years old male patient received PREVNAR 13, intramuscular at 0.5ml single dose on 19Dec2014 around noon. The patient had history of pneumonia four times before and was being prepared for cataract surgery and had history of bypass 10-15 years ago and a surgery for skin cancer. At 7:00 that night, he said he was tired and didn't feel good so went to bed. At 10:00 PM, he got up to go to the bathroom and he stumbled to the door frame. He said he didn't have any power in his legs and he hard of hearing after the fall. At 3:00 AM on 20Dec2014 he had gotten up again and missed the bathroom door and fell down 3 steps to the landing. The wife noticed there was some confusion. At 7:30 AM the wife took him to the ER. He was there for 5-6 hours and they checked everything-blood tests, urine, EKGs and they also give him IV fluids. So then he went home as they couldn't find anything wrong. The rest of the day he pretty much slept away. Early on morning on 21Dec2014 he woke and got himself downstairs. Around 5:00 he just slumped to the floor. He did not have strength to help himself up and the wife couldn't get him up. The wife suggested he roll over to his stomach and maybe using arms and knees he could get up. He couldn't even roll over or didn't understand. About 6:30 an ambulance took him to the ER again. He again slept most of the day and didn't want to eat. The rest of the week, he napped a lot. Concomitant medications included COUMADIN, ZESTRIL, TOPROL, LIPITOR; CARDIZEM; Warfarin; aspirin 81 mg; multivitamin; Vitamin D and Fish Oil, all ongoing. The patient did not received any treatment for the events. Outcome for the events weakness, exhausted, hard of hearing and tired was reported as not recovered while the patient recovered from confusional state, fall, the outcome of the events somnolence, decreased appetite and feeling abnormal was unknown. Follow up (13Jan2015) Additional information reported from the contactable wife's consumer includes details on the clinical course of the patient. Lab data and events added.
Age: 87.0
Sex: M
Vaccine: PNC13
Symptoms: Laboratory test normal, Muscular weakness, Somnolence, Urine analysis normal
Clinical narrative: This is a spontaneous report from a contactable consumer that reporter for his father and from the contactable wife's consumer. A 87 years old male patient received PREVNAR 13, intramuscular at 0.5ml single dose on 19Dec2014 around noon. The patient had history of pneumonia four times before and was being prepared for cataract surgery and had history of bypass 10-15 years ago and a surgery for skin cancer. At 7:00 that night, he said he was tired and didn't feel good so went to bed. At 10:00 PM, he got up to go to the bathroom and he stumbled to the door frame. He said he didn't have any power in his legs and he hard of hearing after the fall. At 3:00 AM on 20Dec2014 he had gotten up again and missed the bathroom door and fell down 3 steps to the landing. The wife noticed there was some confusion. At 7:30 AM the wife took him to the ER. He was there for 5-6 hours and they checked everything-blood tests, urine, EKGs and they also give him IV fluids. So then he went home as they couldn't find anything wrong. The rest of the day he pretty much slept away. Early on morning on 21Dec2014 he woke and got himself downstairs. Around 5:00 he just slumped to the floor. He did not have strength to help himself up and the wife couldn't get him up. The wife suggested he roll over to his stomach and maybe using arms and knees he could get up. He couldn't even roll over or didn't understand. About 6:30 an ambulance took him to the ER again. He again slept most of the day and didn't want to eat. The rest of the week, he napped a lot. Concomitant medications included COUMADIN, ZESTRIL, TOPROL, LIPITOR; CARDIZEM; Warfarin; aspirin 81 mg; multivitamin; Vitamin D and Fish Oil, all ongoing. The patient did not received any treatment for the events. Outcome for the events weakness, exhausted, hard of hearing and tired was reported as not recovered while the patient recovered from confusional state, fall, the outcome of the events somnolence, decreased appetite and feeling abnormal was unknown. Follow up (13Jan2015) Additional information reported from the contactable wife's consumer includes details on the clinical course of the patient. Lab data and events added.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Pt called and stated that her arm was sore that morning but after her nap this afternoon arm was swollen, itchy, and red.  Told pt that she could take a Benadryl if she thinks it is an allergy.  Pt called the doctor and went to see doctor the next day (1/21/15). Dr prescribed cyproheptadine 4mg.  I twice daily for 3 days and then as needed.
Age: 0.23
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Chest X-ray, Culture urine, Differential white blood cell count, Full blood count, Pyrexia
Clinical narrative: 102 FEVER WITHIN 4 HOURS OF RECEIVING VACCINES - SEEN AT EMERGENCY ROOM. ADDITIONAL TESTING DONE TO RULE OUT INFECTION.  TREATED WITH ANTIPYRETICS & RELEASED TO HOME.  FOLLOW UP WITH PCP IN 1 DAY.
Age: 0.01
Sex: F
Vaccine: HEP, HEPA
Symptoms: Wrong drug administered
Clinical narrative: Patient here for a Hep B vaccine and accidentally recieved a Hep A vaccine.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Acne, Rash erythematous
Clinical narrative: Small pinple to side of injection site.  Progressed into non-raised red rash on arms, trunk and Left side of face.  Went to PCP given Steriod injection X1 and po meds.  Immediately improved and rash gone before finished 7 day course of steriods po.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Acne, Injection site reaction, Rash erythematous
Clinical narrative: Small pinple to side of injection site.  Progressed into non-raised red rash on arms, trunk and Left side of face.  Went to PCP given Steriod injection X1 and po meds.  Immediately improved and rash gone before finished 7 day course of steriods po.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, HEP, HEPA, MMRV
Symptoms: Erythema, Injection site swelling, Rash macular, Skin warm
Clinical narrative: Dad noticed pt's arm was red, warm to the touch, & had approx. a 3" "blotchy" area. Said the injection site was swollen & raised.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Pneumonia, Wheezing
Clinical narrative: The patient presented to the ED with community acquired pneumonia 14 days after receiving PPSV 23 vaccine. Cough wheeze. Moxifloxacin 400 mg every day.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This female subject was enrolled in an open label study titled Boostrix Pregnancy Registry: a prospective exploratory, cohort study to detect and describe any abnormal pregnancy outcome sin women intentionally or unintentionally vaccinated with Boostrix during pregnancy or with 26 days preceding conception. The subject received BOOSTRIX Intramuscular) .5 on 5th AUGUST 2014. Co-suspect products included FLUARIX. This subject received BOOSTRIX during the third trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Other possible cause(s) of the vaccine exposure during pregnancy included Influenza Virus Vaccine Polyvalent.   Additional information: The last menstrual period, the due date and the number of gestational weeks were not reported.   This is one of the 17 cases reported by the same reporter for the same vaccine.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse and described the occurrence of expired vaccine used in a patient who received FLUARIX (batch number FS575, expiry date 30th June 2014. On 23rd October 2014, the patient received FLUARIX. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received: 18 patients were involved and investigation still ongoing. Caller did not have patient info. Maladministration caught on 10/23/14.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 34-year-old female subject was enrolled in an open label study titled Boostrix Pregnancy Registry, a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with Boostrix during pregnancy or within 28 days preceding conception. The subject received BOOSTRIX (intramuscular) .5 ml on 19 SEPTEMBER 2014.  Co-suspect products included FLUARIX 2014-2015 season). The subject received BOOSTRIX during the third trimester of pregnancy. On an unknown date, an unknown time after receiving OOSTRIX the subject developed vaccine exposure during pregnancy (non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Other possible cause(S) of the vaccine exposure during pregnancy included Influenza Virus Vaccine Polyvalent.   Additional information:  The last menstrual period, the due date, and the number of gestational weeks were not reported. This is one of the 17 cases reported by the same reporter for the same vaccine.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity, X-ray normal
Clinical narrative: Symptoms began at time of immunization. The patient complained of pain uin her left arm, not being able to lift her arm at all. Patient called the doctor 4 weeks after receiving the shot to ask if this was normal. The doctor stated that this "sometimes happens". Approximately 5 weeks after the immunization, patient said she could not lay on her side because it was very painful. The patient then told her pain management doctor who suggested she get a cat scan and an x-ray and suggested that maybe she had a disconnected shoulder. She saw her primary care doctor approximately 5 weeks ago who sent her to get an x-ray. The x-ray was normal. Her pain management doctor then suggested that it may be muscular and wrote her a prescription for a topical compound to apply to the area. She is currently waiting on the compound to be delivered. If the compound does not work, she will have to get a nerve conduction study to see if the needle hit a nerve. This test is very expensive and she is unsure if her insurance will pay for it.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity, X-ray normal
Clinical narrative: Symptoms began at time of immunization. The patient complained of pain uin her left arm, not being able to lift her arm at all. Patient called the doctor 4 weeks after receiving the shot to ask if this was normal. The doctor stated that this "sometimes happens". Approximately 5 weeks after the immunization, patient said she could not lay on her side because it was very painful. The patient then told her pain management doctor who suggested she get a cat scan and an x-ray and suggested that maybe she had a disconnected shoulder. She saw her primary care doctor approximately 5 weeks ago who sent her to get an x-ray. The x-ray was normal. Her pain management doctor then suggested that it may be muscular and wrote her a prescription for a topical compound to apply to the area. She is currently waiting on the compound to be delivered. If the compound does not work, she will have to get a nerve conduction study to see if the needle hit a nerve. This test is very expensive and she is unsure if her insurance will pay for it.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received FLUARIX Quadrivalent 2014/2015.  On 20th OCTOBER 2014, the patient received the 1st dose of FLUARIX Quadrivalent 2014-2015 season. In October 2014, an unknown time after receiving FLUARIX Quadrivalent 2014-2015 season, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: FLUARIX QIV and BOOSTRIX. This report is for FLUARIX QIV. Both vaccines got down to 30.6 deg F from 20 OCTOBER to 23 OCTOBER 2014. Vaccine was not stable because it was too cold. Then patients were vaccinated during this time period with these vaccines, both adult and pediatric. No demographics or lot numbers were available at the time of this report as they are researching who was vaccinated with each vaccine.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a pharmacist and described the occurrence of incorrect storage of drug in a patient who received FLULAVAL.  On an unknown date, the patient received FLULAVAL at an unknown dose On an unknown date, an unknown time after receiving FLULAVAL the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage od drug was unknown.   Additional information: A dose of FLUVLAV which was stored at an inappropriate temperature was inadvertently administered to a patient. No patient specified or vaccine info available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. From an unspecified date, unspecified patients were vaccinated with 8 doses of improperly stored ROTATEQ (dose and frequency were not reported) (lot # J01234 and expiry date: or J011334) since the excursion. The reporter was unsure about the lot number (J01234 or J011334). No adverse effects reported. No product quality complaint (PQC) was reported for ROTATEQ. This case is linked to 1501USA005041 and 1501USA008491 (same reporter link). Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Cessation of menstruation following vaccination with Gardasil after history of regular periods.
Age: 13.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Child noted red painful swollen area on right posterior upper arm where Varivax was given. Today (1-22-15) the swollen area is larger, approx. 3" diameter and feels hard.  Still red and painful.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Muscle contractions involuntary, Nausea
Clinical narrative: Nausea, vomiting, palor, diaphoresis, warm, dizzy, muscle contortion of immunized arm. Recovery time greater than 30 mins, less than 2 hrs. 20 oz Powerade given once nausea subsided.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Pallor, Vomiting
Clinical narrative: Nausea, vomiting, palor, diaphoresis, warm, dizzy, muscle contortion of immunized arm. Recovery time greater than 30 mins, less than 2 hrs. 20 oz Powerade given once nausea subsided.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: PT REPORTED REDNESS AND ITCHING AT THE INJECTION SITE THE DAY FOLLOWING VACCINATION. OVER THE NEXT COUPLE OF DAYS THE REDNESS EXPANDED FROM BEYOND THE INJECTION SITE OUTWARD AND DOWN THE ARM, RESULTING IN A RED TO PINK CIRCLE ABOUT 3 INCHES IN DIAMETER BY 1/19/15. PATIENT CALLED HER DOCTOR'S OFFICE AND WAS TOLD IT WAS AN INJECTION SITE REACTION. PATIENT WAS PRESCRIBED A COURSE OF KEFLEX TO PREVENT CELLULITIS.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Erythema, Local reaction, Pain, Swelling
Clinical narrative: Reported small localized reaction later that evening but after 12 hours was more significant.  Had redness (~5 inches in diameter), swelling and pain.  Patient also had a low grade temperature (100.9)Treatment included antihistamines three times a day and Tylenol and ice packs to area as needed.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and moderate swelling at injection site.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling, localized in injection area, approximately 6 inches diameter.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Dizziness, Fatigue, Nausea, Pyrexia
Clinical narrative: High fever, dizziness, nausea, extremely fatigue, unable to stay in the school. On 12/21/2015, she went back to school, but came back at noon. That night, ibuprofen cannot bring her fever now. We took her to the ER. The third day, she is still having high fever, which kind of irresponsible to ibuprofen and Tylenol. Her symptoms are very worrisome. We may need to send her to the ER again tonight if fever persists.
Age: 56.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Limb discomfort
Clinical narrative: Patient received flu shot on 1/9/15 and complained of ongoing arm discomfort to us on 1/20/15.
Age: 1.45
Sex: F
Vaccine: DTAP, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Development of urticarial rash on face within 10 minutes of receiving vaccine, while still in office. Benadryl given in office and monitored for difficulty breathing, vomiting, other symptoms. Urticaria resolved, no further symptoms developed. Sent home with instructions to watch for signs of anaphylaxis.
Age: 22.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Adverse event started 1/20/2015 as itching over the left arm where she received her Td shot on 1/14/2015.  This was followed by redness over the same area which cause the patient to start scratching and applying ice on it.  On 1/21/15, patient noted that the redness was larger and the itching increased which prompted her to seek medical attention.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pt came to the pharmacy on 1/22/2015 and said that her right arm was sore, that it still hurts and she has difficulty raising her arm.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: Swelling, pain, that increased over the next 24 hours; itching developed; Caused patient to seek medical attention.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Blood test, Computerised tomogram, Pancreatitis acute
Clinical narrative: Developed severe stomach pain that afternoon and into the evening and overnight; diagnosed with acute pancreatitis the next morning at the ER.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Immediate erythema, heat, swelling to 9 cm around injection site (R) deltoid. DECADRON 8 mg IM.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse and described the occurrence of expired vaccine used in a patient who received FLUARIX Quadrivalent 2014/2015 season) (batch number FS575, expiry dare 30th June 2014). On 23rd OCTOBER 2014, the patient received FLUARIX Quadrivalent 2014-2015 season. On an unknown date, an unknown time after receiving FLUARIX Quadrivalent 2014-2015 season, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.    Additional information received. 18 patients were involved and investigation still ongoing. Caller did not have patient info. Maladministration caught on 10/23/14.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. On unspecified dates the patients received doses of improperly stored ROTATEQ orally (dose, lot number and expiry date were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: This pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 32-year-old female patient who received FLUARIX Quadrivalent 2014-2015 season (batch number 2G3J4, expiry date June 2015). On an unknown date, the patient received FLUARIX Quadrivalent 2014-2015 season. The patients last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. On an unknown date, an unknown time after receiving  FLUARIX Quadrivalent 2014-2015 season, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. It was unknown if the reporter considered the vaccine exposure during pregnancy to be related to FLUARIX Quadrivalent 2014-2015 season.   Additional information: Consumer is 14 weeks gestation. Asymptomatic report of administration during pregnancy. Reporter called to enter consumer in pregnancy registry.
Age: 1.51
Sex: M
Vaccine: DTAPIPV, FLU3, HEPA, HIBV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse and described the occurrence of expired vaccine used in a patient who received FLUARIX Quadrivalent 2014/2015 season (batch number FS575, expiry date 30th June 2014). On 23rd October 2014, the patient received FLUARIX Quadrivalent 2014-2015 season. On an unknown date, an unknown time after receiving FLUARIX Quadrivalent 2014-2015 season, the patient experienced expired vaccine used. On an unknown date, the outcome of expired vaccine used was unknown.   Additional information received: 18 patients were involved and investigation still ongoing. Caller did not have patient info. Maladministration caught on 10/23/2014.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse and described the occurrence of expired vaccine used in a patient who received FLUARIX Quadrivalent 2014-2015 season (batch number FS575, expiry date 30th June 2014). On 23rd October 2014, the patient received FLUARIX Quadrivalent 2014-2015 season. On an unknown date, an unknown time after receiving FLUARIX Quadrivalent 2014-2015 season, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional information received: 18 patients were involved and investigation still ongoing. Caller did not have patient info. Maladministration caught on 10/23/14.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional refers to a unspecified number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. The healthcare professional informed that since 10-NOV-2014 about 40 doses of improperly stored ROTATEQ Lot # K005394 and expiration date: 23-FEB-2016, (dosage and route were not reported) were administered to the patients. No adverse effect reported. Concomitant therapy was not reported. Additional information has been requested.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse and described the occurrence of expired vaccine used in a patient who received FLUARIX Quadrivalent 2014-2015 season (batch number FS575, expiry date 30th June 2014). On 23rd October 2014 the patient received FLUARIX Quadrivalent 2014-2015 season .5 ml. On 23rd October 2014, an unknown time after receiving FLUARIX Quadrivalent 2014-2015 season, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional information: 18 patients were involved and investigation still ongoing. Caller did not have patient info. Maladministration caught on 23 October 2014.
Age: 41.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria Pruritus
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Hypotonia, Irritability, Pallor, Unresponsive to stimuli
Clinical narrative: Baby went pale and limp, was unresponsive for about 30 seconds, very fussy.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Swollen injection site.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of wrong vaccine administered in a 4-year-old female patient who received BOOSTRIX (batch number 7537X, expiry date 15th February 2015). On 12th November 2014, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information received: BOOSTRIX administered to a 4 years old as the 5th DTP vaccine, instead of intended KINRIX.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Hyperhidrosis, Insomnia, Oropharyngeal pain, Pain in extremity
Clinical narrative: That night I developed a sore throat and cough that got worse the following days. Couldn't sleep due to cough and congestion. Forehead sweat but no fever. Sore arm lasted 3 weeks.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Respiratory tract congestion
Clinical narrative: That night I developed a sore throat and cough that got worse the following days. Couldn't sleep due to cough and congestion. Forehead sweat but no fever. Sore arm lasted 3 weeks.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Dizziness, Fall, Loss of consciousness
Clinical narrative: Patient felt dizzy following vaccines, passed out and fell from the exam table to the floor.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Concussion, Contusion, Fall, Tooth fracture
Clinical narrative: Patient felt dizzy following vaccines, passed out and fell from the exam table to the floor.
Sex: M
Vaccine: FLUX
Symptoms: Chills, Feeling cold
Clinical narrative: This case was reported by a physician and described the occurrence of chills in a male patient who received Flue Seasonal TIV Dresden (influenza vaccine). Concomitant products included LATUDAY and KLONOPIN.  In October 2014, the patient received influenza vaccine. In October 2014, 1 day after receiving influenza vaccine, the patient experienced chills and feels ing cold. On an unknown date, the outcome of the chills and feeling cold were recovered/resolved. The reporter considered the chills and feeling cold to be probably related to influenza vaccine.  Additional information received: Male patient of unknown age who experienced the chills and feeling cold while receiving treatment with Latuda. In October 2014, the patient initiated treatment with   Latuda 20 mg every evening with flood (indication for use not provided) and after the second dose experienced the chills and feeling cold for a duration of four hours from 04:30-08:30. The patient indicated he had the flue shot the day before he experienced the events. Concomitant medications included Klonopin while medical history was not provided. The flu shot was considered co-suspect for the events as the physician indicated that the chills may have been from the flu shot. At the time of the report, the action taken with Latuda was unknown while the outcome of the events was considered resolved after four hours. The physician was not able to determine if the events were related to Latuda.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Myalgia, Pain
Clinical narrative: Patient felt unusual pain at time of administration which came back "2 weeks" after date of vaccination. Reported persistent deltoid muscle pain on 1-20-15.
Age: 0.55
Sex: F
Vaccine: RV5
Symptoms: Fontanelle bulging, Pyrexia, Vomiting
Clinical narrative: Vomiting, fever. Parents reported bulging fontanelle but it resolved before she was seeen in offive at 9 am.
Age: 0.51
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chest X-ray normal, Full blood count normal, Influenza virus test negative, Injection site erythema, Injection site pain
Clinical narrative: 14 hours after immunization was seen in ER with fever 101 and parents reporting she was swollen and puffy all over. ER physician reported only redness and tenderness at imm site, but she was treated with acetaminophen, diphenhydramine and dexamethasone. Later on 1/1 at 1400 had pallor and low temp and was taken to ER again.
Age: 0.51
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pallor, Pyrexia, Respiratory syncytial virus test negative, Streptococcus test negative, Swelling
Clinical narrative: 14 hours after immunization was seen in ER with fever 101 and parents reporting she was swollen and puffy all over. ER physician reported only redness and tenderness at imm site, but she was treated with acetaminophen, diphenhydramine and dexamethasone. Later on 1/1 at 1400 had pallor and low temp and was taken to ER again.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: CSF glucose normal, CSF protein normal, CSF red blood cell count positive, CSF white blood cell count negative, Fontanelle bulging
Clinical narrative: Pt had fever to 101.9, vomiting several times and bulging fontanelle. She was seen in ER with normal CSF results, WBC 22K.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Respiratory syncytial virus test negative, Vomiting, White blood cell count increased
Clinical narrative: Pt had fever to 101.9, vomiting several times and bulging fontanelle. She was seen in ER with normal CSF results, WBC 22K.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 22 October 2013. The cases were received on 21 March 2014. A 2 years old child received 0.5ml dose FLUZONE (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 0.6
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: The case was received on 21 March 2014. Initial misuse report received from a healthcare professional on 16 October 2013. A 07-months-old patient had received 0.5 ml dose of FLUZONE on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Age: 1.0
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial misuse case was received from a healthcare professional on 28 OCT 2013. Cases were received on 21 March 2014. A 1 year old patient whose demographic details, medical history and concomitant medication were not reported received a 0.25 ml dose of FLUZONE on 25 SEP 2013 and 01 OCT 2013. (Route, site, dose and Batch number not reported). It was reported that on an unspecified date patient received a vaccine of invalid scheduled. Laboratory investigation were not reported. No adverse event was reported. List of documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: The case was received on 21 March 2014. Initial misuse report received from a healthcare professional on 17 October 2013. A patient had received 0.5 ml dose of FLUZONE on an unspecified date. It was reproted that when injected, the needle separated and the patient did not get the full dose. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: The case was received on 21 March 2014. Initial misuse report received from a healthcare professional on 18 October 2013. A 16-months-old patient had received 0.5 ml dose of FLUZONE on an unspecified date instead of the age appropriate 0.25 ml dose. No adverse event was reported. List of documents held by sender: none.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 24 October 2013. A 2-year-old patient whose gender, medical history, and concomitant medication were not reported had received a 0.5 ml dose of FLUZONE (Lot number, expiration date, dose number, route and site of vaccination was not reported) on an unspecified date i.e. overdose. No adverse event was reported. List of documents held by sender: none.
Sex: F
Vaccine: DTAP, DTAPIPVHIB, FLU3, HIBV, IPV, MEN, MNQ, TDAP
Symptoms: Incorrect product storage, No adverse event, Tuberculin test
Clinical narrative: Initial misuse report received from a healthcare professional on 23 October 2013. The cases were received on 21 March 2014 at GPV. A female patient had received unknown dose of CAPTACEL; IPOL; PENTACEL; ACTHIB; FLUZONE; MENACTRA; MENOMUNE; ADACEL; TENIVAC for 1 hour 16 minutes and unknown dose TUBERSOL had been not properly stored and opened for more than 30 days. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender : none
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 27 September 2013. The cases were received on 21 March 2014 at GPV. Two patients received dose of FLUZONE  which was expired in last season (no other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Age: 0.6
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The case was received on 21 March 2014 at GPV. Initial misuse report received from a healthcare professional on 16 September 2013. A 06-month old patient had received 0.5 ml dose of FLUZONE on an unspecified date. No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from health care professional on 16 Oct 2013.  A 0.25 ml dose of FLUZONE was administered to 2 week old patient on an unspecified date. No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: FLU3, FLUN3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: The case was received on 21 March 2014. Initial misuse report received from a healthcare professional on 17 September 2013. A patient had received a dose of FLUZONE and a dose of FLUMIST on an unspecified date. It was reported that the patient was administered FLUMIST and FLUZONE instead of GARDASIL. No adverse event was reported. List of documents held by sender: none
Age: 0.4
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: The cases were received 21 March 2014 at GPV. Initial misuse report received from a healthcare professional on 20 September 2013. A 04-month-old patient had received FLUZONE. It's an inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: The case was received on 21 March 2014 at GPV. Initial misuse report received from a healthcare professional on 19 September 2013. Four patients (no information was provided regarding the patients) had received an expired dose of FLUZONE on an unspecified date. No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: The cases were received on 21 March 2014 at GPV. Initial misuse report received from a healthcare professional on 18 September 2103. About 6 patients had received FLUZONE which was frozen and advised to discard. A wrong vaccine ws administered. No adverse event was reported. List of documents held by sender: none
Age: 1.7
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: Initial misuse report received from a healthcare professional on 20 September 2013. The cases were received on 21 March 2014 at GPV.  A 19-month-old patient received FLUZONE give a 0.5 ml dose. It was reported that, limited studies have bene done using 0.5 ml for this age group and there were no significant adverse effects. However, two doses 1 month apart are still needed for complete immunization. No adverse event ws reported. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 26 September 2013. The cases were received on 21 March 2014 at GPV. The patient received FLUZONE 5 days before 6 months of age. (No other information was provided regarding the patient).  No adverse event was reported. List of documents held by sender: none
Age: 3.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional on 23 September 2013. The cases were received on 21 March 2014 at GPV. A 03-year-old patient received 0.25 ml of FLUZONE. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Age: 0.2
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 17 September 2013. The cases were received on 21 March 2014 at GPV. A 2-month old patient received 0.25 ml dose of FLUZONE. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 25 September 2013. The cases wer4e received on 21 March 2014 at GPV. The patient received two 0.5 ml intramuscular doses of FLUZONE. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Age: 10.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: the cases were received on 20 March 2014 at GPV.  Initial misuse report received from a healthcare professional on 27 September 2013. A 10-year-old patient had received 0.25 ml of FLUZONE. It's a vaccine over dose. No adverse event was reported. List of documents held by sender: none
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: The cases were received on 21 March 2014 at GPV. Initial misuse report received from a healthcare professional on 24 September 2013. A 03-year-old patient had received 0.25 ml of FLUZONE on 19 September 2013. A 03-year-old patient had received 0.25 ml of FLUZONE on 19 September 2013. It's an underdose. No adverse event was reported. List of documents held by sender: none.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional on 18 October 2013 and at GPV on 21 March 2014. A 03 year-old-10 months-old patient of unknown gender had received FLUZONE 0.25 ml. The patient received an incorrect dose. No adverse event was reported. The list of documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 23 October 2013. The case were received 21 March 2014 at GPV. A pregnant female patient had received 0.5 ml of FLUZONE on 9 October 2013 and again on 23 October 2013 both doses were from an MDV. It's was a vaccine exposure during pregnancy and extra dose administered. No adverse event was reported. List of documens held by sender: none.
Age: 4.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial misuse report received from non-healthcare professional on 228 October 2013.  The cases were received on 21 March 2014 at GPV. A 14-year-old patient received 0.5ml FLUZONE by nasal route (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The case was received on 21 March 2014 at GPV. Initial misuse report received from a healthcare professional. A patient had received 0.5 ml dose of FLUZONE instead of 0.25 ml on an unspecified date. No adverse event was reported. List of documents held by sender: nonTie case was received on 21 March 2014 at GPV. Initial misuse report received from a healthcare professional. A patient had received 0.5 ml dose of FLUZONE instead of 0.25 ml on an unspecified date. No adverse event was reported. List of documents held by sender: nonee
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 22 October 2013.  A patient under the age of 35 months had received 0.5 ml dose of FLUZONE on an unspecified date. No adverse event was reported. List of documents held by sender: none
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from healthcare professional on 30 October 2014. The cases were received on 21 March 2014 at GPV. A 65-year-old male patient received a dose of FLUZONE instead of FLUZONE HD. (No other information was provided regarding the patient). No adverse event was reported. List of documents held  by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: The cases were received on 21 March 2014 at GPV. Initial misuse report received from a healthcare professional on 21 October 2013. An FLUZONE was administered at the request of the patient in the gluteus maximus. The vaccine was administered at inappropriate site. No adverse event was reported. List of documents held by sender: none
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 22 October 2013 and at GPV on 21 March 2014. A 02-year-old patient of unknown gender had received FLUZONE 0.5 ml instead of 0.25 ml. The patient received an incorrect dose. No adverse event was reported. The list of documents held by sender: none
Age: 0.9
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from healthcare professional on 29 October 2013. A 9-month-old patient received 0.5 ml dose of FLUZONE. (No  other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Age: 0.8
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse case was received from a healthcare professional on 18 Oct 2013. Case was received on 21 March 2014 at GPV.  A 8 month old patient whose demographic  details, medical history and concomitant medication were not reported received a 0.5 ml dose of FLUZONE vaccine on unspecified date. (Route, site, dose and batch number not reported). It was reported that on an unspecified date patient received an over dose of 0.5 ml instead of 0.25 ml of vaccine. Laboratory investigations were not reported. No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report receved from a healthcare professional (nurse) on 16 October 2013 and the case was recieved on 21 March 2014. A 31-month-old patient (gender was not provided) had received a dose of 0.5 ml of FLUZONE instead of 0.25 ml an unspecified date. No adverse event was reported. List of documents held by sender: none.
Age: 1.3
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from health care professional on 23 Oct 2013.  A 01 year 03 months old patient had received 0.5 ml dose of FLUZONE from MDV on unspecified date. No adverse event was reported. List of documents held by sender: none
Age: 0.9
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 27 November 2013. The case was received on 21 March 2014 at GPV. A 9-months-old patient received 0.5 ml dose of instead of 0.25 ml FLUZONE. No adverse event was reported.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 21 October 2013. The cases were received at GPV on 21 March 2014. It was reported that 2 year-old patient had received 0.5 ml dose of FLUZONE. No adverse event was reported. List od documents held by sender: none
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 23 October 2013 and the case was received on 21 March 2014 at GPV. A 2-year-old patient (gender was not provided) had subcutaneously received a dose of 0.5 ml of FLUZONE instead of 0.25 ml on an unspecified date. No adverse event was reported. List of documents held by sender: none
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 29 October 2013. The cases were received on 21 March 2014 at GPV. A 2-year-old patient received 0.5 ml dose of FLUZONE instead of 0.25 ml (no other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a  healthcare professional on 18 December 2013. The cases were received on 20 March 2014 at GPV. A patient (no other information was provided regarding the patient), received FLUSONE on unspecified date. It was reported that the patient had received 1st dose on 12 November and 2nd dose on 04 December, thus the patient received extra dose. No adverse event was reported. List of documents held by sender: none.
Age: 1.3
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 04 November 2013. A 15-month old patient was administered FLUSONE NP on August, September and November. The extra dose was administered. No adverse event was reported. List of documents held by sender: none
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 24 October 2013. The cases were received on 21 March 2014. It was reported 3 year-old patient had received 0.25 ml dose of FLUZONE. No adverse event was reported. List of documents held by sender: none.