chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEPA
Symptoms: Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female patient with a history of passing out during immunization who on 05-AUG-2010, was intramuscularly vaccinated with a dose of VAQTA (Lot# 667859/0569Z). On 05-AUG-2010, while the patient was coming out of the patient's room she got syncope. It was noted that this was not the first time the patient passed out during immunization. The patient sought unspecified medical attention. At the time of the report the patient's outcome was unknown. Syncope was considered as an other important medical event by the reporting physician. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Intussusception
Clinical narrative: Information has been received concerning a patient who on an unspecified date was vaccinated with the second dose of series ROTATEQ, oral. It was reported that the patient from a physician's office received two doses of ROTATEQ and then experienced intussusception. No further information is available at this time of reporting. Upon internal review, intussusception was considered to be an other important medical event. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: RUB
Symptoms: Colitis ulcerative, Fatigue, Haematochezia, Malaise, Multiple sclerosis
Clinical narrative: Information has been received from a registered nurse concerning a male in his 40's with allergic reaction to unnamed antibiotics who was vaccinated with MERUVAX II (manufacturer unspecified) on a sugar cube as a child. When he was in his 40's he developed Multiple Sclerosis. He was given interferon for the Multiple Sclerosis but it made him sick and he had a fever. It was discontinued and started on COPAXONE injections but he had a fever and ulcerative colitis, hospitalized for a week with bloody stools. He was now 51 years and was able to walk with a cane but fatigues easily. The doctor felt Multiple Sclerosis was due to the rubella vaccine. At the time of the reporting, the patient's status was unknown. Upon internal review, Multiple Sclerosis was considered to be an other important medical event. This is one of several reports received from the same source. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: RUB
Symptoms: Pyrexia, Walking aid user
Clinical narrative: Information has been received from a registered nurse concerning a male in his 40's with allergic reaction to unnamed antibiotics who was vaccinated with MERUVAX II (manufacturer unspecified) on a sugar cube as a child. When he was in his 40's he developed Multiple Sclerosis. He was given interferon for the Multiple Sclerosis but it made him sick and he had a fever. It was discontinued and started on COPAXONE injections but he had a fever and ulcerative colitis, hospitalized for a week with bloody stools. He was now 51 years and was able to walk with a cane but fatigues easily. The doctor felt Multiple Sclerosis was due to the rubella vaccine. At the time of the reporting, the patient's status was unknown. Upon internal review, Multiple Sclerosis was considered to be an other important medical event. This is one of several reports received from the same source. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: FLUN3
Symptoms: Acoustic neuritis, Chills, Dizziness, Vertigo
Clinical narrative: A non-serious, spontaneous report of inner-ear neuritis, chills and dizziness was received from a nurse concerning her son, a 20-year-old male subsequent to FLUMIST. The patient's medical history included mild, occasional dust allergy, attention deficit/hyperactivity disorder (ADHD) since he was eight-years-old, previous influenza vaccination with FLUMIST (11-Oct-2008), no adverse events following any prior vaccinations, non-smoker, no alcohol use and no surgical history. Concomitant medication included methylphenidate. On 02-Oct-2009, the patient received FLUMIST. On 05-Oct-2009, the patient experienced occasional chills, periodic feeling of dizziness and feeling like his "eyes kept moving" when he turned his head. He did not experience a fever or nasal congestion or other viral symptoms. On 08-Oct-2009, he experienced severe vertigo described as the "room spinning even with eyes closed while laying in bed." He was examined by his doctor who diagnosed him with inner ear neuritis (viral). He was treated with a steroid dose pack and meclizine for seven days. On 14-Oct-2009, the events resolved.
Age: 28.0
Sex: F
Vaccine: FLUN3
Symptoms: Anaemia
Clinical narrative: A non-serious, spontaneous report of anemia has been received from a physician concerning a 28-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST, on an unknown date. On an unknown date, the patient experienced "anemia following FLUMIST in a female in good health". The outcome of the event, anemia, was unknown.
Age: 16.0
Sex: M
Vaccine: FLUN3
Symptoms: Eye swelling, Headache
Clinical narrative: A non-serious spontaneous report of "felt like his eyes were swollen" and headache has been received from a registered nurse concerning a 16-year-old male, subsequent to FLUMIST. The patient denies any medical history of egg allergy. Concomitant medications were not reported. The patient received FLUMIST on 15-Oct-2009 in a school immunization program. After receiving FLUMIST, the patient complained of headache and "felt like his eye were swollen". As of 16-Oct-2009, no symptoms were reported. The outcome of the events was resolved.
Age: 15.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Headache, Myalgia, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: A non-serious spontaneous case of blurred vision, muscle aches, headache, sore throat, cough, and a runny nose was received from a registered nurse concerning a 15-year-old female. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 12-Oct-2009. On 14-Oct-2009, the patient experienced blurred vision, muscle aches, headache, sore throat, cough, and a runny nose. On 15-Oct-2009, the blurred vision resolved. The muscle aches, head, sore throat, cough, and a runny nose were ongoing at the time of the report.
Age: 15.0
Sex: F
Vaccine: FLUN3
Symptoms: Vision blurred
Clinical narrative: A non-serious spontaneous case of blurred vision, muscle aches, headache, sore throat, cough, and a runny nose was received from a registered nurse concerning a 15-year-old female. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 12-Oct-2009. On 14-Oct-2009, the patient experienced blurred vision, muscle aches, headache, sore throat, cough, and a runny nose. On 15-Oct-2009, the blurred vision resolved. The muscle aches, head, sore throat, cough, and a runny nose were ongoing at the time of the report.
Age: 33.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy
Clinical narrative: A non-serious spontaneous report of a pregnant "women" receiving FLUMIST was received from a registered nurse concerning a 33-year-old female. The patient's medical history and obstetrical history were not provided. Early Oct-2009, the patient received FLUMIST. One week after vaccination she realized she missed her period and was pregnant. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable.
Age: 11.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal discomfort, Malaise, Nasal congestion, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of not feeling well, stomach complaints, nasal and throat congestion, and a runny nose has been received from the patient's parent concerning an 11-year-old female patient, subsequent to receiving FLUMIST. The patient's medical history and concomitant medications were not reported. On 14-Oct-2009, patient received FLUMIST. On 17-Oct-2009, the patient experienced not feeling well and developed stomach complaints, nasal and throat congestion, and a runny nose. The outcomes for the reported adverse events were not reported.
Sex: F
Vaccine: FLUN3
Symptoms: Influenza serology positive, Pyrexia
Clinical narrative: A non-serious spontaneous report of positive for flu was received from a consumer concerning a female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST in Oct-2009. Two weeks after receiving FLUMIST, the patient experienced fever and had a flu test positive for A and B viral strains. Neither outcome nor causality was reported.
Sex: U
Vaccine: FLUN3
Symptoms: Wrong technique in drug usage process
Clinical narrative: A non-serious spontaneous report of "administration of full dose of FLUMIST up one nare to several individuals" was received from a registered nurse subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for these patients. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain, Eye discharge, Headache, Pyrexia, Rash
Clinical narrative: A non-serious report of fluid in both eyes, rash, fever, pain in head and pain in abdomen has been received from a consumer, patient's mother, concerning an eight-year-old female subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on Oct-2009. She received a total of one dose of FLUMIST before the onset of the events. The night after receiving FLUMIST, on 07-Oct-2009, the patient experienced fever 103.4 degrees, pain in head, and pain in abdomen. By the next day, 08-Oct-2009, the patient was covered with spots, had fluid in both eyelids (unable to open eyes fully). The reporter, patient's mother, did not take her daughter to the pediatrician since her pediatrician was not at the office. She spoke with another pediatrician on the phone, and he recommended to use diphenhydramine and cetirizine. Fever, pain in head and pain in abdomen were resolved on 10/09/2009, and fluid in both eyelids and rash were resolved on 10/10 2009.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza, Malaise
Clinical narrative: A non-serious spontaneous report of "received FLUMIST, now has the flu and is very sick" has been received from a consumer concerning a 10-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on an unknown date. The patient was healthy when he received FLUMIST. On an unknown date, the patient developed flu and was very sick. Treatment for the event was not provided. The outcome of the event was not reported.
Age: 56.0
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, Myalgia, Nasal congestion, Oropharyngeal pain
Clinical narrative: A non-serious spontaneous report of administered FLUMIST to a patient over 49-years-old, nasal congestion, sore throat and muscle aches has been received from a consumer concerning herself, a 56-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 13-Oct-2009. On 15-Oct-2009, the patient developed nasal congestion, sore throat and muscle aches. The treatment for the events was not provided. The outcome of the events is unknown.
Sex: M
Vaccine: FLUN3
Symptoms: Hypoaesthesia oral
Clinical narrative: A non-serious spontaneous report of upper lip numb has been received from a registered nurse concerning an adult male who is an EMS worked, subsequent to FLUMIST.  The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 19-Oct-2009 at the Fire Station. The morning of the following day after his vaccination, the patient woke up with his upper lip being completely numb. The outcome of the event was not reported.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Pyrexia, Wheezing
Clinical narrative: A non-serious spontaneous report of coughing, wheezing, and fever has been received from a physician concerning an eight-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 14-Oct-2009. On 16-Oct-2009, the patient experienced coughing, wheezing, and fever. No outcome was reported for the event of coughing, wheezing, and fever.
Age: 45.0
Sex: F
Vaccine: FLUN3
Symptoms: Vaccination error
Clinical narrative: A non-serious spontaneous report of FLUMIST administration in one nostril was received from a registered nurse concerning a 45-year-old female. The patient's medical history and concomitant medications were not reported. On 16-Oct-2009, the patient was administered FLUMIST. The patient told the nurse who administered FLUMIST "it all seen (sic) to go in the same nostril." There was no adverse event associated with this vaccine administration error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 17.0
Sex: M
Vaccine: FLUN3
Symptoms: Medication error
Clinical narrative: A non-serious spontaneous report of I gave the patient the whole dose of FLUMIST in one nostril was received from a physician concerning a 17-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 19-Oct-2009, a physician administered the whole content of a FLUMIST dose in one nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 29.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: A spontaneous, non-serious report of pregnancy was received from a registered nurse concerning a 29-year-old female patient. On 15-Sep-2009, the patient received FLUMIST. On 08-Oct-2009, the patient notified the nurse that she was pregnant. There as no adverse event experienced to date. Treatment and reporter/causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
Age: 23.0
Sex: M
Vaccine: FLUN3
Symptoms: Drug administration error, Underdose
Clinical narrative: A non-serious spontaneous report of administration of one-half dose of FLUMIST was received from a pharmacist concerning a 23-year-old male. The patient's medical history was not reported. On 07-Oct-2009, the patient received one-half of FLUMIST dose in one nostril. There was no adverse event associated with this vaccine administration error; therefore, treatment and reporter/sponsor causality assessment are not applicable, and the event is considered resolved.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A spontaneous, non-serious report of two doses of FLUMIST given on the same day was received from a registered nurse concerning a six-year-old female patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious, spontaneous report of got a full vial of FLUMIST in each nostril was received from a nurse practitioner regarding a six-year-old female patient following FLUMIST. On 06-Oct-2009, the patient received two full vials of FLUMIST (0.2 ml in each nostril). There was no adverse event associated with this medication error, therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.
Age: 61.0
Sex: F
Vaccine: FLUN3
Symptoms: Medication error
Clinical narrative: A non-serious Spontaneous report of administration of FLUMIST to a 61-year-old female was received from an office manager. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 47.0
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious spontaneous report of two full vials of FLUMIST administered was received from a nurse practitioner concerning a 47-year-old female. The patient received two full doses, 0.2 ml of FLUMIST in each nostril on 06-Oct-2009. The patient had no complaints and no ill effects were observed. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Malaise, Oropharyngeal pain, Pyrexia, Respiratory tract congestion
Clinical narrative: A non-serious spontaneous report of runny nose, congestion, fever, sore throat, and persistent cough was received from the patient's mother concerning an eight-year-old female patient, subsequent to FLUMIST. The patient's past medical history included allergic rhinitis. Concomitant medications included cetirizine and fluticasone nasal spray. The patient received FLUMIST on 21-Sep-2009. On 21-Sep-2009, within 12 hours after receiving FLUMIST, the patient experienced runny nose, congestion, fever, sore throat, and persistent cough. Per patient's mom, "she was well and since she got the FLUMIST, she has been sick for three weeks." On 23-Sep-2009, the fever resolved. The events of persistent cough and congestion were ongoing at time of the report. The outcome for the event of sore throat and runny nose is unknown.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of runny nose, congestion, fever, sore throat, and persistent cough was received from the patient's mother concerning an eight-year-old female patient, subsequent to FLUMIST. The patient's past medical history included allergic rhinitis. Concomitant medications included cetirizine and fluticasone nasal spray. The patient received FLUMIST on 21-Sep-2009. On 21-Sep-2009, within 12 hours after receiving FLUMIST, the patient experienced runny nose, congestion, fever, sore throat, and persistent cough. Per patient's mom, "she was well and since she got the FLUMIST, she has been sick for three weeks." On 23-Sep-2009, the fever resolved. The events of persistent cough and congestion were ongoing at time of the report. The outcome for the event of sore throat and runny nose is unknown.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Rash erythematous, Rash pruritic, Swelling
Clinical narrative: A spontaneous, non-serious event of itchy, swollen, red rash on face, trunk and arm has been received from a patient parent concerning a nine-year-old female patient subsequent to FLUMIST. Medical history and concomitant medications were not reported. The patient received a single dose of FLUMIST on 05-OCT-2009. After receiving FLUMIST through a school immunization program, the patient developed an itchy, swollen, red rash on her face, with a few spots on her trunk and arm the same day. Treatment included diphenhydramine hydrochloride and calamine lotions. The outcome of the event was not reported.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Malaise, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: A not-serious spontaneous report of sore throat, runny nose and fever has been received from a consumer/mother concerning her ten-year-old female, subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST at her school on 08-Oct-2009. On 10-Oct-2009, the patient's mother reporter that her daughter was not feeling well with a sore throat and runny nose. On 11-Oct-2009, the patient developed a fever of 100 degrees Fahrenheit. The outcome of the events was unknown at the time of the report.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: A non-serious spontaneous report of fever has been received from a patient parent concerning a six-year-old male subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient and his sister (MEDI-0009047) received FLUMIST on 08-Oct-2009. On 10-Oct-2009 the patient and her brother both developed a fever. The outcome of the event was unknown. Rechallenge was not applicable for this product because re-administration of the product was not reported.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Pain in extremity
Clinical narrative: A non-serious spontaneous report of arms and legs hurting badly has been received from a patient parent involving a 7.5 year old male subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 11-Oct-2009. On 12-Oct-2009, the patient reported that his legs and arms were hurting badly. The outcome of the event was not reported.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Chills, Cough, Influenza like illness, Pyrexia
Clinical narrative: A non-serious spontaneous report of flu-like symptoms has been received from a physician concerning a nine-year-old male, subsequent to FLUMIST. Medical history and concomitant medications were not reported. The patient received FLUMIST on 07-Oct-2009. On 12-Oct-2009 the patient returned to the clinic reporting flu-like symptoms of fever of 101 F, cough, chills, and stomach ache. The patient has not received any treatment. The outcome of the event is unknown.
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy
Clinical narrative: A non-serious spontaneous report of a pregnant female received FLUMIST has been received from a MedImmune representative concerning an adult female subsequent to FLUMIST. No medical or obstetrical history or concomitant medications were reported. On an unknown date, the patient received FLUMIST and the next day, she found out she was pregnant. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
Age: 33.0
Sex: F
Vaccine: FLUN3
Symptoms: Unevaluable event
Clinical narrative: A non-serious, spontaneous report of FLUMIST administered to a nursing mother has been received from a consumer concerning a 33-year-old female patient. The patient's medical history and concomitant medications were not provided. The subject received FLUMIST on 12-Oct-2009. The subject came into close contact of her five-month-old infant (MEDI-0009076) by way of breastfeeding. The subject stated "the pharmacist did not read my form to see that I was breastfeeding and I did not know I was not a candidate." There was no adverse event associated with this medication error for the subject; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 5.0
Sex: M
Vaccine: FLUN(H1N1), FLUN3
Symptoms: Inappropriate schedule of drug administration, Medication error, No adverse event
Clinical narrative: A non-serious spontaneous report of doctor gave my child a full dose of FLUMIST in one nostril and a full dose of H1N1 in the other nostril was received from a registered nurse/father concerning his five-year-old son. On 14-Oct-2009, the patient received a full dose of FLUMIST in one nostril and a full dose of H1N1 in the other nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Band neutrophil percentage, Contusion, Eosinophil percentage, Haematocrit increased, Haemoglobin normal
Clinical narrative: A non-serious spontaneous report of bruising has been received from a registered nurse concerning an eight-year-old male, subsequent to FLUMIST. The patient's medical history includes epilepsy described as staring episodes-date of diagnosis unknown. Concomitant medications included divalproex (discontinued Mar-2009) and lamotrigine (16-Mar-2009-ongoing). His last vaccination was administered in 2006. The patient received his first dose of FLUMIST 04-Sep-2009. On 20-Sep-2009, the patient's mother reported to his primary care physician's office that her son had bruises on his legs from an unknown cause. On 23-Sep-2009, the patient's mother reported her son now had bruises under his arms. The patient presented to his primary care physician with multiple bruises and an unspecified amount of weight loss. His respiratory rate was 18 breaths per minute, heart rate was 88 beats per minute and body temperature was 98.5 degrees Fahrenheit. A registered nurse in the primary physician's office noted that physician reported the bruises appeared to be consistent with idiopathic thrombocytopenia purpura. The patient had no nose bleeds or buccal hemorrhages. Labs were drawn. No treatment was provided and the physician indicated the patient should follow-up as needed. On 24-Sep-2009, the lab results showed a platelet count "within normal limits" at 433,000. The final diagnosis was bruising. The bruises were caused by an specified trauma. On 28-Sep-2009, the bruising resolved. Additional information was received on 16-Oct-2009 and incorporated into the narrative: included final outcome and identified cause of bruising as unspecified trauma.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Injury, Mean cell volume normal, Monocyte percentage, Neutrophil count, Neutrophil count increased
Clinical narrative: A non-serious spontaneous report of bruising has been received from a registered nurse concerning an eight-year-old male, subsequent to FLUMIST. The patient's medical history includes epilepsy described as staring episodes-date of diagnosis unknown. Concomitant medications included divalproex (discontinued Mar-2009) and lamotrigine (16-Mar-2009-ongoing). His last vaccination was administered in 2006. The patient received his first dose of FLUMIST 04-Sep-2009. On 20-Sep-2009, the patient's mother reported to his primary care physician's office that her son had bruises on his legs from an unknown cause. On 23-Sep-2009, the patient's mother reported her son now had bruises under his arms. The patient presented to his primary care physician with multiple bruises and an unspecified amount of weight loss. His respiratory rate was 18 breaths per minute, heart rate was 88 beats per minute and body temperature was 98.5 degrees Fahrenheit. A registered nurse in the primary physician's office noted that physician reported the bruises appeared to be consistent with idiopathic thrombocytopenia purpura. The patient had no nose bleeds or buccal hemorrhages. Labs were drawn. No treatment was provided and the physician indicated the patient should follow-up as needed. On 24-Sep-2009, the lab results showed a platelet count "within normal limits" at 433,000. The final diagnosis was bruising. The bruises were caused by an specified trauma. On 28-Sep-2009, the bruising resolved. Additional information was received on 16-Oct-2009 and incorporated into the narrative: included final outcome and identified cause of bruising as unspecified trauma.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Neutrophil percentage, Platelet count normal, Red blood cell count normal, Red blood cell morphology abnormal, Red cell distribution width normal
Clinical narrative: A non-serious spontaneous report of bruising has been received from a registered nurse concerning an eight-year-old male, subsequent to FLUMIST. The patient's medical history includes epilepsy described as staring episodes-date of diagnosis unknown. Concomitant medications included divalproex (discontinued Mar-2009) and lamotrigine (16-Mar-2009-ongoing). His last vaccination was administered in 2006. The patient received his first dose of FLUMIST 04-Sep-2009. On 20-Sep-2009, the patient's mother reported to his primary care physician's office that her son had bruises on his legs from an unknown cause. On 23-Sep-2009, the patient's mother reported her son now had bruises under his arms. The patient presented to his primary care physician with multiple bruises and an unspecified amount of weight loss. His respiratory rate was 18 breaths per minute, heart rate was 88 beats per minute and body temperature was 98.5 degrees Fahrenheit. A registered nurse in the primary physician's office noted that physician reported the bruises appeared to be consistent with idiopathic thrombocytopenia purpura. The patient had no nose bleeds or buccal hemorrhages. Labs were drawn. No treatment was provided and the physician indicated the patient should follow-up as needed. On 24-Sep-2009, the lab results showed a platelet count "within normal limits" at 433,000. The final diagnosis was bruising. The bruises were caused by an specified trauma. On 28-Sep-2009, the bruising resolved. Additional information was received on 16-Oct-2009 and incorporated into the narrative: included final outcome and identified cause of bruising as unspecified trauma.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Weight decreased
Clinical narrative: A non-serious spontaneous report of bruising has been received from a registered nurse concerning an eight-year-old male, subsequent to FLUMIST. The patient's medical history includes epilepsy described as staring episodes-date of diagnosis unknown. Concomitant medications included divalproex (discontinued Mar-2009) and lamotrigine (16-Mar-2009-ongoing). His last vaccination was administered in 2006. The patient received his first dose of FLUMIST 04-Sep-2009. On 20-Sep-2009, the patient's mother reported to his primary care physician's office that her son had bruises on his legs from an unknown cause. On 23-Sep-2009, the patient's mother reported her son now had bruises under his arms. The patient presented to his primary care physician with multiple bruises and an unspecified amount of weight loss. His respiratory rate was 18 breaths per minute, heart rate was 88 beats per minute and body temperature was 98.5 degrees Fahrenheit. A registered nurse in the primary physician's office noted that physician reported the bruises appeared to be consistent with idiopathic thrombocytopenia purpura. The patient had no nose bleeds or buccal hemorrhages. Labs were drawn. No treatment was provided and the physician indicated the patient should follow-up as needed. On 24-Sep-2009, the lab results showed a platelet count "within normal limits" at 433,000. The final diagnosis was bruising. The bruises were caused by an specified trauma. On 28-Sep-2009, the bruising resolved. Additional information was received on 16-Oct-2009 and incorporated into the narrative: included final outcome and identified cause of bruising as unspecified trauma.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Influenza A virus test positive, Oropharyngeal pain, Pyrexia
Clinical narrative: A non-serious, spontaneous report of Influenza A has been received from a physician concerning an 8-year-old male patient subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 03-Oct-2009. On 05-Oct-2009, the patient experienced sore throat, cough, and fever. On 05-Oct-2009, the patient tested positive for Influenza A. The outcome for the reported adverse event was not reported.
Age: 33.0
Sex: M
Vaccine: FLUN3
Symptoms: Dysphagia, Flushing, Paraesthesia
Clinical narrative: A non-serious, spontaneous report of tingling in upper extremities, flushing and dysphagia has been received from a physician on concerning a 33-year-old male patient subsequent to FLUMIST. The patient's medical history included exercises induced asthma. The patient was not receiving any concomitant medications. The patient received FLUMIST, intranasal on 05-Oct-2009. On 05-Oct-2009, immediately after receiving FLUMIST, the patient experienced tingling in both upper extremities, facial flushing and dysphagia. The patient was seen in the emergency department and was noted to have a normal exam. The patient was considered recovered from the events of tingling in upper extremities, flushing and dysphagia on 05-Oct-2009. On 06-Oct-2009 the patient was seen as an outpatient and was asymptomatic.
Age: 19.0
Sex: M
Vaccine: FLUN3
Symptoms: Asthenia, Dyspnoea, Insomnia, Pulmonary congestion, Pyrexia
Clinical narrative: A non-serious spontaneous report of can't sleep, hard to breathe, feeling of fluid in lungs, fever, and no energy has been received from a consumer concerning a 19-year-old male, subsequent to FLUMIST. The patient's past medical history included inhaler dependent asthma. Concomitant medications were not reported. The patient received FLUMIST on 30-Sep-2009. The patient received a single dose before onset of the events. On an unknown date, the patient experienced "can't sleep, hard to breathe, feeling of fluid in lungs, fever (105.8), and no energy". Outcome and causality were not reported.
Age: 66.0
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST administered to a patient over 49 years old was received from a registered nurse concerning a 66 year-old female. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Decreased appetite, Diarrhoea, Dizziness, Faeces discoloured
Clinical narrative: A non-serious, spontaneous report of Influenza B has been received from a physician concerning an 10-year-old male patient subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 26-Sep-2009. A few days later, the patient experienced sore throat, cough, fever, decreased appetite, watery green stools, and dizziness. On 28-Sep-2009, the patient tested positive for Influenza B. The outcome for the reported adverse event was not reported.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza B virus test positive, Oropharyngeal pain, Pyrexia
Clinical narrative: A non-serious, spontaneous report of Influenza B has been received from a physician concerning an 10-year-old male patient subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 26-Sep-2009. A few days later, the patient experienced sore throat, cough, fever, decreased appetite, watery green stools, and dizziness. On 28-Sep-2009, the patient tested positive for Influenza B. The outcome for the reported adverse event was not reported.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Chills, Pyrexia
Clinical narrative: A non-serious, spontaneous report of fever and chills has been received from a consumer concerning a 5-year-old male, subsequent to FLUMIST. Neither past medical history nor concomitant medications were reported for this patient. The patient received FLUMIST on 01-Oct-2009. On the same date, the patient experienced fever and chills. The events of fever and chills are ongoing.
Sex: F
Vaccine: FLUN3
Symptoms: Asthma, Cough
Clinical narrative: A non-serious, spontaneous report of severe asthma and coughing has been received from an adult consumer subsequent to FLUMIST. The subject's medical history and concomitant medications were not reported. In approximately November 2005, the subject received FLUMIST. One week later in November 2005, the patient experienced severe asthma and coughing. On an unknown date in June 2006, the subject reported the adverse events of severe asthma and coughing resolved.
Age: 5.0
Sex: U
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of "received FLUMIST on two consecutive days" has been received from a nurse concerning a five-year-old. During the flu vaccination program at the local School District, the patient received FLUMIST on two consecutive days, 05-Oct-2009 and 06-Oct-2009. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 36.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Diarrhoea, Myalgia, Pyrexia, Sneezing
Clinical narrative: A non-serious, spontaneous report of fever of 100 degrees F, sneezing, achy muscles, coughing and diarrhea has been received from a 36-year-old mother who experienced the events subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 18-Sep-2009 at the pediatrician's office where she takes her children. On 22-Sep-2009, the patient developed several side effects which she believed were related to FLUMIST. These included fever of 100 degrees F for the last 24 hours, sneezing, achy muscles, coughing and diarrhea. On 23-Sep-2009, she treated the fever which has risen to 101 degrees F with acetaminophen. The outcome of the adverse events is unknown.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Chills, Pyrexia
Clinical narrative: A non-serious spontaneous report of chills and fever has been received from a physician's assistant concerning a seven-year-old male subject subsequent to FLUMIST. No medical history or concomitant medications were provided. On an unknown date, the patient received FLUMIST. Two days later, the patient developed chills and fever. No outcome was provided.
Age: 38.0
Sex: F
Vaccine: FLUN3
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: A non-serious spontaneous report of administration of full dose in one nostril was received from a pharmacist concerning a 38-year-old female subsequent to administration of FLUMIST. Relevant medical history and concomitant medications were not reported. On 23-Sep-2009, the patient inadvertently received a full dose of FLUMIST into one nostril. There was no adverse event associated with this vaccination error, therefore treatment and reporter sponsor causality assessment are not applicable and the event is considered to be resolved.
Sex: F
Vaccine: FLUN3
Symptoms: Impaired work ability, Influenza
Clinical narrative: A non-serious spontaneous report of mild influenza has been received from a nurse concerning herself, an adult female, subsequent to FLUMIST. No medical history or concomitant medications were reported. The patient received her first dose of FLUMIST in mid-Sep-2009. For the past ten years ten years she had received a flu shot. Thirty six hours after receiving FLUMIST she experienced a mild case of the flu which caused her to miss a day of work. The event of influenza resolved.
Age: 61.0
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of "a 61-year-old person got FLUMIST at our clinic" has been received from a nurse concerning a 61-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 24-Sep-2009. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessment are not applicable, and the event is considered resolved.
Age: 78.0
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to a 78-year-old had been received from a consumer concerning a male. Neither relevant medical history not concomitant medications have been reported for this patient. The patient received FLUMIST on 25-Sep-2009. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 15.0
Sex: M
Vaccine: FLUN3
Symptoms: Headache, Immediate post-injection reaction
Clinical narrative: A non-serious spontaneous report of headache has been received from a nurse practitioner concerning a 15-year-old male, subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. On 22-Sep-2009, the patient received FLUMIST. Immediately after receiving FLUMIST the patient experienced a headache. He was treated with ibuprofen and acetaminophen. The headache was ongoing at the time of the report.
Age: 40.0
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Impaired work ability
Clinical narrative: A non-serious spontaneous report of flu like symptoms has been received from a consumer concerning herself, a 40-year-old female, subsequent to receiving FLUMIST. No medical history or concomitant medications were reported. The patient received a single dose of FLUMIST on 23-Sep-2009. Six hours after she received FLUMIST the patient experienced flu like symptoms which included the following symptoms: shakes/chills, vomiting, headache, lack of appetite, achy and fatigue. She indicated that she did not have a fever but she does feel awful and missed a day of work. The event of flu like symptoms resolved two days later. Additional information was received on 16-Oct-2009 and incorporated into narrative: event resolved two days later.
Age: 40.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza like illness, Malaise, Pain, Tremor, Vomiting
Clinical narrative: A non-serious spontaneous report of flu like symptoms has been received from a consumer concerning herself, a 40-year-old female, subsequent to receiving FLUMIST. No medical history or concomitant medications were reported. The patient received a single dose of FLUMIST on 23-Sep-2009. Six hours after she received FLUMIST the patient experienced flu like symptoms which included the following symptoms: shakes/chills, vomiting, headache, lack of appetite, achy and fatigue. She indicated that she did not have a fever but she does feel awful and missed a day of work. The event of flu like symptoms resolved two days later. Additional information was received on 16-Oct-2009 and incorporated into narrative: event resolved two days later.
Age: 62.0
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of vaccine administration to a person over 49 years has been received from a company representative concerning a 62-year-old female, subsequent to FLUMIST. No medical history was reported, the only concomitant medication reported was INFLIXIMAB. The patient received a single dose of FLUMIST on 18-Sep-2009. As a result of receiving FLUMIST the patient was instructed by her rheumatologist to discontinue INFLIXIMAB because she had received a FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Eye swelling, Irritability, Pyrexia, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of irritability, eye swelling, fever, congestion, runny nose, and cough has been received from a consumer/mother concerning her five-year-old daughter, subsequent to FLUMIST. The patient's medical history and concurrent medications were not reported. On 01-Oct-2009, the patient received FLUMIST. On 03-Oct-2009, the child experienced sudden irritability, eye swelling, congestion, runny nose and cough. The mother reported that her daughter is "doing better."
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Upper respiratory tract congestion
Clinical narrative: A non-serious spontaneous report of irritability, eye swelling, fever, congestion, runny nose, and cough has been received from a consumer/mother concerning her five-year-old daughter, subsequent to FLUMIST. The patient's medical history and concurrent medications were not reported. On 01-Oct-2009, the patient received FLUMIST. On 03-Oct-2009, the child experienced sudden irritability, eye swelling, congestion, runny nose and cough. The mother reported that her daughter is "doing better."
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Accidental exposure, No adverse event
Clinical narrative: A non-serious spontaneous report of "child moved and we squirted some in his eyes" was received from a non-health care professional concerning an 11-year-old male subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. On 07-Oct-2009, the patient received FLUMIST. During the FLUMIST administration, the patient moved, and some of the vaccine was squirted in his eye. The patient's eye was rinsed out with water. The patient stated that he "never had any problems." There was no adverse event associated with this medication error; therefore, treatment and reported/sponsor causality assessment are not applicable, and the event is considered resolved.
Age: 32.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of a registered nurse giving herself a dose of expired FLUMIST was received from the 32-year-old female registered nurse/patient. The patient's medical history and concomitant medications were not reported. On 06-Sep-2009, the patient received expired FLUMIST (expiration date not reported). There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 37.0
Sex: F
Vaccine: FLUN3
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: A non-serious, spontaneous report of sneezing and runny nose has been received from a nurse practitioner concerning a 37-year-old female patient who works in the reporter's practice subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 23-Sep-2009. Eight hours after receiving FLUMIST, the patient experienced sneezing and runny nose. As of 25-Sep-2009, the adverse events of sneezing and runny nose are still present.
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Fatigue, Influenza, Influenza virus test positive, Oropharyngeal pain
Clinical narrative: A non-serious, spontaneous report of Flu has been received from a registered nurse concerning a 12-year-old female patient subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 25-Sep-2009. On 06-Oct-2009, the patient experienced fever, sore throat, cough, congestion, and tiredness. The patient went to the doctor and tested positive for the Flu. The event outcome was not reported.
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia, Upper respiratory tract congestion
Clinical narrative: A non-serious, spontaneous report of Flu has been received from a registered nurse concerning a 12-year-old female patient subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 25-Sep-2009. On 06-Oct-2009, the patient experienced fever, sore throat, cough, congestion, and tiredness. The patient went to the doctor and tested positive for the Flu. The event outcome was not reported.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Accidental exposure, No adverse event
Clinical narrative: A non-serious, spontaneous report of sprayed in the eye was received from a pharmacist regarding a 43 year-old female following administration of FLUMIST. The patient jerked her head during intranasal administration of FLUMIST, and a little amount of the vaccine was sprayed in her eye. There was no adverse event experienced; therefore treatment and reporter/sponsor causality assessment are not applicable and the event is considered resolved.