chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Urticaria
Clinical narrative: A non-serious spontaneous report of hives has been received from a health professional concerning a sever-year-old male, subsequent to FLUMIST. The patient's past medical history included no allergies and he had received FLUMIST last year with no reaction. No concomitant medications have been reported for this patient. The patient received FLUMIST on 27-Oct-2011 at 9.00AM. On 27-Oct-2011 at 04.00PM, the patient experienced hives and again at 8.00PM. The outcome of event hives was unknown.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Accidental exposure, No adverse event
Clinical narrative: A non-serious spontaneous report of possible eye exposure was received from a health professional concerning a five-year-old male. Neither relevant past medical history nor concomitant medications had been reported for this patient. On 27-Oct-2011, the patient received FLUMIST, some of which have gone in the patient's eye. 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.
Sex: F
Vaccine: FLUN3
Symptoms: Accidental exposure, Oedema peripheral, Rash
Clinical narrative: A non-serious spontaneous report of accidental exposure, swollen hands and rash has been received from a non-health professional concerning an adult female nurse, subsequent to FLUMIST. The patient has a history of an allergy to eggs. No concomitant medications have been reported for this patient. The patient herself did not receive FLUMIST. She was administering FLUMIST to a child, in 2009. The patient experienced swollen hands and rash after administering the vaccine to the child and patient did not actually receive FLUMIST. The child did not experience any reaction. The outcome of event accidental exposure, swollen hands and rash considered resolved. Additional information was received on 26-Jul-201l and incorporated into the narrative: Patient's demographics.
Age: 13.0
Sex: F
Vaccine: FLUN3, HEPA, VARCEL
Symptoms: Ageusia, Tongue discolouration
Clinical narrative: A non-serious spontaneous report of tongue turned black and lost taste bud has been received from a health professional concerning a 13-year-old female, subsequent to FLUMIST. No relevant past medical history had been reported for this patient. Concomitant medications included vaccines for varicella and Hep A given on 20-Oct-2011. On 20-Oct-2011, the patient received FLUMIST. An hour after receiving FLUMIST, the patient's tongue turned black and she lost her taste buds. These events lasted for few hours and got resolved by at 4 pm on 20-Oct-2011. The events of tongue turned black and lost taste bud resolved.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: A non-serious spontaneous report of positive test for influenza on the rapid flu test has been received from a health professional concerning a nine-year-old female, subsequent to FLUMIST. Neither relevant past medical history nor concomitant medications had been reported for this patient. The patient received FLUMIST on 15-Sep-2011. On 17-Oct-2011, the patient tested positive for the Type A influenza strain on the rapid flu test. The outcome of the event was unknown.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Chills, Influenza like illness, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of flu like symptoms manifested by fever, body aches, chills and runny nose has been received from a health professional concerning a four-year-old male, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant past medical history nor concomitant medications had been reported for this patient. On 21-Oct-2011, the patient received FLUMIST. After receiving FLUMIST, the patient had fever and flu like symptoms two days later. The event of flu like symptoms was recovering.
Sex: U
Vaccine: FLUN3
Symptoms: Wheezing
Clinical narrative: A non-serious spontaneous report of wheezing has been received from a non-health professional concerning a child, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST last flu season in 2010-2011. The patient developed wheezing after receiving FLUMIST and was in the office. The outcome of the event was unknown.
Age: 13.0
Sex: F
Vaccine: FLUN3
Symptoms: Erythema, Feeling hot, Pain, Tenderness
Clinical narrative: This is a verbatim narrative as reported on the internet, accessed on 28 July 2011. According to the web site these reported were from FDA VAERS. "FLUMIST problem was reported on Nov 27, 2007. Female patient, 13 years of age, was vaccinated with FLUMIST on Nov 16, 2007. "Rec'd vaccine on 11/13/07. On 11/14/07 began with (L) upper arm tenderness. On 11/15/07 seen in office, significant tenderness with about 2 1/2" area of erythema/warmth, painful to move arm - treated with KEFLEX with improvement." None. N/A. Patient recovered."
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Condition aggravated, Pruritus, Urticaria
Clinical narrative: This is a verbatim narrative as reported on the internet, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Dec 07, 2007. Male patient, child 7 years of age, was vaccinated with FLUMIST on Dec 07, 2007. "Had Intranasal Flu vaccine at around 2:00 p.m. and went back to school, after receiving 2 tsp. Ibuprofen syrup. Mother brought him back about 4 p.m. saying he got off the bus itching and with hives on neck, chest, abdomen, back, no difficulty breathing. We gave him ZYRTEC 7.5 ml and kept him about 40 minutes. He developed no further symptoms but remained with hives. Sent him home with BENADRYL chewable tablets to take at bedtime for hives. Called mother this morning, she said he was fine, hives were gone by time they got home yesterday." "Ibuprofen syrup 2 tsp., ZYRTEC 7.5 ml." "Seasonal allergies, history of hives". Patient recovered."
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of runny nose has been received from a non-health professional concerning a 31-month-old female, subsequent to FLUMIST. This case will be submitted to accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 25-Aug-2011. On 26-Aug-2011, the patient developed a runny nose. The Patient did not receive any medical attention for the symptom. The outcome of the event was unknown.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of 2 doses of FLUMIST in one day was received from a health professional concerning a four-year-old female. On 10-Aug-2011, the patient inadvertently received two doses of FLUMIST. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 1.95
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of gave FLUMIST to a child that is less than 24 months of age was received from a health professional concerning a 24-month-old male. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of fever, cough, congestion and runny nose has been received from a health professional concerning an eight-year-old male, subsequent to FLUMIST. The patient's medical history included breathing treatments off and on, allergies and asthma like symptoms. Concomitant medications have not been reported for this patient. The patient received FLUMIST on 24-Aug-2011. After receiving FLUMIST, the patient developed runny nose, congestion and cough on 26-Aug-2011. The patient had fever on 10-Sep-2011 of 102. The reporter stated that the patient had visited to his pediatrician for all the adverse events. It was not confirmed if the patient had a clear diagnosis of asthma. The outcome of events fever, cough, congestion and runny nose was resolved on 14-Sep-2011. Additional information was received on 14-Dec-2011 and incorporated into the narrative: medical history and outcome of the event.
Sex: F
Vaccine: FLUN3
Symptoms: Accidental exposure, Cough
Clinical narrative: A non-serious spontaneous report of accidental exposure and tight dry cough has been received from a health professional concerning an adult female. Neither relevant medical history nor concomitant medications were reported. The patient did not receive FLUMIST. The patient experienced tight and dry cough within a week of starting to give FLUMIST to patients each year. The patient never had cough any other time of the year. The outcome of both the events were recovered; tight dry cough resolved on 05-Sep-2011.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious spontaneous report of two doses of FLUMIST in the same day was received from a consumer concerning a 35-month-old female. Neither patient's medical history nor concomitant medications were reported. On 12-Sep-2011, the patient received two doses of FLUMIST. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Vomiting
Clinical narrative: A non-serious spontaneous report of vomiting has been received from a consumer concerning a 36-month-old female, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. The patient's past medical history includes patient had FLUMIST last year without incident and patient does not have a fever or any other symptoms. No concomitant medications have been reported for this patient. The patient received FLUMIST on 24-Aug-2011. On 25-Aug-2011, patient was vomiting all morning. The outcome of the event was not resolved.
Sex: M
Vaccine: FLUN3
Symptoms: Wrong technique in drug usage process
Clinical narrative: A Non-serious spontaneous report of administration of full dose in one nostril has been received from a health professional concerning a male child between the ages of 8 and 10 years-old subsequent to FLUMIST. Neither medical history nor concomitant medications were reported for this patient. The patient received FLUMIST on 01 Sep 2011. The patient received a full dose of FLUMIST in one nostril. The outcome of the event was unknown.
Age: 1.9
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to a 22-month-old was received from a health professional concerning a 22-month-old male. Neither the patient's past medical history nor the concomitant medications were reported. On 29-Aug-2011, the nurse inadvertently administered FLUMIST to a 22-month-old male. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received on 14-Sep-2011: No adverse events occurred subsequent to receiving FLUMIST.
Sex: M
Vaccine: FLUN3
Symptoms: Rash erythematous
Clinical narrative: A non-serious spontaneous report of red rash on nose has been received from a physician concerning a male child, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST at the end of the last influenza season 2011. After receiving FLUMIST the patient's nose became red for a short period of time, and he developed a rash on the nose which dissipated quickly. The outcome of the event resolved.
Sex: U
Vaccine: FLUN3, UNK
Symptoms: Crying, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of crying and runny nose has been received from a health professional concerning children of unknown ages, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. No relevant medical history has been reported for these patients. Concomitant medication included injectable vaccines. On an unknown date, the patients received FLUMIST. After the administration of FLUMIST, the patients received unknown injectable vaccines and began crying, consequently they developed runny nose. The outcome of the events was unknown.
Age: 15.0
Sex: F
Vaccine: FLUN3
Symptoms: Feeling abnormal
Clinical narrative: A non-serious spontaneous report of felt kind of crummy has been received from a non health professional concerning a 15-year-old female, subsequent to FLUMIST. Neither medical history nor concomitant medications were reported. The patient received FLUMIST on 02-Sep-2011. On 02-Sep-2011, the patient felt kind of crummy. The outcome of the event was not resolved.
Sex: M
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 health professional concerning an adult male while receiving FLUMIST. Neither relevant medical history nor concomitant medications were reported. The patient between 38-42 years of age received the entire dose of FLUMIST in one nostril on 01-Sep-2011. 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: 15.0
Sex: F
Vaccine: FLUN3
Symptoms: Bronchiolitis, Dyspnoea, Pyrexia, Wheezing
Clinical narrative: A non-serious spontaneous report of acute bronchitis has been received from a health professional concerning a 15-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 19-Aug-2011. On 22-Aug-2011, the patient experienced labored breathing, wheezing and fever of 102 degrees F, subsequently she was diagnosed with acute bronchitis. The patient saw the physician on 24-Aug-2011 and was administered a breathing treatment with albuterol. The outcome of the event was unknown.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administered expired FLUMIST was received from a health professional concerning a child patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired in Mar-2011. The patient received expired FLUMIST on 26-Aug-2011. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 12.0
Sex: F
Vaccine: DTP, FLUN3, MEN
Symptoms: Urticaria
Clinical narrative: A non-serious spontaneous report of hives in the nostril areas and under both eyes has been received from a health professional concerning a 12-year-old female, subsequent to FLUMIST. The patient's medical history included received injectable flu vaccine in past and patient was healthy at the time of vaccination. The patient received FLUMIST on 16-Aug-2011. Vaccines given on the same day included meningococcal vaccine and DTP. About five to ten minutes after patient got FLUMIST, she got hives in the nostril areas and under both eyes. The patient did not received medical attention. The outcome of the event nostril areas and under both eyes was resolved. Additional information was received on 28-Oct-2011 and incorporated into the narrative: outcome, concomitant medications, medical history and suspect drug information.
Sex: F
Vaccine: FLUN3
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: A non-serious spontaneous report of barrel was broken near the white spray nozzle was received from a health professional concerning an adult female. The product broke when she went to administer the dose it seemed to shoot out of the patient's nostril. The nurse thought that she had not given the dose properly and upon administration of second portion of the dose the liquid squirted back at the nurse and covered her glasses. The nurse felt only fine mist on her face. When she removed the sprayer from the patient's nostril she did see a small half moon shaped crack in the glass at the white tip of the sprayer right on the bend. The sprayer had not been dropped or mishandled. The office keeps their doses in the refrigerator in the original packaging and pulls out the sleeve to remove only the necessary doses, then replaces the tray back into the packaging and puts it back into the refrigerator. There was no adverse event associated with this product complaint; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 44.0
Sex: F
Vaccine: FLUN3
Symptoms: No adverse event, Product quality issue, Underdose
Clinical narrative: A non-serious spontaneous report of administration attempted with a cracked sprayer was received from a health professional concerning a 44-year-old female. She did not realize that the FLUMIST sprayer was cracked at the base. She attempted to administer vaccine to patient however realized after that there was no spray action and the vaccine dribbled out of the base of the sprayer. Therefore, the patient did not receive any vaccine from this sprayer (although the plunger was depressed into each nare before realization that vaccine dribbled out of sprayer base). There was no adverse event associated with this product complaint; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired dose was received from a health professional concerning a five-year-old female. Neither relevant medical history nor concomitant medications were reported. FLUMIST expired on 19-Jan-2011. On 13-Sep-2011, the patient received expired FLUMIST. On 12-Oct-2011, the patient was given a flu shot and the patient did not report any adverse event. 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. Additional information was received on 14-Dec-2011 and incorporated in the narrative: other medications given after the FLUMIST dose and the patient did not report any adverse event. Other additional information received was: reporter information and patient's initials.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza B virus test positive, Pyrexia
Clinical narrative: A non-serious spontaneous report of positive influenza B test manifested by fever has been received from a health professional concerning an eight-year-old male, subsequent to FLUMIST. Neither patient's medical history nor concomitant medications were reported. The patient received FLUMIST on 09-Sep-2011. The patient received a total of one dose before onset of the event with the last dose before onset of the event given on 09-Sep-2011. After receiving FLUMIST, the patient had fever of 103F and tested positive for influenza B on 15-Sep-2011. The outcome of positive influenza B test manifested by fever was not recovered.
Age: 47.0
Sex: F
Vaccine: FLUN3
Symptoms: Dyspnoea, Rash vesicular, Urticaria
Clinical narrative: A non-serious spontaneous report of shortness of breath and hives over trunk, back and arms has been received from a health professional concerning a 47-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 2009. On 01-Sep-2009, patient experienced shortness of breath within two days of receiving FLUMIST, then broke out in hives over her trunk, back and arms within a week. Patient described the hives as lesions that looked like chicken pox (raised and clear lesions which were separated). The rash lasted for six weeks. The events resolved in 2009.
Age: 56.0
Sex: M
Vaccine: FLUN3
Symptoms: Medication error, No adverse event
Clinical narrative: A non-serious spontaneous report of 56-year-old received FLUMIST was received from a health professional concerning a 56-year-old male. Neither relevant medical history nor concomitant medications were reported. On 08-Sep-2011, the patient received FLUMIST. 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: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Abasia, Arthritis, Rash
Clinical narrative: A non-serious spontaneous report of arthritis in ankles manifested with inability to walk and rash has been received from a physician concerning a seven-year-old male, subsequent to FLUMIST. Neither the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST on 07-Sep-2011. On 08-Sep-2011, the patient developed rash and arthritis in both ankles, with inability to walk. The outcome of both the events was not recovered.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: A non-serious spontaneous report of fever has been received from a physician concerning a six-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications were reported. The patient received FLUMIST on 09-Sep-2011. On 10-Sep-2011, the patient developed a fever of 105 degrees Fahrenheit and continued to have a fever on 12-Sep-2011. The outcome of the event was not resolved.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Epistaxis, Syringe issue
Clinical narrative: A non-serious spontaneous report of syringe broke and bloody nose has been received from a physician concerning a nine-year-old male, subsequent to FLUMIST. Neither medical history, nor concomitant medications were reported. On 09-Sep-2011, patient received FLUMIST. On 09-Sep-2011, while administering the vaccine syringe broke into half and patient got bloody nose. The doctor checked the child and did not see any glass in the child's nose. The outcome of event syringe broke was resolved and outcome of bloody nose was unknown.
Age: 13.0
Sex: M
Vaccine: FLUN3
Symptoms: Chills, Influenza A virus test positive, Nausea, Pyrexia, Vomiting
Clinical narrative: A non-serious spontaneous report of testing positive for influenza type A has been received from a health professional concerning a 13-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 28-Aug-2011. On 31-Aug-2011, the patient experienced fever, chills, nausea and vomiting. On 06-Sep-2011, the patient tested positive for influenza type A. The outcome of the event was unknown.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza like illness, Oropharyngeal pain, Pain, Pyrexia, Streptococcus test negative
Clinical narrative: A non-serious spontaneous report of flu like symptoms manifested by fever, body ache and sore throat has been received from a health professional concerning a 14-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications were reported. The patient received FLUMIST on 31-Aug-2011. The patient received a total of one dose before onset of the event with the last dose before onset of the event given on 31-Aug-2011. The patient had flu like symptoms of fever, body ache and sore throat. On 06-Sep-2011, the patient received a strep throat test and the test results were negative. The patient was not tested for influenza. The outcome of the event was unknown.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Pain, Pyrexia
Clinical narrative: A non-serious spontaneous report of fever, lots of coughing and aches has been received from a non health professional concerning a eight-year-old female, subsequent to FLUMIST. Patient's past medical history included vaccination with FLUMIST not associated with adverse event. Concomitant medications was not reported. The patient received FLUMIST on 02-Sep-2011. On 02-Sep-2011, the patient experienced aches, lots of coughing and mild fever. The outcome of the event was not recovered.
Age: 36.0
Sex: F
Vaccine: FLUN3
Symptoms: Accidental exposure, No adverse event
Clinical narrative: A non-serious spontaneous report of spray from patient's nostril went into eye of nurse was received from a health professional concerning a 36-year-old female. Neither the patient's past medical history nor concomitant medications were reported. As the nurse was administering FLUMIST into the patient's nostril, as it hit the nostril, some of the FLUMIST sprayed into the nurse's eye. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 15-SEP-2011: there were no late-occurring adverse events.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Condition aggravated, Wheezing
Clinical narrative: A non-serious spontaneous report of wheezing has been received from a health professional concerning a ten-year-old female, subsequent to FLUMIST. The patient's past medical history includes wheezing, but hadn't for four to five years. Concomitant medications were not reported. The patient received FLUMIST in the first week of Aug-2011. The patient had a wheezing episode a few hours after FLUMIST administration. The child was given albuterol treatment and wheezing was cleared. There were no further symptoms. The outcome of the event of wheezing was resolved in Aug-2011. The reporter assessed the event of wheezing as not related to FLUMIST.
Age: 14.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: A non-serious spontaneous report of fever has been received from a physician concerning a 14-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 10-Aug-2011, patient received FLUMIST. On 11-Aug-2011, patient experienced fever. No medical attention or other symptoms were reported. The outcome of event was unknown.
Sex: F
Vaccine: FLUN3
Symptoms: Sinusitis
Clinical narrative: A non-serious spontaneous report of sinus infection has been received from a female consumer concerning herself, subsequent to FLUMIST. Neither relevant past medical history nor concomitant medications had been reported for this patient. The patient received FLUMIST on 23-Sep-2011. After receiving FLUMIST, the patient developed sinus infection which was confirmed by a physician on 06-Oct-2011. The symptoms were mild and no fever was developed. The outcome of the event of sinus infection was not provided.
Age: 22.0
Sex: M
Vaccine: FLUN3
Symptoms: Body temperature, Cough, Fatigue, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of temperature, fatigue, cough and runny nose has been received from a consumer concerning a 22-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 27-Sep-2011. On 29-Sep-2011, the patient experienced temperature, fatigue, cough and runny nose, where coughing went to chest. Rest of the family also have similar symptoms. The outcome of events of temperature, fatigue, cough and runny nose was resolved.
Age: 70.0
Sex: F
Vaccine: FLUN3
Symptoms: Medication error, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST administered to couple in their 70s was received from a health professional concerning an elderly female. Neither relevant medical history nor concomitant medications have been reported for this patient. On Sep-2011, a 70 year old patient received FLUMIST. 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: 1.8
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST given to a 22 month old child was received from a health professional concerning a one-year-old female. Neither relevant past medical history nor concomitant medications had been reported for this patient. The patient received FLUMIST on 07-Oct-2011 and did not have any adverse events. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 41.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of expired FLUMIST was administered was received from a health professional concerning a 41-year-old female. Neither relevant medical history nor concomitant medications were reported for this patient. The patient received expired FLUMIST on 04-Oct-2011. FLUMIST expired on 01-Dec-2010. 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.
Sex: M
Vaccine: FLUN3
Symptoms: Medication error, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST administered to couple in their 70s was received from a health professional concerning an elderly male. Neither relevant medical history nor concomitant medications have been reported for this patient. In Sep-2011, a 70 year old patient received FLUMIST. 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: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Decreased appetite, Headache, Influenza like illness, Influenza virus test positive
Clinical narrative: A non-serious spontaneous report of flu like symptoms manifested with headache and fever, stomach ache and loss of appetite has been received from a health professional concerning a five-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 04-Oct-2011. On 07-Oct-2011, the patient experienced flu like symptoms and rapid test came positive for flu. The patient also experienced headache, fever, stomach ache and loss of appetite. The outcome of flu like symptoms, stomach ache and loss of appetite was not resolved.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: A non-serious spontaneous report of flu like symptoms manifested with headache and fever, stomach ache and loss of appetite has been received from a health professional concerning a five-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 04-Oct-2011. On 07-Oct-2011, the patient experienced flu like symptoms and rapid test came positive for flu. The patient also experienced headache, fever, stomach ache and loss of appetite. The outcome of flu like symptoms, stomach ache and loss of appetite was not resolved.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Abdominal tenderness, Chills, Condition aggravated, Hunger, Pharyngeal erythema
Clinical narrative: This is a verbatim narrative as reported on website, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Nov 15, 2007. Male patient, child 8 years of age, was vaccinated with FLUMIST on Nov 15, 2007. Fever to 102.6 with chills and vomiting developed 12 hours after vaccine was given. She was evaluated 6 hours after the onset of symptoms. She received one dose of TYLENOL. Her exam revealed 3+ red tonsils and generalized abdominal tenderness. Her temp was 98.2 and patient stated she was hungry. CLARITIN 10 mg prn and TYLENOL x 1 dose. Allergic Rhinitis. Patient recovered."
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia, Rhinitis allergic, Vomiting
Clinical narrative: This is a verbatim narrative as reported on website, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Nov 15, 2007. Male patient, child 8 years of age, was vaccinated with FLUMIST on Nov 15, 2007. Fever to 102.6 with chills and vomiting developed 12 hours after vaccine was given. She was evaluated 6 hours after the onset of symptoms. She received one dose of TYLENOL. Her exam revealed 3+ red tonsils and generalized abdominal tenderness. Her temp was 98.2 and patient stated she was hungry. CLARITIN 10 mg prn and TYLENOL x 1 dose. Allergic Rhinitis. Patient recovered."
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Decreased appetite, Fatigue, Pyrexia
Clinical narrative: A non-serious spontaneous report of fever, loss of appetite and fatigue has been received from a consumer concerning a four-year-old female, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant past medical history nor concomitant medications had been reported for this patient. The patient received FLUMIST on 29-Sep-2011. The patient's mother stated that her daughter did receive FLUMIST and was not sure if her daughter received the FLUMIST from one syringe or if a second syringe was used to administer the dose in the other nostril. She stated her view of the nurse was blocked because she was facing the nurse's back and could not see her hands. After receiving FLUMIST, the patient developed a loss of appetite on 30-Sep-2011. On 06-Oct-2011, the patient developed fatigue and fever of 99.6 F. The mother gave ibuprofen on 06-Oct-2011. The event of loss of appetite resolved on 01-Oct-2011 and the events fever and fatigue resolved on 07-Oct-2011.
Age: 13.0
Sex: M
Vaccine: FLUN3
Symptoms: Culture throat negative, Headache, Influenza, Oropharyngeal pain, Pyrexia
Clinical narrative: A non-serious spontaneous report of flu has been received from a health professional concerning a 13-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 31-Aug-2011. On 07-Sep-2011, the patient experienced flu symptoms of sore throat, headache and fever of 102 degrees F. On the same day, the patient was seen in the physician's office. On 07-Sep-2011, a Strep test and a throat culture were negative. On 12-Sep-2011, the patient returned to the physician's office. The outcome of the event was unknown.
Age: 13.0
Sex: M
Vaccine: FLUN3
Symptoms: Streptococcus test negative
Clinical narrative: A non-serious spontaneous report of flu has been received from a health professional concerning a 13-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 31-Aug-2011. On 07-Sep-2011, the patient experienced flu symptoms of sore throat, headache and fever of 102 degrees F. On the same day, the patient was seen in the physician's office. On 07-Sep-2011, a Strep test and a throat culture were negative. On 12-Sep-2011, the patient returned to the physician's office. The outcome of the event was unknown.
Age: 0.83
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST administration to child under 1 year old was received from a health professional concerning a ten-month-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 03-Oct-2011, a child below two years of age received FLUMIST. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Epistaxis
Clinical narrative: A non-serious spontaneous report of nosebleed has been received from a health professional concerning a four-year-old male, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 03-Oct-2011. On 03-Oct-2011, 12 hours after receiving FLUMIST, the patient experienced a nosebleed. The outcome of event nosebleed was resolved.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Decreased appetite, Epistaxis, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: A non-serious spontaneous report of four bloody noses in 24 hours, headache, fever, sore throat and loss of appetite has been received from a consumer concerning her five-year-old son, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 04-Oct-2011. The patient experienced headache, fever, sore throat and loss of appetite. On 05-Oct-2011, the patient experienced four bloody noses in 24 hours. The outcome of events 4 bloody noses in 24 hours, headache, fever, sore throat and loss of appetite was not provided.
Age: 1.7
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent FLUMIST administration to a 20 month old was received from a physician concerning a 20-month-old female. Neither relevant medical history nor concomitant medications were reported for this patient. The patient received FLUMIST on 04-Oct-2011. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 52.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of FLUMIST to a 59 year old was received from a health professional concerning a 52-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 03-Oct-2011, a 52-year-old patient received FLUMIST. 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: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood test, Fatigue, Gait disturbance, Muscular weakness
Clinical narrative: Same day of shot arm painful to slightest touch. Very painful to move my arm (5 days later could move arm, stabs of pain, achiness, weakness, loss of strength). Not able to use my arm & hand normally. Extreme fatigue. 2 wks later: still the same but shooting pains through my neck into hand. 2 1/2 months later, still the same only not able to walk normally. More achy and fatigued.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain, Pain in extremity, Tenderness
Clinical narrative: Same day of shot arm painful to slightest touch. Very painful to move my arm (5 days later could move arm, stabs of pain, achiness, weakness, loss of strength). Not able to use my arm & hand normally. Extreme fatigue. 2 wks later: still the same but shooting pains through my neck into hand. 2 1/2 months later, still the same only not able to walk normally. More achy and fatigued.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: Pt began with fever following immunizations. Fever increased 104.4 degrees. Mother states pt had no other symptoms.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Eye inflammation, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever, eye inflammation, sore throat.
Age: 27.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Dizziness, Palpitations, Syncope
Clinical narrative: Lightheadedness, fainted after injection, heart palpitations for next few days.
Age: 59.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Aspartate aminotransferase increased, Blood bilirubin, Hepatitis A, Hepatitis A antibody, Hepatitis C
Clinical narrative: Patient received both Hep A vaccines in 2007: 6/5/07 and 12/12/07. Possible vaccine failure.
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Feeling hot, Induration, Oedema, Tenderness
Clinical narrative: (R) arm 2x3 cm induration, 9x6 cm erythema/edema/warmth/tenderness.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Asthenia, Dizziness, Syncope
Clinical narrative: Patient was very apprehensive and nervous before getting any immunizations. She was very fearful. After getting injections she felt weak and was dizzy. We had her lay down until she felt better. When she went to leave facility 10 minutes she fainted. Laid her on floor-elevated her feet. Took vitals. Epi - on standby but not used. Patient recovered well and left with her mother 15 min later. Follow up with mother next day - everything OK.
Age: 1.75
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to child less than two years of age was received from a pharmacist concerning a 21-month-old female. Neither relevant medical history nor concomitant medications were reported for this patient. The patient who was under two years of age received FLUMIST on 27-Sep-2011. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Body temperature increased, Vomiting
Clinical narrative: Vomiting, temperature of 103 evening of Flu vaccine.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood test, Body temperature increased, Dyskinesia, Urine analysis, Vomiting
Clinical narrative: 3:00 or 4:00pm 3/22/12 temp 100.8. TYLENOL 0.8mL given every 4-6 hours. At 9:00-10:00pm patient had episode of body & extremities stretching out & body & extremities jerking (once). Mother woke her up. She then vomited once. Mother cleaned her up & took her to ER (10:00-10:20). Pt given PEDIALYTE & TYLENOL dose greater than (.8).
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 16 February 2012 from the investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 13-month-old male subject was identified by the investigator based on review of data from the database. The subject had previously received 3 doses of PENTACEL; dose 1 received on 26 January 2011, dose 2 received on 16 March 2011 and dose 3 received on 23 May 2011 (lot numbers, route and site of administration not reported). The subject developed cold-like symptoms on 23 December 2011, approximately 7 months after the last dose and cough began on 25 December 2011. The subject developed paroxysmal cough on 02 January 2012 with posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 03 January 2012. Chest x-ray results were unknown. Corrective treatments consisted of azithromycin starting on 03 January 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 27 January 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 33 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 16 February 2012 from the investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 13-month-old male subject was identified by the investigator based on review of data from the database. The subject had previously received 3 doses of PENTACEL; dose 1 received on 26 January 2011, dose 2 received on 16 March 2011 and dose 3 received on 23 May 2011 (lot numbers, route and site of administration not reported). The subject developed cold-like symptoms on 23 December 2011, approximately 7 months after the last dose and cough began on 25 December 2011. The subject developed paroxysmal cough on 02 January 2012 with posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 03 January 2012. Chest x-ray results were unknown. Corrective treatments consisted of azithromycin starting on 03 January 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 27 January 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 33 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.