chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth, Laboratory test normal
Clinical narrative: Case number PHEH2012US003537 is an initial spontaneous report received from a consumer and a physician on 09 Feb 2012. This case refers to a 45-year-old female patient. Her medical history included ongoing headache, nerve pain, depression, spasms, tobacco abuse, chronic pain syndrome (continuing: unknown), multiple sclerosis (diagnosed in 2009) and a negative history of cellulitis. Concomitant medications included a TOPAMAX 100mg twice daily for headache, gabapentin 300mg twice daily for nerve pain, ZOLOFT 200mg daily for depression and ZANAFLEX 2mg daily for spasm. She was started therapy with REBIF 44 micrograms three times a week, subcutaneously on 24 May 2011 for multiple sclerosis and it was continuing at the time of this report. On 01 Dec 2011, she went for routine physical examination and was vaccinated with FLUVIRIN (batch number: 1102601 and expiration date: June 2012), and with PNEUMOVAX (batch number: 1138AA and expiration date: 06 Oct 2009). On 02 Dec 2011, she went to the emergency room due to allergic reaction where the arm of the patient swelled in the area of the PNEUMOVAX vaccine and it was hot, red and inflamed. She was admitted to the hospital overnight when the pain was going to her shoulder blade and in her chest. During hospitalization she had laboratory tests which were negative for cardiac issues and blood cultures were negative. She also had an ultrasound of upper right arm that was negative for blood clots. She had serial cardiac and electrocardiogram and they ruled out a myocardial infarction. The symptoms were felt to be non-cardiac in etiology and most likely musculoskeletal in relation to her recent PNEUMOVAX. She received no treatment while in the hospital. On 03 Dec 2011 she was sent back to the emergency room by the physician because the arm was getting worse. She was given intravenous vancomycin in the emergency room for right arm cellulitis. She then had an allergic reaction with hives and her whole body was itching. She was given BENADRYL and antibiotic to prevent her from getting cellulitis. Her top head became spontaneously itchy since the allergic reaction. She stated that she noticed itching of the tip of the head which began in Aug 2011, she continued administration of REBIF. She was discharged from the hospital on 03 Dec 2011 with FIOROCET 50/325 twice daily and VICODIN 10/325 daily as needed for pain. She had recovered from allergic reaction, right arm cellulitis and allergic reaction to vancomycin. The physician assessed the relationship between the allergic reaction and right arm cellulitis and REBIF as suspected and considered PNEUMOVAX vaccine as a suspect causal factor.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal pain, Pruritus generalised, Ultrasound scan normal, Urticaria, Vaccination complication
Clinical narrative: Case number PHEH2012US003537 is an initial spontaneous report received from a consumer and a physician on 09 Feb 2012. This case refers to a 45-year-old female patient. Her medical history included ongoing headache, nerve pain, depression, spasms, tobacco abuse, chronic pain syndrome (continuing: unknown), multiple sclerosis (diagnosed in 2009) and a negative history of cellulitis. Concomitant medications included a TOPAMAX 100mg twice daily for headache, gabapentin 300mg twice daily for nerve pain, ZOLOFT 200mg daily for depression and ZANAFLEX 2mg daily for spasm. She was started therapy with REBIF 44 micrograms three times a week, subcutaneously on 24 May 2011 for multiple sclerosis and it was continuing at the time of this report. On 01 Dec 2011, she went for routine physical examination and was vaccinated with FLUVIRIN (batch number: 1102601 and expiration date: June 2012), and with PNEUMOVAX (batch number: 1138AA and expiration date: 06 Oct 2009). On 02 Dec 2011, she went to the emergency room due to allergic reaction where the arm of the patient swelled in the area of the PNEUMOVAX vaccine and it was hot, red and inflamed. She was admitted to the hospital overnight when the pain was going to her shoulder blade and in her chest. During hospitalization she had laboratory tests which were negative for cardiac issues and blood cultures were negative. She also had an ultrasound of upper right arm that was negative for blood clots. She had serial cardiac and electrocardiogram and they ruled out a myocardial infarction. The symptoms were felt to be non-cardiac in etiology and most likely musculoskeletal in relation to her recent PNEUMOVAX. She received no treatment while in the hospital. On 03 Dec 2011 she was sent back to the emergency room by the physician because the arm was getting worse. She was given intravenous vancomycin in the emergency room for right arm cellulitis. She then had an allergic reaction with hives and her whole body was itching. She was given BENADRYL and antibiotic to prevent her from getting cellulitis. Her top head became spontaneously itchy since the allergic reaction. She stated that she noticed itching of the tip of the head which began in Aug 2011, she continued administration of REBIF. She was discharged from the hospital on 03 Dec 2011 with FIOROCET 50/325 twice daily and VICODIN 10/325 daily as needed for pain. She had recovered from allergic reaction, right arm cellulitis and allergic reaction to vancomycin. The physician assessed the relationship between the allergic reaction and right arm cellulitis and REBIF as suspected and considered PNEUMOVAX vaccine as a suspect causal factor.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious spontaneous report of received only 0.1 ml in one nostril was received from a consumer concerning a four-year-old male. Neither relevant medical  history nor concomitant medications were reported for this patient. The patient got 0.1 ml of FLUMIST in one nostril on 29-Sep-2011. On 03-Oct-2011, the patient received 0.1 ml of FLUMIST in each 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. 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: F
Vaccine: FLUN3
Symptoms: Wheezing
Clinical narrative: A non-serious spontaneous report of wheezing 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 in Sep-2011. On 03-Oct-2011, approximately one week after FLUMIST administration, the patient experienced wheezing. The outcome of wheezing was not provided.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious spontaneous report of extra dose of FLUMIST was received from a consumer concerning an eight-year-old female. Neither the patient's medical history nor the concomitant medications were reported. The patient received the first dose of FLUMIST in the doctor's office on 22-Nov-2011 and the second dose in school by mistake on 13-Dec-2011. The child already had booster dosing in previous years. 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: 49.0
Sex: F
Vaccine: FLUN3
Symptoms: Gingival hypertrophy, Mouth ulceration, Oral pain, Oropharyngeal pain, Pharyngeal ulceration
Clinical narrative: A non-serious spontaneous report of hypertrophy of gums, ulcers in throat manifested with sore throat and ulcerations in mouth has been received from a pharmacist concerning a 49-year-old female, subsequent to FLUMIST. The patient's past medical history included start of a cold, runny nose and cold sores on lips. The patient had received FLUMIST in 2010 with no problem or side effects. Concomitant medications included levothyroxine sodium, esomeprazole and zopiclone. The patient received FLUMIST for flu prevention in Nov-2011. After receiving FLUMIST, the patient experienced severe ulcerations in mouth (too painful to eat), hypertrophy of gums and sore throat. The dentist thought that it was a bacterial infection of the throat, a diagnosis that was discounted by the physician who prescribed antiviral (valacyclovir hydrochloride). Reporter states that improvements may be due to time as well. Two-three weeks have gone by and ulcerations still have not fully recovered. The patient did not have lesions on the lips, she had ulcers in mouth and throat. The outcome of events hypertrophy on gums, ulcerations in mouth and ulcers in throat was recovering.
Age: 12.0
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 12-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 12-Dec-2011, the patient inadvertently received expired FLUMIST. The product expired on 04-Dec-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: 29.0
Sex: F
Vaccine: FLUN3
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to a pregnant female was received from a heath professional concerning a 29-year-old female. The patient's medical history and obstetrical history were not reported. No concomitant medications were reported. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. 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. 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: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a physician concerning a six-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 13-Dec-2011, the patient received expired FLUMIST. The product expired on 20-Nov-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: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a physician concerning a four-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 13-Dec-2011, the patient received expired FLUMIST. The product expired on 20-Nov-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: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain, Local swelling
Clinical narrative: A non-serious spontaneous report of swollen neck on both sides and abdominal pain has been received from a health professional concerning a 14-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 30-Nov-2011. On 07-Dec-2011, the patient experienced abdominal pain which persisted on 13-Dec-2011. Both sides of the patient's neck was swollen. The outcome of the events swollen neck on both sides and abdominal pain was not recovered.
Age: 34.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a physician concerning a 34-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 13-Dec-2011, the patient received expired FLUMIST. The product expired on 20-NOv-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: 29.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a 29-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 06-Dec-2011, the patient inadvertently received expired FLUMIST. The product expired on 04-Dec-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: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Accidental exposure, No adverse event
Clinical narrative: A non-serious spontaneous report of accidentally got in the child's eye was received from a health professional concerning a five-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. During FLUMIST administration on 09-Dec-2011, some FLUMIST got in the child's eye. The patient's eye was rinsed out and there were no adverse events. The patient had no redness or irritation. 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: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a child. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Nov-2011. From 20-Nov-2011 to 02-Dec-2011, 13 patients inadvertently received expired 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: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a six-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 12-Dec-2011, the patient inadvertently received expired FLUMIST. The product expired on 11-Dec-2011. There as no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 33.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a 33-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 06-Dec-3011, the patient inadvertently received expired FLUMIST. The product expired on 04-Dec-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality are not applicable, and the event is considered resolved.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious spontaneous report of received approximately three-quarter of the total dose went onto the child's face was received from a health professional concerning a five-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 13-Dec-2011, the patient received approximately three-quarters of the dose of FLUMIST. The first half of the dose was administered to the first nostril. However, during administration to the second nostril, the child moved and approximately one-quarter of the total dose went onto the patient's face. 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: 16.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a health professional concerning a 16-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 04-Dec-2011. On 06-Dec-2011, the patient received expired product. 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: 11.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a pharmacist concerning an 11-year-old female. The patient's medical history included twin birth. No concomitant medications have been reported for this patient. The product expired on 27-Nov-2011. On 04-Dec-2011, the patient received expired product. 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: U
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a health professional concerning a child. Neither relevant medical history nor concomitant medications have been reported for this patient. On 06-Dec-2011, the patient received expired FLUMIST. The product expired on 04-Dec-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: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a health professional concerning an eight-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 06-Dec-2011, the patient received expired FLUMIST. The product expired on 04-Dec-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.
Sex: F
Vaccine: FLUN3
Symptoms: Maternal exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: A non-serious spontaneous report of a patient was pregnant at the time of FLUMIST administration was received from a health professional concerning a 24-year-old female. Neither the patient's medical history nor obstetrical history was reported. The patient's concomitant medications were also not reported. On 29-Nov-2011, the patient received FLUMIST and on 08-Dec-2011 she was tested positive for pregnancy. She was actually pregnant at the time of FLUMIST administration. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable and the event is considered resolved. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experience any adverse events during the pregnancy.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a six-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 07-Dec-2011, the patient received expired FLUMIST. The product expired on 20-Nov-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: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a five-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 07-Dec-2011, the patient received expired FLUMIST. The product expired on 20-Nov-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.
Sex: U
Vaccine: FLUN3
Symptoms: Pyrexia, Vomiting
Clinical narrative: A non-serious spontaneous report of vomiting and fever has been received from a physician 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 two years to 59 months of age. Neither the patient's medical history nor the concomitant medications were reported. The patient received FLUMIST in Aug-2011. On 08-Dec-3011, the patient experienced vomiting and fever. The outcome of the events vomiting and fever was unknown.
Age: 53.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST administered to a 53 year old was received from a health professional concerning a 53-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 31-Oct-2011, FLUMIST was administered to a 53-year-old patient. 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: 49.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a health professional concerning a 49-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 04-Dec-2011. On 06-Dec-2011, the patient received expired product. 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: 20.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a health professional concerning a 20-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 04-Dec-2011. On 06-Dec-2011, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reported causality assessments are not applicable, and the event is considered resolved.
Sex: U
Vaccine: FLUN3
Symptoms: No adverse event, Underdose
Clinical narrative: A non-serious spontaneous report of partial dose administration of FLUMIST was received from a physician concerning a child. Neither the patient's medical history nor the concomitant medications were reported. On 05-Dec-2011, during FLUMIST administration the child pulled on the nurse's arm for both nostrils so she only got about half in each 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza like illness
Clinical narrative: A non-serious spontaneous report of flu-like symptoms has been received form a physician concerning an eight-year-old male, subsequent to FLUMIST. Neither the patient's medical history nor the concomitant medications were reported. The patient received FLUMIST on 21-Nov-2011. On 05-Dec-2011, the patient experienced flu-like symptoms. The reporter stated that he did not believe that the patient was having a reaction to FLUMIST and he was going to conduct a rapid flu test. The outcome of the event flu-like symptoms was not recovered.
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 FLUMIST was received from a health professional concerning a five-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 04-Dec-2011. On 05-Dec-2011, the patient received expired product. 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: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a nine-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 04-Dec-2011. On 05-Dec-2011, the patient received expired product. There was no adverse event associated with 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: Convulsion
Clinical narrative: A non-serious spontaneous report of seizure has been received form a non health professional concerning a seven-year-old male, subsequent to FLUMIST. Neither the patient's medical history nor the concomitant medications were reported. The patient received FLUMIST on 28-Nov-2011. On 30-Nov-2011, two days after receiving FLUMIST, the patient experienced seizures and then two weeks later he got it again. The outcome of the event seizures was unknown.
Age: 4.0
Sex: M
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 four-year-old male. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 27-Nov-2011. On 01-Dec-2011, the patient received expired product. 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 two years to 59 months of age.
Age: 1.84
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of 22-month old received FLUMIST was received from a health professional concerning a 22-month-old female. No relevant medical history information has been reported for this patient. Concomitant medication included injectable flu vaccine give on the same day as FLUMIST. On 28-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. 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: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Eye swelling, Swelling face, Upper respiratory tract infection, Wheezing
Clinical narrative: A non-serious spontaneous report of facial swelling manifested with upper cheeks swelling, eye swelling, URI and wheezing has been received from a health professional concerning a five-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 15-Nov-2011. On 15-Nov-2011, three hours later receiving FLUMIST the patient experienced facial swelling in upper cheeks and eyes. Also had wheezing then went to emergency room and was diagnosed with upper respiratory infection. The patient was not hospitalized. The patient was prescribed diphenhydramine, prednisolone, azithromycin and ipratropium bromide & albuterol sulfate. At the time of reporting, the patient was ok with no symptoms. The outcome of events facial swelling manifested with upper cheeks swelling, eye swelling, URI and wheezing was resolved.
Age: 0.5
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 6 month old was received from a health professional concerning a six-month-old female. Neither the patient's medical history nor the concomitant medications were reported. On 05-Dec-2011. FLUMIST was administered to the patient. 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 two years to 59 months of age.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a pharmacist concerning an 11-year-old male. The patient's medical history included twin birth. No concomitant medications have been reported for this patient. The product expired on 27-Nov-2011. On 04-Dec-2011, the patient received expired product. 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: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a health professional concerning an adult female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 30-Nov-2011, the patient inadvertently received expired FLUMIST. The product expired on 20-Nov-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: 14.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 14-year-old male. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 20-Nov-2011. On 30-Nov-2011, the patient received expired product. 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: 48.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of a nurse inadvertently gave expired FLUMIST was received from a health professional concerning a 48-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Nov-2011. On 01-Dec-2011, the patient received expired product. 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: 2.0
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 a 21 month old was received from a health professional concerning a 21-month-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 14-Nov-2011, FLUMIST was inadvertently administered to a 21 month old patient. 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 or age.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Asthenia, Blood test, Gait disturbance, Muscular weakness, Vomiting
Clinical narrative: A non-serious spontaneous report of weakness, left foot weak and wobbly, hard time walking, and vomiting has been received from a consumer concerning a four-year-old male, subsequent to receiving 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. On 11-Nov-2011, the patient received the first dose of FLUMIST. On 12-Nov-2011, the patient vomited a few times. The patient also had cetirizine on 12-Nov-2011. On the morning of 14-Nov-2011, the patient complained that his left foot felt weak and wobbly and he was having a hard time walking. He was taken to the emergency room on 14-Nov-2011 and diagnosed with weakness. Per the reporter, "he is walking fine now." The event of hard time walking resolved. The outcome for the events of left foot weak and wobbly and vomiting was unknown.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: X-ray
Clinical narrative: A non-serious spontaneous report of weakness, left foot weak and wobbly, hard time walking, and vomiting has been received from a consumer concerning a four-year-old male, subsequent to receiving 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. On 11-Nov-2011, the patient received the first dose of FLUMIST. On 12-Nov-2011, the patient vomited a few times. The patient also had cetirizine on 12-Nov-2011. On the morning of 14-Nov-2011, the patient complained that his left foot felt weak and wobbly and he was having a hard time walking. He was taken to the emergency room on 14-Nov-2011 and diagnosed with weakness. Per the reporter, "he is walking fine now." The event of hard time walking resolved. The outcome for the events of left foot weak and wobbly and vomiting was unknown.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious spontaneous report of patient received extra dose of FLUMIST was received from a health professional concerning a four-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received a total of two doses of FLUMIST. One dose each on 13-Sep-2011 and on 30-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: 46.0
Sex: M
Vaccine: FLUN3
Symptoms: Nasal congestion, Oropharyngeal pain
Clinical narrative: A non-serious spontaneous report of sore throat and stuffy nose has been received from a consumer concerning a 46-year-old male, subsequent to FLUMIST. Neither relevant past medical history nor concomitant medications had been reported for this patient. On 01-Oct-2011, the patient received FLUMIST. On 01-Oct-2011, after receiving FLUMIST, the patient had sore throat and stuffy nose. The patient did not receive medical attention for the events. The outcome of the events sore throat and stuffy nose was unknown.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Nasal congestion, Oropharyngeal pain
Clinical narrative: A non-serious spontaneous report of sore throat and stuffy nose has been received from a 43-year-old 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 01-Oct-2011. On 01-Oct-2011, after receiving FLUMIST, the patient had sore throat and stuffy nose. The patient did not receive medical attention for the events. The outcome of the events sore throat and runny nose was not provided.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of runny nose has been received from a consumer concerning a 41-month-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. The patient's past medical history included asthma which was diagnosed in 2010. The patient had off and on wheezing problem. No relevant concomitant medications had been reported for this patient. The patient had not received asthma medication since May-2011. The patient received FLUMIST on 27-Sep-2011. The reporter stated that the patient's physician stated that the patient could get FLUMIST if he had not wheezed in the past six months. The patient developed a runny nose since receiving FLUMIST. The outcome of the event of runny nose was unknown.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Nasal congestion, Sneezing
Clinical narrative: A non-serious spontaneous report of coughing, sneezing and nasal congestion has been received from a non health professional concerning a three-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 medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 29-Sep-2011. On 30-Sep-2011, the patient experienced sneezing, nasal congestion and coughing. The outcome of events coughing, sneezing and nasal congestion was unknown.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Erythema, Swelling face
Clinical narrative: A non-serious spontaneous report of bilateral facial redness and bilateral facial swelling after FLUMIST has been received from a physician concerning a five-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 26-Oct-2011. On 26-Oct-2011, the patient experienced bilateral facial swelling (left side) along the jaw line; There were no redness and no tenderness on examination. On 27-Oct-2011, the patient experienced some redness in same area. The outcome of child experienced bilateral facial swelling after FLUMIST was resolved on 28-Oct-2011 and outcome of event bilateral facial redness was unknown.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Discomfort, Dyskinesia, Tic
Clinical narrative: A non-serious spontaneous report of motor tic manifested by head bobbing, has been received from a physician concerning a 12-year-old male, subsequent to FLUMIST. The patient had no medical history of any illness and was not on any medications prior to the event. The patient received FLUMIST on 29-Aug-2011. The patient developed a motor tic on 04-Sep-2011. The child did receive medical attention for the motor tic. The doctor described the event as head bobbing. The patient had been taking some ibuprofen for the discomfort caused by the head movements. The patient was seen on 07-Sep-2011 in the doctor's office. The event had improved since it began. It has been planned for the patient to see a neurologist. The event was recovering.
Sex: U
Vaccine: FLUN3
Symptoms: Drug effect decreased, Influenza
Clinical narrative: A non-serious report of INFLUENZA and decreased effectiveness of LAIV was received from literature concerning cases of influenza amongst recruits vaccinated with LAIV. No past medical history or concomitant medication were provided for the patients. On an unknown date the patients received FLUMIST. Approximately 10, 000 recruits were vaccinated and 69 recruits were confirmed to have contracted influenza in the southeast region of the country. It was reported that cases of influenza among military recruits mirrored that in the surrounding civilian population and CDC data concluded that an antigenic draft was circulating in the area which was responsible for the breakthrough cases H1N1 and that there was no issue with the LAIV. The outcome of the event influenza were not reported.
Sex: F
Vaccine: FLUN3
Symptoms: Maternal exposure before pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of pregnancy was received from a consumer concerning herself, a 25-year-old female. Neither patient's past medical history, concomitant medications nor obstetrical history was reported for this patient. On 12-Aug-2011, the patient received FLUMIST and then two weeks later she got pregnant. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. The event was considered to be recovered. 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: 57.0
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, Medication error, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to 57-year-old was received from a health professional concerning a 57-year-old male. Neither relevant past medical history nor concomitant medications were reported for this patient. The patient received FLUIMST 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.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of fever, cough, sore throat and runny nose has been received from a consumer 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. The patient received FLUMIST on 26-Sep-2011. The patient developed a runny nose a couple of hours after FLUMIST administration on 26-Sep-2011. On the same night, he developed a fever of 103 degrees F. On 28-Sep-2011, the fever was 101 degrees F and the patient had a cough and sore throat. The patient was not taken to the doctor for the symptoms. The outcome of all the events were unknown.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Rash generalised, Urticaria, Vaccination error
Clinical narrative: A non-serious spontaneous report of FLUMIST administered to patient with history of egg allergy, rash over body and hives over body has been received from a non-health professional concerning a six-year-old female, subsequent to FLUMIST. The patient's past medical history included egg allergy in 2007 and milk allergy in 2008. The patient was not ill at the time of vaccination. No concomitant medications have been reported for this patient. The patient received FLUMIST on 20-Sep-2011. The patient had previously received FLUMIST in 2009 and 2010. On 21-Sep-2011 at 6:30 PM, the rash and hives began then at 7:00 PM diphenhydramine was administered. On 22-Sep-2011 at 7:00 AM, the rash subsided. The outcome of FLUMIST administered to patient with history of egg allergy, rash and hives was resolved on 22-Sep-2011.
Sex: M
Vaccine: FLUN3
Symptoms: Drug administration error, No adverse event, Syringe issue
Clinical narrative: A non-serious spontaneous report of received full dose of FLUMIST in one nostril, there was no clip on the syringe was received from a physician concerning himself, an adult male. Neither patient's medical history nor concomitant medications were reported. The patient received the full dose of the FLUMIST dose in one nostril on 21-Sep-2011. There was no clip on the plunger. FLUMIST was present only in side of the vial. There was no adverse event with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 06-Oct-2011 and incorporated in the narrative: Term changed from "one half sprayer in one nostril as total dose" to "received full dose of FLUMIST in one nostril, there was no clip on the syringe." The patient stated that he received a full dose of FLUMIST and explained that there was no clip on the syringe. The patient stated that he had no side effects.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired vaccine was received from a health professional concerning approximately 14 children. Neither relevant medical history nor concomitant medications had been reported for these patients. The product expired in Jan-2011. On 23-Sep-2011, the patients received the expired product. There were no adverse events 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.
Sex: F
Vaccine: FLUN3
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to pregnant female was received from a health professional concerning an adult female. Neither relevant past medical history, obstetrical history nor concomitant medications were reported for this patient. The patient who is 16 weeks pregnant received FLUMIST. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable and the event is considered to be resolved.