chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: FLUN3
Symptoms: Wrong drug administered
Clinical narrative: A non-serious spontaneous report of inadvertent administration to an 85-year old was received from a physician concerning an 85 year old female patient. Upon follow-up inquiry, the reporter confirmed that no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was obtained on 21-Oct-2008 and incorporated into the narrative: Confirmation from the reporter that no adverse event occurred from the administration of FLUMIST to an 85-year old.
Age: 24.0
Sex: M
Vaccine: FLUN3
Symptoms: Chills, Influenza, Influenza serology positive, Malaise, Oropharyngeal pain
Clinical narrative: A non-serious, spontaneous report of positive for type A influenza virus, productive cough, sore throat, runny nose, chills, body ache and malaise was received from a nurse concerning a 24 year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 29-Sep-2008. On 05-Oct-2008 the patient developed symptoms of productive cough, sore throat, runny nose, chills, body ache and malaise. He was evaluated on 09-Oct-2008 and an influenza test was positive for type A influenza virus. The outcome for the reported adverse events was not reported.
Age: 24.0
Sex: M
Vaccine: FLUN3
Symptoms: Pain, Productive cough, Rhinorrhoea
Clinical narrative: A non-serious, spontaneous report of positive for type A influenza virus, productive cough, sore throat, runny nose, chills, body ache and malaise was received from a nurse concerning a 24 year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 29-Sep-2008. On 05-Oct-2008 the patient developed symptoms of productive cough, sore throat, runny nose, chills, body ache and malaise. He was evaluated on 09-Oct-2008 and an influenza test was positive for type A influenza virus. The outcome for the reported adverse events was not reported.
Sex: F
Vaccine: FLUN3
Symptoms: Dysgeusia, Nasopharyngitis, Rhinorrhoea, Sneezing
Clinical narrative: A non-serious spontaneous report of post-nasal drip taste, bad cold, sneezing, and running nose has been received from a female patient of unknown age subsequent to FLUMIST.  No medical history or concomitant medications were provided.  The patient received FLUMIST on an unknown date.  A consumer reported her experience after receiving FLUMIST.  Per the reporter, initially, there was no reaction but then she developed a post-nasal drip taste, the next day and three days after she had sneezing and runny nose; "it felt like I had gotten a bad cold".  The patient had not received a flu immunization in 15 years.  Outcome was not reported.  Per the reporter, she will take the shot next time.
Age: 48.0
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious, spontaneous report of "dosage to left nostril never misted/sprayed" was received from a consumer, concerning a 48 year-old male patient subsequent to FLUMIST. Neither the patient's medical history nor concomitant medications were reported. As of thirteen days after administration of FLUMIST, the patient denies any occurrence of illness or adverse events. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Additional information received on 22-Oct-2008: confirmed that the patient did not experience any adverse effects.
Age: 45.0
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious Spontaneous report of partial dose was received from a nurse practitioner concerning a 45 year old female. On 13-Oct-2008, the patient received a dose of FLUMIST in the left nostril, which ran back out of the nostril. The patient did not receive administration into the right nostril. There were no adverse events; however, the clinic recommended that the patient receive the traditional vaccine shot next month. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 28.0
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious, spontaneous report of "gave half of vaccine" was received from a nurse concerning a 28 year-old female subsequent to FLUMIST. The nurse reported she did not remember to remove the clip from the FLUMIST pre-filled syringe and thinks that she only gave one half of the vaccine. There were no additional events to report after follow-up on day thirteen after vaccination. The patient was re-vaccinated. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Additional information was received on 30-Oct-2008 and incorporated into the narrative: telephone contact received; no adverse events occurred and the patient was re-vaccinated.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Arthralgia, Back pain, Joint stiffness, Musculoskeletal stiffness, Neck pain
Clinical narrative: A non-serious, spontaneous report of sore and stiffness in back, neck and shoulders was received from a consumer, concerning a 43 year-old female patient subsequent to FLUMIST. The patient reported no relevant medical history. Concomitant medications include lisdexamfetamine dimesylate. The patient received FLUMIST on 11-Oct-2008 for flu vaccination. That evening the patient reported soreness and stiffness in the back, neck and shoulders. The patient was seen by her primary care physician and suggested the events may be related to physical exertion earlier in the day. The events were ongoing as of 17-Oct-2008 and described as soreness occurring in the triangular area at the base of the back of the neck.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious spontaneous report of "gave half of vaccine" was received from a nurse concerning a seven-year-old male. The nurse forgot to remove the clip and administered half of the pre-filled FLUMIST syringe. The patient was re-vaccinated at a later date. There was no adverse event associated with this medication error at the time of the report, nor on 30-Oct-2008; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information received 30-Oct-2008 and incorporated into the above narrative: No adverse event occurred and the patient was re-vaccinated.
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect route of drug administration
Clinical narrative: A non-serious spontaneous report of received FLUMIST vaccine via parental (IM) injection has been received from a physician and a combat medic concerning a male soldier. Medical history and concomitant medication were not reported. On 17-Oct-2008, the patient received FLUMIST via parental (intramuscular) injection in the upper arm along with four other soldiers. The medic removed the cap and attached a needle to the end of the FLUMIST syringe. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow up information received on 30-Nov-2008, 17 days after the patient received FLUMIST, indicated that there were no adverse events.
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect route of drug administration
Clinical narrative: A non-spontaneous report of received FLUMIST vaccine via parenteral (IM) injection has been received from a physician and a combat medic concerning a male soldier. Medical history and concomitant medication were not reported. On 17-Oct-2008, the patient received FLUMIST via parenteral (intramuscular) injection in the upper arm along with four other soldiers. The medic removed the cap and attached a needle to the end of the FLUMIST syringe. There was no adverse event associated with this medication error; therefor, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow up information received on 03-Nov-2008, 17 days after the patient received FLUMIST, indicated that there were no adverse events.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Accidental exposure
Clinical narrative: A non-serious, spontaneous report of patient pulled back on one nare and small amount of FLUMIST was sprayed into one eye was received from a physician concerning a seven year-old female patient, subsequent to FLUMIST. Neither medical history nor concomitant medications have been reported for this patient. There were no adverse events reported 15 days after administration. There was no adverse events associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect route of drug administration
Clinical narrative: A non-serious spontaneous report of received FLUMIST vaccine via parenteral (IM) injection has been received from a physician and a combat medic concerning a male soldier. Medical history and concomitant medication  were not reported. On 17-Oct-2008, the patient received FLUMIST via parenteral (intramuscular) injection in the upper arm along with four other soldiers. The medic removed the cap and attached a needle to the end of the FLUMIST syringe. There was no adverse associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow up information received on 03-Nov-2008, 17 days after the patient received FLUMIST, indicated that there were no adverse events.
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect route of drug administration
Clinical narrative: A non-serious spontaneous report of received FLUMIST vaccine via parenteral (IM) injection has been received from a physician and a combat medic concerning a male soldier.  Medical history and concomitant medication were not reported.  On 17-Oct-2008, the patient received FLUMIST via parenteral (intramuscular) injection in the upper arm along with four other soldiers.  The medic removed the cap and attached a needle to the end of the FLUMIST syringe.  There was no adverse event  associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Follow up information received on 03-Nov-2008, 17 days after the patient received FLUMIST, indicated that there were no adverse events.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Accidental exposure
Clinical narrative: A non-serious, spontaneous report of FLUMIST sprayed in the eye  was received from a nurse, concerning an eight-year-old male patient while receiving FLUMIST.  There was no adverse event associated with this medication error;  therefore treatment and reporter/sponsor causality assessment are not applicable and the event is considered resolved.  Additional information received 07-Nov-2008:  No additional adverse events have been reported for the patient since vaccination.
Age: 7.0
Sex: F
Vaccine: FLUN3, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: A non-serious, spontaneous report of asthmatic patient given FLUMIST was received from a physician assistant concerning a seven year-old female patient.  No medical history was reported.  The patient also received varicella vaccine on the same day as receipt of FLUMIST vaccine.  There was no adverse event associated with this medication error;  therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.
Age: 52.0
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious, spontaneous report of vaccination of 52-year-old was received from a consumer, involving a 52-year-old male patient subsequent to FLUMIST. The event was reported 14 days after the administration and the consumer indicated there were no symptoms or problems. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.
Age: 69.0
Sex: U
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious, spontaneous report of administered FLUMIST to an adult greater in age than 49, was received from a physician, involving a a 69-year-old patient subsequent to FLUMIST. The event was reported 19 days after the administration and the physician indicated that the patient was doing fine and no reactivity was reported. There was no adverse associated with this medication error; therefore treatment and reporter/sponsor causality assessment are not applicable and the event is considered resolved.
Age: 16.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy
Clinical narrative: A non-serious report of inadvertently given FLUMIST  has been received from a health department representative concerning a 16-year-old female, subsequent to FLUMIST. The patient's past medical history included being 20 weeks pregnant. No concomitant medications were reported. On 16-Oct-2008 a patient who was 20 weeks pregnant was inadvertently administered FLUMIST. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during pregnancy.
Age: 56.0
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of "FLUMIST should not have been given" was received from a registered nurse concerning a 56-year old male patient. No medical or medication history was reported for this patient. According to the report, the patient presented to the Health Center and stated that he wanted to receive FLUMIST vaccine. The patient did not report his age to the health center staff. The nurse who administered the vaccine only noticed the patient's age in the patient's chart after FLUMIST administration. Upon follow-up inquiry, the reporter confirmed that there was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was obtained on 30-Oct-2008 and incorporated into the narrative: confirmation from the reporter that no adverse events occurred from the administration of FLUMIST.
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Headache, Influenza, Muscle spasms, Secondary transmission
Clinical narrative: A non-serious, spontaneous report of secondary transmission of flu, muscle cramps, headache and chills has been received from a consumer concerning an adult female, subsequent to second hand exposure to FLUMIST. No medical history or concomitant medication information was provided. The patient's sister took her two children to receive FLUMIST on 09-OCT-2008. The children then spent the week-end starting 10-Oct-2008 away from home. On an unreported date in mid 0ct-2008 the patient experienced muscle cramps, headache and chills. The patient picked up her children from school on 15-Oct-2008. She went to the urgent care center for chills, headache and muscle cramps. The reporter states "She said the doctor there told her she probable got the flu from her kids." No outcome was reported.
Age: 76.0
Sex: U
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious, spontaneous report of administered FLUMIST to adult greater in age than 49, from a physician involving a 76 year-old patient subsequent to FLUMIST. The event was reported 19 days after the administration and the physician indicated the patient was doing fine and no reactivity was reported. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.
Age: 62.0
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious, spontaneous report of gave 62-year old female FLUMIST, was received from a health professional, subsequent to FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Additional information on 07-Nov-2008: No additional adverse events have been reported for the patient since vaccination.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Vomiting
Clinical narrative: A non-serious, spontaneous report of vomiting was received from a Registered Nurse concerning a seven year-old male patient, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 21-Oct-2008 the patient received FLUMIST. On 21-Oct-2008, the patient vomited within a couple of hours of receiving FLUMIST. The outcome for the adverse event was not reported.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Abdominal pain, Arthralgia, Henoch-Schonlein purpura, Rash, Urine analysis
Clinical narrative: A non-serious report of Henoch Schonlein Purpura, abdominal pain, joint pain, and rash below the waist line has been received from a nurse concerning a five year-old male. No medical history nor concomitant medications were provided. On 27-Sep-2008, the patient received a dose of FLUMIST. Within hours after receiving FLUMIST on the same day, on 27-Sep-2008, the patient experienced rash below the waist line, abdominal pain and joint pain. The patient was brought to the emergency room by his mother. In the ER, unspecified tests were performed and treatments were administered. The patient was diagnosed with Henoch Schonlein Purpura. The patient was released from the ER and instructed to follow-up with the primary pediatrician. Outcome for the events was considered resolving. The responsible physician assessed the events as not related to FLUMIST.
Sex: M
Vaccine: FLUN3
Symptoms: Accidental exposure
Clinical narrative: A non-serious, spontaneous report of FLUMIST misted into eye of male child between six and twelve years of age was received from a nurse. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: A non-serious report of runny nose and fever was received from a consumer concerning a five-year-old female. No medical history or concomitant medications were reported. The patient received FLUMIST on 13-Oct-2008. On 15-Oct-2008, two days after receiving FLUMIST, the patient and her sibling developed runny nose; the following day on 16-Oct-2008, the patient developed a fever. The event of runny nose and fever resolved on 17-Oct-2008.
Age: 28.0
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect route of drug administration
Clinical narrative: A non-serious spontaneous report of received FLUMIST vaccine via parenteral (IM) injection has been received from a physician (patient's father) and a combat medic concerning a 28-year-old male soldier. Medical history and concomitant medication were not reported. On 17-Oct-2008, the patient received FLUMIST via parenteral (intramuscular) injection in the upper arm along with four other soldiers. The medic removed the cap and attached a needle to the end of the FLUMIST bottle. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow up information received 03-Nov-2008, 17 days after the patient received FLUMIST, indicated that there were no adverse events.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Wrong drug administered
Clinical narrative: A non-serious, spontaneous report of administration to asthmatic was received from a pharmacist, concerning a ten year-old female patient, subsequent to FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious, spontaneous report of full dose of FLUMIST in one nostril was received from a consumer, concerning a nine year-old patient. The pharmacist administering the dose placed all 0.2 ml into one nostril, disregarding the diver clip on the sprayer device. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Urticaria
Clinical narrative: A non-serious spontaneous report of generalized hives has been received from a Registered Nurse concerning a 12-year-old female, subsequent to FLUMIST. Medical history included attention deficit/hyperactivity disorder (ADHD) and childhood epilepsy. Concomitant medication included methylphenidate hydrochloride. The patient's brother or sister experienced hives with the diphtheria, tetanus, and DTP vaccine at 18 months old. On 19-Oct-2008, the patient received FLUMIST, intranasal administration. She had never received FLUMIST before. One hour post administration of FLUMIST, the patient broke out in generalized hives. The hives progressively worsened over the next two days. No other symptoms were reported. The patients mother treated her with diphenhydramine. The outcome of the event was not reported. Additional information received on 30-Oct-2008 and incorporated into the narrative included in medical history concomitant medication and vaccine information.
Age: 13.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Computerised tomogram normal, Headache, Nervousness
Clinical narrative: A non-serious spontaneous report of severe headache has been received from a nurse concerning a 13-year-old female, subsequent to FLUMIST. No relevant medical history has been reported for this patient, who also received a HPV injection at the same time as FLUMIST. The patient received FLUMIST on 13-Oct-2008. The patient experienced a severe headache on 13-Oct-2008 after receiving FLUMIST and the HPV. The reporter stated that the patient was apprehensive about getting the HPV injection and thinks that the headache may have resulted from the patients intense apprehension related to receiving the HPV injection. The patient presented to the ER  and CAT scan was negative on 14-Oct-2008. The headache resolved on 15-Oct-2008. Additional information received 08-Jan-2009 and incorporated into the case: outcome and resolution date.
Age: 50.0
Sex: M
Vaccine: FLUN3
Symptoms: Arthralgia, Malaise
Clinical narrative: A non-serious spontaneous report of a 50-year-old male patient who experienced arthralgia and malaise subsequent to FLUMIST has been received from a physician (patient). No relevant medical and medication history was reported. The patient received FLUMIST on 18-Sep-2008. Two days after FLUMIST administration, the patient experienced malaise and general arthralgia which lasted for about four days. At the time of report, the patient had no symptoms.
Age: 34.0
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious spontaneous report of "patient received only half a dose" was received from a registered nurse concerning a 34-year old male patient. On 23-Oct-2008, the patient received only half a dose (0.1 ml) of FLUMIST because the divider clip was not removed. upon inquiry, the reporter confirmed that there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was obtained on 06-Nov-2008 and incorporated into the narrative: confirmation from the reporter that no adverse events occurred from the medication error.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious spontaneous report of a second dose of FLUMIST given two weeks after first dose was received from a registered nurse concerning a five-year-old male. The patient's medical history and concomitant medications were not reported. On 09-Oct-2008 the patient received FLUMIST vaccine. two weeks later, on 23-Oct-2008, the patient received a second dose of FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Inflammation, Pruritus, Swelling face
Clinical narrative: A non-serious, spontaneous report of inflammation of the face iwth swelling and itching was received from a nurse, concerning an eight year-old male patient, subsequent to FLUMIST. The patient was not taking any concomitant medications. The patient has no known allergies or history of hypersensitivity. The patient received FLUMIST, nasal on 22-Oct-2008 for flu vaccinations. Twelve hours after administration of FLUMIST, the child experienced inflammation of the face with swelling and itching. There was no report of difficulty breathing or swelling of the tongue or throat. The nurse advised the parent to administer the patient diphenhydramine by mouth. The symptoms were ongoing at time of reporting on 24-Oct-2008 The outcome of the events is unknown.
Age: 13.0
Sex: M
Vaccine: FLUN3
Symptoms: Borrelia burgdorferi serology negative, Facial palsy
Clinical narrative: A serious spontaneous report of paralysis on the right side of his face was received from the mother of the patient concerning a 13 year-old male subsequent to FLUMIST.  Medical history included allergies and concomitant medication included fluticasone propionate.  The patient received a dose of FLUMIST on 13-Oct-2008.  A total of one dose was received before onset of the event which occurred eight days later.  The child's mother called to report her son on 21-Oct-2008 complained of paralysis on the right side of her face.  The child stated that, "my right eye will not shut right" and "my smile does not work."  He was taken to an urgent care clinic on 22-Oct-2008 where blood work was drawn but no diagnosis was given.  On 24-Oct-2008 the child was seen by his primary physician who tested for Lyme's disease and was negative.  The child was seen by a Neurologist, exam was negative except for an initial tongue extension test that initially showed deviation to the left but a re-test showed straight extension.  The mother stated that there were no plans for future diagnostic imaging.  Per the mother the child continues to exhibit symptoms no improvement or worsening of condition was noted.  The mother stated that the Neurologist believes the child's symptoms may be attributed to either a virus or FLUMIST.
Age: 8.0
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administered expired FLUMIST was received from a health care worker concerning an eight year old child. No medical history was provided. The reporter indicated that outdated FLUMIST was administered to two children on 24-Oct-2008 (expiration date 10-Jan-2008). The patients were re-administered a flu shot. upon follow-up, no adverse evens were associated with this expired vaccine usage; therefore, treatment and causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information received on 24-Mar-20 included Product Complaint Investigation results.
Age: 34.0
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious spontaneous report of received half dose of FLUMIST was received from a Registered Nurse concerning a 34 year-old male. The divider clip was not removed and the patient received  a half dose (0.1 ml) of FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 37.0
Sex: F
Vaccine: FLUN3
Symptoms: Rash generalised
Clinical narrative: A non-serious, spontaneous report of rash was received from a pharmacist/consumer concerning a 37 year-old female subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 24-Oct-2008. On 24-Oct-2008, five minutes after administration, a rash appeared on the neck which spread over the body. The patient took diphenhydramine and now the rash only appears in a "hot shower".
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Lymphadenopathy
Clinical narrative: A non-serious report of swelling of the glands has been received from a certified medical assistant (CMA) concerning a six-year old male patient, subsequent to FLUMIST.  No medical and drug history information has been reported for this patient.  The patient received 0.2 milliliters of FLUMIST on 27-Oct-2008.  According to the patient's parent, the patient experienced swelling of the glands approximately 16 hours after receiving FLUMIST, at two in the morning of 28-Oct-2008.  The patient was taken to the emergency room.  Information regarding the care the patient received in the emergency room was not available at the time of this report.  The outcome of the adverse event is unknown.
Age: 35.0
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Malaise, Pyrexia, Secondary transmission
Clinical narrative: A non-serious spontaneous report of secondary transmission, fever, chills and malaise was received from a 35-year-old female physician concerning herself, subsequent to her child receiving FLUMIST. Medical history and concomitant medications were not reported. The patient's child received FLUMIST on 23-Oct-2008. On 26-Oct-2008 the mother of the child who received FLUMIST, who is a physician, stated she experienced symptoms of fever, chills and malaise. The mother stated that she understood that risk of transmission was very minimal. The mother stated that on 28-Oct-2008 symptoms lasted for approximately 30 hours and she was feeling better.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious, spontaneous report of should not have gotten two doses this season, in a nine year-old male patient was received from a health professional. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Additional information received 12-Nov-2008: No reactions have been reported in the patient since vaccination.
Age: 59.0
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious spontaneous report of FLUMIST was administered to a 50-year-old was received from a registered nurse concerning a 59-year-old male patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was obtained on 10-Nov-2008: FLUMIST route of administration and confirmation from the reporter that no adverse events occurred from the administration of FLUMIST to a 59-year-old.
Sex: F
Vaccine: FLUN3
Symptoms: Myalgia, Oropharyngeal pain, Pyrexia, Upper respiratory tract congestion
Clinical narrative: A non-serious, spontaneous report of fever, congestion, muscle aches and sore throat was received from a consumer, concerning an adult female subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 22-Oct-2008. Forty-eight hours after administration the patient experienced symptoms of low grade fever, congestion, muscle aches and sorer throat. The symptoms were ongoing at the time of reporting on 30-Oct-2008.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product form previous season and 2) product expiring during peak of flue season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessment are not applicable and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Age: 58.0
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious spontaneous report of administration to a 58 year-old female was received from a Registered Nurse concerning a 58 year-old patient. A 58 year-old was given FLUMIST by mistake. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy patients, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication error that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy patients, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Age: 30.0
Sex: F
Vaccine: FLUN3
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: A non-serious, spontaneous report of aches, fever and sore throat was received from a consumer concerning a 30 year-old female subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 17-Oct-2008. Three days later the patient stayed in bed for 10 days and experienced aches, fever and sore throat. She was taking over-the-counter Theraflu. The outcome of the events was not reported.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Croup infectious
Clinical narrative: A non-serious spontaneous report of croup and cough was received from a physician concerning a five-year-old male, subsequent to FLUMIST. No medical history or concomitant medications were reported. The patient received FLUMIST (date not reported). On 27-Oct-2008 the child experienced cough/croup and was taken to the emergency room. While there he was treated with dexamethason and albuterol. The health status of the child was reported as unchanged. The reporter stated that in his opinion FLUMIST did not cause the coughing experienced by the child. There was no report of causality for the croup.
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy
Clinical narrative: A non-serious spontaneous report of administration to pregnant female was received from a Registered Nurse concerning an adult female. The patient's medical and obstetrical history was not reported. On 31-Oct-2008, FLUMIST was "mistakenly given" to a pregnant female. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had and expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.  Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia, Vomiting
Clinical narrative: A non-serious spontaneous report of fever and vomiting has been received from a consumer concerning an 8-year-old male, subsequent to FLUMIST. Medical history and concomitant medication were not provided. On 28-Oct-2008, the patient received FLUMIST, intranasal administration. On 02-Nov-2008 the parent of the child reported his son was "having symptoms of fever and vomiting." The child was not hospitalized. Per the reporter both the fever and vomiting were resolved the next day and there was no need to seek any medical treatment. On 03-Nov-2008 the events of fever and vomiting were resolved. Follow-up information was received on 13-Jan-2009 and included event outcome information. This information has been incorporated into the above narrative.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST. The vaccine had and expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST. The vaccine had an expiration date March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Pain, Pyrexia
Clinical narrative: A non-serious, spontaneous report of fever of 104, aches and pain was received from a physician, concerning a five-year-old female subsequent to FLUMIST. The patient was not receiving any concomitant medications and there is no relavent medical history. The patient received FLUMIST, intranasal for flu vaccination on 30-Oct-2008. On 01-Nov-2008 the child experienced fever of 104 F, aches and pain. As of 03-Nov-2008 the events resolved.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had and expiration date of March 2008.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.  Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had and expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.  The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.