chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: FLUN3
Symptoms: Pharyngolaryngeal pain
Clinical narrative: MEDI-0004973 is a Not Serious Spontaneous case from a Consumer involving VACCINE EXPOSURE DURING PREGNANCY: (Unlabelled). The reporter causality is Possible to FluMist. A 39-year-old female who is 14-weeks pregnant (obtained via ultrasound) received FluMist on 28-Sep-2006 from her child's pediatrician. A few hours after receiving the vaccine, the patient developed mild sore throat, mild headache and mild fatigue. There were no changes in symptom intensity and the symptoms dissipated on their own without any medical interventions. Sore throat was fully resolved on 30 Sep-2006. Headache and fatigue completed dissipated on 02-Oct-2006. After receiving the vaccine, the patient was told by her obstetrician that a "pregnant woman should not be receiving FluMist* vaccine. After hearing this statement and "reading up on FluMist," patient became "quite concerned and became very anxious." Patient attributed developing anxiety to "worrying about the possible effect FluMist may have on my (unborn) baby." This patient was G4P2 with a history of one elective abortion in April, 2006 for Down Syndrome. Her last menstrual period was 21-Jun-2006 and her estimated date of delivery was 30-Mar-2007. The patient denied having any history of medical problems. She denied taking any medications (prescribed and over the counter) during her pregnancy. The patient stated her anxiety persisted throughout her pregnancy. Her anxiety resolved after she delivered a healthy baby boy via scheduled caesarian-section on 21-Mar-2007. She stated that there were no complications during her pregnancy or during the birth of her baby. The baby "is doing well." The reporter causality is possible to FluMist. 27-Jun-2007: Follow up information obtained and incorporated in above narrative: information regarding clinical outcome.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: A non-serious report of high fever, sore throat, and coughing has been received from a consumer concerning a five-year-old female patient. At the time of this report, medical history or concomitant medications were provided. The patient received FluMist on an unknown date. One to two days after the patient received FluMist, the patient developed a high fever, sore throat, and coughing. No outcome for the events was provided by the reporter. The reporter provided no causality assessment for the events. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 49.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: An event of expired vaccine administered occurred in a 49-year-old female. The report was received from a registered nurse. No medical or drug history information has been reported for this patient. The patient received a 1.05 ml dose of FLUMIST intranasally on 08-Oct-2007. On 08-Oct-2007 the reporter indicated a patient was inadvertently administered FLUMIST that had expired in Feb-2007. The reporter indicated the package was clearly labeled. The expired FLUMIST had been kept in the freezer in order to compare it with new vials received this season for changes. The error was discovered approximately 10 minutes after administering the dose. The reporter considered the patient about 20 minutes after dosing and the patient stated she was fine. No adverse events were observed. Outcome: the patient had no ill effects. Further dosing with FLUMIST is not indicated. The reporter did not provide a causality assessment for this medication error. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Sex: F
Vaccine: FLUN3
Symptoms: Accidental exposure, Hypoaesthesia, Pruritus
Clinical narrative: A non-serious report of accidental exposure, numbness and itching has been received from a nurse concerning a female born 27-Mar-1965.  No medical history nor concomitant medications were provided.  The patient administered FLUMIST in a clinic setting.  The employee of a clinic, develops numbness in her lips and nose, as well as itching of her face and scalp within several minutes of administering a dose of FLUMIST to a patient.  The employee was able to administer doses last year without difficulty.  Symptoms resolved 15 to 20 minutes after dose administration is completed.  The patient did not experience a rechallenge while receiving the suspect product.  The reporter provided no causality assessment for the events.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 46.0
Sex: U
Vaccine: FLUN3
Symptoms: No adverse event
Clinical narrative: An event of entire dosage of FluMist in the same nostril occurred in a 46 year-old employee; the report was received from a registered nurse. No medical history or drug history information has been reported for this employee. The employee received FluMist intranasally. The reporter indicated the employee was inadvertently administered the entire dosage of FluMist in the same nostril; this is not in accordance with FluMist dosage and administration requirements. No adverse events were reported. Outcome the employee had no ill effects. Further dosing with FluMist is not indicated. The reporter did not provide a causality assessment for this medication error. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 34.0
Sex: U
Vaccine: FLUN3
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: An event of entire dosage of FLUMIST in the same nostril occurred in a 34-year-old patient: the report was received from a registered nurse. No medical history or drug history information has been reported for this employee. The patient received FLUMIST intranasally. The reporter indicated the patient was inadvertently administered the entire dosage of FLUMIST in the same nostril, this is not in accordance with FLUMIST dosage and administration requirements. No adverse events were reported. Outcome: the patient had no ill effects. Further dosing with FLUMIST is not indicated. The reporter did not provide a causality assessment for this drug administration error. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Influenza like illness, Pyrexia, Rhinorrhoea
Clinical narrative: A non-serious report of flu-like symptoms was received from a physician concerning a seven-year-old female.  No relevant medical or drug history was reported for this patient.  The patient received FLUMIST on 08-Oct-2007.  One day after receiving FLUMIST, the patient experienced flu-like symptoms of high fever, headache and runny nose.  Outcome of the event was not reported.  Rechallenge of vaccine is not applicable.  The reporting physician did not provide a causality assessment.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow up received on 14-Nov-2008 adds patient information including the date of birth. The reporting physician is no longer associated with this site and the patient no longer comes to his office for medical care. The site therefore had no chart for the patient and was unable to provide FLUMIST dosing information. No further information is availalbe for this patient.
Age: 40.0
Sex: F
Vaccine: FLUN3
Symptoms: Hypoaesthesia facial
Clinical narrative: A spontaneous non-serious report of facial numbness has been received from a nurse concerning a 40-year-old female. No relevant medical or drug history information has been reported for this patient. The patient received the initial dose of FLUMIST on an unknown date. On an unknown date in October 2007, the patient reported numbness of the left side of the face 45 minutes to an hour following administration of FLUMIST into each nostril to a healthcare provider (nurse). The numbness was described as "milder than Novocaine" occurring below the patient's left eye to the margin to the lips. The numbness was without edema or any other side effects. On 15Oct2007, the reporting healthcare provider (nurse) contacted the sponsor's medical information department to discuss numbness after receiving FLUMIST. The outcome was not reported. The reporter did not provide a causality assessment for the adverse event reported. The MedImmune Product Safety Physician conservatively assessed causality for the event as possibly related to FLUMIST therapy.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Musculoskeletal stiffness, Pyrexia
Clinical narrative: A non-serious report of stiff back, stiff neck and fever was received from a consumer concerning a 10-year-old female.  The patient has a cochlear implant.  No concomitant medications were reported.  The patient received FLUMIST vaccine on 03-Oct-2007.  On 05-Oct-2007 the patient experienced fever of up to 103 degrees Fahrenheit, stiff back and stiff neck.  The patient's pediatrician ruled out meningitis.  By 08-Oct-2007, all symptoms have resolved and the patient went to school that day without any problems.  The reporter did not provide a statement of causality for the adverse events.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Urticaria
Clinical narrative: A non-serious spontaneous report was received from a consumer of hives concerning an 11-year-old male. No relevant medial and drug history information has been reported for this patient. The patient initiated FluMist therapy on an unreported date in October of 2007. Twenty-fours following administration of FluMist therapy, the patient broke out with hives all over his body required treatment with Benadryl to relieve symptoms. The reporter indicated that the patient did not experience fever or breathing problems. The symptoms persisted 24 to 48 hours. There was no indication of action taken regarding FluMist. The reporter did not provided a causality assessment for the adverse event reported. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza, Pyrexia
Clinical narrative: A non-serious spontaneous report of fever and influenza B was received from a physician concerning a five-year-old male. No relevant medical or drug history information was reported for this patient. The patient received the initial dose of FLUMIST on an unknown date. On 16Oct2007, a physician reported fever (101.5 F) and a positive antigen test for influenza B strain 72 hours following FLUMIST vaccination. After checking the child's temperature, the physician performed a quick antigen test: results positive for influenza B strain but negative for the A strain. The physician conjectured that since the test was negative for any A strain, the infection may not have been caused by the A strain in the vaccine. The child also attends day care. The physician prescribed the child TAMIFLU and notified the sponsor. The outcome was not reported. The physician indicated that the causality was not clear (wild strain vs. B strain). The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Sex: M
Vaccine: FLUN3
Symptoms: Influenza
Clinical narrative: A spontaneous report of INFLUENZA has been received from a parent concerning a teenaged male.  No relevant medical or drug history information has been reported for this patient.  The patient received the initial dose of FLUMIST on an unknown date.  The reporter states that he "took both of his teenagers to a pediatric practice that specifically had Flumist".  On 23Oct2007, the father reported a "serious case of the flu" in his teenage son, one week after receiving Flumist.  The outcome was not reported.  The reporter did not provide a causality assessment for the adverse event reported.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 34.0
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A spontaneous report of inadvertent use of expired FluMist was received from a nurse concerning a 34-year-old adult. No relevant medical or drug history information was reported for this patient. The patient received the initial dose of FluMist on an unknown date. On 26Oct2007, a nurse reported the inadvertent use of expired FluMist vaccine in an adult. No adverse event was reported. The patient is being considered for re-immunization. The reporter did not provided a causality assessment for the adverse event reported. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 85.0
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: An event of drug administration error when vaccine was administered to an 85-year-old female. The report was received from a registered nurse. No medical or drug history information has been reported for this patient. The woman received a dose of FLUMIST intranasally. On 15-Oct-2007 the reporter indicated an elderly woman was inadvertently administered FLUMIST. The reporter indicated the nurse who dosed the woman was new and not aware of the age restriction for dosing FLUMIST. The reporter stated no adverse events were observed. Outcome: the woman had no ill effects. Further dosing with FLUMIST is not indicated. The reporter did not provide a causality assessment for this medication error. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: MEDI-000610 is a non-serious spontaneous case from a nurse of itching and facial rash concerning a six-year-old male.  The patient has a medical history of behavioral issues and Asperger's Disease.  Concomitant medications include Abilify and Depakote.  The patient received intranasal Flumist on 25 Oct 2007.  Less than 24 hours after administration of Flumist, the patient developed a red facial rash with itching.  The reporter indicated that the patient telephoned the reaction to the clinic, however the patient was not brought to the clinic and was not medically evaluated by the pediatrician.  The reporter indicated that no further information will be available.  Outcome for the events was not reported.  There was no indication of action taken with Flumist.  The reporter did not provide a causality assessment for the adverse events.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 9.0
Sex: M
Vaccine: FLUN3, VARCEL
Symptoms: Cough, Erythema, Face oedema, Livedo reticularis, Wheezing
Clinical narrative: A non-serious spontaneous report of facial edema was received from a nurse concerning a nine-year old male. The patient's medical history was not reported. The child also received VARIVAX simultaneously with FluMist. The patient received on 30-Oct-2007. Four after receiving both FluMist and VARIVAX, the child developed facial edema, mottling with redness on face, red and purple hue of the face, coughing, and expiratory wheezing. The child was taken to the emergency room was not hospitalized. The symptoms resolved the following day. Action taken regarding FluMist was not reported. The reporter's assessment of causality was not provided. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 37.0
Sex: M
Vaccine: FLUN3
Symptoms: Malaise
Clinical narrative: A non-serious report was received from a consumer of feeling sick concerning a 38-year-old male.  No medical history or concomitant medications were reported for this patient.  The patient initiated FLUMIST on an unreported date.  The patient felt sick following FLUMIST vaccine administration.  No further information was provided. Outcome for the adverse event was not reported.  The reporter did not provide a causality assessment for the adverse event reported.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 38.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy (Drug exposure during pregnancy); A non-serious report of vaccine exposure during pregnancy has been received from a nurse concerning a 38-year-old female. No medical history nor concomitant medications were provided. The patient received FluMist on 06-Nov-2007. The patient was pregnant at the time that FluMist was administered. No outcome for the event was provided by the reporter. Dechallenge and rechallenge did not occur. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Sex: M
Vaccine: FLUN3
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: A non-serious report of "full dosage of vaccine delivered up one nostril" was received from a consumer concerning a male patient.  The patient's medical history and concomitant medications were not reported.  The patient received FLUMIST vaccine intranasally on 08-Nov-2007.  The patient inadvertently received the full dosage of the FLUMIST vaccine up on one nostril, instead of the recommended half dose for each nostril.  No adverse event was reported.  No outcome was provided by the reporter.  Rechallange is not applicable.  The reporter did not provide a statement of causality.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 40.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza, Pharyngolaryngeal pain
Clinical narrative: A non-serious spontaneous case was received from a consumer involving flu and sore throat concerning a 40-year-old female.  No relevant medical or drug history information was reported.  The patient received FLUMIST on 06-Nov-2007.  The patient woke-up the following day with the flu and sore throat.  No outcome for the event was provided by the reporter.  The reporter provided no causality assessment for the events.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Anorexia, Influenza, Lethargy, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: A non-serious spontaneous case was received from a consumer involving flu, sore throat, high fever, lethargy, and loss of appetite concerning a six-year-old male.  No relevant medical or drug history information was reported.  The patient received FluMist on 06-Nov-2007.  The patient woke up on the following day with influenza, sore throat, high fever, lethargy, and loss of appetite.  No outcome for the events was provided by the reporter.  The reporter provided no causality assessment for the events.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Wrong drug administered
Clinical narrative: A non-serious spontaneous report of FLUMIST INADVERTENTLY ADMINISTERED TO AN ASTHMATIC was received from a nurse concerning a five-year-old male. The patient's medical history included asthma. Drug history information included previous injectable dose of a flu vaccine in the previous month. The patient received FLUMIST on 08Nov2007. On 03Oct2007, the child received an injectable dose of flu vaccine. On 08Nov2007, the child was inadvertently administered FLUMIST by his school. There were no adverse events reported. The reporter did not provide a causality assessment. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Rash
Clinical narrative: A non-serious report of a rash that looked like sunburn was received from a nurse concerning a five-year-old male.  No medical history or concomitant medication history were reported.  The patient received FLUMIST on 08Nov2007.  On 09Nov2007, the child experienced a rash that looked like sunburn covering large areas of the body, although specific location was not provided.  No outcome was reported.  No dechallenge or rechallenge occurred.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Headache, Influenza, Influenza serology positive, Pain, Pharyngolaryngeal pain
Clinical narrative: A non-serious report was received from a nurse concerning a five-year-old male with influenza, fever, headache, sore throat and vomiting. The child had no known allergies and had a flu shot in the past. FluMist was administered on 06-Nov-2007. Two days later on 08-Nov-2007, the child presented with a fever of 102-103, headache, body ache and vomiting. A rapid flu test revealed positive results and a strep test was negative. The nurse wanted to know if FluMist could cause a false positive flu test. The event outcome was not provided. Additional FluMist dosing is not indicated. The reporter did not provide a causality assessment for the adverse events reported. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia, Streptococcal identification test negative, Vomiting
Clinical narrative: A non-serious report was received from a nurse concerning a five-year-old male with influenza, fever, headache, sore throat and vomiting. The child had no known allergies and had a flu shot in the past. FluMist was administered on 06-Nov-2007. Two days later on 08-Nov-2007, the child presented with a fever of 102-103, headache, body ache and vomiting. A rapid flu test revealed positive results and a strep test was negative. The nurse wanted to know if FluMist could cause a false positive flu test. The event outcome was not provided. Additional FluMist dosing is not indicated. The reporter did not provide a causality assessment for the adverse events reported. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: A non-serious spontaneous case of body ache, fever and malaise has been received from a physician in an eight-year-old male. No medical history or drug history information has been reported for this child. The child received FluMist on 28-Oct-2007. The child's mother, a physician, who reported this case indicated the child received FluMist and within five hours experienced body aches, fever with a temperature of 103, and malaise. His mother indicated that after 12 to 24 hours, the symptoms resolved and no other problems were noted. The adverse events resolved within 24 hours. The child has been dosed with FluMist in the last four seasons, the reporter stated she did not remember the child experiencing adverse events in the past seasons. The child's older brother received FluMist out of the same box as his brother and had no issues. The reporter did not provide a causality assessment for this event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Dry eye, Eye pain, Facial palsy, Hypoaesthesia facial, Mastication disorder
Clinical narrative: A serious medically important event of flattened right facial area with uneven smile, cheek felt heavy, chewing favored on left side, right eye dryness and pain was received from a physician concerning a ten-year-old female. The patient's medical history include a recent treatment with Diflucan for vaginal moniliasis. No concomitant medications were reported. The patient received one dose of FLUMIST intranasally on 06-Nov-2007. On 08-Nov-2007, the patient's father noticed that the patient had an uneven smile; preferred to chew on the left side of her mouth. There was no complaint of pain or difficulty in swallowing. The patient was seen at the reporter's office on the same day. On examination, flattened right facial area was noted along with complaints of right eye felt dry with slight pain and right cheek felt heavy. No redness or swelling noted and patient felt skin touched and pricked. No laboratory tests were done. There was no treatment done except for observation and close contact with patient's father. The events were resolved by 12-Nov-2008. The patient did not experience rechallenge. The reporter did not provide a statement of causality for the events. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 27.0
Sex: M
Vaccine: FLUN3
Symptoms: Feeling abnormal, Lethargy, Pharyngolaryngeal pain, Sinus congestion
Clinical narrative: A non-serious report was received from a consumer involving lethargy, sore throat, clogged sinuses and "feeling crazy" concerning a 27-year-old male. No medical history or concomitant medications were reported for this patient. The patient was administered FLUMIST vaccine on 08 Nov 2007. On 09 Nov 2007, the patient experienced sore throat, clogged sinuses, lethargy and "feeling crazy". No information was reported. The events of lethargy and "feeling crazy" resolved on an unreported date. The events of sore throat and clogged sinuses remain unresolved after three days. Action taken with FLUMIST was not reported. The reporter did not provide a causality assessment for the adverse events reported. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Urticaria
Clinical narrative: A non-serious report of hives has been received from a nurse concerning a seven-year-old male. No medical history nor concomitant medications were provided. The patient received FluMist on 08-Nov-2007. In the morning of 09-Nov-2007, the child developed hives and was directed to be taken to the emergency room because the pediatric clinic did not have any appointments available. No outcome for the event was provided by the reporter. No dechallenge or rechallenge occurred. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: A non-serious report of fever, vomiting, and diarrhea has been received from a nurse concerning a six-year-old female.  No medical history nor concomitant medications were provided.  The patient received the initial FluMist dose out of the two dose series, on an unknown date.  Two days after the dose of FluMist, the patient had a low grade fever, vomiting, and diarrhea.  Outcome for the events was not provided by the reporter.  It is unknown whether the patient received the second dose of the two dose series of FluMist.  The reporter provided no causality assessment for the events.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A nurse reported a non-serious case of vaccination from last year's FluMist involving a six-year-old female. No medical or drug history information has been reported for this patient. The patient received a dose of FluMist on 15-Nov-2007. The nurse reported that a coworker gave last year's FluMist vaccine to the patient. The nurse was familiar with the frozen product and did not noted the vaccine expiration date. The product was hand awaiting return permission from the VFC agency. No ill effects were observed as of 27-Nov-2007. No additional information available. The child was also vaccinated with the 2007-2008 FluMist vaccine on 15-Nov-2007. The reporter did not provide a causality assessment for this medication error. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Linked case MDBI-0006197 report for a sibling.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A nurse reported a non-serious case involving giving last years FluMist vaccine to a nine-year-old male.  No medical or drug history information has been reported for this patient.  The patient received a dose of FluMist on 15-Nov-2007.  The nurse reported that a coworker gave last year's FluMist vaccine to the patient.  The nurse was familiar with the frozen product and did not note the vaccine expiration date.  The product was hand awaiting return permission from the VFC agency.  No additional information is available.  No ill effects were observed as of 27-Nov-2007.  The child was also vaccinated with the 2007-2008 vaccine on 15-Nov-2007.  The reporter did not provide a causality assessment for this event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  Linked to MEDI-0006196 reports the six-year-old sibling received last year's vaccine.
Age: 34.0
Sex: F
Vaccine: FLUN3
Symptoms: Eye pain, Headache, Pain in jaw, Sinus headache, Toothache
Clinical narrative: A non-serious report was received by a pharmaceutical company representative concerning a 34-year-old female. The patient had a history of sinusitis and had been under treatment since 12-Nov-2007. No drug history was reported for this patient. The patient received FLUMIST late on 14-Nov-2007. Within hours she experienced increased sinus, teeth, jaw, eye pain and headache. The teeth, jaw and eye were the most uncomfortable. Outcome for the reported adverse events was not reported. The patient did not experience a rechallenge while receiving the suspect product. The reporter did not provide a causality assessment for the adverse events reported. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia, Vomiting
Clinical narrative: No relevant medical or drug history information was reported.  The patient was given FLUMIST at 10:00AM on 16-Nov-2007.  by 5:00PM on 16-Nov-2007, the patient was "throwing up and had a high fever."  Exact temperature was not stated.  Rechallenge is not applicable.  Causality assessment is not applicable.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 63.0
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious report was received from a physician of FLUMIST INADVERTENTLY ADMINISTERED involving a 63-year-old male. The patient's medical history includes chronic heart disease. No concomitant medications were reported for this patient. The patient received FluMist on 20 Nov 2007. On 20 Nov 2007, the patient was inadvertently administered FluMist vaccine. FluMist vaccine is approved for patients between 5 and 49 years of age. The reporter indicated that no adverse event occurred as a result of FluMist vaccination. No adverse event was reported. Rechallenge is not applicable. The reporter did not provide a causality assessment. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered, Medical device complication, No adverse event
Clinical narrative: A non-serious report of partial dose administered and FLUMIST dripped into patient's mouth was received from a nurse concerning a nine-year old male. No medical or drug history was reported for this patient. The patient received FLUMIST intranasally on 21 Nov 2007. The reporter indicated that while administering FLUMIST the syringe cracked and product inadvertently dripped into the patient's mouth. A partial dose was administered into one nostril. Six days after dosing there were no adverse events reported. The patient had no adverse events. Further dosing with FLUMIST is not indicated. Causality assessment was not reported. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 4.0
Sex: F
Vaccine: FLUN3, IPV
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain, Diarrhoea, Dry throat
Clinical narrative: A non-serious spontaneous case of dry throat, nasal congestion and drainage, diarrhea, headache, fever and abdominal pain characterized by cramps, discomfort and fullness has been received from a consumer for a five-year-old female.  No medical history or drug history information has been reported for this child.  The child received FluMist on 21-Nov-2007.  The child's mother who reported this case indicated the child received FluMist and the next day experienced a dry, scratchy throat.  Nasal congestion and drainage developed two to three days post administration.  Around 25-Nov-2007 the child developed diarrhea, stomach discomfort, abdominal cramping and fullness.  She also began complaining of a headache.  A low grade fever of 101 degrees started on 26-Nov-2007.  No outcome has been provided for this event.  Further dosing was not indicated.  The reporter did not provide a causality assessment for this event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. 03-Jul-2008: Follow-up information obtained and incorporated in above narrative information on child's physical condition on the day of FLUMIST administration.
Age: 4.0
Sex: F
Vaccine: FLUN3, IPV
Symptoms: Headache, Nasal congestion, Pyrexia, Rhinorrhoea, Throat irritation
Clinical narrative: A non-serious spontaneous case of dry throat, nasal congestion and drainage, diarrhea, headache, fever and abdominal pain characterized by cramps, discomfort and fullness has been received from a consumer for a five-year-old female.  No medical history or drug history information has been reported for this child.  The child received FluMist on 21-Nov-2007.  The child's mother who reported this case indicated the child received FluMist and the next day experienced a dry, scratchy throat.  Nasal congestion and drainage developed two to three days post administration.  Around 25-Nov-2007 the child developed diarrhea, stomach discomfort, abdominal cramping and fullness.  She also began complaining of a headache.  A low grade fever of 101 degrees started on 26-Nov-2007.  No outcome has been provided for this event.  Further dosing was not indicated.  The reporter did not provide a causality assessment for this event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. 03-Jul-2008: Follow-up information obtained and incorporated in above narrative information on child's physical condition on the day of FLUMIST administration.
Sex: M
Vaccine: FLUN3
Symptoms: Influenza
Clinical narrative: A non-serious event of flu symptoms has been received from a company from a physician concerning a male adult. No medical or drug history was provided for this patient.
Age: 33.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Nasal congestion, Neck pain, Pain, Pyrexia
Clinical narrative: A non-serious report was received from a consumer of fever, bodyaches, sneezing and coughing involving a 33-year-old female. No medical history or concomitant medication was reported for this patient. The patient was administered FluMist on 29 Nov 2007. On 30 Nov 2007, the patient began to experience body-aches. The following day, the patient developed a fever of 103, experienced sneezing, coughing, nasal congestion and continued to have body aches with pain in her neck. The patient indicated that her symptoms felt like a "strong flu", however she was not taking medications. Outcome for the reported adverse events was not provided. Action taken with FluMist was not indicated. The reporter did not provide a statement of causality for the adverse events. The reporting source of this is spontaneous, thus the sponsor's comment is not applicable.
Age: 33.0
Sex: F
Vaccine: FLUN3
Symptoms: Sneezing
Clinical narrative: A non-serious report was received from a consumer of fever, bodyaches, sneezing and coughing involving a 33-year-old female. No medical history or concomitant medication was reported for this patient. The patient was administered FluMist on 29 Nov 2007. On 30 Nov 2007, the patient began to experience body-aches. The following day, the patient developed a fever of 103, experienced sneezing, coughing, nasal congestion and continued to have body aches with pain in her neck. The patient indicated that her symptoms felt like a "strong flu", however she was not taking medications. Outcome for the reported adverse events was not provided. Action taken with FluMist was not indicated. The reporter did not provide a statement of causality for the adverse events. The reporting source of this is spontaneous, thus the sponsor's comment is not applicable.
Age: 46.0
Sex: F
Vaccine: FLUN3
Symptoms: Burning sensation, Headache, Pyrexia
Clinical narrative: A non-serious report was received from a 46-year-old female consumer coincident with FluMist therapy. No medical history or drug history was reported. The consumer received FluMist from the clinic on 03-Dec-2007. She stated that she had a burning sensation in her nose since receiving the vaccination, a headache since the day of the vaccination and a fever the day after the vaccination. Outcomes for the reported adverse events were not reported. Additional dosing of FluMist is not indicated for current season. The reporter did not provide a causality assessment for the adverse events reported. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Sex: M
Vaccine: FLUN3
Symptoms: Condition aggravated, Epistaxis
Clinical narrative: A non-serious report of nosebleed was received from a physician concerning a male child over five years of age. The patient had a history of nosebleeds. No concomitant medications were reported. The patient received FLUMIST on an unknown date between 03 Dec 2007 and 07 Dec 2007. The patient experienced nosebleed after FLUMIST administration. No outcome for the event was provided by the reporter. Action taken was not provided. The reporter provided no causality assessment for the event. The pharmaceutical company physician conservatively assessed causality for the event as possibly related to FLUMIST therapy.
Age: 33.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Nasal congestion, Pharyngolaryngeal pain
Clinical narrative: A non-serious report was received from a consumer concerning a 33-year-old female, who experienced head congestion, cough and sore throat one day after receiving FLUMIST.  No medical history and concomitant medications were reported.  The patient received one dose of FLUMIST on 07-Dec-2007 in a military clinic.  On 08-Dec-2007, the patient began to experience head congestion, cough and sore throat.  On 13-Dec-2007, the patient reported that the symptoms were somewhat better and indicated that she will be followed up by a military doctor.  The patient did not experience a rechallenge while receiving the suspect vaccine.  The reporter did not provide a statement of causality for the events.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to MEDI-0006287, which is the adverse event report fort the above patient's son.
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Nasal congestion, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: A non-serious report of nasal congestion, fever, sore throat, and headache has been received from a consumer concerning a 12-year-old female. No medical history nor concomitant medications were reported. The patient received FluMist on a Friday (date unknown). Four days later, the patient was sent home with a fever, headache, and severe congestion (sore throat). No outcomes for the events were provided by the reporter, The patient did not experience a rechallenge while receiving the suspect product. The reporter provided no causality assessment for the events. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Conjunctivitis, Eye discharge, Scleral hyperaemia
Clinical narrative: A non-serious report of conjunctivitis was received from a nurse concerning an eight-year-old male.  No medical drug or drug history was reported for this patient.  The patient received FluMist at 6pm on 12-Dec-2007.  Within eight hours of receiving the FluMist, the patient had severe conjunctivitis, with intense redness of sclera and purulent drainage from both eyes.  The outcomes for the reported adverse events were not reported.  Additional FluMist dosing is not indicated.  The reporter did not provide a causality assessment for the adverse events reported.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 33.0
Sex: F
Vaccine: FLUN3
Symptoms: Caesarean section, Drug exposure during pregnancy
Clinical narrative: An event of vaccination exposure during pregnancy occurred in a 33-year-old female.  The report was received from a medical assistant.  The client, who was 4-months pregnant at the time of vaccination, did not indicate she was pregnant.  The patient received a one-time dose of FLUMIST on 13-Dec-2007.  On 13-Dec-2007 the reporter indicated FLUMIST was administered to a woman who was four months pregnant at the time.  The patient did not make known her pregnancy prior to the vaccine administration and no adverse events were reported.  Follow up obtained on 09-Jan-08 confirmed no adverse events were reported.  Outcome: no adverse events.  Further dosing with FLUMIST is not indicated.  Causality assessment is not applicable for this vaccine exposure during pregnancy.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. On 01-May-2008 the patient delivered via C-section a healthy male infant that weighed 6.10 ounces. Follow-up informatoin on 06-Oct-2008 includes the mothers pregnancy history and the outcome of this pregnancy.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Body temperature increased, Cough, Influenza, Influenza serology positive, Vomiting
Clinical narrative: A non-serious report of influenza, temperature of 103 degrees, cough and vomiting was received from a physician concerning a five-year-old female.  No medical or drug history was reported for this patient.  The patient received an initial dose of FLUMIST in October and a booster on 16-Nov-2007.  She had not received influenza vaccinations in previous seasons.  On 18-Dec-2007, the patient presented with a temperature of 103 degrees F with a slight cough and vomiting.  The rapid flu test was positive for both A and B.  Last January, the patient had Flu A with similar symptoms and a positive rapid flu test.  The event outcome is not available.  Additional FLUMIST dosing for this season is not indicated.  The reporter did not provide a causality assessment for the adverse events reported.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 16.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy
Clinical narrative: A non-serious report was received from a physician of VACCINE EXPOSURE DURING PREGNANCY concerning a 16-year-old female.  No medical history or concomitant medications were reported for this patient.  On 19 Dec 2007, the patient was accidentally administered a FLUMIST vaccine.  The patent was 28 weeks gestation at the time, and the reporter indicated that the patient had no experienced any problems.  No further information was provided.  The pregnancy is ongoing.  Rechallenge is not applicable.  The reporter did not provide a causality statement for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Nasal congestion, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: A non-serious report of fever, sore throat and nasal congestion was received from a pharmacist concerning her son, an eight year-old male. No medical history and concomitant medications were reported. The patient received one dose of FluMist vaccine on 13-Dec-2007. One week later on 20-Dec-2007, the patient developed fever of up to 102 degrees, sore throat and nasal congestion. The outcome of the adverse events was not reported. Rechallenge is not applicable. The reporter did not provide a statement of causality for the events. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 30.0
Sex: F
Vaccine: FLUN3
Symptoms: No adverse event, Overdose
Clinical narrative: A non-serious report of inadvertently administered two doses of vaccine was received from a healthcare professional concerning a 30-year-old female.  No medical history and concomitant medications were reported.  The patient received two doses of FLUMIST vaccine on 26-Dec-2007.  The inadvertent administration of two doses of FLUMIST vaccine was realized and reported by a physician's office.  On 01-Feb-2008 the reporter and the patient both confirmed that the patient did not experience any adverse events after receiving two doses of FLUMIST on 26-Dec-2007.  Rechallenge is not applicable.  The reporter did not provide a statement of causality.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  Additional info received on 01-Feb-2008: patient did not experience any adverse events.
Age: 48.0
Sex: F
Vaccine: FLUN3
Symptoms: Paranasal sinus hypersecretion, Pyrexia, Upper respiratory tract congestion, Upper respiratory tract infection
Clinical narrative: A non-serious report has been received from a consumer concerning upper respiratory infection with congestion, purulent sinuses and fever in a 48-year-old female. No medical history nor concomitant medications were reported. The consumer received FluMist on 20-Dec-2007. Four days later, she developed congestion, "green pus is running out of my nose", fever and an "upper respiratory infection". The reporter stated that she was "sick for two weeks" after she received FluMist last year. The symptoms became more severe and persisted at the time of the report. Additional FluMist dosing is not indicated for the 2007-2008 influenza season. The reporter did not provide a causality assessment. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 46.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FluMist administered has been received from a nurse concerning a 46-year-old female. No medical history nor concomitant medications were provided. The patient and her three teenage daughters received FluMist on 27-Dec-2007. The expiration date on the FluMist was 25-Dec-2007. No adverse event was reported. As of 21-feb-2008, patient had not experienced any adverse events. The event was resolved on 27-Dec-2007. The reporter was provided information regarding additional dosing of the product when a patient is inadvertently administered product after the expiration date. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is liked to the cases for the patient's three teenage daughters who also received expired FluMist. MEDI-0006352; MEDI-0006353; MEDI-0006354. Additional information received on 21-Feb-2008 and incorporated into the narrative: No adverse event experienced.
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FluMist administered has been received from a nurse concerning a teenage female. No medical history nor concomitant medications were provided. The patient, her mother, and her two teenage siblings received FluMist on 27-Dec-2007. The expiration date on the FluMist was 25-Dec-2007. No adverse event was reported nor on 21-Feb-2008 when contacted for follow-up. The event was resolved on 27-Dec-2007. The reporter was provided information regarding additional dosing of the product when a patient is inadvertently administered product after the expiration date. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is liked to the cases for the patient's mother and two teenage sibling who also received expired FluMist: MEDI-0006351; MEDI-0006353; MEDI-0006354. Additional information received on 21-Feb-2008 and incorporated into the narrative: No adverse even experienced.