chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A nonserious 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 sibling resolved FluMist on 27-Dec-2007. The expiration date on the FluMist was 25-Dec-2007. No adverse event was report at the time of the report nor as of 21-Feb-2008 when the reporter was 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 siblings who also received expired FluMist: MEDI-0006351; MEDI-0006352; 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 at the time that the report was received, nor on 21-Feb-2008 when the reporter was 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 linked to the case for the patient's mother and two teenage siblings who also received expired. FluMist: MEDI-0006351; MEDI-0006353; MEDI-0006352. Additional information received on 21-Feb-2008 and incorporated into the narrative; No adverse event occurred.
Age: 20.0
Sex: F
Vaccine: FLUN3
Symptoms: Lymphadenopathy, Pharyngolaryngeal pain
Clinical narrative: A non-serious report was received from a consumer concerning his 20-year-old daughter. No medical or drug history was reported for the patient. The patient received FluMist on 27-Dec-2008. The following day she developed a sore throat with swollen lymph nodes. The symptoms resolved after two days. Additional FluMist dosing is not indicated. The reporting source did not provide a causality assessment. 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 non-serious report of expired FluMist administered was received from a nurse concerning a six-year-old female patient. No medical or drug history was reported. The patient received a booster dose of FluMist on 01-Jan-2008. The patient received her first dose of FluMist on 28-Nov-2007 without any reports of adverse events. The product had an expiration date of 27-Dec-2007. The patient was administered expired FluMist. At the time of the report, no adverse events were reported from this error. Information is being sought for the follow-up with the reporter regarding the outcome of this patient. The reporter did not provided a causality assessment. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Facial palsy, Ophthalmoplegia, Oxygen saturation normal
Clinical narrative: A serious report of Bell's Palsy was received from a physician concerning a 12-year-old male, PID 82396059, who enrolled in FM025: A Post  marketing Evaluation of the Safety of Influenza Virus Vaccine Live, Intranasal (FluMist) in Healthy Children and Healthy Adults 5 through 49 years of age. The subject had a medical history of oral sores in July and November 2007. The subject did not have a prior history of Bell's Palsy. No concomitant medications were reported. The subject received FluMist vaccine on 12-Nov-2007. On 01-Dec-2007, 19 days after receiving study vaccine, the subject began to experience "right facial droop, 24 hours of eye and facial paralysis, uneven smile and eyebrow lift". The following day he was seen at the emergency room and then referred to the clinic. On exam, mild right facial droop was noted. He was able to close his right eye and maintain it closed but weaker than the left eye. Uneven smile and eyebrow lift were also reported. Ear exam on both sides was normal. Tympanic membrane was intact without perforation or effusion, external canal normal. Vital signs and oxygen saturation level were within normal limits. A diagnosis of Bell's Palsy was made. Acyclovir 200 mg/5ml one teaspoon five times a day was prescribed. As of 18-Jan-2008, the event was considered resolved. No further doses of FluMist was given. The subject did not experience a rechallenge. The study investigator assessed the severity of the event as moderate. The study investigator assessed causality as possibly related to study vaccine. The sponsor agreed with the study investigator's causality assessment of possibly related to FluMist. Additional information received on 26-Feb-2008 : resolution date and confirmation that subject did not have prior history of Bell's Palsy.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FluMist administered was received from a nurse concerning a nine-year-old male patient. No relevant medical or drug history information was reported. The patient received FluMist on 02-Jan-2008. The product had an expiration date of 24-Dec-2007. No adverse events were reported regarding this incidence. The reporter considered the event resolved. The reporter did not provide a causality assessment. The reporting source of this case is spontaneous, thus the sponsor's comment is not not applicable. 11-Jan-2008: Follow up information obtained and incorporated in above narrative: Clinical outcome.
Age: 10.0
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious event of administration of expired product was received from a health care professional concerning a ten-year-old child. No medical or drug history was provided. FluMist was administered on 04-Jan-2008. The FluMist expired eight days earlier on 27-Dec-2007. Eighteen days after exposure to the expired product, the patient had not experienced ill effects. No additional dosing is indicated. 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: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious event of expired product administered was received from a nurse concerning a 14-year-old female. No medical or drug history was provided. FluMist was administered on 03-Jan-2008. The FluMist expired seven days earlier on 27-Dec-2007. Eighteen days post exposure to the expired FluMist, the patient had not experienced ill effects. No additional dosing is indicated. The reporter did not provide a causality assessment. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. The reporter also reported another patient that was exposed to expired product, case MEDI-0006378.
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FluMist administered was received from a medical assistant concerning an adult female. No medical or drug history was reported. The patient received FluMist on 08-Jan2008 it was determined that the FluMist was passed the expiry date. No adverse events were reported. No information was provided regarding additional dosing with unexpired FluMist. 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: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired dose of vaccine administered has been received from a consumer concerning an eight-year-old female. Neither medical history no concomitant medications were provided. The patient received FluMist on 08-Jan-2008. The FluMist that was administered on 08-Jan-2008 had an expiration date of 27-Dec-2007. No adverse events were reported. The event was considered resolved. The patient did not experience a rechallenge while receiving the suspect product. This 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: Expired drug administered
Clinical narrative: A non-serious event of expired product administered was received from a healthcare professional concerning and adult male. No medical or drug history was provided. FluMist was administered on 14-Jan-2008. The FluMist had expired four days earlier on 10-Jan-2008. The patient opted to be revaccinated with either FluMist or FluZone. No signs or symptoms were present at the time of the report. No additional dosing is indicated. 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: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired dose of vaccine administered has been received from a nurse concerning a nine-year-old female patient. Neither medical history nor concomitant medications were provided. The patient received FluMist on 14-Jan-2008. The FluMist had expired on 10-Jan-2008. The reporter indicated that no adverse events have occurred since the time of the report. The patient did not experienced a rechallenge while receiving the suspect product. 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. 29-Jan-2008: Follow up information obtained and incorporated in above narrative: clinical outcome.
Age: 38.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired dose of vaccine administered has been received from a nurse concerning a 38-year-old male patient.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 14-Jan-2008.  The FluMist had expired on 10-Jan-2008.  The reporter indicated that no adverse events have occurred since the time of the report.  The patient did not experience a rechallenge while receiving the suspect product.  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.  29-Jan-2008:  Follow-up information obtained and incorporated in above narrative: clinical outcome.
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious case of inadvertent administration of expired product was received from a nurse concerning an adult male coincident with FluMist. No medical or drug history was provided. FluMist was administered on 14-Jan-2008. The FluMist expired four days earlier on 10-Jan-2008. No signs or symptoms were present at the time of the report. No additional dosing is indicated. 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: 13.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, Vaccination complication
Clinical narrative: One of nine cases: An event of Expired Drug Administered occurred in a 13 year-old  female. The report was received from a registered nurse. No medical or drug history was reported. The patient received a one-time dose of FluMist intranasally on 15-Jan-2008. On 15-Jan-2008, she received FluMist with an expiration date of 19-Dec-2007. The reporter stated this is one of nine children that was vaccinated on the same date. In discussing the error with two reporters from the site, they both indicated that the front of the FluMist box states "For the 2007/2008 Season", there is an expiration date on the side of the box. The reporter indicated they also administered a competitor's product, which is good for the entire season and does not expire until May/June timeframe. One reporter also stated many of the vaccines they give do not have an expiration date. She also indicated they do look for expiration dates, but it was confusing to have the front of the box indicate the vaccine was "For the 2007/2008 Season". The vaccination nurse at the site stated they placed the order for FluMist on 26-Nov-2007 for up 1 week later, and she was unsure why the site would be supplied with product that was to expire in less than weeks. Outcome: the child had ill effects, the site has not had any contact from  the child's family. Further dosing with FluMist is not indicated. Causality assessment is not applicable for this vaccination 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: Expired drug administered
Clinical narrative: Two of nine cases: An event of Expired Drug Administered occurred in a seven year-old male.  The report was received from a registered nurse.  No medical or drug history was reported for this child.  The child received a one-time dose of FluMist intranasally on 15-Jan-2008.  On 15-Jan-2008, the child received FluMist with an expiration date of 19-Dec-2007.  The reporter stated this is one of nine children that was vaccinated on the same date.  In discussing the error with two reporters from the site, they both indicated that the front of the FluMist box states "For the 2007/2008 Season", there is an expiration date on the side of the box.  The reporter indicated they also administered a competitor's product, which is good for the entire season and does not expire until May/June timeframe.  One reporter also stated many of the vaccines they give do not have an expiration date.  She also indicated they do look for expiration dates but it was confusing to have the front of the box indicate the vaccine was "For the 2007/2008 Season".  The vaccination nurse at the site stated they placed the order for FluMist on 26-Nov-2007 for pick up 1 week later, and she was unsure why the site would be supplied with a product that was to expire in less than three weeks.  Outcome: the child had no ill effects, the site has not had any contact from the child's family.  Further dosing with FluMist is not indicated.  Causality assessment is not applicable for this vaccination error.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: One of nine cases: An event of Expired Drug Administered occurred in a nine-year-old male.  The report was received from a registered nurse.  No medical or drug history was reported for this child.  The child received a one-time dose of FluMist intranasally on 15-Jan-2008.  On 15-Jan-2008 the child received FluMist, which had an expiration date of 19-Dec-2007.  The reporter stated this is one of nine children that was vaccinated on the same date.  In discussing the error with two reporters from the site they both indicated that the front of the FluMist box states "For the 2007/2008 Season", there is an expiration date on the side of the box.  The reporter indicated they also administered a competitor's product which is good for the entire season and does not expire until May/June time frame.  One reporter also stated many of the vaccines they give do no have an expiration date.  She also indicated they do look for expiration dates but it was confusing to have the front of the box indicate the vaccine was "For the 2007/2008 Season".  The vaccination nurse at the site stated they placed the order for FluMist on 26-Nov-2007 for pick up 1 week later, and she was unsure why the site would be supplied with product that was to expire in less than three weeks.  Outcome: the child had no ill effects, the site has not had any contact from the child's family.  Further dosing with FluMist is not indicated.  Causality assessment is not applicable for this vaccination error.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 6.0
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: One of nine expired cases: An event of Expired Drug Administered occurred in a six-year-old female. The report was received from a registered nurse . No medical or drug history was reported for the child. The child received a one-time dose of FluMist intranasally on 15-Jan-2008. On 15-Jan-2008, the child received FluMist which had an expiration date of 19-Dec-2007. The reporter stated this is one of nine children that was vaccinated on the same date. In discussing the error with two reporters from the site, they both indicated that the front of the FluMist box states "For the 2007/2008 Season", there is an expiration date on the side of the box. The reporter indicated they also administer a competitor's product, which is good for that entire season and does not expire until May/June timeframe. One reporter also stated many of the vaccines they give do not have an expiration date. She also indicated they do look for expiration dates but it was confusing to have the front of the box indicate the vaccine was "For the 2007/2008 Season". The vaccination nurse at the site stated they placed the order for FluMist on 26-Nov-2007 for pick up 1 week later, and she was unsure why the site would be supplied with product that was to expire in less than three weeks. Outcome: the child had no ill effects, the site has not had any contact from the child's family. Further dosing with FluMist is not indicated. Causality assessment is not applicable for this vaccination error. This reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 13.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: One of nine expired cases: An event of Expired Drug Administered occurred in a thirteen year-old female. The report was received from a registered nurse . No medical or drug history was reported. The adolescent received a one-time dose of FluMist intranasally on 15-Jan-2008. On 15-Jan-2008 she received FluMist which had an expiration date of 19-Dec-2007. The reporter stated this is one of nine children that was vaccinated on the same date. In discussing the error with two reporters from the site, they both indicated that the front of the FluMist box states "For the 2007/2008 Season", there is an expiration date on the side of the box. The reporter indicated they also administer a competitor's product which is good for that entire season and does not expire until May/June timeframe. One reporter also stated many of the vaccines they give do not have an expiration date. She also indicated they do look for expiration dates but it was confusing to have the front of the box indicate the vaccine was "For the 2007/2008 Season". The vaccination nurse at the site stated they placed the order for FluMist on 26-Nov-2007 for pick up 1 week later, and she was unsure why the site would be supplied with product that was to expire in less than three weeks. Outcome: the child had no ill effects, the site has not had any further contact from the family. Further dosing with FluMist is not indicated. Causality assessment is not applicable for this vaccination error. This reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: One of nine cases: An event of Expired Drug Administered occurred in a seven-year-old female. The report was received from a registered nurse . No medical or drug history was reported for this child. The child received a one-time dose of FluMist intranasally on 15-Jan-2008. On 15-Jan-2008, the child received FluMist which had an expiration date of 19-Dec-2007. The reporter stated this is one of nine children that was vaccinated on the same date. In discussing the error with two reporters from the site, they both indicated that the front of the FluMist box states "For the 2007/2008 Season", there is an expiration date on the side of the box. The reporter indicated they also administer a competitor's product, which is good for that entire season and does not expire until May/June timeframe. One reporter also stated many of the vaccines they give do not have an expiration date. She also indicated they do look for expiration dates but it was confusing to have the front of the box indicate the vaccine was "For the 2007/2008 Season". The vaccination nurse at the site stated they placed the order for FluMist on 26-Nov-2007 for pick up 1 week later, and she was unsure why the site would be supplied with product that was to expire in less than three weeks. Outcome: the child had no ill effects, the site has not had any contact from the child's family. Further dosing with FluMist is not indicated. Causality assessment is not applicable for this vaccination error. This reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: One of nine cases: An event of Expired Drug Administered occurred in a ten year-old male.  The report was received from a registered nurse.  No medical or drug history was reported for this child.  The child received a one-time dose of FluMist intranasally on 15-Jan-2008.  On 15-Jan-2008 the child received FluMist which had an expiration date of 19-Dec-2007.  The reporter stated this is one of nine children that was vaccinated on the same date.  In discussing the error with two reporters from the site, they both indicated that the front of the FluMist box states "For the 2007/2008 Season", there is an expiration date on the side of the box.  The reporter indicated they also administered a competitor's product which is good for the entire season and does not expire until May/June time frame.  One reporter also stated many of the vaccines they give do not have an expiration date.  She also indicated they do look for expiration dates, but it was confusing to have the front of the box indicate the vaccine was "For the 2007/2008 Season".  The vaccination nurse at the site stated they placed the order for FluMist on 26-Nov-2007 for pick up 1 week later, and she was unsure why the site would be supplied with a product that was to expire in less than three weeks.  Outcome: the child had no ill effects, the site has not had any contact from the child's family.  Further dosing with FluMist is not indicated.  Causality assessment is not applicable for this vaccination 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: Expired drug administered
Clinical narrative: One of nine cases: An event of Expired Drug Administered occurred in a six-year-old female. The report was received from a registered nurse . No medical or drug history was reported for this child. The child received a one-time dose of FluMist intranasally on 15-Jan-2008. On 15-Jan-2008, the child received FluMist which had an expiration date of 19-Dec-2007. The reporter stated this is one of nine children that was vaccinated on the same date. In discussing the error with two reporters from the site they both indicated that the front of the FluMist box states "For the 2007/2008 Season", there is an expiration date on the side of the box. The reporter indicated they also administer a competitor's product, which is good for that entire season and does not expire until May/June timeframe. One reporter also stated many of the vaccines they give do not have an expiration date. She also indicated they do look for expiration dates but it was confusing to have the front of the box indicate the vaccine was "For the 2007/2008 Season". The vaccination nurse at the site stated they placed the order for FluMist on 26-Nov-2007 for pick up 1 week later, and she was unsure why the site would be supplied with product that was to expire in less than three weeks. Outcome: the child had no ill effects, the site has not had any contact from the child's family. Further dosing with FluMist is not indicated. Causality assessment is not applicable for this vaccination error. This reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: One of nine cases: An event of Expired Drug Administered occurred in a seven-year-old female. The report was received from a registered nurse . No medical or drug history was reported for the child. The child received a one-time dose of FluMist intranasally on 15-Jan-2008. On 15-Jan-2008, the child received FluMist which had an expiration date of 19-Dec-2007. The reporter stated this is one of nine children that was vaccinated on the same date. In discussing the error with two reporters from the site they both indicated that the front of the FluMist box states "For the 2007/2008 Season", there is an expiration date on the side of the box. The reporter indicated they also administer a competitor's product, which is good for that entire season and does not expire until May/June timeframe. One reporter also stated many of the vaccines they give do not have an expiration date. She also indicated they do look for expiration dates, but it was confusing to have the front of the box indicate the vaccine was "For the 2007/2008 Season". The vaccination nurse at the site stated they placed the order for FluMist on 26-Nov-2007 for pick up 1 week later, and she was unsure why the site would be supplied with product that was to expire in less than three weeks. Outcome: the child had no ill effects, the site has not had any contact from the child's family. Further dosing with FluMist is not indicated. Causality assessment is not applicable for this vaccination error. This reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 12.0
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired dose of vaccine administered has been received from a health care professional concerning a 12-year-old patient of unknown gender.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 28-Jan-2008.  The FluMist had expired on 14-Jan-2008.  The reporter indicated that no adverse events have occurred since the time of the report.  Rechallenge is not applicable to this adverse event.  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: 68.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, Inappropriate schedule of drug administration
Clinical narrative: A nonserious report of expired dose of vaccine administered has been received from a health care professional concerning a 68-year-old female patient. Neither medical history nor concomitant medications were provided. The patient received FluMist on 29-Jan-2008. FluMist is indicated 2-49 year olds. The FluMist had expired on 10-Jan-2008. The patient is a 68-year old. The reporter indicated that no adverse events have occurred since the time of the report. Rechallenge is not applicable. The reporter provided no causality assessment for the event. The reporting source of this spontaneous, thus the sponsor's comment is not applicable.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired dose of vaccine administered has been received from a healthcare professional concerning a six-year-old male patient.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 29-Jan-2008.  The FluMist had expired on 10-Jan-2008.  At the time of the report, no adverse events were reported from this error.  Rechallenge is not applicable.  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: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired dose of vaccine administered was received from a physician concerning a five-year-old female. No medical history or concomitant medications were reported. The patient received FluMist vaccine on 05-Feb-2008. The FluMist vaccine administered had an expiration date of 31-Dec-2007. Follow-up call to the reporter after four weeks on 04-Mar-2008 confirmed that the patient did not experience any adverse events after receiving expired FluMist vaccine. The patient did not experienced a rechallenge while receiving the suspect product. 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 information received on 04-Mar-2008 : reporter confirmed did not experience adverse events.
Age: 31.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired dose of FluMist administered was received from a physician concerning a 31-year-old female.  No medical history or concomitant medications were reported.  The patient received FluMist vaccine on 05-Feb-2008.  The FluMist vaccine administered had an expiration date of 31-Dec-2007.  Follow-up call to the reporter after four weeks on 04-Mar-2008 confirmed that the patient did not experience any adverse events after receiving expired FluMist vaccine.  The patient did not experience a rechallenge while receiving the suspect product.  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 information received on 04-Mar-2008: reporter confirmed patient did not experience any adverse events.
Age: 33.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious report of expired dose of vaccine administered was received from a physician  concerning a 33-year-old male. No medical history or concomitant medications were reported. The patient received FluMist on 05-Feb-2008. The FluMist vaccine administered had an expiration date of 31-Dec-2007. Follow-up call to the reporter after four weeks on 04-Mar-2008 confirmed that the patient did not experience any adverse event after receiving expired FluMist vaccine. The patient did not experience a rechallenge while receiving the suspect product. 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 information received on 04-Mar-2008 : reporter confirmed that the patient did not experienced any adverse events. Additional info: received on 21-Nov-2008 : lot number and patient's date of birth.
Age: 23.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired FluMist was received from a physician concerning a 23-year-old female.  No medical history or concomitant medications were reported.  The patient received FluMist on 11-Feb-2008.  The patient was administered expired FluMist.  Per the physician, no adverse events were associated with the medication error.  No dechallange 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: 31.0
Sex: F
Vaccine: FLUN3
Symptoms: Dizziness, Tachycardia, Tremor
Clinical narrative: A non-serious report of tachycardia, lightheadedness and tremors was received from a physician in concerning a 31-year-old female. The patient had a medical history of neutropenia. Concomitant medications were not reported. The patient received FluMist vaccine on 24-Oct-2007. Seven hours after receiving FluMist vaccine, the patient became lightheaded, became tachycardic and had tremors. The patient went to the emergency room and the symptoms subsided shortly. The patient recovered from all events, is now asymptomic with no problems. The patient did experience a rechallenge after receiving the suspect product. 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: 15.0
Sex: F
Vaccine: FLUN3
Symptoms: Epistaxis
Clinical narrative: A non-serious report of nosebleed has been received from a nurse concerning a 15-year-old female patient.  The patient had no prior medical history and no concomitant medications.  The patient received FluMist and Gardasil on 21-Feb-2008.  The patient developed a bloody nose for two-minutes on 22-Feb-2008 and 23-Feb-2008.  The above event was considered resolved on 23-Feb-2008.  Rechallenge is not applicable to this adverse event.  The reporter did not provide a statement of causality to FluMist.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Fatigue, Influenza like illness, Myalgia, Rash
Clinical narrative: A non-serious spontaneous report of "flu like" symptoms including muscle aches, tiredness and rash has been received from a consumer concerning a 14-year-old female, subsequent to receiving FluMist. No medical history nor drug history was reported.  The child received FluMist nasally on 10-Oct-2007.  The patient's father reported that several weeks after receiving FluMist the patient experienced "flu-like" symptoms including muscle aches, tiredness and a sporadic rash on the face every once in awhile. The patient's pediatric office, however, stated they have not seen the patient, nor were they notified in reference to a reaction with FLUMIST. The outcome is unknown. The events have not resolved; the child continues to experience these symptoms. Follow-up received on 12-Mar-2008: includes patient demographics and FLUMIST dosing information.
Age: 36.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious event of expired dose of vaccine administered was reported by a nurse concerning a 36-year-old female. The patient's medical history and concomitant medications were not reported. On 14-Mar-2008, the patient received FluMist vaccine. It was found out that the FluMist vaccine had an expiration date of 26-Feb-2008. No adverse events, symptoms or any problems were reported. 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.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired FluMist has been received from a nurse concerning a seven-year old male. Neither medical history nor concomitant medications were provided. The patient received FluMist on 12-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. The patient had not adverse events at the time of the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information. The event has resolved. It was not reported whether or not FluMist was re-administered. 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. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006659; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006673L MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired FluMist has been received from a nurse concerning a nine-year-old female. Neither medical history nor concomitant medications were provided. The patient received FluMist on 12-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the Vaccines For Children Program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. The patient had no adverse events at the time the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information. The event has resolved. It was not whether or not FluMist was re-administered. 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. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006659; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired FLUMIST has been received from a nurse in the USA concerning a seven-year old male. Neither medical history nor concomitant medications were provided. The patient received FLUMIST on 12-Mar-2008. The FLUMIST had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FLUMIST from the Vaccines For Children Program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. The patient had no adverse events at the time the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information. The event has resolved. It was not reported whether or not FLUMIST was re-administered. 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. Follow-up information received 10-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to following 25 other cases reported from he same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-00006659; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDRI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired FluMist has been received from a nurse concerning a seven-year-old male.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 12-Mar-2008.  The FluMist had expired on 10-Mar-2008.  The reporter stated that she received 100 doses of FluMist from the Vaccines For Children Program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008.  The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients.  The patient had no adverse events at the time the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information.  The event has resolved.  It was not reported whether or not FluMist was re-administered.  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.  Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred.  This case is linked to the following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006659; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired FLUMIST has been received from a nurse concerning an eight-year old male. Neither medical history nor concomitant medications were provided. The patient received FLUMIST on 13-Mar-2008. The FLUMIST had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FLUMIST on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. The patient had not adverse events at the time the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information. The event has resolved. It was not reported whether or not FLUMIST was re-administered. 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. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006659; MEDI-0006672; MEDI-0006673; MEDI-0006673L MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired FluMist has been received from a nurse concerning an eight-year-old female.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 13-Mar-2008.  The FluMist had expired on 10-Mar-2008.  The reporter stated that she received 100 doses of FluMist from the Vaccines For Children Program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008.  The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients.  The patient had no adverse events at the time the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information.  The event was resolved.  It was not reported whether or not FluMist was re-administered.  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.  Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred.  This case is linked to the following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006659; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired FluMist has been received from a nurse concerning a five-year old male. Neither medical history nor concomitant medications were provided. The patient received FluMist on 13-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the Vaccines For Children Program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 26 patients. The patient had no adverse events at the time the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information. The event has resolved. It was not reported whether or not FluMist was re-administered. 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. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to the following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006659; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired FLUMIST has been received from a nurse concerning a ten-year old female. Neither medical history nor concomitant medications were provided. The patient received FLUMIST on 13-Mar-2008. The FLUMIST had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FLUMIST from the program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. The patient had no adverse events at the time of the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information. The event has resolved. It was not reported whether or not FLUMIST was re-administered. 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. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-000668; MEDI-0006669; MEDI-00066670; MEDI-00066671; MEDI-00006672; MEDI-00006673; MEDI-0006674; MEDI-0006659; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684