chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired vaccine was received from a registered nurse/health professional concerning a seven-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 29-Mar-2010. On 31-Mar-2010, the patient received expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
Age: 84.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "administration of expired product" and "vaccine given to a patient" was received from a non healthcare professional concerning a 84-year-old male out of 18 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. On 20-Jan-2010, the patient received expired H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered resolved.
Age: 52.0
Sex: U
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to 52-year-old was received from a registered nurse concerning a 52-year-old adult patient. Neither medical history nor concomitant medications was reported for this patient. On 06-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 67.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "inadvertent administration of expired H1N1 LAIV" and "vaccine given to a patient" was received from a pharmacist concerning a 67-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 06-Feb-2010, but was then reassigned to 15-Jan-2010. On 26-Jan-2010, the patient received expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered resolved.
Age: 76.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to 76 year old was received from a registered nurse concerning a 76-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 22-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Sex: U
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning 500 children of unknown gender. Neither the patient's medical history nor concomitant medications were reported. The original expiration date of the product was 20-Apr-2010 which was re-assigned to 08-Apr-2010. On an unknown date after 08-Apr-2010, the patients received the expired H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessment is not applicable, and the event was considered resolved.
Age: 7.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "administration H1N1 LAIV with expiry date of 01/15/10" was received from an office manager/healthcare professional concerning a seven-year-old male out of three patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. On 22-Jan-2010, the patient received expired H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 35.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "administration of H1N1 LAIV with expiry date of 01/15/10" was received from a health professional concerning a 35-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. On 22-Jan-2010, the patient received expired H1N1, Intranasal, for an unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 6.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a father/consumer concerning a six-year-old female child. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 28-Mar-2010. On 08-May-2010, the patient received expired H1N1, Intranasal, for unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Sex: U
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of "they inadvertently administered H1N1 to a person greater than 49 years of age", was received from a registered nurse/health professional concerning an adult of unknown gender. Neither relevant medical history nor concomitant medications were reported. On 29-Jan-2010, the patient received H1N1, Intranasal, for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 4.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a father/consumer concerning a four-year-old male child. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 28-Mar-2010. On 08-May-2010, the patient received expired H1N1, Intranasal, for unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 9.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Contraindication to vaccination, Rhinorrhoea, Sneezing
Clinical narrative: A non-serious spontaneous report of the patient with a mild egg allergy received H1N1, several episodes of sneezing, runny nose has been received from a parent concerning a nine-year-old male, subsequent to H1N1, Intranasal. The patient's medical history includes mild allergy to egg. No concomitant medications have been reported for this patient. On 29-Oct-2009, the patient received H1N1, Intranasal for an unspecified indication. On 03-Nov-2009, the patient experienced several episodes of sneezing and runny nose. The outcome of the medication error was resolved and for several episodes of sneezing and runny nose it was resolving.
Age: 10.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 and 10-year-old patient was given 2nd dose was received from a registered nurse/health professional concerning a ten-year-old female. Neither relevant medical history nor concomitant medications have been reported from this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Sex: U
Vaccine: FLUN(H1N1)
Symptoms: No adverse event, Underdose
Clinical narrative: A non-serious spontaneous report of about ten adult patients only got a half dose of H1N1, Intranasal was received from a physician. Neither relevant medical history nor concomitant medications have been reported for this patient. Nurse did not remove the dose divider clip when she administered the doses due to which patients only received a half dose each. On 23-Oct-2009, ten patients received H1N1 vaccine. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event is considered resolved.
Age: 5.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a five-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 8.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning an eight-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose or H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 2.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Erythema, Pyrexia
Clinical narrative: A non-serious spontaneous report of redness around her nose, eyes, mouth and the opening around her ears and fever has been received from a physician concerning a 35-month-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received H1N1, Intranasal on 08-Jan-2010 for an unknown indication. On evening of 08-Jan-2010, the patient experienced redness around her nose, eyes, mouth and the opening around her ears. She also experienced fever that fluctuated for about three days and reached up to 103 F. The redness lasted for at least four days. The patient did not experience swelling on the tongue. All the events had resolved at the time of report. The outcome of all the events was resolved.
Age: 2.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "7 patients were inadvertently administered expired H1N1" was received from an office manager/health professional concerning a 35-month-old female. Neither relevant medical history nor concomitant medication have been reported for this patient. The vaccine expired on 15-Jan-2010. On 19-Jan-2010, the patient received the H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 9.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration expired H1N1 was received from a registered nurse/health professional concerning a nine-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 2.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "7 patients were inadvertently administered expired H1N1" was received from an office manager/health professional concerning a 28-month-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. On 21-Jan-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 4.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a four-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 8.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "7 patients were inadvertently administered expired H1N1 LAIV" was received from an office manager/health professional concerning an eight-year-old female. Neither relevant medical history nor concomitant medication have been reported for this patient. The vaccine expired on 15-Jan-2010. On 25-Jan-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 8.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "7 patient were inadvertently administered expired H1N1" was received from a health professional concerning an eight-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. On 26-Jan-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments were not applicable and the event was considered resolved.
Age: 13.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Feeling abnormal, Pyrexia, Vomiting
Clinical narrative: A non-serious spontaneous report of fever, vomiting and "felt pretty crummy" was received from a consumer/ mother concerning her 13-year-old son, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications was reported for this patient. On 17-Oct 2009, the patient received H1N1, Intranasal for an unknown indication. On 18-Oct 2009, the patient experienced fever of 101.8 degrees F, vomiting for one time and felt pretty crummy. On 20-Oct-2009, the patient was afebrile. The outcome of fever was resolved while the outcome of vomiting and "felt pretty crummy" was unknown.
Age: 10.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "7 patients were inadvertently administered expired H1N1" was received from a health professional concerning a ten-year-old male out of seven patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. On 01-Feb-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments were not applicable and the event was considered resolved.
Age: 5.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "7 patients were inadvertently administered expired H1N1" was received from a health professional concerning a five-year-old male out of seven patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. On 01-Feb-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments were not applicable and the event was considered resolved.
Age: 5.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "7 patients were inadvertently administered expired H1N1" was received from a health professional concerning a five-year-old female out of seven patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. On 19-Jan-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments were not applicable and the event was considered resolved.
Age: 52.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Accidental exposure, Eye irritation, Superficial injury of eye, Vision blurred
Clinical narrative: A non-serious spontaneous report of "I gave a child H1N1 and it got in my eye", irritation, scratchiness and blurred vision has been received from a registered nurse concerning herself who is a 52-year-old female, subsequent to administration of H1N1, Intranasal to a child. Neither relevant medical history nor concomitant medications were reported for this patient. The nurse herself did not receive H1N1, Intranasal. On 05-Nov-2009, the nurse had administered the vaccine to a child, and the child subsequently sprayed the vaccine from his nose into her eye. Immediately after this she flushed her eye with an eye wash. On 05-Nov-2009, she experienced irritation, scratchiness and blurred vision in the evening. The outcome of the events "I gave a child H1N1 and it got in my eye" and blurred vision was resolved. The outcome of irritation and scratchiness was recovering.
Age: 6.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a six-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 7.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a seven-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 40.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Accidental exposure, Dysgeusia, Headache
Clinical narrative: A 40-year-old nurse/health professional reported a non-serious spontaneous report of metallic taste in mouth while administering H1N1 and headache concerning herself, subsequent to H1N1, Intranasal vaccine. Neither medical history nor concomitant medications was reported for this patient. The patient herself did not receive H1N1, Intranasal vaccine. On 05-Nov-2009, while administering H1N1 to several patients, she experienced metallic taste in her mouth and in addition she experienced headache for about ten hours after that. The outcome of the headache is resolved and the outcome of metallic taste was not recovered.
Age: 5.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Pyrexia, Upper respiratory tract infection
Clinical narrative: A non-serious spontaneous report of upper respiratory tract symptoms was received from a physician concerning her five-year-old daughter, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications was reported for this patient. On 24-Oct-2009, the patient received H1N1, Intranasal for an unknown indication. On 25-Oct-2009, the patient experienced fever and upper respiratory tract symptoms which lasted for four days. The outcome of the event was resolved.
Age: 32.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Delivery, Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of pt received H1N1 in third trimester was received from a physician concerning a 32-year-old pregnant female. The patient did not have any medical history. The patient's obstetrical history included gravida two and para one at the time of vaccination. The patient was 29 weeks pregnant or in third trimester of pregnancy at the time of vaccination. The expected delivery date of the patient was 12-Jan-2010. Patient was not taking any concomitant medications. On 31-Oct-2009, the patient received H1N1, Intranasal. On 05-Jan-2010, the patient delivered a normal, healthy baby boy vaginally without complications and the neonate's weight was 8 lbs at birth. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments were not applicable. The outcome of the vaccine exposure during pregnancy was resolved. Additional information was received on 15-Feb-2010 and incorporated into the narrative: about pregnancy outcome, date of delivery, type of delivery and condition of the baby.
Age: 20.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Photopsia
Clinical narrative: A non-serious spontaneous report of woke up with flashing light in eyes has been received from a physician concerning a 20-year-old female, subsequent to H1N1, Intranasal. Neither medical history nor concomitant medications was reported for this patient. In Oct-2009, the patient received H1N1, Intranasal for an unknown indication. On 04-Nov-2009, the patient woke up with flashing light in her eyes. The outcome of the event was unknown.
Age: 5.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non- serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a five-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 8.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from registered nurse/health professional concerning an eight-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, that patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 8.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning an eight-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 8.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning an eight-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 19.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Delivery, Drug exposure during pregnancy, Foetal heart rate normal, Laboratory test normal, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to 21.5 weeks pregnant female was received from a registered nurse/health professional concerning a 19-year-old female. The patient's past medical history included non-specific uterine bleeding and concurrent conditions were peri-rectal abscess, depression and alcohol use. On 09-Sep-2009 patient stopped use of alcohol when she learned she was pregnant. Patient had regular prenatal care, labs and fetal heart tones were normal. The patient's obstetrical history included gravida three, para one and two spontaneous abortions. Patient's estimated date of delivery was 19-Mar-2010. The concomitant medications included Iron tabs, multivitamins, omega 3-fatty acid (all orally, once daily) and calcium (oral, twice daily) as supplement, acetaminophen as needed orally. The previous vaccination was 1 dose of 'TB vaccine' subcutaneously on 09-Sep-2009 and 1 dose of 'Hepatitis B vaccine' IM on 23-Sep-2009. On 12-Nov-2009, the patient received H1N1, Intranasal, for an unknown indication. On 25-Mar-2010, patient was sent to hospital in labour to deliver the infant. The patient delivered a female child on 30-Mar-2010. It was a full term normal induced vaginal delivery with no medical complications. The gestational age was 41 weeks four days. The newborn had a weight of 8 lbs 12 oz. The Apgar score at one minute was seven and at five minute it was nine. The fetus had no complications with delivery. Resuscitation done with mild tactile stimulation. There was no adverse event associated with this pregnancy therefore, treatment and reporter causality assessments were not applicable and the event administration to vaccine exposure during pregnancy was considered resolved. Additional information was received on 18-Nov-2009 and incorporated into the narrative: medical history, concomitant medications, concurrent condition. Also information received on reporter address and pregnancy EDD. Additional information was received on 28-Apr-2010 and incorporated into the narrative: pregnancy outcome, concomitant medication and neonatal information.
Age: 1.8
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious spontaneous report of 22-month-old male child receiving H1N1 was received from a registered nurse/health professional. The patient had no medical history and no concomitant medication was taken by the patient. On 12-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. The child had not developed signs/symptoms of the flu and child remained well. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 12-Nov-2009 and incorporated into the narrative: date of vaccination changed, medical history and concomitant medications. Additional information was received on 18-NOV-2009 and incorporated into the narrative: sex of child changed to male, medical history and concomitant medications verified as none.
Age: 57.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently administered H1N1 to a 57yo male with type I diabetes was received from a registered nurse concerning a 57-year-old male. The patient had type I diabetes and no concomitant medication have been reported. The H1N1, Intranasal was administered on 12-Nov-2009. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments were not applicable, and the event is considered resolved.
Age: 50.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of "50 year old got H1N1 LAIV yesterday" was received from patient's friend/non healthcare professional concerning a 50-year-old female. The patient received H1N1, Intranasal on 11-Nov-2009. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Pyrexia
Clinical narrative: A non-serious spontaneous report of fever of 103 F has been received from a physician concerning his grandson, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 28-Oct-2009, the patient received H1N1, Intranasal for an unknown indication. On 28-Oct-2009, the patient received dose of H1N1 and spiked a fever of 103 F the night after vaccination. The fever diminished within days. The outcome for the reported event was recovered and resolved.
Age: 60.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of H1N1, Intranasal to a 60-year-old female was received from a registered nurse. The patient's medical history was not provided. On 05-Nov-2009, the patient received H1N1 vaccine. There was no adverse event associated with this medication error: therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Age: 25.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Erythema, Oropharyngeal pain, Stomatitis, Tongue ulceration
Clinical narrative: A non-serious spontaneous report of patient licked dripping vaccine, sores on inside of mouth, sores on tongue, slight redness to face and sore throat has been received from a pharmacist concerning her 25-year-old husband, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 9-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. On 9-Nov-2009, the patient was requested to inhale deeply upon receiving the H1N1. Upon administration, the mist began to drip out of the nose. The nurse administering the vaccine told patient to lick the dripping vaccine to ensure full dose. Within hours, the patient reported sores on inside of mouth and tongue, slight redness to face, and sore throat. The symptoms were ongoing at the time of report and were treated with ibuprofen. The outcome of the events was not recovered at the time of reporting.
Age: 27.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of pregnant female was inadvertently given H1N1 was received from a registered nurse concerning a 27-year-old female. Neither relevant medical history nor obstetrical history have been reported. On 05-Nov-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. The outcome of vaccine exposure during pregnancy was considered resolved.
Age: 1.47
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of H1N1 inadvertently administered to a 17-month-old male was received from a registered nurse/health professional. The patient was not having any relevant medical history and concomitant medications. The patient received H1N1, Intranasal on 05-Nov-2009. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved. Additional information was received on 18-Nov-2009 and incorporated into the narrative: event verbatim changed, information on medical history and concomitant medication.
Age: 4.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Malaise, Pain in extremity, Pyrexia, Staring
Clinical narrative: A non-serious spontaneous report of fever of 100 F, pain in legs, not feeling well and eye glossy has been received from a non-health professional concerning a four-year-old male, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 09-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. On 12-Nov-2009, the patient developed fever of 100 F, pain in legs, was not feeling well and eyes glossy. The outcome of the event was unknown.
Age: 0.54
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious spontaneous report of H1N1 inadvertently administered to 6 month old infant was received from a registered nurse concerning a six-month-old male. H1N1, Intranasal was administered on 12-Nov-2009. The patient did not have any past medical history or concomitant medications. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments were not applicable and the event was considered resolved. Additional information received on 16-Nov-2009 and incorporated in narrative: medical history and concomitant medications.
Age: 62.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to 62-year-old was received from a registered nurse/other health professional concerning a 62-year-old female. The patient's medical history included diabetes and chronic lung disease. On 10-Nov-2009, the patient received H1N1, Intranasal, for an unknown indication. There was no adverse event associated with this medication error, therefore, treatment and reporter sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 40.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "administration of H1N1 with expiry date of 01/15/2010" was received from a health professional concerning a 40-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. On 22-Jan-2010, the patient received expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
Age: 2.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Abdominal pain upper, Ear pain, Pain, Pyrexia
Clinical narrative: A non-serious spontaneous report of earache, fever, body aches and stomach ache has been received from a physician concerning a 26-month-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 04-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. On 04-Nov-2009, shortly after the vaccine administration, the patient experienced fever of 103 F and body ache. The patient no longer had fever as of 18-Nov-2009. A stomach and earache were present at the time of report. The outcome of the fever was recovered, body aches was unknown and of stomach and earache not recovered.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site coldness, Injection site pain, Paraesthesia, Sleep disorder, X-ray normal
Clinical narrative: Initial report received on 18 November 2009 from a consumer, who is the patient. A 39 year old female patient, with allergies to codeine and penicillin and a history of hypothyroidism and a pituitary tumor, received a left deltoid intramuscular injection of FLUZONE (lot number not reported) on 28 October 2009. Concomitant medication was SYNTHROID. She received no other vaccinations in the four previous weeks. The patient experienced a very sharp pain upon injection in the left deltoid. At the time of the report, the pain was persisting, it was waking her up at night if she rolled on her side, and the area felt cold. She also had occasional tingling in the fingers of her left hand. The patient was seen by her primary care physician who ordered an x-ray and MRI. The x-ray revealed that the bone was not affected. The MRI was scheduled for 20 November 2009. Corrective treatment was not reported. The patient had not recovered.
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nasopharyngitis
Clinical narrative: Initial case received on 16 February 2010 from a patient. A female patient (age and date of birth not reported) received an injection (route and site not reported) of FLUZONE SV (lot number U210AA-not valid SP lot number) on 16 September 2009. The patient reported she had a bad cold and dizziness for the past 6 months. No further information was provided. Documents held by sender: None.
Age: 26.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug exposure during pregnancy
Clinical narrative: A non-serious spontaneous report of inadvertently administered a dose of H1N1 to 13 weeks pregnant woman was received from a registered nurse concerning a 26-year-old female. The patient did not have ANY past medical history as well as no concomitant medications. The obstetrical history of the patient included two gravida and one para. On 09-Nov-2009, the patient was inadvertently administered H1N1, Intranasal. The last menstrual period was approximately 13-Aug-2009 while 20-May-2010 was the date reported for expected end of pregnancy. The patient was ten weeks pregnant at the time of vaccination. There was no adverse event associated with this pregnancy. Treatment and reporter's causality assessments are not applicable. The outcome of vaccine exposure during pregnancy was considered to be resolved. Additional information was received on 13-Nov-2009 and incorporated into the narrative: LMP date, expected delivery date, gravida, para, gestation period, medical history and concomitant medications. Additional information was received on 03-Jun-2010: Patient name and address, county where the patient was vaccinated, vaccine administered by and vaccinated at.
Sex: F
Vaccine: FLU3, FLUX(H1N1)
Symptoms: Adverse event
Clinical narrative: Initial case received from a consumer on 09 March 2010. A female patient reported that she received FLUZONE SV (lot not reported) and H1N1 (manufacturer and lot number not reported) and subsequently experienced an adverse event. No additional information was reported.
Age: 1.29
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of half dose of H1N1 administered to a 15-month-old child was received from a registered nurse/health professional concerning a 15-month-old female. The patient's medical history was not provided. On 10-Nov-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Fungal infection, Injection site reaction, Pain in extremity, Vulvovaginal discomfort, Vulvovaginal pruritus
Clinical narrative: Initial report received on 20 September 2009 from a consumer. A 36 year old female patient developed a reaction the same day after receiving FLUZONE (lot number was not provided) in the right deltoid on 16 September 2009. Later that day the patient complained of having a sore arm and stated that she yeast infection signs and symptoms such as vaginal irritation and itching. She did not have a fever or discharge. The patient did not receive treatment, however the patient was planning on going to see a health care professional. Recovery status was not reported. Follow-up information was received from a health care professional on 20 November 2009. The reporter stated that "patient is unknown to me, cannot find in my database". No additional information was provided. List of documents held by Sender: none.
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: A non-serious spontaneous report of "we inadvertently gave H1N1 to a person > 49" was received from a registered nurse concerning an adult female. Neither relevant medical history nor concomitant medications were reported. The product expires on 01-Jan-2010. On 09-Nov-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Neck pain, Viral infection
Clinical narrative: Initial report was received 03 September 2010 from a consumer, who is also the patient. A 26-year-old (also reported as a 27-year-old) female patient had received an intramuscular left deltoid injection of FLUZONE, lot number U3565CA on 26 August 2010 and two days later, she developed a pain on the left side of her neck which moved upward, and a severe headache. Sneezing, bending down, and standing up from a sitting or lying position caused the headache to return. She had no concurrent illness, no pre-existing medical conditions and she had not been taking any concomitant medications. She was evaluated by a physician and her diagnosis was "viral headache". The headache lasted five days and she recovered. Documents held by sender: None.
Age: 28.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of full dose (0.2ml) in one nostril was received from a registered nurse/health professional concerning a 28-year-old female. Neither medical history nor concomitant medications was reported for this patient. The patient received H1N1, Intranasal on 10-Nov-2009. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event is considered resolved.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Feeling of body temperature change
Clinical narrative: Initial report received on 13 September 2010 from a consumer who is the patient's spouse. A 72-year-old male patient had received a dose of FLUZONE High-Dose (lot number unknown) at 12:00 pm on 07 September 2010. Two hours post-vaccination, the patient had a cough and chills. He experienced hot and cold feelings all night. At the time of this report, the cough was still persisting. The patient had no concurrent illnesses, no known allergies and was taking blood pressure medication, and medication for his cholesterol. The reporter for this case is the same as for case 2010-04954. Documents held by sender: None.
Age: 12.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error
Clinical narrative: A non-serious spontaneous report of inadvertently administered the entire dose of H1N1 to one nostril was received from a registered nurse/ health professional concerning a 12-year-old female. The relevant medical history was not reported for this patient. On 10-Nov-2009, the patient inadvertently received entire dose of H1N1, Intranasal into one nostril because the divider clip did not stop. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Salivary hypersecretion
Clinical narrative: Initial report was received on 17 September 2009 from a health care professional. A 53-year-old female patient had received an intramuscular left deltoid injection of FLUZONE and one hour later, she developed a metallic taste in her mouth with increased salivation. She had no concurrent illnesses or pre-existing medical conditions and she had not been taking any concomitant medications at the time of vaccination. The reporter also noted that the patient had not received any testing or contrast media, and that she had not experienced these symptoms before. At the time of the report, the patient had not recovered. Documents held by sender: None.
Age: 12.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Wheezing
Clinical narrative: A non-serious spontaneous report of wheezing has been received from a registered nurse concerning a 12-year-old female, subsequent to H1N1, Intranasal. The patient's medical history included asthma and seizure. No other concomitant medications have reported for this patient. On 10-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. On 10-Nov-2009, after receiving the vaccine the patient experienced wheezing. The patient has been in contact with the pediatrician. The outcome of the event was unknown.