chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Non-serious case received from a healthcare professional on 18 September 2009. A 56-year-old female patient developed a two-inch red, raised "hive" at the injection site (two inches above the left elbow), one hour after receiving a left arm injection of FLUZONE (lot number U3191AA, route of administration unknown). The "hive" was hot and itchy. Patient outcome was unknown. Follow-up was received from a healthcare professional on 13 October 2009. The reporter indicated, "Swelling of the lower arm and redden - no distinct hive border." No additional details were provided. Follow-up was received from a healthcare professional on 08 January 2010. The healthcare professional reported no additional information at this time. Documents held by sender: None.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Oedema peripheral
Clinical narrative: Non-serious case received from a healthcare professional on 18 September 2009. A 56-year-old female patient developed a two-inch red, raised "hive" at the injection site (two inches above the left elbow), one hour after receiving a left arm injection of FLUZONE (lot number U3191AA, route of administration unknown). The "hive" was hot and itchy. Patient outcome was unknown. Follow-up was received from a healthcare professional on 13 October 2009. The reporter indicated, "Swelling of the lower arm and redden - no distinct hive border." No additional details were provided. Follow-up was received from a healthcare professional on 08 January 2010. The healthcare professional reported no additional information at this time. Documents held by sender: None.
Age: 6.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Decreased appetite, Epistaxis, Irritability, Malaise, Pyrexia
Clinical narrative: A serious spontaneous report of bloody nose, and non-serious report of fever of 103, vomiting, irritability, just not feeling well and decreased appetite has been received from a registered nurse/healthcare professional concerning a six-year-old male, subsequent to H1N1, Intranasal. The patient had a deviated septum, neither patient nor family had history of nose bleed. Concomitant medications included oral fluoride tablets, once daily. On 06-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. On 06-Nov-2009, after receiving H1N1 vaccine, on the same day the patient experienced fever of 103, vomiting, irritability, just not feeling well and decreased appetite. On 07-Nov-2009, the patient started having spontaneous bloody nose. He never had this prior. The bleeds soaked through blankets and had several blood clots in nasal discharge. At the time of reporting the patient has had a bloody nose everyday since 07-Nov-2009, but had become smaller and smaller until they had a totally stopped on 10-Nov-2009. On 11-Nov-2009, the mother reported that her son had been improving daily; that the fever and vomiting resolved on 08-Nov-2009, the decreased appetite resolved on 09-Nov-2009, and that late in the day on 10-Nov-2009 the unwell feeling, and nose bleeding had resolved. She did report that her son was irritability most of the day on 10-Nov-2009, but when he awoke on 11-Nov-2009, he was happy and back to his normal self. The mother reported that she had used only acetaminophen as needed at home during these events. On 17-Nov-2009, the patient was seen by the ENT specialist and all that was found was a deviated septum. The outcome for reported events was recovered. Additional information was received on 17-Dec-2009 and incorporated into the narrative: patient and family history, concomitant medications, outcome of the events was updated.
Age: 6.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Rhinorrhoea, Thrombosis, Vomiting
Clinical narrative: A serious spontaneous report of bloody nose, and non-serious report of fever of 103, vomiting, irritability, just not feeling well and decreased appetite has been received from a registered nurse/healthcare professional concerning a six-year-old male, subsequent to H1N1, Intranasal. The patient had a deviated septum, neither patient nor family had history of nose bleed. Concomitant medications included oral fluoride tablets, once daily. On 06-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. On 06-Nov-2009, after receiving H1N1 vaccine, on the same day the patient experienced fever of 103, vomiting, irritability, just not feeling well and decreased appetite. On 07-Nov-2009, the patient started having spontaneous bloody nose. He never had this prior. The bleeds soaked through blankets and had several blood clots in nasal discharge. At the time of reporting the patient has had a bloody nose everyday since 07-Nov-2009, but had become smaller and smaller until they had a totally stopped on 10-Nov-2009. On 11-Nov-2009, the mother reported that her son had been improving daily; that the fever and vomiting resolved on 08-Nov-2009, the decreased appetite resolved on 09-Nov-2009, and that late in the day on 10-Nov-2009 the unwell feeling, and nose bleeding had resolved. She did report that her son was irritability most of the day on 10-Nov-2009, but when he awoke on 11-Nov-2009, he was happy and back to his normal self. The mother reported that she had used only acetaminophen as needed at home during these events. On 17-Nov-2009, the patient was seen by the ENT specialist and all that was found was a deviated septum. The outcome for reported events was recovered. Additional information was received on 17-Dec-2009 and incorporated into the narrative: patient and family history, concomitant medications, outcome of the events was updated.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Eye discharge, Ocular hyperaemia
Clinical narrative: Initial report received on 19 September 2009 from a healthcare professional (physician). A patient, whose age, gender and medical history were not reported, received FLUZONE (lot number not reported) on an unspecified date. An unspecified amount of time later, the patient developed redness and discharge from both eyes. Corrective treatment and the patient's recovery status were not reported. Follow up information received on 22 September 2009 from a health care professional concerning a 62 year old male patient with an allergy to sulfa, cataracts, dry eye syndrome, hernia, and a history of prostate cancer. Concomitant therapy includes multivitamins, aspirin, NASACORT, ASMANEX, PULMICORT, and XOPENEX. The patient developed a reaction one day after receiving FLUZONE (U3185AA) intramuscularly in the left deltoid on 17 September 2009. On 18 September 2009 the patient went to the urgent care center with a complaint of eye redness and discharge which caused his eyes to be shut when he woke up. No other information was provided. The recovery status was unknown. Follow-up information received on 13 October 2009 from a health care professional. The patient completely recovered from the adverse events on 24 September 2009. The number of previous doses of FLUZONE, dates of administration and any observed symptoms were reported to be unknown. No further details were provided. List of Documents held by Sender: none.
Age: 15.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error
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 15-year-old male. 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 vaccination error; therefore, treatment and reporter causality assessments are not applicable and the event is considered resolved.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: Initial report received from a health care professional on 24 September 2009 which involved a cluster of ten patients; one of which experienced a serious adverse event which has been captured in case number 2009-04084. A cluster of ten patients (mixed genders, ages not reported) had received an intramuscular left deltoid injection of FLUZONE, lot number U3194AA on 22 September 2009 and within 24 to 48 hours (also reported as 23 September 2009), they complained of scratchy throats,  headache, general malaise, ear pain, GI symptoms and red itchy injection sites. The events required a doctor's visit; however the reporter stated that not all of the patient's experienced all of the reported symptoms. In addition to the reported symptoms, one patient developed a swollen throat and had been sent to the emergency room (captured in case 2009-04084). At the time of the report, the patients had not recovered from the events. Follow-up information received 16 October 2009 from a health care professional who provided patient specific information for one patient out of the remaining nine unidentified patients; This case shall now be the case of reference for a 43-year-old female who had no concurrent illness at the time of vaccination on 22 September 2009 at 08:00 hours. The event began at 22:00 hours on 23 September 2009 and did not require evaluation by a physician (previously reported as requiring a doctor's visit). According to the reporter, the patient recovered (date of recovery not reported). No additional information was provided for the remaining eight unidentified patients. The reporter for this case is the same as case number 2009-04084. Documents held by sender: None.
Age: 10.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Unevaluable event
Clinical narrative: A non-serious spontaneous report of ten-year-old got H1N1 and then symptoms has been received from a pharmacist/health professional concerning a ten-year-old female, subsequent to H1N1, Intranasal. No relevant medical history has been reported for this patient. The patient was administered oseltamivir phosphate within 48 hours of receiving the vaccine. On an unknown date in 2009, the patient received H1N1, Intranasal. On an unknown date in 2009, the patient experienced symptoms after receiving the vaccine. No details regarding the symptoms have been reported. The outcome of the event was unknown at the time of reporting.
Age: 47.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error
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 47-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 vaccination error; therefore, treatment and reporter causality assessments are not applicable and the event is considered resolved.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Cough, Flushing, Nausea, Rash macular
Clinical narrative: Initial report received on 28 September 2009 from a consumer, who is the patient's parent. A 7 year old male patient, with a history of asthma and seasonal allergies, received a left deltoid intramuscular injection of FLUZONE (lot number not reported) on 25 September 2009. He had no illness at the time of vaccination and concomitant medications included SINGULAIR and fluoride. Five minutes after vaccination, the patient began sneezing repeatedly, coughing, he felt nauseous, his face became flushed and facial swelling occurred. He had no difficulty breathing or swallowing. His temperature was 99.9 F (tympanic) and his chest became red and blotchy, but he had no actual hives. Corrective treatment was BENADRYL which was given every four hours. At the time of the report, the patient was much improved, but he had not completely recovered. Follow-up information received on 22 October 2009 from a physician. The vaccine administered on 25 September 2009 was FLUZONE (lot number U3195AA). Per the reporter, the patient recovered (date not provided). No further information is expected. Documents held by sender: None.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Sneezing, Swelling face
Clinical narrative: Initial report received on 28 September 2009 from a consumer, who is the patient's parent. A 7 year old male patient, with a history of asthma and seasonal allergies, received a left deltoid intramuscular injection of FLUZONE (lot number not reported) on 25 September 2009. He had no illness at the time of vaccination and concomitant medications included SINGULAIR and fluoride. Five minutes after vaccination, the patient began sneezing repeatedly, coughing, he felt nauseous, his face became flushed and facial swelling occurred. He had no difficulty breathing or swallowing. His temperature was 99.9 F (tympanic) and his chest became red and blotchy, but he had no actual hives. Corrective treatment was BENADRYL which was given every four hours. At the time of the report, the patient was much improved, but he had not completely recovered. Follow-up information received on 22 October 2009 from a physician. The vaccine administered on 25 September 2009 was FLUZONE (lot number U3195AA). Per the reporter, the patient recovered (date not provided). No further information is expected. Documents held by sender: None.
Age: 15.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious spontaneous report of some of H1N1 went into his eyes was received from a registered nurse concerning a 15-year-old male. The patient's medical history was not reported. On 11-Nov-2009, the patient received H1N1, Intranasal and some of the vaccine went into his eyes when he moved his head during administration. 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: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Initial report was received from a health care professional on 29 September 2009. A cluster of eight to ten patients out of 60 to 70 vaccinees had received an intramuscular injection of FLUZONE (lot number not reported) on 26 September 2009, and immediately within seconds, they experienced a black dot at the injection site after the needle was withdrawn from the deltoid muscle. The black dot could not be wiped off with gauze; however, it could be wiped off with an alcohol prep pad. The needles used to administer the vaccine were 25 gauge one inch in length and were manufactured by BD Dickinson; however, these needles were not used to draw up the vaccine. No additional symptoms were observed. One patient was prepubescent, one patient was a teen, and the remaining patients were adults. None of the patients had any concurrent illnesses and it was unknown if they had received any other vaccinations within four weeks prior to receipt of FLUZONE. All of the patients recovered. Follow-up information was received 13 October 2009 from a health care professional. The patient's had received FLUZONE, lot number U3213AA. No additional information was provided. Documents held by sender: None.
Age: 35.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious spontaneous report of inadvertently administered second dose of H1N1, Intranasal was received from a physician concerning a 35-year-old male. The patient received first dose of H1N1 vaccine on 28-Oct-2009. On 11-Nov-2009, the physician inadvertently administered second dose of same vaccine thinking that it was FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 30.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Neck pain, Pyrexia, Vaccination site pain
Clinical narrative: Initial report was received 02 October 2009 from a consumer. A 30-year-old male patient with no concurrent illness or pre-existing medical conditions, had received a left arm intramuscular injection of H1N1, lot number UP001AA on 30 September 2009 at 11:00 PM, and approximately 8 hours later (also reported as 8.5 hours later), he experienced dizziness, a fever of 101.2 degrees and radiating pain from the vaccination site to the neck area. The events did not require a doctor's visit. The patient had previously received an intramuscular right arm injection of FLUZONE SV (lot number not reported) on 19 September 2009. At the time of the report, the patient reported that all symptoms had resolved. Follow-up information was received from a health care professional on 20 November 2009. The patient recovered within one week, and did not require any treatment for the events. FLUZONE lot number was reported as UP001AA (not a valid FLUZONE lot number). Follow-up information was received from a health care professional on 02 December 2009. The FLUZONE lot number was reported to be U3213AA. No other information was provided. Follow-up information was received from health care professional on 06 August 2010. The patient received FLUZONE on 19 September 2009 and the lot number was corrected to UP001AA with an expiration date of 09 March 2011. The patient reported on 12 October 2009 no fever, dizziness or pain at that time. The treatment received was reported as none. Documents held by sender: None.
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Cough, Influenza virus test positive, Pyrexia
Clinical narrative: A non-serious spontaneous report of positive reaction to the rapid antigen influenza test manifested by fever and cough has been received from a non-health professional concerning a male patient, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 06-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. On 07-Nov-2009, the patient experienced fever and cough which were not present after 24 hours. Oseltamivir phosphate was administered after a positive reaction to the rapid antigen influenza test for the patient. The outcome was resolved.
Age: 56.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently administered a dose of H1N1 to 56 year old woman was received from a physician concerning a 56-year-old female. The relevant medical history was not reported for this patient. On 11-Nov-2009, the patient inadvertently received a dose of 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: 5.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Influenza, Influenza virus test positive, Pyrexia
Clinical narrative: A non-serious spontaneous report of positive for flu with symptom of fever has been received from a non healthcare professional/company representative concerning a five-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. In Nov-2009, the patient received H1N1, Intranasal for an unknown indication. In Nov-2009, after receiving H1N1 vaccine, the patient got sick. Six days later she tested positive for flu. The patient had only fever at the time of reporting. The dose was administered at a clinic. The outcome of this event was not recovered.
Age: 37.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently given half dose of H1N1 was received from a nurse/health professional concerning a 37-year-old female. The patient's medical history and concomitant medications was not reported. On 27-Oct-2009, the patient was inadvertently given half dose (0.1 ml) of 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: 30.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: No adverse event, Underdose
Clinical narrative: A non-serious spontaneous report of inadvertently given half dose of H1N1 LAIV was received from a nurse/health professional concerning a 30-year-old female. The patient's medical history and concomitant medications was not reported. On 27-Oct-2009, the patient was inadvertently given half dose (0.1ml) of 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: 33.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently given half dose of H1N1 was received from a nurse/health professional concerning a 33-year-old female. The patient's medical history and concomitant medications were not reported. On 27-Oct-2009, the patient was inadvertently given half dose (0.1 ml) of 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: 31.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently given half dose of H1N1 was received from a nurse/health professional concerning a 31-year-old male. The patient's medical history and concomitant medications was not reported. On 27-Oct-2009, the patient was inadvertently given half dose (0.1ml) of 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: 34.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently given half dose of H1N1 was received from a registered nurse/health professional concerning a 34-year-old female. The patient's medical history and concomitant medications was not reported. On 27-Oct-2009, the patient was inadvertently given half dose (0.1ml) of 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: 8.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Epistaxis, Laboratory test
Clinical narrative: A serious spontaneous report of daughter got H1N1 and then a nose bleed has been received from a registered nurse/healthcare professional concerning her eight-year-old daughter, subsequent to H1N1, Intranasal. The patient does not have a history of nose bleed and bleeding disorders. Concomitant medications have not been reported for this patient. The patient received H1N1, Intranasal on 15-Nov-2009 for an unknown indication. On 16-Nov-2009, the patient experienced severe nose bleed lasting for about 30 minutes. On 17-Nov-2009, she experienced another severe nose bleed that lasted 1.5 hours. The blood was gushing and they were unable to stop the bleed. She was taken to the emergency room. The doctor did a full work up to ensure that she does not have any bleeding disorder. The outcome of this event was unknown.
Age: 38.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently given half dose of H1N1 was received from a nurse/health professional concerning a 38-year-old female. The patient's medical history and concomitant medications was not reported. On 27-Oct-2009, the patient was inadvertently given half dose of 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: 32.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently given half dose of H1N1 was received from a nurse/health professional concerning a 32-year-old female. The patient's medical history and concomitant medications was not reported. On 27-Oct-2009, the patient was inadvertently given half dose of 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: 42.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently given half dose of H1N1 was received from a nurse/health professional concerning a 42-year-old female. The patient's medical history and concomitant medications was not reported. On 27-Oct-2009, the patient was inadvertently given half dose of H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessment are not applicable, and the event is considered resolved.
Age: 38.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Underdose
Clinical narrative: A non-serious spontaneous report of inadvertently given half dose of H1N1 was received from a nurse/health professional concerning a 38-year-old female. The patient's medical history and concomitant medications was not reported. On 27-Oct-2009, the patient was inadvertently given half dose of 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: 45.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: No adverse event, Underdose
Clinical narrative: A non-serious spontaneous report of inadvertently give half dose of H1N1 was received from a nurse/health professional concerning a 45-year-old female. The patient's medical history and concomitant medications was not reported. On 27-Oct-2009, the patient was inadvertently given half dose of 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: 28.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Underdose
Clinical narrative: A non-serious spontaneous report of inadvertently given half dose of H1N1 was received from a nurse/health professional concerning a 28-year-old male. The patient's medical history and concomitant medications was not reported. On 28-Oct-2009, the patient was inadvertently given half dose of 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: 89.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious spontaneous report of an 89-year-old female with kidney disease got H1N1 was received from a son/consumer. The patient's medical history included chronic kidney disease. The patient did not take any medications for her kidney disease and was not on dialysis. The concomitant medications included cilostazol and blood pressure medications. On 18-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 causality assessments are not applicable and the event was considered resolved.
Age: 48.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: No adverse event, Underdose
Clinical narrative: A non-serious spontaneous report of inadvertently given half dose of H1N1 was received from a nurse/health professional concerning a 48-year-old female. The patient's medical history and concomitant medications was not reported. On 29-Oct-2009, the patient was inadvertently given half dose of H1N1, Intranasal. There as no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 15.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious spontaneous report of gave full dose of H1N1 in one nostril was received from a registered nurse concerning a 15-year-old female. No relevant medical history was reported for his patient. On 18-Nov-2009 the patient inadvertently received 0.2ml of H1N1, Intranasal into a single nostril. 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: 57.0
Sex: U
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious spontaneous report of "administered H1N1 to 57 year old" was received from a pharmacist concerning a 57-year-old patient. The patient was diabetic. On 16-Nov-2009, the patient received 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: 1.58
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious spontaneous report of administrated to 19-month-old male was received from a registered nurse concerning a 18-month-old male patient. On 06-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. The patient had no relevant medical history and no concomitant medications. The patient was doing well and had no symptoms. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 13-Nov-2009 and incorporated into the narrative: The patient's medical history, concomitant medication and current health status was added. The reporter's address was updated. The responsible physician name and address was updated in the respective tabs.
Age: 43.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug exposure during pregnancy
Clinical narrative: A non-serious spontaneous report of H1N1 given to a four weeks pregnant women was received from a nurse/health professional concerning a 43-year-old female. The patient's medical history included trouble in conceiving, required help to become pregnant and obstetrical history was not reported. On 10-Nov-2009, the patient who was four weeks pregnant received H1N1, Intranasal. The estimated date of delivery was 16-Jul-2010. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. The outcome of the vaccine exposure during pregnancy was recovered. Additional information was received of 01-Dec-2009 and incorporated into the narrative: patient's medical history was updated. The title and phone no. of reporter was also received.
Sex: U
Vaccine: FLUN3
Symptoms: Unevaluable event
Clinical narrative: A non-serious spontaneous report of administered a dose of H1N1 within three days to one week was received from a physician concerning four children, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for these patients. The patients received the vaccine on an unspecified dates in year 2009 for immunization. There was no adverse event associated with this medication error; therefore, treatment and report causality assessments are not applicable and the event is considered resolved.
Age: 0.88
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of "H1N1 LAIV given to an 11 month" was received from a registered nurse/health professional in the concerning a 10-month-old male. The patient has been healthy, has not had any symptoms of the flu and has not had any reactions to the vaccination. No other relevant medical history and no concomitant medications have been reported for this patient. On 16-Oct-2009, the patient received 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 as resolved. Additional information was received on 24-Nov-2009 and incorporated this information into the narrative about the patient's past medical history, concomitant medications, prior use of vaccine and reporter's address in detail.
Age: 60.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Medication error
Clinical narrative: A non-serious spontaneous report of gave H1N1 to a man over 50 year old was received from a registered nurse concerning a 60-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 17-Nov-2009 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: 6.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: A non-serious spontaneous report of fever of 102 and sore throat has been received from a parent/consumer concerning his six-year-old daughter, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 18-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. On 19-Nov-2009, the patient woke up with fever of 102 and sore throat. The outcome of this event was unknown.
Age: 1.53
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, Pyrexia, Somnolence
Clinical narrative: A non-serious spontaneous report of administration of H1N1 to 18 month old, low grade fever and a little sleepy and napped has been received from a registered nurse/health professional concerning 18-month-old male, subsequent to H1N1, Intranasal. There was no medical history and the patient was healthy at the time of vaccination. The patient was not on any concomitant medications. On 18-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. After receiving H1N1 vaccine, the child felt a little sleepy and napped most of the afternoon and it was resolved on 19-Nov-2009. Twenty four hours after vaccination, the patient experienced low grade fever which resolved on its own 24-hours later. The outcome of the events was resolved. Additional information was received on 01-Dec-2009 and incorporated into the narrative: Event of low grade fever and the outcome of the event was resolved. Additional information was received on 03-Dec-2009 and incorporated into the narrative: Event of a little sleepy and napped most of the afternoon. The outcome of the event was resolved.
Age: 2.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Anger, Insomnia, Irritability, Sleep talking
Clinical narrative: A non-serious spontaneous report of insomnia, talking in sleep and very angry has been received from a registered nurse/health professional concerning a four to 39-month-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On an unknown date in 2009, the patient received H1N1, Intranasal for an unspecified indication. After vaccination, the patient had trouble sleeping and talking in her sleep. Patient had very fitful sleep and kept walking - very angry. Insomnia began the night after receiving H1N1 and persisted for one week. The patient was recovered from event of insomnia and the outcome of the events talking in sleep and very angry was unknown.
Age: 48.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: A non-serious spontaneous report of shingles has been received from a physician concerning his 48-year-old wife subsequent to H1N1, Intranasal vaccination. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient was in good health prior to vaccination. On 14-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. On 17-Nov-2009, the patient reported pain and rash in the dermatomal distribution consistent with shingles. No fever, no constitutional symptoms for the patient. No other history or physical findings. Shingles were diagnosed. No laboratories were obtained. The outcome of the event was unknown.
Age: 3.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious spontaneous report of received two separate doses of H1N1 on the same day was received from a non-health professional concerning a 44-month-old female. The relevant medical history was not reported for this patient. On 18-Nov-2009, the patient received two separate doses of H1N1, Intranasal. There as no adverse event associated with the medication error; therefore, treatment and reporter causality assessments are not applicable and the event is considered resolved.
Age: 1.46
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of 17 month old received H1N1 was reported by a medical assistant/health professional concerning a 17-month-old male. The patient had no medical history and no concomitant medication was taken by the patient. On 18-Nov-2009, the patient received H1N1, Intranasal at a MD's office. 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 02-Dec-2009 and incorporated into the narrative: Information added for medical history and concomitant medication.
Age: 15.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious spontaneous report of gave full dose of H1N1 in one nostril was received from a registered nurse concerning a 15-year-old male. On relevant medical history was reported for this patient. On 18-Nov-2009 the patient inadvertently received 0.2ml of H1N1, Intranasal into a single nostril. 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: 1.18
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of "we gave H1N1 to a 14-month-old male infant" was received from a physician. No concomitant medications have been reported for this patient. The medical history of the patient included Sturge-Weber disease since childbirth and the patient was treated with oral salbutamol last winter for an unspecified illness. The child was healthy after two weeks of vaccination. 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 30-Nov-2009 and incorporated into the narrative: medical history, concomitant medications and address of the reporter.
Age: 58.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of "H1N1 given to a 58 year old" was received from a registered nurse/health professional concerning a 58-year-old male patient. No relevant medical history have been reported for this patient. On 13-Nov-2009, the patient received 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 as resolved.
Age: 11.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious spontaneous report of gave full dose of H1N1 in one nostril was received from a registered nurse concerning a 11-year-old male. No relevant medical history was reported for this patient. On 18-Nov-2009 the patient inadvertently received 0.2ml of H1N1, Intranasal into a single nostril. 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: 11.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Fatigue, Malaise, Pyrexia, Rhinorrhoea, Vaccine positive rechallenge
Clinical narrative: A non-serious spontaneous report fever, rhinorrhea, fatigue has been received from a father/consumer concerning a 11-year-old female, subsequent to H1N1, Intranasal. The patient's past medical history includes, flu like symptoms for approximately ten days. Her symptoms included fever (99 to 103 F otic), sore throat, runny nose, body aches, headache, chills, and fatigue. The patient's concomitant medication included vaccine injection for seasonal influenza. On an unknown date, the patient received H1N1, Intranasal, for an unknown indication. Following day of vaccination, at school, the patient felt ill (approximately 12 to 20 hours following the vaccinations). The patient was seen by the school nurse who sent her home with a fever of 101 F, fever gradually rose throughout the evening to 104.8 F (otic). Approximately two hours after receiving a dose of ibuprofen her temperature decreased to 101 F. The patient was fever free by the morning. Other symptoms, rhinorrhea and fatigue, subsided the following day. The outcome for the reported events was recovered.
Age: 1.66
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of gave H1N1 to an infant <24 month old was received from a physician concerning a 19-month-old male patient. The patient neither had past medical history nor was on any concomitant medications. On 23-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 causality assessments were not applicable and the event was considered resolved. Additional information was received on 10-Dec-2009 and incorporated into the narrative: Patient initials, past medical history and concomitant medications.
Age: 2.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Pain, Pyrexia, Rhinorrhoea
Clinical narrative: A non serious spontaneous report of fever, runny nose and sore all over has been received from a consumer/non health professional concerning a 29-month-old female, subsequent to H1N1, Intranasal. Neither the patient's past medical history nor the concomitant medications have been reported. The patient received H1N1, Intranasal on 20-Nov-2009 for an unknown indication. The reporter stated that three days after receiving the vaccine, on 23-Nov-2009, the patient developed the symptoms of fever, runny nose and sore all over. The outcome of all these events was unknown.
Age: 55.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of gave H1N1 vaccine to a 55-year-old man was received from a registered nurse/other health professional concerning a 55-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 13-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 causality assessments are not applicable, and the event is considered resolved.
Age: 14.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious spontaneous report of gave full dose of H1N1 in one nostril was received from a registered nurse concerning a 14-year-old female. No relevant medical history was reported for this patient. On 18-Nov-2009 the patient inadvertently received 0.2ml of H1N1, Intranasal into a single nostril. 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: Allergy to vaccine, Decreased appetite, Fatigue, Headache, Pain
Clinical narrative: A non-serious spontaneous report of sick, temperature of 102 F, headache, fatigue, decreased appetite and body aches has been received from a consumer/parent concerning his five-year-old daughter, subsequent to H1N1, Intranasal vaccination. Neither relevant medical history nor concomitant medication have been reported. On 07-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. On 09-Nov-2009 and 10-Nov-2009, the patient experienced reactions to vaccine and developed symptoms of fever of 102 F, headache, fatigue, decreased appetite and body aches. The patient took ibuprofen and symptoms resolved by 11-Nov-2009. The outcome of reported events was resolved.
Age: 5.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Pyrexia
Clinical narrative: A non-serious spontaneous report of sick, temperature of 102 F, headache, fatigue, decreased appetite and body aches has been received from a consumer/parent concerning his five-year-old daughter, subsequent to H1N1, Intranasal vaccination. Neither relevant medical history nor concomitant medication have been reported. On 07-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. On 09-Nov-2009 and 10-Nov-2009, the patient experienced reactions to vaccine and developed symptoms of fever of 102 F, headache, fatigue, decreased appetite and body aches. The patient took ibuprofen and symptoms resolved by 11-Nov-2009. The outcome of reported events was resolved.
Age: 57.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of 57 year old receiving H1N1 LAIV was received from a health professional concerning a 57-year-old female. The patient's medical history was not reported. On 24-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: 11.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious spontaneous report of gave full dose of H1N1 LAIV in one nostril was received from a registered nurse concerning a 11-year-old male. No relevant medical history was reported for this patient. On 18-Nov-2009 the patient inadvertently received 0.2ml of H1N1, Intranasal into a single nostril. 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: 15.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious spontaneous report of gave full dose of H1N1 LAIV in one nostril was received from a registered nurse concerning a 15-year-old male. No relevant medical history was reported for this patient. On 18-Nov-2009 the patient inadvertently received 0.2ml of H1N1, Intranasal into a single nostril. 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: 11.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious spontaneous report of gave full dose of H1N1 LAIV in one nostril was received from a registered nurse concerning a 11-year-old female. No relevant medical history was reported for this patient. On 18-Nov-2009 the patient inadvertently received 0.2ml of H1N1, Intranasal into a single nostril. 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.