chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Pharyngeal hypoaesthesia, Pruritus generalised
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 years old male patient with anaphylactic reaction to hay and no previous illness, was intramuscularly vaccination in right arm with first dose of GARDASIL lot # (671006/1291AA) on 05-MAR-2012. Concomitant vaccine included: the second dose HAVRIX lot# AHAVB541DA, intramuscularly in right arm on 05-MAR-2012. Historical drug included EPIPEN prescribed for anaphylactic reaction to hay, date unknown. On 05-MAR-2012 11:15, the patient presented c/o "itching all over", no rash or hives noted, and denied shortness of air. The patient was administered BENADRYL 25 mg oral and observed for 15 minutes. On 11:35 the patient remembered getting vaccine this a.m., and stated itching was getting worse, throat feels numb. Red raised circular areas, approximately 5 cm ea, hive like rash noted to right upper arm. The patient was administered oxygen at 4L face mask. On 11:40 the patient was administered epinephrine 1:1000 0.5ml intramuscularly. On 11:58 the patient was transported to hospital via EMS. The outcome was unknown. Upon internal review, the adverse events required epinephrine treatment was considered to be an other important medical event. Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Depressed level of consciousness, Influenza, Injection site cellulitis, Pyrexia, Restlessness
Clinical narrative: Information has been received from a physician A clinic via relief system for sufferers from adverse drug reaction concerning a 72 year old male patient with hypertension, no allergy and a history of left eye fundal hemorrhage who on 22-OCT-2009 was vaccinated with pneumococcal vaccine injection (lot number 9MK04R), 0.5 mL into left upper arm at A clinic (indication, and injection route were not reported). Suspect therapies included COUGHCODE tablet, 2 tablet, BISOLVON tablet, 1 tablet, OMSEN tablet, 1 tablet, LOXONIN tablet, 1 tablet, BANAN tablet, 1 tablet, all of these were administered three times a day and started on 23-OCT-2009 for the treatment of "cold?". On 22-OCT-2009, at around 11:00, the patient was vaccinated with pneumococcal vaccine into left upper arm. On 23-OCT-2009, the patient visited B clinic because of flu symptoms. Diprophylline_dihydrocodeine combined drug, bromhexine, serrapeptase loxoprofen sodium, cefpodoxime proxetil were prescribed for 5 days. On 25-OCT-2009, in the morning, the patient experienced unrest and did not open his eyes. The patient developed injection site (left upper arm) cellulitis/cellulitis-like reaction. The patient was admitted to C hospital due to "worsening of consciousness condition with pyrexia". On 03-NOV-2009, the patient recovered from injection site (left upper arm) cellulitis/cellulitis-like reaction and "worsening of consciousness condition with pyrexia", and was discharged from C hospital. During the course, no test was performed at A clinic. The physician's comment (A clinic): It was unknown whether the cause was vaccine or cold medicines which prescribed at B clinic. It might be just symptom from pyrexia. The reporting physician considered that injection site cellulitis/cellulitis-like reaction was non-serious and "worsening of consciousness condition with pyrexia" was serious due to hospitalization. The reporting physician felt that the causal relationship between injection site cellulitis/cellulitis-like reaction and "worsening of consciousness condition with pyrexia" to pneumococcal vaccine and other suspect therapies was unknown. No further information is available.
Age: 45.0
Sex: M
Vaccine: TD
Symptoms: Paraesthesia
Clinical narrative: Paraesthesias of extremities up to several days after immunization.
Age: 55.0
Sex: M
Vaccine: HEPAB, IPV, RAB, TYP
Symptoms: Asthenia, Full blood count, Hot flush, Hyperhidrosis, Laboratory test
Clinical narrative: From 7/30/12 to approximately 8/7/12 developed cyclical (every 50 minutes) episodes of diaphoresis, hot flush and slight weakness. Each episode lasting approximately 5 minutes. Seen in our office on 8/4/12. Vitals were monitored for approximately 2-3 hours. Labs done.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: Site of vaccination/L shoulder remains painful when sleeping on (L) shoulder or actively using (L) shoulder 2 mo after date of vaccination.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram head normal, Fall, Head injury, Loss of consciousness
Clinical narrative: Pt passed out - pt feel off exam table hit head on wall. She was observed and then sent for a CT of the head which was normal.
Age: 1.62
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Papule, Pyrexia, Rash erythematous
Clinical narrative: Red raised papules noticed on 8/16/12. They looked fluid-filled according to mom. Mom called the client's doctor and is providing comfort care. Fever 100.7.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site rash
Clinical narrative: 48 hrs. after injection, mom called and states child had baseball size area of rash around injection site. Not red or warm.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Numbness in left arm immediately after intramuscular injection.
Age: 32.0
Sex: F
Vaccine: YF
Symptoms: Neck pain, Pyrexia, Urticaria
Clinical narrative: Yellow fever vaccine given on 8/12/2012 about 2pm. Patient called 8/16/12 and reported hives all over body, slight fever, soreness on sides of neck. Patient took BENADRYL. Patient told to seek medical attention.
Sex: M
Vaccine: FLUN3
Symptoms: Influenza like illness, Secondary transmission
Clinical narrative: A report has been received from a physician, concerning a male subject, who had been receiving nasal FLUMIST. No pertinent history, concomitant medications and concurrent diseases were reported. FLUMIST started on an unknown date. The patient (who was a physician) stated that for the last (3) years after his kids received FLUMIST, the patient developed flu-like symptoms for several days. At the time of reporting the outcome of the events was unknown. The event of flu-like symptoms was considered to be non-serious by the reporter. The event of after the patient's kids received FLUMIST, the patient developed flu like symptoms was considered to be non serious by company physician.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a four-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 15-Jan-2012. On 16-Jan-2012, the patient received expired product. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was obtained on 02-Apr-2012 and incorporated in the narrative: patient's information.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 28-month-old male. Neither relevant medical history no concomitant medications have been reported for this patient. The product expired on 18-Dec-2011. On 20-Dec-2011, the patient received expired product. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 1.98
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of administration one week prior to 2yo birthday was received from a health professional concerning a 23-month-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 17-Nov-2011, the patient received FLUMIST one week before her second birthday. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received on 02-Apr-2012 and incorporated into the narrative: No late occurring adverse event.
Age: 4.0
Sex: U
Vaccine: FLUN3
Symptoms: Cough, Expired drug administered, Oropharyngeal pain, Rhinorrhoea, Upper respiratory tract infection
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST and URI manifested with cough, running nose and sore throat has been received from a physician concerning a four-year-old patient, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST on 12-Dec-2012. On 9-Jan-2012, the patient had cough, on 13-Feb-2012 the patient had runny nose and sore throat. The patient was diagnosed with URI. The outcome of the events administration of expired FLUMIST was recovered and URI was unknown.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 26-month-old female. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 25-Dec-2011. On 05-Jan-2012, the patient received expired 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age. Additional information was received on 26-Mar-2012 and incorporated into the narrative: No late occurring adverse events.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Received Tdap 8/16/12 approximately 3:50 pm 8/17/12 approximately 8 am developed nausea, vomiting, headache, fever (101.3). No redness/rash at site.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 24-month-old male. Neither the patient's medical history nor the concomitant medications were reported. The reporter indicated that she was not sure whether the patient received FLUMIST IV or not. The product expired on 18-Dec-2011. On 19-Dec-2011, the patient received expired product. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age. Additional information was obtained on 30-Jan-2012: the reporter stated that the patient did not experience any late occurring adverse events.
Age: 4.0
Sex: F
Vaccine: MMR, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: (R) thigh area of erythema is 2 cm in diameter, warm to touch.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Area of erythema is 5 cm in diameter, red & warm.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a four-year-old female. Neither the patient's medical history nor the concomitant medications were reported. The reporter indicated that she was not sure whether the patient received FLUMIST IV or not. The product expired on 18-Dec-2011. On 20-Dec-2011, the patient received expired product. 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. This case will be submitted in accordance with MedImmune FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age. Additional information was obtained on 30-Jan-2012: the reporter stated that the patient did not experience any late occurring adverse events.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a four-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 13-Dec-2011, the patient received expired FLUMIST. The product expired on 11-Dec-2011. 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. This case will be submitted in accordance with MedImmune FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received on 03-Apr-2012 and incorporated into the narrative. No late occurring adverse event.
Age: 1.99
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to child under two years old was received from a health professional concerning a 23-month-old male. Neither the patient's medical history nor the concomitant medications were reported for this patient. On 22-Dec-2011, the patient received 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age. Additional information was obtained on 02-Apr-2012: it was reported that the child received FLUMIST 10 days prior to his second birthday and had no adverse events.
Sex: M
Vaccine: FLUN3
Symptoms: Influenza virus test positive, Streptococcal infection
Clinical narrative: A non-serious spontaneous report of strep and positive influenza test has been received from a non health professional concerning a male child, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age. Neither the patient's medical history nor the concomitant medications were reported. The patient received FLUMIST in Aug-2011. On 27-Dec-2011, the patient experienced strep and positive influenza test. The outcome of the events strep and positive influenza test was unknown.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 4-year-old male. Neither the patient's medical history nor the concomitant medications were reported. The reporter indicated that she was not sure whether the patient received FLUMIST IV or not. The product expired on 05-Dec-2011. On 26-Dec-2011, the patient received expired product. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age. Additional information was obtained on 04-Apr-2012: the reporter stated that the patient did not experience any late occurring adverse events.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a four-year-old female. Neither relevant medical history nor the concomitant medications have been reported for this patient. The product expired on 01-Jan-2012. On 02-Jan-2012, the patient received expired 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age. Additional information was obtained on 02-Apr-2012 and incorporated into the narrative: No late occurring adverse events.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 44-month-old female. Neither the patient's medical history nor the concomitant medications have been reported for this patient. The product expired on 25-Dec-2011. On 05-Jan-2012, the patient received expired 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age. Additional information was obtained on 26-Mar-2012: reporter's information and no late occurring adverse events were reported for this patient.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a four-year-old male. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 04-Dec-2011. On 16-Dec-2011, the patient received expired product. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age. Additional information was obtained on 06-Apr-2012: the reporter stated that the patient did not experience any late occurring adverse events.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 38-month-old female. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 08-Jan-2012. On 09-Jan-2012, the patient received expired product. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age. Additional information was obtained on 02-Apr-2012: The patient had no late occurring adverse events.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a child. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 08-Jan-2012. On 09-Jan-2012, the patient inadvertently received expired 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age. Additional information was received on 26-Mar-2012 and incorporated into the narrative: Expired dose of FLUMIST was not administered to this patient.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a child. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 25-Dec-2011. On 12-Jan-2012, the patient received expired product. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of patient was given FLUMIST that expired two weeks ago was received from a health professional concerning a four-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 18-Dec-2011. On 20-Dec-2011, the patient received expired product. 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. This case will be submitted in accordance with MedImmune FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was obtained on 04-Apr-2012: the reporter stated that the patient did not experience any late occurring adverse events.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, Rash
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a four-year-old male, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. The patient's medical history included ear infection. Concomitant medications included amoxicillin for ear infection. The patient received FLUMIST on 17-Jan-2012. On 26-Jan-2012, the patient experienced rash. The outcome of the events administration of expired FLUMIST and rash was recovered. Additional information was received on 04-Apr-2012 and incorporated into the narrative: an adverse event, medical history and concomitant medication. Additional information was obtained on 25-Apr-2012 and incorporated in the narrative: event information.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a physician concerning a 40-month-old male. Neither relevant medical history nor concomitant medication have been reported for this patient. The product expired on 15-Jan-2012. On 17-Jan-2012, the patient received expired 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. This case will be submitted in accordance with MedImmune FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received on 10-Apr-2012 and incorporated into the narrative: No late occurring adverse event.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 37-month-old male. Neither the patient's medical history nor the concomitant medications were reported. The reporter spoke to patient's mother on 28-Feb-2012, mother did not report any adverse events. She did not want to bring her son in for additional dose of FLUMIST as the expired FLUMIST was his second dose. The product expired on 12-Feb-2012. On 23-Feb-2012, the patient received expired product. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age. Additional information was obtained on 27-Apr-2012: the reporter stated that the patient did not experience any late occurring adverse events.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 24-month-old male. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 22-Jan-2012. On 27-Jan-2012, the patient received expired product. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 35-month-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 05-Feb-2012. The patient received expired FLUMIST on either 07-Feb-2012 or 08-Feb-2012. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a four-year-old male. Neither the patient's medical history nor the concomitant medications have been  reported for this patient. The product expired on 15-Jan-2012. On 24-Jan-2012, expired FLUMIST was administered to the patient. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age. Additional information was received on 09-Apr-2012: The patient did not develop any late occurring adverse events.
Age: 8.0
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a eight-year-old patient. Neither the patient's medical history nor the concomitant medications have been reported for this patient. The product expired on 11-Dec-2011. The patient received the expired FLUMIST 12-Dec-2011. 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. There was no late occurring adverse event reported.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a five-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 05-Feb-2012. The patient received expired FLUMIST on either 07-Feb-2012 or 08-Feb-2012. 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: 18.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administered of expired FLUMIST that was two days old was received from a health professional concerning an 18-year-old female. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 25-Dec-2011. On 27-Dec-2011, the patient received expired product. 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. Additional information was received on 21-Mar-2012: There were no adverse events following administration of expired FLUMIST.
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of we gave 14 doses of expired FLUMIST was received from a health professional concerning a 12-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 22-Jan-2012. On 26-Jan-2012, the patient received expired FLUMIST. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the events is considered resolved.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of received expired FLUMIST was received from a health professional concerning a five-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The product expired 05-Feb-2012. On 09-Feb-2012, the patient received expired product. 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. The reporter stated that the patient did not experience any late occurring adverse events.
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of FLUMIST to a 19 month old was received from a health professional concerning a 19-month male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 26-Jan-2012, the patient received 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. This case will be submitted in accordance with MedImmune FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received on 11-Apr-2012 and incorporated into the narrative. No late occurring adverse event.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently given expired FLUMIST was received from a health professional concerning a 37-month-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2012. On 27-Jan-2012, expired FLUMIST was inadvertently administered to the patient. There was no adverse event associated with this medication, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 58 months of age.
Age: 4.0
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of we gave 14 doses of expired FLUMIST of was received from a health professional concerning a four-year-old child. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 22-Jan-2012. On 26-Jan-2012, the patient received expired product. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of we gave 14 doses of expired FLUMIST was received from a health professional concerning a four-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 22-Jan-2012. On 23-Jan-2012, the patient received expired 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of given expired FLUMIST was received from a health professional concerning a four-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 22-Jan-2012. On 23-Jan-2012, expired FLUMIST was administered to the patient. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of given expired FLUMIST was received from a health professional concerning a 35-month-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 05-Feb-2012. On 06-JFeb-2012, the patient received expired 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received on 11-Apr-2012: The reporter confirmed that there were no late occurring adverse events.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 27-month-old female. Neither the patient's past medical history nor the concomitant medications were reported. FLUMIST was given intranasally. The product expired on 04-Mar-2012. On 12-Mar-2012, the patient received expired product. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was obtained on 17-Apr-2012: Suspect drug information and the reporter stated that the patient did not experience any late occurring adverse events.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of given expired FLUMIST was received from a health professional concerning a four-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 10-Dec-2011, the patient inadvertently received expired FLUMIST. The product expired on 05-Dec-2011. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information as received on 30-Mar-2012 and incorporated into the narrative: No late occurring adverse event.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 47-month-old female. Neither the patient's medical history nor the concomitant medications were reported. The product expired 20-Nov-2011. On 20-Dec-2011, the patient received expired product. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administered 17 doses of expired FLUMIST was received from a health professional concerning children. Neither relevant medical history nor concomitant medications have been reported for this patient. The two lots of the product expired on 08-Jan-2012 and 15-Jan-2012. On 31-Jan-2012, the patient received expired product. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for this indicated population of 2 years to 59 months of age.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of given expired FLUMIST was received from a health professional concerning a four-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 05-Jan-2012. The patient received expired product on either 07-Feb-2012 or 08-Feb-2012. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 19.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of given expired FLUMIST was received from a health professional concerning a 19-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 18-Dec-2011. On 19-Dec-2011, the patient received expired product.. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of given expired FLUMIST was received from a health professional concerning a eight-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 05-Feb-2012. On 19-Feb-2012, the patient received expired 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 24-month-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 19-Feb-2012. On 21-Feb-2012, the patient received expired FLUMIST. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the events its considered resolved. This case will be submitted in accordance with MedImmune FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently administered expired FLUMIST 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. On 10-Dec-2011, the patient inadvertently received expired FLUMIST. The product expired on 05-Dec-2011. 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. Additional information was received on 30-Mar-2012 and incorporated into the narrative. No late occurring adverse event.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of gave expired FLUMIST was received from a health professional concerning a four-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 08-Jan-2012. On 21-Feb-2012, the patient received expired product. 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. This case will be submitted in accordance with MedImmune FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Pain in extremity, Palmar-plantar erythrodysaesthesia syndrome, Rash, Viral infection
Clinical narrative: A non-serious spontaneous report of hand and foot disease manifested with tiny bumps, painful rash on hands, fingers and palms has been received from a physician concerning a 40-month-old female, subsequent to FLUMIST. This case will be submitted in accordance with MedImmunes FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST ON 27-Dec-2011. On approximately 10-Jan-2012, the patient experienced fine tiny bumps (1mm), painful rash on their hands, ventral side mostly fingers, but also palms, which was diagnosed as hand and foot disease. The reporter believed that the rash was probably due to a viral infection, which began with the mother and was transmitted to her sister and then her. The outcome of event was unknown. Additional information was received on 26-Apr-2012 and incorporated into the narrative: event information.
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 12-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 20-Dec-2011, the patient inadvertently received expired FLUMIST. The product expired on 11-Dec-2011. 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: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 24-month-old female. Neither the patient's past medical history nor the concomitant medications were reported. FLUMIST was given intra-nasally for flu prevention. The product expired on 04-Mar-2012, the patient received expired product. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was obtained on 17-Apr-2012: Suspect drug information and the reporter stated that the patient did not experience any late occurring adverse events.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a four-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. FLUMIST was given intra-nasally. The product expired on 04-Mar-2012. On 07-Mar-2012, the patient received expired product. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the events is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was obtained on 17-Apr-2012: Suspect drug information and the reporter stated that the patient did not experience any late occurring adverse events.