chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
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 a 37-year-old female. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 20-Nov-2011. On 09-Jan-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 obtained on 24-Apr-2012: the reporter stated that the patient did not experience any late occurring adverse events. The patient was offered to be revaccinated, but she refused.
Age: 34.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a health professional concerning a 34-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 01-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. Additional information was received on 24-Apr-2012 and incorporated into the narrative: No late occurring adverse event.
Age: 31.0
Sex: F
Vaccine: FLUN3
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to a pregnant woman was received from a health professional concerning a 31-year-old female. Neither relevant medical history, obstetrical history nor concomitant medications have been reported for this patient. On 16-Jan-2012, FLUMIST was administered to the pregnancy 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.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of expired FLUMIST administered was received from a health professional concerning a seven-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 08-Jan-2012. On 11-Jan-2012, the patient inadvertently 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.
Age: 5.0
Sex: M
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 a five-year-old male. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 04-Dec-2011. On 07-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 obtained on 06-Apr-2012: the reporter stated that the patient did not experience any late occurring adverse events.
Age: 6.0
Sex: M
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 a six-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 01-Jan-2012. On 03-Jan-2012, the patient inadvertently 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 26-Mar-2012: No adverse events were experienced by the patient.
Age: 9.0
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 nine-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 04-Mar-2012. On 09-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. Additional information was received on 16-Apr-2012 and incorporated into the narrative: No late occurring adverse event.
Age: 8.0
Sex: M
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 male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 01-Jan-2012. On 03-Jan-2012, the patient inadvertently 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 26-Mar-2012: No adverse events were experienced by the patient.
Age: 7.0
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 seven-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2012. On 17-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.
Age: 6.0
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 a six-year-old female. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 25-Dec-2011. 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.
Age: 20.0
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 20-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 01-Jan-2012. On 04-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.
Age: 16.0
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 16-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 18-Dec-2011. On 21-Dec-2011, 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. Additional information was received on 04-Apr-2012. The patient did not develop any late occurring adverse events.
Age: 5.0
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 five-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 18-Dec-2011. On 21-Dec-2011, 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. Additional information was received on 04-Apr-2012 and incorporated into the narrative: No late occurring adverse event.
Age: 11.0
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 of was received from a health professional concerning an 11-year-old female. Neither the patient's medical history nor 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.
Age: 8.0
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 an eight-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 04-Mar-2012. On 09-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. Additional information was obtained on 18-Apr-2012: the reporter stated that the patient did not experience any late occurring adverse events.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of patient received expired FLUMIST was received from a health professional concerning a five-year-old female. Neither the patient's medical history nor concomitant medications were reported. The product expired on 12-Feb-2012. On 22-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.
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 healthcare 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: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of dose of expired FLUMIST administered was received from a health professional concerning a seven-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 08-Jan-2012. On 09-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. Additional information was received on 02-Apr-2012 and incorporated into the narrative: No late occurring adverse event.
Age: 7.0
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 seven-year-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 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.
Age: 13.0
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 13-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 22-Jan-2012. On 27-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.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of given FLUMIST that expired two weeks ago was received from a health professional concerning a six-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 18-Dec-2012. On 21-Dec-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. Additional information was received on 04-Apr-2012: The patient did not develop any late occurring adverse events.
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 of was received from a health professional concerning a 12-year-old female. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 22-Jan-2012. On-27-2012, 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.
Age: 22.0
Sex: F
Vaccine: FLUN3
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of FLUMIST to a pregnant woman was received from a non-health professional concerning a 22-year-old female. Neither her relevant medical history, concomitant medications nor obstetrical history had been reported for the patient. On 30-Nov-2011, FLUMIST was administered to the pregnant patient. Her last menstrual period was on 19-Sep-2011 and had gestation period of eight weeks when FLUMIST was administered. The patient's estimated date of delivery was on 25-Jun-2012. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable and the event was considered resolved. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
Age: 5.0
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 five-year-old female. Neither the patient's medical history nor 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.
Age: 6.0
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 six-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 12-Feb-2012. On 15-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. Additional information was received on 24-Apr-2012 and incorporated into the narrative: No late occurring adverse events.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of received expired vaccine was received from a health professional concerning an 11-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Nov-2011. The patient received the expired FLUMIST on 29-Nov-2011. The patient received a repeat dose of 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. The reporter stated that the patient did not experience any late occurring adverse events.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Ataxia, Dizziness, Headache, Influenza, Lethargy
Clinical narrative: A non-serious spontaneous report of ataxia, dizziness and flu manifested with lethargy, headache and body ache has been received from a consumer concerning a nine-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 28-Oct-2011. On 02-Nov-2011, the patient experienced lethargy, headache, bodyache and dizziness with no fever. He has had had some neurological symptoms. Then on 07-Nov-2011, he was diagnosed with ataxia with mild flu like symptoms. The outcome of events ataxia, dizziness and flu was not resolved.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Neurological symptom, Pain
Clinical narrative: A non-serious spontaneous report of ataxia, dizziness and flu manifested with lethargy, headache and body ache has been received from a consumer concerning a nine-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 28-Oct-2011. On 02-Nov-2011, the patient experienced lethargy, headache, bodyache and dizziness with no fever. He has had had some neurological symptoms. Then on 07-Nov-2011, he was diagnosed with ataxia with mild flu like symptoms. The outcome of events ataxia, dizziness and flu was not resolved.
Age: 36.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administered expired FLUMIST was received from a health professional concerning an 36-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 13-Feb-2012. The patient inadvertently received expired product on 16-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. Additional information was received on 26-Mar-2012: The reporter stated that the patient did not experience any adverse events and the patient received FLUMIST very soon after it expired.
Age: 44.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administered expired FLUMIST was received from a health professional concerning an 44-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 13-Feb-2012. The patient inadvertently received expired product on 16-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. Additional information was received on 26-Mar-2012: The reporter stated that the patient did not experience any adverse events and the patient received FLUMIST very soon after it expired.
Age: 20.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administered expired FLUMIST was received from a health professional concerning an 20-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 13-Feb-2012. The patient inadvertently expired product on 16-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. Additional information was received on 26-Mar-2012: The reporter stated that the patient did not experience any adverse events and the patient received FLUMIST very soon after it expired.
Age: 15.0
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 15-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 25-Feb-2012. On 27-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.
Age: 14.0
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 14-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Nov-2011. The patient received the expired FLUMIST on 29-Nov-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. The reporter stated that the patient did not experience any late occurring adverse events.
Age: 10.0
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 six-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Nov-2011. The patient received expired FLUMIST on 23-Nov-2011. The patient received a repeat dose. 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.
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 relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Nov-2011. The patient received expired FLUMIST on 01-Dec-2011. The patient received a repeat dose. 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: 15.0
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 15-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 04-Mar-2012. On 09-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. Additional information was received on 16-Apr-2012: No late occurring adverse events were reported.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of received expired vaccine was received from a health professional concerning a 12-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Nov-2012. The patient received the expired FLUMIST on 30-Nov-2011. 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. The reporter stated that the patient did not experience any late occurring adverse events.
Age: 14.0
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 14-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 04-Mar-2012. On 13-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. Additional information was received on 16-Apr-2012 and incorporated into the narrative: No late occurring adverse event.
Age: 8.0
Sex: F
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 an eight-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Nov-2011. The patient received the expired FLUMIST on 23-Nov-2011. The patient was given repeat dose. 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.
Age: 3.0
Sex: F
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 29-month-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Nov-2011. The patient received the expired FLUMIST on 23-Nov-2011. The patient received a repeat dose. 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. 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: 7.0
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 seven-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 04-Mar-2012. On 07-Mar-2012, the patient received expired FLUMIST for flu prevention. 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 17-Apr-2012 and incorporated into the narrative: Suspect drug information and no late occurring adverse event.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of we gave an expired dose of FLUMIST was received from a health professional concerning a seven-year old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 24-Jan-2012. On 17-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 considered resolved.
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 an adult female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 04-Mar-2012. On 13-Mar-2012, the patient received expired FLUMIST for flu prevention. 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 17-Apr-2012 and incorporated into the narrative: Suspect drug information, patient demographics and no late occurring adverse event.
Age: 33.0
Sex: F
Vaccine: FLUN3
Symptoms: Pain in extremity, Palmar-plantar erythrodysaesthesia syndrome, Rash
Clinical narrative: A non-serious spontaneous report of hand and foot disease manifested with tiny bumps, painful rash on hands, finger and palms has been received from a physician concerning a 33-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 27-Dec-2011. On 27-Dec-2011, the patient experienced painful rash on their hands. In Jan-2012, the patient experienced fine tiny bumps (1mm), painful rash on their hands, ventral side mostly fingers, but also palms, which looks like hand and foot disease but the rash bumps were very small in comparison to the hand and foot disease. Two daughters have the same complaint. The outcome of event was unknown. Additional information was received on 26-Apr-2012 and incorporated into the narrative: Outcome and event information.
Age: 8.0
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 an eight-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 27-Dec-2011. In Jan-2012, the patient experienced fine tiny bumps (1mm), painful rash on their hands (around her fingers and on the ventral side of her hands), but also palms. It was non-impressive. She was diagnosed with hand and foot disease (probably viral). She was seen again on 05-Mar-2012 and continued to have the rash. The reporter believed that the rash was probably due to viral infection, which began with the mother and was transmitted to the patient. Mother and her sister had similar complaints at the time of reporting. The outcome of event was unknown. Additional information was received on 26-Apr-2012 and incorporated into the narrative: event information.
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 an adult male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 04-Mar-2012. On 13-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. Additional information was received on 17-Apr-2012 and incorporated into the narrative: Suspect drug information, patient demographics and 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 administration of expired FLUMIST was received from a health professional concerning a four-year-old female. Neither the patient's past medical history nor concomitant medications were reported. The product expired on 04-Mar-2012. On 06-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 16-Apr-2012: the reporter stated that the patient did not experience any late occurring adverse events.
Age: 4.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (Lot#, dose number, dose/frequency, route and duration were unspecified) on 09-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient inadvertently received ZOSTAVAX instead of VARIVAX on 09-AUG-2012. No symptoms reported. It was unspecified whether the patient had sought medical attention. No treatment information was reported. At the time of reporting the outcome was unknown. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an adult male patient. The patient was vaccinated with the first dose of VAQTA on 19-FEB-2006 and a pediatric dose (0.5 ml) of VAQTA (lot # 673181/0325AE, exp date: 09-DEC-2014) for his second dose on 10-JUL-2012. No adverse effects reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypoaesthesia, Influenza like illness, Somnolence, Spinal pain
Clinical narrative: This spontaneous report as received from a consumer refers to herself a 65 years old female patient with tetracycline allergy(give her a headache) and penicillin allergy. The patient's medical history included headache and a prior episode of shingles(in January 2010). The patient was vaccinated with ZOSTAVAX (Lot#, dose/frequency, dose number and route were unspecified) on 29-JUL-2012. No other co-suspects were reported. No concomitant medications were used. It was reported that, while on ZOSTAVAX, the patient experienced a headache, flu like symptom and was sleepy. She also was experiencing a weird, numblike sensation in the right ankle and right foot and a deep pain in the L5 region of her spine on 30-JUL-2012. The patient had sought medical attention via calling the doctor and she was prescribed VALACYCLOVIR HCL as treatment given for the AE. At the time of reporting the outcome was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a pediatric patient of unknown age. No concomitant medications were reported. It was reported that a pediatric patient received an adult dose of VAQTA on an unknown date and there was no adverse reaction reported. It was unspecified whether the patient had sought medical attention or not. No treatment information was reported. At the time of reporting the outcome was unknown. Additional information is not expected.
Age: 63.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a patient of unknown age. The patient was vaccinated with VARIVAX (Lot#, route, dosage unspecified) instead of ZOSTAVAX on 08-AUG-2012. No symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 07-AUG-2012 the patient was vaccinated intramuscularly (IM) with a dose of VAQTA (reported lot# 0271AE, exp. date 20-NOV-2014), that had been stored under refrigeration in a plastic syringe for 28 hours. It was unknown if the patient sought medical attention. No known adverse effects. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Hot flush, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 79 years old female patient with no medical history and no drug allergies. The patient was vaccinated with ZOSTAVAX (Lot# unspecified) on an unspecified date in MAY-2012. No other co-suspects were reported. Concomitant medications included VESICARE, lorazepam, amlodipine, hydrochlorothiazide, potassium chloride (manufacture unknown) and LIPITOR. The pharmacist stated the patient's "whole arm was one massive bruise" after she received ZOSTAVAX. The pharmacist mentioned the bruising resolved, but the patient was in the pharmacy on 10-AUG-2012, stating that she had now (date unspecified) developed "hormonal type side effects and hot flashes that last 20 minutes at a time, as well as itchy breast nipples." No treatment information was reported. The outcome was reported as not recovered for hormonal type side effects, hot flashes and itchy breast nipples. The patient had sought medical attention via office visiting. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Food allergy, Pruritus generalised, Throat irritation
Clinical narrative: This spontaneous report as received from a consumer concerning her 4 year old son with eczema and other food allergies and no drug reactions/allergies who on 05-APR-2005 was vaccinated with the first dose of M-M-R II (dose, route and lot # not provided), on 10-JAN-2007 was vaccinated with the second dose of M-M-R II (dose, route and lot # not provided) and on 17-JUN-2009 receive the third dose of M-M-R II (dose, route and lot # not provided). No other co-suspects were reported. No concomitant medications were reported. . It was reported that prior to receiving the third dose (date not provided), the patient had a slight reaction after eating anything that contained egg. On 18-JUN-2009 "24 hours after the third vaccination with M-M-R II)", the patient's whole body from head to toe was itching "inside and out" as the patient put it. The patient would have an itch, but after the third vaccination he was having more serious reactions like an itching in the throat. The patient's mother stated that there was a mix up as he was given 3 not 2 vaccinations and it was after the third one that her son began to experience the more severe reactions. No treatment was given for the events. No laboratory tests were performed. At the time of the report, the patient was recovering from the events. The relatedness for the events was unknown for M-M-R II). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient was vaccinated with the first dose GARDASIL on 17-AUG-2007, the second dose on 19-DEC-2007, and would receive 3rd dose on 09-AUG-2012. Vaccine lot # and route were unspecified. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (Lot #, dose and route not reported) in 2009. The patient had not received doses and was in the office on 09-AUG-2012 to receive the second dose of GARDASIL (Lot #, dose and route not reported). It was not known if the patient sought for medical attention. No adverse effect reported. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Oedema peripheral, Rash erythematous, Skin warm
Clinical narrative: Information has been received from a registered pharmacist concerning an 80 year old patient who on 20-APR-2012 was vaccinated subcutaneously with one shot of ZOSTAVAX (Merck) (lot # unknown). On 20-APR-2012 the patient developed a "swelling in their upper arm with a red mark that gave off heat". The patient had sought unspecified medical attention. The patient was working with their healthcare provider to address the situation. Follow up information has been received from the registered pharmacist refers the 80 year old female patient. The patient was vaccinated with one shot of ZOSTAVAX (Merck) (lot number 672564/1652AA, expired date 21-JAN-2013) (dose, route and injection site were not reported) subcutaneously on 20-APR-2012. On 20-APR-2012 the patient complained of red rash at injection site, which lasted 3 weeks and went away. The patient was recovered on 18-MAY-2012. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 4 patients of unknown age. The patients were vaccinated with doses of (lot # 0128AE, exp date 10-JAN-2014) M-M-R II (dose and route not reported) on 02-JUL-2012. No other co-suspects and no concomitant medications were reported. The registered nurse reported that while checking temperature stability of multiple vaccines she noticed that the four patients were vaccinated with doses of M-M-R II that had been exposed to 14.9 degrees Celsius for ten hours. No adverse effect was reported. No other vaccines were administered to patients. No treatment information was reported. Follow-up information has been received from a registered nurse stated that were only to 2 children, not 4 children as previously reported. The second child was a 4 year old girl, who on 02-JUL-2012 was vaccinated with dose of M-M-R II )that had been exposed to 14.5 degrees Celsius. Any adverse effects reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HIBV, MEN
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse concerning an unknown number of patients with no known drug reactions/allergies who on unknown dates might have improperly stored LIQUID PEDVAXHIB (dose, route and lot # not provided) that was exposed to 30F for 12 hours. The nurse stated that this temperature excursion occurred during the 1st week of June 2012. Patients might have been exposed to LIQUID PEDVAXHIB after this time frame, approximately in June 2012. There were no known adverse effects. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. The patient was vaccinated with the first and second dose of GARDASIL (lot number not provided) on 11-AUG-2011 and on 13-AUG-2012 the patient was in the office to receive the second dose. No other co-suspects were reported. No concomitant medications were reported. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, IPV, MNQ, FLU3, HPV4, IPV, MNQ
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 14 years old female patient with no medical history and no pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly in the right arm with lot # (670050/1229AA) dose 3 of GARDASIL (dose not reported) on 03-APR-2012. No other co-suspects were reported. Concomitant medications included dose 1 of MENACTRA (lot # U4005AA) IM in left arm, dose 4 of IPOL (lot # G15001) IM in the left arm and dose 1 of FLUZONE (lot # UH456AB) IM in the right arm. On 04-APR-2012 the patient noticed right arm swelling, erythema and pain. It progressively got worse over the next 2 days. The patient walked into the clinic on 05-APR-2012 unable to be seen. The patient was given treatment with KEFLEX and was scheduled a follow up appointment for 06-APR-2012 and the erythematous area was circled in black marker. The patient returned for visit at 1:30pm on 06-APR-2012, the redness was worsening. The patient was taken by the school nurse's car to the hospital at the end of the day at 2pm. The outcome of right arm swelling and right arm pain was unknown. The outcome of right arm erythema was reported as worsening at the time of the report. The relatedness for the reported events was not provided for GARDASIL. The patient required an emergency room visit. This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID # is 453148-1. No further information is available.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Lymphadenopathy
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. This spontaneous report as received from a regulatory authority refers to a 15 years old male patient with no pertinent medical history and no pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly in the right arm (right deltoid injection) with GARDASIL (lot # and dose not reported) on 05-APR-2012. No other co-suspects were reported. There was no concomitant medications. On 07-APR-2012, 2 days post vaccination, the patient developed axilla lymphadenopathy on the side of injection of GARDASIL. No treatment information was reported. The outcome of axilla lymphadenopathy on the side of injection was unknown. The relatedness for the reported event was not provided for GARDASIL. The patient required an emergency room visit. This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID# is 453156-1. No further information is available.