chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a six-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the first dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
Age: 8.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a eight-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the first dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
Age: 8.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of '2 children each received a dose of expired H1N1 LAIV' was received from a pharmacist concerning a eight-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 25-Jan-2010. On 26-Feb-2010, the patient received expired H1N1, Intranasal, for an unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 4.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "inadvertently gave two kids H1N1 LAIV that was expired" was received from a health professional concerning a four-year-old male child. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 23-Feb-2010. On 02-Mar-2010, the patient received expired H1N1, Intranasal, for unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 7.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "inadvertently gave two kids H1N1 LAIV that was expired" was received from a health professional concerning a seven-year-old female child Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 23-Feb-2010. On 02-Mar-2010, the patient received expired H1N1, Intranasal, for unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 45.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a pharmacist concerning a 45-year-old male, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 25-Feb-2010. On 11-Mar-2010, the patient received expired vaccine for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of H1N1 to 2 elderly patients was received from a consumer concerning a male patient who was in his 80's. Neither relevant medical history nor concomitant medications have been reported for this patient. On an unknown, the patient received H1N1, Intranasal, for unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of H1N1 to 2 elderly patients was received from a consumer concerning a female patient who was in her 80's. Neither relevant medical history nor concomitant medications have been reported for this patient. On an unknown, the patient received H1N1, Intranasal, for unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse concerning a male child, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 10-Mar-2010. On 17-Mar-2010, the patient received expired vaccine for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Sex: U
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of product to individuals over 49yo was received from a registered nurse/health professional concerning several individuals of unknown gender who were over the age of 49 years. Neither relevant medical history nor concomitant medications have been reported for these patients. On 19-Mar-2010, the patients received H1N1, Intranasal, for an unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 12.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "we administered expired H1N1 LAIV" 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 01-March-2010. On 15-March-2010, the patient received expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable and the event was considered resolved.
Age: 9.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of we administered expired H1N1 LAIV was received from a health professional concerning a nine-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 01-March-2010. On 15-March-2010, the patient received expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable and the event was considered resolved.
Age: 9.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of we administered expired H1N1 was received from a health professional concerning a nine-year-old female.  Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 01-March-2010. On 15-March-2010, the patient received expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable and the event was considered resolved.
Age: 6.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of we administered expired H1N1 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-March-2010. On 15-March-2010, the patient received expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable and the event was considered resolved.
Age: 4.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "inadvertent administration of expired H1N1 LAIV" was received from a registered nurse/health professional concerning a four-year-old female. Neither relevant medical history nor concomitant medication have been reported for the patient. The vaccine expired on 10-Mar-2010. On 23-Mar-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Hypoaesthesia, Injection site anaesthesia, Injection site erythema
Clinical narrative: Initial report received from a health care professional on 01 September 2010. A 27-year-old female patient with no medical history, takes no medications, no illness at the time of vaccination and had no other vaccinations within 4 weeks, received on 31 August 2010 an intramuscular (IM) deltoid injection of FLUZONE, lot number U3651AA. On 31 August 2010, the patient complained of having numbness and tingling from the injection site at the deltoid all the way down the arm to the fingers. The deltoid area was red, swollen and warm to touch. The patient complained of having fatigue and a headache. The outcome was reported as not recovered. Documents held by sender: None.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth, Paraesthesia
Clinical narrative: Initial report received from a health care professional on 01 September 2010. A 27-year-old female patient with no medical history, takes no medications, no illness at the time of vaccination and had no other vaccinations within 4 weeks, received on 31 August 2010 an intramuscular (IM) deltoid injection of FLUZONE, lot number U3651AA. On 31 August 2010, the patient complained of having numbness and tingling from the injection site at the deltoid all the way down the arm to the fingers. The deltoid area was red, swollen and warm to touch. The patient complained of having fatigue and a headache. The outcome was reported as not recovered. Documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Injection site nodule
Clinical narrative: Initial report was received 02 September 2010 from a health care professional. Eight unidentified patients (noted to be employees) had received FLUZONE on 01 August 2010 (lot number, route and site of administration not reported) and an unspecified amount of time later, seven of the eight patients had developed a 2 inch x 2 inch nodule at the administration site. No additional information was provided at the time of the report. Outcome was not reported. Documents held by sender: None.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Respiratory rate increased, Tachycardia
Clinical narrative: Initial report received on 22 September 2009 from a health care professional. A 41 year old female patient with no reported medical history experienced symptoms after vaccination with FLUZONE (Lot number U3173CA) intramuscularly in the left deltoid, and an intradermal left forearm administration of TUBERSOL 5 TU (lot number number C3151AA) on 21 September 2009. The same day, post vaccination the patient developed tachycardia of 110/minutes and an increased respiratory rate of 30/minutes which cleared by the morning. However, the patient awoke with a stiff neck. No further information was reported. The recovery status was reported as unknown. Follow-up information received on 09 November 2009 from a health care professional. The patient had no concurrent illnesses, pre-existing medical conditions or use of other medications at the time of vaccination on 21 September 2009. The patient had no other vaccinations within four weeks of 21 September 2009; and adverse events with prior vaccinations were reported as "N/A". The patient recovered (date not provided). No further information is expected. List of Documents held by Sender: none.
Age: 8.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a eight-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 16.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Contraindication to vaccination, Delivery, Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of pregnant woman inadvertently received a dose of H1N1 LAIV was received from a registered nurse/health professional concerning a 16-year-old female. The patient did not have any medical history and she was healthy. The patient did not take any concomitant medications and had refused to take prenatal vitamins. The patient was gravida one and para zero. The patient was 26 weeks pregnant; in her second trimester at the time of vaccination. Her LMP was April or May 2009. The patient's EDD was 17-Feb-2010. On 10-Nov-2009, the patient received H1N1, Intranasal, for an unknown indication. The patient gave birth vaginally, on 20-Feb-2010, to a 7 lb and 5 ozs, baby girl who measured 20 inches long. Both the mother and newborn were well and remained healthy. There was no adverse event associated with this pregnancy therefore, treatment and reporter causality assessments are not applicable, and the event vaccine exposure during pregnancy was considered resolved. Additional information was received on 23-Feb-2010 and incorporated into the narrative: concomitant medications, medical and obstetrical history, LMP, EDD, information about baby and other additional information: patient's age, reporter type, facility address.
Age: 4.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of '2 children were each inadvertently administrated an expired dose of H1N1 LAIV as the second dose' was received from a registered nurse/health professional concerning a four-year-old male child. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired in 23-Feb-2010. On an unknown date, the patient received first dose of H1N1 vaccine. On 24-Feb-2010, the patient received second dose of expired H1N1, Intranasal, for unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 40.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non serious spontaneous report of inadvertent administration of expired H1N1 LAIV was received from a registered nurse/health professional concerning a 40-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the first dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
Age: 7.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a seven-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 33.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a 33-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
Age: 9.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a nine-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 5.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a five-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 6.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a six-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 9.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a nine-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which as reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 2.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a 27-month-old male child. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the first dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
Age: 7.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a seven-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Sex: U
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired H1N1 was received from a pharmacist concerning three children of unknown age and gender. Neither relevant medical history nor concomitant medications have been reported for these patients. The product expired in 15-Jan-2010. On 28-Jan-2010, three patients received expired H1N1, Intranasal, for unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 4.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of patient was given expired H1N1 yesterday 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 04-Feb-2010, the patient received expired H1N1, Intranasal, for an unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 1.8
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to a child under 2 years of age was received from a registered nurse/health professional concerning a 21-month-old male child. Neither relevant medical history nor concomitant medications have been reported for this patient. On 05-Nov-2009, the patient received H1N1, Intranasal, for an unknown indication. The patient also received a dose of H1N1 inactivated on 12-Jan-2010 and another dose of H1N1 inactivated on 09-Feb-2010. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 75.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: #1: I received a flu shot on 11/02/2010 at my Dr.'s office; within 4 days I began the symptoms of shingles, despite getting the ZOSTAVAX in 2007. I now have a full-blown case of shingles, which I have never had before. I noticed on the internet that I am not the only one, with a variety of people reporting the same effect of shingles following the flu shot. #2: In 2009 I also received some CELEBREX from my PA-C; within a month I developed a very low platelet count. I immediately stopped the CELEBREX, but my platelet count is now in the low normal range, but never returned to the "pre-CELEBREX" era.
Age: 56.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of "we inadvertently administered H1N1 LAIV to a person over 49" was received from a pharmacist concerning a 56-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 08-Feb-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
Age: 9.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a nine-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reported causality assessments were not applicable and the event was considered to be resolved.
Age: 4.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a four-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 6.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a six-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessment was not applicable and the event was considered to be resolved.
Age: 8.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a eight-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 8.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning an eight-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 9.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a nine-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Migraine, Nausea, Pain, Pyrexia
Clinical narrative: Initial report received on 21 September 2009 from a consumer. A 62 year old female patient with a history of asthma, arthritis, bipolar and allergies to grass, pollen, and cats developed a reaction one day after receiving FLUZONE (lot number was unknown) intramuscularly in the left deltoid on 08 September 2009. Concomitant therapy included lithium carbonate, CYTOMEL, LAMICTAL, PAMELOR, Propanolol, clorazepate. On 09 September 2009, the patient developed migraine headaches which lasted for one week. The patient also developed aches, fatigue, nausea, and a slight fever which continued to persist at the time of the report. The patient stated that she experienced the same reaction the previous year after receiving a flu vaccine (manufacturer was not specified). List of Documents held by Sender: none. This case has the same reporter as case number 2009-04091.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccine positive rechallenge
Clinical narrative: Initial report received on 21 September 2009 from a consumer. A 62 year old female patient with a history of asthma, arthritis, bipolar and allergies to grass, pollen, and cats developed a reaction one day after receiving FLUZONE (lot number was unknown) intramuscularly in the left deltoid on 08 September 2009. Concomitant therapy included lithium carbonate, CYTOMEL, LAMICTAL, PAMELOR, Propanolol, clorazepate. On 09 September 2009, the patient developed migraine headaches which lasted for one week. The patient also developed aches, fatigue, nausea, and a slight fever which continued to persist at the time of the report. The patient stated that she experienced the same reaction the previous year after receiving a flu vaccine (manufacturer was not specified). List of Documents held by Sender: none. This case has the same reporter as case number 2009-04091.
Age: 0.91
Sex: F
Vaccine: FLU3
Symptoms: Cough, Crying, Irritability, Pyrexia, Rhinorrhoea
Clinical narrative: Initial report received on 28 September 2009 from a non health care professional. An eleven month old female patient developed cough, fever, excessive crying, irritable, and a runny nose seven and a half hours after receiving FLUZONE intramuscularly (lot number not reported) on 26 September 2009 at 10:30 AM. The patient has not recovered. Follow-up information was received from the consumer on 13 October 2009. The patient received the injection in the thigh, and other medications included TYLENOL. She had not received any previous doses of FLUZONE, and was not ill at the time of vaccination. List of Documents held by Sender: none.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma
Clinical narrative: Initial report received on 05 October 2009 from a consumer. A 49 year old female patient with no reported past medical history developed a bruise at the injection site one day after she received FLUZONE (lot number not reported) on 26 September 2009 at 11:30 AM. The patient did not note any swelling. At the time of the report the patient had not recovered. Follow-up was received from the consumer on 20 October 2009. The bruise at the injection site resolved by 12 October 2009. FLUZONE lot number is unknown. The patient indicated that she had previously received yearly flu vaccinations for the past six or seven years. It was not reported if the patient had experienced any adverse events following those prior vaccinations. List of Documents held by Sender: none.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hyperhidrosis, Musculoskeletal pain, Nausea, Neck pain
Clinical narrative: Initial report received 21 October 2009 from a consumer, who is also the patient. A 38-year-old female patient with no past medical history had received a left deltoid intramuscular injection of FLUZONE on 19 October 2009 AM and two hours later, she developed left neck pain and left shoulder pain. Two hours after that, she developed chills, body aches, nausea. On 20 October 2009, she developed sweating and fever (temperature not reported). The patient had no concurrent illness and she had not been taking any concomitant medications. Corrective treatments consisted of TYLENOL. At the time of the report on 21 October 2009, the patient's temperature was normal, her body aches were better; however sweating persisted. No additional information was provided. Documents held by sender: None.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Initial report received 21 October 2009 from a consumer, who is also the patient. A 38-year-old female patient with no past medical history had received a left deltoid intramuscular injection of FLUZONE on 19 October 2009 AM and two hours later, she developed left neck pain and left shoulder pain. Two hours after that, she developed chills, body aches, nausea. On 20 October 2009, she developed sweating and fever (temperature not reported). The patient had no concurrent illness and she had not been taking any concomitant medications. Corrective treatments consisted of TYLENOL. At the time of the report on 21 October 2009, the patient's temperature was normal, her body aches were better; however sweating persisted. No additional information was provided. Documents held by sender: None.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray normal, Chills, Myalgia, Oropharyngeal pain, Pain
Clinical narrative: Initial report received on 30 October 2009 from a consumer. A 28 year old female patient who "used to be asthmatic" and also reported a history of a mild reaction such as chills, headache, fever, and body aches with a prior flu vaccination (manufacturer and date were not provided). On 26 October 2009 the patient received an intramuscular left deltoid injection of FLUZONE SV (lot number unknown). On that same day the patient complained of muscle aches, chills, and pain "everywhere" but was most prominent in the back, knees, and neck. The patient was seen in the emergency room 2-3 days later. Erythromycin was prescribed by the family physician. A chest x ray was completed and results were clear. The patient also complained of a sore throat at the time of the report. Her symptoms persisted. The patient's recovery status was reported as not recovered. List of Documents held by Sender: none.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccine positive rechallenge
Clinical narrative: Initial report received on 30 October 2009 from a consumer. A 28 year old female patient who "used to be asthmatic" and also reported a history of a mild reaction such as chills, headache, fever, and body aches with a prior flu vaccination (manufacturer and date were not provided). On 26 October 2009 the patient received an intramuscular left deltoid injection of FLUZONE SV (lot number unknown). On that same day the patient complained of muscle aches, chills, and pain "everywhere" but was most prominent in the back, knees, and neck. The patient was seen in the emergency room 2-3 days later. Erythromycin was prescribed by the family physician. A chest x ray was completed and results were clear. The patient also complained of a sore throat at the time of the report. Her symptoms persisted. The patient's recovery status was reported as not recovered. List of Documents held by Sender: none.
Age: 7.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 LAIV was received from a registered nurse/health professional concerning a seven-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 7.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 LAIV was received from a registered nurse/health professional concerning a seven-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 6.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 LAIV was received from a registered nurse/health professional concerning a six-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment  and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 63.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently given H1N1 to 63-year-old female, was received from a registered nurse concerning a 63-year-old female. Neither medical history nor concomitant medications was reported for this patient. On 04-Nov-2009, the patient received H1N1, Intranasal vaccine for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 05-Nov-2009: Reporter's address, responsible physician details and administrator address received.
Age: 8.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 LAIV was received from a registered nurse/health professional concerning an eight-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessment were not applicable and the event was considered to be resolved.
Age: 75.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently gave H1N1 vaccine to person above age 49 was received from a registered nurse concerning a 75-year-old male. On 29-Oct-2009, the patient inadvertently received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 51.0
Sex: U
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to a 51-year-old was received from a registered nurse concerning a 51-year-old adult patient. Neither medical history nor concomitant medications was reported for this patient. On 06-Nov-2009, the patient received H1N1, Intranasal vaccine for an unknown indication. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 2.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Dyspnoea, Rash, Vaccination error
Clinical narrative: A non-serious spontaneous report of difficulty breathing, vaccination error and "rash on his ears, face and feet" has been received from a nurse practitioner concerning a 28-month-old male, subsequent to H1N1, Intranasal. The patient had a history of asthma. No concomitant medications were reported. On 27-Oct-2009, the patient received H1N1, Intranasal for an unknown indication. On 04-Nov-2009, the patient experienced difficulty breathing. On an unknown date, he had "a rash on his ears, face and feet," which was in presence when he returned to the clinic on 04-Nov-2009. The outcome of the reported events was unknown. This is a corrected report to the previous report: vaccination error was added as a non-serious event; event start date were corrected. The corrected information was incorporated into the narrative.
Age: 39.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Influenza, Influenza A virus test positive, Influenza like illness, Pain, Pyrexia
Clinical narrative: A non-serious spontaneous report of positive for Influenza A by nasal swab was received from a 39-year-old female physician concerning herself, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications was reported for this patient. On 23-Oct-2009, the patient received H1N1, Intranasal for an unknown indication. On 04-Nov-2009, the patient started having flu-like symptoms and experienced body aches, a low fever, and upper respiratory tract symptoms. On 05-Nov-2009, the patient tested positive for influenza A by nasal swab. The outcome of the event was unknown.
Age: 39.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Upper respiratory tract infection
Clinical narrative: A non-serious spontaneous report of positive for Influenza A by nasal swab was received from a 39-year-old female physician concerning herself, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications was reported for this patient. On 23-Oct-2009, the patient received H1N1, Intranasal for an unknown indication. On 04-Nov-2009, the patient started having flu-like symptoms and experienced body aches, a low fever, and upper respiratory tract symptoms. On 05-Nov-2009, the patient tested positive for influenza A by nasal swab. The outcome of the event was unknown.
Age: 9.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a nine-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 9.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a nine-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 8.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning an eight-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 4.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired vaccine was received from a registered nurse/health professional concerning a four-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 29-Mar-2010. On 31-Mar-2010, the patient received expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.