chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Wrong technique in product usage process
Clinical narrative: This health authority case was initially received on 22-Feb-2016. The case report was received from a(n) Health Professional and concerns a (n) 50 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction (s) /event (s): The patient received AFLURIA for indication not reported on 03-Nov-2015- unknown stop date, Batch no: U55806, Route of administration: Intramuscular, Dose: 0.5 ml, site: left arm. Additional suspect drug (s): No additional drugs suspected. Reaction (s) /event (s) and outcome: On 03-Nov-2015, 1 day after starting / treatment with AFLURIA the patient experienced bruising (non serious, outcome: Received / Resolved) and pharmacist required her to rest her arm on the desk. She said the pharmacist's technique was the cause of her bruise. The shot was administered on the deltoid muscle. For relevant test results see appropriate report section. Reporter's assessment: non-serious.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Urticaria
Clinical narrative: The case report was received from a(n) Health Professional and concerns a(n) 71 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 10-Nov-2015 - unknown stop date, Batch no: not provided, route of administration: unknown, dose: 0.5 ml, site: unknown. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 10-Nov-2015, within two hours of vaccination, the patient experienced urticarial on chest, back, neck, arms (non serious, outcome: Unknown). For relevant tests results see appropriate report section. Reporter's assessment: non-serious.
Age: 44.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: HIV antibody negative, HIV antigen negative, Hepatitis B core antibody negative, Hepatitis B surface antibody negative, Hepatitis B surface antigen negative
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 44 year old patient (gender: unknown). On 30-Sep-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (thimerosal containing, batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep B, hep C, HIV), hepatitis B vaccine and flu vaccine. On 05-Oct-2015, the patient underwent laboratory tests which showed negative results for hepatitis B core antibody, hepatitis B core antibody, hepatitis B surface antigen, HIV antigen, HIV antibody and hepatitis C antibody. The outcome was unknown. Reporter's comments: The health authority assessed the events as non-serious.
Age: 44.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Hepatitis C antibody negative, Incorrect product storage, Multiple use of single-use product, Underdose, Wrong technique in product usage process
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 44 year old patient (gender: unknown). On 30-Sep-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (thimerosal containing, batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep B, hep C, HIV), hepatitis B vaccine and flu vaccine. On 05-Oct-2015, the patient underwent laboratory tests which showed negative results for hepatitis B core antibody, hepatitis B core antibody, hepatitis B surface antigen, HIV antigen, HIV antibody and hepatitis C antibody. The outcome was unknown. Reporter's comments: The health authority assessed the events as non-serious.
Age: 44.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Hepatitis C antibody negative, Multiple use of single-use product
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 44 year old patient (gender: unknown). On 30-Sep-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (thimerosal containing, batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep B, hep C, HIV), hepatitis B vaccine and flu vaccine. On 05-Oct-2015, the patient underwent laboratory tests which showed negative results for hepatitis B core antibody, hepatitis B core antibody, hepatitis B surface antigen, HIV antigen, HIV antibody and hepatitis C antibody. The outcome was unknown. Reporter's comments: The health authority assessed the events as non-serious.
Age: 39.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: HIV antibody negative, HIV antigen negative, Hepatitis B core antibody negative, Hepatitis B surface antibody positive, Hepatitis B surface antigen negative
Clinical narrative: This medically confirmed health authority report (initial receipt 22-FEB-2016) concerns a 39 year old patient (Gender unknown). On 30-SEP-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (containing batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep b, hep C, HIV), hepatitis B vaccine and flu vaccine. On 06-OCT-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown. Reporter's comments': The health authority assessed the events as non-serious. Company comments: Seriousness: Non-serious. All other parameters are negative, except for presence of HBs antibodies. Listedness: Unlisted. Assessment: according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the AFLURIA US Product Information all events are unlisted, Causality: Unassessable. Causality is unclassified for the events pertaining to medication error. The positive result for the Hepatitis surface antibody (anti -HBs) is unrelated. The presence of anti-HBs is generally interpreted as indicating recovery and immunity from hepatitis B virus infection. Anti-Hbs also develops in a person who has been successfully vaccinated against hepatitis B. The development of antibodies is a protracted process that cannot be attributable to any intervention, including influenza vaccines, which had only  been given a few days prior to serology tests.
Age: 39.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Hepatitis C antibody negative, Incorrect product storage, Multiple use of single-use product, Underdose, Wrong technique in product usage process
Clinical narrative: This medically confirmed health authority report (initial receipt 22-FEB-2016) concerns a 39 year old patient (Gender unknown). On 30-SEP-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (containing batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep b, hep C, HIV), hepatitis B vaccine and flu vaccine. On 06-OCT-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown. Reporter's comments': The health authority assessed the events as non-serious. Company comments: Seriousness: Non-serious. All other parameters are negative, except for presence of HBs antibodies. Listedness: Unlisted. Assessment: according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the AFLURIA US Product Information all events are unlisted, Causality: Unassessable. Causality is unclassified for the events pertaining to medication error. The positive result for the Hepatitis surface antibody (anti -HBs) is unrelated. The presence of anti-HBs is generally interpreted as indicating recovery and immunity from hepatitis B virus infection. Anti-Hbs also develops in a person who has been successfully vaccinated against hepatitis B. The development of antibodies is a protracted process that cannot be attributable to any intervention, including influenza vaccines, which had only  been given a few days prior to serology tests.
Age: 39.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Hepatitis C antibody negative, Incorrect product storage, Multiple use of single-use product
Clinical narrative: This medically confirmed health authority report (initial receipt 22-FEB-2016) concerns a 39 year old patient (Gender unknown). On 30-SEP-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (containing batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep b, hep C, HIV), hepatitis B vaccine and flu vaccine. On 06-OCT-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown. Reporter's comments': The health authority assessed the events as non-serious. Company comments: Seriousness: Non-serious. All other parameters are negative, except for presence of HBs antibodies. Listedness: Unlisted. Assessment: according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the AFLURIA US Product Information all events are unlisted, Causality: Unassessable. Causality is unclassified for the events pertaining to medication error. The positive result for the Hepatitis surface antibody (anti -HBs) is unrelated. The presence of anti-HBs is generally interpreted as indicating recovery and immunity from hepatitis B virus infection. Anti-Hbs also develops in a person who has been successfully vaccinated against hepatitis B. The development of antibodies is a protracted process that cannot be attributable to any intervention, including influenza vaccines, which had only  been given a few days prior to serology tests.
Age: 64.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: HIV antibody negative, HIV antigen negative, Hepatitis B core antibody negative, Hepatitis B surface antibody positive, Hepatitis B surface antigen negative
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 64 year old patient (gender: Unknown). On 30-Sep-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection containing, batch number: 11049221A in the arm. The patient was offered blood pathogen testing (hep B, hep C, HIV) hepatitis B vaccine and flu vaccine. On 05-Oct-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown. Reporter's comments: The healthy authority assessed the events as non-serious.
Age: 64.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Hepatitis C antibody negative, Incorrect product storage, Multiple use of single-use product, Underdose, Wrong technique in product usage process
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 64 year old patient (gender: Unknown). On 30-Sep-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection containing, batch number: 11049221A in the arm. The patient was offered blood pathogen testing (hep B, hep C, HIV) hepatitis B vaccine and flu vaccine. On 05-Oct-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown. Reporter's comments: The healthy authority assessed the events as non-serious.
Age: 64.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Hepatitis C antibody negative, Incorrect product storage, Multiple use of single-use product
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 64 year old patient (gender: Unknown). On 30-Sep-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection containing, batch number: 11049221A in the arm. The patient was offered blood pathogen testing (hep B, hep C, HIV) hepatitis B vaccine and flu vaccine. On 05-Oct-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown. Reporter's comments: The healthy authority assessed the events as non-serious.
Age: 48.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: HIV antibody negative, HIV antigen negative, Hepatitis B core antibody negative, Hepatitis B surface antibody positive, Hepatitis B surface antigen negative
Clinical narrative: This medically confirmed health authority report (initial receipt 22-FEB-2016) concerns a 48 year old patient (Gender unknown). On 30-SEP-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (containing batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep b, hep C, HIV), hepatitis B vaccine and flu vaccine.On 05-OCT-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown. Reporter's comments': The health authority assessed the events as non-serious. Company comments: Seriousness: Non-serious. All other parameters are negative, except for presence of HBs antibodies. Listedness: Unlisted. Assessment: according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the AFLURIA US Product Information all events are unlisted, Causality: Unassessable. Causality is unclassified for the events pertaining to medication error. The positive result for the Hepatitis surface antibody (anti -HBs) is unrelated. The presence of anti-HBs is generally interpreted as indicating recovery and immunity from hepatitis B virus infection. Anti-Hbs also develops in a person who has been successfully vaccinated against hepatitis B. The development of antibodies is a protracted process that cannot be attributable to any intervention, including influenza vaccines, which had only  been given a few days prior to serology tests.
Age: 48.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Hepatitis C antibody negative, Incorrect product storage, Multiple use of single-use product, Underdose, Wrong technique in product usage process
Clinical narrative: This medically confirmed health authority report (initial receipt 22-FEB-2016) concerns a 48 year old patient (Gender unknown). On 30-SEP-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (containing batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep b, hep C, HIV), hepatitis B vaccine and flu vaccine.On 05-OCT-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown. Reporter's comments': The health authority assessed the events as non-serious. Company comments: Seriousness: Non-serious. All other parameters are negative, except for presence of HBs antibodies. Listedness: Unlisted. Assessment: according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the AFLURIA US Product Information all events are unlisted, Causality: Unassessable. Causality is unclassified for the events pertaining to medication error. The positive result for the Hepatitis surface antibody (anti -HBs) is unrelated. The presence of anti-HBs is generally interpreted as indicating recovery and immunity from hepatitis B virus infection. Anti-Hbs also develops in a person who has been successfully vaccinated against hepatitis B. The development of antibodies is a protracted process that cannot be attributable to any intervention, including influenza vaccines, which had only  been given a few days prior to serology tests.
Age: 48.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Hepatitis C antibody negative, Incorrect product storage, Multiple use of single-use product, Underdose
Clinical narrative: This medically confirmed health authority report (initial receipt 22-FEB-2016) concerns a 48 year old patient (Gender unknown). On 30-SEP-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (containing batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep b, hep C, HIV), hepatitis B vaccine and flu vaccine.On 05-OCT-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown. Reporter's comments': The health authority assessed the events as non-serious. Company comments: Seriousness: Non-serious. All other parameters are negative, except for presence of HBs antibodies. Listedness: Unlisted. Assessment: according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the AFLURIA US Product Information all events are unlisted, Causality: Unassessable. Causality is unclassified for the events pertaining to medication error. The positive result for the Hepatitis surface antibody (anti -HBs) is unrelated. The presence of anti-HBs is generally interpreted as indicating recovery and immunity from hepatitis B virus infection. Anti-Hbs also develops in a person who has been successfully vaccinated against hepatitis B. The development of antibodies is a protracted process that cannot be attributable to any intervention, including influenza vaccines, which had only  been given a few days prior to serology tests.
Age: 30.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: HIV antibody negative, HIV antigen negative, Hepatitis B core antibody negative, Hepatitis B surface antibody positive, Hepatitis B surface antigen negative
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 30 year old patient (gender: unknown). On 30-SEP-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep B, hep C, HIV)), hepatitis B vaccine and flu vaccine. On 04-Oct-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown. Reporter's comments: The health authority assessed the events as non-serious. Company comments: Seriousness: Serious. Listedness: Unlisted. Causality: Possible
Age: 30.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Hepatitis C antibody negative, Incorrect product storage, Multiple use of single-use product, Underdose, Wrong technique in product usage process
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 30 year old patient (gender: unknown). On 30-SEP-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep B, hep C, HIV)), hepatitis B vaccine and flu vaccine. On 04-Oct-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown. Reporter's comments: The health authority assessed the events as non-serious. Company comments: Seriousness: Serious. Listedness: Unlisted. Causality: Possible
Age: 30.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Hepatitis C antibody negative, Incorrect product storage, Multiple use of single-use product
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 30 year old patient (gender: unknown). On 30-SEP-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep B, hep C, HIV)), hepatitis B vaccine and flu vaccine. On 04-Oct-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown. Reporter's comments: The health authority assessed the events as non-serious. Company comments: Seriousness: Serious. Listedness: Unlisted. Causality: Possible
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: HIV antibody negative, HIV antigen negative, Hepatitis B core antibody negative, Hepatitis B surface antibody negative, Hepatitis B surface antigen negative
Clinical narrative: This medically confirmed health authority report (initial receipt 22-FEB-2016) concerns a 36 year old female patient. On 30-SEP-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (containing batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep b, hep C, HIV), hepatitis B vaccine and flu vaccine.On 05-OCT-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown. Reporter's comments': The health authority assessed the events as non-serious. Company comments: Seriousness: Non-serious. All other parameters are negative, except for presence of HBs antibodies. Listedness: Unlisted. Assessment: according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the AFLURIA US Product Information all events are unlisted, Causality: Unassessable. Causality is unclassified for the events pertaining to medication error. The positive result for the Hepatitis surface antibody (anti -HBs) is unrelated. The presence of anti-HBs is generally interpreted as indicating recovery and immunity from hepatitis B virus infection. Anti-Hbs also develops in a person who has been successfully vaccinated against hepatitis B. The development of antibodies is a protracted process that cannot be attributable to any intervention, including influenza vaccines, which had only  been given a few days prior to serology tests.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Incorrect product storage, Multiple use of single-use product, Underdose, Wrong technique in product usage process
Clinical narrative: This medically confirmed health authority report (initial receipt 22-FEB-2016) concerns a 36 year old female patient. On 30-SEP-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (containing batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep b, hep C, HIV), hepatitis B vaccine and flu vaccine.On 05-OCT-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown. Reporter's comments': The health authority assessed the events as non-serious. Company comments: Seriousness: Non-serious. All other parameters are negative, except for presence of HBs antibodies. Listedness: Unlisted. Assessment: according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the AFLURIA US Product Information all events are unlisted, Causality: Unassessable. Causality is unclassified for the events pertaining to medication error. The positive result for the Hepatitis surface antibody (anti -HBs) is unrelated. The presence of anti-HBs is generally interpreted as indicating recovery and immunity from hepatitis B virus infection. Anti-Hbs also develops in a person who has been successfully vaccinated against hepatitis B. The development of antibodies is a protracted process that cannot be attributable to any intervention, including influenza vaccines, which had only  been given a few days prior to serology tests.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Hepatitis C antibody negative, Incorrect product storage, Multiple use of single-use product, Underdose
Clinical narrative: This medically confirmed health authority report (initial receipt 22-FEB-2016) concerns a 36 year old female patient. On 30-SEP-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (containing batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep b, hep C, HIV), hepatitis B vaccine and flu vaccine.On 05-OCT-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown. Reporter's comments': The health authority assessed the events as non-serious. Company comments: Seriousness: Non-serious. All other parameters are negative, except for presence of HBs antibodies. Listedness: Unlisted. Assessment: according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the AFLURIA US Product Information all events are unlisted, Causality: Unassessable. Causality is unclassified for the events pertaining to medication error. The positive result for the Hepatitis surface antibody (anti -HBs) is unrelated. The presence of anti-HBs is generally interpreted as indicating recovery and immunity from hepatitis B virus infection. Anti-Hbs also develops in a person who has been successfully vaccinated against hepatitis B. The development of antibodies is a protracted process that cannot be attributable to any intervention, including influenza vaccines, which had only  been given a few days prior to serology tests.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: HIV antibody negative, HIV antigen negative, Hepatitis B core antibody negative, Hepatitis B surface antibody positive, Hepatitis B surface antigen negative
Clinical narrative: This medically confirmed health authority report (initial receipt 22-FEB-2016) concerns a 36 year old female patient. On 30-SEP-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (containing batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep b, hep C, HIV), hepatitis B vaccine and flu vaccine.On 05-OCT-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown. Reporter's comments': The health authority assessed the events as non-serious. Company comments: Seriousness: Non-serious. All other parameters are negative, except for presence of HBs antibodies. Listedness: Unlisted. Assessment: according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the AFLURIA US Product Information all events are unlisted, Causality: Unassessable. Causality is unclassified for the events pertaining to medication error. The positive result for the Hepatitis surface antibody (anti -HBs) is unrelated. The presence of anti-HBs is generally interpreted as indicating recovery and immunity from hepatitis B virus infection. Anti-Hbs also develops in a person who has been successfully vaccinated against hepatitis B. The development of antibodies is a protracted process that cannot be attributable to any intervention, including influenza vaccines, which had only  been given a few days prior to serology tests.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Hepatitis C antibody negative, Incorrect product storage, Multiple use of single-use product
Clinical narrative: This medically confirmed health authority report (initial receipt 22-FEB-2016) concerns a 36 year old female patient. On 30-SEP-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (containing batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep b, hep C, HIV), hepatitis B vaccine and flu vaccine.On 05-OCT-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown. Reporter's comments': The health authority assessed the events as non-serious. Company comments: Seriousness: Non-serious. All other parameters are negative, except for presence of HBs antibodies. Listedness: Unlisted. Assessment: according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the AFLURIA US Product Information all events are unlisted, Causality: Unassessable. Causality is unclassified for the events pertaining to medication error. The positive result for the Hepatitis surface antibody (anti -HBs) is unrelated. The presence of anti-HBs is generally interpreted as indicating recovery and immunity from hepatitis B virus infection. Anti-Hbs also develops in a person who has been successfully vaccinated against hepatitis B. The development of antibodies is a protracted process that cannot be attributable to any intervention, including influenza vaccines, which had only  been given a few days prior to serology tests.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Hepatitis C antibody negative, Incorrect product storage, Multiple use of single-use product, Underdose, Wrong technique in product usage process
Clinical narrative: This medically confirmed health authority report (initial receipt 22-FEB-2016) concerns a 36 year old female patient. On 30-SEP-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (containing batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep b, hep C, HIV), hepatitis B vaccine and flu vaccine.On 05-OCT-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown. Reporter's comments': The health authority assessed the events as non-serious. Company comments: Seriousness: Non-serious. All other parameters are negative, except for presence of HBs antibodies. Listedness: Unlisted. Assessment: according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the AFLURIA US Product Information all events are unlisted, Causality: Unassessable. Causality is unclassified for the events pertaining to medication error. The positive result for the Hepatitis surface antibody (anti -HBs) is unrelated. The presence of anti-HBs is generally interpreted as indicating recovery and immunity from hepatitis B virus infection. Anti-Hbs also develops in a person who has been successfully vaccinated against hepatitis B. The development of antibodies is a protracted process that cannot be attributable to any intervention, including influenza vaccines, which had only  been given a few days prior to serology tests.
Sex: U
Vaccine: FLU3, FLU3
Symptoms: HIV antibody negative, HIV antigen negative, Hepatitis B core antibody negative, Hepatitis B surface antibody positive, Hepatitis B surface antigen negative
Clinical narrative: This medically confirmed health authority report (initial receipt 22-FEB-2016) concerns a patient with unknown demography. On 30-SEP-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (containing batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep b, hep C, HIV), hepatitis B vaccine and flu vaccine.On 05-OCT-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown. Reporter's comments': The health authority assessed the events as non-serious. Company comments: Seriousness: Non-serious. All other parameters are negative, except for presence of HBs antibodies. Listedness: Unlisted. Assessment: according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the AFLURIA US Product Information all events are unlisted, Causality: Unassessable. Causality is unclassified for the events pertaining to medication error. The positive result for the Hepatitis surface antibody (anti -HBs) is unrelated. The presence of anti-HBs is generally interpreted as indicating recovery and immunity from hepatitis B virus infection. Anti-Hbs also develops in a person who has been successfully vaccinated against hepatitis B. The development of antibodies is a protracted process that cannot be attributable to any intervention, including influenza vaccines, which had only  been given a few days prior to serology tests.
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Hepatitis C antibody negative, Incorrect product storage, Multiple use of single-use product, Underdose, Wrong technique in product usage process
Clinical narrative: This medically confirmed health authority report (initial receipt 22-FEB-2016) concerns a patient with unknown demography. On 30-SEP-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (containing batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep b, hep C, HIV), hepatitis B vaccine and flu vaccine.On 05-OCT-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown. Reporter's comments': The health authority assessed the events as non-serious. Company comments: Seriousness: Non-serious. All other parameters are negative, except for presence of HBs antibodies. Listedness: Unlisted. Assessment: according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the AFLURIA US Product Information all events are unlisted, Causality: Unassessable. Causality is unclassified for the events pertaining to medication error. The positive result for the Hepatitis surface antibody (anti -HBs) is unrelated. The presence of anti-HBs is generally interpreted as indicating recovery and immunity from hepatitis B virus infection. Anti-Hbs also develops in a person who has been successfully vaccinated against hepatitis B. The development of antibodies is a protracted process that cannot be attributable to any intervention, including influenza vaccines, which had only  been given a few days prior to serology tests.