chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU3, FLU3
Symptoms: HIV antibody negative, HIV antigen negative, Hepatitis B core antibody positive, Hepatitis B surface antibody negative, Hepatitis B surface antibody positive
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 B surface antigen negative, 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 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.
Age: 49.0
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 49 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: 49.0
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 49 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: 49.0
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 49 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: 27.0
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 27 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: 27.0
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 27 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: 27.0
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 27 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: 35.0
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 35 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 her 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 6 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, Hepatitis C antibody and hepatitis C RNA. The outcome was unknown. Reporter's comments: The health authority assessed the events as non-serious.
Age: 35.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Hepatitis C RNA negative, 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 35 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 her 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 6 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, Hepatitis C antibody and hepatitis C RNA. The outcome was unknown. Reporter's comments: The health authority assessed the events as non-serious.
Age: 35.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Wrong technique in product usage process
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 35 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 her 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 6 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, Hepatitis C antibody and hepatitis C RNA. The outcome was unknown. Reporter's comments: The health authority assessed the events as non-serious.
Age: 35.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Hepatitis C RNA negative, 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 35 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 her 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 6 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, Hepatitis C antibody and hepatitis C RNA. The outcome was unknown. Reporter's comments: The health authority assessed the events as non-serious.
Age: 47.0
Sex: M
Vaccine: 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 47 year old male 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 syringe 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 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 assess the events as non-serious.
Age: 47.0
Sex: M
Vaccine: 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 47 year old male 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 syringe 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 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 assess the events as non-serious.
Age: 47.0
Sex: M
Vaccine: 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 47 year old male 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 syringe 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 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 assess the events as non-serious.
Age: 47.0
Sex: M
Vaccine: 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 47 year old male 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 syringe 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 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 assess the events as non-serious.
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 (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: 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 (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: 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 (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: 52.0
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 52 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: 52.0
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 52 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: 52.0
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 52 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.
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Foetal disorder
Clinical narrative: This retrospective pregnancy case was reported by a physician and described the occurrence of stillbirth in a female patient who received BOOSTRIX. On 20th May 2016, the patient received BOOSTRIX. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received BOOSTRIX at week 29 of the pregnancy and during the third trimester of pregnancy. On 24th May 2016, 4 days after receiving BOOSTRIX, the patient experienced stillbirth (serious criteria GSK medically significant). On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the stillbirth and vaccine exposure during pregnancy were unknown. It was unknown if the reporter considered the stillbirth to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fetal demise. The physician requested a call back.
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Foetal death, Stillbirth
Clinical narrative: This retrospective pregnancy case was reported by a physician and described the occurrence of stillbirth in a female patient who received BOOSTRIX. On 20th May 2016, the patient received BOOSTRIX. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received BOOSTRIX at week 29 of the pregnancy and during the third trimester of pregnancy. On 24th May 2016, 4 days after receiving BOOSTRIX, the patient experienced stillbirth (serious criteria GSK medically significant). On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the stillbirth and vaccine exposure during pregnancy were unknown. It was unknown if the reporter considered the stillbirth to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fetal demise. The physician requested a call back.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Throat tightness
Clinical narrative: Throat tightness. Required ER visit. Treated with Benadryl and one dose of steroid.
Age: 71.0
Sex: M
Vaccine: IPV, PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: L arm beginning hurting at injection site 3 days post injection of PREVNAR 13. Arm then became more swollen surrounding the injection site, spreading out about 5x8 inches over dorsal surface of arm, with erythema and pain, all which increased over next 12-16 hours with more pain. No fevers, but significant malaise experienced. Symptoms improved with ibuprofen. Still with swelling although improved 2 days after symptoms began.
Age: 27.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: The spot on my arm where I received the GARDASIL 9 vaccine became painful months after vaccination and is swollen up and there is a bump there now. It was painful for a few days after vaccination but now months later the area has swollen up.
Sex: M
Vaccine: MEN, MENB
Symptoms: Blister, Rash erythematous, Rash pruritic
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) via other company (Pfizer) (Manufacturer Report Number: 2016247853) on 18-May-2016. This case was linked to 2016SA098087 (same reporter, same event). This case involves a male patient (age not reported) who was vaccinated with a dose of Meningitis Vaccine (batch number, expiry date, route and site of administration: not reported) on 25-Apr-2016. Other medical conditions was reported as none. Concomitant medications included VYVANSE and CYMBALTA. On an unspecified date (reported as four days ago), following the vaccination, patient experienced blisters and "broke out in little red itchy dots". Laboratory investigations and corrective treatment were not reported. The outcome of the event blisters was not recovered and the outcome of the event little red itchy dots was not reported. List of documents held by sender: none.