chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
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 56 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 05-Oct-2015, the patient underwent laboratory tests which showed negative results for hepatitis B core antibody, hepatitis B surface 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. VAERS ID: 617703.
Age: 56.0
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 56 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 05-Oct-2015, the patient underwent laboratory tests which showed negative results for hepatitis B core antibody, hepatitis B surface 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. VAERS ID: 617703.
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, 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 surface antibody, hepatitis B surface antigen, HIV antigen, HIV antibody and hepatitis C antibody. The outcome was unknown. 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, 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 surface antibody, hepatitis B surface antigen, HIV antigen, HIV antibody and hepatitis C antibody. The outcome was unknown. The health authority assessed the events as non-serious.
Age: 62.0
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 62 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, 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 surface antibody, hepatitis B surface antigen, HIV antigen, HIV antibody and hepatitis C antibody. The outcome was unknown. The health authority assessed the events as non-serious.
Age: 62.0
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 62 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, 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 surface antibody, hepatitis B surface antigen, HIV antigen, HIV antibody and hepatitis C antibody. The outcome was unknown. The health authority assessed the events as non-serious.
Age: 62.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: HIV antibody negative, HIV antigen, 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 62 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, 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 surface antibody, hepatitis B surface antigen, HIV antigen, HIV antibody and hepatitis C antibody. The outcome was unknown. The health authority assessed the events as non-serious.
Age: 62.0
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 62 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, 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 surface antibody, hepatitis B surface antigen, HIV antigen, HIV antibody and hepatitis C antibody. The outcome was unknown. The health authority assessed the events as non-serious.
Age: 60.0
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 60 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, 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 surface antibody, hepatitis B surface antigen, HIV antigen, HIV antibody and hepatitis C antibody. The outcome was unknown. The health authority assessed the events as non-serious.
Age: 60.0
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 60 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, 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 surface antibody, hepatitis B surface antigen, HIV antigen, HIV antibody and hepatitis C antibody. The outcome was unknown. The health authority assessed the events as non-serious.
Age: 60.0
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 60 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, 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 surface antibody, hepatitis B surface antigen, HIV antigen, HIV antibody and hepatitis C antibody. The outcome was unknown. The health authority assessed the events as non-serious.
Age: 56.0
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  56 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, 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 surface antibody, hepatitis B surface antigen, HIV antigen, HIV antibody and hepatitis C antibody. The outcome was unknown. The health authority assessed the events as non-serious.
Age: 56.0
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  56 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, 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 surface antibody, hepatitis B surface antigen, HIV antigen, HIV antibody and hepatitis C antibody. The outcome was unknown. The health authority assessed 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 negative, 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, 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 surface antibody, hepatitis B surface antigen, HIV antigen, HIV antibody and hepatitis C antibody. The outcome was unknown. The health authority assessed the events as non-serious.
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, 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 surface antibody, hepatitis B surface antigen, HIV antigen, HIV antibody and hepatitis C antibody. The outcome was unknown. 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 negative, 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, 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 negative results for hepatitis B core antibody, hepatitis B surface antibody, hepatitis B surface antigen, HIV antigen, HIV antibody and hepatitis C antibody. The outcome was unknown. The health authority assessed the events as non-serious.
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, 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 negative results for hepatitis B core antibody, hepatitis B surface antibody, hepatitis B surface antigen, HIV antigen, HIV antibody and hepatitis C antibody. The outcome was unknown. The health authority assessed the events as non-serious.
Age: 45.0
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 45 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, 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 surface antibody, hepatitis B surface antigen, HIV antigen, HIV antibody and hepatitis C antibody. The outcome was unknown. The health authority assessed the events as non-serious.
Age: 45.0
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 45 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, 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 surface antibody, hepatitis B surface antigen, HIV antigen, HIV antibody and hepatitis C antibody. The outcome was unknown. The health authority assessed the events as non-serious.
Age: 45.0
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 45 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, 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 surface antibody, hepatitis B surface antigen, HIV antigen, HIV antibody and hepatitis C antibody. The outcome was unknown. The health authority assessed the events as non-serious.
Age: 37.0
Sex: M
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 37 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 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, 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 surface antibody, hepatitis B surface antigen, HIV antigen, HIV antibody and hepatitis C antibody. The outcome was unknown. The health authority assessed the events as non-serious.
Age: 37.0
Sex: M
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 37 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 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, 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 surface antibody, hepatitis B surface antigen, HIV antigen, HIV antibody and hepatitis C antibody. The outcome was unknown. The health authority assessed the events as non-serious.
Age: 37.0
Sex: M
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 37 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 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, 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 surface antibody, hepatitis B surface antigen, HIV antigen, HIV antibody and hepatitis C antibody. The outcome was unknown. The health authority assessed the events as non-serious.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL, HEPA, HPV9, VARCEL, HEPA, HPV9, VARCEL
Symptoms: Immediate post-injection reaction, Loss of consciousness, Nausea, Syncope
Clinical narrative: Immediately after given shots to the patient, he became nauseated, fainting, slumping down and totally lost consciousness for 10 seconds and in and out of consciousness for 5mins. 911 was called, oxygen administered, V/S taken B/P 120/60, pulse 74, Resp 20 pulse ox 100%. Patient was kept under close observation until paramedic arrive. At the time of departure patient was responding appropriately to questions asked.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL, HEPA, HPV9, VARCEL, HEPA, HPV9, VARCEL
Symptoms: Consciousness fluctuating, Immediate post-injection reaction, Loss of consciousness, Nausea, Posture abnormal
Clinical narrative: Immediately after given shots to the patient, he became nauseated, fainting, slumping down and totally lost consciousness for 10 seconds and in and out of consciousness for 5mins. 911 was called, oxygen administered, V/S taken B/P 120/60, pulse 74, Resp 20 pulse ox 100%. Patient was kept under close observation until paramedic arrive. At the time of departure patient was responding appropriately to questions asked.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL, HEPA, HPV9, VARCEL, HEPA, HPV9, VARCEL
Symptoms: Syncope
Clinical narrative: Immediately after given shots to the patient, he became nauseated, fainting, slumping down and totally lost consciousness for 10 seconds and in and out of consciousness for 5mins. 911 was called, oxygen administered, V/S taken B/P 120/60, pulse 74, Resp 20 pulse ox 100%. Patient was kept under close observation until paramedic arrive. At the time of departure patient was responding appropriately to questions asked.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Cardiac murmur, Feeling jittery, Heart rate decreased, Hypoaesthesia, Nausea
Clinical narrative: Shortly after HPV #2 vaccine, the patient had an episode of nausea, jitteriness, and numbness/tingling in lower extremities. He needed to lay down and nearly had emesis. He was noted to have a low resting heart rate in the 50s-60s and a cardiac murmur. The duration was 15-20 minutes. A similar episode occurred in this patient following the HPV #1, although he also received HepA, Tdap, and Menveo concurrently.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Paraesthesia
Clinical narrative: Shortly after HPV #2 vaccine, the patient had an episode of nausea, jitteriness, and numbness/tingling in lower extremities. He needed to lay down and nearly had emesis. He was noted to have a low resting heart rate in the 50s-60s and a cardiac murmur. The duration was 15-20 minutes. A similar episode occurred in this patient following the HPV #1, although he also received HepA, Tdap, and Menveo concurrently.
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Rash
Clinical narrative: RASH AND ITCHING.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Basal cell carcinoma, Biopsy skin abnormal, Impaired healing, Injection site reaction, Skin lesion
Clinical narrative: Information has been received from a physician concerning an approximately 67 year old female patient. The patient had fair skin which was freckled. The patient had no known drug reactions or allergies. Concomitant therapies included amlodipine, clonidine, PRINIVIL, hydrochlorothiazide (manufacturer unknown), metformin, simvastatin (manufacturer unknown) and PROZAC. On an unspecified date in 2013, the patient received a 0.65 ml dose of ZOSTAVAX (lot number/expire date unspecified) subcutaneously at an unspecified pharmacy. Shortly after receiving ZOSTAVAX, on an unknown date the patient developed a lesion at the injection site that would not heal. On an unspecified date in June 2014, the patient had the area biopsied which revealed basal cell carcinoma in situ. On an unspecified date, the patient returned to the office to have the area resected. The outcome of the event was reported as recovered on an unknown date. The relationship between the event and ZOSTAVAX was not reported. Upon internal review, basal cell carcinoma was considered to be medical significant. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin neoplasm excision
Clinical narrative: Information has been received from a physician concerning an approximately 67 year old female patient. The patient had fair skin which was freckled. The patient had no known drug reactions or allergies. Concomitant therapies included amlodipine, clonidine, PRINIVIL, hydrochlorothiazide (manufacturer unknown), metformin, simvastatin (manufacturer unknown) and PROZAC. On an unspecified date in 2013, the patient received a 0.65 ml dose of ZOSTAVAX (lot number/expire date unspecified) subcutaneously at an unspecified pharmacy. Shortly after receiving ZOSTAVAX, on an unknown date the patient developed a lesion at the injection site that would not heal. On an unspecified date in June 2014, the patient had the area biopsied which revealed basal cell carcinoma in situ. On an unspecified date, the patient returned to the office to have the area resected. The outcome of the event was reported as recovered on an unknown date. The relationship between the event and ZOSTAVAX was not reported. Upon internal review, basal cell carcinoma was considered to be medical significant. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Initial unsolicited misuse report received from a physician on 23 May 2016. This case involves a six-year-old male patient who was vaccinated with a fifth dose of DAPTACEL (batch number: C4709AA, expiration date 24 February 2017) by intramuscular route in the left deltoid and a fifth dose of IPOL (batch number: L1130-1, expiration date 11 April 2017) by intramuscular in the right deltoid on 19 May 2016. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications were not reported. On 21 May 2016, two days following the vaccination, the patient experienced local reaction going from left deltoid injection site down to the elbow which was red, tender, hot, and itchy and also had trouble in lifting his left arm. It was also a case of wrong route of administration, product use issue and needle issue as the reporter thought that it (vaccine) might not have been given intramuscularly and had given subcutaneously with a shorter needle. On an unspecified date, patient required ER or doctor visit. Lab data and corrective treatment were not reported. Outcome of the events was reported as not recovered. List of documents held by sender: none.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Local reaction
Clinical narrative: Initial unsolicited misuse report received from a physician on 23 May 2016. This case involves a six-year-old male patient who was vaccinated with a fifth dose of DAPTACEL (batch number: C4709AA, expiration date 24 February 2017) by intramuscular route in the left deltoid and a fifth dose of IPOL (batch number: L1130-1, expiration date 11 April 2017) by intramuscular in the right deltoid on 19 May 2016. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications were not reported. On 21 May 2016, two days following the vaccination, the patient experienced local reaction going from left deltoid injection site down to the elbow which was red, tender, hot, and itchy and also had trouble in lifting his left arm. It was also a case of wrong route of administration, product use issue and needle issue as the reporter thought that it (vaccine) might not have been given intramuscularly and had given subcutaneously with a shorter needle. On an unspecified date, patient required ER or doctor visit. Lab data and corrective treatment were not reported. Outcome of the events was reported as not recovered. List of documents held by sender: none.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Anaphylactic reaction
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) on 26 May 2016. This case involves a 10-year-old female patient who was vaccinated with a first dose of ADACEL (batch number, expiry date, dose, route of administration), in the right deltoid on 25 May 2016. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as of severe milk, eggs, beef, lamb, and latex. "None". Any other vaccinations within 4 weeks of vaccinations were reported as none. Concomitant medications were not reported. On 25 May 2016, same day "Within 15 minutes" following the vaccination, the patient developed anaphylactic reaction. The patient was consulted with her allergist who confirmed that the vaccine did not contain anything she was allergic to. On an unknown date, the patient was vaccinated with similar vaccines without any incident (when she was a younger child). The patient was transported by ambulance to the Emergency room (for 5 hour). Patient had no laboratory investigation. The patient was treated with EPIPEN (for respiratory treatment), oral BENADRYL and oral steroids (given in ER) and MEDROL dose pack. On an unknown date, the patient was discharged and was recovered from the event. Upon medical review, the case was considered as serious due to important medical event: anaphylactic reaction. List of documents held by sender: none. Sender's Comments: Anaphylactic reaction is listed with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Time to onset is compatible with the role of the vaccine. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
Age: 49.0
Sex: M
Vaccine: FLU3, IPV
Symptoms: Disability, Immediate post-injection reaction, Injection site pain, Joint injury, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer (Patient) on 27 May 2016. This case involves 49-year-old male patient who was vaccinated with a first dose of IPOL (batch number- H1452-1, expiry date- 15 Sep 2014, site of administration not reported) in right deltoid, first dose of Fluzone (batch number and route of administration not reported) in left deltoid and also received first dose of TUBERCULIN PPD(M) 5 TU (batch number and route of administration not reported) in left forearm on 27 September 2013. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. The patient had medical history of hypertension. The patient had not received any other vaccinations within 4 weeks of vaccinations. Concomitant medications were not reported. On 27 September 2013, immediately following the vaccination, the patient had pain in his full right arm (became so severe). The patient was diagnosed with SIRVA and brachial neuritis. He was permanently disabled. The patient required ER visit for pain management and doctor visit in 2013. Laboratory data included: X-ray was performed. The patient had received physical therapy, medications, and other treatments. The patient was not recovered from events. The case was considered as serious due to seriousness criteria: disability. List of documents held by sender: none. Sender's Comments: This case refers to a 49 years old male patient who received IPV (VERO) in right deltoid simultaneously with INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE in left deltoid and PPD in left forearm and experienced immediate pain in his full right arm which was later diagnosed as SIRVA and Brachial Neuritis. Considering the vaccination site of IPV (VERO), nature of the reported events and positive temporal relationship with the reported events, causality cannot be excluded. However, for other two suspect vaccines, causality can be excluded, based on the site of administration.
Age: 49.0
Sex: M
Vaccine: FLU3, IPV
Symptoms: Radiculitis brachial, X-ray
Clinical narrative: Initial unsolicited report received from a consumer (Patient) on 27 May 2016. This case involves 49-year-old male patient who was vaccinated with a first dose of IPOL (batch number- H1452-1, expiry date- 15 Sep 2014, site of administration not reported) in right deltoid, first dose of Fluzone (batch number and route of administration not reported) in left deltoid and also received first dose of TUBERCULIN PPD(M) 5 TU (batch number and route of administration not reported) in left forearm on 27 September 2013. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. The patient had medical history of hypertension. The patient had not received any other vaccinations within 4 weeks of vaccinations. Concomitant medications were not reported. On 27 September 2013, immediately following the vaccination, the patient had pain in his full right arm (became so severe). The patient was diagnosed with SIRVA and brachial neuritis. He was permanently disabled. The patient required ER visit for pain management and doctor visit in 2013. Laboratory data included: X-ray was performed. The patient had received physical therapy, medications, and other treatments. The patient was not recovered from events. The case was considered as serious due to seriousness criteria: disability. List of documents held by sender: none. Sender's Comments: This case refers to a 49 years old male patient who received IPV (VERO) in right deltoid simultaneously with INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE in left deltoid and PPD in left forearm and experienced immediate pain in his full right arm which was later diagnosed as SIRVA and Brachial Neuritis. Considering the vaccination site of IPV (VERO), nature of the reported events and positive temporal relationship with the reported events, causality cannot be excluded. However, for other two suspect vaccines, causality can be excluded, based on the site of administration.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: LEFT POSTERIOR UPPER ARM TO OUTER SIDE OF ARM WITH ERYTHEMA, SLIGHTLY WARM NO TRUE UNDERNATION AREA INFERIOR AND ANTERIOR TO INJECTION SITE.
Sex: U
Vaccine: HPVX
Symptoms: Death
Clinical narrative: This spontaneous report as received from a physician refers to two patients of unknown demographics. The patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with GARDASIL (strength, dose, frequency, therapy route, indication and lot number were not reported) (unspecified if the product was GARDASIL or GARDASIL 9). Concomitant medications were not reported. The physician reported that, an unspecified patient mentioned that two patients died after receiving the vaccine. The cause of the death was not reported. The outcome of event was fatal. Causality assessment was not provided. No product quality complaint was reported. Upon internal review, death was considered as medically significant. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Still have a lump at the injection site and is becoming sore and hurts to touch again.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Noticed I was still having pain at injection site and in same spot as injection given. As time went on my right shoulder became very painful. This has continued until now.