chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
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 33 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. On 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscularly 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.
Age: 33.0
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 33 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. On 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscularly 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.
Age: 33.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: HIV antibody negative, Hepatitis B core antibody negative, Hepatitis B surface antibody positive, Hepatitis B surface antigen negative, Hepatitis C antibody negative
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 33 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. On 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscularly 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.
Age: 33.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Incorrect product storage, Multiple use of single-use product, Wrong technique in product usage process
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 33 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. On 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscularly 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.
Age: 62.0
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 62 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 core antibody and was negative for hepatitis B surface antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown.
Age: 62.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Incorrect product storage, Multiple use of single-use product, Underdose, Wrong technique in product usage process
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 62 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 core antibody and was negative for hepatitis B surface antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown.
Age: 62.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hepatitis B virus test positive, Hepatitis C antibody negative, Hepatitis C virus test positive, Incorrect product storage, Multiple use of single-use product
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 62 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 core antibody and was negative for hepatitis B surface antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown.
Age: 62.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Underdose
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 62 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 core antibody and was negative for hepatitis B surface antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown.
Age: 51.0
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 51 year old patient with unknown gender. 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 antoher 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 needed 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 (influenza virus vaccine polyvalent, thimerosal containing, batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep B, hep C,  HIV), hepatitis B vaccine and flu vaccine. On 06-OCT-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B core antibody and was negative for hepatitis B surface antibody, hepatitis B surface antigen, hepatitis B IgN, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown. Reporter's comments: The health authority assessed the events as non-serious.
Age: 51.0
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 51 year old patient with unknown gender. 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 antoher 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 needed 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 (influenza virus vaccine polyvalent, thimerosal containing, batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep B, hep C,  HIV), hepatitis B vaccine and flu vaccine. On 06-OCT-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B core antibody and was negative for hepatitis B surface antibody, hepatitis B surface antigen, hepatitis B IgN, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown. Reporter's comments: The health authority assessed the events as non-serious.
Age: 51.0
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 antigen negative
Clinical narrative: This medically confirmed health authority report (initial receipt 22-FEB-2016) concerns a 51 year old patient with unknown gender. 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 antoher 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 needed 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 (influenza virus vaccine polyvalent, thimerosal containing, batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep B, hep C,  HIV), hepatitis B vaccine and flu vaccine. On 06-OCT-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B core antibody and was negative for hepatitis B surface antibody, hepatitis B surface antigen, hepatitis B IgN, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown. Reporter's comments: The health authority assessed the events as non-serious.
Age: 51.0
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 51 year old patient with unknown gender. 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 antoher 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 needed 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 (influenza virus vaccine polyvalent, thimerosal containing, batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep B, hep C,  HIV), hepatitis B vaccine and flu vaccine. On 06-OCT-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B core antibody and was negative for hepatitis B surface antibody, hepatitis B surface antigen, hepatitis B IgN, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown. Reporter's comments: The health authority assessed the events as non-serious.
Age: 47.0
Sex: U
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 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 67 patients) was administered intramuscular AFLURIA, batch number: 11049221A. 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.
Age: 47.0
Sex: U
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 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 67 patients) was administered intramuscular AFLURIA, batch number: 11049221A. 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.
Age: 47.0
Sex: U
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 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 67 patients) was administered intramuscular AFLURIA, batch number: 11049221A. 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.
Age: 47.0
Sex: U
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 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 67 patients) was administered intramuscular AFLURIA, batch number: 11049221A. 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.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 39 year old female patient. The patient did not report any illness at the time of vaccination. The patient was not feeling sick before vaccination. She did not indicate any allergies, chronic conditions or health problems. The patient did not use this pharmacy, therefore it was unknown if she was using any prescription medications at the time of administration. On 11-Dec-2015, the patient received intramuscular AFLURIA (batch number U56907) in the right arm. On an unspecified date, the patient experienced pain and loss of mobility in the immunization arm. She reported that she could not lift her coffee pot. The outcome was reported as unknown.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 39 year old female patient. The patient did not report any illness at the time of vaccination. The patient was not feeling sick before vaccination. She did not indicate any allergies, chronic conditions or health problems. The patient did not use this pharmacy, therefore it was unknown if she was using any prescription medications at the time of administration. On 11-Dec-2015, the patient received intramuscular AFLURIA (batch number U56907) in the right arm. On an unspecified date, the patient experienced pain and loss of mobility in the immunization arm. She reported that she could not lift her coffee pot. The outcome was reported as unknown.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Cellulitis, Erythema, Pyrexia
Clinical narrative: Case number PHHY2016US058662, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 625980) website on 17 Apr 2016. This report refers to a 66 years old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516501) intramuscularly into left arm and PREVNAR 13 (other manufacturer), (batch number: M51194) intramuscularly into right arm, both on 01 Mar 2016. On 02 Mar 2016 after vaccination, the patient experienced some fever, redness on the arm. It was diagnosed as cellulitis. The patient was treated with loratadine (manufacturer unknown) and cefadroxil (manufacturer unknown). The patient visited the emergency room on an unknown date. The final outcome of the events was reported as complete recovery. Seriousness of the events was reported as non serious and causality not reported. Seriousness assessment of the event cellulitis was upgraded based on Novartis Important Medical Events list. Batch review report reference number (1014477) received from quality assurance department on 25 May 2016. Based on the document review, it was stated that the concerned FLUVIRIN batch number (1516501) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow up received from quality assurance department (QA reference number: 1014477) on 04 May 2016: Updates QA number only. Follow up report received from quality assurance department on 25 May 2016: Added expanded batch summary report.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site nodule
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site nodule in a 9-month-old female patient who received PEDIARIX (batch number L49EE, expiry date 4th September 2017). Concomitant products included HIB, Pneumococcal vaccine and PEDIARIX. On 2nd May 2016, the patient received the 2nd dose of PEDIARIX (intramuscular) .5 ml. On 2nd May 2016, an unknown time after receiving PEDIARIX, the patient experienced drug dose administration interval too long. In May 2016, the patient experienced injection site nodule (serious criteria other: as per reporter). On an unknown date, the outcome of the injection site nodule was not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown. The reporter considered the injection site nodule to be almost certainly related to PEDIARIX. Additional details were provided as follows: On 22nd February 2016, the patient received 1st dose of PEDIARIX. On 2nd May 2016, the patient received 2nd dose of PEDIARIX, which led to lengthening of the vaccination schedule. The patient's mother noticed a knot on the patient's right thigh where she received the PEDIARIX, but did not know when exactly it first appeared. The patient also received a pneumococcal and HIB (both were non GSK) vaccine, but they were both administered in the left thigh. The patient would be seen by the doctor at the office on the day of reporting.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Inappropriate schedule of drug administration, Injection site nodule
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site nodule in a 9-month-old female patient who received PEDIARIX (batch number L49EE, expiry date 4th September 2017). Concomitant products included HIB, Pneumococcal vaccine and PEDIARIX. On 2nd May 2016, the patient received the 2nd dose of PEDIARIX (intramuscular) .5 ml. On 2nd May 2016, an unknown time after receiving PEDIARIX, the patient experienced drug dose administration interval too long. In May 2016, the patient experienced injection site nodule (serious criteria other: as per reporter). On an unknown date, the outcome of the injection site nodule was not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown. The reporter considered the injection site nodule to be almost certainly related to PEDIARIX. Additional details were provided as follows: On 22nd February 2016, the patient received 1st dose of PEDIARIX. On 2nd May 2016, the patient received 2nd dose of PEDIARIX, which led to lengthening of the vaccination schedule. The patient's mother noticed a knot on the patient's right thigh where she received the PEDIARIX, but did not know when exactly it first appeared. The patient also received a pneumococcal and HIB (both were non GSK) vaccine, but they were both administered in the left thigh. The patient would be seen by the doctor at the office on the day of reporting.
Sex: U
Vaccine: YF
Symptoms: Exposure via direct contact, Eye irritation
Clinical narrative: Initial unsolicited misuse report received from a physician on 03 June 2015. A patient (age and gender not reported), concomitant medications were not reported, had received a dose of YF VAX (batch number, expiry date, dose, dose number, route and site of administration were not reported) on an unspecified date. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. On an unspecified date, patient had an eyesplash with YF VAX and two weeks later patient experienced eye irritation. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of event was unknown. Documents held by sender: none.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: I have never had fever blisters until June 1,2016 when I developed a fever blister. Not once in 60 years have I had this problem, the only change is the ZOSTAVAX.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV1
Symptoms: Dyskinesia, Head banging, Sensory disturbance
Clinical narrative: Head-banging, arm flapping, punching, extreme need for human contact, hypersensitivity to sensory stimuli.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Fever of 104 degrees F.
Age: 46.0
Sex: M
Vaccine: YF
Symptoms: Injection site bruising, Rash, Rash pruritic
Clinical narrative: Based on additional information received on 11 January 2016, this case become medically confirmed. Initial unsolicited report received from a consumer on 15 October 2015. This case involves a 46-years-old male patient who was vaccinated with a dose of YF-VAX (batch number: unknown, dose, dose in series, route of administration were not reported) in left arm on 27 September 2015. The patient illness at time of vaccination was not reported and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as allergies to bee stings. Concomitant medications were not reported. On an unknown date, fifteen days following the vaccination, the patient had developed intermittent, rash, over chest, arms, and stomach that was sometimes itchy and continues to have "bruise" at injection site. It was reported that rash developed at times of increased body heat such as after a workout or after morning shower which lasts for about twenty minutes and goes away and had intermittent rash over the past 3 days. Laboratory data and corrective treatment was not reported. The patient was not recovered from all the events. Follow up information received from physician on 11 January 2016. The patient was vaccinated with YF-VAX (batch number: UI094AA, expiry date: 30 October 2016) via subcutaneous route in left arm on 27 September 2015. List of documents held by sender: none.
Sex: F
Vaccine: YF
Symptoms: Pain in extremity
Clinical narrative: Initial unsolicited report received from a non healthcare professional on 28-Oct-2015. This case involves a female patient (age was not reported) who was vaccinated with a dose of YF-VAX (manufacturer: Sanofi Pasteur, batch number, expiry date, dose details, route and site of administration were not reported) on an unspecified date (reported as 3 weeks ago). The patient illness at time of vaccination and pre-existing physician diagnosed allergies, medical conditions, birth defects were not reported. It was unknown if the patient was previously vaccinated. On unspecified date, post vaccination, the patient experienced a sore arm. There was no erythema, warmth or tenderness to actual site and there was no fever. It was reported that patient had multiple vaccines administered on the same day (details were not provided). Laboratory investigations and corrective treatment was not reported. The outcome of the event was reported as unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial solicited report received from a physician in the study on 21 April 2016. This case involves a 14-year-old female subject who developed influenza post vaccination. The medical history and concomitant therapy details were not reported. The subject experienced influenza on an unspecified date, after receiving a dose of Flu Vaccine (date of vaccination, site and route of administration and batch number were not reported). The subject received a dose of the above mentioned vaccine (flu vaccine) and then got the flu with serious complications. According to the physician the event of influenza was considered as life threatening. The lab data and corrective treatment details were not reported. The outcome of the event was unknown at the time of report. Relationship to investigational product according to company: not associated. List of documents held by sender: none. Sender's Comments: A 14 year-old female subject received flu vaccine (date, lot are unknown). She developed influenza infection (number of days post- vaccination is unknown) with life-threatening complications. Due to lack of details of influenza infection, medication history and patient immune status at the time of vaccination, the sponsor assesses this event as not related to the study product.
Age: 23.0
Sex: M
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: PATIENT BROKE OUT IN HIVES ALL OVER BODY.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Exposure during pregnancy, Fatigue, Nausea, Pain, Pain in extremity
Clinical narrative: Nausea and vomiting, extreme fatigue, soreness, achy legs and feet.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Vomiting
Clinical narrative: Nausea and vomiting, extreme fatigue, soreness, achy legs and feet.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Arthralgia, Asthenia, Chills, Conversion disorder, Dizziness
Clinical narrative: Chills, subjective fever, cold intolerance, weakness, nausea, vomiting, muscle aches, painful joints, dizziness, pain, tingling/numbness to lower extremities.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Hypoaesthesia, Myalgia, Nausea, Pain, Paraesthesia
Clinical narrative: Chills, subjective fever, cold intolerance, weakness, nausea, vomiting, muscle aches, painful joints, dizziness, pain, tingling/numbness to lower extremities.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Pyrexia, Temperature intolerance, Vomiting
Clinical narrative: Chills, subjective fever, cold intolerance, weakness, nausea, vomiting, muscle aches, painful joints, dizziness, pain, tingling/numbness to lower extremities.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was initially received on 18-DEC-2015. The case report was received from a(n) Health Professional and concerns a(n) 46 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 09-Dec-2015 - 09-Dec-2015, Batch no: U55706, Route of administration: Intramuscular, Dose: 0.5 ml once. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unknown date, after starting / treatment with AFLURIA the patient experienced Pain in her arm/Arm pain (non serious, outcome: not recovered/not resolved). Action taken: discontinued. Event treatment: Rechallenge/Dechallenge Information: For relevant test results see appropriate report section. Reporter's assessment: The reporter assessed the event as non-serious.
Sex: M
Vaccine: MENB
Symptoms: Dyskinesia, Pyrexia, Seizure like phenomena, Syncope
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A male child patient of an unspecified age and ethnicity received a single dose of TRUMENBA, via an unspecified route of administration, on an unspecified date. The patient medical history and concomitant medications were not reported. Upon vaccination, on an unspecified date, the patient fainted and his arms moved uncontrollably (as if having seizure), furthermore the day after the vaccination he presented fever of 102 degrees F. Outcome of events was unknown at the time of this report. No follow-up attempts are possible. No further information is expected.
Age: 7.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Contusion, Erythema, Peripheral swelling
Clinical narrative: Bilateral leg upper leg swelling/redness/bruising. No pain.
Age: 15.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Dizziness, Syncope
Clinical narrative: PATIENT WAS HERE TO RECEIVE 4 VACCINES. SHE RECEIVED BOOSTRIX FIRST, THEN TYPHOID. SHE STATED SHE WAS FEELING LIGHTHEADED, SO WE TOOK A BREAK, AND MOMENTS LATER SHE FAINTED. I CAUGHT HER, AND SHE WAS AWAKE MOMENTS LATER.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Body temperature increased, Haematochezia, Irritability
Clinical narrative: Bloody stools, fussy, temp 101
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, soreness, swelling and itching at the site of the injection.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site vesicles, Rash, Scab, Skin lesion
Clinical narrative: Developed blisters at the vaccination site, fluid filled, very painful vaccinated 3/30. When seen next (4/20) she reported this reaction had occurred. She applied topical hydrocortisone and had improvement in the rash. When seen 4/22 there was some scabbing (about 1 x 2 cm in diameter). No vesicles, erythema, swelling or drainage. Also on L breast there was a small lesion or scab, with no drainage, vesicles, erythema or swelling.
Age: 1.42
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Drooling, Eye swelling, Hypersensitivity, Nasal congestion, Ocular hyperaemia
Clinical narrative: FEVER STARTED ON 5-17-16 ALMOST IMMEDIATELY, THEN ON 5-18 HIS NOSE STARTED RUNNING, BY 5-19 HIS EYES WERE RED AND SWOLLEN, HIS NOSE WAS POURING AND HE HAD EXCESSIVE DROOL....BY 5-20, HIS EYES WERE ALMOST SWOLLEN SHUT AND VERY RED, HIS NOSE SEEMED SWOLLEN INSIDE AND WAS POURING AND HE WAS DROOLING SO BADLY IT WAS AS THOUGH HE WAS HAVING TROUBLE SWALLOWING....AT THIS POINT I GAVE HIM BENADRYL FOR THE ALLERGIC REACTION HE WAS HAVING. WITHIN AN HOUR HIS EYES WEREN'T RED AND RUNNING AND HIS NOSE STOPPED POURING.  HOWEVER...LATER IN THE EVENING HE THEN BROKE OUT IN TINY RED BUMPS FROM HEAD TO TOE...LIKE I HAD DOTTED HIM WITH A PEN (THIS IS THE SAME WAY HE REACTS WHEN HE EAT PEANUT PRODUCTS OR TAKES PENICILLIN) I HAD TO GIVE HIM BENADRYL AGAIN....BY THE NEXT MORNING HIS EYES/ NOSE AND DROOL WERE MUCH BETTER AND HE KEPT THE RASH FOR ANOTHER DAY.
Age: 1.42
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash generalised, Rhinorrhoea
Clinical narrative: FEVER STARTED ON 5-17-16 ALMOST IMMEDIATELY, THEN ON 5-18 HIS NOSE STARTED RUNNING, BY 5-19 HIS EYES WERE RED AND SWOLLEN, HIS NOSE WAS POURING AND HE HAD EXCESSIVE DROOL....BY 5-20, HIS EYES WERE ALMOST SWOLLEN SHUT AND VERY RED, HIS NOSE SEEMED SWOLLEN INSIDE AND WAS POURING AND HE WAS DROOLING SO BADLY IT WAS AS THOUGH HE WAS HAVING TROUBLE SWALLOWING....AT THIS POINT I GAVE HIM BENADRYL FOR THE ALLERGIC REACTION HE WAS HAVING. WITHIN AN HOUR HIS EYES WEREN'T RED AND RUNNING AND HIS NOSE STOPPED POURING.  HOWEVER...LATER IN THE EVENING HE THEN BROKE OUT IN TINY RED BUMPS FROM HEAD TO TOE...LIKE I HAD DOTTED HIM WITH A PEN (THIS IS THE SAME WAY HE REACTS WHEN HE EAT PEANUT PRODUCTS OR TAKES PENICILLIN) I HAD TO GIVE HIM BENADRYL AGAIN....BY THE NEXT MORNING HIS EYES/ NOSE AND DROOL WERE MUCH BETTER AND HE KEPT THE RASH FOR ANOTHER DAY.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Blood test normal, Discomfort, Headache, Musculoskeletal stiffness, Slow speech
Clinical narrative: Physical shaking, extreme headache, stiffness of neck and shoulders, heaviness of body, slowed speech.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Tremor, Urine analysis normal
Clinical narrative: Physical shaking, extreme headache, stiffness of neck and shoulders, heaviness of body, slowed speech.
Age: 69.0
Sex: F
Vaccine: TYP, YF
Symptoms: Cellulitis, Electromyogram normal, Injection site pain
Clinical narrative: Site of the injection became sore; each day it got worse; went to a Dr. and was diagnosed with cellulitis and put on an antibiotic; continued to be more and more painful.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Depressed level of consciousness, Dizziness, Fatigue, Headache, Hyporesponsive to stimuli
Clinical narrative: About 15 minutes after patient received the Gardasil vaccine she felt dizzy, she became very pale. Her lips were white. She said she couldn't see, that everything was getting dark and that she had a loud ringing in her ears. She had to sit down. She wanted to go to sleep, but I encouraged her to stay awake and keep talking to me. It was hard to get her to respond. The Pharmacy called 911. She was like that for about 15 minutes. Then she started talking a little bit but was still quite pale. The 911 responders arrived. She complained of a bad headache and stated she was very thirsty. Slowly she started to regain a more normal level of consciousness. After about 45 minutes she was totally conscious but had a headache and was very tired. She did not go to the hospital. This exact scenario has happened 3 times since her vaccine. The date today is 6/2/16. She has complained of vertigo countless times since the vaccine as well. This has never happened to her before she received this vaccine.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pallor, Somnolence, Thirst, Tinnitus, Vertigo
Clinical narrative: About 15 minutes after patient received the Gardasil vaccine she felt dizzy, she became very pale. Her lips were white. She said she couldn't see, that everything was getting dark and that she had a loud ringing in her ears. She had to sit down. She wanted to go to sleep, but I encouraged her to stay awake and keep talking to me. It was hard to get her to respond. The Pharmacy called 911. She was like that for about 15 minutes. Then she started talking a little bit but was still quite pale. The 911 responders arrived. She complained of a bad headache and stated she was very thirsty. Slowly she started to regain a more normal level of consciousness. After about 45 minutes she was totally conscious but had a headache and was very tired. She did not go to the hospital. This exact scenario has happened 3 times since her vaccine. The date today is 6/2/16. She has complained of vertigo countless times since the vaccine as well. This has never happened to her before she received this vaccine.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Visual impairment
Clinical narrative: About 15 minutes after patient received the Gardasil vaccine she felt dizzy, she became very pale. Her lips were white. She said she couldn't see, that everything was getting dark and that she had a loud ringing in her ears. She had to sit down. She wanted to go to sleep, but I encouraged her to stay awake and keep talking to me. It was hard to get her to respond. The Pharmacy called 911. She was like that for about 15 minutes. Then she started talking a little bit but was still quite pale. The 911 responders arrived. She complained of a bad headache and stated she was very thirsty. Slowly she started to regain a more normal level of consciousness. After about 45 minutes she was totally conscious but had a headache and was very tired. She did not go to the hospital. This exact scenario has happened 3 times since her vaccine. The date today is 6/2/16. She has complained of vertigo countless times since the vaccine as well. This has never happened to her before she received this vaccine.
Age: 78.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Condition aggravated, Rash
Clinical narrative: This spontaneous case was initially received on 30-Nov-2015. The case report was received from a(n) Health Professional and concerns a(n) 78 year old female patient. The patient does not have any drug allergies. The patient received Influenza vaccine on unknown dates, Batch no: not provided, Route of administration: Unknown, Site: Left arm. Additional suspect drug(s): KEYTRUDA, Route: Central intravenous, Dose: 2 mg/kg, Indication: Stage IV melanoma, Site: Right arm. On an unknown date, after starting treatment with Influenza vaccine the patient experienced Rash on her upper right arm. The pharmacist reports that one week after the first dose of pembrolizumab, the patient returned to her physician because she had developed a rash on her upper right arm. No treatment was given. The patient returned to her physician's office on 18-Nov-2015 to receive her second dose of pembrolizumab. Prior to the infusion it was noted by the physician that the rash looked worse, however, the pembrolizumab was still administered. The patient will be treated with hydrocortisone cream and diphenhydramine. The pharmacist also reported that the patient received an influenza vaccination "a couple of weeks ago" in the left arm (unspecified manufacturer, unspecified date). The pharmacist reports the patient's rash is a pre-existing condition which periodically appears then disappears. Pharmacist further explained that prior to starting pembrolizumab therapy, the patient "has always had a rash that comes and goes on her arm". On the day the patient was scheduled to received her first dose of pembrolizumab, she did not have a rash. The first dose was administered and at an unspecified time the rash "reappeared" on her arm and "it currently seems to be getting worse". Reporter's assessment: Not reported. The pharmacist does not believe the reaction (rash) is from the flu shot. The pharmacist states the flu shot was administered in the left arm, but the rash is in the right arm. The right arm is also where the patient gets her KEYTRUDA, which may cause rash. He states he last spoke to the patient 28-Nov-15 and the rash has not gotten any worse. He believes the rash is from the KEYTRUDA or the patient's disease state of melanoma.