chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demography. On 13-NOV-2013 the patient was indicated to be vaccinated with PNEUMOVAX 23 may have received a dose of vaccinated with ZOSTAVAX, 0.5 ml, intramuscular in the right arm. This was reported to be a possible documentation error and not product confusion. No adverse effect reported. No other information was available. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age. The medical assistant reported on an unknown date, unknown number of patients were vaccinated with a dose of GARDASIL (lot#, dose/frequency and route unknown) which were improperly stored. No adverse effects reported. This is one of three reports (MARRS#: 1403USA009143; 1403USA009144) received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age. The medical assistant reported on an unknown date, unknown number of patients were vaccinated with a dose of M-M-R II (lot #, dose/frequency and route unknown) which were improperly stored. No adverse effects reported. This is one of three reports (MARRS# 1403USA008050, 1403USA009144) received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age. The medical assistant reported on an unknown date, unknown number of patients were vaccinated with a dose of ROTATEQ (lot #, dose/frequency and route unknown) which were improperly stored. No adverse effects reported. This is one of three reports (MARRS #: 1403USA008050, 1403USA009143) received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received form a pharmacist refers to an unspecified number of patients of unknown ages and genders. From 13-FEB-2014 to 14-MAR-2014, doses of GARDASIL injection (lot #, expiry date, dose, route and indication unknown) that were exposed to temperatures outside of the prescribing information, might have been administered to the unspecified number of patients. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 05-MAR-2014, the patient was inadvertently administered PROQUAD, 0.5 ml, subcutaneously (SQ), lot # H015784 that had expired on 24-FEB-2014. No adverse effects reported. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Anaphylactic reaction, Pharyngeal oedema, Pyrexia, Urticaria
Clinical narrative: Initial information received on 14 March 2014 from a healthcare provider via another manufacturer. A 2 month old male patient was vaccinated on 15 August 2013 with the following vaccines: ACTHIB, lot number, route, site and number of previous doses unknown, a first dose of PEDIARIX, 0.5 mL GSK, lot number 749CT into the left arm, route not reported, ROTATEQ, manufacturer, route, site and number of previous doses unknown and PREVNAR 13, manufacturer, route, site and number of previous doses unknown. PEDIARIX was administered at inappropriate site as the preferred administration site for PEDIARIX is the anterolateral aspect of the thigh for children younger than 1 year. The patient's medical history included premature birth. Concurrent medications included Vitamin and Children's TYLENOL. Per the physician, the subject "was tested along with several consultations to different doctors." No details were provided as to the tests performed. On 18 August 2013, 3 days post vaccination, the rash worsened and the subject was taken to a hospital "with a pediatric ward." Per the physician, the subject "was hospitalized due to a life threatening condition." The subject was tested along with several consultations to different doctors." The subject was discharged with a diagnosis of erythema multiforme. The subject was referred to an allergist to do allergy testing "to determine which vaccine may have caused" the reaction "before they go forward with administering any vaccines to this child." The subject was hospitalized and the physician considered the events were life threatening. The patient was treated with prednisone. At the time of reporting the patient outcome was recovered. Documents held by sender: None.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Drug administered at inappropriate site, Erythema multiforme, Laboratory test, Rash
Clinical narrative: Initial information received on 14 March 2014 from a healthcare provider via another manufacturer. A 2 month old male patient was vaccinated on 15 August 2013 with the following vaccines: ACTHIB, lot number, route, site and number of previous doses unknown, a first dose of PEDIARIX, 0.5 mL GSK, lot number 749CT into the left arm, route not reported, ROTATEQ, manufacturer, route, site and number of previous doses unknown and PREVNAR 13, manufacturer, route, site and number of previous doses unknown. PEDIARIX was administered at inappropriate site as the preferred administration site for PEDIARIX is the anterolateral aspect of the thigh for children younger than 1 year. The patient's medical history included premature birth. Concurrent medications included Vitamin and Children's TYLENOL. Per the physician, the subject "was tested along with several consultations to different doctors." No details were provided as to the tests performed. On 18 August 2013, 3 days post vaccination, the rash worsened and the subject was taken to a hospital "with a pediatric ward." Per the physician, the subject "was hospitalized due to a life threatening condition." The subject was tested along with several consultations to different doctors." The subject was discharged with a diagnosis of erythema multiforme. The subject was referred to an allergist to do allergy testing "to determine which vaccine may have caused" the reaction "before they go forward with administering any vaccines to this child." The subject was hospitalized and the physician considered the events were life threatening. The patient was treated with prednisone. At the time of reporting the patient outcome was recovered. Documents held by sender: None.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dermatitis allergic, Drug administered at inappropriate site, Erythema multiforme
Clinical narrative: Initial information received on 14 March 2014 from a healthcare provider via another manufacturer. A 2 month old male patient was vaccinated on 15 August 2013 with the following vaccines: ACTHIB, lot number, route, site and number of previous doses unknown, a first dose of PEDIARIX, 0.5 mL GSK, lot number 749CT into the left arm, route not reported, ROTATEQ, manufacturer, route, site and number of previous doses unknown and PREVNAR 13, manufacturer, route, site and number of previous doses unknown. PEDIARIX was administered at inappropriate site as the preferred administration site for PEDIARIX is the anterolateral aspect of the thigh for children younger than 1 year. The patient's medical history included premature birth. Concurrent medications included Vitamin and Children's TYLENOL. Per the physician, the subject "was tested along with several consultations to different doctors." No details were provided as to the tests performed. On 18 August 2013, 3 days post vaccination, the rash worsened and the subject was taken to a hospital "with a pediatric ward." Per the physician, the subject "was hospitalized due to a life threatening condition." The subject was tested along with several consultations to different doctors." The subject was discharged with a diagnosis of erythema multiforme. The subject was referred to an allergist to do allergy testing "to determine which vaccine may have caused" the reaction "before they go forward with administering any vaccines to this child." The subject was hospitalized and the physician considered the events were life threatening. The patient was treated with prednisone. At the time of reporting the patient outcome was recovered. Documents held by sender: None.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Band neutrophil count, Blood alkaline phosphatase increased, Blood bicarbonate normal, Blood chloride normal, Blood creatinine normal
Clinical narrative: Initial information received on 14 March 2014 from a healthcare provider via another manufacturer. A 2 month old male patient was vaccinated on 15 August 2013 with the following vaccines: ACTHIB, lot number, route, site and number of previous doses unknown, a first dose of PEDIARIX, 0.5 mL GSK, lot number 749CT into the left arm, route not reported, ROTATEQ, manufacturer, route, site and number of previous doses unknown and PREVNAR 13, manufacturer, route, site and number of previous doses unknown. PEDIARIX was administered at inappropriate site as the preferred administration site for PEDIARIX is the anterolateral aspect of the thigh for children younger than 1 year. The patient's medical history included premature birth. Concurrent medications included Vitamin and Children's TYLENOL. Per the physician, the subject "was tested along with several consultations to different doctors." No details were provided as to the tests performed. On 18 August 2013, 3 days post vaccination, the rash worsened and the subject was taken to a hospital "with a pediatric ward." Per the physician, the subject "was hospitalized due to a life threatening condition." The subject was tested along with several consultations to different doctors." The subject was discharged with a diagnosis of erythema multiforme. The subject was referred to an allergist to do allergy testing "to determine which vaccine may have caused" the reaction "before they go forward with administering any vaccines to this child." The subject was hospitalized and the physician considered the events were life threatening. The patient was treated with prednisone. At the time of reporting the patient outcome was recovered. Documents held by sender: None.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture, Blood potassium increased, Blood sodium normal, Blood urea normal, C-reactive protein increased
Clinical narrative: Initial information received on 14 March 2014 from a healthcare provider via another manufacturer. A 2 month old male patient was vaccinated on 15 August 2013 with the following vaccines: ACTHIB, lot number, route, site and number of previous doses unknown, a first dose of PEDIARIX, 0.5 mL GSK, lot number 749CT into the left arm, route not reported, ROTATEQ, manufacturer, route, site and number of previous doses unknown and PREVNAR 13, manufacturer, route, site and number of previous doses unknown. PEDIARIX was administered at inappropriate site as the preferred administration site for PEDIARIX is the anterolateral aspect of the thigh for children younger than 1 year. The patient's medical history included premature birth. Concurrent medications included Vitamin and Children's TYLENOL. Per the physician, the subject "was tested along with several consultations to different doctors." No details were provided as to the tests performed. On 18 August 2013, 3 days post vaccination, the rash worsened and the subject was taken to a hospital "with a pediatric ward." Per the physician, the subject "was hospitalized due to a life threatening condition." The subject was tested along with several consultations to different doctors." The subject was discharged with a diagnosis of erythema multiforme. The subject was referred to an allergist to do allergy testing "to determine which vaccine may have caused" the reaction "before they go forward with administering any vaccines to this child." The subject was hospitalized and the physician considered the events were life threatening. The patient was treated with prednisone. At the time of reporting the patient outcome was recovered. Documents held by sender: None.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: CSF culture, Dermatitis allergic, Dermatitis contact, Drug administered at inappropriate site, Erythema
Clinical narrative: Initial information received on 14 March 2014 from a healthcare provider via another manufacturer. A 2 month old male patient was vaccinated on 15 August 2013 with the following vaccines: ACTHIB, lot number, route, site and number of previous doses unknown, a first dose of PEDIARIX, 0.5 mL GSK, lot number 749CT into the left arm, route not reported, ROTATEQ, manufacturer, route, site and number of previous doses unknown and PREVNAR 13, manufacturer, route, site and number of previous doses unknown. PEDIARIX was administered at inappropriate site as the preferred administration site for PEDIARIX is the anterolateral aspect of the thigh for children younger than 1 year. The patient's medical history included premature birth. Concurrent medications included Vitamin and Children's TYLENOL. Per the physician, the subject "was tested along with several consultations to different doctors." No details were provided as to the tests performed. On 18 August 2013, 3 days post vaccination, the rash worsened and the subject was taken to a hospital "with a pediatric ward." Per the physician, the subject "was hospitalized due to a life threatening condition." The subject was tested along with several consultations to different doctors." The subject was discharged with a diagnosis of erythema multiforme. The subject was referred to an allergist to do allergy testing "to determine which vaccine may have caused" the reaction "before they go forward with administering any vaccines to this child." The subject was hospitalized and the physician considered the events were life threatening. The patient was treated with prednisone. At the time of reporting the patient outcome was recovered. Documents held by sender: None.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema multiforme, Haematocrit decreased, Haemoglobin decreased, Lumbar puncture abnormal, Neutrophil count increased
Clinical narrative: Initial information received on 14 March 2014 from a healthcare provider via another manufacturer. A 2 month old male patient was vaccinated on 15 August 2013 with the following vaccines: ACTHIB, lot number, route, site and number of previous doses unknown, a first dose of PEDIARIX, 0.5 mL GSK, lot number 749CT into the left arm, route not reported, ROTATEQ, manufacturer, route, site and number of previous doses unknown and PREVNAR 13, manufacturer, route, site and number of previous doses unknown. PEDIARIX was administered at inappropriate site as the preferred administration site for PEDIARIX is the anterolateral aspect of the thigh for children younger than 1 year. The patient's medical history included premature birth. Concurrent medications included Vitamin and Children's TYLENOL. Per the physician, the subject "was tested along with several consultations to different doctors." No details were provided as to the tests performed. On 18 August 2013, 3 days post vaccination, the rash worsened and the subject was taken to a hospital "with a pediatric ward." Per the physician, the subject "was hospitalized due to a life threatening condition." The subject was tested along with several consultations to different doctors." The subject was discharged with a diagnosis of erythema multiforme. The subject was referred to an allergist to do allergy testing "to determine which vaccine may have caused" the reaction "before they go forward with administering any vaccines to this child." The subject was hospitalized and the physician considered the events were life threatening. The patient was treated with prednisone. At the time of reporting the patient outcome was recovered. Documents held by sender: None.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pharyngeal oedema, Platelet count normal, Pyrexia, Rash, Skin lesion
Clinical narrative: Initial information received on 14 March 2014 from a healthcare provider via another manufacturer. A 2 month old male patient was vaccinated on 15 August 2013 with the following vaccines: ACTHIB, lot number, route, site and number of previous doses unknown, a first dose of PEDIARIX, 0.5 mL GSK, lot number 749CT into the left arm, route not reported, ROTATEQ, manufacturer, route, site and number of previous doses unknown and PREVNAR 13, manufacturer, route, site and number of previous doses unknown. PEDIARIX was administered at inappropriate site as the preferred administration site for PEDIARIX is the anterolateral aspect of the thigh for children younger than 1 year. The patient's medical history included premature birth. Concurrent medications included Vitamin and Children's TYLENOL. Per the physician, the subject "was tested along with several consultations to different doctors." No details were provided as to the tests performed. On 18 August 2013, 3 days post vaccination, the rash worsened and the subject was taken to a hospital "with a pediatric ward." Per the physician, the subject "was hospitalized due to a life threatening condition." The subject was tested along with several consultations to different doctors." The subject was discharged with a diagnosis of erythema multiforme. The subject was referred to an allergist to do allergy testing "to determine which vaccine may have caused" the reaction "before they go forward with administering any vaccines to this child." The subject was hospitalized and the physician considered the events were life threatening. The patient was treated with prednisone. At the time of reporting the patient outcome was recovered. Documents held by sender: None.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urine analysis, Urticaria, White blood cell count normal
Clinical narrative: Initial information received on 14 March 2014 from a healthcare provider via another manufacturer. A 2 month old male patient was vaccinated on 15 August 2013 with the following vaccines: ACTHIB, lot number, route, site and number of previous doses unknown, a first dose of PEDIARIX, 0.5 mL GSK, lot number 749CT into the left arm, route not reported, ROTATEQ, manufacturer, route, site and number of previous doses unknown and PREVNAR 13, manufacturer, route, site and number of previous doses unknown. PEDIARIX was administered at inappropriate site as the preferred administration site for PEDIARIX is the anterolateral aspect of the thigh for children younger than 1 year. The patient's medical history included premature birth. Concurrent medications included Vitamin and Children's TYLENOL. Per the physician, the subject "was tested along with several consultations to different doctors." No details were provided as to the tests performed. On 18 August 2013, 3 days post vaccination, the rash worsened and the subject was taken to a hospital "with a pediatric ward." Per the physician, the subject "was hospitalized due to a life threatening condition." The subject was tested along with several consultations to different doctors." The subject was discharged with a diagnosis of erythema multiforme. The subject was referred to an allergist to do allergy testing "to determine which vaccine may have caused" the reaction "before they go forward with administering any vaccines to this child." The subject was hospitalized and the physician considered the events were life threatening. The patient was treated with prednisone. At the time of reporting the patient outcome was recovered. Documents held by sender: None.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema multiforme, Rash
Clinical narrative: Initial information received on 14 March 2014 from a healthcare provider via another manufacturer. A 2 month old male patient was vaccinated on 15 August 2013 with the following vaccines: ACTHIB, lot number, route, site and number of previous doses unknown, a first dose of PEDIARIX, 0.5 mL GSK, lot number 749CT into the left arm, route not reported, ROTATEQ, manufacturer, route, site and number of previous doses unknown and PREVNAR 13, manufacturer, route, site and number of previous doses unknown. PEDIARIX was administered at inappropriate site as the preferred administration site for PEDIARIX is the anterolateral aspect of the thigh for children younger than 1 year. The patient's medical history included premature birth. Concurrent medications included Vitamin and Children's TYLENOL. Per the physician, the subject "was tested along with several consultations to different doctors." No details were provided as to the tests performed. On 18 August 2013, 3 days post vaccination, the rash worsened and the subject was taken to a hospital "with a pediatric ward." Per the physician, the subject "was hospitalized due to a life threatening condition." The subject was tested along with several consultations to different doctors." The subject was discharged with a diagnosis of erythema multiforme. The subject was referred to an allergist to do allergy testing "to determine which vaccine may have caused" the reaction "before they go forward with administering any vaccines to this child." The subject was hospitalized and the physician considered the events were life threatening. The patient was treated with prednisone. At the time of reporting the patient outcome was recovered. Documents held by sender: None.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Band neutrophil count increased, Blood alkaline phosphatase increased, Blood bicarbonate normal, Blood chloride normal, Blood creatinine normal
Clinical narrative: Initial information received on 14 March 2014 from a healthcare provider via another manufacturer. A 2 month old male patient was vaccinated on 15 August 2013 with the following vaccines: ACTHIB, lot number, route, site and number of previous doses unknown, a first dose of PEDIARIX, 0.5 mL GSK, lot number 749CT into the left arm, route not reported, ROTATEQ, manufacturer, route, site and number of previous doses unknown and PREVNAR 13, manufacturer, route, site and number of previous doses unknown. PEDIARIX was administered at inappropriate site as the preferred administration site for PEDIARIX is the anterolateral aspect of the thigh for children younger than 1 year. The patient's medical history included premature birth. Concurrent medications included Vitamin and Children's TYLENOL. Per the physician, the subject "was tested along with several consultations to different doctors." No details were provided as to the tests performed. On 18 August 2013, 3 days post vaccination, the rash worsened and the subject was taken to a hospital "with a pediatric ward." Per the physician, the subject "was hospitalized due to a life threatening condition." The subject was tested along with several consultations to different doctors." The subject was discharged with a diagnosis of erythema multiforme. The subject was referred to an allergist to do allergy testing "to determine which vaccine may have caused" the reaction "before they go forward with administering any vaccines to this child." The subject was hospitalized and the physician considered the events were life threatening. The patient was treated with prednisone. At the time of reporting the patient outcome was recovered. Documents held by sender: None.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: CSF culture, Culture urine, Dermatitis contact, Erythema, Erythema multiforme
Clinical narrative: Initial information received on 14 March 2014 from a healthcare provider via another manufacturer. A 2 month old male patient was vaccinated on 15 August 2013 with the following vaccines: ACTHIB, lot number, route, site and number of previous doses unknown, a first dose of PEDIARIX, 0.5 mL GSK, lot number 749CT into the left arm, route not reported, ROTATEQ, manufacturer, route, site and number of previous doses unknown and PREVNAR 13, manufacturer, route, site and number of previous doses unknown. PEDIARIX was administered at inappropriate site as the preferred administration site for PEDIARIX is the anterolateral aspect of the thigh for children younger than 1 year. The patient's medical history included premature birth. Concurrent medications included Vitamin and Children's TYLENOL. Per the physician, the subject "was tested along with several consultations to different doctors." No details were provided as to the tests performed. On 18 August 2013, 3 days post vaccination, the rash worsened and the subject was taken to a hospital "with a pediatric ward." Per the physician, the subject "was hospitalized due to a life threatening condition." The subject was tested along with several consultations to different doctors." The subject was discharged with a diagnosis of erythema multiforme. The subject was referred to an allergist to do allergy testing "to determine which vaccine may have caused" the reaction "before they go forward with administering any vaccines to this child." The subject was hospitalized and the physician considered the events were life threatening. The patient was treated with prednisone. At the time of reporting the patient outcome was recovered. Documents held by sender: None.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematocrit decreased, Haemoglobin normal, Lumbar puncture, Neutrophil count increased, Pharyngeal oedema
Clinical narrative: Initial information received on 14 March 2014 from a healthcare provider via another manufacturer. A 2 month old male patient was vaccinated on 15 August 2013 with the following vaccines: ACTHIB, lot number, route, site and number of previous doses unknown, a first dose of PEDIARIX, 0.5 mL GSK, lot number 749CT into the left arm, route not reported, ROTATEQ, manufacturer, route, site and number of previous doses unknown and PREVNAR 13, manufacturer, route, site and number of previous doses unknown. PEDIARIX was administered at inappropriate site as the preferred administration site for PEDIARIX is the anterolateral aspect of the thigh for children younger than 1 year. The patient's medical history included premature birth. Concurrent medications included Vitamin and Children's TYLENOL. Per the physician, the subject "was tested along with several consultations to different doctors." No details were provided as to the tests performed. On 18 August 2013, 3 days post vaccination, the rash worsened and the subject was taken to a hospital "with a pediatric ward." Per the physician, the subject "was hospitalized due to a life threatening condition." The subject was tested along with several consultations to different doctors." The subject was discharged with a diagnosis of erythema multiforme. The subject was referred to an allergist to do allergy testing "to determine which vaccine may have caused" the reaction "before they go forward with administering any vaccines to this child." The subject was hospitalized and the physician considered the events were life threatening. The patient was treated with prednisone. At the time of reporting the patient outcome was recovered. Documents held by sender: None.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Platelet count normal, Pyrexia, Rash, Skin lesion, Urine analysis
Clinical narrative: Initial information received on 14 March 2014 from a healthcare provider via another manufacturer. A 2 month old male patient was vaccinated on 15 August 2013 with the following vaccines: ACTHIB, lot number, route, site and number of previous doses unknown, a first dose of PEDIARIX, 0.5 mL GSK, lot number 749CT into the left arm, route not reported, ROTATEQ, manufacturer, route, site and number of previous doses unknown and PREVNAR 13, manufacturer, route, site and number of previous doses unknown. PEDIARIX was administered at inappropriate site as the preferred administration site for PEDIARIX is the anterolateral aspect of the thigh for children younger than 1 year. The patient's medical history included premature birth. Concurrent medications included Vitamin and Children's TYLENOL. Per the physician, the subject "was tested along with several consultations to different doctors." No details were provided as to the tests performed. On 18 August 2013, 3 days post vaccination, the rash worsened and the subject was taken to a hospital "with a pediatric ward." Per the physician, the subject "was hospitalized due to a life threatening condition." The subject was tested along with several consultations to different doctors." The subject was discharged with a diagnosis of erythema multiforme. The subject was referred to an allergist to do allergy testing "to determine which vaccine may have caused" the reaction "before they go forward with administering any vaccines to this child." The subject was hospitalized and the physician considered the events were life threatening. The patient was treated with prednisone. At the time of reporting the patient outcome was recovered. Documents held by sender: None.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urticaria, White blood cell count normal
Clinical narrative: Initial information received on 14 March 2014 from a healthcare provider via another manufacturer. A 2 month old male patient was vaccinated on 15 August 2013 with the following vaccines: ACTHIB, lot number, route, site and number of previous doses unknown, a first dose of PEDIARIX, 0.5 mL GSK, lot number 749CT into the left arm, route not reported, ROTATEQ, manufacturer, route, site and number of previous doses unknown and PREVNAR 13, manufacturer, route, site and number of previous doses unknown. PEDIARIX was administered at inappropriate site as the preferred administration site for PEDIARIX is the anterolateral aspect of the thigh for children younger than 1 year. The patient's medical history included premature birth. Concurrent medications included Vitamin and Children's TYLENOL. Per the physician, the subject "was tested along with several consultations to different doctors." No details were provided as to the tests performed. On 18 August 2013, 3 days post vaccination, the rash worsened and the subject was taken to a hospital "with a pediatric ward." Per the physician, the subject "was hospitalized due to a life threatening condition." The subject was tested along with several consultations to different doctors." The subject was discharged with a diagnosis of erythema multiforme. The subject was referred to an allergist to do allergy testing "to determine which vaccine may have caused" the reaction "before they go forward with administering any vaccines to this child." The subject was hospitalized and the physician considered the events were life threatening. The patient was treated with prednisone. At the time of reporting the patient outcome was recovered. Documents held by sender: None.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal disorder, Musculoskeletal stiffness, Myalgia, Neuralgia
Clinical narrative: SEVERE MUSCLE, NERVE PAIN TO LEFT ARM, STIFF NECK LEFT SIDE, REMAINS AS OF THIS TIME, WILL BE GOING TO DOCTORS FOR FURTHER TESTING, AM NOT ABLE TO USE ARM FULLY WITHOUT EXPERIENCING SEVERE PAIN.
Sex: U
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration
Clinical narrative: Case received from a healthcare professional (physician) on 17-Mar-2014. Three unidentified patients (no details provided), with no reported illness at the time of vaccination, no reported pre-existing diagnosed allergies, birth defects or medical conditions, and no reported concomitant therapies, had received an intramuscular dose of ADACEL (batch number U4689AA, anatomical site of administration not reported) on unspecified dates in 2014. On an unspecified date in 2014, post-vaccination, the patients experienced cellulitis, induration and redness at the injection site. It was not known whether the patients' symptoms resolved. No relevant diagnostic tests/laboratory data were conducted. This case was reported as non-serious. Upon internal review, the seriousness was upgraded to serious, i.e. important medical event.
Age: 1.08
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Bronchiolitis, Chest X-ray normal, Cough, Full blood count normal, Hypoxia
Clinical narrative: Wheezing started 3/17/14 with cough. Hypoxia noted in ER despite treatment with DUONEB and admitted to hospital. Discharged home 3/20 on inhalers with diagnosis of RSV (-) bronchiolitis. CXR read as normal. Had initial admit to PICU x 1 day.
Age: 1.08
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Influenza virus test negative, Intensive care, Respiratory syncytial virus test negative, Wheezing
Clinical narrative: Wheezing started 3/17/14 with cough. Hypoxia noted in ER despite treatment with DUONEB and admitted to hospital. Discharged home 3/20 on inhalers with diagnosis of RSV (-) bronchiolitis. CXR read as normal. Had initial admit to PICU x 1 day.
Age: 1.75
Sex: F
Vaccine: PNC
Symptoms: Autism, Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: brought patient to doctors for a sick visit because she had a fever, she got diagnosed with an ear infection. Doctor told me she didn't get her 4th vaccine of pneumococcal which she was suppose to get at 15 months. She ask me if I wanted to do it today I told her "but she is sick". She told me that it did not matter. She gave vaccine came home with a fever of 106 degrees for 6 hours straight and now is diagnosed with autism.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red, swollen, tender right deltoid area worsening after 24 hours. No fever, nausea or vomiting. Treated for cellulitis and allergic response.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a physician refers to a 27 year old female patient. She had no pertinent medical history, and no drug reactions/allergies. The patient completed the 3 dose series of GARDASIL, administered intramuscularly on unspecified dates at another practice. The patient took no concomitant medications. On 17-MAR-2014 the patient had a positive HPV DNA Pap test result. The outcome of had positive HPV DNA Pap test result was reported as not recovered/not resolved and the patient received no treatment for the event. A causality assessment was not provided. This case is cross-referenced with case 1403USA010930, regarding the another patient (reported by the same physician), who also had a positive HPV DNA Pap test result after administration of GARDASIL. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a physician refers to a 24 year old female patient. She had no pertinent medical history, and no drug reactions/allergies. The patient completed the 3 dose series of GARDASIL, administered intramuscularly on unspecified dates at another practice. The patient took no concomitant medications. On 17-MAR-2014 the patient had a positive HPV DNA Pap test result. The outcome of had positive HPV DNA pap test result was reported as not recovered/not resolved and the patient received no treatment for the event. A causality assessment was not provided. This case is cross-referenced with 1403USA010840, regarding the another patient (reported by the same physician), who also had a positive HPV DNA pap test result after administration of GARDASIL. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Headache, Poor quality sleep, Tremor
Clinical narrative: "A few hours" after vaccination, pt developed whole body shaking. This progressed to also included weakness, HA, poor sleep, dizziness. Possible tactile temp. Reaction lasted 48-72 hours. Before shakiness resolved it appeared to persist mainly in (B) hands.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site pruritus
Clinical narrative: Pt returned to clinic 3 days later c/o redness and itchiness at the site of injection. She states it started 12 hours post injection. Redness has progressively spread down (L) arm to (L) elbow.
Age: 52.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: 3/11/2014 pt c/o pain upper Rt arm and part of shoulder. Hep B had been given 2/21/2014 with no complaints at the time. 3/17/2014 patient came in to MDO and said the pain was worse. Sent patient to ER. Pain worse in arm that had Hep B vaccine. Patient didn't get into MDO or call until 3/11/2014.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Pyrexia, Vaccination site nodule
Clinical narrative: Baby had 105 fever, some knots at vaccine sites. At 4m shots mother report 103 fever otherwise child looks great.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Pt. seen in office Dr. 3-14-14 at 4:16 PM. Mother reported child awakened from nap 45 minutes ago with hives on face. Improved at time of office visit. (KINRIX, PROQUAD) pt. received on 3-13-14 in our office at 10:58 AM.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Patient developed hives 2 days after receiving GARDASIL vaccine - hives have lasted 1 wk, pt to be treated with steroids.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, White blood cell count normal
Clinical narrative: Cellulitis (redness and swelling) of left upper arm. Parent took patient to ER dx w/ cellulitis (WBC count 10,000) afebrile. Patient received IV ROCEPHIN and put on oral AUGMENTIN.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Coeliac disease
Clinical narrative: Cellulitis (redness and swelling) of left upper arm. Parent took patient to ER dx w/ cellulitis (WBC count 10,000) afebrile. Patient received IV ROCEPHIN and put on oral AUGMENTIN.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: On 3/6 pt's mother called and states pt. had immunizations on 3/4 and now pt. has "a large tennis ball sized knot on his (R) deltoid area - it's very hot and red" Mother states pt says it's painful.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Crying, Depression, Immediate post-injection reaction, Injected limb mobility decreased
Clinical narrative: This spontaneous report as received from a physical therapist, the mother of the patient, refers to a 14 year old female patient. The patient's medical history was unknown. On an unknown date in August 2013 the patient was vaccinated with GARDASIL dose 1 (dosage unknown), intramuscularly. With no adverse effects. On an unknown date in December 2013 the patient was vaccinated with GARDASIL dose 2 (dosage unknown), intramuscularly (IM) in the deltoid, about two fingers below the insertion of the deltoid, (where the IM injection should be). The patient's concomitant medications were not reported. On an unknown date in December 2012 the injection site immediately became red, swollen and very painful. The reporter reported that the swelling was determined at that time to be a hematoma. The patient couldn't raise her arm above shoulder level without severe pain (disability), and that she had trouble in pronating and supinating her arm (disability). She stated that the patient reports feeling depression, cries a lot, concerning the loss of function and that the patient couldn't participate in sports and activities. It was reported that the patient had seen many sports medicine doctors. An ultrasound was performed at an unspecified date and the mass surrounding the injection site was determined to be deltoid based, and was possibly necrotic. It was reported that the injury to rotator cuff was ruled out by the physician. She reported that the non-pharmacological pain relief had not been effective such as E-STEM and heat and ice. The outcome of the events was reported as not recovered/not resolved. The reporter stated that the physician stated that he believes the injury is a result of the GARDASIL vaccine. The reporters causality assessment was not provided. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site haematoma, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a physical therapist, the mother of the patient, refers to a 14 year old female patient. The patient's medical history was unknown. On an unknown date in August 2013 the patient was vaccinated with GARDASIL dose 1 (dosage unknown), intramuscularly. With no adverse effects. On an unknown date in December 2013 the patient was vaccinated with GARDASIL dose 2 (dosage unknown), intramuscularly (IM) in the deltoid, about two fingers below the insertion of the deltoid, (where the IM injection should be). The patient's concomitant medications were not reported. On an unknown date in December 2012 the injection site immediately became red, swollen and very painful. The reporter reported that the swelling was determined at that time to be a hematoma. The patient couldn't raise her arm above shoulder level without severe pain (disability), and that she had trouble in pronating and supinating her arm (disability). She stated that the patient reports feeling depression, cries a lot, concerning the loss of function and that the patient couldn't participate in sports and activities. It was reported that the patient had seen many sports medicine doctors. An ultrasound was performed at an unspecified date and the mass surrounding the injection site was determined to be deltoid based, and was possibly necrotic. It was reported that the injury to rotator cuff was ruled out by the physician. She reported that the non-pharmacological pain relief had not been effective such as E-STEM and heat and ice. The outcome of the events was reported as not recovered/not resolved. The reporter stated that the physician stated that he believes the injury is a result of the GARDASIL vaccine. The reporters causality assessment was not provided. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Mobility decreased, Movement disorder, Musculoskeletal disorder, Ultrasound scan abnormal
Clinical narrative: This spontaneous report as received from a physical therapist, the mother of the patient, refers to a 14 year old female patient. The patient's medical history was unknown. On an unknown date in August 2013 the patient was vaccinated with GARDASIL dose 1 (dosage unknown), intramuscularly. With no adverse effects. On an unknown date in December 2013 the patient was vaccinated with GARDASIL dose 2 (dosage unknown), intramuscularly (IM) in the deltoid, about two fingers below the insertion of the deltoid, (where the IM injection should be). The patient's concomitant medications were not reported. On an unknown date in December 2012 the injection site immediately became red, swollen and very painful. The reporter reported that the swelling was determined at that time to be a hematoma. The patient couldn't raise her arm above shoulder level without severe pain (disability), and that she had trouble in pronating and supinating her arm (disability). She stated that the patient reports feeling depression, cries a lot, concerning the loss of function and that the patient couldn't participate in sports and activities. It was reported that the patient had seen many sports medicine doctors. An ultrasound was performed at an unspecified date and the mass surrounding the injection site was determined to be deltoid based, and was possibly necrotic. It was reported that the injury to rotator cuff was ruled out by the physician. She reported that the non-pharmacological pain relief had not been effective such as E-STEM and heat and ice. The outcome of the events was reported as not recovered/not resolved. The reporter stated that the physician stated that he believes the injury is a result of the GARDASIL vaccine. The reporters causality assessment was not provided. Additional information has been requested.