chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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: This spontaneous report was received from a physician via other company (GlaxoSmithKline, manufacturer control number: A1063242A) and referred to a 2 month old male patient born premature (born at 31 weeks gestation). Per the physician, the patient "was tested along with several consultation to different doctors". No details were provided as to the tests performed. The subject had "routine referral to cardiologist, pulmonary and eye doctor due to premature birth." On 15-AUG-2013 the patient was vaccinated with unspecified dose of ROTATEQ (lot #, expiration date, strength, dose number and frequency were not reported), orally. Other suspect therapies that were administered on the same day (15-AUG-2013) included: unspecified dose of ACTHIB and PREVNAR 13 (dose number unknown) as well as first dose of PEDIARIX (lot # 749CT, 0.5 ml, unknown route, left arm). Concomitant therapies included vitamins (unspecified) and CHILDRENS TYLENOL (also reported as paracetamol). On 17-AUG-2013, 2 days after vaccination with ROTATEQ, ACTHIB and PREVNAR 13 and PEDIARIX the patient experienced rash and was taken to the emergency room. The patient was diagnosed with allergic rash and was sent home on prednisone (manufacturer unknown). On 18-AUG-2013, 3 days after vaccination with ROTATEQ, ACTHIB, PREVNAR 13 and PEDIARIX the rash worsened and the patient was taken to hospital "with a pediatric ward". Per the physician, the patient was hospitalized due to a life threatening condition. The patient was tested along with several consultations to different doctors. The patient was discharged on an unspecified date with a diagnosis of erythema multiforme. The patient 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 vaccine to this child." The patient was treated with prednisone (manufacturer unknown). The outcome of erythema multiforme and allergic rash was reported as recovered/resolved on an unspecified date. The physician considered events of allergic rash and erythema multiforme to be life threatening. The relatedness between events of allergic rash and erythema multiforme and ROTATEQ was not 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: CSF culture, Dermatitis allergic, Dermatitis contact, Drug administered at inappropriate site, Erythema
Clinical narrative: This spontaneous report was received from a physician via other company (GlaxoSmithKline, manufacturer control number: A1063242A) and referred to a 2 month old male patient born premature (born at 31 weeks gestation). Per the physician, the patient "was tested along with several consultation to different doctors". No details were provided as to the tests performed. The subject had "routine referral to cardiologist, pulmonary and eye doctor due to premature birth." On 15-AUG-2013 the patient was vaccinated with unspecified dose of ROTATEQ (lot #, expiration date, strength, dose number and frequency were not reported), orally. Other suspect therapies that were administered on the same day (15-AUG-2013) included: unspecified dose of ACTHIB and PREVNAR 13 (dose number unknown) as well as first dose of PEDIARIX (lot # 749CT, 0.5 ml, unknown route, left arm). Concomitant therapies included vitamins (unspecified) and CHILDRENS TYLENOL (also reported as paracetamol). On 17-AUG-2013, 2 days after vaccination with ROTATEQ, ACTHIB and PREVNAR 13 and PEDIARIX the patient experienced rash and was taken to the emergency room. The patient was diagnosed with allergic rash and was sent home on prednisone (manufacturer unknown). On 18-AUG-2013, 3 days after vaccination with ROTATEQ, ACTHIB, PREVNAR 13 and PEDIARIX the rash worsened and the patient was taken to hospital "with a pediatric ward". Per the physician, the patient was hospitalized due to a life threatening condition. The patient was tested along with several consultations to different doctors. The patient was discharged on an unspecified date with a diagnosis of erythema multiforme. The patient 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 vaccine to this child." The patient was treated with prednisone (manufacturer unknown). The outcome of erythema multiforme and allergic rash was reported as recovered/resolved on an unspecified date. The physician considered events of allergic rash and erythema multiforme to be life threatening. The relatedness between events of allergic rash and erythema multiforme and ROTATEQ was not 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: Erythema multiforme, Haematocrit decreased, Haemoglobin decreased, Lumbar puncture abnormal, Neutrophil count increased
Clinical narrative: This spontaneous report was received from a physician via other company (GlaxoSmithKline, manufacturer control number: A1063242A) and referred to a 2 month old male patient born premature (born at 31 weeks gestation). Per the physician, the patient "was tested along with several consultation to different doctors". No details were provided as to the tests performed. The subject had "routine referral to cardiologist, pulmonary and eye doctor due to premature birth." On 15-AUG-2013 the patient was vaccinated with unspecified dose of ROTATEQ (lot #, expiration date, strength, dose number and frequency were not reported), orally. Other suspect therapies that were administered on the same day (15-AUG-2013) included: unspecified dose of ACTHIB and PREVNAR 13 (dose number unknown) as well as first dose of PEDIARIX (lot # 749CT, 0.5 ml, unknown route, left arm). Concomitant therapies included vitamins (unspecified) and CHILDRENS TYLENOL (also reported as paracetamol). On 17-AUG-2013, 2 days after vaccination with ROTATEQ, ACTHIB and PREVNAR 13 and PEDIARIX the patient experienced rash and was taken to the emergency room. The patient was diagnosed with allergic rash and was sent home on prednisone (manufacturer unknown). On 18-AUG-2013, 3 days after vaccination with ROTATEQ, ACTHIB, PREVNAR 13 and PEDIARIX the rash worsened and the patient was taken to hospital "with a pediatric ward". Per the physician, the patient was hospitalized due to a life threatening condition. The patient was tested along with several consultations to different doctors. The patient was discharged on an unspecified date with a diagnosis of erythema multiforme. The patient 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 vaccine to this child." The patient was treated with prednisone (manufacturer unknown). The outcome of erythema multiforme and allergic rash was reported as recovered/resolved on an unspecified date. The physician considered events of allergic rash and erythema multiforme to be life threatening. The relatedness between events of allergic rash and erythema multiforme and ROTATEQ was not 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: Pharyngeal oedema, Platelet count normal, Pyrexia, Rash, Skin lesion
Clinical narrative: This spontaneous report was received from a physician via other company (GlaxoSmithKline, manufacturer control number: A1063242A) and referred to a 2 month old male patient born premature (born at 31 weeks gestation). Per the physician, the patient "was tested along with several consultation to different doctors". No details were provided as to the tests performed. The subject had "routine referral to cardiologist, pulmonary and eye doctor due to premature birth." On 15-AUG-2013 the patient was vaccinated with unspecified dose of ROTATEQ (lot #, expiration date, strength, dose number and frequency were not reported), orally. Other suspect therapies that were administered on the same day (15-AUG-2013) included: unspecified dose of ACTHIB and PREVNAR 13 (dose number unknown) as well as first dose of PEDIARIX (lot # 749CT, 0.5 ml, unknown route, left arm). Concomitant therapies included vitamins (unspecified) and CHILDRENS TYLENOL (also reported as paracetamol). On 17-AUG-2013, 2 days after vaccination with ROTATEQ, ACTHIB and PREVNAR 13 and PEDIARIX the patient experienced rash and was taken to the emergency room. The patient was diagnosed with allergic rash and was sent home on prednisone (manufacturer unknown). On 18-AUG-2013, 3 days after vaccination with ROTATEQ, ACTHIB, PREVNAR 13 and PEDIARIX the rash worsened and the patient was taken to hospital "with a pediatric ward". Per the physician, the patient was hospitalized due to a life threatening condition. The patient was tested along with several consultations to different doctors. The patient was discharged on an unspecified date with a diagnosis of erythema multiforme. The patient 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 vaccine to this child." The patient was treated with prednisone (manufacturer unknown). The outcome of erythema multiforme and allergic rash was reported as recovered/resolved on an unspecified date. The physician considered events of allergic rash and erythema multiforme to be life threatening. The relatedness between events of allergic rash and erythema multiforme and ROTATEQ was not 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: Urine analysis, Urticaria, White blood cell count normal
Clinical narrative: This spontaneous report was received from a physician via other company (GlaxoSmithKline, manufacturer control number: A1063242A) and referred to a 2 month old male patient born premature (born at 31 weeks gestation). Per the physician, the patient "was tested along with several consultation to different doctors". No details were provided as to the tests performed. The subject had "routine referral to cardiologist, pulmonary and eye doctor due to premature birth." On 15-AUG-2013 the patient was vaccinated with unspecified dose of ROTATEQ (lot #, expiration date, strength, dose number and frequency were not reported), orally. Other suspect therapies that were administered on the same day (15-AUG-2013) included: unspecified dose of ACTHIB and PREVNAR 13 (dose number unknown) as well as first dose of PEDIARIX (lot # 749CT, 0.5 ml, unknown route, left arm). Concomitant therapies included vitamins (unspecified) and CHILDRENS TYLENOL (also reported as paracetamol). On 17-AUG-2013, 2 days after vaccination with ROTATEQ, ACTHIB and PREVNAR 13 and PEDIARIX the patient experienced rash and was taken to the emergency room. The patient was diagnosed with allergic rash and was sent home on prednisone (manufacturer unknown). On 18-AUG-2013, 3 days after vaccination with ROTATEQ, ACTHIB, PREVNAR 13 and PEDIARIX the rash worsened and the patient was taken to hospital "with a pediatric ward". Per the physician, the patient was hospitalized due to a life threatening condition. The patient was tested along with several consultations to different doctors. The patient was discharged on an unspecified date with a diagnosis of erythema multiforme. The patient 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 vaccine to this child." The patient was treated with prednisone (manufacturer unknown). The outcome of erythema multiforme and allergic rash was reported as recovered/resolved on an unspecified date. The physician considered events of allergic rash and erythema multiforme to be life threatening. The relatedness between events of allergic rash and erythema multiforme and ROTATEQ was not 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: Erythema multiforme, Rash
Clinical narrative: This spontaneous report was received from a physician via other company (GlaxoSmithKline, manufacturer control number: A1063242A) and referred to a 2 month old male patient born premature (born at 31 weeks gestation). Per the physician, the patient "was tested along with several consultation to different doctors". No details were provided as to the tests performed. The subject had "routine referral to cardiologist, pulmonary and eye doctor due to premature birth." On 15-AUG-2013 the patient was vaccinated with unspecified dose of ROTATEQ (lot #, expiration date, strength, dose number and frequency were not reported), orally. Other suspect therapies that were administered on the same day (15-AUG-2013) included: unspecified dose of ACTHIB and PREVNAR 13 (dose number unknown) as well as first dose of PEDIARIX (lot # 749CT, 0.5 ml, unknown route, left arm). Concomitant therapies included vitamins (unspecified) and CHILDRENS TYLENOL (also reported as paracetamol). On 17-AUG-2013, 2 days after vaccination with ROTATEQ, ACTHIB and PREVNAR 13 and PEDIARIX the patient experienced rash and was taken to the emergency room. The patient was diagnosed with allergic rash and was sent home on prednisone (manufacturer unknown). On 18-AUG-2013, 3 days after vaccination with ROTATEQ, ACTHIB, PREVNAR 13 and PEDIARIX the rash worsened and the patient was taken to hospital "with a pediatric ward". Per the physician, the patient was hospitalized due to a life threatening condition. The patient was tested along with several consultations to different doctors. The patient was discharged on an unspecified date with a diagnosis of erythema multiforme. The patient 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 vaccine to this child." The patient was treated with prednisone (manufacturer unknown). The outcome of erythema multiforme and allergic rash was reported as recovered/resolved on an unspecified date. The physician considered events of allergic rash and erythema multiforme to be life threatening. The relatedness between events of allergic rash and erythema multiforme and ROTATEQ was not 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: Band neutrophil count increased, Blood alkaline phosphatase increased, Blood bicarbonate normal, Blood chloride normal, Blood creatinine normal
Clinical narrative: This spontaneous report was received from a physician via other company (GlaxoSmithKline, manufacturer control number: A1063242A) and referred to a 2 month old male patient born premature (born at 31 weeks gestation). Per the physician, the patient "was tested along with several consultation to different doctors". No details were provided as to the tests performed. The subject had "routine referral to cardiologist, pulmonary and eye doctor due to premature birth." On 15-AUG-2013 the patient was vaccinated with unspecified dose of ROTATEQ (lot #, expiration date, strength, dose number and frequency were not reported), orally. Other suspect therapies that were administered on the same day (15-AUG-2013) included: unspecified dose of ACTHIB and PREVNAR 13 (dose number unknown) as well as first dose of PEDIARIX (lot # 749CT, 0.5 ml, unknown route, left arm). Concomitant therapies included vitamins (unspecified) and CHILDRENS TYLENOL (also reported as paracetamol). On 17-AUG-2013, 2 days after vaccination with ROTATEQ, ACTHIB and PREVNAR 13 and PEDIARIX the patient experienced rash and was taken to the emergency room. The patient was diagnosed with allergic rash and was sent home on prednisone (manufacturer unknown). On 18-AUG-2013, 3 days after vaccination with ROTATEQ, ACTHIB, PREVNAR 13 and PEDIARIX the rash worsened and the patient was taken to hospital "with a pediatric ward". Per the physician, the patient was hospitalized due to a life threatening condition. The patient was tested along with several consultations to different doctors. The patient was discharged on an unspecified date with a diagnosis of erythema multiforme. The patient 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 vaccine to this child." The patient was treated with prednisone (manufacturer unknown). The outcome of erythema multiforme and allergic rash was reported as recovered/resolved on an unspecified date. The physician considered events of allergic rash and erythema multiforme to be life threatening. The relatedness between events of allergic rash and erythema multiforme and ROTATEQ was not 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: CSF culture, Culture urine, Dermatitis contact, Erythema, Erythema multiforme
Clinical narrative: This spontaneous report was received from a physician via other company (GlaxoSmithKline, manufacturer control number: A1063242A) and referred to a 2 month old male patient born premature (born at 31 weeks gestation). Per the physician, the patient "was tested along with several consultation to different doctors". No details were provided as to the tests performed. The subject had "routine referral to cardiologist, pulmonary and eye doctor due to premature birth." On 15-AUG-2013 the patient was vaccinated with unspecified dose of ROTATEQ (lot #, expiration date, strength, dose number and frequency were not reported), orally. Other suspect therapies that were administered on the same day (15-AUG-2013) included: unspecified dose of ACTHIB and PREVNAR 13 (dose number unknown) as well as first dose of PEDIARIX (lot # 749CT, 0.5 ml, unknown route, left arm). Concomitant therapies included vitamins (unspecified) and CHILDRENS TYLENOL (also reported as paracetamol). On 17-AUG-2013, 2 days after vaccination with ROTATEQ, ACTHIB and PREVNAR 13 and PEDIARIX the patient experienced rash and was taken to the emergency room. The patient was diagnosed with allergic rash and was sent home on prednisone (manufacturer unknown). On 18-AUG-2013, 3 days after vaccination with ROTATEQ, ACTHIB, PREVNAR 13 and PEDIARIX the rash worsened and the patient was taken to hospital "with a pediatric ward". Per the physician, the patient was hospitalized due to a life threatening condition. The patient was tested along with several consultations to different doctors. The patient was discharged on an unspecified date with a diagnosis of erythema multiforme. The patient 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 vaccine to this child." The patient was treated with prednisone (manufacturer unknown). The outcome of erythema multiforme and allergic rash was reported as recovered/resolved on an unspecified date. The physician considered events of allergic rash and erythema multiforme to be life threatening. The relatedness between events of allergic rash and erythema multiforme and ROTATEQ was not 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: Haematocrit decreased, Haemoglobin normal, Lumbar puncture, Neutrophil count increased, Pharyngeal oedema
Clinical narrative: This spontaneous report was received from a physician via other company (GlaxoSmithKline, manufacturer control number: A1063242A) and referred to a 2 month old male patient born premature (born at 31 weeks gestation). Per the physician, the patient "was tested along with several consultation to different doctors". No details were provided as to the tests performed. The subject had "routine referral to cardiologist, pulmonary and eye doctor due to premature birth." On 15-AUG-2013 the patient was vaccinated with unspecified dose of ROTATEQ (lot #, expiration date, strength, dose number and frequency were not reported), orally. Other suspect therapies that were administered on the same day (15-AUG-2013) included: unspecified dose of ACTHIB and PREVNAR 13 (dose number unknown) as well as first dose of PEDIARIX (lot # 749CT, 0.5 ml, unknown route, left arm). Concomitant therapies included vitamins (unspecified) and CHILDRENS TYLENOL (also reported as paracetamol). On 17-AUG-2013, 2 days after vaccination with ROTATEQ, ACTHIB and PREVNAR 13 and PEDIARIX the patient experienced rash and was taken to the emergency room. The patient was diagnosed with allergic rash and was sent home on prednisone (manufacturer unknown). On 18-AUG-2013, 3 days after vaccination with ROTATEQ, ACTHIB, PREVNAR 13 and PEDIARIX the rash worsened and the patient was taken to hospital "with a pediatric ward". Per the physician, the patient was hospitalized due to a life threatening condition. The patient was tested along with several consultations to different doctors. The patient was discharged on an unspecified date with a diagnosis of erythema multiforme. The patient 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 vaccine to this child." The patient was treated with prednisone (manufacturer unknown). The outcome of erythema multiforme and allergic rash was reported as recovered/resolved on an unspecified date. The physician considered events of allergic rash and erythema multiforme to be life threatening. The relatedness between events of allergic rash and erythema multiforme and ROTATEQ was not 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: Platelet count normal, Pyrexia, Rash, Skin lesion, Urine analysis
Clinical narrative: This spontaneous report was received from a physician via other company (GlaxoSmithKline, manufacturer control number: A1063242A) and referred to a 2 month old male patient born premature (born at 31 weeks gestation). Per the physician, the patient "was tested along with several consultation to different doctors". No details were provided as to the tests performed. The subject had "routine referral to cardiologist, pulmonary and eye doctor due to premature birth." On 15-AUG-2013 the patient was vaccinated with unspecified dose of ROTATEQ (lot #, expiration date, strength, dose number and frequency were not reported), orally. Other suspect therapies that were administered on the same day (15-AUG-2013) included: unspecified dose of ACTHIB and PREVNAR 13 (dose number unknown) as well as first dose of PEDIARIX (lot # 749CT, 0.5 ml, unknown route, left arm). Concomitant therapies included vitamins (unspecified) and CHILDRENS TYLENOL (also reported as paracetamol). On 17-AUG-2013, 2 days after vaccination with ROTATEQ, ACTHIB and PREVNAR 13 and PEDIARIX the patient experienced rash and was taken to the emergency room. The patient was diagnosed with allergic rash and was sent home on prednisone (manufacturer unknown). On 18-AUG-2013, 3 days after vaccination with ROTATEQ, ACTHIB, PREVNAR 13 and PEDIARIX the rash worsened and the patient was taken to hospital "with a pediatric ward". Per the physician, the patient was hospitalized due to a life threatening condition. The patient was tested along with several consultations to different doctors. The patient was discharged on an unspecified date with a diagnosis of erythema multiforme. The patient 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 vaccine to this child." The patient was treated with prednisone (manufacturer unknown). The outcome of erythema multiforme and allergic rash was reported as recovered/resolved on an unspecified date. The physician considered events of allergic rash and erythema multiforme to be life threatening. The relatedness between events of allergic rash and erythema multiforme and ROTATEQ was not 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: Urticaria, White blood cell count normal
Clinical narrative: This spontaneous report was received from a physician via other company (GlaxoSmithKline, manufacturer control number: A1063242A) and referred to a 2 month old male patient born premature (born at 31 weeks gestation). Per the physician, the patient "was tested along with several consultation to different doctors". No details were provided as to the tests performed. The subject had "routine referral to cardiologist, pulmonary and eye doctor due to premature birth." On 15-AUG-2013 the patient was vaccinated with unspecified dose of ROTATEQ (lot #, expiration date, strength, dose number and frequency were not reported), orally. Other suspect therapies that were administered on the same day (15-AUG-2013) included: unspecified dose of ACTHIB and PREVNAR 13 (dose number unknown) as well as first dose of PEDIARIX (lot # 749CT, 0.5 ml, unknown route, left arm). Concomitant therapies included vitamins (unspecified) and CHILDRENS TYLENOL (also reported as paracetamol). On 17-AUG-2013, 2 days after vaccination with ROTATEQ, ACTHIB and PREVNAR 13 and PEDIARIX the patient experienced rash and was taken to the emergency room. The patient was diagnosed with allergic rash and was sent home on prednisone (manufacturer unknown). On 18-AUG-2013, 3 days after vaccination with ROTATEQ, ACTHIB, PREVNAR 13 and PEDIARIX the rash worsened and the patient was taken to hospital "with a pediatric ward". Per the physician, the patient was hospitalized due to a life threatening condition. The patient was tested along with several consultations to different doctors. The patient was discharged on an unspecified date with a diagnosis of erythema multiforme. The patient 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 vaccine to this child." The patient was treated with prednisone (manufacturer unknown). The outcome of erythema multiforme and allergic rash was reported as recovered/resolved on an unspecified date. The physician considered events of allergic rash and erythema multiforme to be life threatening. The relatedness between events of allergic rash and erythema multiforme and ROTATEQ was not reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Feeling abnormal, Herpes zoster, Rash erythematous
Clinical narrative: Pt called on 3/18/2014 to state she noticed a Zoster-type lesion below the injection site several days after the immunization and also that she had a shingles outbreak Feb 2014.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: Pt called on 3/18/2014 to state she noticed a Zoster-type lesion below the injection site several days after the immunization and also that she had a shingles outbreak Feb 2014.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Chest X-ray abnormal, Pneumonia, Pyrexia
Clinical narrative: Fever, pneumonia that lasted 10 days.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pruritus, Injection site urticaria, Muscle spasms
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a 50 year old female patient. The patient had no pertinent medical history and no history of drug reactions/allergies. On 03-MAR-2014 the patient was vaccinated with ZOSTAVAX single dose, subcutaneously in the left arm. Strength, dose and lot number were not reported. The patient used no concomitant medication. On 04-MAR-2014, the patient developed a 4 inch by 1 inch hardened, itchy welt at the injection site. Also on 04-MAR-2014, the patient developed a muscle spasm of the right side of the neck. The patient tried hot compresses and MOTRIN with no improvement. The patient called the physician's office and was scheduled for an evaluation at the physician's office on 05-MAR-2014. At the time of report, the patient had not recovered. Additional information has been requested.
Age: 63.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 63 year old patient. On 17-MAR-2014, the patient was vaccinated accidentally with a dose of VARIVAX (Merck), (lot number and expiry date was not reported), 0.5 ml, subcutaneously instead of ZOSTAVAX. No adverse effect was reported. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative refers to a 64 year old female patient. On an unknown date in 2010 (reported as approximately 4 years ago) the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route unspecified). On 17-MAR-2014 the patient presented with shingles in the nurse practitioner's office. Patient visited nurse practitioner on 17-MAR-2014 for medical attention. Patient was treated with VALTREX, Gabapentin and unspecified pain medications. The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 13 month old male patient. On an unknown date the patient was vaccinated with ROTATEQ dose 1 (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date the 13 month old patient received a second dose of ROTATEQ orally. No adverse events were reported. The outcome event was unknown. The action taken with the ROTATEQ was unknown. The relatedness of the events to the therapy with ROTATEQ was unknown. No product quality issue was reported. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test, No therapeutic response
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male college nursing student patient of unkonwn age. On an unknown date, the patient was vaccinated with two doses of VARIVAX (Merck) (lot#, dose and route not reported) unspecified when, and failed to seroconvert. The antibody tests were drawn recently and results were unknown. The outcome of failed to seroconvert was unknown. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Rash morbilliform
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age and unspecified gender. On 06-FEB-2014 the patient was vaccinated with the dose of M-M-R II (lot # J006954, expiration date: 07-JUN-2015; route and anatomical location of administration not reported), 1 vial. According to reporting physician on 18-FEB-2014, the patient developed "measles like rash" after receiving M-M-R II. There was no treatment given for the event. The outcome of measles like rash was reported as recovered/resolved on an unknown date in 2014. The patient sought medical attention by consulting the physician. The relatedness between reported event and M-M-R II administration was not reported. This case is linked to MARRS# 1403USA010827 and 1403USA011146 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and referred to a patient of unknown age (sex not reported). On 01-NOV-2013, the patient was vaccinated with the first GARDASIL (lot #, expiration date, strength, dose, frequency and route of administration were not reported) injection and on 27-NOV-2013, the patient received the second dose of GARDASIL. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient received dose one of RECOMBIVAX HB (dose, lot # and expiration date were not reported) on 03-OCT-2013 and dose two on 18-MAR-2014 (five month interval). No adverse effects reported. The outcome and causality were not provided. 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 pharmacist refers to a patient of unknown age and gender. Relevant medical history and concomitant medication were not provided. On 03-MAR-2014, the patient was vaccinated with M-M-R II. Lot number, dose, route and frequency were not provided. The vaccine was exposed to 56F for 10 days, an excursion that was found to be unsupported by in-house stability data. No adverse event was reported. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The reporter stated that a patient was administered with expired ROTATEQ orally (lot H016842 exp date 14-MAR-2014, dose, strength not reported), on 19-MAR-2014, as the second dose of ROTATEQ. First dose of ROTATEQ was administered on 08-JAN-2014. No adverse experience reported. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Relevant medical history and concomitant medications were not provided. On 26-FEB-2014 the patient was vaccinated with PNEUMOVAX 23. Lot number, dose, route and frequency were not provided. The vaccine was exposed to 56F for 10 days, an excursion that was found to be unsupported by in-house stability data. No adverse event was reported. 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 pharmacist refers to a patient of unknown age and gender. Relevant medical history and concomitant medication were not provided. On 05-MAR-2014, the patient was vaccinated with GARDASIL. Lot number, dose, route and frequency were not provided. The vaccine was exposed to 56F for 10 days, an excursion that was found to be unsupported by in-house stability data. No adverse event was reported. 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 pharmacist refers to a patient of unknown age and gender. Relevant medical history and concomitant medication were not provided. On 03-MAR-2014, the patient was vaccinated with MMR II. lot number, dose, route and frequency were not provided. The vaccine was exposed to 56F for 10 days, an excursion that was found to be unsupported by in-house stability data. No adverse event was reported. 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 pharmacist refers to a patient of unknown age and gender. Relevant medical history and concomitant medication were not provided. On 28-FEB-2014 the patient was vaccinated with GARDASIL. Lot number, dose, route and frequency were not provided. The vaccine was exposed to 56F for 10 days, an excursion that was found to be unsupported by in-house stability data. No adverse event was reported. 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 pharmacist refers to a patient of unknown age and gender. Relevant medical history and concomitant medication were not provided. On 26-FEB-2014 the patient was vaccinated with M-M-R II. Lot number, dose, route and frequency were not provided. The vaccine was exposed to 56F for 10 days, an excursion that was found to be unsupported by in-house stability data. No adverse event was reported. 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 pharmacist refers to a patient of unknown age and gender. Relevant medical history and concomitant medication were not provided. 02-MAR-2013, the patient was vaccinated with MMR II. Lot number, dose, route and frequency were not provided. The vaccine was exposed to 56F for 10 days, an excursion that was found to be unsupported by in-house stability data. No adverse event was reported. 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 pharmacist refers to a patient of unknown age and gender. Relevant medical history and concomitant medication were not provided. On 25-FEB-2014 the patient was vaccinated with GARDASIL. Lot number, dose, route and frequency were not provided. The vaccine was exposed to 56F for 10 days, an excursion that was found to be unsupported by in-house stability data. No adverse event was reported. 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 pharmacist refers to a patient of unknown age and gender. Relevant medical history and concomitant medication were not provided. On 26-FEB-2014 the patient was vaccinated with GARDASIL. Lot number, dose, route and frequency were not provided. The vaccine was exposed to 56F for 10 days, an excursion that was found to be unsupported by in-house stability data. No adverse event was reported. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a male patient of unknown age with Ceclor allergy. The patient's medical history included Gastrooesophageal reflux disease (GERD). On unknown dates in 1998, the patient was vaccinated with 3 doses of unspecified hepatitis B vaccine (recombinant) (Manufacturer unknown). Concomitant therapies included PRILOSEC. On an unknown date a recent lab work showed the patient had negative antibody levels against hepatitis B. No treatment was given. Patient sought medical attention (unspecified). The outcome of patient has negative antibody levels against hepatitis b was unknown. Causality was not reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Dizziness, Feeling cold, Headache, Hyperacusis
Clinical narrative: The patient presents with headache.  These symptoms began today.  She is not having fever.  Other comments include: mom states that pt has a Gardasil injection yesterday. Mom states that pt feels like every time she breathes, she has had some body aches, headache with light and sound sensitive  - HA L front and R back and pulsing, no belly pain now headache and throat feels weird when breathing, + lightheaded, no fever, but some chills and felt cold yesterday and today. She drank water throughout the day and has eaten as well.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Photophobia, Throat irritation
Clinical narrative: The patient presents with headache.  These symptoms began today.  She is not having fever.  Other comments include: mom states that pt has a Gardasil injection yesterday. Mom states that pt feels like every time she breathes, she has had some body aches, headache with light and sound sensitive  - HA L front and R back and pulsing, no belly pain now headache and throat feels weird when breathing, + lightheaded, no fever, but some chills and felt cold yesterday and today. She drank water throughout the day and has eaten as well.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Lt arm red around injection site to area of 3 1/2 x 3 in. Band Aids still intact on arm. Latex free. BENADRYL cream and liquid Rx.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Dyskinesia, Facial pain, Fall, Head injury, Loss of consciousness
Clinical narrative: Pt had an apparent syncopal episode approx. 5 minutes after receiving 3 vaccines, witnessed by myself and a nurse practitioner. He fell forward off exam table hitting his head on chair, after a few seconds of jerking motion of arms and hands he was turned over on his back. He regained consciousness within several seconds had forehead and nose pain. Layed on back for 20-25 min, drank juice, ate crackers (did not have anything to eat all day). Dr. evaluated pt went home.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Pt had an apparent syncopal episode approx. 5 minutes after receiving 3 vaccines, witnessed by myself and a nurse practitioner. He fell forward off exam table hitting his head on chair, after a few seconds of jerking motion of arms and hands he was turned over on his back. He regained consciousness within several seconds had forehead and nose pain. Layed on back for 20-25 min, drank juice, ate crackers (did not have anything to eat all day). Dr. evaluated pt went home.
Age: 1.35
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Abnormal behaviour, Aphasia, Glassy eyes, Mobility decreased, Staring
Clinical narrative: Somewhere between Hep A (1st shot given) & MMR (2nd shot given) vaccination, on left thigh, patient appeared to have an approximately 5-10 second "episode." Vocalizations and movements stopped. Her eyes were open and appeared fixed and glassy. Afterward, she returned to previous behavior.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Discomfort, Immunodeficiency, Injection site reaction, Local reaction, Local swelling
Clinical narrative: Vaccine administered 3/20/14 at school-based Tdap clinic. Small fine pustular-like rash noted at injection site morning of 3/22/14. By evening of 3/22/14 the lesions/rash had increased down upper arm from inj site. Itchiness associated with rash, some discomfort, no other symptoms. Mother reports the area of the rash increased further on 3/23/14 and 3/24/14 but remained confined to upper arm. Rash with unusual pattern of concentric arcs at distal point. (Prior to appearance of rash on 3/22/14, pt had usual local reaction of discomfort and swelling.) On 3/26/14 mother reports child was seen by PCP on 3/25/14; physician stated an unusual reaction following vaccination is likely to occur due to child's compromised immune status.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Rash pruritic, Rash pustular
Clinical narrative: Vaccine administered 3/20/14 at school-based Tdap clinic. Small fine pustular-like rash noted at injection site morning of 3/22/14. By evening of 3/22/14 the lesions/rash had increased down upper arm from inj site. Itchiness associated with rash, some discomfort, no other symptoms. Mother reports the area of the rash increased further on 3/23/14 and 3/24/14 but remained confined to upper arm. Rash with unusual pattern of concentric arcs at distal point. (Prior to appearance of rash on 3/22/14, pt had usual local reaction of discomfort and swelling.) On 3/26/14 mother reports child was seen by PCP on 3/25/14; physician stated an unusual reaction following vaccination is likely to occur due to child's compromised immune status.
Age: 1.7
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Antiacetylcholine receptor antibody, Nuclear magnetic resonance imaging, VIth nerve paralysis
Clinical narrative: This case was reported in a literature article and described the occurrence of abducens palsy in a 20-month-old male subject who was vaccinated with DTPa (manufacturer unspecified) and Hib. No information has been provided on the subject medical, family history or concurrent medication. On an unspecified date, the subject received an unspecified dose of DTPa (administration site and route unknown, batch number not provided) and an unspecified dose of Hib (administration site and route unknown, batch number not provided). 3 weeks after vaccination with DTPa and Hib, the subject experienced abducens palsy (left eye). After 2 to 3 months, the episode resolved. This case was assessed as medically serious by GSK. At 31-month-old, 2.5 weeks after varicella, the abducens palsy recurred. No information has been provided on the clinical examinations performed on the subject during any of the episodes. The authors report that he underwent an MRI and a acetylcholine receptor antibody testing at some point but the results have not been provided. At the time of reporting, the event was improved. The author's conclusion stated that their review corroborated their findings that all patients who had benign sixth nerve palsy temporally related to vaccination had at least one recurrence.
Age: 63.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of possible injection site infection in a 63-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline), ENGERIX B. A physician or other health care professional has not verified this report. On 3 March 2014 the subject received unspecified dose of HAVRIX (route unknown, right arm) and an unspecified dose of ENGERIX B (route unknown, left arm). On 3 March 2014, less than one day after vaccination with ENGERIX B and HAVRIX, the subject experienced injection site pain. It was more painful on the left arm but this went away quickly. Injection site pain from HAVRIX resolved after 4 days. However, it came back about 2 to 3 days ago. According a nurse, the reaction could be an injection site infection. This case was assessed as medically serious by GSK. At the time of reporting, injection site pain in right arm was unresolved.