chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 92.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Arthralgia, Gait disturbance, Injection site pain, Pain, Pain in extremity
Clinical narrative: right arm pain started about 5 hours after vaccines, extended down to hand/fingers. next morning pain had moved down right side causing pain in side and hip. pt unable to walk without her cane and normally doesn't need cane. Heat was helping it feel better. needs to use heat regularly or the pain comes back. arm/side still bothering her today and left side hip started hurting around 11-18-20. still hurts today 11-29-20.
Sex: M
Vaccine: YF, ANTH, TYP, YF
Symptoms: Blood creatinine increased, Chest pain, Coagulopathy, Computerised tomogram thorax normal, Dyspnoea
Clinical narrative: Yellow fever vaccine-associated viscerotropic disease; This case was obtained from a scientific literature.  A 29-year-old male developed "Yellow fever vaccine-associated viscerotropic disease" (PT: Yellow fever vaccine-associated viscerotropic disease), following the administration of BioThrax (anthrax vaccine adsorbed), Vivotif (Typhoid vaccine live oral Ty21A), and yellow fever vaccine for immunisation.  Case report: Nonfatal Yellow fever vaccine-associated viscerotropic disease (YEL-AVD) was suspected in a 29-year-old male who presented two weeks after receipt of yellow fever, anthrax and typhoid vaccines, with chest pain and dyspnea. His evaluation revealed a left-sided pleural effusion, as well as elevated D-dimer levels. Computed tomography pulmonary angiogram ruled out pulmonary embolism. Elevated serum creatinine and liver-associated enzymes also suggested both renal and hepatic dysfunction. Subsequent evaluation also led to a diagnosis of Raynaud's syndrome and transient hypothyroidism.  Author's comment: Despite an exhaustive evaluation by rheumatology, pulmonary, endocrinology and immunology an alternative etiology for the patient's signs and symptoms could not be determined. This patient met the Brighton Collaboration viscerotropic disease major criteria of coagulopathy with the elevated ?brin degradation products and narrowly missed the renal major criteria by 0.1mg/dL and the hepatic major criteria by 2U/L. Furthermore, plaque reduction neutralization testing by the Centers for Disease Control was not inconsistent with YEL-AVD. In the absence of other diagnoses after an exhaustive evaluation, we pro- pose that the patient did in fact have multi-system organ dysfunction consistent with YEL-AVD and suggest a re-evaluation of the current case de?nition for this rare adverse event following immunization.  Company Comment: Despite the patient concomitantly received presumable BioThrax and Vivotif, YEL-AVD is a rare and known complication of yellow fever vaccine, therefore, causality assessment to BioThrax and Vivotif is considered not related. The case is considered serious because of medical significance of YEL-AVD which is unlisted for both BioThrax and Vivotif.; Sender's Comments: Despite the patient concomitantly received presumable BioThrax and Vivotif, YEL-AVD is a rare and known complication of yellow fever vaccine, therefore, causality assessment to BioThrax and Vivotif is considered not related. The case is considered serious because of medical significance of YEL-AVD which is unlisted for both BioThrax and Vivotif.
Sex: M
Vaccine: YF, ANTH, TYP, YF
Symptoms: Fibrin D dimer increased, Hepatic enzyme increased, Hepatic function abnormal, Hypothyroidism, Multiple organ dysfunction syndrome
Clinical narrative: Yellow fever vaccine-associated viscerotropic disease; This case was obtained from a scientific literature.  A 29-year-old male developed "Yellow fever vaccine-associated viscerotropic disease" (PT: Yellow fever vaccine-associated viscerotropic disease), following the administration of BioThrax (anthrax vaccine adsorbed), Vivotif (Typhoid vaccine live oral Ty21A), and yellow fever vaccine for immunisation.  Case report: Nonfatal Yellow fever vaccine-associated viscerotropic disease (YEL-AVD) was suspected in a 29-year-old male who presented two weeks after receipt of yellow fever, anthrax and typhoid vaccines, with chest pain and dyspnea. His evaluation revealed a left-sided pleural effusion, as well as elevated D-dimer levels. Computed tomography pulmonary angiogram ruled out pulmonary embolism. Elevated serum creatinine and liver-associated enzymes also suggested both renal and hepatic dysfunction. Subsequent evaluation also led to a diagnosis of Raynaud's syndrome and transient hypothyroidism.  Author's comment: Despite an exhaustive evaluation by rheumatology, pulmonary, endocrinology and immunology an alternative etiology for the patient's signs and symptoms could not be determined. This patient met the Brighton Collaboration viscerotropic disease major criteria of coagulopathy with the elevated ?brin degradation products and narrowly missed the renal major criteria by 0.1mg/dL and the hepatic major criteria by 2U/L. Furthermore, plaque reduction neutralization testing by the Centers for Disease Control was not inconsistent with YEL-AVD. In the absence of other diagnoses after an exhaustive evaluation, we pro- pose that the patient did in fact have multi-system organ dysfunction consistent with YEL-AVD and suggest a re-evaluation of the current case de?nition for this rare adverse event following immunization.  Company Comment: Despite the patient concomitantly received presumable BioThrax and Vivotif, YEL-AVD is a rare and known complication of yellow fever vaccine, therefore, causality assessment to BioThrax and Vivotif is considered not related. The case is considered serious because of medical significance of YEL-AVD which is unlisted for both BioThrax and Vivotif.; Sender's Comments: Despite the patient concomitantly received presumable BioThrax and Vivotif, YEL-AVD is a rare and known complication of yellow fever vaccine, therefore, causality assessment to BioThrax and Vivotif is considered not related. The case is considered serious because of medical significance of YEL-AVD which is unlisted for both BioThrax and Vivotif.
Sex: M
Vaccine: YF, ANTH, TYP, YF
Symptoms: Pleural effusion, Raynaud's phenomenon, Renal impairment, Viral test, Yellow fever vaccine-associated viscerotropic disease
Clinical narrative: Yellow fever vaccine-associated viscerotropic disease; This case was obtained from a scientific literature.  A 29-year-old male developed "Yellow fever vaccine-associated viscerotropic disease" (PT: Yellow fever vaccine-associated viscerotropic disease), following the administration of BioThrax (anthrax vaccine adsorbed), Vivotif (Typhoid vaccine live oral Ty21A), and yellow fever vaccine for immunisation.  Case report: Nonfatal Yellow fever vaccine-associated viscerotropic disease (YEL-AVD) was suspected in a 29-year-old male who presented two weeks after receipt of yellow fever, anthrax and typhoid vaccines, with chest pain and dyspnea. His evaluation revealed a left-sided pleural effusion, as well as elevated D-dimer levels. Computed tomography pulmonary angiogram ruled out pulmonary embolism. Elevated serum creatinine and liver-associated enzymes also suggested both renal and hepatic dysfunction. Subsequent evaluation also led to a diagnosis of Raynaud's syndrome and transient hypothyroidism.  Author's comment: Despite an exhaustive evaluation by rheumatology, pulmonary, endocrinology and immunology an alternative etiology for the patient's signs and symptoms could not be determined. This patient met the Brighton Collaboration viscerotropic disease major criteria of coagulopathy with the elevated ?brin degradation products and narrowly missed the renal major criteria by 0.1mg/dL and the hepatic major criteria by 2U/L. Furthermore, plaque reduction neutralization testing by the Centers for Disease Control was not inconsistent with YEL-AVD. In the absence of other diagnoses after an exhaustive evaluation, we pro- pose that the patient did in fact have multi-system organ dysfunction consistent with YEL-AVD and suggest a re-evaluation of the current case de?nition for this rare adverse event following immunization.  Company Comment: Despite the patient concomitantly received presumable BioThrax and Vivotif, YEL-AVD is a rare and known complication of yellow fever vaccine, therefore, causality assessment to BioThrax and Vivotif is considered not related. The case is considered serious because of medical significance of YEL-AVD which is unlisted for both BioThrax and Vivotif.; Sender's Comments: Despite the patient concomitantly received presumable BioThrax and Vivotif, YEL-AVD is a rare and known complication of yellow fever vaccine, therefore, causality assessment to BioThrax and Vivotif is considered not related. The case is considered serious because of medical significance of YEL-AVD which is unlisted for both BioThrax and Vivotif.
Sex: M
Vaccine: YF, ANTH, TYP, YF
Symptoms: Angiogram pulmonary normal, Blood creatinine increased, Chest pain, Coagulopathy, Dyspnoea
Clinical narrative: Yellow fever vaccine-associated viscerotropic disease; This case was obtained from a scientific literature.  A 29-year-old male developed "Yellow fever vaccine-associated viscerotropic disease" (PT: Yellow fever vaccine-associated viscerotropic disease), following the administration of BioThrax (anthrax vaccine adsorbed), Vivotif (Typhoid vaccine live oral Ty21A), and yellow fever vaccine for immunisation.  Case report: Nonfatal Yellow fever vaccine-associated viscerotropic disease (YEL-AVD) was suspected in a 29-year-old male who presented two weeks after receipt of yellow fever, anthrax and typhoid vaccines, with chest pain and dyspnea. His evaluation revealed a left-sided pleural effusion, as well as elevated D-dimer levels. Computed tomography pulmonary angiogram ruled out pulmonary embolism. Elevated serum creatinine and liver-associated enzymes also suggested both renal and hepatic dysfunction. Subsequent evaluation also led to a diagnosis of Raynaud's syndrome and transient hypothyroidism.  Author's comment: Despite an exhaustive evaluation by rheumatology, pulmonary, endocrinology and immunology an alternative etiology for the patient's signs and symptoms could not be determined. This patient met the Brighton Collaboration viscerotropic disease major criteria of coagulopathy with the elevated ?brin degradation products and narrowly missed the renal major criteria by 0.1mg/dL and the hepatic major criteria by 2U/L. Furthermore, plaque reduction neutralization testing by the Centers for Disease Control was not inconsistent with YEL-AVD. In the absence of other diagnoses after an exhaustive evaluation, we pro- pose that the patient did in fact have multi-system organ dysfunction consistent with YEL-AVD and suggest a re-evaluation of the current case de?nition for this rare adverse event following immunization.  Company Comment: Despite the patient concomitantly received presumable BioThrax and Vivotif, YEL-AVD is a rare and known complication of yellow fever vaccine, therefore, causality assessment to BioThrax and Vivotif is considered not related. The case is considered serious because of medical significance of YEL-AVD which is unlisted for both BioThrax and Vivotif.; Sender's Comments: Despite the patient concomitantly received presumable BioThrax and Vivotif, YEL-AVD is a rare and known complication of yellow fever vaccine, therefore, causality assessment to BioThrax and Vivotif is considered not related. The case is considered serious because of medical significance of YEL-AVD which is unlisted for both BioThrax and Vivotif.
Sex: M
Vaccine: YF, ANTH, TYP, YF
Symptoms: Fibrin D dimer increased, Hepatic enzyme increased, Hepatic function abnormal, Hypothyroidism, Laboratory test abnormal
Clinical narrative: Yellow fever vaccine-associated viscerotropic disease; This case was obtained from a scientific literature.  A 29-year-old male developed "Yellow fever vaccine-associated viscerotropic disease" (PT: Yellow fever vaccine-associated viscerotropic disease), following the administration of BioThrax (anthrax vaccine adsorbed), Vivotif (Typhoid vaccine live oral Ty21A), and yellow fever vaccine for immunisation.  Case report: Nonfatal Yellow fever vaccine-associated viscerotropic disease (YEL-AVD) was suspected in a 29-year-old male who presented two weeks after receipt of yellow fever, anthrax and typhoid vaccines, with chest pain and dyspnea. His evaluation revealed a left-sided pleural effusion, as well as elevated D-dimer levels. Computed tomography pulmonary angiogram ruled out pulmonary embolism. Elevated serum creatinine and liver-associated enzymes also suggested both renal and hepatic dysfunction. Subsequent evaluation also led to a diagnosis of Raynaud's syndrome and transient hypothyroidism.  Author's comment: Despite an exhaustive evaluation by rheumatology, pulmonary, endocrinology and immunology an alternative etiology for the patient's signs and symptoms could not be determined. This patient met the Brighton Collaboration viscerotropic disease major criteria of coagulopathy with the elevated ?brin degradation products and narrowly missed the renal major criteria by 0.1mg/dL and the hepatic major criteria by 2U/L. Furthermore, plaque reduction neutralization testing by the Centers for Disease Control was not inconsistent with YEL-AVD. In the absence of other diagnoses after an exhaustive evaluation, we pro- pose that the patient did in fact have multi-system organ dysfunction consistent with YEL-AVD and suggest a re-evaluation of the current case de?nition for this rare adverse event following immunization.  Company Comment: Despite the patient concomitantly received presumable BioThrax and Vivotif, YEL-AVD is a rare and known complication of yellow fever vaccine, therefore, causality assessment to BioThrax and Vivotif is considered not related. The case is considered serious because of medical significance of YEL-AVD which is unlisted for both BioThrax and Vivotif.; Sender's Comments: Despite the patient concomitantly received presumable BioThrax and Vivotif, YEL-AVD is a rare and known complication of yellow fever vaccine, therefore, causality assessment to BioThrax and Vivotif is considered not related. The case is considered serious because of medical significance of YEL-AVD which is unlisted for both BioThrax and Vivotif.
Sex: M
Vaccine: YF, ANTH, TYP, YF
Symptoms: Multiple organ dysfunction syndrome, Pleural effusion, Raynaud's phenomenon, Renal impairment, Viral test
Clinical narrative: Yellow fever vaccine-associated viscerotropic disease; This case was obtained from a scientific literature.  A 29-year-old male developed "Yellow fever vaccine-associated viscerotropic disease" (PT: Yellow fever vaccine-associated viscerotropic disease), following the administration of BioThrax (anthrax vaccine adsorbed), Vivotif (Typhoid vaccine live oral Ty21A), and yellow fever vaccine for immunisation.  Case report: Nonfatal Yellow fever vaccine-associated viscerotropic disease (YEL-AVD) was suspected in a 29-year-old male who presented two weeks after receipt of yellow fever, anthrax and typhoid vaccines, with chest pain and dyspnea. His evaluation revealed a left-sided pleural effusion, as well as elevated D-dimer levels. Computed tomography pulmonary angiogram ruled out pulmonary embolism. Elevated serum creatinine and liver-associated enzymes also suggested both renal and hepatic dysfunction. Subsequent evaluation also led to a diagnosis of Raynaud's syndrome and transient hypothyroidism.  Author's comment: Despite an exhaustive evaluation by rheumatology, pulmonary, endocrinology and immunology an alternative etiology for the patient's signs and symptoms could not be determined. This patient met the Brighton Collaboration viscerotropic disease major criteria of coagulopathy with the elevated ?brin degradation products and narrowly missed the renal major criteria by 0.1mg/dL and the hepatic major criteria by 2U/L. Furthermore, plaque reduction neutralization testing by the Centers for Disease Control was not inconsistent with YEL-AVD. In the absence of other diagnoses after an exhaustive evaluation, we pro- pose that the patient did in fact have multi-system organ dysfunction consistent with YEL-AVD and suggest a re-evaluation of the current case de?nition for this rare adverse event following immunization.  Company Comment: Despite the patient concomitantly received presumable BioThrax and Vivotif, YEL-AVD is a rare and known complication of yellow fever vaccine, therefore, causality assessment to BioThrax and Vivotif is considered not related. The case is considered serious because of medical significance of YEL-AVD which is unlisted for both BioThrax and Vivotif.; Sender's Comments: Despite the patient concomitantly received presumable BioThrax and Vivotif, YEL-AVD is a rare and known complication of yellow fever vaccine, therefore, causality assessment to BioThrax and Vivotif is considered not related. The case is considered serious because of medical significance of YEL-AVD which is unlisted for both BioThrax and Vivotif.
Sex: M
Vaccine: YF, ANTH, TYP, YF
Symptoms: Yellow fever vaccine-associated viscerotropic disease
Clinical narrative: Yellow fever vaccine-associated viscerotropic disease; This case was obtained from a scientific literature.  A 29-year-old male developed "Yellow fever vaccine-associated viscerotropic disease" (PT: Yellow fever vaccine-associated viscerotropic disease), following the administration of BioThrax (anthrax vaccine adsorbed), Vivotif (Typhoid vaccine live oral Ty21A), and yellow fever vaccine for immunisation.  Case report: Nonfatal Yellow fever vaccine-associated viscerotropic disease (YEL-AVD) was suspected in a 29-year-old male who presented two weeks after receipt of yellow fever, anthrax and typhoid vaccines, with chest pain and dyspnea. His evaluation revealed a left-sided pleural effusion, as well as elevated D-dimer levels. Computed tomography pulmonary angiogram ruled out pulmonary embolism. Elevated serum creatinine and liver-associated enzymes also suggested both renal and hepatic dysfunction. Subsequent evaluation also led to a diagnosis of Raynaud's syndrome and transient hypothyroidism.  Author's comment: Despite an exhaustive evaluation by rheumatology, pulmonary, endocrinology and immunology an alternative etiology for the patient's signs and symptoms could not be determined. This patient met the Brighton Collaboration viscerotropic disease major criteria of coagulopathy with the elevated ?brin degradation products and narrowly missed the renal major criteria by 0.1mg/dL and the hepatic major criteria by 2U/L. Furthermore, plaque reduction neutralization testing by the Centers for Disease Control was not inconsistent with YEL-AVD. In the absence of other diagnoses after an exhaustive evaluation, we pro- pose that the patient did in fact have multi-system organ dysfunction consistent with YEL-AVD and suggest a re-evaluation of the current case de?nition for this rare adverse event following immunization.  Company Comment: Despite the patient concomitantly received presumable BioThrax and Vivotif, YEL-AVD is a rare and known complication of yellow fever vaccine, therefore, causality assessment to BioThrax and Vivotif is considered not related. The case is considered serious because of medical significance of YEL-AVD which is unlisted for both BioThrax and Vivotif.; Sender's Comments: Despite the patient concomitantly received presumable BioThrax and Vivotif, YEL-AVD is a rare and known complication of yellow fever vaccine, therefore, causality assessment to BioThrax and Vivotif is considered not related. The case is considered serious because of medical significance of YEL-AVD which is unlisted for both BioThrax and Vivotif.
Age: 74.0
Sex: M
Vaccine: FLU4, FLUA4
Symptoms: Chills, Tachycardia, Tremor, Vomiting
Clinical narrative: Chills requiring a blanket to keep warm, uncontrollable rigors, nausea/vomiting. Heart rate was affected.
Age: 74.0
Sex: M
Vaccine: FLU4, FLUA4
Symptoms: Chills, Electrocardiogram, Heart rate, Laboratory test, Nausea
Clinical narrative: Chills requiring a blanket to keep warm, uncontrollable rigors, nausea/vomiting. Heart rate was affected.
Age: 74.0
Sex: M
Vaccine: FLU4, FLUA4
Symptoms: Vomiting, X-ray
Clinical narrative: Chills requiring a blanket to keep warm, uncontrollable rigors, nausea/vomiting. Heart rate was affected.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cold sweat, Dizziness
Clinical narrative: Fainted shortly after administration. Patient was siting in a chair when she became light-headed and fainted
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Syncope
Clinical narrative: Fainted shortly after administration. Patient was siting in a chair when she became light-headed and fainted
Age: 73.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site discolouration, Injection site pruritus, Injection site rash, Injection site reaction, Livedo reticularis
Clinical narrative: significant rash on her right arm about 3 inches below the deltoid muscle; vascular rash/circular look like a big round wheel .; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-healthcare professional (Reference number-00316176) and transmitted to Sanofi on 14-Oct-2020.  This case involves a 73 years old female patient who had rash on her right arm about 3 inches below the deltoid muscle (vaccination site rash) and vascular rash/circular look like a big round wheel (rash maculo-papular) while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no concomitant medications and other vaccines.  On 12-Oct-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ467AA, expiry date 30-Jun-2021) once via intramuscular route in the right deltoid for prophylactic vaccination.  The patient developed a non-serious rash on her right arm about 3 inches belowthe deltoid muscle (vaccination site rash) and vascular rash/circular look like a big round wheel (rash maculo-papular) (same day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was not recovered.
Age: 73.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity
Clinical narrative: significant rash on her right arm about 3 inches below the deltoid muscle; vascular rash/circular look like a big round wheel .; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-healthcare professional (Reference number-00316176) and transmitted to Sanofi on 14-Oct-2020.  This case involves a 73 years old female patient who had rash on her right arm about 3 inches below the deltoid muscle (vaccination site rash) and vascular rash/circular look like a big round wheel (rash maculo-papular) while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no concomitant medications and other vaccines.  On 12-Oct-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ467AA, expiry date 30-Jun-2021) once via intramuscular route in the right deltoid for prophylactic vaccination.  The patient developed a non-serious rash on her right arm about 3 inches belowthe deltoid muscle (vaccination site rash) and vascular rash/circular look like a big round wheel (rash maculo-papular) (same day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was not recovered.
Age: 73.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site rash, Rash maculo-papular
Clinical narrative: significant rash on her right arm about 3 inches below the deltoid muscle; vascular rash/circular look like a big round wheel .; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-healthcare professional (Reference number-00316176) and transmitted to Sanofi on 14-Oct-2020.  This case involves a 73 years old female patient who had rash on her right arm about 3 inches below the deltoid muscle (vaccination site rash) and vascular rash/circular look like a big round wheel (rash maculo-papular) while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no concomitant medications and other vaccines.  On 12-Oct-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ467AA, expiry date 30-Jun-2021) once via intramuscular route in the right deltoid for prophylactic vaccination.  The patient developed a non-serious rash on her right arm about 3 inches belowthe deltoid muscle (vaccination site rash) and vascular rash/circular look like a big round wheel (rash maculo-papular) (same day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was not recovered.
Age: 73.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site discharge
Clinical narrative: clear oily substance outside her arm; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Information  (Reference number- 00319544) and transmitted to Sanofi on 16-Oct-2020.  This case involves a 73 year old female patient who had clear oily substance outside her arm (vaccination site discharge), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), past vaccination(s) and family history were not provided.  The patient had no other vaccines.   On 18-Aug-2020, the patient received a 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ454AB and expiry date: 30-Jun-2021) once via intramuscular route in the right arm for prophylactic vaccination.  On 18-Aug-2020, the patient developed a non-serious clear oily substance outside her arm (vaccination site discharge) a couple of hours after administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Pharmacist wanted to know if there's a possibility that the substance could be the vaccine and if it is recommended for her to be revaccinated.  Laboratory data was not provided.  No corrective treatment was received.  At the time of reporting the outcome of event was recovered.
Age: 17.0
Sex: F
Vaccine: PPV, FLU4, PPV
Symptoms: Arthralgia, Blood culture negative, C-reactive protein increased, Chills, Influenza A virus test negative
Clinical narrative: Severe allergic reaction. She was hospitalized in the PICU for 5 nights & 6 days. It took her weeks to recover she still has pain etc.   She had severe pain in arm & swelling. She could not move her arm. She had high fever, severe rigors, profuse sweating,  severe body pain, rapid heart rate, vomiting, growing bright red rash.  She has tears in muscle we do not know if it is from swelling or unrelated. (Confirmed MRI)   She needed fluids, medication, monitoring for almost a week.  Tested her for virus & infection it was all negative. She was diagnosed with severe febrile systemic reaction to pneumococcal 23 vaccine. Her crp & white cells were very elevated.   She still has arm pain, fatigue, anxiety, etc.
Age: 17.0
Sex: F
Vaccine: PPV, FLU4, PPV
Symptoms: Influenza B virus test, Influenza virus test negative, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Severe allergic reaction. She was hospitalized in the PICU for 5 nights & 6 days. It took her weeks to recover she still has pain etc.   She had severe pain in arm & swelling. She could not move her arm. She had high fever, severe rigors, profuse sweating,  severe body pain, rapid heart rate, vomiting, growing bright red rash.  She has tears in muscle we do not know if it is from swelling or unrelated. (Confirmed MRI)   She needed fluids, medication, monitoring for almost a week.  Tested her for virus & infection it was all negative. She was diagnosed with severe febrile systemic reaction to pneumococcal 23 vaccine. Her crp & white cells were very elevated.   She still has arm pain, fatigue, anxiety, etc.
Age: 17.0
Sex: F
Vaccine: PPV, FLU4, PPV
Symptoms: Metabolic function test normal, Pyrexia, Rash, Tachycardia, White blood cell count increased
Clinical narrative: Severe allergic reaction. She was hospitalized in the PICU for 5 nights & 6 days. It took her weeks to recover she still has pain etc.   She had severe pain in arm & swelling. She could not move her arm. She had high fever, severe rigors, profuse sweating,  severe body pain, rapid heart rate, vomiting, growing bright red rash.  She has tears in muscle we do not know if it is from swelling or unrelated. (Confirmed MRI)   She needed fluids, medication, monitoring for almost a week.  Tested her for virus & infection it was all negative. She was diagnosed with severe febrile systemic reaction to pneumococcal 23 vaccine. Her crp & white cells were very elevated.   She still has arm pain, fatigue, anxiety, etc.
Age: 17.0
Sex: F
Vaccine: PPV, FLU4, PPV
Symptoms: Anxiety, Blood test, C-reactive protein increased, Chills, Fatigue
Clinical narrative: Severe allergic reaction. She was hospitalized in the PICU for 5 nights & 6 days. It took her weeks to recover she still has pain etc.   She had severe pain in arm & swelling. She could not move her arm. She had high fever, severe rigors, profuse sweating,  severe body pain, rapid heart rate, vomiting, growing bright red rash.  She has tears in muscle we do not know if it is from swelling or unrelated. (Confirmed MRI)   She needed fluids, medication, monitoring for almost a week.  Tested her for virus & infection it was all negative. She was diagnosed with severe febrile systemic reaction to pneumococcal 23 vaccine. Her crp & white cells were very elevated.   She still has arm pain, fatigue, anxiety, etc.
Age: 17.0
Sex: F
Vaccine: PPV, FLU4, PPV
Symptoms: Heart rate increased, Hyperhidrosis, Hypersensitivity, Intensive care, Laboratory test normal
Clinical narrative: Severe allergic reaction. She was hospitalized in the PICU for 5 nights & 6 days. It took her weeks to recover she still has pain etc.   She had severe pain in arm & swelling. She could not move her arm. She had high fever, severe rigors, profuse sweating,  severe body pain, rapid heart rate, vomiting, growing bright red rash.  She has tears in muscle we do not know if it is from swelling or unrelated. (Confirmed MRI)   She needed fluids, medication, monitoring for almost a week.  Tested her for virus & infection it was all negative. She was diagnosed with severe febrile systemic reaction to pneumococcal 23 vaccine. Her crp & white cells were very elevated.   She still has arm pain, fatigue, anxiety, etc.
Age: 17.0
Sex: F
Vaccine: PPV, FLU4, PPV
Symptoms: Magnetic resonance imaging abnormal, Mobility decreased, Muscle rupture, Pain, Pain in extremity
Clinical narrative: Severe allergic reaction. She was hospitalized in the PICU for 5 nights & 6 days. It took her weeks to recover she still has pain etc.   She had severe pain in arm & swelling. She could not move her arm. She had high fever, severe rigors, profuse sweating,  severe body pain, rapid heart rate, vomiting, growing bright red rash.  She has tears in muscle we do not know if it is from swelling or unrelated. (Confirmed MRI)   She needed fluids, medication, monitoring for almost a week.  Tested her for virus & infection it was all negative. She was diagnosed with severe febrile systemic reaction to pneumococcal 23 vaccine. Her crp & white cells were very elevated.   She still has arm pain, fatigue, anxiety, etc.
Age: 17.0
Sex: F
Vaccine: PPV, FLU4, PPV
Symptoms: Pyrexia, Rash erythematous, Swelling, Viral test negative, Vomiting
Clinical narrative: Severe allergic reaction. She was hospitalized in the PICU for 5 nights & 6 days. It took her weeks to recover she still has pain etc.   She had severe pain in arm & swelling. She could not move her arm. She had high fever, severe rigors, profuse sweating,  severe body pain, rapid heart rate, vomiting, growing bright red rash.  She has tears in muscle we do not know if it is from swelling or unrelated. (Confirmed MRI)   She needed fluids, medication, monitoring for almost a week.  Tested her for virus & infection it was all negative. She was diagnosed with severe febrile systemic reaction to pneumococcal 23 vaccine. Her crp & white cells were very elevated.   She still has arm pain, fatigue, anxiety, etc.
Age: 17.0
Sex: F
Vaccine: PPV, FLU4, PPV
Symptoms: White blood cell count increased
Clinical narrative: Severe allergic reaction. She was hospitalized in the PICU for 5 nights & 6 days. It took her weeks to recover she still has pain etc.   She had severe pain in arm & swelling. She could not move her arm. She had high fever, severe rigors, profuse sweating,  severe body pain, rapid heart rate, vomiting, growing bright red rash.  She has tears in muscle we do not know if it is from swelling or unrelated. (Confirmed MRI)   She needed fluids, medication, monitoring for almost a week.  Tested her for virus & infection it was all negative. She was diagnosed with severe febrile systemic reaction to pneumococcal 23 vaccine. Her crp & white cells were very elevated.   She still has arm pain, fatigue, anxiety, etc.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Myalgia, Pyrexia, Sleep disorder
Clinical narrative: Within 6 hours Fever was 101.7 Took  a combo of Aspirin 1.3 gm and Tylenol 600 mg. every 6 hours. Had a very bad night with muscle pain --- neck and shoulders. Temp did not go under 100.5 thru out the night. I finally able to sleep around 7:30 AM,  waking up at 1:35 PM.   Temp  was finally below 99.4 for the next 12 hours.  Feel weak without  an appetite.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling cold, Myalgia, Tremor
Clinical narrative: achey muscles all over, shaking like I was super cold and could not get warm or stop shaking. No fever during the duration of reaction.  By day 5 I was recovered.
Age: 37.0
Sex: F
Vaccine: HPV9
Symptoms: Hypotension, Loss of consciousness
Clinical narrative: Blood pressure was severely low; Patient blacked out after rising from bed and taking a few steps; Information has been received on request by the Company from FDA under the act on 22-OCT-2020.  This spontaneous report was received from a physician concerning a 37-year-old non-pregnant patient. The patient was allergic to cottonseed, brewer's yeast, nickel and "sulfa". Concurrent conditions included hypothyroidism. Concomitant medications included tranylcypromine sulfate (PARNATE), liothyronine, thyroid (ARMOUR THYROID), vitamin C, vitamin D3, omega-3 and magnesium (unspecified). There was no information regarding her medical history.  On 07-NOV-2019 at 09:00, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscularly in the right arm (dose, regimen, lot number and expiration date were not reported) administered as prophylaxis.    On 08-NOV-2019 at 09:00, 24 hours after vaccination, the patient's blood pressure was severely low (hypotension) at the time of awakening with a value of 64/42 (units not reported). After rising from her bed and taking a few steps, the patient blacked out (loss of consciousness). Her mother found her after hearing her fall to the floor. The patient came to a few seconds after blacking out. The patient notified the occurred to the Doctor's office, but no treatment was necessary as her blood pressure slowly returned to normal values as the day progressed.  The causality assessment between the events and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.  Follow up information has been received from the physician office on 03-NOV-2020. The reporter reported receiving a vaccine adverse experience form and stated that they were not able to identify this patient, so she would not be able to fill out that form.  The date of vaccination was provided, but the reporter stated she still could not find the patient.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Caller is a nurse reporting a temperature excursion, requesting stability data; This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. The pertinent medical history, concomitant therapies and drug allergy or reactions were unknown.  On 21-OCT-2020, the patient was vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T009929, which has been verified to be valid, expiration date reported and validated as 16-SEP-2021, therapy type: rHA) for prophylaxis (formulation, strength, route of administration and anatomical site of vaccination were not reported). The vaccine administered was improperly stored at a temperature excursion of -6.6 degrees Celsius for a time frame of 1 hour and 45 minutes, as recorded by a data logger. There was no previous temperature excursion reported. The outcome of event was not provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA010299: US-009507513-2010USA010508: US-009507513-2010USA010348: US-009507513-2010USA010735: US-009507513-2010USA010384: US-009507513-2010USA010598: US-009507513-2010USA010518: US-009507513-2010USA010577: US-009507513-2010USA010709:
Age: 1.67
Sex: F
Vaccine: DTAPIPVHIB, HIBV, HIBV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient is not experiencing (nor has she ever experienced) any side effects; interchange of vaccine products; inappropriate schedule of vaccine administered; This spontaneous report was received from a nurse practitioner referring to a 20-month-old female patient. The patient's pertinent medical history, concomitant drugs and allergy to drugs were not reported.     . On 22-APR-2019, 26-AUG-2019 and 28-FEB-2020, she was vaccinated with hib conj vaccine (tet toxoid)(ACTHIB) (dose, strength, lot number and expiration date were not reported) intramuscularly for prophylaxis three times. On 24-JUN-2019, the patient was vaccinated with Hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (MRC-5), tetanus toxoid (PENTACEL) (dose, strength, lot number and expiration date were not reported) intramuscularly for prophylaxis. On 20-OCT-2020, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot number was S021458, expiration date was 27-FEB-2022, dose and strength were not reported) intramuscularly for prophylaxis (Interchange of vaccine products, Inappropriate schedule of product administration). The patient is not experiencing (nor has she ever experienced) any side effects.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from an administrator via a field representative referring to a 59 years old female patient. Information about concurrent condition, concomitant medication, medical history, drug reactions or allergies was unknown. On 22-OCT-2020, the PNEUMOVAX 23 shipment was received a day late (expected arrival date was 21-OCT-2020, product shipment delay) to the reporter's practice, they were not viable for use, and someone in the office mistakenly placed them in the vaccine fridge (confliction information: the box of vaccines got placed into a refrigerator at recommended storage range once received). On 23-OCT-2020, the patient was vaccinated with a dose of PNEUMOVAX 23 (0.5 ml, lot # T020638, expiration date 26-FEB-2022; route was not reported) for prophylaxis (improper storage of product in use).  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020638; expirationdate: 26-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2011USA015361: US-009507513-2011USA015362: US-009507513-2011USA015363: US-009507513-2011USA015360: US-009507513-2011USA015358: US-009507513-2011USA015357: US-009507513-2011USA015359:
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: the patient did not experience any other adverse events; patient administered MMR in their office and given a VARIVAX in another office less than 4 weeks apart; This spontaneous report was received from a registered nurse and a consumer and refers to a 12-month-old female patient. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided.   On 08-OCT-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 mL (site of vaccination not provided) (lot#T015997, expiration date 08-MAY-2022) for prophylaxis. On 22-OCT-2020, less than a month after the first vaccination, she was vaccinated with rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 mL (site of vaccination not provided) (lot# S037498, expiration date 04-OCT-2022) reconstituted with sterile diluent (lot# T005076, expiration date 04-OCT-2020) for prophylaxis. The consumer wanted information on validity of the vaccines that were administered less than a month apart. No adverse events were reported.
Age: 0.58
Sex: F
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: there was a temperature excursion; This spontaneous report as received from a nurse referring to a 7 months old female patient . The patient's drug reactions/ allergies were not reported. The patient had no illness or prior birth defects at the time of her vaccination. The patient had no vaccines within 4 weeks prior to rotavirus vaccine, live, oral, pentavalent (ROTATEQ).        On 02-NOV-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (0.2 ml once, lot#1684163 has been verified as valid, expiration date 26-JUN-2021, strength was not reported) orally for prophylaxis.         The administrated rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced product storage error with temperature excursion: 12.8 degree Celsius, time frame: 3 hours, no previous temperature excursion, not recorded by data logger. Rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered to the patient prior to the nurse knowing there was a temperature excursion.   This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2011USA001021: US-009507513-2011USA001454:
Age: 27.0
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional adverse event reported; expired VAQTA was administered to a patient; This spontaneous report was received from a nurse concerning a 27 year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.           On 03-NOV-2020, the patient was vaccinated with an improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) lot# S024396, expiration date 12-OCT-2020 (dose and route were not provided) for prophylaxis. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S024396; expirationdate: 12-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no adverse event; incorrect product storage/ temperature excursion; This spontaneous report as received from a Medical assitant, referring to a patient (gender and age not reported).  No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 27-OCT-2020 the patient was vaccinated with the patinet was vaccinated with an improperly stored dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # S031287 with expiration date in 08-APR-2022 (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported) for prophylaxis, however no adverse effects reported.    The vaccine administered was stored at temperatures that went to 47.7 F for a time frame of 20 minutes. It was not recorded by a data logger. There was previous temperature excursion of 47.1 F. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S031287; expirationdate: 08-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient was not experiencing any effects; no additional AE; PROQUAD from unknown prior temperature excursion case was administered to patient; Improperly Stored/Expired PROQUAD was administered to patient; Previous excursion had changed expiration to 10/26/2020 from 10/17/2021; Improperly Stored/Expired PROQUAD was administered to patient; This spontaneous report as received from a pharmacist refers to a 4-year-old patient of unknown gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 28-OCT-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot number: T013539, expiration date: 17-OCT-2021; dose and route of administration were not provided) (improper storage of product in use). Excursion parameters were unknown. The temperature excursion changed expiration to 26-OCT-2020 from 17-OCT-2021 (expired vaccine used). Digital data lodger was not involved. No adverse event was reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: incorrect product storage; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 23-SEP-2020, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, 1 dose, lot # S020961, expiration date: 07-JUL-2021 (also reported as 24-MAR-2022) and varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1dose, lot # T010310, expiration date: 24-MAR-2022 (also reported as 07-JUL-2021) (injection sites and routes of administration were not provided) both for prophylaxis.  The administered doses experienced the temperature excursion of 19.32 degrees Celsius (C) for 7 hours and 45 minutes. No previous temperature excursion had occurred.