chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Laboratory test, Pain in extremity, Thrombosis
Clinical narrative: Multifocal Intracerebral Hemorrhage; Disseminated Intravascular Coagulopathy; strokes, Ischemic and Hemorrhagic; strokes, Ischemic and Hemorrhagic; AML; Leukemia; Blood clot diagnosis; Sore lower leg; RDW Stand. Dev. H/RDW Coeff Var H; Platelet Count L, Platelet Vol L; Neutrophils L; Band Neutrophils H; Monocytes H; Metamyelocytes H; Myelocytes H; Absolute Neutrophils L; Other Cell Type Blast Like Cells H; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL9261, via an unspecified route of administration, administered in Arm Right on 02Feb2021 08:30 (Batch/Lot Number: EL9261) as SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer (8 years ago no chemo just radiation). Historical vaccine included first dose of BNT162B2 (lot number: EL0140) on 11Jan2021 for Covid-19 immunization. Concomitant medication included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), calcium citrate, colecalciferol (CALCIUM CITRATE + D3), glucosamine, magnesium citrate, docosahexaenoic acid, eicosapentaenoic acid, tocopheryl acetate (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHERYL ACETATE]) and curcuma longa (TURMERIC [CURCUMA LONGA]). On 04Feb2021, the patient's blood work result showed red cell distribution width (RDW) stand. dev. high; RDW coeff var high, platelet count low, platelet vol low; neutrophils low; band neutrophils high; monocytes high; metamyelocytes high; myelocytes high; absolute neutrophils low; other cell type blast like cells high. On 15Feb2021, the patient experienced sore lower leg. On 16Feb2021, the patient was diagnosed with blood clot. On 19Feb2021, the patient was diagnosed with leukemia. On 20Feb2021, the patient was diagnosed with acute myeloid leukemia (AML). On 21Feb2021, the patient had tow types of stroke, ischemic and hemorrhagic, the patient was intubated. On 23Feb2021, the patient was extubated and died due to multifocal intracerebral hemorrhage, disseminated intravascular coagulopathy, acute myeloid leukemia with blast crisis. The patient received chemotherapy and leukapheresis as treatment. The patient died on 23Feb2021.  An autopsy was not performed.; Reported Cause(s) of Death: Disseminated Intravascular Coagulopathy; Acute Myeloid Leukemia With Blast Crisis; Multifocal Intracerebral Hemorrhage
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acute myeloid leukaemia, Band neutrophil count, Band neutrophil count increased, Blast cell count increased, Blast cells
Clinical narrative: Multifocal Intracerebral Hemorrhage; Disseminated Intravascular Coagulopathy; strokes, Ischemic and Hemorrhagic; strokes, Ischemic and Hemorrhagic; AML; Leukemia; Blood clot diagnosis; Sore lower leg; RDW Stand. Dev. H/RDW Coeff Var H; Platelet Count L, Platelet Vol L; Neutrophils L; Band Neutrophils H; Monocytes H; Metamyelocytes H; Myelocytes H; Absolute Neutrophils L; Other Cell Type Blast Like Cells H; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL9261, via an unspecified route of administration, administered in Arm Right on 02Feb2021 08:30 (Batch/Lot Number: EL9261) as SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer (8 years ago no chemo just radiation). Historical vaccine included first dose of BNT162B2 (lot number: EL0140) on 11Jan2021 for Covid-19 immunization. Concomitant medication included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), calcium citrate, colecalciferol (CALCIUM CITRATE + D3), glucosamine, magnesium citrate, docosahexaenoic acid, eicosapentaenoic acid, tocopheryl acetate (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHERYL ACETATE]) and curcuma longa (TURMERIC [CURCUMA LONGA]). On 04Feb2021, the patient's blood work result showed red cell distribution width (RDW) stand. dev. high; RDW coeff var high, platelet count low, platelet vol low; neutrophils low; band neutrophils high; monocytes high; metamyelocytes high; myelocytes high; absolute neutrophils low; other cell type blast like cells high. On 15Feb2021, the patient experienced sore lower leg. On 16Feb2021, the patient was diagnosed with blood clot. On 19Feb2021, the patient was diagnosed with leukemia. On 20Feb2021, the patient was diagnosed with acute myeloid leukemia (AML). On 21Feb2021, the patient had tow types of stroke, ischemic and hemorrhagic, the patient was intubated. On 23Feb2021, the patient was extubated and died due to multifocal intracerebral hemorrhage, disseminated intravascular coagulopathy, acute myeloid leukemia with blast crisis. The patient received chemotherapy and leukapheresis as treatment. The patient died on 23Feb2021.  An autopsy was not performed.; Reported Cause(s) of Death: Disseminated Intravascular Coagulopathy; Acute Myeloid Leukemia With Blast Crisis; Multifocal Intracerebral Hemorrhage
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral haemorrhage, Disseminated intravascular coagulation, Haemorrhagic stroke, Ischaemic stroke, Leukaemia
Clinical narrative: Multifocal Intracerebral Hemorrhage; Disseminated Intravascular Coagulopathy; strokes, Ischemic and Hemorrhagic; strokes, Ischemic and Hemorrhagic; AML; Leukemia; Blood clot diagnosis; Sore lower leg; RDW Stand. Dev. H/RDW Coeff Var H; Platelet Count L, Platelet Vol L; Neutrophils L; Band Neutrophils H; Monocytes H; Metamyelocytes H; Myelocytes H; Absolute Neutrophils L; Other Cell Type Blast Like Cells H; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL9261, via an unspecified route of administration, administered in Arm Right on 02Feb2021 08:30 (Batch/Lot Number: EL9261) as SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer (8 years ago no chemo just radiation). Historical vaccine included first dose of BNT162B2 (lot number: EL0140) on 11Jan2021 for Covid-19 immunization. Concomitant medication included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), calcium citrate, colecalciferol (CALCIUM CITRATE + D3), glucosamine, magnesium citrate, docosahexaenoic acid, eicosapentaenoic acid, tocopheryl acetate (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHERYL ACETATE]) and curcuma longa (TURMERIC [CURCUMA LONGA]). On 04Feb2021, the patient's blood work result showed red cell distribution width (RDW) stand. dev. high; RDW coeff var high, platelet count low, platelet vol low; neutrophils low; band neutrophils high; monocytes high; metamyelocytes high; myelocytes high; absolute neutrophils low; other cell type blast like cells high. On 15Feb2021, the patient experienced sore lower leg. On 16Feb2021, the patient was diagnosed with blood clot. On 19Feb2021, the patient was diagnosed with leukemia. On 20Feb2021, the patient was diagnosed with acute myeloid leukemia (AML). On 21Feb2021, the patient had tow types of stroke, ischemic and hemorrhagic, the patient was intubated. On 23Feb2021, the patient was extubated and died due to multifocal intracerebral hemorrhage, disseminated intravascular coagulopathy, acute myeloid leukemia with blast crisis. The patient received chemotherapy and leukapheresis as treatment. The patient died on 23Feb2021.  An autopsy was not performed.; Reported Cause(s) of Death: Disseminated Intravascular Coagulopathy; Acute Myeloid Leukemia With Blast Crisis; Multifocal Intracerebral Hemorrhage
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Metamyelocyte count, Metamyelocyte count increased, Monocyte count, Monocyte count increased, Myelocyte count
Clinical narrative: Multifocal Intracerebral Hemorrhage; Disseminated Intravascular Coagulopathy; strokes, Ischemic and Hemorrhagic; strokes, Ischemic and Hemorrhagic; AML; Leukemia; Blood clot diagnosis; Sore lower leg; RDW Stand. Dev. H/RDW Coeff Var H; Platelet Count L, Platelet Vol L; Neutrophils L; Band Neutrophils H; Monocytes H; Metamyelocytes H; Myelocytes H; Absolute Neutrophils L; Other Cell Type Blast Like Cells H; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL9261, via an unspecified route of administration, administered in Arm Right on 02Feb2021 08:30 (Batch/Lot Number: EL9261) as SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer (8 years ago no chemo just radiation). Historical vaccine included first dose of BNT162B2 (lot number: EL0140) on 11Jan2021 for Covid-19 immunization. Concomitant medication included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), calcium citrate, colecalciferol (CALCIUM CITRATE + D3), glucosamine, magnesium citrate, docosahexaenoic acid, eicosapentaenoic acid, tocopheryl acetate (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHERYL ACETATE]) and curcuma longa (TURMERIC [CURCUMA LONGA]). On 04Feb2021, the patient's blood work result showed red cell distribution width (RDW) stand. dev. high; RDW coeff var high, platelet count low, platelet vol low; neutrophils low; band neutrophils high; monocytes high; metamyelocytes high; myelocytes high; absolute neutrophils low; other cell type blast like cells high. On 15Feb2021, the patient experienced sore lower leg. On 16Feb2021, the patient was diagnosed with blood clot. On 19Feb2021, the patient was diagnosed with leukemia. On 20Feb2021, the patient was diagnosed with acute myeloid leukemia (AML). On 21Feb2021, the patient had tow types of stroke, ischemic and hemorrhagic, the patient was intubated. On 23Feb2021, the patient was extubated and died due to multifocal intracerebral hemorrhage, disseminated intravascular coagulopathy, acute myeloid leukemia with blast crisis. The patient received chemotherapy and leukapheresis as treatment. The patient died on 23Feb2021.  An autopsy was not performed.; Reported Cause(s) of Death: Disseminated Intravascular Coagulopathy; Acute Myeloid Leukemia With Blast Crisis; Multifocal Intracerebral Hemorrhage
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Myelocyte count increased, Neutrophil count, Neutrophil count decreased, Pain in extremity, Platelet count
Clinical narrative: Multifocal Intracerebral Hemorrhage; Disseminated Intravascular Coagulopathy; strokes, Ischemic and Hemorrhagic; strokes, Ischemic and Hemorrhagic; AML; Leukemia; Blood clot diagnosis; Sore lower leg; RDW Stand. Dev. H/RDW Coeff Var H; Platelet Count L, Platelet Vol L; Neutrophils L; Band Neutrophils H; Monocytes H; Metamyelocytes H; Myelocytes H; Absolute Neutrophils L; Other Cell Type Blast Like Cells H; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL9261, via an unspecified route of administration, administered in Arm Right on 02Feb2021 08:30 (Batch/Lot Number: EL9261) as SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer (8 years ago no chemo just radiation). Historical vaccine included first dose of BNT162B2 (lot number: EL0140) on 11Jan2021 for Covid-19 immunization. Concomitant medication included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), calcium citrate, colecalciferol (CALCIUM CITRATE + D3), glucosamine, magnesium citrate, docosahexaenoic acid, eicosapentaenoic acid, tocopheryl acetate (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHERYL ACETATE]) and curcuma longa (TURMERIC [CURCUMA LONGA]). On 04Feb2021, the patient's blood work result showed red cell distribution width (RDW) stand. dev. high; RDW coeff var high, platelet count low, platelet vol low; neutrophils low; band neutrophils high; monocytes high; metamyelocytes high; myelocytes high; absolute neutrophils low; other cell type blast like cells high. On 15Feb2021, the patient experienced sore lower leg. On 16Feb2021, the patient was diagnosed with blood clot. On 19Feb2021, the patient was diagnosed with leukemia. On 20Feb2021, the patient was diagnosed with acute myeloid leukemia (AML). On 21Feb2021, the patient had tow types of stroke, ischemic and hemorrhagic, the patient was intubated. On 23Feb2021, the patient was extubated and died due to multifocal intracerebral hemorrhage, disseminated intravascular coagulopathy, acute myeloid leukemia with blast crisis. The patient received chemotherapy and leukapheresis as treatment. The patient died on 23Feb2021.  An autopsy was not performed.; Reported Cause(s) of Death: Disseminated Intravascular Coagulopathy; Acute Myeloid Leukemia With Blast Crisis; Multifocal Intracerebral Hemorrhage
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Red cell distribution width, Red cell distribution width increased, SARS-CoV-2 test, Thrombosis
Clinical narrative: Multifocal Intracerebral Hemorrhage; Disseminated Intravascular Coagulopathy; strokes, Ischemic and Hemorrhagic; strokes, Ischemic and Hemorrhagic; AML; Leukemia; Blood clot diagnosis; Sore lower leg; RDW Stand. Dev. H/RDW Coeff Var H; Platelet Count L, Platelet Vol L; Neutrophils L; Band Neutrophils H; Monocytes H; Metamyelocytes H; Myelocytes H; Absolute Neutrophils L; Other Cell Type Blast Like Cells H; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL9261, via an unspecified route of administration, administered in Arm Right on 02Feb2021 08:30 (Batch/Lot Number: EL9261) as SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer (8 years ago no chemo just radiation). Historical vaccine included first dose of BNT162B2 (lot number: EL0140) on 11Jan2021 for Covid-19 immunization. Concomitant medication included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), calcium citrate, colecalciferol (CALCIUM CITRATE + D3), glucosamine, magnesium citrate, docosahexaenoic acid, eicosapentaenoic acid, tocopheryl acetate (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHERYL ACETATE]) and curcuma longa (TURMERIC [CURCUMA LONGA]). On 04Feb2021, the patient's blood work result showed red cell distribution width (RDW) stand. dev. high; RDW coeff var high, platelet count low, platelet vol low; neutrophils low; band neutrophils high; monocytes high; metamyelocytes high; myelocytes high; absolute neutrophils low; other cell type blast like cells high. On 15Feb2021, the patient experienced sore lower leg. On 16Feb2021, the patient was diagnosed with blood clot. On 19Feb2021, the patient was diagnosed with leukemia. On 20Feb2021, the patient was diagnosed with acute myeloid leukemia (AML). On 21Feb2021, the patient had tow types of stroke, ischemic and hemorrhagic, the patient was intubated. On 23Feb2021, the patient was extubated and died due to multifocal intracerebral hemorrhage, disseminated intravascular coagulopathy, acute myeloid leukemia with blast crisis. The patient received chemotherapy and leukapheresis as treatment. The patient died on 23Feb2021.  An autopsy was not performed.; Reported Cause(s) of Death: Disseminated Intravascular Coagulopathy; Acute Myeloid Leukemia With Blast Crisis; Multifocal Intracerebral Hemorrhage
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acute myeloid leukaemia, Brain stem stroke, Death, Endotracheal intubation, Full blood count abnormal
Clinical narrative: Multifocal Intracerebral Hemorrhage; Disseminated Intravascular Coagulopathy; strokes, Ischemic and Hemorrhagic; strokes, Ischemic and Hemorrhagic; AML; Leukemia; Blood clot diagnosis; Sore lower leg; RDW Stand. Dev. H/RDW Coeff Var H; Platelet Count L, Platelet Vol L; Neutrophils L; Band Neutrophils H; Monocytes H; Metamyelocytes H; Myelocytes H; Absolute Neutrophils L; Other Cell Type Blast Like Cells H; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL9261, via an unspecified route of administration, administered in Arm Right on 02Feb2021 08:30 (Batch/Lot Number: EL9261) as SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer (8 years ago no chemo just radiation). Historical vaccine included first dose of BNT162B2 (lot number: EL0140) on 11Jan2021 for Covid-19 immunization. Concomitant medication included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), calcium citrate, colecalciferol (CALCIUM CITRATE + D3), glucosamine, magnesium citrate, docosahexaenoic acid, eicosapentaenoic acid, tocopheryl acetate (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHERYL ACETATE]) and curcuma longa (TURMERIC [CURCUMA LONGA]). On 04Feb2021, the patient's blood work result showed red cell distribution width (RDW) stand. dev. high; RDW coeff var high, platelet count low, platelet vol low; neutrophils low; band neutrophils high; monocytes high; metamyelocytes high; myelocytes high; absolute neutrophils low; other cell type blast like cells high. On 15Feb2021, the patient experienced sore lower leg. On 16Feb2021, the patient was diagnosed with blood clot. On 19Feb2021, the patient was diagnosed with leukemia. On 20Feb2021, the patient was diagnosed with acute myeloid leukemia (AML). On 21Feb2021, the patient had tow types of stroke, ischemic and hemorrhagic, the patient was intubated. On 23Feb2021, the patient was extubated and died due to multifocal intracerebral hemorrhage, disseminated intravascular coagulopathy, acute myeloid leukemia with blast crisis. The patient received chemotherapy and leukapheresis as treatment. The patient died on 23Feb2021.  An autopsy was not performed.; Reported Cause(s) of Death: Disseminated Intravascular Coagulopathy; Acute Myeloid Leukemia With Blast Crisis; Multifocal Intracerebral Hemorrhage
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ischaemic stroke, Laboratory test, Pain in extremity, Thrombosis
Clinical narrative: Multifocal Intracerebral Hemorrhage; Disseminated Intravascular Coagulopathy; strokes, Ischemic and Hemorrhagic; strokes, Ischemic and Hemorrhagic; AML; Leukemia; Blood clot diagnosis; Sore lower leg; RDW Stand. Dev. H/RDW Coeff Var H; Platelet Count L, Platelet Vol L; Neutrophils L; Band Neutrophils H; Monocytes H; Metamyelocytes H; Myelocytes H; Absolute Neutrophils L; Other Cell Type Blast Like Cells H; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL9261, via an unspecified route of administration, administered in Arm Right on 02Feb2021 08:30 (Batch/Lot Number: EL9261) as SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer (8 years ago no chemo just radiation). Historical vaccine included first dose of BNT162B2 (lot number: EL0140) on 11Jan2021 for Covid-19 immunization. Concomitant medication included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), calcium citrate, colecalciferol (CALCIUM CITRATE + D3), glucosamine, magnesium citrate, docosahexaenoic acid, eicosapentaenoic acid, tocopheryl acetate (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHERYL ACETATE]) and curcuma longa (TURMERIC [CURCUMA LONGA]). On 04Feb2021, the patient's blood work result showed red cell distribution width (RDW) stand. dev. high; RDW coeff var high, platelet count low, platelet vol low; neutrophils low; band neutrophils high; monocytes high; metamyelocytes high; myelocytes high; absolute neutrophils low; other cell type blast like cells high. On 15Feb2021, the patient experienced sore lower leg. On 16Feb2021, the patient was diagnosed with blood clot. On 19Feb2021, the patient was diagnosed with leukemia. On 20Feb2021, the patient was diagnosed with acute myeloid leukemia (AML). On 21Feb2021, the patient had tow types of stroke, ischemic and hemorrhagic, the patient was intubated. On 23Feb2021, the patient was extubated and died due to multifocal intracerebral hemorrhage, disseminated intravascular coagulopathy, acute myeloid leukemia with blast crisis. The patient received chemotherapy and leukapheresis as treatment. The patient died on 23Feb2021.  An autopsy was not performed.; Reported Cause(s) of Death: Disseminated Intravascular Coagulopathy; Acute Myeloid Leukemia With Blast Crisis; Multifocal Intracerebral Hemorrhage
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Breast pain, Heart rate increased, Lymph node pain, Paraesthesia oral
Clinical narrative: Started feeling tingling in the tongue then started feeling funny feeling to swallow/swollen around 1155 numbness when swallowing was given 50mg Benadryl & pepcide 40mg  pt has some relief after observation.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face
Clinical narrative: Started feeling tingling in the tongue then started feeling funny feeling to swallow/swollen around 1155 numbness when swallowing was given 50mg Benadryl & pepcide 40mg  pt has some relief after observation.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Hypoaesthesia, Paraesthesia oral, Swelling
Clinical narrative: Started feeling tingling in the tongue then started feeling funny feeling to swallow/swollen around 1155 numbness when swallowing was given 50mg Benadryl & pepcide 40mg  pt has some relief after observation.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Started off hive like welt on injection site.  injection site became itchy and hard.  As the day progress bumps that apperered like small red bites started to appear on hands and then eventually covered all four limbs including feet and toes.  Rash was extremely itchy.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site induration, Injection site pruritus, Rash, Rash pruritic, Urticaria
Clinical narrative: Started off hive like welt on injection site.  injection site became itchy and hard.  As the day progress bumps that apperered like small red bites started to appear on hands and then eventually covered all four limbs including feet and toes.  Rash was extremely itchy.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphonia, Dyspnoea, Pruritus
Clinical narrative: Patient walked to medical tent complaining of itchy, blotchy  skin chest and hand; voice breaking; throat uncomfortable, shaking BP 164/74 P 111 02 97%. Epi 0.3mg IM administered transferred to EMS for hospital transfer.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphonia, Oropharyngeal discomfort, Pruritus, Rash macular, Tremor
Clinical narrative: Patient walked to medical tent complaining of itchy, blotchy  skin chest and hand; voice breaking; throat uncomfortable, shaking BP 164/74 P 111 02 97%. Epi 0.3mg IM administered transferred to EMS for hospital transfer.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Loss of consciousness, Urinary incontinence
Clinical narrative: After taking the vaccine husband started to feel a bit dizzy then 30 seconds later his whole body when into a shock and no longer control himself and started to shake a little. He had his eyes open but was unconscious for about 1 minute. Then he released his bladder and peed on himself. The pharmacist noticed and came over then he responded and was consious again. Then he began to sweat excessively all over his body. His face turned pale and the pharmacist began taking his blood pressure which dropped very low. He then began to feel nauseated. Then he started to get body chills. We monitored my husband there for another 30min and he slowly was coming back to his normal self. He had a small headache but was fine enough to leave.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure decreased, Chills, Dizziness, Headache, Hyperhidrosis
Clinical narrative: After taking the vaccine husband started to feel a bit dizzy then 30 seconds later his whole body when into a shock and no longer control himself and started to shake a little. He had his eyes open but was unconscious for about 1 minute. Then he released his bladder and peed on himself. The pharmacist noticed and came over then he responded and was consious again. Then he began to sweat excessively all over his body. His face turned pale and the pharmacist began taking his blood pressure which dropped very low. He then began to feel nauseated. Then he started to get body chills. We monitored my husband there for another 30min and he slowly was coming back to his normal self. He had a small headache but was fine enough to leave.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Nausea, Pallor, Shock, Tremor
Clinical narrative: After taking the vaccine husband started to feel a bit dizzy then 30 seconds later his whole body when into a shock and no longer control himself and started to shake a little. He had his eyes open but was unconscious for about 1 minute. Then he released his bladder and peed on himself. The pharmacist noticed and came over then he responded and was consious again. Then he began to sweat excessively all over his body. His face turned pale and the pharmacist began taking his blood pressure which dropped very low. He then began to feel nauseated. Then he started to get body chills. We monitored my husband there for another 30min and he slowly was coming back to his normal self. He had a small headache but was fine enough to leave.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urinary incontinence
Clinical narrative: After taking the vaccine husband started to feel a bit dizzy then 30 seconds later his whole body when into a shock and no longer control himself and started to shake a little. He had his eyes open but was unconscious for about 1 minute. Then he released his bladder and peed on himself. The pharmacist noticed and came over then he responded and was consious again. Then he began to sweat excessively all over his body. His face turned pale and the pharmacist began taking his blood pressure which dropped very low. He then began to feel nauseated. Then he started to get body chills. We monitored my husband there for another 30min and he slowly was coming back to his normal self. He had a small headache but was fine enough to leave.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Pharyngeal swelling, Pruritus, Throat irritation
Clinical narrative: Pt given vaccine at 1334. At 1354 Pt c/o throat itching and was flushed. Pt given Benadryl 50mg tablet PO and continued to observe. 1412 vs 160/92, HR- 74, Spo2 98% on RA Lung soungs , Stidor.  1416 called 911. Fire on site 1422, ambulance on site 1432.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Throat irritation
Clinical narrative: Pt given vaccine at 1334. At 1354 Pt c/o throat itching and was flushed. Pt given Benadryl 50mg tablet PO and continued to observe. 1412 vs 160/92, HR- 74, Spo2 98% on RA Lung soungs , Stidor.  1416 called 911. Fire on site 1422, ambulance on site 1432.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given the wrong dosage of medication. Patient was given two 0.5 ml on the same day ( total 1 ml). Patient was monitored but did not have any immediate side effects from the vaccine. A followup call was made the next day and patient stated she was fine but felt a little tire and arm was sore.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Fatigue, Incorrect dose administered, Pain in extremity
Clinical narrative: Patient was given the wrong dosage of medication. Patient was given two 0.5 ml on the same day ( total 1 ml). Patient was monitored but did not have any immediate side effects from the vaccine. A followup call was made the next day and patient stated she was fine but felt a little tire and arm was sore.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Dizziness, Feeling hot, Tachycardia
Clinical narrative: Within 6 mins of receiving injection, Pt experienced hot flashes, dizzyness, ears ringing. Pt blood pressure was high at time of initial observation. Pt was clammy & noticeably pale.  12 hours after injection, patient was feverish with a high fever and inability to sleep. Pt had sore arm and chest pain along with fever. Patient experienced such issues until the 16 hour mark post injection. Patient took 2 tylenol at 14 hour post injection.  Patient was considering going to emergency room from fear & severity of the fevers but was able to let subside. At 22 hours post injection, patient has sore arm but otherwise is feeling normal. This was only dose 1 for pt.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Cold sweat, Dizziness, Hot flush, Hypertension
Clinical narrative: Within 6 mins of receiving injection, Pt experienced hot flashes, dizzyness, ears ringing. Pt blood pressure was high at time of initial observation. Pt was clammy & noticeably pale.  12 hours after injection, patient was feverish with a high fever and inability to sleep. Pt had sore arm and chest pain along with fever. Patient experienced such issues until the 16 hour mark post injection. Patient took 2 tylenol at 14 hour post injection.  Patient was considering going to emergency room from fear & severity of the fevers but was able to let subside. At 22 hours post injection, patient has sore arm but otherwise is feeling normal. This was only dose 1 for pt.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pallor, Pyrexia, Sleep disorder, Tinnitus
Clinical narrative: Within 6 mins of receiving injection, Pt experienced hot flashes, dizzyness, ears ringing. Pt blood pressure was high at time of initial observation. Pt was clammy & noticeably pale.  12 hours after injection, patient was feverish with a high fever and inability to sleep. Pt had sore arm and chest pain along with fever. Patient experienced such issues until the 16 hour mark post injection. Patient took 2 tylenol at 14 hour post injection.  Patient was considering going to emergency room from fear & severity of the fevers but was able to let subside. At 22 hours post injection, patient has sore arm but otherwise is feeling normal. This was only dose 1 for pt.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Dysphonia, Herpes virus infection, Herpes zoster, Post herpetic neuralgia
Clinical narrative: multiple outbreaks of herpes, herpes zoster; postherpetic neuralgia; dysphonia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown gender who was approximately 75-year-old at the time of this report. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 29-NOV-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for the long-term prevention of shingles and zoster-related conditions at a pharmacy. On an unspecified date, the patient was treated by healthcare providers for multiple outbreaks of herpes, herpes zoster, postherpetic neuralgia, and dysphonia. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No additional adverse effects were reported; temperature excursion for PNEUMOVAX (syringe) which was administered to a patient; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 17-FEB-2021, the patient was vaccinated with an improperly stored dose of pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) lot# T035379, expiration date reported as 31-MAY-2022, for prophylaxis (strength, dose, route and frequency were not reported).  The temperature excursion and the reported time frame was below 36 Fahrenheit degrees (°F) (31.5°F), for 10 hours 0 minutes and 0 seconds. There was no previous temperature excursion. A digital data logger was involved. No additional adverse effects were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Feeling hot, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Heat development; Cellulitis; Swelling the size of an orange; Itchy skin; Red skin covering upper arm; Arm pain; This spontaneous report was reported by a consumer concerning a 58-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm was sore with restricted movement, swelling, site turned red and spread through entire upper arm, itchiness, heat and cellulitis.  The patient's medical history was not reported. The concomitant medication included Metformin, Clonidine, Lisinopril, Metoprolol, Synthroid, Citalopram, Xanax and Vitamin D.   On 2 Mar 2021, 1 day prior to the onset of the event, the patient received the first dose mRNA-1273 (Lot number -013A214) via intramuscular in left arm for prophylaxis of COVID-19 infection.   On same day the patient reported the arm was sore with restricted movement.  On 10 Mar 2021, patient reported swelling near orange size,  the site turned red and spread through entire upper arm and itchy skin.   On an unknown date heat developed and doctor believed patient developed cellulitis secondary to the vaccination.  Action taken with the mRNA-1273 in response to the events was not provided.   The outcome was recovered for swelling, arm pain and red skin and unknown for rest events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Heat development; Cellulitis; Swelling the size of an orange; Itchy skin; Red skin covering upper arm; Arm pain; This spontaneous report was reported by a consumer concerning a 58-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm was sore with restricted movement, swelling, site turned red and spread through entire upper arm, itchiness, heat and cellulitis.  The patient's medical history was not reported. The concomitant medication included Metformin, Clonidine, Lisinopril, Metoprolol, Synthroid, Citalopram, Xanax and Vitamin D.   On 2 Mar 2021, 1 day prior to the onset of the event, the patient received the first dose mRNA-1273 (Lot number -013A214) via intramuscular in left arm for prophylaxis of COVID-19 infection.   On same day the patient reported the arm was sore with restricted movement.  On 10 Mar 2021, patient reported swelling near orange size,  the site turned red and spread through entire upper arm and itchy skin.   On an unknown date heat developed and doctor believed patient developed cellulitis secondary to the vaccination.  Action taken with the mRNA-1273 in response to the events was not provided.   The outcome was recovered for swelling, arm pain and red skin and unknown for rest events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dizziness, Dyspnoea, Gastrointestinal motility disorder
Clinical narrative: sweating; Pain in arm; Fever; Chest pain (left side); No bowel movement-watery; Labored breathing; Over sleeping; Passed out; Chills; Dizziness; Headache; A spontaneous report was received from a consumer concerning a 70-years-old female patient who received Moderna COVID 19 vaccine and experienced pain in arm, dizziness, major chest pain (left side), pain in shoulder, neck, headache, no bowel movement-watery, chills, labored breathing, passed out, over sleeping, no urine, sweating, fever and sore throat.  The patient's medical history included congestive heart failure, high blood pressure and gout and had 3 heart attacks in lifetime. No relevant concomitant medications were reported.  On 12 Mar 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch number: 031A21A) intramuscularly for COVID-19 prophylaxis.  On 12 Mar 2021, the patient experienced headache and dizziness. On 13 Mar 2021, the patient experienced pain in arm, major chest pain (left side), pain in shoulder, neck, no bowel movement-watery, chills, labored breathing, passed out, over sleeping, no urine, sweating, fever and sore throat. Treatment for the event included nitroglycerin and paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event dizziness was resolved on 12 Mar 2021. The outcome of the events chills, fever and headache was resolved on 14 Mar 2021. The outcome of the events pain in arm, major chest pain (left side), pain in shoulder, neck, no bowel movement-watery, labored breathing, passed out, over sleeping, no urine, sweating and sore throat was resolved on 15 Mar 2021.; Reporter's Comments: This case concerns a 70 Y/O F with a serious unexpected loss of consciousness and NS unexpected dizziness, chest pain, dyspnea, gastrointestinal motility disorder, hypersomnia, hyperhidrosis, and expected pain in extremity, pyrexia, chills, headache.  Event onset Day 1 after first dose mRNA-1273. Events resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Hypersomnia, Loss of consciousness, Pain in extremity
Clinical narrative: sweating; Pain in arm; Fever; Chest pain (left side); No bowel movement-watery; Labored breathing; Over sleeping; Passed out; Chills; Dizziness; Headache; A spontaneous report was received from a consumer concerning a 70-years-old female patient who received Moderna COVID 19 vaccine and experienced pain in arm, dizziness, major chest pain (left side), pain in shoulder, neck, headache, no bowel movement-watery, chills, labored breathing, passed out, over sleeping, no urine, sweating, fever and sore throat.  The patient's medical history included congestive heart failure, high blood pressure and gout and had 3 heart attacks in lifetime. No relevant concomitant medications were reported.  On 12 Mar 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch number: 031A21A) intramuscularly for COVID-19 prophylaxis.  On 12 Mar 2021, the patient experienced headache and dizziness. On 13 Mar 2021, the patient experienced pain in arm, major chest pain (left side), pain in shoulder, neck, no bowel movement-watery, chills, labored breathing, passed out, over sleeping, no urine, sweating, fever and sore throat. Treatment for the event included nitroglycerin and paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event dizziness was resolved on 12 Mar 2021. The outcome of the events chills, fever and headache was resolved on 14 Mar 2021. The outcome of the events pain in arm, major chest pain (left side), pain in shoulder, neck, no bowel movement-watery, labored breathing, passed out, over sleeping, no urine, sweating and sore throat was resolved on 15 Mar 2021.; Reporter's Comments: This case concerns a 70 Y/O F with a serious unexpected loss of consciousness and NS unexpected dizziness, chest pain, dyspnea, gastrointestinal motility disorder, hypersomnia, hyperhidrosis, and expected pain in extremity, pyrexia, chills, headache.  Event onset Day 1 after first dose mRNA-1273. Events resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: sweating; Pain in arm; Fever; Chest pain (left side); No bowel movement-watery; Labored breathing; Over sleeping; Passed out; Chills; Dizziness; Headache; A spontaneous report was received from a consumer concerning a 70-years-old female patient who received Moderna COVID 19 vaccine and experienced pain in arm, dizziness, major chest pain (left side), pain in shoulder, neck, headache, no bowel movement-watery, chills, labored breathing, passed out, over sleeping, no urine, sweating, fever and sore throat.  The patient's medical history included congestive heart failure, high blood pressure and gout and had 3 heart attacks in lifetime. No relevant concomitant medications were reported.  On 12 Mar 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch number: 031A21A) intramuscularly for COVID-19 prophylaxis.  On 12 Mar 2021, the patient experienced headache and dizziness. On 13 Mar 2021, the patient experienced pain in arm, major chest pain (left side), pain in shoulder, neck, no bowel movement-watery, chills, labored breathing, passed out, over sleeping, no urine, sweating, fever and sore throat. Treatment for the event included nitroglycerin and paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event dizziness was resolved on 12 Mar 2021. The outcome of the events chills, fever and headache was resolved on 14 Mar 2021. The outcome of the events pain in arm, major chest pain (left side), pain in shoulder, neck, no bowel movement-watery, labored breathing, passed out, over sleeping, no urine, sweating and sore throat was resolved on 15 Mar 2021.; Reporter's Comments: This case concerns a 70 Y/O F with a serious unexpected loss of consciousness and NS unexpected dizziness, chest pain, dyspnea, gastrointestinal motility disorder, hypersomnia, hyperhidrosis, and expected pain in extremity, pyrexia, chills, headache.  Event onset Day 1 after first dose mRNA-1273. Events resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Vaccination site swelling
Clinical narrative: Seizures; Swelling in left arm where she got the vaccine; A spontaneous report was received from a pharmacist concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced seizures and swelling in left arm where she got the vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (batch number: 044A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 12 Mar 2021, the patient experienced swelling in left arm where she got the vaccine. On 15 Mar 2021, the patient had medically significant event of seizures and was hospitalized for less than 24 hours. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of the event swelling in left arm where she got the vaccine was resolved on 12 Mar 2021. The outcome of the event seizure was resolved on 15 Mar 2021.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the mRNA-1273 and the start date of the reported events and excluding any other etiology, a causal relationship with the events cannot be excluded. Injection site swelling is consistent with the safety profile of the product
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Deafness transitory, Hangover, Headache, Tinnitus
Clinical narrative: complete hearing loss in my left ear for about four hours/ noticed but undocumented hearing loss; headache; chills; hangover feeling; incredibly loud ringing in left ear/ intermittent throughout the day, lasting for several hours at some points/ constant dull ringing/ tinnitus/ ringing in both ears; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 22Mar2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable Other Health Professional (patient). A 30-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot EN6201) via intramuscular at left deltoid on 19Feb2021 at 14:30 (30-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included bipolar disorder, ADHD, depression, and low Vit D. The patient had no COVID prior vaccination. There were no known allergies. Concomitant medications included lamotrigine (LAMICTAL) from 2016 and ongoing for bipolar, sertraline hydrochloride (ZOLOFT) from 2020 and ongoing for Bipolar, amfetamine/dexamfetamine (reported as amphetamine/dextroamphetamine salt extended) from 2015 and ongoing for ADHD and depression, Vitamin D3 from 2020 and ongoing for low Vit D, and cyanocobalamin (VITAMIN B12). The patient did not receive other vaccine in four weeks. Facility type was school or student health clinic; vaccine was administered at military facility. On 20Feb2021 at 21:00, patient had the normal headache, chills, "hangover feeling" in addition to an incredibly loud ringing in her left ear after her first dose. The ringing was intermittent throughout the day, lasting for several hours at some points. The intensity of it has subsided but there seems to be a constant dull ringing in her left ear now. She also had some weird effects with her medications the two days following her first dose. Not entirely sure if they're related but her medication seemed to be ineffective on Saturday and have little effect on Sunday. Severe tinnitus began around 10:00 (as reported) following her first vaccination, resulting in complete hearing loss in her left ear for about four hours. After that the severe ringing was intermittent for about five more hours. She now has ringing in both ears since, with noticed but undocumented hearing loss. There were no further complications after the second dose. The second dose (batch/lot number EN6205) was received via Intramuscular at left deltoid on 12Mar2021 at 14:00. The adverse events did not result in emergency room visit or physician office visit. The patient did not test COVID post vaccination. No therapeutic measures were taken as a result of the events. The outcome of tinnitus was not recovered; outcome of other events was recovered with sequel.