chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: FLU LIKE SYMPTOMS; SORENESS OF THE ARM; SEVER CHILLS/CHATTERING TEETH; KNEE ACHES; MUSCLE ACHES; SEVERE HEADACHE; FEVER; NAUSEA; DIZZINESS; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JJ1805022, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 16:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced dizziness. On 08-MAR-2021, the subject experienced soreness of the arm. On 08-MAR-2021, the subject experienced sever chills/chattering teeth. On 08-MAR-2021, the subject experienced knee aches. On 08-MAR-2021, the subject experienced muscle aches. On 08-MAR-2021, the subject experienced severe headache. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced flu like symptoms. Laboratory data included: Body temperature (NR: not provided) 100.6, 100.3-101. On 09-MAR-2021 02:00, Laboratory data included: Body temperature (NR: not provided) 102.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sever chills/chattering teeth, was recovering from soreness of the arm, had not recovered from fever, dizziness, severe headache, knee aches, muscle aches, and nausea, and the outcome of flu like symptoms was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Contusion, Deep vein thrombosis, Haematuria, Paraesthesia, Peripheral artery occlusion
Clinical narrative: BLOOD CLOTS; LOW PLATELET COUNT; LEG SWELLING; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018) dose was not reported, administered in the left arm on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, about one week after the vaccination the patient had right leg swelling and then the left leg. The patient went to urgent care and was told to go to the hospital right away. The patient was admitted to the hospital on 26-MAR-2021 and was discharged on 08-APR-2021. The patient went back to the hospital on 15-APR-2021 and was told she had peripheral vascular disease. She stated that she had blood clots all over her body on an unspecified date.  On an unspecified date, platelets were 7. The patient received 3 doses of platelets and "5 blood". The patient still had swelling in right foot.  The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the blood clots, leg swelling and low platelet count was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:  This 59-year-old female patient was hospitalized for bilateral leg swelling about one week after receiving the Janssen COVID-19 vaccine.  Medical history and concomitant medications were not reported.  She was hospitalized for 13 days, and after 7 days returned to the hospital.  She said that she had unspecified clots all over her body. On an unspecified date her platelet count was 7 (no units provided) and she received 3 doses of platelets and 5  of blood.  She was also told that she had peripheral vascular disease.  Based on the information that is available, the event is assessed as indeterminate with the causal association to immunization, per causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information will be requested for further assessment once contact information is available.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Peripheral artery thrombosis, Peripheral swelling, Platelet transfusion, Skin discolouration, Stent placement
Clinical narrative: BLOOD CLOTS; LOW PLATELET COUNT; LEG SWELLING; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018) dose was not reported, administered in the left arm on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, about one week after the vaccination the patient had right leg swelling and then the left leg. The patient went to urgent care and was told to go to the hospital right away. The patient was admitted to the hospital on 26-MAR-2021 and was discharged on 08-APR-2021. The patient went back to the hospital on 15-APR-2021 and was told she had peripheral vascular disease. She stated that she had blood clots all over her body on an unspecified date.  On an unspecified date, platelets were 7. The patient received 3 doses of platelets and "5 blood". The patient still had swelling in right foot.  The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the blood clots, leg swelling and low platelet count was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:  This 59-year-old female patient was hospitalized for bilateral leg swelling about one week after receiving the Janssen COVID-19 vaccine.  Medical history and concomitant medications were not reported.  She was hospitalized for 13 days, and after 7 days returned to the hospital.  She said that she had unspecified clots all over her body. On an unspecified date her platelet count was 7 (no units provided) and she received 3 doses of platelets and 5  of blood.  She was also told that she had peripheral vascular disease.  Based on the information that is available, the event is assessed as indeterminate with the causal association to immunization, per causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information will be requested for further assessment once contact information is available.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombectomy, Thrombocytopenia, Ultrasound scan abnormal, Vena cava filter insertion
Clinical narrative: BLOOD CLOTS; LOW PLATELET COUNT; LEG SWELLING; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018) dose was not reported, administered in the left arm on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, about one week after the vaccination the patient had right leg swelling and then the left leg. The patient went to urgent care and was told to go to the hospital right away. The patient was admitted to the hospital on 26-MAR-2021 and was discharged on 08-APR-2021. The patient went back to the hospital on 15-APR-2021 and was told she had peripheral vascular disease. She stated that she had blood clots all over her body on an unspecified date.  On an unspecified date, platelets were 7. The patient received 3 doses of platelets and "5 blood". The patient still had swelling in right foot.  The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the blood clots, leg swelling and low platelet count was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:  This 59-year-old female patient was hospitalized for bilateral leg swelling about one week after receiving the Janssen COVID-19 vaccine.  Medical history and concomitant medications were not reported.  She was hospitalized for 13 days, and after 7 days returned to the hospital.  She said that she had unspecified clots all over her body. On an unspecified date her platelet count was 7 (no units provided) and she received 3 doses of platelets and 5  of blood.  She was also told that she had peripheral vascular disease.  Based on the information that is available, the event is assessed as indeterminate with the causal association to immunization, per causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information will be requested for further assessment once contact information is available.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Peripheral swelling, Platelet count, Platelet count decreased, Thrombosis
Clinical narrative: BLOOD CLOTS; LOW PLATELET COUNT; LEG SWELLING; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018) dose was not reported, administered in the left arm on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, about one week after the vaccination the patient had right leg swelling and then the left leg. The patient went to urgent care and was told to go to the hospital right away. The patient was admitted to the hospital on 26-MAR-2021 and was discharged on 08-APR-2021. The patient went back to the hospital on 15-APR-2021 and was told she had peripheral vascular disease. She stated that she had blood clots all over her body on an unspecified date.  On an unspecified date, platelets were 7. The patient received 3 doses of platelets and "5 blood". The patient still had swelling in right foot.  The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the blood clots, leg swelling and low platelet count was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:  This 59-year-old female patient was hospitalized for bilateral leg swelling about one week after receiving the Janssen COVID-19 vaccine.  Medical history and concomitant medications were not reported.  She was hospitalized for 13 days, and after 7 days returned to the hospital.  She said that she had unspecified clots all over her body. On an unspecified date her platelet count was 7 (no units provided) and she received 3 doses of platelets and 5  of blood.  She was also told that she had peripheral vascular disease.  Based on the information that is available, the event is assessed as indeterminate with the causal association to immunization, per causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information will be requested for further assessment once contact information is available.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Intensive care, Thrombosis
Clinical narrative: BLOOD CLOTS; LOW PLATELET COUNT; LEG SWELLING; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018) dose was not reported, administered in the left arm on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, about one week after the vaccination the patient had right leg swelling and then the left leg. The patient went to urgent care and was told to go to the hospital right away. The patient was admitted to the hospital on 26-MAR-2021 and was discharged on 08-APR-2021. The patient went back to the hospital on 15-APR-2021 and was told she had peripheral vascular disease. She stated that she had blood clots all over her body on an unspecified date.  On an unspecified date, platelets were 7. The patient received 3 doses of platelets and "5 blood". The patient still had swelling in right foot.  The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the blood clots, leg swelling and low platelet count was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:  This 59-year-old female patient was hospitalized for bilateral leg swelling about one week after receiving the Janssen COVID-19 vaccine.  Medical history and concomitant medications were not reported.  She was hospitalized for 13 days, and after 7 days returned to the hospital.  She said that she had unspecified clots all over her body. On an unspecified date her platelet count was 7 (no units provided) and she received 3 doses of platelets and 5  of blood.  She was also told that she had peripheral vascular disease.  Based on the information that is available, the event is assessed as indeterminate with the causal association to immunization, per causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information will be requested for further assessment once contact information is available.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Lip oedema, Tachypnoea, Wheezing
Clinical narrative: 15-20 minutes after vaccine light headed, angioedema of face, urticaria of body, flushed, tongue angioedema, lip angioedema, passed out.  Used Epipen and taken to the ER via 911 and hospitalized.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Dizziness, Flushing, Loss of consciousness, Urticaria
Clinical narrative: 15-20 minutes after vaccine light headed, angioedema of face, urticaria of body, flushed, tongue angioedema, lip angioedema, passed out.  Used Epipen and taken to the ER via 911 and hospitalized.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Decreased appetite, Fatigue, Malaise, Pyrexia
Clinical narrative: Patient said 2 days after administration of vaccine, her arm appeared extremely red from her shoulder to her elbow and it was warm to the touch.  As it was the weekend, she went to Urgent care and was diagnosed with cellulitus. She was prescribed a 7 day course of antibiotic (she couldn't remember the name of the medication).  The redness had subsided by the time she finished the antibiotic course and she had no further symptoms.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Patient said 2 days after administration of vaccine, her arm appeared extremely red from her shoulder to her elbow and it was warm to the touch.  As it was the weekend, she went to Urgent care and was diagnosed with cellulitus. She was prescribed a 7 day course of antibiotic (she couldn't remember the name of the medication).  The redness had subsided by the time she finished the antibiotic course and she had no further symptoms.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Axillary pain, Lymphadenopathy, Mammogram
Clinical narrative: PAIN IN THE LEFT ARMPIT; SWOLLEN LEFT ARMPIT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, diabetes, gerd, anxiety, and high cholesterol. The patient experienced drug allergy when treated with insulin lispro. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: 1805018 expiry: UNKNOWN) .5 ml, administered on 04-MAR-2021 09:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 01-MAR-2021, Laboratory data included: Mammogram (NR: not provided) UNKNOWN. On 04-MAR-2021, the subject experienced pain in the left armpit. On 04-MAR-2021, the subject experienced swollen left armpit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in the left armpit, and swollen left armpit. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Axillary pain, Mammogram, Peripheral swelling
Clinical narrative: PAIN IN THE LEFT ARMPIT; SWOLLEN LEFT ARMPIT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, diabetes, gerd, anxiety, and high cholesterol. The patient experienced drug allergy when treated with insulin lispro. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: 1805018 expiry: UNKNOWN) .5 ml, administered on 04-MAR-2021 09:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 01-MAR-2021, Laboratory data included: Mammogram (NR: not provided) UNKNOWN. On 04-MAR-2021, the subject experienced pain in the left armpit. On 04-MAR-2021, the subject experienced swollen left armpit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in the left armpit, and swollen left armpit. This report was non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient had ED visit / hospitalization within 6 weeks of receiving COVID vaccine
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: DVT; armpit turned purple with no sensation; armpit turned purple with no sensation; excruciating pain; axillary swelling in the right arm pit; body aches; headache; chills; brain fog; lightheadedness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (DVT), SKIN DISCOLOURATION (armpit turned purple with no sensation) and SENSORY LOSS (armpit turned purple with no sensation) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included APIXABAN (ELIQUIS), OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]), PARACETAMOL (TYLENOL), OXYCODONE, DOCUSATE SODIUM (COLACE) and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced FEELING ABNORMAL (brain fog), DIZZINESS (lightheadedness), MYALGIA (body aches), HEADACHE (headache) and CHILLS (chills). On 29-Mar-2021, the patient experienced SWELLING (axillary swelling in the right arm pit). On 31-Mar-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT) (seriousness criteria hospitalization and medically significant), SKIN DISCOLOURATION (armpit turned purple with no sensation) (seriousness criterion hospitalization) and SENSORY LOSS (armpit turned purple with no sensation) (seriousness criterion hospitalization). On 02-Apr-2021, the patient experienced PAIN (excruciating pain). On 30-Mar-2021, SWELLING (axillary swelling in the right arm pit) had resolved. At the time of the report, DEEP VEIN THROMBOSIS (DVT), SKIN DISCOLOURATION (armpit turned purple with no sensation), SENSORY LOSS (armpit turned purple with no sensation), FEELING ABNORMAL (brain fog), DIZZINESS (lightheadedness), PAIN (excruciating pain), MYALGIA (body aches), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication - Eliquis
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Lymph node pain, Lymphadenopathy, Pain, SARS-CoV-2 test negative
Clinical narrative: DVT; armpit turned purple with no sensation; armpit turned purple with no sensation; excruciating pain; axillary swelling in the right arm pit; body aches; headache; chills; brain fog; lightheadedness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (DVT), SKIN DISCOLOURATION (armpit turned purple with no sensation) and SENSORY LOSS (armpit turned purple with no sensation) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included APIXABAN (ELIQUIS), OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]), PARACETAMOL (TYLENOL), OXYCODONE, DOCUSATE SODIUM (COLACE) and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced FEELING ABNORMAL (brain fog), DIZZINESS (lightheadedness), MYALGIA (body aches), HEADACHE (headache) and CHILLS (chills). On 29-Mar-2021, the patient experienced SWELLING (axillary swelling in the right arm pit). On 31-Mar-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT) (seriousness criteria hospitalization and medically significant), SKIN DISCOLOURATION (armpit turned purple with no sensation) (seriousness criterion hospitalization) and SENSORY LOSS (armpit turned purple with no sensation) (seriousness criterion hospitalization). On 02-Apr-2021, the patient experienced PAIN (excruciating pain). On 30-Mar-2021, SWELLING (axillary swelling in the right arm pit) had resolved. At the time of the report, DEEP VEIN THROMBOSIS (DVT), SKIN DISCOLOURATION (armpit turned purple with no sensation), SENSORY LOSS (armpit turned purple with no sensation), FEELING ABNORMAL (brain fog), DIZZINESS (lightheadedness), PAIN (excruciating pain), MYALGIA (body aches), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication - Eliquis
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Deep vein thrombosis, Dizziness, Feeling abnormal, Headache
Clinical narrative: DVT; armpit turned purple with no sensation; armpit turned purple with no sensation; excruciating pain; axillary swelling in the right arm pit; body aches; headache; chills; brain fog; lightheadedness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (DVT), SKIN DISCOLOURATION (armpit turned purple with no sensation) and SENSORY LOSS (armpit turned purple with no sensation) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included APIXABAN (ELIQUIS), OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]), PARACETAMOL (TYLENOL), OXYCODONE, DOCUSATE SODIUM (COLACE) and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced FEELING ABNORMAL (brain fog), DIZZINESS (lightheadedness), MYALGIA (body aches), HEADACHE (headache) and CHILLS (chills). On 29-Mar-2021, the patient experienced SWELLING (axillary swelling in the right arm pit). On 31-Mar-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT) (seriousness criteria hospitalization and medically significant), SKIN DISCOLOURATION (armpit turned purple with no sensation) (seriousness criterion hospitalization) and SENSORY LOSS (armpit turned purple with no sensation) (seriousness criterion hospitalization). On 02-Apr-2021, the patient experienced PAIN (excruciating pain). On 30-Mar-2021, SWELLING (axillary swelling in the right arm pit) had resolved. At the time of the report, DEEP VEIN THROMBOSIS (DVT), SKIN DISCOLOURATION (armpit turned purple with no sensation), SENSORY LOSS (armpit turned purple with no sensation), FEELING ABNORMAL (brain fog), DIZZINESS (lightheadedness), PAIN (excruciating pain), MYALGIA (body aches), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication - Eliquis
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain, Sensory loss, Skin discolouration, Swelling
Clinical narrative: DVT; armpit turned purple with no sensation; armpit turned purple with no sensation; excruciating pain; axillary swelling in the right arm pit; body aches; headache; chills; brain fog; lightheadedness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (DVT), SKIN DISCOLOURATION (armpit turned purple with no sensation) and SENSORY LOSS (armpit turned purple with no sensation) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included APIXABAN (ELIQUIS), OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]), PARACETAMOL (TYLENOL), OXYCODONE, DOCUSATE SODIUM (COLACE) and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced FEELING ABNORMAL (brain fog), DIZZINESS (lightheadedness), MYALGIA (body aches), HEADACHE (headache) and CHILLS (chills). On 29-Mar-2021, the patient experienced SWELLING (axillary swelling in the right arm pit). On 31-Mar-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT) (seriousness criteria hospitalization and medically significant), SKIN DISCOLOURATION (armpit turned purple with no sensation) (seriousness criterion hospitalization) and SENSORY LOSS (armpit turned purple with no sensation) (seriousness criterion hospitalization). On 02-Apr-2021, the patient experienced PAIN (excruciating pain). On 30-Mar-2021, SWELLING (axillary swelling in the right arm pit) had resolved. At the time of the report, DEEP VEIN THROMBOSIS (DVT), SKIN DISCOLOURATION (armpit turned purple with no sensation), SENSORY LOSS (armpit turned purple with no sensation), FEELING ABNORMAL (brain fog), DIZZINESS (lightheadedness), PAIN (excruciating pain), MYALGIA (body aches), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication - Eliquis
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Computerised tomogram thorax, Pulmonary embolism
Clinical narrative: On 3/18 I began having shortness of breath upon exertion. On 3/24 I realized that when I felt that shortness of breath my heart rate was also going very high. On 3/26 I was diagnosed with extensive bilateral pulmonary embolisms. I have started on blood thinners. As of today I am still unwell.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Blood test, Cardiac monitoring, Computerised tomogram thorax abnormal, Dyspnoea exertional
Clinical narrative: On 3/18 I began having shortness of breath upon exertion. On 3/24 I realized that when I felt that shortness of breath my heart rate was also going very high. On 3/26 I was diagnosed with extensive bilateral pulmonary embolisms. I have started on blood thinners. As of today I am still unwell.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Fibrin D dimer increased, Heart rate increased, Malaise
Clinical narrative: On 3/18 I began having shortness of breath upon exertion. On 3/24 I realized that when I felt that shortness of breath my heart rate was also going very high. On 3/26 I was diagnosed with extensive bilateral pulmonary embolisms. I have started on blood thinners. As of today I am still unwell.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: On 3/18 I began having shortness of breath upon exertion. On 3/24 I realized that when I felt that shortness of breath my heart rate was also going very high. On 3/26 I was diagnosed with extensive bilateral pulmonary embolisms. I have started on blood thinners. As of today I am still unwell.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Injection site pain, Lymphadenopathy, Pain, Rash erythematous
Clinical narrative: All this on the right side of the body.  Injection site was on the right arm.  Dizziness and weakness, swollen/painful lymph nodes (axillary, cervical, epitrochlear, under jawline and chin).  Parotid gland swollen and painful.  Entire right arm swollen with rash,  Right check swelled.  Right ear pain.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Ear pain, Hemiparesis, Lymph node pain, Lymphadenopathy
Clinical narrative: All this on the right side of the body.  Injection site was on the right arm.  Dizziness and weakness, swollen/painful lymph nodes (axillary, cervical, epitrochlear, under jawline and chin).  Parotid gland swollen and painful.  Entire right arm swollen with rash,  Right check swelled.  Right ear pain.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Parotid gland enlargement, Peripheral swelling, Rash, Swelling face
Clinical narrative: All this on the right side of the body.  Injection site was on the right arm.  Dizziness and weakness, swollen/painful lymph nodes (axillary, cervical, epitrochlear, under jawline and chin).  Parotid gland swollen and painful.  Entire right arm swollen with rash,  Right check swelled.  Right ear pain.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Pharyngeal swelling, Pruritus
Clinical narrative: Immediately after shot, hives began to appear. Within two minutes took a Benadryl, hives became worse , throat began to close and have difficulty breathing. Nurse gave Epi-pen in right leg and after 35 minutes hives began to subside and breathing became easier
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Immediate post-injection reaction, Throat tightness, Urticaria
Clinical narrative: Immediately after shot, hives began to appear. Within two minutes took a Benadryl, hives became worse , throat began to close and have difficulty breathing. Nurse gave Epi-pen in right leg and after 35 minutes hives began to subside and breathing became easier
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Paraesthesia oral, Pruritus, Urticaria
Clinical narrative: BREATHING DIFFICULTY; BLOOD PRESSURE HIGH; RED RASH; ITCHY FACE; SWALLOWING DIFFICULTY; HIVES; TINGLING LIPS; This spontaneous report received from a patient concerned a 29 year old white and non Hispanic or Latino female. The patient's weight, height, and medical history were not reported. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of administration not reported, batch number 043A 2/A, expiry date unknown) dose not reported, administered once on 03-APR-2021 into the right arm for prophylactic vaccination. On 03-APR-2021, the patient stated that she had been experienced side effects and had been to the emergency room 3 different times and wants to know if there was a way to help with the medical bills associated with her costs. The patient reported that about an hour after vaccination, she had hives, red rash, an itchy face and tingling lips. It was reported that 24 hours later, she started having trouble breathing and swallowing (onset dates also reported as 03-APR-2021). After that, she was put on a high (unspecified) dose of prednisone which then aggravated her blood pressure too highly, requiring her to visit the emergency room again and reported that she was 'still dealing with heart and blood pressure issues'. The patient also reported that she would be visiting her doctor to determine what to do with her health. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcome of the events of blood pressure high, hives, red rash, itchy face, breathing difficulty, swallowing difficulty was reported as unknown and the outcome of tingling lips was not reported (entered as unknown). This report was serious (other medically important condition).; Sender's Comments: v0 This spontaneous report concerns a 29-year-old female patient who experienced hives, red rash, an itchy face and tingling lips in about an hour after the Janssen COVID-19 Vaccine Ad26.COV2 had been administered. It was reported that 24 hours later, she started having trouble breathing and swallowing she was put on a high dose of prednisone which then aggravated her blood pressure. Given the close temporal relationship and the nature of the events, the event of hives, red rash, an itchy face, tingling lips, trouble breathing and swallowing are considered possibly related to the vaccination. The causality for the aggravated her blood pressure is assessed not related to the vaccination and attributable to the use of prednisone.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Hypertension, Paraesthesia oral, Pruritus
Clinical narrative: BREATHING DIFFICULTY; BLOOD PRESSURE HIGH; RED RASH; ITCHY FACE; SWALLOWING DIFFICULTY; HIVES; TINGLING LIPS; This spontaneous report received from a patient concerned a 29 year old white and non Hispanic or Latino female. The patient's weight, height, and medical history were not reported. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of administration not reported, batch number 043A 2/A, expiry date unknown) dose not reported, administered once on 03-APR-2021 into the right arm for prophylactic vaccination. On 03-APR-2021, the patient stated that she had been experienced side effects and had been to the emergency room 3 different times and wants to know if there was a way to help with the medical bills associated with her costs. The patient reported that about an hour after vaccination, she had hives, red rash, an itchy face and tingling lips. It was reported that 24 hours later, she started having trouble breathing and swallowing (onset dates also reported as 03-APR-2021). After that, she was put on a high (unspecified) dose of prednisone which then aggravated her blood pressure too highly, requiring her to visit the emergency room again and reported that she was 'still dealing with heart and blood pressure issues'. The patient also reported that she would be visiting her doctor to determine what to do with her health. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcome of the events of blood pressure high, hives, red rash, itchy face, breathing difficulty, swallowing difficulty was reported as unknown and the outcome of tingling lips was not reported (entered as unknown). This report was serious (other medically important condition).; Sender's Comments: v0 This spontaneous report concerns a 29-year-old female patient who experienced hives, red rash, an itchy face and tingling lips in about an hour after the Janssen COVID-19 Vaccine Ad26.COV2 had been administered. It was reported that 24 hours later, she started having trouble breathing and swallowing she was put on a high dose of prednisone which then aggravated her blood pressure. Given the close temporal relationship and the nature of the events, the event of hives, red rash, an itchy face, tingling lips, trouble breathing and swallowing are considered possibly related to the vaccination. The causality for the aggravated her blood pressure is assessed not related to the vaccination and attributable to the use of prednisone.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Urticaria
Clinical narrative: BREATHING DIFFICULTY; BLOOD PRESSURE HIGH; RED RASH; ITCHY FACE; SWALLOWING DIFFICULTY; HIVES; TINGLING LIPS; This spontaneous report received from a patient concerned a 29 year old white and non Hispanic or Latino female. The patient's weight, height, and medical history were not reported. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of administration not reported, batch number 043A 2/A, expiry date unknown) dose not reported, administered once on 03-APR-2021 into the right arm for prophylactic vaccination. On 03-APR-2021, the patient stated that she had been experienced side effects and had been to the emergency room 3 different times and wants to know if there was a way to help with the medical bills associated with her costs. The patient reported that about an hour after vaccination, she had hives, red rash, an itchy face and tingling lips. It was reported that 24 hours later, she started having trouble breathing and swallowing (onset dates also reported as 03-APR-2021). After that, she was put on a high (unspecified) dose of prednisone which then aggravated her blood pressure too highly, requiring her to visit the emergency room again and reported that she was 'still dealing with heart and blood pressure issues'. The patient also reported that she would be visiting her doctor to determine what to do with her health. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcome of the events of blood pressure high, hives, red rash, itchy face, breathing difficulty, swallowing difficulty was reported as unknown and the outcome of tingling lips was not reported (entered as unknown). This report was serious (other medically important condition).; Sender's Comments: v0 This spontaneous report concerns a 29-year-old female patient who experienced hives, red rash, an itchy face and tingling lips in about an hour after the Janssen COVID-19 Vaccine Ad26.COV2 had been administered. It was reported that 24 hours later, she started having trouble breathing and swallowing she was put on a high dose of prednisone which then aggravated her blood pressure. Given the close temporal relationship and the nature of the events, the event of hives, red rash, an itchy face, tingling lips, trouble breathing and swallowing are considered possibly related to the vaccination. The causality for the aggravated her blood pressure is assessed not related to the vaccination and attributable to the use of prednisone.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Rash, Rash erythematous, Swelling
Clinical narrative: vertical linear induration of lateral left breast without erythema  occurred 2 wks after vaccination and after significant axillary adenopathy had resolved.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast induration, Lymphadenopathy
Clinical narrative: vertical linear induration of lateral left breast without erythema  occurred 2 wks after vaccination and after significant axillary adenopathy had resolved.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Heart rate increased, Paraesthesia
Clinical narrative: WIthin one minute I had difficulty breathing, heart racing,  pins and needles in my fingers, hands, arms up into my neck and in my face.  I felt faint like I would pass out.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Loss of consciousness, Palpitations, Paraesthesia
Clinical narrative: WIthin one minute I had difficulty breathing, heart racing,  pins and needles in my fingers, hands, arms up into my neck and in my face.  I felt faint like I would pass out.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Chest discomfort, Dizziness, Dysphagia, Dysphonia
Clinical narrative: Patient felt tightness in her throat and chest after vaccine. Evaluated by EMS. BP 142/98, O2 St 95%, pulse 72.  BP 162/74, O2 sat 98%, pulse 88. 50mg of Benadryl administered PO. Ambulance transport to Hospital for evaluation.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Heart rate increased, Nausea, Throat tightness
Clinical narrative: Patient felt tightness in her throat and chest after vaccine. Evaluated by EMS. BP 142/98, O2 St 95%, pulse 72.  BP 162/74, O2 sat 98%, pulse 88. 50mg of Benadryl administered PO. Ambulance transport to Hospital for evaluation.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Throat tightness
Clinical narrative: Patient felt tightness in her throat and chest after vaccine. Evaluated by EMS. BP 142/98, O2 St 95%, pulse 72.  BP 162/74, O2 sat 98%, pulse 88. 50mg of Benadryl administered PO. Ambulance transport to Hospital for evaluation.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac imaging procedure, Dizziness, Hemiparesis, Imaging procedure, Loss of consciousness
Clinical narrative: Client received Jansen Covid Vaccine on the Left arm and immediately started to feel "weak and lightheaded" client looked pale and sweaty. Position client laying on a cot and elevated her legs. Her BP was 113/75, client is responding appropriately to questions and indicates that is starting to feel better.  5 to 10 minutes later, client indicates that she her Left arm is "numb and tingling" as we are asking her to describe her symptoms she is starting to slurred her words and she said that she can not feel her left side. 911 has been called and on-site paramedics are evaluating the client. Engine on site and transported client to the hospital.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary imaging procedure
Clinical narrative: Client received Jansen Covid Vaccine on the Left arm and immediately started to feel "weak and lightheaded" client looked pale and sweaty. Position client laying on a cot and elevated her legs. Her BP was 113/75, client is responding appropriately to questions and indicates that is starting to feel better.  5 to 10 minutes later, client indicates that she her Left arm is "numb and tingling" as we are asking her to describe her symptoms she is starting to slurred her words and she said that she can not feel her left side. 911 has been called and on-site paramedics are evaluating the client. Engine on site and transported client to the hospital.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Blood glucose, Dizziness, Dysarthria, Electrocardiogram
Clinical narrative: Client received Jansen Covid Vaccine on the Left arm and immediately started to feel "weak and lightheaded" client looked pale and sweaty. Position client laying on a cot and elevated her legs. Her BP was 113/75, client is responding appropriately to questions and indicates that is starting to feel better.  5 to 10 minutes later, client indicates that she her Left arm is "numb and tingling" as we are asking her to describe her symptoms she is starting to slurred her words and she said that she can not feel her left side. 911 has been called and on-site paramedics are evaluating the client. Engine on site and transported client to the hospital.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Pallor, Paraesthesia
Clinical narrative: Client received Jansen Covid Vaccine on the Left arm and immediately started to feel "weak and lightheaded" client looked pale and sweaty. Position client laying on a cot and elevated her legs. Her BP was 113/75, client is responding appropriately to questions and indicates that is starting to feel better.  5 to 10 minutes later, client indicates that she her Left arm is "numb and tingling" as we are asking her to describe her symptoms she is starting to slurred her words and she said that she can not feel her left side. 911 has been called and on-site paramedics are evaluating the client. Engine on site and transported client to the hospital.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Mobility decreased, Paraesthesia
Clinical narrative: Client received Jansen Covid Vaccine on the Left arm and immediately started to feel "weak and lightheaded" client looked pale and sweaty. Position client laying on a cot and elevated her legs. Her BP was 113/75, client is responding appropriately to questions and indicates that is starting to feel better.  5 to 10 minutes later, client indicates that she her Left arm is "numb and tingling" as we are asking her to describe her symptoms she is starting to slurred her words and she said that she can not feel her left side. 911 has been called and on-site paramedics are evaluating the client. Engine on site and transported client to the hospital.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cranial nerve disorder, Eye pain, Ophthalmological examination, Vision blurred
Clinical narrative: Woke up the following morning and had a bad headache, right eye can?t move as far as normal, double & blurry vision. Started 4-6 and continues today 4-23. She saw neurologists, ophthalmologists and primary care. She was also admitted to  clinic 4-9 until 4-12.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Diplopia, Eye movement disorder, Headache, Magnetic resonance imaging
Clinical narrative: Woke up the following morning and had a bad headache, right eye can?t move as far as normal, double & blurry vision. Started 4-6 and continues today 4-23. She saw neurologists, ophthalmologists and primary care. She was also admitted to  clinic 4-9 until 4-12.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scan with contrast, Venogram, Vision blurred
Clinical narrative: Woke up the following morning and had a bad headache, right eye can?t move as far as normal, double & blurry vision. Started 4-6 and continues today 4-23. She saw neurologists, ophthalmologists and primary care. She was also admitted to  clinic 4-9 until 4-12.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dyspnoea, Hyperhidrosis, Tremor
Clinical narrative: Got vaccine at 7:30 PM.  On 4/6/2021 woke up at 2:20 AM with RIGORS.  No fever.  Difficulty walking.  Wheezing and trouble breathing.  In ER initial pulsox was 88% but reduced to 42% and difficult to obtain BP.  Given oxygen, epinephrine, magnesium, steroids and albuterol.  Discharged but continues with coughing and wheezing.