chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Patient fainted / 3 episodes of fainting attack; Feeling bad; Headache; High fever; Vomiting episodes; slept for more than 3 hours after the fainting attack; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Patient fainted / 3 episodes of fainting attack) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 57A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced SYNCOPE (Patient fainted / 3 episodes of fainting attack) (seriousness criterion medically significant), FEELING ABNORMAL (Feeling bad), HEADACHE (Headache), PYREXIA (High fever), VOMITING (Vomiting episodes) and HYPERSOMNIA (slept for more than 3 hours after the fainting attack). At the time of the report, SYNCOPE (Patient fainted / 3 episodes of fainting attack), FEELING ABNORMAL (Feeling bad), HEADACHE (Headache), PYREXIA (High fever), VOMITING (Vomiting episodes) and HYPERSOMNIA (slept for more than 3 hours after the fainting attack) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-073768 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-073768:linked case
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Cranial nerve disorder, Diplopia, Gait disturbance, Paralysis
Clinical narrative: CVA isolated; Diplopia (left eye); Left with a palsy; Inability to walk confidently; Left cranial nerves VI, and III show deficit's; Cannot see out of left eye; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (CVA isolated), DIPLOPIA (Diplopia (left eye)), PARALYSIS (Left with a palsy), GAIT DISTURBANCE (Inability to walk confidently), CRANIAL NERVE DISORDER (Left cranial nerves VI, and III show deficit's) and VISUAL IMPAIRMENT (Cannot see out of left eye) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     Concurrent medical conditions included Obesity (BMI 45-45.9).    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (CVA isolated) (seriousness criteria hospitalization, disability, medically significant and life threatening) and DIPLOPIA (Diplopia (left eye)) (seriousness criteria hospitalization, disability and medically significant). On 12-Apr-2021, the patient experienced PARALYSIS (Left with a palsy) (seriousness criteria disability and medically significant), GAIT DISTURBANCE (Inability to walk confidently) (seriousness criteria disability and medically significant), CRANIAL NERVE DISORDER (Left cranial nerves VI, and III show deficit's) (seriousness criteria disability and medically significant) and VISUAL IMPAIRMENT (Cannot see out of left eye) (seriousness criteria disability and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (CVA isolated), DIPLOPIA (Diplopia (left eye)), PARALYSIS (Left with a palsy), GAIT DISTURBANCE (Inability to walk confidently), CRANIAL NERVE DISORDER (Left cranial nerves VI, and III show deficit's) and VISUAL IMPAIRMENT (Cannot see out of left eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The Patient was Treated with  Lovenox, Coumadin, Brimonidine eye drops.The patient has been taking High Blood Pressure Medication,Severe Obesity medications and Hyperlipidemic Medications.The patient has no known Allergies.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: CVA isolated; Diplopia (left eye); Left with a palsy; Inability to walk confidently; Left cranial nerves VI, and III show deficit's; Cannot see out of left eye; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (CVA isolated), DIPLOPIA (Diplopia (left eye)), PARALYSIS (Left with a palsy), GAIT DISTURBANCE (Inability to walk confidently), CRANIAL NERVE DISORDER (Left cranial nerves VI, and III show deficit's) and VISUAL IMPAIRMENT (Cannot see out of left eye) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     Concurrent medical conditions included Obesity (BMI 45-45.9).    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (CVA isolated) (seriousness criteria hospitalization, disability, medically significant and life threatening) and DIPLOPIA (Diplopia (left eye)) (seriousness criteria hospitalization, disability and medically significant). On 12-Apr-2021, the patient experienced PARALYSIS (Left with a palsy) (seriousness criteria disability and medically significant), GAIT DISTURBANCE (Inability to walk confidently) (seriousness criteria disability and medically significant), CRANIAL NERVE DISORDER (Left cranial nerves VI, and III show deficit's) (seriousness criteria disability and medically significant) and VISUAL IMPAIRMENT (Cannot see out of left eye) (seriousness criteria disability and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (CVA isolated), DIPLOPIA (Diplopia (left eye)), PARALYSIS (Left with a palsy), GAIT DISTURBANCE (Inability to walk confidently), CRANIAL NERVE DISORDER (Left cranial nerves VI, and III show deficit's) and VISUAL IMPAIRMENT (Cannot see out of left eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The Patient was Treated with  Lovenox, Coumadin, Brimonidine eye drops.The patient has been taking High Blood Pressure Medication,Severe Obesity medications and Hyperlipidemic Medications.The patient has no known Allergies.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Excessive eye blinking, Eye movement disorder, Hypoaesthesia
Clinical narrative: TIA; Lips numb; Face numb; Eyes spinning; Right eye winking; Feeling Cloudy vision; Dizziness; CHILLS; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA), HYPOAESTHESIA ORAL (Lips numb), HYPOAESTHESIA (Face numb), EYE MOVEMENT DISORDER (Eyes spinning), EXCESSIVE EYE BLINKING (Right eye winking), VISION BLURRED (Feeling Cloudy vision) and DIZZINESS (Dizziness) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced CHILLS (CHILLS). On 19-Mar-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA) (seriousness criterion hospitalization), HYPOAESTHESIA ORAL (Lips numb) (seriousness criterion hospitalization), HYPOAESTHESIA (Face numb) (seriousness criterion hospitalization), EYE MOVEMENT DISORDER (Eyes spinning) (seriousness criterion hospitalization), EXCESSIVE EYE BLINKING (Right eye winking) (seriousness criterion hospitalization), VISION BLURRED (Feeling Cloudy vision) (seriousness criterion hospitalization) and DIZZINESS (Dizziness) (seriousness criterion hospitalization). The patient was hospitalized from 19-Mar-2021 to 21-Mar-2021 due to DIZZINESS, EXCESSIVE EYE BLINKING, EYE MOVEMENT DISORDER, HYPOAESTHESIA, HYPOAESTHESIA ORAL, TRANSIENT ISCHAEMIC ATTACK and VISION BLURRED. On 21-Mar-2021, TRANSIENT ISCHAEMIC ATTACK (TIA), HYPOAESTHESIA ORAL (Lips numb), HYPOAESTHESIA (Face numb), EYE MOVEMENT DISORDER (Eyes spinning), EXCESSIVE EYE BLINKING (Right eye winking), VISION BLURRED (Feeling Cloudy vision) and DIZZINESS (Dizziness) had resolved. At the time of the report, CHILLS (CHILLS) had resolved.            CT scan of the head was done and MRI. Patient said he was discharged on Sunday, March-21st. He said his symptoms were gone after that and he was given baby aspirin.  The action taken of all the events with the suspect drug Moderna COVID-19 Vaccine was not applicable. The causality of all events was not provided.; Sender'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. However, patient's medical history and concomitant medications are necessary for assessment. Further information has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Transient ischaemic attack, Vision blurred
Clinical narrative: TIA; Lips numb; Face numb; Eyes spinning; Right eye winking; Feeling Cloudy vision; Dizziness; CHILLS; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA), HYPOAESTHESIA ORAL (Lips numb), HYPOAESTHESIA (Face numb), EYE MOVEMENT DISORDER (Eyes spinning), EXCESSIVE EYE BLINKING (Right eye winking), VISION BLURRED (Feeling Cloudy vision) and DIZZINESS (Dizziness) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced CHILLS (CHILLS). On 19-Mar-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA) (seriousness criterion hospitalization), HYPOAESTHESIA ORAL (Lips numb) (seriousness criterion hospitalization), HYPOAESTHESIA (Face numb) (seriousness criterion hospitalization), EYE MOVEMENT DISORDER (Eyes spinning) (seriousness criterion hospitalization), EXCESSIVE EYE BLINKING (Right eye winking) (seriousness criterion hospitalization), VISION BLURRED (Feeling Cloudy vision) (seriousness criterion hospitalization) and DIZZINESS (Dizziness) (seriousness criterion hospitalization). The patient was hospitalized from 19-Mar-2021 to 21-Mar-2021 due to DIZZINESS, EXCESSIVE EYE BLINKING, EYE MOVEMENT DISORDER, HYPOAESTHESIA, HYPOAESTHESIA ORAL, TRANSIENT ISCHAEMIC ATTACK and VISION BLURRED. On 21-Mar-2021, TRANSIENT ISCHAEMIC ATTACK (TIA), HYPOAESTHESIA ORAL (Lips numb), HYPOAESTHESIA (Face numb), EYE MOVEMENT DISORDER (Eyes spinning), EXCESSIVE EYE BLINKING (Right eye winking), VISION BLURRED (Feeling Cloudy vision) and DIZZINESS (Dizziness) had resolved. At the time of the report, CHILLS (CHILLS) had resolved.            CT scan of the head was done and MRI. Patient said he was discharged on Sunday, March-21st. He said his symptoms were gone after that and he was given baby aspirin.  The action taken of all the events with the suspect drug Moderna COVID-19 Vaccine was not applicable. The causality of all events was not provided.; Sender'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. However, patient's medical history and concomitant medications are necessary for assessment. Further information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis
Clinical narrative: Multiple Sclerosis exacerbation; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS RELAPSE (Multiple Sclerosis exacerbation) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Headache, Optic neuritis, Pain and Depression. Concurrent medical conditions included Hypertension, Malignant hyperthermia and Multiple sclerosis relapse. Concomitant products included METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL), LORATADINE (LORATAB), METOPROLOL, ZOLPIDEM, MEMANTINE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) and VENLAFAXINE HCL for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS RELAPSE (Multiple Sclerosis exacerbation) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS RELAPSE (Multiple Sclerosis exacerbation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact; Sender'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: M
Vaccine: COVID19
Symptoms: Blister, Blood culture, Computerised tomogram head, Diarrhoea, Dyspnoea
Clinical narrative: Chickenpox; sick; Shortness of breath; Fever over 102; Hives; Swollen lymph nodes at the back of neck upto head; Fever; Headache; Bad rash all over the body; Blisters; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VARICELLA (Chickenpox) and ILLNESS (sick) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Historical condition not reported.).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache), RASH (Bad rash all over the body), BLISTER (Blisters), DIARRHOEA (Diarrhea), PYREXIA (Fever over 102), URTICARIA (Hives) and LYMPHADENOPATHY (Swollen lymph nodes at the back of neck upto head). On 13-Apr-2021, the patient experienced DYSPNOEA (Shortness of breath). On an unknown date, the patient experienced VARICELLA (Chickenpox) (seriousness criterion hospitalization) and ILLNESS (sick) (seriousness criterion hospitalization). At the time of the report, VARICELLA (Chickenpox), ILLNESS (sick), PYREXIA (Fever), HEADACHE (Headache), RASH (Bad rash all over the body), BLISTER (Blisters), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), PYREXIA (Fever over 102), URTICARIA (Hives) and LYMPHADENOPATHY (Swollen lymph nodes at the back of neck upto head) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood culture: unknown (Inconclusive) unknown. On an unknown date, Computerised tomogram head: unkown (Inconclusive) unknown. On an unknown date, Lumbar puncture: unknown (Inconclusive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 16 Apr 2021: follow up information included consumer being transported to the emergency room (ER).  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   This case was linked to MOD21-075845 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: No specific follow-up information recorded. On 14-Apr-2021: Event - Blisters added. On 16-Apr-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded MOD21-075845:FU
Sex: M
Vaccine: COVID19
Symptoms: Headache, Illness, Lumbar puncture, Lymphadenopathy, Pyrexia
Clinical narrative: Chickenpox; sick; Shortness of breath; Fever over 102; Hives; Swollen lymph nodes at the back of neck upto head; Fever; Headache; Bad rash all over the body; Blisters; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VARICELLA (Chickenpox) and ILLNESS (sick) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Historical condition not reported.).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache), RASH (Bad rash all over the body), BLISTER (Blisters), DIARRHOEA (Diarrhea), PYREXIA (Fever over 102), URTICARIA (Hives) and LYMPHADENOPATHY (Swollen lymph nodes at the back of neck upto head). On 13-Apr-2021, the patient experienced DYSPNOEA (Shortness of breath). On an unknown date, the patient experienced VARICELLA (Chickenpox) (seriousness criterion hospitalization) and ILLNESS (sick) (seriousness criterion hospitalization). At the time of the report, VARICELLA (Chickenpox), ILLNESS (sick), PYREXIA (Fever), HEADACHE (Headache), RASH (Bad rash all over the body), BLISTER (Blisters), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), PYREXIA (Fever over 102), URTICARIA (Hives) and LYMPHADENOPATHY (Swollen lymph nodes at the back of neck upto head) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood culture: unknown (Inconclusive) unknown. On an unknown date, Computerised tomogram head: unkown (Inconclusive) unknown. On an unknown date, Lumbar puncture: unknown (Inconclusive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 16 Apr 2021: follow up information included consumer being transported to the emergency room (ER).  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   This case was linked to MOD21-075845 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: No specific follow-up information recorded. On 14-Apr-2021: Event - Blisters added. On 16-Apr-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded MOD21-075845:FU
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria, Varicella
Clinical narrative: Chickenpox; sick; Shortness of breath; Fever over 102; Hives; Swollen lymph nodes at the back of neck upto head; Fever; Headache; Bad rash all over the body; Blisters; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VARICELLA (Chickenpox) and ILLNESS (sick) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Historical condition not reported.).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache), RASH (Bad rash all over the body), BLISTER (Blisters), DIARRHOEA (Diarrhea), PYREXIA (Fever over 102), URTICARIA (Hives) and LYMPHADENOPATHY (Swollen lymph nodes at the back of neck upto head). On 13-Apr-2021, the patient experienced DYSPNOEA (Shortness of breath). On an unknown date, the patient experienced VARICELLA (Chickenpox) (seriousness criterion hospitalization) and ILLNESS (sick) (seriousness criterion hospitalization). At the time of the report, VARICELLA (Chickenpox), ILLNESS (sick), PYREXIA (Fever), HEADACHE (Headache), RASH (Bad rash all over the body), BLISTER (Blisters), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), PYREXIA (Fever over 102), URTICARIA (Hives) and LYMPHADENOPATHY (Swollen lymph nodes at the back of neck upto head) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood culture: unknown (Inconclusive) unknown. On an unknown date, Computerised tomogram head: unkown (Inconclusive) unknown. On an unknown date, Lumbar puncture: unknown (Inconclusive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 16 Apr 2021: follow up information included consumer being transported to the emergency room (ER).  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   This case was linked to MOD21-075845 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: No specific follow-up information recorded. On 14-Apr-2021: Event - Blisters added. On 16-Apr-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded MOD21-075845:FU
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: Angioedema; This literature-non-study case was reported in a literature article and describes the occurrence of ANGIOEDEMA (Angioedema) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Polyethylene Glycol and Polysorbate Skin Testing in the Evaluation of COVID-19 Vaccine Reactions: Early Report. Annals of Allergy, Asthma & Immunology. 2021     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant). At the time of the report, ANGIOEDEMA (Angioedema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included steroids and antihistamines  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.  Critical details to include patient's medical history, mRNA-1273 administration date and onset date of the event is lacking.  No further information is expected.   This case was linked to MOD-2021-075562, MOD-2021-075577 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.  Critical details to include patient's medical history, mRNA-1273 administration date and onset date of the event is lacking.  No further information is expected. MOD-2021-075562:Same Literature Article MOD-2021-075577:Same Literature Article
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Throat irritation, Wheezing
Clinical narrative: Angioedema; wheezing; throat pruritis; This literature-non-study case was reported in a literature article and describes the occurrence of ANGIOEDEMA (Angioedema) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE:  Polyethylene Glycol and Polysorbate Skin Testing in the Evaluation of COVID-19 Vaccine Reactions. Annals of allergy, asthma & immunology. 2021     Concurrent medical conditions included Allergic rhinitis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), WHEEZING (wheezing) and THROAT IRRITATION (throat pruritis). At the time of the report, ANGIOEDEMA (Angioedema), WHEEZING (wheezing) and THROAT IRRITATION (throat pruritis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included antihistamines and steroids. Lab test included a skin test and the result was negative. The vaccine outcome was minor lip/tongue tingling. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   This case was linked to MOD-2021-075534 (E2B Linked Report). This case was linked to MOD-2021-075577 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded MOD-2021-075534:Same Literature Article
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Computerised tomogram, Pleuritic pain, Pulmonary embolism
Clinical narrative: CT with contrast emergently done this Sunday 11Apr2021 revealing Mid right lobe pulmonary; Experienced pleural pain; chest "Feels like a broken limb; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (CT with contrast emergently done this Sunday 11Apr2021 revealing Mid right lobe pulmonary) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Stenosis (cervical spine stenosis), Carcinoma (on face) and Vomiting (Vomited every other day for 2 weeks straight after 1st dose. ). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Prophylactic.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced PULMONARY EMBOLISM (CT with contrast emergently done this Sunday 11Apr2021 revealing Mid right lobe pulmonary) (seriousness criterion medically significant), PLEURITIC PAIN (Experienced pleural pain) and CHEST DISCOMFORT (chest "Feels like a broken limb). At the time of the report, PULMONARY EMBOLISM (CT with contrast emergently done this Sunday 11Apr2021 revealing Mid right lobe pulmonary), PLEURITIC PAIN (Experienced pleural pain) and CHEST DISCOMFORT (chest "Feels like a broken limb) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Computerised tomogram: unknown (Inconclusive) ct scan with contrast revealed Mid right lobe pulmonary embolism.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included as heavy thrombolytics.  Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-075787 (E2B Linked Report).; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-075787:Case for first dose
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cold sweat, Feeling hot, Loss of consciousness
Clinical narrative: She also passed out going to the bathroom twice.; Felt hot; Clammy; Feels very weak; Pain in left arm,; Difficulty moving left arm; Fever; chills; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (She also passed out going to the bathroom twice.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (She also passed out going to the bathroom twice.) (seriousness criterion medically significant), FEELING HOT (Felt hot), COLD SWEAT (Clammy), ASTHENIA (Feels very weak), PAIN IN EXTREMITY (Pain in left arm,), MOBILITY DECREASED (Difficulty moving left arm), PYREXIA (Fever), CHILLS (chills) and NAUSEA (Nauseous). At the time of the report, LOSS OF CONSCIOUSNESS (She also passed out going to the bathroom twice.), FEELING HOT (Felt hot), COLD SWEAT (Clammy), ASTHENIA (Feels very weak), PAIN IN EXTREMITY (Pain in left arm,), MOBILITY DECREASED (Difficulty moving left arm), PYREXIA (Fever), CHILLS (chills) and NAUSEA (Nauseous) outcome was unknown.            Treatment medication included acetaminophen.  Action taken with m-RNA1273 in response to events is consider as not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Nausea, Pain in extremity, Pyrexia
Clinical narrative: She also passed out going to the bathroom twice.; Felt hot; Clammy; Feels very weak; Pain in left arm,; Difficulty moving left arm; Fever; chills; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (She also passed out going to the bathroom twice.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (She also passed out going to the bathroom twice.) (seriousness criterion medically significant), FEELING HOT (Felt hot), COLD SWEAT (Clammy), ASTHENIA (Feels very weak), PAIN IN EXTREMITY (Pain in left arm,), MOBILITY DECREASED (Difficulty moving left arm), PYREXIA (Fever), CHILLS (chills) and NAUSEA (Nauseous). At the time of the report, LOSS OF CONSCIOUSNESS (She also passed out going to the bathroom twice.), FEELING HOT (Felt hot), COLD SWEAT (Clammy), ASTHENIA (Feels very weak), PAIN IN EXTREMITY (Pain in left arm,), MOBILITY DECREASED (Difficulty moving left arm), PYREXIA (Fever), CHILLS (chills) and NAUSEA (Nauseous) outcome was unknown.            Treatment medication included acetaminophen.  Action taken with m-RNA1273 in response to events is consider as not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: He had a lung infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (He had a lung infection) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (He had a lung infection) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (He had a lung infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was on immunotherapy.   Treatment for the event included amoxicillin as an antibiotic.  Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Haematuria, Haemorrhage urinary tract
Clinical narrative: Patient urinated blood clot in urine; Patient urinated blood in urine; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE URINARY TRACT (Patient urinated blood clot in urine) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lymphoma. Concomitant products included ACALABRUTINIB (CALQUENCE) for Lymphoma, CYANOCOBALAMIN (VITAMIN B-12), CALCIUM and FOLIC ACID for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 09-Apr-2021, the patient experienced HAEMORRHAGE URINARY TRACT (Patient urinated blood clot in urine) (seriousness criterion medically significant) and HAEMATURIA (Patient urinated blood in urine). On 10-Apr-2021, HAEMORRHAGE URINARY TRACT (Patient urinated blood clot in urine) and HAEMATURIA (Patient urinated blood in urine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient recovered (clarified as the patient's urine was clear and did not have blood clots) on 10 Apr 2021. Patient self treated by drinking lots and lots of fluids (not further clarified).  Company comment: Based on the current available information and the temporal association between the product use and the start sate of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start sate of the events a causal relationship cannot be excluded.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Intracranial aneurysm
Clinical narrative: brain aneurysm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INTRACRANIAL ANEURYSM (brain aneurysm) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced INTRACRANIAL ANEURYSM (brain aneurysm) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 09-Apr-2021 due to INTRACRANIAL ANEURYSM. At the time of the report, INTRACRANIAL ANEURYSM (brain aneurysm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment details not provided. The patient was scheduled to receive the second dose on 19 Apr 2021.  Company Comment  Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Impaired work ability, Rhabdomyolysis
Clinical narrative: Rhabdomyolysis; not able to work; Tiredness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHABDOMYOLYSIS (Rhabdomyolysis) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced RHABDOMYOLYSIS (Rhabdomyolysis) (seriousness criterion medically significant), IMPAIRED WORK ABILITY (not able to work) and FATIGUE (Tiredness). On 02-Apr-2021, RHABDOMYOLYSIS (Rhabdomyolysis) outcome was unknown, IMPAIRED WORK ABILITY (not able to work) had resolved. At the time of the report, FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood test: abnormal (abnormal) The result came and showed that he is diagnosed with Rhabdomyolysis..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.  The reporter mentioned that he as well as his doctor is not saying that it is because of the Moderna Vaccine. Since he never experienced this before and happened 2 days after the vaccination, his doctor suggested to report to Moderna. He mentioned that he's been dealing with this symptom for two weeks.  Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Dementia Alzheimer's type, Feeling abnormal, Headache, Influenza like illness
Clinical narrative: Like she has Alzheimers; flu like symptoms; "brain dead"/ "foggy brain"; feels like she has short memory loss - when she is in the middle of doing something, she forgets what she was doing; paranoia; normal arm and body aches; Alzheimer's, as forgetfullness; Arm was sore; Arm was sore; flat fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA ALZHEIMER'S TYPE (Like she has Alzheimers) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced DEMENTIA ALZHEIMER'S TYPE (Like she has Alzheimers) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL ("brain dead"/ "foggy brain"), AMNESIA (feels like she has short memory loss - when she is in the middle of doing something, she forgets what she was doing), PARANOIA (paranoia), PAIN (normal arm and body aches), MEMORY IMPAIRMENT (Alzheimer's, as forgetfullness), PAIN IN EXTREMITY (Arm was sore), VACCINATION SITE PAIN (Arm was sore), PYREXIA (flat fever) and HEADACHE (headache). On 06-Apr-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (normal arm and body aches), PAIN IN EXTREMITY (Arm was sore), VACCINATION SITE PAIN (Arm was sore), PYREXIA (flat fever) and HEADACHE (headache) had resolved. At the time of the report, DEMENTIA ALZHEIMER'S TYPE (Like she has Alzheimers), FEELING ABNORMAL ("brain dead"/ "foggy brain"), AMNESIA (feels like she has short memory loss - when she is in the middle of doing something, she forgets what she was doing), PARANOIA (paranoia) and MEMORY IMPAIRMENT (Alzheimer's, as forgetfullness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       A mother was reporting on behalf of her daughter. The patient's medical history, concomitant medications and treatment information was not reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Pain, Pain in extremity, Paranoia, Pyrexia
Clinical narrative: Like she has Alzheimers; flu like symptoms; "brain dead"/ "foggy brain"; feels like she has short memory loss - when she is in the middle of doing something, she forgets what she was doing; paranoia; normal arm and body aches; Alzheimer's, as forgetfullness; Arm was sore; Arm was sore; flat fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA ALZHEIMER'S TYPE (Like she has Alzheimers) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced DEMENTIA ALZHEIMER'S TYPE (Like she has Alzheimers) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL ("brain dead"/ "foggy brain"), AMNESIA (feels like she has short memory loss - when she is in the middle of doing something, she forgets what she was doing), PARANOIA (paranoia), PAIN (normal arm and body aches), MEMORY IMPAIRMENT (Alzheimer's, as forgetfullness), PAIN IN EXTREMITY (Arm was sore), VACCINATION SITE PAIN (Arm was sore), PYREXIA (flat fever) and HEADACHE (headache). On 06-Apr-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (normal arm and body aches), PAIN IN EXTREMITY (Arm was sore), VACCINATION SITE PAIN (Arm was sore), PYREXIA (flat fever) and HEADACHE (headache) had resolved. At the time of the report, DEMENTIA ALZHEIMER'S TYPE (Like she has Alzheimers), FEELING ABNORMAL ("brain dead"/ "foggy brain"), AMNESIA (feels like she has short memory loss - when she is in the middle of doing something, she forgets what she was doing), PARANOIA (paranoia) and MEMORY IMPAIRMENT (Alzheimer's, as forgetfullness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       A mother was reporting on behalf of her daughter. The patient's medical history, concomitant medications and treatment information was not reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.