chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Factor V Leiden mutation, Platelet count, Pulmonary embolism, Renal haemorrhage
Clinical narrative: DVT; PULMONARY EMBOLISM; KIDNEY BLEEDING; This spontaneous report was received from a physician, and concerned an adult male patient (greater than 50 years old).  Initial report was processed along with additional information received on 12-APR-2021. 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 was not reported) dose and site of vaccination were not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in 2021, the patient experienced deep vein thrombosis (DVT), pulmonary embolism (PE), and kidney bleeding. The patient was admitted to the hospital and was treated with heparin as well as an inferior vena cava (IVC) filter (put in after he experienced bleeding from his kidney). Laboratory data included: a negative COVID-19 virus test, and throughout hospitalization his platelet count (NR: not provided) was normal: 191,000 and 264,000 (units not provided). The patient's test came back positive for one copy of the Factor V Leiden mutation which predisposed him to blood clots. On 12-APR-2021, the patient was to start a trial to Lovenox (enoxaparin sodium); they will assure there is no bleeding, prior to discharge. At the time of this report, the patient was still hospitalized but doing well.  Action taken with Covid-19 vaccine AD26.Cov2.S was not applicable. The patient was recovering from DVT, pulmonary embolism, and kidney bleeding. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: v0 An adult (greater than 50 years old) male patient with a past medical history remarkable for the Factor V Leiden mutation experienced deep vein thrombosis, pulmonary embolism, and kidney bleeding on an unspecified date after receiving Janssen COVID-19 Vaccine Ad26.COV2.S.  The patient was admitted to the hospital and was treated with heparin as well as an inferior vena cava (IVC) filter (put in after he experienced bleeding from his kidney). The patient had a negative COVID-19 virus test, and throughout hospitalization his platelet count was normal: 191,000 and 264,000 (units not provided). The Factor V Leiden mutation is known to predispose patients to venous thrombosis, therefore the causality for deep vein thrombosis, pulmonary embolism as well a consequent kidney bleeding most likely due to heparin treatment is assessed not related to the vaccination.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: DVT; PULMONARY EMBOLISM; KIDNEY BLEEDING; This spontaneous report was received from a physician, and concerned an adult male patient (greater than 50 years old).  Initial report was processed along with additional information received on 12-APR-2021. 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 was not reported) dose and site of vaccination were not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in 2021, the patient experienced deep vein thrombosis (DVT), pulmonary embolism (PE), and kidney bleeding. The patient was admitted to the hospital and was treated with heparin as well as an inferior vena cava (IVC) filter (put in after he experienced bleeding from his kidney). Laboratory data included: a negative COVID-19 virus test, and throughout hospitalization his platelet count (NR: not provided) was normal: 191,000 and 264,000 (units not provided). The patient's test came back positive for one copy of the Factor V Leiden mutation which predisposed him to blood clots. On 12-APR-2021, the patient was to start a trial to Lovenox (enoxaparin sodium); they will assure there is no bleeding, prior to discharge. At the time of this report, the patient was still hospitalized but doing well.  Action taken with Covid-19 vaccine AD26.Cov2.S was not applicable. The patient was recovering from DVT, pulmonary embolism, and kidney bleeding. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: v0 An adult (greater than 50 years old) male patient with a past medical history remarkable for the Factor V Leiden mutation experienced deep vein thrombosis, pulmonary embolism, and kidney bleeding on an unspecified date after receiving Janssen COVID-19 Vaccine Ad26.COV2.S.  The patient was admitted to the hospital and was treated with heparin as well as an inferior vena cava (IVC) filter (put in after he experienced bleeding from his kidney). The patient had a negative COVID-19 virus test, and throughout hospitalization his platelet count was normal: 191,000 and 264,000 (units not provided). The Factor V Leiden mutation is known to predispose patients to venous thrombosis, therefore the causality for deep vein thrombosis, pulmonary embolism as well a consequent kidney bleeding most likely due to heparin treatment is assessed not related to the vaccination.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Bell's palsy, Chills, Erythema, Hot flush
Clinical narrative: left arm started to hurt pretty bad; patient felt flushed and hot; skin was red; shivering and shaking on left side of their body; left side numb, kind of Bells Palsy syndrome; feel cold in their shoulder; cold behind left eye then from wrist to behind both eyes; left side of the body was swollen, like swollen pecks, back and chest, like they had been stung; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (left side numb, kind of Bells Palsy syndrome) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) 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 event).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PERIPHERAL COLDNESS (feel cold in their shoulder), ABNORMAL SENSATION IN EYE (cold behind left eye then from wrist to behind both eyes) and SWELLING (left side of the body was swollen, like swollen pecks, back and chest, like they had been stung). On 09-Jan-2021, the patient experienced FACIAL PARALYSIS (left side numb, kind of Bells Palsy syndrome) (seriousness criterion medically significant) and CHILLS (shivering and shaking on left side of their body). On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (left arm started to hurt pretty bad), HOT FLUSH (patient felt flushed and hot) and ERYTHEMA (skin was red). At the time of the report, FACIAL PARALYSIS (left side numb, kind of Bells Palsy syndrome), PERIPHERAL COLDNESS (feel cold in their shoulder), ABNORMAL SENSATION IN EYE (cold behind left eye then from wrist to behind both eyes), PAIN IN EXTREMITY (left arm started to hurt pretty bad), SWELLING (left side of the body was swollen, like swollen pecks, back and chest, like they had been stung), CHILLS (shivering and shaking on left side of their body), HOT FLUSH (patient felt flushed and hot) and ERYTHEMA (skin was red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Reporter'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. Further information has been requested.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral coldness, Swelling
Clinical narrative: left arm started to hurt pretty bad; patient felt flushed and hot; skin was red; shivering and shaking on left side of their body; left side numb, kind of Bells Palsy syndrome; feel cold in their shoulder; cold behind left eye then from wrist to behind both eyes; left side of the body was swollen, like swollen pecks, back and chest, like they had been stung; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (left side numb, kind of Bells Palsy syndrome) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) 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 event).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PERIPHERAL COLDNESS (feel cold in their shoulder), ABNORMAL SENSATION IN EYE (cold behind left eye then from wrist to behind both eyes) and SWELLING (left side of the body was swollen, like swollen pecks, back and chest, like they had been stung). On 09-Jan-2021, the patient experienced FACIAL PARALYSIS (left side numb, kind of Bells Palsy syndrome) (seriousness criterion medically significant) and CHILLS (shivering and shaking on left side of their body). On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (left arm started to hurt pretty bad), HOT FLUSH (patient felt flushed and hot) and ERYTHEMA (skin was red). At the time of the report, FACIAL PARALYSIS (left side numb, kind of Bells Palsy syndrome), PERIPHERAL COLDNESS (feel cold in their shoulder), ABNORMAL SENSATION IN EYE (cold behind left eye then from wrist to behind both eyes), PAIN IN EXTREMITY (left arm started to hurt pretty bad), SWELLING (left side of the body was swollen, like swollen pecks, back and chest, like they had been stung), CHILLS (shivering and shaking on left side of their body), HOT FLUSH (patient felt flushed and hot) and ERYTHEMA (skin was red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Reporter'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. Further information has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cystitis, Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: bladder infection; Not feeling good in general; Chills; muscle aches and pain; low fever; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS (bladder infection) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bladder cancer.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced FEELING ABNORMAL (Not feeling good in general), CHILLS (Chills), MYALGIA (muscle aches and pain) and PYREXIA (low fever). On 12-Jan-2021, the patient experienced CYSTITIS (bladder infection) (seriousness criterion medically significant). At the time of the report, CYSTITIS (bladder infection), FEELING ABNORMAL (Not feeling good in general), CHILLS (Chills), MYALGIA (muscle aches and pain) and PYREXIA (low fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter'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. Further information has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: bladder infection; Not feeling good in general; Chills; muscle aches and pain; low fever; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS (bladder infection) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bladder cancer.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced FEELING ABNORMAL (Not feeling good in general), CHILLS (Chills), MYALGIA (muscle aches and pain) and PYREXIA (low fever). On 12-Jan-2021, the patient experienced CYSTITIS (bladder infection) (seriousness criterion medically significant). At the time of the report, CYSTITIS (bladder infection), FEELING ABNORMAL (Not feeling good in general), CHILLS (Chills), MYALGIA (muscle aches and pain) and PYREXIA (low fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter'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. Further information has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Rash
Clinical narrative: Redness; Blistered arm; Rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), BLISTER (Blistered arm) and RASH (Rash) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced ERYTHEMA (Redness) (seriousness criterion medically significant), BLISTER (Blistered arm) (seriousness criterion medically significant) and RASH (Rash) (seriousness criterion medically significant). At the time of the report, ERYTHEMA (Redness), BLISTER (Blistered arm) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; Sender's Comments: This case concerns a 77-year-old female with medically significant and serious unexpected events of blistered arm, rash, and erythema. Event onset the same day as first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Atrial fibrillation, Chest discomfort, Dizziness, Extrasystoles
Clinical narrative: is not in rythm (think it's in A-FIB); Skipping of beats; the chest moved not in the right way; could not walk; dizzy; Every joint was aching, ankles, knees, finger, hips, it keep hurting al night long; headache; nausea but did not throw up; have never ache and hurt as bad as they started hurting; sick; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (is not in rythm (think it's in A-FIB)) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthritis and Cardioversion (Had 2 cardioversions). Concurrent medical conditions included Atrial fibrillation.   On 27-Jan-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 27-Jan-2021, the patient experienced PAIN (have never ache and hurt as bad as they started hurting), ILLNESS (sick), GAIT DISTURBANCE (could not walk), DIZZINESS (dizzy), ARTHRALGIA (Every joint was aching, ankles, knees, finger, hips, it keep hurting al night long), HEADACHE (headache) and NAUSEA (nausea but did not throw up). On 29-Jan-2021, the patient experienced ATRIAL FIBRILLATION (is not in rythm (think it's in A-FIB)) (seriousness criterion medically significant), EXTRASYSTOLES (Skipping of beats) and CHEST DISCOMFORT (the chest moved not in the right way). On 28-Jan-2021, PAIN (have never ache and hurt as bad as they started hurting), ILLNESS (sick), GAIT DISTURBANCE (could not walk), DIZZINESS (dizzy), ARTHRALGIA (Every joint was aching, ankles, knees, finger, hips, it keep hurting al night long) and NAUSEA (nausea but did not throw up) had resolved. On 29-Jan-2021, HEADACHE (headache) had resolved. At the time of the report, ATRIAL FIBRILLATION (is not in rythm (think it's in A-FIB)), EXTRASYSTOLES (Skipping of beats) and CHEST DISCOMFORT (the chest moved not in the right way) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Heart rate: 80 (High) 80.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included paracetamol.  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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Heart rate, Illness, Nausea
Clinical narrative: is not in rythm (think it's in A-FIB); Skipping of beats; the chest moved not in the right way; could not walk; dizzy; Every joint was aching, ankles, knees, finger, hips, it keep hurting al night long; headache; nausea but did not throw up; have never ache and hurt as bad as they started hurting; sick; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (is not in rythm (think it's in A-FIB)) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthritis and Cardioversion (Had 2 cardioversions). Concurrent medical conditions included Atrial fibrillation.   On 27-Jan-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 27-Jan-2021, the patient experienced PAIN (have never ache and hurt as bad as they started hurting), ILLNESS (sick), GAIT DISTURBANCE (could not walk), DIZZINESS (dizzy), ARTHRALGIA (Every joint was aching, ankles, knees, finger, hips, it keep hurting al night long), HEADACHE (headache) and NAUSEA (nausea but did not throw up). On 29-Jan-2021, the patient experienced ATRIAL FIBRILLATION (is not in rythm (think it's in A-FIB)) (seriousness criterion medically significant), EXTRASYSTOLES (Skipping of beats) and CHEST DISCOMFORT (the chest moved not in the right way). On 28-Jan-2021, PAIN (have never ache and hurt as bad as they started hurting), ILLNESS (sick), GAIT DISTURBANCE (could not walk), DIZZINESS (dizzy), ARTHRALGIA (Every joint was aching, ankles, knees, finger, hips, it keep hurting al night long) and NAUSEA (nausea but did not throw up) had resolved. On 29-Jan-2021, HEADACHE (headache) had resolved. At the time of the report, ATRIAL FIBRILLATION (is not in rythm (think it's in A-FIB)), EXTRASYSTOLES (Skipping of beats) and CHEST DISCOMFORT (the chest moved not in the right way) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Heart rate: 80 (High) 80.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included paracetamol.  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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: is not in rythm (think it's in A-FIB); Skipping of beats; the chest moved not in the right way; could not walk; dizzy; Every joint was aching, ankles, knees, finger, hips, it keep hurting al night long; headache; nausea but did not throw up; have never ache and hurt as bad as they started hurting; sick; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (is not in rythm (think it's in A-FIB)) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthritis and Cardioversion (Had 2 cardioversions). Concurrent medical conditions included Atrial fibrillation.   On 27-Jan-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 27-Jan-2021, the patient experienced PAIN (have never ache and hurt as bad as they started hurting), ILLNESS (sick), GAIT DISTURBANCE (could not walk), DIZZINESS (dizzy), ARTHRALGIA (Every joint was aching, ankles, knees, finger, hips, it keep hurting al night long), HEADACHE (headache) and NAUSEA (nausea but did not throw up). On 29-Jan-2021, the patient experienced ATRIAL FIBRILLATION (is not in rythm (think it's in A-FIB)) (seriousness criterion medically significant), EXTRASYSTOLES (Skipping of beats) and CHEST DISCOMFORT (the chest moved not in the right way). On 28-Jan-2021, PAIN (have never ache and hurt as bad as they started hurting), ILLNESS (sick), GAIT DISTURBANCE (could not walk), DIZZINESS (dizzy), ARTHRALGIA (Every joint was aching, ankles, knees, finger, hips, it keep hurting al night long) and NAUSEA (nausea but did not throw up) had resolved. On 29-Jan-2021, HEADACHE (headache) had resolved. At the time of the report, ATRIAL FIBRILLATION (is not in rythm (think it's in A-FIB)), EXTRASYSTOLES (Skipping of beats) and CHEST DISCOMFORT (the chest moved not in the right way) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Heart rate: 80 (High) 80.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included paracetamol.  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: Arthralgia, Ear pain, Eyelid rash, Herpes zoster, Hypoaesthesia
Clinical narrative: diagnosed her with shingles; rash on the evening on both of the eye lid; right hand middle finger is feeling like shooting pain almost like nerve pain; knee pain; left hand was having tingling like vibrating pain; numbness that stayed about 3-4 minutes maybe longer; body ache; neck pain; ear pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYELID RASH (rash on the evening on both of the eye lid) and HERPES ZOSTER (diagnosed her with shingles) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical reported history).    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced MYALGIA (body ache), NECK PAIN (neck pain) and EAR PAIN (ear pain). On 05-Feb-2021, the patient experienced EYELID RASH (rash on the evening on both of the eye lid) (seriousness criterion hospitalization). On 06-Feb-2021, the patient experienced HERPES ZOSTER (diagnosed her with shingles) (seriousness criterion hospitalization). On 21-Feb-2021, the patient experienced PARAESTHESIA (left hand was having tingling like vibrating pain) and HYPOAESTHESIA (numbness that stayed about 3-4 minutes maybe longer). On an unknown date, the patient experienced NEURALGIA (right hand middle finger is feeling like shooting pain almost like nerve pain) and ARTHRALGIA (knee pain). On 21-Feb-2021, PARAESTHESIA (left hand was having tingling like vibrating pain) and HYPOAESTHESIA (numbness that stayed about 3-4 minutes maybe longer) had resolved. At the time of the report, EYELID RASH (rash on the evening on both of the eye lid), HERPES ZOSTER (diagnosed her with shingles), MYALGIA (body ache), NECK PAIN (neck pain), EAR PAIN (ear pain), NEURALGIA (right hand middle finger is feeling like shooting pain almost like nerve pain) and ARTHRALGIA (knee pain) outcome was unknown.            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: Myalgia, Neck pain, Neuralgia, Paraesthesia
Clinical narrative: diagnosed her with shingles; rash on the evening on both of the eye lid; right hand middle finger is feeling like shooting pain almost like nerve pain; knee pain; left hand was having tingling like vibrating pain; numbness that stayed about 3-4 minutes maybe longer; body ache; neck pain; ear pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYELID RASH (rash on the evening on both of the eye lid) and HERPES ZOSTER (diagnosed her with shingles) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical reported history).    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced MYALGIA (body ache), NECK PAIN (neck pain) and EAR PAIN (ear pain). On 05-Feb-2021, the patient experienced EYELID RASH (rash on the evening on both of the eye lid) (seriousness criterion hospitalization). On 06-Feb-2021, the patient experienced HERPES ZOSTER (diagnosed her with shingles) (seriousness criterion hospitalization). On 21-Feb-2021, the patient experienced PARAESTHESIA (left hand was having tingling like vibrating pain) and HYPOAESTHESIA (numbness that stayed about 3-4 minutes maybe longer). On an unknown date, the patient experienced NEURALGIA (right hand middle finger is feeling like shooting pain almost like nerve pain) and ARTHRALGIA (knee pain). On 21-Feb-2021, PARAESTHESIA (left hand was having tingling like vibrating pain) and HYPOAESTHESIA (numbness that stayed about 3-4 minutes maybe longer) had resolved. At the time of the report, EYELID RASH (rash on the evening on both of the eye lid), HERPES ZOSTER (diagnosed her with shingles), MYALGIA (body ache), NECK PAIN (neck pain), EAR PAIN (ear pain), NEURALGIA (right hand middle finger is feeling like shooting pain almost like nerve pain) and ARTHRALGIA (knee pain) outcome was unknown.            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: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Extreme diarrhea; This spontaneous case was reported by a non-health professional and describes the occurrence of DIARRHOEA (Extreme diarrhea) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 25-Feb-2021, the patient experienced DIARRHOEA (Extreme diarrhea) (seriousness criterion medically significant). At the time of the report, DIARRHOEA (Extreme diarrhea) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided.  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.   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 this event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Depression, Fatigue, Feeling hot, Pain, Suicidal ideation
Clinical narrative: inflammation in his arm; beyond fatigue; achy; I was hot; gave me suicidal ideation; depression got worse; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (depression got worse) and SUICIDAL IDEATION (gave me suicidal ideation) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) 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 MIRTAZAPINE, VALPROATE SEMISODIUM (DIVALPROEX), CLONAZEPAM, LISINOPRIL, LEVOTHYROXINE SODIUM (SYNTHROID), FOLIC ACID, ACETYLSALICYLIC ACID (BABY ASPIRIN), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM WITH VITAMIN D 3), DOCUSATE SODIUM (STOOL SOFTENER), SIMETHICONE, PRAVASTATIN and ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE (MINTOX) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced DEPRESSION (depression got worse) (seriousness criterion medically significant), SUICIDAL IDEATION (gave me suicidal ideation) (seriousness criteria medically significant and life threatening), PAIN (achy) and FEELING HOT (I was hot). On an unknown date, the patient experienced INFLAMMATION (inflammation in his arm) and FATIGUE (beyond fatigue). At the time of the report, DEPRESSION (depression got worse), SUICIDAL IDEATION (gave me suicidal ideation), INFLAMMATION (inflammation in his arm), PAIN (achy), FEELING HOT (I was hot) and FATIGUE (beyond fatigue) had resolved.        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 was not reported.; 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: M
Vaccine: COVID19
Symptoms: Vaccination site inflammation
Clinical narrative: inflammation in his arm; beyond fatigue; achy; I was hot; gave me suicidal ideation; depression got worse; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (depression got worse) and SUICIDAL IDEATION (gave me suicidal ideation) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) 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 MIRTAZAPINE, VALPROATE SEMISODIUM (DIVALPROEX), CLONAZEPAM, LISINOPRIL, LEVOTHYROXINE SODIUM (SYNTHROID), FOLIC ACID, ACETYLSALICYLIC ACID (BABY ASPIRIN), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM WITH VITAMIN D 3), DOCUSATE SODIUM (STOOL SOFTENER), SIMETHICONE, PRAVASTATIN and ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE (MINTOX) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced DEPRESSION (depression got worse) (seriousness criterion medically significant), SUICIDAL IDEATION (gave me suicidal ideation) (seriousness criteria medically significant and life threatening), PAIN (achy) and FEELING HOT (I was hot). On an unknown date, the patient experienced INFLAMMATION (inflammation in his arm) and FATIGUE (beyond fatigue). At the time of the report, DEPRESSION (depression got worse), SUICIDAL IDEATION (gave me suicidal ideation), INFLAMMATION (inflammation in his arm), PAIN (achy), FEELING HOT (I was hot) and FATIGUE (beyond fatigue) had resolved.        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 was not reported.; 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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: breaking out on hives on her face, neck and chest. She saw a doctor and he told her it was anaphylactic reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (breaking out on hives on her face, neck and chest. She saw a doctor and he told her it was anaphylactic reaction) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Hives. Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL (GIANVI) for an unknown indication.  She had never had an allergic reaction to any vaccination on the past. She does have a skin condition so she gets hives easily and similar hives when taking some beers.  On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced ANAPHYLACTIC REACTION (breaking out on hives on her face, neck and chest. She saw a doctor and he told her it was anaphylactic reaction) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (breaking out on hives on her face, neck and chest. She saw a doctor and he told her it was anaphylactic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication reported  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.; 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.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Seizure
Clinical narrative: Seizures; Redness; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizures) in a 21-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 (No medical history was provided.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced SEIZURE (Seizures) (seriousness criterion medically significant), ERYTHEMA (Redness) and PAIN (Soreness). At the time of the report, SEIZURE (Seizures), ERYTHEMA (Redness) and PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment provided.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Headache, Rhinorrhoea
Clinical narrative: chest pain; dizzy-headed; runny nose; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) in a 68-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.     Concurrent medical conditions included Heart disorder and Lupus erythematosus. Concomitant products included CLONAZEPAM (KLONOPIN) for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization), DIZZINESS (dizzy-headed), RHINORRHOEA (runny nose) and HEADACHE (slight headache). At the time of the report, CHEST PAIN (chest pain), DIZZINESS (dizzy-headed), RHINORRHOEA (runny nose) and HEADACHE (slight headache) outcome was unknown.      Concomitant product included heart medication.  Treatment information included Tylenol.   This case was linked to MOD-2021-060644 (Patient Link).  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.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Hypertension
Clinical narrative: heart irregularities; high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (heart irregularities) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) 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 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (heart irregularities) (seriousness criterion medically significant) and HYPERTENSION (high blood pressure). At the time of the report, ARRHYTHMIA (heart irregularities) and HYPERTENSION (high blood pressure) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information 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 events, a causal relationship cannot be excluded.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Choking, Nausea, Pharyngeal swelling, Throat tightness
Clinical narrative: Throat is constricted; Throat is swollen; Choked on his medication; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHOKING (Choked on his medication) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction. Concomitant products included SERTRALINE, TRAZODONE and GABAPENTIN for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced CHOKING (Choked on his medication) (seriousness criterion medically significant) and NAUSEA (Nausea). On 30-Mar-2021, the patient experienced THROAT TIGHTNESS (Throat is constricted) and PHARYNGEAL SWELLING (Throat is swollen). At the time of the report, CHOKING (Choked on his medication), NAUSEA (Nausea), THROAT TIGHTNESS (Throat is constricted) and PHARYNGEAL SWELLING (Throat is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of these events were 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 events, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Pulmonary congestion, Upper respiratory tract infection
Clinical narrative: Congestion in lungs; Upper respiratory infection; Felt passed out; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY CONGESTION (Congestion in lungs) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A24A) 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 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PULMONARY CONGESTION (Congestion in lungs) (seriousness criterion medically significant), UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection) and PRESYNCOPE (Felt passed out). At the time of the report, PULMONARY CONGESTION (Congestion in lungs), UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection) and PRESYNCOPE (Felt passed out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Patient had fever, chills, headache and sore throat. Then later she developed cough with mucus and shortness of breath. She still had congestion in lungs and at one time almost felt passed out. She has been to emergency 4 times for this and they told her that it was upper respiratory infection. Treatment medications included Loratadine, Dexamethasone and Albuterol.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: pneumonia; This spontaneous case was reported by an other caregiver and describes the occurrence of PNEUMONIA (pneumonia) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes and Pacemaker insertion (cardiac). Concurrent medical conditions included Heart disorder.    On 01-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 PNEUMONIA (pneumonia) (seriousness criterion hospitalization). At the time of the report, PNEUMONIA (pneumonia) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. Patient's husband received his 1st vaccine on 1Mar2021. Her husband have pace maker and heart problem, diabetes and he admitted to ER on Sunday on 28Mar2021 for pneumonia and he is still in the hospital. No treatment information provided.  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.   This case was linked to MOD21-065334 (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 event, a causal relationship cannot be excluded. MOD21-065334:
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Appendicitis, Computerised tomogram, Epigastric discomfort, Insomnia
Clinical narrative: Appendicitis; Developed a pain in his stomach; Could not sleep as the pain persisted in his stomach; Waking up a few times due to stomach irritation; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Appendicitis) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) 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 reported.).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced EPIGASTRIC DISCOMFORT (Waking up a few times due to stomach irritation). On 28-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Developed a pain in his stomach) with INSOMNIA (Could not sleep as the pain persisted in his stomach). On 29-Mar-2021, the patient experienced APPENDICITIS (Appendicitis) (seriousness criterion hospitalization). The patient was hospitalized on 29-Mar-2021 due to APPENDICITIS. On 21-Mar-2021, EPIGASTRIC DISCOMFORT (Waking up a few times due to stomach irritation) had resolved. At the time of the report, APPENDICITIS (Appendicitis) and ABDOMINAL PAIN UPPER (Developed a pain in his stomach) outcome was unknown. admitted for emergency appendectomy    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Computerised tomogram: diagnosed appendicitis (Inconclusive) diagnosed appendicitis..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-062483 (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 these events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-062483:wife case
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chills, Dizziness, Dyspnoea
Clinical narrative: After sinus surgery, low grade fever, shakes, chills, muscle pain, headache that did not fit with recovery time from sinus surgery. Dizziness... overreactive immune response. Rapid heart rate.  Headache severe, throbbing and not helped by Tylenol or Ibuprofen.   Infection from the surgery resolved after antibiotics but symptoms remained. Told I might have a "virus" and my immune system was over reacting. Vitamin B12 shot. Currently taking prednisone but still short of breath and fatigued.