chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Nausea, Vomiting
Clinical narrative: Passed out; Feeling sweaty; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050CZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for COPD.    On 12-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), HYPERHIDROSIS (Feeling sweaty), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), HYPERHIDROSIS (Feeling sweaty), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.            Treatment medication included aspirin and ice pack on injection site.  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: M
Vaccine: COVID19
Symptoms: Eye haemorrhage
Clinical narrative: Second moderna shot 18 hours ago burst blood vessel in eye/burst a blood in eye after my second moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of EYE HAEMORRHAGE (Second moderna shot 18 hours ago burst blood vessel in eye/burst a blood in eye after my second moderna shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EYE HAEMORRHAGE (Second moderna shot 18 hours ago burst blood vessel in eye/burst a blood in eye after my second moderna shot) (seriousness criterion medically significant). At the time of the report, EYE HAEMORRHAGE (Second moderna shot 18 hours ago burst blood vessel in eye/burst a blood in eye after my second moderna shot) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clots in his left leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots in his left leg) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant medical history was reported.  Concomitant products included APIXABAN and ENOXAPARIN for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced THROMBOSIS (Blood clots in his left leg) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Blood clots in his left leg) 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.   Company Comment   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. Further information has been requested.   This case was linked to MOD-2021-220804 (Patient Link).; 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. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Disability, Immunodeficiency
Clinical narrative: Cripple; left with no immune system; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DISABILITY (Cripple) and IMMUNODEFICIENCY (left with no immune system) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DISABILITY (Cripple) (seriousness criterion medically significant) and IMMUNODEFICIENCY (left with no immune system) (seriousness criterion medically significant). At the time of the report, DISABILITY (Cripple) and IMMUNODEFICIENCY (left with no immune system) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided by reporter. Treatment information not provided by reporter.  For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments.  Company Comment   Very limited information regarding these events has been provided at this time. No follow up is possible.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Decreased appetite, Dehydration, Diarrhoea, Hypertension
Clinical narrative: Blood pressure in the 250/110's range, blood pressure has gotten much worse; No appetite; Diarrhea; Dehydrated; Nauseous; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure in the 250/110's range, blood pressure has gotten much worse) in an 81-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 Constipation (Normally she is constipated). Concurrent medical conditions included Hypertension.   On 29-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 an unknown date, the patient experienced HYPERTENSION (Blood pressure in the 250/110's range, blood pressure has gotten much worse) (seriousness criteria hospitalization and disability), DECREASED APPETITE (No appetite), DIARRHOEA (Diarrhea), DEHYDRATION (Dehydrated), NAUSEA (Nauseous) and VOMITING (Vomiting). The patient was hospitalized on 19-May-2021 due to HYPERTENSION. At the time of the report, HYPERTENSION (Blood pressure in the 250/110's range, blood pressure has gotten much worse), DECREASED APPETITE (No appetite), DIARRHOEA (Diarrhea), DEHYDRATION (Dehydrated), NAUSEA (Nauseous) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood pressure measurement: 250/110 (High) High and 200/110 (High) High.         Concomitantly the patient was receiving unspecified medication for hypertension .  Reportedly, the patient was taken to the hospital on 19 May 2021. At the hospital, the patient's blood pressure was high and the doctors were not able to bring it down. Since the second vaccine, the patient's blood pressure has gotten much worse.   No treatment information was provided. 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. Further information has been requested. Of note, the patient's age and medical history of Hypertension are confounding factors that may play possible contributory roles.; 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. Further information has been requested. Of note, the patient's age and medical history of Hypertension are confounding factors that may play possible contributory roles.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Blood pressure in the 250/110's range, blood pressure has gotten much worse; No appetite; Diarrhea; Dehydrated; Nauseous; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure in the 250/110's range, blood pressure has gotten much worse) in an 81-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 Constipation (Normally she is constipated). Concurrent medical conditions included Hypertension.   On 29-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 an unknown date, the patient experienced HYPERTENSION (Blood pressure in the 250/110's range, blood pressure has gotten much worse) (seriousness criteria hospitalization and disability), DECREASED APPETITE (No appetite), DIARRHOEA (Diarrhea), DEHYDRATION (Dehydrated), NAUSEA (Nauseous) and VOMITING (Vomiting). The patient was hospitalized on 19-May-2021 due to HYPERTENSION. At the time of the report, HYPERTENSION (Blood pressure in the 250/110's range, blood pressure has gotten much worse), DECREASED APPETITE (No appetite), DIARRHOEA (Diarrhea), DEHYDRATION (Dehydrated), NAUSEA (Nauseous) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood pressure measurement: 250/110 (High) High and 200/110 (High) High.         Concomitantly the patient was receiving unspecified medication for hypertension .  Reportedly, the patient was taken to the hospital on 19 May 2021. At the hospital, the patient's blood pressure was high and the doctors were not able to bring it down. Since the second vaccine, the patient's blood pressure has gotten much worse.   No treatment information was provided. 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. Further information has been requested. Of note, the patient's age and medical history of Hypertension are confounding factors that may play possible contributory roles.; 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. Further information has been requested. Of note, the patient's age and medical history of Hypertension are confounding factors that may play possible contributory roles.
Sex: U
Vaccine: COVID19
Symptoms: Blindness unilateral, Eye infection
Clinical narrative: blinded right eye; eye infection; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS UNILATERAL (blinded right eye) and EYE INFECTION (eye infection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLINDNESS UNILATERAL (blinded right eye) (seriousness criterion medically significant) and EYE INFECTION (eye infection) (seriousness criterion medically significant). At the time of the report, BLINDNESS UNILATERAL (blinded right eye) and EYE INFECTION (eye infection) outcome was unknown.            Concomitant medication not provided by reporter.  Treatment information not provided by reporter.  Action taken with mRNA-1273 was not applicable.  Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Atrial fibrillation, Blood pressure measurement, Cardiac stress test, Dizziness
Clinical narrative: Atrial fibrillation; Woke up dizzy; Sweating; He felt very weak, he sat on the sofa for the rest of the day; Redness; Big lump; It was very hard; It itched a little bit; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 01-Apr-2021 at 9:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced ERYTHEMA (Redness), MASS (Big lump), INDURATION (It was very hard) and PRURITUS (It itched a little bit). On 30-Apr-2021, the patient experienced DIZZINESS (Woke up dizzy), HYPERHIDROSIS (Sweating) and ASTHENIA (He felt very weak, he sat on the sofa for the rest of the day). On 17-May-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant). The patient was treated with DILTIAZEM ongoing since an unknown date at an unspecified dose and frequency; FUROSEMIDE ongoing since an unknown date at an unspecified dose and frequency; AMIODARONE HYDROCHLORIDE (PACERONE) ongoing since an unknown date for Blood pressure, at a dose of 200 mg once a day and AMIODARONE HYDROCHLORIDE (PACERONE) in April 2021 for Blood pressure, at a dose of 200 mg three times a day. On 30-Apr-2021, ERYTHEMA (Redness), MASS (Big lump), INDURATION (It was very hard), PRURITUS (It itched a little bit), DIZZINESS (Woke up dizzy), HYPERHIDROSIS (Sweating) and ASTHENIA (He felt very weak, he sat on the sofa for the rest of the day) had resolved. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Cardiac stress test: normal (normal) Normal. On 17-May-2021, Electrocardiogram: normal (normal) Normal. On an unknown date, Blood pressure measurement: unknown (Inconclusive) Unknown.         Treatment for the events included Letopherol and cardio inversion. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-220992 (Patient Link).; 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. Further information has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Erythema, Hyperhidrosis, Induration, Mass
Clinical narrative: Atrial fibrillation; Woke up dizzy; Sweating; He felt very weak, he sat on the sofa for the rest of the day; Redness; Big lump; It was very hard; It itched a little bit; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 01-Apr-2021 at 9:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced ERYTHEMA (Redness), MASS (Big lump), INDURATION (It was very hard) and PRURITUS (It itched a little bit). On 30-Apr-2021, the patient experienced DIZZINESS (Woke up dizzy), HYPERHIDROSIS (Sweating) and ASTHENIA (He felt very weak, he sat on the sofa for the rest of the day). On 17-May-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant). The patient was treated with DILTIAZEM ongoing since an unknown date at an unspecified dose and frequency; FUROSEMIDE ongoing since an unknown date at an unspecified dose and frequency; AMIODARONE HYDROCHLORIDE (PACERONE) ongoing since an unknown date for Blood pressure, at a dose of 200 mg once a day and AMIODARONE HYDROCHLORIDE (PACERONE) in April 2021 for Blood pressure, at a dose of 200 mg three times a day. On 30-Apr-2021, ERYTHEMA (Redness), MASS (Big lump), INDURATION (It was very hard), PRURITUS (It itched a little bit), DIZZINESS (Woke up dizzy), HYPERHIDROSIS (Sweating) and ASTHENIA (He felt very weak, he sat on the sofa for the rest of the day) had resolved. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Cardiac stress test: normal (normal) Normal. On 17-May-2021, Electrocardiogram: normal (normal) Normal. On an unknown date, Blood pressure measurement: unknown (Inconclusive) Unknown.         Treatment for the events included Letopherol and cardio inversion. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-220992 (Patient Link).; 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. Further information has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Atrial fibrillation; Woke up dizzy; Sweating; He felt very weak, he sat on the sofa for the rest of the day; Redness; Big lump; It was very hard; It itched a little bit; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 01-Apr-2021 at 9:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced ERYTHEMA (Redness), MASS (Big lump), INDURATION (It was very hard) and PRURITUS (It itched a little bit). On 30-Apr-2021, the patient experienced DIZZINESS (Woke up dizzy), HYPERHIDROSIS (Sweating) and ASTHENIA (He felt very weak, he sat on the sofa for the rest of the day). On 17-May-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant). The patient was treated with DILTIAZEM ongoing since an unknown date at an unspecified dose and frequency; FUROSEMIDE ongoing since an unknown date at an unspecified dose and frequency; AMIODARONE HYDROCHLORIDE (PACERONE) ongoing since an unknown date for Blood pressure, at a dose of 200 mg once a day and AMIODARONE HYDROCHLORIDE (PACERONE) in April 2021 for Blood pressure, at a dose of 200 mg three times a day. On 30-Apr-2021, ERYTHEMA (Redness), MASS (Big lump), INDURATION (It was very hard), PRURITUS (It itched a little bit), DIZZINESS (Woke up dizzy), HYPERHIDROSIS (Sweating) and ASTHENIA (He felt very weak, he sat on the sofa for the rest of the day) had resolved. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Cardiac stress test: normal (normal) Normal. On 17-May-2021, Electrocardiogram: normal (normal) Normal. On an unknown date, Blood pressure measurement: unknown (Inconclusive) Unknown.         Treatment for the events included Letopherol and cardio inversion. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-220992 (Patient Link).; 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. Further information has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood glucose, Blood glucose increased, Nausea, Vomiting
Clinical narrative: stomach infection; blood sugar increased; nausea; vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL DISCOMFORT (stomach infection) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 37B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Chronic kidney disease and Thyroid disorder. Concomitant products included SODIUM BICARBONATE for Chronic kidney disease, LEVOTHYROXINE for Thyroid disorder, INSULIN ASPART (NOVOLOG) and INSULIN GLARGINE (BASAGLAR) for an unknown indication.    On 07-Apr-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 ABDOMINAL DISCOMFORT (stomach infection) (seriousness criterion hospitalization) BLOOD SUGAR INCREASED (blood sugar increased), NAUSEA (nausea), and VOMITING (vomiting). The patient was hospitalized for 4 days due to ABDOMINAL DISCOMFORT. At the time of the report, ABDOMINAL DISCOMFORT (stomach infection), BLOOD SUGAR INCREASED (blood sugar increased), NAUSEA (nausea), and VOMITING (vomiting)outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: high (High) sugar was too high..     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Treatment medications were reported.   This case was linked to MOD-2021-221039 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Additional information included non-significant information. Patient Initials were updated.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Depression
Clinical narrative: Diagnosed with severe depression at the time of discharge; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEPRESSION (Diagnosed with severe depression at the time of discharge). ) in a 60-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.     No medical history information was reported.  Concomitant products included ZOLPIDEM for Difficulty sleeping.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Wife went to doctor on 05Apr2021 and was diagnosed with depression. On 28Apr2021, wife was hospitalized due to depression. According to the husband, wife damaged and burned his car and so he had to send her to the hospital. On 14May2021, wife was discharged and diagnosed with severe depression and was prescribed with 3 medications. On 14-May-2021, the patient experienced DEPRESSION (Diagnosed with severe depression at the time of discharge). The patient was hospitalized from 28-Apr-2021 to 14-May-2021 due to DEPRESSION. The patient was treated with FLUOXETINE HCL for Adverse event, at a dose of 20 mg once a day; OLANZAPINE for Adverse event, at a dose of 10 mg once a day and TRAZODONE for Adverse event, at a dose of 50 mg once a day. At the time of the report, DEPRESSION (Diagnosed with severe depression at the time of discharge) outcome was unknown.            This case was linked to MOD-2021-221012 (Patient Link).; Sender's Comments: Limited information regarding this event has been provided at this time. Further information has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Nausea, Vomiting
Clinical narrative: Throwing up; Feeling nauseous; blood sugar increased; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Throwing up) and NAUSEA (Feeling nauseous) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 37B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Chronic kidney disease and Thyroid disorder. Concomitant products included SODIUM BICARBONATE for Chronic kidney disease, LEVOTHYROXINE for Thyroid disorder, INSULIN ASPART (NOVOLOG) and INSULIN GLARGINE (BASAGLAR) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VOMITING (Throwing up) (seriousness criterion hospitalization) and NAUSEA (Feeling nauseous) (seriousness criterion hospitalization). The patient was treated with PARACETAMOL (TYLENOL) for Back pain, at a dose of UNK dosage form. Patient stated that after each vaccination she was hospitalized but did not remember the specific dates of admission. She stated that it was a week after vaccination but could not provide a specific date. Patient stated that each hospitalization lasted for 4 days and she was in the same hospital for both hospitalization. She was admitted to the the hospital due to stomach infection and sugar was too high BLOOD SUGAR INCREASED (blood sugar increased) (seriousness criterion hospitalization). Another time she was admitted to the hospital was due to sugar was too high, feeling nauseous, throwing up .At the time of the report, VOMITING (Throwing up), BLOOD SUGAR INCREASED (blood sugar increased)  and NAUSEA (Feeling nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: high (High) was admitted to the hospital twice due to sugar was too high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-221023 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Patient initials were updated; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested. Patient medical condition may provide an alternative justification for the events occurrence.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Myocardial infarction, Palpitations, Syncope
Clinical narrative: suffered a massive heart attack; Feeling of faintness; Palpitations; Shortness of Breath; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (suffered a massive heart attack), SYNCOPE (Feeling of faintness), PALPITATIONS (Palpitations) and DYSPNOEA (Shortness of Breath) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced SYNCOPE (Feeling of faintness) (seriousness criterion medically significant), PALPITATIONS (Palpitations) (seriousness criterion medically significant) and DYSPNOEA (Shortness of Breath) (seriousness criterion medically significant). On 09-Jun-2021, the patient experienced MYOCARDIAL INFARCTION (suffered a massive heart attack) (seriousness criteria death and medically significant). The patient died on 09-Jun-2021. The reported cause of death was suffered a massive heart attack. It is unknown if an autopsy was performed. At the time of death, SYNCOPE (Feeling of faintness), PALPITATIONS (Palpitations) and DYSPNOEA (Shortness of Breath) outcome was unknown.            No concomitant information was reported. No treatment information was reported. Action taken with mRNA-1273 was not applicable.  A Patient called to report that two weeks after the first dose of the Moderna Covid-19 vaccine on 27-May-2021, his boyfriend began to experience palpitations, shortness of breath and feeling of faintness. The caller stated that her boyfriend did not want to go to the emergency room and only set an appointment with his Health Care Provider, but on the 09-Jun-2021, the day that he was going to the appointment, he suffered a massive heart attack and passed away.  This is a case of sudden death in a 59-year-old male subject, who died 23 days after receiving first dose of vaccine. Very limited information has been provided at this time. Patient medical history was not provided.; Sender's Comments: This is a case of sudden death in a 59-year-old male subject, who died 23 days after receiving first dose of vaccine. Very limited information has been provided at this time. Patient medical history was not provided.; Reported Cause(s) of Death: suffered a massive heart attack
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization prolonged, medically significant and life threatening). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient experienced a stroke after he got the vaccine and was in subacute for 5 months at the time of reporting.  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. However, details regarding medical  history and concomitant medications are required for further assessment.; 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. However, details regarding medical  history and concomitant medications are required for further assessment.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Problems breathing; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (Problems breathing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Polio.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Problems breathing) (seriousness criterion death). The reported cause of death was problems breathing. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided.  Treatment medications was not provided.  Action taken with mRNA-1273 in response to events was not applicable.  As a young child, patient was in an iron lung.  This is a case of fatal Dyspnoea in a male subject with a hx of polio, who died after receiving the second dose of vaccine. Very limited information has been provided at this time.; Sender's Comments: This is a case of fatal Dyspnoea in a male subject with a hx of polio, who died after receiving the second dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Problems breathing
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Chest pain, Chills, Dyspnoea, Ejection fraction
Clinical narrative: myocarditis; shortness of breath; chest pain; fever; chills; myalgia; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis), DYSPNOEA (shortness of breath) and CHEST PAIN (chest pain) in a 31-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. No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criteria hospitalization prolonged and medically significant), DYSPNOEA (shortness of breath) (seriousness criterion hospitalization prolonged), CHEST PAIN (chest pain) (seriousness criterion hospitalization prolonged), PYREXIA (fever), CHILLS (chills) and MYALGIA (myalgia). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to CHEST PAIN, DYSPNOEA and MYOCARDITIS. The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of UNK dosage form. At the time of the report, MYOCARDITIS (myocarditis) was resolving and DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), PYREXIA (fever), CHILLS (chills) and MYALGIA (myalgia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: high (High) 14 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range). On an unknown date, Ejection fraction: abnormal (abnormal) 34%, generalized hypokinesis. On an unknown date, Electrocardiogram: normal (normal) normal left ventricular function. On an unknown date, Magnetic resonance imaging: abnormal (abnormal) Patchy subepicardial and midmyocardial delayed enhancement. On an unknown date, SARS-CoV-2 test: negative (Negative) negative. On an unknown date, Troponin: high (High) Baseline 39.5 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range) and high (High) peak 46 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was hemodynamically stable, no clinical heart failure. Concomitant medication not provided.  Company Comment  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Magnetic resonance imaging, Myalgia, Myocarditis, Pyrexia
Clinical narrative: myocarditis; shortness of breath; chest pain; fever; chills; myalgia; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis), DYSPNOEA (shortness of breath) and CHEST PAIN (chest pain) in a 31-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. No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criteria hospitalization prolonged and medically significant), DYSPNOEA (shortness of breath) (seriousness criterion hospitalization prolonged), CHEST PAIN (chest pain) (seriousness criterion hospitalization prolonged), PYREXIA (fever), CHILLS (chills) and MYALGIA (myalgia). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to CHEST PAIN, DYSPNOEA and MYOCARDITIS. The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of UNK dosage form. At the time of the report, MYOCARDITIS (myocarditis) was resolving and DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), PYREXIA (fever), CHILLS (chills) and MYALGIA (myalgia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: high (High) 14 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range). On an unknown date, Ejection fraction: abnormal (abnormal) 34%, generalized hypokinesis. On an unknown date, Electrocardiogram: normal (normal) normal left ventricular function. On an unknown date, Magnetic resonance imaging: abnormal (abnormal) Patchy subepicardial and midmyocardial delayed enhancement. On an unknown date, SARS-CoV-2 test: negative (Negative) negative. On an unknown date, Troponin: high (High) Baseline 39.5 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range) and high (High) peak 46 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was hemodynamically stable, no clinical heart failure. Concomitant medication not provided.  Company Comment  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Troponin
Clinical narrative: myocarditis; shortness of breath; chest pain; fever; chills; myalgia; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis), DYSPNOEA (shortness of breath) and CHEST PAIN (chest pain) in a 31-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. No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criteria hospitalization prolonged and medically significant), DYSPNOEA (shortness of breath) (seriousness criterion hospitalization prolonged), CHEST PAIN (chest pain) (seriousness criterion hospitalization prolonged), PYREXIA (fever), CHILLS (chills) and MYALGIA (myalgia). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to CHEST PAIN, DYSPNOEA and MYOCARDITIS. The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of UNK dosage form. At the time of the report, MYOCARDITIS (myocarditis) was resolving and DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), PYREXIA (fever), CHILLS (chills) and MYALGIA (myalgia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: high (High) 14 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range). On an unknown date, Ejection fraction: abnormal (abnormal) 34%, generalized hypokinesis. On an unknown date, Electrocardiogram: normal (normal) normal left ventricular function. On an unknown date, Magnetic resonance imaging: abnormal (abnormal) Patchy subepicardial and midmyocardial delayed enhancement. On an unknown date, SARS-CoV-2 test: negative (Negative) negative. On an unknown date, Troponin: high (High) Baseline 39.5 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range) and high (High) peak 46 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was hemodynamically stable, no clinical heart failure. Concomitant medication not provided.  Company Comment  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Chest pain, Ejection fraction, Electrocardiogram, Magnetic resonance imaging
Clinical narrative: myocarditis; NSVT episodes; chest pain; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis), VENTRICULAR TACHYCARDIA (NSVT episodes) and CHEST PAIN (chest pain) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criteria hospitalization prolonged and medically significant), VENTRICULAR TACHYCARDIA (NSVT episodes) (seriousness criteria hospitalization prolonged and medically significant) and CHEST PAIN (chest pain) (seriousness criterion hospitalization prolonged). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to CHEST PAIN, MYOCARDITIS and VENTRICULAR TACHYCARDIA. At the time of the report, MYOCARDITIS (myocarditis) and VENTRICULAR TACHYCARDIA (NSVT episodes) was resolving and CHEST PAIN (chest pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, C-reactive protein: high (High) 4 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range).. In 2021, Ejection fraction: abnormal (abnormal) 53%, inferolateral hypokinesis. In 2021, Electrocardiogram: abnormal (abnormal) Inferior, anterolateral STelevation. In 2021, imaging: abnormal (abnormal) Edema, delayed enhancement. In 2021, SARS-CoV-2 test: negative (Negative) negative. In 2021, Troponin: high (High) baseline-1327 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range). and high (High) Peak-1433 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range)..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis), VENTRICULAR TACHYCARDIA (NSVT episodes) and CHEST PAIN (chest pain) to be possibly related.    Discharged in stable condition. Treatment information not provided.  Company Comment : Based on current available information and the temporal association between product sue and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product sue and the start date of the events a causal relationship cannot be excluded.