chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Ear discomfort, Ear pain, Headache, Lumbar puncture
Clinical narrative: Headache has been going on for 25 days and hasn't stopped; "my ears are killing me. The pressure behind my ears are killing me."; "my ears are killing me. The pressure behind my ears are killing me."; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EAR DISCOMFORT ("my ears are killing me. The pressure behind my ears are killing me."), EAR PAIN ("my ears are killing me. The pressure behind my ears are killing me.") and HEADACHE (Headache has been going on for 25 days and hasn't stopped) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 immunization.     Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), LEVOTHYROXINE SODIUM (SYNTHROID), HYDROXYCHLOROQUINE, MYCOPHENOLATE MOFETIL (CELLCEPT [MYCOPHENOLATE MOFETIL]) and METOPROLOL SUCCINATE (TOPROL) for an unknown indication.   On 06-Apr-2021 at 8:00 PM, 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) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced EAR DISCOMFORT ("my ears are killing me. The pressure behind my ears are killing me.") (seriousness criteria hospitalization and disability) and EAR PAIN ("my ears are killing me. The pressure behind my ears are killing me.") (seriousness criteria hospitalization and disability). On 07-Apr-2021 at 2:00 PM, the patient experienced HEADACHE (Headache has been going on for 25 days and hasn't stopped) (seriousness criteria hospitalization and disability). At the time of the report, EAR DISCOMFORT ("my ears are killing me. The pressure behind my ears are killing me.") and EAR PAIN ("my ears are killing me. The pressure behind my ears are killing me.") outcome was unknown and HEADACHE (Headache has been going on for 25 days and hasn't stopped) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: negative (Negative) Negative. On an unknown date, Lumbar puncture: negative (Negative) Negative. On an unknown date, Magnetic resonance imaging: negative (Negative) Negative.         Patient was admitted to the hospital. Patient also visited a walk-in clinic.Reported Treatment that patient received including Naproxen, Prednisone, Fioricet, Toradol.  Action taken with mRNA-1273 in response to the events was not Applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging
Clinical narrative: Headache has been going on for 25 days and hasn't stopped; "my ears are killing me. The pressure behind my ears are killing me."; "my ears are killing me. The pressure behind my ears are killing me."; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EAR DISCOMFORT ("my ears are killing me. The pressure behind my ears are killing me."), EAR PAIN ("my ears are killing me. The pressure behind my ears are killing me.") and HEADACHE (Headache has been going on for 25 days and hasn't stopped) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 immunization.     Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), LEVOTHYROXINE SODIUM (SYNTHROID), HYDROXYCHLOROQUINE, MYCOPHENOLATE MOFETIL (CELLCEPT [MYCOPHENOLATE MOFETIL]) and METOPROLOL SUCCINATE (TOPROL) for an unknown indication.   On 06-Apr-2021 at 8:00 PM, 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) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced EAR DISCOMFORT ("my ears are killing me. The pressure behind my ears are killing me.") (seriousness criteria hospitalization and disability) and EAR PAIN ("my ears are killing me. The pressure behind my ears are killing me.") (seriousness criteria hospitalization and disability). On 07-Apr-2021 at 2:00 PM, the patient experienced HEADACHE (Headache has been going on for 25 days and hasn't stopped) (seriousness criteria hospitalization and disability). At the time of the report, EAR DISCOMFORT ("my ears are killing me. The pressure behind my ears are killing me.") and EAR PAIN ("my ears are killing me. The pressure behind my ears are killing me.") outcome was unknown and HEADACHE (Headache has been going on for 25 days and hasn't stopped) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: negative (Negative) Negative. On an unknown date, Lumbar puncture: negative (Negative) Negative. On an unknown date, Magnetic resonance imaging: negative (Negative) Negative.         Patient was admitted to the hospital. Patient also visited a walk-in clinic.Reported Treatment that patient received including Naproxen, Prednisone, Fioricet, Toradol.  Action taken with mRNA-1273 in response to the events was not Applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count decreased
Clinical narrative: Decreased WBC count; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT DECREASED (Decreased WBC count) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 036B21A) for COVID-19 vaccination.     The patient's past medical history included White blood cell count high (high white blood cell count of 65,000 before receiving the vaccine). Concurrent medical conditions included Chronic lymphocytic leukemia.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-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 WHITE BLOOD CELL COUNT DECREASED (Decreased WBC count) (seriousness criterion medically significant). At the time of the report, WHITE BLOOD CELL COUNT DECREASED (Decreased WBC count) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: 44000 (Inconclusive) 1-2 weeks after getting the 1st dose and 36000 (Inconclusive) 1-2 weeks after getting the 2nd dose.         Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  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.; 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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Heart rate, Tachycardia
Clinical narrative: Arrythmia; Elevated Heart Rate; This spontaneous case was reported by a non-health professional and describes the occurrence of ARRHYTHMIA (Arrythmia) and TACHYCARDIA (Elevated Heart Rate) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No relevant medical history reported.    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 29-Apr-2021, the patient experienced ARRHYTHMIA (Arrythmia) (seriousness criteria hospitalization and medically significant) and TACHYCARDIA (Elevated Heart Rate) (seriousness criterion hospitalization). The patient was hospitalized on 30-Apr-2021 due to ARRHYTHMIA and TACHYCARDIA. At the time of the report, ARRHYTHMIA (Arrythmia) and TACHYCARDIA (Elevated Heart Rate) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Heart rate: 173bpm (High) 173bpm.         Patient did Chemical Cardioversion twice to heart to restart. Concomitant product use was not provided by the reporter. Treatment information was not 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.; 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: U
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: passed out; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (passed out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Head titubation, Tinnitus
Clinical narrative: internal head tremors; Tinnitus; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of TINNITUS (Tinnitus) and HEAD TITUBATION (internal head tremors) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.  On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced TINNITUS (Tinnitus) (seriousness criterion medically significant) and HEAD TITUBATION (internal head tremors) (seriousness criterion hospitalization). The patient was hospitalized on sometime in March 2021 due to HEAD TITUBATION. At the time of the report, TINNITUS (Tinnitus) and HEAD TITUBATION (internal head tremors) had not resolved.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment for the event included psychiatric medications and vitamin D.  Concomitant medication use was not reported. Treatment details were not provided for the events (Tinnitus, head titubation) experienced after the 1st dose.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event (tinnitus, head titubation), a causal relationship cannot be excluded.   This case was linked to (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 (tinnitus, head titubation), a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Asthenia, Blood glucose, Blood pressure increased, Blood pressure measurement
Clinical narrative: blood pressure increased; Felt so fatigued; had aching all over / muscle aches; was so nauseous; subsequently started getting headaches; chills; about 10-15 mins after, I started getting arrhythmia; started having trouble catching up my breath; also have lot of pressure on my head; felt very very weak; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (about 10-15 mins after, I started getting arrhythmia) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No  medical history was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METOPROLOL SUCCINATE (TOPROL), LISINOPRIL (ZESTRIL) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced ARRHYTHMIA (about 10-15 mins after, I started getting arrhythmia) (seriousness criterion medically significant). 23-Apr-2021, the patient experienced DYSPNOEA (started having trouble catching up my breath), HEAD DISCOMFORT (also have lot of pressure on my head), ASTHENIA (felt very very weak), FATIGUE (Felt so fatigued), MYALGIA (had aching all over / muscle aches), NAUSEA (was so nauseous), HEADACHE (subsequently started getting headaches) and CHILLS (chills). On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (blood pressure increased). At the time of the report, ARRHYTHMIA (about 10-15 mins after, I started getting arrhythmia), DYSPNOEA (started having trouble catching up my breath), HEAD DISCOMFORT (also have lot of pressure on my head), ASTHENIA (felt very very weak), BLOOD PRESSURE INCREASED (blood pressure increased), FATIGUE (Felt so fatigued), MYALGIA (had aching all over / muscle aches), NAUSEA (was so nauseous), HEADACHE (subsequently started getting headaches) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: Normal. On an unknown date, Blood pressure measurement: 177/90 (High) 177/90.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's EKG was done by EMT.  The patient received I Tylenol and Motrin.  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: Chills, Dyspnoea, Fatigue, Head discomfort, Headache
Clinical narrative: blood pressure increased; Felt so fatigued; had aching all over / muscle aches; was so nauseous; subsequently started getting headaches; chills; about 10-15 mins after, I started getting arrhythmia; started having trouble catching up my breath; also have lot of pressure on my head; felt very very weak; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (about 10-15 mins after, I started getting arrhythmia) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No  medical history was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METOPROLOL SUCCINATE (TOPROL), LISINOPRIL (ZESTRIL) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced ARRHYTHMIA (about 10-15 mins after, I started getting arrhythmia) (seriousness criterion medically significant). 23-Apr-2021, the patient experienced DYSPNOEA (started having trouble catching up my breath), HEAD DISCOMFORT (also have lot of pressure on my head), ASTHENIA (felt very very weak), FATIGUE (Felt so fatigued), MYALGIA (had aching all over / muscle aches), NAUSEA (was so nauseous), HEADACHE (subsequently started getting headaches) and CHILLS (chills). On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (blood pressure increased). At the time of the report, ARRHYTHMIA (about 10-15 mins after, I started getting arrhythmia), DYSPNOEA (started having trouble catching up my breath), HEAD DISCOMFORT (also have lot of pressure on my head), ASTHENIA (felt very very weak), BLOOD PRESSURE INCREASED (blood pressure increased), FATIGUE (Felt so fatigued), MYALGIA (had aching all over / muscle aches), NAUSEA (was so nauseous), HEADACHE (subsequently started getting headaches) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: Normal. On an unknown date, Blood pressure measurement: 177/90 (High) 177/90.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's EKG was done by EMT.  The patient received I Tylenol and Motrin.  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, Nausea
Clinical narrative: blood pressure increased; Felt so fatigued; had aching all over / muscle aches; was so nauseous; subsequently started getting headaches; chills; about 10-15 mins after, I started getting arrhythmia; started having trouble catching up my breath; also have lot of pressure on my head; felt very very weak; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (about 10-15 mins after, I started getting arrhythmia) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No  medical history was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METOPROLOL SUCCINATE (TOPROL), LISINOPRIL (ZESTRIL) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced ARRHYTHMIA (about 10-15 mins after, I started getting arrhythmia) (seriousness criterion medically significant). 23-Apr-2021, the patient experienced DYSPNOEA (started having trouble catching up my breath), HEAD DISCOMFORT (also have lot of pressure on my head), ASTHENIA (felt very very weak), FATIGUE (Felt so fatigued), MYALGIA (had aching all over / muscle aches), NAUSEA (was so nauseous), HEADACHE (subsequently started getting headaches) and CHILLS (chills). On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (blood pressure increased). At the time of the report, ARRHYTHMIA (about 10-15 mins after, I started getting arrhythmia), DYSPNOEA (started having trouble catching up my breath), HEAD DISCOMFORT (also have lot of pressure on my head), ASTHENIA (felt very very weak), BLOOD PRESSURE INCREASED (blood pressure increased), FATIGUE (Felt so fatigued), MYALGIA (had aching all over / muscle aches), NAUSEA (was so nauseous), HEADACHE (subsequently started getting headaches) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: Normal. On an unknown date, Blood pressure measurement: 177/90 (High) 177/90.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's EKG was done by EMT.  The patient received I Tylenol and Motrin.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Aura, Fatigue, Headache, Palpitations
Clinical narrative: aura seizure; aura seizure; fatigue; headache; heart palpitations; aphasia; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (aura seizure) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MARIJUANA for an unknown indication.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PALPITATIONS (heart palpitations), APHASIA (aphasia), FATIGUE (fatigue) and HEADACHE (headache). On 30-Apr-2021, the patient experienced SEIZURE (aura seizure) (seriousness criterion medically significant) and AURA (aura seizure). At the time of the report, SEIZURE (aura seizure), PALPITATIONS (heart palpitations), APHASIA (aphasia), AURA (aura seizure), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was provided by the reporter.  Treatment included Aspirin for headache.  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. However, the previous history of previous injury, is a confounder.; 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, the previous history of previous injury, is a confounder.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: aura seizure; aura seizure; fatigue; headache; heart palpitations; aphasia; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (aura seizure) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MARIJUANA for an unknown indication.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PALPITATIONS (heart palpitations), APHASIA (aphasia), FATIGUE (fatigue) and HEADACHE (headache). On 30-Apr-2021, the patient experienced SEIZURE (aura seizure) (seriousness criterion medically significant) and AURA (aura seizure). At the time of the report, SEIZURE (aura seizure), PALPITATIONS (heart palpitations), APHASIA (aphasia), AURA (aura seizure), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was provided by the reporter.  Treatment included Aspirin for headache.  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. However, the previous history of previous injury, is a confounder.; 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, the previous history of previous injury, is a confounder.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Head titubation, Impaired work ability, Intentional overdose, Sleep deficit
Clinical narrative: Got worse; Overdosed; Sleep deprived for so long; Couldn't function; Felt suicidal/Wanted commit suicide (described as the patient overdosed); Tinnitus; Head tremors; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of INTENTIONAL OVERDOSE (Overdosed), TINNITUS (Tinnitus), HEAD TITUBATION (Head tremors), SLEEP DEFICIT (Sleep deprived for so long), IMPAIRED WORK ABILITY (Couldn't function) and CONDITION AGGRAVATED (Got worse) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced TINNITUS (Tinnitus) (seriousness criterion hospitalization) and HEAD TITUBATION (Head tremors) (seriousness criterion hospitalization). In April 2021, the patient experienced INTENTIONAL OVERDOSE (Overdosed) (seriousness criterion hospitalization), SLEEP DEFICIT (Sleep deprived for so long) (seriousness criterion hospitalization) and IMPAIRED WORK ABILITY (Couldn't function) (seriousness criterion hospitalization). On an unknown date, the patient experienced CONDITION AGGRAVATED (Got worse) (seriousness criterion hospitalization). The patient was hospitalized from sometime in March 2021 to sometime in April 2021 due to CONDITION AGGRAVATED, then on sometime in March 2021 due to SUICIDAL IDEATION, then on 18-Apr-2021 due to HEAD TITUBATION, IMPAIRED WORK ABILITY, INTENTIONAL OVERDOSE, SLEEP DEFICIT and TINNITUS. At the time of the report, INTENTIONAL OVERDOSE (Overdosed), TINNITUS (Tinnitus), HEAD TITUBATION (Head tremors), SLEEP DEFICIT (Sleep deprived for so long), IMPAIRED WORK ABILITY (Couldn't function) and CONDITION AGGRAVATED (Got worse) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment for the event included stomach pumping, psychiatric medications and Vitamin D. The patient was initially hospitalized on an unknown date in Mar 2021 due to suicidal tendency and was discharged on an unknown date in Apr 2021, then readmitted on 18 Apr 2021 due to inability to work, tinnitus, head tremor and suicidal tendency. This case was linked to MOD-2021-100820 (Patient Link).; Sender's Comments: Very limited information regarding the events (Suicidal ideation and other events) has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the event (tinnitus), a causal relationship cannot be excluded. Additional information regarding medical history and concomitant medications are required for further evaluation.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Suicidal ideation, Tinnitus
Clinical narrative: Got worse; Overdosed; Sleep deprived for so long; Couldn't function; Felt suicidal/Wanted commit suicide (described as the patient overdosed); Tinnitus; Head tremors; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of INTENTIONAL OVERDOSE (Overdosed), TINNITUS (Tinnitus), HEAD TITUBATION (Head tremors), SLEEP DEFICIT (Sleep deprived for so long), IMPAIRED WORK ABILITY (Couldn't function) and CONDITION AGGRAVATED (Got worse) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced TINNITUS (Tinnitus) (seriousness criterion hospitalization) and HEAD TITUBATION (Head tremors) (seriousness criterion hospitalization). In April 2021, the patient experienced INTENTIONAL OVERDOSE (Overdosed) (seriousness criterion hospitalization), SLEEP DEFICIT (Sleep deprived for so long) (seriousness criterion hospitalization) and IMPAIRED WORK ABILITY (Couldn't function) (seriousness criterion hospitalization). On an unknown date, the patient experienced CONDITION AGGRAVATED (Got worse) (seriousness criterion hospitalization). The patient was hospitalized from sometime in March 2021 to sometime in April 2021 due to CONDITION AGGRAVATED, then on sometime in March 2021 due to SUICIDAL IDEATION, then on 18-Apr-2021 due to HEAD TITUBATION, IMPAIRED WORK ABILITY, INTENTIONAL OVERDOSE, SLEEP DEFICIT and TINNITUS. At the time of the report, INTENTIONAL OVERDOSE (Overdosed), TINNITUS (Tinnitus), HEAD TITUBATION (Head tremors), SLEEP DEFICIT (Sleep deprived for so long), IMPAIRED WORK ABILITY (Couldn't function) and CONDITION AGGRAVATED (Got worse) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment for the event included stomach pumping, psychiatric medications and Vitamin D. The patient was initially hospitalized on an unknown date in Mar 2021 due to suicidal tendency and was discharged on an unknown date in Apr 2021, then readmitted on 18 Apr 2021 due to inability to work, tinnitus, head tremor and suicidal tendency. This case was linked to MOD-2021-100820 (Patient Link).; Sender's Comments: Very limited information regarding the events (Suicidal ideation and other events) has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the event (tinnitus), a causal relationship cannot be excluded. Additional information regarding medical history and concomitant medications are required for further evaluation.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Headache, Heart rate, Heart rate decreased
Clinical narrative: Heart rate went up to 72; Bad headaches; Nauseated; Vomiting; Briefly lost consciousness; Had trouble breathing; Oxygen saturation dropped to 82 then jumped to 90's and continued to climb; Heart rate 52 bpm; Coughing a lot; Wheezing; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Briefly lost consciousness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (exacerbation medications).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Briefly lost consciousness) (seriousness criterion medically significant), DYSPNOEA (Had trouble breathing), OXYGEN SATURATION DECREASED (Oxygen saturation dropped to 82 then jumped to 90's and continued to climb), HEART RATE DECREASED (Heart rate 52 bpm), COUGH (Coughing a lot), WHEEZING (Wheezing), HEADACHE (Bad headaches), NAUSEA (Nauseated) and VOMITING (Vomiting). On an unknown date, the patient experienced HEART RATE INCREASED (Heart rate went up to 72). On 31-Mar-2021, LOSS OF CONSCIOUSNESS (Briefly lost consciousness) had resolved. At the time of the report, DYSPNOEA (Had trouble breathing), OXYGEN SATURATION DECREASED (Oxygen saturation dropped to 82 then jumped to 90's and continued to climb), HEART RATE DECREASED (Heart rate 52 bpm), COUGH (Coughing a lot), HEART RATE INCREASED (Heart rate went up to 72), HEADACHE (Bad headaches), NAUSEA (Nauseated) and VOMITING (Vomiting) outcome was unknown and WHEEZING (Wheezing) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Heart rate: 52 (Low) low down to 52 bpm and only went back up to 72 for the next 3 days. On 31-Mar-2021, Oxygen saturation: 85 (Low) 82 then jumped to 90's and continued to climb.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported. It was reported that, patient went in for a 2nd shot on thursday and they wouldn't give it to her because she had a severe allergic reaction.  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; 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Loss of consciousness, Nausea, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: Heart rate went up to 72; Bad headaches; Nauseated; Vomiting; Briefly lost consciousness; Had trouble breathing; Oxygen saturation dropped to 82 then jumped to 90's and continued to climb; Heart rate 52 bpm; Coughing a lot; Wheezing; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Briefly lost consciousness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (exacerbation medications).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Briefly lost consciousness) (seriousness criterion medically significant), DYSPNOEA (Had trouble breathing), OXYGEN SATURATION DECREASED (Oxygen saturation dropped to 82 then jumped to 90's and continued to climb), HEART RATE DECREASED (Heart rate 52 bpm), COUGH (Coughing a lot), WHEEZING (Wheezing), HEADACHE (Bad headaches), NAUSEA (Nauseated) and VOMITING (Vomiting). On an unknown date, the patient experienced HEART RATE INCREASED (Heart rate went up to 72). On 31-Mar-2021, LOSS OF CONSCIOUSNESS (Briefly lost consciousness) had resolved. At the time of the report, DYSPNOEA (Had trouble breathing), OXYGEN SATURATION DECREASED (Oxygen saturation dropped to 82 then jumped to 90's and continued to climb), HEART RATE DECREASED (Heart rate 52 bpm), COUGH (Coughing a lot), HEART RATE INCREASED (Heart rate went up to 72), HEADACHE (Bad headaches), NAUSEA (Nauseated) and VOMITING (Vomiting) outcome was unknown and WHEEZING (Wheezing) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Heart rate: 52 (Low) low down to 52 bpm and only went back up to 72 for the next 3 days. On 31-Mar-2021, Oxygen saturation: 85 (Low) 82 then jumped to 90's and continued to climb.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported. It was reported that, patient went in for a 2nd shot on thursday and they wouldn't give it to her because she had a severe allergic reaction.  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; 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, Wheezing
Clinical narrative: Heart rate went up to 72; Bad headaches; Nauseated; Vomiting; Briefly lost consciousness; Had trouble breathing; Oxygen saturation dropped to 82 then jumped to 90's and continued to climb; Heart rate 52 bpm; Coughing a lot; Wheezing; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Briefly lost consciousness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (exacerbation medications).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Briefly lost consciousness) (seriousness criterion medically significant), DYSPNOEA (Had trouble breathing), OXYGEN SATURATION DECREASED (Oxygen saturation dropped to 82 then jumped to 90's and continued to climb), HEART RATE DECREASED (Heart rate 52 bpm), COUGH (Coughing a lot), WHEEZING (Wheezing), HEADACHE (Bad headaches), NAUSEA (Nauseated) and VOMITING (Vomiting). On an unknown date, the patient experienced HEART RATE INCREASED (Heart rate went up to 72). On 31-Mar-2021, LOSS OF CONSCIOUSNESS (Briefly lost consciousness) had resolved. At the time of the report, DYSPNOEA (Had trouble breathing), OXYGEN SATURATION DECREASED (Oxygen saturation dropped to 82 then jumped to 90's and continued to climb), HEART RATE DECREASED (Heart rate 52 bpm), COUGH (Coughing a lot), HEART RATE INCREASED (Heart rate went up to 72), HEADACHE (Bad headaches), NAUSEA (Nauseated) and VOMITING (Vomiting) outcome was unknown and WHEEZING (Wheezing) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Heart rate: 52 (Low) low down to 52 bpm and only went back up to 72 for the next 3 days. On 31-Mar-2021, Oxygen saturation: 85 (Low) 82 then jumped to 90's and continued to climb.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported. It was reported that, patient went in for a 2nd shot on thursday and they wouldn't give it to her because she had a severe allergic reaction.  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; 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
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram
Clinical narrative: atrial fibrillation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation) 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. On an unknown date, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Very limited information regarding this event has been provided at this time. The patient's past history of atrial fibrillation is a confounder.
Age: 76.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Eye inflammation, Facial pain, Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Pain in face; Ophthalmic herpes zoster; Eye inflammation; Shingles; This spontaneous case was reported by a consumer and describes the occurrence of OPHTHALMIC HERPES ZOSTER (Ophthalmic herpes zoster) in a 76-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 05-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) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1. On 02-Feb-2021, the patient experienced EYE INFLAMMATION (Eye inflammation). In February 2021, the patient experienced HERPES ZOSTER (Shingles). In April 2021, the patient experienced OPHTHALMIC HERPES ZOSTER (Ophthalmic herpes zoster) (seriousness criterion medically significant). On an unknown date, the patient experienced FACIAL PAIN (Pain in face). At the time of the report, OPHTHALMIC HERPES ZOSTER (Ophthalmic herpes zoster), EYE INFLAMMATION (Eye inflammation), FACIAL PAIN (Pain in face) and HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included prednisone.  Very limited information regarding the events has been provided at this time. Additional information regarding date of vaccination and Humira infusion, and correct onset date for the events are required for further evaluation.; Sender's Comments: Very limited information regarding the events has been provided at this time. Additional information regarding date of vaccination and Humira infusion, and correct onset date for the events are required for further evaluation.
Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Alopecia, Dry skin, Loss of consciousness, Muscle spasms, Nasal dryness
Clinical narrative: Passed out 3 times after Moderna vaccine; hair thinning; dry skin and nose; dry skin and nose; muscle spasm in back; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out 3 times after Moderna vaccine) in a 73-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.    Co-suspect product included non-company product PALBOCICLIB (IBRANCE) for Breast cancer.    Concurrent medical conditions included Breast cancer, Acute cystitis, Anxiety, Lipid metabolism disorder NOS, Unspecified disorder of thyroid, Dizziness, Giddiness, Hyperlipidemia, Hypokalemia, Pure hypercholesterolemia, Thyrotoxicosis, Acquired hypothyroidism, Urinary tract infection, Drug allergy (Allergy to Amoxycillin), Drug allergy (Allergy to Sulfa) and Drug allergy (Allergy to Penicillin.). Concomitant products included DOCOSANOL (ABREVA), ANASTROZOLE, ATORVASTATIN CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (CALTRATE +VIT.D), MECLIZINE HCL, PROCHLORPERAZINE MALEATE, ZOLEDRONIC ACID MONOHYDRATE (ZOMETA) and LEVOTHYROXINE SODIUM (SYNTHYROID) for an unknown indication.   In February 2021, the patient started PALBOCICLIB (IBRANCE) (unknown route) 125 milligram. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out 3 times after Moderna vaccine) (seriousness criterion medically significant), ALOPECIA (hair thinning), DRY SKIN (dry skin and nose), NASAL DRYNESS (dry skin and nose) and MUSCLE SPASMS (muscle spasm in back). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out 3 times after Moderna vaccine), ALOPECIA (hair thinning), DRY SKIN (dry skin and nose), NASAL DRYNESS (dry skin and nose) and MUSCLE SPASMS (muscle spasm in back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that the co-suspect drug Ibrance (palbociclib) was taken once daily for 21 days.  The patient reported that she went to ER (emergency room) for "passing out".   No treatment information was provided.  Very limited information regarding these events has been provided at this time. The patient's medical history and con meds are confounders.; Sender's Comments: Very limited information regarding these events has been provided at this time. The patient's medical history and con meds are confounders.
Age: 56.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chills, Contusion, Fatigue, Gastrointestinal disorder, Impaired healing
Clinical narrative: Colon stenosis; Unspecified disorder of intestine; Post-procedural pain; Surgical scar; Laceration; Wound healing delayed; Bruise; Nighmare; Chills; Muscle aches; Fever; Fatigue; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of LARGE INTESTINAL STENOSIS (Colon stenosis) in a 56-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    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 and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced LARGE INTESTINAL STENOSIS (Colon stenosis) (seriousness criterion medically significant), GASTROINTESTINAL DISORDER (Unspecified disorder of intestine), PROCEDURAL PAIN (Post-procedural pain), SCAR (Surgical scar), SKIN LACERATION (Laceration), IMPAIRED HEALING (Wound healing delayed), CONTUSION (Bruise), NIGHTMARE (Nighmare), CHILLS (Chills), MYALGIA (Muscle aches), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, LARGE INTESTINAL STENOSIS (Colon stenosis), GASTROINTESTINAL DISORDER (Unspecified disorder of intestine), PROCEDURAL PAIN (Post-procedural pain), SCAR (Surgical scar), SKIN LACERATION (Laceration), IMPAIRED HEALING (Wound healing delayed) and CONTUSION (Bruise) had not resolved and NIGHTMARE (Nighmare), CHILLS (Chills), MYALGIA (Muscle aches), PYREXIA (Fever) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medicines were reported. No treatment information were reported.   Action taken with the drug in response to events was not applicable.  Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. A causal relationship cannot be excluded for the events of fatigue, chills, pyrexia, and myalgia.   This case was linked to (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. A causal relationship cannot be excluded for the events of fatigue, chills, pyrexia, and myalgia.