chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Amnesia, Dysstasia, Fatigue, Headache
Clinical narrative: blacked out; can't remember much about it and don't know how she got on the floor; hard to get up; headache; still tired; stomach is real messed up; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach is real messed up), HEADACHE (headache) and FATIGUE (still tired). On 22-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacked out) (seriousness criterion medically significant), AMNESIA (can't remember much about it and don't know how she got on the floor) and DYSSTASIA (hard to get up). On 22-Apr-2021, LOSS OF CONSCIOUSNESS (blacked out) and DYSSTASIA (hard to get up) had resolved. At the time of the report, AMNESIA (can't remember much about it and don't know how she got on the floor) outcome was unknown, ABDOMINAL DISCOMFORT (stomach is real messed up) and FATIGUE (still tired) had not resolved and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.  Treatment information was not provided.  Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Headache and fatigue are consistent with the product safety profile; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Headache and fatigue are consistent with the product safety profile
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: blacked out; can't remember much about it and don't know how she got on the floor; hard to get up; headache; still tired; stomach is real messed up; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach is real messed up), HEADACHE (headache) and FATIGUE (still tired). On 22-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacked out) (seriousness criterion medically significant), AMNESIA (can't remember much about it and don't know how she got on the floor) and DYSSTASIA (hard to get up). On 22-Apr-2021, LOSS OF CONSCIOUSNESS (blacked out) and DYSSTASIA (hard to get up) had resolved. At the time of the report, AMNESIA (can't remember much about it and don't know how she got on the floor) outcome was unknown, ABDOMINAL DISCOMFORT (stomach is real messed up) and FATIGUE (still tired) had not resolved and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.  Treatment information was not provided.  Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Headache and fatigue are consistent with the product safety profile; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Headache and fatigue are consistent with the product safety profile
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Hernia
Clinical narrative: hernia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERNIA (hernia) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hernia.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERNIA (hernia) (seriousness criterion hospitalization). The patient was hospitalized on 19-Apr-2021 due to HERNIA. At the time of the report, HERNIA (hernia) 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.   Patient also takes blood pressure medication.  Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Dehydration, Dizziness, Feeling abnormal, Loss of consciousness
Clinical narrative: Blacked out and passed out completely; Next morning, around 6:30am, I woke up feeling dizzy; Morning after second dose, my temperature was 99.3degF; Breast pain on my left side which has been there for a while after the second shot; Felt so dehydrated after the second shot; My head felt a little muddled; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Blacked out and passed out completely) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced FEELING ABNORMAL (My head felt a little muddled), BREAST PAIN (Breast pain on my left side which has been there for a while after the second shot) and DEHYDRATION (Felt so dehydrated after the second shot). On 10-Apr-2021, the patient experienced PYREXIA (Morning after second dose, my temperature was 99.3degF). On 10-Apr-2021 at 6:30 AM, the patient experienced DIZZINESS (Next morning, around 6:30am, I woke up feeling dizzy). On 10-Apr-2021 at 9:45 AM, the patient experienced LOSS OF CONSCIOUSNESS (Blacked out and passed out completely) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Blacked out and passed out completely) had resolved, FEELING ABNORMAL (My head felt a little muddled), BREAST PAIN (Breast pain on my left side which has been there for a while after the second shot) and DEHYDRATION (Felt so dehydrated after the second shot) had not resolved and DIZZINESS (Next morning, around 6:30am, I woke up feeling dizzy) and PYREXIA (Morning after second dose, my temperature was 99.3degF) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Physical examination: normal.         On 10-Apr-2021, the patient blacked out and passed out completely. She gained consciousness as her family members were carrying her. Her regular body temperature is 97.6degF. The patient felt so dehydrated after the second shot that her son had to keep on giving her water every 15 minutes. The patient took Tylenol for the symptoms. The patient also had physical examination with her gynecologist before first shot and it was normal.   This case was linked to MOD-2021-089609 (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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Physical examination, Pyrexia
Clinical narrative: Blacked out and passed out completely; Next morning, around 6:30am, I woke up feeling dizzy; Morning after second dose, my temperature was 99.3degF; Breast pain on my left side which has been there for a while after the second shot; Felt so dehydrated after the second shot; My head felt a little muddled; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Blacked out and passed out completely) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced FEELING ABNORMAL (My head felt a little muddled), BREAST PAIN (Breast pain on my left side which has been there for a while after the second shot) and DEHYDRATION (Felt so dehydrated after the second shot). On 10-Apr-2021, the patient experienced PYREXIA (Morning after second dose, my temperature was 99.3degF). On 10-Apr-2021 at 6:30 AM, the patient experienced DIZZINESS (Next morning, around 6:30am, I woke up feeling dizzy). On 10-Apr-2021 at 9:45 AM, the patient experienced LOSS OF CONSCIOUSNESS (Blacked out and passed out completely) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Blacked out and passed out completely) had resolved, FEELING ABNORMAL (My head felt a little muddled), BREAST PAIN (Breast pain on my left side which has been there for a while after the second shot) and DEHYDRATION (Felt so dehydrated after the second shot) had not resolved and DIZZINESS (Next morning, around 6:30am, I woke up feeling dizzy) and PYREXIA (Morning after second dose, my temperature was 99.3degF) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Physical examination: normal.         On 10-Apr-2021, the patient blacked out and passed out completely. She gained consciousness as her family members were carrying her. Her regular body temperature is 97.6degF. The patient felt so dehydrated after the second shot that her son had to keep on giving her water every 15 minutes. The patient took Tylenol for the symptoms. The patient also had physical examination with her gynecologist before first shot and it was normal.   This case was linked to MOD-2021-089609 (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.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: felt a lot of pain from  COVID vaccination; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (felt a lot of pain from  COVID vaccination) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included TREPROSTINIL DIOLAMIN (ORENITRAM) from 17-Jan-2020 to an unknown date for Pulmonary arterial hypertension, MACITENTAN (OPSUMIT) and TADALAFIL (ADCIRCA) for an unknown indication.   On 25-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (felt a lot of pain from  COVID vaccination) (seriousness criterion hospitalization). The patient was hospitalized from 27-Mar-2021 to 04-Apr-2021 due to PAIN. At the time of the report, PAIN (felt a lot of pain from  COVID vaccination) outcome was unknown.            Treatment information 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 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Chest X-ray, Dyspnoea, Respiratory failure
Clinical narrative: Shortness of breath; COVID-19 pneumonia; COVID-19 infection; Hypoxic respiratory failure; sepsis; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of RESPIRATORY FAILURE (Hypoxic respiratory failure), SEPSIS (sepsis), COVID-19 PNEUMONIA (COVID-19 pneumonia), COVID-19 (COVID-19 infection) and DYSPNOEA (Shortness of breath) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart failure with preserved ejection fraction. Concurrent medical conditions included COPD exacerbation (On 2 liters of oxygen at baseline), Squamous cell carcinoma of lung, Schizoaffective disorder and oxygen.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criteria hospitalization and medically significant) and COVID-19 (COVID-19 infection) (seriousness criterion hospitalization). On 16-Apr-2021, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization). On an unknown date, the patient experienced RESPIRATORY FAILURE (Hypoxic respiratory failure) (seriousness criteria hospitalization and medically significant) and SEPSIS (sepsis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized until 21-Apr-2021 due to COVID-19, COVID-19 PNEUMONIA, DYSPNOEA, RESPIRATORY FAILURE and SEPSIS. At the time of the report, RESPIRATORY FAILURE (Hypoxic respiratory failure), SEPSIS (sepsis), COVID-19 PNEUMONIA (COVID-19 pneumonia) and COVID-19 (COVID-19 infection) had resolved and DYSPNOEA (Shortness of breath) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Chest X-ray: abnormal (abnormal) multifocal pneumonia in the setting of chronic Interstitial changes..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information provided included 6L O2 Nasal cannula, Remdesivir for 5 days (stop date : 20 - Apr - 2021) ,Decadron for 6 days (stop date : 21 - Apr - 2021) . The patient was discharged on 21 Apr 2021 to rehabilitation on baseline 2L O2  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.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Sepsis
Clinical narrative: Shortness of breath; COVID-19 pneumonia; COVID-19 infection; Hypoxic respiratory failure; sepsis; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of RESPIRATORY FAILURE (Hypoxic respiratory failure), SEPSIS (sepsis), COVID-19 PNEUMONIA (COVID-19 pneumonia), COVID-19 (COVID-19 infection) and DYSPNOEA (Shortness of breath) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart failure with preserved ejection fraction. Concurrent medical conditions included COPD exacerbation (On 2 liters of oxygen at baseline), Squamous cell carcinoma of lung, Schizoaffective disorder and oxygen.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criteria hospitalization and medically significant) and COVID-19 (COVID-19 infection) (seriousness criterion hospitalization). On 16-Apr-2021, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization). On an unknown date, the patient experienced RESPIRATORY FAILURE (Hypoxic respiratory failure) (seriousness criteria hospitalization and medically significant) and SEPSIS (sepsis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized until 21-Apr-2021 due to COVID-19, COVID-19 PNEUMONIA, DYSPNOEA, RESPIRATORY FAILURE and SEPSIS. At the time of the report, RESPIRATORY FAILURE (Hypoxic respiratory failure), SEPSIS (sepsis), COVID-19 PNEUMONIA (COVID-19 pneumonia) and COVID-19 (COVID-19 infection) had resolved and DYSPNOEA (Shortness of breath) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Chest X-ray: abnormal (abnormal) multifocal pneumonia in the setting of chronic Interstitial changes..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information provided included 6L O2 Nasal cannula, Remdesivir for 5 days (stop date : 20 - Apr - 2021) ,Decadron for 6 days (stop date : 21 - Apr - 2021) . The patient was discharged on 21 Apr 2021 to rehabilitation on baseline 2L O2  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.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's palsy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus, Psoriatic arthritis, Hypertension and Thyroid disorder. Concomitant products included VITAMIN D [VITAMIN D NOS], LORATADINE, METFORMIN HYDROCHLORIDE (METFORMIN 1A PHARMA), SECUKINUMAB (COSENTYX), SIMVASTATIN (SIMVASTATIN +PHARMA) and HCTZ for an unknown indication.   On 11-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 24-Apr-2021, the patient experienced FACIAL PARALYSIS (Bell's palsy) (seriousness criterion disability). At the time of the report, FACIAL PARALYSIS (Bell's palsy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: This case concerns a 59-year-old female with a serious unexpected event of Facial paralysis. Event latency 14 days from second dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: Asthma symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Asthma symptoms) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     medical history of patient was not provided by the reporter.     On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced ASTHMA (Asthma symptoms) (seriousness criterion hospitalization). On 23-Apr-2021, ASTHMA (Asthma symptoms) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing was delayed on an unknown date.       No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Loss of consciousness, Product administration error, Pulmonary embolism
Clinical narrative: Blood clots in the legs and lungs; he passed out and still currently admitted in hospital; Blood clots in the legs and lungs; 2nd dose given 2 weeks from the 1st dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Blood clots in the legs and lungs), LOSS OF CONSCIOUSNESS (he passed out and still currently admitted in hospital) and DEEP VEIN THROMBOSIS (Blood clots in the legs and lungs) in a male patient of an unknown age 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (2nd dose given 2 weeks from the 1st dose). On 22-Apr-2021, the patient experienced PULMONARY EMBOLISM (Blood clots in the legs and lungs) (seriousness criteria hospitalization and medically significant), LOSS OF CONSCIOUSNESS (he passed out and still currently admitted in hospital) (seriousness criteria hospitalization and medically significant) and DEEP VEIN THROMBOSIS (Blood clots in the legs and lungs) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 22-Apr-2021 due to DEEP VEIN THROMBOSIS, LOSS OF CONSCIOUSNESS and PULMONARY EMBOLISM. On 19-Mar-2021, PRODUCT ADMINISTRATION ERROR (2nd dose given 2 weeks from the 1st dose) had resolved. On 22-Apr-2021, LOSS OF CONSCIOUSNESS (he passed out and still currently admitted in hospital) had resolved. At the time of the report, PULMONARY EMBOLISM (Blood clots in the legs and lungs) and DEEP VEIN THROMBOSIS (Blood clots in the legs and lungs) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. Patient reported that he had diagnosed to have blood clots in the leg and lungs and had unspecified procedure. Patient reported that he was given a unknown medication.; 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 reported drug administration error (2nd dose administered 2 weeks from 1st dose) may remain a confounder.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Atrioventricular block complete, Dizziness, Eczema, Rash
Clinical narrative: Complete heart block; Light headed; has eczema on his elbow which is really red and itchy; Rash on arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIOVENTRICULAR BLOCK COMPLETE (Complete heart block) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bundle branch block right.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced ATRIOVENTRICULAR BLOCK COMPLETE (Complete heart block) (seriousness criteria hospitalization prolonged and medically significant), DIZZINESS (Light headed), ECZEMA (has eczema on his elbow which is really red and itchy) and RASH (Rash on arm). The patient was hospitalized for 5 days due to ATRIOVENTRICULAR BLOCK COMPLETE. At the time of the report, ATRIOVENTRICULAR BLOCK COMPLETE (Complete heart block), DIZZINESS (Light headed) and ECZEMA (has eczema on his elbow which is really red and itchy) outcome was unknown and RASH (Rash on arm) was resolving.            Treatment medication included prescription cream for rash and cardiac pace maker implantation.   On 07 Apr 2021, post vaccination, the patient reported feeling really lightheaded and developed a horrible rash on his arm. The patient went to the hospital and was admitted for 4 nights and 5 days. During the hospitalization, it was confirmed the patient had a complete heart block and required a pacemaker to be implanted.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-090429 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-090429:Crosslinked case
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Became sick; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (Became sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GAMMA GLOBULIN from 12-Jan-2021 to an unknown date for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (Became sick) (seriousness criterion hospitalization). The patient was hospitalized from 19-Feb-2021 to 03-Mar-2021 due to ILLNESS. At the time of the report, ILLNESS (Became sick) outcome was unknown. Not Provided          Patient  was going to get the second Gama globulin infusion 4 days after the second dose. Treatment included oxygen since hospitalization (19 Feb 2021). Reporter  wanted to know about the interaction between the Gama globulin infusion affects and the Moderna shot.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Gallbladder disorder, Inappropriate schedule of product administration
Clinical narrative: pneumonia caused by covid-19; Galbladder issues; Inappropriate schedule of vaccine administered; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 PNEUMONIA (pneumonia caused by covid-19) and GALLBLADDER DISORDER (Galbladder issues) in a male patient of an unknown age 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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On an unknown date, the patient experienced COVID-19 PNEUMONIA (pneumonia caused by covid-19) (seriousness criterion hospitalization), GALLBLADDER DISORDER (Galbladder issues) (seriousness criterion hospitalization prolonged) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, COVID-19 PNEUMONIA (pneumonia caused by covid-19) and GALLBLADDER DISORDER (Galbladder issues) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. No treatment information was provided.  It was reported that the patient is currently residing in a nursing facility and was informed by his nurse that on 26Apr2021 or 27Apr2021 he would be taken to get the second dose of the vaccine.  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: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: bell's palsy; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (bell's palsy) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.   No Medical History information was reported.  On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced FACIAL PARALYSIS (bell's palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (bell's palsy) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medications reported. The patient was treated with prednisone.  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: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hallucination, Hypokinesia, Loss of personal independence in daily activities
Clinical narrative: fevers; joint pain; chill; muscle aches; intermittent hallucinations; swelling in bilateral feet; unable to use the right arm; difficulty performing ADL; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HALLUCINATION (intermittent hallucinations) in a 72-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 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PYREXIA (fevers), ARTHRALGIA (joint pain), CHILLS (chill) and MYALGIA (muscle aches). In April 2021, the patient experienced HALLUCINATION (intermittent hallucinations) (seriousness criterion medically significant), PERIPHERAL SWELLING (swelling in bilateral feet), HYPOKINESIA (unable to use the right arm) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty performing ADL). At the time of the report, HALLUCINATION (intermittent hallucinations), PERIPHERAL SWELLING (swelling in bilateral feet), HYPOKINESIA (unable to use the right arm), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty performing ADL), PYREXIA (fevers), ARTHRALGIA (joint pain), CHILLS (chill) and MYALGIA (muscle aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Patient is taking unspecified medications for treatment of the events.  This case concerns a 72-year-old male with a serious unexpected event of hallucination, and nonserious unexpected peripheral swelling, hypokinesia, loss of personal independence in daily activities, and expected pyrexia, chills, myalgia, arthralgia. Event onset 2 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 72-year-old male with a serious unexpected event of hallucination, and nonserious unexpected peripheral swelling, hypokinesia, loss of personal independence in daily activities, and expected pyrexia, chills, myalgia, arthralgia. Event onset 2 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Peripheral swelling, Pyrexia
Clinical narrative: fevers; joint pain; chill; muscle aches; intermittent hallucinations; swelling in bilateral feet; unable to use the right arm; difficulty performing ADL; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HALLUCINATION (intermittent hallucinations) in a 72-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 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PYREXIA (fevers), ARTHRALGIA (joint pain), CHILLS (chill) and MYALGIA (muscle aches). In April 2021, the patient experienced HALLUCINATION (intermittent hallucinations) (seriousness criterion medically significant), PERIPHERAL SWELLING (swelling in bilateral feet), HYPOKINESIA (unable to use the right arm) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty performing ADL). At the time of the report, HALLUCINATION (intermittent hallucinations), PERIPHERAL SWELLING (swelling in bilateral feet), HYPOKINESIA (unable to use the right arm), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty performing ADL), PYREXIA (fevers), ARTHRALGIA (joint pain), CHILLS (chill) and MYALGIA (muscle aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Patient is taking unspecified medications for treatment of the events.  This case concerns a 72-year-old male with a serious unexpected event of hallucination, and nonserious unexpected peripheral swelling, hypokinesia, loss of personal independence in daily activities, and expected pyrexia, chills, myalgia, arthralgia. Event onset 2 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 72-year-old male with a serious unexpected event of hallucination, and nonserious unexpected peripheral swelling, hypokinesia, loss of personal independence in daily activities, and expected pyrexia, chills, myalgia, arthralgia. Event onset 2 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Ultrasound scan
Clinical narrative: Blood clot after receiving his second dose. Found out that he has Deep Vein Thrombosis (DVT); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (Blood clot after receiving his second dose. Found out that he has Deep Vein Thrombosis (DVT)) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 027L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IRON for Iron supplementation, APIXABAN (ELIQUIS), MIDODRINE, CLOPIDOGREL BISULFATE (PLAVIX), HYDROXYCHLOROQUINE, METHYLPREDNISOLONE, MIRABEGRON (MYRBETRIQ), MONTELUKAST, TAMSULOSIN, VITAMIN D3 and CYANOCOBALAMIN (VIT B12) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced DEEP VEIN THROMBOSIS (Blood clot after receiving his second dose. Found out that he has Deep Vein Thrombosis (DVT)) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (Blood clot after receiving his second dose. Found out that he has Deep Vein Thrombosis (DVT)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Ultrasound scan: clear (normal) Clear.         On 08-Mar-2021, the reporter noticed that the patient's left arm was swollen. The patient was taken to the emergency room  and was diagnosed with deep vein thrombosis. The patient was discharged on the same day. The patient was put on apixaban 10mg and later switched to apixaban 5mg. The patient would be monitored until ??-Sep-2021.   Company Comment: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: fighting an infection on a hospital; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFECTION (fighting an infection on a hospital) in a female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFECTION (fighting an infection on a hospital) (seriousness criterion hospitalization). At the time of the report, INFECTION (fighting an infection on a hospital) had not resolved.        Concomitant product use was not provided.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chlamydia test, Chlamydia test positive
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHLAMYDIA TEST POSITIVE (Vaccine caused chlamydia\positive chlamydia test) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 01ZAZ1A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced CHLAMYDIA TEST POSITIVE (Vaccine caused chlamydia\positive chlamydia test) (seriousness criterion medically significant). At the time of the report, CHLAMYDIA TEST POSITIVE (Vaccine caused chlamydia\positive chlamydia test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Chlamydia test: positive (Positive) positive.         Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided.  Company Comment: This case concerns a 29-year-old female with a serious unexpected event of Chlamydia test positive. Event onset with unknown latency after first dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 29-year-old female with a serious unexpected event of Chlamydia test positive. Event onset with unknown latency after first dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Deafness, Ear discomfort, Headache, Tinnitus
Clinical narrative: hearing loss; Ears popping; tinnitus/wavy sounds; headache; joint pain; This spontaneous case was reported by a pharmacist and describes the occurrence of DEAFNESS (hearing loss) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced HEADACHE (headache) and ARTHRALGIA (joint pain). On 18-Apr-2021, the patient experienced DEAFNESS (hearing loss) (seriousness criterion medically significant), EAR DISCOMFORT (Ears popping) and TINNITUS (tinnitus/wavy sounds). At the time of the report, DEAFNESS (hearing loss), EAR DISCOMFORT (Ears popping), TINNITUS (tinnitus/wavy sounds), HEADACHE (headache) and ARTHRALGIA (joint pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment information 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 events, a causal relationship cannot be excluded. However, 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. However, Further  information has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate increased, Hypertensive crisis, Insomnia, Limb injury
Clinical narrative: Had a spike in blood pressure (194/100); Increased heart rate; Toe injury/Minor bruising; Trouble sleeping; Sleeping pattern has changed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSIVE CRISIS (Had a spike in blood pressure (194/100)) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Insomnia. Concurrent medical conditions included White coat hypertension. Concomitant products included CALCIUM for Calcium supplementation, MELATONIN for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced HYPERTENSIVE CRISIS (Had a spike in blood pressure (194/100)) (seriousness criterion medically significant), HEART RATE INCREASED (Increased heart rate), LIMB INJURY (Toe injury/Minor bruising), INSOMNIA (Trouble sleeping) and SLEEP DISORDER (Sleeping pattern has changed). At the time of the report, HYPERTENSIVE CRISIS (Had a spike in blood pressure (194/100)), HEART RATE INCREASED (Increased heart rate), LIMB INJURY (Toe injury/Minor bruising), INSOMNIA (Trouble sleeping) and SLEEP DISORDER (Sleeping pattern has changed) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 194/100 (High) High.         Two weeks after receiving the vaccine the patient had trouble sleeping and sleeping pattern was changed. The patient reported that she had a spike in blood pressure (194/100) and increased heart rate when she went for doctor's appointment. She has white coat syndrome. The patient was prescribed Ativan 1-2 times a week as needed (after sleeping pattern changed). The patient consumed a cup of wine to help her fall asleep. On 06-Apr-2021 or 07-Apr-2021, the patient had a toe injury which caused minor bruising and sleep problems started around that time.  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, 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. However, Further information has been requested.