chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Decreased appetite, Influenza like illness, Mental impairment
Clinical narrative: inability to think straight; stomach ache; loss of appetite; weakness; achy feet and hands; feeling like she had the flu; nausea; fever; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (inability to think straight) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced MENTAL IMPAIRMENT (inability to think straight) (seriousness criterion intervention required), ABDOMINAL PAIN UPPER (stomach ache), DECREASED APPETITE (loss of appetite), ASTHENIA (weakness), PAIN (achy feet and hands), INFLUENZA LIKE ILLNESS (feeling like she had the flu), NAUSEA (nausea) and PYREXIA (fever). On an unknown date, the patient experienced MYALGIA (muscle ache). On 25-Apr-2021, PYREXIA (fever) had resolved. At the time of the report, MENTAL IMPAIRMENT (inability to think straight), ABDOMINAL PAIN UPPER (stomach ache), DECREASED APPETITE (loss of appetite), ASTHENIA (weakness), PAIN (achy feet and hands), INFLUENZA LIKE ILLNESS (feeling like she had the flu), NAUSEA (nausea) and MYALGIA (muscle ache) outcome was unknown.            Company Comment: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Nausea, fever and myalgia are consistent with the product safety profile.   This case was linked to MOD-2021-090510 (Patient Link).; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Nausea, fever and myalgia are consistent with the product safety profile
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: inability to think straight; stomach ache; loss of appetite; weakness; achy feet and hands; feeling like she had the flu; nausea; fever; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (inability to think straight) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced MENTAL IMPAIRMENT (inability to think straight) (seriousness criterion intervention required), ABDOMINAL PAIN UPPER (stomach ache), DECREASED APPETITE (loss of appetite), ASTHENIA (weakness), PAIN (achy feet and hands), INFLUENZA LIKE ILLNESS (feeling like she had the flu), NAUSEA (nausea) and PYREXIA (fever). On an unknown date, the patient experienced MYALGIA (muscle ache). On 25-Apr-2021, PYREXIA (fever) had resolved. At the time of the report, MENTAL IMPAIRMENT (inability to think straight), ABDOMINAL PAIN UPPER (stomach ache), DECREASED APPETITE (loss of appetite), ASTHENIA (weakness), PAIN (achy feet and hands), INFLUENZA LIKE ILLNESS (feeling like she had the flu), NAUSEA (nausea) and MYALGIA (muscle ache) outcome was unknown.            Company Comment: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Nausea, fever and myalgia are consistent with the product safety profile.   This case was linked to MOD-2021-090510 (Patient Link).; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Nausea, fever and myalgia are consistent with the product safety profile
Sex: F
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: Patient got sick after first shot and was admitted in the hospital; Patient missed second dose and its been more than 42 days already; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Patient got sick after first shot and was admitted in the hospital) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Patient got sick after first shot and was admitted in the hospital) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Patient missed second dose and its been more than 42 days already). At the time of the report, ILLNESS (Patient got sick after first shot and was admitted in the hospital) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient missed second dose and its been more than 42 days already) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No corrective treatment was provided. The patient was on several medications and did not want to go about listing all of them. she wants to know whether she should go ahead and get the second shot or not. She consents to follow up.  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: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Passed out for a little bit; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out for a little bit) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    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 LOSS OF CONSCIOUSNESS (Passed out for a little bit) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out for a little bit) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided.  Patient passed out for a little bit after his shot. After he came to, he felt thirsty and got some food.  No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the 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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Computerised tomogram, Concussion, Contusion, Eye injury
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   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 12-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), BACK PAIN (backache), CONCUSSION (concussion), EYE INJURY (injured bone under eye), CONTUSION (bruised hip), PAIN (face still sore) and PYREXIA (fever). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), BACK PAIN (backache), CONCUSSION (concussion), EYE INJURY (injured bone under eye), CONTUSION (bruised hip), PAIN (face still sore) and PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: unknown (Inconclusive) Unknown. On an unknown date, Magnetic resonance imaging: unknown (Inconclusive) Unknown.         Company comment :Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Fever is consistent with the product safety profile; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Fever is consistent with the product safety profile
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Magnetic resonance imaging, Pain, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   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 12-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), BACK PAIN (backache), CONCUSSION (concussion), EYE INJURY (injured bone under eye), CONTUSION (bruised hip), PAIN (face still sore) and PYREXIA (fever). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), BACK PAIN (backache), CONCUSSION (concussion), EYE INJURY (injured bone under eye), CONTUSION (bruised hip), PAIN (face still sore) and PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: unknown (Inconclusive) Unknown. On an unknown date, Magnetic resonance imaging: unknown (Inconclusive) Unknown.         Company comment :Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Fever is consistent with the product safety profile; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Fever is consistent with the product safety profile
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Pain in extremity
Clinical narrative: little Sore Arm; Pressure on the Chest; could not breath; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (could not breath) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy NOS (Patient is feeling fatigue and tired due to allergies.).    On 29-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 DYSPNOEA (could not breath) (seriousness criterion medically significant) and CHEST DISCOMFORT (Pressure on the Chest). On an unknown date, the patient experienced PAIN IN EXTREMITY (little Sore Arm). On 31-Mar-2021, DYSPNOEA (could not breath) and CHEST DISCOMFORT (Pressure on the Chest) had resolved. At the time of the report, PAIN IN EXTREMITY (little Sore Arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 97.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Somnolence
Clinical narrative: Possible Covid Spots; just wants to sleep all the time; "getting very tired"/more progressively tired"/"not wanting to do anything."; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Possible Covid Spots) and FATIGUE ("getting very tired"/more progressively tired"/"not wanting to do anything.") in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 28-Feb-2021, the patient experienced FATIGUE ("getting very tired"/more progressively tired"/"not wanting to do anything.") (seriousness criterion hospitalization). On 16-Apr-2021, the patient experienced SOMNOLENCE (just wants to sleep all the time). On an unknown date, the patient experienced COVID-19 (Possible Covid Spots) (seriousness criterion hospitalization). At the time of the report, COVID-19 (Possible Covid Spots), FATIGUE ("getting very tired"/more progressively tired"/"not wanting to do anything.") and SOMNOLENCE (just wants to sleep all the time) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was hospitalized and prescribed antibiotics. Multiple test were done including head CT and chest x-rays done that showed "possible COVID spots."  Patient was discharged to hospice.; Sender's Comments: Although a temporal association exist, based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the fatal event of Covid-19 and the product use is assessed as unlikely. Fatigue and somnolence are also assess as symptoms of Covid-19.  However, based on temporality, causality with the product use cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Unevaluable event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNEVALUABLE EVENT (Unevaluable event) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-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 17-Apr-2021, the patient experienced UNEVALUABLE EVENT (Unevaluable event) (seriousness criterion disability). At the time of the report, UNEVALUABLE EVENT (Unevaluable event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   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.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Blood pressure fluctuation, Blood test, Chest pain, Chills
Clinical narrative: Numbness on either side from my elbow to each knee; Shooting pain down my sternum; Wide variations in my blood pressure; Serious asthma attack; Body tremors; Dizziness, wooziness; Chills; Nausea; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHMA (Serious asthma attack) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and DIPHENHYDRAMINE for an unknown indication.    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 TREMOR (Body tremors), DIZZINESS (Dizziness, wooziness), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache). On 14-Apr-2021, the patient experienced ASTHMA (Serious asthma attack) (seriousness criterion medically significant). On 16-Apr-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (Wide variations in my blood pressure). On 20-Apr-2021, the patient experienced CHEST PAIN (Shooting pain down my sternum). On 22-Apr-2021, the patient experienced HYPOAESTHESIA (Numbness on either side from my elbow to each knee). On 01-Apr-2021, TREMOR (Body tremors) had resolved. On 16-Apr-2021, ASTHMA (Serious asthma attack) had resolved. On 21-Apr-2021, CHEST PAIN (Shooting pain down my sternum) had resolved. On 22-Apr-2021, HYPOAESTHESIA (Numbness on either side from my elbow to each knee) had resolved. On 25-Apr-2021, DIZZINESS (Dizziness, wooziness), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache) had resolved. At the time of the report, BLOOD PRESSURE FLUCTUATION (Wide variations in my blood pressure) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood test: normal (normal) All kinds of blood work came back fine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taken to the ER (emergency Room) on  20-APR-2021. Treatment for the events included antihistamine combination of Zyrtec and Diphenhydramine, Benadryl, and Baby Aspirin 81 mg.; Sender's Comments: This case concerns a 45-year-old female with a serious unexpected event of asthma, and nonserious unexpected blood pressure fluctuation, dizziness, chest pain, tremor, hypoaesthesia, and expected chills, headache, nausea. Event onset the same day as 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypoaesthesia, Nausea, Tremor
Clinical narrative: Numbness on either side from my elbow to each knee; Shooting pain down my sternum; Wide variations in my blood pressure; Serious asthma attack; Body tremors; Dizziness, wooziness; Chills; Nausea; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHMA (Serious asthma attack) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and DIPHENHYDRAMINE for an unknown indication.    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 TREMOR (Body tremors), DIZZINESS (Dizziness, wooziness), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache). On 14-Apr-2021, the patient experienced ASTHMA (Serious asthma attack) (seriousness criterion medically significant). On 16-Apr-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (Wide variations in my blood pressure). On 20-Apr-2021, the patient experienced CHEST PAIN (Shooting pain down my sternum). On 22-Apr-2021, the patient experienced HYPOAESTHESIA (Numbness on either side from my elbow to each knee). On 01-Apr-2021, TREMOR (Body tremors) had resolved. On 16-Apr-2021, ASTHMA (Serious asthma attack) had resolved. On 21-Apr-2021, CHEST PAIN (Shooting pain down my sternum) had resolved. On 22-Apr-2021, HYPOAESTHESIA (Numbness on either side from my elbow to each knee) had resolved. On 25-Apr-2021, DIZZINESS (Dizziness, wooziness), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache) had resolved. At the time of the report, BLOOD PRESSURE FLUCTUATION (Wide variations in my blood pressure) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood test: normal (normal) All kinds of blood work came back fine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taken to the ER (emergency Room) on  20-APR-2021. Treatment for the events included antihistamine combination of Zyrtec and Diphenhydramine, Benadryl, and Baby Aspirin 81 mg.; Sender's Comments: This case concerns a 45-year-old female with a serious unexpected event of asthma, and nonserious unexpected blood pressure fluctuation, dizziness, chest pain, tremor, hypoaesthesia, and expected chills, headache, nausea. Event onset the same day as 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.
Sex: U
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Fainting reaction) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Fainting reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Aspiration, Asthenia, Blood test, Chest X-ray
Clinical narrative: He had aspirated; Slept all day; Too weak to eat and was given a feeding tube; Not been able to talk; Not been able to swallow; Felt tired; Felt lethargic; Felt  weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASPIRATION (He had aspirated) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Intubation.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced LETHARGY (Felt lethargic), ASTHENIA (Felt  weak) and FATIGUE (Felt tired). On 02-Apr-2021, the patient experienced ASPIRATION (He had aspirated) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced HYPERSOMNIA (Slept all day), FEEDING DISORDER (Too weak to eat and was given a feeding tube), APHASIA (Not been able to talk) and DYSPHAGIA (Not been able to swallow). At the time of the report, ASPIRATION (He had aspirated), LETHARGY (Felt lethargic), ASTHENIA (Felt  weak), HYPERSOMNIA (Slept all day), FEEDING DISORDER (Too weak to eat and was given a feeding tube), APHASIA (Not been able to talk), DYSPHAGIA (Not been able to swallow) and FATIGUE (Felt tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Blood test: unknown unknown. On 01-Apr-2021, Chest X-ray: unknown unknown. On 01-Apr-2021, Magnetic resonance imaging: unknown 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.
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Fatigue, Feeding disorder, Hypersomnia, Lethargy
Clinical narrative: He had aspirated; Slept all day; Too weak to eat and was given a feeding tube; Not been able to talk; Not been able to swallow; Felt tired; Felt lethargic; Felt  weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASPIRATION (He had aspirated) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Intubation.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced LETHARGY (Felt lethargic), ASTHENIA (Felt  weak) and FATIGUE (Felt tired). On 02-Apr-2021, the patient experienced ASPIRATION (He had aspirated) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced HYPERSOMNIA (Slept all day), FEEDING DISORDER (Too weak to eat and was given a feeding tube), APHASIA (Not been able to talk) and DYSPHAGIA (Not been able to swallow). At the time of the report, ASPIRATION (He had aspirated), LETHARGY (Felt lethargic), ASTHENIA (Felt  weak), HYPERSOMNIA (Slept all day), FEEDING DISORDER (Too weak to eat and was given a feeding tube), APHASIA (Not been able to talk), DYSPHAGIA (Not been able to swallow) and FATIGUE (Felt tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Blood test: unknown unknown. On 01-Apr-2021, Chest X-ray: unknown unknown. On 01-Apr-2021, Magnetic resonance imaging: unknown 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.
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging
Clinical narrative: He had aspirated; Slept all day; Too weak to eat and was given a feeding tube; Not been able to talk; Not been able to swallow; Felt tired; Felt lethargic; Felt  weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASPIRATION (He had aspirated) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Intubation.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced LETHARGY (Felt lethargic), ASTHENIA (Felt  weak) and FATIGUE (Felt tired). On 02-Apr-2021, the patient experienced ASPIRATION (He had aspirated) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced HYPERSOMNIA (Slept all day), FEEDING DISORDER (Too weak to eat and was given a feeding tube), APHASIA (Not been able to talk) and DYSPHAGIA (Not been able to swallow). At the time of the report, ASPIRATION (He had aspirated), LETHARGY (Felt lethargic), ASTHENIA (Felt  weak), HYPERSOMNIA (Slept all day), FEEDING DISORDER (Too weak to eat and was given a feeding tube), APHASIA (Not been able to talk), DYSPHAGIA (Not been able to swallow) and FATIGUE (Felt tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Blood test: unknown unknown. On 01-Apr-2021, Chest X-ray: unknown unknown. On 01-Apr-2021, Magnetic resonance imaging: unknown 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.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelids pruritus, Lacrimation increased, Ocular discomfort, Periorbital swelling, Swelling of eyelid
Clinical narrative: Underneath my eyebrow is real puffy and the corner is puffy; Eyelids itching; Bottom of the eyelid itching and is progressed to swelling and it feels like sand paper in my eye; Bottom of the eyelid itching and is progressed to swelling and it feels like sand paper in my eye; it just started to run just a little bit; This spontaneous case was reported by a non-health professional and describes the occurrence of PERIORBITAL SWELLING (Underneath my eyebrow is real puffy and the corner is puffy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. EW0158) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Acid reflux (esophageal) and Anxiety attack. Concurrent medical conditions included Blood pressure high and Acquired hypothyroidism. Concomitant products included CLONAZEPAM for Anxiety attack, METOPROLOL, AMLODIPINE and OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PERIORBITAL SWELLING (Underneath my eyebrow is real puffy and the corner is puffy) (seriousness criterion medically significant), EYELIDS PRURITUS (Eyelids itching), SWELLING OF EYELID (Bottom of the eyelid itching and is progressed to swelling and it feels like sand paper in my eye), OCULAR DISCOMFORT (Bottom of the eyelid itching and is progressed to swelling and it feels like sand paper in my eye) and LACRIMATION INCREASED (it just started to run just a little bit). At the time of the report, PERIORBITAL SWELLING (Underneath my eyebrow is real puffy and the corner is puffy), EYELIDS PRURITUS (Eyelids itching), SWELLING OF EYELID (Bottom of the eyelid itching and is progressed to swelling and it feels like sand paper in my eye), OCULAR DISCOMFORT (Bottom of the eyelid itching and is progressed to swelling and it feels like sand paper in my eye) and LACRIMATION INCREASED (it just started to run just a little bit) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received treatment with Biotrue eye drops.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Tumour pain
Clinical narrative: all the tumor masses in her body were painful; all the tumor masses in her body were painful and uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of TUMOUR PAIN (all the tumor masses in her body were painful) and DISCOMFORT (all the tumor masses in her body were painful and uncomfortable) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Neurofibromatosis (Elephant man disease.). Concomitant products included MORPHINE for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-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 TUMOUR PAIN (all the tumor masses in her body were painful) (seriousness criterion medically significant) and DISCOMFORT (all the tumor masses in her body were painful and uncomfortable) (seriousness criterion medically significant). At the time of the report, TUMOUR PAIN (all the tumor masses in her body were painful) and DISCOMFORT (all the tumor masses in her body were painful and uncomfortable) outcome was unknown. Not Provided    Treatment of these events included the patient's concomitant use of morphine.  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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot in leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot in leg) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 02-Apr-2021, the patient experienced THROMBOSIS (Blood clot in leg) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 02-Apr-2021 to 06-Apr-2021 due to THROMBOSIS. The patient was treated with Surgery (Angioplasty) for Thrombosis. On 06-Apr-2021, THROMBOSIS (Blood clot in leg) had resolved. Not Provided          Concomitant product use was not provided by the reporter.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on current available information and the temporal association between product use and the stat date of the events a causal relationship cannot be excluded.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Asthenia, Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: multiple heart arrhythmias; increased sense of pressure in his chest; shortness of breath; light headed feeling; weakness; welt that was red, sore, and very hot; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (multiple heart arrhythmias) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertrophic cardiomyopathy (experiencing flare ups which he says he has had before).  On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (multiple heart arrhythmias) (seriousness criterion medically significant), CHEST DISCOMFORT (increased sense of pressure in his chest), DYSPNOEA (shortness of breath), DIZZINESS (light headed feeling), ASTHENIA (weakness), URTICARIA (welt that was red, sore, and very hot) and FATIGUE (tiredness). At the time of the report, ARRHYTHMIA (multiple heart arrhythmias), CHEST DISCOMFORT (increased sense of pressure in his chest), DYSPNOEA (shortness of breath), DIZZINESS (light headed feeling), ASTHENIA (weakness), URTICARIA (welt that was red, sore, and very hot) and FATIGUE (tiredness) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Company comment: Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Urticaria
Clinical narrative: multiple heart arrhythmias; increased sense of pressure in his chest; shortness of breath; light headed feeling; weakness; welt that was red, sore, and very hot; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (multiple heart arrhythmias) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertrophic cardiomyopathy (experiencing flare ups which he says he has had before).  On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (multiple heart arrhythmias) (seriousness criterion medically significant), CHEST DISCOMFORT (increased sense of pressure in his chest), DYSPNOEA (shortness of breath), DIZZINESS (light headed feeling), ASTHENIA (weakness), URTICARIA (welt that was red, sore, and very hot) and FATIGUE (tiredness). At the time of the report, ARRHYTHMIA (multiple heart arrhythmias), CHEST DISCOMFORT (increased sense of pressure in his chest), DYSPNOEA (shortness of breath), DIZZINESS (light headed feeling), ASTHENIA (weakness), URTICARIA (welt that was red, sore, and very hot) and FATIGUE (tiredness) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Company comment: Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot) 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clot) (seriousness criterion death). The reported cause of death was Clot blood. It is unknown if an autopsy was performed.            The reporter stated that his wife had recently passed away from a blood clot after receiving a second dose of the Moderna COVID-19 vaccine. Treatment information was not provided. 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.; Reported Cause(s) of Death: Clot blood
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Rash developed on arm opposite of injection site, spread across entire body; Swelling under his arm; lymphadenopathy; Mildly feverish; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of RASH (Rash developed on arm opposite of injection site, spread across entire body) and LYMPHADENOPATHY (Swelling under his arm; lymphadenopathy) in a 63-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 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced LYMPHADENOPATHY (Swelling under his arm; lymphadenopathy) (seriousness criterion hospitalization). On 15-Apr-2021, the patient experienced RASH (Rash developed on arm opposite of injection site, spread across entire body) (seriousness criterion hospitalization) and PYREXIA (Mildly feverish). At the time of the report, RASH (Rash developed on arm opposite of injection site, spread across entire body), LYMPHADENOPATHY (Swelling under his arm; lymphadenopathy) and PYREXIA (Mildly feverish) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication include unknown Inhalers, Blood pressure meds, cholesterol and cough medicine  Patient was treated with IV steroids for an unrelated condition; however, physician believes patient might see some benefit.  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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Husband did have arm soreness after getting the Covid vaccine; This is a spontaneous report received from a contactable consumer (patient's wife). A 68-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for an covid-19 immunisation. Medical history included cardiac disorder, diabetes mellitus from 1995, open heart surgery in 2018 and allergy to tilcid. Clarified he had cardiac & diabetic issues prior to the 1st dose of vaccine. The due date of second vaccine was on 10Feb2021.The patient was on multiple medications for his heart and for his diabetes. On unspecified date, the patient experienced arm soreness after getting the Covid vaccine, but otherwise was fine. The outcome of event was unknown.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Insomnia, Pain
Clinical narrative: my arm slowly became more and more sore; had a hard time sleeping; woke up at 4am with full body aches (particularly felt like severe restless leg syndrome, but in my entire body); woke up at 4am with full body aches (particularly felt like severe restless leg syndrome, but in my entire body); stomach upset; fatigue; Little bit of chills; sluggishness; This is a spontaneous report from a contactable other hcp. A 26-years-old female patient (non pregnant) received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: Unknown) dose 1 via intramuscularly administered in left arm on 31Dec2020 10:00 AM and dose 2 via intramuscularly administered in left arm on 21Jan2021 12:00 PM (at 26-years-old and non pregnant at the time of vaccination )(Batch/Lot Number: EL3247) both as single dose for covid-19 immunization. Medical history included anxiety, asthma, allergies, irritable bowel syndrome from an unknown date and unknown if ongoing. No known allergies were reported. Concomitant medications included Sertraline HCL 100mg, Junel (birth control), Trazodone within two weeks. prior to vaccination. No other vaccine taken within four weeks prior to vaccination. Patient had no Covid prior to vaccination and not tested for Covid post vaccination. On 21Jan2021 at 05:30 PM, after second dose patient experienced sore arm slowly and became more and more. She had a hard time sleeping and woke up at 4am with full body aches (particularly felt like severe restless leg syndrome, but in her entire body). Also had stomach upset and fatigue/sluggishness. Little bit of chills. All of the symptoms continued throughout the rest of the day. Therapeutic measures taken which included Tylenol at 4am, 10am, and 4pm for it. Outcome of the event was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Restless legs syndrome, Sluggishness
Clinical narrative: my arm slowly became more and more sore; had a hard time sleeping; woke up at 4am with full body aches (particularly felt like severe restless leg syndrome, but in my entire body); woke up at 4am with full body aches (particularly felt like severe restless leg syndrome, but in my entire body); stomach upset; fatigue; Little bit of chills; sluggishness; This is a spontaneous report from a contactable other hcp. A 26-years-old female patient (non pregnant) received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: Unknown) dose 1 via intramuscularly administered in left arm on 31Dec2020 10:00 AM and dose 2 via intramuscularly administered in left arm on 21Jan2021 12:00 PM (at 26-years-old and non pregnant at the time of vaccination )(Batch/Lot Number: EL3247) both as single dose for covid-19 immunization. Medical history included anxiety, asthma, allergies, irritable bowel syndrome from an unknown date and unknown if ongoing. No known allergies were reported. Concomitant medications included Sertraline HCL 100mg, Junel (birth control), Trazodone within two weeks. prior to vaccination. No other vaccine taken within four weeks prior to vaccination. Patient had no Covid prior to vaccination and not tested for Covid post vaccination. On 21Jan2021 at 05:30 PM, after second dose patient experienced sore arm slowly and became more and more. She had a hard time sleeping and woke up at 4am with full body aches (particularly felt like severe restless leg syndrome, but in her entire body). Also had stomach upset and fatigue/sluggishness. Little bit of chills. All of the symptoms continued throughout the rest of the day. Therapeutic measures taken which included Tylenol at 4am, 10am, and 4pm for it. Outcome of the event was recovered.  Follow-up attempts are completed. No further information is expected.