chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: experiencing severe and sudden attack of bells palsy on right side of face; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (experiencing severe and sudden attack of bells palsy on right side of face) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN and FENOFIBRIC ACID for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (experiencing severe and sudden attack of bells palsy on right side of face) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (experiencing severe and sudden attack of bells palsy on right side of face) had not resolved.            Patient was treated with Antiviral and Steroid.  Historical condition was not reported.  The patient reports experiencing severe and sudden attack of bells palsy on right side of face which was now paralyzed. No other side effect was reported. The symptoms are ongoing.   This case was linked to MOD-2021-417783.; Sender's Comments: This case concerns a 64-year-old, male patient with no relevant medical history, who experienced the unexpected event of Bell's Palsy. The event occurred at unspecified interval after booster dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as event occurred after booster dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, SARS-CoV-2 test, Vital signs measurement
Clinical narrative: received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired vaccine) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021 at 3:49 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired vaccine). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (received expired vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Nov-2020, SARS-CoV-2 test: positive (Positive) positive. In December 2021, Vital signs measurement: stable (normal) Stable.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (received expired vaccine) to be not related.    Concomitant information was not reported. Treatment information was not reported.  Patient reported that there were no complaints, left arm without redness, swelling or bruising positive ROM.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2021: Updated patient demographics. Added lab test and dosage details. Updated reporter causality. On 27-Dec-2021: Follow up information included no new information.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Vital signs measurement
Clinical narrative: Patients recieved the Moderna COVID-19 vaccination after the expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients recieved the Moderna COVID-19 vaccination after the expiration date) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     The patient's past medical history included SARS-CoV-2 test positive on 29-Apr-2020. Concurrent medical conditions included Allergy to NSAIDs.    On 17-Dec-2021 at 3:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Dec-2021 at 3:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients recieved the Moderna COVID-19 vaccination after the expiration date). On 17-Dec-2021 at 3:00 PM, EXPIRED PRODUCT ADMINISTERED (Patients recieved the Moderna COVID-19 vaccination after the expiration date) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Vital signs measurement: stable (normal) Stable.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Treatment information was not provided.  Patient was recalled and was found to be stable..   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2021: Significant follow up , Patient details (Height, weight) Medical history got updated. On 27-Dec-2021: Followup received on 27 Dec 2021 contains no new information.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were provided.; Sender's Comments: This case concerns a male patient with no relevant medical history, who experienced the unexpected event of Myocardial Infarction. The event occurred at unspecified interval after a dose of mRNA-1273 (Moderna covid-19 vaccine). It's unclear if it was the first or second dose. The rechallenge was not applicable, as the event happened after a dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: My husband developed cellulitis in arm, his arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (My husband developed cellulitis in arm, his arm is swollen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CELLULITIS (My husband developed cellulitis in arm, his arm is swollen) (seriousness criterion medically significant). At the time of the report, CELLULITIS (My husband developed cellulitis in arm, his arm is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided.  Patient was diagnosed with cellulitis and right arm was swollen after receiving the Moderna COVID-19 vaccine. The reporter wanted to know if patient was able to get a booster dose of the Moderna COVID-19 vaccine. Company Comment  This case concerns a male patient of an unknown age with no reported medical history, who experienced the serious unexpected event of Cellulitis. The event occurred on an unspecified date after a dose of mRNA-1273 vaccine. ( Dose sequence not provided). The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a male patient of an unknown age with no reported medical history, who experienced the serious unexpected event of Cellulitis. The event occurred on an unspecified date after a dose of mRNA-1273 vaccine. ( Dose sequence not provided). The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate decreased
Clinical narrative: heart rate had plummeted to 38 BPM; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE DECREASED (heart rate had plummeted to 38 BPM) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031321A) for COVID-19 vaccination.     Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) and VITAMIN COMPLEX for an unknown indication.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-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 HEART RATE DECREASED (heart rate had plummeted to 38 BPM). At the time of the report, HEART RATE DECREASED (heart rate had plummeted to 38 BPM) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 38 (Low) Decreased to 38 BPM.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported   This case was linked to MOD-2021-418614 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 53 doses of the booster of the Moderna COVID19 vaccine were given lot 009c21a with expiration date Oct 15 2021,Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (53 doses of the booster of the Moderna COVID19 vaccine were given lot 009c21a with expiration date Oct 15 2021,Received Expired Dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009c21a) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (53 doses of the booster of the Moderna COVID19 vaccine were given lot 009c21a with expiration date Oct 15 2021,Received Expired Dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (53 doses of the booster of the Moderna COVID19 vaccine were given lot 009c21a with expiration date Oct 15 2021,Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and Treatment medication were reported.  On 27-DEC-2021, upon internal review, case MOD-2021-421914  was merged with case MOD-2021-418891  as case  MOD-2021-418891  was  determined to be the master case and duplicate case as well.   This case was linked to MOD-2021-421942, MOD-2021-421985, MOD-2021-422051, MOD-2021-422057, MOD-2021-422061, MOD-2021-422069, MOD-2021-422084, MOD-2021-422088, MOD-2021-422090, MOD-2021-422101, MOD-2021-422108, MOD-2021-422119, MOD-2021-422129, MOD-2021-422136, MOD-2021-422139, MOD-2021-422143, MOD-2021-422146, MOD-2021-422148, MOD-2021-422166, MOD-2021-422175, MOD-2021-422188, MOD-2021-422190, MOD-2021-422191, MOD-2021-422192, MOD-2021-422194, MOD-2021-422197, MOD-2021-422201, MOD-2021-422202, MOD-2021-422205, MOD-2021-422208, MOD-2021-422210, MOD-2021-422212, MOD-2021-422213, MOD-2021-422215, MOD-2021-422218, MOD-2021-422222, MOD-2021-422223, MOD-2021-422224, MOD-2021-422225, MOD-2021-422227, MOD-2021-422228, MOD-2021-422229, MOD-2021-422230, MOD-2021-422231, MOD-2021-422232, MOD-2021-422233, MOD-2021-422235, MOD-2021-422236, MOD-2021-422238, MOD-2021-422239, MOD-2021-422241, MOD-2021-422243 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Dec-2021: Follow Up contains NNI On 20-Dec-2021: Case made valid upon Follow up received, on 20-Dec-21 includes Significant information : Patient Demographic information updated. On 20-Dec-2021: Significant Follow up- Date of event received, patient identifiers updated On 22-Dec-2021: Follow up received on 22 Dec 2021,contain non significant info
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort, Dyspnoea, Fear of death, Pericarditis
Clinical narrative: diagnosed with pericarditis after receiving the booster dose; pressure on heart sensation; couldn't breath and couldn't call 911; thought I was dying; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (diagnosed with pericarditis after receiving the booster dose) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (diagnosed with pericarditis after receiving the booster dose) (seriousness criterion medically significant), CARDIAC DISCOMFORT (pressure on heart sensation), DYSPNOEA (couldn't breath and couldn't call 911) and FEAR OF DEATH (thought I was dying). At the time of the report, PERICARDITIS (diagnosed with pericarditis after receiving the booster dose), CARDIAC DISCOMFORT (pressure on heart sensation), DYSPNOEA (couldn't breath and couldn't call 911) and FEAR OF DEATH (thought I was dying) outcome was unknown.            No concomitant medications were reported.  Patient reported that she was diagnosed with pericarditis after receiving the booster dose. Patient states that she went to the hospital due to pressure on heart sensation and thought she was dying, couldn't breath, couldn't call 911.  No treatment information was reported.  Company Comment: This spontaneous case concerns an 87-year-old, female patient with no medical history reported, who experienced the expected AESI of pericarditis and other associated unexpected, non-serious events after administration of the booster dose of the Moderna mRNA-1273 vaccine. The vaccine dose date and event start dates were not provided. The patient sought consult, however, no details were provided. Treatment information was also not provided. The outcomes of the events were unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-072624 (Patient Link).; Sender's Comments: This spontaneous case concerns an 87-year-old, female patient with no medical history reported, who experienced the expected AESI of pericarditis and other associated unexpected, non-serious events after administration of the booster dose of the Moderna mRNA-1273 vaccine. The vaccine dose date and event start dates were not provided. The patient sought consult, however, no details were provided. Treatment information was also not provided. The outcomes of the events were unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Pyrexia, Vomiting
Clinical narrative: Then ended up passed out; She was dizzy so she sat on the floor; She came out of that and started vomiting for 10-15 minutes.; Fever the rest of the day; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Then ended up passed out), DIZZINESS (She was dizzy so she sat on the floor), VOMITING (She came out of that and started vomiting for 10-15 minutes.) and PYREXIA (Fever the rest of the day) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced LOSS OF CONSCIOUSNESS (Then ended up passed out), DIZZINESS (She was dizzy so she sat on the floor), VOMITING (She came out of that and started vomiting for 10-15 minutes.) and PYREXIA (Fever the rest of the day). On 21-Nov-2021, LOSS OF CONSCIOUSNESS (Then ended up passed out), DIZZINESS (She was dizzy so she sat on the floor) and VOMITING (She came out of that and started vomiting for 10-15 minutes.) had resolved. On 22-Nov-2021, PYREXIA (Fever the rest of the day) had resolved.        The day after the booster shot, patient felt dizzy so she sat on the floor and then ended up passing out. Patient came out of that and started vomiting for 10 to 15 minutes. Patient had a fever the rest of the day. The next day Patient was back to herself. It was baffling to her, Patient never has fainted before. This shocked her.  No treatment information was provided.  Company Comment: This spontaneous case concerns a 72-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious event of loss of consciousness and other associated expected, non-serious events. The events occurred 1 day after administration of the booster dose of the Moderna mRNA-1273 vaccine. Treatment information was not provided. However, the events had resolved at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-419387 (Patient Link).; Sender's Comments: This spontaneous case concerns a 72-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious event of loss of consciousness and other associated expected, non-serious events. The events occurred 1 day after administration of the booster dose of the Moderna mRNA-1273 vaccine. Treatment information was not provided. However, the events had resolved at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Feeling abnormal, Nausea, Palpitations, Paraesthesia
Clinical narrative: Fast racing heart; the sensation that she had too much medicine; tingling; Bell's palsy; mild fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Fast racing heart), FEELING ABNORMAL (the sensation that she had too much medicine), PARAESTHESIA (tingling), BELL'S PALSY (Bell's palsy) and PYREXIA (mild fever) in a 38-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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Fast racing heart), FEELING ABNORMAL (the sensation that she had too much medicine), PARAESTHESIA (tingling), BELL'S PALSY (Bell's palsy), PYREXIA (mild fever) and NAUSEA (nausea). At the time of the report, PALPITATIONS (Fast racing heart), FEELING ABNORMAL (the sensation that she had too much medicine), PYREXIA (mild fever) and NAUSEA (nausea) outcome was unknown and PARAESTHESIA (tingling) and BELL'S PALSY (Bell's palsy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Patient had a prescribed medication but used to take it when necessary.  After first vaccination, patient had a fast racing heart, mild fever, nausea and the sensation that she had too much medicine for a few days. Two moths later she developed bell's palsy and tingling.  Treatment medication included steroids for tingling.  Company Comment: This case concerns a 38-year-old female patient, with no reported medical history, who experienced the unexpected events of Palpitations, Feeling abnormal, Paraesthesia, and the expected events of Bell's palsy (AESI), Pyrexia and Nausea. The events occurred on an unknown date after the first dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The rechallenge was not applicable as the events occurred after the first dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-419552 (Patient Link).; Sender's Comments: This case concerns a 38-year-old female patient, with no reported medical history, who experienced the unexpected events of Palpitations, Feeling abnormal, Paraesthesia, and the expected events of Bell's palsy (AESI), Pyrexia and Nausea. The events occurred on an unknown date after the first dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The rechallenge was not applicable as the events occurred after the first dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fast racing heart; the sensation that she had too much medicine; tingling; Bell's palsy; mild fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Fast racing heart), FEELING ABNORMAL (the sensation that she had too much medicine), PARAESTHESIA (tingling), BELL'S PALSY (Bell's palsy) and PYREXIA (mild fever) in a 38-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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Fast racing heart), FEELING ABNORMAL (the sensation that she had too much medicine), PARAESTHESIA (tingling), BELL'S PALSY (Bell's palsy), PYREXIA (mild fever) and NAUSEA (nausea). At the time of the report, PALPITATIONS (Fast racing heart), FEELING ABNORMAL (the sensation that she had too much medicine), PYREXIA (mild fever) and NAUSEA (nausea) outcome was unknown and PARAESTHESIA (tingling) and BELL'S PALSY (Bell's palsy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Patient had a prescribed medication but used to take it when necessary.  After first vaccination, patient had a fast racing heart, mild fever, nausea and the sensation that she had too much medicine for a few days. Two moths later she developed bell's palsy and tingling.  Treatment medication included steroids for tingling.  Company Comment: This case concerns a 38-year-old female patient, with no reported medical history, who experienced the unexpected events of Palpitations, Feeling abnormal, Paraesthesia, and the expected events of Bell's palsy (AESI), Pyrexia and Nausea. The events occurred on an unknown date after the first dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The rechallenge was not applicable as the events occurred after the first dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-419552 (Patient Link).; Sender's Comments: This case concerns a 38-year-old female patient, with no reported medical history, who experienced the unexpected events of Palpitations, Feeling abnormal, Paraesthesia, and the expected events of Bell's palsy (AESI), Pyrexia and Nausea. The events occurred on an unknown date after the first dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The rechallenge was not applicable as the events occurred after the first dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Liver injury
Clinical narrative: hepatic injury; This literature-study case was reported in a literature article and describes the occurrence of LIVER INJURY (hepatic injury) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Publication    No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIVER INJURY (hepatic injury) (seriousness criterion medically significant). At the time of the report, LIVER INJURY (hepatic injury) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered LIVER INJURY (hepatic injury) to be related.    Treatment and concomitant medications were not reported  Company comment: This is a  literature-study case concerning a  66-year-old female  patient with no medical history reported, who experienced unexpected event of liver injury. A multicenter cohort of patients with liver injury following COVID19 vaccination was reported, cohort includes 16 total patients aged25 to 74, who presented between 5 to 46 days following their first vaccine dose (Pfizer 12, Moderna 4). Notably 75% of patients presented after their second vaccine dose. Six patients had a history of chronic liver disease including 4 with autoimmune hepatitis in treated remission. The majority of cases demonstrated a hepatocellular pattern of liver injury (peak alanine aminotransferase: 96 to >5,000 U/L). Of the remaining 3 cases, 1 was cholestatic and 2  were mixed. Acute liver injury (ALI, defined as international normalized ratio >1.5) occurred in 3 patients; no patients developed acute liver failure. Treatment details were not disclosed in the abstract. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-419558, MOD-2021-419608, MOD-2021-419609.; Sender's Comments: This is a  literature-study case concerning a  66-year-old female  patient with no medical history reported, who experienced unexpected event of liver injury. A multicenter cohort of patients with liver injury following COVID19 vaccination was reported, cohort includes 16 total patients aged25 to 74, who presented between 5 to 46 days following their first vaccine dose (Pfizer 12, Moderna 4). Notably 75% of patients presented after their second vaccine dose. Six patients had a history of chronic liver disease including 4 with autoimmune hepatitis in treated remission. The majority of cases demonstrated a hepatocellular pattern of liver injury (peak alanine aminotransferase: 96 to >5,000 U/L). Of the remaining 3 cases, 1 was cholestatic and 2  were mixed. Acute liver injury (ALI, defined as international normalized ratio >1.5) occurred in 3 patients; no patients developed acute liver failure. Treatment details were not disclosed in the abstract. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Woman that has died; This spontaneous case was reported by an other health care professional and describes the occurrence of DEATH (Woman that has died) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.  Company comment: This is a spontaneous case concerning a female patient of an unknown age with no medical history reported, who experienced serious, unexpected event of death. On an unknown date the patient received a dose of mRNA-1273 vaccine, patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. Very limited information regarding this event has been provided at this time. Further information has been requested. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a female patient of an unknown age with no medical history reported, who experienced serious, unexpected event of death. On an unknown date the patient received a dose of mRNA-1273 vaccine, patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. Very limited information regarding this event has been provided at this time. Further information has been requested. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: 4th shot  Booster half dose; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (4th shot  Booster half dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jun-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 20-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (4th shot  Booster half dose). On 20-Dec-2021, EXTRA DOSE ADMINISTERED (4th shot  Booster half dose) had resolved.            Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Was given 0.25ml but immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Was given 0.25ml but immunocompromised) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A, 001A21A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included Lung cancer (The right lung was removed due to cancer) and Lung operation NOS (She has one lung (the right lung was removed due to cancer)). Concurrent medical conditions included Hypertension.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 26-Aug-2021, the patient experienced ACCIDENTAL UNDERDOSE (Was given 0.25ml but immunocompromised). On 26-Aug-2021, ACCIDENTAL UNDERDOSE (Was given 0.25ml but immunocompromised) had resolved.            No concomitant medications were reported. No treatment medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vaccination site pain
Clinical narrative: her injection arm was sore; Nausea; Tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (her injection arm was sore), NAUSEA (Nausea) and FATIGUE (Tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A, 031L20A and 013F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (her injection arm was sore), NAUSEA (Nausea) and FATIGUE (Tired). At the time of the report, VACCINATION SITE PAIN (her injection arm was sore), NAUSEA (Nausea) and FATIGUE (Tired) outcome was unknown.            No Concomitant product use was reported.  The patient reported their experiences after receiving the 2nd dose of the Moderna Covid-19 Vaccine. After the 2nd dose, the patient had nausea, was tired, and their injection arm was sore. The patent was concerned that they had no reaction after the booster and wondered if the vaccine decreased in effectiveness as it was getting closer to the expiration date.  No treatment information was provided.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Inappropriate schedule of product administration, Mass, Pruritus, Rash
Clinical narrative: redness; small pinprick red spot underneath their right forearm armpit/ pinprick red spot was only on their right arm; bumps; itches; Rest are irritations; rashes were on both forearms (left and right); skin rash/rashes were on their left and right side of stomach; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), RASH MACULAR (small pinprick red spot underneath their right forearm armpit/ pinprick red spot was only on their right arm), MASS (bumps), PRURITUS (itches) and SKIN IRRITATION (Rest are irritations) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032HZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer Biontech Covid-19 vaccine (Second dose) and Pfizer Biontech Covid-19 vaccine (First dose). Past adverse reactions to the above products included No adverse event with Pfizer Biontech Covid-19 vaccine and Pfizer Biontech Covid-19 vaccine.    On 18-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 20-Dec-2021, the patient experienced ERYTHEMA (redness), RASH MACULAR (small pinprick red spot underneath their right forearm armpit/ pinprick red spot was only on their right arm), MASS (bumps), PRURITUS (itches), SKIN IRRITATION (Rest are irritations), RASH (rashes were on both forearms (left and right)) and RASH (skin rash/rashes were on their left and right side of stomach). On 18-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, ERYTHEMA (redness), RASH MACULAR (small pinprick red spot underneath their right forearm armpit/ pinprick red spot was only on their right arm), MASS (bumps), PRURITUS (itches), SKIN IRRITATION (Rest are irritations), RASH (rashes were on both forearms (left and right)) and RASH (skin rash/rashes were on their left and right side of stomach) had not resolved.            No Concomitant product use was reported.  The patient reported that the previous two doses were Pfizer vaccine and after receiving the booster, two days later, there was skin rash, redness, bumps, and itches. There appeared to be small pinprick red spot underneath their right forearm armpit. Locations of the rashes were on both forearms (left and right) and on their left and right side of stomach. The patient specifically said the pinprick red spot was only on their right arm, and the rest were irritations.  No treatment information was provided.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular, Skin irritation
Clinical narrative: redness; small pinprick red spot underneath their right forearm armpit/ pinprick red spot was only on their right arm; bumps; itches; Rest are irritations; rashes were on both forearms (left and right); skin rash/rashes were on their left and right side of stomach; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), RASH MACULAR (small pinprick red spot underneath their right forearm armpit/ pinprick red spot was only on their right arm), MASS (bumps), PRURITUS (itches) and SKIN IRRITATION (Rest are irritations) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032HZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer Biontech Covid-19 vaccine (Second dose) and Pfizer Biontech Covid-19 vaccine (First dose). Past adverse reactions to the above products included No adverse event with Pfizer Biontech Covid-19 vaccine and Pfizer Biontech Covid-19 vaccine.    On 18-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 20-Dec-2021, the patient experienced ERYTHEMA (redness), RASH MACULAR (small pinprick red spot underneath their right forearm armpit/ pinprick red spot was only on their right arm), MASS (bumps), PRURITUS (itches), SKIN IRRITATION (Rest are irritations), RASH (rashes were on both forearms (left and right)) and RASH (skin rash/rashes were on their left and right side of stomach). On 18-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, ERYTHEMA (redness), RASH MACULAR (small pinprick red spot underneath their right forearm armpit/ pinprick red spot was only on their right arm), MASS (bumps), PRURITUS (itches), SKIN IRRITATION (Rest are irritations), RASH (rashes were on both forearms (left and right)) and RASH (skin rash/rashes were on their left and right side of stomach) had not resolved.            No Concomitant product use was reported.  The patient reported that the previous two doses were Pfizer vaccine and after receiving the booster, two days later, there was skin rash, redness, bumps, and itches. There appeared to be small pinprick red spot underneath their right forearm armpit. Locations of the rashes were on both forearms (left and right) and on their left and right side of stomach. The patient specifically said the pinprick red spot was only on their right arm, and the rest were irritations.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Illness, Pyrexia
Clinical narrative: Felt a little sick; Chills; Joint aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt a little sick), CHILLS (Chills ), ARTHRALGIA (Joint aches) and PYREXIA (Fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Felt a little sick), CHILLS (Chills ), ARTHRALGIA (Joint aches) and PYREXIA (Fever). At the time of the report, ILLNESS (Felt a little sick), CHILLS (Chills ), ARTHRALGIA (Joint aches) and PYREXIA (Fever) had resolved.            The patient was on low dose Fludrocortisone  in November of 2021, was not continuing the medication.  Concomitant medication list was not provided.  Treatment information was not provided.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Received a third dose of the Moderna vaccine on September, patient not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Received a third dose of the Moderna vaccine on September, patient not immunocompromised) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 013L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced OFF LABEL USE (Received a third dose of the Moderna vaccine on September, patient not immunocompromised). On 01-Sep-2021, OFF LABEL USE (Received a third dose of the Moderna vaccine on September, patient not immunocompromised) had resolved.            Concomitant medications were not provided Treatment medications were not provided
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash erythematous
Clinical narrative: really intense itching all over 13 days after booster, itching chest, itching legs, itching bottom of the feet, itching pretty much the whole body, itching even the scalp, Still having itching after 6 days; It's a linear rash, a raised red linear rash, Today she had it all over her back in lines; sore arm after 3 doses; This spontaneous case was reported by a pharmacist and describes the occurrence of PRURITUS (really intense itching all over 13 days after booster, itching chest, itching legs, itching bottom of the feet, itching pretty much the whole body, itching even the scalp, Still having itching after 6 days), RASH ERYTHEMATOUS (It's a linear rash, a raised red linear rash, Today she had it all over her back in lines) and PAIN IN EXTREMITY (sore arm after 3 doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 037K20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient experienced PRURITUS (really intense itching all over 13 days after booster, itching chest, itching legs, itching bottom of the feet, itching pretty much the whole body, itching even the scalp, Still having itching after 6 days) and RASH ERYTHEMATOUS (It's a linear rash, a raised red linear rash, Today she had it all over her back in lines). In December 2021, the patient experienced PAIN IN EXTREMITY (sore arm after 3 doses). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. In December 2021, PAIN IN EXTREMITY (sore arm after 3 doses) had resolved. At the time of the report, PRURITUS (really intense itching all over 13 days after booster, itching chest, itching legs, itching bottom of the feet, itching pretty much the whole body, itching even the scalp, Still having itching after 6 days) and RASH ERYTHEMATOUS (It's a linear rash, a raised red linear rash, Today she had it all over her back in lines) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-420889, MOD-2021-420890 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received an expired dose of the Moderna vaccine) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 032B21A and 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received an expired dose of the Moderna vaccine). On 20-Dec-2021, EXPIRED PRODUCT ADMINISTERED (patient received an expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment details was reported.