chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Suicidal ideation, Tinnitus, Vertigo
Clinical narrative: Feel Suicidal; Brain fog; severe tinnitus; vertigo; This spontaneous case was reported by a consumer and describes the occurrence of SUICIDAL IDEATION (Feel Suicidal) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 02UMZUD) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concurrent medical conditions included Drug allergy (Fluroquinoline antibiotics). Concomitant products included ALPRAZOLAM from 02-Feb-2012 to an unknown date for Sleep disorder NOS, DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-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 TINNITUS (severe tinnitus) and VERTIGO (vertigo). On an unknown date, the patient experienced SUICIDAL IDEATION (Feel Suicidal) (seriousness criterion medically significant) and FEELING ABNORMAL (Brain fog). At the time of the report, SUICIDAL IDEATION (Feel Suicidal) outcome was unknown and FEELING ABNORMAL (Brain fog), TINNITUS (severe tinnitus) and VERTIGO (vertigo) had not resolved.            It was still debilitating an had remained the same for the last 3 weeks. Doctor cleaned patient's ears and told him it was an inflammation from the vaccine, that it would go away.  No treatment information provided.  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.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Added new events suicidal ideation and feeling abnormal; 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: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Ear congestion, Ear pain, Tinnitus
Clinical narrative: high-frequency hearing loss; ringing in left ear; congestion in left ear; on and off pain in left ear; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (high-frequency hearing loss) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 031m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-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 TINNITUS (ringing in left ear), EAR CONGESTION (congestion in left ear) and EAR PAIN (on and off pain in left ear). On an unknown date, the patient experienced DEAFNESS (high-frequency hearing loss) (seriousness criterion medically significant). The patient was treated with VITAMIN C [ASCORBIC ACID] ongoing since an unknown date at an unspecified dose and frequency; CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) ongoing since an unknown date at an unspecified dose and frequency; ALPHA LIPOIC ACID ongoing since an unknown date at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency; AZELASTINE ongoing since an unknown date at an unspecified dose and frequency; FLUTICASONE ongoing since an unknown date at an unspecified dose and frequency and LORATADINE (CLARITINE) at an unspecified dose and frequency. On 04-May-2021, EAR CONGESTION (congestion in left ear) had resolved. At the time of the report, DEAFNESS (high-frequency hearing loss) and TINNITUS (ringing in left ear) had not resolved and EAR PAIN (on and off pain in left ear) outcome was unknown.            The patient was taking no concomitant medications. Treatment included a two week trial for hearing aid that provided notch therapy for tinnitus but patient had not noticed any improvement in hearing or ringing. Completed the course of prednisone and antibiotic with no improvement.  Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Events added, case upgraded to serious and event details updated.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Diabetes mellitus inadequate control, Fatigue, Nausea
Clinical narrative: Having severe problems with blood sugar levels spiking; Fatigue; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIABETES MELLITUS INADEQUATE CONTROL (Having severe problems with blood sugar levels spiking) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included GLIPIZIDE for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced DIABETES MELLITUS INADEQUATE CONTROL (Having severe problems with blood sugar levels spiking) (seriousness criterion medically significant). April 2021, the patient experienced FATIGUE (Fatigue) and NAUSEA (nausea). The patient was treated with GLIPIZIDE for Loss of control of blood sugar, at an unspecified dose and frequency. At the time of the report, DIABETES MELLITUS INADEQUATE CONTROL (Having severe problems with blood sugar levels spiking), FATIGUE (Fatigue) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2021, Blood glucose: high as 360 (High) Blood sugars have spiked up as high as 360. On 27-Apr-2021, Blood glucose: high as 360 (High) Blood sugars have spiked up as high as 360.         Action taken with mRNA-1273 in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-095793, MOD-2021-095337 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Reporter details were updated; 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: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Myocardial infarction, Product dose omission issue
Clinical narrative: Missed second dose; Heart attack; heart was racing; stomach bothering him; 101.4 degrees fever; chills; some headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 22-year-old male patient who received mRNA-1273 (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Flu in February 2020. Concurrent medical conditions included Muscular dystrophy.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 01-May-2021, the patient experienced TACHYCARDIA (heart was racing), ABDOMINAL DISCOMFORT (stomach bothering him), PYREXIA (101.4 degrees fever), CHILLS (chills) and HEADACHE (some headaches). On 16-May-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria death and medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. The patient died on 16-May-2021. The reported cause of death was Heart attack. It is unknown if an autopsy was performed. At the time of death, PRODUCT DOSE OMISSION ISSUE (Missed second dose), TACHYCARDIA (heart was racing), ABDOMINAL DISCOMFORT (stomach bothering him), PYREXIA (101.4 degrees fever), CHILLS (chills) and HEADACHE (some headaches) outcome was unknown.            No Concomitant product use was provided  This is a case of product dose omission issue. Very limited information regarding this patient's death has been provided at this time.  Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Significant follow up received :- Patient died, Reporter email and phone number added, patient's medical history added,events updated; Sender's Comments: This is a case of product dose omission issue. Very limited information regarding this patient's death has been provided at this time.  Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Heart Attack
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia
Clinical narrative: Missed second dose; Heart attack; heart was racing; stomach bothering him; 101.4 degrees fever; chills; some headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 22-year-old male patient who received mRNA-1273 (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Flu in February 2020. Concurrent medical conditions included Muscular dystrophy.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 01-May-2021, the patient experienced TACHYCARDIA (heart was racing), ABDOMINAL DISCOMFORT (stomach bothering him), PYREXIA (101.4 degrees fever), CHILLS (chills) and HEADACHE (some headaches). On 16-May-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria death and medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. The patient died on 16-May-2021. The reported cause of death was Heart attack. It is unknown if an autopsy was performed. At the time of death, PRODUCT DOSE OMISSION ISSUE (Missed second dose), TACHYCARDIA (heart was racing), ABDOMINAL DISCOMFORT (stomach bothering him), PYREXIA (101.4 degrees fever), CHILLS (chills) and HEADACHE (some headaches) outcome was unknown.            No Concomitant product use was provided  This is a case of product dose omission issue. Very limited information regarding this patient's death has been provided at this time.  Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Significant follow up received :- Patient died, Reporter email and phone number added, patient's medical history added,events updated; Sender's Comments: This is a case of product dose omission issue. Very limited information regarding this patient's death has been provided at this time.  Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Heart Attack
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Polymyalgia rheumatica
Clinical narrative: shortness of breath; fatigue; Polymyalgia Rhumaticia; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 03-May-2021. The most recent information was received on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (Polymyalgia Rhumaticia) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced POLYMYALGIA RHEUMATICA (Polymyalgia Rhumaticia) (seriousness criterion medically significant). On an unknown date, the patient experienced DYSPNOEA (shortness of breath) and FATIGUE (fatigue). The patient was treated with PREDNISONE at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, POLYMYALGIA RHEUMATICA (Polymyalgia Rhumaticia) was resolving and DYSPNOEA (shortness of breath) and FATIGUE (fatigue) had not resolved.            Very limited information regarding the events has been provided at this time.  Further information is expected.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: The case upgraded to serious with event polymyalgia rheumatica. The event onset date and outcome of same event updated, event Arthralgia was removed, Treatment medication added.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Thrombosis
Clinical narrative: lots of people who have had blood clots.; have experienced numbness in their hand 4 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (lots of people who have had blood clots.) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (lots of people who have had blood clots.) (seriousness criterion medically significant) and HYPOAESTHESIA (have experienced numbness in their hand 4 hours). At the time of the report, THROMBOSIS (lots of people who have had blood clots.) and HYPOAESTHESIA (have experienced numbness in their hand 4 hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The  concomitant medications on use were not provided. No laboratory data was provided. No treatment information was provided.  Caller reported she is on a forum and lots of people who have had blood clots have experienced numbness in their hand 4 hours after receiving the vaccine.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Cardiac disorder
Clinical narrative: Arrhythmia; Heart problem; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 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 ARRHYTHMIA (Arrhythmia) (seriousness criterion medically significant) and CARDIAC DISORDER (Heart problem). At the time of the report, ARRHYTHMIA (Arrhythmia) and CARDIAC DISORDER (Heart problem) outcome was unknown.            The patient's concomitant medication was not reported. No treatment information was provided.  The patient experienced heart problem and arrhythmia after second dose.  Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, Myalgia, Postoperative abscess
Clinical narrative: Abscess infection after having surgery; incomplete course of vaccination; Body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of POSTOPERATIVE ABSCESS (Abscess infection after having surgery) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced MYALGIA (Body aches). On an unknown date, the patient experienced POSTOPERATIVE ABSCESS (Abscess infection after having surgery) (seriousness criterion hospitalization prolonged) and INCOMPLETE COURSE OF VACCINATION (incomplete course of vaccination). On 22-Jan-2021, MYALGIA (Body aches) had resolved. At the time of the report, POSTOPERATIVE ABSCESS (Abscess infection after having surgery) and INCOMPLETE COURSE OF VACCINATION (incomplete course of vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No corrective treatment was provided.  She had an appointment to get her second vaccine but was in the hospital for a abscess infection after having surgery. The dates of incident were not provided. The patient would wait a little longer to receive the second dose of vaccine. She was in PA when she got the first dose and wanted the second dose .  Company Comment : Very limited information regarding this event/s has been provided at this time.  Patient denied further information.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Patient denied further information.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Cardiac discomfort, Dizziness
Clinical narrative: hospitalized overnight because of problem related to heart.; blood pressure was high in hospital; feeling crappy.; fatigue.; feels dizzy; feels weak / doesn't have lot of strength; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of CARDIAC DISCOMFORT (hospitalized overnight because of problem related to heart.) and BLOOD PRESSURE INCREASED (blood pressure was high in hospital) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (feels dizzy) and ASTHENIA (feels weak / doesn't have lot of strength). On 04-Mar-2021, the patient experienced FEELING ABNORMAL (feeling crappy.) and FATIGUE (fatigue.). On 12-Apr-2021, the patient experienced CARDIAC DISCOMFORT (hospitalized overnight because of problem related to heart.) (seriousness criterion hospitalization) and BLOOD PRESSURE INCREASED (blood pressure was high in hospital) (seriousness criterion hospitalization). The patient was hospitalized on 12-Apr-2021 due to BLOOD PRESSURE INCREASED and CARDIAC DISCOMFORT. At the time of the report, CARDIAC DISCOMFORT (hospitalized overnight because of problem related to heart.), BLOOD PRESSURE INCREASED (blood pressure was high in hospital), DIZZINESS (feels dizzy), ASTHENIA (feels weak / doesn't have lot of strength), FEELING ABNORMAL (feeling crappy.) and FATIGUE (fatigue.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Blood pressure measurement: high (High) Blood pressure increased.         Concomitant medication included Blood pressure medicine. Treatment included Blood pressure medication.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: hospitalized overnight because of problem related to heart.; blood pressure was high in hospital; feeling crappy.; fatigue.; feels dizzy; feels weak / doesn't have lot of strength; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of CARDIAC DISCOMFORT (hospitalized overnight because of problem related to heart.) and BLOOD PRESSURE INCREASED (blood pressure was high in hospital) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (feels dizzy) and ASTHENIA (feels weak / doesn't have lot of strength). On 04-Mar-2021, the patient experienced FEELING ABNORMAL (feeling crappy.) and FATIGUE (fatigue.). On 12-Apr-2021, the patient experienced CARDIAC DISCOMFORT (hospitalized overnight because of problem related to heart.) (seriousness criterion hospitalization) and BLOOD PRESSURE INCREASED (blood pressure was high in hospital) (seriousness criterion hospitalization). The patient was hospitalized on 12-Apr-2021 due to BLOOD PRESSURE INCREASED and CARDIAC DISCOMFORT. At the time of the report, CARDIAC DISCOMFORT (hospitalized overnight because of problem related to heart.), BLOOD PRESSURE INCREASED (blood pressure was high in hospital), DIZZINESS (feels dizzy), ASTHENIA (feels weak / doesn't have lot of strength), FEELING ABNORMAL (feeling crappy.) and FATIGUE (fatigue.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Blood pressure measurement: high (High) Blood pressure increased.         Concomitant medication included Blood pressure medicine. Treatment included Blood pressure medication.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Fatigue, Haematochezia, Headache
Clinical narrative: When I went to the bathroom it was all blood, my bowel movement; diarrhea; fatigue, it was horrible; horrible headache; real bad chest pains; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (When I went to the bathroom it was all blood, my bowel movement) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2020. Concurrent medical conditions included Diabetes. Concomitant products included SEMAGLUTIDE (OZEMPIC), INSULIN GLARGINE (TOUJEO) and INSULIN LISPRO (HUMALOG) for an unknown indication.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced CHEST PAIN (real bad chest pains), OROPHARYNGEAL PAIN (sore throat), FATIGUE (fatigue, it was horrible) and HEADACHE (horrible headache). On 25-May-2021, the patient experienced DIARRHOEA (diarrhea). On 26-May-2021, the patient experienced HAEMATOCHEZIA (When I went to the bathroom it was all blood, my bowel movement) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 24-May-2021, CHEST PAIN (real bad chest pains) had resolved. On 25-May-2021, OROPHARYNGEAL PAIN (sore throat) had resolved. At the time of the report, HAEMATOCHEZIA (When I went to the bathroom it was all blood, my bowel movement), DIARRHOEA (diarrhea), FATIGUE (fatigue, it was horrible) and HEADACHE (horrible headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant drug included beta-blocker (unknown).  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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: When I went to the bathroom it was all blood, my bowel movement; diarrhea; fatigue, it was horrible; horrible headache; real bad chest pains; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (When I went to the bathroom it was all blood, my bowel movement) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2020. Concurrent medical conditions included Diabetes. Concomitant products included SEMAGLUTIDE (OZEMPIC), INSULIN GLARGINE (TOUJEO) and INSULIN LISPRO (HUMALOG) for an unknown indication.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced CHEST PAIN (real bad chest pains), OROPHARYNGEAL PAIN (sore throat), FATIGUE (fatigue, it was horrible) and HEADACHE (horrible headache). On 25-May-2021, the patient experienced DIARRHOEA (diarrhea). On 26-May-2021, the patient experienced HAEMATOCHEZIA (When I went to the bathroom it was all blood, my bowel movement) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 24-May-2021, CHEST PAIN (real bad chest pains) had resolved. On 25-May-2021, OROPHARYNGEAL PAIN (sore throat) had resolved. At the time of the report, HAEMATOCHEZIA (When I went to the bathroom it was all blood, my bowel movement), DIARRHOEA (diarrhea), FATIGUE (fatigue, it was horrible) and HEADACHE (horrible headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant drug included beta-blocker (unknown).  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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Thrombosis
Clinical narrative: Blood clot in left leg; Not feeling like herself since second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood clot in left leg) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE, HYDROCHLOROTHIAZIDE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), FEXOFENADINE, LOSARTAN and SERTRALINE for an unknown indication.   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 22-Apr-2021, the patient experienced FEELING ABNORMAL (Not feeling like herself since second dose). On 16-May-2021, the patient experienced THROMBOSIS (Blood clot in left leg) (seriousness criterion medically significant). The patient was treated with RIVAROXABAN (XARELTO) ongoing since an unknown date for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Blood clot in left leg) outcome was unknown and FEELING ABNORMAL (Not feeling like herself since second dose) had not resolved.            It was reported that the patient was not feeling like herself since the second dose but was unsure if it was a result of the vaccination.  Company Comment : Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Intracranial aneurysm
Clinical narrative: Had a brain aneurism; This spontaneous case was reported by a consumer and describes the occurrence of INTRACRANIAL ANEURYSM (Had a brain aneurism) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History 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, the patient experienced INTRACRANIAL ANEURYSM (Had a brain aneurism) (seriousness criterion medically significant). At the time of the report, INTRACRANIAL ANEURYSM (Had a brain aneurism) outcome was unknown.            No concomitant medication was reported. No treatment information was reported.; Sender's Comments: Very limited information regarding the event has been provided at this time. Further information is not expected. Also it is not known if patient received the Moderna COVID-19 vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Myalgia, Neoplasm malignant, Oropharyngeal pain, Pyrexia
Clinical narrative: had cancer; sore throat; suffering from all of the symptoms; body aches and pains; fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NEOPLASM MALIGNANT (had cancer) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (had cancer) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (sore throat), ADVERSE EVENT (suffering from all of the symptoms), MYALGIA (body aches and pains) and PYREXIA (fever). At the time of the report, NEOPLASM MALIGNANT (had cancer), OROPHARYNGEAL PAIN (sore throat), ADVERSE EVENT (suffering from all of the symptoms), MYALGIA (body aches and pains) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Arthralgia, Bone pain, Pain, Therapeutic response shortened
Clinical narrative: uveitis; canker sores oral; injection site colouration; wearing off effect; bone pain; pain; Injection site pain due to COVID vaccine; aching joints; This spontaneous case was reported by a consumer and describes the occurrence of UVEITIS (uveitis) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis and Panuveitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced UVEITIS (uveitis) (seriousness criterion medically significant), APHTHOUS ULCER (canker sores oral), VACCINATION SITE DISCOLOURATION (injection site colouration), THERAPEUTIC RESPONSE SHORTENED (wearing off effect), BONE PAIN (bone pain), PAIN (pain), VACCINATION SITE PAIN (Injection site pain due to COVID vaccine) and ARTHRALGIA (aching joints). At the time of the report, UVEITIS (uveitis) had not resolved, APHTHOUS ULCER (canker sores oral), VACCINATION SITE DISCOLOURATION (injection site colouration), THERAPEUTIC RESPONSE SHORTENED (wearing off effect), PAIN (pain) and VACCINATION SITE PAIN (Injection site pain due to COVID vaccine) had resolved and BONE PAIN (bone pain) and ARTHRALGIA (aching joints) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient experienced canker sores, injection site pain due to COVID vaccine, shingle shot pain, injection left a purple mark, pain before HUMIRA, injection, episode of uveitis and bones and joints were achy with HUMIRA (ADALIMUMAB).  Company 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  No concomitant medication information was provided  No treatment product information was provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Uveitis, Vaccination site discolouration, Vaccination site pain
Clinical narrative: uveitis; canker sores oral; injection site colouration; wearing off effect; bone pain; pain; Injection site pain due to COVID vaccine; aching joints; This spontaneous case was reported by a consumer and describes the occurrence of UVEITIS (uveitis) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis and Panuveitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced UVEITIS (uveitis) (seriousness criterion medically significant), APHTHOUS ULCER (canker sores oral), VACCINATION SITE DISCOLOURATION (injection site colouration), THERAPEUTIC RESPONSE SHORTENED (wearing off effect), BONE PAIN (bone pain), PAIN (pain), VACCINATION SITE PAIN (Injection site pain due to COVID vaccine) and ARTHRALGIA (aching joints). At the time of the report, UVEITIS (uveitis) had not resolved, APHTHOUS ULCER (canker sores oral), VACCINATION SITE DISCOLOURATION (injection site colouration), THERAPEUTIC RESPONSE SHORTENED (wearing off effect), PAIN (pain) and VACCINATION SITE PAIN (Injection site pain due to COVID vaccine) had resolved and BONE PAIN (bone pain) and ARTHRALGIA (aching joints) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient experienced canker sores, injection site pain due to COVID vaccine, shingle shot pain, injection left a purple mark, pain before HUMIRA, injection, episode of uveitis and bones and joints were achy with HUMIRA (ADALIMUMAB).  Company 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  No concomitant medication information was provided  No treatment product information was provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Back injury, Contusion, Decreased appetite, Gait inability, Head injury
Clinical narrative: bruised; have hit his head because his head was sore; was in lots of pain; sore all over; stiff neck; no appetite; passed out; heard his back crunch when he fell; could not walk; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 71-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 past medical history provided.  Concomitant products included MELOXICAM, TRAMADOL, ATORVASTATIN and CURCUMA LONGA (TURMERIC CURCUMIN [CURCUMA LONGA]) for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021 at 11:12 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced GAIT INABILITY (could not walk). On 22-May-2021 at 8:00 AM, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant) and BACK INJURY (heard his back crunch when he fell). On 23-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck), DECREASED APPETITE (no appetite), PAIN (was in lots of pain) and MYALGIA (sore all over). On 24-May-2021, the patient experienced CONTUSION (bruised) and HEAD INJURY (have hit his head because his head was sore). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), GAIT INABILITY (could not walk), MUSCULOSKELETAL STIFFNESS (stiff neck), DECREASED APPETITE (no appetite), CONTUSION (bruised), HEAD INJURY (have hit his head because his head was sore), BACK INJURY (heard his back crunch when he fell), PAIN (was in lots of pain) and MYALGIA (sore all over) outcome was unknown.            No treatment information reported.  Additional concomitant medications included cardanol and water tablet.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-182269 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: bruised; have hit his head because his head was sore; was in lots of pain; sore all over; stiff neck; no appetite; passed out; heard his back crunch when he fell; could not walk; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 71-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 past medical history provided.  Concomitant products included MELOXICAM, TRAMADOL, ATORVASTATIN and CURCUMA LONGA (TURMERIC CURCUMIN [CURCUMA LONGA]) for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021 at 11:12 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced GAIT INABILITY (could not walk). On 22-May-2021 at 8:00 AM, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant) and BACK INJURY (heard his back crunch when he fell). On 23-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck), DECREASED APPETITE (no appetite), PAIN (was in lots of pain) and MYALGIA (sore all over). On 24-May-2021, the patient experienced CONTUSION (bruised) and HEAD INJURY (have hit his head because his head was sore). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), GAIT INABILITY (could not walk), MUSCULOSKELETAL STIFFNESS (stiff neck), DECREASED APPETITE (no appetite), CONTUSION (bruised), HEAD INJURY (have hit his head because his head was sore), BACK INJURY (heard his back crunch when he fell), PAIN (was in lots of pain) and MYALGIA (sore all over) outcome was unknown.            No treatment information reported.  Additional concomitant medications included cardanol and water tablet.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-182269 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Fatigue, Loss of consciousness, Loss of personal independence in daily activities, Malaise
Clinical narrative: Not responsive at all; Sleeping; Took her to the bathroom at 5 o´clock this morning and she was wet, she is in pull ups; This morning put her back to bed and then told me she is not herself today; Her eyes kind of closing; Threw up; She was tired about 7 o´clock in the evening and went to bed early; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Not responsive at all) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037CZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Insulin dependent diabetic. Concomitant products included LISINOPRIL, ATORVASTATIN and INSULIN for an unknown indication.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced FATIGUE (She was tired about 7 o´clock in the evening and went to bed early). On 27-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Not responsive at all) (seriousness criterion medically significant), SOMNOLENCE (Sleeping), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Took her to the bathroom at 5 o´clock this morning and she was wet, she is in pull ups), ASTHENOPIA (Her eyes kind of closing), VOMITING (Threw up) and MALAISE (This morning put her back to bed and then told me she is not herself today). At the time of the report, LOSS OF CONSCIOUSNESS (Not responsive at all), SOMNOLENCE (Sleeping), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Took her to the bathroom at 5 o´clock this morning and she was wet, she is in pull ups), ASTHENOPIA (Her eyes kind of closing), VOMITING (Threw up), MALAISE (This morning put her back to bed and then told me she is not herself today) and FATIGUE (She was tired about 7 o´clock in the evening and went to bed early) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is insulin dependent. Takes blood pressure medication and cholesterol medication. Treatment information not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. However, the patient's age and medical history of insulin-dependent diabetes mellitus, hypertension and hypercholesterolemia, as well as intake of concomitant medications, are confounding factors that may play possible contributory roles.