chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac operation, Chest pain, Product dose omission issue
Clinical narrative: Chest Pain; Open heart surgery; 2nd dose on 26Mar2021, which she missed; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain) and CARDIAC OPERATION (Open heart surgery) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure, Cholesterol and Diabetes.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose on 26Mar2021, which she missed). On 19-Mar-2021, the patient experienced CHEST PAIN (Chest Pain) (seriousness criteria hospitalization prolonged and life threatening) and CARDIAC OPERATION (Open heart surgery) (seriousness criteria hospitalization prolonged and life threatening). The patient was hospitalized until 03-Apr-2021 due to CHEST PAIN. The patient was treated with Surgery (Open heart surgery) for Chest pain. On 26-Feb-2021, PRODUCT DOSE OMISSION ISSUE (2nd dose on 26Mar2021, which she missed) had resolved. At the time of the report, CHEST PAIN (Chest Pain) and CARDIAC OPERATION (Open heart surgery) 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.   No concomitant medications were reported. No treatment medications were provided.  The patient went to urgent care and they sent her to the hospital. At the hospital the patient and had to have an open-heart surgery. She was hospitalized until 03-Apr-Apr2021. Before the open-heart surgery consumer was taking medications for cholesterol, BP, and diabetes. After the open-heart surgery many meds were added for the patient, but patient does not know the name of the medications at the time. The was due for her 2nd dose on 26-Mar-2021, which was missed.  The patient gave safety consent to follow up via phone.  Based on the current available information and temporal association between the use of the product and the start date of the event chest pain! a causal relationship cannot be excluded; however, for the event "Product dose omission", assessed is not applicable.; 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 chest pain! a causal relationship cannot be excluded; however, for the event "Product dose omission", assessed is not applicable.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Ventricular extrasystoles
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of ARRHYTHMIA (Arrhythmia (PVC) after completing moderna vaccine) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypercholesterolemia. Concomitant products included LOVASTATIN for Cholesterol. 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 05-Jun-2021, the patient experienced ARRHYTHMIA (Arrhythmia (PVC) after completing moderna vaccine) (seriousness criterion medically significant). On an unknown date, the patient experienced VENTRICULAR EXTRASYSTOLES (PVC (Premature ventricular contractions)). At the time of the report, ARRHYTHMIA (Arrhythmia (PVC) after completing moderna vaccine) and VENTRICULAR EXTRASYSTOLES (PVC (Premature ventricular contractions)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information was not provided. This case concerns a 57-year-old female with a serious unexpected event of arrhythmia, and non serious ventricular extrasystoles. Event latency 4 months after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 57-year-old female with a serious unexpected event of arrhythmia, and non serious ventricular extrasystoles. Event latency 4 months after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Dizziness, Off label use
Clinical narrative: Out of it and not acting like herself; Dizzy; 2nd dose administered before 25 days; This spontaneous case was reported by a pharmacist and describes the occurrence of ABNORMAL BEHAVIOUR (Out of it and not acting like herself) and DIZZINESS (Dizzy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 3041B21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced ABNORMAL BEHAVIOUR (Out of it and not acting like herself) (seriousness criterion hospitalization), DIZZINESS (Dizzy) (seriousness criterion hospitalization) and OFF LABEL USE (2nd dose administered before 25 days). At the time of the report, ABNORMAL BEHAVIOUR (Out of it and not acting like herself), DIZZINESS (Dizzy) and OFF LABEL USE (2nd dose administered before 25 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient that received the Moderna 2nd dose 28-MAY-2021 (Exp; 10-Apr-21)   22 days after the 1st dose. Patient's daughter reported that the patient was dizzy, out of it and not acting like her after the 2nd dose. The patient was admitted to the hospital.  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. This report refers to a case of Off label use for mRNA-1273, lot # 3041B21A with no associated AE.  No concomitant medicines were reported. No treatment information were reported.; 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. This report refers to a case of Off label use for mRNA-1273, lot # 3041B21A with no associated AE.
Sex: U
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: Heart Arrhythmias about three months after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Heart Arrhythmias about three months after vaccination) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (Heart Arrhythmias about three months after vaccination) (seriousness criterion medically significant). At the time of the report, ARRHYTHMIA (Heart Arrhythmias about three months after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  On an unknown date in 2021, the patient received mRNA-1273 (Moderna COVID-19 Vaccine) and experienced Heart Arrhythmias about three months after vaccination.  No relevant treatment medication reported.  Company Comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fall, Haemorrhage, Myocardial infarction
Clinical narrative: Died due to heart attack; Lot of blood was on the floor; He fell on bathroom tiles; Feeling weakness/Could not coming out of bed; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Died due to heart attack) and HAEMORRHAGE (Lot of blood was on the floor) in a 42-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.     Concurrent medical conditions included Diabetes (was on anti-diabetic medicine.).    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced ASTHENIA (Feeling weakness/Could not coming out of bed), PYREXIA (Fever) and CHILLS (Chills). On 23-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Died due to heart attack) (seriousness criteria death and medically significant), HAEMORRHAGE (Lot of blood was on the floor) (seriousness criterion medically significant) and FALL (He fell on bathroom tiles). The patient died on 23-Mar-2021. The reported cause of death was Heart attack. It is unknown if an autopsy was performed. At the time of death, HAEMORRHAGE (Lot of blood was on the floor), FALL (He fell on bathroom tiles), ASTHENIA (Feeling weakness/Could not coming out of bed), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Concomitant medication included was anti-diabetic medicine. The treatment information was not provided.  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.; Reported Cause(s) of Death: heart attack
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Died due to heart attack; Lot of blood was on the floor; He fell on bathroom tiles; Feeling weakness/Could not coming out of bed; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Died due to heart attack) and HAEMORRHAGE (Lot of blood was on the floor) in a 42-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.     Concurrent medical conditions included Diabetes (was on anti-diabetic medicine.).    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced ASTHENIA (Feeling weakness/Could not coming out of bed), PYREXIA (Fever) and CHILLS (Chills). On 23-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Died due to heart attack) (seriousness criteria death and medically significant), HAEMORRHAGE (Lot of blood was on the floor) (seriousness criterion medically significant) and FALL (He fell on bathroom tiles). The patient died on 23-Mar-2021. The reported cause of death was Heart attack. It is unknown if an autopsy was performed. At the time of death, HAEMORRHAGE (Lot of blood was on the floor), FALL (He fell on bathroom tiles), ASTHENIA (Feeling weakness/Could not coming out of bed), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Concomitant medication included was anti-diabetic medicine. The treatment information was not provided.  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.; Reported Cause(s) of Death: heart attack
Sex: U
Vaccine: COVID19
Symptoms: Carditis
Clinical narrative: Heart Inflammation; This spontaneous case was reported by a consumer and describes the occurrence of CARDITIS (Heart Inflammation) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDITIS (Heart Inflammation) (seriousness criterion medically significant). At the time of the report, CARDITIS (Heart Inflammation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information were reported.  Company Comment: Very limited information regarding these events has been provided at this time. No follow up is possible.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Limb injury, Loss of consciousness, Syncope
Clinical narrative: Passed out; Fainted; Collapsed on the floor and injured their arm and shoulder; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) and SYNCOPE (Fainted) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant). 18-May-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant) and LIMB INJURY (Collapsed on the floor and injured their arm and shoulder). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), SYNCOPE (Fainted) and LIMB INJURY (Collapsed on the floor and injured their arm and shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported  It was reported that, within 15 minutes of receiving the dose the patient passed out and fainted. The patient collapsed on the floor and injured their arm and shoulder. The patient was seen by the doctor who confirmed no bones were broken.   No treatment medication were reported.  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: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Drug reaction with eosinophilia and systemic symptoms, SARS-CoV-2 antibody test
Clinical narrative: I was hospitalized for the DRESS syndrome; This spontaneous case was reported by a consumer and describes the occurrence of DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (I was hospitalized for the DRESS syndrome) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 001A21A) for COVID-19 vaccination.     No medical history was reported.  Concurrent medical conditions included DRESS syndrome (day of dose 1 of vaccination patient had just completed 2 month course of treatment for DRESS syndrome after severe reactions to medications containing sulfa) and Sulfonamide allergy (severe reactions to medications containing sulfa). Concomitant products included PREDNISONE from 30-Nov-2020 to 29-Jan-2021 for an unknown indication.   On 29-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 18-Feb-2021, the patient experienced DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (I was hospitalized for the DRESS syndrome) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 18-Feb-2021 to 21-Feb-2021 due to DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS. The patient was treated with PREDNISONE (intravenous) from 18-Feb-2021 to 20-Feb-2021 for DRESS syndrome, at a dose of 750 mg twice a day and PREDNISONE (oral) ongoing from 21-Feb-2021 for DRESS syndrome, at a dose of UNK Tab. On 21-Feb-2021, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (I was hospitalized for the DRESS syndrome) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Blood immunoglobulin G: Negative. On 08-Apr-2021, SARS-CoV-2 antibody test: Negative.         Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Product details updated. Patient gender 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 event, a causal relationship cannot be excluded.
Age: 60.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Atrial fibrillation
Clinical narrative: Atrial fibrillation; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product SELEXIPAG for Pulmonary hypertension.    The patient's past medical history included Arrhythmia (Abnormal heart beat Rhythmn) on 26-Apr-2021. Concurrent medical conditions included Pulmonary hypertension. Concomitant products included AMBRISENTAN (LETAIRIS) and TADALAFIL (ADCIRCA) for an unknown indication.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started SELEXIPAG (Oral) 1600 mcg twice a day. On 10-May-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 10-May-2021 to 15-May-2021 due to ATRIAL FIBRILLATION. The patient was treated with APIXABAN (ELIQUIS) ongoing since an unknown date for Blood disorder NOS, at a dose of 1 dosage form. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) 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.   The patient was seen by his primary care physician on 10-May-2021, 12 hours after getting the Moderna vaccine.  The physician admitted the patient to the hospital due to atrial fibrillation.  The patient was discharged on 15-May-2021. The patient reported that he was in the hospital from 26-Apr-2021to 01-May-2021for abnormal heartbeat rhythm and the hospital ended up having to shock his heart to get it back to normal.  The patient had the second Covid vaccine done around 1 week before reporting date 02-Jun-2021 and said he seems to be doing well.  Treatment was not reported.  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. No further information is expected. However, patient has a history of pulmonary hypertension,arrythmia and concomitant medication use of Selexipag considered as co-suspect  that can be stated as confounding factors that may play a possible contributory role.; 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. No further information is expected. However, patient has a history of pulmonary hypertension,arrythmia and concomitant medication use of Selexipag considered as co-suspect  that can be stated as confounding factors that may play a possible contributory role.
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Sepsis
Clinical narrative: Sepsis; hair loss; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (Sepsis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L10A) 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) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced ALOPECIA (hair loss). On an unknown date, the patient experienced SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in April 2021 due to SEPSIS. At the time of the report, SEPSIS (Sepsis) and ALOPECIA (hair loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided.  Very limited information regarding the events has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-216554 (Patient Link).; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up in hands; Hands tingling; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up in hands) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up in hands) (seriousness criterion medically significant) and PARAESTHESIA (Hands tingling). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up in hands) and PARAESTHESIA (Hands tingling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided. Very limited information regarding these events have been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic event; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic event) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 ANAPHYLACTIC REACTION (anaphylactic event) (seriousness criteria hospitalization and medically significant). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic event) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable. Company comment:Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.
Age: 52.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Incorrect dose administered, Injection site haemorrhage, Product administration error, Psoriatic arthropathy
Clinical narrative: Psoriatic arthritis related to a reaction to Moderna vaccine; Injection Site Bled; Can Feel Under Skin Where Injected; Gave injection and much of medication; This spontaneous case was reported by a physician and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis related to a reaction to Moderna vaccine) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Previously administered products included for Diabetes: Insulin. Concurrent medical conditions included Diabetic.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg every two weeks. On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis related to a reaction to Moderna vaccine) (seriousness criterion medically significant), INJECTION SITE HAEMORRHAGE (Injection Site Bled), PRODUCT ADMINISTRATION ERROR (Can Feel Under Skin Where Injected) and INCORRECT DOSE ADMINISTERED (Gave injection and much of medication). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis related to a reaction to Moderna vaccine), INJECTION SITE HAEMORRHAGE (Injection Site Bled), PRODUCT ADMINISTRATION ERROR (Can Feel Under Skin Where Injected) and INCORRECT DOSE ADMINISTERED (Gave injection and much of medication) 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.   Concomitant medications were not reported. 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.  Concomitant administered medication could be potentially confounders/co-suspects for the events.; 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.  Concomitant administered medication could be potentially confounders/co-suspects for the events.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Decreased appetite, Hypersensitivity, Impaired work ability, Loss of consciousness
Clinical narrative: no interest in work; Hypersensitive; No appetite; Put me in bed; Passed out, thought I was gone; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out, thought I was gone) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included DEXTROAMPHETAMINE [DEXAMFETAMINE], CLONAZEPAM (CLONAPIN), TEMAZEPAM and OMEPRAZOLE 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 01-Apr-2021 at 4:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LOSS OF CONSCIOUSNESS (Passed out, thought I was gone) (seriousness criterion medically significant). On an unknown date, the patient experienced IMPAIRED WORK ABILITY (no interest in work), HYPERSENSITIVITY (Hypersensitive), DECREASED APPETITE (No appetite) and BEDRIDDEN (Put me in bed). The patient was treated with ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) at a dose of UNK dosage form. On 02-Apr-2021 at 3:15 AM, LOSS OF CONSCIOUSNESS (Passed out, thought I was gone) had resolved. At the time of the report, IMPAIRED WORK ABILITY (no interest in work), HYPERSENSITIVITY (Hypersensitive), DECREASED APPETITE (No appetite) and BEDRIDDEN (Put me in bed) outcome was unknown.            It was reported that after the 2nd dose, within 75 min, the patient passed out after going home until 3:15AM the next morning (02Apr2021). The patient reported that the nurse at the vaccinating facility, after checking with the Doctor gave the 2nd dose in spite of the patient's concern (he was feeling sick on that day) if he needs to wait for the 2nd shot. The patient stated he made a terrible mistake getting the 2nd shot while still sick from the 1st shot. He is going for lab tests the next Monday (14 Jun 2021).              Other treatment information include more amount water.  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.   This case was linked to MOD-2021-218564 (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: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Condition aggravated, Heart rate increased, Pyrexia, Seizure
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of SEIZURE (Bad seizures) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 106B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included VSD (patient had heart and lung problems when he was born (VSD ). heart murmur.), Bronchopulmonary dysplasia (patient had heart and lung problems when he was born (BPD-bronchopulmonary dysplasia)), Epilepsy, Prematurity, Aspiration pneumonia, Gastroschisis, Inappropriate schedule of vaccine administered and Breathing arrested. Concomitant products included TOPIRAMATE (TOPAMAX) and GABAPENTIN (NEURONTIN) for Seizures, QUETIAPINE FUMARATE (SEROQUEL), SERTRALINE HYDROCHLORIDE (ZOLOFT), CLONAZEPAM (KLONOPIN), LACOSAMIDE (VIMPAT), TRAZODONE, BACLOFEN (LIORESAL), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), CIMETIDINE (TAGAMET [CIMETIDINE]) and EPINEPHRINE (EPIPEN) 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 SEIZURE (Bad seizures) (seriousness criterion medically significant), CHEST PAIN (Chest Pain), URTICARIA (Big old welts / Hives), HEART RATE INCREASED (elevated heart rate) and PYREXIA (On and off fever). On an unknown date, the patient experienced CONDITION AGGRAVATED (condition aggravated/ seizures). The patient was treated with HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]) at a dose of 50 mg three times a day. At the time of the report, SEIZURE (Bad seizures), CHEST PAIN (Chest Pain), URTICARIA (Big old welts / Hives), CONDITION AGGRAVATED (condition aggaravted/ seizures), HEART RATE INCREASED (elevated heart rate) and PYREXIA (On and off fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Heart rate increased: high (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient was born between twenty two and a half and twenty three and a half weeks. Mother states she had German measles/Rubella while pregnant and was bleeding every week. patient was born with his intestine outside which had to be put back inside. 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: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of SEIZURE (Bad seizures) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 106B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included VSD (patient had heart and lung problems when he was born (VSD ). heart murmur.), Bronchopulmonary dysplasia (patient had heart and lung problems when he was born (BPD-bronchopulmonary dysplasia)), Epilepsy, Prematurity, Aspiration pneumonia, Gastroschisis, Inappropriate schedule of vaccine administered and Breathing arrested. Concomitant products included TOPIRAMATE (TOPAMAX) and GABAPENTIN (NEURONTIN) for Seizures, QUETIAPINE FUMARATE (SEROQUEL), SERTRALINE HYDROCHLORIDE (ZOLOFT), CLONAZEPAM (KLONOPIN), LACOSAMIDE (VIMPAT), TRAZODONE, BACLOFEN (LIORESAL), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), CIMETIDINE (TAGAMET [CIMETIDINE]) and EPINEPHRINE (EPIPEN) 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 SEIZURE (Bad seizures) (seriousness criterion medically significant), CHEST PAIN (Chest Pain), URTICARIA (Big old welts / Hives), HEART RATE INCREASED (elevated heart rate) and PYREXIA (On and off fever). On an unknown date, the patient experienced CONDITION AGGRAVATED (condition aggravated/ seizures). The patient was treated with HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]) at a dose of 50 mg three times a day. At the time of the report, SEIZURE (Bad seizures), CHEST PAIN (Chest Pain), URTICARIA (Big old welts / Hives), CONDITION AGGRAVATED (condition aggaravted/ seizures), HEART RATE INCREASED (elevated heart rate) and PYREXIA (On and off fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Heart rate increased: high (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient was born between twenty two and a half and twenty three and a half weeks. Mother states she had German measles/Rubella while pregnant and was bleeding every week. patient was born with his intestine outside which had to be put back inside. 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Breast pain, Breast swelling, Cachexia
Clinical narrative: Not getting 2nd dose; Left breast is swollen; Shortness of breath; Loss of smell; Loss of taste; Lost a lot of weight; diarrhea; She can't lift arm, can't do all the things she used to be able to do; Left breast is very painful; She is afraid; Swollen lymph of nodes; Muscle fatigue; Lump at injection site; heart beats quickly; Headache every night; Feels like she is wasting away; This spontaneous case was reported by a consumer and describes the occurrence of CACHEXIA (Feels like she is wasting away) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced CACHEXIA (Feels like she is wasting away) (seriousness criterion medically significant), BREAST SWELLING (Left breast is swollen), DYSPNOEA (Shortness of breath), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), WEIGHT DECREASED (Lost a lot of weight), DIARRHOEA (diarrhea), MOBILITY DECREASED (She can't lift arm, can't do all the things she used to be able to do), BREAST PAIN (Left breast is very painful),  FEAR (She is afraid), LYMPHADENOPATHY (Swollen lymph of nodes), MUSCLE FATIGUE (Muscle fatigue), INJECTION SITE MASS (Lump at injection site), HEART RATE INCREASED (heart beats quickly), and HEADACHE (Headache every night). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not getting 2nd dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 UNK. At the time of the report, CACHEXIA (Feels like she is wasting away), BREAST SWELLING (Left breast is swollen), DYSPNOEA (Shortness of breath), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), WEIGHT DECREASED (Lost a lot of weight), DIARRHOEA (diarrhea), MOBILITY DECREASED (She can't lift arm, can't do all the things she used to be able to do), BREAST PAIN (Left breast is very painful), LYMPHADENOPATHY (Swollen lymph of nodes), MUSCLE FATIGUE (Muscle fatigue), HEART RATE INCREASED (heart beats quickly), INJECTION SITE MASS (Lump at injection site) and HEADACHE (Headache every night) had not resolved and FEAR (She is afraid) and PRODUCT DOSE OMISSION ISSUE (Not getting 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2021, Heart rate: increased (Inconclusive) heart beats quickly.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.        Concomitant product use was not provided by the reporter.; 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Fear, Headache, Heart rate
Clinical narrative: Not getting 2nd dose; Left breast is swollen; Shortness of breath; Loss of smell; Loss of taste; Lost a lot of weight; diarrhea; She can't lift arm, can't do all the things she used to be able to do; Left breast is very painful; She is afraid; Swollen lymph of nodes; Muscle fatigue; Lump at injection site; heart beats quickly; Headache every night; Feels like she is wasting away; This spontaneous case was reported by a consumer and describes the occurrence of CACHEXIA (Feels like she is wasting away) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced CACHEXIA (Feels like she is wasting away) (seriousness criterion medically significant), BREAST SWELLING (Left breast is swollen), DYSPNOEA (Shortness of breath), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), WEIGHT DECREASED (Lost a lot of weight), DIARRHOEA (diarrhea), MOBILITY DECREASED (She can't lift arm, can't do all the things she used to be able to do), BREAST PAIN (Left breast is very painful),  FEAR (She is afraid), LYMPHADENOPATHY (Swollen lymph of nodes), MUSCLE FATIGUE (Muscle fatigue), INJECTION SITE MASS (Lump at injection site), HEART RATE INCREASED (heart beats quickly), and HEADACHE (Headache every night). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not getting 2nd dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 UNK. At the time of the report, CACHEXIA (Feels like she is wasting away), BREAST SWELLING (Left breast is swollen), DYSPNOEA (Shortness of breath), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), WEIGHT DECREASED (Lost a lot of weight), DIARRHOEA (diarrhea), MOBILITY DECREASED (She can't lift arm, can't do all the things she used to be able to do), BREAST PAIN (Left breast is very painful), LYMPHADENOPATHY (Swollen lymph of nodes), MUSCLE FATIGUE (Muscle fatigue), HEART RATE INCREASED (heart beats quickly), INJECTION SITE MASS (Lump at injection site) and HEADACHE (Headache every night) had not resolved and FEAR (She is afraid) and PRODUCT DOSE OMISSION ISSUE (Not getting 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2021, Heart rate: increased (Inconclusive) heart beats quickly.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.        Concomitant product use was not provided by the reporter.; 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Injection site mass, Lymphadenopathy, Mobility decreased, Muscle fatigue
Clinical narrative: Not getting 2nd dose; Left breast is swollen; Shortness of breath; Loss of smell; Loss of taste; Lost a lot of weight; diarrhea; She can't lift arm, can't do all the things she used to be able to do; Left breast is very painful; She is afraid; Swollen lymph of nodes; Muscle fatigue; Lump at injection site; heart beats quickly; Headache every night; Feels like she is wasting away; This spontaneous case was reported by a consumer and describes the occurrence of CACHEXIA (Feels like she is wasting away) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced CACHEXIA (Feels like she is wasting away) (seriousness criterion medically significant), BREAST SWELLING (Left breast is swollen), DYSPNOEA (Shortness of breath), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), WEIGHT DECREASED (Lost a lot of weight), DIARRHOEA (diarrhea), MOBILITY DECREASED (She can't lift arm, can't do all the things she used to be able to do), BREAST PAIN (Left breast is very painful),  FEAR (She is afraid), LYMPHADENOPATHY (Swollen lymph of nodes), MUSCLE FATIGUE (Muscle fatigue), INJECTION SITE MASS (Lump at injection site), HEART RATE INCREASED (heart beats quickly), and HEADACHE (Headache every night). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not getting 2nd dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 UNK. At the time of the report, CACHEXIA (Feels like she is wasting away), BREAST SWELLING (Left breast is swollen), DYSPNOEA (Shortness of breath), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), WEIGHT DECREASED (Lost a lot of weight), DIARRHOEA (diarrhea), MOBILITY DECREASED (She can't lift arm, can't do all the things she used to be able to do), BREAST PAIN (Left breast is very painful), LYMPHADENOPATHY (Swollen lymph of nodes), MUSCLE FATIGUE (Muscle fatigue), HEART RATE INCREASED (heart beats quickly), INJECTION SITE MASS (Lump at injection site) and HEADACHE (Headache every night) had not resolved and FEAR (She is afraid) and PRODUCT DOSE OMISSION ISSUE (Not getting 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2021, Heart rate: increased (Inconclusive) heart beats quickly.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.        Concomitant product use was not provided by the reporter.; 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