chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Extra dose administered, Illness, Pneumonia
Clinical narrative: Pneumonia; Very ill; Dysphagia; Got 3 Moderna vaccines; This spontaneous case was reported by a nurse and describes the occurrence of PNEUMONIA (Pneumonia) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A, 040B21A and 043B121A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pre-existing disease.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 06-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 06-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Got 3 Moderna vaccines). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), ILLNESS (Very ill) and DYSPHAGIA (Dysphagia). On 06-May-2021, EXTRA DOSE ADMINISTERED (Got 3 Moderna vaccines) had resolved. At the time of the report, PNEUMONIA (Pneumonia), ILLNESS (Very ill) and DYSPHAGIA (Dysphagia) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication were provided. Lot number of 3rd dose of mRNA-1273 - 043B121A. Action taken with mRNA-1273 in response to the event was not applicable.  Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11-May-2021 contains no significant information. Updated lot number of 3rd dose of mRNA-1273. On 16-Jun-2021: Updated events - Pneumonia (medically significant), Illness and Dysphagia. Updated historical condition - comorbid conditions.; Sender's Comments: Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Hives; Warm at the injection site; Itchy at the injection site; Red circle at the injection site, with the shape of a pear; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), VACCINATION SITE WARMTH (Warm at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE ERYTHEMA (Red circle at the injection site, with the shape of a pear) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced URTICARIA (Hives), VACCINATION SITE WARMTH (Warm at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE ERYTHEMA (Red circle at the injection site, with the shape of a pear). At the time of the report, URTICARIA (Hives), VACCINATION SITE WARMTH (Warm at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE ERYTHEMA (Red circle at the injection site, with the shape of a pear) outcome was unknown.            concomitant medication include diabetes medication. no treatment medication reported.   This case was linked to MOD-2021-035951 (Patient Link).
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Transient ischaemic attack
Clinical narrative: Mini stroke; Numbness from shoulder to hand opposite arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Mini stroke) in a 99-year-old female 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 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced HYPOAESTHESIA (Numbness from shoulder to hand opposite arm of injection). On 17-Jun-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Mini stroke) (seriousness criteria hospitalization and medically significant). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Mini stroke) and HYPOAESTHESIA (Numbness from shoulder to hand opposite arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product were not provided. Treatment medication was not provided.  Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Address, date of birth and serious event added upgrading the case; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling sensation in fingers of left arm and going up on arm; Two fingers are numb; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation in fingers of left arm and going up on arm) and HYPOAESTHESIA (Two fingers are numb) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-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 an unknown date, the patient experienced PARAESTHESIA (Tingling sensation in fingers of left arm and going up on arm) and HYPOAESTHESIA (Two fingers are numb). The patient was treated with CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling sensation in fingers of left arm and going up on arm) and HYPOAESTHESIA (Two fingers are numb) outcome was unknown.            Concomitant medications were not provided.  Company Comment : This case concerns a 68-year-old female with serious unexpected events of paraesthesia, and hypoaesthesia. Event onset with unknown latency 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 68-year-old female with serious unexpected events of paraesthesia, and hypoaesthesia. Event onset with unknown latency 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: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Carotid artery occlusion, Electrocardiogram
Clinical narrative: Block; cardiac arrest; This spontaneous case was reported by a nurse and describes the occurrence of CARDIAC ARREST (cardiac arrest) and CAROTID ARTERY OCCLUSION (Block) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A,) for COVID-19 vaccination.     Concomitant products included TICAGRELOR (BRILINTA), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CARVEDILOL PHOSPHATE and ROSUVASTATIN CALCIUM for an unknown indication.    On 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced CARDIAC ARREST (cardiac arrest) (seriousness criterion medically significant). On an unknown date, the patient experienced CAROTID ARTERY OCCLUSION (Block) (seriousness criterion medically significant). At the time of the report, CARDIAC ARREST (cardiac arrest) had resolved and CAROTID ARTERY OCCLUSION (Block) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications 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. Patients age, and concomitant medication with ticagrelor, aspirin, rosuvastatin suggest an underlying cardiovascular disease that is a potential confounder. Additional 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. Patients age, and concomitant medication with ticagrelor, aspirin, rosuvastatin suggest an underlying cardiovascular disease that is a potential confounder. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Hospitalisation
Clinical narrative: Admitted to a hospital ( ICU for 7 seven days); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of HOSPITALISATION (Admitted to a hospital ( ICU for 7 seven days)) 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 HOSPITALISATION (Admitted to a hospital ( ICU for 7 seven days)) (seriousness criterion hospitalization). At the time of the report, HOSPITALISATION (Admitted to a hospital ( ICU for 7 seven days)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication use was provided by the reporter.  No treatment of events was reported.  Company comment: 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Lymphadenopathy, Throat irritation
Clinical narrative: right side of face, lips droopped a little; throat irritation; lymph nodes swelling - under her chin; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (right side of face, lips droopped a little) in a 51-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.     The patient's past medical history included Total hysterectomy in 2016 and Colonoscopy on 14-May-2021. Concurrent medical conditions included HIV disease, Spinal cord injury and Nerve injury.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced FACIAL PARALYSIS (right side of face, lips droopped a little) (seriousness criterion medically significant), THROAT IRRITATION (throat irritation) and LYMPHADENOPATHY (lymph nodes swelling - under her chin). The patient was treated with NAPROXEN for Inflammation, at an unspecified dose and frequency. On 15-Jun-2021, FACIAL PARALYSIS (right side of face, lips droopped a little) had resolved. At the time of the report, THROAT IRRITATION (throat irritation) had not resolved and LYMPHADENOPATHY (lymph nodes swelling - under her chin) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication reporter were hypertension medication, hyperlipidemia medication and HIV medication. Cough lozenges were the treatment medication reported by reporter. Patient also said that she did not have these symptoms before the COVID shot  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: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Flank pain, Hypersensitivity, Pain, Pancreatitis
Clinical narrative: Pancreatitis; Flank Pain; Allergic reaction; Abdominal Pain; Pain; Rash; This spontaneous case was reported by an other health care professional and describes the occurrence of PANCREATITIS (Pancreatitis) in a 62-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 products included non-company products IBRUTINIB (IMBRUVICA) capsule for Chronic lymphocytic leukemia and SEMAGLUTIDE (OZEMPIC) for an unknown indication.    Concurrent medical conditions included Chronic lymphocytic leukemia. Concomitant products included DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), EMPAGLIFLOZIN (JARDIANCE) and METOPROLOL for an unknown indication.   On 20-Dec-2017, the patient IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 140 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, IBRUTINIB (IMBRUVICA) (Oral) 280 milligram once a day and SEMAGLUTIDE (OZEMPIC) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANCREATITIS (Pancreatitis) (seriousness criterion medically significant), FLANK PAIN (Flank Pain), HYPERSENSITIVITY (Allergic reaction), ABDOMINAL PAIN (Abdominal Pain), PAIN (Pain) and RASH (Rash). At the time of the report, PANCREATITIS (Pancreatitis), HYPERSENSITIVITY (Allergic reaction), ABDOMINAL PAIN (Abdominal Pain), PAIN (Pain) and RASH (Rash) outcome was unknown and FLANK PAIN (Flank Pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Company comment: 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.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 antibody test
Clinical narrative: Pancreatitis; Flank Pain; Allergic reaction; Abdominal Pain; Pain; Rash; This spontaneous case was reported by an other health care professional and describes the occurrence of PANCREATITIS (Pancreatitis) in a 62-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 products included non-company products IBRUTINIB (IMBRUVICA) capsule for Chronic lymphocytic leukemia and SEMAGLUTIDE (OZEMPIC) for an unknown indication.    Concurrent medical conditions included Chronic lymphocytic leukemia. Concomitant products included DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), EMPAGLIFLOZIN (JARDIANCE) and METOPROLOL for an unknown indication.   On 20-Dec-2017, the patient IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 140 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, IBRUTINIB (IMBRUVICA) (Oral) 280 milligram once a day and SEMAGLUTIDE (OZEMPIC) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANCREATITIS (Pancreatitis) (seriousness criterion medically significant), FLANK PAIN (Flank Pain), HYPERSENSITIVITY (Allergic reaction), ABDOMINAL PAIN (Abdominal Pain), PAIN (Pain) and RASH (Rash). At the time of the report, PANCREATITIS (Pancreatitis), HYPERSENSITIVITY (Allergic reaction), ABDOMINAL PAIN (Abdominal Pain), PAIN (Pain) and RASH (Rash) outcome was unknown and FLANK PAIN (Flank Pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Company comment: 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.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Computerised tomogram, Head discomfort, Headache
Clinical narrative: passed out from the pain; Dry heaves; head felt swollen; my headache continued to move down to my right jaw; ever had migraines before; stomach sickness; arm hurt at the vaccination site; Chills; head was aching terribly; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out from the pain) in a 53-year-old patient of an unknown 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 20-Apr-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 an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out from the pain) (seriousness criterion medically significant), RETCHING (Dry heaves), HEAD DISCOMFORT (head felt swollen), PAIN IN JAW (my headache continued to move down to my right jaw), MIGRAINE (ever had migraines before), ABDOMINAL DISCOMFORT (stomach sickness), VACCINATION SITE PAIN (arm hurt at the vaccination site), CHILLS (Chills) and HEADACHE (head was aching terribly). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (passed out from the pain), RETCHING (Dry heaves), HEAD DISCOMFORT (head felt swollen), MIGRAINE (ever had migraines before) and VACCINATION SITE PAIN (arm hurt at the vaccination site) outcome was unknown, PAIN IN JAW (my headache continued to move down to my right jaw) and HEADACHE (head was aching terribly) had not resolved and ABDOMINAL DISCOMFORT (stomach sickness) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: inconclusive (Inconclusive) Inconclusive  did not showany problem. On an unknown date, Magnetic resonance imaging: inconclusive (Inconclusive) Inconclusive  did not show any problem. On an unknown date, X-ray: inconclusive (Inconclusive) X-ray confirmed there was nothing wrong in my jaw..         Patient had done blood work that did not show problems No Concomitant medication information was provided. Action taken with mRNA-1273 in response to the events was Not Applicable.  Company comment: 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: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Loss of consciousness, Magnetic resonance imaging, Migraine, Pain in jaw, Retching
Clinical narrative: passed out from the pain; Dry heaves; head felt swollen; my headache continued to move down to my right jaw; ever had migraines before; stomach sickness; arm hurt at the vaccination site; Chills; head was aching terribly; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out from the pain) in a 53-year-old patient of an unknown 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 20-Apr-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 an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out from the pain) (seriousness criterion medically significant), RETCHING (Dry heaves), HEAD DISCOMFORT (head felt swollen), PAIN IN JAW (my headache continued to move down to my right jaw), MIGRAINE (ever had migraines before), ABDOMINAL DISCOMFORT (stomach sickness), VACCINATION SITE PAIN (arm hurt at the vaccination site), CHILLS (Chills) and HEADACHE (head was aching terribly). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (passed out from the pain), RETCHING (Dry heaves), HEAD DISCOMFORT (head felt swollen), MIGRAINE (ever had migraines before) and VACCINATION SITE PAIN (arm hurt at the vaccination site) outcome was unknown, PAIN IN JAW (my headache continued to move down to my right jaw) and HEADACHE (head was aching terribly) had not resolved and ABDOMINAL DISCOMFORT (stomach sickness) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: inconclusive (Inconclusive) Inconclusive  did not showany problem. On an unknown date, Magnetic resonance imaging: inconclusive (Inconclusive) Inconclusive  did not show any problem. On an unknown date, X-ray: inconclusive (Inconclusive) X-ray confirmed there was nothing wrong in my jaw..         Patient had done blood work that did not show problems No Concomitant medication information was provided. Action taken with mRNA-1273 in response to the events was Not Applicable.  Company comment: 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: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, X-ray
Clinical narrative: passed out from the pain; Dry heaves; head felt swollen; my headache continued to move down to my right jaw; ever had migraines before; stomach sickness; arm hurt at the vaccination site; Chills; head was aching terribly; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out from the pain) in a 53-year-old patient of an unknown 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 20-Apr-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 an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out from the pain) (seriousness criterion medically significant), RETCHING (Dry heaves), HEAD DISCOMFORT (head felt swollen), PAIN IN JAW (my headache continued to move down to my right jaw), MIGRAINE (ever had migraines before), ABDOMINAL DISCOMFORT (stomach sickness), VACCINATION SITE PAIN (arm hurt at the vaccination site), CHILLS (Chills) and HEADACHE (head was aching terribly). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (passed out from the pain), RETCHING (Dry heaves), HEAD DISCOMFORT (head felt swollen), MIGRAINE (ever had migraines before) and VACCINATION SITE PAIN (arm hurt at the vaccination site) outcome was unknown, PAIN IN JAW (my headache continued to move down to my right jaw) and HEADACHE (head was aching terribly) had not resolved and ABDOMINAL DISCOMFORT (stomach sickness) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: inconclusive (Inconclusive) Inconclusive  did not showany problem. On an unknown date, Magnetic resonance imaging: inconclusive (Inconclusive) Inconclusive  did not show any problem. On an unknown date, X-ray: inconclusive (Inconclusive) X-ray confirmed there was nothing wrong in my jaw..         Patient had done blood work that did not show problems No Concomitant medication information was provided. Action taken with mRNA-1273 in response to the events was Not Applicable.  Company comment: 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.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Dyspnoea, Lung disorder
Clinical narrative: Copd before but now i have had heart an lung problems was in hosp for 6 days; Copd before but now i have had heart an lung problems was in hosp for 6 days; Bad breathing; 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 CARDIAC DISORDER (Copd before but now i have had heart an lung problems was in hosp for 6 days), LUNG DISORDER (Copd before but now i have had heart an lung problems was in hosp for 6 days) and DYSPNOEA (Bad breathing) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COPD.    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 CARDIAC DISORDER (Copd before but now i have had heart an lung problems was in hosp for 6 days) (seriousness criterion hospitalization), LUNG DISORDER (Copd before but now i have had heart an lung problems was in hosp for 6 days) (seriousness criterion hospitalization) and DYSPNOEA (Bad breathing) (seriousness criterion hospitalization). At the time of the report, CARDIAC DISORDER (Copd before but now i have had heart an lung problems was in hosp for 6 days), LUNG DISORDER (Copd before but now i have had heart an lung problems was in hosp for 6 days) and DYSPNOEA (Bad breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not provided.  Treatment medications were not provided.  Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic shock, Somnolence
Clinical narrative: I slept for most of the day; Anaphylactic shock; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) 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.     Concurrent medical conditions included Drug allergy (to Codeine), Sulfonamide allergy (to sulfa drugs), Allergy to antibiotic (to tetracycline) and Insect bite allergy (to bites of various insects).   On 07-Apr-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 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant). On 08-Apr-2021, the patient experienced SOMNOLENCE (I slept for most of the day). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) 07-Apr-2021 for Allergic reaction, at an unspecified dose and frequency. At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic shock) and SOMNOLENCE (I slept for most of the day) outcome was unknown.            Concomitant product use was not provided. The patient stated that she was monitored at hospital for several hours, as well as given another medication to counter the allergic reaction.  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.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic shock, Hypersensitivity, Somnolence, Vaccination site bruising, Vaccination site pain
Clinical narrative: felt like a bad bruise; injection site felt like I had been extremely punched hard in that spot/the pain was not debilitating; The next day, I slept for most of the day; Anaphylactic shock; allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) 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.     Concurrent medical conditions included Drug allergy (codeine), Drug allergy (sulpha drugs), Drug allergy (tetracyclines) and Allergy (Bites of insects).    On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant) and HYPERSENSITIVITY (allergic reaction). On 08-Apr-2021, the patient experienced SOMNOLENCE (The next day, I slept for most of the day). On an unknown date, the patient experienced VACCINATION SITE BRUISING (felt like a bad bruise) and VACCINATION SITE PAIN (injection site felt like I had been extremely punched hard in that spot/the pain was not debilitating). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergic reaction, at an unspecified dose and frequency. At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic shock), VACCINATION SITE BRUISING (felt like a bad bruise), HYPERSENSITIVITY (allergic reaction), SOMNOLENCE (The next day, I slept for most of the day) and VACCINATION SITE PAIN (injection site felt like I had been extremely punched hard in that spot/the pain was not debilitating) outcome was unknown.            No concomitant medication information was reported. Other treatment medications include an unspecified medication the patient received at the hospital for the allergic reaction.  This case concerns a patient of unknown age and gender with a serious unexpected event of anaphylactic shock, and nonserious hypersensitivity, somnolence, vaccination site bruising and vaccination site pain. Event latency 5 minutes 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 patient of unknown age and gender with a serious unexpected event of anaphylactic shock, and nonserious hypersensitivity, somnolence, vaccination site bruising and vaccination site pain. Event latency 5 minutes 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Dizziness, Dyspnoea, Loss of consciousness
Clinical narrative: worsen episode; heavy breathing; lightheadedness a day; passed out; the left arm was very weak then the whole body very weak; trouble breathing like a shortness breath; tingling feeling in the whole body; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), ASTHENIA (the left arm was very weak then the whole body very weak), DYSPNOEA (trouble breathing like a shortness breath) and PARAESTHESIA (tingling feeling in the whole body). On 12-Jun-2021, the patient experienced RESPIRATORY RATE INCREASED (heavy breathing) and DIZZINESS (lightheadedness a day). On 15-Jun-2021, the patient experienced CONDITION AGGRAVATED (worsen episode). The patient was treated with LORAZEPAM (ATIVAN) on 15-Jun-2021 at an unspecified dose and frequency. On 11-Jun-2021, LOSS OF CONSCIOUSNESS (passed out), DYSPNOEA (trouble breathing like a shortness breath) and PARAESTHESIA (tingling feeling in the whole body) had resolved. At the time of the report, RESPIRATORY RATE INCREASED (heavy breathing), DIZZINESS (lightheadedness a day), CONDITION AGGRAVATED (worsen episode) and ASTHENIA (the left arm was very weak then the whole body very weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include birth control very low dose.  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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Respiratory rate increased
Clinical narrative: worsen episode; heavy breathing; lightheadedness a day; passed out; the left arm was very weak then the whole body very weak; trouble breathing like a shortness breath; tingling feeling in the whole body; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), ASTHENIA (the left arm was very weak then the whole body very weak), DYSPNOEA (trouble breathing like a shortness breath) and PARAESTHESIA (tingling feeling in the whole body). On 12-Jun-2021, the patient experienced RESPIRATORY RATE INCREASED (heavy breathing) and DIZZINESS (lightheadedness a day). On 15-Jun-2021, the patient experienced CONDITION AGGRAVATED (worsen episode). The patient was treated with LORAZEPAM (ATIVAN) on 15-Jun-2021 at an unspecified dose and frequency. On 11-Jun-2021, LOSS OF CONSCIOUSNESS (passed out), DYSPNOEA (trouble breathing like a shortness breath) and PARAESTHESIA (tingling feeling in the whole body) had resolved. At the time of the report, RESPIRATORY RATE INCREASED (heavy breathing), DIZZINESS (lightheadedness a day), CONDITION AGGRAVATED (worsen episode) and ASTHENIA (the left arm was very weak then the whole body very weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include birth control very low dose.  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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (had been put on hypertension medication). Concomitant products included LOSARTAN for Hypertension.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized for 2 days due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.            Concomitant medications were not reported.  Treatment medications were not provided.  This case concerns a 71-year-old female hospitalized with a serious unexpected event of cerebrovascular accident. Event latency 55 days 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.   This case was linked to MOD-2021-066369 (Patient Link).; Sender's Comments: This case concerns a 71-year-old female hospitalized with a serious unexpected event of cerebrovascular accident. Event latency 55 days 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.
Sex: U
Vaccine: COVID19
Symptoms: Facial paralysis, Tongue paralysis
Clinical narrative: the left side of my face became paralysed; my tongue became paralysed; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (the left side of my face became paralysed) and TONGUE PARALYSIS (my tongue became paralysed) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FACIAL PARALYSIS (the left side of my face became paralysed) (seriousness criterion medically significant) and TONGUE PARALYSIS (my tongue became paralysed) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (the left side of my face became paralysed) and TONGUE PARALYSIS (my tongue became paralysed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was mentioned.  No treatment medication information was mentioned.  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: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Neuropathy peripheral, Pain in extremity, Pruritus, Vaccination site erythema
Clinical narrative: redness and swelling of left bicep; redness and swelling of left bicep; fatigue; itching; pain at left arm "neuropathy"; pain at left arm "neuropathy"; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (pain at left arm "neuropathy") in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced NEUROPATHY PERIPHERAL (pain at left arm "neuropathy") (seriousness criterion medically significant) and PAIN IN EXTREMITY (pain at left arm "neuropathy"). On 13-Jun-2021, the patient experienced PRURITUS (itching). On 14-Jun-2021, the patient experienced FATIGUE (fatigue). On 15-Jun-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness and swelling of left bicep) and VACCINATION SITE SWELLING (redness and swelling of left bicep). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORINE) at an unspecified dose and frequency and ETHANOL (ALCOHOL SWABS [ETHANOL]) at an unspecified dose and frequency. On 20-May-2021, NEUROPATHY PERIPHERAL (pain at left arm "neuropathy") and PAIN IN EXTREMITY (pain at left arm "neuropathy") had resolved. On 15-Jun-2021, FATIGUE (fatigue) had resolved. At the time of the report, PRURITUS (itching), VACCINATION SITE ERYTHEMA (redness and swelling of left bicep) and VACCINATION SITE SWELLING (redness and swelling of left bicep) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  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: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: redness and swelling of left bicep; redness and swelling of left bicep; fatigue; itching; pain at left arm "neuropathy"; pain at left arm "neuropathy"; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (pain at left arm "neuropathy") in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced NEUROPATHY PERIPHERAL (pain at left arm "neuropathy") (seriousness criterion medically significant) and PAIN IN EXTREMITY (pain at left arm "neuropathy"). On 13-Jun-2021, the patient experienced PRURITUS (itching). On 14-Jun-2021, the patient experienced FATIGUE (fatigue). On 15-Jun-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness and swelling of left bicep) and VACCINATION SITE SWELLING (redness and swelling of left bicep). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORINE) at an unspecified dose and frequency and ETHANOL (ALCOHOL SWABS [ETHANOL]) at an unspecified dose and frequency. On 20-May-2021, NEUROPATHY PERIPHERAL (pain at left arm "neuropathy") and PAIN IN EXTREMITY (pain at left arm "neuropathy") had resolved. On 15-Jun-2021, FATIGUE (fatigue) had resolved. At the time of the report, PRURITUS (itching), VACCINATION SITE ERYTHEMA (redness and swelling of left bicep) and VACCINATION SITE SWELLING (redness and swelling of left bicep) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  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.