chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain, Thrombosis
Clinical narrative: Throbbing pain in leg right next to my shin bone; Kept me awake at night; Developed a small blood clot in the vein running along shin bone; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Developed a small blood clot in the vein running along shin bone) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Throbbing pain in leg right next to my shin bone), INSOMNIA (Kept me awake at night) and THROMBOSIS (Developed a small blood clot in the vein running along shin bone) (seriousness criterion medically significant). At the time of the report, PAIN (Throbbing pain in leg right next to my shin bone) and THROMBOSIS (Developed a small blood clot in the vein running along shin bone) had resolved and INSOMNIA (Kept me awake at night) outcome was unknown.            No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-017541 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Influenza like illness, Plague, Pruritus
Clinical narrative: flu-like feeling; Redness; Plague pileup; Itchiness; This spontaneous case was reported by a health care professional and describes the occurrence of PLAGUE (Plague pileup) in an 80-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 No adverse event. Concomitant products included CERTOLIZUMAB PEGOL (CIMZIA), GLIPIZIDE, VITAMIN D3, FISH OIL and FLAXSEED for an unknown indication.   On 09-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. On 19-Mar-2021, the patient experienced ERYTHEMA (Redness), PLAGUE (Plague pileup) (seriousness criterion medically significant) and PRURITUS (Itchiness). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like feeling). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like feeling), ERYTHEMA (Redness), PLAGUE (Plague pileup) and PRURITUS (Itchiness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment medications were provided Action taken with mRNA-1273 Is not applicable Concomitant medication includes Cocoa butter   This case was linked to MOD-2021-100453 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Fall, Incomplete course of vaccination, Lower limb fracture, Tinnitus
Clinical narrative: possible loss of hearing; fall; the broken part is behind the left knee; incomplete course of vaccination; Ringing in the Ear/tinnitus since two days after the first shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (possible loss of hearing) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Overweight and Hypertension. Concomitant products included LISINOPRIL and METOPROLOL for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced TINNITUS (Ringing in the Ear/tinnitus since two days after the first shot). On 16-Jun-2021, the patient experienced LOWER LIMB FRACTURE (the broken part is behind the left knee) and INCOMPLETE COURSE OF VACCINATION (incomplete course of vaccination). On an unknown date, the patient experienced DEAFNESS (possible loss of hearing) (seriousness criterion medically significant) and FALL (fall). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain relief, at a dose of 1 dosage form. At the time of the report, DEAFNESS (possible loss of hearing), FALL (fall), LOWER LIMB FRACTURE (the broken part is behind the left knee) and TINNITUS (Ringing in the Ear/tinnitus since two days after the first shot) had not resolved and INCOMPLETE COURSE OF VACCINATION (incomplete course of vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jun-2021, X-ray: abnormal (abnormal) the broken part is behind the left knee, per x-ray examinations..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter stated that the patient has planned a left leg surgery on 21Jun2021. 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.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Significant follow up. Lab data, treatment medication and new events are added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: possible loss of hearing; fall; the broken part is behind the left knee; incomplete course of vaccination; Ringing in the Ear/tinnitus since two days after the first shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (possible loss of hearing) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Overweight and Hypertension. Concomitant products included LISINOPRIL and METOPROLOL for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced TINNITUS (Ringing in the Ear/tinnitus since two days after the first shot). On 16-Jun-2021, the patient experienced LOWER LIMB FRACTURE (the broken part is behind the left knee) and INCOMPLETE COURSE OF VACCINATION (incomplete course of vaccination). On an unknown date, the patient experienced DEAFNESS (possible loss of hearing) (seriousness criterion medically significant) and FALL (fall). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain relief, at a dose of 1 dosage form. At the time of the report, DEAFNESS (possible loss of hearing), FALL (fall), LOWER LIMB FRACTURE (the broken part is behind the left knee) and TINNITUS (Ringing in the Ear/tinnitus since two days after the first shot) had not resolved and INCOMPLETE COURSE OF VACCINATION (incomplete course of vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jun-2021, X-ray: abnormal (abnormal) the broken part is behind the left knee, per x-ray examinations..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter stated that the patient has planned a left leg surgery on 21Jun2021. 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.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Significant follow up. Lab data, treatment medication and new events are added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Hospitalisation, Incomplete course of vaccination
Clinical narrative: Hospitalization; Miisses his second dose due to hodpitalization / unable to get second dose due to hospitalization; This spontaneous case was reported by a pharmacist and describes the occurrence of HOSPITALISATION (Hospitalization) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Hospitalization) (seriousness criterion hospitalization) and INCOMPLETE COURSE OF VACCINATION (Miisses his second dose due to hodpitalization / unable to get second dose due to hospitalization). At the time of the report, HOSPITALISATION (Hospitalization) and INCOMPLETE COURSE OF VACCINATION (Miisses his second dose due to hodpitalization / unable to get second dose due to hospitalization) 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 relevant concomitant medications were reported.  No treatment information was reported.  This is a case of an Incomplete course of vaccination  with mRNA 1273  with limited information available. Further information has been requested.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Initial additional; Sender's Comments: This is a case of an Incomplete course of vaccination  with mRNA 1273  with limited information available. Further information has been requested.
Sex: U
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 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 CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had a stroke following immunization.  Company Comment : Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Myalgia, Nausea, Pyrexia, Syncope
Clinical narrative: Little faint when i move around; Sore arm; Feeling light headed; Nauseous; Feverish this morning; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Little faint when i move around) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Little faint when i move around) (seriousness criterion medically significant), VACCINATION SITE PAIN (Sore arm), DIZZINESS (Feeling light headed), NAUSEA (Nauseous), PYREXIA (Feverish this morning) and MYALGIA (Body aches). At the time of the report, SYNCOPE (Little faint when i move around), VACCINATION SITE PAIN (Sore arm), DIZZINESS (Feeling light headed), NAUSEA (Nauseous), PYREXIA (Feverish this morning) and MYALGIA (Body aches) outcome was unknown.            No concomitant medication was not provided by the reporter. No treatment medication was not provided by the reporter.  Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Little faint when i move around; Sore arm; Feeling light headed; Nauseous; Feverish this morning; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Little faint when i move around) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Little faint when i move around) (seriousness criterion medically significant), VACCINATION SITE PAIN (Sore arm), DIZZINESS (Feeling light headed), NAUSEA (Nauseous), PYREXIA (Feverish this morning) and MYALGIA (Body aches). At the time of the report, SYNCOPE (Little faint when i move around), VACCINATION SITE PAIN (Sore arm), DIZZINESS (Feeling light headed), NAUSEA (Nauseous), PYREXIA (Feverish this morning) and MYALGIA (Body aches) outcome was unknown.            No concomitant medication was not provided by the reporter. No treatment medication was not provided by the reporter.  Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in jaw, Rheumatoid arthritis, Temporomandibular joint syndrome
Clinical narrative: RA has flared up aggressively and spread to the left side of jaw; Diagnosed as TMJ 3 months after Booster; Jaw hurts so bad,  can't even talk; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RA has flared up aggressively and spread to the left side of jaw), TEMPOROMANDIBULAR JOINT SYNDROME (Diagnosed as TMJ 3 months after Booster) and PAIN IN JAW (Jaw hurts so bad,  can't even talk) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis (Have had for 25 years).   In 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. In 2021, the patient experienced RHEUMATOID ARTHRITIS (RA has flared up aggressively and spread to the left side of jaw) (seriousness criterion medically significant), TEMPOROMANDIBULAR JOINT SYNDROME (Diagnosed as TMJ 3 months after Booster) (seriousness criterion medically significant) and PAIN IN JAW (Jaw hurts so bad,  can't even talk) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (RA has flared up aggressively and spread to the left side of jaw), TEMPOROMANDIBULAR JOINT SYNDROME (Diagnosed as TMJ 3 months after Booster) and PAIN IN JAW (Jaw hurts so bad,  can't even talk) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Skin warm, Vaccination site pain, Vaccination site rash
Clinical narrative: Rash is red; Rash is red itchy, swollen, warm to touch, feel like like it's pulling; Rash is red itchy; Rash is red itchy, swollen; Quarter size rash at the injection site; Pain at site of injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH ERYTHEMATOUS (Rash is red) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), COLECALCIFEROL (VITAMIN D3), POTASSIUM and ATENOLOL for an unknown indication.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (Rash is red) (seriousness criterion medically significant), SKIN WARM (Rash is red itchy, swollen, warm to touch, feel like like it's pulling), RASH PRURITIC (Rash is red itchy), VACCINATION SITE SWELLING (Rash is red itchy, swollen), VACCINATION SITE RASH (Quarter size rash at the injection site) and VACCINATION SITE PAIN (Pain at site of injection). The patient was treated with PREDNISONE at an unspecified dose and frequency and LORATADINE (CLARITINE) at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Rash is red), SKIN WARM (Rash is red itchy, swollen, warm to touch, feel like like it's pulling), RASH PRURITIC (Rash is red itchy), VACCINATION SITE SWELLING (Rash is red itchy, swollen), VACCINATION SITE RASH (Quarter size rash at the injection site) and VACCINATION SITE PAIN (Pain at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Rash is red; Rash is red itchy, swollen, warm to touch, feel like like it's pulling; Rash is red itchy; Rash is red itchy, swollen; Quarter size rash at the injection site; Pain at site of injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH ERYTHEMATOUS (Rash is red) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), COLECALCIFEROL (VITAMIN D3), POTASSIUM and ATENOLOL for an unknown indication.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (Rash is red) (seriousness criterion medically significant), SKIN WARM (Rash is red itchy, swollen, warm to touch, feel like like it's pulling), RASH PRURITIC (Rash is red itchy), VACCINATION SITE SWELLING (Rash is red itchy, swollen), VACCINATION SITE RASH (Quarter size rash at the injection site) and VACCINATION SITE PAIN (Pain at site of injection). The patient was treated with PREDNISONE at an unspecified dose and frequency and LORATADINE (CLARITINE) at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Rash is red), SKIN WARM (Rash is red itchy, swollen, warm to touch, feel like like it's pulling), RASH PRURITIC (Rash is red itchy), VACCINATION SITE SWELLING (Rash is red itchy, swollen), VACCINATION SITE RASH (Quarter size rash at the injection site) and VACCINATION SITE PAIN (Pain at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Miscarriage shortly after the 1st dose; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage shortly after the 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (Miscarriage shortly after the 1st dose) (seriousness criterion medically significant) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The delivery occurred on an unknown date.  At the time of the report, ABORTION SPONTANEOUS (Miscarriage shortly after the 1st dose) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was not given.  No treatment information was given.; Sender's Comments: This is a case of exposure of product during pregnancy with the vaccine mRNA -1273 with reported AE of spontaneous abortion. There is very limited information regarding this events  has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic Reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic Reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic Reaction) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic Reaction) 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 product use was not provided.  Treatment information was unknown.  Very limited information regarding this event has been provided at this time. Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Angiocardiogram, C-reactive protein, Chest pain, Echocardiogram, Ejection fraction
Clinical narrative: Ventricular hypokinesia; Chest pain; Hypokinesia; Malaise; This case was received via FDA VAERS (Reference number: 1342336) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of VENTRICULAR HYPOKINESIA (Ventricular hypokinesia), CHEST PAIN (Chest pain), HYPOKINESIA (Hypokinesia) and MALAISE (Malaise) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VENTRICULAR HYPOKINESIA (Ventricular hypokinesia) (seriousness criteria hospitalization and medically significant), CHEST PAIN (Chest pain) (seriousness criterion hospitalization), HYPOKINESIA (Hypokinesia) (seriousness criterion hospitalization) and MALAISE (Malaise) (seriousness criterion hospitalization). At the time of the report, VENTRICULAR HYPOKINESIA (Ventricular hypokinesia), CHEST PAIN (Chest pain), HYPOKINESIA (Hypokinesia) and MALAISE (Malaise) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Angiocardiogram: unknown (Inconclusive) unknown. On 25-Mar-2021, C-reactive protein: increased (High) CRP 6.3mg/dL. On 25-Mar-2021, Echocardiogram: unknown (Inconclusive) unknown. On 25-Mar-2021, Ejection fraction: decreased (Low) LVEF 45-50%. On 25-Mar-2021, Electrocardiogram ST segment elevation: unknown (Inconclusive) near diffuse ST elevations with the exception of lead V1. On 25-Mar-2021, Red blood cell sedimentation rate: unknown (Inconclusive) ESR 20. On 25-Mar-2021, Troponin: increased (High) Troponin elevated peak 11.9 ng/mL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not provided. Action taken with mRNA-1273 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 events, a causal relationship cannot be excluded.  Further information cannot be obtained.; 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 cannot be obtained.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram ST segment elevation, Hypokinesia, Malaise, Red blood cell sedimentation rate, Troponin
Clinical narrative: Ventricular hypokinesia; Chest pain; Hypokinesia; Malaise; This case was received via FDA VAERS (Reference number: 1342336) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of VENTRICULAR HYPOKINESIA (Ventricular hypokinesia), CHEST PAIN (Chest pain), HYPOKINESIA (Hypokinesia) and MALAISE (Malaise) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VENTRICULAR HYPOKINESIA (Ventricular hypokinesia) (seriousness criteria hospitalization and medically significant), CHEST PAIN (Chest pain) (seriousness criterion hospitalization), HYPOKINESIA (Hypokinesia) (seriousness criterion hospitalization) and MALAISE (Malaise) (seriousness criterion hospitalization). At the time of the report, VENTRICULAR HYPOKINESIA (Ventricular hypokinesia), CHEST PAIN (Chest pain), HYPOKINESIA (Hypokinesia) and MALAISE (Malaise) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Angiocardiogram: unknown (Inconclusive) unknown. On 25-Mar-2021, C-reactive protein: increased (High) CRP 6.3mg/dL. On 25-Mar-2021, Echocardiogram: unknown (Inconclusive) unknown. On 25-Mar-2021, Ejection fraction: decreased (Low) LVEF 45-50%. On 25-Mar-2021, Electrocardiogram ST segment elevation: unknown (Inconclusive) near diffuse ST elevations with the exception of lead V1. On 25-Mar-2021, Red blood cell sedimentation rate: unknown (Inconclusive) ESR 20. On 25-Mar-2021, Troponin: increased (High) Troponin elevated peak 11.9 ng/mL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not provided. Action taken with mRNA-1273 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 events, a causal relationship cannot be excluded.  Further information cannot be obtained.; 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 cannot be obtained.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Ventricular hypokinesia
Clinical narrative: Ventricular hypokinesia; Chest pain; Hypokinesia; Malaise; This case was received via FDA VAERS (Reference number: 1342336) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of VENTRICULAR HYPOKINESIA (Ventricular hypokinesia), CHEST PAIN (Chest pain), HYPOKINESIA (Hypokinesia) and MALAISE (Malaise) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VENTRICULAR HYPOKINESIA (Ventricular hypokinesia) (seriousness criteria hospitalization and medically significant), CHEST PAIN (Chest pain) (seriousness criterion hospitalization), HYPOKINESIA (Hypokinesia) (seriousness criterion hospitalization) and MALAISE (Malaise) (seriousness criterion hospitalization). At the time of the report, VENTRICULAR HYPOKINESIA (Ventricular hypokinesia), CHEST PAIN (Chest pain), HYPOKINESIA (Hypokinesia) and MALAISE (Malaise) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Angiocardiogram: unknown (Inconclusive) unknown. On 25-Mar-2021, C-reactive protein: increased (High) CRP 6.3mg/dL. On 25-Mar-2021, Echocardiogram: unknown (Inconclusive) unknown. On 25-Mar-2021, Ejection fraction: decreased (Low) LVEF 45-50%. On 25-Mar-2021, Electrocardiogram ST segment elevation: unknown (Inconclusive) near diffuse ST elevations with the exception of lead V1. On 25-Mar-2021, Red blood cell sedimentation rate: unknown (Inconclusive) ESR 20. On 25-Mar-2021, Troponin: increased (High) Troponin elevated peak 11.9 ng/mL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not provided. Action taken with mRNA-1273 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 events, a causal relationship cannot be excluded.  Further information cannot be obtained.; 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 cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Hospitalisation, Inappropriate schedule of product administration
Clinical narrative: Was hospitalized; Pharmacist wants to know should the second dose be given; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of HOSPITALISATION (Was hospitalized) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Was hospitalized) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pharmacist wants to know should the second dose be given). At the time of the report, HOSPITALISATION (Was hospitalized) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pharmacist wants to know should the second dose be given) outcome was unknown. Not Provided      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 product used was not provided by the reporter. A pharmacist received a call from a doctor that a patient received first dose of vaccine and was hospitalized. No additional patient information. Treatment information was not reported by the reporter.  Very limited information regarding this event has been provided at this time. Details regarding if AE associated to vaccination was the cause for hospitalization is required for further assessment. This report refers to a case of product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.; Sender's Comments: Very limited information regarding this event has been provided at this time. Details regarding if AE associated to vaccination was the cause for hospitalization is required for further assessment. This report refers to a case of product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Ear discomfort, Headache
Clinical narrative: Loss of hearing; Blockage in left ear/ Pressure in her ear; Terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Loss of hearing) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (Loss of hearing) (seriousness criterion medically significant), EAR DISCOMFORT (Blockage in left ear/ Pressure in her ear) and HEADACHE (Terrible headache). At the time of the report, DEAFNESS (Loss of hearing), EAR DISCOMFORT (Blockage in left ear/ Pressure in her ear) and HEADACHE (Terrible headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment medication information were not reported.  Patient need Pfizer vaccine because she believed it was the gold standard vaccine but vaccinated with Moderna vaccine.  It was reported that patient already consulted with her health care professional.  This case concerns a 67-year-old female with a serious unexpected event of deafness, and nonserious ear discomfort and headache. Event onset with unknown latency after first 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 67-year-old female with a serious unexpected event of deafness, and nonserious ear discomfort and headache. Event onset with unknown latency after first 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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Small cell carcinoma; cancer of pancreas / metastasized; Metastases to lungs; Metastates to bone; Metastases to brain; Wheezing; This spontaneous case was reported by a consumer and describes the occurrence of SMALL CELL CARCINOMA (Small cell carcinoma), METASTASES TO PANCREAS (cancer of pancreas / metastasized), METASTASES TO LUNG (Metastases to lungs), METASTASES TO BONE (Metastates to bone), METASTASES TO CENTRAL NERVOUS SYSTEM (Metastases to brain) and WHEEZING (Wheezing) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced WHEEZING (Wheezing) (seriousness criterion hospitalization). On an unknown date, the patient experienced SMALL CELL CARCINOMA (Small cell carcinoma) (seriousness criteria death, hospitalization and medically significant), METASTASES TO PANCREAS (cancer of pancreas / metastasized) (seriousness criteria death, hospitalization and medically significant), METASTASES TO LUNG (Metastases to lungs) (seriousness criteria death, hospitalization and medically significant), METASTASES TO BONE (Metastates to bone) (seriousness criteria death, hospitalization and medically significant) and METASTASES TO CENTRAL NERVOUS SYSTEM (Metastases to brain) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized from 25-Apr-2021 to 10-May-2021 due to METASTASES TO BONE, METASTASES TO CENTRAL NERVOUS SYSTEM, METASTASES TO LUNG, METASTASES TO PANCREAS, SMALL CELL CARCINOMA and WHEEZING. The patient died on 10-May-2021. The reported cause of death was Cancer of lung, Bone cancer, Metastases to brain, Pancreas cancer and Small cell carcinoma. It is unknown if an autopsy was performed. At the time of death, WHEEZING (Wheezing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant Product use was not provided.  LABORATORY / DIAGNOSTIC TEST: Ultrasound, computerized tomography (CAT) scan and numerous other tests; result was not provided.   Treatment information was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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.; Reported Cause(s) of Death: cancer of lung; bone cancer; metastases to brain; pancreas cancer; small cell carcinoma
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Dysphagia, Gastrooesophageal reflux disease, Glossodynia, Pharyngeal swelling
Clinical narrative: swollen throat; Her doctor diagnosed that it was an allergic reaction to the vaccine.; weird sensation while swalloing; Reflux; Sporadic sharp pain in the tip of the tongue; This spontaneous case was reported by a patient and describes the occurrence of PHARYNGEAL SWELLING (swollen throat) and ALLERGY TO VACCINE (Her doctor diagnosed that it was an allergic reaction to the vaccine.) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.  Concomitant products included LISINOPRIL for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PHARYNGEAL SWELLING (swollen throat) (seriousness criterion hospitalization), ALLERGY TO VACCINE (Her doctor diagnosed that it was an allergic reaction to the vaccine.) (seriousness criterion hospitalization), DYSPHAGIA (weird sensation while swalloing), GASTROOESOPHAGEAL REFLUX DISEASE (Reflux) and GLOSSODYNIA (Sporadic sharp pain in the tip of the tongue). The patient was treated with CETIRIZINE HYDROCHLORIDE (CETRIZINE) at an unspecified dose and frequency; MONTELUKAST at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROXYZINE at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (swollen throat), ALLERGY TO VACCINE (Her doctor diagnosed that it was an allergic reaction to the vaccine.), DYSPHAGIA (weird sensation while swalloing), GASTROOESOPHAGEAL REFLUX DISEASE (Reflux) and GLOSSODYNIA (Sporadic sharp pain in the tip of the tongue) 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 include birth control pills.  Treatment medications also include d18 days with IV corticoids and other days orally.  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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Stent placement, Tenderness
Clinical narrative: 2 stents were put in; Tender arm; Tired; Difficulty breathing/trouble breathing; This spontaneous case was reported by a consumer and describes the occurrence of STENT PLACEMENT (2 stents were put in), DYSPNOEA (Difficulty breathing/trouble breathing), TENDERNESS (Tender arm) and FATIGUE (Tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included Stent replacement (2 stents were put in) on 19-May-2021. Concomitant products included LOSARTAN for Blood pressure, EVOLOCUMAB (REPATHA) for Cholesterol, PRASUGREL and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing/trouble breathing) (seriousness criterion medically significant) and FATIGUE (Tired) (seriousness criterion medically significant). On 19-May-2021, the patient experienced STENT PLACEMENT (2 stents were put in) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced TENDERNESS (Tender arm) (seriousness criterion medically significant). At the time of the report, STENT PLACEMENT (2 stents were put in), DYSPNOEA (Difficulty breathing/trouble breathing), TENDERNESS (Tender arm) and FATIGUE (Tired) outcome was unknown.            Patient received the 2nd dose of vaccination on 21MAY202, she felt tired, had trouble breathing when going upstairs. The day after 22Apr2021, it increased, but was not gasping for air. She contacted to the doctor who told her to wait 2-3 days to see if her breathing improved. Patient reported that she made an appointment with her doctor and then Saw cardiologist on an unknown date. Patient reported that her breathing was better after the stents placements, but not perfect.  On unknown date, Lab tests included stress test and ultrasound and heart test on 19-May-21 with outcome unknown. Patient reported that she is in cardiac rehab. Treatment information was not provided.; Sender's Comments: Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Her son has died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Her son has died) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No relevant concomitant medications were reported.  No treatment information was provided.  This is a case of death in a male subject who died after receiving first dose of vaccine Very limited information has been provided at this time.; Sender's Comments: This is a case of death in a male subject who died after receiving first dose of vaccine Very limited information has been provided at this time.; Reported Cause(s) of Death: unknown cause of death