chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Facial bones fracture, Product dose omission issue, Road traffic accident
Clinical narrative: broke his nose; car accident; He has not received his 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL BONES FRACTURE (broke his nose) in a 20-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.     The patient's past medical history included Surgery (Nose surgery).    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FACIAL BONES FRACTURE (broke his nose) (seriousness criterion medically significant), ROAD TRAFFIC ACCIDENT (car accident) and PRODUCT DOSE OMISSION ISSUE (He has not received his 2nd dose). At the time of the report, FACIAL BONES FRACTURE (broke his nose) and ROAD TRAFFIC ACCIDENT (car accident) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (He has not received his 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication information has been provided by the reporter. No concomitant medication information has been provided by the reporter. No lab data has been provided by the reporter.  This report refers to a case of Product dose omission issue for mRNA-1273,  with associated adverse events of Road traffic accident and Facial bones fracture. Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273,  with associated adverse events of Road traffic accident and Facial bones fracture. Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Feeling abnormal, Pain in extremity, Skin discolouration
Clinical narrative: blood clot in his left leg and diagnosed with a DVT; leg was hurting; leg was purple; feeling crappy; This spontaneous case was reported by a patient and describes the occurrence of DEEP VEIN THROMBOSIS (blood clot in his left leg and diagnosed with a DVT) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jun-2021, the patient experienced FEELING ABNORMAL (feeling crappy). On 22-Jun-2021, the patient experienced DEEP VEIN THROMBOSIS (blood clot in his left leg and diagnosed with a DVT) (seriousness criterion medically significant), PAIN IN EXTREMITY (leg was hurting) and SKIN DISCOLOURATION (leg was purple). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency. At the time of the report, DEEP VEIN THROMBOSIS (blood clot in his left leg and diagnosed with a DVT), FEELING ABNORMAL (feeling crappy), PAIN IN EXTREMITY (leg was hurting) and SKIN DISCOLOURATION (leg was purple) outcome was unknown.            The patient had reported on the evening of 21 June 2021 to be feeling crappy. The next day, on  22 June 2021, the patient had reported that his leg was hurting and was purple, so he went to the doctor, who found out he had a blood clot in his left leg, and the patient was diagnosed with a DVT. The patient reported being put on a blood thinner Eliquis to treat the blood clot. No concomitant medication was provided by the reporter.  Based on current available information and the temporal association between produce use and the start date of the events cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between produce use and the start date of the events cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This spontaneous case was reported by an other health care professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and 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.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Malaise, Pneumonia, Pyrexia
Clinical narrative: Pneumonia NOS; something was swollen; Cough; feeling very bad right now; shivering; fever; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia NOS) 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 PNEUMONIA (Pneumonia NOS) (seriousness criterion medically significant), SWELLING (something was swollen), CHILLS (shivering), COUGH (Cough), PYREXIA (fever) and MALAISE (feeling very bad right now). At the time of the report, PNEUMONIA (Pneumonia NOS), SWELLING (something was swollen), CHILLS (shivering), COUGH (Cough), PYREXIA (fever) and MALAISE (feeling very bad right now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information 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. Events Pneumonia NOS and Cough were added as per narrative.   This case was linked to MOD-2021-244433 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events Pneumonia NOS and Cough were added as per narrative.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Pneumonia NOS; something was swollen; Cough; feeling very bad right now; shivering; fever; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia NOS) 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 PNEUMONIA (Pneumonia NOS) (seriousness criterion medically significant), SWELLING (something was swollen), CHILLS (shivering), COUGH (Cough), PYREXIA (fever) and MALAISE (feeling very bad right now). At the time of the report, PNEUMONIA (Pneumonia NOS), SWELLING (something was swollen), CHILLS (shivering), COUGH (Cough), PYREXIA (fever) and MALAISE (feeling very bad right now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information 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. Events Pneumonia NOS and Cough were added as per narrative.   This case was linked to MOD-2021-244433 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events Pneumonia NOS and Cough were added as per narrative.
Sex: M
Vaccine: COVID19
Symptoms: Coma, Death, Disorientation, Malaise
Clinical narrative: feeling very ill; in an induced coma; in a complete disorientation; passed away; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (passed away), MALAISE (feeling very ill), COMA (in an induced coma) and DISORIENTATION (in a complete disorientation) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (feeling very ill) (seriousness criterion hospitalization), COMA (in an induced coma) (seriousness criterion medically significant) and DISORIENTATION (in a complete disorientation) (seriousness criterion medically significant). The patient died on 27-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, MALAISE (feeling very ill), COMA (in an induced coma) and DISORIENTATION (in a complete disorientation) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) 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: Unknown cause of death
Age: 44.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Chest discomfort, Grip strength decreased, Headache, Hypoaesthesia
Clinical narrative: pain in hips; flare up on prednisone taper; numbness in hands; pain in legs; difficulty grasping things; chest tightness like an elephant sitting on her chest; headache; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS RELAPSE (flare up on prednisone taper) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TERIFLUNOMIDE (AUBAGIO) for Multiple sclerosis.    Concomitant products included NAPROXEN SODIUM (ALEVE) for Cephalgia, PARACETAMOL and SUMATRIPTAN for Migraine, PREDNISONE, ACETYLSALICYLIC ACID, CAFFEINE, MECLOZINE, HYDROXYZINE and COLECALCIFEROL for an unknown indication.   In 2020, the patient started TERIFLUNOMIDE (AUBAGIO) (Oral) 14 mg. 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 MULTIPLE SCLEROSIS RELAPSE (flare up on prednisone taper) (seriousness criterion medically significant), HYPOAESTHESIA (numbness in hands), PAIN IN EXTREMITY (pain in legs), GRIP STRENGTH DECREASED (difficulty grasping things), CHEST DISCOMFORT (chest tightness like an elephant sitting on her chest), HEADACHE (headache) and ARTHRALGIA (pain in hips). At the time of the report, MULTIPLE SCLEROSIS RELAPSE (flare up on prednisone taper), HYPOAESTHESIA (numbness in hands), PAIN IN EXTREMITY (pain in legs), GRIP STRENGTH DECREASED (difficulty grasping things), CHEST DISCOMFORT (chest tightness like an elephant sitting on her chest), HEADACHE (headache) and ARTHRALGIA (pain in hips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company Comment: Very limited information regarding this event has been provided at this time. Dates of administration for vaccine and onset date for the events are required for further assessment.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. Dates of administration for vaccine and onset date for the events are required for further assessment.
Age: 44.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Multiple sclerosis relapse, Pain in extremity
Clinical narrative: pain in hips; flare up on prednisone taper; numbness in hands; pain in legs; difficulty grasping things; chest tightness like an elephant sitting on her chest; headache; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS RELAPSE (flare up on prednisone taper) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TERIFLUNOMIDE (AUBAGIO) for Multiple sclerosis.    Concomitant products included NAPROXEN SODIUM (ALEVE) for Cephalgia, PARACETAMOL and SUMATRIPTAN for Migraine, PREDNISONE, ACETYLSALICYLIC ACID, CAFFEINE, MECLOZINE, HYDROXYZINE and COLECALCIFEROL for an unknown indication.   In 2020, the patient started TERIFLUNOMIDE (AUBAGIO) (Oral) 14 mg. 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 MULTIPLE SCLEROSIS RELAPSE (flare up on prednisone taper) (seriousness criterion medically significant), HYPOAESTHESIA (numbness in hands), PAIN IN EXTREMITY (pain in legs), GRIP STRENGTH DECREASED (difficulty grasping things), CHEST DISCOMFORT (chest tightness like an elephant sitting on her chest), HEADACHE (headache) and ARTHRALGIA (pain in hips). At the time of the report, MULTIPLE SCLEROSIS RELAPSE (flare up on prednisone taper), HYPOAESTHESIA (numbness in hands), PAIN IN EXTREMITY (pain in legs), GRIP STRENGTH DECREASED (difficulty grasping things), CHEST DISCOMFORT (chest tightness like an elephant sitting on her chest), HEADACHE (headache) and ARTHRALGIA (pain in hips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company Comment: Very limited information regarding this event has been provided at this time. Dates of administration for vaccine and onset date for the events are required for further assessment.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. Dates of administration for vaccine and onset date for the events are required for further assessment.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram, Headache, Hyperhidrosis, Pain in jaw
Clinical narrative: tingling and tremors; sweating profusely; tremors; warm to the touch; Very hard and warm to the touch; bad headache; itches in the injection site; Pain down chest (touhgt was a heart attack); extreme pain in the left jaw...then right jaw; Redness in the Injection site with the size of a half dollar coin; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain down chest (touhgt was a heart attack)) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness in the Injection site with the size of a half dollar coin). On 24-Jun-2021, the patient experienced CHEST PAIN (Pain down chest (touhgt was a heart attack)) (seriousness criterion medically significant) and PAIN IN JAW (extreme pain in the left jaw...then right jaw). On 02-Jul-2021, the patient experienced VACCINATION SITE PRURITUS (itches in the injection site). On an unknown date, the patient experienced PARAESTHESIA (tingling and tremors), HYPERHIDROSIS (sweating profusely), TREMOR (tremors), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE INDURATION (Very hard and warm to the touch) and HEADACHE (bad headache). At the time of the report, CHEST PAIN (Pain down chest (touhgt was a heart attack)), PAIN IN JAW (extreme pain in the left jaw..then right jaw), PARAESTHESIA (tingling and tremors), HYPERHIDROSIS (sweating profusely), TREMOR (tremors), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE INDURATION (Very hard and warm to the touch) and HEADACHE (bad headache) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness in the Injection site with the size of a half dollar coin) and VACCINATION SITE PRURITUS (itches in the injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jun-2021, Electrocardiogram: normal (normal) Normal. On 24-Jun-2021, Troponin: normal (normal) Normal.         No treatment information was provided. No relevant concomitant medications were reported.  Action taken with mRNA-1273 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. 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Tremor, Troponin, Vaccination site erythema, Vaccination site induration
Clinical narrative: tingling and tremors; sweating profusely; tremors; warm to the touch; Very hard and warm to the touch; bad headache; itches in the injection site; Pain down chest (touhgt was a heart attack); extreme pain in the left jaw...then right jaw; Redness in the Injection site with the size of a half dollar coin; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain down chest (touhgt was a heart attack)) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness in the Injection site with the size of a half dollar coin). On 24-Jun-2021, the patient experienced CHEST PAIN (Pain down chest (touhgt was a heart attack)) (seriousness criterion medically significant) and PAIN IN JAW (extreme pain in the left jaw...then right jaw). On 02-Jul-2021, the patient experienced VACCINATION SITE PRURITUS (itches in the injection site). On an unknown date, the patient experienced PARAESTHESIA (tingling and tremors), HYPERHIDROSIS (sweating profusely), TREMOR (tremors), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE INDURATION (Very hard and warm to the touch) and HEADACHE (bad headache). At the time of the report, CHEST PAIN (Pain down chest (touhgt was a heart attack)), PAIN IN JAW (extreme pain in the left jaw..then right jaw), PARAESTHESIA (tingling and tremors), HYPERHIDROSIS (sweating profusely), TREMOR (tremors), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE INDURATION (Very hard and warm to the touch) and HEADACHE (bad headache) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness in the Injection site with the size of a half dollar coin) and VACCINATION SITE PRURITUS (itches in the injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jun-2021, Electrocardiogram: normal (normal) Normal. On 24-Jun-2021, Troponin: normal (normal) Normal.         No treatment information was provided. No relevant concomitant medications were reported.  Action taken with mRNA-1273 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. 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: tingling and tremors; sweating profusely; tremors; warm to the touch; Very hard and warm to the touch; bad headache; itches in the injection site; Pain down chest (touhgt was a heart attack); extreme pain in the left jaw...then right jaw; Redness in the Injection site with the size of a half dollar coin; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain down chest (touhgt was a heart attack)) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness in the Injection site with the size of a half dollar coin). On 24-Jun-2021, the patient experienced CHEST PAIN (Pain down chest (touhgt was a heart attack)) (seriousness criterion medically significant) and PAIN IN JAW (extreme pain in the left jaw...then right jaw). On 02-Jul-2021, the patient experienced VACCINATION SITE PRURITUS (itches in the injection site). On an unknown date, the patient experienced PARAESTHESIA (tingling and tremors), HYPERHIDROSIS (sweating profusely), TREMOR (tremors), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE INDURATION (Very hard and warm to the touch) and HEADACHE (bad headache). At the time of the report, CHEST PAIN (Pain down chest (touhgt was a heart attack)), PAIN IN JAW (extreme pain in the left jaw..then right jaw), PARAESTHESIA (tingling and tremors), HYPERHIDROSIS (sweating profusely), TREMOR (tremors), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE INDURATION (Very hard and warm to the touch) and HEADACHE (bad headache) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness in the Injection site with the size of a half dollar coin) and VACCINATION SITE PRURITUS (itches in the injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jun-2021, Electrocardiogram: normal (normal) Normal. On 24-Jun-2021, Troponin: normal (normal) Normal.         No treatment information was provided. No relevant concomitant medications were reported.  Action taken with mRNA-1273 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. 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash pruritic, Urticaria
Clinical narrative: Dull Headache; Itchy hives /tchy hives which started on her right arm and expanded to her right hand and right shoulder; Itchy hives and rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Itchy hives /tchy hives which started on her right arm and expanded to her right hand and right shoulder) and RASH PRURITIC (Itchy hives and rash) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, the patient experienced URTICARIA (Itchy hives /tchy hives which started on her right arm and expanded to her right hand and right shoulder) (seriousness criterion medically significant) and RASH PRURITIC (Itchy hives and rash) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (Dull Headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, URTICARIA (Itchy hives /tchy hives which started on her right arm and expanded to her right hand and right shoulder), RASH PRURITIC (Itchy hives and rash) and HEADACHE (Dull Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. 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 02-Jul-2021: Additional information included Patient demographics updated, Suspect product details updated, treatment medications added, Additional events and seriousness criteria added. Reporter address and phone number updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Sinus disorder
Clinical narrative: sinus cavities expand; This spontaneous case was reported by a consumer and describes the occurrence of SINUS DISORDER (sinus cavities expand) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced SINUS DISORDER (sinus cavities expand) (seriousness criterion medically significant). At the time of the report, SINUS DISORDER (sinus cavities expand) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Chest X-ray: negative (Negative) came back negative.         No treatment information was provided.  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-2021-245604 (Patient Link).; Sender's Comments: 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: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chest pain, Feeling abnormal, Myocarditis
Clinical narrative: On and off pain in his chest- myocarditis; Chest pain radiates from his front to back; Patient is a little a little scared; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (On and off pain in his chest- myocarditis) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 039C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (On and off pain in his chest- myocarditis) (seriousness criterion medically significant), CHEST PAIN (Chest pain radiates from his front to back) and FEELING ABNORMAL (Patient is a little a little scared). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (On and off pain in his chest- myocarditis), CHEST PAIN (Chest pain radiates from his front to back) and FEELING ABNORMAL (Patient is a little a little scared) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jun-2021, Body temperature increased: 37.5c' (Inconclusive) Temperature increased to 37.5C'.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient stated that he received his first dose of the Moderna COVID-19 vaccine on 24 May 2021 and his second dose on 21 Jun 2021 at a local Pharmacy. He was fine following the first dose. The second day after receiving the second dose, he had a temperature that increased to 37.5 C. He took Ibuprofen and Tylenol as treatment medications, which helped. About 5 days ago, he started having on and off pain in his chest- myocarditis, and the pain radiated from his front to back. He was a little scared, as he had read on the CDC website that myocarditis is a side effect of the Moderna COVID-19 vaccine. He has never experienced symptoms like these before, as he is athletic but has not worked hard. Hence, the side effect was strange to him. He planned to call his doctor on Monday 5 Jul 2021.  No concomitant medication was provided by the reporter.  Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Chills, Fatigue, Limb mass, Transient ischaemic attack
Clinical narrative: TIA; Lost vision on the left side; lump in left leg; vasculitis in the  varicose vein; Chills; Feels tired; This spontaneous case was reported by a health care professional and describes the occurrence of VASCULITIS (vasculitis in the  varicose vein), TRANSIENT ISCHAEMIC ATTACK (TIA) and BLINDNESS (Lost vision on the left side) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (Chills) and FATIGUE (Feels tired). On 05-Mar-2021, the patient experienced VASCULITIS (vasculitis in the  varicose vein) (seriousness criteria medically significant and intervention required). On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA) (seriousness criterion medically significant), BLINDNESS (Lost vision on the left side) (seriousness criterion medically significant) and LIMB MASS (lump in left leg). At the time of the report, VASCULITIS (vasculitis in the  varicose vein), TRANSIENT ISCHAEMIC ATTACK (TIA), BLINDNESS (Lost vision on the left side), LIMB MASS (lump in left leg), CHILLS (Chills) and FATIGUE (Feels tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were given by the reporter. No Treatment information were provided by the reporter.  Patient required on full anticoagulation due to events experienced.  Lab details were 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Vasculitis
Clinical narrative: TIA; Lost vision on the left side; lump in left leg; vasculitis in the  varicose vein; Chills; Feels tired; This spontaneous case was reported by a health care professional and describes the occurrence of VASCULITIS (vasculitis in the  varicose vein), TRANSIENT ISCHAEMIC ATTACK (TIA) and BLINDNESS (Lost vision on the left side) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (Chills) and FATIGUE (Feels tired). On 05-Mar-2021, the patient experienced VASCULITIS (vasculitis in the  varicose vein) (seriousness criteria medically significant and intervention required). On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA) (seriousness criterion medically significant), BLINDNESS (Lost vision on the left side) (seriousness criterion medically significant) and LIMB MASS (lump in left leg). At the time of the report, VASCULITIS (vasculitis in the  varicose vein), TRANSIENT ISCHAEMIC ATTACK (TIA), BLINDNESS (Lost vision on the left side), LIMB MASS (lump in left leg), CHILLS (Chills) and FATIGUE (Feels tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were given by the reporter. No Treatment information were provided by the reporter.  Patient required on full anticoagulation due to events experienced.  Lab details were 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.; 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: Myocardial infarction, Weight decreased
Clinical narrative: Heart attack; Lost alot of weight; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure fluctuation.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced WEIGHT DECREASED (Lost alot of weight). The patient was hospitalized from 22-Mar-2021 to 26-Mar-2021 due to MYOCARDIAL INFARCTION. The patient was treated with Rehabilitation therapy (On 01 Apr 2021, the patient was put in cardiac pulmonary rehab, currently in sixth week.) for Myocardial infarction. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) and WEIGHT DECREASED (Lost alot of weight) outcome was unknown.            No concomitant medications reported.  The patient had a heart attack following stents. The patient had a cardiac catheterization on 22 Mar2021 and then was admitted to the (hospital) critical care unit (CCU) for 1 night, and then went home on 26 Mar2021. The patient may possibly have to do a total of 12 weeks of cardiac pulmonary rehab, but the patient would not know until he has his cardiologist appointment on 14 May2021.  Company Comment : Very limited information regarding the events has been provided at this time.  Further information is not expected.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is not expected.
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Ended up hospitalized for vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (Ended up hospitalized for vertigo) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Ended up hospitalized for vertigo) (seriousness criterion hospitalization). At the time of the report, VERTIGO (Ended up hospitalized for vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported .  Treatment information was not provided.  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: Hospitalisation, Product dose omission issue
Clinical narrative: hospital  after their first dose of Moderna Covid-19 Vaccine; first Moderna Covid-19 Vaccine around  2 months ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of HOSPITALISATION (hospital  after their first dose of Moderna Covid-19 Vaccine) 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 (hospital  after their first dose of Moderna Covid-19 Vaccine) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (first Moderna Covid-19 Vaccine around  2 months ago). At the time of the report, HOSPITALISATION (hospital  after their first dose of Moderna Covid-19 Vaccine) and PRODUCT DOSE OMISSION ISSUE (first Moderna Covid-19 Vaccine around  2 months ago) 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 treatment information was provided. No relevant concomitant medications were reported. The patient did not receive any treatment. Lab details were not provided.  Based on reporter's causality and the available information suggesting  the event hospitalization was related to underlying medical condition, causality assessed as unlikely related to mRNA-1273 vaccine. Causality for Product dose omission issue assessed as not applicable.; Sender's Comments: Based on reporter's causality and the available information suggesting  the event hospitalization was related to underlying medical condition, causality assessed as unlikely related to mRNA-1273 vaccine. Causality for Product dose omission issue assessed as not applicable.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Loss of personal independence in daily activities, Monoplegia, Product dose omission issue, Tremor
Clinical narrative: His arm is still shaky; Has difficulties with function in his had doing daily activities; He has trouble getting out of bed; Patient is worried he will lose function in that arm as well and eventually die; did not receive the second dose; Arm is very painful; Patient describes full paralysis in that arm; This spontaneous case was reported by a consumer and describes the occurrence of MONOPLEGIA (Patient describes full paralysis in that arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, AMLODIPINE, EZETIMIBE, ALOGLIPTIN and METHYLPREDNISOLONE SODIUM SUCCINATE (PREFORIN) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced MONOPLEGIA (Patient describes full paralysis in that arm) (seriousness criterion medically significant). On an unknown date, the patient experienced TREMOR (His arm is still shaky), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has difficulties with function in his had doing daily activities), VACCINATION COMPLICATION (He has trouble getting out of bed), ANXIETY (Patient is worried he will lose function in that arm as well and eventually die), PRODUCT DOSE OMISSION ISSUE (did not receive the second dose) and VACCINATION SITE PAIN (Arm is very painful). At the time of the report, MONOPLEGIA (Patient describes full paralysis in that arm), TREMOR (His arm is still shaky), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has difficulties with function in his had doing daily activities), VACCINATION COMPLICATION (He has trouble getting out of bed), ANXIETY (Patient is worried he will lose function in that arm as well and eventually die) and VACCINATION SITE PAIN (Arm is very painful) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not receive the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included exercise nerve tests with electricity.   The patient has been to his hospital and has not seen any success in his treatments.  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: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site pain
Clinical narrative: His arm is still shaky; Has difficulties with function in his had doing daily activities; He has trouble getting out of bed; Patient is worried he will lose function in that arm as well and eventually die; did not receive the second dose; Arm is very painful; Patient describes full paralysis in that arm; This spontaneous case was reported by a consumer and describes the occurrence of MONOPLEGIA (Patient describes full paralysis in that arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, AMLODIPINE, EZETIMIBE, ALOGLIPTIN and METHYLPREDNISOLONE SODIUM SUCCINATE (PREFORIN) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced MONOPLEGIA (Patient describes full paralysis in that arm) (seriousness criterion medically significant). On an unknown date, the patient experienced TREMOR (His arm is still shaky), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has difficulties with function in his had doing daily activities), VACCINATION COMPLICATION (He has trouble getting out of bed), ANXIETY (Patient is worried he will lose function in that arm as well and eventually die), PRODUCT DOSE OMISSION ISSUE (did not receive the second dose) and VACCINATION SITE PAIN (Arm is very painful). At the time of the report, MONOPLEGIA (Patient describes full paralysis in that arm), TREMOR (His arm is still shaky), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has difficulties with function in his had doing daily activities), VACCINATION COMPLICATION (He has trouble getting out of bed), ANXIETY (Patient is worried he will lose function in that arm as well and eventually die) and VACCINATION SITE PAIN (Arm is very painful) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not receive the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included exercise nerve tests with electricity.   The patient has been to his hospital and has not seen any success in his treatments.  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.