chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Dyspnoea, Fatigue
Clinical narrative: flu-like symptoms; heart rate was fast; eyes are blurry; pain in his left arm which is hot; difficulty to breathing; bed all day today; weakness; dizzy; pain under his shoulder, at his arm pit that goes all the way down; tired; massive headaches; pain in the shot area; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), HEART RATE INCREASED (heart rate was fast), VISION BLURRED (eyes are blurry), VACCINATION SITE WARMTH (pain in his left arm which is hot) and DYSPNOEA (difficulty to breathing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), HEART RATE INCREASED (heart rate was fast), VISION BLURRED (eyes are blurry), VACCINATION SITE WARMTH (pain in his left arm which is hot), DYSPNOEA (difficulty to breathing), SOMNOLENCE (bed all day today), ASTHENIA (weakness), DIZZINESS (dizzy), ARTHRALGIA (pain under his shoulder, at his arm pit that goes all the way down), FATIGUE (tired), HEADACHE (massive headaches), VACCINATION SITE PAIN (pain in the shot area) and NAUSEA (nausea). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), HEART RATE INCREASED (heart rate was fast), VISION BLURRED (eyes are blurry), VACCINATION SITE WARMTH (pain in his left arm which is hot), DYSPNOEA (difficulty to breathing), SOMNOLENCE (bed all day today), ASTHENIA (weakness), DIZZINESS (dizzy), ARTHRALGIA (pain under his shoulder, at his arm pit that goes all the way down), FATIGUE (tired), HEADACHE (massive headaches), VACCINATION SITE PAIN (pain in the shot area) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Influenza like illness, Nausea, Somnolence
Clinical narrative: flu-like symptoms; heart rate was fast; eyes are blurry; pain in his left arm which is hot; difficulty to breathing; bed all day today; weakness; dizzy; pain under his shoulder, at his arm pit that goes all the way down; tired; massive headaches; pain in the shot area; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), HEART RATE INCREASED (heart rate was fast), VISION BLURRED (eyes are blurry), VACCINATION SITE WARMTH (pain in his left arm which is hot) and DYSPNOEA (difficulty to breathing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), HEART RATE INCREASED (heart rate was fast), VISION BLURRED (eyes are blurry), VACCINATION SITE WARMTH (pain in his left arm which is hot), DYSPNOEA (difficulty to breathing), SOMNOLENCE (bed all day today), ASTHENIA (weakness), DIZZINESS (dizzy), ARTHRALGIA (pain under his shoulder, at his arm pit that goes all the way down), FATIGUE (tired), HEADACHE (massive headaches), VACCINATION SITE PAIN (pain in the shot area) and NAUSEA (nausea). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), HEART RATE INCREASED (heart rate was fast), VISION BLURRED (eyes are blurry), VACCINATION SITE WARMTH (pain in his left arm which is hot), DYSPNOEA (difficulty to breathing), SOMNOLENCE (bed all day today), ASTHENIA (weakness), DIZZINESS (dizzy), ARTHRALGIA (pain under his shoulder, at his arm pit that goes all the way down), FATIGUE (tired), HEADACHE (massive headaches), VACCINATION SITE PAIN (pain in the shot area) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth, Vision blurred
Clinical narrative: flu-like symptoms; heart rate was fast; eyes are blurry; pain in his left arm which is hot; difficulty to breathing; bed all day today; weakness; dizzy; pain under his shoulder, at his arm pit that goes all the way down; tired; massive headaches; pain in the shot area; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), HEART RATE INCREASED (heart rate was fast), VISION BLURRED (eyes are blurry), VACCINATION SITE WARMTH (pain in his left arm which is hot) and DYSPNOEA (difficulty to breathing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), HEART RATE INCREASED (heart rate was fast), VISION BLURRED (eyes are blurry), VACCINATION SITE WARMTH (pain in his left arm which is hot), DYSPNOEA (difficulty to breathing), SOMNOLENCE (bed all day today), ASTHENIA (weakness), DIZZINESS (dizzy), ARTHRALGIA (pain under his shoulder, at his arm pit that goes all the way down), FATIGUE (tired), HEADACHE (massive headaches), VACCINATION SITE PAIN (pain in the shot area) and NAUSEA (nausea). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), HEART RATE INCREASED (heart rate was fast), VISION BLURRED (eyes are blurry), VACCINATION SITE WARMTH (pain in his left arm which is hot), DYSPNOEA (difficulty to breathing), SOMNOLENCE (bed all day today), ASTHENIA (weakness), DIZZINESS (dizzy), ARTHRALGIA (pain under his shoulder, at his arm pit that goes all the way down), FATIGUE (tired), HEADACHE (massive headaches), VACCINATION SITE PAIN (pain in the shot area) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling cold, Influenza, Limb discomfort
Clinical narrative: Hot to touch site of injection; Site of injection swollen; Chills; Arm started hurting; Dizzy; Flu Symptoms; Aches; Very cold; Was not able to lift it up her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm started hurting), DIZZINESS (Dizzy), INFLUENZA (Flu Symptoms), VACCINATION SITE WARMTH (Hot to touch site of injection) and PAIN IN EXTREMITY (Aches) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced PAIN IN EXTREMITY (Arm started hurting), DIZZINESS (Dizzy), INFLUENZA (Flu Symptoms), PAIN IN EXTREMITY (Aches), FEELING COLD (Very cold), LIMB DISCOMFORT (Was not able to lift it up her arm) and CHILLS (Chills). On 09-May-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch site of injection) and VACCINATION SITE SWELLING (Site of injection swollen). At the time of the report, PAIN IN EXTREMITY (Arm started hurting), DIZZINESS (Dizzy), INFLUENZA (Flu Symptoms), VACCINATION SITE WARMTH (Hot to touch site of injection), PAIN IN EXTREMITY (Aches), FEELING COLD (Very cold), LIMB DISCOMFORT (Was not able to lift it up her arm), VACCINATION SITE SWELLING (Site of injection swollen) and CHILLS (Chills) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot to touch site of injection; Site of injection swollen; Chills; Arm started hurting; Dizzy; Flu Symptoms; Aches; Very cold; Was not able to lift it up her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm started hurting), DIZZINESS (Dizzy), INFLUENZA (Flu Symptoms), VACCINATION SITE WARMTH (Hot to touch site of injection) and PAIN IN EXTREMITY (Aches) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced PAIN IN EXTREMITY (Arm started hurting), DIZZINESS (Dizzy), INFLUENZA (Flu Symptoms), PAIN IN EXTREMITY (Aches), FEELING COLD (Very cold), LIMB DISCOMFORT (Was not able to lift it up her arm) and CHILLS (Chills). On 09-May-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch site of injection) and VACCINATION SITE SWELLING (Site of injection swollen). At the time of the report, PAIN IN EXTREMITY (Arm started hurting), DIZZINESS (Dizzy), INFLUENZA (Flu Symptoms), VACCINATION SITE WARMTH (Hot to touch site of injection), PAIN IN EXTREMITY (Aches), FEELING COLD (Very cold), LIMB DISCOMFORT (Was not able to lift it up her arm), VACCINATION SITE SWELLING (Site of injection swollen) and CHILLS (Chills) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Feeling abnormal, Pharyngeal swelling, Rash, Swelling
Clinical narrative: swollen neck; swollen face; swollen throat; Hard to swallow; swollen tongue; felt like she was on fire; rash behind her head on her neck; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollen neck), SWELLING FACE (swollen face), PHARYNGEAL SWELLING (swollen throat), DYSPHAGIA (Hard to swallow) and SWOLLEN TONGUE (swollen tongue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (swollen neck), SWELLING FACE (swollen face), PHARYNGEAL SWELLING (swollen throat), DYSPHAGIA (Hard to swallow), SWOLLEN TONGUE (swollen tongue), FEELING ABNORMAL (felt like she was on fire) and RASH (rash behind her head on her neck). At the time of the report, SWELLING (swollen neck), SWELLING FACE (swollen face), PHARYNGEAL SWELLING (swollen throat), DYSPHAGIA (Hard to swallow), SWOLLEN TONGUE (swollen tongue), FEELING ABNORMAL (felt like she was on fire) and RASH (rash behind her head on her neck) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient wanted to report her adverse event of yellow/ brown stool and dark urine.  No concomitant medication was reported. The treatment information was not given.  Action taken with m-RNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-114324 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Significant follow up appended; Sender's Comments:  MOD-2021-114324:reporter's case
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swollen tongue
Clinical narrative: swollen neck; swollen face; swollen throat; Hard to swallow; swollen tongue; felt like she was on fire; rash behind her head on her neck; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollen neck), SWELLING FACE (swollen face), PHARYNGEAL SWELLING (swollen throat), DYSPHAGIA (Hard to swallow) and SWOLLEN TONGUE (swollen tongue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (swollen neck), SWELLING FACE (swollen face), PHARYNGEAL SWELLING (swollen throat), DYSPHAGIA (Hard to swallow), SWOLLEN TONGUE (swollen tongue), FEELING ABNORMAL (felt like she was on fire) and RASH (rash behind her head on her neck). At the time of the report, SWELLING (swollen neck), SWELLING FACE (swollen face), PHARYNGEAL SWELLING (swollen throat), DYSPHAGIA (Hard to swallow), SWOLLEN TONGUE (swollen tongue), FEELING ABNORMAL (felt like she was on fire) and RASH (rash behind her head on her neck) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient wanted to report her adverse event of yellow/ brown stool and dark urine.  No concomitant medication was reported. The treatment information was not given.  Action taken with m-RNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-114324 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Significant follow up appended; Sender's Comments:  MOD-2021-114324:reporter's case
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal, Feeling hot, Hypoaesthesia, Myalgia
Clinical narrative: her leg got swollen but swelling went down; shoulder going numb at least once or twice during the day/travelling down the arm now.; feels weird and strange; Arm Itchy; Arm swollen; Arm Hot; breathing issue; cough; arm of injection site was Hurting; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm Itchy), PERIPHERAL SWELLING (Arm swollen), FEELING HOT (Arm Hot), HYPOAESTHESIA (shoulder going numb at least once or twice during the day/travelling down the arm now.) and FEELING ABNORMAL (feels weird and strange) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) 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 HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (ANTIBIOTIC EAR) for Ear infection, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S) for an unknown indication.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced PRURITUS (Arm Itchy), PERIPHERAL SWELLING (Arm swollen), FEELING HOT (Arm Hot), RESPIRATORY DISORDER (breathing issue), COUGH (cough) and MYALGIA (arm of injection site was Hurting). On 04-May-2021, the patient experienced HYPOAESTHESIA (shoulder going numb at least once or twice during the day/travelling down the arm now.) and FEELING ABNORMAL (feels weird and strange). On 06-May-2021, the patient experienced PERIPHERAL SWELLING (her leg got swollen but swelling went down). On 25-Apr-2021, RESPIRATORY DISORDER (breathing issue) and COUGH (cough) had resolved. On 07-May-2021, PERIPHERAL SWELLING (her leg got swollen but swelling went down) had resolved. At the time of the report, PRURITUS (Arm Itchy), PERIPHERAL SWELLING (Arm swollen), FEELING HOT (Arm Hot), HYPOAESTHESIA (shoulder going numb at least once or twice during the day/travelling down the arm now.), FEELING ABNORMAL (feels weird and strange) and MYALGIA (arm of injection site was Hurting) outcome was unknown.     Treatment medication was not provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Respiratory disorder
Clinical narrative: her leg got swollen but swelling went down; shoulder going numb at least once or twice during the day/travelling down the arm now.; feels weird and strange; Arm Itchy; Arm swollen; Arm Hot; breathing issue; cough; arm of injection site was Hurting; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm Itchy), PERIPHERAL SWELLING (Arm swollen), FEELING HOT (Arm Hot), HYPOAESTHESIA (shoulder going numb at least once or twice during the day/travelling down the arm now.) and FEELING ABNORMAL (feels weird and strange) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) 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 HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (ANTIBIOTIC EAR) for Ear infection, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S) for an unknown indication.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced PRURITUS (Arm Itchy), PERIPHERAL SWELLING (Arm swollen), FEELING HOT (Arm Hot), RESPIRATORY DISORDER (breathing issue), COUGH (cough) and MYALGIA (arm of injection site was Hurting). On 04-May-2021, the patient experienced HYPOAESTHESIA (shoulder going numb at least once or twice during the day/travelling down the arm now.) and FEELING ABNORMAL (feels weird and strange). On 06-May-2021, the patient experienced PERIPHERAL SWELLING (her leg got swollen but swelling went down). On 25-Apr-2021, RESPIRATORY DISORDER (breathing issue) and COUGH (cough) had resolved. On 07-May-2021, PERIPHERAL SWELLING (her leg got swollen but swelling went down) had resolved. At the time of the report, PRURITUS (Arm Itchy), PERIPHERAL SWELLING (Arm swollen), FEELING HOT (Arm Hot), HYPOAESTHESIA (shoulder going numb at least once or twice during the day/travelling down the arm now.), FEELING ABNORMAL (feels weird and strange) and MYALGIA (arm of injection site was Hurting) outcome was unknown.     Treatment medication was not provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever of 103F; This spontaneous case was reported by an other and describes the occurrence of PYREXIA (fever of 103F) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced PYREXIA (fever of 103F). At the time of the report, PYREXIA (fever of 103F) outcome was unknown.            Treatment given included Aspirin and Tyelenol
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: she has been itching ever since and it wont; Redness on arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (she has been itching ever since and it wont) and ERYTHEMA (Redness on arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced PRURITUS (she has been itching ever since and it wont) and ERYTHEMA (Redness on arm). At the time of the report, PRURITUS (she has been itching ever since and it wont) and ERYTHEMA (Redness on arm) outcome was unknown. Not Provided          This case was linked to MOD-2021-114662 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Oropharyngeal discomfort
Clinical narrative: Having trouble breathing while walking; My throat started closing around 10:30am; Harder for me to swallow; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Having trouble breathing while walking), OROPHARYNGEAL DISCOMFORT (My throat started closing around 10:30am) and DYSPHAGIA (Harder for me to swallow) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OLANZAPINE (ZYPREXA), VALPROATE SEMISODIUM (DEPAKOTE), METFORMIN and GABAPENTIN for an unknown indication.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Having trouble breathing while walking), OROPHARYNGEAL DISCOMFORT (My throat started closing around 10:30am) and DYSPHAGIA (Harder for me to swallow). At the time of the report, DYSPNOEA (Having trouble breathing while walking) and DYSPHAGIA (Harder for me to swallow) 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.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Nausea, Pyrexia, Vaccination site erythema
Clinical narrative: sore arm; redness of arm; swelling; fever of 101 degrees Fahrenheit; diarrhea; nausea; stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), VACCINATION SITE ERYTHEMA (redness of arm), VACCINATION SITE SWELLING (swelling), PYREXIA (fever of 101 degrees Fahrenheit) and DIARRHOEA (diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm), VACCINATION SITE ERYTHEMA (redness of arm), VACCINATION SITE SWELLING (swelling), PYREXIA (fever of 101 degrees Fahrenheit), DIARRHOEA (diarrhea), NAUSEA (nausea) and ABDOMINAL PAIN UPPER (stomach pain). At the time of the report, VACCINATION SITE PAIN (sore arm), VACCINATION SITE ERYTHEMA (redness of arm), VACCINATION SITE SWELLING (swelling), PYREXIA (fever of 101 degrees Fahrenheit), DIARRHOEA (diarrhea), NAUSEA (nausea) and ABDOMINAL PAIN UPPER (stomach pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD-2021-114704 (Patient Link).
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: sore arm; redness of arm; swelling; fever of 101 degrees Fahrenheit; diarrhea; nausea; stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), VACCINATION SITE ERYTHEMA (redness of arm), VACCINATION SITE SWELLING (swelling), PYREXIA (fever of 101 degrees Fahrenheit) and DIARRHOEA (diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm), VACCINATION SITE ERYTHEMA (redness of arm), VACCINATION SITE SWELLING (swelling), PYREXIA (fever of 101 degrees Fahrenheit), DIARRHOEA (diarrhea), NAUSEA (nausea) and ABDOMINAL PAIN UPPER (stomach pain). At the time of the report, VACCINATION SITE PAIN (sore arm), VACCINATION SITE ERYTHEMA (redness of arm), VACCINATION SITE SWELLING (swelling), PYREXIA (fever of 101 degrees Fahrenheit), DIARRHOEA (diarrhea), NAUSEA (nausea) and ABDOMINAL PAIN UPPER (stomach pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD-2021-114704 (Patient Link).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Pain that went down my leg to my foot, feeling it going down my thighs and knees; Pain that went down my leg to my foot, feeling it going down my thighs and knees; Pain that went down my leg to my foot, feeling it going down my thighs and knees; Pain that went down my leg to my foot, feeling it going down my thighs and knees; Started with one side of the hip then both; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), the second episode of PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), the third episode of PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), ARTHRALGIA (Pain that went down my leg to my foot, feeling it going down my thighs and knees) and ARTHRALGIA (Started with one side of the hip then both) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 the first episode of PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), the second episode of PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), the third episode of PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), ARTHRALGIA (Pain that went down my leg to my foot, feeling it going down my thighs and knees) and ARTHRALGIA (Started with one side of the hip then both). At the time of the report, last episode of PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), ARTHRALGIA (Pain that went down my leg to my foot, feeling it going down my thighs and knees) and ARTHRALGIA (Started with one side of the hip then both) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable  No concomitant medications were reported  No treatment drugs were reported
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Limb injury, Product dose omission issue
Clinical narrative: Broke arm,broke her shoulder; 2nd dose was suppose to be on March 31st but on 30th she broke her shoulder; tenderness on injection site; This spontaneous case was reported by a consumer and describes the occurrence of LIMB INJURY (Broke arm,broke her shoulder), INJECTION SITE PAIN (tenderness on injection site) and PRODUCT DOSE OMISSION ISSUE (2nd dose was suppose to be on March 31st but on 30th she broke her shoulder) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, METOPROLOL, CHLORTHALIDONE, CLOPIDOGREL BISULFATE (PLAVIX), ACETYLSALICYLIC ACID (ASPRIN) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced INJECTION SITE PAIN (tenderness on injection site). On 30-Mar-2021, the patient experienced LIMB INJURY (Broke arm,broke her shoulder) and PRODUCT DOSE OMISSION ISSUE (2nd dose was suppose to be on March 31st but on 30th she broke her shoulder). On 30-Mar-2021, PRODUCT DOSE OMISSION ISSUE (2nd dose was suppose to be on March 31st but on 30th she broke her shoulder) had resolved. At the time of the report, LIMB INJURY (Broke arm,broke her shoulder) and INJECTION SITE PAIN (tenderness on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-114387 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114387:Case for husband
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Diarrhoea, Nausea, Pyrexia
Clinical narrative: diarrhea; stomach pain; swelling; Rash aggravated; Vaccination site induration; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pain), SWELLING (swelling), RASH (Rash aggravated) and VACCINATION SITE INDURATION (Vaccination site induration) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004B21A and 008B21A) 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 ETHINYLESTRADIOL, NORGESTREL (CRYSELLE) for Birth control.   On 20-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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pain), SWELLING (swelling), RASH (Rash aggravated), VACCINATION SITE INDURATION (Vaccination site induration), PYREXIA (fever) and NAUSEA (nausea). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Stomach pain, at a dose of 1 dosage form; PARACETAMOL (TYLENOL) for Stomach pain, at a dose of 1 dosage form and ONDANSETRON for Stomach pain, at a dose of 1 dosage form. At the time of the report, DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pain), SWELLING (swelling), RASH (Rash aggravated), VACCINATION SITE INDURATION (Vaccination site induration) and NAUSEA (nausea) outcome was unknown and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (Inconclusive) 101degree Fahrenheit.         Action taken for Moderna COVID-19 Vaccine was not applicable.   This case was linked to MOD-2021-114684 (Patient Link).
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling, Vaccination site induration
Clinical narrative: diarrhea; stomach pain; swelling; Rash aggravated; Vaccination site induration; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pain), SWELLING (swelling), RASH (Rash aggravated) and VACCINATION SITE INDURATION (Vaccination site induration) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004B21A and 008B21A) 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 ETHINYLESTRADIOL, NORGESTREL (CRYSELLE) for Birth control.   On 20-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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pain), SWELLING (swelling), RASH (Rash aggravated), VACCINATION SITE INDURATION (Vaccination site induration), PYREXIA (fever) and NAUSEA (nausea). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Stomach pain, at a dose of 1 dosage form; PARACETAMOL (TYLENOL) for Stomach pain, at a dose of 1 dosage form and ONDANSETRON for Stomach pain, at a dose of 1 dosage form. At the time of the report, DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pain), SWELLING (swelling), RASH (Rash aggravated), VACCINATION SITE INDURATION (Vaccination site induration) and NAUSEA (nausea) outcome was unknown and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (Inconclusive) 101degree Fahrenheit.         Action taken for Moderna COVID-19 Vaccine was not applicable.   This case was linked to MOD-2021-114684 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient only received 1st dose 28DEC2020; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient only received 1st dose 28DEC2020) 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 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient only received 1st dose 28DEC2020). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient only received 1st dose 28DEC2020) outcome was unknown. Not Provided      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 and treatment medications information were provided.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Elevated adverse reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of ADVERSE REACTION (Elevated adverse reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) 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 ADVERSE REACTION (Elevated adverse reaction). At the time of the report, ADVERSE REACTION (Elevated adverse reaction) 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 use was provided by the reporter.  Treatment of events was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Non significant follow up received on 25-06-2021. contact information provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Influenza like illness, SARS-CoV-2 antibody test
Clinical narrative: Sharp spasmodic pain in upper abdomen/Pain from upper abdomen to lower thoracic; Flu like symptoms; This spontaneous case was reported by a health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (Sharp spasmodic pain in upper abdomen/Pain from upper abdomen to lower thoracic) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced ABDOMINAL PAIN UPPER (Sharp spasmodic pain in upper abdomen/Pain from upper abdomen to lower thoracic) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, ABDOMINAL PAIN UPPER (Sharp spasmodic pain in upper abdomen/Pain from upper abdomen to lower thoracic) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2020, SARS-CoV-2 antibody test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported by the reporter No treatment medications was  provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up was received in that  patient stated that she did not experience any AE from her second dose  the person she spoke to misunderstood that these symptoms were related to something else entirely and not the vaccine that patient  had 3 days later.
Age: 0.83
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Insomnia
Clinical narrative: Explosive diaper/Had diarrhea; Upset stomach; Hard time sleeping; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Hard time sleeping), DIARRHOEA (Explosive diaper/Had diarrhea) and ABDOMINAL DISCOMFORT (Upset stomach) in a 10-month-old male infant exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the mother 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 06-May-2021, the infant was diagnosed with INSOMNIA (Hard time sleeping) and ABDOMINAL DISCOMFORT (Upset stomach). On 07-May-2021, the infant was diagnosed with DIARRHOEA (Explosive diaper/Had diarrhea). The Infant was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, INSOMNIA (Hard time sleeping), DIARRHOEA (Explosive diaper/Had diarrhea) and ABDOMINAL DISCOMFORT (Upset stomach) 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.   Upon in internal review on 17 May 2021, the age was corrected to 10 months.   This case was linked to US-MODERNATX, INC.-MOD-2021-114699, US-MODERNATX, INC.-MOD-2021-114699 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114699:Mother's case US-MODERNATX, INC.-MOD-2021-114699:Mother's case
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient is taking concomitant medications. Treatment information was not provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain, Urticaria
Clinical narrative: hives around neck; dizzy; pain all over her body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives around neck), DIZZINESS (dizzy) and PAIN (pain all over her body) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives around neck), DIZZINESS (dizzy) and PAIN (pain all over her body). At the time of the report, URTICARIA (hives around neck), DIZZINESS (dizzy) and PAIN (pain all over her body) 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.   Treatment information not provided. List of concomitant medication were not given
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Headache
Clinical narrative: She is like lost, she doesn't know anything, she don't, her memory is still lost; Headache; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (She is like lost, she doesn't know anything, she don't, her memory is still lost) and HEADACHE (Headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AMNESIA (She is like lost, she doesn't know anything, she don't, her memory is still lost) and HEADACHE (Headache). At the time of the report, AMNESIA (She is like lost, she doesn't know anything, she don't, her memory is still lost) had not resolved and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medication was not provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: can't breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (can't breath) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced DYSPNOEA (can't breath). At the time of the report, DYSPNOEA (can't breath) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       description/name of concomitant medication was not reported no treatment was reported
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Everyone in the office was brutally sick, all but one person; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Everyone in the office was brutally sick, all but one person) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Everyone in the office was brutally sick, all but one person). At the time of the report, ILLNESS (Everyone in the office was brutally sick, all but one person) outcome was unknown. Not Provided      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.   This case was linked to MOD21-088258, US-MODERNATX, INC.-MOD-2021-114635, US-MODERNATX, INC.-MOD-2021-114654 (Linked Report).; Sender's Comments:  MOD21-088258: US-MODERNATX, INC.-MOD-2021-114635: US-MODERNATX, INC.-MOD-2021-114654:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Pain in his left hand and left arm that has not gone away; Second dose taken after 39 days of first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in his left hand and left arm that has not gone away) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose taken after 39 days of first dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in his left hand and left arm that has not gone away) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose taken after 39 days of first dose). On 01-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose taken after 39 days of first dose) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in his left hand and left arm that has not gone away) had not resolved. Not Provided          Concomitant product use included pills for sugar. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11-May-2021 has no new information.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by an other and describes the occurrence of RASH (Rash) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.            Treatment : Therapy with Rybelsus