chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm to the touch on injection site / warmer than touching other parts of body; Itching like a mosquito bite; Swelling on injection site; Red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch on injection site / warmer than touching other parts of body), VACCINATION SITE PRURITUS (Itching like a mosquito bite), VACCINATION SITE SWELLING (Swelling on injection site) and VACCINATION SITE ERYTHEMA (Red) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066DLA) for COVID-19 vaccination.     The patient's past medical history included Anxiety and Depression. Concomitant products included OMEPRAZOLE for Product used for unknown indication.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm to the touch on injection site / warmer than touching other parts of body), VACCINATION SITE PRURITUS (Itching like a mosquito bite), VACCINATION SITE SWELLING (Swelling on injection site) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch on injection site / warmer than touching other parts of body), VACCINATION SITE PRURITUS (Itching like a mosquito bite), VACCINATION SITE SWELLING (Swelling on injection site) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Nausea
Clinical narrative: Brain fog; Nausea for weeks; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog), NAUSEA (Nausea for weeks) and MYALGIA (Sore arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) 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. In April 2021, the patient experienced FEELING ABNORMAL (Brain fog), NAUSEA (Nausea for weeks) and MYALGIA (Sore arm). At the time of the report, FEELING ABNORMAL (Brain fog), NAUSEA (Nausea for weeks) and MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.   This case was linked to MOD-2021-296133 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood cholesterol decreased, Blood triglycerides, Blood triglycerides decreased, High density lipoprotein
Clinical narrative: cholesterol levels were significantly low/lower cholesterol levels in 20 years/overall cholesterol went from 237 down to 219; HDL increase; lower triglyceride levels; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BLOOD CHOLESTEROL DECREASED (cholesterol levels were significantly low/lower cholesterol levels in 20 years/overall cholesterol went from 237 down to 219), HIGH DENSITY LIPOPROTEIN INCREASED (HDL increase) and BLOOD TRIGLYCERIDES DECREASED (lower triglyceride levels) 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 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-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 BLOOD CHOLESTEROL DECREASED (cholesterol levels were significantly low/lower cholesterol levels in 20 years/overall cholesterol went from 237 down to 219), HIGH DENSITY LIPOPROTEIN INCREASED (HDL increase) and BLOOD TRIGLYCERIDES DECREASED (lower triglyceride levels). At the time of the report, BLOOD CHOLESTEROL DECREASED (cholesterol levels were significantly low/lower cholesterol levels in 20 years/overall cholesterol went from 237 down to 219), HIGH DENSITY LIPOPROTEIN INCREASED (HDL increase) and BLOOD TRIGLYCERIDES DECREASED (lower triglyceride levels) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: 237 (High) High and 219 (Low) cholesterol levels were significantly lower than before. On an unknown date, Blood triglycerides: down (Low) low. On an unknown date, High density lipoprotein: increased (High) High.         No concomitant medications were provided. No Treatment medications were reported. Patient also went through Lipid Panel Test which resulted into lower cholesterol levels than before.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: High density lipoprotein increased
Clinical narrative: cholesterol levels were significantly low/lower cholesterol levels in 20 years/overall cholesterol went from 237 down to 219; HDL increase; lower triglyceride levels; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BLOOD CHOLESTEROL DECREASED (cholesterol levels were significantly low/lower cholesterol levels in 20 years/overall cholesterol went from 237 down to 219), HIGH DENSITY LIPOPROTEIN INCREASED (HDL increase) and BLOOD TRIGLYCERIDES DECREASED (lower triglyceride levels) 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 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-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 BLOOD CHOLESTEROL DECREASED (cholesterol levels were significantly low/lower cholesterol levels in 20 years/overall cholesterol went from 237 down to 219), HIGH DENSITY LIPOPROTEIN INCREASED (HDL increase) and BLOOD TRIGLYCERIDES DECREASED (lower triglyceride levels). At the time of the report, BLOOD CHOLESTEROL DECREASED (cholesterol levels were significantly low/lower cholesterol levels in 20 years/overall cholesterol went from 237 down to 219), HIGH DENSITY LIPOPROTEIN INCREASED (HDL increase) and BLOOD TRIGLYCERIDES DECREASED (lower triglyceride levels) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: 237 (High) High and 219 (Low) cholesterol levels were significantly lower than before. On an unknown date, Blood triglycerides: down (Low) low. On an unknown date, High density lipoprotein: increased (High) High.         No concomitant medications were provided. No Treatment medications were reported. Patient also went through Lipid Panel Test which resulted into lower cholesterol levels than before.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus) 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 TINNITUS (tinnitus). At the time of the report, TINNITUS (tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Discomfort, Foot deformity, Pain in extremity
Clinical narrative: uncomfortable; Arthritic pains/pain moved up to left ankle; burning sensation in right foot; swelling in both feet; left foot pain/side of foot is painful to touch; crook in her foot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left foot pain/side of foot is painful to touch  ), FOOT DEFORMITY (crook in her foot), BURNING SENSATION (burning sensation in right foot), PERIPHERAL SWELLING (swelling in both feet) and DISCOMFORT (uncomfortable) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMINS [VITAMINS NOS], LEVOTHYROXINE SODIUM (SYNTHROID) and ANGELICA SINENSIS ROOT, CIMICIFUGA RACEMOSA ROOT, DIOSCOREA SPP., GLYCINE MAX (PHYTOESTROGEN) for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (left foot pain/side of foot is painful to touch  ) and FOOT DEFORMITY (crook in her foot). On 29-Jul-2021, the patient experienced BURNING SENSATION (burning sensation in right foot) and PERIPHERAL SWELLING (swelling in both feet). On an unknown date, the patient experienced DISCOMFORT (uncomfortable) and ARTHRALGIA (Arthritic pains/pain moved up to left ankle). At the time of the report, PAIN IN EXTREMITY (left foot pain/side of foot is painful to touch  ), FOOT DEFORMITY (crook in her foot), BURNING SENSATION (burning sensation in right foot), PERIPHERAL SWELLING (swelling in both feet), DISCOMFORT (uncomfortable) and ARTHRALGIA (Arthritic pains/pain moved up to left ankle) outcome was unknown.            Patient reported that a week and a half after the second dose she experienced left foot pain and a crook in her foot which she went to her podiatrist and was given an ace band for her foot. Patient reported after she has been experiencing a burning sensation in her right foot, swelling in both feet on 29 July 2021, uncomfortable, arthritic pain , pain in left foot moved up to left ankle, discomfort, side of foot was painful to touch.  No treatment information was provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: uncomfortable; Arthritic pains/pain moved up to left ankle; burning sensation in right foot; swelling in both feet; left foot pain/side of foot is painful to touch; crook in her foot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left foot pain/side of foot is painful to touch  ), FOOT DEFORMITY (crook in her foot), BURNING SENSATION (burning sensation in right foot), PERIPHERAL SWELLING (swelling in both feet) and DISCOMFORT (uncomfortable) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMINS [VITAMINS NOS], LEVOTHYROXINE SODIUM (SYNTHROID) and ANGELICA SINENSIS ROOT, CIMICIFUGA RACEMOSA ROOT, DIOSCOREA SPP., GLYCINE MAX (PHYTOESTROGEN) for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (left foot pain/side of foot is painful to touch  ) and FOOT DEFORMITY (crook in her foot). On 29-Jul-2021, the patient experienced BURNING SENSATION (burning sensation in right foot) and PERIPHERAL SWELLING (swelling in both feet). On an unknown date, the patient experienced DISCOMFORT (uncomfortable) and ARTHRALGIA (Arthritic pains/pain moved up to left ankle). At the time of the report, PAIN IN EXTREMITY (left foot pain/side of foot is painful to touch  ), FOOT DEFORMITY (crook in her foot), BURNING SENSATION (burning sensation in right foot), PERIPHERAL SWELLING (swelling in both feet), DISCOMFORT (uncomfortable) and ARTHRALGIA (Arthritic pains/pain moved up to left ankle) outcome was unknown.            Patient reported that a week and a half after the second dose she experienced left foot pain and a crook in her foot which she went to her podiatrist and was given an ace band for her foot. Patient reported after she has been experiencing a burning sensation in her right foot, swelling in both feet on 29 July 2021, uncomfortable, arthritic pain , pain in left foot moved up to left ankle, discomfort, side of foot was painful to touch.  No treatment information was provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Influenza like illness, Pain in extremity, Sleep disorder
Clinical narrative: Wakes up in the middle of the night; Flu like symptoms; Pain in right hip and knee; Trouble with his 3 fingers which feels like someone hitting them with a hammer for 15-30 second; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Trouble with his 3 fingers which feels like someone hitting them with a hammer for 15-30 second), SLEEP DISORDER (Wakes up in the middle of the night), INFLUENZA LIKE ILLNESS (Flu like symptoms) and ARTHRALGIA (Pain in right hip and knee) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Iodine allergy, Blood pressure abnormal since May 2013 and Heartburn since May 2013. Concomitant products included LISINOPRIL for Blood pressure abnormal, OMEPRAZOLE for Heartburn.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (Trouble with his 3 fingers which feels like someone hitting them with a hammer for 15-30 second). In May 2021, the patient experienced ARTHRALGIA (Pain in right hip and knee). On an unknown date, the patient experienced SLEEP DISORDER (Wakes up in the middle of the night) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, PAIN IN EXTREMITY (Trouble with his 3 fingers which feels like someone hitting them with a hammer for 15-30 second) and ARTHRALGIA (Pain in right hip and knee) had not resolved and SLEEP DISORDER (Wakes up in the middle of the night) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.            Patient had got X-Rays done for Hip and Knee, results were not provided and was getting physical Therapy done for the same.  Patient received both shots on the left arm and ever since had been having trouble with his 3 fingers which feels like someone hitting them with a hammer for 15-30 second. It being bothering 2-3 times per day and even wakes up in the middle of the night. The family doctor wasn't sure if was related to the vaccine.     Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Additional event, event outcome, patient demographics, medical history, concomitant medications, reporter contact details updated
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Lip swelling, Paraesthesia oral, Sneezing
Clinical narrative: Left side of her face was red and swollen.; She woke up in the morning and found little swelling on left side of body.; Left side of her face was red and swollen.; About 2 minutes later, her lips got tingling; her lips got tingling and they were swollen for about an hour.; 10 hours later, she had 2 big sneezes; She couldn't breathe through her nose; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (About 2 minutes later, her lips got tingling), LIP SWELLING (her lips got tingling and they were swollen for about an hour.), SNEEZING (10 hours later, she had 2 big sneezes), DYSPNOEA (She couldn't breathe through her nose) and SWELLING FACE (Left side of her face was red and swollen.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) 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 LEVOTHYROXINE SODIUM (SYNTHROID) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced PARAESTHESIA ORAL (About 2 minutes later, her lips got tingling), LIP SWELLING (her lips got tingling and they were swollen for about an hour.), SNEEZING (10 hours later, she had 2 big sneezes), DYSPNOEA (She couldn't breathe through her nose) and ERYTHEMA (Left side of her face was red and swollen.). On an unknown date, the patient experienced SWELLING FACE (Left side of her face was red and swollen.) and SWELLING (She woke up in the morning and found little swelling on left side of body.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA ORAL (About 2 minutes later, her lips got tingling), LIP SWELLING (her lips got tingling and they were swollen for about an hour.), SNEEZING (10 hours later, she had 2 big sneezes), DYSPNOEA (She couldn't breathe through her nose), SWELLING FACE (Left side of her face was red and swollen.), ERYTHEMA (Left side of her face was red and swollen.) and SWELLING (She woke up in the morning and found little swelling on left side of 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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling face
Clinical narrative: Left side of her face was red and swollen.; She woke up in the morning and found little swelling on left side of body.; Left side of her face was red and swollen.; About 2 minutes later, her lips got tingling; her lips got tingling and they were swollen for about an hour.; 10 hours later, she had 2 big sneezes; She couldn't breathe through her nose; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (About 2 minutes later, her lips got tingling), LIP SWELLING (her lips got tingling and they were swollen for about an hour.), SNEEZING (10 hours later, she had 2 big sneezes), DYSPNOEA (She couldn't breathe through her nose) and SWELLING FACE (Left side of her face was red and swollen.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) 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 LEVOTHYROXINE SODIUM (SYNTHROID) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced PARAESTHESIA ORAL (About 2 minutes later, her lips got tingling), LIP SWELLING (her lips got tingling and they were swollen for about an hour.), SNEEZING (10 hours later, she had 2 big sneezes), DYSPNOEA (She couldn't breathe through her nose) and ERYTHEMA (Left side of her face was red and swollen.). On an unknown date, the patient experienced SWELLING FACE (Left side of her face was red and swollen.) and SWELLING (She woke up in the morning and found little swelling on left side of body.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA ORAL (About 2 minutes later, her lips got tingling), LIP SWELLING (her lips got tingling and they were swollen for about an hour.), SNEEZING (10 hours later, she had 2 big sneezes), DYSPNOEA (She couldn't breathe through her nose), SWELLING FACE (Left side of her face was red and swollen.), ERYTHEMA (Left side of her face was red and swollen.) and SWELLING (She woke up in the morning and found little swelling on left side of 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.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Limb discomfort, Myalgia, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Any time he lifts something, he has issues with right arm), PAIN IN EXTREMITY (The right arm is so much painful that he can barely lift), CONDITION AGGRAVATED (The pain in my arm became unbearable, Severe pain in arm) and MYALGIA (After 2nd dose, he had more soreness.) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. Concurrent medical conditions included Seasonal allergy.On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced MYALGIA (After 2nd dose, he had more soreness.). On 03-Aug-2021, the patient experienced PAIN IN EXTREMITY (The right arm is so much painful that he can barely lift). On an unknown date, the patient experienced LIMB DISCOMFORT (Any time he lifts something, he has issues with right arm) and CONDITION AGGRAVATED (The pain in my arm became unbearable, Severe pain in arm). At the time of the report, LIMB DISCOMFORT (Any time he lifts something, he has issues with right arm), PAIN IN EXTREMITY (The right arm is so much painful that he can barely lift), CONDITION AGGRAVATED (The pain in my arm became unbearable, Severe pain in arm) and MYALGIA (After 2nd dose, he had more soreness.) had not resolved. The patient stated that he had worsened pain in arm  and could feel the soreness on a daily bases. Patient race information contain Black. The patient stated that some time in late July early August, his pain in my arm became unbearable, while he was helping unload a container. He stated that it has gotten to the point where he can't lift anything weighting around ten pounds above his waist without experiencing severe pain. No concomitant medication was reported. No treatment medication was reported. This case was linked to MOD-2021-295912 (Patient Link).Most recent FOLLOW-UP information incorporated above includes:  On 01-Sep-2021: Significant Followup. Vaccine information updated. Patient's race information and relevant history updated. New event-condition aggravated included.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Myalgia, Product dose omission issue
Clinical narrative: He was sick; he was super sore; He did not receive the second one because he didn't want to have further reactions; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (He was sick), MYALGIA (he was super sore) and PRODUCT DOSE OMISSION ISSUE (He did not receive the second one because he didn't want to have further reactions) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-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 ILLNESS (He was sick), MYALGIA (he was super sore) and PRODUCT DOSE OMISSION ISSUE (He did not receive the second one because he didn't want to have further reactions). At the time of the report, ILLNESS (He was sick) and MYALGIA (he was super sore) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (He did not receive the second one because he didn't want to have further reactions) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were provided. No treatments were provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Reporter details, Patient details, Product Start date, Batch no. were added and new events Myalgia and Illness were added.
Sex: M
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: second dose they administered a 1mL dose and not the recommended 0.5mL dose; This spontaneous case was reported by a pharmacist and describes the occurrence of OVERDOSE (second dose they administered a 1mL dose and not the recommended 0.5mL dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced OVERDOSE (second dose they administered a 1mL dose and not the recommended 0.5mL dose). At the time of the report, OVERDOSE (second dose they administered a 1mL dose and not the recommended 0.5mL dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore right injection site arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore right injection site arm) and FATIGUE (fatigue) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (sore right injection site arm) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (sore right injection site arm) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was provided.  No Treatment medications was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass
Clinical narrative: Reaction at the injection site  Big, red lump or mark; Reaction at the injection site  Big, red lump or mark; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Reaction at the injection site  Big, red lump or mark) and VACCINATION SITE ERYTHEMA (Reaction at the injection site  Big, red lump or mark) in a 63-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 VACCINATION SITE MASS (Reaction at the injection site  Big, red lump or mark) and VACCINATION SITE ERYTHEMA (Reaction at the injection site  Big, red lump or mark). At the time of the report, VACCINATION SITE MASS (Reaction at the injection site  Big, red lump or mark) and VACCINATION SITE ERYTHEMA (Reaction at the injection site  Big, red lump or mark) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.  The patient had big red lump measuring 5 inches vertically 3 or 4 inches horizontally at the injection site after one week of COVID-19 vaccination.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Contusion, Platelet count, Product dose omission issue
Clinical narrative: small bruising in her legs; anxiety; only received one dose; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (small bruising in her legs), ANXIETY (anxiety) and PRODUCT DOSE OMISSION ISSUE (only received one dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (small bruising in her legs), ANXIETY (anxiety) and PRODUCT DOSE OMISSION ISSUE (only received one dose). At the time of the report, CONTUSION (small bruising in her legs), ANXIETY (anxiety) and PRODUCT DOSE OMISSION ISSUE (only received one dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Platelet count: low (Low) Low. In June 2021, Platelet count: 190 (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient experienced platelet count drop so severe that doctors recommended not getting the second dose.  A month ago she did her bloodwork and her platelets were at 190 which is good & would like to get it.    Concomitant medications was not provided by the reporter Treatment information was not provided
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature
Clinical narrative: Stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M2DA and 028A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypersensitivity, Gluten intolerance, Shellfish allergy and Allergic contact dermatitis (contact allergy).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-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 ABDOMINAL PAIN UPPER (Stomach pain). The patient was treated with PARACETAMOL (TYLENOL) from 26-Mar-2021 to 28-Mar-2021 at a dose of 1 dosage form twice a day. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Body temperature: 100.6 (High) 100.6 degrees fahrenheit. On 27-Mar-2021, Body temperature: 100.4 (High) 100.4 degrees fahrenheit. On 28-Mar-2021, Body temperature: 99 (normal) 99 degrees fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.   This case was linked to MOD-2021-059765 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: Arm got a big thing on it, on hands. It hurt a little bit and it itched./It came back again. It's pink and itchy; arm got a big thing on it; Arm got a big thing on it, on hands. It hurt a little bit and it itched; Arm got a big thing on it, on hands. It hurt a little bit and it itched./It came back again. It's pink and itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (arm got a big thing on it), VACCINATION SITE PAIN (Arm got a big thing on it, on hands. It hurt a little bit and it itched), VACCINATION SITE PRURITUS (Arm got a big thing on it, on hands. It hurt a little bit and it itched./It came back again. It's pink and itchy) and VACCINATION SITE ERYTHEMA (Arm got a big thing on it, on hands. It hurt a little bit and it itched./It came back again. It's pink and itchy) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced VACCINATION SITE REACTION (arm got a big thing on it), VACCINATION SITE PAIN (Arm got a big thing on it, on hands. It hurt a little bit and it itched) and VACCINATION SITE PRURITUS (Arm got a big thing on it, on hands. It hurt a little bit and it itched./It came back again. It's pink and itchy). On 24-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm got a big thing on it, on hands. It hurt a little bit and it itched./It came back again. It's pink and itchy). On 20-Aug-2021, VACCINATION SITE REACTION (arm got a big thing on it), VACCINATION SITE PAIN (Arm got a big thing on it, on hands. It hurt a little bit and it itched) and VACCINATION SITE PRURITUS (Arm got a big thing on it, on hands. It hurt a little bit and it itched./It came back again. It's pink and itchy) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Arm got a big thing on it, on hands. It hurt a little bit and it itched./It came back again. It's pink and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Swelling, Vaccination site erythema, Vaccination site swelling
Clinical narrative: There is a knot/nodule between the armpits and arm; Armpits on the left side are swollen; The injection site is red and swollen; The injection site is red and swollen; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NODULE (There is a knot/nodule between the armpits and arm), SWELLING (Armpits on the left side are swollen), VACCINATION SITE ERYTHEMA (The injection site is red and swollen) and VACCINATION SITE SWELLING (The injection site is red and swollen) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 and Sickness. Concurrent medical conditions included Rheumatoid arthritis.    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced SWELLING (Armpits on the left side are swollen), VACCINATION SITE ERYTHEMA (The injection site is red and swollen) and VACCINATION SITE SWELLING (The injection site is red and swollen). On an unknown date, the patient experienced NODULE (There is a knot/nodule between the armpits and arm). The patient was treated with PARACETAMOL (TYLENOL) for Nodule, Swelling, Vaccination site erythema and Vaccination site swelling, at an unspecified dose and frequency. At the time of the report, NODULE (There is a knot/nodule between the armpits and arm) and SWELLING (Armpits on the left side are swollen) had not resolved and VACCINATION SITE ERYTHEMA (The injection site is red and swollen) and VACCINATION SITE SWELLING (The injection site is red and swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.She stated that she takes several medications but does not provide additional details
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Feeling abnormal, Nausea
Clinical narrative: Droopy; Feeling minimal pain now; Drugged; Nausea; Possible Fever; Real bad chills; Pain in left Shoulder and Neck; Couldn't stop Shaking; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Droopy), TREMOR (Couldn't stop Shaking), PAIN (Feeling minimal pain now), FEELING ABNORMAL (Drugged) and ARTHRALGIA (Pain in left Shoulder and Neck) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A, 030M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced TREMOR (Couldn't stop Shaking), ARTHRALGIA (Pain in left Shoulder and Neck) and CHILLS (Real bad chills). On an unknown date, the patient experienced ASTHENIA (Droopy), PAIN (Feeling minimal pain now), FEELING ABNORMAL (Drugged), NAUSEA (Nausea) and PYREXIA (Possible Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Droopy), TREMOR (Couldn't stop Shaking), PAIN (Feeling minimal pain now), FEELING ABNORMAL (Drugged), ARTHRALGIA (Pain in left Shoulder and Neck), NAUSEA (Nausea), CHILLS (Real bad chills) and PYREXIA (Possible Fever) outcome was unknown.        Concomitant medication included Thyroid medication.   This case was linked to MOD-2021-298768, MOD-2021-298769 (Patient Link).
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: Droopy; Feeling minimal pain now; Drugged; Nausea; Possible Fever; Real bad chills; Pain in left Shoulder and Neck; Couldn't stop Shaking; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Droopy), TREMOR (Couldn't stop Shaking), PAIN (Feeling minimal pain now), FEELING ABNORMAL (Drugged) and ARTHRALGIA (Pain in left Shoulder and Neck) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A, 030M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced TREMOR (Couldn't stop Shaking), ARTHRALGIA (Pain in left Shoulder and Neck) and CHILLS (Real bad chills). On an unknown date, the patient experienced ASTHENIA (Droopy), PAIN (Feeling minimal pain now), FEELING ABNORMAL (Drugged), NAUSEA (Nausea) and PYREXIA (Possible Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Droopy), TREMOR (Couldn't stop Shaking), PAIN (Feeling minimal pain now), FEELING ABNORMAL (Drugged), ARTHRALGIA (Pain in left Shoulder and Neck), NAUSEA (Nausea), CHILLS (Real bad chills) and PYREXIA (Possible Fever) outcome was unknown.        Concomitant medication included Thyroid medication.   This case was linked to MOD-2021-298768, MOD-2021-298769 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Pain in extremity
Clinical narrative: can't walk; hurts to walk; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (can't walk) and PAIN IN EXTREMITY (hurts to walk) in a female 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 GAIT INABILITY (can't walk) and PAIN IN EXTREMITY (hurts to walk). At the time of the report, GAIT INABILITY (can't walk) and PAIN IN EXTREMITY (hurts to walk) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2021-218564, MOD-2021-218567, MOD-2021-293322 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Mild rash 6in long injection site 3rd day after the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Mild rash 6in long injection site 3rd day after the shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE RASH (Mild rash 6in long injection site 3rd day after the shot). At the time of the report, VACCINATION SITE RASH (Mild rash 6in long injection site 3rd day after the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment medications was provided.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Incorrect route of product administration
Clinical narrative: 3rd dose subcutaneous; Inappropriate scheduled of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (3rd dose subcutaneous) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduled of vaccine administered) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 001A21A and 201B21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunodeficiency. Concomitant products included LAMOTRIGINE (LAMICTAL), OXCARBAZEPINE, GABAPENTIN, QUETIAPINE, HYDROCHLOROTHIAZIDE, OMEPRAZOLE, NALTREXONE HYDROCHLORIDE (NALTREXONE [NALTREXONE HYDROCHLORIDE]), BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]), LYSINE, COLECALCIFEROL (D3), MELATONIN, NATTOKINASE, RESVERATROL, GLYCERINE MONOLAURATE, INOSINE (MONOLAURIN [GLYCERINE MONOLAURATE;INOSINE]), FISH OIL, ASCORBIC ACID (VIT C), LEVETIRACETAM (LEVRA) and IMMUNOGLOBULIN G HUMAN (IGG) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (3rd dose subcutaneous). 25-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduled of vaccine administered). On 25-Aug-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (3rd dose subcutaneous) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduled of vaccine administered) had resolved.            Caller states that Patient is immunodeficient. She also stated that she got a sore arm with the1st dose and with the 2nd she got fever. Concomitant medications also included Sertiamen along with above mentioned medications. No treatment details were reported.   This case was linked to MOD-2021-296521, MOD-2021-296516 (Patient Link).