chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Peripheral swelling, Vaccination site erythema, Vaccination site urticaria
Clinical narrative: arms started swelling and now there is a big red welt right around the injection site; arms started swelling and now there is a big red welt right around the injection site/welt is larger; arms started swelling and now there is a big red welt right around the injection site; within 30 minutes of both doses began to feel really sore throat and mouth; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (within 30 minutes of both doses began to feel really sore throat and mouth), PERIPHERAL SWELLING (arms started swelling and now there is a big red welt right around the injection site), VACCINATION SITE URTICARIA (arms started swelling and now there is a big red welt right around the injection site/welt is larger) and VACCINATION SITE ERYTHEMA (arms started swelling and now there is a big red welt right around the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (within 30 minutes of both doses began to feel really sore throat and mouth). On 22-Mar-2021, the patient experienced PERIPHERAL SWELLING (arms started swelling and now there is a big red welt right around the injection site), VACCINATION SITE URTICARIA (arms started swelling and now there is a big red welt right around the injection site/welt is larger) and VACCINATION SITE ERYTHEMA (arms started swelling and now there is a big red welt right around the injection site). At the time of the report, OROPHARYNGEAL PAIN (within 30 minutes of both doses began to feel really sore throat and mouth), PERIPHERAL SWELLING (arms started swelling and now there is a big red welt right around the injection site), VACCINATION SITE URTICARIA (arms started swelling and now there is a big red welt right around the injection site/welt is larger) and VACCINATION SITE ERYTHEMA (arms started swelling and now there is a big red welt right around the injection site) outcome was unknown.            Concomitant medications were not reported. Treatment details not provided. Action taken with mRNA-1273 in response to the events was not applicable    This case was linked.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium, Computerised tomogram head, Computerised tomogram neck, Dizziness, Electrocardiogram
Clinical narrative: Vertigo; nauseous; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), VERTIGO (Vertigo) and NAUSEA (nauseous) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (sulfa), Drug allergy (Codeine), Drug allergy (Percocet), Drug allergy (Demerol), Blood pressure high, Hypercholesteraemia and Anxiety. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE & HCTZ) from an unknown date to 27-Apr-2021 for Blood pressure high, ROSUVASTATIN CALCIUM for Cholesterol blood excessive, VITAMIN C [ASCORBIC ACID] from 18-Mar-2020 to 28-Feb-2021 and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 03-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (nauseous). On an unknown date, the patient experienced VERTIGO (Vertigo). The patient was treated with POTASSIUM for Potassium supplementation, at an unspecified dose and frequency. On 06-May-2021, DIZZINESS (dizziness) and NAUSEA (nauseous) had resolved. At the time of the report, VERTIGO (Vertigo) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Apr-2021, Blood potassium: low (Low) low. On 18-Apr-2021, Computerised tomogram head: normal (normal) normal. On 18-Apr-2021, Computerised tomogram neck: normal (normal) normal. On 18-Apr-2021, Electrocardiogram: normal (normal) normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Patient's demographics, medical history were updated, lab test was added,  Second dose information was added and Concomitant products added, event outcome for nausea and vertigo were updated from unknown to recovered and vertigo was added and treatment medication specified.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vertigo
Clinical narrative: Vertigo; nauseous; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), VERTIGO (Vertigo) and NAUSEA (nauseous) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (sulfa), Drug allergy (Codeine), Drug allergy (Percocet), Drug allergy (Demerol), Blood pressure high, Hypercholesteraemia and Anxiety. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE & HCTZ) from an unknown date to 27-Apr-2021 for Blood pressure high, ROSUVASTATIN CALCIUM for Cholesterol blood excessive, VITAMIN C [ASCORBIC ACID] from 18-Mar-2020 to 28-Feb-2021 and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 03-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (nauseous). On an unknown date, the patient experienced VERTIGO (Vertigo). The patient was treated with POTASSIUM for Potassium supplementation, at an unspecified dose and frequency. On 06-May-2021, DIZZINESS (dizziness) and NAUSEA (nauseous) had resolved. At the time of the report, VERTIGO (Vertigo) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Apr-2021, Blood potassium: low (Low) low. On 18-Apr-2021, Computerised tomogram head: normal (normal) normal. On 18-Apr-2021, Computerised tomogram neck: normal (normal) normal. On 18-Apr-2021, Electrocardiogram: normal (normal) normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Patient's demographics, medical history were updated, lab test was added,  Second dose information was added and Concomitant products added, event outcome for nausea and vertigo were updated from unknown to recovered and vertigo was added and treatment medication specified.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Limb discomfort, Pain
Clinical narrative: could not move her arm with second shot; second shot hurt a lot more than the first; This spontaneous case was reported by a physician and describes the occurrence of LIMB DISCOMFORT (could not move her arm with second shot) and PAIN (second shot hurt a lot more than the first) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included OMEPRAZOLE, EMPAGLIFLOZIN (JARDIANCE), METOPROLOL, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN + HIDROCLOROTIAZIDA), ACETYLSALICYLIC ACID (BABY ASPIRIN), LEVOTHYROXINE SODIUM (THYROXINE), METFORMIN, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced LIMB DISCOMFORT (could not move her arm with second shot) and PAIN (second shot hurt a lot more than the first). At the time of the report, LIMB DISCOMFORT (could not move her arm with second shot) and PAIN (second shot hurt a lot more than the first) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Antibody test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided.   Action taken with mRNA-1273 in response to the events was not applicable   This case was linked to MOD21-060488, MOD-2021-054449.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Pain in extremity, Somnolence, Vaccination site erythema
Clinical narrative: Lightheadedness; Red spot on arm that is tender and warm; Red spot on arm that is tender and warm; Red spot on arm that is tender and warm; Arm was sore; Slept alot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), SOMNOLENCE (Slept alot), DIZZINESS (Lightheadedness), VACCINATION SITE WARMTH (Red spot on arm that is tender and warm) and VACCINATION SITE ERYTHEMA (Red spot on arm that is tender and warm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore) and SOMNOLENCE (Slept alot). On 23-Mar-2021, the patient experienced DIZZINESS (Lightheadedness), VACCINATION SITE WARMTH (Red spot on arm that is tender and warm), VACCINATION SITE ERYTHEMA (Red spot on arm that is tender and warm) and VACCINATION SITE PAIN (Red spot on arm that is tender and warm). At the time of the report, PAIN IN EXTREMITY (Arm was sore), SOMNOLENCE (Slept alot), DIZZINESS (Lightheadedness), VACCINATION SITE WARMTH (Red spot on arm that is tender and warm), VACCINATION SITE ERYTHEMA (Red spot on arm that is tender and warm) and VACCINATION SITE PAIN (Red spot on arm that is tender and warm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Heart rate: 117 (High) Increased and 105 (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment medication included that the patient took Pedialyte on 23 Mar 2021.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: Lightheadedness; Red spot on arm that is tender and warm; Red spot on arm that is tender and warm; Red spot on arm that is tender and warm; Arm was sore; Slept alot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), SOMNOLENCE (Slept alot), DIZZINESS (Lightheadedness), VACCINATION SITE WARMTH (Red spot on arm that is tender and warm) and VACCINATION SITE ERYTHEMA (Red spot on arm that is tender and warm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore) and SOMNOLENCE (Slept alot). On 23-Mar-2021, the patient experienced DIZZINESS (Lightheadedness), VACCINATION SITE WARMTH (Red spot on arm that is tender and warm), VACCINATION SITE ERYTHEMA (Red spot on arm that is tender and warm) and VACCINATION SITE PAIN (Red spot on arm that is tender and warm). At the time of the report, PAIN IN EXTREMITY (Arm was sore), SOMNOLENCE (Slept alot), DIZZINESS (Lightheadedness), VACCINATION SITE WARMTH (Red spot on arm that is tender and warm), VACCINATION SITE ERYTHEMA (Red spot on arm that is tender and warm) and VACCINATION SITE PAIN (Red spot on arm that is tender and warm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Heart rate: 117 (High) Increased and 105 (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment medication included that the patient took Pedialyte on 23 Mar 2021.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Anxiety, Chills, Condition aggravated, Contusion
Clinical narrative: Small cyst on kidney; Stomach pain; Will not be getting the second vaccine; Vomiting; Arm is still sore on occasion at the shot site; Same as first event but worse; Diarrhea; Flashes of adrenaline or anxiety; Chills; Nausea/ Nausea became worse; Arm bruised for 1 month; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), CONDITION AGGRAVATED (Same as first event but worse), RENAL CYST (Small cyst on kidney), DIARRHOEA (Diarrhea) and ANXIETY (Flashes of adrenaline or anxiety) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Nausea, Diarrhea and Chills.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced NAUSEA (Nausea/ Nausea became worse). On 19-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ANXIETY (Flashes of adrenaline or anxiety) and CHILLS (Chills). On 24-Mar-2021, the patient experienced CONDITION AGGRAVATED (Same as first event but worse). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), RENAL CYST (Small cyst on kidney), CONTUSION (Arm bruised for 1 month), INTENTIONAL DOSE OMISSION (Will not be getting the second vaccine), VOMITING (Vomiting) and VACCINATION SITE PAIN (Arm is still sore on occasion at the shot site). At the time of the report, DIARRHOEA (Diarrhea), NAUSEA (Nausea/ Nausea became worse) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included Dramamine.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Additional1
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Intentional dose omission, Nausea, Renal cyst, Vaccination site pain
Clinical narrative: Small cyst on kidney; Stomach pain; Will not be getting the second vaccine; Vomiting; Arm is still sore on occasion at the shot site; Same as first event but worse; Diarrhea; Flashes of adrenaline or anxiety; Chills; Nausea/ Nausea became worse; Arm bruised for 1 month; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), CONDITION AGGRAVATED (Same as first event but worse), RENAL CYST (Small cyst on kidney), DIARRHOEA (Diarrhea) and ANXIETY (Flashes of adrenaline or anxiety) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Nausea, Diarrhea and Chills.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced NAUSEA (Nausea/ Nausea became worse). On 19-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ANXIETY (Flashes of adrenaline or anxiety) and CHILLS (Chills). On 24-Mar-2021, the patient experienced CONDITION AGGRAVATED (Same as first event but worse). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), RENAL CYST (Small cyst on kidney), CONTUSION (Arm bruised for 1 month), INTENTIONAL DOSE OMISSION (Will not be getting the second vaccine), VOMITING (Vomiting) and VACCINATION SITE PAIN (Arm is still sore on occasion at the shot site). At the time of the report, DIARRHOEA (Diarrhea), NAUSEA (Nausea/ Nausea became worse) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included Dramamine.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Additional1
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Small cyst on kidney; Stomach pain; Will not be getting the second vaccine; Vomiting; Arm is still sore on occasion at the shot site; Same as first event but worse; Diarrhea; Flashes of adrenaline or anxiety; Chills; Nausea/ Nausea became worse; Arm bruised for 1 month; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), CONDITION AGGRAVATED (Same as first event but worse), RENAL CYST (Small cyst on kidney), DIARRHOEA (Diarrhea) and ANXIETY (Flashes of adrenaline or anxiety) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Nausea, Diarrhea and Chills.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced NAUSEA (Nausea/ Nausea became worse). On 19-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ANXIETY (Flashes of adrenaline or anxiety) and CHILLS (Chills). On 24-Mar-2021, the patient experienced CONDITION AGGRAVATED (Same as first event but worse). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), RENAL CYST (Small cyst on kidney), CONTUSION (Arm bruised for 1 month), INTENTIONAL DOSE OMISSION (Will not be getting the second vaccine), VOMITING (Vomiting) and VACCINATION SITE PAIN (Arm is still sore on occasion at the shot site). At the time of the report, DIARRHOEA (Diarrhea), NAUSEA (Nausea/ Nausea became worse) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included Dramamine.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Additional1
Sex: U
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Nausea
Clinical narrative: dizziness; felt disoriented; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), DISORIENTATION (felt disoriented) and NAUSEA (nausea) 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 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), DISORIENTATION (felt disoriented) and NAUSEA (nausea). At the time of the report, DIZZINESS (dizziness), DISORIENTATION (felt disoriented) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.    Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate, Heart rate abnormal, Nausea, Pain in extremity
Clinical narrative: swelling on left side on check and eye; wasn't feeling good in general; heart rate went back up again, in the morning; nausea; Both my legs felt like I had glue on; sunburn rash on my face and chest; sore arm; tingling in my tongue; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Both my legs felt like I had glue on), RASH ERYTHEMATOUS (sunburn rash on my face and chest), PAIN IN EXTREMITY (sore arm), PARAESTHESIA ORAL (tingling in my tongue) and SWELLING FACE (swelling on left side on check and eye) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced FEELING ABNORMAL (Both my legs felt like I had glue on), RASH ERYTHEMATOUS (sunburn rash on my face and chest), PAIN IN EXTREMITY (sore arm), PARAESTHESIA ORAL (tingling in my tongue) and NAUSEA (nausea). On 05-Mar-2021, the patient experienced SWELLING FACE (swelling on left side on check and eye), FEELING ABNORMAL (wasn't feeling good in general) and HEART RATE ABNORMAL (heart rate went back up again, in the morning). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. On 05-Mar-2021, SWELLING FACE (swelling on left side on check and eye) had resolved. At the time of the report, FEELING ABNORMAL (Both my legs felt like I had glue on), RASH ERYTHEMATOUS (sunburn rash on my face and chest), PAIN IN EXTREMITY (sore arm), PARAESTHESIA ORAL (tingling in my tongue), FEELING ABNORMAL (wasn't feeling good in general), HEART RATE ABNORMAL (heart rate went back up again, in the morning) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Heart rate: 110 (abnormal) 110 heart rate 30 minutes after the shot..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Rash erythematous, Swelling face
Clinical narrative: swelling on left side on check and eye; wasn't feeling good in general; heart rate went back up again, in the morning; nausea; Both my legs felt like I had glue on; sunburn rash on my face and chest; sore arm; tingling in my tongue; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Both my legs felt like I had glue on), RASH ERYTHEMATOUS (sunburn rash on my face and chest), PAIN IN EXTREMITY (sore arm), PARAESTHESIA ORAL (tingling in my tongue) and SWELLING FACE (swelling on left side on check and eye) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced FEELING ABNORMAL (Both my legs felt like I had glue on), RASH ERYTHEMATOUS (sunburn rash on my face and chest), PAIN IN EXTREMITY (sore arm), PARAESTHESIA ORAL (tingling in my tongue) and NAUSEA (nausea). On 05-Mar-2021, the patient experienced SWELLING FACE (swelling on left side on check and eye), FEELING ABNORMAL (wasn't feeling good in general) and HEART RATE ABNORMAL (heart rate went back up again, in the morning). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. On 05-Mar-2021, SWELLING FACE (swelling on left side on check and eye) had resolved. At the time of the report, FEELING ABNORMAL (Both my legs felt like I had glue on), RASH ERYTHEMATOUS (sunburn rash on my face and chest), PAIN IN EXTREMITY (sore arm), PARAESTHESIA ORAL (tingling in my tongue), FEELING ABNORMAL (wasn't feeling good in general), HEART RATE ABNORMAL (heart rate went back up again, in the morning) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Heart rate: 110 (abnormal) 110 heart rate 30 minutes after the shot..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Feeling cold, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Sore throat; Nasal Drainage; Cough; scratchy throat; tiredness; Chillness; Soreness of the right arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Chillness), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Nasal Drainage), COUGH (Cough) and THROAT IRRITATION (scratchy throat) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 18-Mar-2021, the patient experienced FEELING COLD (Chillness) and VACCINATION SITE PAIN (Soreness of the right arm). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Nasal Drainage), COUGH (Cough), THROAT IRRITATION (scratchy throat) and FATIGUE (tiredness). The patient was treated with TRIAMCINOLONE ACETONIDE (NASACORT) for Nasal discharge, at an unspecified dose and frequency. At the time of the report, FEELING COLD (Chillness), OROPHARYNGEAL PAIN (Sore throat), VACCINATION SITE PAIN (Soreness of the right arm) and FATIGUE (tiredness) had resolved, RHINORRHOEA (Nasal Drainage) had not resolved, COUGH (Cough) was resolving and THROAT IRRITATION (scratchy throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment:Nasal drip for scratchy throat, Nasacort for nasal drainage in addition to allergy medicine patient also took cough suppressant
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Vaccination site pain
Clinical narrative: Sore throat; Nasal Drainage; Cough; scratchy throat; tiredness; Chillness; Soreness of the right arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Chillness), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Nasal Drainage), COUGH (Cough) and THROAT IRRITATION (scratchy throat) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 18-Mar-2021, the patient experienced FEELING COLD (Chillness) and VACCINATION SITE PAIN (Soreness of the right arm). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Nasal Drainage), COUGH (Cough), THROAT IRRITATION (scratchy throat) and FATIGUE (tiredness). The patient was treated with TRIAMCINOLONE ACETONIDE (NASACORT) for Nasal discharge, at an unspecified dose and frequency. At the time of the report, FEELING COLD (Chillness), OROPHARYNGEAL PAIN (Sore throat), VACCINATION SITE PAIN (Soreness of the right arm) and FATIGUE (tiredness) had resolved, RHINORRHOEA (Nasal Drainage) had not resolved, COUGH (Cough) was resolving and THROAT IRRITATION (scratchy throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment:Nasal drip for scratchy throat, Nasacort for nasal drainage in addition to allergy medicine patient also took cough suppressant
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: a small ball in the arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (a small ball in the arm at injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE SWELLING (a small ball in the arm at injection site). At the time of the report, VACCINATION SITE SWELLING (a small ball in the arm at injection site) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. No concomitant medication information was provided. No treatment product information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Confusional state, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Crummy; Listless; Discombabulated; fever blisters; Fuzzy headed/could not think straight; Bad headache; Fever (T100.8F); Hurt all over as if hit by a truck; Felt tired; Little sore at the injection site; Dizzy/head spinning/equilibrium problem; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy/head spinning/equilibrium problem), FEELING ABNORMAL (Fuzzy headed/could not think straight), CONFUSIONAL STATE (Discombabulated), ORAL HERPES (fever blisters) and MALAISE (Crummy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced DIZZINESS (Dizzy/head spinning/equilibrium problem) and VACCINATION SITE PAIN (Little sore at the injection site). On 11-Mar-2021, the patient experienced FEELING ABNORMAL (Fuzzy headed/could not think straight), HEADACHE (Bad headache), PYREXIA (Fever (T100.8F)), MYALGIA (Hurt all over as if hit by a truck) and FATIGUE (Felt tired). On 12-Mar-2021, the patient experienced ORAL HERPES (fever blisters). On 13-Mar-2021, the patient experienced CONFUSIONAL STATE (Discombabulated). On 16-Mar-2021, the patient experienced MALAISE (Crummy) and LISTLESS (Listless). On 12-Mar-2021, PYREXIA (Fever (T100.8F)) had resolved. On 22-Mar-2021, DIZZINESS (Dizzy/head spinning/equilibrium problem) had resolved. At the time of the report, FEELING ABNORMAL (Fuzzy headed/could not think straight), CONFUSIONAL STATE (Discombabulated), ORAL HERPES (fever blisters), MALAISE (Crummy), LISTLESS (Listless), MYALGIA (Hurt all over as if hit by a truck), FATIGUE (Felt tired) and VACCINATION SITE PAIN (Little sore at the injection site) outcome was unknown and HEADACHE (Bad headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 100.8 (High) degree F.         No relevant concomitant medications were reported. Treatment information included paracetamol. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-054451 (E2B Linked Report).; Sender's Comments:  MOD-2021-054451:First dose
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Listless, Malaise, Myalgia, Oral herpes
Clinical narrative: Crummy; Listless; Discombabulated; fever blisters; Fuzzy headed/could not think straight; Bad headache; Fever (T100.8F); Hurt all over as if hit by a truck; Felt tired; Little sore at the injection site; Dizzy/head spinning/equilibrium problem; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy/head spinning/equilibrium problem), FEELING ABNORMAL (Fuzzy headed/could not think straight), CONFUSIONAL STATE (Discombabulated), ORAL HERPES (fever blisters) and MALAISE (Crummy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced DIZZINESS (Dizzy/head spinning/equilibrium problem) and VACCINATION SITE PAIN (Little sore at the injection site). On 11-Mar-2021, the patient experienced FEELING ABNORMAL (Fuzzy headed/could not think straight), HEADACHE (Bad headache), PYREXIA (Fever (T100.8F)), MYALGIA (Hurt all over as if hit by a truck) and FATIGUE (Felt tired). On 12-Mar-2021, the patient experienced ORAL HERPES (fever blisters). On 13-Mar-2021, the patient experienced CONFUSIONAL STATE (Discombabulated). On 16-Mar-2021, the patient experienced MALAISE (Crummy) and LISTLESS (Listless). On 12-Mar-2021, PYREXIA (Fever (T100.8F)) had resolved. On 22-Mar-2021, DIZZINESS (Dizzy/head spinning/equilibrium problem) had resolved. At the time of the report, FEELING ABNORMAL (Fuzzy headed/could not think straight), CONFUSIONAL STATE (Discombabulated), ORAL HERPES (fever blisters), MALAISE (Crummy), LISTLESS (Listless), MYALGIA (Hurt all over as if hit by a truck), FATIGUE (Felt tired) and VACCINATION SITE PAIN (Little sore at the injection site) outcome was unknown and HEADACHE (Bad headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 100.8 (High) degree F.         No relevant concomitant medications were reported. Treatment information included paracetamol. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-054451 (E2B Linked Report).; Sender's Comments:  MOD-2021-054451:First dose
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Crummy; Listless; Discombabulated; fever blisters; Fuzzy headed/could not think straight; Bad headache; Fever (T100.8F); Hurt all over as if hit by a truck; Felt tired; Little sore at the injection site; Dizzy/head spinning/equilibrium problem; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy/head spinning/equilibrium problem), FEELING ABNORMAL (Fuzzy headed/could not think straight), CONFUSIONAL STATE (Discombabulated), ORAL HERPES (fever blisters) and MALAISE (Crummy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced DIZZINESS (Dizzy/head spinning/equilibrium problem) and VACCINATION SITE PAIN (Little sore at the injection site). On 11-Mar-2021, the patient experienced FEELING ABNORMAL (Fuzzy headed/could not think straight), HEADACHE (Bad headache), PYREXIA (Fever (T100.8F)), MYALGIA (Hurt all over as if hit by a truck) and FATIGUE (Felt tired). On 12-Mar-2021, the patient experienced ORAL HERPES (fever blisters). On 13-Mar-2021, the patient experienced CONFUSIONAL STATE (Discombabulated). On 16-Mar-2021, the patient experienced MALAISE (Crummy) and LISTLESS (Listless). On 12-Mar-2021, PYREXIA (Fever (T100.8F)) had resolved. On 22-Mar-2021, DIZZINESS (Dizzy/head spinning/equilibrium problem) had resolved. At the time of the report, FEELING ABNORMAL (Fuzzy headed/could not think straight), CONFUSIONAL STATE (Discombabulated), ORAL HERPES (fever blisters), MALAISE (Crummy), LISTLESS (Listless), MYALGIA (Hurt all over as if hit by a truck), FATIGUE (Felt tired) and VACCINATION SITE PAIN (Little sore at the injection site) outcome was unknown and HEADACHE (Bad headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 100.8 (High) degree F.         No relevant concomitant medications were reported. Treatment information included paracetamol. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-054451 (E2B Linked Report).; Sender's Comments:  MOD-2021-054451:First dose
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Product dose omission issue
Clinical narrative: 2nd dose passed the recommended 25 days to 35 days after dose 1; Shingles; A spontaneous report was received from a healthcare professional dear concerning a 44-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shingles, second dose passed the recommended 25 days to 35 days after dose 1.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 18 Mar 2021, the patient experienced shingles. On an unknown date, the patients second dose passed the recommended 25 days to 35 days after dose 1.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of shingles was not recovered and for missed dose recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness postural, Dyspnoea, Facial discomfort
Clinical narrative: Pain when breathing; Chills; Felt like she was having a fever; Very tired; Intense pain all over her body; Felt like her face was about to get facial palsy; Felt very bad; Terribly dizzy on her head; hard to stand; Pain on her right leg, specially when pressure on it; Joint pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL DISCOMFORT (Felt like her face was about to get facial palsy), FEELING ABNORMAL (Felt very bad), DIZZINESS POSTURAL (Terribly dizzy on her head; hard to stand), PAIN IN EXTREMITY (Pain on her right leg, specially when pressure on it) and DYSPNOEA (Pain when breathing) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia, Sjogren's syndrome, Rheumatoid arthritis and Breast cancer (remission). Concomitant products included EZETIMIBE for Cholesterol blood excessive, DULOXETINE for Fibromyalgia, BACOPA MONNIERI, CITICOLINE, PHOSPHATIDYL SERINE (CEREBRA) for Memory impaired, ACETYLCYSTEINE (N-ACETILCISTEINA) for Muscle disorder, PILOCARPINE and CEVIMELINE for Sjogren's syndrome, FOLIC ACID for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced FACIAL DISCOMFORT (Felt like her face was about to get facial palsy), FEELING ABNORMAL (Felt very bad), DIZZINESS POSTURAL (Terribly dizzy on her head; hard to stand), PAIN IN EXTREMITY (Pain on her right leg, specially when pressure on it), ARTHRALGIA (Joint pain) and MYALGIA (Intense pain all over her body). On 04-Mar-2021, the patient experienced CHILLS (Chills), PYREXIA (Felt like she was having a fever) and FATIGUE (Very tired). On 21-Mar-2021, the patient experienced DYSPNOEA (Pain when breathing). On 23-Mar-2021, DYSPNOEA (Pain when breathing) had resolved. At the time of the report, FACIAL DISCOMFORT (Felt like her face was about to get facial palsy), FEELING ABNORMAL (Felt very bad), DIZZINESS POSTURAL (Terribly dizzy on her head; hard to stand), PAIN IN EXTREMITY (Pain on her right leg, specially when pressure on it), ARTHRALGIA (Joint pain), CHILLS (Chills), PYREXIA (Felt like she was having a fever), FATIGUE (Very tired) and MYALGIA (Intense pain all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment drugs included - acetaminophen, zinc and multivitamins. Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Pain when breathing; Chills; Felt like she was having a fever; Very tired; Intense pain all over her body; Felt like her face was about to get facial palsy; Felt very bad; Terribly dizzy on her head; hard to stand; Pain on her right leg, specially when pressure on it; Joint pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL DISCOMFORT (Felt like her face was about to get facial palsy), FEELING ABNORMAL (Felt very bad), DIZZINESS POSTURAL (Terribly dizzy on her head; hard to stand), PAIN IN EXTREMITY (Pain on her right leg, specially when pressure on it) and DYSPNOEA (Pain when breathing) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia, Sjogren's syndrome, Rheumatoid arthritis and Breast cancer (remission). Concomitant products included EZETIMIBE for Cholesterol blood excessive, DULOXETINE for Fibromyalgia, BACOPA MONNIERI, CITICOLINE, PHOSPHATIDYL SERINE (CEREBRA) for Memory impaired, ACETYLCYSTEINE (N-ACETILCISTEINA) for Muscle disorder, PILOCARPINE and CEVIMELINE for Sjogren's syndrome, FOLIC ACID for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced FACIAL DISCOMFORT (Felt like her face was about to get facial palsy), FEELING ABNORMAL (Felt very bad), DIZZINESS POSTURAL (Terribly dizzy on her head; hard to stand), PAIN IN EXTREMITY (Pain on her right leg, specially when pressure on it), ARTHRALGIA (Joint pain) and MYALGIA (Intense pain all over her body). On 04-Mar-2021, the patient experienced CHILLS (Chills), PYREXIA (Felt like she was having a fever) and FATIGUE (Very tired). On 21-Mar-2021, the patient experienced DYSPNOEA (Pain when breathing). On 23-Mar-2021, DYSPNOEA (Pain when breathing) had resolved. At the time of the report, FACIAL DISCOMFORT (Felt like her face was about to get facial palsy), FEELING ABNORMAL (Felt very bad), DIZZINESS POSTURAL (Terribly dizzy on her head; hard to stand), PAIN IN EXTREMITY (Pain on her right leg, specially when pressure on it), ARTHRALGIA (Joint pain), CHILLS (Chills), PYREXIA (Felt like she was having a fever), FATIGUE (Very tired) and MYALGIA (Intense pain all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment drugs included - acetaminophen, zinc and multivitamins. Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Felt like he was going to die; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Felt like he was going to die) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart failure and AFib.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced FEELING ABNORMAL (Felt like he was going to die). At the time of the report, FEELING ABNORMAL (Felt like he was going to die) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not provided. The treatment information was not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Pain, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Lost 8 pounds in the last two weeks), PAIN (Aches), URTICARIA (Hives from head to toe), ASTHENIA (Weakness) and DIARRHOEA (Diarrhea a few times) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (Aches), PYREXIA (Fever) and CHILLS (Chills). On 18-Mar-2021, the patient experienced URTICARIA (Hives from head to toe) and RASH (Rash from head to toe). On an unknown date, the patient experienced WEIGHT DECREASED (Lost 8 pounds in the last two weeks), ASTHENIA (Weakness) and DIARRHOEA (Diarrhea a few times). On 18-Mar-2021, PAIN (Aches), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, WEIGHT DECREASED (Lost 8 pounds in the last two weeks), URTICARIA (Hives from head to toe), ASTHENIA (Weakness), DIARRHOEA (Diarrhea a few times) and RASH (Rash from head to toe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not provided.