chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: Vaccine thawed for only 45 minutes; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine thawed for only 45 minutes) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine thawed for only 45 minutes). On 08-Mar-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine thawed for only 45 minutes) had resolved.        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.   This report refers to a case of wrong technique in product usage process for mRNA-1273, lot # 027A21A with no associated AEs.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of wrong technique in product usage process for mRNA-1273, lot # 027A21A with no associated AEs.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Headache, Influenza virus test
Clinical narrative: headache; body aches; chills; 104 F. fever; Patient lost 9 pounds; congestion; cough; very weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of   in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Impaired liver function and Kidney function abnormal. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LOSARTAN for an unknown indication.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Influenza virus test: Negative. In February 2021, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Pyrexia, SARS-CoV-2 test, Weight decreased
Clinical narrative: headache; body aches; chills; 104 F. fever; Patient lost 9 pounds; congestion; cough; very weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of   in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Impaired liver function and Kidney function abnormal. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LOSARTAN for an unknown indication.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Influenza virus test: Negative. In February 2021, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Rash, Vaccination site pain, Vaccination site rash
Clinical narrative: rashes on arm pit where injection site is and around to her legs; rashes on arm pit where injection site is and around to her legs; joint pain; soreness around injection site; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rashes on arm pit where injection site is and around to her legs), RASH (rashes on arm pit where injection site is and around to her legs), ARTHRALGIA (joint pain), VACCINATION SITE PAIN (soreness around injection site) and FATIGUE (Fatigue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included TAMOXIFEN, GABAPENTIN and DICLOFENAC for an unknown indication.    On 02-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 VACCINATION SITE RASH (rashes on arm pit where injection site is and around to her legs), RASH (rashes on arm pit where injection site is and around to her legs), ARTHRALGIA (joint pain), VACCINATION SITE PAIN (soreness around injection site) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE RASH (rashes on arm pit where injection site is and around to her legs), RASH (rashes on arm pit where injection site is and around to her legs), ARTHRALGIA (joint pain), VACCINATION SITE PAIN (soreness around injection site) and FATIGUE (Fatigue) 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: 5 DAYS LATER DEVELOPED REDNESS; SWELLING; ITCHINESS; SORENESS AT THE INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (5 DAYS LATER DEVELOPED REDNESS), VACCINATION SITE SWELLING (SWELLING), VACCINATION SITE PRURITUS (ITCHINESS) and VACCINATION SITE PAIN (SORENESS AT THE INJECTION SITE) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-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 VACCINATION SITE ERYTHEMA (5 DAYS LATER DEVELOPED REDNESS), VACCINATION SITE SWELLING (SWELLING), VACCINATION SITE PRURITUS (ITCHINESS) and VACCINATION SITE PAIN (SORENESS AT THE INJECTION SITE). At the time of the report, VACCINATION SITE ERYTHEMA (5 DAYS LATER DEVELOPED REDNESS), VACCINATION SITE SWELLING (SWELLING), VACCINATION SITE PRURITUS (ITCHINESS) and VACCINATION SITE PAIN (SORENESS AT THE INJECTION SITE) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: fever; chills; fatigue; nausea; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue), NAUSEA (nausea) and ARTHRALGIA (joint pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was reported by the reporter.     On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue), NAUSEA (nausea) and ARTHRALGIA (joint pain). On 10-Mar-2021, PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue), NAUSEA (nausea) and ARTHRALGIA (joint pain) had resolved.            Treatment medications were not reported. Concomitant medications were not reported.   This case was linked to MOD-2021-101857 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Significant follow up appended
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dysstasia, Gait disturbance, Myalgia
Clinical narrative: This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of MYALGIA (all over achy), NAUSEA (nauseous), PYREXIA (fever), CHILLS (chills) and ASTHENIA (couldn't get out of bed for more than 24 hours, feeling weak) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 04-Nov-2020. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, ATORVASTATIN from 11-May-2021 to an unknown date for Hyperlipidemia, GABAPENTIN from 30-Dec-2020 to an unknown date for Leg pain, LEVOTHYROXINE from 06-Mar-2020 to an unknown date for Thyroid disorder, BIOTIN, VITAMIN C [ASCORBIC ACID], BROMELAINS (BROMELIN [BROMELAINS]), FISH OIL, CALCIUM CARBONATE, COLECALCIFEROL (CALTRATE 600 + D), ASPIRIN [ACETYLSALICYLIC ACID], COLECALCIFEROL (VIT D3), MULTIVITAMINS [VITAMINS NOS], SENNOSIDE A+B (SENADE [SENNOSIDE A+B]) and MELATONIN for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced MYALGIA (all over achy), NAUSEA (nauseous), PYREXIA (fever), CHILLS (chills), ASTHENIA (couldn't get out of bed for more than 24 hours, feeling weak), VACCINATION COMPLICATION (reaction to the first dose), DYSSTASIA (couldn't sit or stand up) and GAIT DISTURBANCE (couldn't walk). At the time of the report, MYALGIA (all over achy), NAUSEA (nauseous), PYREXIA (fever), CHILLS (chills), ASTHENIA (couldn't get out of bed for more than 24 hours, feeling weak), VACCINATION COMPLICATION (reaction to the first dose), DYSSTASIA (couldn't sit or stand up) and GAIT DISTURBANCE (couldn't walk) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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.   This case was linked to MOD-2021-131229 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Patient details (height, weight and race) and AE's updated. Concomitant medications added.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination complication
Clinical narrative: This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of MYALGIA (all over achy), NAUSEA (nauseous), PYREXIA (fever), CHILLS (chills) and ASTHENIA (couldn't get out of bed for more than 24 hours, feeling weak) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 04-Nov-2020. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, ATORVASTATIN from 11-May-2021 to an unknown date for Hyperlipidemia, GABAPENTIN from 30-Dec-2020 to an unknown date for Leg pain, LEVOTHYROXINE from 06-Mar-2020 to an unknown date for Thyroid disorder, BIOTIN, VITAMIN C [ASCORBIC ACID], BROMELAINS (BROMELIN [BROMELAINS]), FISH OIL, CALCIUM CARBONATE, COLECALCIFEROL (CALTRATE 600 + D), ASPIRIN [ACETYLSALICYLIC ACID], COLECALCIFEROL (VIT D3), MULTIVITAMINS [VITAMINS NOS], SENNOSIDE A+B (SENADE [SENNOSIDE A+B]) and MELATONIN for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced MYALGIA (all over achy), NAUSEA (nauseous), PYREXIA (fever), CHILLS (chills), ASTHENIA (couldn't get out of bed for more than 24 hours, feeling weak), VACCINATION COMPLICATION (reaction to the first dose), DYSSTASIA (couldn't sit or stand up) and GAIT DISTURBANCE (couldn't walk). At the time of the report, MYALGIA (all over achy), NAUSEA (nauseous), PYREXIA (fever), CHILLS (chills), ASTHENIA (couldn't get out of bed for more than 24 hours, feeling weak), VACCINATION COMPLICATION (reaction to the first dose), DYSSTASIA (couldn't sit or stand up) and GAIT DISTURBANCE (couldn't walk) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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.   This case was linked to MOD-2021-131229 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Patient details (height, weight and race) and AE's updated. Concomitant medications added.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Dyspnoea, Flushing, Headache
Clinical narrative: Flushing; trouble breathing; headache; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushing), DYSPNOEA (trouble breathing), BODY TEMPERATURE INCREASED (temperature around 99) and HEADACHE (headache) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Fracture vertebral. Concurrent medical conditions included COPD and Arthritis. Concomitant products included CARVEDILOL (COREG), CLOPIDOGREL BISULFATE (PLAVIX), OXYBUTYNIN HYDROCHLORIDE (DITROPAN), TIZANIDINE, LISINOPRIL, DICYCLOVERINE HYDROCHLORIDE (DICYCLOMINE [DICYCLOVERINE HYDROCHLORIDE]), VITAMIN B12 [VITAMIN B12 NOS], GABAPENTIN, OLANZAPINE (ZOLAPINE), ALBUTEROL [SALBUTAMOL], ASPIRIN [ACETYLSALICYLIC ACID], OXYCODONE, HYDROCODONE and MONTELUKAST for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced FLUSHING (Flushing), DYSPNOEA (trouble breathing), BODY TEMPERATURE INCREASED (temperature around 99) and HEADACHE (headache). On 08-Mar-2021, FLUSHING (Flushing), DYSPNOEA (trouble breathing), BODY TEMPERATURE INCREASED (temperature around 99) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: 2 hours after receiving the vaccine is experiencing itchy neck; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (2 hours after receiving the vaccine is experiencing itchy neck) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PRURITUS (2 hours after receiving the vaccine is experiencing itchy neck). At the time of the report, PRURITUS (2 hours after receiving the vaccine is experiencing itchy neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported. No treatments were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up received on 21-Jul-2021 contains non-significant information. The primary reporter mailing address was updated.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Hypoaesthesia, Injection site pain
Clinical narrative: left hand increased numbness above baseline/right foot increased numbness above baseline; arm pit blotch; red and sore streaks on arm; red four inch blotch at injection site, red and sore streaks on arm; arm pit soreness; achiness; tiredness; very mild headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (arm pit blotch), HYPOAESTHESIA (left hand increased numbness above baseline/right foot increased numbness above baseline), PAIN (achiness), FATIGUE (tiredness) and HEADACHE (very mild headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder and Neuromuscular disorder NOS.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 05-Mar-2021, the patient experienced PAIN (achiness), FATIGUE (tiredness) and HEADACHE (very mild headache). On 07-Mar-2021, the patient experienced INJECTION SITE PAIN (red and sore streaks on arm), VACCINATION SITE ERYTHEMA (red four inch blotch at injection site, red and sore streaks on arm) and AXILLARY PAIN (arm pit soreness). On 08-Mar-2021, the patient experienced RASH MACULAR (arm pit blotch). On an unknown date, the patient experienced HYPOAESTHESIA (left hand increased numbness above baseline/right foot increased numbness above baseline). At the time of the report, RASH MACULAR (arm pit blotch), HYPOAESTHESIA (left hand increased numbness above baseline/right foot increased numbness above baseline), PAIN (achiness), FATIGUE (tiredness), HEADACHE (very mild headache), INJECTION SITE PAIN (red and sore streaks on arm), VACCINATION SITE ERYTHEMA (red four inch blotch at injection site, red and sore streaks on arm) and AXILLARY PAIN (arm pit soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Rash macular, Vaccination site erythema
Clinical narrative: left hand increased numbness above baseline/right foot increased numbness above baseline; arm pit blotch; red and sore streaks on arm; red four inch blotch at injection site, red and sore streaks on arm; arm pit soreness; achiness; tiredness; very mild headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (arm pit blotch), HYPOAESTHESIA (left hand increased numbness above baseline/right foot increased numbness above baseline), PAIN (achiness), FATIGUE (tiredness) and HEADACHE (very mild headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder and Neuromuscular disorder NOS.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 05-Mar-2021, the patient experienced PAIN (achiness), FATIGUE (tiredness) and HEADACHE (very mild headache). On 07-Mar-2021, the patient experienced INJECTION SITE PAIN (red and sore streaks on arm), VACCINATION SITE ERYTHEMA (red four inch blotch at injection site, red and sore streaks on arm) and AXILLARY PAIN (arm pit soreness). On 08-Mar-2021, the patient experienced RASH MACULAR (arm pit blotch). On an unknown date, the patient experienced HYPOAESTHESIA (left hand increased numbness above baseline/right foot increased numbness above baseline). At the time of the report, RASH MACULAR (arm pit blotch), HYPOAESTHESIA (left hand increased numbness above baseline/right foot increased numbness above baseline), PAIN (achiness), FATIGUE (tiredness), HEADACHE (very mild headache), INJECTION SITE PAIN (red and sore streaks on arm), VACCINATION SITE ERYTHEMA (red four inch blotch at injection site, red and sore streaks on arm) and AXILLARY PAIN (arm pit soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over his body; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH (Rash all over his body) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced RASH (Rash all over his body). In February 2021, RASH (Rash all over his body) had resolved.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  The concomitant medications and treatment details were not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased
Clinical narrative: heart rate increased to 150; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of HEART RATE INCREASED (heart rate increased to 150) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Diabetes since an unknown date and Atrial fibrillation since an unknown date. Concurrent medical conditions included Egg allergy and Allergic reaction (allergic reaction to swine flu that resulted in hospitalization).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced HEART RATE INCREASED (heart rate increased to 150) and HEADACHE (Headache). On 06-Mar-2021, HEART RATE INCREASED (heart rate increased to 150) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Heart rate: 150 (High) increased heart rate to 150.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included calcium channel blockers and unspecified medications for atrial fibrillation and diabetes.  Treatment medication was not provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 09-Mar-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of HEART RATE INCREASED (heart rate increased to 150) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Diabetes since an unknown date and Atrial fibrillation since an unknown date. Concurrent medical conditions included Egg allergy and Allergic reaction (allergic reaction to swine flu that resulted in hospitalization).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced HEART RATE INCREASED (heart rate increased to 150) and HEADACHE (Headache). On 06-Mar-2021, HEART RATE INCREASED (heart rate increased to 150) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Heart rate: 150 (High) increased heart rate to 150.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included calcium channel blockers and unspecified medications for atrial fibrillation and diabetes.  Treatment medication was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Diagnosed with COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID-19) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN POTASSIUM, DILTIAZEM HCL, ALENDRONATE SODIUM, LORATADINE, ACETYLSALICYLIC ACID (BAYER ASPIRIN) and MULTIVITAMIN & MINERAL for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced COVID-19 (Diagnosed with COVID-19). At the time of the report, COVID-19 (Diagnosed with COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Paraesthesia
Clinical narrative: Tingling right arm; red mark appearance; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling right arm) and INJECTION SITE ERYTHEMA (red mark appearance) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (red mark appearance). On 07-Mar-2021, the patient experienced PARAESTHESIA (Tingling right arm). At the time of the report, PARAESTHESIA (Tingling right arm) and INJECTION SITE ERYTHEMA (red mark appearance) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Decreased appetite, Fatigue, Feeling abnormal, Influenza like illness
Clinical narrative: her right arm extremely sore; achy; tiredness; they both felt like flu-like symptoms; partial loss of taste; don't feel good; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (they both felt like flu-like symptoms), AGEUSIA (partial loss of taste), FEELING ABNORMAL (don't feel good), DECREASED APPETITE (no appetite) and PAIN IN EXTREMITY (her right arm extremely sore) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer. Concurrent medical conditions included Diabetic. Concomitant products included INSULIN, VITAMIN D NOS and VITAMIN B COMPLEX (B COMPLEX (B50)) 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 INFLUENZA LIKE ILLNESS (they both felt like flu-like symptoms), AGEUSIA (partial loss of taste), FEELING ABNORMAL (don't feel good), DECREASED APPETITE (no appetite), PAIN (achy) and FATIGUE (tiredness). On an unknown date, the patient experienced PAIN IN EXTREMITY (her right arm extremely sore). On 06-Mar-2021, INFLUENZA LIKE ILLNESS (they both felt like flu-like symptoms), AGEUSIA (partial loss of taste), FEELING ABNORMAL (don't feel good), DECREASED APPETITE (no appetite), PAIN (achy) and FATIGUE (tiredness) had resolved. At the time of the report, PAIN IN EXTREMITY (her right arm extremely sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: her right arm extremely sore; achy; tiredness; they both felt like flu-like symptoms; partial loss of taste; don't feel good; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (they both felt like flu-like symptoms), AGEUSIA (partial loss of taste), FEELING ABNORMAL (don't feel good), DECREASED APPETITE (no appetite) and PAIN IN EXTREMITY (her right arm extremely sore) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer. Concurrent medical conditions included Diabetic. Concomitant products included INSULIN, VITAMIN D NOS and VITAMIN B COMPLEX (B COMPLEX (B50)) 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 INFLUENZA LIKE ILLNESS (they both felt like flu-like symptoms), AGEUSIA (partial loss of taste), FEELING ABNORMAL (don't feel good), DECREASED APPETITE (no appetite), PAIN (achy) and FATIGUE (tiredness). On an unknown date, the patient experienced PAIN IN EXTREMITY (her right arm extremely sore). On 06-Mar-2021, INFLUENZA LIKE ILLNESS (they both felt like flu-like symptoms), AGEUSIA (partial loss of taste), FEELING ABNORMAL (don't feel good), DECREASED APPETITE (no appetite), PAIN (achy) and FATIGUE (tiredness) had resolved. At the time of the report, PAIN IN EXTREMITY (her right arm extremely sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Dyspepsia, Ultrasound abdomen
Clinical narrative: bad stomach; had stomach pain; heartburn; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL DISCOMFORT (bad stomach), ABDOMINAL PAIN UPPER (had stomach pain) and DYSPEPSIA (heartburn) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M201) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included ATORVASTATIN for Cholesterol, OMEPRAZOLE, PROBIOTICS NOS and FAMOTIDINE for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (bad stomach), ABDOMINAL PAIN UPPER (had stomach pain) and DYSPEPSIA (heartburn). At the time of the report, ABDOMINAL DISCOMFORT (bad stomach), ABDOMINAL PAIN UPPER (had stomach pain) and DYSPEPSIA (heartburn) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound abdomen: inconclusive (Inconclusive) inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include blood pressure medication. No treatment medications was reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Photophobia
Clinical narrative: eyes are sensitive to light; constant headache; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPHOBIA (eyes are sensitive to light) and HEADACHE (constant headache) 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 25-Feb-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 PHOTOPHOBIA (eyes are sensitive to light) and HEADACHE (constant headache). At the time of the report, PHOTOPHOBIA (eyes are sensitive to light) and HEADACHE (constant headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment reported   Reporter did not allow further contact
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (her arm became very very very red) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (her arm became very very very red). At the time of the report, VACCINATION SITE ERYTHEMA (her arm became very very very red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No corrective treatment was reported
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: arm was throbbing and hot; Itchiness; Redness; pain; swelling; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), ERYTHEMA (Redness), PAIN (pain), SWELLING (swelling) and PAIN (arm was throbbing and hot) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PRURITUS (Itchiness), ERYTHEMA (Redness), PAIN (pain) and SWELLING (swelling). On 05-Mar-2021, the patient experienced PAIN (arm was throbbing and hot). On 03-Mar-2021, PRURITUS (Itchiness), ERYTHEMA (Redness), PAIN (pain) and SWELLING (swelling) had resolved. On 08-Mar-2021, PAIN (arm was throbbing and hot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  Treatment information was reported as Benadryl, Topical ointment.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Fatigue; A little headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and HEADACHE (A little headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue) and HEADACHE (A little headache). At the time of the report, FATIGUE (Fatigue) and HEADACHE (A little headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment medications was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Adverse reaction, Asthenia, Chills, Erythema
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ADVERSE REACTION (adverse reaction 12-14 hours after 2nd dose), FEELING ABNORMAL (woke up feeling miserable), FEELING HOT (hot), HYPERHIDROSIS (sweaty) and FEELING COLD (couldnt get warm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037k20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concurrent medical conditions included Hay fever.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-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 ADVERSE REACTION (adverse reaction 12-14 hours after 2nd dose). 06-Feb-2021, the patient experienced FEELING ABNORMAL (woke up feeling miserable), FEELING HOT (hot), HYPERHIDROSIS (sweaty), FEELING COLD (couldnt get warm), RETCHING (dry heaving), ABDOMINAL PAIN UPPER (stomach ache), ASTHENIA (felt really weak), RASH (5 inch diameter rash), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever between 102 to 103). On an unknown date, the patient experienced ERYTHEMA (erythema), PRURITUS (itching), TENDERNESS (tenderness), SWELLING (Did not lose swelling), FATIGUE (Extreme fatigue/Still fatigue/Slight fatigue) and VOMITING (Threw up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) (oral) at a dose of 29 mg. On 08-Feb-2021, FEELING ABNORMAL (woke up feeling miserable), FEELING HOT (hot), HYPERHIDROSIS (sweaty), FEELING COLD (couldnt get warm), RETCHING (dry heaving), ABDOMINAL PAIN UPPER (stomach ache), ASTHENIA (felt really weak), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever between 102 to 103) had resolved. On 10-Feb-2021, ADVERSE REACTION (adverse reaction 12-14 hours after 2nd dose) and RASH (5 inch diameter rash) had resolved. At the time of the report, ERYTHEMA (erythema), PRURITUS (itching), TENDERNESS (tenderness), SWELLING (Did not lose swelling), FATIGUE (Extreme fatigue/Still fatigue/Slight fatigue) and VOMITING (Threw up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Pyrexia: 102-103 (High) 102 to 103 degree F.         No concomitant medications were reported.     Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received and does not contain any new information. On 21-Jun-2021: Significant follow-up. Events added and ADR form received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Feeling cold, Feeling hot, Headache
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ADVERSE REACTION (adverse reaction 12-14 hours after 2nd dose), FEELING ABNORMAL (woke up feeling miserable), FEELING HOT (hot), HYPERHIDROSIS (sweaty) and FEELING COLD (couldnt get warm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037k20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concurrent medical conditions included Hay fever.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-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 ADVERSE REACTION (adverse reaction 12-14 hours after 2nd dose). 06-Feb-2021, the patient experienced FEELING ABNORMAL (woke up feeling miserable), FEELING HOT (hot), HYPERHIDROSIS (sweaty), FEELING COLD (couldnt get warm), RETCHING (dry heaving), ABDOMINAL PAIN UPPER (stomach ache), ASTHENIA (felt really weak), RASH (5 inch diameter rash), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever between 102 to 103). On an unknown date, the patient experienced ERYTHEMA (erythema), PRURITUS (itching), TENDERNESS (tenderness), SWELLING (Did not lose swelling), FATIGUE (Extreme fatigue/Still fatigue/Slight fatigue) and VOMITING (Threw up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) (oral) at a dose of 29 mg. On 08-Feb-2021, FEELING ABNORMAL (woke up feeling miserable), FEELING HOT (hot), HYPERHIDROSIS (sweaty), FEELING COLD (couldnt get warm), RETCHING (dry heaving), ABDOMINAL PAIN UPPER (stomach ache), ASTHENIA (felt really weak), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever between 102 to 103) had resolved. On 10-Feb-2021, ADVERSE REACTION (adverse reaction 12-14 hours after 2nd dose) and RASH (5 inch diameter rash) had resolved. At the time of the report, ERYTHEMA (erythema), PRURITUS (itching), TENDERNESS (tenderness), SWELLING (Did not lose swelling), FATIGUE (Extreme fatigue/Still fatigue/Slight fatigue) and VOMITING (Threw up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Pyrexia: 102-103 (High) 102 to 103 degree F.         No concomitant medications were reported.     Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received and does not contain any new information. On 21-Jun-2021: Significant follow-up. Events added and ADR form received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Pruritus, Pyrexia, Rash
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ADVERSE REACTION (adverse reaction 12-14 hours after 2nd dose), FEELING ABNORMAL (woke up feeling miserable), FEELING HOT (hot), HYPERHIDROSIS (sweaty) and FEELING COLD (couldnt get warm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037k20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concurrent medical conditions included Hay fever.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-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 ADVERSE REACTION (adverse reaction 12-14 hours after 2nd dose). 06-Feb-2021, the patient experienced FEELING ABNORMAL (woke up feeling miserable), FEELING HOT (hot), HYPERHIDROSIS (sweaty), FEELING COLD (couldnt get warm), RETCHING (dry heaving), ABDOMINAL PAIN UPPER (stomach ache), ASTHENIA (felt really weak), RASH (5 inch diameter rash), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever between 102 to 103). On an unknown date, the patient experienced ERYTHEMA (erythema), PRURITUS (itching), TENDERNESS (tenderness), SWELLING (Did not lose swelling), FATIGUE (Extreme fatigue/Still fatigue/Slight fatigue) and VOMITING (Threw up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) (oral) at a dose of 29 mg. On 08-Feb-2021, FEELING ABNORMAL (woke up feeling miserable), FEELING HOT (hot), HYPERHIDROSIS (sweaty), FEELING COLD (couldnt get warm), RETCHING (dry heaving), ABDOMINAL PAIN UPPER (stomach ache), ASTHENIA (felt really weak), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever between 102 to 103) had resolved. On 10-Feb-2021, ADVERSE REACTION (adverse reaction 12-14 hours after 2nd dose) and RASH (5 inch diameter rash) had resolved. At the time of the report, ERYTHEMA (erythema), PRURITUS (itching), TENDERNESS (tenderness), SWELLING (Did not lose swelling), FATIGUE (Extreme fatigue/Still fatigue/Slight fatigue) and VOMITING (Threw up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Pyrexia: 102-103 (High) 102 to 103 degree F.         No concomitant medications were reported.     Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received and does not contain any new information. On 21-Jun-2021: Significant follow-up. Events added and ADR form received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Retching, Swelling, Tenderness, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ADVERSE REACTION (adverse reaction 12-14 hours after 2nd dose), FEELING ABNORMAL (woke up feeling miserable), FEELING HOT (hot), HYPERHIDROSIS (sweaty) and FEELING COLD (couldnt get warm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037k20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concurrent medical conditions included Hay fever.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-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 ADVERSE REACTION (adverse reaction 12-14 hours after 2nd dose). 06-Feb-2021, the patient experienced FEELING ABNORMAL (woke up feeling miserable), FEELING HOT (hot), HYPERHIDROSIS (sweaty), FEELING COLD (couldnt get warm), RETCHING (dry heaving), ABDOMINAL PAIN UPPER (stomach ache), ASTHENIA (felt really weak), RASH (5 inch diameter rash), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever between 102 to 103). On an unknown date, the patient experienced ERYTHEMA (erythema), PRURITUS (itching), TENDERNESS (tenderness), SWELLING (Did not lose swelling), FATIGUE (Extreme fatigue/Still fatigue/Slight fatigue) and VOMITING (Threw up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) (oral) at a dose of 29 mg. On 08-Feb-2021, FEELING ABNORMAL (woke up feeling miserable), FEELING HOT (hot), HYPERHIDROSIS (sweaty), FEELING COLD (couldnt get warm), RETCHING (dry heaving), ABDOMINAL PAIN UPPER (stomach ache), ASTHENIA (felt really weak), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever between 102 to 103) had resolved. On 10-Feb-2021, ADVERSE REACTION (adverse reaction 12-14 hours after 2nd dose) and RASH (5 inch diameter rash) had resolved. At the time of the report, ERYTHEMA (erythema), PRURITUS (itching), TENDERNESS (tenderness), SWELLING (Did not lose swelling), FATIGUE (Extreme fatigue/Still fatigue/Slight fatigue) and VOMITING (Threw up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Pyrexia: 102-103 (High) 102 to 103 degree F.         No concomitant medications were reported.     Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received and does not contain any new information. On 21-Jun-2021: Significant follow-up. Events added and ADR form received.