chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site discolouration
Clinical narrative: Vaccination site discoloration; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Vaccination site discoloration) and PRURITUS (Itchiness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ATORVASTATIN CALCIUM and IRBESARTAN 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 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (Vaccination site discoloration) and PRURITUS (Itchiness). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE DISCOLOURATION (Vaccination site discoloration) and PRURITUS (Itchiness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient had itchiness and stated it was pink only 3 inches.
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: Fall on an already injured knee; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fall on an already injured knee) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee injury.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced FALL (Fall on an already injured knee). At the time of the report, FALL (Fall on an already injured knee) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: I feel dizzy; Fever of 101°F for 4 days; My arm is swollen at injection site; My arm is red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I feel dizzy), PYREXIA (Fever of 101°F for 4 days), VACCINATION SITE SWELLING (My arm is swollen at injection site) and VACCINATION SITE ERYTHEMA (My arm is red at injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced DIZZINESS (I feel dizzy), PYREXIA (Fever of 101°F for 4 days), VACCINATION SITE SWELLING (My arm is swollen at injection site) and VACCINATION SITE ERYTHEMA (My arm is red at injection site). On 16-Mar-2021, PYREXIA (Fever of 101°F for 4 days) had resolved. At the time of the report, DIZZINESS (I feel dizzy), VACCINATION SITE SWELLING (My arm is swollen at injection site) and VACCINATION SITE ERYTHEMA (My arm is red at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 101°f (Inconclusive) 101°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details included paracetamol and ice.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Vaccination site warmth
Clinical narrative: swelling quadrupole in size; arm SORENESS; arm started to swell, warm and red.; arm redness; warm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm SORENESS), PERIPHERAL SWELLING (arm started to swell, warm and red.), ERYTHEMA (arm redness), VACCINATION SITE WARMTH (warm) and PERIPHERAL SWELLING (swelling quadrupole in size) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder (Autoimmune Disease - Undifferentiated Connective Tissue Disease.), Constipation, Heartburn and Allergy (indoor and outdoor allergies). Concomitant products included LINACLOTIDE (LINZESS) for Constipation, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Heartburn, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S) for Joint pain, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Multiple allergies, VITAMIN D NOS and MULTIVITAMIN [VITAMINS NOS] for Supplementation therapy.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm SORENESS), PERIPHERAL SWELLING (arm started to swell, warm and red.), ERYTHEMA (arm redness) and VACCINATION SITE WARMTH (warm). On 14-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling quadrupole in size). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (arm SORENESS), PERIPHERAL SWELLING (arm started to swell, warm and red.), ERYTHEMA (arm redness), VACCINATION SITE WARMTH (warm) and PERIPHERAL SWELLING (swelling quadrupole in size) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was reported
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral, Pain in extremity
Clinical narrative: Metallic taste in the mouth; Tongue went numb; Sore arm; This spontaneous case was reported by a patient and describes the occurrence of DYSGEUSIA (Metallic taste in the mouth), HYPOAESTHESIA ORAL (Tongue went numb) and PAIN IN EXTREMITY (Sore arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040-21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced DYSGEUSIA (Metallic taste in the mouth), HYPOAESTHESIA ORAL (Tongue went numb) and PAIN IN EXTREMITY (Sore arm). At the time of the report, DYSGEUSIA (Metallic taste in the mouth) outcome was unknown and HYPOAESTHESIA ORAL (Tongue went numb) and PAIN IN EXTREMITY (Sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Patient provided email address and wanted to have details of her second shot when she received it, for documentation purposes. On 22-May-2021: The patient stated that she had not experienced nausea
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Belly pain; Restless arm syndrome; Fatigue; Fever /Chills; Diarrhea, 5-6 times per day; Little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea, 5-6 times per day), PAIN IN EXTREMITY (Little sore arm), ABDOMINAL PAIN (Belly pain), RESTLESS ARM SYNDROME (Restless arm syndrome) and PYREXIA (Fever /Chills) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included High cholesterol (High cholesterol) in 2000. Concomitant products included TAMSULOSIN for Benign prostatic hyperplasia, PRAVASTATIN, MORNIFLUMATE (FLOMAX [MORNIFLUMATE]), TRAMADOL, VITAMIN C [ASCORBIC ACID], VITAMINS NOS (MULTIPLE VITAMIN) and GLUCOSAMINE HCL for an unknown indication.    On 04-Feb-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DIARRHOEA (Diarrhea, 5-6 times per day), PAIN IN EXTREMITY (Little sore arm) and PYREXIA (Fever /Chills). On an unknown date, the patient experienced ABDOMINAL PAIN (Belly pain), RESTLESS ARM SYNDROME (Restless arm syndrome) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) ongoing from 14-Mar-2021 for Diarrhea, at an unspecified dose and frequency. On 07-Feb-2021, PYREXIA (Fever /Chills) had resolved. On 12-Feb-2021, PAIN IN EXTREMITY (Little sore arm) had resolved. On 15-May-2021, DIARRHOEA (Diarrhea, 5-6 times per day) had resolved with sequelae. At the time of the report, ABDOMINAL PAIN (Belly pain) outcome was unknown, RESTLESS ARM SYNDROME (Restless arm syndrome) had not resolved and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There were not changes in patient diet or everyday activities Patient had no history of COVID-19   This case was linked to MOD-2021-044568 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on07MAY2021, updated reporter details, patient demographics, past medical history, additional concomitant medications Vitamin C, Multiple vitamins, Tamsulosin and additional event Fever. On 14-Jul-2021: Significant follow-up received on 14-jul-2021, updated concomitant drug details and outcome of events
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Restless arm syndrome
Clinical narrative: Belly pain; Restless arm syndrome; Fatigue; Fever /Chills; Diarrhea, 5-6 times per day; Little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea, 5-6 times per day), PAIN IN EXTREMITY (Little sore arm), ABDOMINAL PAIN (Belly pain), RESTLESS ARM SYNDROME (Restless arm syndrome) and PYREXIA (Fever /Chills) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included High cholesterol (High cholesterol) in 2000. Concomitant products included TAMSULOSIN for Benign prostatic hyperplasia, PRAVASTATIN, MORNIFLUMATE (FLOMAX [MORNIFLUMATE]), TRAMADOL, VITAMIN C [ASCORBIC ACID], VITAMINS NOS (MULTIPLE VITAMIN) and GLUCOSAMINE HCL for an unknown indication.    On 04-Feb-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DIARRHOEA (Diarrhea, 5-6 times per day), PAIN IN EXTREMITY (Little sore arm) and PYREXIA (Fever /Chills). On an unknown date, the patient experienced ABDOMINAL PAIN (Belly pain), RESTLESS ARM SYNDROME (Restless arm syndrome) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) ongoing from 14-Mar-2021 for Diarrhea, at an unspecified dose and frequency. On 07-Feb-2021, PYREXIA (Fever /Chills) had resolved. On 12-Feb-2021, PAIN IN EXTREMITY (Little sore arm) had resolved. On 15-May-2021, DIARRHOEA (Diarrhea, 5-6 times per day) had resolved with sequelae. At the time of the report, ABDOMINAL PAIN (Belly pain) outcome was unknown, RESTLESS ARM SYNDROME (Restless arm syndrome) had not resolved and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There were not changes in patient diet or everyday activities Patient had no history of COVID-19   This case was linked to MOD-2021-044568 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on07MAY2021, updated reporter details, patient demographics, past medical history, additional concomitant medications Vitamin C, Multiple vitamins, Tamsulosin and additional event Fever. On 14-Jul-2021: Significant follow-up received on 14-jul-2021, updated concomitant drug details and outcome of events
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pyrexia, Vaccination site pain, Vaccination site rash
Clinical narrative: Joint pain; Low grade fever; Rash at injection site; Sore at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARTHRALGIA (Joint pain), PYREXIA (Low grade fever), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE PAIN (Sore at injection site) 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 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced ARTHRALGIA (Joint pain), PYREXIA (Low grade fever), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE PAIN (Sore at injection site). At the time of the report, ARTHRALGIA (Joint pain), PYREXIA (Low grade fever), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE PAIN (Sore at injection site) outcome was unknown. Not Provided          For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. No concomitant and treatment medications were reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Feeling abnormal, Pyrexia
Clinical narrative: Dizziness/ light headed; Brain fog; Temperature of 99; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness/ light headed), FEELING ABNORMAL (Brain fog) and PYREXIA (Temperature of 99) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026a21a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure fluctuation. Concomitant products included PANTOPRAZOLE and HYDROXYCHLOROQUINE 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 12-Feb-2021, the patient experienced DIZZINESS (Dizziness/ light headed), FEELING ABNORMAL (Brain fog) and PYREXIA (Temperature of 99). At the time of the report, DIZZINESS (Dizziness/ light headed), FEELING ABNORMAL (Brain fog) and PYREXIA (Temperature of 99) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Body temperature: 99 (Inconclusive) 99.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-046395 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) 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 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Cyst-like red rashes on the chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Cyst-like red rashes on the chest) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced RASH ERYTHEMATOUS (Cyst-like red rashes on the chest). At the time of the report, RASH ERYTHEMATOUS (Cyst-like red rashes on the chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    This case was linked to MOD-2021-058216, MOD-2021-058216 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling
Clinical narrative: Bumps and lumps are spread all over the body; Patient started with bumps and lumps that started itching; When she goes out in Sun, they get aggravated; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Patient started with bumps and lumps that started itching), PRURITUS (When she goes out in Sun, they get aggravated) and SWELLING (Bumps and lumps are spread all over the body) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa allergy). Concomitant products included CALCIUM and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 08-Mar-2021, the patient experienced PRURITUS (Patient started with bumps and lumps that started itching) and PRURITUS (When she goes out in Sun, they get aggravated). On 15-Mar-2021, the patient experienced SWELLING (Bumps and lumps are spread all over the body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Patient started with bumps and lumps that started itching), PRURITUS (When she goes out in Sun, they get aggravated) and SWELLING (Bumps and lumps are spread all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included acidophillus. Treatment medication also included steroid cream.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Rash
Clinical narrative: dull ache in the arm spread down the arm below the elbow to the inside; Very warm; Very hot; Rash continues to grow every day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Very hot), FEELING HOT (Very warm), PAIN IN EXTREMITY (dull ache in the arm spread down the arm below the elbow to the inside) and RASH (Rash continues to grow every day) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included METFORMIN, LISINOPRIL and FLUTICASONE for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced FEELING HOT (Very hot) and RASH (Rash continues to grow every day). On 27-Feb-2021, the patient experienced FEELING HOT (Very warm). On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (dull ache in the arm spread down the arm below the elbow to the inside). The patient was treated with LORATADINE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 27-Feb-2021, FEELING HOT (Very hot) had resolved. On 02-Mar-2021, FEELING HOT (Very warm) had resolved. On 14-Mar-2021, PAIN IN EXTREMITY (dull ache in the arm spread down the arm below the elbow to the inside) outcome was unknown. At the time of the report, RASH (Rash continues to grow every day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Feeling abnormal, Headache, Influenza like illness
Clinical narrative: Flu-like symptoms; Started feeling bad; Lower back pain; Achy all over; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), FEELING ABNORMAL (Started feeling bad), BACK PAIN (Lower back pain), MYALGIA (Achy all over) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis and Cardiac disorder NOS. Concomitant products included IBUPROFEN for Arthritis.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), FEELING ABNORMAL (Started feeling bad), BACK PAIN (Lower back pain), MYALGIA (Achy all over), HEADACHE (Headache) and CHILLS (Chills). On 11-Mar-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms), FEELING ABNORMAL (Started feeling bad), BACK PAIN (Lower back pain), MYALGIA (Achy all over), HEADACHE (Headache) and CHILLS (Chills) had resolved.            Reportedly, the symptoms started in the afternoon on the day of vaccination. The patient took ibuprofen which she was taking for arthritis.   This case was linked to MOD-2021-044492 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Flu-like symptoms; Started feeling bad; Lower back pain; Achy all over; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), FEELING ABNORMAL (Started feeling bad), BACK PAIN (Lower back pain), MYALGIA (Achy all over) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis and Cardiac disorder NOS. Concomitant products included IBUPROFEN for Arthritis.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), FEELING ABNORMAL (Started feeling bad), BACK PAIN (Lower back pain), MYALGIA (Achy all over), HEADACHE (Headache) and CHILLS (Chills). On 11-Mar-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms), FEELING ABNORMAL (Started feeling bad), BACK PAIN (Lower back pain), MYALGIA (Achy all over), HEADACHE (Headache) and CHILLS (Chills) had resolved.            Reportedly, the symptoms started in the afternoon on the day of vaccination. The patient took ibuprofen which she was taking for arthritis.   This case was linked to MOD-2021-044492 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Headache; Achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) and HEADACHE (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 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced PAIN (Achy). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, PAIN (Achy) and HEADACHE (Headache) outcome was unknown.            Concomitant and treatment information not provided. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot to Touch - Near Injection Site; Swelling - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to Touch - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot to Touch - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of UNK dosage form. On 26-Feb-2021, VACCINATION SITE WARMTH (Hot to Touch - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up received on 05 May 2021 included reporter information.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Cold sore on lip; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Cold sore on lip) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN, LISINOPRIL, CARVEDILOL, ALLOPURINOL, FINASTERIDE and LOVASTATIN for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced ORAL HERPES (Cold sore on lip). The patient was treated with BENZOCAINE, WHITE SOFT PARAFFIN (CARMEX COLD SORE) at an unspecified dose and frequency and BENZOCAINE, WHITE SOFT PARAFFIN (CARMEX COLD SORE) for Cold sores lip, at an unspecified dose and frequency. At the time of the report, ORAL HERPES (Cold sore on lip) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Peripheral swelling, Tremor, Vaccination site erythema
Clinical narrative: Swollen arm; red and raised rash about 3 inches around the injection; Extreme nausea; Shaky; Itchy; red and raised rash about 3 inches around the injection; Migraines; Swollen arm; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraines), TREMOR (Shaky), VACCINATION SITE PRURITUS (Itchy), the first episode of PERIPHERAL SWELLING (Swollen arm) and the second episode of PERIPHERAL SWELLING (Swollen arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hepatitis autoimmune since an unknown date. Concomitant products included OMEPRAZOLE, PROMETHAZINE and METHADONE 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 MIGRAINE (Migraines), the first episode of PERIPHERAL SWELLING (Swollen arm) and NAUSEA (Nausea). On 14-Mar-2021, the patient experienced TREMOR (Shaky), VACCINATION SITE PRURITUS (Itchy), the second episode of PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE RASH (red and raised rash about 3 inches around the injection), NAUSEA (Extreme nausea) and VACCINATION SITE ERYTHEMA (red and raised rash about 3 inches around the injection). The patient was treated with HYDROCORTISONE (topical) at a dose of 2 %. On 04-Mar-2021, MIGRAINE (Migraines) and NAUSEA (Nausea) had resolved. At the time of the report, TREMOR (Shaky), VACCINATION SITE PRURITUS (Itchy), the last episode of PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE RASH (red and raised rash about 3 inches around the injection), NAUSEA (Extreme nausea) and VACCINATION SITE ERYTHEMA (red and raised rash about 3 inches around the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Swollen arm; red and raised rash about 3 inches around the injection; Extreme nausea; Shaky; Itchy; red and raised rash about 3 inches around the injection; Migraines; Swollen arm; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraines), TREMOR (Shaky), VACCINATION SITE PRURITUS (Itchy), the first episode of PERIPHERAL SWELLING (Swollen arm) and the second episode of PERIPHERAL SWELLING (Swollen arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hepatitis autoimmune since an unknown date. Concomitant products included OMEPRAZOLE, PROMETHAZINE and METHADONE 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 MIGRAINE (Migraines), the first episode of PERIPHERAL SWELLING (Swollen arm) and NAUSEA (Nausea). On 14-Mar-2021, the patient experienced TREMOR (Shaky), VACCINATION SITE PRURITUS (Itchy), the second episode of PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE RASH (red and raised rash about 3 inches around the injection), NAUSEA (Extreme nausea) and VACCINATION SITE ERYTHEMA (red and raised rash about 3 inches around the injection). The patient was treated with HYDROCORTISONE (topical) at a dose of 2 %. On 04-Mar-2021, MIGRAINE (Migraines) and NAUSEA (Nausea) had resolved. At the time of the report, TREMOR (Shaky), VACCINATION SITE PRURITUS (Itchy), the last episode of PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE RASH (red and raised rash about 3 inches around the injection), NAUSEA (Extreme nausea) and VACCINATION SITE ERYTHEMA (red and raised rash about 3 inches around the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received his 2nd dose 44-46 days after his 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received his 2nd dose 44-46 days after his 1st dose) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LAMOTRIGINE and ESCITALOPRAM OXALATE for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received his 2nd dose 44-46 days after his 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received his 2nd dose 44-46 days after his 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided. Concomitant medications were not provided.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years old/less than 18 y/o got the 1st dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old/less than 18 y/o got the 1st dose of vaccine) in a 17-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).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old/less than 18 y/o got the 1st dose of vaccine). On 10-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old/less than 18 y/o got the 1st dose of vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Half dollar red circle that is slightly raised; Itches a little bit at injection site; Slightly raised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Half dollar red circle that is slightly raised), VACCINATION SITE PRURITUS (Itches a little bit at injection site) and VACCINATION SITE SWELLING (Slightly raised) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-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 VACCINATION SITE ERYTHEMA (Half dollar red circle that is slightly raised), VACCINATION SITE PRURITUS (Itches a little bit at injection site) and VACCINATION SITE SWELLING (Slightly raised). At the time of the report, VACCINATION SITE ERYTHEMA (Half dollar red circle that is slightly raised) was resolving and VACCINATION SITE PRURITUS (Itches a little bit at injection site) and VACCINATION SITE SWELLING (Slightly raised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Pyrexia, Swelling
Clinical narrative: Feels warm; Swelling pink; Temperature 100.6F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feels warm), SWELLING (Swelling pink) and PYREXIA (Temperature 100.6F) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031L20A) for COVID-19 vaccination.     Concomitant products included IRBESARTAN and ATORVASTATIN CALCIUM 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 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Feels warm), SWELLING (Swelling pink) and PYREXIA (Temperature 100.6F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING HOT (Feels warm), SWELLING (Swelling pink) and PYREXIA (Temperature 100.6F) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.6 (High) 100.6F.         No concomitant medications were reported.   Action taken with mRNA-1273 in response to the events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I had this reaction 15 hours after I received my vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I had this reaction 15 hours after I received my vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (I had this reaction 15 hours after I received my vaccine). At the time of the report, VACCINATION COMPLICATION (I had this reaction 15 hours after I received my vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  The patient believed the reason the patient had the reaction 15 hours after receiving the vaccine. The patient did not believed it was a reaction from the vaccine. The patient though it was because the patient already had COVID 19 and didn't know it. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: Weakness in legs and arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness in legs and arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCULAR WEAKNESS (Weakness in legs and arm). At the time of the report, MUSCULAR WEAKNESS (Weakness in legs and arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications were provided    This case was linked to MOD-2021-044585 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: 42 days after her 1st dose and did not have second dose yet; Loss her sense of smell; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Loss her sense of smell) and PRODUCT DOSE OMISSION ISSUE (42 days after her 1st dose and did not have second dose yet) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced ANOSMIA (Loss her sense of smell). On 17-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (42 days after her 1st dose and did not have second dose yet). On 17-May-2021, PRODUCT DOSE OMISSION ISSUE (42 days after her 1st dose and did not have second dose yet) had resolved. At the time of the report, ANOSMIA (Loss her sense of smell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: unknown (Inconclusive) Unknown. She tested for Corona disease 10 days ago but had not heard back her result..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.  The patient reported that she had to cancel her schedule to receive her second dose as her husband tested positive for Corona virus disease.    Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Now new information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Oropharyngeal pain
Clinical narrative: Pretty severe sore throat; Hard to sleep; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Pretty severe sore throat), INSOMNIA (Hard to sleep), CHILLS (Chills) and HEADACHE (Headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced CHILLS (Chills) and HEADACHE (Headache). On 14-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Pretty severe sore throat) and INSOMNIA (Hard to sleep). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Pretty severe sore throat), INSOMNIA (Hard to sleep), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            No relevant concomitant medications were provided.  The patient received lozenges as treatment.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness
Clinical narrative: Flu like symptoms; Really tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Really tired) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Really tired). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Really tired) had resolved.            Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information received on 21-May-2021 contains updated event outcome.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Dizziness, Hyperglycaemia
Clinical narrative: Little dizzy; Sugar level is high, around 200mg%; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Little dizzy) and HYPERGLYCAEMIA (Sugar level is high, around 200mg%) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Pre-diabetic. Concomitant products included METOPROLOL and PREGABALIN for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Little dizzy) and HYPERGLYCAEMIA (Sugar level is high, around 200mg%). At the time of the report, DIZZINESS (Little dizzy) and HYPERGLYCAEMIA (Sugar level is high, around 200mg%) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 200 (High) sugar level high ( around 200mg%).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Blood pressure medication is the other concomitant medication reported by reporter. No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: headache on temple area; feel like throw up; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache on temple area) and NAUSEA (feel like throw up) 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 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced HEADACHE (headache on temple area) and NAUSEA (feel like throw up). On 15-Mar-2021, HEADACHE (headache on temple area) and NAUSEA (feel like throw up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Headache was reported to be in one side of the head in temple area. No concomitant and treatment medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Illness, Incoherent
Clinical narrative: Dizzy; Incoherrent; Sick; Disoriented; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), INCOHERENT (Incoherrent), ILLNESS (Sick) and DISORIENTATION (Disoriented) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-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 DIZZINESS (Dizzy), INCOHERENT (Incoherrent), ILLNESS (Sick) and DISORIENTATION (Disoriented). On 04-Mar-2021, DIZZINESS (Dizzy), INCOHERENT (Incoherrent), ILLNESS (Sick) and DISORIENTATION (Disoriented) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  Reportedly, all the symptoms lasted for about two hours and the patient seemed fine at time of reporting.   No treatment information was provided.   Reporter did not allow further contact