chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia, Swelling
Clinical narrative: chills; low grade fever; Reports a painful lump in armpit area; she had felt pain in the armpit area but the pain worsened after receiving vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Reports a painful lump in armpit area), CHILLS (chills), PAIN IN EXTREMITY (she had felt pain in the armpit area but the pain worsened after receiving vaccine.) and PYREXIA (low grade fever) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 06-May-2021, the patient experienced SWELLING (Reports a painful lump in armpit area) and PAIN IN EXTREMITY (she had felt pain in the armpit area but the pain worsened after receiving vaccine.). On 07-May-2021, the patient experienced CHILLS (chills) and PYREXIA (low grade fever). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Paracetamol, at an unspecified dose and frequency. At the time of the report, SWELLING (Reports a painful lump in armpit area), CHILLS (chills), PAIN IN EXTREMITY (she had felt pain in the armpit area but the pain worsened after receiving vaccine.) and PYREXIA (low grade fever) 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.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Illness, Vaccination site rash
Clinical narrative: got really sick/as sick as she's ever been; dizzy; immediately had a rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick/as sick as she's ever been), DIZZINESS (dizzy) and VACCINATION SITE RASH (immediately had a rash at the injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE RASH (immediately had a rash at the injection site). On an unknown date, the patient experienced ILLNESS (got really sick/as sick as she's ever been) and DIZZINESS (dizzy). At the time of the report, ILLNESS (got really sick/as sick as she's ever been), DIZZINESS (dizzy) and VACCINATION SITE RASH (immediately had a rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Enlarged uvula
Clinical narrative: uvula swelled up; This spontaneous case was reported by a consumer and describes the occurrence of ENLARGED UVULA (uvula swelled up) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and PREDNISONE for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced ENLARGED UVULA (uvula swelled up). At the time of the report, ENLARGED UVULA (uvula swelled up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-114280 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of POLYMENORRHOEA (Menstrual period started a week early) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A or 037B2HA) for COVID-19 vaccination. No Medical History information was reported. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POLYMENORRHOEA (Menstrual period started a week early). At the time of the report, POLYMENORRHOEA (Menstrual period started a week early) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.This case was linked to MOD-2021-114277 (Patient Link).
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication was provided. Patient stated that she has been icing the injection site but wanted to know if it can use Aspercreme or muscle rub.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Event outcome updated to resolved.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Swelling, Urticaria
Clinical narrative: there were hives; there was biggest lump in my arm; it was itchy; arm hurt badly; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (there were hives), SWELLING (there was biggest lump in my arm), PRURITUS (it was itchy) and MYALGIA (arm hurt badly) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (there were hives), SWELLING (there was biggest lump in my arm), PRURITUS (it was itchy) and MYALGIA (arm hurt badly). At the time of the report, URTICARIA (there were hives), SWELLING (there was biggest lump in my arm) and PRURITUS (it was itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No concomitant and treatment details were provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Fatigue, Pain in extremity
Clinical narrative: fatigue; huge bruise; sore, tender arm; severe chills; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (huge bruise), PAIN IN EXTREMITY (sore, tender arm), CHILLS (severe chills) and FATIGUE (fatigue) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included NAPROXEN SODIUM (ALEVE) and PARACETAMOL (TYLENOL) for Rheumatoid arthritis.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore, tender arm) and CHILLS (severe chills). On 25-Mar-2021, the patient experienced CONTUSION (huge bruise). On an unknown date, the patient experienced FATIGUE (fatigue). On 25-Mar-2021, PAIN IN EXTREMITY (sore, tender arm) had resolved. On 26-Mar-2021, CHILLS (severe chills) had resolved. At the time of the report, CONTUSION (huge bruise) had not resolved and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information, if any, was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Additional information added include a new event.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itches all across arm - itching), INSOMNIA (up all night), HEADACHE (Headache), FATIGUE (Fatigue) and ARTHRALGIA (joint pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included INSULIN GLARGINE (TOUJEO), INSULIN ASPART (NOVOLOG), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), HYDROXYZINE, CARVEDILOL and METFORMIN for an unknown indication. On 28-Apr-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 28-Apr-2021, the patient experienced PRURITUS (itches all across arm - itching), INSOMNIA (up all night), HEADACHE (Headache), FATIGUE (Fatigue), ARTHRALGIA (joint pain), INJECTION SITE PAIN (Vaccination site pain,Vaccination site ache), MYALGIA (muscle aches), PYREXIA (Fever), INJECTION SITE SWELLING (swelling at injection site) and NAUSEA (Nausea). On an unknown date, the patient experienced CHILLS (chills). On 29-Apr-2021, INSOMNIA (up all night), HEADACHE (Headache), FATIGUE (Fatigue), ARTHRALGIA (joint pain), INJECTION SITE PAIN (Vaccination site pain,Vaccination site ache), MYALGIA (muscle aches) and PYREXIA (Fever) outcome was unknown. At the time of the report, PRURITUS (itches all across arm - itching), INJECTION SITE SWELLING (swelling at injection site) and NAUSEA (Nausea) outcome was unknown and CHILLS (chills) had resolved.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Insomnia, Myalgia, Nausea, Pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itches all across arm - itching), INSOMNIA (up all night), HEADACHE (Headache), FATIGUE (Fatigue) and ARTHRALGIA (joint pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included INSULIN GLARGINE (TOUJEO), INSULIN ASPART (NOVOLOG), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), HYDROXYZINE, CARVEDILOL and METFORMIN for an unknown indication. On 28-Apr-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 28-Apr-2021, the patient experienced PRURITUS (itches all across arm - itching), INSOMNIA (up all night), HEADACHE (Headache), FATIGUE (Fatigue), ARTHRALGIA (joint pain), INJECTION SITE PAIN (Vaccination site pain,Vaccination site ache), MYALGIA (muscle aches), PYREXIA (Fever), INJECTION SITE SWELLING (swelling at injection site) and NAUSEA (Nausea). On an unknown date, the patient experienced CHILLS (chills). On 29-Apr-2021, INSOMNIA (up all night), HEADACHE (Headache), FATIGUE (Fatigue), ARTHRALGIA (joint pain), INJECTION SITE PAIN (Vaccination site pain,Vaccination site ache), MYALGIA (muscle aches) and PYREXIA (Fever) outcome was unknown. At the time of the report, PRURITUS (itches all across arm - itching), INJECTION SITE SWELLING (swelling at injection site) and NAUSEA (Nausea) outcome was unknown and CHILLS (chills) had resolved.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itches all across arm - itching), INSOMNIA (up all night), HEADACHE (Headache), FATIGUE (Fatigue) and ARTHRALGIA (joint pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included INSULIN GLARGINE (TOUJEO), INSULIN ASPART (NOVOLOG), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), HYDROXYZINE, CARVEDILOL and METFORMIN for an unknown indication. On 28-Apr-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 28-Apr-2021, the patient experienced PRURITUS (itches all across arm - itching), INSOMNIA (up all night), HEADACHE (Headache), FATIGUE (Fatigue), ARTHRALGIA (joint pain), INJECTION SITE PAIN (Vaccination site pain,Vaccination site ache), MYALGIA (muscle aches), PYREXIA (Fever), INJECTION SITE SWELLING (swelling at injection site) and NAUSEA (Nausea). On an unknown date, the patient experienced CHILLS (chills). On 29-Apr-2021, INSOMNIA (up all night), HEADACHE (Headache), FATIGUE (Fatigue), ARTHRALGIA (joint pain), INJECTION SITE PAIN (Vaccination site pain,Vaccination site ache), MYALGIA (muscle aches) and PYREXIA (Fever) outcome was unknown. At the time of the report, PRURITUS (itches all across arm - itching), INJECTION SITE SWELLING (swelling at injection site) and NAUSEA (Nausea) outcome was unknown and CHILLS (chills) had resolved.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low-grade fever) and MYALGIA (muscle aches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. Concurrent medical conditions included Allergy and Heart block. Concomitant products included ATENOLOL, AMLODIPINE and ENALAPRIL for Hypertension, CLOPIDOGREL and ACETYLSALICYLIC ACID (BAYER ASPIRIN) for an unknown indication. On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PYREXIA (Low-grade fever) and MYALGIA (muscle aches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PYREXIA (Low-grade fever) and MYALGIA (muscle aches) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: making sleepy / went to sleep between 1400 and 1800; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (making sleepy / went to sleep between 1400 and 1800) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced SOMNOLENCE (making sleepy / went to sleep between 1400 and 1800). On 06-May-2021, SOMNOLENCE (making sleepy / went to sleep between 1400 and 1800) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Nausea
Clinical narrative: Flu like symptoms; nausea; nuchal headache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), NAUSEA (nausea), HEADACHE (nuchal headache) and FATIGUE (Tiredness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), NAUSEA (nausea), HEADACHE (nuchal headache) and FATIGUE (Tiredness). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), NAUSEA (nausea), HEADACHE (nuchal headache) and FATIGUE (Tiredness) outcome was unknown.            The concomitant medications information was not reported. Treatment information was not provided.    This case was linked to MOD-2021-051274 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow up was received. No new information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Possible administration of vaccines that are past 'use by date'.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Possible administration of vaccines that are past 'use by date'.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Possible administration of vaccines that are past 'use by date'.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Possible administration of vaccines that are past 'use by date'.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: fever of 102; tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 102) and FATIGUE (tired) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and PREDNISONE for an unknown indication.    On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced PYREXIA (fever of 102) and FATIGUE (tired). On 24-Apr-2021, PYREXIA (fever of 102) had resolved. On 25-Apr-2021, FATIGUE (tired) had resolved. Not Provided          No treatment medications were reported.   This case was linked to MOD-2021-114264 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Myalgia, Peripheral swelling
Clinical narrative: arm became swollen immediately; shortness of breath/Runs out of breath right away; chest pain; Pain on left side of the body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (arm became swollen immediately), DYSPNEA (shortness of breath/Runs out of breath right away), CHEST PAIN (chest pain) and MYALGIA (Pain on left side of the body) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LINACLOTIDE (LINZESS) for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm became swollen immediately), DYSPNEA (shortness of breath/Runs out of breath right away), CHEST PAIN (chest pain) and MYALGIA (Pain on left side of the body). On 07-May-2021, PERIPHERAL SWELLING (arm became swollen immediately) had resolved. At the time of the report, DYSPNEA (shortness of breath/Runs out of breath right away), CHEST PAIN (chest pain) and MYALGIA (Pain on left side of the body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient took Tylenol and an Inhaler(name not provided) as advised by her doctor, to relieve the symptoms.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: left leg pain; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (left leg pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (left leg pain). At the time of the report, PAIN IN EXTREMITY (left leg pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Rash erythematous
Clinical narrative: Red rashes have expended all over the body/It's getting worse; Red rashes on both hands; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rashes on both hands) and CONDITION AGGRAVATED (Red rashes have expended all over the body/It's getting worse) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rashes on both hands). On 07-May-2021, the patient experienced CONDITION AGGRAVATED (Red rashes have expended all over the body/It's getting worse). At the time of the report, RASH ERYTHEMATOUS (Red rashes on both hands) and CONDITION AGGRAVATED (Red rashes have expended all over the body/It's getting worse) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. Treatment medications included antihistamine  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Fatigue, Feeling abnormal, Feeling cold, Head discomfort
Clinical narrative: always cold; no energy, just wants to sleep; does not feel like herself; sore arm; pressure in her head and shooting pain; pink circle at injection site; vertigo; She will loose her balance; pressure in her head and shooting pain; feeling exhausted all the time; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (always cold), SOMNOLENCE (no energy, just wants to sleep), FEELING ABNORMAL (does not feel like herself), PAIN IN EXTREMITY (sore arm) and HEAD DISCOMFORT (pressure in her head and shooting pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (always cold), SOMNOLENCE (no energy, just wants to sleep), FEELING ABNORMAL (does not feel like herself), PAIN IN EXTREMITY (sore arm), HEAD DISCOMFORT (pressure in her head and shooting pain), VACCINATION SITE DISCOLOURATION (pink circle at injection site), VERTIGO (vertigo), BALANCE DISORDER (She will loose her balance), HEADACHE (pressure in her head and shooting pain) and FATIGUE (feeling exhausted all the time). At the time of the report, FEELING COLD (always cold), SOMNOLENCE (no energy, just wants to sleep), FEELING ABNORMAL (does not feel like herself), PAIN IN EXTREMITY (sore arm), HEAD DISCOMFORT (pressure in her head and shooting pain), VACCINATION SITE DISCOLOURATION (pink circle at injection site), VERTIGO (vertigo), BALANCE DISORDER (She will loose her balance), HEADACHE (pressure in her head and shooting pain) and FATIGUE (feeling exhausted all the time) outcome was unknown. Not Provided          Concomitant medication was not provided. Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.    This case was linked to MOD-2021-051775 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Somnolence, Vaccination site discolouration, Vertigo
Clinical narrative: always cold; no energy, just wants to sleep; does not feel like herself; sore arm; pressure in her head and shooting pain; pink circle at injection site; vertigo; She will loose her balance; pressure in her head and shooting pain; feeling exhausted all the time; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (always cold), SOMNOLENCE (no energy, just wants to sleep), FEELING ABNORMAL (does not feel like herself), PAIN IN EXTREMITY (sore arm) and HEAD DISCOMFORT (pressure in her head and shooting pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (always cold), SOMNOLENCE (no energy, just wants to sleep), FEELING ABNORMAL (does not feel like herself), PAIN IN EXTREMITY (sore arm), HEAD DISCOMFORT (pressure in her head and shooting pain), VACCINATION SITE DISCOLOURATION (pink circle at injection site), VERTIGO (vertigo), BALANCE DISORDER (She will loose her balance), HEADACHE (pressure in her head and shooting pain) and FATIGUE (feeling exhausted all the time). At the time of the report, FEELING COLD (always cold), SOMNOLENCE (no energy, just wants to sleep), FEELING ABNORMAL (does not feel like herself), PAIN IN EXTREMITY (sore arm), HEAD DISCOMFORT (pressure in her head and shooting pain), VACCINATION SITE DISCOLOURATION (pink circle at injection site), VERTIGO (vertigo), BALANCE DISORDER (She will loose her balance), HEADACHE (pressure in her head and shooting pain) and FATIGUE (feeling exhausted all the time) outcome was unknown. Not Provided          Concomitant medication was not provided. Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.    This case was linked to MOD-2021-051775 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain, Product dose omission issue
Clinical narrative: she is past 42 day mark for 2nd dose; aching; sweating; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aching), HYPERHIDROSIS (sweating) and PRODUCT DOSE OMISSION ISSUE (she is past 42 day mark for 2nd dose) 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 23-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 PAIN (aching), HYPERHIDROSIS (sweating) and PRODUCT DOSE OMISSION ISSUE (she is past 42 day mark for 2nd dose). At the time of the report, PAIN (aching) and HYPERHIDROSIS (sweating) had not resolved and PRODUCT DOSE OMISSION ISSUE (she is past 42 day mark for 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  The patient reported that she missed the second dose of the vaccine that she was scheduled to receive on 20-Apr-2021 and requested guidance on whether she should receive the second dose or not.  The patient disconnected the call before Customer Care could transfer her over to Medical Information.  No treatment information was provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Patient declined consent for further follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Eye swelling, Facial pain, Lip swelling, Pyrexia
Clinical narrative: Swelling of the eyes (more prominent on the right side); Swelling of the lips (more prominent on the right side); "Face was hurting"; Fever 100°F; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Swelling of the eyes (more prominent on the right side)), LIP SWELLING (Swelling of the lips (more prominent on the right side)), FACIAL PAIN ("Face was hurting") and PYREXIA (Fever 100°F) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (in February), Dermal filler injection (Patient had fillers in eye at least 2 years ago) and Dermal filler injection (5 or 6 months ago).    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PYREXIA (Fever 100°F). On 08-May-2021, the patient experienced EYE SWELLING (Swelling of the eyes (more prominent on the right side)), LIP SWELLING (Swelling of the lips (more prominent on the right side)) and FACIAL PAIN ("Face was hurting"). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Swelling, at an unspecified dose and frequency. At the time of the report, EYE SWELLING (Swelling of the eyes (more prominent on the right side)), LIP SWELLING (Swelling of the lips (more prominent on the right side)), FACIAL PAIN ("Face was hurting") and PYREXIA (Fever 100°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, Body temperature: 100 (abnormal) Fever 100°F.     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.   No concomitant medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: covid positive after 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (covid positive after 1st shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), METOPROLOL, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (covid positive after 1st shot). At the time of the report, SARS-COV-2 TEST POSITIVE (covid positive after 1st shot) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, COVID-19: positive (Positive) covid positive.     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.   The treatment information was unknown. second dose was scheduled for second dose on 11May2021.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymphadenopathy, Pruritus
Clinical narrative: Red and warm/covid arm at the injection site; Slightly itchy; Inflamed lymph nodes on arm pit; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red and warm), PRURITUS (Slightly itchy) and LYMPHADENOPATHY (Inflamed lymph nodes on arm pit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 19B29A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-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 ERYTHEMA (Red and warm), PRURITUS (Slightly itchy) and LYMPHADENOPATHY (Inflamed lymph nodes on arm pit). At the time of the report, ERYTHEMA (Red and warm), PRURITUS (Slightly itchy) and LYMPHADENOPATHY (Inflamed lymph nodes on arm pit) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm) and fatigue (feeling tired) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. Concurrent medical conditions included type 2 diabetes mellitus and neuropathy. On May 6, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 7, 2021, patient experienced pain in extremity (sore arm) and fatigue (feeling tired). At the time of the report, pain in extremity (sore arm) and fatigue (feeling tired): resolving. Other concomitant medications included medication for type 2 diabetes and neuropathy. Treatment information not provided. Action taken with mRNA-1273 in response to the events not applicable. Reporter did not allow further contact.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dysuria, Flushing, Headache
Clinical narrative: strong urinary infection; weakness; pressure to urinate and not being able to go; flushing in arms and legs (not redness, an uncomfortable sensation); vicious headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (strong urinary infection), ASTHENIA (weakness), DYSURIA (pressure to urinate and not being able to go), FLUSHING (flushing in arms and legs (not redness, an uncomfortable sensation)) and HEADACHE (vicious headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.  Concomitant products included GABAPENTIN for Headache, TELMISARTAN and HYDROCHLOROTHIAZID for Hypertension, ALLOPURINOL and POTASSIUM for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced URINARY TRACT INFECTION (strong urinary infection), ASTHENIA (weakness), DYSURIA (pressure to urinate and not being able to go), FLUSHING (flushing in arms and legs (not redness, an uncomfortable sensation)), HEADACHE (vicious headache), PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and BUTALBITAL, PARACETAMOL (BUTALBITAL AND ACETAMINOPHEN) for Urinary tract infection, at an unspecified dose and frequency. On 05-Mar-2021, ASTHENIA (weakness), PYREXIA (fever) and CHILLS (chills) had resolved. On 14-Apr-2021, HEADACHE (vicious headache) had resolved. At the time of the report, URINARY TRACT INFECTION (strong urinary infection), DYSURIA (pressure to urinate and not being able to go) and FLUSHING (flushing in arms and legs (not redness, an uncomfortable sensation)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-114326 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urinary tract infection
Clinical narrative: strong urinary infection; weakness; pressure to urinate and not being able to go; flushing in arms and legs (not redness, an uncomfortable sensation); vicious headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (strong urinary infection), ASTHENIA (weakness), DYSURIA (pressure to urinate and not being able to go), FLUSHING (flushing in arms and legs (not redness, an uncomfortable sensation)) and HEADACHE (vicious headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.  Concomitant products included GABAPENTIN for Headache, TELMISARTAN and HYDROCHLOROTHIAZID for Hypertension, ALLOPURINOL and POTASSIUM for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced URINARY TRACT INFECTION (strong urinary infection), ASTHENIA (weakness), DYSURIA (pressure to urinate and not being able to go), FLUSHING (flushing in arms and legs (not redness, an uncomfortable sensation)), HEADACHE (vicious headache), PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and BUTALBITAL, PARACETAMOL (BUTALBITAL AND ACETAMINOPHEN) for Urinary tract infection, at an unspecified dose and frequency. On 05-Mar-2021, ASTHENIA (weakness), PYREXIA (fever) and CHILLS (chills) had resolved. On 14-Apr-2021, HEADACHE (vicious headache) had resolved. At the time of the report, URINARY TRACT INFECTION (strong urinary infection), DYSURIA (pressure to urinate and not being able to go) and FLUSHING (flushing in arms and legs (not redness, an uncomfortable sensation)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-114326 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: Patient had symptoms after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ADVERSE DRUG REACTION (Patient had symptoms after first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Patient had symptoms after first dose). At the time of the report, ADVERSE DRUG REACTION (Patient had symptoms after first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided.No concomitant medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diplopia, Myalgia, Pyrexia
Clinical narrative: double vision; body aches; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (double vision), MYALGIA (body aches) and PYREXIA (low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 025B21A) for COVID-19 vaccination.     Concomitant products included LAMOTRIGINE (LAMICTAL), OLANZAPINE (ZYPREXA), QUETIAPINE FUMARATE (SEROQUEL), METOPROLOL and MELATONIN for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced MYALGIA (body aches). 06-May-2021, the patient experienced PYREXIA (low grade fever). On 07-May-2021, the patient experienced DIPLOPIA (double vision). On 07-May-2021, DIPLOPIA (double vision), MYALGIA (body aches) and PYREXIA (low grade fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, Body temperature: low (Low) Low grade fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included Birth control pill for unknown indication. No treatment medications were provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, SARS-CoV-2 test: unknown (Positive) Unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain, Palpitations, Pyrexia
Clinical narrative: heart palpitation; dizziness; body aches; 101 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitation), DIZZINESS (dizziness), PAIN (body aches) and PYREXIA (101 degrees Fahrenheit) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced PALPITATIONS (heart palpitation), DIZZINESS (dizziness), PAIN (body aches) and PYREXIA (101 degrees Fahrenheit). At the time of the report, PALPITATIONS (heart palpitation), DIZZINESS (dizziness), PAIN (body aches) and PYREXIA (101 degrees Fahrenheit) outcome was unknown.            No concomitant medications were mentioned. Treatment medication reported includes Tylenol.  Denied to follow-up with Safety team   Reporter did not allow further contact
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: Got exposed to Covid infection after receiving the 1st dose of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Got exposed to Covid infection after receiving the 1st dose of Moderna vaccine) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (Got exposed to Covid infection after receiving the 1st dose of Moderna vaccine). At the time of the report, EXPOSURE TO SARS-COV-2 (Got exposed to Covid infection after receiving the 1st dose of Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment information provided.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache
Clinical narrative: headache;pain in the stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER pain in the stomach) and HEADACHE headache) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced ABDOMINAL PAIN UPPER pain in the stomach). On 07-May-2021, the patient experienced HEADACHE headache). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (MORTIN) at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER pain in the stomach) and HEADACHE  headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up information received on 07-JUN-2021, contains non-significant information.