chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Limb discomfort, Myalgia, Nausea
Clinical narrative: inability to move arm; lightheadedness; nausea; excruciating pain in arm; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (inability to move arm), DIZZINESS (lightheadedness), NAUSEA (nausea) and MYALGIA (excruciating pain in arm) in a 38-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 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced LIMB DISCOMFORT (inability to move arm), DIZZINESS (lightheadedness), NAUSEA (nausea) and MYALGIA (excruciating pain in arm). The patient was treated with IBUPROFEN at a dose of 800 mg twice a day. At the time of the report, LIMB DISCOMFORT (inability to move arm), DIZZINESS (lightheadedness), NAUSEA (nausea) and MYALGIA (excruciating pain in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Influenza like illness, Myalgia
Clinical narrative: back pain; Pain in neck; flu-like symptoms; pain moves from neck to her arm; Muscle ache; Fatigue; chills; pain on the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), NECK PAIN (Pain in neck), INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (pain moves from neck to her arm) and MYALGIA (Muscle ache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESTRADIOL, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE), PANTOPRAZOLE, HYOSCYAMINE, PROBIOTICS NOS, VITAMIN E NOS and BACLOFEN for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-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 BACK PAIN (back pain), NECK PAIN (Pain in neck), INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (pain moves from neck to her arm), MYALGIA (Muscle ache), FATIGUE (Fatigue), CHILLS (chills) and VACCINATION SITE PAIN (pain on the site of injection). At the time of the report, BACK PAIN (back pain), NECK PAIN (Pain in neck), INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (pain moves from neck to her arm), MYALGIA (Muscle ache), FATIGUE (Fatigue), CHILLS (chills) and VACCINATION SITE PAIN (pain on the site of injection) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drugs were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Vaccination site pain
Clinical narrative: back pain; Pain in neck; flu-like symptoms; pain moves from neck to her arm; Muscle ache; Fatigue; chills; pain on the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), NECK PAIN (Pain in neck), INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (pain moves from neck to her arm) and MYALGIA (Muscle ache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESTRADIOL, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE), PANTOPRAZOLE, HYOSCYAMINE, PROBIOTICS NOS, VITAMIN E NOS and BACLOFEN for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-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 BACK PAIN (back pain), NECK PAIN (Pain in neck), INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (pain moves from neck to her arm), MYALGIA (Muscle ache), FATIGUE (Fatigue), CHILLS (chills) and VACCINATION SITE PAIN (pain on the site of injection). At the time of the report, BACK PAIN (back pain), NECK PAIN (Pain in neck), INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (pain moves from neck to her arm), MYALGIA (Muscle ache), FATIGUE (Fatigue), CHILLS (chills) and VACCINATION SITE PAIN (pain on the site of injection) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drugs were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Limb discomfort, Peripheral swelling
Clinical narrative: Right deltoid swell up more than left deltoid/ It has migrated from the middle of his shoulder to the middle of his bicep; It was red; He has high pressure in his right arm/ Feels like someone is holding his right arm and cutting circulation; He has pain in his elbow joint where he can't bend it; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Right deltoid swell up more than left deltoid/ It has migrated from the middle of his shoulder to the middle of his bicep), ERYTHEMA (It was red), LIMB DISCOMFORT (He has high pressure in his right arm/ Feels like someone is holding his right arm and cutting circulation) and ARTHRALGIA (He has pain in his elbow joint where he can't bend it) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PERIPHERAL SWELLING (Right deltoid swell up more than left deltoid/ It has migrated from the middle of his shoulder to the middle of his bicep), ERYTHEMA (It was red), LIMB DISCOMFORT (He has high pressure in his right arm/ Feels like someone is holding his right arm and cutting circulation) and ARTHRALGIA (He has pain in his elbow joint where he can't bend it). The patient was treated with IBUPROFEN at a dose of 600 mg. At the time of the report, PERIPHERAL SWELLING (Right deltoid swell up more than left deltoid/ It has migrated from the middle of his shoulder to the middle of his bicep), ERYTHEMA (It was red), LIMB DISCOMFORT (He has high pressure in his right arm/ Feels like someone is holding his right arm and cutting circulation) and ARTHRALGIA (He has pain in his elbow joint where he can't bend it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Peripheral swelling, Rash erythematous, Somnolence, Vaccination site mass
Clinical narrative: warm arm at the injection site; very sleepy, could not stay awake; Very lethargic; Lump over area of vaccine; swollen arm; Red rash over the area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm arm at the injection site), SOMNOLENCE (very sleepy, could not stay awake), LETHARGY (Very lethargic), VACCINATION SITE MASS (Lump over area of vaccine) and PERIPHERAL SWELLING (swollen arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE WARMTH (warm arm at the injection site), SOMNOLENCE (very sleepy, could not stay awake), LETHARGY (Very lethargic), VACCINATION SITE MASS (Lump over area of vaccine), PERIPHERAL SWELLING (swollen arm) and RASH ERYTHEMATOUS (Red rash over the area). At the time of the report, VACCINATION SITE WARMTH (warm arm at the injection site), SOMNOLENCE (very sleepy, could not stay awake), LETHARGY (Very lethargic), VACCINATION SITE MASS (Lump over area of vaccine), PERIPHERAL SWELLING (swollen arm) and RASH ERYTHEMATOUS (Red rash over the area) outcome was unknown.            Concomitant medication were not provided by the reporter.  Treatment medication were not provided by the reporter.  Action taken with mRNA-1273 in response to the events was Not Applicable
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: warm arm at the injection site; very sleepy, could not stay awake; Very lethargic; Lump over area of vaccine; swollen arm; Red rash over the area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm arm at the injection site), SOMNOLENCE (very sleepy, could not stay awake), LETHARGY (Very lethargic), VACCINATION SITE MASS (Lump over area of vaccine) and PERIPHERAL SWELLING (swollen arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE WARMTH (warm arm at the injection site), SOMNOLENCE (very sleepy, could not stay awake), LETHARGY (Very lethargic), VACCINATION SITE MASS (Lump over area of vaccine), PERIPHERAL SWELLING (swollen arm) and RASH ERYTHEMATOUS (Red rash over the area). At the time of the report, VACCINATION SITE WARMTH (warm arm at the injection site), SOMNOLENCE (very sleepy, could not stay awake), LETHARGY (Very lethargic), VACCINATION SITE MASS (Lump over area of vaccine), PERIPHERAL SWELLING (swollen arm) and RASH ERYTHEMATOUS (Red rash over the area) outcome was unknown.            Concomitant medication were not provided by the reporter.  Treatment medication were not provided by the reporter.  Action taken with mRNA-1273 in response to the events was Not Applicable
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: vitamin B deficiency; feeling horrible; weak; tired; excruciating pain in left arm, it is sore /painful/ body ache; fever; severe chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of VITAMIN B COMPLEX DEFICIENCY (vitamin B deficiency), FEELING ABNORMAL (feeling horrible), ASTHENIA (weak), MYALGIA (excruciating pain in left arm, it is sore /painful/ body ache) and PYREXIA (fever) in a 49-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 VITAMIN D NOS for Supplementation therapy, VITAMIN B COMPLEX and VITAMIN B12 NOS for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced MYALGIA (excruciating pain in left arm, it is sore /painful/ body ache), PYREXIA (fever), CHILLS (severe chills) and HEADACHE (headache). On an unknown date, the patient experienced VITAMIN B COMPLEX DEFICIENCY (vitamin B deficiency), FEELING ABNORMAL (feeling horrible), ASTHENIA (weak) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) for Cold, at an unspecified dose and frequency. At the time of the report, VITAMIN B COMPLEX DEFICIENCY (vitamin B deficiency), FEELING ABNORMAL (feeling horrible), ASTHENIA (weak), MYALGIA (excruciating pain in left arm, it is sore /painful/ body ache), PYREXIA (fever), CHILLS (severe chills), HEADACHE (headache) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Pyrexia: 103 (Inconclusive) Fever up to 103°F and 101.3 (Inconclusive) fever went down to 101.3°F. On an unknown date, Pyrexia: 102 (Inconclusive) fever went down to 102°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.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vitamin B complex deficiency
Clinical narrative: vitamin B deficiency; feeling horrible; weak; tired; excruciating pain in left arm, it is sore /painful/ body ache; fever; severe chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of VITAMIN B COMPLEX DEFICIENCY (vitamin B deficiency), FEELING ABNORMAL (feeling horrible), ASTHENIA (weak), MYALGIA (excruciating pain in left arm, it is sore /painful/ body ache) and PYREXIA (fever) in a 49-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 VITAMIN D NOS for Supplementation therapy, VITAMIN B COMPLEX and VITAMIN B12 NOS for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced MYALGIA (excruciating pain in left arm, it is sore /painful/ body ache), PYREXIA (fever), CHILLS (severe chills) and HEADACHE (headache). On an unknown date, the patient experienced VITAMIN B COMPLEX DEFICIENCY (vitamin B deficiency), FEELING ABNORMAL (feeling horrible), ASTHENIA (weak) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) for Cold, at an unspecified dose and frequency. At the time of the report, VITAMIN B COMPLEX DEFICIENCY (vitamin B deficiency), FEELING ABNORMAL (feeling horrible), ASTHENIA (weak), MYALGIA (excruciating pain in left arm, it is sore /painful/ body ache), PYREXIA (fever), CHILLS (severe chills), HEADACHE (headache) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Pyrexia: 103 (Inconclusive) Fever up to 103°F and 101.3 (Inconclusive) fever went down to 101.3°F. On an unknown date, Pyrexia: 102 (Inconclusive) fever went down to 102°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.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash macular, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Red blotches; warm to the touch; was swollen; the injection site was itching a lot; headache; injection site had a rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red blotches), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE SWELLING (was swollen), VACCINATION SITE PRURITUS (the injection site was itching a lot) and HEADACHE (headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL for an unknown indication.    On 08-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced RASH MACULAR (Red blotches), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE SWELLING (was swollen), VACCINATION SITE PRURITUS (the injection site was itching a lot), HEADACHE (headache) and VACCINATION SITE RASH (injection site had a rash). The patient was treated with IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (ADVIL COLD) at an unspecified dose and frequency and CHLORPHENAMINE MALEATE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (SINUS [CHLORPHENAMINE MALEATE;PARACETAMOL;PSEUDOEPHEDRINE HYDROCHLORIDE]) for Headache, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (Red blotches), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE SWELLING (was swollen), VACCINATION SITE PRURITUS (the injection site was itching a lot), HEADACHE (headache) and VACCINATION SITE RASH (injection site had a rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Red blotches; warm to the touch; was swollen; the injection site was itching a lot; headache; injection site had a rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red blotches), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE SWELLING (was swollen), VACCINATION SITE PRURITUS (the injection site was itching a lot) and HEADACHE (headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL for an unknown indication.    On 08-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced RASH MACULAR (Red blotches), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE SWELLING (was swollen), VACCINATION SITE PRURITUS (the injection site was itching a lot), HEADACHE (headache) and VACCINATION SITE RASH (injection site had a rash). The patient was treated with IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (ADVIL COLD) at an unspecified dose and frequency and CHLORPHENAMINE MALEATE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (SINUS [CHLORPHENAMINE MALEATE;PARACETAMOL;PSEUDOEPHEDRINE HYDROCHLORIDE]) for Headache, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (Red blotches), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE SWELLING (was swollen), VACCINATION SITE PRURITUS (the injection site was itching a lot), HEADACHE (headache) and VACCINATION SITE RASH (injection site had a rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria, Vaccination site rash
Clinical narrative: small hives that are like mosquito bites; Rash; second dose, she developed a rash on site of injection and on her forearm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (small hives that are like mosquito bites), RASH (Rash) and VACCINATION SITE RASH (second dose, she developed a rash on site of injection and on her forearm) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (small hives that are like mosquito bites), RASH (Rash) and VACCINATION SITE RASH (second dose, she developed a rash on site of injection and on her forearm). At the time of the report, URTICARIA (small hives that are like mosquito bites), RASH (Rash) and VACCINATION SITE RASH (second dose, she developed a rash on site of injection and on her forearm) outcome was unknown.            No treatment medications provided  No concomitant medications provided
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: symptoms of UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (symptoms of UTI) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) and SIMVASTATIN for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced URINARY TRACT INFECTION (symptoms of UTI). The patient was treated with CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]) at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (symptoms of UTI) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other treatment for UTII include Cranberry juice, apple cider vinegar and stopped drinking coffee. Patient received second dose of MODERNA COVID-19 vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow up received on 17-Apr-2021 contains significant information including event  outcome updated from unknown to recovered and 2nd dose information.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Feeling cold, Headache, Hot flush
Clinical narrative: pain in arm; hot flashes; swelling on the arm; coughing; cold; chills; headache; This spontaneous case was reported by an other caregiver and describes the occurrence of PAIN IN EXTREMITY (pain in arm), HOT FLUSH (hot flashes), PERIPHERAL SWELLING (swelling on the arm), COUGH (coughing) and FEELING COLD (cold) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced COUGH (coughing), FEELING COLD (cold), CHILLS (chills) and HEADACHE (headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm), HOT FLUSH (hot flashes) and PERIPHERAL SWELLING (swelling on the arm). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in arm), HOT FLUSH (hot flashes), PERIPHERAL SWELLING (swelling on the arm), COUGH (coughing), FEELING COLD (cold), CHILLS (chills) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: pain in arm; hot flashes; swelling on the arm; coughing; cold; chills; headache; This spontaneous case was reported by an other caregiver and describes the occurrence of PAIN IN EXTREMITY (pain in arm), HOT FLUSH (hot flashes), PERIPHERAL SWELLING (swelling on the arm), COUGH (coughing) and FEELING COLD (cold) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced COUGH (coughing), FEELING COLD (cold), CHILLS (chills) and HEADACHE (headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm), HOT FLUSH (hot flashes) and PERIPHERAL SWELLING (swelling on the arm). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in arm), HOT FLUSH (hot flashes), PERIPHERAL SWELLING (swelling on the arm), COUGH (coughing), FEELING COLD (cold), CHILLS (chills) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site movement impairment
Clinical narrative: Unable to lift her left arm; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to lift her left arm) and FATIGUE (Extreme fatigue) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to lift her left arm) and FATIGUE (Extreme fatigue). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to lift her left arm) and FATIGUE (Extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Headache, Myalgia, Vaccination site pain
Clinical narrative: she is in bed and having difficulty getting up; Headache; pain and swelling in injection site; swelling in injection site; chills; severe muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (she is in bed and having difficulty getting up), HEADACHE (Headache), VACCINATION SITE PAIN (pain and swelling in injection site), VACCINATION SITE SWELLING (swelling in injection site) and CHILLS (chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced HEADACHE (Headache), VACCINATION SITE PAIN (pain and swelling in injection site), VACCINATION SITE SWELLING (swelling in injection site), CHILLS (chills) and MYALGIA (severe muscle ache). On 17-Apr-2021, the patient experienced BEDRIDDEN (she is in bed and having difficulty getting up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BEDRIDDEN (she is in bed and having difficulty getting up), HEADACHE (Headache), VACCINATION SITE PAIN (pain and swelling in injection site), VACCINATION SITE SWELLING (swelling in injection site), CHILLS (chills) and MYALGIA (severe muscle ache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: she is in bed and having difficulty getting up; Headache; pain and swelling in injection site; swelling in injection site; chills; severe muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (she is in bed and having difficulty getting up), HEADACHE (Headache), VACCINATION SITE PAIN (pain and swelling in injection site), VACCINATION SITE SWELLING (swelling in injection site) and CHILLS (chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced HEADACHE (Headache), VACCINATION SITE PAIN (pain and swelling in injection site), VACCINATION SITE SWELLING (swelling in injection site), CHILLS (chills) and MYALGIA (severe muscle ache). On 17-Apr-2021, the patient experienced BEDRIDDEN (she is in bed and having difficulty getting up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BEDRIDDEN (she is in bed and having difficulty getting up), HEADACHE (Headache), VACCINATION SITE PAIN (pain and swelling in injection site), VACCINATION SITE SWELLING (swelling in injection site), CHILLS (chills) and MYALGIA (severe muscle ache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided.
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Headache, Myalgia, Urticaria, Vaccination site dysaesthesia
Clinical narrative: yesterday he felt terrible/felt he was hit with a rubber hose; today he broke out in hives on stomach, back and arms; had pain in his head, eyes, and all over his body; had pain in his head, eyes, and all over his body; had pain in his head, eyes, and all over his body; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DYSAESTHESIA (yesterday he felt terrible/felt he was hit with a rubber hose), URTICARIA (today he broke out in hives on stomach, back and arms), HEADACHE (had pain in his head, eyes, and all over his body), EYE PAIN (had pain in his head, eyes, and all over his body) and MYALGIA (had pain in his head, eyes, and all over his body) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE DYSAESTHESIA (yesterday he felt terrible/felt he was hit with a rubber hose), URTICARIA (today he broke out in hives on stomach, back and arms), HEADACHE (had pain in his head, eyes, and all over his body), EYE PAIN (had pain in his head, eyes, and all over his body) and MYALGIA (had pain in his head, eyes, and all over his body). At the time of the report, VACCINATION SITE DYSAESTHESIA (yesterday he felt terrible/felt he was hit with a rubber hose), URTICARIA (today he broke out in hives on stomach, back and arms), HEADACHE (had pain in his head, eyes, and all over his body), EYE PAIN (had pain in his head, eyes, and all over his body) and MYALGIA (had pain in his head, eyes, and all over his body) outcome was unknown.            No Concomitant medications were provided No Treatment medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hot flush, Vaccination site pain, Vaccination site swelling
Clinical narrative: Hot flashes; Headache; pain and swelling in injection site; swelling in injection site; chills; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes), HEADACHE (Headache), VACCINATION SITE PAIN (pain and swelling in injection site), VACCINATION SITE SWELLING (swelling in injection site) and CHILLS (chills) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced HOT FLUSH (Hot flashes), HEADACHE (Headache), VACCINATION SITE PAIN (pain and swelling in injection site), VACCINATION SITE SWELLING (swelling in injection site) and CHILLS (chills). On 16-Apr-2021, HOT FLUSH (Hot flashes), HEADACHE (Headache), VACCINATION SITE PAIN (pain and swelling in injection site), VACCINATION SITE SWELLING (swelling in injection site) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment information not provided.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: 0.125 mL of a dose was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (0.125 mL of a dose was administered) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included METFORMIN, ATORVASTATIN, INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (HUMULIN 70/30) and LOSARTAN for an unknown indication.   On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .125 milliliter. 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 ACCIDENTAL UNDERDOSE (0.125 mL of a dose was administered). At the time of the report, ACCIDENTAL UNDERDOSE (0.125 mL of a dose was administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable No treatment medications were reported
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Headache, Insomnia, Photophobia
Clinical narrative: intense dull, throbbing pain behind eyes; Light sensitivity; Loss of sleep; Headache; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (intense dull, throbbing pain behind eyes), PHOTOPHOBIA (Light sensitivity), INSOMNIA (Loss of sleep) and HEADACHE (Headache) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-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 EYE PAIN (intense dull, throbbing pain behind eyes), PHOTOPHOBIA (Light sensitivity), INSOMNIA (Loss of sleep) and HEADACHE (Headache). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, EYE PAIN (intense dull, throbbing pain behind eyes), PHOTOPHOBIA (Light sensitivity), INSOMNIA (Loss of sleep) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: she fell body ache and muscle pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYALGIA (she fell body ache and muscle pain) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 16-Apr-2021, the patient experienced MYALGIA (she fell body ache and muscle pain). At the time of the report, MYALGIA (she fell body ache and muscle pain) outcome was unknown.            The concomitant medications were not provided. The Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Myalgia
Clinical narrative: raised hot spot of 4 inches below the injection site; fatigued; arm was sore; chills; temperature of 101.2 degrees Fahrenheit; Headache; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (raised hot spot of 4 inches below the injection site), PAIN IN EXTREMITY (arm was sore), CHILLS (chills), PYREXIA (temperature of 101.2 degrees Fahrenheit) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018821A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.  Concomitant products included FLUTICASONE PROPIONATE (FLOVENT), LEVOSALBUTAMOL HYDROCHLORIDE (XOPENEX), TRAMADOL, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and AZELASTINE for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), CHILLS (chills), PYREXIA (temperature of 101.2 degrees Fahrenheit), HEADACHE (Headache) and MYALGIA (muscle ache). On 17-Apr-2021, the patient experienced VACCINATION SITE WARMTH (raised hot spot of 4 inches below the injection site) and FATIGUE (fatigued). The patient was treated with NAPROXEN SODIUM (ALEVE) on 17-Apr-2021 at an unspecified dose and frequency and PARACETAMOL (TYLENOL) on 17-Apr-2021 at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (raised hot spot of 4 inches below the injection site), PAIN IN EXTREMITY (arm was sore), CHILLS (chills), PYREXIA (temperature of 101.2 degrees Fahrenheit), HEADACHE (Headache), MYALGIA (muscle ache) and FATIGUE (fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Body temperature: 101.2 degree fahrenheit (High) 101.2 Degree Fahrenheit. On 17-Apr-2021, Body temperature: 99.2 degree fahrenheit (High) 99.2 Degree Fahrenheit.         Other treatment Medication includes Ice pack  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site warmth
Clinical narrative: raised hot spot of 4 inches below the injection site; fatigued; arm was sore; chills; temperature of 101.2 degrees Fahrenheit; Headache; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (raised hot spot of 4 inches below the injection site), PAIN IN EXTREMITY (arm was sore), CHILLS (chills), PYREXIA (temperature of 101.2 degrees Fahrenheit) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018821A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.  Concomitant products included FLUTICASONE PROPIONATE (FLOVENT), LEVOSALBUTAMOL HYDROCHLORIDE (XOPENEX), TRAMADOL, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and AZELASTINE for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), CHILLS (chills), PYREXIA (temperature of 101.2 degrees Fahrenheit), HEADACHE (Headache) and MYALGIA (muscle ache). On 17-Apr-2021, the patient experienced VACCINATION SITE WARMTH (raised hot spot of 4 inches below the injection site) and FATIGUE (fatigued). The patient was treated with NAPROXEN SODIUM (ALEVE) on 17-Apr-2021 at an unspecified dose and frequency and PARACETAMOL (TYLENOL) on 17-Apr-2021 at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (raised hot spot of 4 inches below the injection site), PAIN IN EXTREMITY (arm was sore), CHILLS (chills), PYREXIA (temperature of 101.2 degrees Fahrenheit), HEADACHE (Headache), MYALGIA (muscle ache) and FATIGUE (fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Body temperature: 101.2 degree fahrenheit (High) 101.2 Degree Fahrenheit. On 17-Apr-2021, Body temperature: 99.2 degree fahrenheit (High) 99.2 Degree Fahrenheit.         Other treatment Medication includes Ice pack  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: flare up of Complex regional pain syndrome; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (flare up of Complex regional pain syndrome) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Complex regional pain syndrome (flare up of Complex regional pain syndrome (CRPS) of right arm and spread to left arm.). Concomitant products included FLUTICASONE PROPIONATE (FLOVENT), LEVOSALBUTAMOL HYDROCHLORIDE (XOPENEX), TRAMADOL, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and AZELASTINE for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced CONDITION AGGRAVATED (flare up of Complex regional pain syndrome). At the time of the report, CONDITION AGGRAVATED (flare up of Complex regional pain syndrome) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: sweating; bone pain; headache; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), BONE PAIN (bone pain), HEADACHE (headache), PYREXIA (fever) and FATIGUE (fatigue) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN and METFORMIN for Diabetes.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced HYPERHIDROSIS (sweating), BONE PAIN (bone pain), HEADACHE (headache), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, HYPERHIDROSIS (sweating), BONE PAIN (bone pain), HEADACHE (headache), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Minimal coughing; Dizziness; Immediately after receiving the injection, he had nausea; Soreness on the injection site; Swelling on the injection site; Headache; He was very fatigue throughout the remainder of 15Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Minimal coughing), DIZZINESS (Dizziness), NAUSEA (Immediately after receiving the injection, he had nausea), VACCINATION SITE PAIN (Soreness on the injection site) and VACCINATION SITE SWELLING (Swelling on the injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-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 COUGH (Minimal coughing), DIZZINESS (Dizziness), NAUSEA (Immediately after receiving the injection, he had nausea), VACCINATION SITE PAIN (Soreness on the injection site), VACCINATION SITE SWELLING (Swelling on the injection site), HEADACHE (Headache) and FATIGUE (He was very fatigue throughout the remainder of 15Apr2021). On 16-Apr-2021, COUGH (Minimal coughing), DIZZINESS (Dizziness), NAUSEA (Immediately after receiving the injection, he had nausea), VACCINATION SITE SWELLING (Swelling on the injection site), HEADACHE (Headache) and FATIGUE (He was very fatigue throughout the remainder of 15Apr2021) had resolved. At the time of the report, VACCINATION SITE PAIN (Soreness on the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment information not provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Minimal coughing; Dizziness; Immediately after receiving the injection, he had nausea; Soreness on the injection site; Swelling on the injection site; Headache; He was very fatigue throughout the remainder of 15Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Minimal coughing), DIZZINESS (Dizziness), NAUSEA (Immediately after receiving the injection, he had nausea), VACCINATION SITE PAIN (Soreness on the injection site) and VACCINATION SITE SWELLING (Swelling on the injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-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 COUGH (Minimal coughing), DIZZINESS (Dizziness), NAUSEA (Immediately after receiving the injection, he had nausea), VACCINATION SITE PAIN (Soreness on the injection site), VACCINATION SITE SWELLING (Swelling on the injection site), HEADACHE (Headache) and FATIGUE (He was very fatigue throughout the remainder of 15Apr2021). On 16-Apr-2021, COUGH (Minimal coughing), DIZZINESS (Dizziness), NAUSEA (Immediately after receiving the injection, he had nausea), VACCINATION SITE SWELLING (Swelling on the injection site), HEADACHE (Headache) and FATIGUE (He was very fatigue throughout the remainder of 15Apr2021) had resolved. At the time of the report, VACCINATION SITE PAIN (Soreness on the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment information not provided.