chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itchiness at injection site; Red blotchy arm  that spread at injection site; Red blotchy arm  that spread at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red blotchy arm  that spread at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and RASH MACULAR (Red blotchy arm  that spread at injection site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red blotchy arm  that spread at injection site) and RASH MACULAR (Red blotchy arm  that spread at injection site). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchiness at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red blotchy arm  that spread at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and RASH MACULAR (Red blotchy arm  that spread at injection site) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details included Antibiotics.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dysarthria, Headache, Pyrexia
Clinical narrative: dizzy; speech slurred; weak; high fever (100F); slight headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), DYSARTHRIA (speech slurred), ASTHENIA (weak), PYREXIA (high fever (100F)) and HEADACHE (slight headache) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced DIZZINESS (dizzy), DYSARTHRIA (speech slurred), ASTHENIA (weak), PYREXIA (high fever (100F)) and HEADACHE (slight headache). At the time of the report, DIZZINESS (dizzy), DYSARTHRIA (speech slurred), ASTHENIA (weak), PYREXIA (high fever (100F)) and HEADACHE (slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin haemorrhage, Vaccination site discolouration
Clinical narrative: developed reddish-brown, irregular shaped circles on her foot and ankle; like hemorrhaging underneath the skin; now the marks or a yellowish white color.; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (developed reddish-brown, irregular shaped circles on her foot and ankle), SKIN HAEMORRHAGE (like hemorrhaging underneath the skin) and VACCINATION SITE DISCOLOURATION (now the marks or a yellowish white color.) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Diabetes. Concomitant products included AMLODIPINE, GLIMEPIRIDE, METFORMIN and ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication.    On 18-Jan-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 (developed reddish-brown, irregular shaped circles on her foot and ankle), SKIN HAEMORRHAGE (like hemorrhaging underneath the skin) and VACCINATION SITE DISCOLOURATION (now the marks or a yellowish white color.). At the time of the report, ERYTHEMA (developed reddish-brown, irregular shaped circles on her foot and ankle) and VACCINATION SITE DISCOLOURATION (now the marks or a yellowish white color.) outcome was unknown and SKIN HAEMORRHAGE (like hemorrhaging underneath the skin) was resolving. 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.   Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Rapid test and is positive; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Rapid test and is positive) 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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Rapid test and is positive). At the time of the report, SARS-COV-2 TEST POSITIVE (Rapid test and is positive) 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.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Redness; Itchiness; Hives; A spontaneous report was received from a consumer concerning a 49-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness(erythema), itchiness(pruritus) and hives(urticaria).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Feb 2021, approximately one week later the patient experienced the event redness, itchiness, and hives.  Treatment details were not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The seriousness criteria of all events was non serious.  The outcome of events redness, itchiness, hives was unknown on 12 Feb 2021.; Reporter's Comments: Based on a temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itchiness; Red circle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (Red circle) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (Red circle). At the time of the report, VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (Red circle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus, Vaccination site papule
Clinical narrative: itchy; developed a bump at the injection site; arm started getting red; arm was sore, red, and itchy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore, red, and itchy), ERYTHEMA (arm started getting red), PRURITUS (itchy) and VACCINATION SITE PAPULE (developed a bump at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sore, red, and itchy). On 09-Feb-2021, the patient experienced ERYTHEMA (arm started getting red) and VACCINATION SITE PAPULE (developed a bump at the injection site). On an unknown date, the patient experienced PRURITUS (itchy). On 05-Feb-2021, PAIN IN EXTREMITY (arm was sore, red, and itchy) had resolved. At the time of the report, ERYTHEMA (arm started getting red), PRURITUS (itchy) and VACCINATION SITE PAPULE (developed a bump at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details included None.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blister, Chills, Diarrhoea, Fatigue
Clinical narrative: flu-like symptoms; Diarrhea; Weak; unstable; Blisters around mouth and in the nose; chills; fever does not know how high but get very hot; tired of being sick; Sleeps alot; Tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), DIARRHOEA (Diarrhea), ASTHENIA (Weak), FEELING ABNORMAL (unstable) and BLISTER (Blisters around mouth and in the nose) in a 75-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.     The patient's past medical history included COVID-19, Heart attack (COVID-19 virus which gave her a massive heart attack) and Hospitalization (between the hospital and rehab) from 15-Mar-2020 to May 2020. Concurrent medical conditions included Asthma, Stevens Johnson syndrome (dry mouth from SJS), Osteoarthritis (left shoulder injury) and Bursitis. Concomitant products included PILOCARPINE for Dry mouth, MENTHOL, METHYL SALICYLATE (BEN GAY) for Shoulder pain, ACETYLSALICYLIC ACID (ASPIRIN CUPAL [ACETYLSALICYLIC ACID]), MONTELUKAST, BUSPIRONE, METOPROLOL SUCCINATE, ESTRADIOL, DIAZEPAM, ATORVASTATIN, ESOMEPRAZOLE, LISINOPRIL, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), MELATONIN, AZELASTINE HYDROCHLORIDE (AZELASTINE [AZELASTINE HYDROCHLORIDE]), CORTICOSTEROID NOS, TICAGRELOR (BRILINTA) and FESOTERODINE FUMARATE (TOVIAZ) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), DIARRHOEA (Diarrhea), ASTHENIA (Weak), FEELING ABNORMAL (unstable), BLISTER (Blisters around mouth and in the nose), CHILLS (chills), PYREXIA (fever does not know how high but get very hot), MALAISE (tired of being sick), HYPERSOMNIA (Sleeps alot) and FATIGUE (Tired). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) ongoing since an unknown date for Diarrhea, at a dose of UNK dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), DIARRHOEA (Diarrhea), ASTHENIA (Weak), FEELING ABNORMAL (unstable), BLISTER (Blisters around mouth and in the nose), CHILLS (chills), PYREXIA (fever does not know how high but get very hot), MALAISE (tired of being sick), HYPERSOMNIA (Sleeps alot) and FATIGUE (Tired) outcome was unknown.            Patient reported that she had no side effects from the first dose of vaccine. Patient was instructed to not to take Montelukast 7 days before the shot.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypersomnia, Influenza like illness, Malaise, Pyrexia
Clinical narrative: flu-like symptoms; Diarrhea; Weak; unstable; Blisters around mouth and in the nose; chills; fever does not know how high but get very hot; tired of being sick; Sleeps alot; Tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), DIARRHOEA (Diarrhea), ASTHENIA (Weak), FEELING ABNORMAL (unstable) and BLISTER (Blisters around mouth and in the nose) in a 75-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.     The patient's past medical history included COVID-19, Heart attack (COVID-19 virus which gave her a massive heart attack) and Hospitalization (between the hospital and rehab) from 15-Mar-2020 to May 2020. Concurrent medical conditions included Asthma, Stevens Johnson syndrome (dry mouth from SJS), Osteoarthritis (left shoulder injury) and Bursitis. Concomitant products included PILOCARPINE for Dry mouth, MENTHOL, METHYL SALICYLATE (BEN GAY) for Shoulder pain, ACETYLSALICYLIC ACID (ASPIRIN CUPAL [ACETYLSALICYLIC ACID]), MONTELUKAST, BUSPIRONE, METOPROLOL SUCCINATE, ESTRADIOL, DIAZEPAM, ATORVASTATIN, ESOMEPRAZOLE, LISINOPRIL, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), MELATONIN, AZELASTINE HYDROCHLORIDE (AZELASTINE [AZELASTINE HYDROCHLORIDE]), CORTICOSTEROID NOS, TICAGRELOR (BRILINTA) and FESOTERODINE FUMARATE (TOVIAZ) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), DIARRHOEA (Diarrhea), ASTHENIA (Weak), FEELING ABNORMAL (unstable), BLISTER (Blisters around mouth and in the nose), CHILLS (chills), PYREXIA (fever does not know how high but get very hot), MALAISE (tired of being sick), HYPERSOMNIA (Sleeps alot) and FATIGUE (Tired). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) ongoing since an unknown date for Diarrhea, at a dose of UNK dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), DIARRHOEA (Diarrhea), ASTHENIA (Weak), FEELING ABNORMAL (unstable), BLISTER (Blisters around mouth and in the nose), CHILLS (chills), PYREXIA (fever does not know how high but get very hot), MALAISE (tired of being sick), HYPERSOMNIA (Sleeps alot) and FATIGUE (Tired) outcome was unknown.            Patient reported that she had no side effects from the first dose of vaccine. Patient was instructed to not to take Montelukast 7 days before the shot.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain
Clinical narrative: Little Pain; Flu like Symptoms; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Little Pain) and INFLUENZA LIKE ILLNESS (Flu like Symptoms) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN (Little Pain) and INFLUENZA LIKE ILLNESS (Flu like Symptoms). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Little Pain) and INFLUENZA LIKE ILLNESS (Flu like Symptoms) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itching at the injection site; Redness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling). At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Feeling hot, Headache, Hypoaesthesia
Clinical narrative: Anxiety; Pain in arm; Temperature that lasted for four days; Headaches that lasted for several days; tired; itching that started in the palm of right hand and spread to the palm of the left hand; pins and needles and numbness in both palms of their hands; hands feel hot and inflamed; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety), PAIN IN EXTREMITY (Pain in arm), PYREXIA (Temperature that lasted for four days), HEADACHE (Headaches that lasted for several days) and FATIGUE (tired) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis and Type 2 diabetes mellitus. Concomitant products included TOFACITINIB CITRATE (XELJANZ), MELATONIN, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and PREDNISONE for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANXIETY (Anxiety), PAIN IN EXTREMITY (Pain in arm), PYREXIA (Temperature that lasted for four days), HEADACHE (Headaches that lasted for several days), FATIGUE (tired), PRURITUS (itching that started in the palm of right hand and spread to the palm of the left hand), HYPOAESTHESIA (pins and needles and numbness in both palms of their hands) and FEELING HOT (hands feel hot and inflamed). At the time of the report, ANXIETY (Anxiety), PAIN IN EXTREMITY (Pain in arm), HEADACHE (Headaches that lasted for several days), FATIGUE (tired), PRURITUS (itching that started in the palm of right hand and spread to the palm of the left hand), HYPOAESTHESIA (pins and needles and numbness in both palms of their hands) and FEELING HOT (hands feel hot and inflamed) outcome was unknown and PYREXIA (Temperature that lasted for four days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Anxiety; Pain in arm; Temperature that lasted for four days; Headaches that lasted for several days; tired; itching that started in the palm of right hand and spread to the palm of the left hand; pins and needles and numbness in both palms of their hands; hands feel hot and inflamed; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety), PAIN IN EXTREMITY (Pain in arm), PYREXIA (Temperature that lasted for four days), HEADACHE (Headaches that lasted for several days) and FATIGUE (tired) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis and Type 2 diabetes mellitus. Concomitant products included TOFACITINIB CITRATE (XELJANZ), MELATONIN, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and PREDNISONE for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANXIETY (Anxiety), PAIN IN EXTREMITY (Pain in arm), PYREXIA (Temperature that lasted for four days), HEADACHE (Headaches that lasted for several days), FATIGUE (tired), PRURITUS (itching that started in the palm of right hand and spread to the palm of the left hand), HYPOAESTHESIA (pins and needles and numbness in both palms of their hands) and FEELING HOT (hands feel hot and inflamed). At the time of the report, ANXIETY (Anxiety), PAIN IN EXTREMITY (Pain in arm), HEADACHE (Headaches that lasted for several days), FATIGUE (tired), PRURITUS (itching that started in the palm of right hand and spread to the palm of the left hand), HYPOAESTHESIA (pins and needles and numbness in both palms of their hands) and FEELING HOT (hands feel hot and inflamed) outcome was unknown and PYREXIA (Temperature that lasted for four days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Thumbing in ear like a heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Thumbing in ear like a heartbeat) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced TINNITUS (Thumbing in ear like a heartbeat). At the time of the report, TINNITUS (Thumbing in ear like a heartbeat) outcome was unknown. Not Provided          No relevant concomitant medications were reported. Treatment information for the event was not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Periorbital swelling, Vision blurred
Clinical narrative: left eye started to puff up; left eye blurry; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIORBITAL SWELLING (left eye started to puff up) and VISION BLURRED (left eye blurry) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PERIORBITAL SWELLING (left eye started to puff up) and VISION BLURRED (left eye blurry). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOMYCIN AND POLYMYXIN B SULF & DEXAMETH) for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIORBITAL SWELLING (left eye started to puff up) and VISION BLURRED (left eye blurry) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-034778 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded MOD-2021-034778:Case for 2nd dose of vaccine
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Rash
Clinical narrative: rash on neck; shoulder pain; felt bad for couple of hours; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad for couple of hours), RASH (rash on neck) and ARTHRALGIA (shoulder pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included EVOLOCUMAB (REPATHA), CEPHALEXIN [CEFALEXIN], ASPIRIN [ACETYLSALICYLIC ACID] and RANOLAZINE (RANOLAZINE EXTENDED RELEASE) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced FEELING ABNORMAL (felt bad for couple of hours) and ARTHRALGIA (shoulder pain). On 04-Mar-2021, the patient experienced RASH (rash on neck). At the time of the report, FEELING ABNORMAL (felt bad for couple of hours), RASH (rash on neck) and ARTHRALGIA (shoulder pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported. .No lab data was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Event outcome updated
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Nausea, Pain, Vaccination site swelling
Clinical narrative: redness; soreness & achy; Swelling at the injection site; body aches; slightly nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), PAIN (soreness & achy), VACCINATION SITE SWELLING (Swelling at the injection site), MYALGIA (body aches) and NAUSEA (slightly nauseous) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced ERYTHEMA (redness), PAIN (soreness & achy), VACCINATION SITE SWELLING (Swelling at the injection site), MYALGIA (body aches) and NAUSEA (slightly nauseous). At the time of the report, ERYTHEMA (redness), PAIN (soreness & achy), VACCINATION SITE SWELLING (Swelling at the injection site), MYALGIA (body aches) and NAUSEA (slightly nauseous) 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.   No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Musculoskeletal stiffness
Clinical narrative: arm is hurting, it has become a bit stiff and she has some hard time moving and lifting her arm; arm is hurting, it has become a bit stiff and she has some hard time moving and lifting her arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (arm is hurting, it has become a bit stiff and she has some hard time moving and lifting her arm) and LIMB DISCOMFORT (arm is hurting, it has become a bit stiff and she has some hard time moving and lifting her arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and SIMVASTATIN for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (arm is hurting, it has become a bit stiff and she has some hard time moving and lifting her arm) and LIMB DISCOMFORT (arm is hurting, it has become a bit stiff and she has some hard time moving and lifting her arm). At the time of the report, MUSCULOSKELETAL STIFFNESS (arm is hurting, it has become a bit stiff and she has some hard time moving and lifting her arm) and LIMB DISCOMFORT (arm is hurting, it has become a bit stiff and she has some hard time moving and lifting her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Diarrhoea
Clinical narrative: Diarrhea; Coughing; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and COUGH (Coughing) 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 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea) and COUGH (Coughing). At the time of the report, DIARRHOEA (Diarrhea) and COUGH (Coughing) outcome was unknown.            Patient reported that before patient was administered first dose of shot, patient felt sick. On unknown date, Covid test was performed on patient with negative results.  No concomitant medications were reported.  No treatment information was reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Light headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Light headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced HEADACHE (Light headache). At the time of the report, HEADACHE (Light headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information not provided.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Myalgia, Vaccination site pain, Vaccination site swelling
Clinical narrative: stomach issues; injection site pain; body aches; Swelling at injection site; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL DISCOMFORT (stomach issues), VACCINATION SITE PAIN (injection site pain), MYALGIA (body aches) and VACCINATION SITE SWELLING (Swelling at injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach issues), VACCINATION SITE PAIN (injection site pain), MYALGIA (body aches) and VACCINATION SITE SWELLING (Swelling at injection site). At the time of the report, ABDOMINAL DISCOMFORT (stomach issues), VACCINATION SITE PAIN (injection site pain), MYALGIA (body aches) and VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown.        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 were reported.  No treatment information was reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site joint movement impairment
Clinical narrative: Arm was really sore; Hard for her to lift her arm up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was really sore) and VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Hard for her to lift her arm up) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was really sore) and VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Hard for her to lift her arm up). At the time of the report, PAIN IN EXTREMITY (Arm was really sore) and VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Hard for her to lift her arm up) outcome was unknown. Not applicable      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: really achy; nausea; really tired; really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (really achy), HEADACHE (really bad headache), NAUSEA (nausea) and FATIGUE (really tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Crohns disease aggravated.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced HEADACHE (really bad headache). On 12-Feb-2021, the patient experienced PAIN (really achy), NAUSEA (nausea) and FATIGUE (really tired). At the time of the report, PAIN (really achy), HEADACHE (really bad headache), NAUSEA (nausea) and FATIGUE (really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rhinorrhoea, Salivary gland disorder, Seasonal allergy
Clinical narrative: blocked salivary gland; "hay fever type of response"; sniffling off and on; burning sensation in both legs; A spontaneous report was received from a consumer concerning herself, 78 years old, female patient who developed blocked salivary gland/salivary gland disorder, burning sensation in both legs/burning sensation, "hay fever type of response"/seasonal allergy, sniffling off and on/rhinorrhoea.  The patient's medical history included blocked salivary glands.  Products known to have been used by the patient, within two weeks prior to the event, included Hydrochlorothiazide, Valsartan.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 030M20A) on  11 Feb 2021 intramuscularly at unknown injection site for prophylaxis of COVID-19 infection.    On 11 Feb 2021 the patient experienced burning sensation in both legs (from ankles to above knees) that resolved the next day. On 12 Feb 2021, she also reported hay fever type of response with sniffling that was on and off. On 27 Feb 2021, she reported a blocked salivary gland. Treatment of the events included amoxicillin and clavulanate potassium and prednisone.    Action taken with mRNA-1273 in response to the event was not provided.  The event burning sensation in both legs was considered resolved. The outcome of the events blocked salivary gland, hay fever type of response, sniffling off and on was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness on the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness on the injection arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness on the injection arm). At the time of the report, VACCINATION SITE PAIN (Soreness on the injection arm) outcome was unknown.            No Concomitant product use was reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Carpal tunnel syndrome, Erythema, Hyperhidrosis, Pain
Clinical narrative: sweaty; sugar level went down so bad she couldn't get out of bed to eat something sweet; Redness went down through the middle of the arm; feeling like a mosquito stung her; have Carpal tunnel in it; so painful she thought the finger would explode; itchiness; terrible pain at the arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweaty), BLOOD GLUCOSE DECREASED (sugar level went down so bad she couldn't get out of bed to eat something sweet), ERYTHEMA (Redness went down through the middle of the arm), PAIN (feeling like a mosquito stung her) and CARPAL TUNNEL SYNDROME (have Carpal tunnel in it) in a 72-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.     Concurrent medical conditions included Diabetes and Lung cancer stage IV. Concomitant products included NIVOLUMAB (OPDIVO) and METOPROLOL for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweaty), BLOOD GLUCOSE DECREASED (sugar level went down so bad she couldn't get out of bed to eat something sweet), ERYTHEMA (Redness went down through the middle of the arm), PAIN (feeling like a mosquito stung her), CARPAL TUNNEL SYNDROME (have Carpal tunnel in it), PAIN IN EXTREMITY (so painful she thought the finger would explode), PRURITUS (itchiness) and VACCINATION SITE PAIN (terrible pain at the arm of injection). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweaty), BLOOD GLUCOSE DECREASED (sugar level went down so bad she couldn't get out of bed to eat something sweet), ERYTHEMA (Redness went down through the middle of the arm), PAIN (feeling like a mosquito stung her), CARPAL TUNNEL SYNDROME (have Carpal tunnel in it), PAIN IN EXTREMITY (so painful she thought the finger would explode), PRURITUS (itchiness) and VACCINATION SITE PAIN (terrible pain at the arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Vaccination site pain
Clinical narrative: sweaty; sugar level went down so bad she couldn't get out of bed to eat something sweet; Redness went down through the middle of the arm; feeling like a mosquito stung her; have Carpal tunnel in it; so painful she thought the finger would explode; itchiness; terrible pain at the arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweaty), BLOOD GLUCOSE DECREASED (sugar level went down so bad she couldn't get out of bed to eat something sweet), ERYTHEMA (Redness went down through the middle of the arm), PAIN (feeling like a mosquito stung her) and CARPAL TUNNEL SYNDROME (have Carpal tunnel in it) in a 72-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.     Concurrent medical conditions included Diabetes and Lung cancer stage IV. Concomitant products included NIVOLUMAB (OPDIVO) and METOPROLOL for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweaty), BLOOD GLUCOSE DECREASED (sugar level went down so bad she couldn't get out of bed to eat something sweet), ERYTHEMA (Redness went down through the middle of the arm), PAIN (feeling like a mosquito stung her), CARPAL TUNNEL SYNDROME (have Carpal tunnel in it), PAIN IN EXTREMITY (so painful she thought the finger would explode), PRURITUS (itchiness) and VACCINATION SITE PAIN (terrible pain at the arm of injection). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweaty), BLOOD GLUCOSE DECREASED (sugar level went down so bad she couldn't get out of bed to eat something sweet), ERYTHEMA (Redness went down through the middle of the arm), PAIN (feeling like a mosquito stung her), CARPAL TUNNEL SYNDROME (have Carpal tunnel in it), PAIN IN EXTREMITY (so painful she thought the finger would explode), PRURITUS (itchiness) and VACCINATION SITE PAIN (terrible pain at the arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pain
Clinical narrative: A little bit of aching; Sore throat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (A little bit of aching), OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS 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 PAIN (A little bit of aching), OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 04-Mar-2021, OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache) had resolved. At the time of the report, PAIN (A little bit of aching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included high blood pressure medication.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received: Contain Non- significant information
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site discolouration, Vaccination site pruritus
Clinical narrative: body itchy; black and blue at injection site; injection site itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (body itchy), VACCINATION SITE DISCOLOURATION (black and blue at injection site) and VACCINATION SITE PRURITUS (injection site itchy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031620A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Pain.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PRURITUS (body itchy), VACCINATION SITE DISCOLOURATION (black and blue at injection site) and VACCINATION SITE PRURITUS (injection site itchy). At the time of the report, PRURITUS (body itchy), VACCINATION SITE DISCOLOURATION (black and blue at injection site) and VACCINATION SITE PRURITUS (injection site itchy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were asthma medicine, pain medicine. Treatment details was not reported by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Enamel anomaly, Tooth injury
Clinical narrative: Broke her tooth; Half of the enamel bonding came off; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INJURY (Broke her tooth) and ENAMEL ANOMALY (Half of the enamel bonding came off) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced TOOTH INJURY (Broke her tooth) and ENAMEL ANOMALY (Half of the enamel bonding came off). At the time of the report, TOOTH INJURY (Broke her tooth) and ENAMEL ANOMALY (Half of the enamel bonding came off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: Dizziness; Tired; Weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), DIZZINESS (Dizziness) and FATIGUE (Tired) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced ASTHENIA (Weak) and FATIGUE (Tired). On 04-Mar-2021, the patient experienced DIZZINESS (Dizziness). On 27-Feb-2021, ASTHENIA (Weak) and FATIGUE (Tired) had resolved. At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment information was not provided.