chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment, Musculoskeletal stiffness, Myalgia, Pain in extremity, SARS-CoV-2 test
Clinical narrative: pain in his legs/feet; stiffness, lost flexibility, stiffness in arm and leg; face was flushed and he was red; could not remember how to take Tylenol; could not move arm and leg, could not lift arm; muscle pain; Urinary incontinence; very very weak; confused; This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (Urinary incontinence), ASTHENIA (very very weak), CONFUSIONAL STATE (confused), PAIN IN EXTREMITY (pain in his legs/feet) and MUSCULOSKELETAL STIFFNESS (stiffness, lost flexibility, stiffness in arm and leg) in a 62-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.     The patient's past medical history included Multiple sclerosis and COVID-19 (Tested positive for COVID-19 last year). Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced ASTHENIA (very very weak) and CONFUSIONAL STATE (confused). On 21-Apr-2021, the patient experienced URINARY INCONTINENCE (Urinary incontinence), PAIN IN EXTREMITY (pain in his legs/feet), MUSCULOSKELETAL STIFFNESS (stiffness, lost flexibility, stiffness in arm and leg), FLUSHING (face was flushed and he was red), MEMORY IMPAIRMENT (could not remember how to take Tylenol), HYPOKINESIA (could not move arm and leg, could not lift arm) and MYALGIA (muscle pain). On 22-Apr-2021, HYPOKINESIA (could not move arm and leg, could not lift arm) had resolved. At the time of the report, URINARY INCONTINENCE (Urinary incontinence), ASTHENIA (very very weak), CONFUSIONAL STATE (confused), PAIN IN EXTREMITY (pain in his legs/feet), MUSCULOSKELETAL STIFFNESS (stiffness, lost flexibility, stiffness in arm and leg), FLUSHING (face was flushed and he was red), MEMORY IMPAIRMENT (could not remember how to take Tylenol) and MYALGIA (muscle pain) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 (High) 99 degrees Fahrenheit and 101 (High) 101 degrees Fahrenheit. On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19 last year.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Treatment drug included as IV hydration infusion.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: reporter contact details were added, route of administration for suspect drug is added, concomitant medication is added, Event was added.Dechallenge Results, Rechallenge Results was updated.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary incontinence
Clinical narrative: pain in his legs/feet; stiffness, lost flexibility, stiffness in arm and leg; face was flushed and he was red; could not remember how to take Tylenol; could not move arm and leg, could not lift arm; muscle pain; Urinary incontinence; very very weak; confused; This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (Urinary incontinence), ASTHENIA (very very weak), CONFUSIONAL STATE (confused), PAIN IN EXTREMITY (pain in his legs/feet) and MUSCULOSKELETAL STIFFNESS (stiffness, lost flexibility, stiffness in arm and leg) in a 62-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.     The patient's past medical history included Multiple sclerosis and COVID-19 (Tested positive for COVID-19 last year). Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced ASTHENIA (very very weak) and CONFUSIONAL STATE (confused). On 21-Apr-2021, the patient experienced URINARY INCONTINENCE (Urinary incontinence), PAIN IN EXTREMITY (pain in his legs/feet), MUSCULOSKELETAL STIFFNESS (stiffness, lost flexibility, stiffness in arm and leg), FLUSHING (face was flushed and he was red), MEMORY IMPAIRMENT (could not remember how to take Tylenol), HYPOKINESIA (could not move arm and leg, could not lift arm) and MYALGIA (muscle pain). On 22-Apr-2021, HYPOKINESIA (could not move arm and leg, could not lift arm) had resolved. At the time of the report, URINARY INCONTINENCE (Urinary incontinence), ASTHENIA (very very weak), CONFUSIONAL STATE (confused), PAIN IN EXTREMITY (pain in his legs/feet), MUSCULOSKELETAL STIFFNESS (stiffness, lost flexibility, stiffness in arm and leg), FLUSHING (face was flushed and he was red), MEMORY IMPAIRMENT (could not remember how to take Tylenol) and MYALGIA (muscle pain) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 (High) 99 degrees Fahrenheit and 101 (High) 101 degrees Fahrenheit. On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19 last year.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Treatment drug included as IV hydration infusion.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: reporter contact details were added, route of administration for suspect drug is added, concomitant medication is added, Event was added.Dechallenge Results, Rechallenge Results was updated.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Thirst
Clinical narrative: he was drinking lots of water; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (he was drinking lots of water) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE, METOPROLOL TARTRATE, LOVASTATIN, CLOPIDOGREL, FINASTERIDE, MONTELUKAST, FUROSEMIDE, FELODIPINE, BUSPIRONE, SPIRONOLACTONE, DOXAZOSIN MESYLATE, LABETALOL, ASA and IRON for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THIRST (he was drinking lots of water). At the time of the report, THIRST (he was drinking lots of water) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) Blood Pressure has gone up since first dose.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication taken by the patient included thiazine. No treatment information was provided.   This case was linked to MOD-2021-089099 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up information received on 26-May-2021 and contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: a single vaginal blood clot,; This spontaneous case was reported by a pharmacist and describes the occurrence of MENSTRUAL DISORDER (a single vaginal blood clot,) 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 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced MENSTRUAL DISORDER (a single vaginal blood clot,). At the time of the report, MENSTRUAL DISORDER (a single vaginal blood clot,) 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 concomitant medications were provided.  No treatment medications were provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: Welt at her arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Welt at her arm at injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE URTICARIA (Welt at her arm at injection site). At the time of the report, VACCINATION SITE URTICARIA (Welt at her arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Ultrasound scan
Clinical narrative: Left leg became very swollen due to lymph node swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPHADENOPATHY (Left leg became very swollen due to lymph node swelling) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-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 LYMPHADENOPATHY (Left leg became very swollen due to lymph node swelling). At the time of the report, LYMPHADENOPATHY (Left leg became very swollen due to lymph node swelling) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Ultrasound scan: showed the swelling was due to lymph node swelling (abnormal) showed the swelling was due to lymph node swelling.     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: The patient was taking aspirin for the swelling before the ultrasound in anticipation of a blood clot. She has also been taking Tylenol, Aleve, and using elevation and compression for her leg.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Erythema, Pruritus, Skin burning sensation
Clinical narrative: Then it spread to her face and lower leg; Itching on her chest, back, lower leg, arm, neck and face; It was red; Her arm started burning; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (Her arm started burning), CONDITION AGGRAVATED (Then it spread to her face and lower leg), PRURITUS (Itching on her chest, back, lower leg, arm, neck and face) and ERYTHEMA (It was red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TIMOLOL, AMLODIPINE, CHLORTHALIDONE, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), METOPROLOL, CYANOCOBALAMIN (VITAMINE B12) and ASCORBIC ACID (VITAMINE C) for an unknown indication.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced SKIN BURNING SENSATION (Her arm started burning) and ERYTHEMA (It was red). On an unknown date, the patient experienced CONDITION AGGRAVATED (Then it spread to her face and lower leg) and PRURITUS (Itching on her chest, back, lower leg, arm, neck and face). At the time of the report, SKIN BURNING SENSATION (Her arm started burning), CONDITION AGGRAVATED (Then it spread to her face and lower leg) and ERYTHEMA (It was red) outcome was unknown and PRURITUS (Itching on her chest, back, lower leg, arm, neck and face) had not resolved. Not Provided          Treatment information included hydrocortisone cream.   This case was linked to MOD-2021-089102 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Nasal discomfort, Nausea
Clinical narrative: ringing in ears; nasal pressure; body ache; head ache; joint pain; slight nausea; tiredness\quite debilitating; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (ringing in ears), NASAL DISCOMFORT (nasal pressure), PAIN (body ache), HEADACHE (head ache) and ARTHRALGIA (joint pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Iodine allergy.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced NASAL DISCOMFORT (nasal pressure), PAIN (body ache), HEADACHE (head ache), ARTHRALGIA (joint pain), NAUSEA (slight nausea) and FATIGUE (tiredness\quite debilitating). On 04-Apr-2021, the patient experienced TINNITUS (ringing in ears). At the time of the report, TINNITUS (ringing in ears) had not resolved and NASAL DISCOMFORT (nasal pressure), PAIN (body ache), HEADACHE (head ache), ARTHRALGIA (joint pain), NAUSEA (slight nausea) and FATIGUE (tiredness\quite debilitating) outcome was unknown.            No concomitant medications were reported.  Treatment medications were not provided by the reporter.    This case was linked to MOD-2021-089103 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Documents attached
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Tinnitus
Clinical narrative: ringing in ears; nasal pressure; body ache; head ache; joint pain; slight nausea; tiredness\quite debilitating; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (ringing in ears), NASAL DISCOMFORT (nasal pressure), PAIN (body ache), HEADACHE (head ache) and ARTHRALGIA (joint pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Iodine allergy.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced NASAL DISCOMFORT (nasal pressure), PAIN (body ache), HEADACHE (head ache), ARTHRALGIA (joint pain), NAUSEA (slight nausea) and FATIGUE (tiredness\quite debilitating). On 04-Apr-2021, the patient experienced TINNITUS (ringing in ears). At the time of the report, TINNITUS (ringing in ears) had not resolved and NASAL DISCOMFORT (nasal pressure), PAIN (body ache), HEADACHE (head ache), ARTHRALGIA (joint pain), NAUSEA (slight nausea) and FATIGUE (tiredness\quite debilitating) outcome was unknown.            No concomitant medications were reported.  Treatment medications were not provided by the reporter.    This case was linked to MOD-2021-089103 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Documents attached
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm is little sore from vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm is little sore from vaccine) 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 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-Apr-2021, the patient experienced VACCINATION SITE PAIN (arm is little sore from vaccine). At the time of the report, VACCINATION SITE PAIN (arm is little sore from vaccine) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Patient wanted information on single dose efficacy of Moderna vaccine "has cholesterol" and she did not want to get 2nd dose. No treatment of events was reported. No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-089130, US-MODERNATX, INC.-MOD-2021-089137 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089137:Friends case US-MODERNATX, INC.-MOD-2021-089130:neighbor case
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: flu like symptoms; had fever; had chills; Joint and muscle pain in his left arm, shoulder, hand, and neck; Joint and muscle pain in his left arm, shoulder, hand, and neck; This spontaneous case was reported by an other caregiver and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (had fever), CHILLS (had chills), MYALGIA (Joint and muscle pain in his left arm, shoulder, hand, and neck) and ARTHRALGIA (Joint and muscle pain in his left arm, shoulder, hand, and neck) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 006M20A) for COVID-19 vaccination.     The patient's past medical history included COPD and Post-traumatic stress disorder. Concomitant products included LORATADINE, FLUTICASONE, OXYBUTYNIN, BUDESONIDE, SALBUTAMOL (ALBUTEROL HFA), VITAMIN B12 NOS, VITAMIN D3, OMEPRAZOLE, METFORMIN, DOCUSATE, MULTIVITAMIN [VITAMINS NOS], FISH OIL (OMEGA-3 FISH OIL), TRAMADOL, FLUOXETINE, BUSPIRONE, SERTRALINE, BUPROPION, PREGABALIN (LYRICA), ZIPRASIDONE, MAGNESIUM OXIDE and FERROUS SULFATE (IRON SULFATE) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (had fever), CHILLS (had chills), MYALGIA (Joint and muscle pain in his left arm, shoulder, hand, and neck) and ARTHRALGIA (Joint and muscle pain in his left arm, shoulder, hand, and neck). The patient was treated with PARACETAMOL at a dose of 1 dosage form. On 22-Feb-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (had fever) and CHILLS (had chills) had resolved. At the time of the report, MYALGIA (Joint and muscle pain in his left arm, shoulder, hand, and neck) and ARTHRALGIA (Joint and muscle pain in his left arm, shoulder, hand, and neck) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-089129 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pharyngitis, Rhinorrhoea, SARS-CoV-2 test negative, Upper-airway cough syndrome
Clinical narrative: colds; runny nose; post nasal drip; pharyngitis; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (colds), RHINORRHOEA (runny nose), UPPER-AIRWAY COUGH SYNDROME (post nasal drip) and PHARYNGITIS (pharyngitis) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0088B21-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced NASOPHARYNGITIS (colds), RHINORRHOEA (runny nose), UPPER-AIRWAY COUGH SYNDROME (post nasal drip) and PHARYNGITIS (pharyngitis). At the time of the report, NASOPHARYNGITIS (colds), RHINORRHOEA (runny nose), UPPER-AIRWAY COUGH SYNDROME (post nasal drip) and PHARYNGITIS (pharyngitis) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, SARS-CoV-2 test negative: negative Results negative and negative Results negative.     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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Asthenia, Back pain, Body temperature
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt a little weak), PILOERECTION (she started to have goose bumps), PERIPHERAL SWELLING (noticed that her hands were swelling and the next day they were more swollen), DIZZINESS (light headed) and BACK PAIN (lower back was hurting) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced ASTHENIA (felt a little weak), PILOERECTION (she started to have goose bumps), PERIPHERAL SWELLING (noticed that her hands were swelling and the next day they were more swollen), PYREXIA (low fever 99.3), CHILLS (chills) and FATIGUE (tired). On 22-Apr-2021, the patient experienced DIZZINESS (light headed), BACK PAIN (lower back was hurting) and ARTHRALGIA (all the joints in her body hurt (ongoing)). On 23-Apr-2021, the patient experienced AGEUSIA (noticed couldn't taste my food (ongoing).). At the time of the report, ASTHENIA (felt a little weak), PILOERECTION (she started to have goose bumps), PERIPHERAL SWELLING (noticed that her hands were swelling and the next day they were more swollen), DIZZINESS (light headed), BACK PAIN (lower back was hurting), AGEUSIA (noticed couldn't taste my food (ongoing).), PYREXIA (low fever 99.3), CHILLS (chills), FATIGUE (tired) and ARTHRALGIA (all the joints in her body hurt (ongoing)) outcome was unknown. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.3 (abnormal) Low fever 99.3. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment- iced cold patch and panadol 500 mg
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Peripheral swelling, Piloerection
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt a little weak), PILOERECTION (she started to have goose bumps), PERIPHERAL SWELLING (noticed that her hands were swelling and the next day they were more swollen), DIZZINESS (light headed) and BACK PAIN (lower back was hurting) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced ASTHENIA (felt a little weak), PILOERECTION (she started to have goose bumps), PERIPHERAL SWELLING (noticed that her hands were swelling and the next day they were more swollen), PYREXIA (low fever 99.3), CHILLS (chills) and FATIGUE (tired). On 22-Apr-2021, the patient experienced DIZZINESS (light headed), BACK PAIN (lower back was hurting) and ARTHRALGIA (all the joints in her body hurt (ongoing)). On 23-Apr-2021, the patient experienced AGEUSIA (noticed couldn't taste my food (ongoing).). At the time of the report, ASTHENIA (felt a little weak), PILOERECTION (she started to have goose bumps), PERIPHERAL SWELLING (noticed that her hands were swelling and the next day they were more swollen), DIZZINESS (light headed), BACK PAIN (lower back was hurting), AGEUSIA (noticed couldn't taste my food (ongoing).), PYREXIA (low fever 99.3), CHILLS (chills), FATIGUE (tired) and ARTHRALGIA (all the joints in her body hurt (ongoing)) outcome was unknown. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.3 (abnormal) Low fever 99.3. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment- iced cold patch and panadol 500 mg
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt a little weak), PILOERECTION (she started to have goose bumps), PERIPHERAL SWELLING (noticed that her hands were swelling and the next day they were more swollen), DIZZINESS (light headed) and BACK PAIN (lower back was hurting) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced ASTHENIA (felt a little weak), PILOERECTION (she started to have goose bumps), PERIPHERAL SWELLING (noticed that her hands were swelling and the next day they were more swollen), PYREXIA (low fever 99.3), CHILLS (chills) and FATIGUE (tired). On 22-Apr-2021, the patient experienced DIZZINESS (light headed), BACK PAIN (lower back was hurting) and ARTHRALGIA (all the joints in her body hurt (ongoing)). On 23-Apr-2021, the patient experienced AGEUSIA (noticed couldn't taste my food (ongoing).). At the time of the report, ASTHENIA (felt a little weak), PILOERECTION (she started to have goose bumps), PERIPHERAL SWELLING (noticed that her hands were swelling and the next day they were more swollen), DIZZINESS (light headed), BACK PAIN (lower back was hurting), AGEUSIA (noticed couldn't taste my food (ongoing).), PYREXIA (low fever 99.3), CHILLS (chills), FATIGUE (tired) and ARTHRALGIA (all the joints in her body hurt (ongoing)) outcome was unknown. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.3 (abnormal) Low fever 99.3. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment- iced cold patch and panadol 500 mg
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: a fewhours later he began to have abdominal pain; a fewhours later he began to have loose stools; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (a fewhours later he began to have abdominal pain) and DIARRHOEA (a fewhours later he began to have loose stools) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.        No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced ABDOMINAL PAIN (a fewhours later he began to have abdominal pain) and DIARRHOEA (a fewhours later he began to have loose stools). At the time of the report, ABDOMINAL PAIN (a fewhours later he began to have abdominal pain) and DIARRHOEA (a fewhours later he began to have loose stools) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered). On 23-Apr-2021, EXPIRED PRODUCT ADMINISTERED (expired dose administered) had resolved. 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.   Concomitant product use was not provided by the reporter. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow up was received on 01 jun 2021 included no new information.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered to 17 years old patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to 17 years old patient) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 014C21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma since 04-Feb-2012.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to 17 years old patient). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to 17 years old patient) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment medications were reported. Action taken with mRNA-1273 in response to the events were Not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow up information received contains significant information. Added second dose information and his medical history.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: red hot ring on the arm; red hot ring on the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (red hot ring on the arm) and VACCINATION SITE ERYTHEMA (red hot ring on the arm) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE WARMTH (red hot ring on the arm) and VACCINATION SITE ERYTHEMA (red hot ring on the arm). At the time of the report, VACCINATION SITE WARMTH (red hot ring on the arm) and VACCINATION SITE ERYTHEMA (red hot ring on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed dose; This spontaneous case was reported by an other and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (Scheduled knee surgery due to bad previous surgery.) since 2018.    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 PRODUCT DOSE OMISSION ISSUE (missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment information was reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Nausea, Pain in extremity
Clinical narrative: fever; chills; fatigue; nausea; sweating; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), PAIN IN EXTREMITY (arm hurt), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included SPIRONOLACTONE and METOPROLOL for Hypertension.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm hurt). On 12-Apr-2021, the patient experienced HYPERHIDROSIS (sweating), PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue) and NAUSEA (nausea). On 11-Apr-2021, PAIN IN EXTREMITY (arm hurt) had resolved. At the time of the report, HYPERHIDROSIS (sweating), PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Erythromycin.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; chills; fatigue; nausea; sweating; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), PAIN IN EXTREMITY (arm hurt), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included SPIRONOLACTONE and METOPROLOL for Hypertension.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm hurt). On 12-Apr-2021, the patient experienced HYPERHIDROSIS (sweating), PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue) and NAUSEA (nausea). On 11-Apr-2021, PAIN IN EXTREMITY (arm hurt) had resolved. At the time of the report, HYPERHIDROSIS (sweating), PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Erythromycin.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: swelling around his site of injection on his arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling around his site of injection on his arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE SWELLING (swelling around his site of injection on his arm). At the time of the report, VACCINATION SITE SWELLING (swelling around his site of injection on his arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot arm; Itchy arm; Arm swelling, huge like grapefruit; Red arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot arm), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE SWELLING (Arm swelling, huge like grapefruit) and VACCINATION SITE ERYTHEMA (Red arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included COPD. Concomitant products included BUDESONIDE and IBUPROFEN for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced VACCINATION SITE WARMTH (Hot arm), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE SWELLING (Arm swelling, huge like grapefruit) and VACCINATION SITE ERYTHEMA (Red arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot arm), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE SWELLING (Arm swelling, huge like grapefruit) and VACCINATION SITE ERYTHEMA (Red arm) had not resolved.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Joint and muscle pain in his right arm, shoulder, hand, and neck; Joint and muscle pain in his right arm, shoulder, hand, and neck; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint and muscle pain in his right arm, shoulder, hand, and neck) and MYALGIA (Joint and muscle pain in his right arm, shoulder, hand, and neck) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 006M21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Post-traumatic stress disorder. Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), OXYBUTYNIN, BUDESONIDE, SALBUTAMOL (ALBUTEROL HFA), ATORVASTATIN, VITAMIN B12 NOS, VITAMIN D3, OMEPRAZOLE, METFORMIN, FISH OIL (OMEGA-3 FISH OIL), TRAMADOL, FLUOXETINE, BUSPIRONE, SERTRALINE, BUPROPION, PREGABALIN (LYRICA), ZIPRASIDONE, MAGNESIUM OXIDE and FERROUS SULFATE (IRON SULFATE) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced ARTHRALGIA (Joint and muscle pain in his right arm, shoulder, hand, and neck) and MYALGIA (Joint and muscle pain in his right arm, shoulder, hand, and neck). At the time of the report, ARTHRALGIA (Joint and muscle pain in his right arm, shoulder, hand, and neck) and MYALGIA (Joint and muscle pain in his right arm, shoulder, hand, and neck) had not resolved. Not Provided          Patient took Tylenol as treatment drug.   This case was linked to MOD-2021-089115 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Gastrooesophageal reflux disease
Clinical narrative: body went from cold to warm; feet and face swollen; feet and face swollen; tired; weak; acid reflux; flu like symptom; chills; nausea; arm hurt, I taught it was going to fall off; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Apr-2021 and was forwarded to Moderna on 24-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt, I taught it was going to fall off), FEELING ABNORMAL (body went from cold to warm), SWELLING FACE (feet and face swollen), PERIPHERAL SWELLING (feet and face swollen) and FATIGUE (tired) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LANSOPRAZOLE, FAMOTIDINE and LACTOBACILLUS NOS (CULTURELLE) for an unknown indication.    On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm hurt, I taught it was going to fall off). On an unknown date, the patient experienced FEELING ABNORMAL (body went from cold to warm), SWELLING FACE (feet and face swollen), PERIPHERAL SWELLING (feet and face swollen), FATIGUE (tired), ASTHENIA (weak), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), INFLUENZA LIKE ILLNESS (flu like symptom), CHILLS (chills) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (arm hurt, I taught it was going to fall off), FEELING ABNORMAL (body went from cold to warm), SWELLING FACE (feet and face swollen), PERIPHERAL SWELLING (feet and face swollen), FATIGUE (tired), ASTHENIA (weak), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), INFLUENZA LIKE ILLNESS (flu like symptom), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took Tylenol for treatment.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea, Pain in extremity, Peripheral swelling, Swelling face
Clinical narrative: body went from cold to warm; feet and face swollen; feet and face swollen; tired; weak; acid reflux; flu like symptom; chills; nausea; arm hurt, I taught it was going to fall off; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Apr-2021 and was forwarded to Moderna on 24-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt, I taught it was going to fall off), FEELING ABNORMAL (body went from cold to warm), SWELLING FACE (feet and face swollen), PERIPHERAL SWELLING (feet and face swollen) and FATIGUE (tired) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LANSOPRAZOLE, FAMOTIDINE and LACTOBACILLUS NOS (CULTURELLE) for an unknown indication.    On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm hurt, I taught it was going to fall off). On an unknown date, the patient experienced FEELING ABNORMAL (body went from cold to warm), SWELLING FACE (feet and face swollen), PERIPHERAL SWELLING (feet and face swollen), FATIGUE (tired), ASTHENIA (weak), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), INFLUENZA LIKE ILLNESS (flu like symptom), CHILLS (chills) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (arm hurt, I taught it was going to fall off), FEELING ABNORMAL (body went from cold to warm), SWELLING FACE (feet and face swollen), PERIPHERAL SWELLING (feet and face swollen), FATIGUE (tired), ASTHENIA (weak), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), INFLUENZA LIKE ILLNESS (flu like symptom), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took Tylenol for treatment.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 ( COVID-19) in a 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced COVID-19 ( COVID-19). At the time of the report, COVID-19 ( COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided. No concomitant medication were provided.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Rash, Vomiting
Clinical narrative: does not feel well; has had rash on body for 2 days; been throwing up for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (does not feel well), RASH (has had rash on body for 2 days) and VOMITING (been throwing up for 2 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (does not feel well), RASH (has had rash on body for 2 days) and VOMITING (been throwing up for 2 days). At the time of the report, MALAISE (does not feel well), RASH (has had rash on body for 2 days) and VOMITING (been throwing up for 2 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No corrective treatment was provided.   Reporter did not allow further contact