chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (heat and hot at the injection site.), VACCINATION SITE PRURITUS (arm itches like a bee sting itch), VACCINATION SITE ERYTHEMA (Patient have redness soreness, heat and hot at the injection site) and VACCINATION SITE PAIN (Patient have redness soreness, heat and hot at the injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-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 WARMTH (heat and hot at the injection site.), VACCINATION SITE PRURITUS (arm itches like a bee sting itch), VACCINATION SITE ERYTHEMA (Patient have redness soreness, heat and hot at the injection site) and VACCINATION SITE PAIN (Patient have redness soreness, heat and hot at the injection site). At the time of the report, VACCINATION SITE WARMTH (heat and hot at the injection site.), VACCINATION SITE PRURITUS (arm itches like a bee sting itch), VACCINATION SITE ERYTHEMA (Patient have redness soreness, heat and hot at the injection site) and VACCINATION SITE PAIN (Patient have redness soreness, heat and hot at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea, a whole lot of bowel movement; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea, a whole lot of bowel movement) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure (high blood pressure) and Diabetes.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (diarrhea, a whole lot of bowel movement). At the time of the report, DIARRHOEA (diarrhea, a whole lot of bowel movement) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was unknown   This case was linked to MOD21-074180 (E2B Linked Report).; Sender's Comments:  MOD21-074180:MOD-2021-074773 -1st dose of Vaccine
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Energy increased, Headache, Migraine
Clinical narrative: felt tremendous energy for a week, as if she were 15 years old; had a few headaches; the migraines that she usually suffers were gone; This spontaneous case was reported by a physician and describes the occurrence of ENERGY INCREASED (felt tremendous energy for a week, as if she were 15 years old), MIGRAINE (the migraines that she usually suffers were gone) and HEADACHE (had a few headaches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Migraine.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MIGRAINE (the migraines that she usually suffers were gone). On 10-Apr-2021, the patient experienced HEADACHE (had a few headaches). On an unknown date, the patient experienced ENERGY INCREASED (felt tremendous energy for a week, as if she were 15 years old). At the time of the report, ENERGY INCREASED (felt tremendous energy for a week, as if she were 15 years old), MIGRAINE (the migraines that she usually suffers were gone) and HEADACHE (had a few headaches) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported. No treatment medication details was reported.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Cyanopsia, Magnetic resonance imaging, Ultrasound scan, Vision blurred
Clinical narrative: blue chicken wires vision came back; mesh like vision (what you see in one of those mesh hats); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VISION BLURRED (mesh like vision (what you see in one of those mesh hats)) and CYANOPSIA (blue chicken wires vision came back) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025J20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Macular degeneration and Dry eyes. Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), VITAMINS NOS and VITAMIN B12 NOS for an unknown indication.   On 07-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021 at 2:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced VISION BLURRED (mesh like vision (what you see in one of those mesh hats)). On 05-Feb-2021, the patient experienced CYANOPSIA (blue chicken wires vision came back). At the time of the report, VISION BLURRED (mesh like vision (what you see in one of those mesh hats)) and CYANOPSIA (blue chicken wires vision came back) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Magnetic resonance imaging: all cleared (normal) All cleared. In January 2021, Ultrasound scan: all cleared (normal) All cleared.         Concomitant medications include unspecified eye drops for macular degeneration and dry eyes.  The patient was seen by his optometrist who "did all the tests" and said nothing was wrong with his eyes. The patient was then seen by his primary doctor to rule out a possible stroke. Per the reporter: just before the second vaccine, the mesh like vision was still there but the blue chicken wires vision was gone. Then the patient got his second vaccine and both mesh like vision and blue chicken wires vision came back and have not gone away.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Added patient details and Updated patient event outcome from unknown to not recovered/resolved.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Dyspnoea, Fatigue, Hypoaesthesia
Clinical narrative: pain on L arm of injection, like numbness, like inside of the arm and it goes to the heart; weak; feels discomfort in the chest; feels discomfort in the chest like if he is lack of breath; fatigue; pain on L arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (pain on L arm of injection, like numbness, like inside of the arm and it goes to the heart), ASTHENIA (weak), CHEST DISCOMFORT (feels discomfort in the chest), DYSPNOEA (feels discomfort in the chest like if he is lack of breath) and FATIGUE (fatigue ) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Iron overload. Concurrent medical conditions included Hemochromatosis (The patient referred he suffers from Inherit Hemochromatosis diagnose it on 2016 that caused cirrhosis hepatic, diabetes, heart issues.) in 2016, Cirrhosis liver, Diabetes, Osteoporosis, Heart disorder (heart issues: he has inflammation on the left ventricle) and Arthritis. Concomitant products included ENALAPRIL for Heart disorder, INSULIN, OMEPRAZOLE, FUROSEMIDE and SPIRONOLACTONE (SPIRONOLACTONA) for an unknown indication.    On 30-Mar-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 HYPOAESTHESIA (pain on L arm of injection, like numbness, like inside of the arm and it goes to the heart), ASTHENIA (weak), CHEST DISCOMFORT (feels discomfort in the chest), DYSPNOEA (feels discomfort in the chest like if he is lack of breath), FATIGUE (fatigue ) and VACCINATION SITE PAIN (pain on L arm of injection). At the time of the report, HYPOAESTHESIA (pain on L arm of injection, like numbness, like inside of the arm and it goes to the heart), ASTHENIA (weak), CHEST DISCOMFORT (feels discomfort in the chest), DYSPNOEA (feels discomfort in the chest like if he is lack of breath) and FATIGUE (fatigue ) outcome was unknown and VACCINATION SITE PAIN (pain on L arm of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient described chest discomfort  like anguish and it´s located on the left side of his heart. Treatment information was not provided by the reporter.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain on L arm of injection, like numbness, like inside of the arm and it goes to the heart; weak; feels discomfort in the chest; feels discomfort in the chest like if he is lack of breath; fatigue; pain on L arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (pain on L arm of injection, like numbness, like inside of the arm and it goes to the heart), ASTHENIA (weak), CHEST DISCOMFORT (feels discomfort in the chest), DYSPNOEA (feels discomfort in the chest like if he is lack of breath) and FATIGUE (fatigue ) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Iron overload. Concurrent medical conditions included Hemochromatosis (The patient referred he suffers from Inherit Hemochromatosis diagnose it on 2016 that caused cirrhosis hepatic, diabetes, heart issues.) in 2016, Cirrhosis liver, Diabetes, Osteoporosis, Heart disorder (heart issues: he has inflammation on the left ventricle) and Arthritis. Concomitant products included ENALAPRIL for Heart disorder, INSULIN, OMEPRAZOLE, FUROSEMIDE and SPIRONOLACTONE (SPIRONOLACTONA) for an unknown indication.    On 30-Mar-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 HYPOAESTHESIA (pain on L arm of injection, like numbness, like inside of the arm and it goes to the heart), ASTHENIA (weak), CHEST DISCOMFORT (feels discomfort in the chest), DYSPNOEA (feels discomfort in the chest like if he is lack of breath), FATIGUE (fatigue ) and VACCINATION SITE PAIN (pain on L arm of injection). At the time of the report, HYPOAESTHESIA (pain on L arm of injection, like numbness, like inside of the arm and it goes to the heart), ASTHENIA (weak), CHEST DISCOMFORT (feels discomfort in the chest), DYSPNOEA (feels discomfort in the chest like if he is lack of breath) and FATIGUE (fatigue ) outcome was unknown and VACCINATION SITE PAIN (pain on L arm of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient described chest discomfort  like anguish and it´s located on the left side of his heart. Treatment information was not provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Fatigue, Headache
Clinical narrative: chills; chest pain\different aches going through the chest; headache; fatigue \  from the left side to the right side and is felt more when tired; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain\different aches going through the chest), HEADACHE (headache), FATIGUE (fatigue \  from the left side to the right side and is felt more when tired) and CHILLS (chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced CHEST PAIN (chest pain\different aches going through the chest), HEADACHE (headache) and FATIGUE (fatigue \  from the left side to the right side and is felt more when tired). On an unknown date, the patient experienced CHILLS (chills). At the time of the report, CHEST PAIN (chest pain\different aches going through the chest) had not resolved and HEADACHE (headache), FATIGUE (fatigue \  from the left side to the right side and is felt more when tired) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment  medication includes Benadryl, Ibuprofen.  The patient tried taking Benadryl which did not help and then started taking ibuprofen which has helped but the chest pain is still on going.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Reporter name and email updated. On 06-May-2021: Non Significant follow up appended. On 15-May-2021: No specific follow-up information recorded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Feeling of relaxation, Headache
Clinical narrative: she was very sick; Felt really bad; Couldn't get up from bed; dizziness; headaches; nausea; slight fever; Couldn't get up from bed, couldn't do things, she was feeling very tired.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she was very sick), FEELING ABNORMAL (Felt really bad), FEELING OF RELAXATION (Couldn't get up from bed), DIZZINESS (dizziness) and HEADACHE (headaches) in a 73-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 No adverse event. Concomitant products included METOPROLOL and VITAMINS NOS for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced ILLNESS (she was very sick), FEELING ABNORMAL (Felt really bad), FEELING OF RELAXATION (Couldn't get up from bed), DIZZINESS (dizziness), HEADACHE (headaches), NAUSEA (nausea), PYREXIA (slight fever) and FATIGUE (Couldn't get up from bed, couldn't do things, she was feeling very tired.). At the time of the report, ILLNESS (she was very sick), FEELING ABNORMAL (Felt really bad), FEELING OF RELAXATION (Couldn't get up from bed), DIZZINESS (dizziness), HEADACHE (headaches), NAUSEA (nausea), PYREXIA (slight fever) and FATIGUE (Couldn't get up from bed, couldn't do things, she was feeling very tired.) outcome was unknown.            Patient reported using Tylenol for reported adverse reactions.   This case was linked to MOD21-074495, US-MODERNATX, INC.-MOD-2021-075133 (E2B Linked Report).; Sender's Comments:  MOD21-074495: US-MODERNATX, INC.-MOD-2021-075133:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, Pyrexia
Clinical narrative: she was very sick; Felt really bad; Couldn't get up from bed; dizziness; headaches; nausea; slight fever; Couldn't get up from bed, couldn't do things, she was feeling very tired.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she was very sick), FEELING ABNORMAL (Felt really bad), FEELING OF RELAXATION (Couldn't get up from bed), DIZZINESS (dizziness) and HEADACHE (headaches) in a 73-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 No adverse event. Concomitant products included METOPROLOL and VITAMINS NOS for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced ILLNESS (she was very sick), FEELING ABNORMAL (Felt really bad), FEELING OF RELAXATION (Couldn't get up from bed), DIZZINESS (dizziness), HEADACHE (headaches), NAUSEA (nausea), PYREXIA (slight fever) and FATIGUE (Couldn't get up from bed, couldn't do things, she was feeling very tired.). At the time of the report, ILLNESS (she was very sick), FEELING ABNORMAL (Felt really bad), FEELING OF RELAXATION (Couldn't get up from bed), DIZZINESS (dizziness), HEADACHE (headaches), NAUSEA (nausea), PYREXIA (slight fever) and FATIGUE (Couldn't get up from bed, couldn't do things, she was feeling very tired.) outcome was unknown.            Patient reported using Tylenol for reported adverse reactions.   This case was linked to MOD21-074495, US-MODERNATX, INC.-MOD-2021-075133 (E2B Linked Report).; Sender's Comments:  MOD21-074495: US-MODERNATX, INC.-MOD-2021-075133:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia
Clinical narrative: Chills; muscle aches; Joint pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (muscle aches), ARTHRALGIA (Joint pain) and HEADACHE (Headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced CHILLS (Chills), MYALGIA (muscle aches), ARTHRALGIA (Joint pain) and HEADACHE (Headache). At the time of the report, CHILLS (Chills), MYALGIA (muscle aches), ARTHRALGIA (Joint pain) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medicines was not reported by reporter   treatment information was not provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments   Reporter did not allow further contact
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity, Pruritus, Vaccination site erythema, Vaccination site pain
Clinical narrative: vaccination site bruise; itchiness; vaccination site redness; vaccination site swelling; pain in the injection site; pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in the injection site), PAIN IN EXTREMITY (pain in arm), VACCINATION SITE ERYTHEMA (vaccination site redness), VACCINATION SITE SWELLING (vaccination site swelling) and CONTUSION (vaccination site bruise) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain in the injection site) and PAIN IN EXTREMITY (pain in arm). On 05-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (vaccination site redness) and VACCINATION SITE SWELLING (vaccination site swelling). On 08-Apr-2021, the patient experienced PRURITUS (itchiness). On an unknown date, the patient experienced CONTUSION (vaccination site bruise). At the time of the report, VACCINATION SITE PAIN (pain in the injection site), PAIN IN EXTREMITY (pain in arm), VACCINATION SITE ERYTHEMA (vaccination site redness), VACCINATION SITE SWELLING (vaccination site swelling), CONTUSION (vaccination site bruise) and PRURITUS (itchiness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not have any pre-existing medical condition includes and concomitant medication includes.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: vaccination site bruise; itchiness; vaccination site redness; vaccination site swelling; pain in the injection site; pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in the injection site), PAIN IN EXTREMITY (pain in arm), VACCINATION SITE ERYTHEMA (vaccination site redness), VACCINATION SITE SWELLING (vaccination site swelling) and CONTUSION (vaccination site bruise) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain in the injection site) and PAIN IN EXTREMITY (pain in arm). On 05-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (vaccination site redness) and VACCINATION SITE SWELLING (vaccination site swelling). On 08-Apr-2021, the patient experienced PRURITUS (itchiness). On an unknown date, the patient experienced CONTUSION (vaccination site bruise). At the time of the report, VACCINATION SITE PAIN (pain in the injection site), PAIN IN EXTREMITY (pain in arm), VACCINATION SITE ERYTHEMA (vaccination site redness), VACCINATION SITE SWELLING (vaccination site swelling), CONTUSION (vaccination site bruise) and PRURITUS (itchiness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not have any pre-existing medical condition includes and concomitant medication includes.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain, Vaccination site rash
Clinical narrative: rash on left shoulder that is painful to touch; rash on left shoulder that is painful to touch; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), VACCINATION SITE RASH (rash on left shoulder that is painful to touch) and VACCINATION SITE PAIN (rash on left shoulder that is painful to touch) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     The patient's medical history information was not provided.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for Feeling of total lack of energy.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced FATIGUE (fatigue). On 04-Apr-2021, the patient experienced VACCINATION SITE RASH (rash on left shoulder that is painful to touch) and VACCINATION SITE PAIN (rash on left shoulder that is painful to touch). At the time of the report, FATIGUE (fatigue) and VACCINATION SITE PAIN (rash on left shoulder that is painful to touch) outcome was unknown and VACCINATION SITE RASH (rash on left shoulder that is painful to touch) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included application of coconut oil to the rash at the injection site.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (pain at injection site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 013A21A) for COVID-19 vaccination.     The patient's past medical history included Shoulder replacement (right shoulder) in June 2018, Chemotherapy (for colon cancer) in August 2018 and Radiation therapy in January 2019. Concurrent medical conditions included Neuropathy (on right hand since shoulder replacement).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site). At the time of the report, VACCINATION SITE PAIN (pain at injection site) outcome was unknown.            no concomitant medication provided. no treatment medication provided.       Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow up received Contact information updated.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old received the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the vaccine). On 12-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dry mouth, Fatigue, Feeling abnormal
Clinical narrative: runny nose; body soreness; altered taste; shaking; generalized weakness; dry mouth; increased mucus production; Occasional headache; Tiredness; Fuzzy feeling; Decreased appetite; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Fuzzy feeling), DECREASED APPETITE (Decreased appetite), RHINORRHOEA (runny nose), PAIN (body soreness) and TASTE DISORDER (altered taste) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 2101912) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included RIOCIGUAT (ADEMPAS), APIXABAN (ELIQUIS) and AMLODIPINE.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Fuzzy feeling), DECREASED APPETITE (Decreased appetite), RHINORRHOEA (runny nose), PAIN (body soreness), TASTE DISORDER (altered taste), TREMOR (shaking), ASTHENIA (generalized weakness), DRY MOUTH (dry mouth), SECRETION DISCHARGE (increased mucus production), HEADACHE (Occasional headache) and FATIGUE (Tiredness). At the time of the report, FEELING ABNORMAL (Fuzzy feeling), DECREASED APPETITE (Decreased appetite), RHINORRHOEA (runny nose), PAIN (body soreness), TASTE DISORDER (altered taste), TREMOR (shaking), ASTHENIA (generalized weakness), DRY MOUTH (dry mouth), SECRETION DISCHARGE (increased mucus production), HEADACHE (Occasional headache) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-102381 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Duplicate case found MOD-2021-102381. merged documents added.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Rhinorrhoea, Secretion discharge, Taste disorder
Clinical narrative: runny nose; body soreness; altered taste; shaking; generalized weakness; dry mouth; increased mucus production; Occasional headache; Tiredness; Fuzzy feeling; Decreased appetite; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Fuzzy feeling), DECREASED APPETITE (Decreased appetite), RHINORRHOEA (runny nose), PAIN (body soreness) and TASTE DISORDER (altered taste) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 2101912) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included RIOCIGUAT (ADEMPAS), APIXABAN (ELIQUIS) and AMLODIPINE.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Fuzzy feeling), DECREASED APPETITE (Decreased appetite), RHINORRHOEA (runny nose), PAIN (body soreness), TASTE DISORDER (altered taste), TREMOR (shaking), ASTHENIA (generalized weakness), DRY MOUTH (dry mouth), SECRETION DISCHARGE (increased mucus production), HEADACHE (Occasional headache) and FATIGUE (Tiredness). At the time of the report, FEELING ABNORMAL (Fuzzy feeling), DECREASED APPETITE (Decreased appetite), RHINORRHOEA (runny nose), PAIN (body soreness), TASTE DISORDER (altered taste), TREMOR (shaking), ASTHENIA (generalized weakness), DRY MOUTH (dry mouth), SECRETION DISCHARGE (increased mucus production), HEADACHE (Occasional headache) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-102381 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Duplicate case found MOD-2021-102381. merged documents added.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: runny nose; body soreness; altered taste; shaking; generalized weakness; dry mouth; increased mucus production; Occasional headache; Tiredness; Fuzzy feeling; Decreased appetite; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Fuzzy feeling), DECREASED APPETITE (Decreased appetite), RHINORRHOEA (runny nose), PAIN (body soreness) and TASTE DISORDER (altered taste) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 2101912) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included RIOCIGUAT (ADEMPAS), APIXABAN (ELIQUIS) and AMLODIPINE.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Fuzzy feeling), DECREASED APPETITE (Decreased appetite), RHINORRHOEA (runny nose), PAIN (body soreness), TASTE DISORDER (altered taste), TREMOR (shaking), ASTHENIA (generalized weakness), DRY MOUTH (dry mouth), SECRETION DISCHARGE (increased mucus production), HEADACHE (Occasional headache) and FATIGUE (Tiredness). At the time of the report, FEELING ABNORMAL (Fuzzy feeling), DECREASED APPETITE (Decreased appetite), RHINORRHOEA (runny nose), PAIN (body soreness), TASTE DISORDER (altered taste), TREMOR (shaking), ASTHENIA (generalized weakness), DRY MOUTH (dry mouth), SECRETION DISCHARGE (increased mucus production), HEADACHE (Occasional headache) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-102381 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Duplicate case found MOD-2021-102381. merged documents added.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness in her shoulder also; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in her shoulder also) 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 an unknown date, the patient experienced VACCINATION SITE PAIN (soreness in her shoulder also). At the time of the report, VACCINATION SITE PAIN (soreness in her shoulder also) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by the reporter No treatment medication reported   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up information received on 04-MAY-2021 contains updated outcome of the event as recovered.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in extremity; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in extremity ) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in extremity ). On 18-Mar-2021, PAIN IN EXTREMITY (Pain in extremity ) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Myalgia, Pain in extremity
Clinical narrative: legs pain; Ache in knee/joint pain; Muscle in legs not comfortable; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (legs pain), ARTHRALGIA (Ache in knee/joint pain) and MYALGIA (Muscle in legs not comfortable) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL SUCCINATE and VALSARTAN for Hypertension.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (legs pain), ARTHRALGIA (Ache in knee/joint pain) and MYALGIA (Muscle in legs not comfortable). The patient was treated with ACETAMINOPHEN at a dose of 325 mg, 4-6 tablets in 24 hours. At the time of the report, PAIN IN EXTREMITY (legs pain), ARTHRALGIA (Ache in knee/joint pain) and MYALGIA (Muscle in legs not comfortable) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Blood pressure measurement: 200/100 mmhg (High) 200/100.         Additionally the patient received treatment with heating pads.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Acarodermatitis, Adverse reaction, Formication, Papule, Pruritus
Clinical narrative: scabies; little bumps; burning; breaking out with a rash; blowing up 8 days later; itching has gotten worse; feels like she is crawling out of her skin.; normal side effects; after the 1st dose it was hives 8 days later; This spontaneous case was reported by a consumer and describes the occurrence of ACARODERMATITIS (scabies), ADVERSE REACTION (blowing up 8 days later), PRURITUS (itching has gotten worse), FORMICATION (feels like she is crawling out of her skin.) and URTICARIA (after the 1st dose it was hives 8 days later) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Apr-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) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced URTICARIA (after the 1st dose it was hives 8 days later). On 04-Apr-2021, the patient experienced ADVERSE REACTION (normal side effects). On 12-Apr-2021, the patient experienced ADVERSE REACTION (blowing up 8 days later), PRURITUS (itching has gotten worse), FORMICATION (feels like she is crawling out of her skin.) and RASH (breaking out with a rash). On an unknown date, the patient experienced ACARODERMATITIS (scabies), PAPULE (little bumps) and SKIN BURNING SENSATION (burning). The patient was treated with FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and MONTELUKAST SODIUM (SINGULAIR) at an unspecified dose and frequency. At the time of the report, ACARODERMATITIS (scabies), ADVERSE REACTION (blowing up 8 days later), PRURITUS (itching has gotten worse), FORMICATION (feels like she is crawling out of her skin.), URTICARIA (after the 1st dose it was hives 8 days later), ADVERSE REACTION (normal side effects), PAPULE (little bumps), SKIN BURNING SENSATION (burning) and RASH (breaking out with a rash) outcome was unknown.            No concomitant drugs were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-074825 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Significant FU / extra events added and 2nd dose events updated with outcome; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074825:2nd dose
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin burning sensation, Urticaria
Clinical narrative: scabies; little bumps; burning; breaking out with a rash; blowing up 8 days later; itching has gotten worse; feels like she is crawling out of her skin.; normal side effects; after the 1st dose it was hives 8 days later; This spontaneous case was reported by a consumer and describes the occurrence of ACARODERMATITIS (scabies), ADVERSE REACTION (blowing up 8 days later), PRURITUS (itching has gotten worse), FORMICATION (feels like she is crawling out of her skin.) and URTICARIA (after the 1st dose it was hives 8 days later) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Apr-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) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced URTICARIA (after the 1st dose it was hives 8 days later). On 04-Apr-2021, the patient experienced ADVERSE REACTION (normal side effects). On 12-Apr-2021, the patient experienced ADVERSE REACTION (blowing up 8 days later), PRURITUS (itching has gotten worse), FORMICATION (feels like she is crawling out of her skin.) and RASH (breaking out with a rash). On an unknown date, the patient experienced ACARODERMATITIS (scabies), PAPULE (little bumps) and SKIN BURNING SENSATION (burning). The patient was treated with FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and MONTELUKAST SODIUM (SINGULAIR) at an unspecified dose and frequency. At the time of the report, ACARODERMATITIS (scabies), ADVERSE REACTION (blowing up 8 days later), PRURITUS (itching has gotten worse), FORMICATION (feels like she is crawling out of her skin.), URTICARIA (after the 1st dose it was hives 8 days later), ADVERSE REACTION (normal side effects), PAPULE (little bumps), SKIN BURNING SENSATION (burning) and RASH (breaking out with a rash) outcome was unknown.            No concomitant drugs were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-074825 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Significant FU / extra events added and 2nd dose events updated with outcome; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074825:2nd dose
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chills, Cough, Fatigue
Clinical narrative: weakness; cough; fatigue; a temperature/fever; chills; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), ASTHENIA (weakness), COUGH (cough), FATIGUE (fatigue) and PYREXIA (a temperature/fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced ASTHENIA (weakness), COUGH (cough), FATIGUE (fatigue), PYREXIA (a temperature/fever) and CHILLS (chills). The patient was treated with VITAMINS NOS at a dose of UNK dosage form and PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, COVID-19 (COVID-19), ASTHENIA (weakness), COUGH (cough), FATIGUE (fatigue), PYREXIA (a temperature/fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Oxygen saturation: 91/93 (Low) oxygen lower than normal (91/93). On 11-Apr-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Additional treatment medication included unspecified cough medicine.
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Pyrexia, SARS-CoV-2 test
Clinical narrative: weakness; cough; fatigue; a temperature/fever; chills; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), ASTHENIA (weakness), COUGH (cough), FATIGUE (fatigue) and PYREXIA (a temperature/fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced ASTHENIA (weakness), COUGH (cough), FATIGUE (fatigue), PYREXIA (a temperature/fever) and CHILLS (chills). The patient was treated with VITAMINS NOS at a dose of UNK dosage form and PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, COVID-19 (COVID-19), ASTHENIA (weakness), COUGH (cough), FATIGUE (fatigue), PYREXIA (a temperature/fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Oxygen saturation: 91/93 (Low) oxygen lower than normal (91/93). On 11-Apr-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Additional treatment medication included unspecified cough medicine.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included Parkinson's disease and Thyroid disorder. Concomitant products included ZONISAMIDE for Parkinson's disease, THYROID HORMONES for Thyroid disorder.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with GABAPENTIN for Shingles, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.            Action taken with mRNA 1273 in response to event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: As per the follow up document, the patient has authorized physician for further contact
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Really bad diarrhea after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Really bad diarrhea after 1st dose) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030b21a) 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) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced DIARRHOEA (Really bad diarrhea after 1st dose). At the time of the report, DIARRHOEA (Really bad diarrhea after 1st dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication information was reported. Patient reported that she was shopping in the grocery store where she got the shot, and about 25 minutes after the vaccine, experienced really bad diarrhea. She stated that  this is a change for her as she is usually constipated and that the diarrhea happened just that one time.