chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Chills, Decreased appetite, Eye pain, Hyperhidrosis
Clinical narrative: severe eye aches; dripping sweat; every joint was shaking; "Juice tasted like oil"; No taste at all; no appetite; felt like he had Covid again; intense fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (severe eye aches), HYPERHIDROSIS (dripping sweat), TREMOR (every joint was shaking), TASTE DISORDER ("Juice tasted like oil") and AGEUSIA (No taste at all) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included COVID-19 in November 2020.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced EYE PAIN (severe eye aches), HYPERHIDROSIS (dripping sweat), TREMOR (every joint was shaking), TASTE DISORDER ("Juice tasted like oil"), AGEUSIA (No taste at all), DECREASED APPETITE (no appetite), SUSPECTED COVID-19 (felt like he had Covid again), PYREXIA (intense fever) and CHILLS (chills). At the time of the report, EYE PAIN (severe eye aches), HYPERHIDROSIS (dripping sweat), TREMOR (every joint was shaking), TASTE DISORDER ("Juice tasted like oil"), AGEUSIA (No taste at all), DECREASED APPETITE (no appetite), SUSPECTED COVID-19 (felt like he had Covid again), PYREXIA (intense fever) and CHILLS (chills) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications and No Treatment medications were reported.   This case was linked to MOD-2021-067425 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Non significant follow-up contains primary reporter Email address.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Suspected COVID-19, Taste disorder, Tremor
Clinical narrative: severe eye aches; dripping sweat; every joint was shaking; "Juice tasted like oil"; No taste at all; no appetite; felt like he had Covid again; intense fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (severe eye aches), HYPERHIDROSIS (dripping sweat), TREMOR (every joint was shaking), TASTE DISORDER ("Juice tasted like oil") and AGEUSIA (No taste at all) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included COVID-19 in November 2020.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced EYE PAIN (severe eye aches), HYPERHIDROSIS (dripping sweat), TREMOR (every joint was shaking), TASTE DISORDER ("Juice tasted like oil"), AGEUSIA (No taste at all), DECREASED APPETITE (no appetite), SUSPECTED COVID-19 (felt like he had Covid again), PYREXIA (intense fever) and CHILLS (chills). At the time of the report, EYE PAIN (severe eye aches), HYPERHIDROSIS (dripping sweat), TREMOR (every joint was shaking), TASTE DISORDER ("Juice tasted like oil"), AGEUSIA (No taste at all), DECREASED APPETITE (no appetite), SUSPECTED COVID-19 (felt like he had Covid again), PYREXIA (intense fever) and CHILLS (chills) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications and No Treatment medications were reported.   This case was linked to MOD-2021-067425 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Non significant follow-up contains primary reporter Email address.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient tested positive for covid next day of receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient tested positive for covid next day of receiving 1st dose) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B2A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 04-Apr-2021, the patient experienced COVID-19 (Patient tested positive for covid next day of receiving 1st dose). At the time of the report, COVID-19 (Patient tested positive for covid next day of receiving 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was taken by patient.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Weight increased
Clinical narrative: Lingering shortness of breath; Weight gain; lingering shortness of breath for two weeks and described it as severe; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Lingering shortness of breath), WEIGHT INCREASED (Weight gain) and DYSPNOEA (lingering shortness of breath for two weeks and described it as severe) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (codeine) and Drug allergy (Demerol). Concomitant products included PRAVASTATIN, EZETIMIBE (ZETIA) and HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HYDROCHLOORTHIAZIDE) for an unknown indication.    On 07-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 DYSPNOEA (Lingering shortness of breath), WEIGHT INCREASED (Weight gain) and DYSPNOEA (lingering shortness of breath for two weeks and described it as severe). At the time of the report, DYSPNOEA (Lingering shortness of breath), WEIGHT INCREASED (Weight gain) and DYSPNOEA (lingering shortness of breath for two weeks and described it as severe) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        The Patient did not inform her primary health care provider about her symptoms but she had consulted a cardiologist prior to her first dose.  The patient second dose is scheduled on 11Apr2021
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 infection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19 infection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 infection). At the time of the report, COVID-19 (COVID-19 infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication, treatment details were not reported.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration interrupted, Product availability issue
Clinical narrative: Ran out of vaccines; Second dose greater than 36 days after first dose/ran out of vaccines; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT AVAILABILITY ISSUE (Ran out of vaccines) and PRODUCT ADMINISTRATION INTERRUPTED (Second dose greater than 36 days after first dose/ran out of vaccines) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    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 PRODUCT AVAILABILITY ISSUE (Ran out of vaccines) and PRODUCT ADMINISTRATION INTERRUPTED (Second dose greater than 36 days after first dose/ran out of vaccines). At the time of the report, PRODUCT AVAILABILITY ISSUE (Ran out of vaccines) and PRODUCT ADMINISTRATION INTERRUPTED (Second dose greater than 36 days after first dose/ran out of vaccines) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling, Pruritus, Rash macular
Clinical narrative: there are red spots on her skin that go across her arm; her arm got really swollen; red; itchy; swollen,; red warm; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (there are red spots on her skin that go across her arm), PERIPHERAL SWELLING (her arm got really swollen), ERYTHEMA (red), PRURITUS (itchy) and SWELLING (swollen,) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced RASH MACULAR (there are red spots on her skin that go across her arm), PERIPHERAL SWELLING (her arm got really swollen), ERYTHEMA (red), PRURITUS (itchy), SWELLING (swollen,) and FEELING HOT (red warm). At the time of the report, RASH MACULAR (there are red spots on her skin that go across her arm), PERIPHERAL SWELLING (her arm got really swollen), ERYTHEMA (red), PRURITUS (itchy) and FEELING HOT (red warm) had not resolved and SWELLING (swollen,) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: there are red spots on her skin that go across her arm; her arm got really swollen; red; itchy; swollen,; red warm; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (there are red spots on her skin that go across her arm), PERIPHERAL SWELLING (her arm got really swollen), ERYTHEMA (red), PRURITUS (itchy) and SWELLING (swollen,) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced RASH MACULAR (there are red spots on her skin that go across her arm), PERIPHERAL SWELLING (her arm got really swollen), ERYTHEMA (red), PRURITUS (itchy), SWELLING (swollen,) and FEELING HOT (red warm). At the time of the report, RASH MACULAR (there are red spots on her skin that go across her arm), PERIPHERAL SWELLING (her arm got really swollen), ERYTHEMA (red), PRURITUS (itchy) and FEELING HOT (red warm) had not resolved and SWELLING (swollen,) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Diarrhoea, Headache
Clinical narrative: Sore Left Arm; Stomach Messed up; Diarrhea; Severe Headache; Fever; Severe Muscle Pain; Joint Pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Left Arm), ABDOMINAL DISCOMFORT (Stomach Messed up), DIARRHOEA (Diarrhea), HEADACHE (Severe Headache) and PYREXIA (Fever) in a 34-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 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore Left Arm), ABDOMINAL DISCOMFORT (Stomach Messed up), DIARRHOEA (Diarrhea), HEADACHE (Severe Headache), PYREXIA (Fever), MYALGIA (Severe Muscle Pain), ARTHRALGIA (Joint Pain) and CHILLS (Chills). On 04-Apr-2021, PAIN IN EXTREMITY (Sore Left Arm), ABDOMINAL DISCOMFORT (Stomach Messed up), DIARRHOEA (Diarrhea), HEADACHE (Severe Headache), PYREXIA (Fever), MYALGIA (Severe Muscle Pain), ARTHRALGIA (Joint Pain) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medication was reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Sore Left Arm; Stomach Messed up; Diarrhea; Severe Headache; Fever; Severe Muscle Pain; Joint Pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Left Arm), ABDOMINAL DISCOMFORT (Stomach Messed up), DIARRHOEA (Diarrhea), HEADACHE (Severe Headache) and PYREXIA (Fever) in a 34-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 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore Left Arm), ABDOMINAL DISCOMFORT (Stomach Messed up), DIARRHOEA (Diarrhea), HEADACHE (Severe Headache), PYREXIA (Fever), MYALGIA (Severe Muscle Pain), ARTHRALGIA (Joint Pain) and CHILLS (Chills). On 04-Apr-2021, PAIN IN EXTREMITY (Sore Left Arm), ABDOMINAL DISCOMFORT (Stomach Messed up), DIARRHOEA (Diarrhea), HEADACHE (Severe Headache), PYREXIA (Fever), MYALGIA (Severe Muscle Pain), ARTHRALGIA (Joint Pain) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medication was reported.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: sore arm; inability to lift arm; body ache; mild COVID-19-like symptoms; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (inability to lift arm), PAIN (body ache), COVID-19 (mild COVID-19-like symptoms) and FATIGUE (tiredness) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Seasonal allergy.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (inability to lift arm), PAIN (body ache), COVID-19 (mild COVID-19-like symptoms) and FATIGUE (tiredness). On 11-Mar-2021, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (inability to lift arm), PAIN (body ache), COVID-19 (mild COVID-19-like symptoms) and FATIGUE (tiredness) had resolved. On 12-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Nov-2020, SARS-CoV-2 test: positive (Positive) Positive. On 03-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment drugs were reported.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: sore arm; inability to lift arm; body ache; mild COVID-19-like symptoms; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (inability to lift arm), PAIN (body ache), COVID-19 (mild COVID-19-like symptoms) and FATIGUE (tiredness) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Seasonal allergy.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (inability to lift arm), PAIN (body ache), COVID-19 (mild COVID-19-like symptoms) and FATIGUE (tiredness). On 11-Mar-2021, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (inability to lift arm), PAIN (body ache), COVID-19 (mild COVID-19-like symptoms) and FATIGUE (tiredness) had resolved. On 12-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Nov-2020, SARS-CoV-2 test: positive (Positive) Positive. On 03-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment drugs were reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia
Clinical narrative: sleeping all the time; fatigued; This spontaneous case was reported by a nurse and describes the occurrence of HYPERSOMNIA (sleeping all the time) and FATIGUE (fatigued) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced HYPERSOMNIA (sleeping all the time) and FATIGUE (fatigued). At the time of the report, HYPERSOMNIA (sleeping all the time) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    relevant concomitant products usage were not reported by the reporter. Treatment details included ibuprofen.   Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Autoimmune disorder, Fatigue, Feeling abnormal
Clinical narrative: Autoimmune Disorder; still feel like really fatigued; weak; still lowly; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (Autoimmune Disorder) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder, Rheumatoid arthritis and Fibromyalgia.   On 01-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 01-Apr-2021, the patient experienced FATIGUE (still feel like really fatigued), ASTHENIA (weak) and FEELING ABNORMAL (still lowly). On an unknown date, the patient experienced AUTOIMMUNE DISORDER (Autoimmune Disorder) (seriousness criterion medically significant). At the time of the report, FATIGUE (still feel like really fatigued), ASTHENIA (weak), FEELING ABNORMAL (still lowly) and AUTOIMMUNE DISORDER (Autoimmune Disorder) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The patient did not receive any treatment
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: foot numb and tingling; left side face little numb and tingling; left arm from elbow down to fingers (numb); left leg from knees to foot (numb); This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (foot numb and tingling), HYPOAESTHESIA (left side face little numb and tingling), HYPOAESTHESIA (left arm from elbow down to fingers (numb)) and HYPOAESTHESIA (left leg from knees to foot (numb)) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concomitant products included FINASTERIDE for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced HYPOAESTHESIA (foot numb and tingling), HYPOAESTHESIA (left side face little numb and tingling), HYPOAESTHESIA (left arm from elbow down to fingers (numb)) and HYPOAESTHESIA (left leg from knees to foot (numb)). At the time of the report, HYPOAESTHESIA (foot numb and tingling), HYPOAESTHESIA (left side face little numb and tingling), HYPOAESTHESIA (left arm from elbow down to fingers (numb)) and HYPOAESTHESIA (left leg from knees to foot (numb)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pyrexia, Rash, Urticaria
Clinical narrative: Flu like symptoms; Rash; Chills; Fever; Bad hives all over the body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Bad hives all over the body), INFLUENZA LIKE ILLNESS (Flu like symptoms), RASH (Rash), CHILLS (Chills) and PYREXIA (Fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced URTICARIA (Bad hives all over the body), RASH (Rash), CHILLS (Chills) and PYREXIA (Fever). On 04-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, URTICARIA (Bad hives all over the body), INFLUENZA LIKE ILLNESS (Flu like symptoms), RASH (Rash), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Treatment  medication included antihistamines.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow up was received on 7-Apr-2021, additional event of bad hives all over body was reported, treatment information of antihistamines was reported, start date of event chills was changed from 4 Apr 2021 to 3 Apr 2021.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: fast heart beat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (fast heart beat) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (fast heart beat). At the time of the report, HEART RATE INCREASED (fast heart beat) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided.    Reporter did not allow further contact
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Tongue eruption
Clinical narrative: rash under tongue. little pouches under tongue and lower lip; difficult to eat and cannot wear lower dentures; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE ERUPTION (rash under tongue. little pouches under tongue and lower lip) and DYSPHAGIA (difficult to eat and cannot wear lower dentures) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Denture wearer. Concomitant products included TAMSULOSIN, APIXABAN (ELIQUIS) and LISINOPRIL for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced TONGUE ERUPTION (rash under tongue. little pouches under tongue and lower lip) and DYSPHAGIA (difficult to eat and cannot wear lower dentures). At the time of the report, TONGUE ERUPTION (rash under tongue. little pouches under tongue and lower lip) and DYSPHAGIA (difficult to eat and cannot wear lower dentures) outcome was unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Emotional distress, Lethargy
Clinical narrative: lethargic; No appetite; run down; severe diarrhea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Apr-2021 and was forwarded to Moderna on 05-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea), LETHARGY (lethargic), DECREASED APPETITE (No appetite) and EMOTIONAL DISTRESS (run down) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not reported ). Concomitant products included METFORMIN for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced DIARRHOEA (severe diarrhea). On 05-Apr-2021, the patient experienced LETHARGY (lethargic), DECREASED APPETITE (No appetite) and EMOTIONAL DISTRESS (run down). On 05-Apr-2021, DIARRHOEA (severe diarrhea) had resolved. At the time of the report, LETHARGY (lethargic), DECREASED APPETITE (No appetite) and EMOTIONAL DISTRESS (run down) had not resolved. Not Provided          Treatment included Imodium and vitamin water.   This case was linked to MODERNATX, INC.-MOD-2021-067212 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-067212:crosslink
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: red rash two inches circular the whole way around around the inoculation site; red rash two inches circular the whole way around around the inoculation site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (red rash two inches circular the whole way around around the inoculation site) and VACCINATION SITE ERYTHEMA (red rash two inches circular the whole way around around the inoculation site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (red rash two inches circular the whole way around around the inoculation site) and VACCINATION SITE ERYTHEMA (red rash two inches circular the whole way around around the inoculation site). At the time of the report, VACCINATION SITE RASH (red rash two inches circular the whole way around around the inoculation site) and VACCINATION SITE ERYTHEMA (red rash two inches circular the whole way around around the inoculation 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.  No treatment information was reported.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error, Product storage error
Clinical narrative: Vaccine with 34F temperature administered to patient; Vaccine with 34F temperature administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Vaccine with 34F temperature administered to patient) and PRODUCT STORAGE ERROR (Vaccine with 34F temperature administered to patient) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Vaccine with 34F temperature administered to patient) and PRODUCT STORAGE ERROR (Vaccine with 34F temperature administered to patient). On 05-Apr-2021, PRODUCT ADMINISTRATION ERROR (Vaccine with 34F temperature administered to patient) and PRODUCT STORAGE ERROR (Vaccine with 34F temperature administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PRODUCT ADMINISTRATION ERROR (Vaccine with 34F temperature administered to patient) and PRODUCT STORAGE ERROR (Vaccine with 34F temperature administered to patient) to be not applicable.    Concomitant product use was not provided by the reporter.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Back pain, Diarrhoea, Feeling abnormal, Illness
Clinical narrative: Feeling bad; Diarrhea; upset stomach; Back pain; sick/doesnt know if she has a bug or if she ate something bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling bad), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (upset stomach), BACK PAIN (Back pain) and ILLNESS (sick/doesnt know if she has a bug or if she ate something bad) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced FEELING ABNORMAL (Feeling bad), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (upset stomach), BACK PAIN (Back pain) and ILLNESS (sick/doesnt know if she has a bug or if she ate something bad). At the time of the report, FEELING ABNORMAL (Feeling bad), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (upset stomach), BACK PAIN (Back pain) and ILLNESS (sick/doesnt know if she has a bug or if she ate something bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Additional information received on 19-May-2021. Patient informed that he did not experience any of the mentioned events.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Dizziness, Erythema
Clinical narrative: Really bad lower back pain on left and right side; So dizzy they could not stand up.; Like something was ripping out their kidneys; Arm red; Arm swollen; fever; Tired; joint pain; muscle pain; headache; nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Really bad lower back pain on left and right side), DIZZINESS (So dizzy they could not stand up.), FEELING ABNORMAL (Like something was ripping out their kidneys), ERYTHEMA (Arm red) and PERIPHERAL SWELLING (Arm swollen) in a male 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 02-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) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced BACK PAIN (Really bad lower back pain on left and right side), DIZZINESS (So dizzy they could not stand up.), FEELING ABNORMAL (Like something was ripping out their kidneys), ERYTHEMA (Arm red), PERIPHERAL SWELLING (Arm swollen), PYREXIA (fever), FATIGUE (Tired), ARTHRALGIA (joint pain), MYALGIA (muscle pain), HEADACHE (headache), NAUSEA (nausea) and CHILLS (Chills). At the time of the report, BACK PAIN (Really bad lower back pain on left and right side), DIZZINESS (So dizzy they could not stand up.), FEELING ABNORMAL (Like something was ripping out their kidneys), ERYTHEMA (Arm red), PERIPHERAL SWELLING (Arm swollen), PYREXIA (fever), FATIGUE (Tired), ARTHRALGIA (joint pain), MYALGIA (muscle pain), HEADACHE (headache), NAUSEA (nausea) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to MOD-2021-067367 (E2B Linked Report).; Sender's Comments:  MOD-2021-067367:Wife Case
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Myalgia, Nausea
Clinical narrative: Really bad lower back pain on left and right side; So dizzy they could not stand up.; Like something was ripping out their kidneys; Arm red; Arm swollen; fever; Tired; joint pain; muscle pain; headache; nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Really bad lower back pain on left and right side), DIZZINESS (So dizzy they could not stand up.), FEELING ABNORMAL (Like something was ripping out their kidneys), ERYTHEMA (Arm red) and PERIPHERAL SWELLING (Arm swollen) in a male 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 02-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) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced BACK PAIN (Really bad lower back pain on left and right side), DIZZINESS (So dizzy they could not stand up.), FEELING ABNORMAL (Like something was ripping out their kidneys), ERYTHEMA (Arm red), PERIPHERAL SWELLING (Arm swollen), PYREXIA (fever), FATIGUE (Tired), ARTHRALGIA (joint pain), MYALGIA (muscle pain), HEADACHE (headache), NAUSEA (nausea) and CHILLS (Chills). At the time of the report, BACK PAIN (Really bad lower back pain on left and right side), DIZZINESS (So dizzy they could not stand up.), FEELING ABNORMAL (Like something was ripping out their kidneys), ERYTHEMA (Arm red), PERIPHERAL SWELLING (Arm swollen), PYREXIA (fever), FATIGUE (Tired), ARTHRALGIA (joint pain), MYALGIA (muscle pain), HEADACHE (headache), NAUSEA (nausea) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to MOD-2021-067367 (E2B Linked Report).; Sender's Comments:  MOD-2021-067367:Wife Case
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Really bad lower back pain on left and right side; So dizzy they could not stand up.; Like something was ripping out their kidneys; Arm red; Arm swollen; fever; Tired; joint pain; muscle pain; headache; nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Really bad lower back pain on left and right side), DIZZINESS (So dizzy they could not stand up.), FEELING ABNORMAL (Like something was ripping out their kidneys), ERYTHEMA (Arm red) and PERIPHERAL SWELLING (Arm swollen) in a male 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 02-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) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced BACK PAIN (Really bad lower back pain on left and right side), DIZZINESS (So dizzy they could not stand up.), FEELING ABNORMAL (Like something was ripping out their kidneys), ERYTHEMA (Arm red), PERIPHERAL SWELLING (Arm swollen), PYREXIA (fever), FATIGUE (Tired), ARTHRALGIA (joint pain), MYALGIA (muscle pain), HEADACHE (headache), NAUSEA (nausea) and CHILLS (Chills). At the time of the report, BACK PAIN (Really bad lower back pain on left and right side), DIZZINESS (So dizzy they could not stand up.), FEELING ABNORMAL (Like something was ripping out their kidneys), ERYTHEMA (Arm red), PERIPHERAL SWELLING (Arm swollen), PYREXIA (fever), FATIGUE (Tired), ARTHRALGIA (joint pain), MYALGIA (muscle pain), HEADACHE (headache), NAUSEA (nausea) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to MOD-2021-067367 (E2B Linked Report).; Sender's Comments:  MOD-2021-067367:Wife Case
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Injection site itching; Red rash at the injection site and it is blotchy, itchy; Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Injection site itching), VACCINATION SITE RASH (Red rash at the injection site and it is blotchy, itchy) and VACCINATION SITE SWELLING (Vaccination site swelling) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-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 INJECTION SITE PRURITUS (Injection site itching), VACCINATION SITE RASH (Red rash at the injection site and it is blotchy, itchy) and VACCINATION SITE SWELLING (Vaccination site swelling). On 05-Apr-2021, INJECTION SITE PRURITUS (Injection site itching), VACCINATION SITE RASH (Red rash at the injection site and it is blotchy, itchy) and VACCINATION SITE SWELLING (Vaccination site swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product details were provided by the reporter.  Patient advised the reported AE from the 1st vaccine resolved.  No Treatment information was provided.   This case was linked to MOD-2021-279725 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up received on 06-Aug-2021 and included non-significant information.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, Product dose omission issue, Seasonal allergy
Clinical narrative: Seasonal allergy symptoms; Missed 2nd dose on 25 Mar 2021; positive PCR; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive PCR), SEASONAL ALLERGY (Seasonal allergy symptoms) and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose on 25 Mar 2021) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced COVID-19 (positive PCR). On 25-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose on 25 Mar 2021). On an unknown date, the patient experienced SEASONAL ALLERGY (Seasonal allergy symptoms). On 25-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose on 25 Mar 2021) had resolved. On 30-Mar-2021, COVID-19 (positive PCR) had resolved. At the time of the report, SEASONAL ALLERGY (Seasonal allergy symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jul-2020, Polymerase chain reaction: negative (Negative) Negative-not detected (Source of sample-Nasopharyngeal). On 15-Mar-2021, Polymerase chain reaction: positive (Positive) Positive-detected Source of sample-Saliva).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  The patient had done with quarantine on 30 Mar 2021. The patient experienced COVID-19 symptoms of chills and fatigue.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received updated patient demographic details, laboratory data, narrative information. On 28-Jul-2021: Follow  up information Received on 28-JUL-2021 contains No New Information.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Rash is itchy; Rash is warm; COVID arm rash; Rash is swollen; Rash is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Rash is itchy), VACCINATION SITE WARMTH (Rash is warm), VACCINATION SITE RASH (COVID arm rash), VACCINATION SITE SWELLING (Rash is swollen) and VACCINATION SITE ERYTHEMA (Rash is red) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Rash is itchy), VACCINATION SITE WARMTH (Rash is warm), VACCINATION SITE RASH (COVID arm rash), VACCINATION SITE SWELLING (Rash is swollen) and VACCINATION SITE ERYTHEMA (Rash is red). In April 2021, VACCINATION SITE PRURITUS (Rash is itchy), VACCINATION SITE WARMTH (Rash is warm), VACCINATION SITE RASH (COVID arm rash), VACCINATION SITE SWELLING (Rash is swollen) and VACCINATION SITE ERYTHEMA (Rash is red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 02-Apr-2021, 7 days post vaccination, the patient experienced COVID arm rash and it was reported to be swollen, red, warm and itchy.  No information of treatment was provided. The events were recovered.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: Nausea; Severe body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), MYALGIA (Severe body aches) and HEADACHE (Headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-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) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced NAUSEA (Nausea), MYALGIA (Severe body aches) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL 12HOUR) at an unspecified dose and frequency. At the time of the report, NAUSEA (Nausea), MYALGIA (Severe body aches) and HEADACHE (Headache) outcome was unknown.     Action taken with mRNA-1273 in response to the events was not applicable   No concomitant medications provided
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Pain in extremity
Clinical narrative: Arm soreness; HR raised a bit (from 54 to 70); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and HEART RATE INCREASED (HR raised a bit (from 54 to 70)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Iodine allergy, Shellfish allergy, Allergy (A lot of things), MS and Cholesterol blood excessive. Concomitant products included ATORVASTATIN for Cholesterol, GLATIRAMER ACETATE (GLATOPA) for MS, VANEX for Sleep disorder, DULOXETINE HYDROCHLORIDE (CYMBALTA), ACETYLSALICYLIC ACID (BABY ASPIRIN), BACLOFEN, VITAMIN D3 and FISH OIL (OMEGA 3 FISH OILS) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and HEART RATE INCREASED (HR raised a bit (from 54 to 70)). On 04-Mar-2021, HEART RATE INCREASED (HR raised a bit (from 54 to 70)) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 54 (Inconclusive) 54 beats per minute at rest and 70 (Inconclusive) 70 after the vaccine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment Information was not provided.   This case was linked to MOD-2021-066704 (Patient Link).