chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Myalgia
Clinical narrative: Diarrhea; Chills; Headache; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Muscle ache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Muscle ache). At the time of the report, DIARRHOEA (Diarrhea), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Muscle ache) outcome was unknown.            No concomitant medications were provided. No treatment medications were taken by the patient.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: hot; hard; the injection site was red; injection site was about the size of quarter (circumference).; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (the injection site was red), VACCINATION SITE SWELLING (injection site was about the size of quarter (circumference).), VACCINATION SITE WARMTH (hot) and VACCINATION SITE INDURATION (hard) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (the injection site was red) and VACCINATION SITE SWELLING (injection site was about the size of quarter (circumference).). On 30-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot) and VACCINATION SITE INDURATION (hard). At the time of the report, VACCINATION SITE ERYTHEMA (the injection site was red), VACCINATION SITE SWELLING (injection site was about the size of quarter (circumference).), VACCINATION SITE WARMTH (hot) and VACCINATION SITE INDURATION (hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No relevant concomitant medications were reported.  Treatment for the events was not reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Vomiting
Clinical narrative: Diarrhea; Vomiting; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), VOMITING (Vomiting), CHILLS (Chills) and FATIGUE (Fatigue) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), VOMITING (Vomiting), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, DIARRHOEA (Diarrhea), VOMITING (Vomiting), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up information received. Contain no new significant information. Only Contact details were updated.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Flu like symptoms; Muscle pain; Headache; Fever; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Muscle pain), HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (Tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Muscle pain), HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (Tiredness). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Muscle pain), HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced COUGH (Cough). At the time of the report, COUGH (Cough) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: Red around neck; Bad rash all over the body like in the back, in the neck, in the leg; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red around neck) and RASH (Bad rash all over the body like in the back, in the neck, in the leg) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced ERYTHEMA (Red around neck) and RASH (Bad rash all over the body like in the back, in the neck, in the leg). At the time of the report, ERYTHEMA (Red around neck) and RASH (Bad rash all over the body like in the back, in the neck, in the leg) was resolving.            Patient was taking other concomitant medications. Treatment medications were unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling
Clinical narrative: Eyes swollen; Lips swollen; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eyes swollen) and LIP SWELLING (Lips swollen) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE SWELLING (Eyes swollen) and LIP SWELLING (Lips swollen). At the time of the report, EYE SWELLING (Eyes swollen) and LIP SWELLING (Lips swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow-up information received on 30-APR-2021 does not contain any new information.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Vaccination complication
Clinical narrative: Strange reaction; almost immediately after the shot right side of her neck shoulder blade got stiff, but she could; lower leg from knee to her toe was feeling like somebody is scrapping her leg with knife, had bad pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Strange reaction), MUSCULOSKELETAL STIFFNESS (almost immediately after the shot right side of her neck shoulder blade got stiff, but she could) and PAIN IN EXTREMITY (lower leg from knee to her toe was feeling like somebody is scrapping her leg with knife, had bad pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION COMPLICATION (Strange reaction), MUSCULOSKELETAL STIFFNESS (almost immediately after the shot right side of her neck shoulder blade got stiff, but she could) and PAIN IN EXTREMITY (lower leg from knee to her toe was feeling like somebody is scrapping her leg with knife, had bad pain). At the time of the report, VACCINATION COMPLICATION (Strange reaction) and MUSCULOSKELETAL STIFFNESS (almost immediately after the shot right side of her neck shoulder blade got stiff, but she could) outcome was unknown and PAIN IN EXTREMITY (lower leg from knee to her toe was feeling like somebody is scrapping her leg with knife, had bad pain) had resolved with sequelae.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took Tylenol , it helped and it's fine now like 90% better than before.   Patient  also takes COQ10 every day .
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Arthralgia, Chills, Fatigue, Feeling abnormal
Clinical narrative: some really weird side effects; left arm hurt; feeling awful; left arm swollen; joint pain/ left knee is hurting; Nausea; headaches; Fatigues; Chills; This spontaneous case was reported by a nurse and describes the occurrence of ADVERSE EVENT (some really weird side effects), PAIN IN EXTREMITY (left arm hurt), FEELING ABNORMAL (feeling awful), PERIPHERAL SWELLING (left arm swollen) and ARTHRALGIA (joint pain/ left knee is hurting) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (some really weird side effects), PAIN IN EXTREMITY (left arm hurt), FEELING ABNORMAL (feeling awful), PERIPHERAL SWELLING (left arm swollen), ARTHRALGIA (joint pain/ left knee is hurting), NAUSEA (Nausea), HEADACHE (headaches), FATIGUE (Fatigues) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and PROMETHAZINE at an unspecified dose and frequency. At the time of the report, ADVERSE EVENT (some really weird side effects), PAIN IN EXTREMITY (left arm hurt), FEELING ABNORMAL (feeling awful), PERIPHERAL SWELLING (left arm swollen), ARTHRALGIA (joint pain/ left knee is hurting), NAUSEA (Nausea), HEADACHE (headaches), FATIGUE (Fatigues) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was reported
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: some really weird side effects; left arm hurt; feeling awful; left arm swollen; joint pain/ left knee is hurting; Nausea; headaches; Fatigues; Chills; This spontaneous case was reported by a nurse and describes the occurrence of ADVERSE EVENT (some really weird side effects), PAIN IN EXTREMITY (left arm hurt), FEELING ABNORMAL (feeling awful), PERIPHERAL SWELLING (left arm swollen) and ARTHRALGIA (joint pain/ left knee is hurting) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (some really weird side effects), PAIN IN EXTREMITY (left arm hurt), FEELING ABNORMAL (feeling awful), PERIPHERAL SWELLING (left arm swollen), ARTHRALGIA (joint pain/ left knee is hurting), NAUSEA (Nausea), HEADACHE (headaches), FATIGUE (Fatigues) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and PROMETHAZINE at an unspecified dose and frequency. At the time of the report, ADVERSE EVENT (some really weird side effects), PAIN IN EXTREMITY (left arm hurt), FEELING ABNORMAL (feeling awful), PERIPHERAL SWELLING (left arm swollen), ARTHRALGIA (joint pain/ left knee is hurting), NAUSEA (Nausea), HEADACHE (headaches), FATIGUE (Fatigues) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was reported
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Injection site reaction, Vaccination site erythema, Vaccination site induration, Vaccination site inflammation
Clinical narrative: Had a little problem breathing; Left arm, where she got the shot, is a lot bigger than her right arm now; Injection arm warm; Injection arm is inflamed; Injection arm hard; Injection arm red; Injection arm swollen; Injection arm sore / hurts; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Had a little problem breathing), INJECTION SITE REACTION (Left arm, where she got the shot, is a lot bigger than her right arm now), VACCINATION SITE WARMTH (Injection arm warm), VACCINATION SITE INFLAMMATION (Injection arm is inflamed) and VACCINATION SITE INDURATION (Injection arm hard) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Penicillin allergy, Allergy to antibiotic (Allergy to antibiotics) and Drug allergy (Allergy to Ibuprofen, the patient was hospitalized for taking ibuprofen 3 times).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced INJECTION SITE REACTION (Left arm, where she got the shot, is a lot bigger than her right arm now), VACCINATION SITE WARMTH (Injection arm warm), VACCINATION SITE INFLAMMATION (Injection arm is inflamed), VACCINATION SITE INDURATION (Injection arm hard), VACCINATION SITE ERYTHEMA (Injection arm red), VACCINATION SITE SWELLING (Injection arm swollen) and VACCINATION SITE PAIN (Injection arm sore / hurts). On an unknown date, the patient experienced DYSPNOEA (Had a little problem breathing). At the time of the report, DYSPNOEA (Had a little problem breathing), INJECTION SITE REACTION (Left arm, where she got the shot, is a lot bigger than her right arm now), VACCINATION SITE WARMTH (Injection arm warm), VACCINATION SITE INFLAMMATION (Injection arm is inflamed), VACCINATION SITE INDURATION (Injection arm hard), VACCINATION SITE ERYTHEMA (Injection arm red), VACCINATION SITE SWELLING (Injection arm swollen) and VACCINATION SITE PAIN (Injection arm sore / hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Had a little problem breathing; Left arm, where she got the shot, is a lot bigger than her right arm now; Injection arm warm; Injection arm is inflamed; Injection arm hard; Injection arm red; Injection arm swollen; Injection arm sore / hurts; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Had a little problem breathing), INJECTION SITE REACTION (Left arm, where she got the shot, is a lot bigger than her right arm now), VACCINATION SITE WARMTH (Injection arm warm), VACCINATION SITE INFLAMMATION (Injection arm is inflamed) and VACCINATION SITE INDURATION (Injection arm hard) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Penicillin allergy, Allergy to antibiotic (Allergy to antibiotics) and Drug allergy (Allergy to Ibuprofen, the patient was hospitalized for taking ibuprofen 3 times).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced INJECTION SITE REACTION (Left arm, where she got the shot, is a lot bigger than her right arm now), VACCINATION SITE WARMTH (Injection arm warm), VACCINATION SITE INFLAMMATION (Injection arm is inflamed), VACCINATION SITE INDURATION (Injection arm hard), VACCINATION SITE ERYTHEMA (Injection arm red), VACCINATION SITE SWELLING (Injection arm swollen) and VACCINATION SITE PAIN (Injection arm sore / hurts). On an unknown date, the patient experienced DYSPNOEA (Had a little problem breathing). At the time of the report, DYSPNOEA (Had a little problem breathing), INJECTION SITE REACTION (Left arm, where she got the shot, is a lot bigger than her right arm now), VACCINATION SITE WARMTH (Injection arm warm), VACCINATION SITE INFLAMMATION (Injection arm is inflamed), VACCINATION SITE INDURATION (Injection arm hard), VACCINATION SITE ERYTHEMA (Injection arm red), VACCINATION SITE SWELLING (Injection arm swollen) and VACCINATION SITE PAIN (Injection arm sore / hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Urinary tract infection
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (Patient developing a UTI) and INFECTION (Developed an infection at the scratch site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included METFORMIN for Diabetes.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (Patient developing a UTI) and INFECTION (Developed an infection at the scratch site). At the time of the report, URINARY TRACT INFECTION (Patient developing a UTI) and INFECTION (Developed an infection at the scratch site) 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.   The patient was treated with antibiotics for infection at the scratch site and Bactrim for the UTI.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: Chills; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) 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 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was not provided.  The patient had trouble conceiving and was scheduled for an ultrasound procedure with water and was recommend to take Motrin or Advil before procedure. Wanted to know if it is ok to take medication before procedure.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Vaccination site pruritus
Clinical narrative: face started feeling numb; good amount of pain in her arm; Arm was itchy around the site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a physician and describes the occurrence of HYPOAESTHESIA (face started feeling numb), PAIN IN EXTREMITY (good amount of pain in her arm) and VACCINATION SITE PRURITUS (Arm was itchy around the site) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Proair Inhaler, ortho tricyclin lo and Adderall IR for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (face started feeling numb), PAIN IN EXTREMITY (good amount of pain in her arm) and VACCINATION SITE PRURITUS (Arm was itchy around the site). At the time of the report, HYPOAESTHESIA (face started feeling numb), PAIN IN EXTREMITY (good amount of pain in her arm) and VACCINATION SITE PRURITUS (Arm was itchy around the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Felt dizzy this morning; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt dizzy this morning) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CALCIUM, COLECALCIFEROL (VITAMIN D 3), LISINOPRIL, ATORVASTATIN and GLIMEPIRIDE (GLIMEPIRID) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 11-Feb-2021, the patient experienced DIZZINESS (Felt dizzy this morning).   On 11-Feb-2021, DIZZINESS (Felt dizzy this morning) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Pyrexia
Clinical narrative: fever; chills; fatigue; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue) and DIARRHOEA (diarrhea) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00417120A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue) and DIARRHOEA (diarrhea). On 30-Jan-2021, PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue) and DIARRHOEA (diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No Treatment details included.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Mobility decreased, Neck pain, Pain
Clinical narrative: Shoulder became frozen; Real severe pain; Couldn't move for 2 days; Pain has been extended over the neck (L side); Pain has been extended over the leg (L side); Pain has been extended over to the hips (L side); This spontaneous case was reported by a consumer and describes the occurrence of PERIARTHRITIS (Shoulder became frozen), PAIN (Real severe pain), MOBILITY DECREASED (Couldn't move for 2 days), NECK PAIN (Pain has been extended over the neck (L side)) and PAIN IN EXTREMITY (Pain has been extended over the leg (L side)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010"N" 120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy, Food allergy (Sensitive to food additives) and Chronic fatigue. Concomitant products included GABAPENTIN for Neuropathy and Hot flashes, AMITRIPTYLINE for Sleep deficit.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PERIARTHRITIS (Shoulder became frozen), PAIN (Real severe pain), MOBILITY DECREASED (Couldn't move for 2 days), NECK PAIN (Pain has been extended over the neck (L side)), PAIN IN EXTREMITY (Pain has been extended over the leg (L side)) and ARTHRALGIA (Pain has been extended over to the hips (L side)). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 27-Feb-2021, PERIARTHRITIS (Shoulder became frozen), PAIN (Real severe pain), MOBILITY DECREASED (Couldn't move for 2 days), NECK PAIN (Pain has been extended over the neck (L side)), PAIN IN EXTREMITY (Pain has been extended over the leg (L side)) and ARTHRALGIA (Pain has been extended over to the hips (L side)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 103 f 103 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: VAER's report received. patient details ,concomitant medication, medical history updated.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Periarthritis
Clinical narrative: Shoulder became frozen; Real severe pain; Couldn't move for 2 days; Pain has been extended over the neck (L side); Pain has been extended over the leg (L side); Pain has been extended over to the hips (L side); This spontaneous case was reported by a consumer and describes the occurrence of PERIARTHRITIS (Shoulder became frozen), PAIN (Real severe pain), MOBILITY DECREASED (Couldn't move for 2 days), NECK PAIN (Pain has been extended over the neck (L side)) and PAIN IN EXTREMITY (Pain has been extended over the leg (L side)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010"N" 120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy, Food allergy (Sensitive to food additives) and Chronic fatigue. Concomitant products included GABAPENTIN for Neuropathy and Hot flashes, AMITRIPTYLINE for Sleep deficit.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PERIARTHRITIS (Shoulder became frozen), PAIN (Real severe pain), MOBILITY DECREASED (Couldn't move for 2 days), NECK PAIN (Pain has been extended over the neck (L side)), PAIN IN EXTREMITY (Pain has been extended over the leg (L side)) and ARTHRALGIA (Pain has been extended over to the hips (L side)). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 27-Feb-2021, PERIARTHRITIS (Shoulder became frozen), PAIN (Real severe pain), MOBILITY DECREASED (Couldn't move for 2 days), NECK PAIN (Pain has been extended over the neck (L side)), PAIN IN EXTREMITY (Pain has been extended over the leg (L side)) and ARTHRALGIA (Pain has been extended over to the hips (L side)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 103 f 103 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: VAER's report received. patient details ,concomitant medication, medical history updated.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Feeding disorder
Clinical narrative: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 03-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diaarhea), ASTHENIA (weakness), GAIT INABILITY (unable to walk), DIZZINESS (Dizziness) and FEEDING DISORDER (unable to eat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event from 05-Apr-2021 to 18-Mar-2021. On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced DIARRHEA (Diaarhea), ASTHENIA (weakness), GAIT INABILITY (unable to walk), DIZZINESS (Dizziness), FEEDING DISORDER (unable to eat), HEADACHE (Headache), NAUSEA (nauseous), MYALGIA (muscle aches and pains/whole body ached) and CHILLS (SHIVERS). On 28-Feb-2021, DIARRHEA (Diaarhea), ASTHENIA (weakness), GAIT INABILITY (unable to walk), DIZZINESS (Dizziness), FEEDING DISORDER (unable to eat), HEADACHE (Headache), MYALGIA (muscle aches and pains/whole body ached) and CHILLS (SHIVERS) had resolved. At the time of the report, NAUSEA (nauseous) had resolved.  This case was linked to MOD-2021-101676.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Headache, Myalgia, Nausea
Clinical narrative: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 03-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diaarhea), ASTHENIA (weakness), GAIT INABILITY (unable to walk), DIZZINESS (Dizziness) and FEEDING DISORDER (unable to eat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event from 05-Apr-2021 to 18-Mar-2021. On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced DIARRHEA (Diaarhea), ASTHENIA (weakness), GAIT INABILITY (unable to walk), DIZZINESS (Dizziness), FEEDING DISORDER (unable to eat), HEADACHE (Headache), NAUSEA (nauseous), MYALGIA (muscle aches and pains/whole body ached) and CHILLS (SHIVERS). On 28-Feb-2021, DIARRHEA (Diaarhea), ASTHENIA (weakness), GAIT INABILITY (unable to walk), DIZZINESS (Dizziness), FEEDING DISORDER (unable to eat), HEADACHE (Headache), MYALGIA (muscle aches and pains/whole body ached) and CHILLS (SHIVERS) had resolved. At the time of the report, NAUSEA (nauseous) had resolved.  This case was linked to MOD-2021-101676.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm; Legs were so sore; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN IN EXTREMITY (Legs were so sore) and HEADACHE (Headache) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PAIN IN EXTREMITY (Legs were so sore) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), PAIN IN EXTREMITY (Legs were so sore) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-032136 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Pain in extremity, Spinal pain
Clinical narrative: Head pressure; Pain in arm (LEFT); Spine ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm (LEFT)), SPINAL PAIN (Spine ache) and HEAD DISCOMFORT (Head pressure) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer since 2012 and Rheumatoid arthritis. Concomitant products included UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm (LEFT)) and SPINAL PAIN (Spine ache). On 11-Feb-2021, the patient experienced HEAD DISCOMFORT (Head pressure). On 11-Feb-2021, PAIN IN EXTREMITY (Pain in arm (LEFT)) and HEAD DISCOMFORT (Head pressure) had resolved. On 12-Feb-2021, SPINAL PAIN (Spine ache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Severe headache; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache) and MYALGIA (Arm soreness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-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 HEADACHE (Severe headache) and MYALGIA (Arm soreness). At the time of the report, HEADACHE (Severe headache) and MYALGIA (Arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dry mouth, Paraesthesia, Pharyngeal paraesthesia
Clinical narrative: Bumps on back of my tongue; chills; swelling face/Face and neck puffy; swelling throat; tingling in throat; weakness; Tingling in lower jaw; Mouth was dry; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (swelling face/Face and neck puffy), PHARYNGEAL SWELLING (swelling throat), PHARYNGEAL PARAESTHESIA (tingling in throat), ASTHENIA (weakness) and PARAESTHESIA (Tingling in lower jaw) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Kidney stone and Pulseless electrical activity. Concurrent medical conditions included Drug allergy (Allergic to chlorhexidine, ciprofloxacin, Propofol and sevoflurane.) and Contrast media allergy (Allergic to Iohexol and omnipaque.). Concomitant products included ROSUVASTATIN for Cholesterol, TAMSULOSIN for Prostatic hyperplasia.    On 01-Mar-2021 at 9:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SWELLING FACE (swelling face/Face and neck puffy), PHARYNGEAL SWELLING (swelling throat), PHARYNGEAL PARAESTHESIA (tingling in throat), ASTHENIA (weakness), PARAESTHESIA (Tingling in lower jaw), DRY MOUTH (Mouth was dry) and CHILLS (chills). On 11-Mar-2021, the patient experienced TONGUE DISORDER (Bumps on back of my tongue). At the time of the report, SWELLING FACE (swelling face/Face and neck puffy), PHARYNGEAL SWELLING (swelling throat), PHARYNGEAL PARAESTHESIA (tingling in throat), ASTHENIA (weakness), PARAESTHESIA (Tingling in lower jaw), DRY MOUTH (Mouth was dry) and CHILLS (chills) had resolved and TONGUE DISORDER (Bumps on back of my tongue) 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.   Treatment included Benadryl, Pepcid and Prednisone.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Added patient's demographics, medical history, concomitant medications. Events ( tongue disorder, paresthesia and dry mouth) were added. Event outcome updated to recovered.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swelling face, Tongue disorder
Clinical narrative: Bumps on back of my tongue; chills; swelling face/Face and neck puffy; swelling throat; tingling in throat; weakness; Tingling in lower jaw; Mouth was dry; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (swelling face/Face and neck puffy), PHARYNGEAL SWELLING (swelling throat), PHARYNGEAL PARAESTHESIA (tingling in throat), ASTHENIA (weakness) and PARAESTHESIA (Tingling in lower jaw) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Kidney stone and Pulseless electrical activity. Concurrent medical conditions included Drug allergy (Allergic to chlorhexidine, ciprofloxacin, Propofol and sevoflurane.) and Contrast media allergy (Allergic to Iohexol and omnipaque.). Concomitant products included ROSUVASTATIN for Cholesterol, TAMSULOSIN for Prostatic hyperplasia.    On 01-Mar-2021 at 9:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SWELLING FACE (swelling face/Face and neck puffy), PHARYNGEAL SWELLING (swelling throat), PHARYNGEAL PARAESTHESIA (tingling in throat), ASTHENIA (weakness), PARAESTHESIA (Tingling in lower jaw), DRY MOUTH (Mouth was dry) and CHILLS (chills). On 11-Mar-2021, the patient experienced TONGUE DISORDER (Bumps on back of my tongue). At the time of the report, SWELLING FACE (swelling face/Face and neck puffy), PHARYNGEAL SWELLING (swelling throat), PHARYNGEAL PARAESTHESIA (tingling in throat), ASTHENIA (weakness), PARAESTHESIA (Tingling in lower jaw), DRY MOUTH (Mouth was dry) and CHILLS (chills) had resolved and TONGUE DISORDER (Bumps on back of my tongue) 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.   Treatment included Benadryl, Pepcid and Prednisone.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Added patient's demographics, medical history, concomitant medications. Events ( tongue disorder, paresthesia and dry mouth) were added. Event outcome updated to recovered.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Fatigue, Headache, Pyrexia
Clinical narrative: Fatigue; Fever; Headache; COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19), FATIGUE (Fatigue), PYREXIA (Fever) and HEADACHE (Headache) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced FATIGUE (Fatigue), PYREXIA (Fever) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19), FATIGUE (Fatigue), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: the patient experienced fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Influenza like illness, Myalgia, Pain
Clinical narrative: Flu-like symptoms; Feeling weak; Whole body is aching; Pain in right arm; Dizziness; No energy; Some negative reactions; Muscle pain in right arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), ASTHENIA (Feeling weak), PAIN (Whole body is aching), PAIN IN EXTREMITY (Pain in right arm) and DIZZINESS (Dizziness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included High cholesterol. Concomitant products included ROSUVASTATIN for Cholesterol.    On 01-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 01-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), ASTHENIA (Feeling weak), PAIN (Whole body is aching), PAIN IN EXTREMITY (Pain in right arm), DIZZINESS (Dizziness), ASTHENIA (No energy), VACCINATION COMPLICATION (Some negative reactions) and MYALGIA (Muscle pain in right arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 01-Mar-2021 for Pain, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), ASTHENIA (Feeling weak), PAIN (Whole body is aching), PAIN IN EXTREMITY (Pain in right arm), DIZZINESS (Dizziness), ASTHENIA (No energy), VACCINATION COMPLICATION (Some negative reactions) and MYALGIA (Muscle pain in right arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination complication
Clinical narrative: Flu-like symptoms; Feeling weak; Whole body is aching; Pain in right arm; Dizziness; No energy; Some negative reactions; Muscle pain in right arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), ASTHENIA (Feeling weak), PAIN (Whole body is aching), PAIN IN EXTREMITY (Pain in right arm) and DIZZINESS (Dizziness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included High cholesterol. Concomitant products included ROSUVASTATIN for Cholesterol.    On 01-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 01-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), ASTHENIA (Feeling weak), PAIN (Whole body is aching), PAIN IN EXTREMITY (Pain in right arm), DIZZINESS (Dizziness), ASTHENIA (No energy), VACCINATION COMPLICATION (Some negative reactions) and MYALGIA (Muscle pain in right arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 01-Mar-2021 for Pain, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), ASTHENIA (Feeling weak), PAIN (Whole body is aching), PAIN IN EXTREMITY (Pain in right arm), DIZZINESS (Dizziness), ASTHENIA (No energy), VACCINATION COMPLICATION (Some negative reactions) and MYALGIA (Muscle pain in right arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Bad outbreak; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Bad outbreak) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Bad outbreak). The patient was treated with PREDNISONE for Vaccination site reaction, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Bad outbreak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-032203, MOD-2021-032000, MOD-2021-032203 (Patient Link).