chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Tingling in her lower extremities, legs and feet; Pain in her jaw, around her molars on right side; Mild chest pressure; Feels like she has mild anxiety; Mild shortness of breath; Strong headaches; Fatigue; nausea; Body aches; Strong chills; Fever 102; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in her lower extremities, legs and feet), PAIN IN JAW (Pain in her jaw, around her molars on right side), CHEST DISCOMFORT (Mild chest pressure), ANXIETY (Feels like she has mild anxiety) and DYSPNOEA (Mild shortness of breath) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Antiphospholipid syndrome. Concomitant products included RIVAROXABAN (XARELTO) for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PARAESTHESIA (Tingling in her lower extremities, legs and feet), PAIN IN JAW (Pain in her jaw, around her molars on right side), CHEST DISCOMFORT (Mild chest pressure), ANXIETY (Feels like she has mild anxiety), DYSPNOEA (Mild shortness of breath), HEADACHE (Strong headaches), FATIGUE (Fatigue), NAUSEA (nausea), MYALGIA (Body aches), CHILLS (Strong chills) and PYREXIA (Fever 102). At the time of the report, PARAESTHESIA (Tingling in her lower extremities, legs and feet), PAIN IN JAW (Pain in her jaw, around her molars on right side), CHEST DISCOMFORT (Mild chest pressure), ANXIETY (Feels like she has mild anxiety), DYSPNOEA (Mild shortness of breath), HEADACHE (Strong headaches), FATIGUE (Fatigue), NAUSEA (nausea), MYALGIA (Body aches), CHILLS (Strong chills) and PYREXIA (Fever 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Body temperature: 102 (High) Fever 102.         No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Batch number updated
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Headache, Pain, Pyrexia
Clinical narrative: Rash on her left breast; Bull's eye sized rash on her left armpit and its itchy; metallic taste in her mouth; body ache; low grade fever; Chills; very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Bull's eye sized rash on her left armpit and its itchy), DYSGEUSIA (metallic taste in her mouth), RASH (Rash on her left breast), PAIN (body ache) and PYREXIA (low grade fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL and LEVOTHYROXINE for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced DYSGEUSIA (metallic taste in her mouth), PAIN (body ache), PYREXIA (low grade fever), CHILLS (Chills) and HEADACHE (very bad headache). On 24-Apr-2021, the patient experienced RASH PRURITIC (Bull's eye sized rash on her left armpit and its itchy). On 25-Apr-2021, the patient experienced RASH (Rash on her left breast). At the time of the report, RASH PRURITIC (Bull's eye sized rash on her left armpit and its itchy), DYSGEUSIA (metallic taste in her mouth), RASH (Rash on her left breast), PAIN (body ache), PYREXIA (low grade fever), CHILLS (Chills) and HEADACHE (very bad headache) outcome was unknown.            Treatment details include, Cortisone and Zink oxide ointment.   This case was linked to MOD-2021-090178 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash on her left breast; Bull's eye sized rash on her left armpit and its itchy; metallic taste in her mouth; body ache; low grade fever; Chills; very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Bull's eye sized rash on her left armpit and its itchy), DYSGEUSIA (metallic taste in her mouth), RASH (Rash on her left breast), PAIN (body ache) and PYREXIA (low grade fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL and LEVOTHYROXINE for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced DYSGEUSIA (metallic taste in her mouth), PAIN (body ache), PYREXIA (low grade fever), CHILLS (Chills) and HEADACHE (very bad headache). On 24-Apr-2021, the patient experienced RASH PRURITIC (Bull's eye sized rash on her left armpit and its itchy). On 25-Apr-2021, the patient experienced RASH (Rash on her left breast). At the time of the report, RASH PRURITIC (Bull's eye sized rash on her left armpit and its itchy), DYSGEUSIA (metallic taste in her mouth), RASH (Rash on her left breast), PAIN (body ache), PYREXIA (low grade fever), CHILLS (Chills) and HEADACHE (very bad headache) outcome was unknown.            Treatment details include, Cortisone and Zink oxide ointment.   This case was linked to MOD-2021-090178 (Patient Link).
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fatigue, Headache, Muscle strain
Clinical narrative: Pulled muscle that was very painful; Sore arm; Very tired for a few days; Fever; Headache; Increased feeling of dizziness; Worsening loss of balance; Feeling sleepy; bad strain on the left side; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE STRAIN (Pulled muscle that was very painful), PAIN IN EXTREMITY (Sore arm), FATIGUE (Very tired for a few days), MUSCLE STRAIN (bad strain on the left side) and DIZZINESS (Increased feeling of dizziness) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included PRAVASTATIN, LISINOPRIL, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and FISH OIL for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced MUSCLE STRAIN (bad strain on the left side) and SOMNOLENCE (Feeling sleepy). On 23-Apr-2021, the patient experienced DIZZINESS (Increased feeling of dizziness) and BALANCE DISORDER (Worsening loss of balance). On an unknown date, the patient experienced MUSCLE STRAIN (Pulled muscle that was very painful), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Very tired for a few days). At the time of the report, MUSCLE STRAIN (Pulled muscle that was very painful), PAIN IN EXTREMITY (Sore arm), FATIGUE (Very tired for a few days), MUSCLE STRAIN (bad strain on the left side), DIZZINESS (Increased feeling of dizziness), BALANCE DISORDER (Worsening loss of balance) and SOMNOLENCE (Feeling sleepy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication include generic MEDROL dose pak.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: reporter details  .new concomitants ,events were updated.Route of administration was updated On 27-May-2021: TCR form, patient has no email or fax. Son will call on her behalf.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Somnolence
Clinical narrative: Pulled muscle that was very painful; Sore arm; Very tired for a few days; Fever; Headache; Increased feeling of dizziness; Worsening loss of balance; Feeling sleepy; bad strain on the left side; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE STRAIN (Pulled muscle that was very painful), PAIN IN EXTREMITY (Sore arm), FATIGUE (Very tired for a few days), MUSCLE STRAIN (bad strain on the left side) and DIZZINESS (Increased feeling of dizziness) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included PRAVASTATIN, LISINOPRIL, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and FISH OIL for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced MUSCLE STRAIN (bad strain on the left side) and SOMNOLENCE (Feeling sleepy). On 23-Apr-2021, the patient experienced DIZZINESS (Increased feeling of dizziness) and BALANCE DISORDER (Worsening loss of balance). On an unknown date, the patient experienced MUSCLE STRAIN (Pulled muscle that was very painful), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Very tired for a few days). At the time of the report, MUSCLE STRAIN (Pulled muscle that was very painful), PAIN IN EXTREMITY (Sore arm), FATIGUE (Very tired for a few days), MUSCLE STRAIN (bad strain on the left side), DIZZINESS (Increased feeling of dizziness), BALANCE DISORDER (Worsening loss of balance) and SOMNOLENCE (Feeling sleepy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication include generic MEDROL dose pak.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: reporter details  .new concomitants ,events were updated.Route of administration was updated On 27-May-2021: TCR form, patient has no email or fax. Son will call on her behalf.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia
Clinical narrative: Arms hurt after receiving a dose; In bed sick like the flu; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arms hurt after receiving a dose) and INFLUENZA LIKE ILLNESS (In bed sick like the flu) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced MYALGIA (Arms hurt after receiving a dose) and INFLUENZA LIKE ILLNESS (In bed sick like the flu). At the time of the report, MYALGIA (Arms hurt after receiving a dose) and INFLUENZA LIKE ILLNESS (In bed sick like the flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications listed.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site induration, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Hurts to touch; Raised hives; Hard knot below the skin underneath each hive; Area below injection site was rashy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Hurts to touch), VACCINATION SITE PRURITUS (Raised hives), VACCINATION SITE INDURATION (Hard knot below the skin underneath each hive) and VACCINATION SITE RASH (Area below injection site was rashy) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced PAIN (Hurts to touch) and VACCINATION SITE RASH (Area below injection site was rashy). 25-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Raised hives) and VACCINATION SITE INDURATION (Hard knot below the skin underneath each hive). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of UNK, qd. At the time of the report, PAIN (Hurts to touch), VACCINATION SITE PRURITUS (Raised hives), VACCINATION SITE INDURATION (Hard knot below the skin underneath each hive) and VACCINATION SITE RASH (Area below injection site was rashy) outcome was unknown.            No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: temperature of 102 degrees F after second dose; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (temperature of 102 degrees F after second dose) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 23-Apr-2021, the patient experienced PYREXIA (temperature of 102 degrees F after second dose). At the time of the report, PYREXIA (temperature of 102 degrees F after second dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Body temperature increased: 102 High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-090662 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090662:Same reporter
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Dyspnoea, Fatigue, Hypokinesia
Clinical narrative: pinch nerve; cannot bend down; muscle pain includes neck, shoulder, back, groin, arm, legs/pain in neck, pain in arm, pain in both shoulders; joint pain includes neck, shoulder, back, groin, arm, legs and every joint; feels like he has a bump on arm of injection; left hand is weak; felt ill; fatigue; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of NERVE COMPRESSION (pinch nerve), HYPOKINESIA (cannot bend down), MYALGIA (muscle pain includes neck, shoulder, back, groin, arm, legs/pain in neck, pain in arm, pain in both shoulders), ARTHRALGIA (joint pain includes neck, shoulder, back, groin, arm, legs and every joint) and MALAISE (felt ill) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthritis.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 22-Apr-2021, the patient experienced MALAISE (felt ill), FATIGUE (fatigue) and DYSPNOEA (shortness of breath). On an unknown date, the patient experienced NERVE COMPRESSION (pinch nerve), HYPOKINESIA (cannot bend down), MYALGIA (muscle pain includes neck, shoulder, back, groin, arm, legs/pain in neck, pain in arm, pain in both shoulders), ARTHRALGIA (joint pain includes neck, shoulder, back, groin, arm, legs and every joint), VACCINATION SITE SWELLING (feels like he has a bump on arm of injection) and MUSCULAR WEAKNESS (left hand is weak). The patient was treated with PREDNISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, NERVE COMPRESSION (pinch nerve), HYPOKINESIA (cannot bend down), MYALGIA (muscle pain includes neck, shoulder, back, groin, arm, legs/pain in neck, pain in arm, pain in both shoulders), ARTHRALGIA (joint pain includes neck, shoulder, back, groin, arm, legs and every joint), MALAISE (felt ill), FATIGUE (fatigue), DYSPNOEA (shortness of breath), VACCINATION SITE SWELLING (feels like he has a bump on arm of injection) and MUSCULAR WEAKNESS (left hand is weak) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, COVID-19: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   pain management included in the medical history.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Significant Follow-up included new events
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Muscular weakness, Myalgia, Nerve compression, Vaccination site swelling
Clinical narrative: pinch nerve; cannot bend down; muscle pain includes neck, shoulder, back, groin, arm, legs/pain in neck, pain in arm, pain in both shoulders; joint pain includes neck, shoulder, back, groin, arm, legs and every joint; feels like he has a bump on arm of injection; left hand is weak; felt ill; fatigue; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of NERVE COMPRESSION (pinch nerve), HYPOKINESIA (cannot bend down), MYALGIA (muscle pain includes neck, shoulder, back, groin, arm, legs/pain in neck, pain in arm, pain in both shoulders), ARTHRALGIA (joint pain includes neck, shoulder, back, groin, arm, legs and every joint) and MALAISE (felt ill) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthritis.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 22-Apr-2021, the patient experienced MALAISE (felt ill), FATIGUE (fatigue) and DYSPNOEA (shortness of breath). On an unknown date, the patient experienced NERVE COMPRESSION (pinch nerve), HYPOKINESIA (cannot bend down), MYALGIA (muscle pain includes neck, shoulder, back, groin, arm, legs/pain in neck, pain in arm, pain in both shoulders), ARTHRALGIA (joint pain includes neck, shoulder, back, groin, arm, legs and every joint), VACCINATION SITE SWELLING (feels like he has a bump on arm of injection) and MUSCULAR WEAKNESS (left hand is weak). The patient was treated with PREDNISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, NERVE COMPRESSION (pinch nerve), HYPOKINESIA (cannot bend down), MYALGIA (muscle pain includes neck, shoulder, back, groin, arm, legs/pain in neck, pain in arm, pain in both shoulders), ARTHRALGIA (joint pain includes neck, shoulder, back, groin, arm, legs and every joint), MALAISE (felt ill), FATIGUE (fatigue), DYSPNOEA (shortness of breath), VACCINATION SITE SWELLING (feels like he has a bump on arm of injection) and MUSCULAR WEAKNESS (left hand is weak) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, COVID-19: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   pain management included in the medical history.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Significant Follow-up included new events
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history was not provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced DYSGEUSIA (metallic taste). At the time of the report, DYSGEUSIA (metallic taste) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        relevant concomitant products usage were not reported by the reporter. Treatment details not included.   This case was linked to US-MODERNATX, INC.-MOD-2021-090205 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090205:case for wife
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Fatigue, Muscular weakness, Pyrexia
Clinical narrative: hair is falling; muscle weakness; fever; Was in bed all the time; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair is falling), MUSCULAR WEAKNESS (muscle weakness), PYREXIA (fever) and FATIGUE (Was in bed all the time) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 030A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced ALOPECIA (hair is falling), MUSCULAR WEAKNESS (muscle weakness), PYREXIA (fever) and FATIGUE (Was in bed all the time). At the time of the report, ALOPECIA (hair is falling), MUSCULAR WEAKNESS (muscle weakness), PYREXIA (fever) and FATIGUE (Was in bed all the time) outcome was unknown.       Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-090231 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive tested for COVID-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (positive tested for COVID-19) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FISH OIL and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced COVID-19 (positive tested for COVID-19). The patient was treated with AZITHROMYCIN at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form; IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form and VITAMINS NOS at a dose of 1 dosage form. At the time of the report, COVID-19 (positive tested for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, SARS-CoV-2 test: Positive.     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.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 1st dose about 2-2.5 months ago; 2nd dose has not been given; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st dose about 2-2.5 months ago; 2nd dose has not been given) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose about 2-2.5 months ago; 2nd dose has not been given). At the time of the report, PRODUCT DOSE OMISSION ISSUE (1st dose about 2-2.5 months ago; 2nd dose has not been given) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Product dose omission issue, Vaccination site pain
Clinical narrative: The patient is now looking for information on how to reschedule her second Moderna Covid-19 vaccination shot.; migrain; sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migrain), VACCINATION SITE PAIN (sore right injection site arm) and PRODUCT DOSE OMISSION ISSUE (The patient is now looking for information on how to reschedule her second Moderna Covid-19 vaccination shot.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore right injection site arm). On 23-Apr-2021, the patient experienced MIGRAINE (migrain). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (The patient is now looking for information on how to reschedule her second Moderna Covid-19 vaccination shot.). At the time of the report, MIGRAINE (migrain), VACCINATION SITE PAIN (sore right injection site arm) and PRODUCT DOSE OMISSION ISSUE (The patient is now looking for information on how to reschedule her second Moderna Covid-19 vaccination shot.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.    This case was linked to MOD-2021-101890 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face, Urticaria
Clinical narrative: swelling on his face and lip; swelling on his face and lip; hives all over his body; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling on his face and lip), LIP SWELLING (swelling on his face and lip) and URTICARIA (hives all over his body) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  Concomitant products were not provided.  On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced SWELLING FACE (swelling on his face and lip), LIP SWELLING (swelling on his face and lip) and URTICARIA (hives all over his body). At the time of the report, SWELLING FACE (swelling on his face and lip), LIP SWELLING (swelling on his face and lip) and URTICARIA (hives all over his body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.    Treatment products included Benadryl.   Reporter did not allow further contact
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication reported.  Treatment information not provided.      This case was linked to MOD-2021-090212.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Red circle around injection site; Itchy circle around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red circle around injection site) and VACCINATION SITE PRURITUS (Itchy circle around injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red circle around injection site) and VACCINATION SITE PRURITUS (Itchy circle around injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red circle around injection site) outcome was unknown and VACCINATION SITE PRURITUS (Itchy circle around injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Metallic taste). At the time of the report, DYSGEUSIA (Metallic taste) outcome was unknown. Not Provided      The action taken with 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 US-MODERNATX, INC.-MOD-2021-090193 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090193:case for husband
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Heart rate, Hypersensitivity, Hypoaesthesia
Clinical narrative: Allergic reaction; Dizziness; Water blisters around injection site; No energy; Fingers were numb; Feeling like fainting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), DIZZINESS (Dizziness), VACCINATION SITE VESICLES (Water blisters around injection site), ASTHENIA (No energy) and HYPOAESTHESIA (Fingers were numb) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy NOS.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction), DIZZINESS (Dizziness), VACCINATION SITE VESICLES (Water blisters around injection site), ASTHENIA (No energy), HYPOAESTHESIA (Fingers were numb) and PRESYNCOPE (Feeling like fainting). At the time of the report, HYPERSENSITIVITY (Allergic reaction), DIZZINESS (Dizziness), VACCINATION SITE VESICLES (Water blisters around injection site), ASTHENIA (No energy), HYPOAESTHESIA (Fingers were numb) and PRESYNCOPE (Feeling like fainting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Heart rate: (High) Fast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Vaccination site vesicles
Clinical narrative: Allergic reaction; Dizziness; Water blisters around injection site; No energy; Fingers were numb; Feeling like fainting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), DIZZINESS (Dizziness), VACCINATION SITE VESICLES (Water blisters around injection site), ASTHENIA (No energy) and HYPOAESTHESIA (Fingers were numb) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy NOS.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction), DIZZINESS (Dizziness), VACCINATION SITE VESICLES (Water blisters around injection site), ASTHENIA (No energy), HYPOAESTHESIA (Fingers were numb) and PRESYNCOPE (Feeling like fainting). At the time of the report, HYPERSENSITIVITY (Allergic reaction), DIZZINESS (Dizziness), VACCINATION SITE VESICLES (Water blisters around injection site), ASTHENIA (No energy), HYPOAESTHESIA (Fingers were numb) and PRESYNCOPE (Feeling like fainting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Heart rate: (High) Fast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain, Vaccination site rash
Clinical narrative: rash all over her body; pain at the injection site; rash mostly around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over her body), VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE RASH (rash mostly around the injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced RASH (rash all over her body), VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE RASH (rash mostly around the injection site). At the time of the report, RASH (rash all over her body) and VACCINATION SITE RASH (rash mostly around the injection site) had not resolved and VACCINATION SITE PAIN (pain at the injection site) had resolved.            Concomitant included allergy medications Treatment information was not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia, Rash
Clinical narrative: Saturday evening, she had rash on lower belly from navel down and all the way across her stomach; The next day she had fever of 101.7; She also had fatigue; light headache next day; On same day after receiving 2nd dose, injection site was swollen about 2 inches in diameter; It was red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Saturday evening, she had rash on lower belly from navel down and all the way across her stomach) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for an unknown indication.   On 22-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 22-Apr-2021, the patient experienced VACCINATION SITE SWELLING (On same day after receiving 2nd dose, injection site was swollen about 2 inches in diameter) and VACCINATION SITE ERYTHEMA (It was red). On 23-Apr-2021, the patient experienced PYREXIA (The next day she had fever of 101.7), FATIGUE (She also had fatigue) and HEADACHE (light headache next day). On 24-Apr-2021, the patient experienced RASH (Saturday evening, she had rash on lower belly from navel down and all the way across her stomach) (seriousness criterion medically significant). At the time of the report, RASH (Saturday evening, she had rash on lower belly from navel down and all the way across her stomach), VACCINATION SITE SWELLING (On same day after receiving 2nd dose, injection site was swollen about 2 inches in diameter), VACCINATION SITE ERYTHEMA (It was red), PYREXIA (The next day she had fever of 101.7), FATIGUE (She also had fatigue) and HEADACHE (light headache next day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Body temperature: 101.7.         Treatment included acetaminophen. The patient went to the emergency room on Saturday night because of rash on stomach and they put her on antibiotics.; Sender's Comments: Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Saturday evening, she had rash on lower belly from navel down and all the way across her stomach; The next day she had fever of 101.7; She also had fatigue; light headache next day; On same day after receiving 2nd dose, injection site was swollen about 2 inches in diameter; It was red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Saturday evening, she had rash on lower belly from navel down and all the way across her stomach) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for an unknown indication.   On 22-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 22-Apr-2021, the patient experienced VACCINATION SITE SWELLING (On same day after receiving 2nd dose, injection site was swollen about 2 inches in diameter) and VACCINATION SITE ERYTHEMA (It was red). On 23-Apr-2021, the patient experienced PYREXIA (The next day she had fever of 101.7), FATIGUE (She also had fatigue) and HEADACHE (light headache next day). On 24-Apr-2021, the patient experienced RASH (Saturday evening, she had rash on lower belly from navel down and all the way across her stomach) (seriousness criterion medically significant). At the time of the report, RASH (Saturday evening, she had rash on lower belly from navel down and all the way across her stomach), VACCINATION SITE SWELLING (On same day after receiving 2nd dose, injection site was swollen about 2 inches in diameter), VACCINATION SITE ERYTHEMA (It was red), PYREXIA (The next day she had fever of 101.7), FATIGUE (She also had fatigue) and HEADACHE (light headache next day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Body temperature: 101.7.         Treatment included acetaminophen. The patient went to the emergency room on Saturday night because of rash on stomach and they put her on antibiotics.; Sender's Comments: Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First Moderna vaccine on 1-3-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna vaccine on 1-3-2021) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna vaccine on 1-3-2021). On 03-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna vaccine on 1-3-2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant product usage were not reported by the reporter. No treatment details were added. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: itchiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 VACCINATION SITE PRURITUS (itchiness). On 02-Apr-2021, VACCINATION SITE PRURITUS (itchiness) had resolved.            Concomitant product use was not provided by the reporter.  No treatment information was provided. Action taken with mRNA-1273 in response to the events was not Applicable    This case was linked to US-MODERNATX, INC.-MOD-2021-044453 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-044453:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea
Clinical narrative: Chills; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and DIARRHOEA (Diarrhea) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) 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) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced CHILLS (Chills) and DIARRHOEA (Diarrhea). At the time of the report, CHILLS (Chills) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  Treatment details include, acetaminophen
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Tenderness
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of blisters (underneath the skin in hands, arms and legs) and tenderness (blisters tender to the touch and like she burnt herself) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 036A21A) for COVID-19 immunization. No medical history reported. Concomitant products included anastrozole for an unknown indication. On Mar 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced blisters (underneath the skin in hands, arms and legs) and tenderness (blisters tender to the touch and like she burnt herself). The patient treated with prednisone ongoing since an unknown date, at an unspecified dose and frequency. At the time of the report, blisters (underneath the skin in hands, arms and legs) and tenderness (blisters tender to the touch and like she burnt herself) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The patient uses an inhaler. Action taken with mRNA-1273 in response to the event: unknown.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypokinesia
Clinical narrative: Had trouble getting out of a car or a chair; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Had trouble getting out of a car or a chair) and FATIGUE (Very tired) in a 79-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 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced HYPOKINESIA (Had trouble getting out of a car or a chair) and FATIGUE (Very tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form. At the time of the report, HYPOKINESIA (Had trouble getting out of a car or a chair) and FATIGUE (Very tired) outcome was unknown. Unknown          Action taken with mRNA-1273 in response to the event was not applicable
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 13-Apr-2021, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.