chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Coordination abnormal, Hypoaesthesia, Muscle tightness, Paraesthesia, Rash
Clinical narrative: tingling in arm; numbness; Pinched Ulnar nerve; Tightness in forearm; limp hand no grip no control; rash on left arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in arm), HYPOAESTHESIA (numbness), ULNAR NERVE INJURY (Pinched Ulnar nerve), MUSCLE TIGHTNESS (Tightness in forearm) and COORDINATION ABNORMAL (limp hand no grip no control) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PARAESTHESIA (tingling in arm), HYPOAESTHESIA (numbness), ULNAR NERVE INJURY (Pinched Ulnar nerve), MUSCLE TIGHTNESS (Tightness in forearm), COORDINATION ABNORMAL (limp hand no grip no control) and RASH (rash on left arm). On 05-Mar-2021, COORDINATION ABNORMAL (limp hand no grip no control) had resolved. At the time of the report, PARAESTHESIA (tingling in arm), HYPOAESTHESIA (numbness), ULNAR NERVE INJURY (Pinched Ulnar nerve) and MUSCLE TIGHTNESS (Tightness in forearm) was resolving and RASH (rash on left arm) 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.   Other relevant medication history included Multivitamin. No treatment information was provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Ulnar nerve injury
Clinical narrative: tingling in arm; numbness; Pinched Ulnar nerve; Tightness in forearm; limp hand no grip no control; rash on left arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in arm), HYPOAESTHESIA (numbness), ULNAR NERVE INJURY (Pinched Ulnar nerve), MUSCLE TIGHTNESS (Tightness in forearm) and COORDINATION ABNORMAL (limp hand no grip no control) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PARAESTHESIA (tingling in arm), HYPOAESTHESIA (numbness), ULNAR NERVE INJURY (Pinched Ulnar nerve), MUSCLE TIGHTNESS (Tightness in forearm), COORDINATION ABNORMAL (limp hand no grip no control) and RASH (rash on left arm). On 05-Mar-2021, COORDINATION ABNORMAL (limp hand no grip no control) had resolved. At the time of the report, PARAESTHESIA (tingling in arm), HYPOAESTHESIA (numbness), ULNAR NERVE INJURY (Pinched Ulnar nerve) and MUSCLE TIGHTNESS (Tightness in forearm) was resolving and RASH (rash on left arm) 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.   Other relevant medication history included Multivitamin. No treatment information was provided.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Pyrexia, Urinary tract infection
Clinical narrative: felt weak.; diagnosed with an UTI; high fevers; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak.), URINARY TRACT INFECTION (diagnosed with an UTI) and PYREXIA (high fevers) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced ASTHENIA (felt weak.), URINARY TRACT INFECTION (diagnosed with an UTI) and PYREXIA (high fevers). The patient was treated with FLUCONAZOLE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, ASTHENIA (felt weak.), URINARY TRACT INFECTION (diagnosed with an UTI) and PYREXIA (high fevers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Cough, Dyspnoea, Fatigue, Sleep disorder
Clinical narrative: got worse throughout the night; shortness of breath; kept waking her up from her sleep; coughing uncontrollably; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (got worse throughout the night), DYSPNOEA (shortness of breath), SLEEP DISORDER (kept waking her up from her sleep), COUGH (coughing uncontrollably) and FATIGUE (fatigue) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Depression, Panic disorder, Allergic reaction to drug (Allergic to steroids) and Latex allergy. Concomitant products included ALLOPURINOL (ELAVIL [ALLOPURINOL]) and CLONAZEPAM for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced CONDITION AGGRAVATED (got worse throughout the night), DYSPNOEA (shortness of breath), SLEEP DISORDER (kept waking her up from her sleep), COUGH (coughing uncontrollably) and FATIGUE (fatigue). The patient was treated with PROMETHAZINE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, CONDITION AGGRAVATED (got worse throughout the night), DYSPNOEA (shortness of breath), SLEEP DISORDER (kept waking her up from her sleep), COUGH (coughing uncontrollably) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Depression, Dizziness, Electrocardiogram, Glucose tolerance test
Clinical narrative: looked bleak; ran out of energy; Light headedness; Weak in both hands; dizzy; looked paled; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (ran out of energy), DIZZINESS (Light headedness), MUSCULAR WEAKNESS (Weak in both hands), DIZZINESS (dizzy) and PALLOR (looked paled) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced ASTHENIA (ran out of energy), DIZZINESS (Light headedness), MUSCULAR WEAKNESS (Weak in both hands), DIZZINESS (dizzy) and PALLOR (looked paled). On 03-Feb-2021, the patient experienced DEPRESSION (looked bleak). At the time of the report, ASTHENIA (ran out of energy), DIZZINESS (Light headedness), MUSCULAR WEAKNESS (Weak in both hands), DIZZINESS (dizzy), PALLOR (looked paled) and DEPRESSION (looked bleak) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, Heart rate: increased (High) increased. On an unknown date, Electrocardiogram: unknown (Inconclusive) Unknown. On an unknown date, Glucose tolerance test: unknown (Inconclusive) Unknown. On an unknown date, Pulmonary function test: unknown (Inconclusive) Unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.   This case was linked to MOD-2021-035131 (Patient Link).
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Muscular weakness, Pallor, Pulmonary function test
Clinical narrative: looked bleak; ran out of energy; Light headedness; Weak in both hands; dizzy; looked paled; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (ran out of energy), DIZZINESS (Light headedness), MUSCULAR WEAKNESS (Weak in both hands), DIZZINESS (dizzy) and PALLOR (looked paled) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced ASTHENIA (ran out of energy), DIZZINESS (Light headedness), MUSCULAR WEAKNESS (Weak in both hands), DIZZINESS (dizzy) and PALLOR (looked paled). On 03-Feb-2021, the patient experienced DEPRESSION (looked bleak). At the time of the report, ASTHENIA (ran out of energy), DIZZINESS (Light headedness), MUSCULAR WEAKNESS (Weak in both hands), DIZZINESS (dizzy), PALLOR (looked paled) and DEPRESSION (looked bleak) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, Heart rate: increased (High) increased. On an unknown date, Electrocardiogram: unknown (Inconclusive) Unknown. On an unknown date, Glucose tolerance test: unknown (Inconclusive) Unknown. On an unknown date, Pulmonary function test: unknown (Inconclusive) Unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.   This case was linked to MOD-2021-035131 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: nausea; diarrhea; fever; sore and swollen arm; sore and swollen arm; feeling terrible overall; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), DIARRHOEA (diarrhea), PYREXIA (fever), PERIPHERAL SWELLING (sore and swollen arm) and PAIN IN EXTREMITY (sore and swollen arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-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 NAUSEA (nausea), DIARRHOEA (diarrhea), PYREXIA (fever), PERIPHERAL SWELLING (sore and swollen arm), PAIN IN EXTREMITY (sore and swollen arm) and MALAISE (feeling terrible overall). At the time of the report, NAUSEA (nausea), DIARRHOEA (diarrhea), PYREXIA (fever), PERIPHERAL SWELLING (sore and swollen arm), PAIN IN EXTREMITY (sore and swollen arm) and MALAISE (feeling terrible overall) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: nausea; diarrhea; fever; sore and swollen arm; sore and swollen arm; feeling terrible overall; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), DIARRHOEA (diarrhea), PYREXIA (fever), PERIPHERAL SWELLING (sore and swollen arm) and PAIN IN EXTREMITY (sore and swollen arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-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 NAUSEA (nausea), DIARRHOEA (diarrhea), PYREXIA (fever), PERIPHERAL SWELLING (sore and swollen arm), PAIN IN EXTREMITY (sore and swollen arm) and MALAISE (feeling terrible overall). At the time of the report, NAUSEA (nausea), DIARRHOEA (diarrhea), PYREXIA (fever), PERIPHERAL SWELLING (sore and swollen arm), PAIN IN EXTREMITY (sore and swollen arm) and MALAISE (feeling terrible overall) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain, Piloerection, SARS-CoV-2 test
Clinical narrative: Headache; Positive COVID test; Diarrhea; Body pain; Goose bumps; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (Headache), DIARRHOEA (Diarrhea), PAIN (Body pain), PILOERECTION (Goose bumps) and SARS-COV-2 TEST POSITIVE (Positive COVID test) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history is provided and concomitant drugs are provided.  Concomitant products included Blood pressure medication, Cholesterol medication, Sleeping medication and Tranquilizer for an unknown indication.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), PAIN (Body pain) and PILOERECTION (Goose bumps). On 12-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive COVID test). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache), DIARRHOEA (Diarrhea), PAIN (Body pain), PILOERECTION (Goose bumps) and SARS-COV-2 TEST POSITIVE (Positive COVID test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, SARS-CoV-2 test: Positive.     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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Headache; Positive COVID test; Diarrhea; Body pain; Goose bumps; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (Headache), DIARRHOEA (Diarrhea), PAIN (Body pain), PILOERECTION (Goose bumps) and SARS-COV-2 TEST POSITIVE (Positive COVID test) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history is provided and concomitant drugs are provided.  Concomitant products included Blood pressure medication, Cholesterol medication, Sleeping medication and Tranquilizer for an unknown indication.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), PAIN (Body pain) and PILOERECTION (Goose bumps). On 12-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive COVID test). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache), DIARRHOEA (Diarrhea), PAIN (Body pain), PILOERECTION (Goose bumps) and SARS-COV-2 TEST POSITIVE (Positive COVID test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, SARS-CoV-2 test: Positive.     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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Pain in extremity
Clinical narrative: sore arm; chest and some back pain; chest and some back pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHEST PAIN (chest and some back pain) and BACK PAIN (chest and some back pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     medical history is not provided and concomitant drugs are provided.  Concomitant products included MELATONIN and CALCIUM for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), CHEST PAIN (chest and some back pain) and BACK PAIN (chest and some back pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), CHEST PAIN (chest and some back pain) and BACK PAIN (chest and some back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Electrocardiogram, Glucose tolerance test, Palpitations
Clinical narrative: Weakness; hard time catching his breathe; Fast heart rate; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Weakness), DYSPNOEA (hard time catching his breathe) and PALPITATIONS (Fast heart rate) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced ASTHENIA (Weakness) and DYSPNOEA (hard time catching his breathe). 03-Feb-2021, the patient experienced PALPITATIONS (Fast heart rate). At the time of the report, ASTHENIA (Weakness), DYSPNOEA (hard time catching his breathe) and PALPITATIONS (Fast heart rate) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: unknown (Inconclusive) Unknown. On an unknown date, Glucose tolerance test: unknown (Inconclusive) Unknown. On an unknown date, Pulmonary function test: unknown (Inconclusive) Unknown.         Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Concomitant medications was  not reported.  Treatment information was not provided.   This case was linked to MOD-2021-035114 (Patient Link).
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary function test
Clinical narrative: Weakness; hard time catching his breathe; Fast heart rate; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Weakness), DYSPNOEA (hard time catching his breathe) and PALPITATIONS (Fast heart rate) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced ASTHENIA (Weakness) and DYSPNOEA (hard time catching his breathe). 03-Feb-2021, the patient experienced PALPITATIONS (Fast heart rate). At the time of the report, ASTHENIA (Weakness), DYSPNOEA (hard time catching his breathe) and PALPITATIONS (Fast heart rate) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: unknown (Inconclusive) Unknown. On an unknown date, Glucose tolerance test: unknown (Inconclusive) Unknown. On an unknown date, Pulmonary function test: unknown (Inconclusive) Unknown.         Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Concomitant medications was  not reported.  Treatment information was not provided.   This case was linked to MOD-2021-035114 (Patient Link).
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Swelling below the Injection Site) and INJECTION SITE WARMTH (Warm to the touch Injection Site) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced INJECTION SITE SWELLING (Swelling below the Injection Site) and INJECTION SITE WARMTH (Warm to the touch Injection Site). At the time of the report, INJECTION SITE SWELLING (Swelling below the Injection Site) and INJECTION SITE WARMTH (Warm to the touch Injection Site) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Arm was little sore; injection site itchy; injection site swelling; injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was little sore), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site redness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was little sore), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site redness). On 02-Mar-2021, PAIN IN EXTREMITY (Arm was little sore), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. Treatment medication include Baby Benadryl
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Myalgia, Nausea
Clinical narrative: nauseous; vomiting; continuous diarrhea; fatigue; low grade fever; no appetite; muscle aches and pains; rash on chest and neck area; could not work due to "Blahh feeling"; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of NAUSEA (nauseous), VOMITING (vomiting), DIARRHOEA (continuous diarrhea), FATIGUE (fatigue) and PYREXIA (low grade fever) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-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 NAUSEA (nauseous), VOMITING (vomiting), DIARRHOEA (continuous diarrhea), FATIGUE (fatigue), PYREXIA (low grade fever), DECREASED APPETITE (no appetite), MYALGIA (muscle aches and pains), RASH (rash on chest and neck area) and VACCINATION COMPLICATION (could not work due to "Blahh feeling"). At the time of the report, NAUSEA (nauseous), VOMITING (vomiting), DIARRHOEA (continuous diarrhea), FATIGUE (fatigue), PYREXIA (low grade fever), DECREASED APPETITE (no appetite), MYALGIA (muscle aches and pains), RASH (rash on chest and neck area) and VACCINATION COMPLICATION (could not work due to "Blahh feeling") 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.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Vaccination complication, Vomiting
Clinical narrative: nauseous; vomiting; continuous diarrhea; fatigue; low grade fever; no appetite; muscle aches and pains; rash on chest and neck area; could not work due to "Blahh feeling"; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of NAUSEA (nauseous), VOMITING (vomiting), DIARRHOEA (continuous diarrhea), FATIGUE (fatigue) and PYREXIA (low grade fever) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-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 NAUSEA (nauseous), VOMITING (vomiting), DIARRHOEA (continuous diarrhea), FATIGUE (fatigue), PYREXIA (low grade fever), DECREASED APPETITE (no appetite), MYALGIA (muscle aches and pains), RASH (rash on chest and neck area) and VACCINATION COMPLICATION (could not work due to "Blahh feeling"). At the time of the report, NAUSEA (nauseous), VOMITING (vomiting), DIARRHOEA (continuous diarrhea), FATIGUE (fatigue), PYREXIA (low grade fever), DECREASED APPETITE (no appetite), MYALGIA (muscle aches and pains), RASH (rash on chest and neck area) and VACCINATION COMPLICATION (could not work due to "Blahh feeling") 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.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Injection site warmth, Pain in extremity
Clinical narrative: warm to the touch; Reaction was red; sore arm; Warm arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INJECTION SITE WARMTH (warm to the touch), FEELING HOT (Warm arm) and ERYTHEMA (Reaction was red) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FEELING HOT (Warm arm). On 27-Feb-2021, the patient experienced INJECTION SITE WARMTH (warm to the touch) and ERYTHEMA (Reaction was red). At the time of the report, PAIN IN EXTREMITY (sore arm), INJECTION SITE WARMTH (warm to the touch), FEELING HOT (Warm arm) and ERYTHEMA (Reaction was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Very cold; Sore and Hard arm; light headedness; Chills; Fever; Headache; Nausea; Fatigue; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Very cold), MUSCLE SPASTICITY (Sore and Hard arm), DIZZINESS (light headedness), CHILLS (Chills) and PYREXIA (Fever) in a 67-year-old female 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.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced NASOPHARYNGITIS (Very cold), MUSCLE SPASTICITY (Sore and Hard arm), DIZZINESS (light headedness), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain). At the time of the report, NASOPHARYNGITIS (Very cold), MUSCLE SPASTICITY (Sore and Hard arm), DIZZINESS (light headedness), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) 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 details included Tylenol + concomitant.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasticity, Nasopharyngitis, Nausea, Pyrexia
Clinical narrative: Very cold; Sore and Hard arm; light headedness; Chills; Fever; Headache; Nausea; Fatigue; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Very cold), MUSCLE SPASTICITY (Sore and Hard arm), DIZZINESS (light headedness), CHILLS (Chills) and PYREXIA (Fever) in a 67-year-old female 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.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced NASOPHARYNGITIS (Very cold), MUSCLE SPASTICITY (Sore and Hard arm), DIZZINESS (light headedness), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain). At the time of the report, NASOPHARYNGITIS (Very cold), MUSCLE SPASTICITY (Sore and Hard arm), DIZZINESS (light headedness), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) 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 details included Tylenol + concomitant.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Rash pruritic
Clinical narrative: tired; rash with itching; headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired), RASH PRURITIC (rash with itching) and HEADACHE (headache) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder (Patient is suffering from auto immune disease and she is on her prescription medication.).    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced FATIGUE (tired), RASH PRURITIC (rash with itching) and HEADACHE (headache). The patient was treated with PROCHLORPERAZINE EDISYLATE (COMPAZINE [PROCHLORPERAZINE EDISYLATE]) at an unspecified dose and frequency. On 05-Feb-2021, FATIGUE (tired), RASH PRURITIC (rash with itching) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Compazine is used as treatment medication.   This case was linked to MOD-2021-035160 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Constipation, Headache, Heart rate increased
Clinical narrative: abdominal pain; constipation; very severe headache; joint pain; fast heart rate; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (abdominal pain), CONSTIPATION (constipation), HEADACHE (very severe headache), ARTHRALGIA (joint pain) and HEART RATE INCREASED (fast heart rate) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-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 ABDOMINAL PAIN (abdominal pain), CONSTIPATION (constipation), HEADACHE (very severe headache), ARTHRALGIA (joint pain) and HEART RATE INCREASED (fast heart rate). At the time of the report, ABDOMINAL PAIN (abdominal pain), CONSTIPATION (constipation), HEADACHE (very severe headache), ARTHRALGIA (joint pain) and HEART RATE INCREASED (fast heart rate) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Upon internal review on 21-May-2021, the age was corrected to unknown.   Reporter did not allow further contact
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anosmia, Diarrhoea, Feeling abnormal, Malaise
Clinical narrative: Upset stomach; Diarrhea; Can't smell; Felt bad; Not feeling well; Nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), NASAL CONGESTION (Nasal congestion), FEELING ABNORMAL (Felt bad), ANOSMIA (Can't smell) and ABDOMINAL DISCOMFORT (Upset stomach) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) for Hypertension, VITAMINS NOS for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced MALAISE (Not feeling well) and NASAL CONGESTION (Nasal congestion). On 01-Mar-2021, the patient experienced FEELING ABNORMAL (Felt bad). On 04-Mar-2021, the patient experienced ANOSMIA (Can't smell). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach) and DIARRHOEA (Diarrhea). At the time of the report, MALAISE (Not feeling well), NASAL CONGESTION (Nasal congestion), FEELING ABNORMAL (Felt bad), ANOSMIA (Can't smell), ABDOMINAL DISCOMFORT (Upset stomach) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the events included none.   This case was linked to MOD-2021-035164 (Patient Link).
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: Upset stomach; Diarrhea; Can't smell; Felt bad; Not feeling well; Nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), NASAL CONGESTION (Nasal congestion), FEELING ABNORMAL (Felt bad), ANOSMIA (Can't smell) and ABDOMINAL DISCOMFORT (Upset stomach) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) for Hypertension, VITAMINS NOS for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced MALAISE (Not feeling well) and NASAL CONGESTION (Nasal congestion). On 01-Mar-2021, the patient experienced FEELING ABNORMAL (Felt bad). On 04-Mar-2021, the patient experienced ANOSMIA (Can't smell). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach) and DIARRHOEA (Diarrhea). At the time of the report, MALAISE (Not feeling well), NASAL CONGESTION (Nasal congestion), FEELING ABNORMAL (Felt bad), ANOSMIA (Can't smell), ABDOMINAL DISCOMFORT (Upset stomach) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the events included none.   This case was linked to MOD-2021-035164 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain (whole body hurting) and arthralgia (both shoulders hurting) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 036A21A) for COVID-19 vaccination. Concomitant products included simvastatin and levothyroxine for an unknown indication. On Mar 3, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 3, 2021, patient experienced pain (whole body hurting) and arthralgia (both shoulders hurting). At the time of the report, pain (whole body hurting) and arthralgia (both shoulders hurting) outcome: unknown. Treatment include (1) naproxen (unknown strength) x1 dose; (2) acetaminophen (unknown strength) x2 doses; (3) ice packs applied topically (as needed). Reporter did not allow further contact.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Diarrhoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: my arm started hurting; Little bit of diarrhea; Headache; ca't smell; I felt bad; I was not feeling well; Nasal congestion; I felt tired immediately; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (my arm started hurting), NASAL CONGESTION (Nasal congestion), FEELING ABNORMAL (I felt bad), DIARRHOEA (Little bit of diarrhea) and MALAISE (I was not feeling well) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Stomach discomfort. Concomitant products included LOSARTAN for Blood pressure high, HYDROCHLOROTHIAZIDE and VITAMINS NOS for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced FATIGUE (I felt tired immediately). On 28-Feb-2021, the patient experienced NASAL CONGESTION (Nasal congestion) and MALAISE (I was not feeling well). On 01-Mar-2021, the patient experienced FEELING ABNORMAL (I felt bad). On 04-Mar-2021, the patient experienced ANOSMIA (ca't smell). On an unknown date, the patient experienced PAIN IN EXTREMITY (my arm started hurting), DIARRHOEA (Little bit of diarrhea) and HEADACHE (Headache). On 02-Mar-2021, FEELING ABNORMAL (I felt bad) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (my arm started hurting), NASAL CONGESTION (Nasal congestion), DIARRHOEA (Little bit of diarrhea), MALAISE (I was not feeling well), ANOSMIA (ca't smell), FATIGUE (I felt tired immediately) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No laboratory data was provided. Treatment included pseudoephedrine and two paracetamol.   This case was linked to MOD-2021-035159 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasal congestion, Pain in extremity
Clinical narrative: my arm started hurting; Little bit of diarrhea; Headache; ca't smell; I felt bad; I was not feeling well; Nasal congestion; I felt tired immediately; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (my arm started hurting), NASAL CONGESTION (Nasal congestion), FEELING ABNORMAL (I felt bad), DIARRHOEA (Little bit of diarrhea) and MALAISE (I was not feeling well) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Stomach discomfort. Concomitant products included LOSARTAN for Blood pressure high, HYDROCHLOROTHIAZIDE and VITAMINS NOS for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced FATIGUE (I felt tired immediately). On 28-Feb-2021, the patient experienced NASAL CONGESTION (Nasal congestion) and MALAISE (I was not feeling well). On 01-Mar-2021, the patient experienced FEELING ABNORMAL (I felt bad). On 04-Mar-2021, the patient experienced ANOSMIA (ca't smell). On an unknown date, the patient experienced PAIN IN EXTREMITY (my arm started hurting), DIARRHOEA (Little bit of diarrhea) and HEADACHE (Headache). On 02-Mar-2021, FEELING ABNORMAL (I felt bad) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (my arm started hurting), NASAL CONGESTION (Nasal congestion), DIARRHOEA (Little bit of diarrhea), MALAISE (I was not feeling well), ANOSMIA (ca't smell), FATIGUE (I felt tired immediately) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No laboratory data was provided. Treatment included pseudoephedrine and two paracetamol.   This case was linked to MOD-2021-035159 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pain in extremity, Pruritus
Clinical narrative: Injection site redness; itchiness; arm soreness; A spontaneous report was received from a consumer concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm soreness, itchiness, redness at injection site.  The patient's medical history was not provided. Concomitant medications reported were Simvastatin, Hydrochlorothiazide for drug use for unknown indication.  On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 001A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 3 Mar 2021, the patient experienced the event(s) arm soreness. itchiness, redness at injection site.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm soreness, itchiness,redness at injection site was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events side effects.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) of unknown  for prophylaxis of COVID-19 infection.   on unknown date patient experienced side effects.  Treatment details included UNKNOWN.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), side effects,  was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Lymph node pain
Clinical narrative: lymph nodes are terrible sore; very uncomfortable and difficult to swallow; A spontaneous report was received from a consumer concerning a 69-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events lymph nodes are terrible sore, very uncomfortable and difficult to swallow.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received their last of two planned doses of mRNA-1273 (lot/batch: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 8 Feb 2021, the patient experienced the events lymph nodes are terrible sore. very uncomfortable and difficult to swallow.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, lymph nodes are terrible sore, very uncomfortable and difficult to swallow was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: she's breastfeeding; A spontaneous report was received from a consumer concerning a 40-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events- exposure during breastfeeding .  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event- exposure during breastfeeding.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event- exposure during breastfeeding was considered unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE ERYTHEMA (Red marks on right arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 08-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE ERYTHEMA (Red marks on right arm). At the time of the report, VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE ERYTHEMA (Red marks on right arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient post receiving their first dose of Moderna vaccine reported that their site of injection began itching and developed red marks.   On 23-Apr-2021, the patient reported that the patient was feeling fine and received their 2nd dose a month ago with no side effect.  No Concomitant product use was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: TCR Received. Updated the outcome of the event. Updated the action taken as per received information.