chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Hypoaesthesia, Visual impairment
Clinical narrative: Shortness of Breath; Facial Numbness; eyesight problems Can't see past his foot; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of Breath), HYPOAESTHESIA (Facial Numbness) and VISUAL IMPAIRMENT (eyesight problems Can't see past his foot) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O46B21A) for COVID-19 vaccination.     no medical history was reported by reporter.  Concomitant products included TESTOSTERONE CIPIONATE (DEPO-TESTOSTERONE), BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE), LISINOPRIL and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced DYSPNOEA (Shortness of Breath), HYPOAESTHESIA (Facial Numbness) and VISUAL IMPAIRMENT (eyesight problems Can't see past his foot). At the time of the report, DYSPNOEA (Shortness of Breath), HYPOAESTHESIA (Facial Numbness) and VISUAL IMPAIRMENT (eyesight problems Can't see past his foot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Blood pressure measurement (140/90-Unknown mmHg): 200/120 mmHg (High) elevated blood pressure.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: armpit is really badly swollen; body aches; collar bone is swollen; broken out in a fever; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (armpit is really badly swollen), PAIN (body aches), SWELLING (collar bone is swollen) and PYREXIA (broken out in a fever) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 19-Apr-2021, the patient experienced SWELLING (armpit is really badly swollen), PAIN (body aches), SWELLING (collar bone is swollen) and PYREXIA (broken out in a fever). At the time of the report, SWELLING (armpit is really badly swollen), PAIN (body aches), SWELLING (collar bone is swollen) and PYREXIA (broken out in a fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Feeling of relaxation, Headache, Nasopharyngitis
Clinical narrative: feels much better; positive for COVID; fever 101.1; headache; chest congestion; Running nose; Coughing; slight pain at arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), VACCINATION SITE PAIN (slight pain at arm at injection site), PYREXIA (fever 101.1), HEADACHE (headache) and CHEST DISCOMFORT (chest congestion) in a 79-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 information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (slight pain at arm at injection site). On 04-Apr-2021, the patient experienced COUGH (Coughing). On 05-Apr-2021, the patient experienced PYREXIA (fever 101.1), HEADACHE (headache), CHEST DISCOMFORT (chest congestion) and NASOPHARYNGITIS (Running nose). On 07-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (positive for COVID). On 21-Apr-2021, the patient experienced FEELING OF RELAXATION (feels much better). On 21-Apr-2021, COUGH (Coughing), PYREXIA (fever 101.1), HEADACHE (headache), CHEST DISCOMFORT (chest congestion) and NASOPHARYNGITIS (Running nose) had resolved. At the time of the report, VACCINATION SITE PAIN (slight pain at arm at injection site), SARS-COV-2 TEST POSITIVE (positive for COVID) and FEELING OF RELAXATION (feels much better) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive, Vaccination site pain
Clinical narrative: feels much better; positive for COVID; fever 101.1; headache; chest congestion; Running nose; Coughing; slight pain at arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), VACCINATION SITE PAIN (slight pain at arm at injection site), PYREXIA (fever 101.1), HEADACHE (headache) and CHEST DISCOMFORT (chest congestion) in a 79-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 information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (slight pain at arm at injection site). On 04-Apr-2021, the patient experienced COUGH (Coughing). On 05-Apr-2021, the patient experienced PYREXIA (fever 101.1), HEADACHE (headache), CHEST DISCOMFORT (chest congestion) and NASOPHARYNGITIS (Running nose). On 07-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (positive for COVID). On 21-Apr-2021, the patient experienced FEELING OF RELAXATION (feels much better). On 21-Apr-2021, COUGH (Coughing), PYREXIA (fever 101.1), HEADACHE (headache), CHEST DISCOMFORT (chest congestion) and NASOPHARYNGITIS (Running nose) had resolved. At the time of the report, VACCINATION SITE PAIN (slight pain at arm at injection site), SARS-COV-2 TEST POSITIVE (positive for COVID) and FEELING OF RELAXATION (feels much better) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Rash
Clinical narrative: Itching on chest; Rash; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on chest), RASH (Rash) and MYALGIA (Body aches) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M70) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PRURITUS (Itching on chest), RASH (Rash) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of Half. At the time of the report, PRURITUS (Itching on chest), RASH (Rash) and MYALGIA (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-083047 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up received contains No New Information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083047:2st dose Case
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: arm was hurting; pinpoint headaches; like a pressure in a couple of places; Now it is starting to hurt again like it was earlier; it keeps hurting in certain areas; Numbness in hand; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was hurting), HEADACHE (pinpoint headaches), HEAD DISCOMFORT (like a pressure in a couple of places), HYPOAESTHESIA (Numbness in hand) and PAIN (Now it is starting to hurt again like it was earlier) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.  The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ATORVASTATIN, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), MAGNESIUM and TURMERIC [CURCUMA LONGA RHIZOME] 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 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 16-Apr-2021, the patient experienced HYPOAESTHESIA (Numbness in hand). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was hurting), HEADACHE (pinpoint headaches), HEAD DISCOMFORT (like a pressure in a couple of places), PAIN (Now it is starting to hurt again like it was earlier) and PAIN (it keeps hurting in certain areas). At the time of the report, PAIN IN EXTREMITY (arm was hurting), HEADACHE (pinpoint headaches), HEAD DISCOMFORT (like a pressure in a couple of places), HYPOAESTHESIA (Numbness in hand), PAIN (Now it is starting to hurt again like it was earlier) and PAIN (it keeps hurting in certain areas) outcome was unknown. Not Provided          No  Treatment History was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Significant follow up appended. On 20-May-2021: TCR: outcome of AE
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: fever 102; body aches; chills; shivers; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 102), MYALGIA (body aches), CHILLS (chills) and CHILLS (shivers) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PYREXIA (fever 102), MYALGIA (body aches), CHILLS (chills) and CHILLS (shivers). At the time of the report, PYREXIA (fever 102), MYALGIA (body aches), CHILLS (chills) and CHILLS (shivers) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, SARS-CoV-2 test positive
Clinical narrative: her doctor told her to wait 90 days; COVID-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) and OFF LABEL USE (her doctor told her to wait 90 days) 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 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive). On an unknown date, the patient experienced OFF LABEL USE (her doctor told her to wait 90 days). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) outcome was unknown and OFF LABEL USE (her doctor told her to wait 90 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, SARS-CoV-2 test positive: covid positive Pt tested positive for COVID, 8 days after first vaccine..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs and treatment medications were reported.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose was received 44 days ago) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose was received 44 days ago). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose was received 44 days ago) 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.   Concomitant medications were not provided. Treatment information was not provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, Presyncope, Pyrexia
Clinical narrative: On 21st Apr 2021, Patient mentioned as waking up super tired and feverish; On 21st Apr 2021, Patient mentioned as waking up super tired and feverish; on 20th Apr 2021 she developed injection site reactions on the right arm as rash, itchy and redness; on 20th Apr 2021 she developed injection site reactions on the right arm as rash, itchy and redness; on 20th Apr 2021 she developed injection site reactions on the right arm as rash, itchy and redness; Felt like passing out; Dizziness; Vomiting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Felt like passing out), DIZZINESS (Dizziness), VACCINATION SITE PRURITUS (on 20th Apr 2021 she developed injection site reactions on the right arm as rash, itchy and redness), VOMITING (Vomiting) and NAUSEA (nausea) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced DIZZINESS (Dizziness), VOMITING (Vomiting) and NAUSEA (nausea). On 10-Apr-2021, the patient experienced PRESYNCOPE (Felt like passing out). On 20-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (on 20th Apr 2021 she developed injection site reactions on the right arm as rash, itchy and redness), VACCINATION SITE RASH (on 20th Apr 2021 she developed injection site reactions on the right arm as rash, itchy and redness) and VACCINATION SITE ERYTHEMA (on 20th Apr 2021 she developed injection site reactions on the right arm as rash, itchy and redness). On 21-Apr-2021, the patient experienced FATIGUE (On 21st Apr 2021, Patient mentioned as waking up super tired and feverish) and PYREXIA (On 21st Apr 2021, Patient mentioned as waking up super tired and feverish). At the time of the report, PRESYNCOPE (Felt like passing out), DIZZINESS (Dizziness), VACCINATION SITE PRURITUS (on 20th Apr 2021 she developed injection site reactions on the right arm as rash, itchy and redness), VOMITING (Vomiting), NAUSEA (nausea), VACCINATION SITE RASH (on 20th Apr 2021 she developed injection site reactions on the right arm as rash, itchy and redness), VACCINATION SITE ERYTHEMA (on 20th Apr 2021 she developed injection site reactions on the right arm as rash, itchy and redness), FATIGUE (On 21st Apr 2021, Patient mentioned as waking up super tired and feverish) and PYREXIA (On 21st Apr 2021, Patient mentioned as waking up super tired and feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not reported.  Treatment information was not reported.   Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vomiting
Clinical narrative: On 21st Apr 2021, Patient mentioned as waking up super tired and feverish; On 21st Apr 2021, Patient mentioned as waking up super tired and feverish; on 20th Apr 2021 she developed injection site reactions on the right arm as rash, itchy and redness; on 20th Apr 2021 she developed injection site reactions on the right arm as rash, itchy and redness; on 20th Apr 2021 she developed injection site reactions on the right arm as rash, itchy and redness; Felt like passing out; Dizziness; Vomiting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Felt like passing out), DIZZINESS (Dizziness), VACCINATION SITE PRURITUS (on 20th Apr 2021 she developed injection site reactions on the right arm as rash, itchy and redness), VOMITING (Vomiting) and NAUSEA (nausea) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced DIZZINESS (Dizziness), VOMITING (Vomiting) and NAUSEA (nausea). On 10-Apr-2021, the patient experienced PRESYNCOPE (Felt like passing out). On 20-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (on 20th Apr 2021 she developed injection site reactions on the right arm as rash, itchy and redness), VACCINATION SITE RASH (on 20th Apr 2021 she developed injection site reactions on the right arm as rash, itchy and redness) and VACCINATION SITE ERYTHEMA (on 20th Apr 2021 she developed injection site reactions on the right arm as rash, itchy and redness). On 21-Apr-2021, the patient experienced FATIGUE (On 21st Apr 2021, Patient mentioned as waking up super tired and feverish) and PYREXIA (On 21st Apr 2021, Patient mentioned as waking up super tired and feverish). At the time of the report, PRESYNCOPE (Felt like passing out), DIZZINESS (Dizziness), VACCINATION SITE PRURITUS (on 20th Apr 2021 she developed injection site reactions on the right arm as rash, itchy and redness), VOMITING (Vomiting), NAUSEA (nausea), VACCINATION SITE RASH (on 20th Apr 2021 she developed injection site reactions on the right arm as rash, itchy and redness), VACCINATION SITE ERYTHEMA (on 20th Apr 2021 she developed injection site reactions on the right arm as rash, itchy and redness), FATIGUE (On 21st Apr 2021, Patient mentioned as waking up super tired and feverish) and PYREXIA (On 21st Apr 2021, Patient mentioned as waking up super tired and feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not reported.  Treatment information was not reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Injection site very swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection site very swollen) 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. No relevant concomitant medication was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Injection site very swollen). At the time of the report, VACCINATION SITE SWELLING (Injection site very swollen) outcome was unknown.     Treatment medication was not provided   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Product storage error
Clinical narrative: the vaccine wasn't store at right temperature; chills; running fever; body aches; really bad headache. Next morning was really tired.; Next morning was really tired; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (the vaccine wasn't store at right temperature), CHILLS (chills), PYREXIA (running fever), MYALGIA (body aches) and HEADACHE (really bad headache. Next morning was really tired.) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced CHILLS (chills), PYREXIA (running fever), MYALGIA (body aches), HEADACHE (really bad headache. Next morning was really tired.) and FATIGUE (Next morning was really tired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vaccine wasn't store at right temperature). At the time of the report, PRODUCT STORAGE ERROR (the vaccine wasn't store at right temperature), CHILLS (chills), PYREXIA (running fever), MYALGIA (body aches), HEADACHE (really bad headache. Next morning was really tired.) and FATIGUE (Next morning was really tired) outcome was unknown. Not Provided          No concomitant and treatment drugs were reported.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: the vaccine wasn't store at right temperature; chills; running fever; body aches; really bad headache. Next morning was really tired.; Next morning was really tired; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (the vaccine wasn't store at right temperature), CHILLS (chills), PYREXIA (running fever), MYALGIA (body aches) and HEADACHE (really bad headache. Next morning was really tired.) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced CHILLS (chills), PYREXIA (running fever), MYALGIA (body aches), HEADACHE (really bad headache. Next morning was really tired.) and FATIGUE (Next morning was really tired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vaccine wasn't store at right temperature). At the time of the report, PRODUCT STORAGE ERROR (the vaccine wasn't store at right temperature), CHILLS (chills), PYREXIA (running fever), MYALGIA (body aches), HEADACHE (really bad headache. Next morning was really tired.) and FATIGUE (Next morning was really tired) outcome was unknown. Not Provided          No concomitant and treatment drugs were reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: severe diarrhea all night; severe vomiting all night; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea all night) and VOMITING (severe vomiting all night) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced DIARRHOEA (severe diarrhea all night) and VOMITING (severe vomiting all night). On 20-Apr-2021, VOMITING (severe vomiting all night) had resolved. At the time of the report, DIARRHOEA (severe diarrhea all night) was resolving. Not Provided          No concomitant medication was reported. No treatment was provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient not receive his 2nd dose on due date; Patient possibly getting 2nd dose outside of days 25-35 post 1st dose; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient not receive his 2nd dose on due date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient possibly getting 2nd dose outside of days 25-35 post 1st dose) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient not receive his 2nd dose on due date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient possibly getting 2nd dose outside of days 25-35 post 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient not receive his 2nd dose on due date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient possibly getting 2nd dose outside of days 25-35 post 1st dose) 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.   No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain
Clinical narrative: Chills; Body aches/ Pain; pain; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (Body aches/ Pain) and PAIN (pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-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 CHILLS (Chills), MYALGIA (Body aches/ Pain) and PAIN (pain). At the time of the report, CHILLS (Chills), MYALGIA (Body aches/ Pain) and PAIN (pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Patient asked whether she can take ibuprofen to alleviate the pain.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Crying, Feeling abnormal, Rash
Clinical narrative: extremely upset; crying; clumps of hair started to coming out, scalp is healthy, healthy person.; same rash which was worse; This spontaneous case was reported by a consumer and describes the occurrence of RASH (same rash which was worse), ALOPECIA (clumps of hair started to coming out, scalp is healthy, healthy person.), FEELING ABNORMAL (extremely upset) and CRYING (crying) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M70) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced RASH (same rash which was worse). On 07-Apr-2021, the patient experienced ALOPECIA (clumps of hair started to coming out, scalp is healthy, healthy person.). On 21-Apr-2021, the patient experienced FEELING ABNORMAL (extremely upset) and CRYING (crying). At the time of the report, RASH (same rash which was worse), ALOPECIA (clumps of hair started to coming out, scalp is healthy, healthy person.), FEELING ABNORMAL (extremely upset) and CRYING (crying) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicine and medical history were not provided. Treatment medicine were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-083025 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up document contains No New Information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083025:1st dose vaccine
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: sore arm - right arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm - right arm) and HEADACHE (headache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced MYALGIA (sore arm - right arm) and HEADACHE (headache). On 02-Mar-2021, MYALGIA (sore arm - right arm) and HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.    This case was linked to MOD-2021-083276, MOD-2021-083116 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. MOD-2021-083276:Wife case MOD-2021-083116:Second dose
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: invalid dose greater 37 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (invalid dose greater 37 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (invalid dose greater 37 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (invalid dose greater 37 days) 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.   No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-083534 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083534:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pruritus, Vaccination site pain
Clinical narrative: itches; injection site pain; cant raise arm 90 degrees; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (cant raise arm 90 degrees), PRURITUS (itches) and VACCINATION SITE PAIN (injection site pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced LIMB DISCOMFORT (cant raise arm 90 degrees) and VACCINATION SITE PAIN (injection site pain). On 21-Apr-2021, the patient experienced PRURITUS (itches). At the time of the report, LIMB DISCOMFORT (cant raise arm 90 degrees), PRURITUS (itches) and VACCINATION SITE PAIN (injection site 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.   No concomitant medications information was reported. No treatment medications were provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer
Clinical narrative: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of APHTHOUS ULCER (whole mouth broke out on canker sores) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Medical history were diabetes - pacemaker - heart valve replacement, as provided by the patient.  The patient's past medical history included Pacemaker insertion (cardiac) (heart valve replacement).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced APHTHOUS ULCER (whole mouth broke out on canker sores). On 19-Mar-2021, APHTHOUS ULCER (whole mouth broke out on canker sores) had resolved. 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-083076 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083076:First dose
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Rhinorrhoea
Clinical narrative: Not feeling good; Has lot of mucus; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling good) and RHINORRHOEA (Has lot of mucus) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-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 MALAISE (Not feeling good) and RHINORRHOEA (Has lot of mucus). At the time of the report, MALAISE (Not feeling good) and RHINORRHOEA (Has lot of mucus) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Did not receive 2nd dose. It has been 2 months since they received their 1st dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose. It has been 2 months since they received their 1st dose.) 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 (Did not receive 2nd dose. It has been 2 months since they received their 1st dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose. It has been 2 months since they received their 1st dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.  It had been 2 months since he received his 1st dose. He was in a nursing home (rehab) and the facility would not give them a 2nd dose.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: patient received 2nd dose on 4/22/21; Patient under 18 years old that was given the first dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years old that was given the first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received 2nd dose on 4/22/21) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years old that was given the first dose). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received 2nd dose on 4/22/21). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years old that was given the first dose) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received 2nd dose on 4/22/21) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant follow up- On 20 -JUL-2021 , Containing Patient received second dose also
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Feeling abnormal, Vaccination site pruritus
Clinical narrative: brain fog feeling; extremely uncomfortable; left arm where the injection was given until the bottom of left breast, the whole area on the left side was itchy; low energy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain fog feeling), DISCOMFORT (extremely uncomfortable), VACCINATION SITE PRURITUS (left arm where the injection was given until the bottom of left breast, the whole area on the left side was itchy) and FATIGUE (low energy) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced FEELING ABNORMAL (brain fog feeling), DISCOMFORT (extremely uncomfortable), VACCINATION SITE PRURITUS (left arm where the injection was given until the bottom of left breast, the whole area on the left side was itchy) and FATIGUE (low energy). On 20-Apr-2021, DISCOMFORT (extremely uncomfortable) had resolved. At the time of the report, FEELING ABNORMAL (brain fog feeling), VACCINATION SITE PRURITUS (left arm where the injection was given until the bottom of left breast, the whole area on the left side was itchy) and FATIGUE (low energy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was not reported. Treatment medication included pain relieving roll-on.   This case was linked to MOD-2021-083044 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Non Significant FU received on 03-aug-2021- patient did not seek medical treatment from her HCP and requested to send forms via mailing address; Sender's Comments:  MOD-2021-083044:first dose
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy
Clinical narrative: 8.5 weeks pregnant; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (8.5 weeks pregnant) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 20B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (DICLEGIS) for Morning sickness, ASCORBIC ACID, FERROUS FUMARATE, FOLIC ACID, RETINOL (PRENATAL [ASCORBIC ACID;FERROUS FUMARATE;FOLIC ACID;RETINOL]) for Vitamin deficiency.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 27-Nov-2021. On 13-Feb-2021, the patient experienced PREGNANCY (8.5 weeks pregnant). At the time of the report, PREGNANCY (8.5 weeks pregnant) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: Lumps on both hands.; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Lumps on both hands.) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced MASS (Lumps on both hands.). At the time of the report, MASS (Lumps on both hands.) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. Treatment information includes Short-term antibiotics and ice packs   This case was linked to US-MODERNATX, INC.-MOD-2021-083098 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083098:case for second dose
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Speech disorder
Clinical narrative: couldn't talk; Canker sores or hives came back; This spontaneous case was reported by a consumer and describes the occurrence of SPEECH DISORDER (couldn't talk) and APHTHOUS ULCER (Canker sores or hives came back) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Pacemaker insertion (cardiac) and Heart valve replacement. Concurrent medical conditions included Diabetes.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced SPEECH DISORDER (couldn't talk) and APHTHOUS ULCER (Canker sores or hives came back). On 11-Apr-2021, SPEECH DISORDER (couldn't talk) had resolved. At the time of the report, APHTHOUS ULCER (Canker sores or hives came back) 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.   Concomitant medications include Meds for her diabetes Treatment medications include Over the counter things for canker sores   This case was linked to US-MODERNATX, INC.-MOD-2021-083060 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083060:First dose
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Gastrooesophageal reflux disease, Vaccination site pain
Clinical narrative: minor side effects; soreness in right arm; acid reflux; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (minor side effects), VACCINATION SITE PAIN (soreness in right arm) and GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     Concomitant products included MIRTAZAPINE, OLANZAPINE and PRAZOSIN for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (minor side effects), VACCINATION SITE PAIN (soreness in right arm) and GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux). At the time of the report, ADVERSE REACTION (minor side effects), VACCINATION SITE PAIN (soreness in right arm) and GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment Ibuprofen   This case was linked to MOD-2021-154713 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Mass
Clinical narrative: Raised her arm and saw and felt there was a lump under the armpit; pain in the armpit; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Raised her arm and saw and felt there was a lump under the armpit), AXILLARY PAIN (pain in the armpit) and LYMPHADENOPATHY (Swollen lymph nodes) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-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 MASS (Raised her arm and saw and felt there was a lump under the armpit), AXILLARY PAIN (pain in the armpit) and LYMPHADENOPATHY (Swollen lymph nodes). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of UNK dosage form. At the time of the report, MASS (Raised her arm and saw and felt there was a lump under the armpit), AXILLARY PAIN (pain in the armpit) and LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took Tylenol for the pain and said she was getting ready to put on warm compresses. Concomitant product use was not provided by the reporter.