chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort, Pain in extremity, Toothache
Clinical narrative: Face to hurt; Some type of nerve issue; Hot and cold sensation on the left side of her mouth; Which tooth was bothering her; Tired; Headache; Aching pain and sensitivity in teeth; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (Aching pain and sensitivity in teeth), PAIN IN EXTREMITY (Sore arm), FACIAL PAIN (Face to hurt), NERVOUS SYSTEM DISORDER (Some type of nerve issue) and ORAL DISCOMFORT (Hot and cold sensation on the left side of her mouth) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for Vitamin supplementation.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced TOOTHACHE (Aching pain and sensitivity in teeth), PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired) and HEADACHE (Headache). On an unknown date, the patient experienced FACIAL PAIN (Face to hurt), NERVOUS SYSTEM DISORDER (Some type of nerve issue), ORAL DISCOMFORT (Hot and cold sensation on the left side of her mouth) and DENTAL DISCOMFORT (Which tooth was bothering her). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form; ACETYLSALICYLIC ACID (ASPIRIN 81) for Headache, at a dose of 1 dosage form; IBUPROFEN for Pain, at a dose of 1 dosage form and GABAPENTIN for Nerve pain, at a dose of 300 mg three times a day. At the time of the report, TOOTHACHE (Aching pain and sensitivity in teeth) had not resolved and PAIN IN EXTREMITY (Sore arm), FACIAL PAIN (Face to hurt), NERVOUS SYSTEM DISORDER (Some type of nerve issue), ORAL DISCOMFORT (Hot and cold sensation on the left side of her mouth), DENTAL DISCOMFORT (Which tooth was bothering her), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The other concomitant was cholesterol medication and blood pressure medication. The Patient went to the ENT for Nerve Pain and take her a CT scan. The patient treatment medications includes Antibiotics and steroids.   This case was linked to MOD-2021-067637 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: The Significant follow up received in which treatment information is added.(Gabapentin).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Dizziness, Eyelid pain
Clinical narrative: my eyelid hurts; back hurts really bad; fever 101.5degF; every piece of my body hurts; had the worst headache of my life; also have chills; my throat was bothering me; Not feeling good; really dizzy; arm started hurting and killing me; felt like I was going to fell; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021 and was forwarded to Moderna on 02-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (my throat was bothering me), MALAISE (Not feeling good), DIZZINESS (really dizzy), PAIN IN EXTREMITY (arm started hurting and killing me) and FEELING ABNORMAL (felt like I was going to fell) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and Lot# 012A21A) 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 reported medical history).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (my throat was bothering me), MALAISE (Not feeling good), DIZZINESS (really dizzy), PAIN IN EXTREMITY (arm started hurting and killing me) and FEELING ABNORMAL (felt like I was going to fell). On 02-Apr-2021, the patient experienced EYELID PAIN (my eyelid hurts), BACK PAIN (back hurts really bad), PYREXIA (fever 101.5degF), MYALGIA (every piece of my body hurts), HEADACHE (had the worst headache of my life) and CHILLS (also have chills). At the time of the report, OROPHARYNGEAL DISCOMFORT (my throat was bothering me), MALAISE (Not feeling good), DIZZINESS (really dizzy), PAIN IN EXTREMITY (arm started hurting and killing me), FEELING ABNORMAL (felt like I was going to fell), EYELID PAIN (my eyelid hurts), BACK PAIN (back hurts really bad), PYREXIA (fever 101.5degF), MYALGIA (every piece of my body hurts), HEADACHE (had the worst headache of my life) and CHILLS (also have chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Body temperature: 101.5 f.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment details include ibuprofen. OK for safety to follow up with caller via phone.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Malaise, Myalgia, Oropharyngeal discomfort
Clinical narrative: my eyelid hurts; back hurts really bad; fever 101.5degF; every piece of my body hurts; had the worst headache of my life; also have chills; my throat was bothering me; Not feeling good; really dizzy; arm started hurting and killing me; felt like I was going to fell; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021 and was forwarded to Moderna on 02-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (my throat was bothering me), MALAISE (Not feeling good), DIZZINESS (really dizzy), PAIN IN EXTREMITY (arm started hurting and killing me) and FEELING ABNORMAL (felt like I was going to fell) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and Lot# 012A21A) 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 reported medical history).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (my throat was bothering me), MALAISE (Not feeling good), DIZZINESS (really dizzy), PAIN IN EXTREMITY (arm started hurting and killing me) and FEELING ABNORMAL (felt like I was going to fell). On 02-Apr-2021, the patient experienced EYELID PAIN (my eyelid hurts), BACK PAIN (back hurts really bad), PYREXIA (fever 101.5degF), MYALGIA (every piece of my body hurts), HEADACHE (had the worst headache of my life) and CHILLS (also have chills). At the time of the report, OROPHARYNGEAL DISCOMFORT (my throat was bothering me), MALAISE (Not feeling good), DIZZINESS (really dizzy), PAIN IN EXTREMITY (arm started hurting and killing me), FEELING ABNORMAL (felt like I was going to fell), EYELID PAIN (my eyelid hurts), BACK PAIN (back hurts really bad), PYREXIA (fever 101.5degF), MYALGIA (every piece of my body hurts), HEADACHE (had the worst headache of my life) and CHILLS (also have chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Body temperature: 101.5 f.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment details include ibuprofen. OK for safety to follow up with caller via phone.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: my eyelid hurts; back hurts really bad; fever 101.5degF; every piece of my body hurts; had the worst headache of my life; also have chills; my throat was bothering me; Not feeling good; really dizzy; arm started hurting and killing me; felt like I was going to fell; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021 and was forwarded to Moderna on 02-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (my throat was bothering me), MALAISE (Not feeling good), DIZZINESS (really dizzy), PAIN IN EXTREMITY (arm started hurting and killing me) and FEELING ABNORMAL (felt like I was going to fell) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and Lot# 012A21A) 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 reported medical history).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (my throat was bothering me), MALAISE (Not feeling good), DIZZINESS (really dizzy), PAIN IN EXTREMITY (arm started hurting and killing me) and FEELING ABNORMAL (felt like I was going to fell). On 02-Apr-2021, the patient experienced EYELID PAIN (my eyelid hurts), BACK PAIN (back hurts really bad), PYREXIA (fever 101.5degF), MYALGIA (every piece of my body hurts), HEADACHE (had the worst headache of my life) and CHILLS (also have chills). At the time of the report, OROPHARYNGEAL DISCOMFORT (my throat was bothering me), MALAISE (Not feeling good), DIZZINESS (really dizzy), PAIN IN EXTREMITY (arm started hurting and killing me), FEELING ABNORMAL (felt like I was going to fell), EYELID PAIN (my eyelid hurts), BACK PAIN (back hurts really bad), PYREXIA (fever 101.5degF), MYALGIA (every piece of my body hurts), HEADACHE (had the worst headache of my life) and CHILLS (also have chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Body temperature: 101.5 f.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment details include ibuprofen. OK for safety to follow up with caller via phone.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, SARS-CoV-2 test positive
Clinical narrative: COVID-19 Disease and tested Positive post first vaccine; Low Oxygen Levels; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 Disease and tested Positive post first vaccine) and OXYGEN SATURATION DECREASED (Low Oxygen Levels) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 Disease and tested Positive post first vaccine) and OXYGEN SATURATION DECREASED (Low Oxygen Levels). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 Disease and tested Positive post first vaccine) and OXYGEN SATURATION DECREASED (Low Oxygen Levels) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: bad headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE in a female patient of an unknown age 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE. The patient was treated with ASPIRIN at a dose of 1 dosage form. At the time of the report, HEADACHE outcome was unknown. Not Provided.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error, Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) had resolved.        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.   HCP reported on 02Apr2021 that they had power outage on 02Apr2021 and vials were in freezer and refrigerator where temperature dropped to : Frozen Vaccine 47Minutes -13.79 C, Refrigerator 59 Minutes 12 C and effected vials are: Lot no 003B21A, 100 doses, Lot no 027B21A 100 doses, Lot no 030B21A 100 doses and Lot No 02B21A 140 doses. HCP stated that 63 doses were administered to 63 patients.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 14-MAY-2021 contains No New Information
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Rash
Clinical narrative: Broke out in a rash all over body; told her to wait until the rash clears before taking the 2nd shot.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Broke out in a rash all over body) and OFF LABEL USE (told her to wait until the rash clears before taking the 2nd shot.) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007MZ0A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced OFF LABEL USE (told her to wait until the rash clears before taking the 2nd shot.). On an unknown date, the patient experienced RASH (Broke out in a rash all over body). On 02-Apr-2021, OFF LABEL USE (told her to wait until the rash clears before taking the 2nd shot.) had resolved. At the time of the report, RASH (Broke out in a rash all over body) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported. Treatment information was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: TCR- outcome of the event updated. Patient had received second dose. The listed events was resolved.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use
Clinical narrative: received 3rd dose of Moderna vaccine; received 3rd dose of Moderna vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (received 3rd dose of Moderna vaccine) and OFF LABEL USE (received 3rd dose of Moderna vaccine) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A, 014M20A and 028A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (received 3rd dose of Moderna vaccine) and OFF LABEL USE (received 3rd dose of Moderna vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (received 3rd dose of Moderna vaccine) and OFF LABEL USE (received 3rd dose of Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: Vaccine administered after temperature excursion; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Apr-2021 and was forwarded to Moderna on 04-Apr-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after temperature excursion) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after temperature excursion). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after temperature excursion) 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.   concomitant information was not provided. Treatment information was not provided.   This case was linked to MOD21-068620 (E2B Linked Report).; Sender's Comments:  MOD21-068620:cross link
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain
Clinical narrative: Achy; Fatigued; Had muscle aches the next day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), FATIGUE (Fatigued) and MYALGIA (Had muscle aches the next day) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN (Achy), FATIGUE (Fatigued) and MYALGIA (Had muscle aches the next day). At the time of the report, PAIN (Achy), FATIGUE (Fatigued) and MYALGIA (Had muscle aches the next day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: side effects; This spontaneous case was reported by a patient and describes the occurrence of ADVERSE DRUG REACTION (side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 ADVERSE DRUG REACTION (side effects). At the time of the report, ADVERSE DRUG REACTION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-066399 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: PAIN (sore); INJECTION SITE INDURATION (Hard); Pain at injection site under the band aid; INJECTION SITE SWELLING (swollen); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (PAIN (sore)), VACCINATION SITE INDURATION (INJECTION SITE INDURATION (Hard)), VACCINATION SITE PAIN (Pain at injection site under the band aid) and VACCINATION SITE SWELLING (INJECTION SITE SWELLING (swollen)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 631B2A) for COVID-19 vaccination.  No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN (PAIN (sore)), VACCINATION SITE INDURATION (INJECTION SITE INDURATION (Hard)), VACCINATION SITE PAIN (Pain at injection site under the band aid) and VACCINATION SITE SWELLING (INJECTION SITE SWELLING (swollen)). At the time of the report, PAIN (PAIN (sore)), VACCINATION SITE INDURATION (INJECTION SITE INDURATION (Hard)), VACCINATION SITE PAIN (Pain at injection site under the band aid) and VACCINATION SITE SWELLING (INJECTION SITE SWELLING (swollen)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: reporter declined consent for further follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Diarrhoea, Feeling abnormal
Clinical narrative: she is dying and by the end of this week she may not be alive; Sweating in the middle of the night like someone pour a glass in bed; Severe pain from the bones and muscle; throwing up; shivering at night; severe diarrhea that she had to go to the bathroom 24/7; no appetite; itchy face; nose was running that she uses 1 pack of Kleenex; felt like she wasn't a human being right now; could not exercise like she used to; losing her brain; cannot get up since she received the 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea that she had to go to the bathroom 24/7), CHILLS (shivering at night), DECREASED APPETITE (no appetite), PRURITUS (itchy face) and VOMITING (throwing up) in a 64-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 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 18-Mar-2021, the patient experienced DIARRHOEA (severe diarrhea that she had to go to the bathroom 24/7), CHILLS (shivering at night), DECREASED APPETITE (no appetite), PRURITUS (itchy face), VOMITING (throwing up), RHINORRHOEA (nose was running that she uses 1 pack of Kleenex), FEELING ABNORMAL (felt like she wasn't a human being right now), ASTHENIA (could not exercise like she used to), MALAISE (losing her brain) and ASTHENIA (cannot get up since she received the 2nd shot). On an unknown date, the patient experienced FEELING ABNORMAL (she is dying and by the end of this week she may not be alive), NIGHT SWEATS (Sweating in the middle of the night like someone pour a glass in bed) and MUSCULOSKELETAL PAIN (Severe pain from the bones and muscle). At the time of the report, DIARRHOEA (severe diarrhea that she had to go to the bathroom 24/7), CHILLS (shivering at night), DECREASED APPETITE (no appetite), PRURITUS (itchy face), VOMITING (throwing up), RHINORRHOEA (nose was running that she uses 1 pack of Kleenex), FEELING ABNORMAL (felt like she wasn't a human being right now), ASTHENIA (could not exercise like she used to), MALAISE (losing her brain) and ASTHENIA (cannot get up since she received the 2nd shot) had not resolved and FEELING ABNORMAL (she is dying and by the end of this week she may not be alive), NIGHT SWEATS (Sweating in the middle of the night like someone pour a glass in bed) and MUSCULOSKELETAL PAIN (Severe pain from the bones and muscle) outcome was unknown.            Patient was prescribed by her doctor to take 1 Cholestyramine oral every day for diarrhea and Zofran for throwing up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Musculoskeletal pain, Night sweats, Pruritus, Rhinorrhoea
Clinical narrative: she is dying and by the end of this week she may not be alive; Sweating in the middle of the night like someone pour a glass in bed; Severe pain from the bones and muscle; throwing up; shivering at night; severe diarrhea that she had to go to the bathroom 24/7; no appetite; itchy face; nose was running that she uses 1 pack of Kleenex; felt like she wasn't a human being right now; could not exercise like she used to; losing her brain; cannot get up since she received the 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea that she had to go to the bathroom 24/7), CHILLS (shivering at night), DECREASED APPETITE (no appetite), PRURITUS (itchy face) and VOMITING (throwing up) in a 64-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 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 18-Mar-2021, the patient experienced DIARRHOEA (severe diarrhea that she had to go to the bathroom 24/7), CHILLS (shivering at night), DECREASED APPETITE (no appetite), PRURITUS (itchy face), VOMITING (throwing up), RHINORRHOEA (nose was running that she uses 1 pack of Kleenex), FEELING ABNORMAL (felt like she wasn't a human being right now), ASTHENIA (could not exercise like she used to), MALAISE (losing her brain) and ASTHENIA (cannot get up since she received the 2nd shot). On an unknown date, the patient experienced FEELING ABNORMAL (she is dying and by the end of this week she may not be alive), NIGHT SWEATS (Sweating in the middle of the night like someone pour a glass in bed) and MUSCULOSKELETAL PAIN (Severe pain from the bones and muscle). At the time of the report, DIARRHOEA (severe diarrhea that she had to go to the bathroom 24/7), CHILLS (shivering at night), DECREASED APPETITE (no appetite), PRURITUS (itchy face), VOMITING (throwing up), RHINORRHOEA (nose was running that she uses 1 pack of Kleenex), FEELING ABNORMAL (felt like she wasn't a human being right now), ASTHENIA (could not exercise like she used to), MALAISE (losing her brain) and ASTHENIA (cannot get up since she received the 2nd shot) had not resolved and FEELING ABNORMAL (she is dying and by the end of this week she may not be alive), NIGHT SWEATS (Sweating in the middle of the night like someone pour a glass in bed) and MUSCULOSKELETAL PAIN (Severe pain from the bones and muscle) outcome was unknown.            Patient was prescribed by her doctor to take 1 Cholestyramine oral every day for diarrhea and Zofran for throwing up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: she is dying and by the end of this week she may not be alive; Sweating in the middle of the night like someone pour a glass in bed; Severe pain from the bones and muscle; throwing up; shivering at night; severe diarrhea that she had to go to the bathroom 24/7; no appetite; itchy face; nose was running that she uses 1 pack of Kleenex; felt like she wasn't a human being right now; could not exercise like she used to; losing her brain; cannot get up since she received the 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea that she had to go to the bathroom 24/7), CHILLS (shivering at night), DECREASED APPETITE (no appetite), PRURITUS (itchy face) and VOMITING (throwing up) in a 64-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 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 18-Mar-2021, the patient experienced DIARRHOEA (severe diarrhea that she had to go to the bathroom 24/7), CHILLS (shivering at night), DECREASED APPETITE (no appetite), PRURITUS (itchy face), VOMITING (throwing up), RHINORRHOEA (nose was running that she uses 1 pack of Kleenex), FEELING ABNORMAL (felt like she wasn't a human being right now), ASTHENIA (could not exercise like she used to), MALAISE (losing her brain) and ASTHENIA (cannot get up since she received the 2nd shot). On an unknown date, the patient experienced FEELING ABNORMAL (she is dying and by the end of this week she may not be alive), NIGHT SWEATS (Sweating in the middle of the night like someone pour a glass in bed) and MUSCULOSKELETAL PAIN (Severe pain from the bones and muscle). At the time of the report, DIARRHOEA (severe diarrhea that she had to go to the bathroom 24/7), CHILLS (shivering at night), DECREASED APPETITE (no appetite), PRURITUS (itchy face), VOMITING (throwing up), RHINORRHOEA (nose was running that she uses 1 pack of Kleenex), FEELING ABNORMAL (felt like she wasn't a human being right now), ASTHENIA (could not exercise like she used to), MALAISE (losing her brain) and ASTHENIA (cannot get up since she received the 2nd shot) had not resolved and FEELING ABNORMAL (she is dying and by the end of this week she may not be alive), NIGHT SWEATS (Sweating in the middle of the night like someone pour a glass in bed) and MUSCULOSKELETAL PAIN (Severe pain from the bones and muscle) outcome was unknown.            Patient was prescribed by her doctor to take 1 Cholestyramine oral every day for diarrhea and Zofran for throwing up.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Delusion, Insomnia, Memory impairment, Night sweats, Scar
Clinical narrative: delusional thinking; lost 25 pounds in less than a month; night sweats; knuckles were swollen; now it is becoming a scar; slept very little; terrible verbal memory recall; This spontaneous case was reported by a physician and describes the occurrence of DELUSION (delusional thinking), WEIGHT DECREASED (lost 25 pounds in less than a month), NIGHT SWEATS (night sweats), SWELLING (knuckles were swollen) and SCAR (now it is becoming a scar) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    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 DELUSION (delusional thinking), WEIGHT DECREASED (lost 25 pounds in less than a month), NIGHT SWEATS (night sweats), SWELLING (knuckles were swollen), SCAR (now it is becoming a scar), INSOMNIA (slept very little) and MEMORY IMPAIRMENT (terrible verbal memory recall). At the time of the report, DELUSION (delusional thinking), WEIGHT DECREASED (lost 25 pounds in less than a month), NIGHT SWEATS (night sweats), SWELLING (knuckles were swollen), SCAR (now it is becoming a scar), INSOMNIA (slept very little) and MEMORY IMPAIRMENT (terrible verbal memory recall) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Weight decreased
Clinical narrative: delusional thinking; lost 25 pounds in less than a month; night sweats; knuckles were swollen; now it is becoming a scar; slept very little; terrible verbal memory recall; This spontaneous case was reported by a physician and describes the occurrence of DELUSION (delusional thinking), WEIGHT DECREASED (lost 25 pounds in less than a month), NIGHT SWEATS (night sweats), SWELLING (knuckles were swollen) and SCAR (now it is becoming a scar) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    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 DELUSION (delusional thinking), WEIGHT DECREASED (lost 25 pounds in less than a month), NIGHT SWEATS (night sweats), SWELLING (knuckles were swollen), SCAR (now it is becoming a scar), INSOMNIA (slept very little) and MEMORY IMPAIRMENT (terrible verbal memory recall). At the time of the report, DELUSION (delusional thinking), WEIGHT DECREASED (lost 25 pounds in less than a month), NIGHT SWEATS (night sweats), SWELLING (knuckles were swollen), SCAR (now it is becoming a scar), INSOMNIA (slept very little) and MEMORY IMPAIRMENT (terrible verbal memory recall) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site nodule
Clinical narrative: knot on arm; sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (knot on arm), MYALGIA (sore arm) and FATIGUE (fatigue) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE NODULE (knot on arm), MYALGIA (sore arm) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE NODULE (knot on arm), MYALGIA (sore arm) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: NNI, patient does not recall dates of vaccination, patient declined to give email and disconnected the call
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Nasal discomfort, Ocular discomfort, Sinusitis
Clinical narrative: Dizziness; Bad sinus problem; Pressure felling over both eyes but more towards right eye; Pressure symptom over the nostrils.; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), SINUSITIS (Bad sinus problem), OCULAR DISCOMFORT (Pressure felling over both eyes but more towards right eye) and NASAL DISCOMFORT (Pressure symptom over the nostrils.) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Sinus infection since an unknown date.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced DIZZINESS (Dizziness), SINUSITIS (Bad sinus problem), OCULAR DISCOMFORT (Pressure felling over both eyes but more towards right eye) and NASAL DISCOMFORT (Pressure symptom over the nostrils.). At the time of the report, DIZZINESS (Dizziness), SINUSITIS (Bad sinus problem), OCULAR DISCOMFORT (Pressure felling over both eyes but more towards right eye) and NASAL DISCOMFORT (Pressure symptom over the nostrils.) 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.   Treatment was OTC Qu pill. Concomitant medication was not provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Aches and pains in entire body; Injection site arm itched; Injection site arm swelled; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches and pains in entire body), VACCINATION SITE PRURITUS (Injection site arm itched) and VACCINATION SITE SWELLING (Injection site arm swelled) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN (Aches and pains in entire body), VACCINATION SITE PRURITUS (Injection site arm itched) and VACCINATION SITE SWELLING (Injection site arm swelled). At the time of the report, PAIN (Aches and pains in entire body), VACCINATION SITE PRURITUS (Injection site arm itched) and VACCINATION SITE SWELLING (Injection site arm swelled) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Product Information was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: red arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (red arm). At the time of the report, VACCINATION SITE ERYTHEMA (red arm) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: right arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (right arm was sore) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 019A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE PAIN (right arm was sore). At the time of the report, INJECTION SITE PAIN (right arm was sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided No treatment information was provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow-up information received captured no new information.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Red Spot on arm; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH MACULAR (Red Spot on arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced RASH MACULAR (Red Spot on arm). At the time of the report, RASH MACULAR (Red Spot on arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Pyrexia, Somnolence
Clinical narrative: Felt pretty terrible; Very Sleepy; Very sore; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt pretty terrible), SOMNOLENCE (Very Sleepy), PAIN (Very sore) and PYREXIA (Fever) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No specified medical history has been reported.     On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced FEELING ABNORMAL (Felt pretty terrible), SOMNOLENCE (Very Sleepy), PAIN (Very sore) and PYREXIA (Fever). At the time of the report, FEELING ABNORMAL (Felt pretty terrible), SOMNOLENCE (Very Sleepy), PAIN (Very sore) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: TCR received on 08-jul-2021 contains significant information i.e. AE outcome
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant caller received the 1st dose of the Moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant caller received the 1st dose of the Moderna vaccine) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-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 12-Jul-2021. On 01-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant caller received the 1st dose of the Moderna vaccine). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant caller received the 1st dose of the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. It was reported that patient wanted to wanted to be in the Pregnancy Registry.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Pruritus, Swelling, Vaccination site induration
Clinical narrative: right arm was itching; right arm was swelling; right arm was warm/and hot to the touch; lump at the injection site; knot at the injection site; right arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (right arm was itching), SWELLING (right arm was swelling), FEELING HOT (right arm was warm/and hot to the touch), VACCINATION SITE MASS (lump at the injection site) and VACCINATION SITE INDURATION (knot at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (right arm was sore). On 30-Mar-2021, the patient experienced PRURITUS (right arm was itching), SWELLING (right arm was swelling), FEELING HOT (right arm was warm/and hot to the touch), VACCINATION SITE MASS (lump at the injection site) and VACCINATION SITE INDURATION (knot at the injection site). At the time of the report, PRURITUS (right arm was itching), SWELLING (right arm was swelling), FEELING HOT (right arm was warm/and hot to the touch), VACCINATION SITE MASS (lump at the injection site), VACCINATION SITE INDURATION (knot at the injection site) and PAIN IN EXTREMITY (right arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up received on 07-Aug-2021 and included Non-significant information