chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache for 3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache for 3 weeks) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache for 3 weeks). At the time of the report, HEADACHE (headache for 3 weeks) outcome was unknown. US      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: No new information received.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Injection site pain
Clinical narrative: sore arm after the 1st shot; Patient got positive for covid after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient got positive for covid after receiving 1st dose) and INJECTION SITE PAIN (sore arm after the 1st shot) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 16-Feb-2021, the patient experienced COVID-19 (Patient got positive for covid after receiving 1st dose). On an unknown date, the patient experienced INJECTION SITE PAIN (sore arm after the 1st shot). The patient was treated with PLASMA at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient got positive for covid after receiving 1st dose) and INJECTION SITE PAIN (sore arm after the 1st shot) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included heart medication. Event included Sore arm .   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: TCR Document received on 15-JUN-2021 Contains Patient reported AE outcomes added, event was updated Sore arm .
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness of left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of left arm) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness of left arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Mar-2021, PAIN IN EXTREMITY (Soreness of left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity, Presyncope, Tachycardia
Clinical narrative: I almost passed out; sore arm; dizzy/lights started getting darker; heart was racing; headache; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (I almost passed out), PAIN IN EXTREMITY (sore arm), DIZZINESS (dizzy/lights started getting darker), TACHYCARDIA (heart was racing) and HEADACHE (headache) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced PRESYNCOPE (I almost passed out), PAIN IN EXTREMITY (sore arm), DIZZINESS (dizzy/lights started getting darker), TACHYCARDIA (heart was racing) and HEADACHE (headache). On 07-Mar-2021, DIZZINESS (dizzy/lights started getting darker) and TACHYCARDIA (heart was racing) had resolved. On 11-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved. On 13-Mar-2021, HEADACHE (headache) had resolved. At the time of the report, PRESYNCOPE (I almost passed out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Live Follow-up was added on 16-APR-2021, New Event Added (almost passed out) On 12-May-2021: Live follow up added on 12-May-2021 in which Updated Email id. On 16-Jul-2021: Follow-up doc attached and It was reported that patient no longer wanted to fill in any additional forms for Moderna.; 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.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Respiratory tract congestion
Clinical narrative: Respiratory problems of congestion and had shortness of breath; Shortness of breath really badly for one day; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT CONGESTION (Respiratory problems of congestion and had shortness of breath) and DYSPNOEA (Shortness of breath really badly for one day) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced RESPIRATORY TRACT CONGESTION (Respiratory problems of congestion and had shortness of breath) and DYSPNOEA (Shortness of breath really badly for one day). At the time of the report, RESPIRATORY TRACT CONGESTION (Respiratory problems of congestion and had shortness of breath) and DYSPNOEA (Shortness of breath really badly for one day) 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.; 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
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Swelling; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: sweating; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating). At the time of the report, HYPERHIDROSIS (sweating) 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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Headache, Illness
Clinical narrative: Felt very sick; Headache; Vomiting; Nausea; chills; 99 degree fever; Couldnt move; Dizziness; Dry heaving; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Couldnt move), DIZZINESS (Dizziness), RETCHING (Dry heaving), ILLNESS (Felt very sick) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020, Asthma and Hospitalisation (hospitalized in the past).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced MOBILITY DECREASED (Couldnt move), DIZZINESS (Dizziness), RETCHING (Dry heaving), HEADACHE (Headache), VOMITING (Vomiting), NAUSEA (Nausea), CHILLS (chills) and PYREXIA (99 degree fever). On an unknown date, the patient experienced ILLNESS (Felt very sick). At the time of the report, MOBILITY DECREASED (Couldnt move), DIZZINESS (Dizziness), RETCHING (Dry heaving), ILLNESS (Felt very sick), HEADACHE (Headache), VOMITING (Vomiting), NAUSEA (Nausea), CHILLS (chills) and PYREXIA (99 degree fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 99 (High) 99 degree.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that received her first dose of the Moderna covid-19 vaccine on march 24th after which didn't feel well. She experienced severe vomiting, chills and felt very sick. She stated she was given zofran by her doctor. Currently she is outside the dosing window for the second dose and wants to know if she can still received the second dose, and if not what is the efficacy of her just receiving one dose? Her doctor recommended she does not get the second dose due to extensive vomiting she experienced.  concomitant product include an inhaler  Treatment medication include Anti-nausea medication   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Added event , lab data and concomitant product information
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Nausea, Pyrexia, Retching, Vomiting
Clinical narrative: Felt very sick; Headache; Vomiting; Nausea; chills; 99 degree fever; Couldnt move; Dizziness; Dry heaving; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Couldnt move), DIZZINESS (Dizziness), RETCHING (Dry heaving), ILLNESS (Felt very sick) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020, Asthma and Hospitalisation (hospitalized in the past).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced MOBILITY DECREASED (Couldnt move), DIZZINESS (Dizziness), RETCHING (Dry heaving), HEADACHE (Headache), VOMITING (Vomiting), NAUSEA (Nausea), CHILLS (chills) and PYREXIA (99 degree fever). On an unknown date, the patient experienced ILLNESS (Felt very sick). At the time of the report, MOBILITY DECREASED (Couldnt move), DIZZINESS (Dizziness), RETCHING (Dry heaving), ILLNESS (Felt very sick), HEADACHE (Headache), VOMITING (Vomiting), NAUSEA (Nausea), CHILLS (chills) and PYREXIA (99 degree fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 99 (High) 99 degree.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that received her first dose of the Moderna covid-19 vaccine on march 24th after which didn't feel well. She experienced severe vomiting, chills and felt very sick. She stated she was given zofran by her doctor. Currently she is outside the dosing window for the second dose and wants to know if she can still received the second dose, and if not what is the efficacy of her just receiving one dose? Her doctor recommended she does not get the second dose due to extensive vomiting she experienced.  concomitant product include an inhaler  Treatment medication include Anti-nausea medication   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Added event , lab data and concomitant product information
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Neck pain, Pyrexia
Clinical narrative: Sore Neck; 102 Fever; Very Fatigued; This spontaneous case was reported by a nurse and describes the occurrence of NECK PAIN (Sore Neck), PYREXIA (102 Fever) and FATIGUE (Very Fatigued) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-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 26-Mar-2021, the patient experienced NECK PAIN (Sore Neck), PYREXIA (102 Fever) and FATIGUE (Very Fatigued). At the time of the report, NECK PAIN (Sore Neck), PYREXIA (102 Fever) and FATIGUE (Very Fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Body temperature: 102 (High) 102.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling face, Swelling of eyelid, Urticaria
Clinical narrative: Now the temples and eyelids and eyebrows are swollen; Now the temples and eyelids and eyebrows are swollen; the hoods of the brow are handing down and was not like that this weekend; temples are wider and puffier; breaking out in hives in random parts of the body on 29Mar2021; ankles and armpits were itchy; Significant body rashes; Rash all over the body; Face is swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face is swollen), SWELLING OF EYELID (Now the temples and eyelids and eyebrows are swollen), SWELLING FACE (Now the temples and eyelids and eyebrows are swollen), SWELLING FACE (the hoods of the brow are handing down and was not like that this weekend) and SWELLING FACE (temples are wider and puffier) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced SWELLING FACE (Face is swollen), URTICARIA (breaking out in hives in random parts of the body on 29Mar2021), PRURITUS (ankles and armpits were itchy), RASH (Significant body rashes) and RASH (Rash all over the body). On 29-Mar-2021, the patient experienced SWELLING OF EYELID (Now the temples and eyelids and eyebrows are swollen), SWELLING FACE (Now the temples and eyelids and eyebrows are swollen), SWELLING FACE (the hoods of the brow are handing down and was not like that this weekend) and SWELLING FACE (temples are wider and puffier). At the time of the report, SWELLING FACE (Face is swollen), SWELLING OF EYELID (Now the temples and eyelids and eyebrows are swollen), SWELLING FACE (Now the temples and eyelids and eyebrows are swollen), SWELLING FACE (the hoods of the brow are handing down and was not like that this weekend), SWELLING FACE (temples are wider and puffier), URTICARIA (breaking out in hives in random parts of the body on 29Mar2021), PRURITUS (ankles and armpits were itchy), RASH (Significant body rashes) and RASH (Rash all over the body) 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 concomitant medication were provided  Treatment medication included Benadryl
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Heart rate increased
Clinical narrative: Fast Heartbeat; Warm allover - first in chest and then rest of the body; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast Heartbeat) and FEELING HOT (Warm allover - first in chest and then rest of the body) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    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 HEART RATE INCREASED (Fast Heartbeat) and FEELING HOT (Warm allover - first in chest and then rest of the body). On 12-Mar-2021, HEART RATE INCREASED (Fast Heartbeat) and FEELING HOT (Warm allover - first in chest and then rest of the body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment details not provided She was being monitored for 30 minutes for event. Consent provided for safety follow-up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Nausea
Clinical narrative: Diarrhea; Stomach cramping; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramping) and NAUSEA (Nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramping) and NAUSEA (Nausea). The patient was treated with CALCIUM CARBONATE, MAGNESIUM HYDROXIDE (ROLAIDS [CALCIUM CARBONATE;MAGNESIUM HYDROXIDE]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) at an unspecified dose and frequency. On 12-Mar-2021, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramping) and NAUSEA (Nausea) had resolved.        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.   Second dose scheduled on 09-APR-2021.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dizziness, Nausea, SARS-CoV-2 test
Clinical narrative: Loss of smell and taste; COVID-19 virus test positive; Loss of smell and taste; dizziness; Nauseated for 2-3 days after second dose; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021. The most recent information was received on 12-May-2021 and was forwarded to Moderna on 12-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of smell and taste), SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive), ANOSMIA (Loss of smell and taste), DIZZINESS (dizziness) and NAUSEA (Nauseated for 2-3 days after second dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 015M2O8) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (Nauseated for 2-3 days after second dose). On 24-Mar-2021, the patient experienced AGEUSIA (Loss of smell and taste). 24-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) and ANOSMIA (Loss of smell and taste). On 20-Mar-2021, NAUSEA (Nauseated for 2-3 days after second dose) had resolved. At the time of the report, AGEUSIA (Loss of smell and taste), SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive), ANOSMIA (Loss of smell and taste) and DIZZINESS (dizziness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were taken. Treatment medication included IV infusion.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Updated events from unknown to recovered. On 22-Jul-2021: Follow-up Information Received contains No New Information
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Loss of smell and taste; COVID-19 virus test positive; Loss of smell and taste; dizziness; Nauseated for 2-3 days after second dose; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021. The most recent information was received on 12-May-2021 and was forwarded to Moderna on 12-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of smell and taste), SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive), ANOSMIA (Loss of smell and taste), DIZZINESS (dizziness) and NAUSEA (Nauseated for 2-3 days after second dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 015M2O8) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (Nauseated for 2-3 days after second dose). On 24-Mar-2021, the patient experienced AGEUSIA (Loss of smell and taste). 24-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) and ANOSMIA (Loss of smell and taste). On 20-Mar-2021, NAUSEA (Nauseated for 2-3 days after second dose) had resolved. At the time of the report, AGEUSIA (Loss of smell and taste), SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive), ANOSMIA (Loss of smell and taste) and DIZZINESS (dizziness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were taken. Treatment medication included IV infusion.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Updated events from unknown to recovered. On 22-Jul-2021: Follow-up Information Received contains No New Information
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Inflammation, Pain, Paraesthesia, Pruritus
Clinical narrative: small red rash; most of the upper-arm is now itchy; baseball size bump; arm is numb; tingly; rash; fever; small red bump; achy and it lasted few days; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (small red bump), PAIN (achy and it lasted few days), RASH ERYTHEMATOUS (small red rash), PRURITUS (most of the upper-arm is now itchy) and SWELLING (baseball size bump) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced INFLAMMATION (small red bump), PAIN (achy and it lasted few days), RASH (rash) and PYREXIA (fever). On 28-Mar-2021, the patient experienced RASH ERYTHEMATOUS (small red rash), PRURITUS (most of the upper-arm is now itchy), SWELLING (baseball size bump), HYPOAESTHESIA (arm is numb) and PARAESTHESIA (tingly). At the time of the report, INFLAMMATION (small red bump), PAIN (achy and it lasted few days), RASH ERYTHEMATOUS (small red rash), PRURITUS (most of the upper-arm is now itchy), SWELLING (baseball size bump), HYPOAESTHESIA (arm is numb), PARAESTHESIA (tingly), RASH (rash) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment includes ice pack
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Rash erythematous, Swelling
Clinical narrative: small red rash; most of the upper-arm is now itchy; baseball size bump; arm is numb; tingly; rash; fever; small red bump; achy and it lasted few days; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (small red bump), PAIN (achy and it lasted few days), RASH ERYTHEMATOUS (small red rash), PRURITUS (most of the upper-arm is now itchy) and SWELLING (baseball size bump) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced INFLAMMATION (small red bump), PAIN (achy and it lasted few days), RASH (rash) and PYREXIA (fever). On 28-Mar-2021, the patient experienced RASH ERYTHEMATOUS (small red rash), PRURITUS (most of the upper-arm is now itchy), SWELLING (baseball size bump), HYPOAESTHESIA (arm is numb) and PARAESTHESIA (tingly). At the time of the report, INFLAMMATION (small red bump), PAIN (achy and it lasted few days), RASH ERYTHEMATOUS (small red rash), PRURITUS (most of the upper-arm is now itchy), SWELLING (baseball size bump), HYPOAESTHESIA (arm is numb), PARAESTHESIA (tingly), RASH (rash) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment includes ice pack
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder and Gastroesophageal reflux. Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She was taking  thyroid medication and gastric reflux medication on regular basis.  Treatment information was not Provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Limb discomfort
Clinical narrative: left arm feels useless; red left arm; warm left arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (left arm feels useless), ERYTHEMA (red left arm) and FEELING HOT (warm left arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-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 29-Mar-2021, the patient experienced LIMB DISCOMFORT (left arm feels useless), ERYTHEMA (red left arm) and FEELING HOT (warm left arm). At the time of the report, LIMB DISCOMFORT (left arm feels useless), ERYTHEMA (red left arm) and FEELING HOT (warm left arm) outcome was unknown. Not Provided          No concomitant medication was reported. The treatment medication was unknown.  Action taken with mRNA-1273 in response to the events were not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: followup received with no newinformation
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: felt faint; soreness at the vaccination site; swelling at the vaccination site; Redness at the vaccination site; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (felt faint), VACCINATION SITE PAIN (soreness at the vaccination site), VACCINATION SITE SWELLING (swelling at the vaccination site) and VACCINATION SITE ERYTHEMA (Redness at the vaccination site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (felt faint), VACCINATION SITE PAIN (soreness at the vaccination site), VACCINATION SITE SWELLING (swelling at the vaccination site) and VACCINATION SITE ERYTHEMA (Redness at the vaccination site). At the time of the report, DIZZINESS (felt faint), VACCINATION SITE PAIN (soreness at the vaccination site), VACCINATION SITE SWELLING (swelling at the vaccination site) and VACCINATION SITE ERYTHEMA (Redness at the vaccination site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information not provided. Treatment information not provided.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Inappropriate schedule of product administration, Weight decreased
Clinical narrative: Has not received the 2nd Moderna vaccine; Loss of appetite; Lost 20 pounds; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of DECREASED APPETITE (Loss of appetite), WEIGHT DECREASED (Lost 20 pounds) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Has not received the 2nd Moderna vaccine) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Broken hip since 16-Jan-2021 and Dementia.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced DECREASED APPETITE (Loss of appetite) and WEIGHT DECREASED (Lost 20 pounds). On 26-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Has not received the 2nd Moderna vaccine). On 26-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Has not received the 2nd Moderna vaccine) had resolved. At the time of the report, DECREASED APPETITE (Loss of appetite) and WEIGHT DECREASED (Lost 20 pounds) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided/unknown. Patient originally weighed 100 pounds and is now 80 pounds.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Incorrect route of product administration, Skin mass
Clinical narrative: ball under the skin; week later she has a palm size area of redness; warmth; Area of injection felt too down for deltoid- sounds like it was given in subcutaneous site; This spontaneous case was reported by a physician assistant and describes the occurrence of SKIN MASS (ball under the skin), ERYTHEMA (week later she has a palm size area of redness), FEELING HOT (warmth) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Area of injection felt too down for deltoid- sounds like it was given in subcutaneous site) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Area of injection felt too down for deltoid- sounds like it was given in subcutaneous site). On an unknown date, the patient experienced SKIN MASS (ball under the skin), ERYTHEMA (week later she has a palm size area of redness) and FEELING HOT (warmth). On 22-Mar-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Area of injection felt too down for deltoid- sounds like it was given in subcutaneous site) had resolved. At the time of the report, SKIN MASS (ball under the skin), ERYTHEMA (week later she has a palm size area of redness) and FEELING HOT (warmth) 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 details were provided.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: chills; rash mild below injection site; slight burning feeling mild below injection site; itchy mild below injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy mild below injection site), VACCINATION SITE RASH (rash mild below injection site), VACCINATION SITE PAIN (slight burning feeling mild below injection site) and CHILLS (chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchy mild below injection site) and VACCINATION SITE PAIN (slight burning feeling mild below injection site). On 27-Mar-2021, the patient experienced VACCINATION SITE RASH (rash mild below injection site). On an unknown date, the patient experienced CHILLS (chills). At the time of the report, VACCINATION SITE PRURITUS (itchy mild below injection site), VACCINATION SITE RASH (rash mild below injection site), VACCINATION SITE PAIN (slight burning feeling mild below injection site) and CHILLS (chills) 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. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swelling on her arm and her hands; swollen hand; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling on her arm and her hands) and PERIPHERAL SWELLING (swollen hand) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling on her arm and her hands) and PERIPHERAL SWELLING (swollen hand). At the time of the report, PERIPHERAL SWELLING (swelling on her arm and her hands) had resolved and PERIPHERAL SWELLING (swollen hand) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that she would be receiving her second dose of vaccine (30-Mar-2021). Follow-Up: Patient stated that her hand is still swollen and has visited the doctor to find out the reason, she had undergone a blood test and an ultrasound of her hand, results are yet to be known.  The doctor has said that the patient's swollen hand had nothing to do with vaccine and would be able to know the cause once the test results are known.    Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Report  follow-up: Updated event swollen arm to recovered/resolved.Added lab data.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional dose omission
Clinical narrative: She declined to receive second dose during recommended interval; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INTENTIONAL DOSE OMISSION (She declined to receive second dose during recommended interval) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-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 INTENTIONAL DOSE OMISSION (She declined to receive second dose during recommended interval). At the time of the report, INTENTIONAL DOSE OMISSION (She declined to receive second dose during recommended interval) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Concomitant medications were not provided.  Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site discharge
Clinical narrative: Leakage out of the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE DISCHARGE (Leakage out of the injection site) 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 28-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 DISCHARGE (Leakage out of the injection site). At the time of the report, VACCINATION SITE DISCHARGE (Leakage out of the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Rash, Vaccination site mass, Vaccination site warmth
Clinical narrative: Rash on her arm - bellow the injection site/Rash spread a little bit; Arm feels stiff,hard; Arm feels lumpy; Arm feels warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Arm feels stiff,hard), VACCINATION SITE MASS (Arm feels lumpy), VACCINATION SITE WARMTH (Arm feels warm to the touch) and RASH (Rash on her arm - bellow the injection site/Rash spread a little bit) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to vaccine (Patient reported that she had allergic reaction to a shingles shot ) and Allergy to chemicals NOS (Patient reported that she has allergic to preservatives such as thimerosal and parabens.).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Arm feels stiff,hard), VACCINATION SITE MASS (Arm feels lumpy) and VACCINATION SITE WARMTH (Arm feels warm to the touch). On 29-Mar-2021, the patient experienced RASH (Rash on her arm - bellow the injection site/Rash spread a little bit). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. At the time of the report, MUSCULOSKELETAL STIFFNESS (Arm feels stiff,hard), VACCINATION SITE MASS (Arm feels lumpy), VACCINATION SITE WARMTH (Arm feels warm to the touch) and RASH (Rash on her arm - bellow the injection site/Rash spread a little bit) was resolving.            No Concomitant medication provided  by the reporter.  Treatment medications includes application of ice on the am.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Event outcome was updated.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hot flush, Muscle spasms, Peripheral swelling, Pyrexia
Clinical narrative: legs swollen and cramping; hot flashes; chills; fever; arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swollen), MUSCLE SPASMS (legs swollen and cramping), HOT FLUSH (hot flashes), CHILLS (chills) and PYREXIA (fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0L0M01A) for COVID-19 vaccination.     No medical history.  The patient's past medical history included No adverse event. Concurrent medical conditions included No adverse event and No adverse event. Concomitant products included GABAPENTIN, HYDROXYCHLOROQUINE, POTASSIUM, LOSARTAN, BENZONATATE, LEVOTHYROXINE, MONTELUKAST, VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), DORZOLAMIDE, PREDNISOLONE, CICLOSPORIN (RESTASIS), BRINZOLAMIDE (AZOPT), BRIMONIDINE TARTRATE, BRINZOLAMIDE (SIMBRINZA), FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) and ALBUTEROL [SALBUTAMOL].   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen). On 26-Mar-2021, the patient experienced HOT FLUSH (hot flashes), CHILLS (chills) and PYREXIA (fever). On 29-Mar-2021, the patient experienced MUSCLE SPASMS (legs swollen and cramping). At the time of the report, PERIPHERAL SWELLING (arm was swollen), MUSCLE SPASMS (legs swollen and cramping), HOT FLUSH (hot flashes), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Treatment information were Tylenol.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: vaccination site swelling; Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 73-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 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). At the time of the report, VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs not provided. Treatment information not reported.