chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site warmth
Clinical narrative: COVID arm; More irritated; More red; More painful; More warm to touch; Swollen arm; Itchy; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE REACTION (COVID arm), SKIN IRRITATION (More irritated), ERYTHEMA (More red), PAIN (More painful) and VACCINATION SITE WARMTH (More warm to touch) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN and ATORVASTATIN for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE REACTION (COVID arm), SKIN IRRITATION (More irritated), ERYTHEMA (More red), PAIN (More painful), VACCINATION SITE WARMTH (More warm to touch), PERIPHERAL SWELLING (Swollen arm) and PRURITUS (Itchy). At the time of the report, VACCINATION SITE REACTION (COVID arm), SKIN IRRITATION (More irritated), ERYTHEMA (More red), PAIN (More painful), VACCINATION SITE WARMTH (More warm to touch), PERIPHERAL SWELLING (Swollen arm) and PRURITUS (Itchy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-022335.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain
Clinical narrative: Pain; Chills; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), CHILLS (Chills) and MYALGIA (Body Aches) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Pain), CHILLS (Chills) and MYALGIA (Body Aches). At the time of the report, PAIN (Pain), CHILLS (Chills) and MYALGIA (Body Aches) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant Medication not provided by the reporter.  Treatment information was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: worse headache; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and HEADACHE (worse headache) 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 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced HEADACHE (headache). On 20-Feb-2021, the patient experienced HEADACHE (worse headache). On 16-Feb-2021, HEADACHE (headache) had resolved. On 22-Feb-2021, HEADACHE (worse headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Positive COVID Test after vaccination; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive COVID Test after vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive COVID Test after vaccination). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive COVID Test after vaccination) 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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: NNI
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Chills, Headache, Nausea, Pyrexia
Clinical narrative: Hair falling (hair loss); Fever; Strong Headache; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair falling (hair loss)), PYREXIA (Fever), HEADACHE (Strong Headache), NAUSEA (Nausea) and CHILLS (Chills) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0371C20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRINE), VITAMINS NOS and BIOTIN for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced ALOPECIA (Hair falling (hair loss)), PYREXIA (Fever), HEADACHE (Strong Headache), NAUSEA (Nausea) and CHILLS (Chills). At the time of the report, ALOPECIA (Hair falling (hair loss)), PYREXIA (Fever), HEADACHE (Strong Headache), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       he has acupuncture therapy coming up.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Crying, Headache, Migraine, Pain
Clinical narrative: a severe headache; close to a migraine for almost 10 days; she is in tears; pain has been from a 1-10 scale from 10 to 6; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (a severe headache), MIGRAINE (close to a migraine for almost 10 days), CRYING (she is in tears) and PAIN (pain has been from a 1-10 scale from 10 to 6) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (a severe headache), MIGRAINE (close to a migraine for almost 10 days), CRYING (she is in tears) and PAIN (pain has been from a 1-10 scale from 10 to 6). At the time of the report, HEADACHE (a severe headache), MIGRAINE (close to a migraine for almost 10 days), CRYING (she is in tears) and PAIN (pain has been from a 1-10 scale from 10 to 6) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Injection site erythema, Injection site warmth, Vaccination site pain, Vaccination site pruritus
Clinical narrative: delayed injection site reaction that continue for a week still; injection site redness; injection site warmth; vaccination site pain; vaccination site pruritus; This spontaneous case was reported by a consumer and describes the occurrence of   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 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore at injection site) 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 Lymph nodes enlarged.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore at injection site). At the time of the report, VACCINATION SITE PAIN (sore at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: TCR was Added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Swelling, Vaccination site rash
Clinical narrative: redness; swollen; warm; itchy; painful; COVID ARM; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (redness), SWELLING (swollen), VACCINATION SITE WARMTH (warm), PRURITUS (itchy) and PAIN (painful) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN and ATORVASTATIN for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, 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 experienced ERYTHEMA (redness), SWELLING (swollen), VACCINATION SITE WARMTH (warm), PRURITUS (itchy), PAIN (painful) and VACCINATION SITE RASH (COVID ARM). The patient was treated with CORTISONE at an unspecified dose and frequency; Aloe cream at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (redness), SWELLING (swollen), VACCINATION SITE WARMTH (warm), PRURITUS (itchy), PAIN (painful) and VACCINATION SITE RASH (COVID ARM) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details also included ice.   This case was linked to MOD-2021-022327, MOD-2021-022327 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2021: No specific follow-up information recorded.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: redness; swollen; warm; itchy; painful; COVID ARM; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (redness), SWELLING (swollen), VACCINATION SITE WARMTH (warm), PRURITUS (itchy) and PAIN (painful) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN and ATORVASTATIN for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, 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 experienced ERYTHEMA (redness), SWELLING (swollen), VACCINATION SITE WARMTH (warm), PRURITUS (itchy), PAIN (painful) and VACCINATION SITE RASH (COVID ARM). The patient was treated with CORTISONE at an unspecified dose and frequency; Aloe cream at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (redness), SWELLING (swollen), VACCINATION SITE WARMTH (warm), PRURITUS (itchy), PAIN (painful) and VACCINATION SITE RASH (COVID ARM) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details also included ice.   This case was linked to MOD-2021-022327, MOD-2021-022327 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2021: No specific follow-up information recorded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling hot, Hypertension, Palpitations
Clinical narrative: burning in chest; felt very hot; heart racing; high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (burning in chest), FEELING HOT (felt very hot), PALPITATIONS (heart racing) and HYPERTENSION (high blood pressure) in a 69-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 medical history reported. ). Concomitant products included TELMISARTAN, LEVOTHYROXINE SODIUM (SYNTHROID), SIMVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced CHEST PAIN (burning in chest), FEELING HOT (felt very hot), PALPITATIONS (heart racing) and HYPERTENSION (high blood pressure). On 20-Feb-2021, CHEST PAIN (burning in chest), FEELING HOT (felt very hot), PALPITATIONS (heart racing) and HYPERTENSION (high blood pressure) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Nausea; Fever of 104 Degrees; Chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), PYREXIA (Fever of 104 Degrees), CHILLS (Chills) and HEADACHE (headache) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event .  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced NAUSEA (Nausea), PYREXIA (Fever of 104 Degrees), CHILLS (Chills) and HEADACHE (headache). At the time of the report, NAUSEA (Nausea), PYREXIA (Fever of 104 Degrees), CHILLS (Chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Rash
Clinical narrative: warm feeling around neck; Rash to upper body/rash has developed on upper body; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (warm feeling around neck) and RASH (Rash to upper body/rash has developed on upper body) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025L20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included IRBESARTAN for Blood pressure, ATORVASTATIN for Cholesterol.   On 03-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced FEELING HOT (warm feeling around neck) and RASH (Rash to upper body/rash has developed on upper body). At the time of the report, FEELING HOT (warm feeling around neck) and RASH (Rash to upper body/rash has developed on upper body) had not resolved.            Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow up contain Non significant info, patient name change and email address added. On 06-Jul-2021: Significant follow-up information received.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain
Clinical narrative: Sore Throat and fatigue; Sore Throat and fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat and fatigue) and FATIGUE (Sore Throat and fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore Throat and fatigue) and FATIGUE (Sore Throat and fatigue). At the time of the report, OROPHARYNGEAL PAIN (Sore Throat and fatigue) and FATIGUE (Sore Throat and fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Vaccination site rash
Clinical narrative: Swelling on the face left; COVID Arm with red patches on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling on the face left) and VACCINATION SITE RASH (COVID Arm with red patches on her left arm) in a 56-year-old female patient 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 21-Feb-2021, the patient experienced VACCINATION SITE RASH (COVID Arm with red patches on her left arm). On 22-Feb-2021, the patient experienced SWELLING FACE (Swelling on the face left). At the time of the report, SWELLING FACE (Swelling on the face left) and VACCINATION SITE RASH (COVID Arm with red patches on her left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment information provided.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Tender arm; pink to red area below injection site; slightly swollen; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tender arm), VACCINATION SITE ERYTHEMA (pink to red area below injection site) and VACCINATION SITE SWELLING (slightly swollen) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, HYDROCHLOROTHIAZIDE, TRIAMTERENE (MAXZIDE) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced TENDERNESS (Tender arm), VACCINATION SITE ERYTHEMA (pink to red area below injection site) and VACCINATION SITE SWELLING (slightly swollen). At the time of the report, TENDERNESS (Tender arm), VACCINATION SITE ERYTHEMA (pink to red area below injection site) and VACCINATION SITE SWELLING (slightly swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included heating pad. The patient did not experience fever.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Updated patient's email address.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain in the shoulders and knees; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain in the shoulders and knees) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included Cholesterol medication and High blood pressure medication for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced ARTHRALGIA (joint pain in the shoulders and knees). At the time of the report, ARTHRALGIA (joint pain in the shoulders and knees) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: soreness and body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness and body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (soreness and body aches). At the time of the report, PAIN (soreness and body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Vaccine information updated and event onset date was added. Patient declined for follow-up was given.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: feels like she's getting a fever now; she felt like somebody hit her with a bat, her whole body was aching pretty bad; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (she felt like somebody hit her with a bat, her whole body was aching pretty bad), HEADACHE (headache) and PYREXIA (feels like she's getting a fever now) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (she felt like somebody hit her with a bat, her whole body was aching pretty bad) and HEADACHE (headache). On 24-Feb-2021, the patient experienced PYREXIA (feels like she's getting a fever now). At the time of the report, PAIN (she felt like somebody hit her with a bat, her whole body was aching pretty bad), HEADACHE (headache) and PYREXIA (feels like she's getting a fever now) had resolved.            Concomitant product use was  not reported by reporter    Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: fallow up received on 3-jun-202 out come of the events was updated from unknown to recovered /resolved; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: arm was hurting bad; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was hurting bad), CHILLS (chills) and PYREXIA (fever) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was hurting bad), CHILLS (chills) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (arm was hurting bad), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication information was reported.   This case was linked to MOD-2021-022360.; 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: started experiencing diarrhea/gets diarrhea every time she eats; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (started experiencing diarrhea/gets diarrhea every time she eats) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant (patient had a kidney transplant 7 months ago.).    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (started experiencing diarrhea/gets diarrhea every time she eats). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (started experiencing diarrhea/gets diarrhea every time she eats) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant drugs were not provided    Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: follow up received on 14-07-2021 contain non significant follow up
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Insomnia, Pain
Clinical narrative: Diagnosed them with Shingles; States they cannot sleep; pain, not just on the arm, but also on their shoulder, neck, back and down the arm. The pain isonly getting worse and worse, so much that it makes them jump and make sounds; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN (pain, not just on the arm, but also on their shoulder, neck, back and down the arm. The pain isonly getting worse and worse, so much that it makes them jump and make sounds), HERPES ZOSTER (Diagnosed them with Shingles) and INSOMNIA (States they cannot sleep) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN (pain, not just on the arm, but also on their shoulder, neck, back and down the arm. The pain isonly getting worse and worse, so much that it makes them jump and make sounds). On an unknown date, the patient experienced HERPES ZOSTER (Diagnosed them with Shingles) and INSOMNIA (States they cannot sleep). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) at an unspecified dose and frequency. At the time of the report, PAIN (pain, not just on the arm, but also on their shoulder, neck, back and down the arm. The pain isonly getting worse and worse, so much that it makes them jump and make sounds), HERPES ZOSTER (Diagnosed them with Shingles) and INSOMNIA (States they cannot sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: lower body pains; knee pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (lower body pains) and ARTHRALGIA (knee pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis. Concomitant products included Methotrexate for Rheumatoid arthritis.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN (lower body pains) and ARTHRALGIA (knee pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN (lower body pains) and ARTHRALGIA (knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pollakiuria
Clinical narrative: kept on on going to the bathroom to urinate; fever (T-104.6F); joint pains; body aches; real bad headache; chills; This spontaneous case was reported by a health care professional and describes the occurrence of POLLAKIURIA (kept on on going to the bathroom to urinate), PYREXIA (fever (T-104.6F)), ARTHRALGIA (joint pains), MYALGIA (body aches) and HEADACHE (real bad headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced POLLAKIURIA (kept on on going to the bathroom to urinate), PYREXIA (fever (T-104.6F)), ARTHRALGIA (joint pains), MYALGIA (body aches), HEADACHE (real bad headache) and CHILLS (chills). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 09-Feb-2021, POLLAKIURIA (kept on on going to the bathroom to urinate), PYREXIA (fever (T-104.6F)), ARTHRALGIA (joint pains), MYALGIA (body aches), HEADACHE (real bad headache) and CHILLS (chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-022363 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: kept on on going to the bathroom to urinate; fever (T-104.6F); joint pains; body aches; real bad headache; chills; This spontaneous case was reported by a health care professional and describes the occurrence of POLLAKIURIA (kept on on going to the bathroom to urinate), PYREXIA (fever (T-104.6F)), ARTHRALGIA (joint pains), MYALGIA (body aches) and HEADACHE (real bad headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced POLLAKIURIA (kept on on going to the bathroom to urinate), PYREXIA (fever (T-104.6F)), ARTHRALGIA (joint pains), MYALGIA (body aches), HEADACHE (real bad headache) and CHILLS (chills). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 09-Feb-2021, POLLAKIURIA (kept on on going to the bathroom to urinate), PYREXIA (fever (T-104.6F)), ARTHRALGIA (joint pains), MYALGIA (body aches), HEADACHE (real bad headache) and CHILLS (chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-022363 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Soft tissue pain in arches of feet and calves; fatigue; Hand and arm soreness; Leg shaking; Swollen glands; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Hand and arm soreness), TREMOR (Leg shaking), SOFT TISSUE DISORDER (Soft tissue pain in arches of feet and calves), LYMPHADENOPATHY (Swollen glands) and FATIGUE (fatigue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MIRTAZAPINE (REMERON) and ALPRAZOLAM (XANAX) for an unknown indication.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen glands) and CHILLS (Chills). On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (Hand and arm soreness) and TREMOR (Leg shaking). On 01-Feb-2021, the patient experienced FATIGUE (fatigue). On an unknown date, the patient experienced SOFT TISSUE DISORDER (Soft tissue pain in arches of feet and calves). The patient was treated with PARACETAMOL (TYLENOL) for Chills, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) for Soreness of joint, at an unspecified dose and frequency. On 27-Jan-2021, LYMPHADENOPATHY (Swollen glands) and CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Hand and arm soreness), TREMOR (Leg shaking), SOFT TISSUE DISORDER (Soft tissue pain in arches of feet and calves) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2020, SARS-CoV-2 test: negative (Negative) Negative and results pending (Inconclusive) results pending.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-021419 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Soft tissue disorder, Tremor
Clinical narrative: Soft tissue pain in arches of feet and calves; fatigue; Hand and arm soreness; Leg shaking; Swollen glands; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Hand and arm soreness), TREMOR (Leg shaking), SOFT TISSUE DISORDER (Soft tissue pain in arches of feet and calves), LYMPHADENOPATHY (Swollen glands) and FATIGUE (fatigue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MIRTAZAPINE (REMERON) and ALPRAZOLAM (XANAX) for an unknown indication.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen glands) and CHILLS (Chills). On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (Hand and arm soreness) and TREMOR (Leg shaking). On 01-Feb-2021, the patient experienced FATIGUE (fatigue). On an unknown date, the patient experienced SOFT TISSUE DISORDER (Soft tissue pain in arches of feet and calves). The patient was treated with PARACETAMOL (TYLENOL) for Chills, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) for Soreness of joint, at an unspecified dose and frequency. On 27-Jan-2021, LYMPHADENOPATHY (Swollen glands) and CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Hand and arm soreness), TREMOR (Leg shaking), SOFT TISSUE DISORDER (Soft tissue pain in arches of feet and calves) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2020, SARS-CoV-2 test: negative (Negative) Negative and results pending (Inconclusive) results pending.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-021419 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth, Pruritus, Swelling, Vaccination site swelling
Clinical narrative: lots of heat coming out; it also itched; big fat swollen arm; red; pretty hard; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (lots of heat coming out), PRURITUS (it also itched), SWELLING (big fat swollen arm), INJECTION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (pretty hard) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included blood pressure med for Blood pressure, cholesterol med for Cholesterol, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced INJECTION SITE WARMTH (lots of heat coming out), PRURITUS (it also itched), SWELLING (big fat swollen arm), INJECTION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (pretty hard). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (lots of heat coming out), PRURITUS (it also itched), SWELLING (big fat swollen arm), INJECTION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (pretty hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details also included anti itch cream.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Myalgia, Nausea, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Elevated temperature), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills) and MYALGIA (body aches) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (Elevated temperature), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills) and MYALGIA (body aches). At the time of the report, BODY TEMPERATURE INCREASED (Elevated temperature), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.            No concomitant medications were provided. No treatment information provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Heart rate increased, Pyrexia
Clinical narrative: Fast heart rate of 117BPM; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heart rate of 117BPM), PYREXIA (Fever) and CHILLS (Chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included Blood Pressure Medications, FISH OIL and MULTI VITAMINS & MINERALS for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced HEART RATE INCREASED (Fast heart rate of 117BPM), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (Fast heart rate of 117BPM), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Dyspnoea, Headache, Heart rate increased
Clinical narrative: upset stomach; short of breath; fast heartbeat; lack of sleep; feels weak; headache; Off and on headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), DYSPNOEA (short of breath), HEART RATE INCREASED (fast heartbeat), INSOMNIA (lack of sleep) and ASTHENIA (feels weak) in an 82-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 was provided by the reporter.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), DYSPNOEA (short of breath), HEART RATE INCREASED (fast heartbeat), INSOMNIA (lack of sleep), ASTHENIA (feels weak), HEADACHE (headache) and HEADACHE (Off and on headache). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), DYSPNOEA (short of breath), HEART RATE INCREASED (fast heartbeat), INSOMNIA (lack of sleep), ASTHENIA (feels weak), HEADACHE (headache) and HEADACHE (Off and on headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: upset stomach; short of breath; fast heartbeat; lack of sleep; feels weak; headache; Off and on headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), DYSPNOEA (short of breath), HEART RATE INCREASED (fast heartbeat), INSOMNIA (lack of sleep) and ASTHENIA (feels weak) in an 82-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 was provided by the reporter.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), DYSPNOEA (short of breath), HEART RATE INCREASED (fast heartbeat), INSOMNIA (lack of sleep), ASTHENIA (feels weak), HEADACHE (headache) and HEADACHE (Off and on headache). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), DYSPNOEA (short of breath), HEART RATE INCREASED (fast heartbeat), INSOMNIA (lack of sleep), ASTHENIA (feels weak), HEADACHE (headache) and HEADACHE (Off and on headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema
Clinical narrative: redness at injection site; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at injection site) and FATIGUE (fatigue) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included hormonal IUD for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at injection site) and FATIGUE (fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 11-Feb-2021, FATIGUE (fatigue) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.