chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Myalgia, Pain in extremity, Periarthritis
Clinical narrative: diagnosed with Frozen shoulder; Pain in the Shoulder and wrist; Pain in the Arm,forearm,hand; Could not sleep well; The soreness moving down to the middle arm/ soreness getting worse,I feel the soreness 24 hrs a day; Feeling sore on the location of the administration site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep well), PAIN IN EXTREMITY (The soreness moving down to the middle arm/ soreness getting worse,I feel the soreness 24 hrs a day), PERIARTHRITIS (diagnosed with Frozen shoulder), ARTHRALGIA (Pain in the Shoulder and wrist) and MYALGIA (Pain in the Arm,forearm,hand) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis since November 1997 and Drug allergy. Concomitant products included LISINOPRIL, OMEPRAZOLE, INTERFERON BETA-1A (AVONEX), ALPRAZOLAM and HYDROCODONE for an unknown indication.   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-Feb-2021, the patient experienced VACCINATION SITE PAIN (Feeling sore on the location of the administration site). On 18-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INSOMNIA (Could not sleep well), PAIN IN EXTREMITY (The soreness moving down to the middle arm/ soreness getting worse,I feel the soreness 24 hrs a day) and MYALGIA (Pain in the Arm,forearm,hand). On an unknown date, the patient experienced PERIARTHRITIS (diagnosed with Frozen shoulder) and ARTHRALGIA (Pain in the Shoulder and wrist). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN) for Vaccination site pain and Pain in extremity, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Could not sleep well), PAIN IN EXTREMITY (The soreness moving down to the middle arm/ soreness getting worse,I feel the soreness 24 hrs a day), PERIARTHRITIS (diagnosed with Frozen shoulder), ARTHRALGIA (Pain in the Shoulder and wrist), MYALGIA (Pain in the Arm,forearm,hand) and VACCINATION SITE PAIN (Feeling sore on the location of the administration site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Concomitant medications and other relevant history were updated On 17-Jun-2021: Initial Additional-1 : VAERS, AE details and outcome On 17-Jun-2021: Non Significant follow up appended to AER
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: diagnosed with Frozen shoulder; Pain in the Shoulder and wrist; Pain in the Arm,forearm,hand; Could not sleep well; The soreness moving down to the middle arm/ soreness getting worse,I feel the soreness 24 hrs a day; Feeling sore on the location of the administration site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep well), PAIN IN EXTREMITY (The soreness moving down to the middle arm/ soreness getting worse,I feel the soreness 24 hrs a day), PERIARTHRITIS (diagnosed with Frozen shoulder), ARTHRALGIA (Pain in the Shoulder and wrist) and MYALGIA (Pain in the Arm,forearm,hand) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis since November 1997 and Drug allergy. Concomitant products included LISINOPRIL, OMEPRAZOLE, INTERFERON BETA-1A (AVONEX), ALPRAZOLAM and HYDROCODONE for an unknown indication.   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-Feb-2021, the patient experienced VACCINATION SITE PAIN (Feeling sore on the location of the administration site). On 18-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INSOMNIA (Could not sleep well), PAIN IN EXTREMITY (The soreness moving down to the middle arm/ soreness getting worse,I feel the soreness 24 hrs a day) and MYALGIA (Pain in the Arm,forearm,hand). On an unknown date, the patient experienced PERIARTHRITIS (diagnosed with Frozen shoulder) and ARTHRALGIA (Pain in the Shoulder and wrist). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN) for Vaccination site pain and Pain in extremity, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Could not sleep well), PAIN IN EXTREMITY (The soreness moving down to the middle arm/ soreness getting worse,I feel the soreness 24 hrs a day), PERIARTHRITIS (diagnosed with Frozen shoulder), ARTHRALGIA (Pain in the Shoulder and wrist), MYALGIA (Pain in the Arm,forearm,hand) and VACCINATION SITE PAIN (Feeling sore on the location of the administration site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Concomitant medications and other relevant history were updated On 17-Jun-2021: Initial Additional-1 : VAERS, AE details and outcome On 17-Jun-2021: Non Significant follow up appended to AER
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Feeling hot, Headache
Clinical narrative: Tingling from my neck to left side of my mouth; Tongue was swollen; Face swelled; Sensation of feverish feeling in mouth; Headache; Tired; Had chills; Felt drained; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Felt drained), PARAESTHESIA (Tingling from my neck to left side of my mouth), SWOLLEN TONGUE (Tongue was swollen), SWELLING FACE (Face swelled) and FEELING HOT (Sensation of feverish feeling in mouth) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced ASTHENIA (Felt drained). On 18-Apr-2021, the patient experienced PARAESTHESIA (Tingling from my neck to left side of my mouth), SWOLLEN TONGUE (Tongue was swollen), SWELLING FACE (Face swelled), FEELING HOT (Sensation of feverish feeling in mouth), HEADACHE (Headache), FATIGUE (Tired) and CHILLS (Had chills). At the time of the report, ASTHENIA (Felt drained), SWELLING FACE (Face swelled), HEADACHE (Headache) and CHILLS (Had chills) had resolved and PARAESTHESIA (Tingling from my neck to left side of my mouth), SWOLLEN TONGUE (Tongue was swollen), FEELING HOT (Sensation of feverish feeling in mouth) and FATIGUE (Tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.    No treatment information was provided.   This case was linked to MOD-2021-137894 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Swelling face, Swollen tongue
Clinical narrative: Tingling from my neck to left side of my mouth; Tongue was swollen; Face swelled; Sensation of feverish feeling in mouth; Headache; Tired; Had chills; Felt drained; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Felt drained), PARAESTHESIA (Tingling from my neck to left side of my mouth), SWOLLEN TONGUE (Tongue was swollen), SWELLING FACE (Face swelled) and FEELING HOT (Sensation of feverish feeling in mouth) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced ASTHENIA (Felt drained). On 18-Apr-2021, the patient experienced PARAESTHESIA (Tingling from my neck to left side of my mouth), SWOLLEN TONGUE (Tongue was swollen), SWELLING FACE (Face swelled), FEELING HOT (Sensation of feverish feeling in mouth), HEADACHE (Headache), FATIGUE (Tired) and CHILLS (Had chills). At the time of the report, ASTHENIA (Felt drained), SWELLING FACE (Face swelled), HEADACHE (Headache) and CHILLS (Had chills) had resolved and PARAESTHESIA (Tingling from my neck to left side of my mouth), SWOLLEN TONGUE (Tongue was swollen), FEELING HOT (Sensation of feverish feeling in mouth) and FATIGUE (Tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.    No treatment information was provided.   This case was linked to MOD-2021-137894 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm; Dull headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (Dull headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 072Bor8L70A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic kidney disease stage 3 (Stage 3 Kidney Disease) and Diabetic. Concomitant products included METFORMIN, LISINOPRIL, SIMVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81), UBIDECARENONE (COQ 10) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Dull headache). At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Dull headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication included vitamin 400 IU once daily was noted. No treatment information was provided by the reporter. Second dose vaccine given on 21 Feb 2021 in left upper arm deltoid with lot number 012M20A was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-137848, US-MODERNATX, INC.-MOD-2021-137965 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up information received on 17-JUN-2021 contains no newsignificant information. On 16-Jul-2021: Non Significant FU- Follow up included no new significant information. Patient declined further follow up.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-137848:Relative's case US-MODERNATX, INC.-MOD-2021-137965:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: mother's blood pressure went up; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (mother's blood pressure went up) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (mother's blood pressure went up). At the time of the report, BLOOD PRESSURE INCREASED (mother's blood pressure went up) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: blood pressure went up (High) mother's blood pressure went up.         No treatment information was provided.  The action taken with response to the drug is not applicable.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Product dose omission issue, Rhinitis, SARS-CoV-2 test, Sneezing
Clinical narrative: Sneezing; Coryza; tested positive for COVID-19 infection, was asymptomatic; Missed second dose of the Moderna COVID-19 Vaccine; This spontaneous case was reported by a non-health professional and describes the occurrence of ASYMPTOMATIC COVID-19 (tested positive for COVID-19 infection, was asymptomatic), SNEEZING (Sneezing), RHINITIS (Coryza) and PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 Vaccine) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ENALAPRIL for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 Vaccine). On 07-May-2021, the patient experienced ASYMPTOMATIC COVID-19 (tested positive for COVID-19 infection, was asymptomatic). On 12-May-2021, the patient experienced SNEEZING (Sneezing) and RHINITIS (Coryza). The patient was treated with VITAMIN C [ASCORBIC ACID] at a dose of UNK dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK UNK, bid and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of UNK UNK, qd. On 06-May-2021, PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 Vaccine) had resolved. On 15-May-2021, SNEEZING (Sneezing) and RHINITIS (Coryza) had resolved. At the time of the report, ASYMPTOMATIC COVID-19 (tested positive for COVID-19 infection, was asymptomatic) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID-19 infection. On 17-May-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   .
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: Atopic dermatitis worse since vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Atopic dermatitis worse since vaccine) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026b21a and 017c21a) for COVID-19 vaccination.     Concurrent medical conditions included Atopic dermatitis. Concomitant products included DUPILUMAB (DUPIXENT) for Atopic dermatitis.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-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 CONDITION AGGRAVATED (Atopic dermatitis worse since vaccine). At the time of the report, CONDITION AGGRAVATED (Atopic dermatitis worse since vaccine) had not resolved.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia, Somnolence
Clinical narrative: Headache; Low grade fever; Stayed in bed all day; Was very fatigued; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Stayed in bed all day), FATIGUE (Was very fatigued), HEADACHE (Headache) and PYREXIA (Low grade fever) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced SOMNOLENCE (Stayed in bed all day), FATIGUE (Was very fatigued) and PYREXIA (Low grade fever). On 17-May-2021, the patient experienced HEADACHE (Headache). The patient was treated with IBUPROFEN for Fever and Fatigue, at an unspecified dose and frequency and GATIFLOXACIN (GATOR) at an unspecified dose and frequency. On 16-May-2021, SOMNOLENCE (Stayed in bed all day) and PYREXIA (Low grade fever) had resolved. At the time of the report, FATIGUE (Was very fatigued) had not resolved and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. Treatment included use of Ginger ale and Gator aide.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swelling in her arm after receiving injection; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in her arm after receiving injection) 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 PERIPHERAL SWELLING (Swelling in her arm after receiving injection). At the time of the report, PERIPHERAL SWELLING (Swelling in her arm after receiving injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-137942 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-137942:Reporter's case
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 2nd dose of Moderna COVID 19 vaccine at 21 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose of Moderna COVID 19 vaccine at 21 days) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 041B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergy to SULFA Antibiotics.) and Iodine allergy (iodine/iodide products). Concomitant products included ATORVASTATIN from 23-Nov-2020 to an unknown date for Hyperlipidemia, LOSARTAN from 04-Aug-2020 to an unknown date for Hypertension, FUROSEMIDE from 12-Nov-2020 to an unknown date for Hypertension and Heart failure.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose of Moderna COVID 19 vaccine at 21 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose of Moderna COVID 19 vaccine at 21 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatments was reported. Action taken with mRNA-1273 in response to the events was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up information received on 19-JUL-2021 and contains updated patient allergies , concomitant medications and details of vaccine.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Headache; Sweat for about a hour; Really tired; Body aching; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweat for about a hour), FATIGUE (Really tired), MYALGIA (Body aching), PYREXIA (Fever) and CHILLS (Chills) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced HYPERHIDROSIS (Sweat for about a hour), FATIGUE (Really tired), MYALGIA (Body aching), PYREXIA (Fever) and CHILLS (Chills). On 15-Apr-2021, the patient experienced HEADACHE (Headache). On 15-Apr-2021, HYPERHIDROSIS (Sweat for about a hour), FATIGUE (Really tired), MYALGIA (Body aching), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.  No concomitant medication provided.  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.   This case was linked to MOD-2021-137951 (Patient Link).; 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: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache; Sweat for about a hour; Really tired; Body aching; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweat for about a hour), FATIGUE (Really tired), MYALGIA (Body aching), PYREXIA (Fever) and CHILLS (Chills) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced HYPERHIDROSIS (Sweat for about a hour), FATIGUE (Really tired), MYALGIA (Body aching), PYREXIA (Fever) and CHILLS (Chills). On 15-Apr-2021, the patient experienced HEADACHE (Headache). On 15-Apr-2021, HYPERHIDROSIS (Sweat for about a hour), FATIGUE (Really tired), MYALGIA (Body aching), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.  No concomitant medication provided.  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.   This case was linked to MOD-2021-137951 (Patient Link).; 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: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itching that turned to a rash/ had itching; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itching that turned to a rash/ had itching) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for AFib, APIXABAN (ELIQUIS) for Anticoagulant therapy.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced RASH PRURITIC (Itching that turned to a rash/ had itching). At the time of the report, RASH PRURITIC (Itching that turned to a rash/ had itching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient has used steroid cream as treatment.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Lymph node swelling; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph node swelling) and PAIN IN EXTREMITY (sore arm) in a 75-year-old male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Lymph node swelling) and PAIN IN EXTREMITY (sore arm). At the time of the report, LYMPHADENOPATHY (Lymph node swelling) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Severe fatigue; Body soreness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Severe fatigue) and MYALGIA (Body soreness) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-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 FATIGUE (Severe fatigue) and MYALGIA (Body soreness). At the time of the report, FATIGUE (Severe fatigue) and MYALGIA (Body soreness) had not resolved.            No concomitant medication was reported.  No treatment medication was reported.  Action taken with mRNA-1273 with respect to events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Pain
Clinical narrative: cannot sleep/up all night; soreness; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (cannot sleep/up all night), PAIN (soreness) and MYALGIA (muscle ache) in an elderly 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 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 03-May-2021, the patient experienced INSOMNIA (cannot sleep/up all night), PAIN (soreness) and MYALGIA (muscle ache). At the time of the report, INSOMNIA (cannot sleep/up all night), PAIN (soreness) and MYALGIA (muscle ache) had resolved.            No treatment medication was reported. No concomitant medication was provided. The action taken was Not applicable as the 2 doses were administered.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up email received on 17-JUN-2021: TCR (Telephone Contact Report) Adverse events outcome were updated.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for COVID 19 after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID 19 after 1st dose) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced COVID-19 (Tested positive for COVID 19 after 1st dose). At the time of the report, COVID-19 (Tested positive for COVID 19 after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Loss of personal independence in daily activities
Clinical narrative: Patient stated her back left side (where kidneys located) was sore; Try to go to the bathroom but couldn't go; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Patient stated her back left side (where kidneys located) was sore) and DYSURIA (Try to go to the bathroom but couldn't go) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     Concurrent medical conditions included Lymphoedema (in left arm (constantly draining and swollen)) and Breast cancer.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced BACK PAIN (Patient stated her back left side (where kidneys located) was sore) and DYSURIA (Try to go to the bathroom but couldn't go). At the time of the report, BACK PAIN (Patient stated her back left side (where kidneys located) was sore) had not resolved and DYSURIA (Try to go to the bathroom but couldn't go) 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-137903 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-137903:Same reporter
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: ongoing hives from neck to tows; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (ongoing hives from neck to tows) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced URTICARIA (ongoing hives from neck to tows). At the time of the report, URTICARIA (ongoing hives from neck to tows) had not resolved.            For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. No concomitant and treatment medications were reported.   This case was linked to MOD-2021-137917 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Hyperhidrosis
Clinical narrative: fatigued; sweat for about a hour; difficulty breathing; Headache; chills; fever; body aching; Really Tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), HEADACHE (Headache), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigued) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 039B21A) 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 LISINOPRIL and TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced CHILLS (chills), PYREXIA (fever), FATIGUE (Really Tired) and MYALGIA (body aching). On 15-Apr-2021, the patient experienced HEADACHE (Headache). On 14-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (difficulty breathing). On 14-Jun-2021, the patient experienced FATIGUE (fatigued) and HYPERHIDROSIS (sweat for about a hour). On 15-Apr-2021, CHILLS (chills), PYREXIA (fever), FATIGUE (Really Tired) and MYALGIA (body aching) had resolved. On 15-Jun-2021, FATIGUE (fatigued) and HYPERHIDROSIS (sweat for about a hour) had resolved. At the time of the report, DYSPNOEA (difficulty breathing) and HEADACHE (Headache) outcome was unknown.            No treatment information was provided.  The Action taken for mRNA-1273 (Moderna COVID-19 Vaccine) was unknown  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. Further information has been requested.   This case was linked to MOD-2021-137911 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: ADR Form blank. Read Email.; 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. Further information has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: fatigued; sweat for about a hour; difficulty breathing; Headache; chills; fever; body aching; Really Tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), HEADACHE (Headache), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigued) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 039B21A) 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 LISINOPRIL and TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced CHILLS (chills), PYREXIA (fever), FATIGUE (Really Tired) and MYALGIA (body aching). On 15-Apr-2021, the patient experienced HEADACHE (Headache). On 14-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (difficulty breathing). On 14-Jun-2021, the patient experienced FATIGUE (fatigued) and HYPERHIDROSIS (sweat for about a hour). On 15-Apr-2021, CHILLS (chills), PYREXIA (fever), FATIGUE (Really Tired) and MYALGIA (body aching) had resolved. On 15-Jun-2021, FATIGUE (fatigued) and HYPERHIDROSIS (sweat for about a hour) had resolved. At the time of the report, DYSPNOEA (difficulty breathing) and HEADACHE (Headache) outcome was unknown.            No treatment information was provided.  The Action taken for mRNA-1273 (Moderna COVID-19 Vaccine) was unknown  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. Further information has been requested.   This case was linked to MOD-2021-137911 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: ADR Form blank. Read Email.; 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. Further information has been requested.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Rash, Urticaria
Clinical narrative: rash, looked like hives; "you could see clear liquid underneath, kind of like ant bites"; A rash in his arm that was injected / rash, right about the elbow / rash, broke out on his neck; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (rash, looked like hives), BLISTER ("you could see clear liquid underneath, kind of like ant bites") and RASH (A rash in his arm that was injected / rash, right about the elbow / rash, broke out on his neck) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced URTICARIA (rash, looked like hives), BLISTER ("you could see clear liquid underneath, kind of like ant bites") and RASH (A rash in his arm that was injected / rash, right about the elbow / rash, broke out on his neck). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, URTICARIA (rash, looked like hives), BLISTER ("you could see clear liquid underneath, kind of like ant bites") and RASH (A rash in his arm that was injected / rash, right about the elbow / rash, broke out on his neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned.  Consumer was vaccinated with first dose on 19APR2021 (lot: 030B21A), about 4 hours after, he developed a rash in his arm that was injected, it was right about the elbow, no pain no swelling, no itching. It looked like hives, "you could see clear liquid underneath, kind of like ant bites", he also broke out on his neck. Consumer took ibuprofen after vaccination. He has not had any guidance, from his primarily doctor, the pharmacist at the pharmacy, the CDC or the state department of health on whether or not he can get the second dose which is scheduled for today 17 MAY 2021.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Flushing, Headache, Myalgia
Clinical narrative: face flushed; body was mixed up; dull headache; sore arm for four days; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (face flushed), FEELING ABNORMAL (body was mixed up), HEADACHE (dull headache) and MYALGIA (sore arm for four days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02or7B? 0r8? L7OA and 031orIL70A) for COVID-19 vaccination.     Concurrent medical conditions included Heart murmur, Cardiac valve leak, Chronic sinusitis, Bronchitis and Carotid artery atheroma. Concomitant products included ATORVASTATIN, VITAMINS NOS, FLUTICASONE PROPIONATE, SODIUM FLUORIDE (FLUORIDE [SODIUM FLUORIDE]) and VITAMIN D3 for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FLUSHING (face flushed), FEELING ABNORMAL (body was mixed up), HEADACHE (dull headache) and MYALGIA (sore arm for four days). At the time of the report, FLUSHING (face flushed), HEADACHE (dull headache) and MYALGIA (sore arm for four days) had resolved and FEELING ABNORMAL (body was mixed up) outcome was unknown.            Patient is not sure of the Lot Numbers of the vaccines. No treatment information is provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-137883, MODERNATX, INC.-MOD-2021-137848 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: TCR Received. Event outcome updated as recovered.; Sender's Comments:  MODERNATX, INC.-MOD-2021-137883:husband case MODERNATX, INC.-MOD-2021-137848:family member case
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Rash, Skin swelling, Vaccination site erythema, Vaccination site pain
Clinical narrative: felt flu like symptoms; under the shoulder "not swollen but puffy"; puffy rash on shoulder; itchiness of arm; hives on arm; redness about 5 inches long up and down arm around site of injection; tenderness of injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt flu like symptoms), SKIN SWELLING (under the shoulder "not swollen but puffy"), RASH (puffy rash on shoulder), VACCINATION SITE PRURITUS (itchiness of arm) and VACCINATION SITE URTICARIA (hives on arm) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced SKIN SWELLING (under the shoulder "not swollen but puffy"), RASH (puffy rash on shoulder), VACCINATION SITE PRURITUS (itchiness of arm), VACCINATION SITE URTICARIA (hives on arm), VACCINATION SITE ERYTHEMA (redness about 5 inches long up and down arm around site of injection) and VACCINATION SITE PAIN (tenderness of injection site). On 14-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt flu like symptoms). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (felt flu like symptoms), SKIN SWELLING (under the shoulder "not swollen but puffy"), RASH (puffy rash on shoulder), VACCINATION SITE PRURITUS (itchiness of arm), VACCINATION SITE URTICARIA (hives on arm), VACCINATION SITE ERYTHEMA (redness about 5 inches long up and down arm around site of injection) and VACCINATION SITE PAIN (tenderness of injection site) 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.   The 2nd dose scheduled on 26-May-2021. Tylenol used as treatment. No concomitant products reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Updated patient demographics, no other new information was received.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: felt flu like symptoms; under the shoulder "not swollen but puffy"; puffy rash on shoulder; itchiness of arm; hives on arm; redness about 5 inches long up and down arm around site of injection; tenderness of injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt flu like symptoms), SKIN SWELLING (under the shoulder "not swollen but puffy"), RASH (puffy rash on shoulder), VACCINATION SITE PRURITUS (itchiness of arm) and VACCINATION SITE URTICARIA (hives on arm) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced SKIN SWELLING (under the shoulder "not swollen but puffy"), RASH (puffy rash on shoulder), VACCINATION SITE PRURITUS (itchiness of arm), VACCINATION SITE URTICARIA (hives on arm), VACCINATION SITE ERYTHEMA (redness about 5 inches long up and down arm around site of injection) and VACCINATION SITE PAIN (tenderness of injection site). On 14-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt flu like symptoms). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (felt flu like symptoms), SKIN SWELLING (under the shoulder "not swollen but puffy"), RASH (puffy rash on shoulder), VACCINATION SITE PRURITUS (itchiness of arm), VACCINATION SITE URTICARIA (hives on arm), VACCINATION SITE ERYTHEMA (redness about 5 inches long up and down arm around site of injection) and VACCINATION SITE PAIN (tenderness of injection site) 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.   The 2nd dose scheduled on 26-May-2021. Tylenol used as treatment. No concomitant products reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Updated patient demographics, no other new information was received.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: has not received 2nd dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (has not received 2nd dose yet) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-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 PRODUCT DOSE OMISSION ISSUE (has not received 2nd dose yet). On 21-Mar-2021, PRODUCT DOSE OMISSION ISSUE (has not received 2nd dose yet) had resolved.        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.