chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was administered the second dose of the vaccine 10 days after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was administered the second dose of the vaccine 10 days after the first dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Historical condition not reported.).   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was administered the second dose of the vaccine 10 days after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was administered the second dose of the vaccine 10 days after the first dose) 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: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Myalgia, Pyrexia
Clinical narrative: chills; Body aches; Fever of 104; Bone aches; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone aches), CHILLS (chills), MYALGIA (Body aches) and PYREXIA (Fever of 104) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for an unknown indication.     The patient's past medical history included No adverse event (No historical condition reported.).    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced BONE PAIN (Bone aches). On 11-Apr-2021, the patient experienced CHILLS (chills), MYALGIA (Body aches) and PYREXIA (Fever of 104). At the time of the report, BONE PAIN (Bone aches), CHILLS (chills), MYALGIA (Body aches) and PYREXIA (Fever of 104) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Nausea
Clinical narrative: The day after receiving 1st dose, he had nausea.; he had dizziness; He couldn't eat or drink anything; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (The day after receiving 1st dose, he had nausea.), DIZZINESS (he had dizziness) and DECREASED APPETITE (He couldn't eat or drink anything) in a male 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 (No reported medical history).    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Mar-2021, the patient experienced NAUSEA (The day after receiving 1st dose, he had nausea.), DIZZINESS (he had dizziness) and DECREASED APPETITE (He couldn't eat or drink anything). At the time of the report, NAUSEA (The day after receiving 1st dose, he had nausea.), DIZZINESS (he had dizziness) and DECREASED APPETITE (He couldn't eat or drink anything) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Insomnia, Lymphadenopathy
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes on left side of neck enlarged), PAIN (body ache), LYMPHADENOPATHY (swelling in the lymph nodes of the right side), INSOMNIA (hard time sleeping) and MALAISE (malaise) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 038A21A) 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 fish oil and collagen peptide powder for Cholesterol, levothyroxine for Thyroid therapy, ergocalciferol (vitamin D), tocopherol (vitamin E), women's multivitamin, probiotic capsule, aspirin, calcium, niacin and atorvastatin for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced INSOMNIA (hard time sleeping), CHILLS (chills), VACCINATION SITE PAIN (Sore left arm, 6 hours after the vaccine) and NAUSEA (nausea). On 10-Apr-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes on left side of neck enlarged), PAIN (body ache), MALAISE (malaise), PYREXIA (Slight fever), HEADACHE (Dull headache) and FATIGUE (fatigue). On 11-Apr-2021, the patient experienced LYMPHADENOPATHY (swelling in the lymph nodes of the right side). At the time of the report, LYMPHADENOPATHY (Lymph nodes on left side of neck enlarged), PAIN (body ache), LYMPHADENOPATHY (swelling in the lymph nodes of the right side), INSOMNIA (hard time sleeping), MALAISE (malaise), CHILLS (chills), VACCINATION SITE PAIN (Sore left arm, 6 hours after the vaccine), NAUSEA (nausea), PYREXIA (Slight fever), HEADACHE (Dull headache) and FATIGUE (fatigue) outcome was unknown. The treatment medication was Tylenol 325mg for symptoms. Action taken with mRNA-1273 in response to the events were not applicable. This case was linked to MOD-2021-073673 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: ADR Form; Sender's Comments: MOD-2021-073673:first dose case
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain, Pyrexia, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes on left side of neck enlarged), PAIN (body ache), LYMPHADENOPATHY (swelling in the lymph nodes of the right side), INSOMNIA (hard time sleeping) and MALAISE (malaise) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 038A21A) 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 fish oil and collagen peptide powder for Cholesterol, levothyroxine for Thyroid therapy, ergocalciferol (vitamin D), tocopherol (vitamin E), women's multivitamin, probiotic capsule, aspirin, calcium, niacin and atorvastatin for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced INSOMNIA (hard time sleeping), CHILLS (chills), VACCINATION SITE PAIN (Sore left arm, 6 hours after the vaccine) and NAUSEA (nausea). On 10-Apr-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes on left side of neck enlarged), PAIN (body ache), MALAISE (malaise), PYREXIA (Slight fever), HEADACHE (Dull headache) and FATIGUE (fatigue). On 11-Apr-2021, the patient experienced LYMPHADENOPATHY (swelling in the lymph nodes of the right side). At the time of the report, LYMPHADENOPATHY (Lymph nodes on left side of neck enlarged), PAIN (body ache), LYMPHADENOPATHY (swelling in the lymph nodes of the right side), INSOMNIA (hard time sleeping), MALAISE (malaise), CHILLS (chills), VACCINATION SITE PAIN (Sore left arm, 6 hours after the vaccine), NAUSEA (nausea), PYREXIA (Slight fever), HEADACHE (Dull headache) and FATIGUE (fatigue) outcome was unknown. The treatment medication was Tylenol 325mg for symptoms. Action taken with mRNA-1273 in response to the events were not applicable. This case was linked to MOD-2021-073673 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: ADR Form; Sender's Comments: MOD-2021-073673:first dose case
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Irritability, Lethargy
Clinical narrative: lethargic; very irritable; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic) and IRRITABILITY (very irritable) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included Generalized anxiety disorder and Gastric bypass in June 2020. Concomitant products included DIAZEPAM, DULOXETINE HYDROCHLORIDE (CYMBALTA) and ALPRAZOLAM (XANAX) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced LETHARGY (lethargic) and IRRITABILITY (very irritable). At the time of the report, LETHARGY (lethargic) and IRRITABILITY (very irritable) outcome was unknown.               Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 100 F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 100 F) in a 65-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 (Historical condition not reported.).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (Fever of 100 F). On 03-Apr-2021, PYREXIA (Fever of 100 F) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to -MODERNATX, INC.-MOD-2021-073761 (E2B Linked Report).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-073761:wife case
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache
Clinical narrative: little upset stomach; headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (little upset stomach), HEADACHE (headache) and FATIGUE (tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Lot# 022M20A and 019B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Historical condition not reported.).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (little upset stomach), HEADACHE (headache) and FATIGUE (tired). At the time of the report, ABDOMINAL DISCOMFORT (little upset stomach), HEADACHE (headache) and FATIGUE (tired) 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) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-073685 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073685:Dose 2
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Pain in extremity, Pruritus
Clinical narrative: Sore arm; Nose Bleed; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), EPISTAXIS (Nose Bleed) and PRURITUS (Itching) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Historical condition not provided.).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), EPISTAXIS (Nose Bleed) and PRURITUS (Itching). At the time of the report, PAIN IN EXTREMITY (Sore arm), EPISTAXIS (Nose Bleed) and PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed 2nd dose of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose of Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose of Moderna vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose of Moderna vaccine) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.No treatment information was provided.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: rashes were itchy; developed rashes all over the body; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rashes were itchy) and RASH (developed rashes all over the body) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced RASH PRURITIC (rashes were itchy) and RASH (developed rashes all over the body). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (rashes were itchy) and RASH (developed rashes all over the body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.            No concomitant medication were reported.No treatment information was provided.Action taken with mRNA-1273 in response to the events was not applicable.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neuralgia, Pain in extremity
Clinical narrative: neuropathic; shooting pain down arms; myalgia in both arms; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA, PAIN IN EXTREMITY, and MYALGIA in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEURALGIA, PAIN IN EXTREMITY, and MYALGIA. The patient was treated with TYLENOL at an unspecified dose and frequency. At the time of the report, NEURALGIA, PAIN IN EXTREMITY and MYALGIA had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No concomitant medications were reported.   This case was linked to US-MODERNATX, INC-MOD-2021-073650, MOD-2021-073913. Sender's Comments:  US-MODERNATX, INC-MOD-2021-073650: MOD-2021-073913.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: very bad body aches; a lot of pain in the arm of the injection; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (very bad body aches), PAIN IN EXTREMITY (a lot of pain in the arm of the injection) and HEADACHE (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 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (very bad body aches), PAIN IN EXTREMITY (a lot of pain in the arm of the injection) and HEADACHE (headache). At the time of the report, PAIN (very bad body aches), PAIN IN EXTREMITY (a lot of pain in the arm of the injection) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  No treatment information was provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site erythema, Vaccination site inflammation, Vaccination site pain
Clinical narrative: Older vaccination site (childhood vaccination area) is inflamed; Older vaccination site (childhood vaccination area) is soreness; Older vaccination site (childhood vaccination area) was pink/Older site of injection (childhood vaccination area) experienced redness; Fatigue; Slight headache; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Older vaccination site (childhood vaccination area) is inflamed), VACCINATION SITE PAIN (Older vaccination site (childhood vaccination area) is soreness), VACCINATION SITE ERYTHEMA (Older vaccination site (childhood vaccination area) was pink/Older site of injection (childhood vaccination area) experienced redness), FATIGUE (Fatigue) and HEADACHE (Slight headache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced FATIGUE (fatigue) and HEADACHE (headache). On 04-Apr-2021, the patient experienced VACCINATION SITE INFLAMMATION (Older vaccination site (childhood vaccination area) is inflamed), VACCINATION SITE PAIN (Older vaccination site (childhood vaccination area) is soreness), VACCINATION SITE ERYTHEMA (Older vaccination site (childhood vaccination area) was pink/Older site of injection (childhood vaccination area) experienced redness), FATIGUE (Fatigue) and HEADACHE (Slight headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INFLAMMATION (Older vaccination site (childhood vaccination area) is inflamed), VACCINATION SITE PAIN (Older vaccination site (childhood vaccination area) is soreness), VACCINATION SITE ERYTHEMA (Older vaccination site (childhood vaccination area) was pink/Older site of injection (childhood vaccination area) experienced redness), FATIGUE (Fatigue) and HEADACHE (Slight headache) outcome was unknown and FATIGUE (fatigue) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was vaccinated 1 inch above the site where she was vaccinated as a child. No concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Limb injury, Neck injury, Oropharyngeal pain
Clinical narrative: on a ladder pulling wire, turned wrong and popped his shoulder; on a ladder pulling wire, turned wrong and popped his shoulder and neck; Sore throat; headache; This spontaneous case was reported by a consumer and describes the occurrence of LIMB INJURY (on a ladder pulling wire, turned wrong and popped his shoulder), NECK INJURY (on a ladder pulling wire, turned wrong and popped his shoulder and neck), OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     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. In April 2021, the patient experienced LIMB INJURY (on a ladder pulling wire, turned wrong and popped his shoulder), NECK INJURY (on a ladder pulling wire, turned wrong and popped his shoulder and neck), OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (headache). On 12-Apr-2021, OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (headache) had resolved. At the time of the report, LIMB INJURY (on a ladder pulling wire, turned wrong and popped his shoulder) and NECK INJURY (on a ladder pulling wire, turned wrong and popped his shoulder and neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The patient's granddaughter visited one week prior to 12-Arp-2021 and the granddaughter tested positive for Covid-19.  The patient did not take a Covid-19 test.  The patient was taking steroids, unknown dose and frequency for shoulder and neck injury.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of cough and pain in extremity (arm pain) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 031B21H) for COVID-19 immunization. No medical history reported. Apr 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 2, 2021, patient experienced cough and pain in extremity (arm pain). The patient treated with Coricidin (oxymetazoline hydrochloride), at an unspecified dose and frequency. At the time of the report, cough and pain in extremity (arm pain) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; unknown. No concomitant medications reported. Treatment for the events included unspecified cough medicines and hot tea.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
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 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced COVID-19 (Tested positive for COVID 19 after 1st dose). On 06-Apr-2021, COVID-19 (Tested positive for COVID 19 after 1st dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, SARS-CoV-2 test: (Positive) Covid-19 tested positive. On 06-Apr-2021, SARS-CoV-2 test: (Negative) Covid-19 tested negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.No treatment information was provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Diabetes mellitus, Dizziness, Loss of personal independence in daily activities
Clinical narrative: got diabetes 2 weeks after taking the vaccine; dizziness/lightheadedness; This is stopping him from doing things; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS (got diabetes 2 weeks after taking the vaccine), DIZZINESS (dizziness/lightheadedness) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (This is stopping him from doing things) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced DIZZINESS (dizziness/lightheadedness) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (This is stopping him from doing things). On 13-Apr-2021, the patient experienced DIABETES MELLITUS (got diabetes 2 weeks after taking the vaccine). At the time of the report, DIABETES MELLITUS (got diabetes 2 weeks after taking the vaccine), DIZZINESS (dizziness/lightheadedness) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (This is stopping him from doing things) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatments or concomitant medications were reported.  The patient reported they got diabetes 2 weeks after taking the vaccine, the patient stated symptoms were better but still ongoing.  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.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: No specific follow-up information recorded. On 13-May-2021: Case upgraded to serious, new serious event 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 the events, a causal relationship cannot be excluded.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17year old patient given first dose of vaccine; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old patient given first dose of vaccine) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old patient given first dose of vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old patient given first dose of vaccine) 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.   No concomitant medications were reported.No treatment information was provided.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Fatigue, Musculoskeletal discomfort, Myalgia, Pain in extremity
Clinical narrative: Sore arm; Swelling in the arm pit; Ear pressure pain; Pressure in the neck; Fatigue; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), SWELLING (Swelling in the arm pit), EAR PAIN (Ear pressure pain), MUSCULOSKELETAL DISCOMFORT (Pressure in the neck) and FATIGUE (Fatigue) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), SWELLING (Swelling in the arm pit), EAR PAIN (Ear pressure pain), MUSCULOSKELETAL DISCOMFORT (Pressure in the neck), FATIGUE (Fatigue) and MYALGIA (Body ache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), SWELLING (Swelling in the arm pit), EAR PAIN (Ear pressure pain), MUSCULOSKELETAL DISCOMFORT (Pressure in the neck), FATIGUE (Fatigue) and MYALGIA (Body ache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Sore arm; Swelling in the arm pit; Ear pressure pain; Pressure in the neck; Fatigue; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), SWELLING (Swelling in the arm pit), EAR PAIN (Ear pressure pain), MUSCULOSKELETAL DISCOMFORT (Pressure in the neck) and FATIGUE (Fatigue) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), SWELLING (Swelling in the arm pit), EAR PAIN (Ear pressure pain), MUSCULOSKELETAL DISCOMFORT (Pressure in the neck), FATIGUE (Fatigue) and MYALGIA (Body ache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), SWELLING (Swelling in the arm pit), EAR PAIN (Ear pressure pain), MUSCULOSKELETAL DISCOMFORT (Pressure in the neck), FATIGUE (Fatigue) and MYALGIA (Body ache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, full-term birth.) on 11-Dec-2006, Pregnancy (Live, full-term birth.) on 30-Jul-2008, Pregnancy (Live, pre-term birth. Born at 7 months.) on 15-Feb-2010 and Pregnancy (Live, full-term birth.) on 17-Sep-2013. Concurrent medical conditions included Gestational diabetes since November 2020. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy, INSULIN, HYDROXYPROGESTERONE CAPROATE (MAKENA) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 12-Apr-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 04-Oct-2020 and the estimated date of delivery was 20-Jul-2021. On 12-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-seventh week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (pregnant) 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 considered EXPOSURE DURING PREGNANCY (pregnant) to be not applicable.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Difficulty to sleep; Throbbing pain at injection site; Swelling at the injection site like a nut; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Difficulty to sleep), VACCINATION SITE PAIN (Throbbing pain at injection site) and VACCINATION SITE SWELLING (Swelling at the injection site like a nut) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRINE), LOSARTAN, BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (BISOPROLOL /HCTZ) and ATORVASTATIN for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced INSOMNIA (Difficulty to sleep), VACCINATION SITE PAIN (Throbbing pain at injection site) and VACCINATION SITE SWELLING (Swelling at the injection site like a nut). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pain, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Difficulty to sleep) and VACCINATION SITE SWELLING (Swelling at the injection site like a nut) outcome was unknown and VACCINATION SITE PAIN (Throbbing pain at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Throbbing pain caused difficulty to sleep.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024m20a) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE, TELMISARTAN (MICARDIS HCT), DILTIAZEM (CARDIZEM [DILTIAZEM]), ZOLPIDEM, COLECALCIFEROL (VITAMIN D 3), FISH OIL, MULTIVITAMIN [VITAMINS NOS], CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE, MANGANESE ASCORBATE (COSAMIN), VITAMIN B6, VITAMIN B3, VITAMIN B12 NOS and ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication.    On 15-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 PAIN IN EXTREMITY (sore arm). On 17-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included cinnamon and green tea.Treatment information not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-073751 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073751:2st dose events
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Off label use
Clinical narrative: second dose early; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (second dose early) and HEADACHE (slight headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, LISINOPRIL, HYDROCHLOROTHIAZIDE, ACETYLSALICYLIC ACID (ASPIRINE) and CALCIUM for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced OFF LABEL USE (second dose early) and HEADACHE (slight headache). The patient was treated with NAPROXEN SODIUM (ALEVE) on 11-Apr-2021 for Headache, at a dose of 1 dosage form. On 11-Apr-2021, OFF LABEL USE (second dose early) and HEADACHE (slight headache) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Gait disturbance, Nausea
Clinical narrative: could not walk far without getting out of breath; did not eat; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (could not walk far without getting out of breath), DECREASED APPETITE (did not eat) and NAUSEA (nauseous) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (could not walk far without getting out of breath), DECREASED APPETITE (did not eat) and NAUSEA (nauseous). At the time of the report, GAIT DISTURBANCE (could not walk far without getting out of breath), DECREASED APPETITE (did not eat) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Cerebral disorder, Nightmare
Clinical narrative: nightmares; brain feels compromised; This spontaneous case was reported by a consumer and describes the occurrence of NIGHTMARE (nightmares) and CEREBRAL DISORDER (brain feels compromised) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NIGHTMARE (nightmares) and CEREBRAL DISORDER (brain feels compromised). At the time of the report, NIGHTMARE (nightmares) and CEREBRAL DISORDER (brain feels compromised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       At night he has very weird and bad dreams especially on his diabetes medication.No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Injection site discomfort, Pain in extremity, Vaccination site discolouration, Vaccination site pruritus
Clinical narrative: sensation in the arm; Arm is kind of sore; a little warm; When she touches the injection site it was sensitive and warm; it itches; swelling; warm; the injection site was pink/can see the shape; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm), INJECTION SITE DISCOMFORT (sensation in the arm), PAIN IN EXTREMITY (Arm is kind of sore), VACCINATION SITE WARMTH (a little warm) and VACCINATION SITE DISCOLOURATION (the injection site was pink/can see the shape) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lymph node dissection (had lymph nodes removed in her right side). Concurrent medical conditions included Breast cancer (she had breast cancer 12 years ago and had lymph nodes removed in her right side) since 2009. Concomitant products included METFORMIN, LEVOTHYROXINE, OMEPRAZOLE, ROSUVASTATIN, VITAMIN C [ASCORBIC ACID] and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE WARMTH (warm), VACCINATION SITE DISCOLOURATION (the injection site was pink/can see the shape) and VACCINATION SITE SWELLING (swelling). On an unknown date, the patient experienced INJECTION SITE DISCOMFORT (sensation in the arm), PAIN IN EXTREMITY (Arm is kind of sore), VACCINATION SITE WARMTH (a little warm), VACCINATION SITE REACTION (When she touches the injection site it was sensitive and warm) and VACCINATION SITE PRURITUS (it itches). At the time of the report, VACCINATION SITE WARMTH (warm), INJECTION SITE DISCOMFORT (sensation in the arm) and VACCINATION SITE PRURITUS (it itches) had not resolved, PAIN IN EXTREMITY (Arm is kind of sore), VACCINATION SITE WARMTH (a little warm) and VACCINATION SITE REACTION (When she touches the injection site it was sensitive and warm) outcome was unknown and VACCINATION SITE DISCOLOURATION (the injection site was pink/can see the shape) and VACCINATION SITE SWELLING (swelling) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 92 (High) 92 degrees.         Treatment for the events included armica sublingually and cold compress.Action taken with mRNA-1273 in response to the events was not applicable.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: sensation in the arm; Arm is kind of sore; a little warm; When she touches the injection site it was sensitive and warm; it itches; swelling; warm; the injection site was pink/can see the shape; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm), INJECTION SITE DISCOMFORT (sensation in the arm), PAIN IN EXTREMITY (Arm is kind of sore), VACCINATION SITE WARMTH (a little warm) and VACCINATION SITE DISCOLOURATION (the injection site was pink/can see the shape) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lymph node dissection (had lymph nodes removed in her right side). Concurrent medical conditions included Breast cancer (she had breast cancer 12 years ago and had lymph nodes removed in her right side) since 2009. Concomitant products included METFORMIN, LEVOTHYROXINE, OMEPRAZOLE, ROSUVASTATIN, VITAMIN C [ASCORBIC ACID] and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE WARMTH (warm), VACCINATION SITE DISCOLOURATION (the injection site was pink/can see the shape) and VACCINATION SITE SWELLING (swelling). On an unknown date, the patient experienced INJECTION SITE DISCOMFORT (sensation in the arm), PAIN IN EXTREMITY (Arm is kind of sore), VACCINATION SITE WARMTH (a little warm), VACCINATION SITE REACTION (When she touches the injection site it was sensitive and warm) and VACCINATION SITE PRURITUS (it itches). At the time of the report, VACCINATION SITE WARMTH (warm), INJECTION SITE DISCOMFORT (sensation in the arm) and VACCINATION SITE PRURITUS (it itches) had not resolved, PAIN IN EXTREMITY (Arm is kind of sore), VACCINATION SITE WARMTH (a little warm) and VACCINATION SITE REACTION (When she touches the injection site it was sensitive and warm) outcome was unknown and VACCINATION SITE DISCOLOURATION (the injection site was pink/can see the shape) and VACCINATION SITE SWELLING (swelling) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 92 (High) 92 degrees.         Treatment for the events included armica sublingually and cold compress.Action taken with mRNA-1273 in response to the events was not applicable.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Vaccination site nodule, Vaccination site pruritus, Vaccination site rash
Clinical narrative: red nodule at injection site; Elevated Injection Site; Itching Injection Site/and it is itching; rash is persisiting; rash was itchy; rash below the injection site on the right arm; This spontaneous case was reported by a nurse and describes the occurrence of RASH PRURITIC (rash was itchy), VACCINATION SITE NODULE (red nodule at injection site), VACCINATION SITE REACTION (Elevated Injection Site), VACCINATION SITE PRURITUS (Itching Injection Site/and it is itching) and RASH (rash is persisiting) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ONDANSETRON for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE RASH (rash below the injection site on the right arm). On 08-Apr-2021, the patient experienced RASH PRURITIC (rash was itchy) and RASH (rash is persisiting). On 10-Apr-2021, the patient experienced VACCINATION SITE NODULE (red nodule at injection site), VACCINATION SITE REACTION (Elevated Injection Site) and VACCINATION SITE PRURITUS (Itching Injection Site/and it is itching). The patient was treated with TRIAMTERENE (topical) for Vaccination site rash, Itchy rash, Rash and Injection site nodule, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (rash was itchy), VACCINATION SITE NODULE (red nodule at injection site), VACCINATION SITE REACTION (Elevated Injection Site), VACCINATION SITE PRURITUS (Itching Injection Site/and it is itching), RASH (rash is persisiting) and VACCINATION SITE RASH (rash below the injection site on the right arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD21-073525 (Linked Report).; Sender's Comments:  MOD21-073525: