chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Nausea
Clinical narrative: head felt heavy; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (head felt heavy) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (head felt heavy) and NAUSEA (Nausea). The patient was treated with DIAZEPAM (VALIUM) at an unspecified dose and frequency. At the time of the report, HEAD DISCOMFORT (head felt heavy) and NAUSEA (Nausea) outcome was unknown.            No medical history and concomitant medications were provided.  Treatment information include Valium   This case was linked to MOD-2021-049548 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Induration, Pruritus
Clinical narrative: Very hard big circle; Itchiness; Hottness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (Very hard big circle), PRURITUS (Itchiness) and FEELING HOT (Hottness of the arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol, Hypertension and Thyroid disorder. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, LOSARTAN for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS, TRAZODONE and OXYCODONE 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 15-Apr-2021, the patient experienced INDURATION (Very hard big circle), PRURITUS (Itchiness) and FEELING HOT (Hottness of the arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INDURATION (Very hard big circle), PRURITUS (Itchiness) and FEELING HOT (Hottness of the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort
Clinical narrative: popped blood vessels in both eyes after the vaccination; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of OCULAR DISCOMFORT (popped blood vessels in both eyes after the vaccination) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 002C21A) 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 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced OCULAR DISCOMFORT (popped blood vessels in both eyes after the vaccination). At the time of the report, OCULAR DISCOMFORT (popped blood vessels in both eyes after the vaccination) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: lost balance for a moment; dizziness; felt little lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (lost balance for a moment), DIZZINESS (dizziness) and DIZZINESS (felt little lightheaded) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced BALANCE DISORDER (lost balance for a moment), DIZZINESS (dizziness) and DIZZINESS (felt little lightheaded). At the time of the report, BALANCE DISORDER (lost balance for a moment), DIZZINESS (dizziness) and DIZZINESS (felt little lightheaded) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported  No treatment information was provided    This case was linked to US-MODERNATX, INC.-MOD-2021-089650, US-MODERNATX, INC.-MOD-2021-089661 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089661:Reporter case US-MODERNATX, INC.-MOD-2021-089650:Reporter case
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Insomnia, Limb discomfort, Musculoskeletal discomfort, Pain
Clinical narrative: Had excruciating pain; felt as if I pulled something in my shoulder; Cannot lift my arm; Had trouble sleeping; Shot too high up on the arm  It may not be in the deltoid muscle; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Had excruciating pain), MUSCULOSKELETAL DISCOMFORT (felt as if I pulled something in my shoulder), LIMB DISCOMFORT (Cannot lift my arm), INSOMNIA (Had trouble sleeping) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Shot too high up on the arm  It may not be in the deltoid muscle) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C2IA) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS (MULTIVITAMINUM) for an unknown indication.    On 21-Apr-2021 at 12:35 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN (Had excruciating pain), MUSCULOSKELETAL DISCOMFORT (felt as if I pulled something in my shoulder), LIMB DISCOMFORT (Cannot lift my arm), INSOMNIA (Had trouble sleeping) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Shot too high up on the arm  It may not be in the deltoid muscle). The patient was treated with METHYLPREDNISOLONE at an unspecified dose and frequency. At the time of the report, PAIN (Had excruciating pain), MUSCULOSKELETAL DISCOMFORT (felt as if I pulled something in my shoulder), LIMB DISCOMFORT (Cannot lift my arm), INSOMNIA (Had trouble sleeping) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Shot too high up on the arm  It may not be in the deltoid muscle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gastrointestinal disorder, Nausea, Vomiting
Clinical narrative: nauseousness; vomiting; gastro intestinal issues; diarrhea; This spontaneous case was reported by a health care professional and describes the occurrence of GASTROINTESTINAL DISORDER (gastro intestinal issues), DIARRHOEA (diarrhea), NAUSEA (nauseousness) and VOMITING (vomiting) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced GASTROINTESTINAL DISORDER (gastro intestinal issues) and DIARRHOEA (diarrhea). On 05-Apr-2021, the patient experienced NAUSEA (nauseousness) and VOMITING (vomiting). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency and SODIUM ALGINATE (GAVISCON ADVANCE [SODIUM ALGINATE]) at an unspecified dose and frequency. On 05-Apr-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, GASTROINTESTINAL DISORDER (gastro intestinal issues), NAUSEA (nauseousness) and VOMITING (vomiting) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient has underlying disabilities medical condition.  There is no concomitant list provided. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up received on 27-may-2021. no new information received
Sex: M
Vaccine: COVID19
Symptoms: Skin disorder, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: skin started feeling funny; itchy spots on arm the size of bug bites; red  itchy spots on arm the size of bug bites; This spontaneous case was reported by a pharmacist and describes the occurrence of SKIN DISORDER (skin started feeling funny), VACCINATION SITE PRURITUS (itchy spots on arm the size of bug bites) and VACCINATION SITE ERYTHEMA (red  itchy spots on arm the size of bug bites) 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 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itchy spots on arm the size of bug bites) and VACCINATION SITE ERYTHEMA (red  itchy spots on arm the size of bug bites). On an unknown date, the patient experienced SKIN DISORDER (skin started feeling funny). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SKIN DISORDER (skin started feeling funny), VACCINATION SITE PRURITUS (itchy spots on arm the size of bug bites) and VACCINATION SITE ERYTHEMA (red  itchy spots on arm the size of bug bites) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: patient got a double dose(1 cc) as his first dose of vaccine and reported no AE; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (patient got a double dose(1 cc) as his first dose of vaccine and reported no AE) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 21-Apr-2021, the patient experienced ACCIDENTAL OVERDOSE (patient got a double dose(1 cc) as his first dose of vaccine and reported no AE). At the time of the report, ACCIDENTAL OVERDOSE (patient got a double dose(1 cc) as his first dose of vaccine and reported no AE) 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Coordination abnormal, Fatigue, Motor dysfunction, Paraesthesia oral
Clinical narrative: Having difficulty with coordination; Can't grasp objects; Feeling tingling in my mouth; Have extreme joint pain; Have Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COORDINATION ABNORMAL (Having difficulty with coordination), MOTOR DYSFUNCTION (Can't grasp objects), PARAESTHESIA ORAL (Feeling tingling in my mouth), ARTHRALGIA (Have extreme joint pain) and FATIGUE (Have Fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergy to metronidazole (Flagyl)), Drug allergy (allergy to infliximab (Remicade)) and Ankylosing spondylitis (ankylosing spondylitis). Concomitant products included ESTRADIOL (ESTROGEN), GABAPENTIN, BUSPIRONE and PROGESTERONE for an unknown indication.   On 10-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 23-Apr-2021, the patient experienced COORDINATION ABNORMAL (Having difficulty with coordination), MOTOR DYSFUNCTION (Can't grasp objects), PARAESTHESIA ORAL (Feeling tingling in my mouth), ARTHRALGIA (Have extreme joint pain) and FATIGUE (Have Fatigue). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, COORDINATION ABNORMAL (Having difficulty with coordination), MOTOR DYSFUNCTION (Can't grasp objects), PARAESTHESIA ORAL (Feeling tingling in my mouth), ARTHRALGIA (Have extreme joint pain) and FATIGUE (Have Fatigue) had not resolved.            As treatment, the patient took acetaminophen but it did not help alleviate any of the symptoms.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old) 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 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up was received on 26 May 2021 included no adverse events involved.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Chills, Headache, Influenza
Clinical narrative: Delayed reaction to the first shot; About 10 days later, I started getting chills; Fever; Headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (Delayed reaction to the first shot), CHILLS (About 10 days later, I started getting chills), PYREXIA (Fever) and HEADACHE (Headaches) in a 49-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 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Delayed reaction to the first shot), CHILLS (About 10 days later, I started getting chills), PYREXIA (Fever) and HEADACHE (Headaches). At the time of the report, VACCINATION COMPLICATION (Delayed reaction to the first shot), CHILLS (About 10 days later, I started getting chills), PYREXIA (Fever) and HEADACHE (Headaches) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal normal. On an unknown date, COVID-19: negative Negative. On an unknown date, Influenza: negative Negative. On an unknown date, SARS-CoV-2 test: negative Negative. On an unknown date, Urine analysis: normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment included Steroids for 5 days and symptoms stopped for that time. As soon as patient stopped, fever and chills came back. No concomitant medication reported Patient symptoms have continued on daily basis until now. Patient saw the primary care physician and she said may be I got COVID. Patient been 3 weeks now with all these symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Non-significant follow-up information included reporter mail id added
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Urine analysis, Vaccination complication
Clinical narrative: Delayed reaction to the first shot; About 10 days later, I started getting chills; Fever; Headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (Delayed reaction to the first shot), CHILLS (About 10 days later, I started getting chills), PYREXIA (Fever) and HEADACHE (Headaches) in a 49-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 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Delayed reaction to the first shot), CHILLS (About 10 days later, I started getting chills), PYREXIA (Fever) and HEADACHE (Headaches). At the time of the report, VACCINATION COMPLICATION (Delayed reaction to the first shot), CHILLS (About 10 days later, I started getting chills), PYREXIA (Fever) and HEADACHE (Headaches) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal normal. On an unknown date, COVID-19: negative Negative. On an unknown date, Influenza: negative Negative. On an unknown date, SARS-CoV-2 test: negative Negative. On an unknown date, Urine analysis: normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment included Steroids for 5 days and symptoms stopped for that time. As soon as patient stopped, fever and chills came back. No concomitant medication reported Patient symptoms have continued on daily basis until now. Patient saw the primary care physician and she said may be I got COVID. Patient been 3 weeks now with all these symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Non-significant follow-up information included reporter mail id added
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bowel movement irregularity, Constipation, Fatigue
Clinical narrative: stomach ache; constipation; LBM; patient feels very tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache), CONSTIPATION (constipation), BOWEL MOVEMENT IRREGULARITY (LBM) and FATIGUE (patient feels very tired) 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 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), CONSTIPATION (constipation), BOWEL MOVEMENT IRREGULARITY (LBM) and FATIGUE (patient feels very tired). At the time of the report, ABDOMINAL PAIN UPPER (stomach ache), CONSTIPATION (constipation), BOWEL MOVEMENT IRREGULARITY (LBM) and FATIGUE (patient feels very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: received less than half of the recommended dose; needle screwed onto the syringe coming off; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (received less than half of the recommended dose) and DEVICE CONNECTION ISSUE (needle screwed onto the syringe coming off) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced UNDERDOSE (received less than half of the recommended dose) and DEVICE CONNECTION ISSUE (needle screwed onto the syringe coming off). At the time of the report, UNDERDOSE (received less than half of the recommended dose) and DEVICE CONNECTION ISSUE (needle screwed onto the syringe coming off) outcome was unknown. 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.   No concomitant medication reported  No treatment information was provided
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Haemoptysis, Headache, Myalgia, Pyrexia
Clinical narrative: Headache; Sorearm; Low grade Fever; Coughing; blood when she spits; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Sorearm), PYREXIA (Low grade Fever), COUGH (Coughing) and HAEMOPTYSIS (blood when she spits) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), MYALGIA (Sorearm), PYREXIA (Low grade Fever), COUGH (Coughing) and HAEMOPTYSIS (blood when she spits). At the time of the report, HEADACHE (Headache), MYALGIA (Sorearm), PYREXIA (Low grade Fever), COUGH (Coughing) and HAEMOPTYSIS (blood when she spits) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment drugs were reported.  Husband stated that she had headache, sore arm, low grade fever. It lasted for few days. Then she started coughing and when she spits there is blood in spit. This happened after the 1st shot as well. After 1st shot it lasted for few days and then it was fine   This case was linked to MOD-2021-089371 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive after three days; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive after three days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lung disorder and Psychotic disorder.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive after three days). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive after three days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, SARS-CoV-2 test: tested positive, three days later (Positive) Tested positive, three days later.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Oropharyngeal pain, Paraesthesia oral
Clinical narrative: Felt like sore throat; not able to swallow like normal; tongue feels fat; shortness of breath when laying down; This spontaneous case was reported by a non-health professional and describes the occurrence of OROPHARYNGEAL PAIN (Felt like sore throat), DYSPNOEA (shortness of breath when laying down), DYSPHAGIA (not able to swallow like normal) and PARAESTHESIA ORAL (tongue feels fat) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced DYSPNOEA (shortness of breath when laying down). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Felt like sore throat), DYSPHAGIA (not able to swallow like normal) and PARAESTHESIA ORAL (tongue feels fat). At the time of the report, OROPHARYNGEAL PAIN (Felt like sore throat), DYSPNOEA (shortness of breath when laying down), DYSPHAGIA (not able to swallow like normal) and PARAESTHESIA ORAL (tongue feels fat) 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.   Concomitant drug was not reported. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Added reporter's information. On 21-Jul-2021: Follow up received contains no new information
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Red mark around the injection the size of a plum; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Red mark around the injection the size of a plum) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red mark around the injection the size of a plum). At the time of the report, VACCINATION SITE ERYTHEMA (Red mark around the injection the size of a plum) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.  Patient who returned a callback from Safety under Argus number MOD21-2021089298. The patient said that didn't want to provide any personal information declining address and email address as contact information then hang.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: TCR received on 27 May 2021 and does not contain any new information On 03-Jun-2021: Additional information received from the initial reporter and does not contain new information
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Myalgia, Pyrexia
Clinical narrative: chest pain; body ache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), MYALGIA (body ache), PYREXIA (fever) and CHILLS (chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced CHEST PAIN (chest pain), MYALGIA (body ache), PYREXIA (fever) and CHILLS (chills). At the time of the report, CHEST PAIN (chest pain) had not resolved and MYALGIA (body ache), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            No concomitant medication reported  No treatment information was provided  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Heart rate increased, Tremor
Clinical narrative: high heart rate of 137; dizziness; tremors; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (high heart rate of 137), DIZZINESS (dizziness), TREMOR (tremors) and FATIGUE (Fatigue) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031321A) for COVID-19 vaccination.     Concurrent medical conditions included Fish allergy (Stated her reaction was similar to the reaction she had when she ate fish.).    On 09-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 HEART RATE INCREASED (high heart rate of 137), DIZZINESS (dizziness), TREMOR (tremors) and FATIGUE (Fatigue). At the time of the report, HEART RATE INCREASED (high heart rate of 137), DIZZINESS (dizziness), TREMOR (tremors) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information reported.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Insomnia, Muscle spasms, Pyrexia
Clinical narrative: didn't sleep all night; knot in arm; Chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (didn't sleep all night), MUSCLE SPASMS (knot in arm), CHILLS (Chills) and PYREXIA (fever) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced INSOMNIA (didn't sleep all night), MUSCLE SPASMS (knot in arm), CHILLS (Chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INSOMNIA (didn't sleep all night), MUSCLE SPASMS (knot in arm), CHILLS (Chills) and PYREXIA (fever) had not resolved.            No concomitant information was reported.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: she can't raise her arm; very sore; a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (she can't raise her arm), PAIN IN EXTREMITY (very sore) and PERIPHERAL SWELLING (a little swollen) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced MOBILITY DECREASED (she can't raise her arm), PAIN IN EXTREMITY (very sore) and PERIPHERAL SWELLING (a little swollen). At the time of the report, MOBILITY DECREASED (she can't raise her arm), PAIN IN EXTREMITY (very sore) and PERIPHERAL SWELLING (a little swollen) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided. The action taken for mRNA-1273 was not applicable.   This case was linked to MOD-2021-066762 (Patient Link).
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pain in extremity
Clinical narrative: Leg pain; Cold legs; Chills; Muscle pain; Headache; Feverish; Knee joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg pain), PERIPHERAL COLDNESS (Cold legs), CHILLS (Chills), MYALGIA (Muscle pain) and HEADACHE (Headache) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-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 PAIN IN EXTREMITY (Leg pain), PERIPHERAL COLDNESS (Cold legs), CHILLS (Chills), MYALGIA (Muscle pain), HEADACHE (Headache), PYREXIA (Feverish) and ARTHRALGIA (Knee joint pain). The patient was treated with ACETAMINOPHEN (oral) at a dose of 200 milligram, 2 Tablets. At the time of the report, PAIN IN EXTREMITY (Leg pain), PERIPHERAL COLDNESS (Cold legs), CHILLS (Chills), MYALGIA (Muscle pain), HEADACHE (Headache), PYREXIA (Feverish) and ARTHRALGIA (Knee joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral coldness, Pyrexia
Clinical narrative: Leg pain; Cold legs; Chills; Muscle pain; Headache; Feverish; Knee joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg pain), PERIPHERAL COLDNESS (Cold legs), CHILLS (Chills), MYALGIA (Muscle pain) and HEADACHE (Headache) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-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 PAIN IN EXTREMITY (Leg pain), PERIPHERAL COLDNESS (Cold legs), CHILLS (Chills), MYALGIA (Muscle pain), HEADACHE (Headache), PYREXIA (Feverish) and ARTHRALGIA (Knee joint pain). The patient was treated with ACETAMINOPHEN (oral) at a dose of 200 milligram, 2 Tablets. At the time of the report, PAIN IN EXTREMITY (Leg pain), PERIPHERAL COLDNESS (Cold legs), CHILLS (Chills), MYALGIA (Muscle pain), HEADACHE (Headache), PYREXIA (Feverish) and ARTHRALGIA (Knee joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Vomiting
Clinical narrative: vomited a lot; episode of fatigue for 3days; joint pain for 3days; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomited a lot), FATIGUE (episode of fatigue for 3days) and ARTHRALGIA (joint pain for 3days) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pancreatic cancer in 2019, Immune disorder (NOS) and Psoriatic arthritis in 2011. Concurrent medical conditions included Allergy (General allergy). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and CLONAZEPAM for Anxiety, ACETYLSALICYLIC ACID, CAFFEINE, CODEINE PHOSPHATE, PARACETAMOL (FIORINAL CODEINE) for Migraine, OXYCODONE, PROMETHAZINE, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), PANCREATIN (CREON), METOPROLOL and OMEPRAZOLE for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced VOMITING (vomited a lot), FATIGUE (episode of fatigue for 3days) and ARTHRALGIA (joint pain for 3days). On 26-Mar-2021, FATIGUE (episode of fatigue for 3days) and ARTHRALGIA (joint pain for 3days) had resolved. At the time of the report, VOMITING (vomited a lot) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-089285 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089285:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Swelling, Swelling face
Clinical narrative: Hardening swollen area ranging from behind ear to neck and jaw line; Hardening swollen area ranging from behind ear to neck and jaw line; Hardening swollen area ranging from behind ear to neck and jaw line; This spontaneous case was reported by a consumer and describes the occurrence of EAR SWELLING (Hardening swollen area ranging from behind ear to neck and jaw line), SWELLING (Hardening swollen area ranging from behind ear to neck and jaw line) and SWELLING FACE (Hardening swollen area ranging from behind ear to neck and jaw line) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 008B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced EAR SWELLING (Hardening swollen area ranging from behind ear to neck and jaw line), SWELLING (Hardening swollen area ranging from behind ear to neck and jaw line) and SWELLING FACE (Hardening swollen area ranging from behind ear to neck and jaw line). At the time of the report, EAR SWELLING (Hardening swollen area ranging from behind ear to neck and jaw line), SWELLING (Hardening swollen area ranging from behind ear to neck and jaw line) and SWELLING FACE (Hardening swollen area ranging from behind ear to neck and jaw line) outcome was unknown. Not Provided          No concomitant and treatment details were provided. Action taken in response to mRNA-1273 was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up received on 27-MAY-2021. TCR document was attached. No new information was reported.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Headache, Myalgia
Clinical narrative: Increased stomach pain; Increased headache; Muscle pain in both legs; Pain in the upper part of shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Increased stomach pain), HEADACHE (Increased headache), MYALGIA (Muscle pain in both legs) and ARTHRALGIA (Pain in the upper part of shoulder) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Gastritis, Stomach mass and Back pain.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Increased stomach pain), HEADACHE (Increased headache) and ARTHRALGIA (Pain in the upper part of shoulder). 16-Apr-2021, the patient experienced MYALGIA (Muscle pain in both legs). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Increased stomach pain), HEADACHE (Increased headache), MYALGIA (Muscle pain in both legs) and ARTHRALGIA (Pain in the upper part of shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Vertigo
Clinical narrative: mental fogginess; balance issues; Dizziness; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021 and was forwarded to Moderna on 23-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (mental fogginess), VERTIGO (balance issues), DIZZINESS (Dizziness) and FATIGUE (Fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Anaemia. Concomitant products included LEVOTHYROXINE, VITAMIN D3 and VITAMIN B COMPLEX for an unknown indication.   On 21-Jan-2021 at 3:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 10:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced FEELING ABNORMAL (mental fogginess), VERTIGO (balance issues) and DIZZINESS (Dizziness). 22-Mar-2021, the patient experienced FATIGUE (Fatigue). The patient was treated with MECLIZINE HCL from 23-Mar-2021 to 11-Apr-2021 for Vertigo, at a dose of 25 mg. At the time of the report, FEELING ABNORMAL (mental fogginess), VERTIGO (balance issues), DIZZINESS (Dizziness) and FATIGUE (Fatigue) had not resolved.            The patient had cat scan of head and ultrasound of carotid artery. The patient was diagnosed with vertigo   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Added patient medical history Anemia , Added concomitant and treatment medications , Added event fatigue
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Family member got pregnant after receiving the 1st dose of Moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Family member got pregnant after receiving the 1st dose of Moderna vaccine) 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 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 30-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Family member got pregnant after receiving the 1st dose of Moderna vaccine). On 30-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Family member got pregnant after receiving the 1st dose of Moderna vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient got pregnant after receiving the first dose of vaccine. The second dose of Moderna vaccine was due on 27-Apr-2021.   No treatment of events was reported. No concomitant medications were reported.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nausea, Vaccination site lymphadenopathy, Vaccination site pain, Vaccination site pruritus
Clinical narrative: injection site arm itchy; injection site arm hot to touch; Vaccination site swelling; lethargic; nausea; Vaccination site pain; lymph nodes on injection site arm feel swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site arm hot to touch), LETHARGY (lethargic), VACCINATION SITE PRURITUS (injection site arm itchy), NAUSEA (nausea) and VACCINATION SITE PAIN (Vaccination site pain) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced LETHARGY (lethargic), NAUSEA (nausea), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE LYMPHADENOPATHY (lymph nodes on injection site arm feel swollen). On 21-Apr-2021, the patient experienced VACCINATION SITE WARMTH (injection site arm hot to touch), VACCINATION SITE PRURITUS (injection site arm itchy) and VACCINATION SITE SWELLING (Vaccination site swelling). On 14-Apr-2021, LETHARGY (lethargic) and NAUSEA (nausea) had resolved. On 18-Apr-2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved. At the time of the report, VACCINATION SITE WARMTH (injection site arm hot to touch), VACCINATION SITE PRURITUS (injection site arm itchy), VACCINATION SITE LYMPHADENOPATHY (lymph nodes on injection site arm feel swollen) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site arm itchy; injection site arm hot to touch; Vaccination site swelling; lethargic; nausea; Vaccination site pain; lymph nodes on injection site arm feel swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site arm hot to touch), LETHARGY (lethargic), VACCINATION SITE PRURITUS (injection site arm itchy), NAUSEA (nausea) and VACCINATION SITE PAIN (Vaccination site pain) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced LETHARGY (lethargic), NAUSEA (nausea), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE LYMPHADENOPATHY (lymph nodes on injection site arm feel swollen). On 21-Apr-2021, the patient experienced VACCINATION SITE WARMTH (injection site arm hot to touch), VACCINATION SITE PRURITUS (injection site arm itchy) and VACCINATION SITE SWELLING (Vaccination site swelling). On 14-Apr-2021, LETHARGY (lethargic) and NAUSEA (nausea) had resolved. On 18-Apr-2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved. At the time of the report, VACCINATION SITE WARMTH (injection site arm hot to touch), VACCINATION SITE PRURITUS (injection site arm itchy), VACCINATION SITE LYMPHADENOPATHY (lymph nodes on injection site arm feel swollen) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided.