chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Achy from head to toe on both side of the body; Headache; Fever; Fatigue; Sore Left Arm; Achy on the left side of body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Left Arm), PAIN (Achy on the left side of body), PAIN (Achy from head to toe on both side of the body), HEADACHE (Headache) and PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Low blood pressure.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Left Arm), PAIN (Achy on the left side of body), PYREXIA (Fever) and FATIGUE (Fatigue). On 25-Mar-2021, the patient experienced PAIN (Achy from head to toe on both side of the body) and HEADACHE (Headache). On 13-Mar-2021, PAIN IN EXTREMITY (Sore Left Arm), PAIN (Achy on the left side of body) and FATIGUE (Fatigue) had resolved. On 24-Mar-2021, PYREXIA (Fever) outcome was unknown. At the time of the report, PAIN (Achy from head to toe on both side of the body) and HEADACHE (Headache) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment information was provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nasal congestion
Clinical narrative: dry stuffy nose; fatigue; muscle aches; headache; chills; arm soreness; runny nose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm soreness), RHINORRHOEA (runny nose), NASAL CONGESTION (dry stuffy nose), FATIGUE (fatigue) and MYALGIA (muscle aches) in a 57-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 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm soreness), RHINORRHOEA (runny nose), FATIGUE (fatigue), MYALGIA (muscle aches), HEADACHE (headache) and CHILLS (chills). On 25-Mar-2021, the patient experienced NASAL CONGESTION (dry stuffy nose). On 24-Mar-2021, RHINORRHOEA (runny nose) had resolved. At the time of the report, VACCINATION SITE PAIN (arm soreness), NASAL CONGESTION (dry stuffy nose), FATIGUE (fatigue), MYALGIA (muscle aches), HEADACHE (headache) and CHILLS (chills) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Non-significant Follow up Appended - reporter email address added
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Vaccination site pain
Clinical narrative: dry stuffy nose; fatigue; muscle aches; headache; chills; arm soreness; runny nose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm soreness), RHINORRHOEA (runny nose), NASAL CONGESTION (dry stuffy nose), FATIGUE (fatigue) and MYALGIA (muscle aches) in a 57-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 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm soreness), RHINORRHOEA (runny nose), FATIGUE (fatigue), MYALGIA (muscle aches), HEADACHE (headache) and CHILLS (chills). On 25-Mar-2021, the patient experienced NASAL CONGESTION (dry stuffy nose). On 24-Mar-2021, RHINORRHOEA (runny nose) had resolved. At the time of the report, VACCINATION SITE PAIN (arm soreness), NASAL CONGESTION (dry stuffy nose), FATIGUE (fatigue), MYALGIA (muscle aches), HEADACHE (headache) and CHILLS (chills) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Non-significant Follow up Appended - reporter email address added
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported  No treatment information was provided
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: In a lot of pain; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (In a lot of pain) and HEADACHE (headaches) in a 79-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 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN (In a lot of pain) and HEADACHE (headaches). At the time of the report, PAIN (In a lot of pain) and HEADACHE (headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product include blood pressure medication No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received on 23JUN2021 , contains reporter's contact information.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: patient felt weak; light headed; This spontaneous case was reported by a pharmacist and describes the occurrence of ASTHENIA (patient felt weak) and DIZZINESS (light headed) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) 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 25-Mar-2021, the patient experienced ASTHENIA (patient felt weak) and DIZZINESS (light headed). At the time of the report, ASTHENIA (patient felt weak) and DIZZINESS (light headed) 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.
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Fatigue
Clinical narrative: worse side effects; side effects; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (worse side effects), ADVERSE REACTION (side effects) and FATIGUE (tiredness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (worse side effects), ADVERSE REACTION (side effects) and FATIGUE (tiredness). At the time of the report, ADVERSE REACTION (worse side effects), ADVERSE REACTION (side effects) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Illness, Limb discomfort, Myalgia
Clinical narrative: Could not lift Right Arm; Muscle Pain; Joint Pain; Sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), LIMB DISCOMFORT (Could not lift Right Arm), MYALGIA (Muscle Pain) and ARTHRALGIA (Joint Pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced ILLNESS (Sick). On 25-Mar-2021, the patient experienced LIMB DISCOMFORT (Could not lift Right Arm), MYALGIA (Muscle Pain) and ARTHRALGIA (Joint Pain). At the time of the report, ILLNESS (Sick), LIMB DISCOMFORT (Could not lift Right Arm), MYALGIA (Muscle Pain) and ARTHRALGIA (Joint Pain) outcome was unknown.            Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: NNI
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Pruritus, Rash
Clinical narrative: Muscle soreness; Itching on the arms; Redness; Rashes on the arm down the elbow; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on the arms), ERYTHEMA (Redness), RASH (Rashes on the arm down the elbow) and MYALGIA (Muscle soreness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PRURITUS (Itching on the arms). On an unknown date, the patient experienced ERYTHEMA (Redness), RASH (Rashes on the arm down the elbow) and MYALGIA (Muscle soreness). At the time of the report, PRURITUS (Itching on the arms), ERYTHEMA (Redness) and RASH (Rashes on the arm down the elbow) had resolved and MYALGIA (Muscle soreness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use included thyroid medication.  Treatment: Benadryl and Triple Antibiotic Ointment.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up information was received on 11 May 2021 wherein treatment, event outcome and event were added.
Sex: U
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: red rash underneath eye and on forehead; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash underneath eye and on forehead) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red rash underneath eye and on forehead). At the time of the report, RASH ERYTHEMATOUS (red rash underneath eye and on forehead) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash underneath eye and on forehead) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red rash underneath eye and on forehead). At the time of the report, RASH ERYTHEMATOUS (red rash underneath eye and on forehead) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tooth infection
Clinical narrative: Dental Infection; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INFECTION (Dental Infection) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced TOOTH INFECTION (Dental Infection). At the time of the report, TOOTH INFECTION (Dental Infection) had not 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.   Treatment medication for the event included Antibiotics.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Liquid product physical issue
Clinical narrative: black speck floating in the vial; This spontaneous case was reported by a pharmacist and describes the occurrence of LIQUID PRODUCT PHYSICAL ISSUE (black speck floating in the vial) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) 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) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced LIQUID PRODUCT PHYSICAL ISSUE (black speck floating in the vial). At the time of the report, LIQUID PRODUCT PHYSICAL ISSUE (black speck floating in the vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: low fever with temperature around 99; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low fever with temperature around 99) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PYREXIA (low fever with temperature around 99). At the time of the report, PYREXIA (low fever with temperature around 99) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 f Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were provided by reporter. She was scheduled to receive her 2nd dose of vaccine on 31st March.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash macular
Clinical narrative: sore arm/pain in arm that is going away; red blotches that feels warm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm/pain in arm that is going away) and RASH MACULAR (red blotches that feels warm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (pill). Concomitant products included VITAMINS NOS for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm/pain in arm that is going away) and RASH MACULAR (red blotches that feels warm). At the time of the report, PAIN IN EXTREMITY (sore arm/pain in arm that is going away) was resolving and RASH MACULAR (red blotches that feels warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included Blood pressure pills. Treatment medications were not provided by reporter.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Myalgia, Nausea, Pain in extremity
Clinical narrative: Feeling Dizzy; nausea; Soreness of arm; Body ache; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling Dizzy), PAIN IN EXTREMITY (Soreness of arm), MYALGIA (Body ache), FATIGUE (feeling tired) and NAUSEA (nausea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) 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 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm), MYALGIA (Body ache) and FATIGUE (feeling tired). On 25-Mar-2021, the patient experienced DIZZINESS (Feeling Dizzy) and NAUSEA (nausea). At the time of the report, DIZZINESS (Feeling Dizzy), PAIN IN EXTREMITY (Soreness of arm), MYALGIA (Body ache), FATIGUE (feeling tired) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: nausea; headache; fatigue; fever; muscle ache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), HEADACHE (headache), FATIGUE (fatigue), PYREXIA (fever) and MYALGIA (muscle ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 23-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 NAUSEA (nausea), HEADACHE (headache), FATIGUE (fatigue), PYREXIA (fever), MYALGIA (muscle ache) and PAIN IN EXTREMITY (sore arm). At the time of the report, NAUSEA (nausea), HEADACHE (headache), FATIGUE (fatigue), PYREXIA (fever), MYALGIA (muscle ache) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment medications were not provided.   This case was linked to MOD-2021-058049 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: nausea; headache; fatigue; fever; muscle ache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), HEADACHE (headache), FATIGUE (fatigue), PYREXIA (fever) and MYALGIA (muscle ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 23-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 NAUSEA (nausea), HEADACHE (headache), FATIGUE (fatigue), PYREXIA (fever), MYALGIA (muscle ache) and PAIN IN EXTREMITY (sore arm). At the time of the report, NAUSEA (nausea), HEADACHE (headache), FATIGUE (fatigue), PYREXIA (fever), MYALGIA (muscle ache) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment medications were not provided.   This case was linked to MOD-2021-058049 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) 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 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information were not provided No treatment medication information were not provided   This case was linked to MOD21-062631 (E2B Linked Report).; Sender's Comments:  MOD21-062631:crosslinked
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash macular
Clinical narrative: Redness; Itching; Red spots; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (Redness), RASH MACULAR (Red spots) and PRURITUS (Itching) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient did not have any history of allergies.     On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced RASH MACULAR (Red spots). On 17-Jan-2021, the patient experienced PRURITUS (Itching). On 19-Jan-2021, the patient experienced ERYTHEMA (Redness). The patient was treated with CORTISONE (topical) for Adverse event, at a dose of UNK dosage form. At the time of the report, ERYTHEMA (Redness), RASH MACULAR (Red spots) and PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's weight was reported as "159" (units not reported). Concomitant medication was not reported. Treatment included antibiotic cream. The patient visited Physician on 19-Jan-2021 and recommended Zyrtec (was not administered).; 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: vaccination site tenderness; Very Sore Injection Site; Big Red Circle Injection Site; Itchy Injection Site; Sore Arm Injection Site (A Little); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm Injection Site (A Little)), VACCINATION SITE PAIN (vaccination site tenderness), VACCINATION SITE PAIN (Very Sore Injection Site), VACCINATION SITE ERYTHEMA (Big Red Circle Injection Site) and VACCINATION SITE PRURITUS (Itchy Injection Site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm Injection Site (A Little)). On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (vaccination site tenderness), VACCINATION SITE PAIN (Very Sore Injection Site), VACCINATION SITE ERYTHEMA (Big Red Circle Injection Site) and VACCINATION SITE PRURITUS (Itchy Injection Site). On 18-Mar-2021, VACCINATION SITE PAIN (Sore Arm Injection Site (A Little)) had resolved. At the time of the report, VACCINATION SITE PAIN (vaccination site tenderness), VACCINATION SITE PAIN (Very Sore Injection Site), VACCINATION SITE ERYTHEMA (Big Red Circle Injection Site) and VACCINATION SITE PRURITUS (Itchy Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medications were not provided by reporter.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: body aches; felt tired; week of joint pain; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (body aches), FATIGUE (felt tired) and ARTHRALGIA (week of joint pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 and Thyroidectomy. Concomitant products included VITAMINS NOS, VITAMIN D [VITAMIN D NOS] and LEVOTHYROXINE for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced MYALGIA (body aches), FATIGUE (felt tired) and ARTHRALGIA (week of joint pain). On 06-Mar-2021, ARTHRALGIA (week of joint pain) had resolved. At the time of the report, MYALGIA (body aches) and FATIGUE (felt tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were not provided by reporter.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: vomiting; dizziness; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), NAUSEA (nausea) and VOMITING (vomiting) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (nausea). On 07-Mar-2021, the patient experienced VOMITING (vomiting). On 07-Mar-2021, VOMITING (vomiting) had resolved. On 09-Mar-2021, DIZZINESS (dizziness) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medications were not provided by reporter.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 30-year-old female patient (gravida 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) 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. The patient's last menstrual period was on 05-Feb-2021 and the estimated date of delivery was 12-Nov-2021. On 25-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixth week of the pregnancy.  On 25-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by reporter. Treatment medications were not provided by reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: Increased blood sugar; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Increased blood sugar) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (Increased blood sugar). At the time of the report, BLOOD GLUCOSE INCREASED (Increased blood sugar) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant and treatment medications were not provided by reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: itchy where she got the shot; huge bright red circle where she got the shot; Headache; Tired; Arm hurt like there was a huge knot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt like there was a huge knot), VACCINATION SITE ERYTHEMA (huge bright red circle where she got the shot), VACCINATION SITE PRURITUS (itchy where she got the shot), HEADACHE (Headache) and FATIGUE (Tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's medical history was not reported.  Concomitant products included METRONIDAZOLE for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt like there was a huge knot). On 15-Jan-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Tired). On 27-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (huge bright red circle where she got the shot) and VACCINATION SITE PRURITUS (itchy where she got the shot). The patient was treated with PARACETAMOL (TYLENOL) in January 2021 for Adverse event, at a dose of UNK dosage form. On 15-Jan-2021, PAIN IN EXTREMITY (Arm hurt like there was a huge knot) had resolved. On 16-Jan-2021, HEADACHE (Headache) and FATIGUE (Tired) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (huge bright red circle where she got the shot) and VACCINATION SITE PRURITUS (itchy where she got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that Tylenol helped. The huge bright red circle where she got the shot was not tender.   This case was linked to MOD-2021-020285 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: hurting a lot; my arm was slightly hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (my arm was slightly hurting) and PAIN (hurting a lot) 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 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (my arm was slightly hurting). On 25-Mar-2021, the patient experienced PAIN (hurting a lot). At the time of the report, PAIN IN EXTREMITY (my arm was slightly hurting) and PAIN (hurting a lot) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment products information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (sick) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included Tylenol                                                        not often for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (sick). At the time of the report, MALAISE (sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided by reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chest pain, Insomnia, Myalgia, Peripheral swelling
Clinical narrative: arm, part of chest and back were burning; could not sleep well; armpit was sore and swollen; armpit was sore and swollen; aches; arm trembled violently six times; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (arm trembled violently six times), CHEST PAIN (arm, part of chest and back were burning), INSOMNIA (could not sleep well), PERIPHERAL SWELLING (armpit was sore and swollen) and AXILLARY PAIN (armpit was sore and swollen) in a 50-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 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced TREMOR (arm trembled violently six times). On 23-Mar-2021, the patient experienced CHEST PAIN (arm, part of chest and back were burning), INSOMNIA (could not sleep well), PERIPHERAL SWELLING (armpit was sore and swollen), AXILLARY PAIN (armpit was sore and swollen) and MYALGIA (aches). On 22-Mar-2021, TREMOR (arm trembled violently six times) had resolved. At the time of the report, CHEST PAIN (arm, part of chest and back were burning), INSOMNIA (could not sleep well), PERIPHERAL SWELLING (armpit was sore and swollen), AXILLARY PAIN (armpit was sore and swollen) and MYALGIA (aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medications were not provided by reporter.   This case was linked to MOD-2021-057906 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: arm, part of chest and back were burning; could not sleep well; armpit was sore and swollen; armpit was sore and swollen; aches; arm trembled violently six times; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (arm trembled violently six times), CHEST PAIN (arm, part of chest and back were burning), INSOMNIA (could not sleep well), PERIPHERAL SWELLING (armpit was sore and swollen) and AXILLARY PAIN (armpit was sore and swollen) in a 50-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 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced TREMOR (arm trembled violently six times). On 23-Mar-2021, the patient experienced CHEST PAIN (arm, part of chest and back were burning), INSOMNIA (could not sleep well), PERIPHERAL SWELLING (armpit was sore and swollen), AXILLARY PAIN (armpit was sore and swollen) and MYALGIA (aches). On 22-Mar-2021, TREMOR (arm trembled violently six times) had resolved. At the time of the report, CHEST PAIN (arm, part of chest and back were burning), INSOMNIA (could not sleep well), PERIPHERAL SWELLING (armpit was sore and swollen), AXILLARY PAIN (armpit was sore and swollen) and MYALGIA (aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medications were not provided by reporter.   This case was linked to MOD-2021-057906 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Asthenia, Diarrhoea, Dizziness, Headache
Clinical narrative: felt weak; dizzy; whole body hurt; diarrhea; terrible night; raging headache; This spontaneous case was reported by a physician and describes the occurrence of ASTHENIA (felt weak), DIZZINESS (dizzy), MYALGIA (whole body hurt), DIARRHOEA (diarrhea) and ADVERSE DRUG REACTION (terrible night) in a 55-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.     The patient's past medical history included COVID-19 and Thyroidectomy. Concomitant products included VITAMINS NOS, VITAMIN D NOS and LEVOTHYROXINE for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced ASTHENIA (felt weak), DIZZINESS (dizzy), MYALGIA (whole body hurt), DIARRHOEA (diarrhea), ADVERSE DRUG REACTION (terrible night) and HEADACHE (raging headache). On 25-Mar-2021, ASTHENIA (felt weak), DIZZINESS (dizzy) and ADVERSE DRUG REACTION (terrible night) had resolved. At the time of the report, MYALGIA (whole body hurt), DIARRHOEA (diarrhea) and HEADACHE (raging headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were not provided by reporter.   This case was linked to MOD-2021-057863 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: felt weak; dizzy; whole body hurt; diarrhea; terrible night; raging headache; This spontaneous case was reported by a physician and describes the occurrence of ASTHENIA (felt weak), DIZZINESS (dizzy), MYALGIA (whole body hurt), DIARRHOEA (diarrhea) and ADVERSE DRUG REACTION (terrible night) in a 55-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.     The patient's past medical history included COVID-19 and Thyroidectomy. Concomitant products included VITAMINS NOS, VITAMIN D NOS and LEVOTHYROXINE for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced ASTHENIA (felt weak), DIZZINESS (dizzy), MYALGIA (whole body hurt), DIARRHOEA (diarrhea), ADVERSE DRUG REACTION (terrible night) and HEADACHE (raging headache). On 25-Mar-2021, ASTHENIA (felt weak), DIZZINESS (dizzy) and ADVERSE DRUG REACTION (terrible night) had resolved. At the time of the report, MYALGIA (whole body hurt), DIARRHOEA (diarrhea) and HEADACHE (raging headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were not provided by reporter.   This case was linked to MOD-2021-057863 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Has not got second shot after 70 days; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not got second shot after 70 days) 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 reaction.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not got second shot after 70 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not got second shot after 70 days) 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.   No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever, fever again,it was a very low fever; Chills, chills again; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), SYMPTOM RECURRENCE (fever again), PYREXIA (it was a very low fever) and SYMPTOM RECURRENCE (chills again) 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 not  included .  relevant concomitant products usage were not reported by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.  On 20-Mar-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 24-Mar-2021, the patient experienced SYMPTOM RECURRENCE (fever again), PYREXIA (it was a very low fever) and SYMPTOM RECURRENCE (chills again).  On 21-Mar-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, SYMPTOM RECURRENCE (fever again), PYREXIA (it was a very low fever) and SYMPTOM RECURRENCE (chills again) outcome was unknown.        The patient received both scheduled doses of mRNA 1273 before the events, therefore Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Swelling
Clinical narrative: swelling; Chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), CHILLS (Chills) 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 information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (swelling), CHILLS (Chills) and NAUSEA (nausea). At the time of the report, SWELLING (swelling), CHILLS (Chills) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: Heel Pain; Feeling terrible; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Heel Pain) and FEELING ABNORMAL (Feeling terrible) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Heel Pain) and FEELING ABNORMAL (Feeling terrible). On 26-Mar-2021, PAIN IN EXTREMITY (Heel Pain) and FEELING ABNORMAL (Feeling terrible) had resolved. Not Provided          No concomitant medication information was provided. No treatment medication information was provided.  Action taken with mRNA-1273 in response to the drug was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Patient said she is feeling fine and her events were resolved the next day after they have started.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Rash, Urticaria
Clinical narrative: Breakout on her face going down to her neck/Rash has been present in various areas of the face for approximately 12 days/Rash on ear; lymph nodes swelling; welts on her arm that are the same on forehead; Pain that goes away and comes back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Breakout on her face going down to her neck/Rash has been present in various areas of the face for approximately 12 days/Rash on ear), LYMPHADENOPATHY (lymph nodes swelling), URTICARIA (welts on her arm that are the same on forehead) and PAIN (Pain that goes away and comes back) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Immunocompromised. Concomitant products included AMLODIPINE BESILATE (NORVASC) and MYCOPHENOLATE MOFETIL (CELLCEPT [MYCOPHENOLATE MOFETIL]) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced RASH (Breakout on her face going down to her neck/Rash has been present in various areas of the face for approximately 12 days/Rash on ear), LYMPHADENOPATHY (lymph nodes swelling) and PAIN (Pain that goes away and comes back). 29-Jan-2021, the patient experienced URTICARIA (welts on her arm that are the same on forehead). At the time of the report, RASH (Breakout on her face going down to her neck/Rash has been present in various areas of the face for approximately 12 days/Rash on ear), LYMPHADENOPATHY (lymph nodes swelling), URTICARIA (welts on her arm that are the same on forehead) and PAIN (Pain that goes away and comes back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient was using cellecept.   This case was linked to MOD21-060009 (E2B Linked Report). This case was linked to MOD-2021-071068 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: No specific follow-up information recorded.; Sender's Comments:  MOD21-060009:crosslinked