chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received first dose 11 weeks ago and has not received second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received first dose 11 weeks ago and has not received second dose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received first dose 11 weeks ago and has not received second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received first dose 11 weeks ago and has not received second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.      Reporter called to ask what should a member of reporters family do if received first dose of Moderna COVID-19 Vaccine 11 weeks ago and still has not received second dose. Consent for Safety to follow up: provided   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up received and contain no new information.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Can't move the right arm/Can't use the right arm because of pain; pain in the right arm/Can't use the right arm because of pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move the right arm/Can't use the right arm because of pain) and VACCINATION SITE PAIN (pain in the right arm/Can't use the right arm because of pain) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jun-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move the right arm/Can't use the right arm because of pain) and VACCINATION SITE PAIN (pain in the right arm/Can't use the right arm because of pain). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move the right arm/Can't use the right arm because of pain) and VACCINATION SITE PAIN (pain in the right arm/Can't use the right arm because of pain) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided. for mRNA-1273 (Moderna COVID-19 Vaccine) (intramuscular), the reporter did not provide any causality assessment. action taken with mRNA-1273 (COVID 19 Vaccine Moderna)(intramuscular), was not applicable
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Nail disorder, Nail psoriasis
Clinical narrative: psoriasis like symptoms on fingernails / currently have extreme fingernail; diagnosed with nail psoriasis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NAIL DISORDER (psoriasis like symptoms on fingernails / currently have extreme fingernail) and NAIL PSORIASIS (diagnosed with nail psoriasis) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002V21A and 011M20A) for COVID-19 vaccination.     The patient's past medical history included Neuropathy (in leg.). Family history included Skin disorder since an unknown date, Psoriasis (Mother's side) and Eczema (father's side). Concurrent medical conditions included Diabetes (2), Drug allergy (Statins), Rheumatoid arthritis, Cholesterol and Asthma. Concomitant products included MONTELUKAST from 05-Jan-2020 to an unknown date and SALBUTAMOL (ALBUTEROL HFA) from 05-Jan-2020 to an unknown date for Asthma, EZETIMIBE from 01-Jan-2016 to an unknown date for Cholesterol, METFORMIN HCL from 01-Jan-2016 to an unknown date for Diabetes, VITAMINS NOS for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NAIL DISORDER (psoriasis like symptoms on fingernails / currently have extreme fingernail) and NAIL PSORIASIS (diagnosed with nail psoriasis). The patient was treated with HYDROGEN PEROXIDE at an unspecified dose and frequency. At the time of the report, NAIL DISORDER (psoriasis like symptoms on fingernails / currently have extreme fingernail) and NAIL PSORIASIS (diagnosed with nail psoriasis) had not resolved.            Patient had COVID-19 test in Feb 2021. Patient visited general practitioner(GP) on 06 Apr 2021 and he sent pictures of nail on 22 May 2021. Patient visited dermatologist on 14 Jul 2021,fungal samples and toe nails samples were given and awaiting for results.     .   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up Information Received. Event Outcome updated from unknown to Not recovered On 14-Jul-2021: Follow-up Information Received.  Added new event [diagnosed with nail psoriasis]. On 16-Jul-2021: Updated family history [ Psoriasis and Eczema]. Added Vaccination center details. Added Concomitant medicines[ ALBUTEROL HFA] and other concomitant doses.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Appendicitis perforated, Diarrhoea, Product dose omission issue
Clinical narrative: they thought he may have an appendix burst; Severe stomach pain; Diarrhea; Outside of 42 days for second dose. First dose given 2 mar21; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS PERFORATED (they thought he may have an appendix burst) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M2049) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Caller is consider a "long hauler", person who had Covid for extended period of time, according to patient.  His symptoms lasted for an covid from December 18 through march.  Caller was put in the ICU.  Caller was on a ventilator for 23 days.  Caller had blood plasma transfusions.  Caller said he was on dialysis because kidney shut down.  Caller received first dose on 2march21.  Caller said stomach hurt to point that they thought he may have an appendix burst.  His appendix did not burst.), Kidney failure, Intensive care, Mechanical ventilation (23 Days), Plasma transfusion and Dialysis.    On 02-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 ABDOMINAL PAIN UPPER (Severe stomach pain), DIARRHOEA (Diarrhea), PRODUCT DOSE OMISSION ISSUE (Outside of 42 days for second dose. First dose given 2 mar21) and APPENDICITIS PERFORATED (they thought he may have an appendix burst) (seriousness criterion medically significant). At the time of the report, ABDOMINAL PAIN UPPER (Severe stomach pain), DIARRHOEA (Diarrhea) and PRODUCT DOSE OMISSION ISSUE (Outside of 42 days for second dose. First dose given 2 mar21) outcome was unknown and APPENDICITIS PERFORATED (they thought he may have an appendix burst) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Caller  wanted to know if he needed a second dose and if so he wanted to knw when.  Caller wanted to know if he needed the second dose because of having Covid.
Sex: U
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: can't stop sweating; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (can't stop sweating) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (can't stop sweating). At the time of the report, HYPERHIDROSIS (can't stop sweating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No concomitant medications were reported. for mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) ,the reporter did not find any causality assessment.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed the Recommended interval inter doses; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the Recommended interval inter doses) 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 21-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 PRODUCT DOSE OMISSION ISSUE (Missed the Recommended interval inter doses). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the Recommended interval inter doses) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was reported. No concomitant medication was reported.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd dose given from beyond use date vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concurrent and treatment medication was reported by patient.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: The side effect; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (The side effect) 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 19-Jun-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 an unknown date, the patient experienced VACCINATION COMPLICATION (The side effect). At the time of the report, VACCINATION COMPLICATION (The side effect) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Incontinence
Clinical narrative: Can not stop using the bathroom; This spontaneous case was reported by a consumer and describes the occurrence of INCONTINENCE (Can not stop using the bathroom) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCONTINENCE (Can not stop using the bathroom). At the time of the report, INCONTINENCE (Can not stop using the bathroom) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for covid) 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 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 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 06-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Second dose 42 day period had passed; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose 42 day period had passed) 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 03-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 PRODUCT DOSE OMISSION ISSUE (Second dose 42 day period had passed). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose 42 day period had passed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Heart rate, Hypertension, Tachycardia
Clinical narrative: Tachycardia; Blood pressure High; This spontaneous case was reported by a patient and describes the occurrence of TACHYCARDIA (Tachycardia) and HYPERTENSION (Blood pressure High) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0181321A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis, Drug allergy (Levaquin) and Allergy to antibiotic (Topical ointment creams). Concomitant products included CELECOXIB for Arthritis, HYDROCHLOROTHIAZIDE and LOSARTAN POTASSIUM (LOSARTIN) for Hypertension, TRAMADOL for Pain, LEVOTHYROXINE, ATORVASTATIN and GABAPENTIN for an unknown indication.   On 12-Apr-2021 at 1:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced HYPERTENSION (Blood pressure High). On 12-Apr-2021 at 10:00 PM, the patient experienced TACHYCARDIA (Tachycardia). On 16-Mar-2021, HYPERTENSION (Blood pressure High) had resolved. On 13-Apr-2021, TACHYCARDIA (Tachycardia) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2020, COVID-19: positive. On 12-Apr-2021, Heart rate: 111 High.    Patient's normal heart rate was 77 beats per minute. Patient went to hospital after events and stayed there  for about 4.5 hours in the emergency room. They could not find an issue with heart.  After unspecified tests and blood work, the patient went home at about 05:00 on 13-Apr-2021.  No Treatment information was Reported
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site pruritus (injection site itching) and vaccination site erythema (injection site redness) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 20, 2021, patient experienced vaccination site pruritus (injection site itching) and vaccination site erythema (injection site redness). At the time of the report, vaccination site pruritus (injection site itching) and vaccination site erythema (injection site redness) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medications and treatment information not provided.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: Anxiety; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANXIETY (Anxiety). At the time of the report, ANXIETY (Anxiety) outcome was unknown.            No concomitant medication was reported.  No treatment information was reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Body and muscle aches for about two weeks ongoing; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body and muscle aches for about two weeks ongoing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body and muscle aches for about two weeks ongoing). At the time of the report, MYALGIA (Body and muscle aches for about two weeks ongoing) had not resolved.            No concomitant medications were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm hurts very bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts very bad) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medication history was provided.     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 PAIN IN EXTREMITY (arm hurts very bad). At the time of the report, PAIN IN EXTREMITY (arm hurts very bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown
Sex: U
Vaccine: COVID19
Symptoms: Eye disorder
Clinical narrative: the eyes are changing sometimes to like a cat eye; This spontaneous case was reported by a patient and describes the occurrence of EYE DISORDER (the eyes are changing sometimes to like a cat eye) 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 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 EYE DISORDER (the eyes are changing sometimes to like a cat eye). At the time of the report, EYE DISORDER (the eyes are changing sometimes to like a cat eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd dose given from beyond use date vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-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(s). On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   1 vial affected Lot# 041C21A Refrigeration expiration/ Beyond use date:10Jun2021. No concomitant medications was included. No treatment drug details was provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) 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 20-Jun-2021, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   The patient was admitted to the Emergency Room following vaccine administration.   No treatment medication information was provided by the reporter.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old that received Moderna; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old that received Moderna) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old that received Moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old that received Moderna) 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.   No concomitant medications were provided No treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up information received on 15 Jul 2021 contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Swelling, Vaccination site warmth
Clinical narrative: Arm is red; swelling; it's warm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm is red), SWELLING (swelling) and VACCINATION SITE WARMTH (it's warm) 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 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 ERYTHEMA (Arm is red), SWELLING (swelling) and VACCINATION SITE WARMTH (it's warm). At the time of the report, ERYTHEMA (Arm is red), SWELLING (swelling) and VACCINATION SITE WARMTH (it's warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Dizzy; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) and NAUSEA (Nauseous) 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 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 DIZZINESS (Dizzy) and NAUSEA (Nauseous). At the time of the report, DIZZINESS (Dizzy) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness in arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027c21a and 027c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced MYALGIA (Soreness in arm). At the time of the report, MYALGIA (Soreness in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication reported by the reporter
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd dose given from beyond use date vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial) 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 infection) 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 COVID-19 (COVID-19 infection). At the time of the report, COVID-19 (COVID-19 infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications was provided by the reporter.  No Treatment medications was provided by the reporter.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: Headache; chills; one month after second vaccination body aches; Knocked me to my knees; Body Aches/ felt like I had hit with the basketball/ Unbearable pain in my body; chills; Headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (one month after second vaccination body aches), the second episode of HEADACHE (Headache), the second episode of CHILLS (chills), ARTHRALGIA (Knocked me to my knees) and MYALGIA (Body Aches/ felt like I had hit with the basketball/ Unbearable pain in my body) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced ARTHRALGIA (Knocked me to my knees), MYALGIA (Body Aches/ felt like I had hit with the basketball/ Unbearable pain in my body), the first episode of CHILLS (chills), the first episode of HEADACHE (Headache) and NAUSEA (nausea). In June 2021, the patient experienced MYALGIA (one month after second vaccination body aches). On 17-Jun-2021, the patient experienced the second episode of HEADACHE (Headache) and the second episode of CHILLS (chills). On 30-May-2021, MYALGIA (Body Aches/ felt like I had hit with the basketball/ Unbearable pain in my body) outcome was unknown, NAUSEA (nausea) had resolved. On 01-Jun-2021, ARTHRALGIA (Knocked me to my knees) had resolved. On 02-Jul-2021, MYALGIA (one month after second vaccination body aches), the last episode of HEADACHE (Headache) and the last episode of CHILLS (chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  No Treatment medication reported. Action taken with mRNA-1273 in response to the event was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow Up received contains Updated recovered Event Dates and one Event added.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling
Clinical narrative: itching; swollen; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and SWELLING (swollen) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching) and SWELLING (swollen). At the time of the report, PRURITUS (itching) and SWELLING (swollen) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Pyrexia
Clinical narrative: Loss of appetite; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), CHILLS (Chills) and PYREXIA (Fever) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, DECREASED APPETITE (Loss of appetite), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: Soreness at the injection site that felt bruised; Soreness at the injection site that felt bruised and hot; Soreness at the injection site; chills; fever; fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Soreness at the injection site that felt bruised), VACCINATION SITE WARMTH (Soreness at the injection site that felt bruised and hot), VACCINATION SITE PAIN (Soreness at the injection site), CHILLS (chills) and PYREXIA (fever) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient prior had Covid before receiving the vaccine.).    On 17-Jun-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 BRUISING (Soreness at the injection site that felt bruised), VACCINATION SITE WARMTH (Soreness at the injection site that felt bruised and hot), VACCINATION SITE PAIN (Soreness at the injection site), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue) and NAUSEA (nausea). At the time of the report, VACCINATION SITE BRUISING (Soreness at the injection site that felt bruised), VACCINATION SITE WARMTH (Soreness at the injection site that felt bruised and hot), VACCINATION SITE PAIN (Soreness at the injection site), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site pain, Vaccination site warmth
Clinical narrative: Soreness at the injection site that felt bruised; Soreness at the injection site that felt bruised and hot; Soreness at the injection site; chills; fever; fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Soreness at the injection site that felt bruised), VACCINATION SITE WARMTH (Soreness at the injection site that felt bruised and hot), VACCINATION SITE PAIN (Soreness at the injection site), CHILLS (chills) and PYREXIA (fever) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient prior had Covid before receiving the vaccine.).    On 17-Jun-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 BRUISING (Soreness at the injection site that felt bruised), VACCINATION SITE WARMTH (Soreness at the injection site that felt bruised and hot), VACCINATION SITE PAIN (Soreness at the injection site), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue) and NAUSEA (nausea). At the time of the report, VACCINATION SITE BRUISING (Soreness at the injection site that felt bruised), VACCINATION SITE WARMTH (Soreness at the injection site that felt bruised and hot), VACCINATION SITE PAIN (Soreness at the injection site), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Fatigue, Tension headache
Clinical narrative: tension headache only when I cough; tension headache only when I cough; fatigue; This spontaneous case was reported by a patient and describes the occurrence of COUGH (tension headache only when I cough), TENSION HEADACHE (tension headache only when I cough) and FATIGUE (fatigue) 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 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 COUGH (tension headache only when I cough), TENSION HEADACHE (tension headache only when I cough) and FATIGUE (fatigue). At the time of the report, COUGH (tension headache only when I cough), TENSION HEADACHE (tension headache only when I cough) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hair disorder, Joint swelling, Neck pain, Pain in extremity
Clinical narrative: Swelling ankle; Neck pain; Hair shedding; Pain in the back leg; Wrist pain; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swelling ankle), NECK PAIN (Neck pain), HAIR DISORDER (Hair shedding), PAIN IN EXTREMITY (Pain in the back leg) and ARTHRALGIA (Wrist pain) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (Swelling ankle), NECK PAIN (Neck pain), HAIR DISORDER (Hair shedding), PAIN IN EXTREMITY (Pain in the back leg) and ARTHRALGIA (Wrist pain). At the time of the report, JOINT SWELLING (Swelling ankle), NECK PAIN (Neck pain), HAIR DISORDER (Hair shedding), PAIN IN EXTREMITY (Pain in the back leg) and ARTHRALGIA (Wrist pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Fatigue, Headache, Herpes zoster, Insomnia
Clinical narrative: Shingles; Started noticing bumps; Left eye swollen; Rash on his forehead above left eye; Bad headache on left side of head/Bad headache on left side of eye/ Headache lasted all night; Could not sleep; soreness in arm; Very Tired; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep), EYE SWELLING (Left eye swollen), HERPES ZOSTER (Shingles), SKIN MASS (Started noticing bumps) and MYALGIA (soreness in arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027c21a and 027c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced MYALGIA (soreness in arm) and FATIGUE (Very Tired). On 02-Jun-2021, the patient experienced INSOMNIA (Could not sleep) and HEADACHE (Bad headache on left side of head/Bad headache on left side of eye/ Headache lasted all night). On 06-Jun-2021, the patient experienced EYE SWELLING (Left eye swollen), SKIN MASS (Started noticing bumps) and RASH (Rash on his forehead above left eye). On 09-Jun-2021, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with PREDNISOLONE at a dose of 1 dosage form and ACYCLOVIR [ACICLOVIR] at a dose of 1 dosage form. At the time of the report, INSOMNIA (Could not sleep), EYE SWELLING (Left eye swollen), HERPES ZOSTER (Shingles), SKIN MASS (Started noticing bumps), MYALGIA (soreness in arm), HEADACHE (Bad headache on left side of head/Bad headache on left side of eye/ Headache lasted all night), FATIGUE (Very Tired) and RASH (Rash on his forehead above left eye) outcome was unknown.             No concomitant Medication was reported by reporter.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Rash, Skin mass
Clinical narrative: Shingles; Started noticing bumps; Left eye swollen; Rash on his forehead above left eye; Bad headache on left side of head/Bad headache on left side of eye/ Headache lasted all night; Could not sleep; soreness in arm; Very Tired; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep), EYE SWELLING (Left eye swollen), HERPES ZOSTER (Shingles), SKIN MASS (Started noticing bumps) and MYALGIA (soreness in arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027c21a and 027c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced MYALGIA (soreness in arm) and FATIGUE (Very Tired). On 02-Jun-2021, the patient experienced INSOMNIA (Could not sleep) and HEADACHE (Bad headache on left side of head/Bad headache on left side of eye/ Headache lasted all night). On 06-Jun-2021, the patient experienced EYE SWELLING (Left eye swollen), SKIN MASS (Started noticing bumps) and RASH (Rash on his forehead above left eye). On 09-Jun-2021, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with PREDNISOLONE at a dose of 1 dosage form and ACYCLOVIR [ACICLOVIR] at a dose of 1 dosage form. At the time of the report, INSOMNIA (Could not sleep), EYE SWELLING (Left eye swollen), HERPES ZOSTER (Shingles), SKIN MASS (Started noticing bumps), MYALGIA (soreness in arm), HEADACHE (Bad headache on left side of head/Bad headache on left side of eye/ Headache lasted all night), FATIGUE (Very Tired) and RASH (Rash on his forehead above left eye) outcome was unknown.             No concomitant Medication was reported by reporter.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Decreased appetite, Dyspnoea, Fatigue, SARS-CoV-2 antibody test
Clinical narrative: I belive I had COVID just before Shot 2; Shortness of breath; no appetite; extreme fatigue; This case was initially received via the Regulatory Authority (Reference number: US-irms-MOD21-113330   ) on 20-Jun-2021. The most recent information was received on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I belive I had COVID just before Shot 2), DYSPNOEA (Shortness of breath), DECREASED APPETITE (no appetite) and FATIGUE (extreme fatigue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 17-Feb-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath), DECREASED APPETITE (no appetite) and FATIGUE (extreme fatigue). On an unknown date, the patient experienced COVID-19 (I belive I had COVID just before Shot 2). At the time of the report, COVID-19 (I belive I had COVID just before Shot 2), DYSPNOEA (Shortness of breath), DECREASED APPETITE (no appetite) and FATIGUE (extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive for COVID antibodies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  It was reported the patient had Shortness of breath, extreme  fatigue and no appetite from 18-Feb-2021 to 20-Feb-2021 and again from 13-Mar-2021 to 15-Mar-2021.  No Treatment information was provided by the reporter.   This case was linked to MOD-2021-261939 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow-up received contains Non significant information. On 26-Jul-2021: Follow-up information Received on 26-JUL-2021 contains No New Information. On 10-Aug-2021: Significant follow-up received included new event (COVID-19) and lab. Onset date for the events fatigue, decreased appetite and shortness of breath was added that was missed to capture in the previous version.
Sex: U
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: sweating; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating). At the time of the report, HYPERHIDROSIS (sweating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Mild Rash/ a rash in her lower back and buttocks; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Mild Rash/ a rash in her lower back and buttocks) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced RASH (Mild Rash/ a rash in her lower back and buttocks). On 15-May-2021, RASH (Mild Rash/ a rash in her lower back and buttocks) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information were not provided.   This case was linked to MOD-2021-229622 (Patient Link).