chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Bradykinesia, Chills, Erythema, Feeling abnormal, Headache
Clinical narrative: arm itching; arm hurt bad; arm was red; arm was hard; muscle pain; fever(low grade); vomiting; headache; chills; she started going in slow motion; felt very bad; felt like the flu; This spontaneous case was reported by a consumer and describes the occurrence of BRADYKINESIA (she started going in slow motion), FEELING ABNORMAL (felt very bad), INFLUENZA LIKE ILLNESS (felt like the flu), PRURITUS (arm itching) and PAIN IN EXTREMITY (arm hurt bad) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced BRADYKINESIA (she started going in slow motion), FEELING ABNORMAL (felt very bad), INFLUENZA LIKE ILLNESS (felt like the flu), PAIN IN EXTREMITY (arm hurt bad), ERYTHEMA (arm was red), INDURATION (arm was hard), MYALGIA (muscle pain), PYREXIA (fever(low grade)), VOMITING (vomiting), HEADACHE (headache) and CHILLS (chills). On 19-Apr-2021, the patient experienced PRURITUS (arm itching). On 17-Apr-2021, BRADYKINESIA (she started going in slow motion), FEELING ABNORMAL (felt very bad), INFLUENZA LIKE ILLNESS (felt like the flu), MYALGIA (muscle pain), PYREXIA (fever(low grade)), VOMITING (vomiting), HEADACHE (headache) and CHILLS (chills) had resolved. At the time of the report, PRURITUS (arm itching) had not resolved and PAIN IN EXTREMITY (arm hurt bad), ERYTHEMA (arm was red) and INDURATION (arm was hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medicines include Vitamins  No treatment medications were provided.  Action taken with mRNA-1273 in response to the event was unknown   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: On 22-May-2021: Follow up received (Source document-not readable)
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Influenza like illness, Myalgia, Pain in extremity, Pruritus
Clinical narrative: arm itching; arm hurt bad; arm was red; arm was hard; muscle pain; fever(low grade); vomiting; headache; chills; she started going in slow motion; felt very bad; felt like the flu; This spontaneous case was reported by a consumer and describes the occurrence of BRADYKINESIA (she started going in slow motion), FEELING ABNORMAL (felt very bad), INFLUENZA LIKE ILLNESS (felt like the flu), PRURITUS (arm itching) and PAIN IN EXTREMITY (arm hurt bad) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced BRADYKINESIA (she started going in slow motion), FEELING ABNORMAL (felt very bad), INFLUENZA LIKE ILLNESS (felt like the flu), PAIN IN EXTREMITY (arm hurt bad), ERYTHEMA (arm was red), INDURATION (arm was hard), MYALGIA (muscle pain), PYREXIA (fever(low grade)), VOMITING (vomiting), HEADACHE (headache) and CHILLS (chills). On 19-Apr-2021, the patient experienced PRURITUS (arm itching). On 17-Apr-2021, BRADYKINESIA (she started going in slow motion), FEELING ABNORMAL (felt very bad), INFLUENZA LIKE ILLNESS (felt like the flu), MYALGIA (muscle pain), PYREXIA (fever(low grade)), VOMITING (vomiting), HEADACHE (headache) and CHILLS (chills) had resolved. At the time of the report, PRURITUS (arm itching) had not resolved and PAIN IN EXTREMITY (arm hurt bad), ERYTHEMA (arm was red) and INDURATION (arm was hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medicines include Vitamins  No treatment medications were provided.  Action taken with mRNA-1273 in response to the event was unknown   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: On 22-May-2021: Follow up received (Source document-not readable)
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: arm itching; arm hurt bad; arm was red; arm was hard; muscle pain; fever(low grade); vomiting; headache; chills; she started going in slow motion; felt very bad; felt like the flu; This spontaneous case was reported by a consumer and describes the occurrence of BRADYKINESIA (she started going in slow motion), FEELING ABNORMAL (felt very bad), INFLUENZA LIKE ILLNESS (felt like the flu), PRURITUS (arm itching) and PAIN IN EXTREMITY (arm hurt bad) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced BRADYKINESIA (she started going in slow motion), FEELING ABNORMAL (felt very bad), INFLUENZA LIKE ILLNESS (felt like the flu), PAIN IN EXTREMITY (arm hurt bad), ERYTHEMA (arm was red), INDURATION (arm was hard), MYALGIA (muscle pain), PYREXIA (fever(low grade)), VOMITING (vomiting), HEADACHE (headache) and CHILLS (chills). On 19-Apr-2021, the patient experienced PRURITUS (arm itching). On 17-Apr-2021, BRADYKINESIA (she started going in slow motion), FEELING ABNORMAL (felt very bad), INFLUENZA LIKE ILLNESS (felt like the flu), MYALGIA (muscle pain), PYREXIA (fever(low grade)), VOMITING (vomiting), HEADACHE (headache) and CHILLS (chills) had resolved. At the time of the report, PRURITUS (arm itching) had not resolved and PAIN IN EXTREMITY (arm hurt bad), ERYTHEMA (arm was red) and INDURATION (arm was hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medicines include Vitamins  No treatment medications were provided.  Action taken with mRNA-1273 in response to the event was unknown   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: On 22-May-2021: Follow up received (Source document-not readable)
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site warmth
Clinical narrative: Warm  and red on the injection site; Rash on the injection site; Warm  and red on the injection site; Slight soreness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm  and red on the injection site), VACCINATION SITE PAIN (Slight soreness on the injection site), VACCINATION SITE RASH (Rash on the injection site) and VACCINATION SITE ERYTHEMA (Warm and red on the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concomitant products included WARFARIN and SIMVASTATIN.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE PAIN (Slight soreness on the injection site). On 19-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Warm  and red on the injection site), VACCINATION SITE RASH (Rash on the injection site) and VACCINATION SITE ERYTHEMA (Warm  and red on the injection site). At the time of the report, VACCINATION SITE WARMTH (Warm  and red on the injection site), VACCINATION SITE PAIN (Slight soreness on the injection site), VACCINATION SITE RASH (Rash on the injection site) and VACCINATION SITE ERYTHEMA (Warm  and red on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment information not provided   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Reporter email address was added
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngitis
Clinical narrative: Feels like she has head cold; lack of drug effect; COVID-19; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021. The most recent information was received on 19-Apr-2021 and was forwarded to Moderna on an unknown date.    This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Feels like she has head cold), DRUG INEFFECTIVE (lack of drug effect) and COVID-19 (COVID-19) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Allergy to antibiotic.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced DRUG INEFFECTIVE (lack of drug effect) and COVID-19 (COVID-19). On an unknown date, the patient experienced NASOPHARYNGITIS (Feels like she has head cold). On 15-Apr-2021, DRUG INEFFECTIVE (lack of drug effect) outcome was unknown. At the time of the report, NASOPHARYNGITIS (Feels like she has head cold) had not resolved and COVID-19 (COVID-19) outcome was unknown. Not Provided          No concomitant medications provided. No treatment information provided. Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19  and mRNA-1273 use is assessed as not applicable. The event of drug ineffective remains as possible.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Upon internal review on 15 Jul 2021, an event (lack of efficacy) was added at Moderna's request.; Sender's Comments: Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19  and mRNA-1273 use is assessed as not applicable. The event of drug ineffective remains as possible.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: The rash is a few inches around,rash is not as red anymore but continues to spread; Rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (The rash is a few inches around,rash is not as red anymore but continues to spread) and VACCINATION SITE RASH (Rash at the injection site) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided.).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced RASH (The rash is a few inches around,rash is not as red anymore but continues to spread) and VACCINATION SITE RASH (Rash at the injection site). At the time of the report, RASH (The rash is a few inches around,rash is not as red anymore but continues to spread) and VACCINATION SITE RASH (Rash at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information included Benadryl.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Musculoskeletal stiffness, Myalgia, Neck pain
Clinical narrative: mild hives, nightmarish hives over my entire body, They were painful and itchy; I had soreness at the injection site; muscle aches in both arms; redness; stiffness in my neck; pain in my neck; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), MUSCULOSKELETAL STIFFNESS (stiffness in my neck), NECK PAIN (pain in my neck), URTICARIA (mild hives, nightmarish hives over my entire body, They were painful and itchy) and INJECTION SITE PAIN (I had soreness at the injection site) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced ERYTHEMA (redness), MUSCULOSKELETAL STIFFNESS (stiffness in my neck), NECK PAIN (pain in my neck), INJECTION SITE PAIN (I had soreness at the injection site) and MYALGIA (muscle aches in both arms). On 16-Apr-2021, the patient experienced URTICARIA (mild hives, nightmarish hives over my entire body, They were painful and itchy). At the time of the report, ERYTHEMA (redness), MUSCULOSKELETAL STIFFNESS (stiffness in my neck), NECK PAIN (pain in my neck), URTICARIA (mild hives, nightmarish hives over my entire body, They were painful and itchy), INJECTION SITE PAIN (I had soreness at the injection site) and MYALGIA (muscle aches in both arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided Treatment medications Benadryl
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: mild hives, nightmarish hives over my entire body, They were painful and itchy; I had soreness at the injection site; muscle aches in both arms; redness; stiffness in my neck; pain in my neck; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), MUSCULOSKELETAL STIFFNESS (stiffness in my neck), NECK PAIN (pain in my neck), URTICARIA (mild hives, nightmarish hives over my entire body, They were painful and itchy) and INJECTION SITE PAIN (I had soreness at the injection site) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced ERYTHEMA (redness), MUSCULOSKELETAL STIFFNESS (stiffness in my neck), NECK PAIN (pain in my neck), INJECTION SITE PAIN (I had soreness at the injection site) and MYALGIA (muscle aches in both arms). On 16-Apr-2021, the patient experienced URTICARIA (mild hives, nightmarish hives over my entire body, They were painful and itchy). At the time of the report, ERYTHEMA (redness), MUSCULOSKELETAL STIFFNESS (stiffness in my neck), NECK PAIN (pain in my neck), URTICARIA (mild hives, nightmarish hives over my entire body, They were painful and itchy), INJECTION SITE PAIN (I had soreness at the injection site) and MYALGIA (muscle aches in both arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided Treatment medications Benadryl
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vomiting
Clinical narrative: Achiness; Vomiting; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achiness), VOMITING (Vomiting) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced MYALGIA (Achiness), VOMITING (Vomiting) and HEADACHE (Headache). At the time of the report, MYALGIA (Achiness), VOMITING (Vomiting) and HEADACHE (Headache) was resolving.            Products known to have been used by the patient, within two weeks prior to the event, included unspecified migraine medication. Treatment medication included Paracetamol.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Somnolence
Clinical narrative: Severe lower back pain; sleepy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Severe lower back pain) and SOMNOLENCE (sleepy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included IBUPROFEN for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SOMNOLENCE (sleepy). On 17-Apr-2021, the patient experienced BACK PAIN (Severe lower back pain). At the time of the report, BACK PAIN (Severe lower back pain) had not resolved and SOMNOLENCE (sleepy) outcome was unknown. Not Provided          Treatment details included ibuprofen.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-080129, MOD21-078128 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080129:1st Dose Case MOD21-078128:Husband report
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Dizziness
Clinical narrative: strong dizziness/felt like was falling; Pressure rose to 165; weakening; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (strong dizziness/felt like was falling), BLOOD PRESSURE INCREASED (Pressure rose to 165) and ASTHENIA (weakening) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN, ATORVASTATIN, VITAMINS NOS, MACROGOL 3350 (CLEARLAX [MACROGOL 3350]), FINASTERIDE and TAMSULOSIN for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced DIZZINESS (strong dizziness/felt like was falling), BLOOD PRESSURE INCREASED (Pressure rose to 165) and ASTHENIA (weakening). On 31-Mar-2021, DIZZINESS (strong dizziness/felt like was falling) and BLOOD PRESSURE INCREASED (Pressure rose to 165) had resolved. At the time of the report, ASTHENIA (weakening) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was received. The doctor listened to his heart and lungs, and he measured oxygen saturation and pressure.   This case was linked to US-MODERNATX, INC.-MOD-2021-079968 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079968:Wife's Case
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle ache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) 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 19-Apr-2021, the patient experienced MYALGIA (Muscle ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MYALGIA (Muscle ache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 2 nd dose not received; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2 nd dose not received) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported ).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (2 nd dose not received). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2 nd dose not received) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient received monoclonal antibody treatment for liver on 12-APR-2021 and reporter would like to know that the patient should wait 90 days due to the monoclonal treatment administration.  No concomitant medication reported   No treatment medication reported
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: He has already crossed the window period.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (He has already crossed the window period.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No specified medical history has been reported.     On 14-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 (He has already crossed the window period.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (He has already crossed the window period.) 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.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up was done,  no new information received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: stiffness; pain at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness) and VACCINATION SITE PAIN (pain at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness) and VACCINATION SITE PAIN (pain at the injection site). The patient was treated with ARNICA MONTANA (ARNICA (PLANTA TOTA) "WELEDA") for Pain in arm, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness) and VACCINATION SITE PAIN (pain at the injection site) 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.   No concomitant medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-080157 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080157:2 nd dose of vaccine
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Nausea
Clinical narrative: Numbness in hand; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in hand), NAUSEA (nausea) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 HYPOAESTHESIA (Numbness in hand), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, HYPOAESTHESIA (Numbness in hand), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Dizziness, Dyspnoea, Hypoaesthesia
Clinical narrative: numbness in arm that goes all over body; chills; dizziness; shortness of breath; losing balance; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in arm that goes all over body), CHILLS (chills), DIZZINESS (dizziness), DYSPNOEA (shortness of breath) and BALANCE DISORDER (losing balance) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse effect.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 17-Apr-2021, the patient experienced HYPOAESTHESIA (numbness in arm that goes all over body), CHILLS (chills), DIZZINESS (dizziness), DYSPNOEA (shortness of breath) and BALANCE DISORDER (losing balance). At the time of the report, HYPOAESTHESIA (numbness in arm that goes all over body), CHILLS (chills), DIZZINESS (dizziness), DYSPNOEA (shortness of breath) and BALANCE DISORDER (losing balance) outcome was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in the arm above elbow area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the arm above elbow area) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Heart disease, unspecified.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain in the arm above elbow area). At the time of the report, VACCINATION SITE PAIN (Pain in the arm above elbow area) outcome was unknown.            Pain killer was taken as a treatment medication. Concomitant medication included Heart medication, Diabetic medication.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Synovial cyst
Clinical narrative: ganglion on knees and wrist; This spontaneous case was reported by a consumer and describes the occurrence of SYNOVIAL CYST (ganglion on knees and wrist) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced SYNOVIAL CYST (ganglion on knees and wrist). At the time of the report, SYNOVIAL CYST (ganglion on knees and wrist) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discomfort, Breast swelling, Erythema, Feeling hot, Injection site swelling
Clinical narrative: Missed the 2nd  dose of Moderna vaccine; Redness; rash in the left arm / rash over outer side of left breast; big lump was almost 6 inches in size on arm; left breast was swollen; left breast was sensitive to touch; Swollen arm / arm was swollen /  swelling of the left arm/still have lump; sore arm; Feeling hot and warm / warm to touch; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (Feeling hot and warm / warm to touch), PRODUCT DOSE OMISSION ISSUE (Missed the 2nd  dose of Moderna vaccine), LIMB MASS (big lump was almost 6 inches in size on arm), BREAST SWELLING (left breast was swollen) and BREAST DISCOMFORT (left breast was sensitive to touch) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Right breast surgery). Concomitant products included clonapril.    On 23-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 FEELING HOT (Feeling hot and warm / warm to touch), INJECTION SITE SWELLING (Swollen arm / arm was swollen /  swelling of the left arm/still have lump) and MYALGIA (sore arm). On 31-Mar-2021, the patient experienced LIMB MASS (big lump was almost 6 inches in size on arm), BREAST SWELLING (left breast was swollen), BREAST DISCOMFORT (left breast was sensitive to touch) and RASH (rash in the left arm / rash over outer side of left breast). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the 2nd  dose of Moderna vaccine) and ERYTHEMA (Redness). At the time of the report, FEELING HOT (Feeling hot and warm / warm to touch), LIMB MASS (big lump was almost 6 inches in size on arm), BREAST DISCOMFORT (left breast was sensitive to touch), INJECTION SITE SWELLING (Swollen arm / arm was swollen /  swelling of the left arm/still have lump), MYALGIA (sore arm) and RASH (rash in the left arm / rash over outer side of left breast) had resolved and PRODUCT DOSE OMISSION ISSUE (Missed the 2nd  dose of Moderna vaccine), BREAST SWELLING (left breast was swollen) and ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication listed in Source Document was Clonapril 10 mg daily.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Significant follow up
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Limb mass, Myalgia, Product dose omission issue, Rash
Clinical narrative: Missed the 2nd  dose of Moderna vaccine; Redness; rash in the left arm / rash over outer side of left breast; big lump was almost 6 inches in size on arm; left breast was swollen; left breast was sensitive to touch; Swollen arm / arm was swollen /  swelling of the left arm/still have lump; sore arm; Feeling hot and warm / warm to touch; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (Feeling hot and warm / warm to touch), PRODUCT DOSE OMISSION ISSUE (Missed the 2nd  dose of Moderna vaccine), LIMB MASS (big lump was almost 6 inches in size on arm), BREAST SWELLING (left breast was swollen) and BREAST DISCOMFORT (left breast was sensitive to touch) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Right breast surgery). Concomitant products included clonapril.    On 23-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 FEELING HOT (Feeling hot and warm / warm to touch), INJECTION SITE SWELLING (Swollen arm / arm was swollen /  swelling of the left arm/still have lump) and MYALGIA (sore arm). On 31-Mar-2021, the patient experienced LIMB MASS (big lump was almost 6 inches in size on arm), BREAST SWELLING (left breast was swollen), BREAST DISCOMFORT (left breast was sensitive to touch) and RASH (rash in the left arm / rash over outer side of left breast). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the 2nd  dose of Moderna vaccine) and ERYTHEMA (Redness). At the time of the report, FEELING HOT (Feeling hot and warm / warm to touch), LIMB MASS (big lump was almost 6 inches in size on arm), BREAST DISCOMFORT (left breast was sensitive to touch), INJECTION SITE SWELLING (Swollen arm / arm was swollen /  swelling of the left arm/still have lump), MYALGIA (sore arm) and RASH (rash in the left arm / rash over outer side of left breast) had resolved and PRODUCT DOSE OMISSION ISSUE (Missed the 2nd  dose of Moderna vaccine), BREAST SWELLING (left breast was swollen) and ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication listed in Source Document was Clonapril 10 mg daily.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Significant follow up
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Vaccination site pain
Clinical narrative: deep pain under her right breast as if she had received a blow there,which goes down to her stomach and passes to her back; pain at the injection site; right hand felt stiff in the mornings, she cannot open it well and it increased after the second dose; This spontaneous case was reported by a physician and describes the occurrence of MUSCULOSKELETAL STIFFNESS (right hand felt stiff in the mornings, she cannot open it well and it increased after the second dose), MYALGIA (deep pain under her right breast as if she had received a blow there,which goes down to her stomach and passes to her back) and VACCINATION SITE PAIN (pain at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (right hand felt stiff in the mornings, she cannot open it well and it increased after the second dose) and VACCINATION SITE PAIN (pain at the injection site). On 14-Apr-2021, the patient experienced MYALGIA (deep pain under her right breast as if she had received a blow there,which goes down to her stomach and passes to her back). At the time of the report, MUSCULOSKELETAL STIFFNESS (right hand felt stiff in the mornings, she cannot open it well and it increased after the second dose), MYALGIA (deep pain under her right breast as if she had received a blow there,which goes down to her stomach and passes to her back) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medicine included Arnica   This case was linked to MOD-2021-080150 (E2B Linked Report).; Sender's Comments:  MOD-2021-080150:1 st dose of vaccine
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Ear pain, Myalgia, Pruritus
Clinical narrative: Ear Infection; itching; ear ache; soreness in ear canal; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (Ear Infection), PRURITUS (itching), EAR PAIN (ear ache) and MYALGIA (soreness in ear canal) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     no medical history information was reported.  Concomitant products included BUPROPIONE for Depression, SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced EAR INFECTION (Ear Infection), PRURITUS (itching), EAR PAIN (ear ache) and MYALGIA (soreness in ear canal). At the time of the report, EAR INFECTION (Ear Infection), PRURITUS (itching), EAR PAIN (ear ache) and MYALGIA (soreness in ear canal) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient described that ear infection, pruritus, myalgia, ear pain are common to her.   Reporter did not allow further contact
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Some Liquid Vaccine leaked out of the Injection Site; Small Redness Injection Site; Bump Injection Site; Itching Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Some Liquid Vaccine leaked out of the Injection Site), VACCINATION SITE ERYTHEMA (Small Redness Injection Site), VACCINATION SITE MASS (Bump Injection Site) and VACCINATION SITE PRURITUS (Itching Injection Site) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Some Liquid Vaccine leaked out of the Injection Site), VACCINATION SITE ERYTHEMA (Small Redness Injection Site), VACCINATION SITE MASS (Bump Injection Site) and VACCINATION SITE PRURITUS (Itching Injection Site). At the time of the report, PRODUCT ADMINISTRATION ERROR (Some Liquid Vaccine leaked out of the Injection Site), VACCINATION SITE ERYTHEMA (Small Redness Injection Site), VACCINATION SITE MASS (Bump Injection Site) and VACCINATION SITE PRURITUS (Itching Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Pain in extremity, Polymenorrhoea
Clinical narrative: arm hurt; having a very heavy period, being 2 weeks early; having a very heavy period, being 2 weeks early. She's still bleeding; This spontaneous case was reported by a consumer and describes the occurrence of POLYMENORRHOEA (having a very heavy period, being 2 weeks early), HEAVY MENSTRUAL BLEEDING (having a very heavy period, being 2 weeks early. She's still bleeding) and PAIN IN EXTREMITY (arm hurt) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 031M20A) for COVID-19 vaccination.     Concomitant products included GLATIRAMER ACETATE (COPAXONE) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced POLYMENORRHOEA (having a very heavy period, being 2 weeks early) and HEAVY MENSTRUAL BLEEDING (having a very heavy period, being 2 weeks early. She's still bleeding). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt). At the time of the report, POLYMENORRHOEA (having a very heavy period, being 2 weeks early), HEAVY MENSTRUAL BLEEDING (having a very heavy period, being 2 weeks early. She's still bleeding) and PAIN IN EXTREMITY (arm hurt) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. treatment information not provided.No Concomitant medication was reported.   This case was linked to MOD-2021-226247 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: reported an adverse event after receiving the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reported an adverse event after receiving the 1st dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Hypertension and Penicillin allergy. Concomitant products included GLIPIZIDE and METFORMIN for Diabetes, OMEPRAZOLE (PROTONIX (OMEPRAZOLE) for Gastric disorder, NIFEDIPINE and ATENOLOL for Hypertension, METFORMIN HYDROCHLORIDE (GLUCOPHAGE), MAGNESIUM, POTASSIUM and MULTIVITAMIN (VITAMINS NOS) for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (reported an adverse event after receiving the 1st dose). At the time of the report, VACCINATION COMPLICATION (reported an adverse event after receiving the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication details were reported      Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: Follow up received and  patient demographics updated, medical history updated,first dose details updated and additional concomitant medication added
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient under 18 years of age old received vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age old received vaccine) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age old received vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age old received vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   want to know what the follow steps are and if they should schedule a follow up. No further information provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rhinorrhoea
Clinical narrative: spider bite-like spots/rash on her back, arms and legs that was itching, red, and swollen; runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (spider bite-like spots/rash on her back, arms and legs that was itching, red, and swollen) and RHINORRHOEA (runny nose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced RASH ERYTHEMATOUS (spider bite-like spots/rash on her back, arms and legs that was itching, red, and swollen) and RHINORRHOEA (runny nose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (spider bite-like spots/rash on her back, arms and legs that was itching, red, and swollen) and RHINORRHOEA (runny nose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Mydriasis, Ophthalmological examination, Photophobia, Vision blurred, Visual impairment
Clinical narrative: eyes were dilatated; issue with the vision; His vision was blurry; very sanative to light; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (issue with the vision), VISION BLURRED (His vision was blurry), PHOTOPHOBIA (very sanative to light) and MYDRIASIS (eyes were dilatated) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 027A21A) 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) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced VISUAL IMPAIRMENT (issue with the vision), VISION BLURRED (His vision was blurry) and PHOTOPHOBIA (very sanative to light). On 15-Apr-2021, the patient experienced MYDRIASIS (eyes were dilatated). At the time of the report, VISUAL IMPAIRMENT (issue with the vision) and VISION BLURRED (His vision was blurry) was resolving and PHOTOPHOBIA (very sanative to light) and MYDRIASIS (eyes were dilatated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ophthalmological examination: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.  Reporter stated that the patient never had eye issues before.   Reporter did not allow further contact