chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Myalgia
Clinical narrative: Wasn't feeling really good; Body aches; Chills; A little bit of a headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Wasn't feeling really good), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (A little bit of a headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007c21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACECLOFENAC (ACENAC), METOPROLOL and ATORVASTATIN for an unknown indication.    On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced MALAISE (Wasn't feeling really good), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (A little bit of a headache). At the time of the report, MALAISE (Wasn't feeling really good), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (A little bit of a headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included cyclodenpatarne. Treatment information was not provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Pyrexia
Clinical narrative: Fever; Chills; Back aches; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back aches), PYREXIA (Fever) and CHILLS (Chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BACK PAIN (Back aches). On an unknown date, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, BACK PAIN (Back aches), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            No concomitant product reported by reporter. No treatment medication reported by reporter. Patient states she was "fully vaccinated" 8-May-2021. Consent for follow-up was given.   This case was linked to MOD-2021-058111 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow up received. New event added.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heartbeat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 021M20A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-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 HEART RATE INCREASED (Fast heartbeat). At the time of the report, HEART RATE INCREASED (Fast heartbeat) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: other (High) Patient developed fast heart beat and never had it before. No concomitant medications were reported. No treatment details were reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 655C21a) for COVID-19 vaccination.     No medical history was reported.  Concurrent medical conditions included Blood pressure. Concomitant products included VERAPAMIL for Blood pressure.    On 24-Jun-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 MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) 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.   Patient did not take anything for treatment. Concomitant medication included allergy shots.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Petechiae, Rash
Clinical narrative: Petechial rash on his lower extremities; Rash has come and gone with varying intensity over the last several weeks; This spontaneous case was reported by an other health care professional and describes the occurrence of PETECHIAE (Petechial rash on his lower extremities) and RASH (Rash has come and gone with varying intensity over the last several weeks) in a 40-year-old male patient 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 PETECHIAE (Petechial rash on his lower extremities) and RASH (Rash has come and gone with varying intensity over the last several weeks). At the time of the report, PETECHIAE (Petechial rash on his lower extremities) and RASH (Rash has come and gone with varying intensity over the last several weeks) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Patient's age was added, lab data was updated, event outcome was updated.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Disturbance in attention, Hyperacusis, Pain in extremity, Vaccination site pain
Clinical narrative: Left arm soreness; right arm soreness (injection site) for 3-4 days; a lot of anxieties; has hypersensitivity to a lot of noise; when he hears more than one person talking - he cannot concentrate; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm soreness), ANXIETY (a lot of anxieties), HYPERACUSIS (has hypersensitivity to a lot of noise), DISTURBANCE IN ATTENTION (when he hears more than one person talking - he cannot concentrate) and VACCINATION SITE PAIN (right arm soreness (injection site) for 3-4 days) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced PAIN IN EXTREMITY (Left arm soreness) and VACCINATION SITE PAIN (right arm soreness (injection site) for 3-4 days). In May 2021, the patient experienced ANXIETY (a lot of anxieties), HYPERACUSIS (has hypersensitivity to a lot of noise) and DISTURBANCE IN ATTENTION (when he hears more than one person talking - he cannot concentrate). At the time of the report, PAIN IN EXTREMITY (Left arm soreness), ANXIETY (a lot of anxieties), HYPERACUSIS (has hypersensitivity to a lot of noise), DISTURBANCE IN ATTENTION (when he hears more than one person talking - he cannot concentrate) and VACCINATION SITE PAIN (right arm soreness (injection site) for 3-4 days) outcome was unknown.            No concomitant medications were provided. No treatment information was provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Myalgia
Clinical narrative: This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MYALGIA (Mild sore arm) and EXPOSURE DURING PREGNANCY (Patient received the Moderna COVID-19 vaccine while pregnant) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination. No medical history was provided by the reporter,. Concomitant products included Prenatal Multivitamins. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 25-Jan-2021 and the estimated date of delivery was 01-Nov-2021. On 03-Jun-2021, the patient experienced MYALGIA (Mild sore arm) and EXPOSURE DURING PREGNANCY (Patient received the Moderna COVID-19 vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the eighteenth week of the pregnancy. At the time of the report, MYALGIA (Mild sore arm) and EXPOSURE DURING PREGNANCY (Patient received the Moderna COVID-19 vaccine while pregnant) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Treatment medication was provided. Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up information received it includes First dose of Moderna vaccine, Date of last menstrual period, estimated due date.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Dry skin, Feeling abnormal, Feeling hot, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT ("both hands were very hot "), DRY SKIN ("both hands were dry"), FEELING ABNORMAL (heat of hands "felt like pepper seed" on skin), ALLERGY TO VACCINE (injection site of left arm "I had a allergic reaction but could have been from the Band-Aid") and TEMPERATURE DIFFERENCE OF EXTREMITIES (right hand read 100.1 degrees F., left hand temperature was 100.3 degrees) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included CARBINOXAMINE MALEATE (OMEGA 100) for an unknown indication. On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, the patient experienced FEELING HOT ("both hands were very hot "), DRY SKIN ("both hands were dry"), FEELING ABNORMAL (heat of hands "felt like pepper seed" on skin), ALLERGY TO VACCINE (injection site of left arm "I had a allergic reaction but could have been from the Band-Aid"), TEMPERATURE DIFFERENCE OF EXTREMITIES (right hand read 100.1 degrees F., left hand temperature was 100.3 degrees), VACCINATION SITE PRURITUS (injection site was "a little itchy"), VACCINATION SITE RASH (red circular rash at injection site.), VACCINATION SITE ERYTHEMA (red circular rash at injection site.) and PYREXIA ("fever under 99 degrees"). In June 2021, FEELING HOT ("both hands were very hot "), DRY SKIN ("both hands were dry"), FEELING ABNORMAL (heat of hands "felt like pepper seed" on skin), TEMPERATURE DIFFERENCE OF EXTREMITIES (right hand read 100.1 degrees F., left hand temperature was 100.3 degrees), VACCINATION SITE PRURITUS (injection site was "a little itchy"), VACCINATION SITE RASH (red circular rash at injection site), VACCINATION SITE ERYTHEMA (red circular rash at injection site) and PYREXIA ("fever under 99 degrees") outcome was unknown and ALLERGY TO VACCINE (injection site of left arm "I had a allergic reaction but could have been from the Band-Aid") 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. Concomitant medication include magnesium potassium supplement. Treatment includes wet washcloths to cool the temperature of hands down. 2nd dose scheduled for tomorrow 2Jul2021.
Sex: F
Vaccine: COVID19
Symptoms: Temperature difference of extremities, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT ("both hands were very hot "), DRY SKIN ("both hands were dry"), FEELING ABNORMAL (heat of hands "felt like pepper seed" on skin), ALLERGY TO VACCINE (injection site of left arm "I had a allergic reaction but could have been from the Band-Aid") and TEMPERATURE DIFFERENCE OF EXTREMITIES (right hand read 100.1 degrees F., left hand temperature was 100.3 degrees) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included CARBINOXAMINE MALEATE (OMEGA 100) for an unknown indication. On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, the patient experienced FEELING HOT ("both hands were very hot "), DRY SKIN ("both hands were dry"), FEELING ABNORMAL (heat of hands "felt like pepper seed" on skin), ALLERGY TO VACCINE (injection site of left arm "I had a allergic reaction but could have been from the Band-Aid"), TEMPERATURE DIFFERENCE OF EXTREMITIES (right hand read 100.1 degrees F., left hand temperature was 100.3 degrees), VACCINATION SITE PRURITUS (injection site was "a little itchy"), VACCINATION SITE RASH (red circular rash at injection site.), VACCINATION SITE ERYTHEMA (red circular rash at injection site.) and PYREXIA ("fever under 99 degrees"). In June 2021, FEELING HOT ("both hands were very hot "), DRY SKIN ("both hands were dry"), FEELING ABNORMAL (heat of hands "felt like pepper seed" on skin), TEMPERATURE DIFFERENCE OF EXTREMITIES (right hand read 100.1 degrees F., left hand temperature was 100.3 degrees), VACCINATION SITE PRURITUS (injection site was "a little itchy"), VACCINATION SITE RASH (red circular rash at injection site), VACCINATION SITE ERYTHEMA (red circular rash at injection site) and PYREXIA ("fever under 99 degrees") outcome was unknown and ALLERGY TO VACCINE (injection site of left arm "I had a allergic reaction but could have been from the Band-Aid") 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. Concomitant medication include magnesium potassium supplement. Treatment includes wet washcloths to cool the temperature of hands down. 2nd dose scheduled for tomorrow 2Jul2021.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. No Medical history was provided by the Reporter. On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced VOMITING (Vomiting). At the time of the report, VOMITING (Vomiting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medications were not provided. Concomitant medications were not provided by the reporter. This case was linked to MOD-2021-244657 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired vaccine as a 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine as a 1st dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine as a 1st dose). On 01-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine as a 1st dose) 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 was reported. No treatment drug details was reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Incorrect dose administered, Injection site pain, Vomiting
Clinical narrative: Received the second dose 51 days after the first dose; Pain on injection site; Fatigue; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received the second dose 51 days after the first dose), INJECTION SITE PAIN (Pain on injection site), FATIGUE (Fatigue) and VOMITING (Vomiting) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Received the second dose 51 days after the first dose), INJECTION SITE PAIN (Pain on injection site), FATIGUE (Fatigue) and VOMITING (Vomiting). On 30-Jun-2021, INCORRECT DOSE ADMINISTERED (Received the second dose 51 days after the first dose) had resolved. At the time of the report, INJECTION SITE PAIN (Pain on injection site), FATIGUE (Fatigue) and VOMITING (Vomiting) outcome was unknown.            Concomitant product use was not provided by the reporter.   Treatment information was not provided.    This case was linked to MOD-2021-244648 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (it's been 46 days since the first injection) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-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 PRODUCT DOSE OMISSION ISSUE (it's been 46 days since the first injection). At the time of the report, PRODUCT DOSE OMISSION ISSUE (it's been 46 days since the first injection) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. Treatment information not reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation irregular
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (side effects from the Moderna vaccine related to my menstrual cycle/significant issues with my menstrual cycle since I received the vaccine, I should have, but it was light and only lasted 3 days) and MENSTRUATION IRREGULAR (listed the day that I should have started my period, but it never came, should have had another period, but didn't, I am referring to starting my period about 2 weeks sooner than I should have) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 042B21A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy. Concomitant products included VITAMIN D [VITAMIN D NOS] and ZINC for an unknown indication. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced MENSTRUAL DISORDER (side effects from the modern vaccine related to my menstrual cycle/significant issues with my menstrual cycle since I received the vaccine, I should have, but it was light and only lasted 3 days). On an unknown date, the patient experienced MENSTRUATION IRREGULAR (listed the day that I should have started my period, but it never came, should have had another period, but didn't, I am referring to starting my period about 2 weeks sooner than I should have). On 06-May-2021, MENSTRUAL DISORDER (side effects from the modern vaccine related to my menstrual cycle/significant issues with my menstrual cycle since I received the vaccine, I should have, but it was light and only lasted 3 days) had resolved. At the time of the report, MENSTRUATION IRREGULAR (listed the day that I should have started my period, but it never came, should have had another period, but didn't, I am referring to starting my period about 2 weeks sooner than I should have) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment details were not reported by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: significant follow up appended; Vaccine details, event outcome and patient information are updated.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose given from vial that had been opened for 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose given from vial that had been opened for 24 hours) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jul-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 01-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose given from vial that had been opened for 24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose given from vial that had been opened for 24 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Erythema, Fatigue, Headache, Skin warm
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (Hot to the touch), ASTHENIA (Doesn´t have the energy as it used too), ERYTHEMA (Redness started to go up the arm), HEADACHE (More frequent head aches) and FATIGUE (Feeling more tired) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced HEADACHE (More frequent head aches), FATIGUE (Feeling more tired) and VOMITING (Felt like going to throw up). On an unknown date, the patient experienced SKIN WARM (Hot to the touch), ASTHENIA (Doesn´t have the energy as it used too) and ERYTHEMA (Redness started to go up the arm). At the time of the report, SKIN WARM (Hot to the touch), ASTHENIA (Doesn´t have the energy as it used too), ERYTHEMA (Redness started to go up the arm), HEADACHE (More frequent head aches), FATIGUE (Feeling more tired) and VOMITING (Felt like going to throw up) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. Treatment information was not provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (Hot to the touch), ASTHENIA (Doesn´t have the energy as it used too), ERYTHEMA (Redness started to go up the arm), HEADACHE (More frequent head aches) and FATIGUE (Feeling more tired) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced HEADACHE (More frequent head aches), FATIGUE (Feeling more tired) and VOMITING (Felt like going to throw up). On an unknown date, the patient experienced SKIN WARM (Hot to the touch), ASTHENIA (Doesn´t have the energy as it used too) and ERYTHEMA (Redness started to go up the arm). At the time of the report, SKIN WARM (Hot to the touch), ASTHENIA (Doesn´t have the energy as it used too), ERYTHEMA (Redness started to go up the arm), HEADACHE (More frequent head aches), FATIGUE (Feeling more tired) and VOMITING (Felt like going to throw up) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. Treatment information was not provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (he got his third dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A, 046B21A and 004C21A) for COVID-19 vaccination. Concurrent medical conditions included Heart disease, unspecified and Atrial fibrillation. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jul-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jul-2021, the patient experienced ACCIDENTAL OVERDOSE (he got his third dose). On 01-Jul-2021, ACCIDENTAL OVERDOSE (he got his third dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product information, if any, was not provided by the reporter. Action taken with mRNA-1273 in response to the event was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up Information received on 01-JUL-2021 doesn't  contains any significant Information.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, COVID-19, Diarrhoea, Ear pain, Headache
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea), EAR PAIN (Ear pain), HYPERHIDROSIS (Sweats) and HEADACHE (Headache) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy and Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism, DICYCLOMINE [DICYCLOVERINE] for an unknown indication. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2021, the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea), EAR PAIN (Ear pain), HYPERHIDROSIS (Sweats), HEADACHE (Headache), PHARYNGITIS STREPTOCOCCAL (Strep Pharyngitis) and NAUSEA (Nausea). The patient was treated with AMOXICILLIN at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea), EAR PAIN (Ear pain), HYPERHIDROSIS (Sweats), HEADACHE (Headache), PHARYNGITIS STREPTOCOCCAL (Strep Pharyngitis), COVID-19 (Tested positive for COVID-19) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jul-2021, SARS-CoV-2 antibody test: positive (Positive) Tested positive for COVID-19. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PHARYNGITIS STREPTOCOCCAL (Strep Pharyngitis) to be not related. No further causality assessments were provided for ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea), EAR PAIN (Ear pain), HYPERHIDROSIS (Sweats), HEADACHE (Headache), COVID-19 (Tested positive for COVID-19) and NAUSEA (Nausea). Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Significant follow up appended: Reporter details (address, phone number and fax number), patient's demographics (pregnancy details was changed from 'no to unknown', height, weight, race, and ethnicity), medical history details (allergy, current condition and COVID-19 was deleted from medical history section), concomitant medication details (Levothyroxine's indication for use, route and dose), vaccine facility information, additional event (Tested positive for COVID-19), event verbatim (updated from Strep to Strep Pharyngitis) and causality for the event Strep Pharyngitis (updated from not provided to not related) were provided.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Pharyngitis streptococcal, SARS-CoV-2 antibody test
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea), EAR PAIN (Ear pain), HYPERHIDROSIS (Sweats) and HEADACHE (Headache) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy and Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism, DICYCLOMINE [DICYCLOVERINE] for an unknown indication. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2021, the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea), EAR PAIN (Ear pain), HYPERHIDROSIS (Sweats), HEADACHE (Headache), PHARYNGITIS STREPTOCOCCAL (Strep Pharyngitis) and NAUSEA (Nausea). The patient was treated with AMOXICILLIN at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea), EAR PAIN (Ear pain), HYPERHIDROSIS (Sweats), HEADACHE (Headache), PHARYNGITIS STREPTOCOCCAL (Strep Pharyngitis), COVID-19 (Tested positive for COVID-19) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jul-2021, SARS-CoV-2 antibody test: positive (Positive) Tested positive for COVID-19. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PHARYNGITIS STREPTOCOCCAL (Strep Pharyngitis) to be not related. No further causality assessments were provided for ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea), EAR PAIN (Ear pain), HYPERHIDROSIS (Sweats), HEADACHE (Headache), COVID-19 (Tested positive for COVID-19) and NAUSEA (Nausea). Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Significant follow up appended: Reporter details (address, phone number and fax number), patient's demographics (pregnancy details was changed from 'no to unknown', height, weight, race, and ethnicity), medical history details (allergy, current condition and COVID-19 was deleted from medical history section), concomitant medication details (Levothyroxine's indication for use, route and dose), vaccine facility information, additional event (Tested positive for COVID-19), event verbatim (updated from Strep to Strep Pharyngitis) and causality for the event Strep Pharyngitis (updated from not provided to not related) were provided.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (On 26 Apr I started with fever so I took the test the next day and it was positive), PRODUCT DOSE OMISSION ISSUE (More than 35 days since first shot) and PYREXIA (Fever after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PYREXIA (Fever after first dose). On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (On 26Apr I started with fever so I took the test the next day and it was positive) and PRODUCT DOSE OMISSION ISSUE (More than 35 days since first shot). At the time of the report, SARS-COV-2 TEST POSITIVE (On 26 Apr I started with fever so I took the test the next day and it was positive), PRODUCT DOSE OMISSION ISSUE (More than 35 days since first shot) and PYREXIA (Fever after first dose) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2021, COVID-19: positive (Positive) patient stated she started with fever so took the test next day and it was positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication not provided. Treatment information not provided. The second dose was scheduled for 18-May-2021, but the patient was out of the country.
Age: 89.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Past the 42 day mark) in an 89-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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 28-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Past the 42 day mark). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Past the 42 day mark) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient has received the first dose of Moderna vaccine on 28 January 2021, and lost the vaccine card, and took another dose on 29-June 2021 and recorded in the vaccine card as first dose. Reporter did not allow further contact.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Caller stated her patient missed his second dose and wants to get it today which is after 35 day mark/he was supposed to get his second dose on 6May2021 but missed) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Caller stated her patient missed his second dose and wants to get it today which is after 35 day mark/he was supposed to get his second dose on 6May2021 but missed). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Caller stated her patient missed his second dose and wants to get it today which is after 35 day mark/he was supposed to get his second dose on 6May2021 but missed) 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 provided by reporter. No treatment medications were provided by reporter. Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up information received on 01-JUN-2021 contains No Significant Information. On 01-Jul-2021: Follow-up information received on 01-JUN-2021 contains No Significant Information.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (loss of smell) and AGEUSIA (loss of taste) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 016M20A) for COVID-19 vaccination. No Medical History information was reported. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced ANOSMIA (loss of smell) and AGEUSIA (loss of taste). At the time of the report, ANOSMIA (loss of smell) and AGEUSIA (loss of taste) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. No concomitant medications reported. No treatment reported.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (When the pharmacist pulled the needle out, some of it came out) and UNDERDOSE (patient received a good 0.4 mL) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, the patient experienced DEVICE CONNECTION ISSUE (When the pharmacist pulled the needle out, some of it came out) and UNDERDOSE (patient received a good 0.4 mL). On 01-Jul-2021, DEVICE CONNECTION ISSUE (When the pharmacist pulled the needle out, some of it came out) and UNDERDOSE (patient received a good 0.4 mL) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (loss of smell) and AGEUSIA (loss of taste) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 019B21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. In June 2021, the patient experienced ANOSMIA (loss of smell) and AGEUSIA (loss of taste). At the time of the report, ANOSMIA (loss of smell) and AGEUSIA (loss of taste) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication use was unknown. Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist at the store gave a Moderna vaccine to a patient outside of the 12 hour puncture time) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist at the store gave a Moderna vaccine to a patient outside of the 12 hour puncture time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist at the store gave a Moderna vaccine to a patient outside of the 12 hour puncture time) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment details were reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case was reported by an other caregiver and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Gone beyond the 42 day mark between doses) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The patient's past medical history included Surgery on 26-May-2021. Concurrent medical conditions included Throat cancer since 30-Apr-2021. On 08-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 PRODUCT DOSE OMISSION ISSUE (Gone beyond the 42 day mark between doses). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Gone beyond the 42 day mark between doses) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided by the reporter. Treatment information was not provided by the reporter. Reporter stated that the patient did not receive the second dose on time because the patient was in the hospital at the time. Patient was diagnosed on 30-Apr-2021 with throat cancer and had surgery on 26-May-2021. The reporter stated the patient was hospitalized until 20-Jun-2021.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Echocardiogram, Palpitations, Product dose omission issue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Had COVID Disease), PALPITATIONS (Palpitations) and PRODUCT DOSE OMISSION ISSUE (missed dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The patient's past medical history included COVID-19. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PALPITATIONS (Palpitations). On an unknown date, the patient experienced COVID-19 (Had COVID Disease) and PRODUCT DOSE OMISSION ISSUE (missed dose). At the time of the report, COVID-19 (Had COVID Disease) and PALPITATIONS (Palpitations) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (missed dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):- In February 2021, COVID-19: positive (Positive) Had COVID disease. On an unknown date, Echocardiogram: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient received IV fluids as treatment. Patient reported that she experienced heart palpitations 1.5 hours after receiving the vaccine, Patient reported cardiac lab data as ECG, cardiac test, cardiac enzymes. Patient reported that Echo was normal. Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Event updated.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (was "sick" at that time) and PRODUCT DOSE OMISSION ISSUE (did not get the second vaccine when scheduled) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. No medical history was provided by the reporter. On 06-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 ILLNESS (was "sick" at that time) and PRODUCT DOSE OMISSION ISSUE (did not get the second vaccine when scheduled). At the time of the report, ILLNESS (was "sick" at that time) and PRODUCT DOSE OMISSION ISSUE (did not get the second vaccine when scheduled) 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 products included Unspecified medication for Hypertension. Treatment medication was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (haven't gotten my second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (haven't gotten my second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (haven't gotten my second dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment drugs were reported.