chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product label confusion, Wrong product administered
Clinical narrative: He reported that the vial label is confusing/a Dark Blue Cap and a label with purple border. On the vial label it states, Booster dose only.; No adverse event; Received Monovalent booster instead of Bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Monovalent booster instead of Bivalent booster), PRODUCT LABEL CONFUSION (He reported that the vial label is confusing/a Dark Blue Cap and a label with purple border. On the vial label it states, Booster dose only.) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received Monovalent booster instead of Bivalent booster). On an unknown date, the patient experienced PRODUCT LABEL CONFUSION (He reported that the vial label is confusing/a Dark Blue Cap and a label with purple border. On the vial label it states, Booster dose only.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Monovalent booster instead of Bivalent booster), PRODUCT LABEL CONFUSION (He reported that the vial label is confusing/a Dark Blue Cap and a label with purple border. On the vial label it states, Booster dose only.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Received Monovalent booster instead of Bivalent booster) and PRODUCT LABEL CONFUSION (He reported that the vial label is confusing/a Dark Blue Cap and a label with purple border. On the vial label it states, Booster dose only.).    Concomitant product use was not provided by the reporter.  It was reported that received a shipment of NDC 80777-275--05 after receiving the Bivalent vials.  Treatment information was not provided.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Nasopharyngitis, Peripheral swelling
Clinical narrative: I felt sick, like bad cold; My right arm was red; My right arm was swollen; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (My right arm was red), PERIPHERAL SWELLING (My right arm was swollen) and NASOPHARYNGITIS (I felt sick, like bad cold) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced ERYTHEMA (My right arm was red) and PERIPHERAL SWELLING (My right arm was swollen). On 08-Mar-2021, the patient experienced NASOPHARYNGITIS (I felt sick, like bad cold). In March 2021, NASOPHARYNGITIS (I felt sick, like bad cold) had resolved. At the time of the report, ERYTHEMA (My right arm was red) and PERIPHERAL SWELLING (My right arm was swollen) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant medications were provided.  It was reported that after receiving first dose of Moderna Covid-19 vaccine patient felt sick, like bad cold for about 5 days.  No treatment medications were provided.   This case was linked to MOD-2022-664780, MOD-2021-093399 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Erythema, Influenza like illness, Peripheral swelling
Clinical narrative: I felt sick, like bad cold; My right arm was red; My right arm was swollen; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (My right arm was red), PERIPHERAL SWELLING (My right arm was swollen) and NASOPHARYNGITIS (I felt sick, like bad cold) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced ERYTHEMA (My right arm was red) and PERIPHERAL SWELLING (My right arm was swollen). On 08-Mar-2021, the patient experienced NASOPHARYNGITIS (I felt sick, like bad cold). In March 2021, NASOPHARYNGITIS (I felt sick, like bad cold) had resolved. At the time of the report, ERYTHEMA (My right arm was red) and PERIPHERAL SWELLING (My right arm was swollen) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant medications were provided.  It was reported that after receiving first dose of Moderna Covid-19 vaccine patient felt sick, like bad cold for about 5 days.  No treatment medications were provided.   This case was linked to MOD-2022-664780, MOD-2021-093399 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: chills; headache; nausea; fatigue; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     It was unknown if patient received any other vaccines within 1 month prior to Moderna COVID-19 vaccine. It was unknown if patient had ever tested or diagnosed for COVID-19. It was unknown if patient had allergy. It was unknown if patient had acute and Chronic illnesses at the time of vaccination.     In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced CHILLS (chills), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue). In March 2021, CHILLS (chills), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that with 1st dose symptoms lasted might be for 1 day. Patient was taking Tylenol, Aspirin and another medication but it was not clear if it was regular medication or the treatment given for her symptoms.   This case was linked to MOD-2022-664696, MOD-2022-664687 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Inappropriate schedule of product administration, Nausea
Clinical narrative: chills; headache; nausea; fatigue; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     It was unknown if patient received any other vaccines within 1 month prior to Moderna COVID-19 vaccine. It was unknown if patient had ever tested or diagnosed for COVID-19. It was unknown if patient had allergy. It was unknown if patient had acute and Chronic illnesses at the time of vaccination.     In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced CHILLS (chills), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue). In March 2021, CHILLS (chills), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that with 1st dose symptoms lasted might be for 1 day. Patient was taking Tylenol, Aspirin and another medication but it was not clear if it was regular medication or the treatment given for her symptoms.   This case was linked to MOD-2022-664696, MOD-2022-664687 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: chills; headache; nausea; fatigue; she received 1st dose of Moderna COVID-19 Vaccine on Mar2021 and 2nd dose on Jun2021; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills), HEADACHE (headache), NAUSEA (nausea), FATIGUE (fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she received 1st dose of Moderna COVID-19 Vaccine on Mar2021 and 2nd dose on Jun2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 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 CHILLS (chills), HEADACHE (headache), NAUSEA (nausea), FATIGUE (fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she received 1st dose of Moderna COVID-19 Vaccine on Mar2021 and 2nd dose on Jun2021). In June 2021, CHILLS (chills), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she received 1st dose of Moderna COVID-19 Vaccine on Mar2021 and 2nd dose on Jun2021) outcome was unknown.            It was reported that with 1st shot symptoms lasted might be for 1 day.  Patient stated she was taking Tylenol, Aspirin and another medication but it was not clear if it was regular medication or the treatment given for her symptoms.   This case was linked to MOD-2022-664696, MOD-2022-664670 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Inappropriate schedule of product administration, Nausea
Clinical narrative: chills; headache; nausea; fatigue; she received 1st dose of Moderna COVID-19 Vaccine on Mar2021 and 2nd dose on Jun2021; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills), HEADACHE (headache), NAUSEA (nausea), FATIGUE (fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she received 1st dose of Moderna COVID-19 Vaccine on Mar2021 and 2nd dose on Jun2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 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 CHILLS (chills), HEADACHE (headache), NAUSEA (nausea), FATIGUE (fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she received 1st dose of Moderna COVID-19 Vaccine on Mar2021 and 2nd dose on Jun2021). In June 2021, CHILLS (chills), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she received 1st dose of Moderna COVID-19 Vaccine on Mar2021 and 2nd dose on Jun2021) outcome was unknown.            It was reported that with 1st shot symptoms lasted might be for 1 day.  Patient stated she was taking Tylenol, Aspirin and another medication but it was not clear if it was regular medication or the treatment given for her symptoms.   This case was linked to MOD-2022-664696, MOD-2022-664670 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Illness, Mobility decreased
Clinical narrative: headache; nausea; real fatigue; Chills; symptoms are worse and she had to stay in bed all day; Sick; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (symptoms are worse and she had to stay in bed all day), ILLNESS (Sick), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (real fatigue) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced ILLNESS (Sick). On 25-Oct-2022, the patient experienced MOBILITY DECREASED (symptoms are worse and she had to stay in bed all day), HEADACHE (headache), NAUSEA (nausea), FATIGUE (real fatigue) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (symptoms are worse and she had to stay in bed all day) outcome was unknown and ILLNESS (Sick), HEADACHE (headache), NAUSEA (nausea), FATIGUE (real fatigue) and CHILLS (Chills) had not resolved.            No concomitant medications were reported.  On Mar-2021, the patient had received the 1st dose of Moderna COVID-19 vaccine by intramuscular route. (batch number: unknown). On Jun-2021, the patient had received the 2nd dose of Moderna COVID-19 vaccine (batch number: unknown). was taking Tylenol, Aspirin and another medication   This case was linked to MOD-2022-664670, MOD-2022-664687 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: headache; nausea; real fatigue; Chills; symptoms are worse and she had to stay in bed all day; Sick; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (symptoms are worse and she had to stay in bed all day), ILLNESS (Sick), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (real fatigue) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced ILLNESS (Sick). On 25-Oct-2022, the patient experienced MOBILITY DECREASED (symptoms are worse and she had to stay in bed all day), HEADACHE (headache), NAUSEA (nausea), FATIGUE (real fatigue) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (symptoms are worse and she had to stay in bed all day) outcome was unknown and ILLNESS (Sick), HEADACHE (headache), NAUSEA (nausea), FATIGUE (real fatigue) and CHILLS (Chills) had not resolved.            No concomitant medications were reported.  On Mar-2021, the patient had received the 1st dose of Moderna COVID-19 vaccine by intramuscular route. (batch number: unknown). On Jun-2021, the patient had received the 2nd dose of Moderna COVID-19 vaccine (batch number: unknown). was taking Tylenol, Aspirin and another medication   This case was linked to MOD-2022-664670, MOD-2022-664687 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: was achy all over the body after the First and 2nd Monovalent Booster; Tired after first and 2nd Monovalent Booster; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (was achy all over the body after the First and 2nd Monovalent Booster) and FATIGUE (Tired after first and 2nd Monovalent Booster) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A and 054A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced MYALGIA (was achy all over the body after the First and 2nd Monovalent Booster) and FATIGUE (Tired after first and 2nd Monovalent Booster). On 05-Nov-2021, MYALGIA (was achy all over the body after the First and 2nd Monovalent Booster) and FATIGUE (Tired after first and 2nd Monovalent Booster) had resolved.            Concomitant product use was not provided by the reporter.  The patient was feeling achy all over the body and tired for 2 days after second Monovalent Booster from 27-May-2022 to 29-May-2022.             Treatment information was not provided.   This case was linked to MOD-2022-664781, MOD-2022-664782 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: He had COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (He had COVID) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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. In September 2022, the patient experienced COVID-19 (He had COVID). At the time of the report, COVID-19 (He had COVID) outcome was unknown.            No concomitant drug were reported.   Patient last booster was 7-8 months ago from the date of reporting.   Patient had COVID last month from the date of reporting.  No treatment drug were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-664540 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-664540:wife case
Age: 26.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received 0.5 ml of a first dose of bivalent instead of monovalent; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received 0.5 ml of a first dose of bivalent instead of monovalent) and NO ADVERSE EVENT (No adverse event) in a 26-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 26-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received 0.5 ml of a first dose of bivalent instead of monovalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received 0.5 ml of a first dose of bivalent instead of monovalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received 0.5 ml of a first dose of bivalent instead of monovalent).    Concomitant drugs were not reported.  It was reported that physician received the bivalent shots from the state.   Treatment medications were not provided.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scratch, Vaccination site erythema, Vaccination site pain, Vaccination site reaction
Clinical narrative: COVID Arm (left arm injection site) right away after first primary dose; Red left arm from shoulder to forearm, right away after first primary dose; Painful left arm from shoulder to forearm, right away after first primary dose; Scratched a lot, left arm injection site, right away after first primary dose; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (COVID Arm (left arm injection site) right away after first primary dose), VACCINATION SITE ERYTHEMA (Red left arm from shoulder to forearm, right away after first primary dose), VACCINATION SITE PAIN (Painful left arm from shoulder to forearm, right away after first primary dose) and SCRATCH (Scratched a lot, left arm injection site, right away after first primary dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE REACTION (COVID Arm (left arm injection site) right away after first primary dose), VACCINATION SITE ERYTHEMA (Red left arm from shoulder to forearm, right away after first primary dose), VACCINATION SITE PAIN (Painful left arm from shoulder to forearm, right away after first primary dose) and SCRATCH (Scratched a lot, left arm injection site, right away after first primary dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 18-Jan-2021, VACCINATION SITE REACTION (COVID Arm (left arm injection site) right away after first primary dose), VACCINATION SITE ERYTHEMA (Red left arm from shoulder to forearm, right away after first primary dose), VACCINATION SITE PAIN (Painful left arm from shoulder to forearm, right away after first primary dose) and SCRATCH (Scratched a lot, left arm injection site, right away after first primary dose) had resolved.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.  No concomitant medications was provided. It was reported that, all symptoms last for 2 weeks.   This case was linked to MOD-2022-664771, MOD-2022-664782 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site reaction
Clinical narrative: COVID Arm (left arm injection site) right away after first primary dose; Red left arm from shoulder to forearm, right away after first primary dose; Painful left arm from shoulder to forearm, right away after first primary dose; Scratched a lot, left arm injection site, right away after first primary dose; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (COVID Arm (left arm injection site) right away after first primary dose), VACCINATION SITE ERYTHEMA (Red left arm from shoulder to forearm, right away after first primary dose), VACCINATION SITE PAIN (Painful left arm from shoulder to forearm, right away after first primary dose) and SCRATCH (Scratched a lot, left arm injection site, right away after first primary dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE REACTION (COVID Arm (left arm injection site) right away after first primary dose), VACCINATION SITE ERYTHEMA (Red left arm from shoulder to forearm, right away after first primary dose), VACCINATION SITE PAIN (Painful left arm from shoulder to forearm, right away after first primary dose) and SCRATCH (Scratched a lot, left arm injection site, right away after first primary dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 18-Jan-2021, VACCINATION SITE REACTION (COVID Arm (left arm injection site) right away after first primary dose), VACCINATION SITE ERYTHEMA (Red left arm from shoulder to forearm, right away after first primary dose), VACCINATION SITE PAIN (Painful left arm from shoulder to forearm, right away after first primary dose) and SCRATCH (Scratched a lot, left arm injection site, right away after first primary dose) had resolved.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.  No concomitant medications was provided. It was reported that, all symptoms last for 2 weeks.   This case was linked to MOD-2022-664771, MOD-2022-664782 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scratch, Vaccination site erythema, Vaccination site pain, Vaccination site reaction
Clinical narrative: Less severe COVID Arm (Left Arm) again 2 weeks after 2nd primary dose/2nd primary dose side effects were not as bad  as the first shot; Red Left Arm  from Shoulder to Forearm 2 weeks after 2nd primary dose; Less painful left arm injection site 2 weeks after 2nd primary dose; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (Less severe COVID Arm (Left Arm) again 2 weeks after 2nd primary dose/2nd primary dose side effects were not as bad  as the first shot), VACCINATION SITE ERYTHEMA (Red Left Arm  from Shoulder to Forearm 2 weeks after 2nd primary dose) and VACCINATION SITE PAIN (Less painful left arm injection site 2 weeks after 2nd primary dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE REACTION (Less severe COVID Arm (Left Arm) again 2 weeks after 2nd primary dose/2nd primary dose side effects were not as bad  as the first shot), VACCINATION SITE ERYTHEMA (Red Left Arm  from Shoulder to Forearm 2 weeks after 2nd primary dose) and VACCINATION SITE PAIN (Less painful left arm injection site 2 weeks after 2nd primary dose). On 21-Feb-2021, VACCINATION SITE REACTION (Less severe COVID Arm (Left Arm) again 2 weeks after 2nd primary dose/2nd primary dose side effects were not as bad  as the first shot), VACCINATION SITE ERYTHEMA (Red Left Arm  from Shoulder to Forearm 2 weeks after 2nd primary dose) and VACCINATION SITE PAIN (Less painful left arm injection site 2 weeks after 2nd primary dose) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-664781, MOD-2022-664771 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site reaction
Clinical narrative: Less severe COVID Arm (Left Arm) again 2 weeks after 2nd primary dose/2nd primary dose side effects were not as bad  as the first shot; Red Left Arm  from Shoulder to Forearm 2 weeks after 2nd primary dose; Less painful left arm injection site 2 weeks after 2nd primary dose; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (Less severe COVID Arm (Left Arm) again 2 weeks after 2nd primary dose/2nd primary dose side effects were not as bad  as the first shot), VACCINATION SITE ERYTHEMA (Red Left Arm  from Shoulder to Forearm 2 weeks after 2nd primary dose) and VACCINATION SITE PAIN (Less painful left arm injection site 2 weeks after 2nd primary dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE REACTION (Less severe COVID Arm (Left Arm) again 2 weeks after 2nd primary dose/2nd primary dose side effects were not as bad  as the first shot), VACCINATION SITE ERYTHEMA (Red Left Arm  from Shoulder to Forearm 2 weeks after 2nd primary dose) and VACCINATION SITE PAIN (Less painful left arm injection site 2 weeks after 2nd primary dose). On 21-Feb-2021, VACCINATION SITE REACTION (Less severe COVID Arm (Left Arm) again 2 weeks after 2nd primary dose/2nd primary dose side effects were not as bad  as the first shot), VACCINATION SITE ERYTHEMA (Red Left Arm  from Shoulder to Forearm 2 weeks after 2nd primary dose) and VACCINATION SITE PAIN (Less painful left arm injection site 2 weeks after 2nd primary dose) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-664781, MOD-2022-664771 (Patient Link).
Sex: F
Vaccine: COVID19-2
Symptoms: Influenza like illness
Clinical narrative: Nurse whom gave her the bivalent Covid-19 Moderna booster reported that she had flu like symptoms after receiving the Moderna bivalent vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Nurse whom gave her the bivalent Covid-19 Moderna booster reported that she had flu like symptoms after receiving the Moderna bivalent vaccine.) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Nurse whom gave her the bivalent Covid-19 Moderna booster reported that she had flu like symptoms after receiving the Moderna bivalent vaccine.). At the time of the report, INFLUENZA LIKE ILLNESS (Nurse whom gave her the bivalent Covid-19 Moderna booster reported that she had flu like symptoms after receiving the Moderna bivalent vaccine.) outcome was unknown.            No concomitant medications were reported.  No treatment details were reported.   Reporter did not allow further contact
Age: 100.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; Received 2 Bivalent booster doses, in 1 month/2nd Bivalent booster dose was administered 21 days after the first bivalent booster by mistake; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (Received 2 Bivalent booster doses, in 1 month/2nd Bivalent booster dose was administered 21 days after the first bivalent booster by mistake) and NO ADVERSE EVENT (No adverse event) in a 100-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 055F22B and AS7147B) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Oct-2022, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2022, the patient experienced EXTRA DOSE ADMINISTERED (Received 2 Bivalent booster doses, in 1 month/2nd Bivalent booster dose was administered 21 days after the first bivalent booster by mistake). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Received 2 Bivalent booster doses, in 1 month/2nd Bivalent booster dose was administered 21 days after the first bivalent booster by mistake) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Received 2 Bivalent booster doses, in 1 month/2nd Bivalent booster dose was administered 21 days after the first bivalent booster by mistake).    Concomitant medications were not reported. Patient had 4 Monovalent shots previously, 2 Primary and 2 boosters. Patient did not have the Monovalent shot information handy, but the last Monovalent booster was administered more than 3 months ago. No treatment information was provided by the reporter. The patient received a 2nd Bivalent dose by mistake on 26-Oct-2022.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received first dose on 04-Feb-2021 and second dose on 14-Mar-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 04-Feb-2021 and second dose on 14-Mar-2021) and NO ADVERSE EVENT (No adverse event) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A, 029L20A, 939903 and 005M2A9) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Ibuprofen (Sulfa Ibuprofen). Past adverse reactions to the above products included Allergy with Ibuprofen. Concurrent medical conditions included Asthma, Allergy (Allergies) and Solitary kidney (one kidney). Concomitant products included MELOXICAM from 01-Jan-2021 to an unknown date for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 04-Feb-2021 and second dose on 14-Mar-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 04-Feb-2021 and second dose on 14-Mar-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Currently the patient is of 76 years.  The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  No treatment information was reported.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Sluggishness
Clinical narrative: Moderna vaccine dose 1: 12 Mar 2021 , Dose 2: 19 Apr 2021,; sluggishness; This spontaneous case was reported by a patient and describes the occurrence of SLUGGISHNESS (sluggishness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna vaccine dose 1: 12 Mar 2021 , Dose 2: 19 Apr 2021,) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced SLUGGISHNESS (sluggishness). On 19-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna vaccine dose 1: 12 Mar 2021 , Dose 2: 19 Apr 2021,). In April 2021, SLUGGISHNESS (sluggishness) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna vaccine dose 1: 12 Mar 2021 , Dose 2: 19 Apr 2021,) outcome was unknown.            No concomitant medications were reported.  Reported that she had normal sluggishness for a few hours after the Moderna Vaccines  No treatment medications were reported.   This case was linked to MOD-2022-664518 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sluggishness
Clinical narrative: Moderna vaccine dose 1: 12 Mar 2021 , Dose 2: 19 Apr 2021,; sluggishness; This spontaneous case was reported by a patient and describes the occurrence of SLUGGISHNESS (sluggishness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna vaccine dose 1: 12 Mar 2021 , Dose 2: 19 Apr 2021,) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced SLUGGISHNESS (sluggishness). On 19-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna vaccine dose 1: 12 Mar 2021 , Dose 2: 19 Apr 2021,). In April 2021, SLUGGISHNESS (sluggishness) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna vaccine dose 1: 12 Mar 2021 , Dose 2: 19 Apr 2021,) outcome was unknown.            No concomitant medications were reported.  Reported that she had normal sluggishness for a few hours after the Moderna Vaccines  No treatment medications were reported.   This case was linked to MOD-2022-664518 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse event; Patient had taken first dose on 03-JAN-2022 and second dose on 22-MAY-2022.; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had taken first dose on 03-JAN-2022 and second dose on 22-MAY-2022.) and NO ADVERSE EVENT (No Adverse event) in a 53-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 033C21A and 013H21B) for COVID-19 prophylaxis.     Concurrent medical conditions included RA and Sulfonamide allergy.   On 03-Jan-2022 at 9:00 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-May-2022 at 2:00 PM, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 22-May-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had taken first dose on 03-JAN-2022 and second dose on 22-MAY-2022.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had taken first dose on 03-JAN-2022 and second dose on 22-MAY-2022.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Necrotising myositis
Clinical narrative: Delayed localized necrotizing inflammatory myositis; This literature-non-study case was reported in a literature article and describes the occurrence of NECROTISING MYOSITIS (Delayed localized necrotizing inflammatory myositis) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE.     No Medical History information was reported.  On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECROTISING MYOSITIS (Delayed localized necrotizing inflammatory myositis) (seriousness criterion medically significant). At the time of the report, NECROTISING MYOSITIS (Delayed localized necrotizing inflammatory myositis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: confirmed delayed inflammatory myositis.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  This report described the presentation and successful treatment of delayed localized necrotizing inflammatory myositis following a third dose of the mRNA-1273 SARS-CoV-2 vaccine.  Company comment: This literature non study case concerns a 64-year-old, male patient with no medical history information reported, who experienced the unexpected serious (medically significant) event of necrotizing myositis. The event occurred on an unknown date after the third dose of mRNA-1273. As reported, patient had delayed localized necrotizing inflammatory myositis which was confirmed by biopsy. No further information about the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This literature non study case concerns a 64-year-old, male patient with no medical history information reported, who experienced the unexpected serious (medically significant) event of necrotizing myositis. The event occurred on an unknown date after the third dose of mRNA-1273. As reported, patient had delayed localized necrotizing inflammatory myositis which was confirmed by biopsy. No further information about the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; First dose-24-12-2020/ Second dose-14-01-21; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose-24-12-2020/ Second dose-14-01-21) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and LOSARTAN for an unknown indication.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose-24-12-2020/ Second dose-14-01-21). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose-24-12-2020/ Second dose-14-01-21) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose-24-12-2020/ Second dose-14-01-21).    Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2022-662495 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: Immunisation reaction, Insomnia, Pain
Clinical narrative: a very bad thing on body and not ok; suffering in pain; Did not sleep; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (a very bad thing on body and not ok), PAIN (suffering in pain) and INSOMNIA (Did not sleep) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced IMMUNISATION REACTION (a very bad thing on body and not ok), PAIN (suffering in pain) and INSOMNIA (Did not sleep). At the time of the report, IMMUNISATION REACTION (a very bad thing on body and not ok), PAIN (suffering in pain) and INSOMNIA (Did not sleep) outcome was unknown.            No concomitant medications were reported.  Patient received the bivalent booster dose on 26-Oct-2022 and reported to had very bad thing on body and not ok. Patient did not sleep also had suffered in pain.  No treatment information was reported.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received a double dose of the Moderna COVID19 vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (received a double dose of the Moderna COVID19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (received a double dose of the Moderna COVID19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (received a double dose of the Moderna COVID19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (received a double dose of the Moderna COVID19 vaccine).    Concomitant drugs were not reported. It was reported that the reporter's daughter received a double dose of the Moderna COVID-19 vaccine. Treatment medications were not provided.   Reporter did not allow further contact