chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient did not receive the 2nd dose between 25-35 of the1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive the 2nd dose between 25-35 of the1st dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-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 (Patient did not receive the 2nd dose between 25-35 of the1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive the 2nd dose between 25-35 of the1st dose) 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 relevant concomitant medications reported.  No treatment information was provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Issued expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED  in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 042LA20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 24-Jul-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Patient details, facility details and dose 1 details updated.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Fatigue, Heart rate increased, Pruritus
Clinical narrative: itchy; redness; deeply very good sleep/sleeps extra; tired; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy), ERYTHEMA (redness), SOMNOLENCE (deeply very good sleep/sleeps extra) and FATIGUE (tired) in a 72-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.     Concomitant products included CALCIUM for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy), ERYTHEMA (redness), SOMNOLENCE (deeply very good sleep/sleeps extra) and FATIGUE (tired). The patient was treated with HYDROCORTISONE for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy), ERYTHEMA (redness), SOMNOLENCE (deeply very good sleep/sleeps extra) and FATIGUE (tired) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.4f (High) temperature was 98.4. On an unknown date, Heart rate increased: 80 (High) pulse was also high. evening it was 80..         Concomitant medication includes: Vitamins   This case was linked to MOD-2021-049559, MOD-2021-049579 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: itchy; redness; deeply very good sleep/sleeps extra; tired; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy), ERYTHEMA (redness), SOMNOLENCE (deeply very good sleep/sleeps extra) and FATIGUE (tired) in a 72-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.     Concomitant products included CALCIUM for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy), ERYTHEMA (redness), SOMNOLENCE (deeply very good sleep/sleeps extra) and FATIGUE (tired). The patient was treated with HYDROCORTISONE for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy), ERYTHEMA (redness), SOMNOLENCE (deeply very good sleep/sleeps extra) and FATIGUE (tired) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.4f (High) temperature was 98.4. On an unknown date, Heart rate increased: 80 (High) pulse was also high. evening it was 80..         Concomitant medication includes: Vitamins   This case was linked to MOD-2021-049559, MOD-2021-049579 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain, Vaccination site pruritus, Vaccination site reaction, Vaccination site urticaria
Clinical narrative: COVID arm; Itchy; Huge welt; Painful; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE URTICARIA (Huge welt), VACCINATION SITE PAIN (Painful) and FATIGUE (Fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CELECOXIB (CELEBREX) and GABAPENTIN for an unknown indication.    On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jul-2021, the patient experienced VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE URTICARIA (Huge welt), VACCINATION SITE PAIN (Painful) and FATIGUE (Fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 25-Jul-2021 at a dose of UNK dosage form. At the time of the report, VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE URTICARIA (Huge welt), VACCINATION SITE PAIN (Painful) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I got the first covid vaccine moderna 29 may 2021 and the second dose 24 july 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I got the first covid vaccine moderna 29 may 2021 and the second dose 24 july 2021) 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 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I got the first covid vaccine moderna 29 may 2021 and the second dose 24 july 2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I got the first covid vaccine moderna 29 may 2021 and the second dose 24 july 2021) had resolved.            No concomitant medications were reported.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient didn't receive second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient didn't receive second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-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 (Patient didn't receive second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient didn't receive second dose) 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.   The concomitant medications were not reported ? The treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jul-2021, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.            The patient broke out hives. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 High.         The patient was running a fever of 102 after receiving my second dose. No concomitant medications were reported. No treatment medications were reported
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Dyspnoea, Hyperhidrosis, Nausea
Clinical narrative: bruise down left arm; sweats; hives on her face down to torso and back; rash down left arm; fever; chills; nausea; shortness of breath; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jul-2021 and was forwarded to Moderna on 26-Jul-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of DYSPNOEA (shortness of breath), CONTUSION (bruise down left arm), HYPERHIDROSIS (sweats), URTICARIA (hives on her face down to torso and back) and RASH (rash down left arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (The patient had COVID in December 2020 or January 2021.).    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced DYSPNOEA (shortness of breath). On 24-Jul-2021, the patient experienced CONTUSION (bruise down left arm), HYPERHIDROSIS (sweats), URTICARIA (hives on her face down to torso and back), RASH (rash down left arm), PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at a dose of unknown. At the time of the report, DYSPNOEA (shortness of breath), HYPERHIDROSIS (sweats), PYREXIA (fever) and CHILLS (chills) outcome was unknown and CONTUSION (bruise down left arm), URTICARIA (hives on her face down to torso and back), RASH (rash down left arm) and NAUSEA (nausea) had not 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.   Concomitant product use was unknown by the reporter.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: bruise down left arm; sweats; hives on her face down to torso and back; rash down left arm; fever; chills; nausea; shortness of breath; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jul-2021 and was forwarded to Moderna on 26-Jul-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of DYSPNOEA (shortness of breath), CONTUSION (bruise down left arm), HYPERHIDROSIS (sweats), URTICARIA (hives on her face down to torso and back) and RASH (rash down left arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (The patient had COVID in December 2020 or January 2021.).    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced DYSPNOEA (shortness of breath). On 24-Jul-2021, the patient experienced CONTUSION (bruise down left arm), HYPERHIDROSIS (sweats), URTICARIA (hives on her face down to torso and back), RASH (rash down left arm), PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at a dose of unknown. At the time of the report, DYSPNOEA (shortness of breath), HYPERHIDROSIS (sweats), PYREXIA (fever) and CHILLS (chills) outcome was unknown and CONTUSION (bruise down left arm), URTICARIA (hives on her face down to torso and back), RASH (rash down left arm) and NAUSEA (nausea) had not 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.   Concomitant product use was unknown by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient did not receive the 2nd dose between 25-35 of the1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive the 2nd dose between 25-35 of the1st dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not receive the 2nd dose between 25-35 of the1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive the 2nd dose between 25-35 of the1st dose) 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 medication were reported. No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: his wife started feeling nauseous after the first dose of the Moderna COVID-19 vaccine taken earlier on the week; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (his wife started feeling nauseous after the first dose of the Moderna COVID-19 vaccine taken earlier on the week) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (his wife started feeling nauseous after the first dose of the Moderna COVID-19 vaccine taken earlier on the week). At the time of the report, NAUSEA (his wife started feeling nauseous after the first dose of the Moderna COVID-19 vaccine taken earlier on the week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient feeling nauseous after the first dose. No concomitant medications were reported. No treatment details were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate, Pain in extremity, Tachycardia
Clinical narrative: After 2nd shot  I now have three arms; Third arm hurts; Heart rate 450bpm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (After 2nd shot  I now have three arms), PAIN IN EXTREMITY (Third arm hurts) and TACHYCARDIA (Heart rate 450bpm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (After 2nd shot  I now have three arms), PAIN IN EXTREMITY (Third arm hurts) and TACHYCARDIA (Heart rate 450bpm). At the time of the report, FEELING ABNORMAL (After 2nd shot  I now have three arms), PAIN IN EXTREMITY (Third arm hurts) and TACHYCARDIA (Heart rate 450bpm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 450 (High) 450bpm.         No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling face
Clinical narrative: Face swelling; Face red; Face itchy; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face swelling), ERYTHEMA (Face red) and PRURITUS (Face itchy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Face swelling), ERYTHEMA (Face red) and PRURITUS (Face itchy). At the time of the report, SWELLING FACE (Face swelling), ERYTHEMA (Face red) and PRURITUS (Face itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's concomitant medications were not reported.   No treatment information was provided by the reporter.
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 female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 18-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) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  No corrective treatment was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Vaccination site rash
Clinical narrative: Chapped lips; Moderna rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHAPPED LIPS (Chapped lips) and VACCINATION SITE RASH (Moderna rash at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 025L20A) for COVID-19 vaccination.     Concomitant products included METOPROLOL, HYDROCHLOROTHIAZIDE, ATORVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], COLECALCIFEROL (VITAMIN D3), FISH OIL and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHAPPED LIPS (Chapped lips) and VACCINATION SITE RASH (Moderna rash at the injection site). At the time of the report, CHAPPED LIPS (Chapped lips) had not resolved and VACCINATION SITE RASH (Moderna rash at the injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication include Chapstick for patient lips
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Palpitations
Clinical narrative: Chest pain; Heart pounding; Difficulty breathing; This spontaneous case was reported by a nurse and describes the occurrence of CHEST PAIN (Chest pain), PALPITATIONS (Heart pounding) and DYSPNOEA (Difficulty breathing) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced CHEST PAIN (Chest pain), PALPITATIONS (Heart pounding) and DYSPNOEA (Difficulty breathing). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Chest pain), PALPITATIONS (Heart pounding) and DYSPNOEA (Difficulty breathing) 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.   The concomitant medications were not reported. The treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received and had no new information.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Disorientation, Flushing, Heart rate increased, Paraesthesia
Clinical narrative: felt a little disoriented; anxious; tingling in his left arm/tingling of the face from chin going upward/tingling on his chin; flushing of the face from chin going upward; face felt swollen; his heartbeat was rapid; tingling on his lower lip; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (felt a little disoriented), ANXIETY (anxious), PARAESTHESIA (tingling in his left arm/tingling of the face from chin going upward/tingling on his chin), FLUSHING (flushing of the face from chin going upward) and SWELLING FACE (face felt swollen) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol high and Allergic reaction (Red dye).    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced DISORIENTATION (felt a little disoriented), ANXIETY (anxious), PARAESTHESIA (tingling in his left arm/tingling of the face from chin going upward/tingling on his chin), FLUSHING (flushing of the face from chin going upward), SWELLING FACE (face felt swollen), HEART RATE INCREASED (his heartbeat was rapid) and PARAESTHESIA ORAL (tingling on his lower lip). On 22-Apr-2021, DISORIENTATION (felt a little disoriented) and ANXIETY (anxious) had resolved. On 23-Apr-2021, PARAESTHESIA (tingling in his left arm/tingling of the face from chin going upward/tingling on his chin), FLUSHING (flushing of the face from chin going upward), SWELLING FACE (face felt swollen) and HEART RATE INCREASED (his heartbeat was rapid) had resolved. At the time of the report, PARAESTHESIA ORAL (tingling on his lower lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Patient was advised Benadryl and Tylenol by the doctor, but the patient didn't take either.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral, Swelling face
Clinical narrative: felt a little disoriented; anxious; tingling in his left arm/tingling of the face from chin going upward/tingling on his chin; flushing of the face from chin going upward; face felt swollen; his heartbeat was rapid; tingling on his lower lip; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (felt a little disoriented), ANXIETY (anxious), PARAESTHESIA (tingling in his left arm/tingling of the face from chin going upward/tingling on his chin), FLUSHING (flushing of the face from chin going upward) and SWELLING FACE (face felt swollen) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol high and Allergic reaction (Red dye).    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced DISORIENTATION (felt a little disoriented), ANXIETY (anxious), PARAESTHESIA (tingling in his left arm/tingling of the face from chin going upward/tingling on his chin), FLUSHING (flushing of the face from chin going upward), SWELLING FACE (face felt swollen), HEART RATE INCREASED (his heartbeat was rapid) and PARAESTHESIA ORAL (tingling on his lower lip). On 22-Apr-2021, DISORIENTATION (felt a little disoriented) and ANXIETY (anxious) had resolved. On 23-Apr-2021, PARAESTHESIA (tingling in his left arm/tingling of the face from chin going upward/tingling on his chin), FLUSHING (flushing of the face from chin going upward), SWELLING FACE (face felt swollen) and HEART RATE INCREASED (his heartbeat was rapid) had resolved. At the time of the report, PARAESTHESIA ORAL (tingling on his lower lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Patient was advised Benadryl and Tylenol by the doctor, but the patient didn't take either.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia, Tremor
Clinical narrative: chills were so bad that she couldn't hold anything because her hands were shaking so bad; chills were so bad that she couldn't hold anything because her hands were shaking so bad; fever of 101.8; bad headache; felt nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills were so bad that she couldn't hold anything because her hands were shaking so bad), TREMOR (chills were so bad that she couldn't hold anything because her hands were shaking so bad), PYREXIA (fever of 101.8), HEADACHE (bad headache) and NAUSEA (felt nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2021, the patient experienced CHILLS (chills were so bad that she couldn't hold anything because her hands were shaking so bad), TREMOR (chills were so bad that she couldn't hold anything because her hands were shaking so bad), PYREXIA (fever of 101.8), HEADACHE (bad headache) and NAUSEA (felt nausea). On 26-Jul-2021, CHILLS (chills were so bad that she couldn't hold anything because her hands were shaking so bad), TREMOR (chills were so bad that she couldn't hold anything because her hands were shaking so bad), HEADACHE (bad headache) and NAUSEA (felt nausea) had resolved and PYREXIA (fever of 101.8) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jul-2021, Pyrexia: 101.8 (High) 101.8.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided. Upon in internal review on 04-Aug-2021, the age was corrected to 69 years
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: How long can the delay be on the side effects; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jul-2021 and was forwarded to Moderna on 26-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (How long can the delay be on the side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (How long can the delay be on the side effects). At the time of the report, VACCINATION COMPLICATION (How long can the delay be on the side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.  No treatment information was provided
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: received the vaccine two months ago. You know get tested and the results are positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (received the vaccine two months ago. You know get tested and the results are positive) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (received the vaccine two months ago. You know get tested and the results are positive). At the time of the report, SARS-COV-2 TEST POSITIVE (received the vaccine two months ago. You know get tested and the results are positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: abnormal (Positive) Tested and the results are positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.    Reporter did not allow further contact
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity, SARS-CoV-2 test
Clinical narrative: having diarrhea every single day/loose stool once in a while/still experiencing diarrhea; soreness in her left arm for two to three days; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (having diarrhea every single day/loose stool once in a while/still experiencing diarrhea) and PAIN IN EXTREMITY (soreness in her left arm for two to three days) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002CIA) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced PAIN IN EXTREMITY (soreness in her left arm for two to three days). On 16-Jul-2021, the patient experienced DIARRHOEA (having diarrhea every single day/loose stool once in a while/still experiencing diarrhea). At the time of the report, DIARRHOEA (having diarrhea every single day/loose stool once in a while/still experiencing diarrhea) and PAIN IN EXTREMITY (soreness in her left arm for two to three days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient has not taken any medications for her side effects. No concomitant medication was provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Non-Significant Follow up: No new information.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Vaccination site pruritus, Vaccination site scar, Vaccination site vesicles
Clinical narrative: Little blisters break out around the punctured site; The Darker spot is the injection point; He was weak as a kitten for about 2 days; The injection site was itchy; Totally exhausted; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE VESICLES (Little blisters break out around the punctured site), VACCINATION SITE SCAR (The Darker spot is the injection point), ASTHENIA (He was weak as a kitten for about 2 days), VACCINATION SITE PRURITUS (The injection site was itchy) and FATIGUE (Totally exhausted) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 011021A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, High cholesterol and Enlarged prostate. Concomitant products included SIMVASTATIN, HYDROCHLOROTHIAZIDE, DOXAZOSIN, FAMOTIDINE, ASCORBIC ACID, CALCIUM PHOSPHATE, LACTOBACILLUS NOS, VACCINIUM MACROCARPON (AZO CRANBERRY), POTASSIUM, VITAMIN C [ASCORBIC ACID], MULTIVITAMINS [VITAMINS NOS] and CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE (OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]) for an unknown indication, CURCUMA LONGA RHIZOME (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]).   On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jul-2021, the patient experienced VACCINATION SITE SCAR (The Darker spot is the injection point), ASTHENIA (He was weak as a kitten for about 2 days), VACCINATION SITE PRURITUS (The injection site was itchy) and FATIGUE (Totally exhausted). On 26-Jul-2021, the patient experienced VACCINATION SITE VESICLES (Little blisters break out around the punctured site). At the time of the report, VACCINATION SITE VESICLES (Little blisters break out around the punctured site), VACCINATION SITE SCAR (The Darker spot is the injection point), ASTHENIA (He was weak as a kitten for about 2 days) and FATIGUE (Totally exhausted) had resolved and VACCINATION SITE PRURITUS (The injection site was itchy) had not resolved.            It was reported that the punctured site was still visible. The patient was on the couch all weekend. The injection site was still itching. The patient did not receive any treatment medications.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Significant Follow-up contained new events Darker spot is the injection point and He was weak as a kitten for about 2 days. Patient DOB updated.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Product dose omission issue, Vaccination site pain
Clinical narrative: Greater than 35 days since the first Moderna covid-19 vaccine dose; sore throat; sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since the first Moderna covid-19 vaccine dose), OROPHARYNGEAL PAIN (sore throat) and VACCINATION SITE PAIN (sore injection site arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-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 (Greater than 35 days since the first Moderna covid-19 vaccine dose), OROPHARYNGEAL PAIN (sore throat) and VACCINATION SITE PAIN (sore injection site arm). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since the first Moderna covid-19 vaccine dose) had resolved and OROPHARYNGEAL PAIN (sore throat) and VACCINATION SITE PAIN (sore injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received contains non-significant information.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Contracted new strain of covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted new strain of covid) in an adult female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Contracted new strain of covid). At the time of the report, COVID-19 (Contracted new strain of covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case involves a patient of age in 20's. Concomitant product use was not provided by the reporter.   No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: Never received the second dose; Diagnosed with COVID-19 7 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID-19 7 days after the first dose) and PRODUCT DOSE OMISSION ISSUE (Never received the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced COVID-19 (Diagnosed with COVID-19 7 days after the first dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Never received the second dose). At the time of the report, COVID-19 (Diagnosed with COVID-19 7 days after the first dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Never received the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.            No concomitant medications were reported.   No treatment information was provided.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Mass, Pain
Clinical narrative: I grew like a little bump on the bottom of the armpit, closer to the side of my heart.; It hurts when  moving; Hot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot), MASS (I grew like a little bump on the bottom of the armpit, closer to the side of my heart.) and PAIN (It hurts when  moving) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, the patient experienced FEELING HOT (Hot). On 25-Jul-2021, the patient experienced MASS (I grew like a little bump on the bottom of the armpit, closer to the side of my heart.) and PAIN (It hurts when  moving). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING HOT (Hot), MASS (I grew like a little bump on the bottom of the armpit, closer to the side of my heart.) and PAIN (It hurts when  moving) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Was supposed to receive second dose on 23JUL2021, but the home health nurse never came to give him that vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Was supposed to receive second dose on 23JUL2021, but the home health nurse never came to give him that vaccine) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Was supposed to receive second dose on 23JUL2021, but the home health nurse never came to give him that vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Was supposed to receive second dose on 23JUL2021, but the home health nurse never came to give him that vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose given after expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose given after expiration date) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (dose given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: vials that underwent temperature excursion administered to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vials that underwent temperature excursion administered to patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vials that underwent temperature excursion administered to patients). On 16-Mar-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (vials that underwent temperature excursion administered to patients) 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 provided by the reporter. No Treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: She did not receive the second dose yet,  It's been about 7 months; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jul-2021 and was forwarded to Moderna on 26-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (She did not receive the second dose yet,  It's been about 7 months) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (She did not receive the second dose yet,  It's been about 7 months). In January 2021, PRODUCT DOSE OMISSION ISSUE (She did not receive the second dose yet,  It's been about 7 months) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information has provided.   Reporter did not allow further contact