chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) 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 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown. Not Provided    No concomitant medication was provided. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-114251 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114251:MOD21-088160
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: swollen at injection site; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen at injection site) and VACCINATION SITE ERYTHEMA (redness at injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038821A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE SWELLING (swollen at injection site) and VACCINATION SITE ERYTHEMA (redness at injection site). On 27-Mar-2021, VACCINATION SITE SWELLING (swollen at injection site) and VACCINATION SITE ERYTHEMA (redness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications were provided. No treatment information was provided.   This case was linked to MOD21-088140, US-MODERNATX, INC.-MOD-2021-114482 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Updated events of dose 1.; Sender's Comments:  MOD21-088140: US-MODERNATX, INC.-MOD-2021-114482:Dose 2
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-114386, MOD-2021-114386 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Diarrhoea, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Diarrhea; Stomach ache; Second dose given on day 37; Fever, 39°C; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach ache), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 37) and PYREXIA (Fever, 39°C) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 37) and PYREXIA (Fever, 39°C). On 07-May-2021, the patient experienced DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Stomach ache). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 05-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 37) had resolved. On 07-May-2021, PYREXIA (Fever, 39°C) had resolved. At the time of the report, DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Stomach ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Body temperature: 39 (abnormal) fever of 39°C.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.   This case was linked to MOD-2021-114377 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site hypoaesthesia
Clinical narrative: numbness in the left arm/numbness that comes and goes and it runs through her entire left arm but is more pronounced at injection side; excruciating arm pain/left arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HYPOAESTHESIA (numbness in the left arm/numbness that comes and goes and it runs through her entire left arm but is more pronounced at injection side) and PAIN IN EXTREMITY (excruciating arm pain/left arm pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 004M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for Hypothyroidism.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (excruciating arm pain/left arm pain). On 13-Feb-2021, the patient experienced VACCINATION SITE HYPOAESTHESIA (numbness in the left arm/numbness that comes and goes and it runs through her entire left arm but is more pronounced at injection side). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of UNK dosage form, prn. On 07-Mar-2021, PAIN IN EXTREMITY (excruciating arm pain/left arm pain) was resolving. At the time of the report, VACCINATION SITE HYPOAESTHESIA (numbness in the left arm/numbness that comes and goes and it runs through her entire left arm but is more pronounced at injection side) had not resolved. Unknown          The patient was never been diagnosed with/ tested positive for COVID-19.   Patient reported that her left arm has gotten much better, she was able to move it now without excruciating pain and she reported pain now was very subtle and she could almost lift her arm over her head. The patient reported that there was still residual effect of sore arm.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: significant follow up received on 08-JUN-2021, Patient demographics updated, concomitant medication updated, out come of event was recovered. On 24-Jul-2021: Significant follow up/outcome updated to recovering. Event term and onset date updated to excruciating arm pain/left arm pain. Clinical course updated.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Mass, Myalgia, Pain, Pruritus
Clinical narrative: pain; itch; bumps on the back; chills; body aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of MASS (bumps on the back), PAIN (pain), PRURITUS (itch), CHILLS (chills) and MYALGIA (body aches) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced CHILLS (chills), MYALGIA (body aches) and PYREXIA (fever). On 03-May-2021, the patient experienced MASS (bumps on the back) and PRURITUS (itch). On an unknown date, the patient experienced PAIN (pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-May-2021, CHILLS (chills), MYALGIA (body aches) and PYREXIA (fever) had resolved. At the time of the report, MASS (bumps on the back), PAIN (pain) and PRURITUS (itch) outcome was unknown.            No concomitant product use was reported
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: pain; itch; bumps on the back; chills; body aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of MASS (bumps on the back), PAIN (pain), PRURITUS (itch), CHILLS (chills) and MYALGIA (body aches) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced CHILLS (chills), MYALGIA (body aches) and PYREXIA (fever). On 03-May-2021, the patient experienced MASS (bumps on the back) and PRURITUS (itch). On an unknown date, the patient experienced PAIN (pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-May-2021, CHILLS (chills), MYALGIA (body aches) and PYREXIA (fever) had resolved. At the time of the report, MASS (bumps on the back), PAIN (pain) and PRURITUS (itch) outcome was unknown.            No concomitant product use was reported
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis acneiform, Rash pruritic
Clinical narrative: Itching of rash; Little patches like pimple size on body/ arms, legs, torso, neck; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itching of rash) and DERMATITIS ACNEIFORM (Little patches like pimple size on body/ arms, legs, torso, neck) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced RASH PRURITIC (Itching of rash) and DERMATITIS ACNEIFORM (Little patches like pimple size on body/ arms, legs, torso, neck). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Itching of rash) and DERMATITIS ACNEIFORM (Little patches like pimple size on body/ arms, legs, torso, neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-114381 (Patient Link).
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose not received in allowed time window; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose not received in allowed time window) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose not received in allowed time window). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose not received in allowed time window) outcome was unknown. Not Provided      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.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: He has pain around injection site; Last night, He noticed swelling around injection site on left arm/This morning it swelled up; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Last night, He noticed swelling around injection site on left arm/This morning it swelled up) and VACCINATION SITE PAIN (He has pain around injection site) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced VACCINATION SITE SWELLING (Last night, He noticed swelling around injection site on left arm/This morning it swelled up). On 07-May-2021, the patient experienced VACCINATION SITE PAIN (He has pain around injection site). At the time of the report, VACCINATION SITE SWELLING (Last night, He noticed swelling around injection site on left arm/This morning it swelled up) and VACCINATION SITE PAIN (He has pain around injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications include BP medicine, heart medicine, Diabetes medicine. The Treatment information was not provided.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Joint pain; Fatigue; Muscle pain; Nausea; Headache; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), FATIGUE (Fatigue), MYALGIA (Muscle pain), NAUSEA (Nausea) and HEADACHE (Headache) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced ARTHRALGIA (Joint pain), FATIGUE (Fatigue), MYALGIA (Muscle pain), NAUSEA (Nausea), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, ARTHRALGIA (Joint pain), FATIGUE (Fatigue), MYALGIA (Muscle pain), NAUSEA (Nausea), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) had not resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Treatment information was not provided.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Joint pain; Fatigue; Muscle pain; Nausea; Headache; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), FATIGUE (Fatigue), MYALGIA (Muscle pain), NAUSEA (Nausea) and HEADACHE (Headache) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced ARTHRALGIA (Joint pain), FATIGUE (Fatigue), MYALGIA (Muscle pain), NAUSEA (Nausea), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, ARTHRALGIA (Joint pain), FATIGUE (Fatigue), MYALGIA (Muscle pain), NAUSEA (Nausea), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) had not resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart racing; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart racing) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014L21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PALPITATIONS (Heart racing). At the time of the report, PALPITATIONS (Heart racing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Feeling abnormal, Gait disturbance, Headache, Pain in extremity
Clinical narrative: normal pain in arm after the vaccine; lower back and down there is in pain; walking is difficult.; feel something weird after the vaccine; my legs bothered me after the vaccine; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (normal pain in arm after the vaccine), BACK PAIN (lower back and down there is in pain), GAIT DISTURBANCE (walking is difficult.), FEELING ABNORMAL (feel something weird after the vaccine) and PAIN IN EXTREMITY (my legs bothered me after the vaccine) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PAIN IN EXTREMITY (normal pain in arm after the vaccine), BACK PAIN (lower back and down there is in pain), GAIT DISTURBANCE (walking is difficult.), FEELING ABNORMAL (feel something weird after the vaccine), PAIN IN EXTREMITY (my legs bothered me after the vaccine) and HEADACHE (headache). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pain, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (normal pain in arm after the vaccine), BACK PAIN (lower back and down there is in pain), GAIT DISTURBANCE (walking is difficult.), FEELING ABNORMAL (feel something weird after the vaccine), PAIN IN EXTREMITY (my legs bothered me after the vaccine) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medication was provided.   This case was linked to MOD-2021-213975 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow-up information received which contains dose 2 events.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Chills, Dizziness, Pyrexia
Clinical narrative: Shaking; chest pain; dizzy; Fever of 103 degrees; chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), CHEST PAIN (chest pain), DIZZINESS (dizzy), PYREXIA (Fever of 103 degrees) and CHILLS (chills) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Depression, Cholesterol and Heart disease, unspecified. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced TREMOR (Shaking), CHEST PAIN (chest pain), DIZZINESS (dizzy), PYREXIA (Fever of 103 degrees) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TREMOR (Shaking), CHEST PAIN (chest pain), DIZZINESS (dizzy), PYREXIA (Fever of 103 degrees) and CHILLS (chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2021, Body temperature: 103 (abnormal) Fever of 103 degrees.     Concomitant products included Heart medication, Cholesterol medication.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Shaking; chest pain; dizzy; Fever of 103 degrees; chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), CHEST PAIN (chest pain), DIZZINESS (dizzy), PYREXIA (Fever of 103 degrees) and CHILLS (chills) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Depression, Cholesterol and Heart disease, unspecified. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced TREMOR (Shaking), CHEST PAIN (chest pain), DIZZINESS (dizzy), PYREXIA (Fever of 103 degrees) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TREMOR (Shaking), CHEST PAIN (chest pain), DIZZINESS (dizzy), PYREXIA (Fever of 103 degrees) and CHILLS (chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2021, Body temperature: 103 (abnormal) Fever of 103 degrees.     Concomitant products included Heart medication, Cholesterol medication.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Tonsillar hypertrophy
Clinical narrative: swollen tonsils; Sore arm; 100.9 degrees Fahrenheit/low grade fever of 99.7 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of TONSILLAR HYPERTROPHY (swollen tonsils), PAIN IN EXTREMITY (Sore arm) and PYREXIA (100.9 degrees Fahrenheit/low grade fever of 99.7 degrees Fahrenheit) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 045B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VERAPAMIL, METOPROLOL and PANTOPRAZOLE for an unknown indication.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced TONSILLAR HYPERTROPHY (swollen tonsils), PAIN IN EXTREMITY (Sore arm) and PYREXIA (100.9 degrees Fahrenheit/low grade fever of 99.7 degrees Fahrenheit). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TONSILLAR HYPERTROPHY (swollen tonsils), PAIN IN EXTREMITY (Sore arm) and PYREXIA (100.9 degrees Fahrenheit/low grade fever of 99.7 degrees Fahrenheit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itched; Arm swelled up quite a lot into a 4" across area; burned; It was a little red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itched), VACCINATION SITE ERYTHEMA (It was a little red), VACCINATION SITE SWELLING (Arm swelled up quite a lot into a 4" across area) and VACCINATION SITE PAIN (burned) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (It was a little red). On 14-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itched), VACCINATION SITE SWELLING (Arm swelled up quite a lot into a 4" across area) and VACCINATION SITE PAIN (burned). On 16-Apr-2021, VACCINATION SITE PRURITUS (itched), VACCINATION SITE ERYTHEMA (It was a little red), VACCINATION SITE SWELLING (Arm swelled up quite a lot into a 4" across area) and VACCINATION SITE PAIN (burned) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.   This case was linked to MOD-2021-114410 (Patient Link).
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Oropharyngeal pain, Periorbital swelling, Wheezing
Clinical narrative: sore throat; puffy eyes; wheezing; adverse reaction; This spontaneous case was reported by a patient family member or friend and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), PERIORBITAL SWELLING (puffy eyes), WHEEZING (wheezing) and ADVERSE REACTION (adverse reaction) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patient's past medical history included Anaphylactic reaction (when she was 9 yr old but could not determine why she had that.) since an unknown date. Concurrent medical conditions included Seasonal allergy and Asthma.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), PERIORBITAL SWELLING (puffy eyes), WHEEZING (wheezing) and ADVERSE REACTION (adverse reaction). The patient was treated with CETIRIZINE HYDROCHLORIDE (CETRIZINE) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat), PERIORBITAL SWELLING (puffy eyes), WHEEZING (wheezing) and ADVERSE REACTION (adverse reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Motion sickness, Myalgia, Nausea, Oropharyngeal pain
Clinical narrative: motion sickness; flue like symptoms; clear drainage coming from her nose; sore throat; body ache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MOTION SICKNESS (motion sickness), INFLUENZA LIKE ILLNESS (flue like symptoms), RHINORRHOEA (clear drainage coming from her nose), OROPHARYNGEAL PAIN (sore throat) and MYALGIA (body ache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced MOTION SICKNESS (motion sickness), INFLUENZA LIKE ILLNESS (flue like symptoms), RHINORRHOEA (clear drainage coming from her nose), OROPHARYNGEAL PAIN (sore throat), MYALGIA (body ache) and NAUSEA (nausea). On 08-May-2021, OROPHARYNGEAL PAIN (sore throat) had resolved. At the time of the report, MOTION SICKNESS (motion sickness), INFLUENZA LIKE ILLNESS (flue like symptoms), RHINORRHOEA (clear drainage coming from her nose), MYALGIA (body ache) and NAUSEA (nausea) outcome was unknown.      No concomitant and treatment details were provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: motion sickness; flue like symptoms; clear drainage coming from her nose; sore throat; body ache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MOTION SICKNESS (motion sickness), INFLUENZA LIKE ILLNESS (flue like symptoms), RHINORRHOEA (clear drainage coming from her nose), OROPHARYNGEAL PAIN (sore throat) and MYALGIA (body ache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced MOTION SICKNESS (motion sickness), INFLUENZA LIKE ILLNESS (flue like symptoms), RHINORRHOEA (clear drainage coming from her nose), OROPHARYNGEAL PAIN (sore throat), MYALGIA (body ache) and NAUSEA (nausea). On 08-May-2021, OROPHARYNGEAL PAIN (sore throat) had resolved. At the time of the report, MOTION SICKNESS (motion sickness), INFLUENZA LIKE ILLNESS (flue like symptoms), RHINORRHOEA (clear drainage coming from her nose), MYALGIA (body ache) and NAUSEA (nausea) outcome was unknown.      No concomitant and treatment details were provided.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Hot flush, Pain in extremity, Paraesthesia
Clinical narrative: knot in the stomach; Puking; Diarrhea; Hot flash from waist down to the upper thighs; Patient decided not to get second dose; Tingling of fingers; soreness of the left arm; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (knot in the stomach), VOMITING (Puking), DIARRHOEA (Diarrhea), HOT FLUSH (Hot flash from waist down to the upper thighs) and PARAESTHESIA (Tingling of fingers) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced PARAESTHESIA (Tingling of fingers) and PAIN IN EXTREMITY (soreness of the left arm). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (knot in the stomach), VOMITING (Puking), DIARRHOEA (Diarrhea), HOT FLUSH (Hot flash from waist down to the upper thighs) and PRODUCT DOSE OMISSION ISSUE (Patient decided not to get second dose). On 28-Mar-2021, PARAESTHESIA (Tingling of fingers) had resolved. On 03-Apr-2021, PAIN IN EXTREMITY (soreness of the left arm) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (knot in the stomach), VOMITING (Puking), DIARRHOEA (Diarrhea), HOT FLUSH (Hot flash from waist down to the upper thighs) and PRODUCT DOSE OMISSION ISSUE (Patient decided not to get second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Vomiting
Clinical narrative: knot in the stomach; Puking; Diarrhea; Hot flash from waist down to the upper thighs; Patient decided not to get second dose; Tingling of fingers; soreness of the left arm; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (knot in the stomach), VOMITING (Puking), DIARRHOEA (Diarrhea), HOT FLUSH (Hot flash from waist down to the upper thighs) and PARAESTHESIA (Tingling of fingers) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced PARAESTHESIA (Tingling of fingers) and PAIN IN EXTREMITY (soreness of the left arm). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (knot in the stomach), VOMITING (Puking), DIARRHOEA (Diarrhea), HOT FLUSH (Hot flash from waist down to the upper thighs) and PRODUCT DOSE OMISSION ISSUE (Patient decided not to get second dose). On 28-Mar-2021, PARAESTHESIA (Tingling of fingers) had resolved. On 03-Apr-2021, PAIN IN EXTREMITY (soreness of the left arm) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (knot in the stomach), VOMITING (Puking), DIARRHOEA (Diarrhea), HOT FLUSH (Hot flash from waist down to the upper thighs) and PRODUCT DOSE OMISSION ISSUE (Patient decided not to get second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pain
Clinical narrative: hot rash at the injection site; hardness at the injection site; swelling at the injection site; red rash at the injection site; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (hot rash at the injection site), PAIN (sore arm), INJECTION SITE INDURATION (hardness at the injection site), INJECTION SITE SWELLING (swelling at the injection site) and INJECTION SITE ERYTHEMA (red rash at the injection site) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced PAIN (sore arm). On 07-May-2021, the patient experienced INJECTION SITE WARMTH (hot rash at the injection site), INJECTION SITE INDURATION (hardness at the injection site), INJECTION SITE SWELLING (swelling at the injection site) and INJECTION SITE ERYTHEMA (red rash at the injection site). On 03-May-2021, PAIN (sore arm) had resolved. At the time of the report, INJECTION SITE WARMTH (hot rash at the injection site), INJECTION SITE INDURATION (hardness at the injection site), INJECTION SITE SWELLING (swelling at the injection site) and INJECTION SITE ERYTHEMA (red rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Product dose omission issue, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: She can't get the second dose until 26Jun2021 or later; positive COVID results; felt off; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (She can't get the second dose until 26Jun2021 or later), FEELING ABNORMAL (felt off) and SARS-COV-2 TEST POSITIVE (positive COVID results) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PREDNISONE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and LOSARTAN for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced FEELING ABNORMAL (felt off). On 26-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (positive COVID results). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She can't get the second dose until 26Jun2021 or later). At the time of the report, PRODUCT DOSE OMISSION ISSUE (She can't get the second dose until 26Jun2021 or later) had resolved and FEELING ABNORMAL (felt off) and SARS-COV-2 TEST POSITIVE (positive COVID results) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.   Treatment medication included Monoclonal Antibody Treatment for Covid 19. After being tested positive for COVID-19 she was started on monoclonal antibody treatment. She can't get the second dose until 26Jun2021 or later.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received and contains non significant information.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Hypertension, Oxygen saturation, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), HYPERTENSION (Hypertension aggravated), PAIN (Ache) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044b21a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Hypertension. Concomitant products included VALSARTAN (DIOVAN) for Hypertension.    On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced HYPERTENSION (Hypertension aggravated). On an unknown date, the patient experienced DYSPNOEA (difficulty breathing), PAIN (Ache) and PYREXIA (fever). The patient was treated with HYDROCHLOROTHIAZIDE on 07-May-2021 for Hypertension, at a dose of 12.5 milligram once a day. At the time of the report, DYSPNOEA (difficulty breathing), HYPERTENSION (Hypertension aggravated), PAIN (Ache) and PYREXIA (fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) within a week after the shot, increase was around 140-150s over 80-90s and 120/80 (normal) 120/80. On an unknown date, Oxygen saturation: 91-92 (Low) lasted several hours and then returned to normal..         The patient had not yet started treatment with hydrochlorothiazide.    This case was linked to MOD-2021-089262 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Reporter information was updated.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), HYPERTENSION (Hypertension aggravated), PAIN (Ache) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044b21a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Hypertension. Concomitant products included VALSARTAN (DIOVAN) for Hypertension.    On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced HYPERTENSION (Hypertension aggravated). On an unknown date, the patient experienced DYSPNOEA (difficulty breathing), PAIN (Ache) and PYREXIA (fever). The patient was treated with HYDROCHLOROTHIAZIDE on 07-May-2021 for Hypertension, at a dose of 12.5 milligram once a day. At the time of the report, DYSPNOEA (difficulty breathing), HYPERTENSION (Hypertension aggravated), PAIN (Ache) and PYREXIA (fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) within a week after the shot, increase was around 140-150s over 80-90s and 120/80 (normal) 120/80. On an unknown date, Oxygen saturation: 91-92 (Low) lasted several hours and then returned to normal..         The patient had not yet started treatment with hydrochlorothiazide.    This case was linked to MOD-2021-089262 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Reporter information was updated.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Discomfort, Feeling cold, Nausea
Clinical narrative: could hardly talk.; nausea; pain became extremely intense and terrible to tolerate/"the pain was like some one stabbing in my stomach multiple times"; weakness in my legs/weakness; I was freezing cold; I thought I might die,given the intensity of the discomfort.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN UPPER (pain became extremely intense and terrible to tolerate/"the pain was like some one stabbing in my stomach multiple times"), FEELING COLD (I was freezing cold), DISCOMFORT (I thought I might die,given the intensity of the discomfort.), ASTHENIA (weakness in my legs/weakness) and SPEECH DISORDER (could hardly talk.) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Aortic dissection on 10-Sep-2019. Previously administered products included for an unreported indication: STREPTOCOCCUS PNEUMONIAE and FLU. Concurrent medical conditions included Epilepsy (for 13 years.). Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN+HIDROCLOROTIAZIDA) and LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for an unknown indication.    On 05-May-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced FEELING COLD (I was freezing cold) and DISCOMFORT (I thought I might die,given the intensity of the discomfort.). On 07-May-2021, the patient experienced ABDOMINAL PAIN UPPER (pain became extremely intense and terrible to tolerate/"the pain was like some one stabbing in my stomach multiple times"), ASTHENIA (weakness in my legs/weakness) and NAUSEA (nausea). On an unknown date, the patient experienced SPEECH DISORDER (could hardly talk.). The patient was treated with PARACETAMOL (TYLENOL) (oral) on 08-May-2021 for Adverse event, at an unspecified dose and frequency. On 07-May-2021, DISCOMFORT (I thought I might die,given the intensity of the discomfort.) had resolved. On 23-May-2021, ASTHENIA (weakness in my legs/weakness) and NAUSEA (nausea) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (pain became extremely intense and terrible to tolerate/"the pain was like some one stabbing in my stomach multiple times"), FEELING COLD (I was freezing cold) and SPEECH DISORDER (could hardly talk.) 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.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow up includes patient demographics , event outcome updated On 22-Jul-2021: Follow up done. No new information received.