chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Loss of personal independence in daily activities, Pain, Pyrexia, Sinusitis
Clinical narrative: Sinus infection; Attention deficit hyperactivity disorder; Problems in walking; Felt like garbage; Problems in washing or dressin/Some problems with performing usual activities; Pain/Aches; Discomfort; Back pain; Chills; Fever; This spontaneous case was reported by a physician and describes the occurrence of SINUSITIS (Sinus infection), ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit hyperactivity disorder), GAIT DISTURBANCE (Problems in walking), FEELING ABNORMAL (Felt like garbage) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Problems in washing or dressin/Some problems with performing usual activities) in a 21-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.     The patient's past medical history included Vitamin D deficiency in August 2020, Ankylosing spondylitis and Shortness of breath. Concurrent medical conditions included Depression, Anxiety, Anemia, Asthma, Cough and Rheumatoid arthritis. Concomitant products included ADALIMUMAB (HUMIRA) from 12-Jan-2021 to 26-Jan-2021 for Ankylosing spondylitis, ESCITALOPRAM OXALATE (LEXAPRO) for Depression, VITAMIN D3 for Vitamin D deficiency, VORTIOXETINE HYDROBROMIDE (TRINTELLIX).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 SINUSITIS (Sinus infection), ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit hyperactivity disorder), GAIT DISTURBANCE (Problems in walking), FEELING ABNORMAL (Felt like garbage), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Problems in washing or dressin/Some problems with performing usual activities), PAIN (Pain/Aches), DISCOMFORT (Discomfort), BACK PAIN (Back pain), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, SINUSITIS (Sinus infection) had resolved, ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit hyperactivity disorder), FEELING ABNORMAL (Felt like garbage), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown, GAIT DISTURBANCE (Problems in walking), PAIN (Pain/Aches), DISCOMFORT (Discomfort) and BACK PAIN (Back pain) was resolving and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Problems in washing or dressin/Some problems with performing usual activities) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. the lab data reported was tuberculosis on unknown date and results. concomitant medication includes Antibitics.  Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Illness, Lymphadenopathy, Migraine
Clinical narrative: right arm swollen; chemical taste in mouth; lymph nodes on my right side swollen; Fever; muscle aches; migraine; The right side of my neck got sore; The right side of my neck got swollen; Longer than 35 days between Covid-19 Moderna vaccine; extremely sick; fatigued; Myalgia; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Longer than 35 days between Covid-19 Moderna vaccine), ILLNESS (extremely sick), FATIGUE (fatigued), MYALGIA (Myalgia) and MYALGIA (muscle aches) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was provided.).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Longer than 35 days between Covid-19 Moderna vaccine), ILLNESS (extremely sick), FATIGUE (fatigued) and MYALGIA (Myalgia). On 21-Feb-2021, the patient experienced MYALGIA (muscle aches), MIGRAINE (migraine), NECK PAIN (The right side of my neck got sore) and SWELLING (The right side of my neck got swollen). On 22-Feb-2021, the patient experienced PERIPHERAL SWELLING (right arm swollen), DYSGEUSIA (chemical taste in mouth), LYMPHADENOPATHY (lymph nodes on my right side swollen) and PYREXIA (Fever). On 20-Feb-2021, PRODUCT DOSE OMISSION ISSUE (Longer than 35 days between Covid-19 Moderna vaccine) had resolved. On 01-Mar-2021, ILLNESS (extremely sick), FATIGUE (fatigued), MYALGIA (Myalgia), MYALGIA (muscle aches), MIGRAINE (migraine), NECK PAIN (The right side of my neck got sore), SWELLING (The right side of my neck got swollen), PERIPHERAL SWELLING (right arm swollen), DYSGEUSIA (chemical taste in mouth) and LYMPHADENOPATHY (lymph nodes on my right side swollen) had resolved. At the time of the report, PYREXIA (Fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were provided. At the hospital, patient was told that the event chemical taste in mouth was due to the vaccine.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Peripheral swelling, Product dose omission issue, Pyrexia
Clinical narrative: right arm swollen; chemical taste in mouth; lymph nodes on my right side swollen; Fever; muscle aches; migraine; The right side of my neck got sore; The right side of my neck got swollen; Longer than 35 days between Covid-19 Moderna vaccine; extremely sick; fatigued; Myalgia; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Longer than 35 days between Covid-19 Moderna vaccine), ILLNESS (extremely sick), FATIGUE (fatigued), MYALGIA (Myalgia) and MYALGIA (muscle aches) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was provided.).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Longer than 35 days between Covid-19 Moderna vaccine), ILLNESS (extremely sick), FATIGUE (fatigued) and MYALGIA (Myalgia). On 21-Feb-2021, the patient experienced MYALGIA (muscle aches), MIGRAINE (migraine), NECK PAIN (The right side of my neck got sore) and SWELLING (The right side of my neck got swollen). On 22-Feb-2021, the patient experienced PERIPHERAL SWELLING (right arm swollen), DYSGEUSIA (chemical taste in mouth), LYMPHADENOPATHY (lymph nodes on my right side swollen) and PYREXIA (Fever). On 20-Feb-2021, PRODUCT DOSE OMISSION ISSUE (Longer than 35 days between Covid-19 Moderna vaccine) had resolved. On 01-Mar-2021, ILLNESS (extremely sick), FATIGUE (fatigued), MYALGIA (Myalgia), MYALGIA (muscle aches), MIGRAINE (migraine), NECK PAIN (The right side of my neck got sore), SWELLING (The right side of my neck got swollen), PERIPHERAL SWELLING (right arm swollen), DYSGEUSIA (chemical taste in mouth) and LYMPHADENOPATHY (lymph nodes on my right side swollen) had resolved. At the time of the report, PYREXIA (Fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were provided. At the hospital, patient was told that the event chemical taste in mouth was due to the vaccine.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: right arm swollen; chemical taste in mouth; lymph nodes on my right side swollen; Fever; muscle aches; migraine; The right side of my neck got sore; The right side of my neck got swollen; Longer than 35 days between Covid-19 Moderna vaccine; extremely sick; fatigued; Myalgia; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Longer than 35 days between Covid-19 Moderna vaccine), ILLNESS (extremely sick), FATIGUE (fatigued), MYALGIA (Myalgia) and MYALGIA (muscle aches) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was provided.).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Longer than 35 days between Covid-19 Moderna vaccine), ILLNESS (extremely sick), FATIGUE (fatigued) and MYALGIA (Myalgia). On 21-Feb-2021, the patient experienced MYALGIA (muscle aches), MIGRAINE (migraine), NECK PAIN (The right side of my neck got sore) and SWELLING (The right side of my neck got swollen). On 22-Feb-2021, the patient experienced PERIPHERAL SWELLING (right arm swollen), DYSGEUSIA (chemical taste in mouth), LYMPHADENOPATHY (lymph nodes on my right side swollen) and PYREXIA (Fever). On 20-Feb-2021, PRODUCT DOSE OMISSION ISSUE (Longer than 35 days between Covid-19 Moderna vaccine) had resolved. On 01-Mar-2021, ILLNESS (extremely sick), FATIGUE (fatigued), MYALGIA (Myalgia), MYALGIA (muscle aches), MIGRAINE (migraine), NECK PAIN (The right side of my neck got sore), SWELLING (The right side of my neck got swollen), PERIPHERAL SWELLING (right arm swollen), DYSGEUSIA (chemical taste in mouth) and LYMPHADENOPATHY (lymph nodes on my right side swollen) had resolved. At the time of the report, PYREXIA (Fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were provided. At the hospital, patient was told that the event chemical taste in mouth was due to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: dizziness/Light-headed feeling; confusion; posterior neck pain; tinnitus; made my day to day living very difficult; brain fog; fatigue; chronic headache/pulsing pain in head; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness/Light-headed feeling), CONFUSIONAL STATE (confusion), NECK PAIN (posterior neck pain), TINNITUS (tinnitus) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (made my day to day living very difficult) in a female patient of an unknown age 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 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, the patient experienced DIZZINESS (dizziness/Light-headed feeling), CONFUSIONAL STATE (confusion), NECK PAIN (posterior neck pain), TINNITUS (tinnitus), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (made my day to day living very difficult), FEELING ABNORMAL (brain fog), FATIGUE (fatigue) and HEADACHE (chronic headache/pulsing pain in head). At the time of the report, DIZZINESS (dizziness/Light-headed feeling), CONFUSIONAL STATE (confusion), NECK PAIN (posterior neck pain), TINNITUS (tinnitus), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (made my day to day living very difficult), FEELING ABNORMAL (brain fog), FATIGUE (fatigue) and HEADACHE (chronic headache/pulsing pain in head) outcome was unknown.            Treatment medication not provided. Concomitant medication not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up received contains reporter's updated information.
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Neck pain, Tinnitus
Clinical narrative: dizziness/Light-headed feeling; confusion; posterior neck pain; tinnitus; made my day to day living very difficult; brain fog; fatigue; chronic headache/pulsing pain in head; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness/Light-headed feeling), CONFUSIONAL STATE (confusion), NECK PAIN (posterior neck pain), TINNITUS (tinnitus) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (made my day to day living very difficult) in a female patient of an unknown age 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 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, the patient experienced DIZZINESS (dizziness/Light-headed feeling), CONFUSIONAL STATE (confusion), NECK PAIN (posterior neck pain), TINNITUS (tinnitus), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (made my day to day living very difficult), FEELING ABNORMAL (brain fog), FATIGUE (fatigue) and HEADACHE (chronic headache/pulsing pain in head). At the time of the report, DIZZINESS (dizziness/Light-headed feeling), CONFUSIONAL STATE (confusion), NECK PAIN (posterior neck pain), TINNITUS (tinnitus), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (made my day to day living very difficult), FEELING ABNORMAL (brain fog), FATIGUE (fatigue) and HEADACHE (chronic headache/pulsing pain in head) outcome was unknown.            Treatment medication not provided. Concomitant medication not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up received contains reporter's updated information.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia
Clinical narrative: Voice was shaky; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPHONIA (Voice was shaky) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis (Rheumatoid factor of multiple sites without organ or systems involvement,) and Keratoconjunctivitis sicca (Sicca syndrome with keratoconjunctivitis). Concomitant products included TOCILIZUMAB (ACTEMRA) for an unknown indication.    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 DYSPHONIA (Voice was shaky). At the time of the report, DYSPHONIA (Voice was shaky) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue, Syringe issue
Clinical narrative: 3 patients did not receive actual vaccine; There were a few vaccines that went in easy; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (3 patients did not receive actual vaccine) and SYRINGE ISSUE (There were a few vaccines that went in easy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (3 patients did not receive actual vaccine) and SYRINGE ISSUE (There were a few vaccines that went in easy). On 16-Apr-2021, PRODUCT DOSE OMISSION ISSUE (3 patients did not receive actual vaccine) and SYRINGE ISSUE (There were a few vaccines that went in easy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   An pharmacist reports that 20 patient received the Moderna vaccine, where mixed patient received 1st and 2nd dose, but there were 3 remaining syringes containing vaccine at the end of Vaccination clinic. HCP feels that 3 patient didn't received the vaccine and the administrator felt that few Vaccine went in too easy.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: The follow up received on 20-APR-2021, with information on Batch/lot number and expiration date
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: red rush around where the injection site was, it is a little painful, but not itchy; red rush around where the injection site was, it is a little painful, but not itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red rush around where the injection site was, it is a little painful, but not itchy) and VACCINATION SITE PAIN (red rush around where the injection site was, it is a little painful, but not itchy) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (The patient takes nasal spray for allergy). Concomitant products included GABAPENTIN, LEVOTHYROXINE SODIUM (SYNTHROID), VITAMIN D3 and KALLIDINOGENASE (SOMAX) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red rush around where the injection site was, it is a little painful, but not itchy) and VACCINATION SITE PAIN (red rush around where the injection site was, it is a little painful, but not itchy). At the time of the report, VACCINATION SITE ERYTHEMA (red rush around where the injection site was, it is a little painful, but not itchy) and VACCINATION SITE PAIN (red rush around where the injection site was, it is a little painful, but not itchy) outcome was unknown. associated with second dose of vaccine      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included antidepressants and nasal spray for allergy. The patient did not receive any treatment medications.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Occupational exposure to product
Clinical narrative: while injecting the Moderna Covid-19 vaccine, the needle fell off and the vaccine went into the intern's left eye; This spontaneous case was reported by a pharmacist and describes the occurrence of OCCUPATIONAL EXPOSURE TO PRODUCT (while injecting the Moderna Covid-19 vaccine, the needle fell off and the vaccine went into the intern's left eye) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced OCCUPATIONAL EXPOSURE TO PRODUCT (while injecting the Moderna Covid-19 vaccine, the needle fell off and the vaccine went into the intern's left eye). On 20-Apr-2021, OCCUPATIONAL EXPOSURE TO PRODUCT (while injecting the Moderna Covid-19 vaccine, the needle fell off and the vaccine went into the intern's left eye) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medication details was reported.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest X-ray, Chest pain, Full blood count, Heart rate
Clinical narrative: soreness in his left chest and left arm; heart rate was a little high; soreness in his left chest and left arm; pain felt like achy muscles/body aches; a fever of 100 degrees F; achiness in his back and a little bit in his chest; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in his left chest and left arm), PALPITATIONS (heart rate was a little high), CHEST PAIN (soreness in his left chest and left arm), MYALGIA (pain felt like achy muscles/body aches) and PYREXIA (a fever of 100 degrees F) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006_321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 03-Apr-2021, the patient experienced MYALGIA (achiness in his back and a little bit in his chest). On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness in his left chest and left arm), PALPITATIONS (heart rate was a little high), CHEST PAIN (soreness in his left chest and left arm), MYALGIA (pain felt like achy muscles/body aches) and PYREXIA (a fever of 100 degrees F). On 05-Apr-2021, MYALGIA (achiness in his back and a little bit in his chest) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in his left chest and left arm), PALPITATIONS (heart rate was a little high), CHEST PAIN (soreness in his left chest and left arm), MYALGIA (pain felt like achy muscles/body aches) and PYREXIA (a fever of 100 degrees F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Body temperature: 100 (High) 100 F. On 12-Apr-2021, Chest X-ray: normal (normal) Normal. On 12-Apr-2021, Full blood count: normal (normal) Normal. On 12-Apr-2021, Heart rate: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported. The patient used to be heavily involved in weight lifting and states that the pain felt like achy muscles to him. Patient states his 2nd shot is due on 30Apr2021
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Palpitations, Pyrexia
Clinical narrative: soreness in his left chest and left arm; heart rate was a little high; soreness in his left chest and left arm; pain felt like achy muscles/body aches; a fever of 100 degrees F; achiness in his back and a little bit in his chest; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in his left chest and left arm), PALPITATIONS (heart rate was a little high), CHEST PAIN (soreness in his left chest and left arm), MYALGIA (pain felt like achy muscles/body aches) and PYREXIA (a fever of 100 degrees F) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006_321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 03-Apr-2021, the patient experienced MYALGIA (achiness in his back and a little bit in his chest). On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness in his left chest and left arm), PALPITATIONS (heart rate was a little high), CHEST PAIN (soreness in his left chest and left arm), MYALGIA (pain felt like achy muscles/body aches) and PYREXIA (a fever of 100 degrees F). On 05-Apr-2021, MYALGIA (achiness in his back and a little bit in his chest) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in his left chest and left arm), PALPITATIONS (heart rate was a little high), CHEST PAIN (soreness in his left chest and left arm), MYALGIA (pain felt like achy muscles/body aches) and PYREXIA (a fever of 100 degrees F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Body temperature: 100 (High) 100 F. On 12-Apr-2021, Chest X-ray: normal (normal) Normal. On 12-Apr-2021, Full blood count: normal (normal) Normal. On 12-Apr-2021, Heart rate: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported. The patient used to be heavily involved in weight lifting and states that the pain felt like achy muscles to him. Patient states his 2nd shot is due on 30Apr2021
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown. Not Provided          No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD21-078782, US-MODERNATX, INC.-MOD-2021-078032 (E2B Linked Report). This case was linked to MOD-2021-081263 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dizziness, Tinnitus, Vaccination complication
Clinical narrative: Atrial fibrillation; dizziness; tinnitus; tinnitus, along with other reactions; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a female patient of an unknown age 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant), DIZZINESS (dizziness), TINNITUS (tinnitus) and VACCINATION COMPLICATION (tinnitus, along with other reactions). At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) outcome was unknown and DIZZINESS (dizziness), TINNITUS (tinnitus) and VACCINATION COMPLICATION (tinnitus, along with other reactions) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication reported. No treatment information was provided.  Company Comment:  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up was received : case upgraded to serious, added event of A.fib; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Intentional product use issue
Clinical narrative: Patient also states that was sick after receiving the first dose; Potential Adverse Event : Deviation of time between the two doses; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Patient also states that was sick after receiving the first dose) and INTENTIONAL PRODUCT USE ISSUE (Potential Adverse Event : Deviation of time between the two doses) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Patient also states that was sick after receiving the first dose) and INTENTIONAL PRODUCT USE ISSUE (Potential Adverse Event : Deviation of time between the two doses). At the time of the report, ILLNESS (Patient also states that was sick after receiving the first dose) and INTENTIONAL PRODUCT USE ISSUE (Potential Adverse Event : Deviation of time between the two doses) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Severe headache/normal headache; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache/normal headache) and PYREXIA (slight fever) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine (History of migraines). Concomitant products included TOPIRAMATE (TOPAMAX) for Migraine prophylaxis, ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced HEADACHE (Severe headache/normal headache) and PYREXIA (slight fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 14-Apr-2021, HEADACHE (Severe headache/normal headache) had resolved. At the time of the report, PYREXIA (slight fever) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.
Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Colonoscopy, Fatigue, Large intestine polyp, Pain, Pyrexia
Clinical narrative: Colonoscopy showed polyp was benign; Generalised aching; Fatigue; Fever; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LARGE INTESTINE POLYP (Colonoscopy showed polyp was benign), PAIN (Generalised aching), FATIGUE (Fatigue) and PYREXIA (Fever) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (moderate to severe).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage form. On 26-Feb-2021, the patient experienced LARGE INTESTINE POLYP (Colonoscopy showed polyp was benign). On an unknown date, the patient experienced PAIN (Generalised aching), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, LARGE INTESTINE POLYP (Colonoscopy showed polyp was benign), PAIN (Generalised aching), FATIGUE (Fatigue) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Colonoscopy: abnormal (abnormal) Benign polyp about the size of a dime.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On an unknown date, patient received 1st dose COVID-19 vaccine manufactured by unknown, lot number unknown, expiration date unknown.  Based on current available information and the temporal association between product use and he start date of the events a causal relationship cannot be excluded except for the event of Large intestine polyp which is unlikely.  Treatment included polypectomy (on 26 Feb 2021, doctor removed a polyp and recommended a follow-up colonoscopy in one year).; Reporter's Comments: The reporter's causality for the events of colonoscopy showed polyp was benign was not provided. The reporter's causality for the events of fatigue, body aches, and fever with Humira (adalimumab) was no reasonable possibility. Abbvie's opinion is that there is no reasonable possibility that the events of colonoscopy showed polyp was benign, fatigue, body aches, and fever are related to Humira (adalimubab).; Sender's Comments: Based on current available information and the temporal association between product use and he start date of the events a causal relationship cannot be excluded except for the event of Large intestine polyp which is unlikely.
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) 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 were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow-up information received on 28-MAY-2021 and contains no new information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Nausea, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (Unable to finish dinner), VACCINATION SITE PAIN (Sore arm) and NAUSEA (Thought she would throw up while eating) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced FEEDING DISORDER (Unable to finish dinner), VACCINATION SITE PAIN (Sore arm) and NAUSEA (Thought she would throw up while eating). At the time of the report, FEEDING DISORDER (Unable to finish dinner), VACCINATION SITE PAIN (Sore arm) and NAUSEA (Thought she would throw up while eating) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication include weight lost medication. Treatment information was not provided. This case was linked to US-MODERNATX, INC.-MOD-2021-082299 (E2B Linked Report). This case was linked to MOD-2021-082299. Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information received on 22-MAY-2021 and contains no new information.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-082299:Cross link to Dose 2.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Fatigue, Headache, Vaccination site pain
Clinical narrative: headache; tiredness; Vaccine exposure during pregnancy; a little sore arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), VACCINATION SITE PAIN (a little sore arm), HEADACHE (headache) and FATIGUE (tiredness) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 11-May-2021. On 19-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and VACCINATION SITE PAIN (a little sore arm). On 20-Apr-2021, the patient experienced HEADACHE (headache) and FATIGUE (tiredness). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 19-Apr-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, VACCINATION SITE PAIN (a little sore arm), HEADACHE (headache) and FATIGUE (tiredness) outcome was unknown.            No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-058276, US-MODERNATX, INC.-MOD-2021-058563 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-058276:Case for dose 2 US-MODERNATX, INC.-MOD-2021-058563:cross linked case (case for mother)
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: fatigue; chills; headache; nausea; pain at injection site for a couple of days; not sure if the vaccine was correctly injected / vaccine was injected incorrectly; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (not sure if the vaccine was correctly injected / vaccine was injected incorrectly), FATIGUE (fatigue), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037142B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 07-Apr-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (not sure if the vaccine was correctly injected / vaccine was injected incorrectly) and INJECTION SITE PAIN (pain at injection site for a couple of days). On 19-Apr-2021, the patient experienced FATIGUE (fatigue), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. In April 2021, INJECTION SITE PAIN (pain at injection site for a couple of days) had resolved. At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (not sure if the vaccine was correctly injected / vaccine was injected incorrectly) outcome was unknown and FATIGUE (fatigue), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. On 19-Apr-2021 he was feeling like getting the flu or COVID   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: follow up received contain no significant information
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: fatigue; chills; headache; nausea; pain at injection site for a couple of days; not sure if the vaccine was correctly injected / vaccine was injected incorrectly; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (not sure if the vaccine was correctly injected / vaccine was injected incorrectly), FATIGUE (fatigue), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037142B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 07-Apr-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (not sure if the vaccine was correctly injected / vaccine was injected incorrectly) and INJECTION SITE PAIN (pain at injection site for a couple of days). On 19-Apr-2021, the patient experienced FATIGUE (fatigue), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. In April 2021, INJECTION SITE PAIN (pain at injection site for a couple of days) had resolved. At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (not sure if the vaccine was correctly injected / vaccine was injected incorrectly) outcome was unknown and FATIGUE (fatigue), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. On 19-Apr-2021 he was feeling like getting the flu or COVID   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: follow up received contain no significant information
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia, Vaccination site rash
Clinical narrative: Injection site rash; Fever; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE RASH (Injection site rash), PYREXIA (Fever) and HEADACHE (Headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 025J20-2A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included VITAMIN D3 for an unknown indication.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE RASH (Injection site rash). 25-Jan-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). On 28-Jan-2021, HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE RASH (Injection site rash) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 99.8 (High) Low grade fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was reported to be prescribed a topical cream but she did not fill the prescription.   This case was linked to MOD-2021-002588 (Patient Link).
Sex: F
Vaccine: COVID19, UNK
Symptoms: Myalgia, Pyrexia
Clinical narrative: low grade fever; generalized aching; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (low grade fever) and PAIN (generalized aching) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   In August 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 21-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced PYREXIA (low grade fever) and PAIN (generalized aching). At the time of the report, PYREXIA (low grade fever) and PAIN (generalized aching) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site pain
Clinical narrative: Sore arm; Cloudy feeling; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FEELING ABNORMAL (Cloudy feeling) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease. Concomitant products included ADALIMUMAB (HUMIRA) for Crohn's disease.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FEELING ABNORMAL (Cloudy feeling). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved and FEELING ABNORMAL (Cloudy feeling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment was not reported/ unknown.