chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Colitis
Clinical narrative: Colon inflammation; This spontaneous case was reported by a physician and describes the occurrence of COLITIS (Colon inflammation) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 004M20A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    The patient's past medical history included Tobacco user from 1965 to 30-Apr-2006, Bowel resection in 1980, Gallbladder removal, Colonoscopy on 15-Apr-2021 and Renal surgery. Concurrent medical conditions included Ulcerative colitis, Kidney infection, Pollen allergy (manifested by eyes watery, nose runs, sinus headache,dizzy), Respiratory disorder NOS, Bladder disorder NOS, Restless leg syndrome, Vitamin D low, Crohn's, Blood pressure high, Emphysema, Blood cholesterol abnormal, Allergy, Depression and Somnolence. Concomitant products included SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) for Abnormal breathing, MONTELUKAST SODIUM (SINGULAIR) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, AZITHROMYCIN (AZO) for Bladder disorder NOS, FENOFIBRATE for Blood cholesterol abnormal, ATENOLOL and AMLODIPINE for Blood pressure high, CHOLESTYRAMINE and PREDNISONE for Crohn's, ESCITALOPRAM for Depression, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for Emphysema, CARMELLOSE SODIUM (THERATEARS) for Eye disorder NOS, FLUTICASONE for Nasal disorder NOS, FOLIC ACID for Nutritional supplement, IPRATROPIUM BROMIDE, CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and AZELASTINE for Respiratory disorder NOS, GABAPENTIN and ROPINIROLE for Restless leg syndrome, MODAFINIL for Sleepiness, POTASSIUM CHLORIDE, TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) and CENTRUM SILVER WOMEN 50+ for Supplementation therapy, VITAMIN D NOS for Vitamin D low and Supplementation therapy, ESTROGENS CONJUGATED (PREMARIN), MELOXICAM and ACETYLSALICYLIC ACID (ASPIRIN LOW) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 15-Apr-2021, the patient experienced COLITIS (Colon inflammation). At the time of the report, COLITIS (Colon inflammation) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: BROKE OUT IN NECK AREA,ARM,LOWER BACK WITH RASH/ITCH AFTER GOT THE COVID VACCINE; This spontaneous case was reported by a health care professional and describes the occurrence of RASH (BROKE OUT IN NECK AREA,ARM,LOWER BACK WITH RASH/ITCH AFTER GOT THE COVID VACCINE) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient's past medical history included Non-smoker and Abstains from alcohol. Previously administered products included for an unreported indication: METHOTREXATE (for rheumatoid arthritis).   In 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced RASH (BROKE OUT IN NECK AREA,ARM,LOWER BACK WITH RASH/ITCH AFTER GOT THE COVID VACCINE). At the time of the report, RASH (BROKE OUT IN NECK AREA,ARM,LOWER BACK WITH RASH/ITCH AFTER GOT THE COVID VACCINE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site pruritus
Clinical narrative: Typical side effect the next day or two; itching at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (itching at injection site) and VACCINATION COMPLICATION (Typical side effect the next day or two) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2021, the patient experienced VACCINATION SITE PRURITUS (itching at injection site). On an unknown date, the patient experienced VACCINATION COMPLICATION (Typical side effect the next day or two). At the time of the report, VACCINATION SITE PRURITUS (itching at injection site) and VACCINATION COMPLICATION (Typical side effect the next day or two) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pains after the 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (Chest pains after the 1st dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2021, the patient experienced CHEST PAIN (Chest pains after the 1st dose). At the time of the report, CHEST PAIN (Chest pains after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test abnormal, Pain in extremity
Clinical narrative: pain in arm; Lab test abnormal; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (pain in arm) and LABORATORY TEST ABNORMAL (Lab test abnormal) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    The patient's past medical history included No adverse event.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm) and LABORATORY TEST ABNORMAL (Lab test abnormal). At the time of the report, PAIN IN EXTREMITY (pain in arm) and LABORATORY TEST ABNORMAL (Lab test abnormal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Ran a fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Ran a fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    In May 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 PYREXIA (Ran a fever). At the time of the report, PYREXIA (Ran a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Pharyngeal ulceration, Stomatitis, Swelling
Clinical narrative: swell up a lot; sores on tounge; sores on throat; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swell up a lot), STOMATITIS (sores on tounge) and PHARYNGEAL ULCERATION (sores on throat) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (swell up a lot), STOMATITIS (sores on tounge) and PHARYNGEAL ULCERATION (sores on throat). At the time of the report, SWELLING (swell up a lot), STOMATITIS (sores on tounge) and PHARYNGEAL ULCERATION (sores on throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Conduction disorder
Clinical narrative: electrical system in my heart failed; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CONDUCTION DISORDER (electrical system in my heart failed) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONDUCTION DISORDER (electrical system in my heart failed). At the time of the report, CONDUCTION DISORDER (electrical system in my heart failed) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold). At the time of the report, NASOPHARYNGITIS (Cold) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were provided. No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Illness, Malaise
Clinical narrative: weakness; General malaise; feeling really sick; This spontaneous case was reported by an other health care professional and describes the occurrence of ASTHENIA (weakness), MALAISE (General malaise) and ILLNESS (feeling really sick) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-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 ASTHENIA (weakness), MALAISE (General malaise) and ILLNESS (feeling really sick). At the time of the report, ASTHENIA (weakness), MALAISE (General malaise) and ILLNESS (feeling really sick) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter.  Treatment medications was not provided.   This case was linked to MOD-2021-196263 (Patient Link).
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15 year old received the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received the Moderna COVID-19 vaccine) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received the Moderna COVID-19 vaccine). On 30-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.     Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up information contains No Newinformation. On 29-Jun-2021: Follow-up information contains No NewInformation On 12-Jul-2021: Followup received contains second dose details.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchy skin; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy skin) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchy skin). At the time of the report, PRURITUS (Itchy skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not reported.   Treatment information was not reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Intermenstrual bleeding, Migraine, Myalgia, Pyrexia
Clinical narrative: Fever - 104F; Spotting; Chills; Aches; migraine; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever - 104F), INTERMENSTRUAL BLEEDING (Spotting), CHILLS (Chills), MYALGIA (Aches) and MIGRAINE (migraine) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 29-Apr-2021, the patient experienced MIGRAINE (migraine). On 29-May-2021, the patient experienced PYREXIA (Fever - 104F), INTERMENSTRUAL BLEEDING (Spotting), CHILLS (Chills) and MYALGIA (Aches). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 30-Apr-2021, MIGRAINE (migraine) had resolved. On 30-May-2021, CHILLS (Chills) and MYALGIA (Aches) had resolved. On 31-May-2021, PYREXIA (Fever - 104F) and INTERMENSTRUAL BLEEDING (Spotting) had resolved.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature fluctuation, Decreased appetite, Dizziness, Fatigue
Clinical narrative: feel not well; I am cold, I am hot; little bit dizzy; sweating; could not sleep; loss of appetite; a little bit of fever; little pain in the shoulder.; felt a lot of burning from the injection site; nauseous; lots of muscle pain; a little headache; very tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feel not well), BODY TEMPERATURE FLUCTUATION (I am cold, I am hot), DIZZINESS (little bit dizzy), HYPERHIDROSIS (sweating) and INSOMNIA (could not sleep) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (feel not well), BODY TEMPERATURE FLUCTUATION (I am cold, I am hot), DIZZINESS (little bit dizzy), HYPERHIDROSIS (sweating), INSOMNIA (could not sleep), DECREASED APPETITE (loss of appetite), PYREXIA (a little bit of fever), ARTHRALGIA (little pain in the shoulder.), VACCINATION SITE PAIN (felt a lot of burning from the injection site), NAUSEA (nauseous), MYALGIA (lots of muscle pain), HEADACHE (a little headache) and FATIGUE (very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (feel not well), BODY TEMPERATURE FLUCTUATION (I am cold, I am hot), DIZZINESS (little bit dizzy), HYPERHIDROSIS (sweating), INSOMNIA (could not sleep), DECREASED APPETITE (loss of appetite), PYREXIA (a little bit of fever), VACCINATION SITE PAIN (felt a lot of burning from the injection site), NAUSEA (nauseous), MYALGIA (lots of muscle pain), HEADACHE (a little headache) and FATIGUE (very tired) had resolved and ARTHRALGIA (little pain in the shoulder.) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Insomnia, Malaise, Myalgia
Clinical narrative: feel not well; I am cold, I am hot; little bit dizzy; sweating; could not sleep; loss of appetite; a little bit of fever; little pain in the shoulder.; felt a lot of burning from the injection site; nauseous; lots of muscle pain; a little headache; very tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feel not well), BODY TEMPERATURE FLUCTUATION (I am cold, I am hot), DIZZINESS (little bit dizzy), HYPERHIDROSIS (sweating) and INSOMNIA (could not sleep) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (feel not well), BODY TEMPERATURE FLUCTUATION (I am cold, I am hot), DIZZINESS (little bit dizzy), HYPERHIDROSIS (sweating), INSOMNIA (could not sleep), DECREASED APPETITE (loss of appetite), PYREXIA (a little bit of fever), ARTHRALGIA (little pain in the shoulder.), VACCINATION SITE PAIN (felt a lot of burning from the injection site), NAUSEA (nauseous), MYALGIA (lots of muscle pain), HEADACHE (a little headache) and FATIGUE (very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (feel not well), BODY TEMPERATURE FLUCTUATION (I am cold, I am hot), DIZZINESS (little bit dizzy), HYPERHIDROSIS (sweating), INSOMNIA (could not sleep), DECREASED APPETITE (loss of appetite), PYREXIA (a little bit of fever), VACCINATION SITE PAIN (felt a lot of burning from the injection site), NAUSEA (nauseous), MYALGIA (lots of muscle pain), HEADACHE (a little headache) and FATIGUE (very tired) had resolved and ARTHRALGIA (little pain in the shoulder.) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain
Clinical narrative: feel not well; I am cold, I am hot; little bit dizzy; sweating; could not sleep; loss of appetite; a little bit of fever; little pain in the shoulder.; felt a lot of burning from the injection site; nauseous; lots of muscle pain; a little headache; very tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feel not well), BODY TEMPERATURE FLUCTUATION (I am cold, I am hot), DIZZINESS (little bit dizzy), HYPERHIDROSIS (sweating) and INSOMNIA (could not sleep) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (feel not well), BODY TEMPERATURE FLUCTUATION (I am cold, I am hot), DIZZINESS (little bit dizzy), HYPERHIDROSIS (sweating), INSOMNIA (could not sleep), DECREASED APPETITE (loss of appetite), PYREXIA (a little bit of fever), ARTHRALGIA (little pain in the shoulder.), VACCINATION SITE PAIN (felt a lot of burning from the injection site), NAUSEA (nauseous), MYALGIA (lots of muscle pain), HEADACHE (a little headache) and FATIGUE (very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (feel not well), BODY TEMPERATURE FLUCTUATION (I am cold, I am hot), DIZZINESS (little bit dizzy), HYPERHIDROSIS (sweating), INSOMNIA (could not sleep), DECREASED APPETITE (loss of appetite), PYREXIA (a little bit of fever), VACCINATION SITE PAIN (felt a lot of burning from the injection site), NAUSEA (nauseous), MYALGIA (lots of muscle pain), HEADACHE (a little headache) and FATIGUE (very tired) had resolved and ARTHRALGIA (little pain in the shoulder.) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Soar  throat for weeks after vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Soar throat for weeks after vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Soar throat for weeks after vaccine). At the time of the report, OROPHARYNGEAL PAIN (Soar throat for weeks after vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives like reaction a week after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives like reaction a week after the vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives like reaction a week after the vaccination). At the time of the report, URTICARIA (Hives like reaction a week after the vaccination) outcome was unknown.            No concomitants were reported.  Treatment information was not provided.  Action taken with mRNA1273 Moderna vaccine was Not Applicable
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart disorder; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC DISORDER (heart disorder) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     o medical history provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On 12-Apr-2021, the patient experienced CARDIAC DISORDER (heart disorder). At the time of the report, CARDIAC DISORDER (heart disorder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided by the reporter. No  concomitant medical  provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Is it ok to wait an extra week to get the 2nd dose? It would be a month plus a week; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Is it ok to wait an extra week to get the 2nd dose? It would be a month plus a week) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Is it ok to wait an extra week to get the 2nd dose? It would be a month plus a week). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Is it ok to wait an extra week to get the 2nd dose? It would be a month plus a week) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It has been one month and a week since first dose.  No concomitant medication were provided  Treatment medication was not provided
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: Slept for two hours; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept for two hours) and FATIGUE (Tiredness) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Slept for two hours) and FATIGUE (Tiredness). At the time of the report, SOMNOLENCE (Slept for two hours) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.   This case was linked to MOD-2021-094738 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itching; swelling the size of an egg; redness around the injection site; headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (swelling the size of an egg), VACCINATION SITE ERYTHEMA (redness around the injection site), HEADACHE (headache) and PYREXIA (fever) in an elderly 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 16-Feb-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 an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (swelling the size of an egg), VACCINATION SITE ERYTHEMA (redness around the injection site), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (swelling the size of an egg), VACCINATION SITE ERYTHEMA (redness around the injection site), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) had resolved.            No relevant concomitant medications were provided.   This case was linked to MOD-2021-018001 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Itching; swelling the size of an egg; redness around the injection site; headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (swelling the size of an egg), VACCINATION SITE ERYTHEMA (redness around the injection site), HEADACHE (headache) and PYREXIA (fever) in an elderly 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 16-Feb-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 an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (swelling the size of an egg), VACCINATION SITE ERYTHEMA (redness around the injection site), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (swelling the size of an egg), VACCINATION SITE ERYTHEMA (redness around the injection site), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) had resolved.            No relevant concomitant medications were provided.   This case was linked to MOD-2021-018001 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (A little bit of fever) and NAUSEA (Nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), PYREXIA (A little bit of fever) and NAUSEA (Nausea). At the time of the report, HEADACHE (Headache), PYREXIA (A little bit of fever) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were provided. No treatment information was provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: A patient experience sore arm after her first Moderna Covid-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (A patient experience sore arm after her first Moderna Covid-19 vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN.    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 MYALGIA (A patient experience sore arm after her first Moderna Covid-19 vaccine).        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.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Flu symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Flu symptoms). At the time of the report, INFLUENZA (Flu symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.    Most recent FOLLOW-UP information incorporated above includes: On 23-May-2021: Follow-up information received on 02-JUN-2021 does not contain any new information.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Very itching skin; rash all over her body except face and feet; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Very itching skin) and RASH (rash all over her body except face and feet) in a 51-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Very itching skin) and RASH (rash all over her body except face and feet). The patient was treated with CORTISONE for Rash, at an unspecified dose and frequency. At the time of the report, PRURITUS (Very itching skin) and RASH (rash all over her body except face and feet) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.    This case was linked to MOD-2021-198080 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pruritus, Rash, Swelling face, Throat irritation
Clinical narrative: Cheeks swelled up; Itchy roof of mouth and throat and ears tried to flare up; Itchy roof of mouth and throat and ears tried to flare up; Rash on arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Cheeks swelled up), THROAT IRRITATION (Itchy roof of mouth and throat and ears tried to flare up), ORAL PRURITUS (Itchy roof of mouth and throat and ears tried to flare up) and RASH (Rash on arm) 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 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Cheeks swelled up), THROAT IRRITATION (Itchy roof of mouth and throat and ears tried to flare up), ORAL PRURITUS (Itchy roof of mouth and throat and ears tried to flare up) and RASH (Rash on arm). At the time of the report, SWELLING FACE (Cheeks swelled up), THROAT IRRITATION (Itchy roof of mouth and throat and ears tried to flare up), ORAL PRURITUS (Itchy roof of mouth and throat and ears tried to flare up) and RASH (Rash on arm) 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.   This case was linked to MOD-2021-067735 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of swelling (whenever she itches, she feels a bump is coming out) and rash (all over body except face and feet/really itchy) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 20, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 19, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced swelling (whenever she itches, she feels a bump is coming out) and rash (all over body except face and feet/really itch). The patient treated with cortisone for itching, at a dose of 1 dosage form. At the time of the report, swelling (whenever she itches, she feels a bump is coming out) outcome: unknown; and rash (all over body except face and feet/really itch): not resolved. The patient stated when she applied OTC cortisone cream; it helped a little bit but after she washed her body, itching came back again. Concomitant medications not provided. This case linked to MOD-2021-197793 (patient link).
Sex: F
Vaccine: COVID19
Symptoms: Diplopia
Clinical narrative: Double Vision; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Double Vision) 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 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced DIPLOPIA (Double Vision). At the time of the report, DIPLOPIA (Double Vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-May-2021: Follow up received on 02 Jun 2021 contains non-significant information
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment, Weight increased
Clinical narrative: Visual disturbance; Weight gain; Blood sugar increased; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Jun-2021 and was forwarded to Moderna on 02-Jun-2021.    This spontaneous case was reported by a patient and describes the occurrence of VISUAL IMPAIRMENT (Visual disturbance), WEIGHT INCREASED (Weight gain) and BLOOD GLUCOSE INCREASED (Blood sugar increased) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1F890A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VISUAL IMPAIRMENT (Visual disturbance), WEIGHT INCREASED (Weight gain) and BLOOD GLUCOSE INCREASED (Blood sugar increased). At the time of the report, VISUAL IMPAIRMENT (Visual disturbance), WEIGHT INCREASED (Weight gain) and BLOOD GLUCOSE INCREASED (Blood sugar increased) outcome was unknown.            No concomitant medication was reported . No treatment medication was reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: Hand swelling; Pain worsened; This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL SWELLING (Hand swelling) and PAIN (Pain worsened) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 029A21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Alcohol use (A glass of beer, occasionally) from 1960 to 2020 and Tobacco user (pack and a half of cigarettes a day) from 1960 to 1991. Previously administered products included for Rheumatoid arthritis: Enbrel. Past adverse reactions to the above products included No adverse reaction with Enbrel. Concurrent medical conditions included Rheumatoid arthritis (Could not make a fist), Tiredness (easily gets tired), Impaired driving ability (uncomfortable driving due to wrist pain), Wrist pain (uncomfortable driving due to wrist pain), Drug allergy (allergy with unspecified prescription pill to stop smoking manifestated by sweating and fingers swell), Blood pressure high and Diabetes. Concomitant products included VALSARTAN for Blood pressure high, INSULIN DEGLUDEC (TRESIBA) for Diabetes, PREDNISONE for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg every two weeks. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN (Pain worsened). On 25-May-2021, the patient experienced PERIPHERAL SWELLING (Hand swelling). The patient was treated with DICLOFENAC SODIUM at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Hand swelling) and PAIN (Pain worsened) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PERIPHERAL SWELLING (Hand swelling) and PAIN (Pain worsened) to be not related.    It was reported that, in Apr-2021 (date unspecified), the patient experienced worsened soreness/more pain on palms, each finger of both hands and on 25-May-2021, the patient experienced recurrent right hand swelling.   This case was linked to MOD-2021-198372 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Injection site pain, Malaise, Pain
Clinical narrative: Feeling sick; Abdominal pain; Generalized aching; Tiredness; Injection site pain; This spontaneous case was reported by a health care professional and describes the occurrence of MALAISE (Feeling sick), ABDOMINAL PAIN (Abdominal pain), PAIN (Generalized aching), FATIGUE (Tiredness) and INJECTION SITE PAIN (Injection site pain) in a 43-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 Spondylitis ankylosing.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MALAISE (Feeling sick), ABDOMINAL PAIN (Abdominal pain), PAIN (Generalized aching), FATIGUE (Tiredness) and INJECTION SITE PAIN (Injection site pain). At the time of the report, MALAISE (Feeling sick), ABDOMINAL PAIN (Abdominal pain), PAIN (Generalized aching), FATIGUE (Tiredness) and INJECTION SITE PAIN (Injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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.   Reporter did not allow further contact
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in Hand; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Pain in Hand) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB for Psoriasis.    No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for Gastroesophageal reflux disease, CLOBETASOL for Psoriasis, LISINOPRIL, IBUPROFEN and DICLOFENAC for an unknown indication.   In 2008, the patient started ADALIMUMAB (Subcutaneous) 40 mg. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in Hand). At the time of the report, PAIN IN EXTREMITY (Pain in Hand) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 19 May2021, received an update to event information, suspect drug and narrative description, The event of  PAIN WHEN CLOSING THE FIST  was amended to EXTREME PAIN ON RIGHT HAND WHEN CLOSING THE FIST.  No treatment information was provided.