chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Well I get sick but the second shot; 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 VACCINATION COMPLICATION (Well I get sick but the second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Well I get sick but the second shot). At the time of the report, VACCINATION COMPLICATION (Well I get sick but the second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Have to report adverse event; 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 ADVERSE EVENT (Have to report adverse event) 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 ADVERSE EVENT (Have to report adverse event). At the time of the report, ADVERSE EVENT (Have to report adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Illness
Clinical narrative: Called Sick to work; Threw-up, Could not eat,could not hold anything (Food), Threw up every day; Nauseous; Pounding head pain; Shaking; Stayed in Bed; Chills; fever 102 F; Severe Body Ache; Lightheaded; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheaded), DIZZINESS (Dizzy), ILLNESS (Called Sick to work), TREMOR (Shaking) and CHILLS (Chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 11-Apr-2021, the patient experienced DIZZINESS (Lightheaded), DIZZINESS (Dizzy), CHILLS (Chills), PYREXIA (fever 102 F) and MYALGIA (Severe Body Ache). On 14-May-2021, the patient experienced TREMOR (Shaking) and FATIGUE (Stayed in Bed). On an unknown date, the patient experienced ILLNESS (Called Sick to work), VOMITING (Threw-up, Could not eat,could not hold anything (Food), Threw up every day), NAUSEA (Nauseous) and HEADACHE (Pounding head pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 18-Apr-2021, DIZZINESS (Lightheaded), DIZZINESS (Dizzy), CHILLS (Chills), PYREXIA (fever 102 F) and MYALGIA (Severe Body Ache) outcome was unknown. On 17-May-2021, FATIGUE (Stayed in Bed) outcome was unknown. On 24-May-2021, TREMOR (Shaking) outcome was unknown. At the time of the report, ILLNESS (Called Sick to work), VOMITING (Threw-up, Could not eat,could not hold anything (Food), Threw up every day), NAUSEA (Nauseous) and HEADACHE (Pounding head pain) outcome was unknown.            No concomitant medication was reported   This case was linked to MOD-2021-163918 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Tremor, Vomiting
Clinical narrative: Called Sick to work; Threw-up, Could not eat,could not hold anything (Food), Threw up every day; Nauseous; Pounding head pain; Shaking; Stayed in Bed; Chills; fever 102 F; Severe Body Ache; Lightheaded; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheaded), DIZZINESS (Dizzy), ILLNESS (Called Sick to work), TREMOR (Shaking) and CHILLS (Chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 11-Apr-2021, the patient experienced DIZZINESS (Lightheaded), DIZZINESS (Dizzy), CHILLS (Chills), PYREXIA (fever 102 F) and MYALGIA (Severe Body Ache). On 14-May-2021, the patient experienced TREMOR (Shaking) and FATIGUE (Stayed in Bed). On an unknown date, the patient experienced ILLNESS (Called Sick to work), VOMITING (Threw-up, Could not eat,could not hold anything (Food), Threw up every day), NAUSEA (Nauseous) and HEADACHE (Pounding head pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 18-Apr-2021, DIZZINESS (Lightheaded), DIZZINESS (Dizzy), CHILLS (Chills), PYREXIA (fever 102 F) and MYALGIA (Severe Body Ache) outcome was unknown. On 17-May-2021, FATIGUE (Stayed in Bed) outcome was unknown. On 24-May-2021, TREMOR (Shaking) outcome was unknown. At the time of the report, ILLNESS (Called Sick to work), VOMITING (Threw-up, Could not eat,could not hold anything (Food), Threw up every day), NAUSEA (Nauseous) and HEADACHE (Pounding head pain) outcome was unknown.            No concomitant medication was reported   This case was linked to MOD-2021-163918 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; 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 RASH (Rash) 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 RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.   This case was linked to MOD-2021-163756 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received on 23-JUN-2021. No new information in Follow up document; Sender's Comments:  MOD-2021-163756:reporter case
Sex: U
Vaccine: COVID19
Symptoms: Injection site bruising
Clinical narrative: Bruise at the place of injection; 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 INJECTION SITE BRUISING (Bruise at the place of injection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication 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 INJECTION SITE BRUISING (Bruise at the place of injection). At the time of the report, INJECTION SITE BRUISING (Bruise at the place of injection) outcome was unknown.            Treatment information not provided. List of concomitant medication were not given.
Age: 54.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain, Therapeutic product effect decreased
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) and PAIN (Pain) in a 54-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. Concurrent medical conditions included Psoriatic arthritis. 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 THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) and PAIN (Pain). At the time of the report, THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) had not resolved and PAIN (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 concomitant medications were reported. Treatment information was not provided. This is not a valid case because there's no information about the date the patient took the vaccine and the start date of the adverse events. Therefore it is not possible to establish a causal relationship.; Sender's Comments: This is not a valid case because there's no information about the date the patient took the vaccine and the start date of the adverse events. Therefore it is not possible to establish a causal relationship.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fall
Clinical narrative: Fell; Bruises on both knees; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell) and CONTUSION (Bruises on both knees) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included Walker user and Falling. Concurrent medical conditions included Blood pressure high, Arthritis, Muscle spasms, Cane user, Weakness and Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS), HYDROCHLOROTHIAZIDE, METOPROLOL TARTRATE, BACLOFEN, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN B3, DULOXETINE and TIZANIDINE 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 20-Apr-2021, the patient experienced FALL (Fell) and CONTUSION (Bruises on both knees). At the time of the report, FALL (Fell) and CONTUSION (Bruises on both knees) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears; 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 TINNITUS (Ringing in ears) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.     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 TINNITUS (Ringing in ears). At the time of the report, TINNITUS (Ringing in ears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Erythema, Rash
Clinical narrative: red spots on her chest; chest tightness; red face that developed today; This spontaneous case was reported by a consumer and describes the occurrence of RASH (red spots on her chest), CHEST DISCOMFORT (chest tightness) and ERYTHEMA (red face that developed today) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (red spots on her chest), CHEST DISCOMFORT (chest tightness) and ERYTHEMA (red face that developed today). At the time of the report, RASH (red spots on her chest), CHEST DISCOMFORT (chest tightness) and ERYTHEMA (red face that developed today) outcome was unknown.            Concomitant information was not provided. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Injection site pain, Intentional dose omission, Lymphadenopathy
Clinical narrative: Palpitations in the heart; Drowsiness; Not taking second dose; Swelling in his left arm pit glands; Left arm pits sweat more comparatively than the right one; Swollen glands; Headaches; Tender pain on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations in the heart), SOMNOLENCE (Drowsiness), INTENTIONAL DOSE OMISSION (Not taking second dose), PERIPHERAL SWELLING (Swelling in his left arm pit glands) and HYPERHIDROSIS (Left arm pits sweat more comparatively than the right one) in a male 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 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Palpitations in the heart), SOMNOLENCE (Drowsiness), INTENTIONAL DOSE OMISSION (Not taking second dose), PERIPHERAL SWELLING (Swelling in his left arm pit glands), HYPERHIDROSIS (Left arm pits sweat more comparatively than the right one), LYMPHADENOPATHY (Swollen glands), HEADACHE (Headaches) and INJECTION SITE PAIN (Tender pain on the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, PALPITATIONS (Palpitations in the heart), SOMNOLENCE (Drowsiness), INTENTIONAL DOSE OMISSION (Not taking second dose), PERIPHERAL SWELLING (Swelling in his left arm pit glands), HYPERHIDROSIS (Left arm pits sweat more comparatively than the right one), LYMPHADENOPATHY (Swollen glands), HEADACHE (Headaches) and INJECTION SITE PAIN (Tender pain on the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       The concomitant medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received on 23-jul-21 with E mail updated and new event added.
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Peripheral swelling, Somnolence
Clinical narrative: Palpitations in the heart; Drowsiness; Not taking second dose; Swelling in his left arm pit glands; Left arm pits sweat more comparatively than the right one; Swollen glands; Headaches; Tender pain on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations in the heart), SOMNOLENCE (Drowsiness), INTENTIONAL DOSE OMISSION (Not taking second dose), PERIPHERAL SWELLING (Swelling in his left arm pit glands) and HYPERHIDROSIS (Left arm pits sweat more comparatively than the right one) in a male 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 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Palpitations in the heart), SOMNOLENCE (Drowsiness), INTENTIONAL DOSE OMISSION (Not taking second dose), PERIPHERAL SWELLING (Swelling in his left arm pit glands), HYPERHIDROSIS (Left arm pits sweat more comparatively than the right one), LYMPHADENOPATHY (Swollen glands), HEADACHE (Headaches) and INJECTION SITE PAIN (Tender pain on the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, PALPITATIONS (Palpitations in the heart), SOMNOLENCE (Drowsiness), INTENTIONAL DOSE OMISSION (Not taking second dose), PERIPHERAL SWELLING (Swelling in his left arm pit glands), HYPERHIDROSIS (Left arm pits sweat more comparatively than the right one), LYMPHADENOPATHY (Swollen glands), HEADACHE (Headaches) and INJECTION SITE PAIN (Tender pain on the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       The concomitant medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received on 23-jul-21 with E mail updated and new event added.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Tiredness; Headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FATIGUE (Tiredness) and HEADACHE (Headache) in a 44-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.    No Medical History information was reported.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 19-Mar-2021, the patient experienced HEADACHE (Headache). On 18-May-2021, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) and HEADACHE (Headache) 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.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     no medical history was provided.     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 VOMITING (vomiting). At the time of the report, VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was reported , No treatment medication was reported .   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia
Clinical narrative: My husband is having hard time swallowing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (My husband is having hard time swallowing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPHAGIA (My husband is having hard time swallowing). At the time of the report, DYSPHAGIA (My husband is having hard time swallowing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
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 female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    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 and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. 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 concomitant medication was reported. Treatment drug information was not given.   This case was linked to MOD-2021-163978 (Patient Link).
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Suspected COVID-19
Clinical narrative: Never received his second dose of the vaccine; Felt as if he had the COVID-19 virus all over again; This spontaneous case was reported by an other health care professional and describes the occurrence of SUSPECTED COVID-19 (Felt as if he had the COVID-19 virus all over again) and PRODUCT DOSE OMISSION ISSUE (Never received his second dose of the vaccine) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient was contracted with COVID-19 ,5 weeks before initial vaccination).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced SUSPECTED COVID-19 (Felt as if he had the COVID-19 virus all over again). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Never received his second dose of the vaccine). At the time of the report, SUSPECTED COVID-19 (Felt as if he had the COVID-19 virus all over again) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Never received his second dose of the vaccine) 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.   Concomitant product use was not provided by the reporter.  Patient received his first dose of the Moderna vaccine. One week later, he felt as if he had the COVID-19 virus all over again, and so the patient never received his second dose of the vaccine.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Unlikely, that the event  COVID-19 is related to the vaccine.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Unlikely, that the event  COVID-19 is related to the vaccine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Unlikely, that the event  COVID-19 is related to the vaccine.
Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Laboratory test abnormal, White blood cell count
Clinical narrative: joint pain; This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (joint pain) in a 48-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.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-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) 1 dosage form. In April 2021, the patient experienced ARTHRALGIA (joint pain). At the time of the report, ARTHRALGIA (joint pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Laboratory test abnormal: abnormal (abnormal) abnormal. In 2021, White blood cell count: low (Low) WBC count decresed.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No information on concomitant and treatment medication were reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Rashes are red; itchy; Rashes on right arm/ Rashes are comes and go; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Rashes are red), RASH PRURITIC (itchy) and RASH (Rashes on right arm/ Rashes are comes and go) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     Concurrent medical conditions included Bladder disorder and Neuropathy. Concomitant products included Blood pressure medicine.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, the patient experienced RASH ERYTHEMATOUS (Rashes are red), RASH PRURITIC (itchy) and RASH (Rashes on right arm/ Rashes are comes and go). At the time of the report, RASH ERYTHEMATOUS (Rashes are red), RASH PRURITIC (itchy) and RASH (Rashes on right arm/ Rashes are comes and go) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient is taking blood pressure medicine as concomitant. No treatment medication was taken.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: pain in muscles and body; 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 MYALGIA (pain in muscles and body) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter .     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 MYALGIA (pain in muscles and body). At the time of the report, MYALGIA (pain in muscles and body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Age: 69.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, COVID-19, Hangover, Hyperhidrosis, Mobility decreased
Clinical narrative: COVID-19; Sweating; Mobility decreased; Painful joints; Hangover; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19), HANGOVER (Hangover), HYPERHIDROSIS (Sweating), MOBILITY DECREASED (Mobility decreased) and ARTHRALGIA (Painful joints) in a 69-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) for Rheumatoid arthritis.    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. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In January 2021, the patient experienced COVID-19 (COVID-19) and HYPERHIDROSIS (Sweating). In 2021, the patient experienced HANGOVER (Hangover), MOBILITY DECREASED (Mobility decreased) and ARTHRALGIA (Painful joints). In 2021, COVID-19 (COVID-19), HANGOVER (Hangover) and ARTHRALGIA (Painful joints) had resolved. At the time of the report, HYPERHIDROSIS (Sweating) and MOBILITY DECREASED (Mobility decreased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  No treatment information was provided.
Age: 69.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: SARS-CoV-2 test
Clinical narrative: COVID-19; Sweating; Mobility decreased; Painful joints; Hangover; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19), HANGOVER (Hangover), HYPERHIDROSIS (Sweating), MOBILITY DECREASED (Mobility decreased) and ARTHRALGIA (Painful joints) in a 69-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) for Rheumatoid arthritis.    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. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In January 2021, the patient experienced COVID-19 (COVID-19) and HYPERHIDROSIS (Sweating). In 2021, the patient experienced HANGOVER (Hangover), MOBILITY DECREASED (Mobility decreased) and ARTHRALGIA (Painful joints). In 2021, COVID-19 (COVID-19), HANGOVER (Hangover) and ARTHRALGIA (Painful joints) had resolved. At the time of the report, HYPERHIDROSIS (Sweating) and MOBILITY DECREASED (Mobility decreased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I feel like I have 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 (I feel like I have a fever) 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 PYREXIA (I feel like I have a fever). At the time of the report, PYREXIA (I feel like I have a fever) outcome was unknown.            Reporter did not allow further contact
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Improper storage of product in use; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Improper storage of product in use) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PRODUCT STORAGE ERROR (Improper storage of product in use) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Mar-2021, PRODUCT STORAGE ERROR (Improper storage of product in use) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provider by the reporter.  Treatment information was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-163779 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-163779:Same reporter
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: pain at injection right arm; fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-May-2021 and was forwarded to Moderna on 24-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection right arm) and FATIGUE (fatigue) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014MZ01 and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at injection right arm) and FATIGUE (fatigue). On 18-Mar-2021, VACCINATION SITE PAIN (pain at injection right arm) and FATIGUE (fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported  No treatment medication was reported
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 female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No medical history were 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. 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 concomitant information was reported. No treatment information was provided.   This case was linked to MOD-2021-163966 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed second dose, and its over 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose, and its over 42 days) 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 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose, and its over 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose, and its over 42 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Report side effects; 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 VACCINATION COMPLICATION (report side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (report side effects). At the time of the report, VACCINATION COMPLICATION (report side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: have a fever of 102; 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 (have a fever of 102) 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 PYREXIA (have a fever of 102). At the time of the report, PYREXIA (have a fever of 102) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (Inconclusive) 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Bad reaction to the Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Bad reaction to the Moderna vaccine). At the time of the report, VACCINATION COMPLICATION (Bad reaction to the Moderna vaccine) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not  reported.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Incorrect route of product administration
Clinical narrative: Incorrect route of product administration; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Incorrect route of product administration) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for CLL.    On an unknown date, the patient experienced NO ANTIBODIES AFTER COVID VACCINE.  COVID-19 VACCINE was also considered suspect.  Patient was not enrolled in a COVID-19 Vaccine Trial.  On unknown date, the patient received 1st dose COVID-19 Vaccine manufactured by Moderna, lot number unknown, expiration date unknown.  The patient's past medical history included Breast cancer. Concurrent medical conditions included High cholesterol and Low blood pressure. Concomitant products included CALCIUM CITRATE, DIMENHYDRINATE (DRAMAMINE), IRON, OMEPRAZOLE, PREDNISOLONE, PREDNISONE, SIMVASTATIN and PARACETAMOL (TYLENOL) for an unknown indication.   On 14-Sep-2020, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 mg. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Incorrect route of product administration). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Incorrect route of product administration) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative (Negative) Antibody test negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) was unknown.       Adverse reaction: Antibody test Negative
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: feelingtired; have low 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 FATIGUE (feelingtired) and PYREXIA (have low fever) 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 FATIGUE (feelingtired) and PYREXIA (have low fever). At the time of the report, FATIGUE (feelingtired) and PYREXIA (have low fever) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. No concomitant medications were reported. Treatment information was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This spontaneous case was reported by an other and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    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 INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was provided.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15 years old received vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 years old received vaccine) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021 at 2:02 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 years old received vaccine). On 24-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 years old received vaccine) had resolved.        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.   The patient at the time of receiving the first dose of Moderna Vaccine was 15 year old and it was noticed only when the patient appeared for second dose. No adverse reaction was reported per patient's parent statement and said that the patient was fine.  No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-239381 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow up information was received on 25-Jun-2021. Updated patient demographics. Updated the action taken to no change from unknown. Updated the description of the event in the i-narrative.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID 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 COVID-19 (COVID 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 COVID-19 (COVID symptoms). At the time of the report, COVID-19 (COVID symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided  Treatment medication was not provided  Action taken with mRNA-1273 Moderna vaccine was Not applicable