chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Red blood cell count, Slow speech, Urine analysis, Vaccination site pain
Clinical narrative: Weakness of the hands; Muscle weakness; Memory is "funky"; Slow speech; Unable to stand; Difficulty swallowing; Lost a lot of weight; Not eating; Rashes all over the body; Feeling tired all the time; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness of the hands), MUSCULAR WEAKNESS (Muscle weakness), MEMORY IMPAIRMENT (Memory is "funky"), SLOW SPEECH (Slow speech) and DYSSTASIA (Unable to stand) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 0308218) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced MUSCULAR WEAKNESS (Weakness of the hands), MUSCULAR WEAKNESS (Muscle weakness), MEMORY IMPAIRMENT (Memory is "funky"), SLOW SPEECH (Slow speech), DYSSTASIA (Unable to stand), DYSPHAGIA (Difficulty swallowing), WEIGHT DECREASED (Lost a lot of weight), RASH (Rashes all over the body), FATIGUE (Feeling tired all the time) and VACCINATION SITE PAIN (Pain at the injection site). 04-Apr-2021, the patient experienced DECREASED APPETITE (Not eating). At the time of the report, MUSCULAR WEAKNESS (Weakness of the hands), MUSCULAR WEAKNESS (Muscle weakness), MEMORY IMPAIRMENT (Memory is "funky"), SLOW SPEECH (Slow speech), FATIGUE (Feeling tired all the time) and VACCINATION SITE PAIN (Pain at the injection site) had not resolved, DYSSTASIA (Unable to stand), DYSPHAGIA (Difficulty swallowing), WEIGHT DECREASED (Lost a lot of weight) and DECREASED APPETITE (Not eating) outcome was unknown and RASH (Rashes all over the body) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Amino acid level: high (High) high. On an unknown date, Blood test: normal (normal) normal. On an unknown date, Protein total: high (High) high. On an unknown date, Protein urine: high (High) high. On an unknown date, Red blood cell count: 4.48 (Low) 4.48. On an unknown date, Urine analysis: normal (normal) normal.         No treatment medications were reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Weakness of the hands; Muscle weakness; Memory is "funky"; Slow speech; Unable to stand; Difficulty swallowing; Lost a lot of weight; Not eating; Rashes all over the body; Feeling tired all the time; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness of the hands), MUSCULAR WEAKNESS (Muscle weakness), MEMORY IMPAIRMENT (Memory is "funky"), SLOW SPEECH (Slow speech) and DYSSTASIA (Unable to stand) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 0308218) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced MUSCULAR WEAKNESS (Weakness of the hands), MUSCULAR WEAKNESS (Muscle weakness), MEMORY IMPAIRMENT (Memory is "funky"), SLOW SPEECH (Slow speech), DYSSTASIA (Unable to stand), DYSPHAGIA (Difficulty swallowing), WEIGHT DECREASED (Lost a lot of weight), RASH (Rashes all over the body), FATIGUE (Feeling tired all the time) and VACCINATION SITE PAIN (Pain at the injection site). 04-Apr-2021, the patient experienced DECREASED APPETITE (Not eating). At the time of the report, MUSCULAR WEAKNESS (Weakness of the hands), MUSCULAR WEAKNESS (Muscle weakness), MEMORY IMPAIRMENT (Memory is "funky"), SLOW SPEECH (Slow speech), FATIGUE (Feeling tired all the time) and VACCINATION SITE PAIN (Pain at the injection site) had not resolved, DYSSTASIA (Unable to stand), DYSPHAGIA (Difficulty swallowing), WEIGHT DECREASED (Lost a lot of weight) and DECREASED APPETITE (Not eating) outcome was unknown and RASH (Rashes all over the body) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Amino acid level: high (High) high. On an unknown date, Blood test: normal (normal) normal. On an unknown date, Protein total: high (High) high. On an unknown date, Protein urine: high (High) high. On an unknown date, Red blood cell count: 4.48 (Low) 4.48. On an unknown date, Urine analysis: normal (normal) normal.         No treatment medications were reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Enlarged uvula, Gingival pruritus, Hypersensitivity, Tongue pruritus
Clinical narrative: Allergic reaction; Gums and tongue itchy; Gums and tongue itchy; Uvula was swollen; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), TONGUE PRURITUS (Gums and tongue itchy), GINGIVAL PRURITUS (Gums and tongue itchy) and ENLARGED UVULA (Uvula was swollen) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction), TONGUE PRURITUS (Gums and tongue itchy), GINGIVAL PRURITUS (Gums and tongue itchy) and ENLARGED UVULA (Uvula was swollen). The patient was treated with EPINEPHRINE (EPIPEN) at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Allergic reaction), TONGUE PRURITUS (Gums and tongue itchy), GINGIVAL PRURITUS (Gums and tongue itchy) and ENLARGED UVULA (Uvula was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  The patient was transported to emergency room on ambulance. In Emergency room, some medicine was given.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received third covid shot by accident; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received third covid shot by accident) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ALPRAZOLAM (XANAX), SIMVASTATIN and ATENOLOL for an unknown indication.   On 17-May-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 17-May-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient received third covid shot by accident). On 17-May-2021, EXTRA DOSE ADMINISTERED (Patient received third covid shot by accident) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received third shot  two weeks later after the first dose by accident.  Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headaches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 013N20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) had not resolved.            No concomitant and treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Flushing, Haemoptysis
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Shortness of breath\shortness of breath when active), FLUSHING (Hot face), DIZZINESS (Dizziness), HAEMOPTYSIS (Cough had bright red bleeding) and CHILLS (Freezing) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product TREPROSTINIL SODIUM (TYVASO) for Pulmonary arterial hypertension. Concurrent medical conditions included Pulmonary arterial hypertension. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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 started TREPROSTINIL SODIUM (TYVASO) (Nasal) 18-54 µg, QID. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath\shortness of breath when active), FLUSHING (Hot face), DIZZINESS (Dizziness), HAEMOPTYSIS (Cough had bright red bleeding) and CHILLS (Freezing). At the time of the report, DYSPNOEA (Shortness of breath\shortness of breath when active), FLUSHING (Hot face), HAEMOPTYSIS (Cough had bright red bleeding) and CHILLS (Freezing) outcome was unknown and DIZZINESS (Dizziness) was resolving. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Oxygen saturation: 87 (Low) Abnormal and 70-80 (Low) Abnormal. On 03-Mar-2021, Oxygen saturation: 85 (Low) Abnormal, 50 (Low) Abnormal and 60 (Low) Abnormal. On an unknown date, Heart rate: 100 (High) Abnormal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication list was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Oxygen saturation
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Shortness of breath\shortness of breath when active), FLUSHING (Hot face), DIZZINESS (Dizziness), HAEMOPTYSIS (Cough had bright red bleeding) and CHILLS (Freezing) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product TREPROSTINIL SODIUM (TYVASO) for Pulmonary arterial hypertension. Concurrent medical conditions included Pulmonary arterial hypertension. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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 started TREPROSTINIL SODIUM (TYVASO) (Nasal) 18-54 µg, QID. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath\shortness of breath when active), FLUSHING (Hot face), DIZZINESS (Dizziness), HAEMOPTYSIS (Cough had bright red bleeding) and CHILLS (Freezing). At the time of the report, DYSPNOEA (Shortness of breath\shortness of breath when active), FLUSHING (Hot face), HAEMOPTYSIS (Cough had bright red bleeding) and CHILLS (Freezing) outcome was unknown and DIZZINESS (Dizziness) was resolving. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Oxygen saturation: 87 (Low) Abnormal and 70-80 (Low) Abnormal. On 03-Mar-2021, Oxygen saturation: 85 (Low) Abnormal, 50 (Low) Abnormal and 60 (Low) Abnormal. On an unknown date, Heart rate: 100 (High) Abnormal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication list was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Stiff neck; Sore arm; Tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck), PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included METOPROLOL for Blood pressure management, VITAMINS NOS for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck), PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired) and HEADACHE (Headache). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck), PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.   This case was linked to MOD-2021-141949 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on foot between two toes and going on top of foot after 2nd dose/Rash on other side of foot after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on foot between two toes and going on top of foot after 2nd dose/Rash on other side of foot after 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced RASH (Rash on foot between two toes and going on top of foot after 2nd dose/Rash on other side of foot after 2nd dose). At the time of the report, RASH (Rash on foot between two toes and going on top of foot after 2nd dose/Rash on other side of foot after 2nd dose) outcome was unknown.            No concomitant products were reported.  Treatment information provided included cold compress on the rash.  She says that cleared up too, then she got one on the side of her foot, which she still has. She said she now had one on the other side of her foot.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Started having symptom after 1st dose after having Covid; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Started having symptom after 1st dose after having Covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not provided) 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) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (Started having symptom after 1st dose after having Covid). At the time of the report, VACCINATION COMPLICATION (Started having symptom after 1st dose after having Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity
Clinical narrative: Arm pain; Lower back pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) and BACK PAIN (Lower back pain) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019BZ1A and 026AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included BPH. Concomitant products included TAMSULOSIN for BPH, METOPROLOL and LISINOPRIL (ZESTRIL) for Blood pressure high, ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for Cholesterol blood excessive, IBUPROFEN (ADVIL [IBUPROFEN]) and VARENICLINE TARTRATE (CHANTIX) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm pain) and BACK PAIN (Lower back pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) and BACK PAIN (Lower back pain) outcome was unknown.            No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysphagia, Formication, Headache, Hyperhidrosis
Clinical narrative: Has been sick ever since; It feels tight in throat/feeling throat closing up; Big lumps in head, one in ear; Throat felt like could not swallow; Something crawling up body; Itching all over the body; Perspiration all over body; Liquid came out from ear; Want to scratch; Chills; Headache terrible; Body aches; Waves of nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Has been sick ever since), THROAT TIGHTNESS (It feels tight in throat/feeling throat closing up), MASS (Big lumps in head, one in ear), DYSPHAGIA (Throat felt like could not swallow) and FORMICATION (Something crawling up body) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LOSARTAN POTASSIUM (COZAAR) and OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 11-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 ILLNESS (Has been sick ever since), THROAT TIGHTNESS (It feels tight in throat/feeling throat closing up), MASS (Big lumps in head, one in ear), DYSPHAGIA (Throat felt like could not swallow), FORMICATION (Something crawling up body), PRURITUS (Itching all over the body), HYPERHIDROSIS (Perspiration all over body), OTORRHOEA (Liquid came out from ear), SCRATCH (Want to scratch), CHILLS (Chills), HEADACHE (Headache terrible), MYALGIA (Body aches) and NAUSEA (Waves of nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ILLNESS (Has been sick ever since), THROAT TIGHTNESS (It feels tight in throat/feeling throat closing up), MASS (Big lumps in head, one in ear), DYSPHAGIA (Throat felt like could not swallow), FORMICATION (Something crawling up body), PRURITUS (Itching all over the body), HYPERHIDROSIS (Perspiration all over body), OTORRHOEA (Liquid came out from ear), SCRATCH (Want to scratch), CHILLS (Chills), MYALGIA (Body aches) and NAUSEA (Waves of nausea) outcome was unknown and HEADACHE (Headache terrible) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up received contains no new information.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Mass, Myalgia, Nausea, Otorrhoea
Clinical narrative: Has been sick ever since; It feels tight in throat/feeling throat closing up; Big lumps in head, one in ear; Throat felt like could not swallow; Something crawling up body; Itching all over the body; Perspiration all over body; Liquid came out from ear; Want to scratch; Chills; Headache terrible; Body aches; Waves of nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Has been sick ever since), THROAT TIGHTNESS (It feels tight in throat/feeling throat closing up), MASS (Big lumps in head, one in ear), DYSPHAGIA (Throat felt like could not swallow) and FORMICATION (Something crawling up body) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LOSARTAN POTASSIUM (COZAAR) and OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 11-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 ILLNESS (Has been sick ever since), THROAT TIGHTNESS (It feels tight in throat/feeling throat closing up), MASS (Big lumps in head, one in ear), DYSPHAGIA (Throat felt like could not swallow), FORMICATION (Something crawling up body), PRURITUS (Itching all over the body), HYPERHIDROSIS (Perspiration all over body), OTORRHOEA (Liquid came out from ear), SCRATCH (Want to scratch), CHILLS (Chills), HEADACHE (Headache terrible), MYALGIA (Body aches) and NAUSEA (Waves of nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ILLNESS (Has been sick ever since), THROAT TIGHTNESS (It feels tight in throat/feeling throat closing up), MASS (Big lumps in head, one in ear), DYSPHAGIA (Throat felt like could not swallow), FORMICATION (Something crawling up body), PRURITUS (Itching all over the body), HYPERHIDROSIS (Perspiration all over body), OTORRHOEA (Liquid came out from ear), SCRATCH (Want to scratch), CHILLS (Chills), MYALGIA (Body aches) and NAUSEA (Waves of nausea) outcome was unknown and HEADACHE (Headache terrible) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up received contains no new information.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Scratch, Throat tightness
Clinical narrative: Has been sick ever since; It feels tight in throat/feeling throat closing up; Big lumps in head, one in ear; Throat felt like could not swallow; Something crawling up body; Itching all over the body; Perspiration all over body; Liquid came out from ear; Want to scratch; Chills; Headache terrible; Body aches; Waves of nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Has been sick ever since), THROAT TIGHTNESS (It feels tight in throat/feeling throat closing up), MASS (Big lumps in head, one in ear), DYSPHAGIA (Throat felt like could not swallow) and FORMICATION (Something crawling up body) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LOSARTAN POTASSIUM (COZAAR) and OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 11-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 ILLNESS (Has been sick ever since), THROAT TIGHTNESS (It feels tight in throat/feeling throat closing up), MASS (Big lumps in head, one in ear), DYSPHAGIA (Throat felt like could not swallow), FORMICATION (Something crawling up body), PRURITUS (Itching all over the body), HYPERHIDROSIS (Perspiration all over body), OTORRHOEA (Liquid came out from ear), SCRATCH (Want to scratch), CHILLS (Chills), HEADACHE (Headache terrible), MYALGIA (Body aches) and NAUSEA (Waves of nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ILLNESS (Has been sick ever since), THROAT TIGHTNESS (It feels tight in throat/feeling throat closing up), MASS (Big lumps in head, one in ear), DYSPHAGIA (Throat felt like could not swallow), FORMICATION (Something crawling up body), PRURITUS (Itching all over the body), HYPERHIDROSIS (Perspiration all over body), OTORRHOEA (Liquid came out from ear), SCRATCH (Want to scratch), CHILLS (Chills), MYALGIA (Body aches) and NAUSEA (Waves of nausea) outcome was unknown and HEADACHE (Headache terrible) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up received contains no new information.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Strong headache; Fever; Body aches; Joint aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Strong headache), PYREXIA (Fever), MYALGIA (Body aches), ARTHRALGIA (Joint aches) and CHILLS (Chills) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 006C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Allergy (sneezing, runny nose). Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced HEADACHE (Strong headache), PYREXIA (Fever), MYALGIA (Body aches), ARTHRALGIA (Joint aches) and CHILLS (Chills). At the time of the report, HEADACHE (Strong headache), PYREXIA (Fever), MYALGIA (Body aches), ARTHRALGIA (Joint aches) and CHILLS (Chills) outcome was unknown.            Concomitant medication included high blood pressure medication.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza, Nausea, Pyrexia
Clinical narrative: Full blown flu symptoms; Headache; Fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Full blown flu symptoms), HEADACHE (Headache), PYREXIA (Fever) and NAUSEA (nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No medical history information was reported.     On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced INFLUENZA (Full blown flu symptoms), HEADACHE (Headache), PYREXIA (Fever) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-May-2021, INFLUENZA (Full blown flu symptoms), HEADACHE (Headache), PYREXIA (Fever) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medication include progesterone, estrogen, testosterone for menopause.  Within 20 minutes she experienced a headache, 10 minutes after that a fever. Temperature unknown. Within 1 hour, she experienced full blown flu symptoms and nausea.   Patient described symptoms as a cross between the worst hangover and flu. Patient is not actively experiencing any symptoms at the current time.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 36 days without receiving the second dose.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days without receiving the second dose.) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-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 PRODUCT DOSE OMISSION ISSUE (More than 36 days without receiving the second dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days without receiving the second dose.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided No treatment was reported
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Malaise, Pain in extremity
Clinical narrative: Feeling sick/ been in bed; Dizzy; Feels bad; Right arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick/ been in bed), DIZZINESS (Dizzy), FEELING ABNORMAL (Feels bad) and PAIN IN EXTREMITY (Right arm hurts) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Diabetes and Sarcoidosis.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced MALAISE (Feeling sick/ been in bed), DIZZINESS (Dizzy), FEELING ABNORMAL (Feels bad) and PAIN IN EXTREMITY (Right arm hurts). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MALAISE (Feeling sick/ been in bed) had not resolved and DIZZINESS (Dizzy), FEELING ABNORMAL (Feels bad) and PAIN IN EXTREMITY (Right arm hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included blood pressure medication, diabetes injectable medication, medication for sarcoidosis and t-galopen.
Sex: M
Vaccine: COVID19
Symptoms: Breast enlargement, Breast pain, Joint swelling, Myalgia, Wrist deformity
Clinical narrative: Swelling in his joints; Soft tissue of his breast is enlarged; Soft tissue of the breast was very tender; Wrist nodules poke out on the side of wrists; Been feeling achy ever since; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swelling in his joints), BREAST ENLARGEMENT (Soft tissue of his breast is enlarged), BREAST PAIN (Soft tissue of the breast was very tender), WRIST DEFORMITY (Wrist nodules poke out on the side of wrists) and MYALGIA (Been feeling achy ever since) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (Swelling in his joints), BREAST ENLARGEMENT (Soft tissue of his breast is enlarged), BREAST PAIN (Soft tissue of the breast was very tender), WRIST DEFORMITY (Wrist nodules poke out on the side of wrists) and MYALGIA (Been feeling achy ever since). At the time of the report, JOINT SWELLING (Swelling in his joints), BREAST ENLARGEMENT (Soft tissue of his breast is enlarged), BREAST PAIN (Soft tissue of the breast was very tender), WRIST DEFORMITY (Wrist nodules poke out on the side of wrists) and MYALGIA (Been feeling achy ever since) had not resolved.            Concomitant product use was not provided by the reporter.  No treatment information was provided.    Reporter did not allow further contact
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Malaise, Oropharyngeal pain, Pain in extremity, Tongue disorder
Clinical narrative: Sore throat; Bumps on tongue; Not feeling good at all; Shoulder and arms hurt really bad; Shoulder and arms hurt really bad; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), TONGUE DISORDER (Bumps on tongue), MALAISE (Not feeling good at all), PAIN IN EXTREMITY (Shoulder and arms hurt really bad) and ARTHRALGIA (Shoulder and arms hurt really bad) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seizures and Blood pressure high. Concomitant products included AMLODIPINE and ENALAPRIL for Blood pressure high, ACETYLSALICYLIC ACID (ASPIRIN 81) for Cardiac disorder, GABAPENTIN (GABAPENTINE) for Seizures.   On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), TONGUE DISORDER (Bumps on tongue), MALAISE (Not feeling good at all), PAIN IN EXTREMITY (Shoulder and arms hurt really bad) and ARTHRALGIA (Shoulder and arms hurt really bad). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), TONGUE DISORDER (Bumps on tongue), MALAISE (Not feeling good at all), PAIN IN EXTREMITY (Shoulder and arms hurt really bad) and ARTHRALGIA (Shoulder and arms hurt really bad) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Chills, Discomfort, Fatigue, Malaise
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick to her stomach), DISCOMFORT (Uncomfortable), ALOPECIA (Hair loss), PAIN IN EXTREMITY (Arm started to hurt across the back and to the other arm) and PYREXIA (Fever of 101-102 degrees Fahrenheit) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013N20A and 013N20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ATORVASTATIN, HYDROCHLOROTHIAZIDE, VITAMIN C [ASCORBIC ACID], ZINC, COLECALCIFEROL (VITAMIN D3) and LOTEPREDNOL ETABONATE (LOTEMAX) for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced ALOPECIA (Hair loss). On 16-Apr-2021, the patient experienced MALAISE (Feeling sick to her stomach), DISCOMFORT (Uncomfortable) and PYREXIA (Fever of 101-102 degrees Fahrenheit). 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm started to hurt across the back and to the other arm) and FATIGUE (In bed for 24 hours). 16-Apr-2021, the patient experienced CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. On 17-Apr-2021, FATIGUE (In bed for 24 hours) and CHILLS (Chills) had resolved. At the time of the report, MALAISE (Feeling sick to her stomach), DISCOMFORT (Uncomfortable), ALOPECIA (Hair loss), PAIN IN EXTREMITY (Arm started to hurt across the back and to the other arm) and PYREXIA (Fever of 101-102 degrees Fahrenheit) outcome was unknown. Action taken with the drug in response to events was not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-143038, US-MODERNATX, INC.-MOD-2021-142994 (E2B Linked Report). This case was linked to MOD-2021-142282 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-143038:crosslinked; husband dose 2. US-MODERNATX, INC.-MOD-2021-142994:crosslinked; husband dose 1.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick to her stomach), DISCOMFORT (Uncomfortable), ALOPECIA (Hair loss), PAIN IN EXTREMITY (Arm started to hurt across the back and to the other arm) and PYREXIA (Fever of 101-102 degrees Fahrenheit) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013N20A and 013N20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ATORVASTATIN, HYDROCHLOROTHIAZIDE, VITAMIN C [ASCORBIC ACID], ZINC, COLECALCIFEROL (VITAMIN D3) and LOTEPREDNOL ETABONATE (LOTEMAX) for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced ALOPECIA (Hair loss). On 16-Apr-2021, the patient experienced MALAISE (Feeling sick to her stomach), DISCOMFORT (Uncomfortable) and PYREXIA (Fever of 101-102 degrees Fahrenheit). 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm started to hurt across the back and to the other arm) and FATIGUE (In bed for 24 hours). 16-Apr-2021, the patient experienced CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. On 17-Apr-2021, FATIGUE (In bed for 24 hours) and CHILLS (Chills) had resolved. At the time of the report, MALAISE (Feeling sick to her stomach), DISCOMFORT (Uncomfortable), ALOPECIA (Hair loss), PAIN IN EXTREMITY (Arm started to hurt across the back and to the other arm) and PYREXIA (Fever of 101-102 degrees Fahrenheit) outcome was unknown. Action taken with the drug in response to events was not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-143038, US-MODERNATX, INC.-MOD-2021-142994 (E2B Linked Report). This case was linked to MOD-2021-142282 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-143038:crosslinked; husband dose 2. US-MODERNATX, INC.-MOD-2021-142994:crosslinked; husband dose 1.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: overdue to take the second dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (overdue to take the second dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (overdue to take the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (overdue to take the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Mobility decreased, Peripheral swelling
Clinical narrative: moreso in left leg; chills; struggle to get up,legs will just give out; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (struggle to get up,legs will just give out), PERIPHERAL SWELLING (moreso in left leg) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and 027C218) for COVID-19 vaccination.     Concomitant products included DULOXETINE.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced MOBILITY DECREASED (struggle to get up,legs will just give out) and CHILLS (chills). On an unknown date, the patient experienced PERIPHERAL SWELLING (moreso in left leg). On 15-May-2021, CHILLS (chills) had resolved. At the time of the report, MOBILITY DECREASED (struggle to get up,legs will just give out) and PERIPHERAL SWELLING (moreso in left leg) outcome was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash
Clinical narrative: "Rash localized on right inner thigh", Rash description: "Lacey, reticulated, localized vascular pattern"; "Had a little headache"; This spontaneous case was reported by a patient and describes the occurrence of RASH ("Rash localized on right inner thigh", Rash description: "Lacey, reticulated, localized vascular pattern") and HEADACHE ("Had a little headache") in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     Concomitant products included VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), ZINC, MULTIVITAMIN [VITAMINS NOS] and CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE (OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]) for an unknown indication.    On 12-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 RASH ("Rash localized on right inner thigh", Rash description: "Lacey, reticulated, localized vascular pattern") and HEADACHE ("Had a little headache"). At the time of the report, RASH ("Rash localized on right inner thigh", Rash description: "Lacey, reticulated, localized vascular pattern") and HEADACHE ("Had a little headache") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment products reported.   This case was linked to MOD21-091683, MOD21-091684, MOD21-091689, US-MODERNATX, INC.-MOD-2021-143088 (E2B Linked Report). This case was linked to MOD-2021-142886 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Non-significant follow up received on 18 May 2021; Sender's Comments:  MOD21-091683:crosslinked MOD21-091684:crosslinked MOD21-091689:crosslinked US-MODERNATX, INC.-MOD-2021-143088:Crosslink
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Swelling face
Clinical narrative: bruising all over body; swelling to the left side of face; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling to the left side of face) and CONTUSION (bruising all over body) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced SWELLING FACE (swelling to the left side of face). On 10-Apr-2021, the patient experienced CONTUSION (bruising all over body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, SWELLING FACE (swelling to the left side of face) and CONTUSION (bruising all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.         No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: my son is extremely sick after the Moderna vaccination doses; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (my son is extremely sick after the Moderna vaccination doses) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced ILLNESS (my son is extremely sick after the Moderna vaccination doses). At the time of the report, ILLNESS (my son is extremely sick after the Moderna vaccination doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-073303 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073303:crosslinked
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Rushed to the emergency department day after second dose of 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 ADVERSE EVENT (Rushed to the emergency department day after second dose of 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 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 17-May-2021, the patient experienced ADVERSE EVENT (Rushed to the emergency department day after second dose of vaccine). At the time of the report, ADVERSE EVENT (Rushed to the emergency department day after second dose of vaccine) outcome was unknown.            No concomitant medications were reported.  No treatment medications were provided by the reporter.