chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: Describes a feeling of taking a nap in a deep sleep and he wakes up and things are groggy; fogginess this feeling lasts all day; Hard to focus, hard to concentrate, and does not feel like himself; Major headaches in temple, top of head and whole head; Extreme Fatigue once he got home; Nauseas within 15 minutes of the vaccine; Arm was warm at injection site within 15 minutes of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm was warm at injection site within 15 minutes of the vaccine), SOMNOLENCE (Describes a feeling of taking a nap in a deep sleep and he wakes up and things are groggy), FEELING ABNORMAL (fogginess this feeling lasts all day ), DISTURBANCE IN ATTENTION (Hard to focus, hard to concentrate, and does not feel like himself) and HEADACHE (Major headaches in temple, top of head and whole head) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A - 51 - 042870) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN, NAPROXEN, CYCLOBENZAPRINE, GABAPENTIN and MARIJUANA for an unknown indication.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced VACCINATION SITE WARMTH (Arm was warm at injection site within 15 minutes of the vaccine), HEADACHE (Major headaches in temple, top of head and whole head), FATIGUE (Extreme Fatigue once he got home) and NAUSEA (Nauseas within 15 minutes of the vaccine). On an unknown date, the patient experienced SOMNOLENCE (Describes a feeling of taking a nap in a deep sleep and he wakes up and things are groggy), FEELING ABNORMAL (fogginess this feeling lasts all day ) and DISTURBANCE IN ATTENTION (Hard to focus, hard to concentrate, and does not feel like himself). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 19-May-2021, NAUSEA (Nauseas within 15 minutes of the vaccine) had resolved. At the time of the report, VACCINATION SITE WARMTH (Arm was warm at injection site within 15 minutes of the vaccine), SOMNOLENCE (Describes a feeling of taking a nap in a deep sleep and he wakes up and things are groggy), FEELING ABNORMAL (fogginess this feeling lasts all day ), DISTURBANCE IN ATTENTION (Hard to focus, hard to concentrate, and does not feel like himself), HEADACHE (Major headaches in temple, top of head and whole head) and FATIGUE (Extreme Fatigue once he got home) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site warmth
Clinical narrative: Describes a feeling of taking a nap in a deep sleep and he wakes up and things are groggy; fogginess this feeling lasts all day; Hard to focus, hard to concentrate, and does not feel like himself; Major headaches in temple, top of head and whole head; Extreme Fatigue once he got home; Nauseas within 15 minutes of the vaccine; Arm was warm at injection site within 15 minutes of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm was warm at injection site within 15 minutes of the vaccine), SOMNOLENCE (Describes a feeling of taking a nap in a deep sleep and he wakes up and things are groggy), FEELING ABNORMAL (fogginess this feeling lasts all day ), DISTURBANCE IN ATTENTION (Hard to focus, hard to concentrate, and does not feel like himself) and HEADACHE (Major headaches in temple, top of head and whole head) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A - 51 - 042870) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN, NAPROXEN, CYCLOBENZAPRINE, GABAPENTIN and MARIJUANA for an unknown indication.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced VACCINATION SITE WARMTH (Arm was warm at injection site within 15 minutes of the vaccine), HEADACHE (Major headaches in temple, top of head and whole head), FATIGUE (Extreme Fatigue once he got home) and NAUSEA (Nauseas within 15 minutes of the vaccine). On an unknown date, the patient experienced SOMNOLENCE (Describes a feeling of taking a nap in a deep sleep and he wakes up and things are groggy), FEELING ABNORMAL (fogginess this feeling lasts all day ) and DISTURBANCE IN ATTENTION (Hard to focus, hard to concentrate, and does not feel like himself). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 19-May-2021, NAUSEA (Nauseas within 15 minutes of the vaccine) had resolved. At the time of the report, VACCINATION SITE WARMTH (Arm was warm at injection site within 15 minutes of the vaccine), SOMNOLENCE (Describes a feeling of taking a nap in a deep sleep and he wakes up and things are groggy), FEELING ABNORMAL (fogginess this feeling lasts all day ), DISTURBANCE IN ATTENTION (Hard to focus, hard to concentrate, and does not feel like himself), HEADACHE (Major headaches in temple, top of head and whole head) and FATIGUE (Extreme Fatigue once he got home) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Report a side effect; 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 a side effect) 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 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 a side effect). At the time of the report, VACCINATION COMPLICATION (Report a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Sinus disorder, Viral infection
Clinical narrative: He had bad sinus; He lost his appetite.; It felt just like a viral infection.; About 4 hours later, he had headache.; He had fatigue; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SINUS DISORDER (He had bad sinus), DECREASED APPETITE (He lost his appetite.), VIRAL INFECTION (It felt just like a viral infection.), HEADACHE (About 4 hours later, he had headache.) and FATIGUE (He had fatigue) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     Medical history was not reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced SINUS DISORDER (He had bad sinus), DECREASED APPETITE (He lost his appetite.), VIRAL INFECTION (It felt just like a viral infection.), HEADACHE (About 4 hours later, he had headache.) and FATIGUE (He had fatigue). The patient was treated with CHLORPHENAMINE MALEATE, IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (ADVIL COLD AND SINUS PLUS) ongoing since an unknown date at an unspecified dose and frequency and PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SINUS DISORDER (He had bad sinus), DECREASED APPETITE (He lost his appetite.), VIRAL INFECTION (It felt just like a viral infection.) and HEADACHE (About 4 hours later, he had headache.) outcome was unknown and FATIGUE (He had fatigue) had not resolved.        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.   Concomitant medication includes Blood pressure medication.   The reporter stated the symptoms were all the like having virus but exaggerated.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Averse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION (Averse event) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Averse event). At the time of the report, VACCINATION COMPLICATION (Averse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Stent placement
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of STENT PLACEMENT (I have had first moderna. Have heart stent and 79) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Stent placement (Have heart stent and 79.). 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 STENT PLACEMENT (I have had first moderna. Have heart stent and 79). At the time of the report, STENT PLACEMENT (I have had first moderna. Have heart stent and 79) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitants were reported. No treatment was reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort
Clinical narrative: Temporary numbness between wrist and shoulder of left arm; Temporary loss of function in left arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Temporary numbness between wrist and shoulder of left arm) and LIMB DISCOMFORT (Temporary loss of function in left arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis (Gradual improvement.) since 1996 and Hypertension since 2018. Concomitant products included HYDROXYCHLOROQUINE and ASPIRIN [ACETYLSALICYLIC ACID] for Arthritis, METOPROLOL for Hypertension, METHOTREXATE and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for Rheumatoid arthritis.    On 08-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 HYPOAESTHESIA (Temporary numbness between wrist and shoulder of left arm) and LIMB DISCOMFORT (Temporary loss of function in left arm). On 11-Apr-2021, HYPOAESTHESIA (Temporary numbness between wrist and shoulder of left arm) and LIMB DISCOMFORT (Temporary loss of function in left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided   This case was linked to MOD-2021-266384 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up received  on 24-jul-2021. No New Information. On 25-Jul-2021: Significant Follow up received on 26-Jul-2021.Patient medical history updated, concomitant medications, 2nd dose events updated.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Illness, Vomiting
Clinical narrative: sick really bad; Vomiting; Bad headache; 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 ILLNESS (sick really bad), VOMITING (Vomiting) and HEADACHE (Bad headache) 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 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 ILLNESS (sick really bad), VOMITING (Vomiting) and HEADACHE (Bad headache). At the time of the report, ILLNESS (sick really bad), VOMITING (Vomiting) and HEADACHE (Bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided by the reporter no treatment information reported by the reporter   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; 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 VERTIGO (vertigo) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo). At the time of the report, VERTIGO (vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not reported.   Treatment information not reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Really Bad 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 (Really Bad Side effects). At the time of the report, VACCINATION COMPLICATION (Really Bad Side effects) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided. Treatment information was not provided. Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: A rash on her wrist; This spontaneous case was reported by a consumer and describes the occurrence of RASH (A rash on her wrist) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (A rash on her wrist). At the time of the report, RASH (A rash on her wrist) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got sick after second shot; 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 ILLNESS (Got sick after 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 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 ILLNESS (Got sick after second shot). At the time of the report, ILLNESS (Got sick after second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site erythema, Vaccination site swelling
Clinical narrative: little bump/ arm began to turn red and raised around the area; red circle/ arm began to turn red and raised around the area; Arm was tender; 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 TENDERNESS (Arm was tender), VACCINATION SITE ERYTHEMA (red circle/ arm began to turn red and raised around the area) and VACCINATION SITE SWELLING (little bump/ arm began to turn red and raised around the area) 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 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced TENDERNESS (Arm was tender). On 14-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (red circle/ arm began to turn red and raised around the area). On 21-May-2021, the patient experienced VACCINATION SITE SWELLING (little bump/ arm began to turn red and raised around the area). On 18-May-2021, VACCINATION SITE ERYTHEMA (red circle/ arm began to turn red and raised around the area) had resolved. At the time of the report, TENDERNESS (Arm was tender) and VACCINATION SITE SWELLING (little bump/ arm began to turn red and raised around the area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis, Feeling abnormal
Clinical narrative: my nose started bleeding a midnight; I'm kinda freaking out; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (my nose started bleeding a midnight) and FEELING ABNORMAL (I'm kinda freaking out) 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 22-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (my nose started bleeding a midnight) and FEELING ABNORMAL (I'm kinda freaking out). At the time of the report, EPISTAXIS (my nose started bleeding a midnight) and FEELING ABNORMAL (I'm kinda freaking out) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant drug was not reported. Treatment medication was not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; 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 DIZZINESS (Dizziness) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not reported. Concomitant medications were not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Have a cold; 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 NASOPHARYNGITIS (Have a cold) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Have a cold). At the time of the report, NASOPHARYNGITIS (Have a cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: A large hot swollen area down her left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (A large hot swollen area down her left arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 VACCINATION SITE SWELLING (A large hot swollen area down her left arm). At the time of the report, VACCINATION SITE SWELLING (A large hot swollen area down her left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance
Clinical narrative: so dizzy I cannot walk in a straight line; so dizzy I cannot walk in a straight line; 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 DIZZINESS (so dizzy I cannot walk in a straight line) and GAIT DISTURBANCE (so dizzy I cannot walk in a straight line) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medication history was provided.    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. On 22-May-2021, the patient experienced DIZZINESS (so dizzy I cannot walk in a straight line). On an unknown date, the patient experienced GAIT DISTURBANCE (so dizzy I cannot walk in a straight line). At the time of the report, DIZZINESS (so dizzy I cannot walk in a straight line) and GAIT DISTURBANCE (so dizzy I cannot walk in a straight line) outcome was unknown.            Concomitant medication use was unknown Treatment information was unknown
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Haematemesis, Headache, Pulmonary pain, Vaccination site pain
Clinical narrative: threw up blood; lungs hurt; sore arm; headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HAEMATEMESIS (threw up blood), PULMONARY PAIN (lungs hurt), VACCINATION SITE PAIN (sore arm) and HEADACHE (headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 001B2HA) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 18-May-2021, the patient experienced VACCINATION SITE PAIN (sore arm) and HEADACHE (headache). On 24-May-2021, the patient experienced HAEMATEMESIS (threw up blood) and PULMONARY PAIN (lungs hurt). At the time of the report, HAEMATEMESIS (threw up blood), PULMONARY PAIN (lungs hurt), VACCINATION SITE PAIN (sore arm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported.  No treatment details were provided. Up to that time the patient had not sought for medical care.   Patient received the first dose of the Moderna Covid-19 vaccine on 20 APR 2021 nd had no side effects. Patient received the second dose on 18 MAY 2021 and had a sore arm and headache and threwup blood and his lungs hurt. Lot number reported for the second dose is 001B2HA. Patient is not on any medications  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.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: The shot area is hot; The shot area is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (The shot area is hot) and VACCINATION SITE ERYTHEMA (The shot area is red) 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) (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 VACCINATION SITE WARMTH (The shot area is hot) and VACCINATION SITE ERYTHEMA (The shot area is red). At the time of the report, VACCINATION SITE WARMTH (The shot area is hot) and VACCINATION SITE ERYTHEMA (The shot area is red) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Night sweats, Vaccination site erythema
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats), VACCINATION SITE WARMTH (arm is still very warm to the touch), VACCINATION SITE PAIN (arm is still very sore), VACCINATION SITE ERYTHEMA (arm is still very red) and VACCINATION SITE SWELLING (arm is still very swollen) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NIGHT SWEATS (night sweats), VACCINATION SITE WARMTH (arm is still very warm to the touch), VACCINATION SITE PAIN (arm is still very sore), VACCINATION SITE ERYTHEMA (arm is still very red), VACCINATION SITE SWELLING (arm is still very swollen), MYALGIA (body aches), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, NIGHT SWEATS (night sweats), MYALGIA (body aches), CHILLS (chills) and FATIGUE (fatigue) was resolving and VACCINATION SITE WARMTH (arm is still very warm to the touch), VACCINATION SITE PAIN (arm is still very sore), VACCINATION SITE ERYTHEMA (arm is still very red) and VACCINATION SITE SWELLING (arm is still very swollen) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats), VACCINATION SITE WARMTH (arm is still very warm to the touch), VACCINATION SITE PAIN (arm is still very sore), VACCINATION SITE ERYTHEMA (arm is still very red) and VACCINATION SITE SWELLING (arm is still very swollen) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NIGHT SWEATS (night sweats), VACCINATION SITE WARMTH (arm is still very warm to the touch), VACCINATION SITE PAIN (arm is still very sore), VACCINATION SITE ERYTHEMA (arm is still very red), VACCINATION SITE SWELLING (arm is still very swollen), MYALGIA (body aches), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, NIGHT SWEATS (night sweats), MYALGIA (body aches), CHILLS (chills) and FATIGUE (fatigue) was resolving and VACCINATION SITE WARMTH (arm is still very warm to the touch), VACCINATION SITE PAIN (arm is still very sore), VACCINATION SITE ERYTHEMA (arm is still very red) and VACCINATION SITE SWELLING (arm is still very swollen) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite
Clinical narrative: haven't eaten in 4 weeks; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (haven't eaten in 4 weeks) 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 information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced DECREASED APPETITE (haven't eaten in 4 weeks). At the time of the report, DECREASED APPETITE (haven't eaten in 4 weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment medicines relevant to events were not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Feel like I am experiencing side effect; 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 SITE REACTION (Feel like I am experiencing side effect) 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 VACCINATION SITE REACTION (Feel like I am experiencing side effect). At the time of the report, VACCINATION SITE REACTION (Feel like I am experiencing side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: I am having chest pain on the right side; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (I am having chest pain on the right side) 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 CHEST PAIN (I am having chest pain on the right side). At the time of the report, CHEST PAIN (I am having chest pain on the right side) had not resolved.            No concomitant medications were reported. No treatment details were reported.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hive developed after 2nd dose of Covid 19 vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received 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. On an unknown date, the patient experienced URTICARIA (Hive developed after 2nd dose of Covid 19 vaccine). At the time of the report, URTICARIA (Hive developed after 2nd dose of Covid 19 vaccine) outcome was unknown. No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter. Reporter did not allow further contact.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) 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.   No treatment information was provided. No relevant concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Neck pain
Clinical narrative: Pain in neck; Tired/ Feet get tired after the first dose; 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 NECK PAIN (Pain in neck) and FATIGUE (Tired/ Feet get tired after the first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 NECK PAIN (Pain in neck) and FATIGUE (Tired/ Feet get tired after the first dose). At the time of the report, NECK PAIN (Pain in neck) and FATIGUE (Tired/ Feet get tired after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: Lump in right arm where she got the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump in right arm where she got the shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer stage IV and Lymphedema (lymphedema in left arm).    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced VACCINATION SITE MASS (Lump in right arm where she got the shot). At the time of the report, VACCINATION SITE MASS (Lump in right arm where she got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: a nasty headache after taking the 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 HEADACHE (a nasty headache after taking the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (a nasty headache after taking the vaccine). At the time of the report, HEADACHE (a nasty headache after taking the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Pruritus
Clinical narrative: itching is bothering; itched  for about 6 days before going away; allergic reaction on arm; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (allergic reaction on arm), PRURITUS (itched  for about 6 days before going away) and PRURITUS (itching is bothering) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concomitant products included IBANDRONATE SODIUM (IBANDRONATE), ROSUVASTATIN and FLUDROCORTISONE.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced ALLERGY TO VACCINE (allergic reaction on arm). On 04-May-2021, the patient experienced PRURITUS (itched  for about 6 days before going away). On 23-May-2021, the patient experienced PRURITUS (itching is bothering). The patient was treated with HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) at an unspecified dose and frequency and TRIAMCINOLONE at an unspecified dose and frequency. On 10-Feb-2021, ALLERGY TO VACCINE (allergic reaction on arm) had resolved. On 10-May-2021, PRURITUS (itched  for about 6 days before going away) had resolved. At the time of the report, PRURITUS (itching is bothering) outcome was unknown.            Patient reported to have used an expired cortisone cream and triamcinolone cream that had been prescribed previously for something else as treatment.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pruritus, Rash, Rash erythematous, Skin haemorrhage
Clinical narrative: Bleeding and continue to erupt; Rash started on Right Arm and Spread (After Second Dose); Little Bumps All over the body (After Second Dose); Itchy All over the body (After Second Dose); Bleeding from scratching All over the body (After Second Dose); This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Little Bumps All over the body (After Second Dose)), PRURITUS (Itchy All over the body (After Second Dose)), SKIN HAEMORRHAGE (Bleeding from scratching All over the body (After Second Dose)), RASH ERYTHEMATOUS (Bleeding and continue to erupt) and RASH (Rash started on Right Arm and Spread (After Second Dose)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced BLISTER (Little Bumps All over the body (After Second Dose)), PRURITUS (Itchy All over the body (After Second Dose)), SKIN HAEMORRHAGE (Bleeding from scratching All over the body (After Second Dose)) and RASH (Rash started on Right Arm and Spread (After Second Dose)). On an unknown date, the patient experienced RASH ERYTHEMATOUS (Bleeding and continue to erupt). At the time of the report, BLISTER (Little Bumps All over the body (After Second Dose)), PRURITUS (Itchy All over the body (After Second Dose)), SKIN HAEMORRHAGE (Bleeding from scratching All over the body (After Second Dose)), RASH ERYTHEMATOUS (Bleeding and continue to erupt) and RASH (Rash started on Right Arm and Spread (After Second Dose)) had not resolved.            No concomitant medication reported. Treatment medication included topical allergy medicine, anti iItch medicine green pills, Steroid Dose pack.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pains; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pains) 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 20-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced CHEST PAIN (chest pains). At the time of the report, CHEST PAIN (chest pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. No concomitant medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: that I got the first modern vaccine and it gave me 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 (that I got the first modern vaccine and it gave me a fever) 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 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 (that I got the first modern vaccine and it gave me a fever). At the time of the report, PYREXIA (that I got the first modern vaccine and it gave me a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.   Reporter did not allow further contact
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Myalgia, Nausea
Clinical narrative: dizziness; nausea; sore all over; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), NAUSEA (nausea), MYALGIA (sore all over) and HEADACHE (headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Schizophrenia. Concomitant products included FLUPHENAZINE DECANOATE (PROLIXIN [FLUPHENAZINE DECANOATE]) for Schizophrenia.    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 DIZZINESS (dizziness), NAUSEA (nausea), MYALGIA (sore all over) and HEADACHE (headache). At the time of the report, DIZZINESS (dizziness), NAUSEA (nausea), MYALGIA (sore all over) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Hypoaesthesia, Myalgia, Pyrexia
Clinical narrative: Numbness in arm / Numbness in pinky / Numbness in ring finger; Developed a dry cough; Severe muscle pain; Fever of 104; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (Numbness in arm / Numbness in pinky / Numbness in ring finger), COUGH (Developed a dry cough), MYALGIA (Severe muscle pain) and PYREXIA (Fever of 104) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 04-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 05-May-2021, the patient experienced HYPOAESTHESIA (Numbness in arm / Numbness in pinky / Numbness in ring finger), COUGH (Developed a dry cough), MYALGIA (Severe muscle pain) and PYREXIA (Fever of 104). At the time of the report, HYPOAESTHESIA (Numbness in arm / Numbness in pinky / Numbness in ring finger), COUGH (Developed a dry cough), MYALGIA (Severe muscle pain) and PYREXIA (Fever of 104) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Body temperature: other (High) Temp: 104F.         No concomitant medications or treatment details provided. No Treatment Medications were reported
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: second dose was improperly stored and administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (second dose was improperly stored and administered) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A Í¾ 20Sep2021) 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-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (second dose was improperly stored and administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (second dose was improperly stored and administered) 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.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-163779:Same reporter