chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Rhinorrhoea, Urinary tract infection
Clinical narrative: Viral UTI symptoms; runny nose; myalgias; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Viral UTI symptoms), RHINORRHOEA (runny nose) and MYALGIA (myalgias) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (Viral UTI symptoms), RHINORRHOEA (runny nose) and MYALGIA (myalgias). At the time of the report, URINARY TRACT INFECTION (Viral UTI symptoms), RHINORRHOEA (runny nose) and MYALGIA (myalgias) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information is provided  No treatment product information is provided
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Vaccination site rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Vaccination site rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Vaccination site rash). At the time of the report, VACCINATION SITE RASH (Vaccination site rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient asked if it is normal to have rash at site of the shot. No concomitant medications were reported. No information regarding corrective treatment was reported by the patient.   Reporter did not allow further contact
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given to somebody who is underage; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to somebody who is underage) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History Information was reported.     On 01-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to somebody who is underage). On 01-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to somebody who is underage) had 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.   No concomitant medications were reported. No treatment was reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: muscle pain in injection site for a month; 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 VACCINATION SITE PAIN (muscle pain in injection site for a month) 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 SITE PAIN (muscle pain in injection site for a month). At the time of the report, VACCINATION SITE PAIN (muscle pain in injection site for a month) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.   No treatment was reported for the events.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Depressed mood
Clinical narrative: down for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (down for 3 days) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEPRESSED MOOD (down for 3 days). At the time of the report, DEPRESSED MOOD (down for 3 days) outcome was unknown.            The patient's concomitant medication was not reported. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Intentional product use issue, SARS-CoV-2 test
Clinical narrative: More than 36 days for second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (More than 36 days for second shot) 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 COVID-19 (Patient was hospitalized. Start date of covid-19 infection is 05-Mar-2021.) on 05-Mar-2021.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (More than 36 days for second shot). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (More than 36 days for second shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The adverse event was reported through chatbot. Concomitant medications were not reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (102 fever for 4 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No medical history was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (102 fever for 4 days). At the time of the report, PYREXIA (102 fever for 4 days) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No concomitant medication was reported , No treatment medication was reported .
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: 24 hours after injection she is tingling and numbness of left leg coming from her foot up to knee; 24 hours after injection she is tingling and numbness of left leg coming from her foot up to knee; This spontaneous case was reported by a pharmacist and describes the occurrence of PARAESTHESIA (24 hours after injection she is tingling and numbness of left leg coming from her foot up to knee) and HYPOAESTHESIA (24 hours after injection she is tingling and numbness of left leg coming from her foot up to knee) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-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 PARAESTHESIA (24 hours after injection she is tingling and numbness of left leg coming from her foot up to knee) and HYPOAESTHESIA (24 hours after injection she is tingling and numbness of left leg coming from her foot up to knee). At the time of the report, PARAESTHESIA (24 hours after injection she is tingling and numbness of left leg coming from her foot up to knee) and HYPOAESTHESIA (24 hours after injection she is tingling and numbness of left leg coming from her foot up to knee) 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.   Treatment drug was not provided.  no concomitant medications was provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain
Clinical narrative: I feel wered; Chill achace; Chill achace; 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 MALAISE (I feel wered), PAIN (Chill achace) and CHILLS (Chill achace) 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 MALAISE (I feel wered), PAIN (Chill achace) and CHILLS (Chill achace). At the time of the report, MALAISE (I feel wered), PAIN (Chill achace) and CHILLS (Chill achace) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment drug information was not given. The patient also enquired about how long they should wait to see a doctor.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Localized redness at injection site; Swelling at injection site; 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 ERYTHEMA (Localized redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Medical history was not provided.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (Localized redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Localized redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) 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.
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) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced 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.       Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Hyperhidrosis, Myalgia, Pyrexia, Tachycardia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Incredible body aches), ARTHRALGIA (joint pain), TACHYCARDIA (Fast heartbeat), PYREXIA (fever) and HYPERHIDROSIS (Sweats) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced MYALGIA (Incredible body aches), TACHYCARDIA (Fast heartbeat), PYREXIA (fever) and HYPERHIDROSIS (Sweats). On 23-May-2021, the patient experienced VOMITING (threw up). On an unknown date, the patient experienced ARTHRALGIA (joint pain). On 24-May-2021, VOMITING (threw up) had resolved. At the time of the report, MYALGIA (Incredible body aches), ARTHRALGIA (joint pain), TACHYCARDIA (Fast heartbeat), PYREXIA (fever) and HYPERHIDROSIS (Sweats) outcome was unknown. Patient  threw up on Sunday morning on 5/24/21 but he wasn't sure if it was from the chicken he ate the night before. Treatment medication was not  provided. Concomitant product use was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Incredible body aches), ARTHRALGIA (joint pain), TACHYCARDIA (Fast heartbeat), PYREXIA (fever) and HYPERHIDROSIS (Sweats) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced MYALGIA (Incredible body aches), TACHYCARDIA (Fast heartbeat), PYREXIA (fever) and HYPERHIDROSIS (Sweats). On 23-May-2021, the patient experienced VOMITING (threw up). On an unknown date, the patient experienced ARTHRALGIA (joint pain). On 24-May-2021, VOMITING (threw up) had resolved. At the time of the report, MYALGIA (Incredible body aches), ARTHRALGIA (joint pain), TACHYCARDIA (Fast heartbeat), PYREXIA (fever) and HYPERHIDROSIS (Sweats) outcome was unknown. Patient  threw up on Sunday morning on 5/24/21 but he wasn't sure if it was from the chicken he ate the night before. Treatment medication was not  provided. Concomitant product use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient passed the recommend time frame to receive the second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient passed the recommend time frame to receive the second 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 19-Apr-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient passed the recommend time frame to receive the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient passed the recommend time frame to receive the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication provided. Patient wanted to know that If the time between the two doses is 49 days, then  the first dose still going to be effective.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Pyrexia, Vertigo
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), DIZZINESS (Dizziness), PYREXIA (Slight fever), HEADACHE (Headache) and FATIGUE (Tiredness) 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 21-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 VERTIGO (Vertigo), DIZZINESS (Dizziness), PYREXIA (Slight fever), HEADACHE (Headache) and FATIGUE (Tiredness). At the time of the report, VERTIGO (Vertigo), DIZZINESS (Dizziness), PYREXIA (Slight fever), HEADACHE (Headache) and FATIGUE (Tiredness) outcome was unknown.   No concomitants were reported. No treatment was reported. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Developed a bitter taste in mouth ,tasted super bitter to cheescake,had an odd taste to it; This spontaneous case was reported by a health care professional and describes the occurrence of DYSGEUSIA (Developed a bitter taste in mouth ,tasted super bitter to cheescake,had an odd taste to it) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced DYSGEUSIA (Developed a bitter taste in mouth ,tasted super bitter to cheescake,had an odd taste to it). At the time of the report, DYSGEUSIA (Developed a bitter taste in mouth ,tasted super bitter to cheescake,had an odd taste to it) 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.   treatment to the events not provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Renal pain
Clinical narrative: Feels like pain is constant muscle pain in kidney/ whole left side was hurting/ pain is just centralized to his kidney area; Severe discomfort in kidney area; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-May-2021 and was forwarded to Moderna on 24-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (Feels like pain is constant muscle pain in kidney/ whole left side was hurting/ pain is just centralized to his kidney area) and DISCOMFORT (Severe discomfort in kidney area) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     The patient's past medical history included Kidney stones.   On 20-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 22-May-2021, the patient experienced RENAL PAIN (Feels like pain is constant muscle pain in kidney/ whole left side was hurting/ pain is just centralized to his kidney area) and DISCOMFORT (Severe discomfort in kidney area). The patient was treated with ACETAMINOPHEN for Pain kidney, at an unspecified dose and frequency. At the time of the report, RENAL PAIN (Feels like pain is constant muscle pain in kidney/ whole left side was hurting/ pain is just centralized to his kidney area) and DISCOMFORT (Severe discomfort in kidney area) outcome was unknown.            No concomitant medications were provided.. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Have been really feeling the side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Have been really feeling the side effects) 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 (Have been really feeling the side effects). At the time of the report, VACCINATION COMPLICATION (Have been really feeling the side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain; 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 PAIN (pain) 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 PAIN (pain). At the time of the report, PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Body temperature decreased, Dizziness, Fatigue, Freezing phenomenon
Clinical narrative: pain in arm; Lightheadedness; pain in arm; temperature was 94 then 93.8; Tiredness; unsteady; Flu- like symptoms; left side of his face feels slightly num; freezing; vivid dreams; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of PAIN IN EXTREMITY (pain in arm), DIZZINESS (Lightheadedness), GAIT DISTURBANCE (unsteady), INFLUENZA LIKE ILLNESS (Flu- like symptoms) and HYPOAESTHESIA (left side of his face feels slightly num) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (doxycycline series antibiotics) and Drug allergy (Morphine). Concomitant products included OMEPRAZOLE, CEFADROXIL and FENTANYL for an unknown indication.    On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced GAIT DISTURBANCE (unsteady), INFLUENZA LIKE ILLNESS (Flu- like symptoms), HYPOAESTHESIA (left side of his face feels slightly num), FREEZING PHENOMENON (freezing), ABNORMAL DREAMS (vivid dreams) and FATIGUE (Tiredness). On an unknown date, the patient experienced the first episode of PAIN IN EXTREMITY (pain in arm), DIZZINESS (Lightheadedness), BODY TEMPERATURE DECREASED (temperature was 94 then 93.8) and the second episode of PAIN IN EXTREMITY (pain in arm). At the time of the report, DIZZINESS (Lightheadedness), GAIT DISTURBANCE (unsteady), INFLUENZA LIKE ILLNESS (Flu- like symptoms), HYPOAESTHESIA (left side of his face feels slightly num), ABNORMAL DREAMS (vivid dreams), the last episode of PAIN IN EXTREMITY (pain in arm) and FATIGUE (Tiredness) outcome was unknown and FREEZING PHENOMENON (freezing) and BODY TEMPERATURE DECREASED (temperature was 94 then 93.8) had not resolved.            No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-163697 (Patient Link).   Reporter did not allow further contact
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Influenza like illness, Pain in extremity
Clinical narrative: pain in arm; Lightheadedness; pain in arm; temperature was 94 then 93.8; Tiredness; unsteady; Flu- like symptoms; left side of his face feels slightly num; freezing; vivid dreams; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of PAIN IN EXTREMITY (pain in arm), DIZZINESS (Lightheadedness), GAIT DISTURBANCE (unsteady), INFLUENZA LIKE ILLNESS (Flu- like symptoms) and HYPOAESTHESIA (left side of his face feels slightly num) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (doxycycline series antibiotics) and Drug allergy (Morphine). Concomitant products included OMEPRAZOLE, CEFADROXIL and FENTANYL for an unknown indication.    On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced GAIT DISTURBANCE (unsteady), INFLUENZA LIKE ILLNESS (Flu- like symptoms), HYPOAESTHESIA (left side of his face feels slightly num), FREEZING PHENOMENON (freezing), ABNORMAL DREAMS (vivid dreams) and FATIGUE (Tiredness). On an unknown date, the patient experienced the first episode of PAIN IN EXTREMITY (pain in arm), DIZZINESS (Lightheadedness), BODY TEMPERATURE DECREASED (temperature was 94 then 93.8) and the second episode of PAIN IN EXTREMITY (pain in arm). At the time of the report, DIZZINESS (Lightheadedness), GAIT DISTURBANCE (unsteady), INFLUENZA LIKE ILLNESS (Flu- like symptoms), HYPOAESTHESIA (left side of his face feels slightly num), ABNORMAL DREAMS (vivid dreams), the last episode of PAIN IN EXTREMITY (pain in arm) and FATIGUE (Tiredness) outcome was unknown and FREEZING PHENOMENON (freezing) and BODY TEMPERATURE DECREASED (temperature was 94 then 93.8) had not resolved.            No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-163697 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Fatigued; Chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigued) and CHILLS (chills) 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 FATIGUE (fatigued) and CHILLS (chills). At the time of the report, FATIGUE (fatigued) and CHILLS (chills) 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: F
Vaccine: COVID19
Symptoms: Antibody test, Arthralgia, Dizziness, Dyspnoea, Dysstasia
Clinical narrative: Bad reaction; Red body; Dizziness; Couldn't stand; Difficulty breathing; Spotty rash elsewhere; Pain; joint pain; fatigue; Muscle aches; Fever of 100.7; A bad rash down arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Bad reaction), ERYTHEMA (Red body), DIZZINESS (Dizziness), DYSSTASIA (Couldn't stand) and DYSPNOEA (Difficulty breathing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had a COVID  worse.) in October 2020 and Pneumonia (Because of Covid-19.) in October 2020. Concurrent medical conditions included Colitis and Hypothyroidism.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced VACCINATION COMPLICATION (Bad reaction), ERYTHEMA (Red body), DIZZINESS (Dizziness), DYSSTASIA (Couldn't stand), DYSPNOEA (Difficulty breathing), RASH MACULAR (Spotty rash elsewhere), PAIN (Pain), ARTHRALGIA (joint pain), FATIGUE (fatigue), MYALGIA (Muscle aches), PYREXIA (Fever of 100.7) and RASH (A bad rash down arm). At the time of the report, VACCINATION COMPLICATION (Bad reaction), ERYTHEMA (Red body), DIZZINESS (Dizziness), DYSSTASIA (Couldn't stand), DYSPNOEA (Difficulty breathing), RASH MACULAR (Spotty rash elsewhere), PAIN (Pain), ARTHRALGIA (joint pain), FATIGUE (fatigue), MYALGIA (Muscle aches), PYREXIA (Fever of 100.7) and RASH (A bad rash down arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Antibody test: positive (Positive) Positive. In November 2020, Pyrexia: 100.7 (High) 100.7F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       In addition to the others historical condition patient has several other problems. No concomitant medication was reported.  Reported said that most of the symptoms occurred at times from 1-May-2021 to about 7-May-2021. No treatment was reported.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: Bad reaction; Red body; Dizziness; Couldn't stand; Difficulty breathing; Spotty rash elsewhere; Pain; joint pain; fatigue; Muscle aches; Fever of 100.7; A bad rash down arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Bad reaction), ERYTHEMA (Red body), DIZZINESS (Dizziness), DYSSTASIA (Couldn't stand) and DYSPNOEA (Difficulty breathing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had a COVID  worse.) in October 2020 and Pneumonia (Because of Covid-19.) in October 2020. Concurrent medical conditions included Colitis and Hypothyroidism.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced VACCINATION COMPLICATION (Bad reaction), ERYTHEMA (Red body), DIZZINESS (Dizziness), DYSSTASIA (Couldn't stand), DYSPNOEA (Difficulty breathing), RASH MACULAR (Spotty rash elsewhere), PAIN (Pain), ARTHRALGIA (joint pain), FATIGUE (fatigue), MYALGIA (Muscle aches), PYREXIA (Fever of 100.7) and RASH (A bad rash down arm). At the time of the report, VACCINATION COMPLICATION (Bad reaction), ERYTHEMA (Red body), DIZZINESS (Dizziness), DYSSTASIA (Couldn't stand), DYSPNOEA (Difficulty breathing), RASH MACULAR (Spotty rash elsewhere), PAIN (Pain), ARTHRALGIA (joint pain), FATIGUE (fatigue), MYALGIA (Muscle aches), PYREXIA (Fever of 100.7) and RASH (A bad rash down arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Antibody test: positive (Positive) Positive. In November 2020, Pyrexia: 100.7 (High) 100.7F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       In addition to the others historical condition patient has several other problems. No concomitant medication was reported.  Reported said that most of the symptoms occurred at times from 1-May-2021 to about 7-May-2021. No treatment was reported.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular, Vaccination complication
Clinical narrative: Bad reaction; Red body; Dizziness; Couldn't stand; Difficulty breathing; Spotty rash elsewhere; Pain; joint pain; fatigue; Muscle aches; Fever of 100.7; A bad rash down arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Bad reaction), ERYTHEMA (Red body), DIZZINESS (Dizziness), DYSSTASIA (Couldn't stand) and DYSPNOEA (Difficulty breathing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had a COVID  worse.) in October 2020 and Pneumonia (Because of Covid-19.) in October 2020. Concurrent medical conditions included Colitis and Hypothyroidism.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced VACCINATION COMPLICATION (Bad reaction), ERYTHEMA (Red body), DIZZINESS (Dizziness), DYSSTASIA (Couldn't stand), DYSPNOEA (Difficulty breathing), RASH MACULAR (Spotty rash elsewhere), PAIN (Pain), ARTHRALGIA (joint pain), FATIGUE (fatigue), MYALGIA (Muscle aches), PYREXIA (Fever of 100.7) and RASH (A bad rash down arm). At the time of the report, VACCINATION COMPLICATION (Bad reaction), ERYTHEMA (Red body), DIZZINESS (Dizziness), DYSSTASIA (Couldn't stand), DYSPNOEA (Difficulty breathing), RASH MACULAR (Spotty rash elsewhere), PAIN (Pain), ARTHRALGIA (joint pain), FATIGUE (fatigue), MYALGIA (Muscle aches), PYREXIA (Fever of 100.7) and RASH (A bad rash down arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Antibody test: positive (Positive) Positive. In November 2020, Pyrexia: 100.7 (High) 100.7F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       In addition to the others historical condition patient has several other problems. No concomitant medication was reported.  Reported said that most of the symptoms occurred at times from 1-May-2021 to about 7-May-2021. No treatment was reported.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Myalgia, Product administered to patient of inappropriate age
Clinical narrative: Diarrhea within 14 days after the second dose; Body ache within 14 days after the second dose; Headache within 14 days after the second dose; Tiredness within 14 days after the second dose; Moderna COVID-19 vaccine administered to a patient under 18 years old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID-19 vaccine administered to a patient under 18 years old), DIARRHOEA (Diarrhea within 14 days after the second dose), MYALGIA (Body ache within 14 days after the second dose), HEADACHE (Headache within 14 days after the second dose) and FATIGUE (Tiredness within 14 days after the second dose) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID-19 vaccine administered to a patient under 18 years old). On an unknown date, the patient experienced DIARRHOEA (Diarrhea within 14 days after the second dose), MYALGIA (Body ache within 14 days after the second dose), HEADACHE (Headache within 14 days after the second dose) and FATIGUE (Tiredness within 14 days after the second dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID-19 vaccine administered to a patient under 18 years old) had resolved. At the time of the report, DIARRHOEA (Diarrhea within 14 days after the second dose), MYALGIA (Body ache within 14 days after the second dose), HEADACHE (Headache within 14 days after the second dose) and FATIGUE (Tiredness within 14 days after the second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the 17-year old patient experienced sore arm at injection site and headache after first dose and body ache, headache, tiredness and diarrhea within 14 days after receiving the second vaccination dose.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Heart rate increased
Clinical narrative: Myocarditis; Heart rate increased; Blood pressure increased; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis), HEART RATE INCREASED (Heart rate increased) and BLOOD PRESSURE INCREASED (Blood pressure increased) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis), HEART RATE INCREASED (Heart rate increased) and BLOOD PRESSURE INCREASED (Blood pressure increased). At the time of the report, MYOCARDITIS (Myocarditis), HEART RATE INCREASED (Heart rate increased) and BLOOD PRESSURE INCREASED (Blood pressure increased) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment medications provided by the reporter.   The patient asked if he was reporting a side effect to the vaccine; to which he stated not sure of myocarditis. Also, experienced increased blood pressure and increased heart rate although not significant enough to require hospital.  Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Body temperature, Myalgia, Pyrexia, Vomiting
Clinical narrative: experienced a side effect; pain all over; vomiting; fever 101.4f; 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 ADVERSE EVENT (experienced a side effect), MYALGIA (pain all over), VOMITING (vomiting) and PYREXIA (fever 101.4f) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-May-2021, the patient experienced ADVERSE EVENT (experienced a side effect), MYALGIA (pain all over), VOMITING (vomiting) and PYREXIA (fever 101.4f). At the time of the report, ADVERSE EVENT (experienced a side effect), MYALGIA (pain all over), VOMITING (vomiting) and PYREXIA (fever 101.4f) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2021, Body temperature: 101.4 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced VERTIGO (Vertigo). The patient was treated with ONDANSETRON at an unspecified dose and frequency and MECLIZINE [MECLOZINE] at an unspecified dose and frequency. At the time of the report, VERTIGO (Vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of product administered to patient of inappropriate age (14-year-old son given the Moderna vaccine by mistake) in a male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, product administered to patient of inappropriate age (14-year-old son given the Moderna vaccine by mistake). At the time of the report, product administered to patient of inappropriate age (14-year-old son given the Moderna vaccine by mistake) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Dry mouth, Myalgia, Nausea
Clinical narrative: Mental lapsing; Cotton mouth; Nausea; Arm sore from injection; This spontaneous case was reported by a consumer and describes the occurrence of DISTURBANCE IN ATTENTION (Mental lapsing), DRY MOUTH (Cotton mouth), NAUSEA (Nausea) and MYALGIA (Arm sore from injection) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     medical history was not provided by the Reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 15-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced DISTURBANCE IN ATTENTION (Mental lapsing), DRY MOUTH (Cotton mouth), NAUSEA (Nausea) and MYALGIA (Arm sore from injection). At the time of the report, DISTURBANCE IN ATTENTION (Mental lapsing), DRY MOUTH (Cotton mouth), NAUSEA (Nausea) and MYALGIA (Arm sore from injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: fainted
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Client received the COVID19 Janssen vaccine (Lot# 205A21A) at 12:17. The client was with a friend and after receiving the vaccine they proceeded to the observation area.  Once seated in a chair, the client?s friend waived to the EMT, that the client was ?feeling dizzy like he is going to pass out.?  The EMT waived and the Vaccine Monitor RN, went to assist.  He also radioed to Lead RN to come over, and she arrived at 12:22.  Co-Lead RN went to assist the client as well.  Lead RN observed that the client was diaphoretic and a little pale while Vaccine Monitor RN was asking the client questions.  Lead RN observed that the client was oriented to person, place, time, and situation.  Client stated he had no shortness of breath, difficulty breathing, or chest pain.  Lead RN and Vaccine Monitor RN transferred the client into a zero-gravity chair and positioned the client at a 45-degree angle.  Lead RN also got 2 ice packs and placed them on the back of the client?s neck and forehead.  The client?s friend assisted with the ice packs to hold them in place.  Vaccine Monitor RN brought the client a bottle of water, which he started drinking.  EMT took the client?s vitals at 12:23 (BP: 100/50, HR: 76 & SPO2: 99%).  Client stated he has no underlying health conditions, takes no medications, and has no allergies.  He stated he took a couple of Advil before he came to prevent his arm from becoming soar.  Client kept apologizing saying he would be OK and was starting to feel better.  Client stated had eaten and drank before he came.  He also indicated he felt ?like a twinge? in his heart, like fluttering, but that he had drank coffee and an energy drink earlier.  Client did not know what his blood pressure normally was, but he did indicate that he has a history of fainting when getting blood draws.  Lead RN gave the client a juice box, which he gulped down.  EMT took the client?s vitals again at 12:32 (BP: 102/50, HR: 76 & SPO2 98%).  Client continued to state that he was feeling much better.  Co-Lead RN educated client on both the potentially normal and adverse side effects of the vaccine and the client stated he understood.  Lead RN observed that the client was less diaphoretic, and his color was coming back to his face.  Lead RNs adjusted client?s chair to have him sit in an upright position and requested the client sit for an additional 15 minutes.  The client agreed.  At 12:55 EMT took client?s vitals (BP: 105/60, RH: 72 & SPO2: 98%).  Lead RN asked client if he felt he was ready to stand up to which the client replied, ?yes.?  Once standing, the client stated he felt fine and was ready to go.  Lead RN observed the client leave with his friend at 12:58. Client was walking with a steady gait.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Feeling abnormal, Headache, Neck pain, Pyrexia
Clinical narrative: Headache and pain down right side of neck within 7 hours. Fever 12 hours after for 48 hours. Foggy words not coming out right 2 days after 2nd shot still l at 4 days later
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Diarrhoea haemorrhagic, Thrombosis
Clinical narrative: Bloody watery diarrhea with sizable blood clot.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain, Vaginal haemorrhage
Clinical narrative: I had an oophrectomy 2.5 years ago and I?m on HRT> I have not had a period since then. The night of the vaccine i had spotting which has now progressed to heavy spotting /bleeding and severe cramps. I am taking ibuprofen around the clock and IM toradol with minor relief. This is not acceptable. I have already had COVID and have antibodies and now have to go through this excruciating pain.  Everting out there stating this is stress related is nonsense. Tell that to someone not in the medical field. I?m a nurse. Stress makes you loose your period not have someone without ovaries start bleeding and cramping heavily. This is directly related to the vaccine.