chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Certain side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Certain 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Certain side effect). At the time of the report, VACCINATION COMPLICATION (Certain side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was reported
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pain in extremity, Vaccination site mass, Vaccination site pain
Clinical narrative: After 2-3 weeks from the 2nd dose I noticed a knot in my arm at the injection site/the knot is not hard to touch; It is getting worse and not getting better; It hurts real bad; Pain in arm/but it came right back after a week; After the 2nd dose, after a day or so I noticed pain in my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (After the 2nd dose, after a day or so I noticed pain in my arm), VACCINATION SITE MASS (After 2-3 weeks from the 2nd dose I noticed a knot in my arm at the injection site/the knot is not hard to touch), CONDITION AGGRAVATED (It is getting worse and not getting better), PAIN IN EXTREMITY (Pain in arm/but it came right back after a week) and VACCINATION SITE PAIN (It hurts real bad) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Thyroid disorder and Blood pressure.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (After the 2nd dose, after a day or so I noticed pain in my arm). On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm/but it came right back after a week). On 27-Mar-2021, the patient experienced VACCINATION SITE MASS (After 2-3 weeks from the 2nd dose I noticed a knot in my arm at the injection site/the knot is not hard to touch), CONDITION AGGRAVATED (It is getting worse and not getting better) and VACCINATION SITE PAIN (It hurts real bad). On 15-Mar-2021, PAIN IN EXTREMITY (After the 2nd dose, after a day or so I noticed pain in my arm) had resolved. At the time of the report, VACCINATION SITE MASS (After 2-3 weeks from the 2nd dose I noticed a knot in my arm at the injection site/the knot is not hard to touch), CONDITION AGGRAVATED (It is getting worse and not getting better) and VACCINATION SITE PAIN (It hurts real bad) had not resolved and PAIN IN EXTREMITY (Pain in arm/but it came right back after a week) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included medications for diabetes, medications for thyroid and medications for high blood pressure.  The pain in arm seemed to go away after the patient rubbed with alcohol.   No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Tinnitus
Clinical narrative: New onset of tinittus; Rash; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (New onset of tinittus) and RASH (Rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced TINNITUS (New onset of tinittus) and RASH (Rash). At the time of the report, TINNITUS (New onset of tinittus) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  The patient had the events 24 hours after the first dose.   Treatment medication was not provided by the reporter.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Palpitations
Clinical narrative: Heart is racing/Feels palpitations; Heart hurts worse; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart is racing/Feels palpitations) and CARDIAC DISORDER (Heart hurts worse) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Heart is racing/Feels palpitations) and CARDIAC DISORDER (Heart hurts worse). At the time of the report, PALPITATIONS (Heart is racing/Feels palpitations) and CARDIAC DISORDER (Heart hurts worse) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  It was reported the patient felt his heart racing and palpitations and his heart hurt more when he was doing manual labor. Patient visited urgent care where an electrocardiogram was performed which revealed normal results. Patient was encouraged to go to the emergency department but couldn't. He was scheduled for an appointment with his doctor and was told not to get the second dose.  No treatment medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: bruising at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (bruising at injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M70A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ESTRIOL, SIMVASTATIN, OMEPRAZOLE, ALPRAZOLAM (XANAX), VALACICLOVIR HYDROCHLORIDE (VALTREX), ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN D3, ZINC, VITAMIN C [ASCORBIC ACID], COENZYME Q10 [UBIDECARENONE] and CALCIUM for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE BRUISING (bruising at injection site). At the time of the report, VACCINATION SITE BRUISING (bruising at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include Multivitamins. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: tested positive (COVID-19)between first and second doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive (COVID-19)between first and second doses) 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 COVID-19 (tested positive (COVID-19)between first and second doses). At the time of the report, COVID-19 (tested positive (COVID-19)between first and second doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive)   No concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: pink rash on her stomach and back; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (pink rash on her stomach and back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 828L20A) for COVID-19 vaccination.     The patient's past medical history included Arthritis. Concurrent medical conditions included Diabetic. Concomitant products included HYDROXYCHLOROQUINE for Arthritis, EZETIMIBE, SIMVASTATIN (VYTORIN) for High cholesterol.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (pink rash on her stomach and back). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at a dose of UNK dosage form. At the time of the report, RASH ERYTHEMATOUS (pink rash on her stomach and back) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient wants to know is it safe for her to get vaccination as she is Diabetic and having Arthritis.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 59 days out from her first dose of the Moderna Covid 19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (59 days out from her first dose of the Moderna Covid 19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (59 days out from her first dose of the Moderna Covid 19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (59 days out from her first dose of the Moderna Covid 19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were provided.  No treatment information  was  provided by the reporter.   Reporter did not allow further contact
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Nasopharyngitis, Tenderness
Clinical narrative: Cold-like symptoms; Loss taste; tender arm; had arm tenderness right after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold-like symptoms), AGEUSIA (Loss taste), TENDERNESS (had arm tenderness right after the 2nd dose) and TENDERNESS (tender arm) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 018B21A) for COVID-19 vaccination.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 24-Apr-2021, the patient experienced TENDERNESS (had arm tenderness right after the 2nd dose). On 14-Jun-2021, the patient experienced TENDERNESS (tender arm). On an unknown date, the patient experienced NASOPHARYNGITIS (Cold-like symptoms) and AGEUSIA (Loss taste). At the time of the report, NASOPHARYNGITIS (Cold-like symptoms), AGEUSIA (Loss taste), TENDERNESS (had arm tenderness right after the 2nd dose) and TENDERNESS (tender arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, COVID-19: negative (Negative) Test results - Negative.         No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up received  and it contains the information :Patient said that she is doing fine and declined for further follow-up
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed second dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 immunisation.     The patient's medical history was not reported.  Concomitant products included METFORMIN for an unknown indication.    On 13-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 PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: losing taste; 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 AGEUSIA (losing taste) 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 No adverse event.    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 AGEUSIA (losing taste). At the time of the report, AGEUSIA (losing taste) outcome was unknown.            Concomitant medications were not provided by the reporter.  Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects about two months after The last dose/delayed symptoms of side effects months after the second 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 VACCINATION COMPLICATION (Side effects about two months after The last dose/delayed symptoms of side effects months after the second 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 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 COMPLICATION (Side effects about two months after The last dose/delayed symptoms of side effects months after the second dose). At the time of the report, VACCINATION COMPLICATION (Side effects about two months after The last dose/delayed symptoms of side effects months after the second dose) outcome was unknown.            No relevant concomitant medications were reported.   Patient experienced side effects about two months after vaccination.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms 2 days after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms 2 days after the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms 2 days after the vaccine). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms 2 days after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Gait disturbance, Headache, Memory impairment
Clinical narrative: Dizzy; Cant  walk very well; Memory issue; weak/ falling down; Vomiting; Headache; Pyrexia; Vaccination site erythmea; Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), GAIT DISTURBANCE (Cant  walk very well), MEMORY IMPAIRMENT (Memory issue), ASTHENIA (weak/ falling down) and VOMITING (Vomiting) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer since 25-Dec-2007. Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy), GAIT DISTURBANCE (Cant  walk very well), MEMORY IMPAIRMENT (Memory issue), ASTHENIA (weak/ falling down), VOMITING (Vomiting), HEADACHE (Headache), PYREXIA (Pyrexia), VACCINATION SITE ERYTHEMA (Vaccination site erythmea) and VACCINATION SITE SWELLING (Vaccination site swelling). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy), GAIT DISTURBANCE (Cant  walk very well), MEMORY IMPAIRMENT (Memory issue), ASTHENIA (weak/ falling down), VOMITING (Vomiting), HEADACHE (Headache) and PYREXIA (Pyrexia) had not resolved and VACCINATION SITE ERYTHEMA (Vaccination site erythmea) and VACCINATION SITE SWELLING (Vaccination site swelling) had resolved. Not Provided          Dose 2 case. Dose 1 case: MOD-2021-039583
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site swelling, Vomiting
Clinical narrative: Dizzy; Cant  walk very well; Memory issue; weak/ falling down; Vomiting; Headache; Pyrexia; Vaccination site erythmea; Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), GAIT DISTURBANCE (Cant  walk very well), MEMORY IMPAIRMENT (Memory issue), ASTHENIA (weak/ falling down) and VOMITING (Vomiting) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer since 25-Dec-2007. Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy), GAIT DISTURBANCE (Cant  walk very well), MEMORY IMPAIRMENT (Memory issue), ASTHENIA (weak/ falling down), VOMITING (Vomiting), HEADACHE (Headache), PYREXIA (Pyrexia), VACCINATION SITE ERYTHEMA (Vaccination site erythmea) and VACCINATION SITE SWELLING (Vaccination site swelling). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy), GAIT DISTURBANCE (Cant  walk very well), MEMORY IMPAIRMENT (Memory issue), ASTHENIA (weak/ falling down), VOMITING (Vomiting), HEADACHE (Headache) and PYREXIA (Pyrexia) had not resolved and VACCINATION SITE ERYTHEMA (Vaccination site erythmea) and VACCINATION SITE SWELLING (Vaccination site swelling) had resolved. Not Provided          Dose 2 case. Dose 1 case: MOD-2021-039583
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia
Clinical narrative: can barely move the arm; Pain on the arm,lots of pain throughout her body; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (can barely move the arm) and MYALGIA (Pain on the arm,lots of pain throughout her body) 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 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced MOBILITY DECREASED (can barely move the arm) and MYALGIA (Pain on the arm,lots of pain throughout her body). At the time of the report, MOBILITY DECREASED (can barely move the arm) and MYALGIA (Pain on the arm,lots of pain throughout her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment medication was not provided.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Off label use, Pyrexia, Rash
Clinical narrative: Second dose was scheduled for 04MAY2021, but she did not receive it due to the advice of her doctor; Started noticing a rash / the rash kept getting worse; 103 fever; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Second dose was scheduled for 04MAY2021, but she did not receive it due to the advice of her doctor), RASH (Started noticing a rash / the rash kept getting worse) and PYREXIA (103 fever) in a 23-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 06-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 OFF LABEL USE (Second dose was scheduled for 04MAY2021, but she did not receive it due to the advice of her doctor), RASH (Started noticing a rash / the rash kept getting worse) and PYREXIA (103 fever). At the time of the report, OFF LABEL USE (Second dose was scheduled for 04MAY2021, but she did not receive it due to the advice of her doctor), RASH (Started noticing a rash / the rash kept getting worse) and PYREXIA (103 fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103 Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were mentioned. Treatment medication reported included Two antibiotics, pain medication and steroids. She went to the ER twice. On her second visit she was asked to follow up with her primary care physician who prescribed a steroid for her. The second dose was scheduled for 04MAY2021, but she did not receive it due to the advice of her doctor.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Vaccination site bruising, Vaccination site pain
Clinical narrative: bruised very easily on her tummy, legs, waist, thigh and arm; bruised on shot area; little sore on shot area; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruised very easily on her tummy, legs, waist, thigh and arm), VACCINATION SITE BRUISING (bruised on shot area) and VACCINATION SITE PAIN (little sore on shot area) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Blood pressure. Concomitant products included AMLODIPINE for Blood pressure, ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONTUSION (bruised very easily on her tummy, legs, waist, thigh and arm), VACCINATION SITE BRUISING (bruised on shot area) and VACCINATION SITE PAIN (little sore on shot area). At the time of the report, CONTUSION (bruised very easily on her tummy, legs, waist, thigh and arm) and VACCINATION SITE BRUISING (bruised on shot area) was resolving and VACCINATION SITE PAIN (little sore on shot area) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatments were reported. Concomitant medication included hormone for an unknown indication.   This case was linked to MOD-2021-220863 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I was scared too take the second... is it too late; 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 PRODUCT DOSE OMISSION ISSUE (I was scared too take the second... is it too late) 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 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I was scared too take the second... is it too late). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I was scared too take the second.. is it too late) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Patient reported to have had adverse effects after first dose and was scared to have the second shot No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Pyrexia, Swelling
Clinical narrative: armpit on the arm I received the shot is swollen; armpit on the arm I received the shot is sore; was running 100 degree temp; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jun-2021 and was forwarded to Moderna on 14-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (armpit on the arm I received the shot is swollen), AXILLARY PAIN (armpit on the arm I received the shot is sore) and PYREXIA (was running 100 degree temp) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (armpit on the arm I received the shot is swollen), AXILLARY PAIN (armpit on the arm I received the shot is sore) and PYREXIA (was running 100 degree temp). At the time of the report, SWELLING (armpit on the arm I received the shot is swollen), AXILLARY PAIN (armpit on the arm I received the shot is sore) and PYREXIA (was running 100 degree temp) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient was administered dose of vaccine from vial that was refrigerated over 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered dose of vaccine from vial that was refrigerated over 30 days) 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 EXPIRED PRODUCT ADMINISTERED (patient was administered dose of vaccine from vial that was refrigerated over 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered dose of vaccine from vial that was refrigerated over 30 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Migraine, Pain in extremity, Pyrexia
Clinical narrative: Arm hurt so bad it went all the way up an around back of my neck; I had migraines; Lost weight; Real fatigued; Fever; Chills; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt so bad it went all the way up an around back of my neck), MIGRAINE (I had migraines), WEIGHT DECREASED (Lost weight), FATIGUE (Real fatigued) and PYREXIA (Fever) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt so bad it went all the way up an around back of my neck), MIGRAINE (I had migraines), WEIGHT DECREASED (Lost weight), FATIGUE (Real fatigued), PYREXIA (Fever), CHILLS (Chills) and VOMITING (Throwing up). At the time of the report, PAIN IN EXTREMITY (Arm hurt so bad it went all the way up an around back of my neck), MIGRAINE (I had migraines), WEIGHT DECREASED (Lost weight), FATIGUE (Real fatigued), PYREXIA (Fever), CHILLS (Chills) and VOMITING (Throwing up) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       All these symptoms went on for a week. No concomitant information was reported. No treatment information was reported.   This case was linked to MOD-2021-220850 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vomiting, Weight decreased
Clinical narrative: Arm hurt so bad it went all the way up an around back of my neck; I had migraines; Lost weight; Real fatigued; Fever; Chills; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt so bad it went all the way up an around back of my neck), MIGRAINE (I had migraines), WEIGHT DECREASED (Lost weight), FATIGUE (Real fatigued) and PYREXIA (Fever) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt so bad it went all the way up an around back of my neck), MIGRAINE (I had migraines), WEIGHT DECREASED (Lost weight), FATIGUE (Real fatigued), PYREXIA (Fever), CHILLS (Chills) and VOMITING (Throwing up). At the time of the report, PAIN IN EXTREMITY (Arm hurt so bad it went all the way up an around back of my neck), MIGRAINE (I had migraines), WEIGHT DECREASED (Lost weight), FATIGUE (Real fatigued), PYREXIA (Fever), CHILLS (Chills) and VOMITING (Throwing up) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       All these symptoms went on for a week. No concomitant information was reported. No treatment information was reported.   This case was linked to MOD-2021-220850 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: 48 hours of body aches; 48 hours of tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (48 hours of body aches) and FATIGUE (48 hours of 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 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 PAIN (48 hours of body aches) and FATIGUE (48 hours of tiredness). At the time of the report, PAIN (48 hours of body aches) and FATIGUE (48 hours of tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment drug details was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: patient came down with COVID; fever; chills; headache; myalgia; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (patient came down with COVID), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (myalgia) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014c21a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive on 27-Jan-2021.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (patient came down with COVID), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (myalgia). At the time of the report, COVID-19 (patient came down with COVID), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (myalgia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, SARS-CoV-2 test: positive (Positive) patient came down with COVID.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-226267 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up information  received on 17-Jun-2021 contains the patient details updated and  dosage 2 added in products tab.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: patient came down with COVID; fever; chills; headache; myalgia; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (patient came down with COVID), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (myalgia) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014c21a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive on 27-Jan-2021.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (patient came down with COVID), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (myalgia). At the time of the report, COVID-19 (patient came down with COVID), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (myalgia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, SARS-CoV-2 test: positive (Positive) patient came down with COVID.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-226267 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up information  received on 17-Jun-2021 contains the patient details updated and  dosage 2 added in products tab.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) 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, the patient experienced RASH (rash). At the time of the report, RASH (rash) outcome was unknown.            No information regarding concomitant medication was provided.  No information regarding treatment was provided .
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Pruritus, Psoriasis, SARS-CoV-2 test, Skin fissures
Clinical narrative: severe psoriasis; Eczema; Mild itching on both her hands and feet; Fishers on her feet; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (severe psoriasis), ECZEMA (Eczema), PRURITUS (Mild itching on both her hands and feet) and SKIN FISSURES (Fishers on her feet) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2020. Concurrent medical conditions included Autoimmune disorder (autoimmune diseases).   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PSORIASIS (severe psoriasis), ECZEMA (Eczema), PRURITUS (Mild itching on both her hands and feet) and SKIN FISSURES (Fishers on her feet). At the time of the report, PSORIASIS (severe psoriasis), ECZEMA (Eczema), PRURITUS (Mild itching on both her hands and feet) and SKIN FISSURES (Fishers on her feet) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2020, SARS-CoV-2 test: positive (Positive) COVID Positive.         No concomitant medications were reported by the reporter.  The patient had fishers three weeks after her second dose.  Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-220879 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got real sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got real sick) 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 real sick). At the time of the report, ILLNESS (got real sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Illness, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: got sick; headache; diarrhea; cold symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick), HEADACHE (headache), DIARRHOEA (diarrhea) and NASOPHARYNGITIS (cold symptoms) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) 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) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced ILLNESS (got sick), HEADACHE (headache), DIARRHOEA (diarrhea) and NASOPHARYNGITIS (cold symptoms). On 25-May-2021, ILLNESS (got sick), HEADACHE (headache), DIARRHOEA (diarrhea) and NASOPHARYNGITIS (cold symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2021, SARS-CoV-2 test: positive (Positive) positive (all symptoms resolved on 25May2021).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient took cold medicine for treatment, not specified. No other treatment information provided.   Reporter did not allow further contact
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata, Myalgia, Pain in extremity
Clinical narrative: Hair loss/hair started falling out; Left arm achy; body aches; alopecia areata diagnosed after the vaccine.; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss/hair started falling out), ALOPECIA AREATA (alopecia areata diagnosed after the vaccine.), PAIN IN EXTREMITY (Left arm achy) and MYALGIA (body aches) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A2119 and 030B2117) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX in January 2021. Concurrent medical conditions included Blood pressure high since 2018. Concomitant products included LISINOPRIL for Blood pressure high, DOXYCYCLINE for Rosacea, FLUOXETINE and CLONAZEPAM for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 21-Mar-2021, the patient experienced ALOPECIA AREATA (alopecia areata diagnosed after the vaccine.). On an unknown date, the patient experienced ALOPECIA (Hair loss/hair started falling out), PAIN IN EXTREMITY (Left arm achy) and MYALGIA (body aches). At the time of the report, ALOPECIA (Hair loss/hair started falling out) had not resolved, ALOPECIA AREATA (alopecia areata diagnosed after the vaccine.) outcome was unknown and PAIN IN EXTREMITY (Left arm achy) and MYALGIA (body aches) had resolved.            It was reported that patient had thyroid test normal. Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received on 28-June-2021which contains added events: Body ache, Left arm achy and alopecia areata. Added event outcome: unknown to recovered. Added medical history: Shingles vaccine. Added concomitant medications :   Lisinopril, Fluoxetine, Doxycycline and Clonazepam.Added product details : Dose number, drug start ate and Batch number.Added patient demographics : age On 08-Jul-2021: Follow up received on 08-June-2021which contains . Added concomitant medications dose details.Added patient demographics : Hight weight and pregnancy informationAdded medical history: High blood pressureAdded Vaccine facility information.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: can no longer smell or taste anything; can no longer smell or taste anything!; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (can no longer smell or taste anything) and AGEUSIA (can no longer smell or taste anything!) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (can no longer smell or taste anything) and AGEUSIA (can no longer smell or taste anything!). At the time of the report, ANOSMIA (can no longer smell or taste anything) and AGEUSIA (can no longer smell or taste anything!) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug details were provided. No treatment details were provided.   Reporter did not allow further contact
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Tiredness; Injection arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) and VACCINATION SITE PAIN (Injection arm soreness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 023M20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (left side).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced FATIGUE (Tiredness) and VACCINATION SITE PAIN (Injection arm soreness). At the time of the report, FATIGUE (Tiredness) and VACCINATION SITE PAIN (Injection arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was provided.