chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: makes my head feel really high; shaking; kinda feel weak; makes my stomach nauseous; shot site was itchy and a little painful; shot site is itchy, was a little painful; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (makes my head feel really high), TREMOR (shaking), ASTHENIA (kinda feel weak), VACCINATION SITE PRURITUS (shot site is itchy, was a little painful) and NAUSEA (makes my stomach nauseous) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Erythromycin) and Drug allergy (Halidol.). Concomitant products included AMITRIPTYLINE, CITALOPRAM, FOLIC ACID, ADALIMUMAB (HUMIRA), HYDROXYCHLOROQUINE, CALCIUM FOLINATE (LEUCOVORINE), LEVOTHYROXINE, LOSARTAN and METHOTREXATE for an unknown indication.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (shot site is itchy, was a little painful) and VACCINATION SITE PAIN (shot site was itchy and a little painful). On 09-Aug-2021, the patient experienced HEAD DISCOMFORT (makes my head feel really high), TREMOR (shaking), ASTHENIA (kinda feel weak) and NAUSEA (makes my stomach nauseous). At the time of the report, HEAD DISCOMFORT (makes my head feel really high), TREMOR (shaking), ASTHENIA (kinda feel weak), VACCINATION SITE PRURITUS (shot site is itchy, was a little painful), NAUSEA (makes my stomach nauseous) and VACCINATION SITE PAIN (shot site was itchy and a little painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reported that the patient was having the same as the effects when she took Erythromycin.  No treatment information was provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite
Clinical narrative: Loss of appetite; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Idiopathic pulmonary fibrosis. Concomitant products included PIRFENIDONE (ESBRIET) for an unknown indication.    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 DECREASED APPETITE (Loss of appetite). At the time of the report, DECREASED APPETITE (Loss of appetite) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Hospitalisation
Clinical narrative: Hospitalization; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (Hospitalization) 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 HOSPITALISATION (Hospitalization) (seriousness criterion hospitalization). At the time of the report, HOSPITALISATION (Hospitalization) had resolved. Not Provided          Concomitant products were not provided. Treatment medication were not reported. Patient was hospitalized for 2 to 3 days.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got very 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got very sick). At the time of the report, ILLNESS (Got very sick) outcome was unknown.            No concomitant medication reported . No treatment medication reported .   This case was linked to MOD-2021-281964 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site pain, Lymph node pain, Nodule, Peripheral swelling
Clinical narrative: 2 little balls or nodules very close together on her left clavicle that were painful to touch; Left arm pit was swollen; Next to her chest beside her breast was painful; Under her arm was painful; Left Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (2 little balls or nodules very close together on her left clavicle that were painful to touch), PERIPHERAL SWELLING (Left arm pit was swollen), LYMPH NODE PAIN (Next to her chest beside her breast was painful), INJECTION SITE PAIN (Left Arm hurt) and AXILLARY PAIN (Under her arm was painful) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045C21A and 045C21A) for COVID-19 vaccination.     Concurrent medical conditions included Menopause.   On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Aug-2021, the patient experienced INJECTION SITE PAIN (Left Arm hurt). On 09-Aug-2021 at 6:00 PM, the patient experienced NODULE (2 little balls or nodules very close together on her left clavicle that were painful to touch), PERIPHERAL SWELLING (Left arm pit was swollen), LYMPH NODE PAIN (Next to her chest beside her breast was painful) and AXILLARY PAIN (Under her arm was painful). At the time of the report, NODULE (2 little balls or nodules very close together on her left clavicle that were painful to touch) was resolving and PERIPHERAL SWELLING (Left arm pit was swollen), LYMPH NODE PAIN (Next to her chest beside her breast was painful), INJECTION SITE PAIN (Left Arm hurt) and AXILLARY PAIN (Under her arm was painful) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: diagnosed with blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (diagnosed with blood clots) 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.    In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (diagnosed with blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (diagnosed with blood clots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was mentioned by reporter  No treatment medication information was mentioned by reporter  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up received on 10-Aug-2021 and included no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Respiratory rate increased, Throat tightness
Clinical narrative: 1st dose 31Mar2021; 2nd dose scheduled today (10Aug2021); fast breathing; felt that her throat was closing; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY RATE INCREASED (fast breathing) and THROAT TIGHTNESS (felt that her throat was closing) 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.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced RESPIRATORY RATE INCREASED (fast breathing) (seriousness criterion medically significant) and THROAT TIGHTNESS (felt that her throat was closing) (seriousness criterion medically significant). On 10-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 31Mar2021; 2nd dose scheduled today (10Aug2021)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. On 31-Mar-2021, RESPIRATORY RATE INCREASED (fast breathing) had resolved. On 10-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 31Mar2021; 2nd dose scheduled today (10Aug2021)) had resolved. At the time of the report, THROAT TIGHTNESS (felt that her throat was closing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Patient was scheduled for second dose on 10-Aug-2021.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events of throat tightness and respiratory rate increase, a causal relationship cannot be excluded. This report refers to a case of Product administration error  for mRNA-1273, with no associated AEs; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events of throat tightness and respiratory rate increase, a causal relationship cannot be excluded. This report refers to a case of Product administration error  for mRNA-1273, with no associated AEs
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness, Fatigue, Gait disturbance
Clinical narrative: Vaccination adverse reaction/ severe reaction; Could not get out of bed; Held on to walk a few feet to bathroom; No appetite; No sleeping; A bit dizzy; Weak; Vomiting; Nausea; Tired; Fever of 101 for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction/ severe reaction), VACCINATION COMPLICATION (Could not get out of bed), GAIT DISTURBANCE (Held on to walk a few feet to bathroom), DECREASED APPETITE (No appetite) and INSOMNIA (No sleeping) 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 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 (Vaccination adverse reaction/ severe reaction), VACCINATION COMPLICATION (Could not get out of bed), GAIT DISTURBANCE (Held on to walk a few feet to bathroom), DECREASED APPETITE (No appetite), INSOMNIA (No sleeping), DIZZINESS (A bit dizzy), ASTHENIA (Weak), VOMITING (Vomiting), NAUSEA (Nausea), FATIGUE (Tired) and PYREXIA (Fever of 101 for 3 days). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction/ severe reaction), VACCINATION COMPLICATION (Could not get out of bed), GAIT DISTURBANCE (Held on to walk a few feet to bathroom), DECREASED APPETITE (No appetite), INSOMNIA (No sleeping), DIZZINESS (A bit dizzy), ASTHENIA (Weak), VOMITING (Vomiting), NAUSEA (Nausea), FATIGUE (Tired) and PYREXIA (Fever of 101 for 3 days) outcome was unknown. Not Provided          No concomitant medication information was provided.  No treatment medication information was given.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow up received, contains information about the events occurred.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Pyrexia, Vaccination complication, Vomiting
Clinical narrative: Vaccination adverse reaction/ severe reaction; Could not get out of bed; Held on to walk a few feet to bathroom; No appetite; No sleeping; A bit dizzy; Weak; Vomiting; Nausea; Tired; Fever of 101 for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction/ severe reaction), VACCINATION COMPLICATION (Could not get out of bed), GAIT DISTURBANCE (Held on to walk a few feet to bathroom), DECREASED APPETITE (No appetite) and INSOMNIA (No sleeping) 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 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 (Vaccination adverse reaction/ severe reaction), VACCINATION COMPLICATION (Could not get out of bed), GAIT DISTURBANCE (Held on to walk a few feet to bathroom), DECREASED APPETITE (No appetite), INSOMNIA (No sleeping), DIZZINESS (A bit dizzy), ASTHENIA (Weak), VOMITING (Vomiting), NAUSEA (Nausea), FATIGUE (Tired) and PYREXIA (Fever of 101 for 3 days). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction/ severe reaction), VACCINATION COMPLICATION (Could not get out of bed), GAIT DISTURBANCE (Held on to walk a few feet to bathroom), DECREASED APPETITE (No appetite), INSOMNIA (No sleeping), DIZZINESS (A bit dizzy), ASTHENIA (Weak), VOMITING (Vomiting), NAUSEA (Nausea), FATIGUE (Tired) and PYREXIA (Fever of 101 for 3 days) outcome was unknown. Not Provided          No concomitant medication information was provided.  No treatment medication information was given.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow up received, contains information about the events occurred.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: wife received first dosage of moderna vaccine after getting his 2 doses; This spontaneous case was reported by a patient family member or friend and describes the occurrence of EXTRA DOSE ADMINISTERED (wife received first dosage of moderna vaccine after getting his 2 doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (wife received first dosage of moderna vaccine after getting his 2 doses). At the time of the report, EXTRA DOSE ADMINISTERED (wife received first dosage of moderna vaccine after getting his 2 doses) had resolved.            No concomitant medication information provided.  It was reported the reporter's wife got the shot again after her 2 doses thinking it was a booster shot.     Reporter did not allow further contact
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: extreme thirst; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (extreme thirst) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX from July 2020 to October 2020.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-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 THIRST (extreme thirst). At the time of the report, THIRST (extreme thirst) outcome was unknown.            It was stated that before the 2nd dose he drank about 5 glasses of water before going to the vaccination facility.  He began feeling thirsty again while waiting the 15 minutes, drank 8 ounces of water that he brought with him, then drank 32 ounces he had in the car on the way home, then drank more water once he got home.    The concomitant medication was centrum.  The treatment information was not reported.   This case was linked to MOD-2021-282241 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm was little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was little sore) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 038K20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, LOVASTATIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) and LISINOPRIL for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm was little sore). On 05-Feb-2021, VACCINATION SITE PAIN (arm was little sore) had resolved.            No treatment medications were provided   This case was linked to MOD-2021-282847 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Headache, Nausea, Pyrexia
Clinical narrative: Feels bad; Big Headache; Fever up to 102 degrees; Feels nauseous; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels bad), HEADACHE (Big Headache), PYREXIA (Fever up to 102 degrees) and NAUSEA (Feels nauseous) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 939902) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced FEELING ABNORMAL (Feels bad), HEADACHE (Big Headache), PYREXIA (Fever up to 102 degrees) and NAUSEA (Feels nauseous). At the time of the report, FEELING ABNORMAL (Feels bad), HEADACHE (Big Headache), PYREXIA (Fever up to 102 degrees) and NAUSEA (Feels nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Aug-2021, Body temperature: 102 degrees (High) 102 degrees.         Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling abnormal, Oropharyngeal pain, Pain in extremity
Clinical narrative: today I feel kind of tired; last night I felt kind of bad; I didn't sleep well; developed a runny nose; sore throat; arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was a little sore), RHINORRHOEA (developed a runny nose), OROPHARYNGEAL PAIN (sore throat), FEELING ABNORMAL (last night I felt kind of bad) and POOR QUALITY SLEEP (I didn't sleep well) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE, LOVASTATIN, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]) and LISINOPRIL for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was a little sore). On 08-Aug-2021, the patient experienced RHINORRHOEA (developed a runny nose) and OROPHARYNGEAL PAIN (sore throat). On 09-Aug-2021, the patient experienced FEELING ABNORMAL (last night I felt kind of bad) and POOR QUALITY SLEEP (I didn't sleep well). On 10-Aug-2021, the patient experienced FATIGUE (today I feel kind of tired). On 05-Mar-2021, PAIN IN EXTREMITY (arm was a little sore) had resolved. At the time of the report, RHINORRHOEA (developed a runny nose), OROPHARYNGEAL PAIN (sore throat), FEELING ABNORMAL (last night I felt kind of bad), POOR QUALITY SLEEP (I didn't sleep well) and FATIGUE (today I feel kind of tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: 98.6 (High) usually around 97.7 degrees Fahrenheit and it increased to 98.6 degrees Fahrenheit.         No treatment medications was provided by reporter.  On 09-AUG-2021 patient felt a little uncomfortable.   This case was linked to MOD-2021-282798 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality sleep, Rhinorrhoea
Clinical narrative: today I feel kind of tired; last night I felt kind of bad; I didn't sleep well; developed a runny nose; sore throat; arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was a little sore), RHINORRHOEA (developed a runny nose), OROPHARYNGEAL PAIN (sore throat), FEELING ABNORMAL (last night I felt kind of bad) and POOR QUALITY SLEEP (I didn't sleep well) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE, LOVASTATIN, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]) and LISINOPRIL for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was a little sore). On 08-Aug-2021, the patient experienced RHINORRHOEA (developed a runny nose) and OROPHARYNGEAL PAIN (sore throat). On 09-Aug-2021, the patient experienced FEELING ABNORMAL (last night I felt kind of bad) and POOR QUALITY SLEEP (I didn't sleep well). On 10-Aug-2021, the patient experienced FATIGUE (today I feel kind of tired). On 05-Mar-2021, PAIN IN EXTREMITY (arm was a little sore) had resolved. At the time of the report, RHINORRHOEA (developed a runny nose), OROPHARYNGEAL PAIN (sore throat), FEELING ABNORMAL (last night I felt kind of bad), POOR QUALITY SLEEP (I didn't sleep well) and FATIGUE (today I feel kind of tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: 98.6 (High) usually around 97.7 degrees Fahrenheit and it increased to 98.6 degrees Fahrenheit.         No treatment medications was provided by reporter.  On 09-AUG-2021 patient felt a little uncomfortable.   This case was linked to MOD-2021-282798 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Tinnitus
Clinical narrative: Tinnitus; fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) and FATIGUE (fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005021A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, TINNITUS (Tinnitus) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication  were provided  No treatment medication was provided  It reported that the patient will not be getting second dose.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Tinnitus
Clinical narrative: Constant Tinitus; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Constant Tinitus) and FATIGUE (Extreme fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007m20A and 017L20) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to antibiotics (Sulfa allergy).   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced TINNITUS (Constant Tinitus) and FATIGUE (Extreme fatigue). At the time of the report, TINNITUS (Constant Tinitus) had not resolved and FATIGUE (Extreme fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Lab Data include Hearing test, ECHO and Lab investigations.  No Concomitant medications were reported. No Treatment information was reported.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: One dose was given to a patient from this vaccine vial after 12-hour puncture.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (One dose was given to a patient from this vaccine vial after 12-hour puncture.) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021 at 2:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (One dose was given to a patient from this vaccine vial after 12-hour puncture.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (One dose was given to a patient from this vaccine vial after 12-hour puncture.) 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 medication was provided.  No treatment medication was provided. This vaccine vial was punctured at 1:15pm on 09-Aug-2021 and stored in room temperature since then. This vial was then given to patient at 2pm on 10-Aug-2021.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata, Lyme disease, Madarosis
Clinical narrative: Lyme disease; Diagnosed with alopecia areata; Loss of hair on his head; Loss of eye lashes/losing of eyelashes/Loss of his eyebrows; This spontaneous case was reported by a consumer and describes the occurrence of LYME DISEASE (Lyme disease) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Environmental allergy (takes allergy shot for his allergy and uses inhaler) and Asthma.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced ALOPECIA (Loss of hair on his head) and MADAROSIS (Loss of eye lashes/losing of eyelashes/Loss of his eyebrows). On an unknown date, the patient experienced LYME DISEASE (Lyme disease) (seriousness criterion medically significant) and ALOPECIA AREATA (Diagnosed with alopecia areata). The patient was treated with MINOXIDIL (ROGAINE) (oral) for Ingrown hair, at an unspecified dose and frequency. At the time of the report, LYME DISEASE (Lyme disease), ALOPECIA (Loss of hair on his head), MADAROSIS (Loss of eye lashes/losing of eyelashes/Loss of his eyebrows) and ALOPECIA AREATA (Diagnosed with alopecia areata) outcome was unknown.            Concomitant medications included allergy shot for his allergy and uses inhaler.  On May-2021, the patient started losing his eyes lashes, the hair on his head and his eyebrows. He went to the dermatologist; he was diagnosed with alopecia areata. Patient was currently getting steroid shot at the dermatologist office and was previously on oral rogaine to regrow his hair but had to stop because it was dropping his blood pressure.   The patient recently got a tick bite, so he was also dealing with lyme disease now.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache on and off since then; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache on and off since then) 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.    In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced HEADACHE (headache on and off since then). At the time of the report, HEADACHE (headache on and off since then) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information was provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling cold, Headache, Night sweats
Clinical narrative: Felt under the weather; Reaction started left arm that was hot to the touch on arm; Red, splotchy in circle patterns (started out fairly small and are now 2 inches in length); Surrounding area where splotches are not, are cold to touch; Night sweats; Fever, it was pretty intense/ I still feel like I have a low grade fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt under the weather), SKIN WARM (Reaction started left arm that was hot to the touch on arm), RASH ERYTHEMATOUS (Red, splotchy in circle patterns (started out fairly small and are now 2 inches in length)), FEELING COLD (Surrounding area where splotches are not, are cold to touch) and NIGHT SWEATS (Night sweats) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 88221S and 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-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 VACCINATION COMPLICATION (Felt under the weather), SKIN WARM (Reaction started left arm that was hot to the touch on arm), RASH ERYTHEMATOUS (Red, splotchy in circle patterns (started out fairly small and are now 2 inches in length)), FEELING COLD (Surrounding area where splotches are not, are cold to touch), NIGHT SWEATS (Night sweats), PYREXIA (Fever, it was pretty intense/ I still feel like I have a low grade fever), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) on 08-Aug-2021 for Fever, at an unspecified dose and frequency and IBUPROFEN on 08-Aug-2021 for Pain, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Felt under the weather), SKIN WARM (Reaction started left arm that was hot to the touch on arm), RASH ERYTHEMATOUS (Red, splotchy in circle patterns (started out fairly small and are now 2 inches in length)), FEELING COLD (Surrounding area where splotches are not, are cold to touch), NIGHT SWEATS (Night sweats), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown and PYREXIA (Fever, it was pretty intense/ I still feel like I have a low grade fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.6 degrees fahrenheit (High) 99.6 degrees Fahrenheit.         Patient's concomitant medications were reported as none, though she takes Tylenol and ibuprofen as needed for unassociated pain and swelling throughout normal life pattern. Onset date of events was reported as an unspecified date in Aug-2021. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-283124 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash erythematous, Skin warm, Vaccination complication
Clinical narrative: Felt under the weather; Reaction started left arm that was hot to the touch on arm; Red, splotchy in circle patterns (started out fairly small and are now 2 inches in length); Surrounding area where splotches are not, are cold to touch; Night sweats; Fever, it was pretty intense/ I still feel like I have a low grade fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt under the weather), SKIN WARM (Reaction started left arm that was hot to the touch on arm), RASH ERYTHEMATOUS (Red, splotchy in circle patterns (started out fairly small and are now 2 inches in length)), FEELING COLD (Surrounding area where splotches are not, are cold to touch) and NIGHT SWEATS (Night sweats) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 88221S and 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-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 VACCINATION COMPLICATION (Felt under the weather), SKIN WARM (Reaction started left arm that was hot to the touch on arm), RASH ERYTHEMATOUS (Red, splotchy in circle patterns (started out fairly small and are now 2 inches in length)), FEELING COLD (Surrounding area where splotches are not, are cold to touch), NIGHT SWEATS (Night sweats), PYREXIA (Fever, it was pretty intense/ I still feel like I have a low grade fever), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) on 08-Aug-2021 for Fever, at an unspecified dose and frequency and IBUPROFEN on 08-Aug-2021 for Pain, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Felt under the weather), SKIN WARM (Reaction started left arm that was hot to the touch on arm), RASH ERYTHEMATOUS (Red, splotchy in circle patterns (started out fairly small and are now 2 inches in length)), FEELING COLD (Surrounding area where splotches are not, are cold to touch), NIGHT SWEATS (Night sweats), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown and PYREXIA (Fever, it was pretty intense/ I still feel like I have a low grade fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.6 degrees fahrenheit (High) 99.6 degrees Fahrenheit.         Patient's concomitant medications were reported as none, though she takes Tylenol and ibuprofen as needed for unassociated pain and swelling throughout normal life pattern. Onset date of events was reported as an unspecified date in Aug-2021. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-283124 (Patient Link).
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: patient who received the J&J COVID-19 vaccine back in May, and on 10-Aug-2021 received the first Moderna shot; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (patient who received the J&J COVID-19 vaccine back in May, and on 10-Aug-2021 received the first Moderna shot) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (patient who received the J&J COVID-19 vaccine back in May, and on 10-Aug-2021 received the first Moderna shot). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (patient who received the J&J COVID-19 vaccine back in May, and on 10-Aug-2021 received the first Moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Co-suspect vaccine was J&J COVID-19 vaccine. The patient received the J&J COVID-19 vaccine back in May and on 10-Aug-2021 received the first Moderna shot.   Reporter did not allow further contact
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Eye disorder, Hypoaesthesia, Incontinence, Malabsorption
Clinical narrative: Full dose of the vial, enough for 6 doses/ 3 milliliters; It won't come back up the way it's supposed to/drop foot; Numbness on the whole left side of my body; Incontinence; Malabsorption; Eye pattern disorder; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Full dose of the vial, enough for 6 doses/ 3 milliliters) in a 30-year-old female patient 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 Hysterectomy.    On 17-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced ACCIDENTAL OVERDOSE (Full dose of the vial, enough for 6 doses/ 3 milliliters) (seriousness criterion hospitalization). On an unknown date, the patient experienced PERONEAL NERVE PALSY (It won't come back up the way it's supposed to/drop foot), HYPOAESTHESIA (Numbness on the whole left side of my body), INCONTINENCE (Incontinence), MALABSORPTION (Malabsorption) and EYE DISORDER (Eye pattern disorder). The patient was hospitalized from 17-Mar-2021 to 18-Mar-2021 due to ACCIDENTAL OVERDOSE. The patient was treated with Physical therapy for Peroneal nerve palsy and Physical therapy for Hypoaesthesia. At the time of the report, ACCIDENTAL OVERDOSE (Full dose of the vial, enough for 6 doses/ 3 milliliters), PERONEAL NERVE PALSY (It won't come back up the way it's supposed to/drop foot), HYPOAESTHESIA (Numbness on the whole left side of my body), INCONTINENCE (Incontinence), MALABSORPTION (Malabsorption) and EYE DISORDER (Eye pattern disorder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter. The treatment information was not provided. It was said that the patient was hospitalized for a day and a half on 17-Mar-2021 to 18-Mar-2021. Again was hospitalized on 24-Mar-2021, then again on 19-Jul-2021. The patient was struggling with a lot of things.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Peroneal nerve palsy
Clinical narrative: Full dose of the vial, enough for 6 doses/ 3 milliliters; It won't come back up the way it's supposed to/drop foot; Numbness on the whole left side of my body; Incontinence; Malabsorption; Eye pattern disorder; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Full dose of the vial, enough for 6 doses/ 3 milliliters) in a 30-year-old female patient 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 Hysterectomy.    On 17-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced ACCIDENTAL OVERDOSE (Full dose of the vial, enough for 6 doses/ 3 milliliters) (seriousness criterion hospitalization). On an unknown date, the patient experienced PERONEAL NERVE PALSY (It won't come back up the way it's supposed to/drop foot), HYPOAESTHESIA (Numbness on the whole left side of my body), INCONTINENCE (Incontinence), MALABSORPTION (Malabsorption) and EYE DISORDER (Eye pattern disorder). The patient was hospitalized from 17-Mar-2021 to 18-Mar-2021 due to ACCIDENTAL OVERDOSE. The patient was treated with Physical therapy for Peroneal nerve palsy and Physical therapy for Hypoaesthesia. At the time of the report, ACCIDENTAL OVERDOSE (Full dose of the vial, enough for 6 doses/ 3 milliliters), PERONEAL NERVE PALSY (It won't come back up the way it's supposed to/drop foot), HYPOAESTHESIA (Numbness on the whole left side of my body), INCONTINENCE (Incontinence), MALABSORPTION (Malabsorption) and EYE DISORDER (Eye pattern disorder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter. The treatment information was not provided. It was said that the patient was hospitalized for a day and a half on 17-Mar-2021 to 18-Mar-2021. Again was hospitalized on 24-Mar-2021, then again on 19-Jul-2021. The patient was struggling with a lot of things.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Blister, Urticaria
Clinical narrative: Abnormal Hives; fluid filled bumps; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Abnormal Hives) and BLISTER (fluid filled bumps) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Abnormal Hives) and BLISTER (fluid filled bumps). At the time of the report, URTICARIA (Abnormal Hives) and BLISTER (fluid filled bumps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: any minor aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (any minor aches) 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 (any minor aches). At the time of the report, PAIN (any minor aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient enquired whether ibuprofen can be used for minor aches. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   Reporter did not allow further contact