chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Dyskinesia, Feeling abnormal, Gait inability, Laboratory test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of GAIT INABILITY (I can't walk sometimes), SCRATCH (Scratching my skin like crazy), TINNITUS (Hearing active voices in my head), MOBILITY DECREASED (I also cannot move my body sometimes, I feel like I am paralyzed, I am unable to bend over) and DYSKINESIA (My body moves uncontrollable like someone is moving my body) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (I can't walk sometimes), SCRATCH (Scratching my skin like crazy), TINNITUS (Hearing active voices in my head), MOBILITY DECREASED (I also cannot move my body sometimes, I feel like I am paralyzed, I am unable to bend over), DYSKINESIA (My body moves uncontrollable like someone is moving my body), FEELING ABNORMAL (I feel like worm are moving around in my stomach and body/ I still feel like something is wrong with my body), BACK PAIN (Feel my back hurts), MIGRAINE (Migraines) and MYALGIA (Muscle aches). At the time of the report, GAIT INABILITY (I can't walk sometimes), SCRATCH (Scratching my skin like crazy), TINNITUS (Hearing active voices in my head), MOBILITY DECREASED (I also cannot move my body sometimes, I feel like I am paralyzed, I am unable to bend over), DYSKINESIA (My body moves uncontrollable like someone is moving my body), FEELING ABNORMAL (I feel like worm are moving around in my stomach and body/ I still feel like something is wrong with my body), BACK PAIN (Feel my back hurts), MIGRAINE (Migraines) and MYALGIA (Muscle aches) had not resolved.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: Normal. On an unknown date, SARS-CoV-2 test: (Negative) Negative. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication was reported. It was reported that the patient had been experiencing weird symptoms. The patient not had any runny nose symptoms or fevers. It was reported that the patient had migraines when the patient passed the 5g towers on the highways. The patient had been to the hospital and the patient  test results came back normal, but still felt like something was wrong with the patient's body. The patient got denied disability as well. No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Migraine, Mobility decreased, Myalgia, SARS-CoV-2 test, Scratch
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of GAIT INABILITY (I can't walk sometimes), SCRATCH (Scratching my skin like crazy), TINNITUS (Hearing active voices in my head), MOBILITY DECREASED (I also cannot move my body sometimes, I feel like I am paralyzed, I am unable to bend over) and DYSKINESIA (My body moves uncontrollable like someone is moving my body) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (I can't walk sometimes), SCRATCH (Scratching my skin like crazy), TINNITUS (Hearing active voices in my head), MOBILITY DECREASED (I also cannot move my body sometimes, I feel like I am paralyzed, I am unable to bend over), DYSKINESIA (My body moves uncontrollable like someone is moving my body), FEELING ABNORMAL (I feel like worm are moving around in my stomach and body/ I still feel like something is wrong with my body), BACK PAIN (Feel my back hurts), MIGRAINE (Migraines) and MYALGIA (Muscle aches). At the time of the report, GAIT INABILITY (I can't walk sometimes), SCRATCH (Scratching my skin like crazy), TINNITUS (Hearing active voices in my head), MOBILITY DECREASED (I also cannot move my body sometimes, I feel like I am paralyzed, I am unable to bend over), DYSKINESIA (My body moves uncontrollable like someone is moving my body), FEELING ABNORMAL (I feel like worm are moving around in my stomach and body/ I still feel like something is wrong with my body), BACK PAIN (Feel my back hurts), MIGRAINE (Migraines) and MYALGIA (Muscle aches) had not resolved.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: Normal. On an unknown date, SARS-CoV-2 test: (Negative) Negative. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication was reported. It was reported that the patient had been experiencing weird symptoms. The patient not had any runny nose symptoms or fevers. It was reported that the patient had migraines when the patient passed the 5g towers on the highways. The patient had been to the hospital and the patient  test results came back normal, but still felt like something was wrong with the patient's body. The patient got denied disability as well. No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of GAIT INABILITY (I can't walk sometimes), SCRATCH (Scratching my skin like crazy), TINNITUS (Hearing active voices in my head), MOBILITY DECREASED (I also cannot move my body sometimes, I feel like I am paralyzed, I am unable to bend over) and DYSKINESIA (My body moves uncontrollable like someone is moving my body) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (I can't walk sometimes), SCRATCH (Scratching my skin like crazy), TINNITUS (Hearing active voices in my head), MOBILITY DECREASED (I also cannot move my body sometimes, I feel like I am paralyzed, I am unable to bend over), DYSKINESIA (My body moves uncontrollable like someone is moving my body), FEELING ABNORMAL (I feel like worm are moving around in my stomach and body/ I still feel like something is wrong with my body), BACK PAIN (Feel my back hurts), MIGRAINE (Migraines) and MYALGIA (Muscle aches). At the time of the report, GAIT INABILITY (I can't walk sometimes), SCRATCH (Scratching my skin like crazy), TINNITUS (Hearing active voices in my head), MOBILITY DECREASED (I also cannot move my body sometimes, I feel like I am paralyzed, I am unable to bend over), DYSKINESIA (My body moves uncontrollable like someone is moving my body), FEELING ABNORMAL (I feel like worm are moving around in my stomach and body/ I still feel like something is wrong with my body), BACK PAIN (Feel my back hurts), MIGRAINE (Migraines) and MYALGIA (Muscle aches) had not resolved.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: Normal. On an unknown date, SARS-CoV-2 test: (Negative) Negative. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication was reported. It was reported that the patient had been experiencing weird symptoms. The patient not had any runny nose symptoms or fevers. It was reported that the patient had migraines when the patient passed the 5g towers on the highways. The patient had been to the hospital and the patient  test results came back normal, but still felt like something was wrong with the patient's body. The patient got denied disability as well. No treatment medication was provided.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccine from the refrigerator past its 30 use by date to 3 patients), PRODUCT STORAGE ERROR (initially stored in the refrigerator on 15JUL2022 and administration of vaccine on 18AUG2022) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 vaccination. No Medical History information was reported. On 18-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccine from the refrigerator past its 30 use by date to 3 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (initially stored in the refrigerator on 15JUL2022 and administration of vaccine on 18AUG2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccine from the refrigerator past its 30 use by date to 3 patients.), PRODUCT STORAGE ERROR (initially stored in the refrigerator on 15JUL2022 and administration of vaccine on 18AUG2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccine from the refrigerator past its 30 use by date to 3 patients.) and PRODUCT STORAGE ERROR (initially stored in the refrigerator on 15JUL2022 and administration of vaccine on 18AUG2022). Concomitant medications were not reported. They administered Moderna Covid-19 vaccine from the refrigerator past its 30 use by date to 3 patients. The total number of doses were 3 doses. The vial did not undergo any temperature excursions. They were unsure of which injection in the series this was for the patient. No other adverse reactions reported. Treatment medications were not reported.
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 15-JUL-2022 and administered on 16-Aug-2022; No adverse event; nursing staff at his health center administered Moderna Covid-19 vaccine from the refrigerator past its 30 use by date to 3 patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (nursing staff at his health center administered Moderna Covid-19 vaccine from the refrigerator past its 30 use by date to 3 patients.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 15-JUL-2022 and administered on 16-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 7-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (nursing staff at his health center administered Moderna Covid-19 vaccine from the refrigerator past its 30 use by date to 3 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 15-JUL-2022 and administered on 16-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (nursing staff at his health center administered Moderna Covid-19 vaccine from the refrigerator past its 30 use by date to 3 patients.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 15-JUL-2022 and administered on 16-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (nursing staff at his health center administered Moderna Covid-19 vaccine from the refrigerator past its 30 use by date to 3 patients.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 15-JUL-2022 and administered on 16-Aug-2022).    No concomitant medications was reported. The reporter was unsure of which injection in the series was this for the patient.  The vial was initially stored in the refrigerator on 15-JUL-2022. The vial did not underwent any temperature excursions. No other adverse reactions reported. No treatment drug details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Disability, Illness
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of DISABILITY (Patient stated she was very sick and disabled) and ILLNESS (Very sick) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DISABILITY (Patient stated she was very sick and disabled) and ILLNESS (Very sick). At the time of the report, DISABILITY (Patient stated she was very sick and disabled) and ILLNESS (Very sick) outcome was unknown. No concomitant information was reported. It was reported that patient wanted a nurse to go to her home to provide her another dose. No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to a patient after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 prophylaxis. No Medical History information was reported. On 23-Aug-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to a patient after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to a patient after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered to a patient after manufacturer date of expiry). Concomitant product use was not provided by the reporter. The vial was initially stored in the refrigerator on 15-Aug-2022. The vial did not undergo any temperature excursions. The pharmacy buyer stated that they gave a first booster dose of the Moderna COVID-19 vaccine to a patient from a vial after the manufacturer's expiry date. Treatment information was not provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose beyond 12 hours post puncture), PRODUCT STORAGE ERROR (Vial was first punctured on 22-Aug-2022 9:00 AM and administered on 23-Aug-2022 9:00 AM) and NO ADVERSE EVENT (No Adverse Event) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013B22A) for COVID-19 vaccination. No Medical History information was reported. On 23-Aug-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2022 at 9:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose beyond 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 22-Aug-2022 9:00 AM and administered on 23-Aug-2022 9:00 AM) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose beyond 12 hours post puncture), PRODUCT STORAGE ERROR (Vial was first punctured on 22-Aug-2022 9:00 AM and administered on 23-Aug-2022 9:00 AM) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose beyond 12 hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 22-Aug-2022 9:00 AM and administered on 23-Aug-2022 9:00 AM). Concomitant medication was not provided. It was reported that patient was administered with First booster dose. The vial was initially stored in the refrigerator on 15-Aug-2022. The vial was first punctured at 22-Aug-2022 at 9:00 AM and the vaccine was administered on 23-Aug-2022 at 9:00 AM. The vial was stored post puncture in room temperature. The vial did not undergo any temperature excursion. For roughly 24 hours vial was exposed to room temperature range. Treatment information was not provided.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia, Product administration interrupted
Clinical narrative: Patient did not go back to receive his second shot of the Moderna Covid-19 vaccine/Greater than 35 days in between doses of the Moderna Covid-19 vaccine.; Could hardly move after first dose of his primary series; Muscle and body aches; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (Could hardly move after first dose of his primary series), MYALGIA (Muscle and body aches) and PRODUCT ADMINISTRATION INTERRUPTED (Patient did not go back to receive his second shot of the Moderna Covid-19 vaccine/Greater than 35 days in between doses of the Moderna Covid-19 vaccine.) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced MOBILITY DECREASED (Could hardly move after first dose of his primary series) and MYALGIA (Muscle and body aches). On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient did not go back to receive his second shot of the Moderna Covid-19 vaccine/Greater than 35 days in between doses of the Moderna Covid-19 vaccine.). At the time of the report, MOBILITY DECREASED (Could hardly move after first dose of his primary series), MYALGIA (Muscle and body aches) and PRODUCT ADMINISTRATION INTERRUPTED (Patient did not go back to receive his second shot of the Moderna Covid-19 vaccine/Greater than 35 days in between doses of the Moderna Covid-19 vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  The height of the patient reported as 5 feet 7 inches.  The patient received his first shot of the Moderna Covid-19 vaccine on 15-Jun-2021 and did not go back to receive their second shot of the Moderna Covid-19 vaccine and it had been greater than 35 days in between doses of the Moderna Covid-19 vaccine.  The patient did not remember which arm he received the vaccine in.  The patient did not report taking any Medications and did not report any disease states.  No treatment information was provided by the reporter.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a medical assistant and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator after puncture), EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis. No Medical History information was reported. On 19-Aug-2022 at 9:18 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2022 at 9:18 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator after puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator after puncture), EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator after puncture) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 12 hours post puncture). No concomitant medications were reported. Number of doses/vials includes 2 doses from 1 vial. Date the vial was initially stored in the refrigerator was reported as 04-Aug-2022. Date and time vial was first punctured was reported as 18-Aug-2022 at 10:30 AM. Vial was stored in fridge post puncture. Vial did not undergone any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree Celsius which was 46 degree to 77 degree Fahrenheit) was total of 30 minutes. Vial was not exposed to room temperature for more than 24 hours. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Crying, Vaccination complication
Clinical narrative: the patient has been crying since the day he received the vaccine; problems caused by the vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CRYING (the patient has been crying since the day he received the vaccine) and VACCINATION COMPLICATION (problems caused by the vaccine) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CRYING (the patient has been crying since the day he received the vaccine) and VACCINATION COMPLICATION (problems caused by the vaccine). At the time of the report, CRYING (the patient has been crying since the day he received the vaccine) had not resolved and VACCINATION COMPLICATION (problems caused by the vaccine) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication information was provided. Treatment reported was unknown. Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine past the 30 day beyond use), PRODUCT STORAGE ERROR (Administered with vaccine past the 30 day beyond use) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vaccine past the 30 day beyond use), PRODUCT STORAGE ERROR (Administered with vaccine past the 30 day beyond use) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine past the 30 day beyond use), PRODUCT STORAGE ERROR (Administered with vaccine past the 30 day beyond use) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered with vaccine past the 30 day beyond use) and PRODUCT STORAGE ERROR (Administered with vaccine past the 30 day beyond use). No concomitant medications was reported. No treatment drug details was reported. Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Palpitations, Pyrexia, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Just like I had the flu), PALPITATIONS (Heart was racing), PYREXIA (Fever), MYALGIA (Severe body aches) and VOMITING (Throwing up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Just like I had the flu), PALPITATIONS (Heart was racing), PYREXIA (Fever), MYALGIA (Severe body aches) and VOMITING (Throwing up). At the time of the report, INFLUENZA LIKE ILLNESS (Just like I had the flu), PALPITATIONS (Heart was racing), PYREXIA (Fever), MYALGIA (Severe body aches) and VOMITING (Throwing up) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided. Treatment medication was not provided by the reporter. Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer the vaccine on the 22Aug2022 and 23Aug2022 after the use by date 21Aug2022, to two pediatric patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Jul-2022 and administered on the 22-Aug-2022 and 23-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis. No Medical History information was reported. In August 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer the vaccine on the 22Aug2022 and 23Aug2022 after the use by date 21Aug2022, to two pediatric patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Jul-2022 and administered on the 22-Aug-2022 and 23-Aug-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer the vaccine on the 22Aug2022 and 23Aug2022 after the use by date 21Aug2022, to two pediatric patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Jul-2022 and administered on the 22-Aug-2022 and 23-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administer the vaccine on the 22Aug2022 and 23Aug2022 after the use  by date 21Aug2022, to two pediatric patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Jul-2022 and administered on the 22-Aug-2022 and 23-Aug-2022). This case contains information for the 1st of the 2 pediatric patients who received the vaccine on 22-AUG-2022 and 23-AUG-2022 as described by the reporter. No concomitant medications was reported. The vial was initially stored in the refrigerator on 22-July-2022. The vial did not undergo any temperature excursions. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2022-632635 (E2B Linked Report). Sender's Comments: US-MODERNATX, INC.-MOD-2022-632635: Patient- 2 from two pediatric patients.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Crying, Stomatitis
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of CRYING (Moderna Covid-19 shot 3 days ago and he has been crying non stop for 3 days) and STOMATITIS (sores in his mouth after his Moderna Covid-19 vaccine.) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 20-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2022, the patient experienced CRYING (Moderna Covid-19 shot 3 days ago and he has been crying non stop for 3 days) and STOMATITIS (sores in his mouth after his Moderna Covid-19 vaccine.). At the time of the report, CRYING (Moderna Covid-19 shot 3 days ago and he has been crying non stop for 3 days) and STOMATITIS (sores in his mouth after his Moderna Covid-19 vaccine.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient's age was reported as 2 years 9 months. No concomitant medication information was provided. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administer the vaccine on the 22-Aug-2022 and 23-Aug-2022 after the use by date 21-Aug-2022, to two pediatric patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Jul-2022 and administered on the 22-Aug-2022 and 23-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis. No Medical History information was reported. In August 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administer the vaccine on the 22-Aug-2022 and 23-Aug-2022 after the use by date 21-Aug-2022, to two pediatric patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Jul-2022 and administered on the 22-Aug-2022 and 23-Aug-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administer the vaccine on the 22-Aug-2022 and 23-Aug-2022 after the use by date 21-Aug-2022, to two pediatric patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Jul-2022 and administered on the 22-Aug-2022 and 23-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient administer the vaccine on the 22-Aug-2022 and 23-Aug-2022 after the use by date 21-Aug-2022, to two pediatric patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Jul-2022 and administered on the 22-Aug-2022 and 23-Aug-2022). No concomitant medications was reported. The vial did not undergo any temperature excursions. No treatment  medications was reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; 103 degrees fever/Fever; Body aches; Tiredness; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (103 degrees fever/Fever), MYALGIA (Body aches) and FATIGUE (Tiredness) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013421A, 020B21A and 051F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (103 degrees fever/Fever), MYALGIA (Body aches) and FATIGUE (Tiredness). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (103 degrees fever/Fever), MYALGIA (Body aches) and FATIGUE (Tiredness) had resolved.     DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 degree fever. No concomitant drug information was provided. It was reported that the patient had experienced  mild to moderately severe reactions after the Moderna vaccination. Experienced 103 degree fever with the 2nd dose. The adverse reactions experienced by the patient had lasted for approximately 2 days and there were no additional problems. Patient didn't ever had COVID-19 positive test or diagnosis previously. No treatment drug information was provided. Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2022: Follow-up received and updated vaccination dates and lot numbers.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 IMMUNISATION (Patient recieved dose 1 of Pfizer and dose 2 of moderna (Mixed primary series)), INTERCHANGE OF VACCINE PRODUCTS (Mixed primary series 1st dose of Pfizer and 2nd dose of Moderna COVID-19 Vaccine), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was given before the minimum recommended interval) and NO ADVERSE EVENT (No adverse event.) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis. Patient had no allergies to medications, food and other products. Patient had no medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: Pfizer (first dose) on 06-Aug-2022. Past adverse reactions to the above products included No adverse event with Pfizer. On 22-Aug-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2022, the patient experienced COVID-19 IMMUNISATION (Patient recived dose 1 of pfizer and dose 2 of moderna (Mixed primary series)) and INTERCHANGE OF VACCINE PRODUCTS (Mixed primary series 1st dose of Pfizer and 2nd dose of Moderna COVID-19 Vaccine). 22-Aug-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was given before the minimum recommended interval). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event.). At the time of the report, COVID-19 IMMUNISATION (Patient recived dose 1 of pfizer and dose 2 of moderna (Mixed primary series)), INTERCHANGE OF VACCINE PRODUCTS (Mixed primary series 1st dose of Pfizer and 2nd dose of Moderna COVID-19 Vaccine), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was given before the minimum recommended interval) and NO ADVERSE EVENT (No adverse event.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event.) to be not related. No further causality assessments were provided for COVID-19 IMMUNISATION (Patient recived dose 1 of pfizer and dose 2 of moderna (Mixed primary series)), INTERCHANGE OF VACCINE PRODUCTS (Mixed primary series 1st dose of Pfizer and 2nd dose of Moderna COVID-19 Vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was given before the minimum recommended interval).  It was reported that patient received the vaccine in right leg and was not aware of any symptoms experienced by the patient after the vaccine was administered. HCP did not know if patient was under any treatment for any symptom, of if patient was under any concomitant or regular medication.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cheilitis
Clinical narrative: Bad rash on lower lip started to appear 2 weeks after they got first Covid booster; This spontaneous case was reported by a patient and describes the occurrence of CHEILITIS (Bad rash on lower lip started to appear 2 weeks after they got first Covid booster) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 004C21A and 021B21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high (takes blood pressure medication). Concomitant products included LISINOPRIL and WOMEN'S MULTI [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;ELEUTHEROCOCCUS SENTICOSUS ROOT;FOLIC ACID;IODINE;IRON;MAGNESIUM;MANGANESE;NICOTINIC ACID;PANTOTHENIC ACID;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;SELENIUM; for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEILITIS (Bad rash on lower lip started to appear 2 weeks after they got first Covid booster). The patient was treated with CORTISONE at a dose of cortisone 10 over the counter; HYDROCORTISONE at a dose of Hydrocortisone 1.5; HYDROCORTISONE at a dose of Hydrocortisone 2.5 and TACROLIMUS at a dose of 0.1 % percent. At the time of the report, CHEILITIS (Bad rash on lower lip started to appear 2 weeks after they got first Covid booster) had not resolved.            Concomitant medication also included only blood pressure medication and Hydra something. Treatment medication included patient had been to the dermatologist and MDs and had tried all types of creams and ointments. Patient had Cortisone 10 Over the counter and Keto something.   This case was linked to MOD-2022-633016 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cheilitis, Condition aggravated
Clinical narrative: Bad rash on lower lip started to appear 2 weeks after they got first Covid booster; This spontaneous case was reported by a patient and describes the occurrence of CHEILITIS (Bad rash on lower lip started to appear 2 weeks after they got first Covid booster) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 004C21A and 021B21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high (takes blood pressure medication). Concomitant products included LISINOPRIL and WOMEN'S MULTI [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;ELEUTHEROCOCCUS SENTICOSUS ROOT;FOLIC ACID;IODINE;IRON;MAGNESIUM;MANGANESE;NICOTINIC ACID;PANTOTHENIC ACID;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;SELENIUM; for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEILITIS (Bad rash on lower lip started to appear 2 weeks after they got first Covid booster). The patient was treated with CORTISONE at a dose of cortisone 10 over the counter; HYDROCORTISONE at a dose of Hydrocortisone 1.5; HYDROCORTISONE at a dose of Hydrocortisone 2.5 and TACROLIMUS at a dose of 0.1 % percent. At the time of the report, CHEILITIS (Bad rash on lower lip started to appear 2 weeks after they got first Covid booster) had not resolved.            Concomitant medication also included only blood pressure medication and Hydra something. Treatment medication included patient had been to the dermatologist and MDs and had tried all types of creams and ointments. Patient had Cortisone 10 Over the counter and Keto something.   This case was linked to MOD-2022-633016 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cheilitis
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of CHEILITIS (bad rash on lower lip/ got worse when they got the second Covid booster/rash is extending past the lower lip, extends even further) and CONDITION AGGRAVATED (bad rash on lower lip/ got worse when they got the second Covid booster/rash was extending past the lower lip, extends even further) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054A22A, 068H21A, 004C21A and 021B21A) for COVID-19 prophylaxis.  Concurrent medical conditions included Blood pressure high (takes blood pressure medication). Concomitant products included LISINOPRIL for Blood pressure high, WOMEN'S MULTIVITE for an unknown indication. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEILITIS (bad rash on lower lip/ got worse when they got the second Covid booster/rash is extending past the lower lip, extends even further) and CONDITION AGGRAVATED (bad rash on lower lip/ got worse when they got the second Covid booster/rash was extending past the lower lip, extends even further). The patient was treated with CORTISONE at a dose of cortisone 10; HYDROCORTISONE at a dose of Hydrocortisone 1.5; HYDROCORTISONE at a dose of Hydrocortisone 2.5 and TACROLIMUS at a dose of 0.1 % percent. At the time of the report, CHEILITIS (bad rash on lower lip/ got worse when they got the second Covid booster/rash is extending past the lower lip, extends even further) had not resolved and CONDITION AGGRAVATED (bad rash on lower lip/ got worse when they got the second Covid booster/rash was extending past the lower lip, extends even further) outcome was unknown. Concomitant medication also included blood pressure medication and Hydra something. Treatment medication included patient had been to the dermatologist and MDs and had tried all types of creams and ointments. Patient had Cortisone 10 over the counter and Keto something. This case was linked to MOD-2022-632647 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cheilitis, Condition aggravated
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of CHEILITIS (bad rash on lower lip/ got worse when they got the second Covid booster/rash is extending past the lower lip, extends even further) and CONDITION AGGRAVATED (bad rash on lower lip/ got worse when they got the second Covid booster/rash was extending past the lower lip, extends even further) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054A22A, 068H21A, 004C21A and 021B21A) for COVID-19 prophylaxis.  Concurrent medical conditions included Blood pressure high (takes blood pressure medication). Concomitant products included LISINOPRIL for Blood pressure high, WOMEN'S MULTIVITE for an unknown indication. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEILITIS (bad rash on lower lip/ got worse when they got the second Covid booster/rash is extending past the lower lip, extends even further) and CONDITION AGGRAVATED (bad rash on lower lip/ got worse when they got the second Covid booster/rash was extending past the lower lip, extends even further). The patient was treated with CORTISONE at a dose of cortisone 10; HYDROCORTISONE at a dose of Hydrocortisone 1.5; HYDROCORTISONE at a dose of Hydrocortisone 2.5 and TACROLIMUS at a dose of 0.1 % percent. At the time of the report, CHEILITIS (bad rash on lower lip/ got worse when they got the second Covid booster/rash is extending past the lower lip, extends even further) had not resolved and CONDITION AGGRAVATED (bad rash on lower lip/ got worse when they got the second Covid booster/rash was extending past the lower lip, extends even further) outcome was unknown. Concomitant medication also included blood pressure medication and Hydra something. Treatment medication included patient had been to the dermatologist and MDs and had tried all types of creams and ointments. Patient had Cortisone 10 over the counter and Keto something. This case was linked to MOD-2022-632647 (Patient Link).