chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Ejection fraction, Fatigue, Heart rate
Clinical narrative: Tired; Weak; vaccine reaction; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired), ASTHENIA (Weak) and VACCINATION COMPLICATION (vaccine reaction) in a 57-year-old female patient 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 FATIGUE (Tired) (seriousness criterion hospitalization), ASTHENIA (Weak) (seriousness criterion hospitalization) and VACCINATION COMPLICATION (vaccine reaction) (seriousness criterion hospitalization). At the time of the report, FATIGUE (Tired), ASTHENIA (Weak) and VACCINATION COMPLICATION (vaccine reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) Dropped. On an unknown date, Ejection fraction: increased 10 points Increased 10 points. On an unknown date, Heart rate: 125-135 (abnormal) High heart rate 125-135..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was hospitalized for vaccine reaction to Moderna vaccine within 24 hours, with high heart rate 125-135 and dropped BP and tired and weak with 24 hours of the vaccine. Patient had another echo on 18 Nov 2021 and there was no change since the last one (Results not provided).  Company comment: This case concerns a 57-year-old female patient, with no reported medical history, who experienced the serious, unexpected events of vaccine complication, fatigue and asthenia. The events occurred within 24 hrs after unspecified dose of mRNA 1273 vaccine. The patient was hospitalized for vaccine reaction, fatigue and weakness, her BP dropped and heart rate increased. The rechallenge is not applicable as there is no information regarding dose number. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 57-year-old female patient, with no reported medical history, who experienced the serious, unexpected events of vaccine complication, fatigue and asthenia. The events occurred within 24 hrs after unspecified dose of mRNA 1273 vaccine. The patient was hospitalized for vaccine reaction, fatigue and weakness, her BP dropped and heart rate increased. The rechallenge is not applicable as there is no information regarding dose number. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Tired; Weak; vaccine reaction; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired), ASTHENIA (Weak) and VACCINATION COMPLICATION (vaccine reaction) in a 57-year-old female patient 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 FATIGUE (Tired) (seriousness criterion hospitalization), ASTHENIA (Weak) (seriousness criterion hospitalization) and VACCINATION COMPLICATION (vaccine reaction) (seriousness criterion hospitalization). At the time of the report, FATIGUE (Tired), ASTHENIA (Weak) and VACCINATION COMPLICATION (vaccine reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) Dropped. On an unknown date, Ejection fraction: increased 10 points Increased 10 points. On an unknown date, Heart rate: 125-135 (abnormal) High heart rate 125-135..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was hospitalized for vaccine reaction to Moderna vaccine within 24 hours, with high heart rate 125-135 and dropped BP and tired and weak with 24 hours of the vaccine. Patient had another echo on 18 Nov 2021 and there was no change since the last one (Results not provided).  Company comment: This case concerns a 57-year-old female patient, with no reported medical history, who experienced the serious, unexpected events of vaccine complication, fatigue and asthenia. The events occurred within 24 hrs after unspecified dose of mRNA 1273 vaccine. The patient was hospitalized for vaccine reaction, fatigue and weakness, her BP dropped and heart rate increased. The rechallenge is not applicable as there is no information regarding dose number. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 57-year-old female patient, with no reported medical history, who experienced the serious, unexpected events of vaccine complication, fatigue and asthenia. The events occurred within 24 hrs after unspecified dose of mRNA 1273 vaccine. The patient was hospitalized for vaccine reaction, fatigue and weakness, her BP dropped and heart rate increased. The rechallenge is not applicable as there is no information regarding dose number. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 66.0
Sex: M
Vaccine: COVID19, FLUX, PNC13
Symptoms: Arthralgia, Condition aggravated, Cyst, Infection, Myalgia
Clinical narrative: Cyst in his back is 3 times bigger; Patient stated that all his infections grows; After getting the three shots he felt that the infection grows; Patient is very sore; Patient has very much pain in his artificial knee; This spontaneous case was reported by a consumer and describes the occurrence of CYST (Cyst in his back is 3 times bigger), INFECTION (Patient stated that all his infections grows), CONDITION AGGRAVATED (After getting the three shots he felt that the infection grows), MYALGIA (Patient is very sore) and ARTHRALGIA (Patient has very much pain in his artificial knee) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination.    Co-suspect products included non-company products INFLUENZA VACCINE (FLU) for an unknown indication and PNEUMOCOCCAL VACCINE 13V for an unknown indication.    Concurrent medical conditions included Abscess oral (little abscess in mouth (before taking the booster shot)), Knee replacement (artificial knee) and Cyst (cyst in the back caused by a black pore).   On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, dose of INFLUENZA VACCINE (FLU) (unknown route) 1 dosage form and dose of PNEUMOCOCCAL VACCINE 13V (unknown route) 1 dosage form. On an unknown date, the patient experienced CYST (Cyst in his back is 3 times bigger), INFECTION (Patient stated that all his infections grows), CONDITION AGGRAVATED (After getting the three shots he felt that the infection grows), MYALGIA (Patient is very sore) and ARTHRALGIA (Patient has very much pain in his artificial knee). At the time of the report, CYST (Cyst in his back is 3 times bigger), INFECTION (Patient stated that all his infections grows), CONDITION AGGRAVATED (After getting the three shots he felt that the infection grows), MYALGIA (Patient is very sore) and ARTHRALGIA (Patient has very much pain in his artificial knee) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.  Patient states after getting the three shots he felt that the infection grows, he has a lot of pain in his knee and the cyst in his back was three times bigger. He is very sore.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants were provided. No treatment was provided.   This case was linked to MOD-2021-405660, MOD-2021-405864 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling hot, Headache, Swelling
Clinical narrative: Swelling and heat; Swelling and heat; chills, all that stuff; Shot hurt the moment it was given to her; Headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling and heat), FEELING HOT (Swelling and heat), CHILLS (chills, all that stuff), VACCINATION SITE PAIN (Shot hurt the moment it was given to her) and HEADACHE (Headache) in a 64-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.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling and heat), FEELING HOT (Swelling and heat), CHILLS (chills, all that stuff), VACCINATION SITE PAIN (Shot hurt the moment it was given to her), HEADACHE (Headache) and FATIGUE (tired). At the time of the report, SWELLING (Swelling and heat), FEELING HOT (Swelling and heat), CHILLS (chills, all that stuff), VACCINATION SITE PAIN (Shot hurt the moment it was given to her), HEADACHE (Headache) and FATIGUE (tired) outcome was unknown.            Patient is on concomitant medication, but does not mention which ones. No treatment was reported by the reporter.   This case was linked to MOD-2021-405931 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Swelling and heat; Swelling and heat; chills, all that stuff; Shot hurt the moment it was given to her; Headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling and heat), FEELING HOT (Swelling and heat), CHILLS (chills, all that stuff), VACCINATION SITE PAIN (Shot hurt the moment it was given to her) and HEADACHE (Headache) in a 64-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.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling and heat), FEELING HOT (Swelling and heat), CHILLS (chills, all that stuff), VACCINATION SITE PAIN (Shot hurt the moment it was given to her), HEADACHE (Headache) and FATIGUE (tired). At the time of the report, SWELLING (Swelling and heat), FEELING HOT (Swelling and heat), CHILLS (chills, all that stuff), VACCINATION SITE PAIN (Shot hurt the moment it was given to her), HEADACHE (Headache) and FATIGUE (tired) outcome was unknown.            Patient is on concomitant medication, but does not mention which ones. No treatment was reported by the reporter.   This case was linked to MOD-2021-405931 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 12 or 13 expired booster doses were administered past manufacturer expiration; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 or 13 expired booster doses were administered past manufacturer expiration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 or 13 expired booster doses were administered past manufacturer expiration). On 06-Dec-2021, EXPIRED PRODUCT ADMINISTERED (12 or 13 expired booster doses were administered past manufacturer expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter. Dose administered after 30 day use by date or after manufacturer date of expiry.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Lymph node pain, Migraine, Myalgia
Clinical narrative: freezing; tenderness of lymph nodes of left arm injection site underarm; woke up and threw up/again threw up; "almost passed out"; migraine; body aches; tired; shaking; woke up nauseous; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), FEELING COLD (freezing), PRESYNCOPE ("almost passed out"), MIGRAINE (migraine) and LYMPH NODE PAIN (tenderness of lymph nodes of left arm injection site underarm) 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 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, the patient experienced TREMOR (shaking) and NAUSEA (woke up nauseous). On 06-Dec-2021 at 9:00 AM, the patient experienced FATIGUE (tired). On 06-Dec-2021 at 7:00 PM, the patient experienced MYALGIA (body aches). On 07-Dec-2021, the patient experienced PRESYNCOPE ("almost passed out") and MIGRAINE (migraine). On 07-Dec-2021 at 2:00 AM, the patient experienced VOMITING (woke up and threw up/again threw up). On an unknown date, the patient experienced FEELING COLD (freezing) and LYMPH NODE PAIN (tenderness of lymph nodes of left arm injection site underarm). At the time of the report, TREMOR (shaking), FEELING COLD (freezing), PRESYNCOPE ("almost passed out"), MIGRAINE (migraine), LYMPH NODE PAIN (tenderness of lymph nodes of left arm injection site underarm), FATIGUE (tired), MYALGIA (body aches), VOMITING (woke up and threw up/again threw up) and NAUSEA (woke up nauseous) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Presyncope, Tremor, Vomiting
Clinical narrative: freezing; tenderness of lymph nodes of left arm injection site underarm; woke up and threw up/again threw up; "almost passed out"; migraine; body aches; tired; shaking; woke up nauseous; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), FEELING COLD (freezing), PRESYNCOPE ("almost passed out"), MIGRAINE (migraine) and LYMPH NODE PAIN (tenderness of lymph nodes of left arm injection site underarm) 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 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, the patient experienced TREMOR (shaking) and NAUSEA (woke up nauseous). On 06-Dec-2021 at 9:00 AM, the patient experienced FATIGUE (tired). On 06-Dec-2021 at 7:00 PM, the patient experienced MYALGIA (body aches). On 07-Dec-2021, the patient experienced PRESYNCOPE ("almost passed out") and MIGRAINE (migraine). On 07-Dec-2021 at 2:00 AM, the patient experienced VOMITING (woke up and threw up/again threw up). On an unknown date, the patient experienced FEELING COLD (freezing) and LYMPH NODE PAIN (tenderness of lymph nodes of left arm injection site underarm). At the time of the report, TREMOR (shaking), FEELING COLD (freezing), PRESYNCOPE ("almost passed out"), MIGRAINE (migraine), LYMPH NODE PAIN (tenderness of lymph nodes of left arm injection site underarm), FATIGUE (tired), MYALGIA (body aches), VOMITING (woke up and threw up/again threw up) and NAUSEA (woke up nauseous) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: Nausea; Feeling still tired; Fever (100.5-100.7); Uncomfortable and druggy; chills; Throwing up; Real bad headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Uncomfortable and druggy), CHILLS (chills), VOMITING (Throwing up), HEADACHE (Real bad headache) and NAUSEA (Nausea) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 030L20A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, the patient experienced FEELING ABNORMAL (Uncomfortable and druggy), CHILLS (chills), VOMITING (Throwing up), HEADACHE (Real bad headache) and PYREXIA (Fever (100.5-100.7)). On 07-Dec-2021, the patient experienced NAUSEA (Nausea) and FATIGUE (Feeling still tired). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Uncomfortable and druggy), CHILLS (chills), VOMITING (Throwing up), HEADACHE (Real bad headache) and NAUSEA (Nausea) outcome was unknown and PYREXIA (Fever (100.5-100.7)) and FATIGUE (Feeling still tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Dec-2021, Body temperature: 100.7 (High) High. On 07-Dec-2021, Body temperature: 100.5 (High) High.         No concomitant medication was reported.   This case was linked to MOD-2021-406043 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea; Feeling still tired; Fever (100.5-100.7); Uncomfortable and druggy; chills; Throwing up; Real bad headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Uncomfortable and druggy), CHILLS (chills), VOMITING (Throwing up), HEADACHE (Real bad headache) and NAUSEA (Nausea) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 030L20A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, the patient experienced FEELING ABNORMAL (Uncomfortable and druggy), CHILLS (chills), VOMITING (Throwing up), HEADACHE (Real bad headache) and PYREXIA (Fever (100.5-100.7)). On 07-Dec-2021, the patient experienced NAUSEA (Nausea) and FATIGUE (Feeling still tired). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Uncomfortable and druggy), CHILLS (chills), VOMITING (Throwing up), HEADACHE (Real bad headache) and NAUSEA (Nausea) outcome was unknown and PYREXIA (Fever (100.5-100.7)) and FATIGUE (Feeling still tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Dec-2021, Body temperature: 100.7 (High) High. On 07-Dec-2021, Body temperature: 100.5 (High) High.         No concomitant medication was reported.   This case was linked to MOD-2021-406043 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Patient received a booster dose 0.25mg and this should have been full dose 0.5mg as it is first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received a booster dose 0.25mg and this should have been full dose 0.5mg as it is first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milligram. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient received a booster dose 0.25mg and this should have been full dose 0.5mg as it is first dose). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received a booster dose 0.25mg and this should have been full dose 0.5mg as it is first dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications was not reported. Treatment medications was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: More than 12 hours after puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (More than 12 hours after puncture) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021 at 11:14 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021 at 11:14 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (More than 12 hours after puncture). On 07-Dec-2021 at 11:14 AM, EXPIRED PRODUCT ADMINISTERED (More than 12 hours after puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial had been initially punctured at 14:48 on 06-DEC-2021.  Concomitant medications were not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bone pain
Clinical narrative: Lots of pain in mystomech area; Lots of pain in bones; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL PAIN UPPER (Lotsof pain in mystomech eria) and BONE PAIN (Lotsof pain in bones) 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 ABDOMINAL PAIN UPPER (Lotsof pain in my stomach area) and BONE PAIN (Lots of pain in bones). At the time of the report, ABDOMINAL PAIN UPPER (Lotsof pain in mystomech eria) and BONE PAIN (Lots of pain in bones) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dysgeusia, Feeling abnormal, Gait disturbance, Headache
Clinical narrative: Diarrhea; Metallic taste in my mouth; I stagger when I walk. Walking is difficult. I feel like I am losing balance; My heart was racing right after I got the vaccine, My heart speeds up and then settles down; Headaches; I do not feel the same since I received the Moderna Covid-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I do not feel the same since I received the Moderna Covid-19 vaccine.), DIARRHOEA (Diarrhea), DYSGEUSIA (Metallic taste in my mouth), GAIT DISTURBANCE (I stagger when I walk. Walking is difficult. I feel like I am losing balance) and PALPITATIONS (My heart was racing right after I got the vaccine, My heart speeds up and then settles down) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. FC-014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced FEELING ABNORMAL (I do not feel the same since I received the Moderna Covid-19 vaccine.). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), DYSGEUSIA (Metallic taste in my mouth), GAIT DISTURBANCE (I stagger when I walk. Walking is difficult. I feel like I am losing balance), PALPITATIONS (My heart was racing right after I got the vaccine, My heart speeds up and then settles down) and HEADACHE (Headaches). At the time of the report, FEELING ABNORMAL (I do not feel the same since I received the Moderna Covid-19 vaccine.) had not resolved and DIARRHOEA (Diarrhea), DYSGEUSIA (Metallic taste in my mouth), GAIT DISTURBANCE (I stagger when I walk. Walking is difficult. I feel like I am losing balance), PALPITATIONS (My heart was racing right after I got the vaccine, My heart speeds up and then settles down) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received the vaccine in her left arm shoulder deltoid muscle.   No concomitant medication was provided.  No treatment medication was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Diarrhea; Metallic taste in my mouth; I stagger when I walk. Walking is difficult. I feel like I am losing balance; My heart was racing right after I got the vaccine, My heart speeds up and then settles down; Headaches; I do not feel the same since I received the Moderna Covid-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I do not feel the same since I received the Moderna Covid-19 vaccine.), DIARRHOEA (Diarrhea), DYSGEUSIA (Metallic taste in my mouth), GAIT DISTURBANCE (I stagger when I walk. Walking is difficult. I feel like I am losing balance) and PALPITATIONS (My heart was racing right after I got the vaccine, My heart speeds up and then settles down) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. FC-014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced FEELING ABNORMAL (I do not feel the same since I received the Moderna Covid-19 vaccine.). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), DYSGEUSIA (Metallic taste in my mouth), GAIT DISTURBANCE (I stagger when I walk. Walking is difficult. I feel like I am losing balance), PALPITATIONS (My heart was racing right after I got the vaccine, My heart speeds up and then settles down) and HEADACHE (Headaches). At the time of the report, FEELING ABNORMAL (I do not feel the same since I received the Moderna Covid-19 vaccine.) had not resolved and DIARRHOEA (Diarrhea), DYSGEUSIA (Metallic taste in my mouth), GAIT DISTURBANCE (I stagger when I walk. Walking is difficult. I feel like I am losing balance), PALPITATIONS (My heart was racing right after I got the vaccine, My heart speeds up and then settles down) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received the vaccine in her left arm shoulder deltoid muscle.   No concomitant medication was provided.  No treatment medication was provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Her period was already over a day before vaccination. After vaccination, however, her menstrual period came back/Prolongation of Menstrual bleeding; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Her period was already over a day before vaccination. After vaccination, however, her menstrual period came back/Prolongation of Menstrual bleeding) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Previously administered products included for COVID-19 vaccination: Pfizer (First dose she had on time menstrual periods but heavy bleeding during menstrual period for 3 months) in March 2021 and Pfizer (Second Dose she had on time menstrual periods but heavy bleeding during menstrual period for 3 months) in April 2021. Past adverse reactions to the above products included Heavy menstrual bleeding with Pfizer and Pfizer.    On 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, the patient experienced MENSTRUAL DISORDER (Her period was already over a day before vaccination. After vaccination, however, her menstrual period came back/Prolongation of Menstrual bleeding). At the time of the report, MENSTRUAL DISORDER (Her period was already over a day before vaccination. After vaccination, however, her menstrual period came back/Prolongation of Menstrual bleeding) outcome was unknown.            No concomitant medications were reported   The patient stated that she had Medium menstrual bleeding after booster.  No treatment information was provided   Reporter did not allow further contact
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and CHILLS (chills) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021F21B, 021C21A and 0441321A) for COVID-19 vaccination. No Medical History information was reported. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, the patient experienced MYALGIA (Body aches) and CHILLS (chills). On 03-Dec-2021, MYALGIA (Body aches) and CHILLS (chills) had resolved. Patient had body aches and chills for 3 hours after the booster. Patient might  had Covid-19 in FEB/2020 since he was very sick at that time, however was not diagnosed as Covid-19. It was reported that patient thinks she received her Moderna Booster dose on 03-DEC-2021.No Concomitant medication reported. No Treatment medication reported. This case was linked to MOD-2021-406202, MOD-2021-406148 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: Eczema on hands and feet after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema on hands and feet after 2nd shot) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 040E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced ECZEMA (Eczema on hands and feet after 2nd shot). At the time of the report, ECZEMA (Eczema on hands and feet after 2nd shot) outcome was unknown.            No any concomitant medications were reported. No any treatment medications were reported.  Patient noticed eczema on hands and feet a week after the second shot.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Feeling abnormal, Feeling drunk
Clinical narrative: with in  20 min. i was feeling almost like i had been drinking, a little sore throat, then the chills started to set in. By the evening i was exhausted and feeling like crap muscle aches set in in the early morning hours and all day the following day between 12-24 hrs i felt horrible arm was swollen and very red and painful and hot at the injection site. Hands and feet started to swell to the point my wedding ring didn't fit, chills and fever started to set in massive excruciating muscle pains in my biceps, and quads.  Fever was 101.2 as the highest, coughing and lethargic, extreme exhaustion. at 48 hrs everything was still the same. and then by wednesday i started to get a strange rash and such bad itching all over the injection site which is still hurting pretty bad and sooo itchy. rash on my back left thigh and  hives on the left arm/ wrist . i was unable to go to work since Monday 12/6/2021 till 12/9/2021 and even then it is very hard to work when my arm is very painful to touch or even the rubbing of my shirt on it. i'm itchy all over my body and I have tried to take Benadryl for the allergic reaction but it only works for  a little while
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: with in  20 min. i was feeling almost like i had been drinking, a little sore throat, then the chills started to set in. By the evening i was exhausted and feeling like crap muscle aches set in in the early morning hours and all day the following day between 12-24 hrs i felt horrible arm was swollen and very red and painful and hot at the injection site. Hands and feet started to swell to the point my wedding ring didn't fit, chills and fever started to set in massive excruciating muscle pains in my biceps, and quads.  Fever was 101.2 as the highest, coughing and lethargic, extreme exhaustion. at 48 hrs everything was still the same. and then by wednesday i started to get a strange rash and such bad itching all over the injection site which is still hurting pretty bad and sooo itchy. rash on my back left thigh and  hives on the left arm/ wrist . i was unable to go to work since Monday 12/6/2021 till 12/9/2021 and even then it is very hard to work when my arm is very painful to touch or even the rubbing of my shirt on it. i'm itchy all over my body and I have tried to take Benadryl for the allergic reaction but it only works for  a little while
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Lethargy, Myalgia, Oropharyngeal pain
Clinical narrative: with in  20 min. i was feeling almost like i had been drinking, a little sore throat, then the chills started to set in. By the evening i was exhausted and feeling like crap muscle aches set in in the early morning hours and all day the following day between 12-24 hrs i felt horrible arm was swollen and very red and painful and hot at the injection site. Hands and feet started to swell to the point my wedding ring didn't fit, chills and fever started to set in massive excruciating muscle pains in my biceps, and quads.  Fever was 101.2 as the highest, coughing and lethargic, extreme exhaustion. at 48 hrs everything was still the same. and then by wednesday i started to get a strange rash and such bad itching all over the injection site which is still hurting pretty bad and sooo itchy. rash on my back left thigh and  hives on the left arm/ wrist . i was unable to go to work since Monday 12/6/2021 till 12/9/2021 and even then it is very hard to work when my arm is very painful to touch or even the rubbing of my shirt on it. i'm itchy all over my body and I have tried to take Benadryl for the allergic reaction but it only works for  a little while
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Rash, Urticaria
Clinical narrative: with in  20 min. i was feeling almost like i had been drinking, a little sore throat, then the chills started to set in. By the evening i was exhausted and feeling like crap muscle aches set in in the early morning hours and all day the following day between 12-24 hrs i felt horrible arm was swollen and very red and painful and hot at the injection site. Hands and feet started to swell to the point my wedding ring didn't fit, chills and fever started to set in massive excruciating muscle pains in my biceps, and quads.  Fever was 101.2 as the highest, coughing and lethargic, extreme exhaustion. at 48 hrs everything was still the same. and then by wednesday i started to get a strange rash and such bad itching all over the injection site which is still hurting pretty bad and sooo itchy. rash on my back left thigh and  hives on the left arm/ wrist . i was unable to go to work since Monday 12/6/2021 till 12/9/2021 and even then it is very hard to work when my arm is very painful to touch or even the rubbing of my shirt on it. i'm itchy all over my body and I have tried to take Benadryl for the allergic reaction but it only works for  a little while
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Pain in extremity, Sleep disorder, Swelling
Clinical narrative: Extreme pain under armpit; same arm as injection site. Started after day 1 from getting the shot and ispersistent. By day 3, affecting sleep. The pain from under arm is also extending to hands and fingers, but not as pain but feels slightly swollen.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Headache, Nausea
Clinical narrative: Booster shot after a dose of Jannsen was given in August. Since vaccination, I have had a headache, nausea, and abdominal pain
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: right arm injection for Moderna booster.  noticed mild tingling in right hand, specifically thumb, pointer, and middle fingers. lasted for 24 hrs from morning after injection on the 7th, through morning of the 8th.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: I received the booster shot in my right arm and 2 days later a large bruise appeared on the opposite (left) arm.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Erythema, Peripheral swelling, Pruritus, Swelling
Clinical narrative: Redness, swelling and itching of skin (very similar to hives). The reaction occurs spontaneously as well as after scratching the skin. Mainly occurs on arms, chest, stomach and back. Goes away within 15-30 minutes after appearing. Cause unknown. No known allergens or prior allergies.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and warmth with itchiness near injection site about 2 inches wide and 4-5 inches long
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: numbing on lip, tongue; I got dizzy sometimes; numbing on arm, leg, hands and feet/only her face is still numb/went from the body to her face,/went from the body to her face, numbing on lip, tongue, cheek, and forehead; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbing on arm, leg, hands and feet/only her face is still numb/went from the body to her face,/went from the body to her face, numbing on lip, tongue, cheek, and forehead), HYPOAESTHESIA ORAL (numbing on lip, tongue) and DIZZINESS (I got dizzy sometimes) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included VITAMIN B COMPLEX, BIOTIN and Vitamin C for an unknown indication. On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Nov-2021, the patient experienced HYPOAESTHESIA (numbing on arm, leg, hands and feet/only her face is still numb/went from the body to her face,/went from the body to her face, numbing on lip, tongue, cheek, and forehead). On 03-Dec-2021, the patient experienced HYPOAESTHESIA ORAL (numbing on lip, tongue) and DIZZINESS (I got dizzy sometimes). At the time of the report, HYPOAESTHESIA (numbing on arm, leg, hands and feet/only her face is still numb/went from the body to her face,/went from the body to her face, numbing on lip, tongue, cheek, and forehead), HYPOAESTHESIA ORAL (numbing on lip, tongue) and DIZZINESS (I got dizzy sometimes) had not resolved. No concomitant medications were reported.Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2021: Significant Follow-up received contains dose number, route of administration and event dates.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the jab and got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporter's aunt. The age at vaccination was not reported. The patient got Shingles vaccine and got shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Pain, Pain in extremity, Throat tightness
Clinical narrative: pain left arm; throat closing; aches of entire body, "hit by a truck"; hard to breathe; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number G2J53, expiry date 17th April 2023) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of overdose (1st dose received on 24th September 2021, refer case US2021AMR248492).   On 29th November 2021, the patient received Shingrix (intramuscular) .5 ml. On 30th November 2021, 1 days after receiving Shingrix, the patient experienced pain in arm, throat constriction, general body pain and difficulty breathing. The patient was treated with ibuprofen and dronabinol (Thc). On 1st December 2021, the outcome of the general body pain was recovering/resolving. On an unknown date, the outcome of the pain in arm, throat constriction and difficulty breathing were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, throat constriction, general body pain and difficulty breathing to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine and experienced pain on the left arm (where he was vaccinated), aches and throat closing which started on 30th November 2021 and all were still ongoing.  The patient stated that his arm pain was a bit better today (day of reporting). The aches he was experiencing was of his entire body he felt like he got hit by a truck, it was better today (day of reporting). The patient lastly stated that he felt like his throat was closed and it was hard to breathe, this was still not yet resolved.  The patient took 400mg ibuprofen and 12.5mg THC to help with the pain and aches. The reporter did not consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR248492:Same patient, different dose
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Injection site mass
Clinical narrative: ULTRASOUND DOPPLER ABNORMAL; ARTHRALGIA; CHILLS; PARAESTHESIA; FATIGUE; NAUSEA; PYREXIA; SUPERFICIAL VEIN THROMBOSIS; TREMOR; PERIPHERAL SWELLING; INJECTION SITE MASS; PAIN; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) concerned a 34-year-old female. The patient's height, and weight were not reported. The patient's past medical history included: breastfeeding. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1, suspension for injection, route of admin not reported, batch number: 042a21a expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-APR-2021 for an unknown indication. Vaccine was given about 1.5 cm below the acromion process per doctor measurement. No concomitant medications were reported. On 08-APR-2021, the patient experienced a small lump at injection site within 15 minutes of vaccination. That night patient had 'pins and needles' (paraesthesia) down her left arm. The patient experienced hand tremors, chills, fever 102.3, nausea, body aches, fatigue and shoulder pain (arthralgia). On 09-APR-2021, The patient took ibuprofen at 4 AM. On 10-APR-2021 patient noticed a lump on her left forearm. On 14-APR-2021, The patient had an Ultrasound Doppler done on her left arm and a supraficial venous thrombosis in the cephalic vein of the left forearm was found. Patient was told to start aspirin 81 mg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arthralgia, chills, fatigue, injection site mass, nausea, pain, paraesthesia, peripheral swelling, pyrexia, superficial vein thrombosis, tremor and ultrasound doppler abnormal was not reported. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 30-NOV-2021. Upon review following information was amended: seriousness of event superficial vein thrombosis updated to serious (other medically important).; Sender's Comments: V1. This follow up version was created to update the following information: seriousness of event superficial vein thrombosis updated to serious (other medically important).  20211201391-covid-19 vaccine ad26.cov2.s -superficial vein thrombosis . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).