chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Haematemesis, Haematochezia
Clinical narrative: hemorrhaging/bleeding; Throwing up blood; Pure blood coming out in his stool; hives; sweats; extreme stomach ache; achiness; diarrhea; chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2022 and was forwarded to Moderna on 22-Jan-2022.    This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (hemorrhaging/bleeding), HAEMATEMESIS (Throwing up blood) and HAEMATOCHEZIA (Pure blood coming out in his stool) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (hemorrhaging/bleeding) (seriousness criterion medically significant), HAEMATEMESIS (Throwing up blood) (seriousness criterion medically significant), HAEMATOCHEZIA (Pure blood coming out in his stool) (seriousness criterion medically significant), URTICARIA (hives), HYPERHIDROSIS (sweats), ABDOMINAL PAIN UPPER (extreme stomach ache), PAIN (achiness), DIARRHOEA (diarrhea) and CHILLS (chills). At the time of the report, HAEMORRHAGE (hemorrhaging/bleeding), HAEMATEMESIS (Throwing up blood), HAEMATOCHEZIA (Pure blood coming out in his stool), URTICARIA (hives), HYPERHIDROSIS (sweats), ABDOMINAL PAIN UPPER (extreme stomach ache), PAIN (achiness), DIARRHOEA (diarrhea) and CHILLS (chills) outcome was unknown.            No treatment medication information was provided. No concomitant medications were provided.; Sender's Comments: This is a spontaneous case concerning a 64-year-old male patient with no medical history reported, who experienced the serious unexpected events of Haemorrhage, Haematemesis, and Haematochezia(seriousness criterion medically significant).On 21-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine). All events occurred on an unknown date. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage, Hyperhidrosis, Pain, Urticaria
Clinical narrative: hemorrhaging/bleeding; Throwing up blood; Pure blood coming out in his stool; hives; sweats; extreme stomach ache; achiness; diarrhea; chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2022 and was forwarded to Moderna on 22-Jan-2022.    This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (hemorrhaging/bleeding), HAEMATEMESIS (Throwing up blood) and HAEMATOCHEZIA (Pure blood coming out in his stool) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (hemorrhaging/bleeding) (seriousness criterion medically significant), HAEMATEMESIS (Throwing up blood) (seriousness criterion medically significant), HAEMATOCHEZIA (Pure blood coming out in his stool) (seriousness criterion medically significant), URTICARIA (hives), HYPERHIDROSIS (sweats), ABDOMINAL PAIN UPPER (extreme stomach ache), PAIN (achiness), DIARRHOEA (diarrhea) and CHILLS (chills). At the time of the report, HAEMORRHAGE (hemorrhaging/bleeding), HAEMATEMESIS (Throwing up blood), HAEMATOCHEZIA (Pure blood coming out in his stool), URTICARIA (hives), HYPERHIDROSIS (sweats), ABDOMINAL PAIN UPPER (extreme stomach ache), PAIN (achiness), DIARRHOEA (diarrhea) and CHILLS (chills) outcome was unknown.            No treatment medication information was provided. No concomitant medications were provided.; Sender's Comments: This is a spontaneous case concerning a 64-year-old male patient with no medical history reported, who experienced the serious unexpected events of Haemorrhage, Haematemesis, and Haematochezia(seriousness criterion medically significant).On 21-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine). All events occurred on an unknown date. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 3 patients received vaccine from vial opened more than 12 hours ago; Administered vaccine from a Moderna COVID-19 vial that had been left out at room temperature and was punctured on 14-Dec-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients received vaccine from vial opened more than 12 hours ago) and PRODUCT STORAGE ERROR (Administered vaccine from a Moderna COVID-19 vial that had been left out at room temperature and was punctured on 14-Dec-2021) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Dec-2021 at 4:20 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients received vaccine from vial opened more than 12 hours ago) and PRODUCT STORAGE ERROR (Administered vaccine from a Moderna COVID-19 vial that had been left out at room temperature and was punctured on 14-Dec-2021). On 15-Dec-2021, EXPIRED PRODUCT ADMINISTERED (3 patients received vaccine from vial opened more than 12 hours ago) and PRODUCT STORAGE ERROR (Administered vaccine from a Moderna COVID-19 vial that had been left out at room temperature and was punctured on 14-Dec-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   It was reported that the vial was punctured on 14-Dec-2021.The vial did not undergone any temperature excursions. The vial was stored at room temperature post puncture.   This case was linked to MOD-2022-459158, MOD-2022-459148 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: High fever, 104.0 for the booster. Along with major body aches/then again after the booster, I was subject to a high fever,over 105; High fever, 104.0 for the booster. Along with major body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (High fever, 104.0 for the booster. Along with major body aches/then again after the booster, I was subject to a high fever,over 105) and PAIN (High fever, 104.0 for the booster. Along with major body aches) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 5 milliliter. On 22-Jan-2022, the patient experienced PYREXIA (High fever, 104.0 for the booster. Along with major body aches/then again after the booster, I was subject to a high fever,over 105) (seriousness criterion medically significant) and PAIN (High fever, 104.0 for the booster. Along with major body aches) (seriousness criterion medically significant). On 23-Jan-2022, PYREXIA (High fever, 104.0 for the booster. Along with major body aches/then again after the booster, I was subject to a high fever,over 105) and PAIN (High fever, 104.0 for the booster. Along with major body aches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other medications not provided by the reporter. Patient Reduced body temperature by laying in a bathtub with water at 101 degree for extended periods.  Company comment: This case concerns a 57-year-old male patient with no prior medical history, who experienced serious, unexpected PYREXIA and PAIN one day after the third dose of mRNA-1273. Outcome had resolved on the following day. The reporter who is a health care professional, assessed the events as serious. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-458864.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2022: Follow up received and contains No new information.; Sender's Comments: This case concerns a 57-year-old male patient with no prior medical history, who experienced serious, unexpected PYREXIA and PAIN one day after the third dose of mRNA-1273. Outcome had resolved on the following day. The reporter who is a health care professional, assessed the events as serious. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Migraine, Pyrexia
Clinical narrative: had a migraine and later in the day the migraine subsided; Fever; Chills; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (had a migraine and later in the day the migraine subsided), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (bad headache) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    On 21-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2022, the patient experienced HEADACHE (bad headache). On 22-Jan-2022 at 4:30 AM, the patient experienced MIGRAINE (had a migraine and later in the day the migraine subsided), PYREXIA (Fever) and CHILLS (Chills). On 22-Jan-2022, MIGRAINE (had a migraine and later in the day the migraine subsided) had resolved. At the time of the report, PYREXIA (Fever), CHILLS (Chills) and HEADACHE (bad headache) outcome was unknown.            Patient never had any adverse reaction to immunizations. Patient took COVID shot in June and the booster on 21 January 2022. On 22 January 2022, at 04.30 am patient woke up with fever and chills and had a migraine. Patient had a really bad headache and rested for most of the day. Migraine had subsided later on that day. No concomitant medications were reported.  Treatment information was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Movement disorder
Clinical narrative: felt weak; hard to move; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak) and MOVEMENT DISORDER (hard to move) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Concurrent medical conditions included Diabetes and Depression. Concomitant products included METFORMIN for Diabetes.  On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (felt weak) and MOVEMENT DISORDER (hard to move). At the time of the report, ASTHENIA (felt weak) and MOVEMENT DISORDER (hard to move) had resolved.      The patient had no chronic conditions.  Concomitant medication of the patient also included anti-depressant medication.  The patient had adverse events for 24 hours and then symptom stopped. The patient reported that her healthcare provider did not recommend booster shot.   No treatment information was provided by the reporter.   This case was linked to MOD-2021-029273 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: Heart Arrhythmia; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Heart Arrhythmia) in a 44-year-old male 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (Heart Arrhythmia) (seriousness criterion medically significant). At the time of the report, ARRHYTHMIA (Heart Arrhythmia) outcome was unknown.            Concomitant medications were not provided. Patient was under medical treatment.  Company comment: This case concerns a 44-year-old, male patient with no relevant medical history, who experienced the unexpected serious event of Arrhythmia. The event occurred at an unknown interval after a booster dose of mRNA-1273 (Moderna covid-19 vaccine). Patient reportedly was medical treatment. The rechallenge was not applicable as event occurred after the booster dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 44-year-old, male patient with no relevant medical history, who experienced the unexpected serious event of Arrhythmia. The event occurred at an unknown interval after a booster dose of mRNA-1273 (Moderna covid-19 vaccine). Patient reportedly was medical treatment. The rechallenge was not applicable as event occurred after the booster dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Received a 0.25mL dosage for a 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received a 0.25mL dosage for a 1st dose) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (Received a 0.25mL dosage for a 1st dose). On 23-Dec-2021, ACCIDENTAL UNDERDOSE (Received a 0.25mL dosage for a 1st dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Patient was rejected to have the 2nd dose.  No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Haemorrhagic stroke
Clinical narrative: Hemorrhage stroke; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGIC STROKE (Hemorrhage stroke) 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 HAEMORRHAGIC STROKE (Hemorrhage stroke) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGIC STROKE (Hemorrhage stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.  Company comment: This is a spontaneous case concerning a patient of unknown demographics with no medical history reported, who experienced the unexpected serious AESI of Haemorrhagic stroke in an unknown timeframe with the unspecified dose of mRNA-1273 vaccine. The outcome was reported as unknown, however the event was reported by the patient. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown demographics with no medical history reported, who experienced the unexpected serious AESI of Haemorrhagic stroke in an unknown timeframe with the unspecified dose of mRNA-1273 vaccine. The outcome was reported as unknown, however the event was reported by the patient. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Nasopharyngitis, Neck pain, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Still quite lame; Now Have a cold; Sore throat; sneezing; Neck hurts; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Still quite lame), NASOPHARYNGITIS (Now Have a cold), OROPHARYNGEAL PAIN (Sore throat), SNEEZING (sneezing) and NECK PAIN (Neck hurts) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Muscle disorder NOS.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced ILLNESS (Still quite lame), NASOPHARYNGITIS (Now Have a cold), OROPHARYNGEAL PAIN (Sore throat), SNEEZING (sneezing) and NECK PAIN (Neck hurts). At the time of the report, ILLNESS (Still quite lame) had not resolved and NASOPHARYNGITIS (Now Have a cold), OROPHARYNGEAL PAIN (Sore throat), SNEEZING (sneezing) and NECK PAIN (Neck hurts) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) tested negative for Covid..         no concomitant medication were reported  no treatment medication were reported
Sex: U
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: Still quite lame; Now Have a cold; Sore throat; sneezing; Neck hurts; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Still quite lame), NASOPHARYNGITIS (Now Have a cold), OROPHARYNGEAL PAIN (Sore throat), SNEEZING (sneezing) and NECK PAIN (Neck hurts) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Muscle disorder NOS.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced ILLNESS (Still quite lame), NASOPHARYNGITIS (Now Have a cold), OROPHARYNGEAL PAIN (Sore throat), SNEEZING (sneezing) and NECK PAIN (Neck hurts). At the time of the report, ILLNESS (Still quite lame) had not resolved and NASOPHARYNGITIS (Now Have a cold), OROPHARYNGEAL PAIN (Sore throat), SNEEZING (sneezing) and NECK PAIN (Neck hurts) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) tested negative for Covid..         no concomitant medication were reported  no treatment medication were reported
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criteria death and medically significant). The reported cause of death was Myocarditis. It is unknown if an autopsy was performed.            No Concomitant drugs were reported.  No Treatment information  were reported.  Company comment:This is a spontaneous case concerning a male patient of an unknown age with no medical history reported, who experienced the serious unexpected fatal event of myocarditis(seriousness criteria death and medically significant). Patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) on unknown date, with Myocarditis and death occurring within a month of dose.The reported cause of death was Myocarditis.The rechallenge was unknown since there's only information about the second dose.The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.  It was reported that, the reporters' father died within a month after his 2nd shot from myocarditis. Just months before his vaccine, he had a full physical, when he was given vaccine he was  in perfect health.; Sender's Comments: This is a spontaneous case concerning a male patient of an unknown age with no medical history reported, who experienced the serious unexpected fatal event of myocarditis(seriousness criteria death and medically significant). Patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) on unknown date, with Myocarditis and death occurring within a month of dose.The reported cause of death was Myocarditis.The rechallenge was unknown since there's only information about the second dose.The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Reported Cause(s) of Death: myocarditis
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: leg pain as a side effect of the COVID booster; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (leg pain as a side effect of the COVID booster) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (leg pain as a side effect of the COVID booster). At the time of the report, PAIN IN EXTREMITY (leg pain as a side effect of the COVID booster) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The patient wanted to know how long the adverse event would last.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: Diarrhea; tiredness; This spontaneous case was reported by a nurse and describes the occurrence of DIARRHOEA (Diarrhea) and FATIGUE (tiredness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A, 028L20A and 049C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-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 DIARRHOEA (Diarrhea) and FATIGUE (tiredness). At the time of the report, DIARRHOEA (Diarrhea) and FATIGUE (tiredness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided. The patient had tiredness and diarrhea after what she thinks was the 2nd dose, although she was not exactly sure.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: breaking out on hives; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (breaking out on hives) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (breaking out on hives). At the time of the report, URTICARIA (breaking out on hives) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature increased, Pyrexia, Vaccination complication
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Vaccination Symptoms) and PYREXIA (body temperature increase up to 37.5 degrees C after injection) 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 VACCINATION COMPLICATION (Vaccination Symptoms) and PYREXIA (body temperature increase up to 37.5 degrees C after injection). At the time of the report, VACCINATION COMPLICATION (Vaccination Symptoms) and PYREXIA (body temperature increase up to 37.5 degrees C after injection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature increased: 37.5 degrees C (High) temperature increase up to 37.5 degrees C after injection. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant Drug details were reported. No Treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Headache
Clinical narrative: Redness in arm; Some kind of headachy feeling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness in arm) and HEADACHE (Some kind of headachy feeling) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from 01-Jan-2020 to 12-Jan-2020.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ERYTHEMA (Redness in arm) and HEADACHE (Some kind of headachy feeling). At the time of the report, ERYTHEMA (Redness in arm) and HEADACHE (Some kind of headachy feeling) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that the patient had a blood test 8 months later after the COVID and found that she had antibodies and donated her plasma.  No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-460387 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chills, Hyperhidrosis, Illness, Loss of consciousness
Clinical narrative: Redness in arm; Some kind of headachy feeling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness in arm) and HEADACHE (Some kind of headachy feeling) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from 01-Jan-2020 to 12-Jan-2020.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ERYTHEMA (Redness in arm) and HEADACHE (Some kind of headachy feeling). At the time of the report, ERYTHEMA (Redness in arm) and HEADACHE (Some kind of headachy feeling) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that the patient had a blood test 8 months later after the COVID and found that she had antibodies and donated her plasma.  No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-460387 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Redness in arm; Some kind of headachy feeling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness in arm) and HEADACHE (Some kind of headachy feeling) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from 01-Jan-2020 to 12-Jan-2020.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ERYTHEMA (Redness in arm) and HEADACHE (Some kind of headachy feeling). At the time of the report, ERYTHEMA (Redness in arm) and HEADACHE (Some kind of headachy feeling) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that the patient had a blood test 8 months later after the COVID and found that she had antibodies and donated her plasma.  No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-460387 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Myalgia, Pain
Clinical narrative: Achy; Don't feel good; Chills; Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), FEELING ABNORMAL (Don't feel good), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Achy), FEELING ABNORMAL (Don't feel good), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache). At the time of the report, PAIN (Achy), FEELING ABNORMAL (Don't feel good), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.            Treatment information not provided.  Concomitant medications not provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2022: Follow-up document received contains No new information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered from a 2 days post punctured vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered from a 2 days post punctured vial) 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 EXPIRED PRODUCT ADMINISTERED (Dose administered from a 2 days post punctured vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered from a 2 days post punctured vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Expired product administered, Fatigue, Somnolence, Swelling
Clinical narrative: expired vaccine administered; felt weak; couldn´t stay awake/slept her whole working shift from 8-2/just woke up periodically; a little swelling; felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak), SOMNOLENCE (couldn´t stay awake/slept her whole working shift from 8-2/just woke up periodically), SWELLING (a little swelling), FATIGUE (felt very tired) and EXPIRED PRODUCT ADMINISTERED (expired vaccine administered) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2022 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced ASTHENIA (felt weak), SOMNOLENCE (couldn´t stay awake/slept her whole working shift from 8-2/just woke up periodically), SWELLING (a little swelling) and FATIGUE (felt very tired). On 22-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered). On 22-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered) had resolved. At the time of the report, ASTHENIA (felt weak), SOMNOLENCE (couldn´t stay awake/slept her whole working shift from 8-2/just woke up periodically), SWELLING (a little swelling) and FATIGUE (felt very tired) outcome was unknown.            No concomitant medications were reported No treatment medications were reported   This case was linked to MOD-2022-460314 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Booster dose that has been punctured for more than 12 hours was administered to a patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose that has been punctured for more than 12 hours was administered to a patient) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2022 at 8:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022 at 8:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose that has been punctured for more than 12 hours was administered to a patient). On 18-Jan-2022 at 8:30 AM, EXPIRED PRODUCT ADMINISTERED (Booster dose that has been punctured for more than 12 hours was administered to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.  Lot number(s): 034F21A Number of doses/vials: 1 Date the vial was initially stored in the refrigerator: 17JAN2022 Date(s) and time(S) vial was first punctured: 17JAN2022 at 10:13 am Date(s) and time(s) of administration of vaccine: 18JAN2022 at 8:30 am Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F)
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Still complaining of pain at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Still complaining of pain at the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A and 011F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Still complaining of pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Still complaining of pain at the injection site) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided. No treatment medications are provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: felt sleepy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (felt sleepy) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (felt sleepy). At the time of the report, SOMNOLENCE (felt sleepy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug details were reported. No treatment details were reported.   This case was linked to MOD-2022-460300 (Patient Link).   Reporter did not allow further contact
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Feeling abnormal, Madarosis
Clinical narrative: Her hair started falling out about 6 weeks after getting the doses/This is the worst it's ever been/says this is really bad & she doesn't want to be seen or go anywhere/Loss of eyelashes; She lost her eyelashes a little bit too; says this is really bad & she doesn't want to be seen or go anywhere; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Her hair started falling out about 6 weeks after getting the doses/This is the worst it's ever been/says this is really bad & she doesn't want to be seen or go anywhere/Loss of eyelashes), MADAROSIS (She lost her eyelashes a little bit too) and FEELING ABNORMAL (says this is really bad & she doesn't want to be seen or go anywhere) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 037B21A) for COVID-19 vaccination.     The patient's past medical history included Alopecia (It had been in remission, and it had only happened a few times.).   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Her hair started falling out about 6 weeks after getting the doses/This is the worst it's ever been/says this is really bad & she doesn't want to be seen or go anywhere/Loss of eyelashes), MADAROSIS (She lost her eyelashes a little bit too) and FEELING ABNORMAL (says this is really bad & she doesn't want to be seen or go anywhere). At the time of the report, ALOPECIA (Her hair started falling out about 6 weeks after getting the doses/This is the worst it's ever been/says this is really bad & she doesn't want to be seen or go anywhere/Loss of eyelashes), MADAROSIS (She lost her eyelashes a little bit too) and FEELING ABNORMAL (says this is really bad & she doesn't want to be seen or go anywhere) outcome was unknown.            No concomitant products were reported.  The patient had a history of alopecia, it had been in remission and had only happened a few times, that was the worst. Her hair started falling out about 6 weeks after getting the doses, before the vaccine it was just the hair on her head. She stated that was really bad and doesn't want to be seen or go anywhere. She was looks like a cancer patient.  No treatment information was reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: second dose administered from a expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (second dose administered from a expired vaccine) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A and 011F21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included CLONIDINE and HYDROCHLOROTHIAZIDE for Blood pressure management, ATORVASTATIN, NIFEDIPINE and METOPROLOL SUCCINATE for an unknown indication.   On 20-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 24-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (second dose administered from a expired vaccine). On 24-Jan-2022, EXPIRED PRODUCT ADMINISTERED (second dose administered from a expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   HCP stated that dose was administered after 30-day use by date or after manufacturer date of expiry. Number of doses/vials was 1 vial, 1 dose administered. Vaccine was kept in the freezer till the day it was used. On the day of reporting, it was removed from the freezer. The vial did not undergo any temperature excursions.  No treatment information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: mildly sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.    Linked case(s) involving the same patient: US2022AMR010795  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had no real side effects from the 1st dose except for a mildly sore arm.  The follow up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR010795:same reporter, other dose
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 15 month old pt administered Kinrix; administered a dose of Kinrix instead of just a DTaP; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th January 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 11th January 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter reported that a 15 month old patient was administered a dose of Kinrix instead of just a DTaP dose ,which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up. The reporter gave permission for follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal mucosal blistering
Clinical narrative: VAGINAL BLISTERS; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered 1 in total, therapy start date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced vaginal blisters, and was hospitalized (dates and duration unspecified). The patient symptoms went away after treatment with (dates unspecified) valaciclovir hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaginal blisters. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20220141559.; Sender's Comments: V0:20220141775-covid-19 vaccine ad26.cov2.s - vaginal blisters . 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).
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced low grade fever, body ache and fatigue and tested positive for covid-19 (suspected covid-19 infection, suspected clinical vaccination failure). Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint. Product quality number has been requested.; Sender's Comments: V0-20220146069-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS