chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in an 86-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported by any patients.  No treatment medication reported.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 32-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. No adverse reactions were reported by patient.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion); Patient administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) in a 50-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that, their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.   It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.  No treatment medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 63-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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 40-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the State.   The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 48-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported. The reporter stated that because their facility has not been able to download the digital data logger, they have been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the State was made.  There had been no power outages that would have impacted the Moderna vaccine. However, she reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion.  Reporter stated that no adverse reactions were reported by any patients. No treatment medication were provided.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 34-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  There have been no power outages that would have impacted the Moderna vaccine. However, reiterates that because facility was unable to download the digital data logger, they will need to treat this issue as a temperature excursion. The data logger that caller was unable to download were for the months of DEC2021, JAN2022, and FEB2022. She says that they are filling out a temperature excursion assessment with the State at this time. The doses was administered while the temperature excursion assessment has been ongoing same.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient administered moderna covid vaccine while temperature excursion was ongoing; Patient administered moderna covid vaccine while temperature excursion was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) in a 53-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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment medication were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) in a 59-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-501575 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 66-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec 2021, Jan 2022, and Feb 2022. It was reported that the patients have been administered doses while the temperature excursion assessment was ongoing and reported that no adverse reactions were reported by any patients. No treatment information was provided.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 31-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) 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.  Patient has taken 0.25 mL, since dose number is not provided, it is presumed to be booster.  No adverse events were reported.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients have been administered doses while the temperature excursion assessment was ongoing; patients have been administered doses while the temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing) in an 89-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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  No treatment information provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 46-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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blood pressure abnormal, Confusional state, Dizziness, Eye swelling
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: <10 mins post moderna booster pt reported "feeling faint and tingling lips." pt received previous vaccine doses 5/12/21+6/9/21 without issue. h/o anaphylaxis to lactose. symptoms began to worsen: pulse faint, bp undetectable, loss conciousness (<1min). came to upon arrousal, still weak pulse/tingling mouth. administered epi x 1, ems arrived and took over care. transported to er.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypotension, Loss of consciousness, Mouth swelling, Paraesthesia
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: <10 mins post moderna booster pt reported "feeling faint and tingling lips." pt received previous vaccine doses 5/12/21+6/9/21 without issue. h/o anaphylaxis to lactose. symptoms began to worsen: pulse faint, bp undetectable, loss conciousness (<1min). came to upon arrousal, still weak pulse/tingling mouth. administered epi x 1, ems arrived and took over care. transported to er.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pulse abnormal, Swelling face, Swollen tongue, Syncope
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: <10 mins post moderna booster pt reported "feeling faint and tingling lips." pt received previous vaccine doses 5/12/21+6/9/21 without issue. h/o anaphylaxis to lactose. symptoms began to worsen: pulse faint, bp undetectable, loss conciousness (<1min). came to upon arrousal, still weak pulse/tingling mouth. administered epi x 1, ems arrived and took over care. transported to er.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: <10 mins post moderna booster pt reported "feeling faint and tingling lips." pt received previous vaccine doses 5/12/21+6/9/21 without issue. h/o anaphylaxis to lactose. symptoms began to worsen: pulse faint, bp undetectable, loss conciousness (<1min). came to upon arrousal, still weak pulse/tingling mouth. administered epi x 1, ems arrived and took over care. transported to er.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint injury, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Malaise, Pallor, Vomiting
Clinical narrative: Systemic: Flushed / Sweating-Medium, Systemic: Vomiting-Medium, Additional Details: Several minutes after covid booster patient reported feeling unwell. Looked pale and sweaty. And he reported feeling sweaty himself. A minute later he started vomiting. Lasted for a few minutes and than patient reported feeling much better. He did not want me to call ambulance or EMT. He stayed alittle longer and said he was completely better and left.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain in jaw
Clinical narrative: Systemic: Headache-Medium, Systemic: Joint Pain-Medium, Additional Details: Headache and jaw pain lasting for over 3 weeks at this point - ongoing
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pruritus, Rash papular, Scratch
Clinical narrative: Started with itching all over body. Itchy palms and neck. Itchy scalp. Then red scratch marks wherever I would scratch. Then horrible hives/raised bumps and burning sensation in different parts of my body. Would last about a half hour in each location before moving on to the next. Had hives on my feet, legs, back, flank, chest, arms and neck.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Started with itching all over body. Itchy palms and neck. Itchy scalp. Then red scratch marks wherever I would scratch. Then horrible hives/raised bumps and burning sensation in different parts of my body. Would last about a half hour in each location before moving on to the next. Had hives on my feet, legs, back, flank, chest, arms and neck.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardioversion, Electrocardiogram abnormal, Heart rate irregular
Clinical narrative: AFib heartbeat.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Injection site pain, Pyrexia
Clinical narrative: moderna 1 5/4/2021  0.5/0.25ml     moderna 2   6/1/2021   0.5/0.25ml     moderna 3 0.5/0.25ml     moderna 3 booster sht should be 1/2 dose of 1 & 2   i waserror given full doze  hosp should NOT allow prefill syringe and give all pt same dose   I was overdose   in vovid19 vaccine.    RN who gave the shot at the hospital.   Hosp  manager supervisor is responsible for this lazy and improper care to pt.   exclude me unknown how many pt got full dose as booster instead of 1/2 dose.   I happen lucky to catch this serious error and wrong name spelling.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Mobility decreased, Muscular weakness, Pain, Pain in extremity
Clinical narrative: Pain in left arm, couldn't raise arm without pain for three or 5 days. Weakness in muscle, couldn't use hand or arm for days.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough   dose 1 Moderna 2/18/21 013M20A dose 2 Moderna 3/18/21 030A21A
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: covid vaccine breakthrough   dose 1 Moderna 2/18/21 013M20A dose 2 Moderna 3/18/21 030A21A
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dyspnoea, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Difficulty breathing, Arm/hand numbness, sweating, stomach pain.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Computerised tomogram thorax abnormal, Dyspnoea, Fatigue, Pneumonitis
Clinical narrative: About weeks later, I felt fatigued, had joint pain with SOB. Went to the doctor, ran Chest CT and diagnosis was inflammation in lungs. Doctor was not sure if diagnosis was vaccine related. Symptoms lasted about 2 months, now taking steroids.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary function test
Clinical narrative: About weeks later, I felt fatigued, had joint pain with SOB. Went to the doctor, ran Chest CT and diagnosis was inflammation in lungs. Doctor was not sure if diagnosis was vaccine related. Symptoms lasted about 2 months, now taking steroids.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Atrial fibrillation, Blood creatinine increased, COVID-19, COVID-19 pneumonia
Clinical narrative: Admit date 08/24/21 HPI: pt presented to the ER complaining of shortness of breath; pt stated he had URI symptoms for 1 week; tested COVID negative 1 week prior; home health nurse says he is now positive for COVID; hypoxic at home, oxygenating in 70s; placed on nasal cannula; dry cough  Creatinine of 1.9; chest xray showed patchy infiltrates concerning for COVID; pt has hx of asthma Treatment plan: oxygen prn, lovenox 40 mg subq bid,  albuterol prn, Tylenol prn, dexamethasone 6 mg qd, remdesivir, normal saline 75 cc/hour Transferred to icu on 08/27 with COVID pneumonia and worsening respiratory failure with hypoxemia; started on baricitinib; intubated on 08/29/2021; sedated; prone positioning; amiodarone infusion for atrial fibrillation with rapid ventricular response; 09/02/21 hyperkalemia; Eliquis to replace lovenox; versed on 09/03; tracheostomy and PEG tube placed on 09/08/21; patient deteriorated throughout the day; received maximal pressor therapy and was noted to have decreasing heart rate; pt was dnr and passed away the afternoon of 09/09/2021
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Cough, Death, Dyspnoea, Endotracheal intubation
Clinical narrative: Admit date 08/24/21 HPI: pt presented to the ER complaining of shortness of breath; pt stated he had URI symptoms for 1 week; tested COVID negative 1 week prior; home health nurse says he is now positive for COVID; hypoxic at home, oxygenating in 70s; placed on nasal cannula; dry cough  Creatinine of 1.9; chest xray showed patchy infiltrates concerning for COVID; pt has hx of asthma Treatment plan: oxygen prn, lovenox 40 mg subq bid,  albuterol prn, Tylenol prn, dexamethasone 6 mg qd, remdesivir, normal saline 75 cc/hour Transferred to icu on 08/27 with COVID pneumonia and worsening respiratory failure with hypoxemia; started on baricitinib; intubated on 08/29/2021; sedated; prone positioning; amiodarone infusion for atrial fibrillation with rapid ventricular response; 09/02/21 hyperkalemia; Eliquis to replace lovenox; versed on 09/03; tracheostomy and PEG tube placed on 09/08/21; patient deteriorated throughout the day; received maximal pressor therapy and was noted to have decreasing heart rate; pt was dnr and passed away the afternoon of 09/09/2021
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrostomy, General physical health deterioration, Heart rate decreased, Hyperkalaemia, Hypoxia
Clinical narrative: Admit date 08/24/21 HPI: pt presented to the ER complaining of shortness of breath; pt stated he had URI symptoms for 1 week; tested COVID negative 1 week prior; home health nurse says he is now positive for COVID; hypoxic at home, oxygenating in 70s; placed on nasal cannula; dry cough  Creatinine of 1.9; chest xray showed patchy infiltrates concerning for COVID; pt has hx of asthma Treatment plan: oxygen prn, lovenox 40 mg subq bid,  albuterol prn, Tylenol prn, dexamethasone 6 mg qd, remdesivir, normal saline 75 cc/hour Transferred to icu on 08/27 with COVID pneumonia and worsening respiratory failure with hypoxemia; started on baricitinib; intubated on 08/29/2021; sedated; prone positioning; amiodarone infusion for atrial fibrillation with rapid ventricular response; 09/02/21 hyperkalemia; Eliquis to replace lovenox; versed on 09/03; tracheostomy and PEG tube placed on 09/08/21; patient deteriorated throughout the day; received maximal pressor therapy and was noted to have decreasing heart rate; pt was dnr and passed away the afternoon of 09/09/2021
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Infusion, Intensive care, Lung infiltration, Prone position, Respiratory failure
Clinical narrative: Admit date 08/24/21 HPI: pt presented to the ER complaining of shortness of breath; pt stated he had URI symptoms for 1 week; tested COVID negative 1 week prior; home health nurse says he is now positive for COVID; hypoxic at home, oxygenating in 70s; placed on nasal cannula; dry cough  Creatinine of 1.9; chest xray showed patchy infiltrates concerning for COVID; pt has hx of asthma Treatment plan: oxygen prn, lovenox 40 mg subq bid,  albuterol prn, Tylenol prn, dexamethasone 6 mg qd, remdesivir, normal saline 75 cc/hour Transferred to icu on 08/27 with COVID pneumonia and worsening respiratory failure with hypoxemia; started on baricitinib; intubated on 08/29/2021; sedated; prone positioning; amiodarone infusion for atrial fibrillation with rapid ventricular response; 09/02/21 hyperkalemia; Eliquis to replace lovenox; versed on 09/03; tracheostomy and PEG tube placed on 09/08/21; patient deteriorated throughout the day; received maximal pressor therapy and was noted to have decreasing heart rate; pt was dnr and passed away the afternoon of 09/09/2021
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory symptom, SARS-CoV-2 test positive, Tracheostomy
Clinical narrative: Admit date 08/24/21 HPI: pt presented to the ER complaining of shortness of breath; pt stated he had URI symptoms for 1 week; tested COVID negative 1 week prior; home health nurse says he is now positive for COVID; hypoxic at home, oxygenating in 70s; placed on nasal cannula; dry cough  Creatinine of 1.9; chest xray showed patchy infiltrates concerning for COVID; pt has hx of asthma Treatment plan: oxygen prn, lovenox 40 mg subq bid,  albuterol prn, Tylenol prn, dexamethasone 6 mg qd, remdesivir, normal saline 75 cc/hour Transferred to icu on 08/27 with COVID pneumonia and worsening respiratory failure with hypoxemia; started on baricitinib; intubated on 08/29/2021; sedated; prone positioning; amiodarone infusion for atrial fibrillation with rapid ventricular response; 09/02/21 hyperkalemia; Eliquis to replace lovenox; versed on 09/03; tracheostomy and PEG tube placed on 09/08/21; patient deteriorated throughout the day; received maximal pressor therapy and was noted to have decreasing heart rate; pt was dnr and passed away the afternoon of 09/09/2021
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Chills, Fatigue, Headache, Interchange of vaccine products
Clinical narrative: Body Aches, chills, fever, head ache and tiredness
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Body Aches, chills, fever, head ache and tiredness
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypertension, Vision blurred
Clinical narrative: at 13:15 patient in observation area presented with dizziness and blurred vision. Patient walked unassisted about 100ft to observation medical tent for evaluation. Pt presented with hypertension and denied headache, chest pain or difficulty breathing. due to HTN with blurred vision recommended transport via ambulance. Transported via medic to hospital.  13:21 209/114 p56 r16 13:21 204/108 p57 r16 13:26 211/128 p62 r16 13:32 229/130 p65 r16
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Feeling abnormal, Full blood count, Heart rate increased
Clinical narrative: Service Member has experienced continued pain and cramping in the arm of the injection site, does not present in the other arm. Has demonstrated symptoms of physical fatigue, migraine headaches, mental fatigue and fogginess.  Additional symptoms observed show increased heart rate, muscle cramping, and patient states presence of trouble sleeping and increase in cold sore frequency.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Mental fatigue, Migraine, Muscle spasms, Oral herpes
Clinical narrative: Service Member has experienced continued pain and cramping in the arm of the injection site, does not present in the other arm. Has demonstrated symptoms of physical fatigue, migraine headaches, mental fatigue and fogginess.  Additional symptoms observed show increased heart rate, muscle cramping, and patient states presence of trouble sleeping and increase in cold sore frequency.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Service Member has experienced continued pain and cramping in the arm of the injection site, does not present in the other arm. Has demonstrated symptoms of physical fatigue, migraine headaches, mental fatigue and fogginess.  Additional symptoms observed show increased heart rate, muscle cramping, and patient states presence of trouble sleeping and increase in cold sore frequency.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: Muscle pain, tenderness at injection site for first 12 hours increasing to nausea, fatigue, headache, fever for another 24 hours
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Muscle pain, tenderness at injection site for first 12 hours increasing to nausea, fatigue, headache, fever for another 24 hours
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Injection site pain, Neck pain
Clinical narrative: Fever, chills, headache, neck ache, injection site pain; diarrhea
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, chills, headache, neck ache, injection site pain; diarrhea
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Decreased vibratory sense, Electromyogram normal, Hypoaesthesia, Nerve conduction studies abnormal
Clinical narrative: Concurrent with fever 102.6 developed burning/ tingling sensation in feet. Numbness and occ shooting pains have continued in both feet, worse after the booster shot, and continuing to this day with worsening of numbness slowly ascending/ loss of vibratory perception in gt toes (diminished at ankles) and no motor weakness detected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Peripheral motor neuropathy, Peripheral sensory neuropathy, Pyrexia
Clinical narrative: Concurrent with fever 102.6 developed burning/ tingling sensation in feet. Numbness and occ shooting pains have continued in both feet, worse after the booster shot, and continuing to this day with worsening of numbness slowly ascending/ loss of vibratory perception in gt toes (diminished at ankles) and no motor weakness detected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Malaise, Palpitations, Sleep disorder
Clinical narrative: About 2 hours later after shot, I started experiencing a headache and not feeling well.  woke up at 12 am with racing heart beat, heart rate was in the 130s and it lasted all night long until the morning.  Finally my heart rate got back to normal later in the morning.