chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
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 50-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. No adverse reactions were reported by patient.
Age: 26.0
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 26-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 milligram. 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 were reported.  Reporter states 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 is made. There have been no power outages that would have impacted the Moderna vaccine. However, she reiterates that because her facility is unable to download the digital data logger, they will need to treat this issue as a temperature excursion. The data logger that caller is unable to download are 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 and she is calling in to report the same.  Patients have been administered doses while the temperature excursion assessment has been ongoing.  No adverse reactions were reported by any patients.  No treatment information were provided.    This case was linked to MOD-2022-501575 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose on 27-Jan -2021 and Second dose 27-Aug-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 27-Jan -2021 and Second dose 27-Aug-2021) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 27-Jan -2021 and Second dose 27-Aug-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 27-Jan -2021 and Second dose 27-Aug-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  Treatment details were not given   This case was linked to MOD-2022-503785 (Patient Link).
Age: 58.0
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 58-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.   No concomitant and treatment medications were reported.  No adverse reactions were reported by patient.
Age: 51.0
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 51-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 (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 (Moderna COVID-19 Vaccine) (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: 38.0
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 38-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) .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 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment 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.
Age: 25.0
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 25-year-old female patient who received mRNA-1273  for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273  (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  (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: 37.0
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 37-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.   No concomitant medications information was reported.  It was reported that there have been no power outages that would have impacted the Moderna vaccine. However, reporter reiterated 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 that caller was unable to download for the months of DEC2021, JAN2022, and FEB2022. Reporter said that they are filling out a temperature excursion assessment with the State at this time and she was calling in to report the same to Moderna.  Reporter confirmed that patients have been administered doses while the temperature excursion assessment has been ongoing. It was reported that no adverse reactions were reported by any patients.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient administered moderna covid vaccine while temperature excursion assessment was ongoing(possible temperature excursion); Patient administered moderna covid 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 covid vaccine while temperature excursion assessment was ongoing(possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion assessment was ongoing(possible temperature excursion)) in a 66-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 (Patient administered moderna covid vaccine while temperature excursion assessment was ongoing(possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion assessment was ongoing(possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion assessment was ongoing(possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while 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 were reported.  No treatment medication were reported.
Age: 58.0
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 58-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 was reported. It was reported that, the facility was unable to download the data they would need to treat this issue as a temperature excursion. The data was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. No adverse event was reported by patient.  No treatment information was reported.
Age: 24.0
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 24-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 information was not reported.  Reporter stated that no adverse reactions were reported by any patients.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Influenza, Pain
Clinical narrative: Life destroyed/Feels like someone at night hits her with a baseball bat in the face; Now the pain is so bad/Achy/The pain is like the worst part of childbirth; Felt like she had the flu; Weak as water for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Life destroyed/Feels like someone at night hits her with a baseball bat in the face), PAIN (Now the pain is so bad/Achy/The pain is like the worst part of childbirth), INFLUENZA (Felt like she had the flu) and ASTHENIA (Weak as water for 4 days) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 005C21A and 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Depression, Trigeminal neuralgia (for 11 years with no symptoms and now the pain was so bad. It is called "The suicide disease"), Hypothyroidism, Cholesterol and Anxiety. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, PRAVASTATIN for Cholesterol, DULOXETINE HYDROCHLORIDE (CYMBALTA) for Depression, GABAPENTIN (NEUROTIN [GABAPENTIN]) for Trigeminal neuralgia.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2022, the patient experienced FEELING ABNORMAL (Life destroyed/Feels like someone at night hits her with a baseball bat in the face), PAIN (Now the pain is so bad/Achy/The pain is like the worst part of childbirth), INFLUENZA (Felt like she had the flu) and ASTHENIA (Weak as water for 4 days). The patient was treated with METHYLPREDNISOLONE at a dose of 4 milligram. On 02-Mar-2022, ASTHENIA (Weak as water for 4 days) had resolved. At the time of the report, FEELING ABNORMAL (Life destroyed/Feels like someone at night hits her with a baseball bat in the face), PAIN (Now the pain is so bad/Achy/The pain is like the worst part of childbirth) and INFLUENZA (Felt like she had the flu) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received booster dose on 21-Feb-2022. Patient had no allergies and never tested positive for COVID-19 and She did not receive any other vaccine within one month prior to Moderna. Patient was using unknown medication of 0.50mg, once a day for Hypothyroidism. Patient had stated that said that she was furious because there was no warning on not taking the vaccine with her condition. Patient was not hospitalized.
Age: 23.0
Sex: F
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 23-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 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 was reported.   The treatment information was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Initially vial was first punctured on 04-Mar-2022 at 8:15, but administered on 07-Mar-2022 at 8:10-Past the 12 hour post puncture; administered a booster shot past the 12 hour post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Initially vial was first punctured on 04-Mar-2022 at 8:15, but administered on 07-Mar-2022 at 8:10-Past the 12 hour post puncture) and EXPIRED PRODUCT ADMINISTERED (administered a booster shot past the 12 hour post puncture) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A and 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2022 at 8:10 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2022 at 8:10 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a booster shot past the 12 hour post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Initially vial was first punctured on 04-Mar-2022 at 8:15, but administered on 07-Mar-2022 at 8:10-Past the 12 hour post puncture). At the time of the report, PRODUCT STORAGE ERROR (Initially vial was first punctured on 04-Mar-2022 at 8:15, but administered on 07-Mar-2022 at 8:10-Past the 12 hour post puncture) and EXPIRED PRODUCT ADMINISTERED (administered a booster shot past the 12 hour post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. It was reported that 30 day mark expiration date of Lot number 033K21-2A is on 04-Apr-2022, the vial did not undergo any temperature excursions, total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) No Treatments were reported.
Age: 45.0
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 45-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.  Caller was an Office Manager. She stated that because their facility had not been able to download the digital data logger for the months of Dec2021, Jan2022, and Feb2022, they have been put on hold by the agency at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the agency was made.  There have been no power outages that would have impacted the Moderna vaccine. However, she reiterated that because her facility was unable to download the digital data logger, they will need to treat this issue as a temperature excursion.  No adverse event reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Vaccination site discolouration, Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Arm begun to get red "about the size of an orange"; Hard underneath; Warm; Middle has started to turn purple; Moderna 3rd dose: 6Aug2021, 047621A,Moderna Booster dose: 4Mar2022, 003K21-2A; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Arm begun to get red "about the size of an orange"), VACCINATION SITE INDURATION (Hard underneath), VACCINATION SITE WARMTH (Warm), VACCINATION SITE DISCOLOURATION (Middle has started to turn purple) and EXTRA DOSE ADMINISTERED (Moderna 3rd dose: 6Aug2021, 047621A,Moderna Booster dose: 4Mar2022, 003K21-2A) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 047621A, 022M20A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Arthritis. Concomitant products included METHOTREXATE for an unknown indication.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2022, the patient experienced EXTRA DOSE ADMINISTERED (Moderna 3rd dose: 6Aug2021, 047621A,Moderna Booster dose: 4Mar2022, 003K21-2A). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Arm begun to get red "about the size of an orange"), VACCINATION SITE INDURATION (Hard underneath), VACCINATION SITE WARMTH (Warm) and VACCINATION SITE DISCOLOURATION (Middle has started to turn purple). At the time of the report, VACCINATION SITE ERYTHEMA (Arm begun to get red "about the size of an orange"), VACCINATION SITE INDURATION (Hard underneath), VACCINATION SITE WARMTH (Warm), VACCINATION SITE DISCOLOURATION (Middle has started to turn purple) and EXTRA DOSE ADMINISTERED (Moderna 3rd dose: 6Aug2021, 047621A,Moderna Booster dose: 4Mar2022, 003K21-2A) outcome was unknown.     No treatment medication was provided by the reporter.   This case was linked to MOD-2022-504008 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Moderna 1st dose: 3Jan2021, 007M20A,Moderna 2nd dose: 28Feb2021, 022M20A; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 1st dose: 3Jan2021, 007M20A,Moderna 2nd dose: 28Feb2021, 022M20A) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 007M20A) for COVID-19 vaccination.     Concomitant products included METHOTREXATE for an unknown indication.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 1st dose: 3Jan2021, 007M20A,Moderna 2nd dose: 28Feb2021, 022M20A). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 1st dose: 3Jan2021, 007M20A,Moderna 2nd dose: 28Feb2021, 022M20A) outcome was unknown.            No Treatment Medications were provided by the Reporter   This case was linked to MOD-2022-503979 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: hives all over my body; possible delayed allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over my body) and HYPERSENSITIVITY (possible delayed allergic reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H211A) for COVID-19 vaccination.     Concurrent medical conditions included Fruit allergy (Allergy to Kiwis).   On 29-Dec-2021, the patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, the patient experienced URTICARIA (hives all over my body) and HYPERSENSITIVITY (possible delayed allergic reaction). The patient was treated with PREDNISOLONE for Hives, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives all over my body) and HYPERSENSITIVITY (possible delayed allergic reaction) had not resolved. No concomitant medications were reported. Patient received 2 doses of the Moderna vaccine prior to the booster and did not have this reaction.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: My husband had ringing in the ear after the Moderna booster; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (My husband had ringing in the ear after the Moderna booster) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (My husband had ringing in the ear after the Moderna booster). At the time of the report, TINNITUS (My husband had ringing in the ear after the Moderna booster) outcome was unknown.            No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Dyspnoea, Throat irritation
Clinical narrative: Difficulty breathing 14 hours after booster/Shortness of Breath after booster; Coughing 14 hours after booster; Tingling in throat 14 hours after booster; Rapid convulsions 12 hours after booster/Uncontrollable shaking 12 hours after booster; Diarrhea after coughing after booster; Vomiting after coughing after booster; Cold chills 12 hours after booster; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing 14 hours after booster/Shortness of Breath after booster), COUGH (Coughing 14 hours after booster), THROAT IRRITATION (Tingling in throat 14 hours after booster), TREMOR (Rapid convulsions 12 hours after booster/Uncontrollable shaking 12 hours after booster) and DIARRHOEA (Diarrhea after coughing after booster) in a 30-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.     Previously administered products included for Product used for unknown indication: Pfizer vaccine in 2021 and Pfizer vaccine in 2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On 03-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2022, the patient experienced DYSPNOEA (Difficulty breathing 14 hours after booster/Shortness of Breath after booster), COUGH (Coughing 14 hours after booster), THROAT IRRITATION (Tingling in throat 14 hours after booster), TREMOR (Rapid convulsions 12 hours after booster/Uncontrollable shaking 12 hours after booster), DIARRHOEA (Diarrhea after coughing after booster), VOMITING (Vomiting after coughing after booster) and CHILLS (Cold chills 12 hours after booster). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for Adverse event, at an unspecified dose and frequency. On 06-Mar-2022, TREMOR (Rapid convulsions 12 hours after booster/Uncontrollable shaking 12 hours after booster) and CHILLS (Cold chills 12 hours after booster) had resolved. At the time of the report, DYSPNOEA (Difficulty breathing 14 hours after booster/Shortness of Breath after booster) and COUGH (Coughing 14 hours after booster) had not resolved and THROAT IRRITATION (Tingling in throat 14 hours after booster), DIARRHOEA (Diarrhea after coughing after booster) and VOMITING (Vomiting after coughing after booster) outcome was unknown.            It was reported that 12 hours after receiving the Booster, patient had cold chills, rapid convulsions and uncontrollable shaking. 14 hours after booster patient started coughing, tingling in throat, and difficulty breathing. He developed diarrhea and vomiting 30 minutes after coughing. Patient still has cough and shortness of breath. Patient lung and intestine was sore. Patient has been taking Dayquil on his own. Patient did not take a COVID test after the booster vaccine.  No concomitant details were provided.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Difficulty breathing 14 hours after booster/Shortness of Breath after booster; Coughing 14 hours after booster; Tingling in throat 14 hours after booster; Rapid convulsions 12 hours after booster/Uncontrollable shaking 12 hours after booster; Diarrhea after coughing after booster; Vomiting after coughing after booster; Cold chills 12 hours after booster; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing 14 hours after booster/Shortness of Breath after booster), COUGH (Coughing 14 hours after booster), THROAT IRRITATION (Tingling in throat 14 hours after booster), TREMOR (Rapid convulsions 12 hours after booster/Uncontrollable shaking 12 hours after booster) and DIARRHOEA (Diarrhea after coughing after booster) in a 30-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.     Previously administered products included for Product used for unknown indication: Pfizer vaccine in 2021 and Pfizer vaccine in 2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On 03-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2022, the patient experienced DYSPNOEA (Difficulty breathing 14 hours after booster/Shortness of Breath after booster), COUGH (Coughing 14 hours after booster), THROAT IRRITATION (Tingling in throat 14 hours after booster), TREMOR (Rapid convulsions 12 hours after booster/Uncontrollable shaking 12 hours after booster), DIARRHOEA (Diarrhea after coughing after booster), VOMITING (Vomiting after coughing after booster) and CHILLS (Cold chills 12 hours after booster). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for Adverse event, at an unspecified dose and frequency. On 06-Mar-2022, TREMOR (Rapid convulsions 12 hours after booster/Uncontrollable shaking 12 hours after booster) and CHILLS (Cold chills 12 hours after booster) had resolved. At the time of the report, DYSPNOEA (Difficulty breathing 14 hours after booster/Shortness of Breath after booster) and COUGH (Coughing 14 hours after booster) had not resolved and THROAT IRRITATION (Tingling in throat 14 hours after booster), DIARRHOEA (Diarrhea after coughing after booster) and VOMITING (Vomiting after coughing after booster) outcome was unknown.            It was reported that 12 hours after receiving the Booster, patient had cold chills, rapid convulsions and uncontrollable shaking. 14 hours after booster patient started coughing, tingling in throat, and difficulty breathing. He developed diarrhea and vomiting 30 minutes after coughing. Patient still has cough and shortness of breath. Patient lung and intestine was sore. Patient has been taking Dayquil on his own. Patient did not take a COVID test after the booster vaccine.  No concomitant details were provided.