chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: HCP is calling because she reported an excursion about a month ago; Expired Vaccine Used; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP is calling because she reported an excursion about a month ago) and EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP is calling because she reported an excursion about a month ago) and EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP is calling because she reported an excursion about a month ago) and EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.  Maximum Temperature reached 64°F. Excursion duration: Approximately 7 hours.  Those vials were returned to the freezer/refrigerator or maintained at room temperature. Temperature excursion date was as 10-Mar-2022.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) in a 24-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 10-Mar-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion). On 15-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that an excursion about a month ago and the excursion duration was 7 hours instead 5 min (previously stated) and the patient had been administered from these vaccines. The vaccine was stored in refrigerator at the time of the excursion. Date of temperature excursion was 10-Mar-2022. Lot number was 027L21A and vaccine was administered on 15-Mar-2022. The other lot number and expiration date was reported as 046L21A and 06-Jul-2022. The maximum temperature reached was reported as 64°F. The vials were returned to the refrigerator. No vaccine state change was reported. The vials were unpunctured at the time of excursions. Tran date was reported as 15-Mar-2022. The patient did not experience any adverse events post injection. No treatment medications were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients have been administered from vaccines that experienced a T excursion; Patients have been administered from vaccines that experienced a T excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion). On 22-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No information on concomitant medication was reported. Tran date was reported as 23-Mar-2022. It was reported that , the patient did not have any adverse events post injection. Storage condition at the time of the excursion was refrigerator. Maximum or minimum temperatures reached was 64 degrees Fahrenheit. Excursion duration was approximately 7 hours. The vials were returned to the refrigerator. No changes in visual inspection. Pertinent details: At the time they were unpunctured. Excursion occurred on 10-Apr-2022. No information on treatment medications was reported.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients have been administered from vaccines that experienced a Temperature excursion; Patients have been administered from vaccines that experienced a Temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a Temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a Temperature excursion) in a 22-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 15-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a Temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a Temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a Temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a Temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that the storage condition at the time of excursion was refrigerator.   Max Temperature reached to 64 F.  Reporter mentioned that the excursion duration was 7 hours instead 5 min.  They were returned to the refrigerator after administration.   Tran date was reported as 15-Mar-2022.  It was reported that the patient did not experienced any adverse event.  Treatment medications were not provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients have been administered from vaccines that experienced a T excursion; Patients have been administered from vaccines that experienced a T excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) in a 31-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Mar-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Max Temperature reached was 64°F Excursion duration was approximately 7 hours Three was no changes in visual inspection. It was reported patient had not any adverse events post injection. No treatment information was reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients have been administered from vaccines that experienced a T excursion; Patients have been administered from vaccines that experienced a T excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T 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 information was provided.  Excursion about a month ago was observed where excursion duration was found to be approximately 7 hours. HCP also mentioned that the excursion duration was 7 hours instead 5 min (previously stated). The vial was refrigerated at the time of excursion. Maximum temperature reached was 64 degree fahrenheit. There were no changes in vaccine state on visual inspection. It was reported in pertinent detail that at the time vials were unpunctured.  Patients have been administered from these vaccines but patient experienced no adverse events post injection.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a temperature excursion) in a 23-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a temperature excursion) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. The vial was stored at the refrigerator at the time of the temperature excursion. The temperature excursion issue occurred on 10-Mar-2022. Maximum temperature reached by the vial was 64 degree Fahrenheit and excursion duration was approximately 7 hours. No changes were noted in the vaccine state. At the time, the vials were unpunctured. The transfer date was reported as 15-Mar-2022.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient was administered from vaccine that experienced a T excursion; Patient was administered from vaccine that experienced a T excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered from vaccine that experienced a T excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered from vaccine that experienced a T excursion) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered from vaccine that experienced a T excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered from vaccine that experienced a T excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered from vaccine that experienced a T excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered from vaccine that experienced a T excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The patient did not have any adverse events post injection. It was reported that the storage condition at the time of the excursion was at refrigerator. Maximum temperature reached was 64-degree Fahrenheit, and excursion duration was approximately 7 hours. The vials were returned to the refrigerator. No changes in visual inspection. Pertinent details: At the time they were unpunctured. As per source document the Tran date was reported as 24-Mar-2022. No treatment medication information was given.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient have been administered vaccine while the temperature excursion; Patient have been administered vaccine while the temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient have been administered vaccine while the temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient have been administered vaccine while the temperature excursion) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.  On 23-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient have been administered vaccine while the temperature excursion). On 23-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient have been administered vaccine while the temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient have been administered vaccine while the temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient have been administered vaccine while the temperature excursion) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The healthcare professional (HCP) reported an excursion about a month ago. The HCP also mentioned that the excursion duration was 7 hours instead 5min (previously stated) and the patient had been administered from these vaccines.  The vaccine was stored in refrigerator at the time of the excursion. The lot number and expiration date was reported as 046L21A and 06-Jul-2022 in source document. The maximum temperature reached was reported as 64°F. The vials were returned to the refrigerator No vaccine state change was reported. The vials were unpunctured at the time of excursions. The frequency was reported as times per.  Treatment information was not provided.
Age: 102.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) in a 102-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion). On 17-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Date of temperature excursion was 10-Mar-2022. Maximum or minimum temperatures reached was 64 degrees Fahrenheit. Excursion duration was approximately 7 hours. The vaccine was stored in refrigerator at the time of the excursion. There were no changes in visual inspection. Pertinent details: At the time they were unpunctured. Vaccine was administered on 17-Mar-2022 and vials were returned to the refrigerator. Tran date was 17-Mar-2022. The patient did not experience any adverse events post injection. No treatment medications were reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients have been administered from vaccines that experienced a temperature excursion; Patients have been administered from vaccines that experienced a 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 from vaccines that experienced a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion) in a 38-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Mar-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion). On 14-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. It was reported that the temperature excursion duration was approximately 7 hours. The vial had reached the max temperature of 64 degree F.  It was reported that the vial was stored in refrigerator at the time of excursion. After administration the vial was returned to refrigerator. The date vial was moved from freezer to refrigerator was unknown. It was reported that the vaccine did not presented any state change on visual inspection. It was unknown the number of vials/doses impacted. Pertinent details of the vial was reported as unpunctured. It was reported that patient did not experienced any adverse events. Treatment medications were not reported.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients have been administered from vaccines that experienced a temperature excursion; Patients have been administered from vaccines that experienced a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a temperature excursion) in a 25-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 15-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Date of temperature excursion was 10-Mar-2022. Maximum or minimum temperatures reached was 64 degrees Fahrenheit. Excursion duration was approximately 7 hours. The vaccine was stored in refrigerator at the time of the excursion. There were no changes in visual inspection. Pertinent details: At the time they were unpunctured. Vaccine was administered on 15-Mar-2022 and vials were returned to the refrigerator. Tran date was 15-Mar-2022.The patient did not experience any adverse events post injection. No treatment medications were reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant product use was reported. The reporter who was an HCP reported an excursion about a month ago, at the time the reporter didn't asked for a stability report but now the reporter had been asked to send the stability report. The patient didn't had any adverse events post injection. The reporter stated that they were yet to receive the temperature stability report for this excursion that occurred on 10-Mar-2022. The transmission date reported as 15-Mar-2022. No treatment information was provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: administered from vaccines that experienced a temperature excursion; administered from vaccines that experienced a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (administered from vaccines that experienced a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered from vaccines that experienced a temperature excursion) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered from vaccines that experienced a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administered from vaccines that experienced a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (administered from vaccines that experienced a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered from vaccines that experienced a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was reported that, the vial underwent an excursion on 10-Mar-2022 for 7 hours while stored in refrigerator. The maximum temperature reached was 64 F. The vial was returned to the refrigerator.  There were no visual inspection noting any vaccine state change. It was reported the vial was unpunctured at the time.  The patient had no adverse events post vaccination.  No treatment details were reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients have been administered from vaccines that experienced a T excursion; Patients have been administered from vaccines that experienced a T excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) in a 65-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion). On 24-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   It was reported that the temperature excursion duration was approximately 7 hours. The vial had reached the max temperature of 64 degree F.  It was reported that the vial was stored in refrigerator at the time of excursion. After administration the vial was returned to refrigerator. The date vial was moved from freezer to refrigerator was unknown. It was reported that the vaccine did not presented any state change on visual inspection. It was unknown the number of vials/doses impacted. Pertinent details of the vial was reported as unpunctured.  It was reported that patient did not experienced any adverse events. Treatment medications were not reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients have been administered from vaccines that experienced a temperature excursion; Patients have been administered from vaccines that underwent a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that underwent a temperature excursion) in a 41-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that underwent a temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date of temperature excursion was 10-Mar-2022. Maximum or minimum temperatures reached was 64 degrees Fahrenheit. Excursion duration was approximately 7 hours. The vaccine was stored in refrigerator at the time of the excursion. There were no changes in visual inspection. Pertinent details: At the time they were unpunctured. Vaccine was administered on 14-Mar-2022 and vials were returned to the refrigerator. Tran date was 15-Mar-2022.The patient did not experience any adverse events post injection.  No treatment medications were reported.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients have been administered from vaccines that experienced a T excursion; Patients have been administered from vaccines that experienced a T excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion). In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T 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 product excursion was occurred on 10-Mar-2022. Storage condition at the time of the excursion was reported as refrigerator. Max temperature reached was 64°F. Excursion duration was approximately 7 hours. Three was no changes in visual inspection. It was reported patient had not any adverse events post injection.  No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Contusion, Skin discolouration, Skin induration, Swelling
Clinical narrative: left thumb got hard; left thumb turned purple/ the color is all around finger nail/ the purple color is travelling down her palm/ugly purple color on thumb and palm; swelling; tiny bruises on left lower arm; nod in stomach; This spontaneous case was reported by a consumer and describes the occurrence of SKIN INDURATION (left thumb got hard), SKIN DISCOLOURATION (left thumb turned purple/ the color is all around finger nail/ the purple color is travelling down her palm/ugly purple color on thumb and palm), SWELLING (swelling), CONTUSION (tiny bruises on left lower arm) and ABDOMINAL DISCOMFORT (nod in stomach) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     Patient did not have any allergies, never had COVID positive test or diagnosis and not had both acute and chronic illnesses at the time of vaccination. Did not given other vaccines within 1 month prior to Moderna COVID-19 vaccine.    On 16-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, the patient experienced SKIN INDURATION (left thumb got hard), SKIN DISCOLOURATION (left thumb turned purple/ the color is all around finger nail/ the purple color is travelling down her palm/ugly purple color on thumb and palm), SWELLING (swelling), CONTUSION (tiny bruises on left lower arm) and ABDOMINAL DISCOMFORT (nod in stomach). At the time of the report, SKIN INDURATION (left thumb got hard), SKIN DISCOLOURATION (left thumb turned purple/ the color is all around finger nail/ the purple color is travelling down her palm/ugly purple color on thumb and palm), SWELLING (swelling), CONTUSION (tiny bruises on left lower arm) and ABDOMINAL DISCOMFORT (nod in stomach) had not resolved.      She was not on any concomitant medication. The caller just provided the information for the last dose that she received since she did not experience any side effects with the other doses. All the vaccines received were from Moderna. She was very worried and scared because it did not stop moving down. Patient primary physician and the pharmacist who administered the vaccine told her it was because of the Booster dose. She saw her primary doctor and the pharmacist who administered the vaccine. She said she would have to go to the urgent care to take a look at it. No treatment was given.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeding disorder, Headache, Nausea, Somnolence
Clinical narrative: Significant stomach ache; Could not eat, could not drink; napped most of the day. Thought she was going to vomit, felt Nauseated; significant headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Significant stomach ache), FEEDING DISORDER (Could not eat, could not drink), SOMNOLENCE (napped most of the day.), NAUSEA (thought she was going to vomit, felt Nauseated) and HEADACHE (significant headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2022 at 10:00 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2022, the patient experienced ABDOMINAL PAIN UPPER (Significant stomach ache), FEEDING DISORDER (Could not eat, could not drink), SOMNOLENCE (napped most of the day.), NAUSEA (thought she was going to vomit, felt Nauseated) and HEADACHE (significant headache). On 16-Apr-2022, ABDOMINAL PAIN UPPER (Significant stomach ache), FEEDING DISORDER (Could not eat, could not drink), SOMNOLENCE (napped most of the day.) and NAUSEA (thought she was going to vomit, felt Nauseated) had resolved. On 19-Apr-2022, HEADACHE (significant headache) had resolved.            No concomitant medication was reported.    No treatment information was reported.  The patient received the Moderna 2nd Booster dose.  Patient reported that by Tuesday 19-Apr-2022 patient had no other issues.   This case was linked to MOD-2022-546346 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nauseated after the 2nd Primary dose; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseated after the 2nd Primary dose) in a 52-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nauseated after the 2nd Primary dose). At the time of the report, NAUSEA (nauseated after the 2nd Primary dose) had resolved.            No Concomitant Drug details were reported.  No Treatment information was provided.  The patient mentioned feeling nauseated after the 2nd dose of Moderna but it only lasted a couple hours.   This case was linked to MOD-2022-546339 (Patient Link).
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after 30-day Use By Date or after manufacturer date of expiry. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry.) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant drug information was provided. Patient had a second booster dose of Moderna vaccine. It was unknown if the patient had allergies to any medications, food and other products. The vial had not undergone any temperature excursion issue. The vial was initially stored in refrigerator on 11-Apr-2022. No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Follow-up received contains no new information.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Costochondritis, Dyspnoea
Clinical narrative: Shortness of breath; Costochondritis/Need to take deep breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) and COSTOCHONDRITIS (Costochondritis/Need to take deep breath) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Non-smoker (Never smoked).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DYSPNOEA (Shortness of breath) and COSTOCHONDRITIS (Costochondritis/Need to take deep breath). At the time of the report, DYSPNOEA (Shortness of breath) and COSTOCHONDRITIS (Costochondritis/Need to take deep breath) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   It was reported that the patient never had lung/breathing problems. No concomitant medications were reported. It was reported that after two-three weeks after the first dose, the patient had noticed a little shortness of breath. It was further reported by the patient that periodically felt would need to take deep breath and determined it was costochondritis (where ribs attach to the sternum). The patient was due to get the vaccine (second booster). No treatment medications were reported for events.   This case was linked to MOD-2022-546342, MOD-2022-546366 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Follow up received includes no new information
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Costochondritis, Dyspnoea, Pyrexia
Clinical narrative: Shortness of breath; Costochondritis/Need to take deep breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) and COSTOCHONDRITIS (Costochondritis/Need to take deep breath) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Non-smoker (Never smoked).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DYSPNOEA (Shortness of breath) and COSTOCHONDRITIS (Costochondritis/Need to take deep breath). At the time of the report, DYSPNOEA (Shortness of breath) and COSTOCHONDRITIS (Costochondritis/Need to take deep breath) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   It was reported that the patient never had lung/breathing problems. No concomitant medications were reported. It was reported that after two-three weeks after the first dose, the patient had noticed a little shortness of breath. It was further reported by the patient that periodically felt would need to take deep breath and determined it was costochondritis (where ribs attach to the sternum). The patient was due to get the vaccine (second booster). No treatment medications were reported for events.   This case was linked to MOD-2022-546342, MOD-2022-546366 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Follow up received includes no new information
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Chest pain, Chills, Chronic obstructive pulmonary disease, Dyspnoea
Clinical narrative: Shortness of breath; Costochondritis/Need to take deep breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) and COSTOCHONDRITIS (Costochondritis/Need to take deep breath) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Non-smoker (Never smoked).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DYSPNOEA (Shortness of breath) and COSTOCHONDRITIS (Costochondritis/Need to take deep breath). At the time of the report, DYSPNOEA (Shortness of breath) and COSTOCHONDRITIS (Costochondritis/Need to take deep breath) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   It was reported that the patient never had lung/breathing problems. No concomitant medications were reported. It was reported that after two-three weeks after the first dose, the patient had noticed a little shortness of breath. It was further reported by the patient that periodically felt would need to take deep breath and determined it was costochondritis (where ribs attach to the sternum). The patient was due to get the vaccine (second booster). No treatment medications were reported for events.   This case was linked to MOD-2022-546342, MOD-2022-546366 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Follow up received includes no new information