chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient got COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient got COVID-19) in a child 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient got COVID-19). At the time of the report, COVID-19 (Patient got COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided.  It was reported that It was unknown if patient experienced any symptoms after getting 1st dose of the vaccine, or if any treatment was given for the symptoms. The patient was listed in a Moderna clinical trial.   No treatment medication information provided.  Company Comment: This is a spontaneous case concerning  a child male patient with no reported medical history, who experienced the unexpected non-serious AESI events of Covid-19. The events occurred on an unknown date after the first dose of mRNA-1273  Vaccine which was administered on an unknown date. It was reported that It was unknown if patient experienced any symptoms after getting 1st dose of the vaccine, or if any treatment was given for the symptoms. The patient was listed in a Moderna clinical trial. No treatment medication information provided. Outcome of the event was unknown, at the time of report. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning  a child male patient with no reported medical history, who experienced the unexpected non-serious AESI events of Covid-19. The events occurred on an unknown date after the first dose of mRNA-1273  Vaccine which was administered on an unknown date. It was reported that It was unknown if patient experienced any symptoms after getting 1st dose of the vaccine, or if any treatment was given for the symptoms. The patient was listed in a Moderna clinical trial. No treatment medication information provided. Outcome of the event was unknown, at the time of report. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Age: 53.0
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 (Received doses from vials affected by temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Received doses from vials affected by temperature excursion) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049L21A) for COVID-19 prophylaxis. No Medical History information was reported. On 10-Jun-2022 at 9:51 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2022 at 9:51 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received doses from vials affected by temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Received doses from vials affected by temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Received doses from vials affected by temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Received doses from vials affected by temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. 20 patients received doses from the lot number affected by a temperature excursion as the freezer went out of range. Patient received half dose. It was reported that no adverse event occurred at time of administration or were reported thereafter. Treatment medications were not reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; 20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and POOR QUALITY PRODUCT ADMINISTERED (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jun-2022 at 11:40 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2022 at 11:40 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and POOR QUALITY PRODUCT ADMINISTERED (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient received half dose. It was reported that no adverse event occurred at time of administration or were reported thereafter. Treatment medications were not reported.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; 20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and POOR QUALITY PRODUCT ADMINISTERED (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jun-2022 at 1:16 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2022 at 1:16 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and POOR QUALITY PRODUCT ADMINISTERED (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  The patient received half dose.  It was reported that no adverse event occurred at time of administration or were reported thereafter. Treatment medications was not reported.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and POOR QUALITY PRODUCT ADMINISTERED (patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jun-2022 at 1:20 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Jun-2022 at 1:20 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and POOR QUALITY PRODUCT ADMINISTERED (patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vial was reported as 3. No concomitant product reported by reporter. No adverse events occurred at time of administration or were reported thereafter. No treatment medication reported by reporter.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; Patient received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and POOR QUALITY PRODUCT ADMINISTERED (Patient received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) in a 36-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jun-2022 at 6:25 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Jun-2022 at 6:25 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and POOR QUALITY PRODUCT ADMINISTERED (Patient received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that the patient received a full dose and no adverse events occurred at time of administration or were reported thereafter. No treatment medication was reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: receiving doses from vials affected by a temperature excursion; receiving doses from vials affected by a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses from vials affected by a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jun-2022 at 6:43 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2022 at 6:43 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses from vials affected by a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses from vials affected by a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Reportedly, 20 patients received doses from the lot number affected by a temperature excursion as their freezer went out of range. Patient received half dose. Vail number reported as 4. No adverse event occurred at time of administration or were reported thereafter. No treatment information was provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; 20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and POOR QUALITY PRODUCT ADMINISTERED (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jun-2022 at 11:28 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2022 at 11:28 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and POOR QUALITY PRODUCT ADMINISTERED (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that patient received half dose. It was reported that no adverse event occurred at time of administration or were reported thereafter. Treatment medications were not reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: receiving doses from vials affected by a temperature excursion; receiving doses from vials affected by a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses from vials affected by a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jun-2022 at 9:53 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses from vials affected by a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses from vials affected by a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range. Patient received half dose. It was reported that no adverse event occurred at time of administration or were reported thereafter. Treatment medications were not reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: receiving doses from vials affected by a temperature excursion; receiving doses from vials affected by a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses from vials affected by a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049l21) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jun-2022 at 11:35 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2022 at 11:35 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses from vials affected by a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses from vials affected by a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received half dose of Moderna vaccine.  No concomitant medications were reported.  20 patients received doses from the lot number affected by a temperature excursion as the freezer went out of range. It was reported that no adverse event occurred at time of administration or were reported thereafter.  No treatment medications were reported.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; 20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jun-2022 at 11:43 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2022 at 11:43 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient received half dose. It was reported that no adverse event occurred at time of administration or were reported thereafter. Treatment medications were not reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received doses affected by a temperature excursion as their freezer went out of range; Patient received doses affected by a temperature excursion as their freezer went out of range; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received doses affected by a temperature excursion as their freezer went out of range) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received doses affected by a temperature excursion as their freezer went out of range) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jun-2022 at 11:50 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2022 at 11:50 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received doses affected by a temperature excursion as their freezer went out of range). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received doses affected by a temperature excursion as their freezer went out of range). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received doses affected by a temperature excursion as their freezer went out of range) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received doses affected by a temperature excursion as their freezer went out of range) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Patient received half dose. It was reported that no adverse event occurred at time of administration or were reported thereafter. Treatment medications were not reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea, SARS-CoV-2 test
Clinical narrative: "yucky"; felt nauseated; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL ("yucky") and NAUSEA (felt nauseated) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 032L20A and 002A21A) for COVID-19 prophylaxis.     Previously administered products included for Flu vaccination: Flu vaccine (flu vaccine in Jan or Feb2022). Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Lung cancer (but has not had any chemotherapy or radiation therapy after getting the 1st dose of the vaccine.) since 2017, Drug allergy (Codeine) and Allergy to antibiotic (Erythromycin).   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL ("yucky") and NAUSEA (felt nauseated). At the time of the report, FEELING ABNORMAL ("yucky") and NAUSEA (felt nauseated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) dozens of Covid tests which were all negative.         Concomitant medications was not provided by the reporter. Patient mentioned that she felt nauseated and "yucky" every after the 1st 3 doses but that was nothing compared to the side effects she had after the 2nd booster. Treatment information was not provided.   This case was linked to MOD-2022-610254 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Receiving doses from vials affected by a temperature excursion; Receiving doses from vials affected by a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Receiving doses from vials affected by a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Receiving doses from vials affected by a temperature excursion) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jun-2022 at 1:09 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2022 at 1:09 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Receiving doses from vials affected by a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Receiving doses from vials affected by a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Receiving doses from vials affected by a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Receiving doses from vials affected by a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Number of vails was reported as 6. 20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range. Patient received half dose. It was reported that no adverse event occurred at time of administration or were reported thereafter. Treatment medications were not reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: 20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; 20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; receiving doses from vials affected by a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range), PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jun-2022 at 11:53 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2022 at 11:53 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range). At the time of the report, PRODUCT STORAGE ERROR (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range), PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range. Patient received half dose. It was reported that no adverse event occurred at time of administration or were reported thereafter. Treatment medications were not reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Received doses from vials affected by a temperature excursion; Received doses from vials affected by a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Received doses from vials affected by a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Received doses from vials affected by a temperature excursion) in a 54-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2022 at 3:09 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Jul-2022 at 3:09 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received doses from vials affected by a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Received doses from vials affected by a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Received doses from vials affected by a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Received doses from vials affected by a temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. Treatment medication was not provided by the reporter.  Patient had received full dose from seventh vial. Patient received dose from the lot number 049l21a affected by a temperature excursion as the freezer went out of range.  No adverse event occurred at time of administration or were reported thereafter.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: receiving doses from vials affected by a temperature excursion; receiving doses from vials affected by a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses from vials affected by a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2022 at 1:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2022 at 1:30 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses from vials affected by a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses from vials affected by a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range. Patient received half dose. It was reported that no adverse event occurred at time of administration or were reported thereafter.  Treatment medications were not reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blastomycosis
Clinical narrative: blastomycosis/fungus in lung; This spontaneous case was reported by a patient and describes the occurrence of BLASTOMYCOSIS (blastomycosis/fungus in lung) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 043L20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced BLASTOMYCOSIS (blastomycosis/fungus in lung) (seriousness criterion medically significant). The patient was treated with ITRACONAZOLE at an unspecified dose and frequency. At the time of the report, BLASTOMYCOSIS (blastomycosis/fungus in lung) outcome was unknown.            Concomitant medication details were not reported by the reporter. Reporter asked if it was safe to get second booster with reported medication (itraconazole) because diagnosed with the blastomycosis - fungus in lung on April 2022.  Company comment: This spontaneous case reported by a patient, concerns a 73 year old female patient, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of Blastomycosis about 5 months after receiving the 3 dose of mRNA1273 vaccine in the covid 19 vaccination series. Patient previously had received the 2 primary doses of Moderna vaccine at an interval of 25 days, with the 2 dose taken about 9 months prior to the 3 dose. Patient was treated with Itraconazole for the event. No information was provided about the comorbidities, risk factors, labs, diagnostic tests, symptoms, clinical course and concomitant medications. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case reported by a patient, concerns a 73 year old female patient, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of Blastomycosis about 5 months after receiving the 3 dose of mRNA1273 vaccine in the covid 19 vaccination series. Patient previously had received the 2 primary doses of Moderna vaccine at an interval of 25 days, with the 2 dose taken about 9 months prior to the 3 dose. Patient was treated with Itraconazole for the event. No information was provided about the comorbidities, risk factors, labs, diagnostic tests, symptoms, clinical course and concomitant medications. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator: 09Jun2022. The vial was first punctured: 9:30 AM on 14Jul2022.; Doses administered more than 12 hours after post puncture. patient had received an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered more than 12 hours after post puncture. patient had received an expired dose) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator: 09Jun2022. The vial was first punctured: 9:30 AM on 14Jul2022.) in an 85-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 049L21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 25-Jan-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Feb-2021, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2022, received dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jul-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered more than 12 hours after post puncture. patient had received an expired dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator: 09Jun2022. The vial was first punctured: 9:30 AM on 14Jul2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered more than 12 hours after post puncture. patient had received an expired dose) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator: 09Jun2022. The vial was first punctured: 9:30 AM on 14Jul2022.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. The vial was initially stored in the refrigerator: 09Jun2022. The vial was first punctured: 9:30 AM on 14Jul2022. The vaccine administration of a total of 3 doses were all given on 14JUL2022 sometime after 9:30. The vial was stored in refrigerator post puncture. The vial did not undergo any temperature excursions. The  vial of Moderna COVID-19 vaccine was punctured and a dose was withdrawn and given to a patient. The punctured vial was then placed in a bag in the refrigerator. A few days later the bag was removed from the refrigerator and a dose was given to a second patient more than 12 hours after the vial had been punctured No treatment medication was provided by reporter.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received his 2nd dose of vaccine at 3 weeks instead of 4 weeks; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received his 2nd dose of vaccine at 3 weeks instead of 4 weeks) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received his 2nd dose of vaccine at 3 weeks instead of 4 weeks). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received his 2nd dose of vaccine at 3 weeks instead of 4 weeks) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported.  It was reported that patient received second dose of vaccine at 3 weeks instead of 4 weeks. Dose given too early.  Treatment details were not reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: recently tested positive for Covid; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (recently tested positive for Covid) in a female patient of an unknown age 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) 1 dosage form. On an unknown date, the patient experienced COVID-19 (recently tested positive for Covid). At the time of the report, COVID-19 (recently tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported.  Reported that patient had chills and a cough for 3 days and was horribly tired after getting a Covid-19 Vaccine.  No treatment information was reported.  Company comment: This is a spontaneous case concerning a female patient of unknown age, with no reported medical and vaccination history. Patient experienced the unexpected non-serious AESI event of Covid-19. On unknown date, the patient received unspecified product of Covid-19 vaccine. On unknown date, patient was tested positive for Covid-19. It was reported that the patient had chills and cough for 3 days and was horribly tired after the patient received the unspecified product of Covid-19 vaccine. No other information surrounding the event was reported. The outcome of the event was unknown. The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-608760 (E2B Linked Report).; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age, with no reported medical and vaccination history. Patient experienced the unexpected non-serious AESI event of Covid-19. On unknown date, the patient received unspecified product of Covid-19 vaccine. On unknown date, patient was tested positive for Covid-19. It was reported that the patient had chills and cough for 3 days and was horribly tired after the patient received the unspecified product of Covid-19 vaccine. No other information surrounding the event was reported. The outcome of the event was unknown. The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-608760:Case Crosslinked with MOD22-018820,MOD22-019092 (Husband case)
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 09Jun2022. The vial was first punctured on 14Jul2022; Patient received Moderna Covid-19 vaccine more than 12 hours after the vial had been punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine more than 12 hours after the vial had been punctured) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 09Jun2022. The vial was first punctured on 14Jul2022) in an 85-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 049L21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-May-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Jun-2021, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2022 at 10:30 AM, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2022 at 10:30 AM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine more than 12 hours after the vial had been punctured). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 09Jun2022. The vial was first punctured on 14Jul2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine more than 12 hours after the vial had been punctured) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 09Jun2022. The vial was first punctured on 14Jul2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. The vial was initially stored in the refrigerator on 09Jul2022.  The vial was first punctured on 14Jul2022 at 9:30 AM.  The post puncture vial was stored in refrigerator. The vial did not undergo any temperature excursions. The total amount of time the vial was exposed to room temperature range (8 degree to 25 degree C, 46 degree to 77 degree F) under 12 hours. No treatment medication was provided by reporter.