chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 10:58 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 10:58 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 72.51 years.  No concomitant medications were reported.  On 19-Apr-2021, vaccines were moved to the fridge. On 29-Apr-2021, 05 vials were sent to the clinic, On the same date, at 10 AM, vials underwent temperature excursion with temperature of 33 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 19-May-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  No treatment medications were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other healthcare professional, describes the occurrence of product temperature excursion issue (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and poor quality product administered (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 022M20A) for COVID-19 immunization. No medical history reported. On Feb 17, 2021, at 10:10 am, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; .5 milliliter. On Feb 17, 2021, at 10:10 am, patient experienced poor quality product administered (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, patient experienced product temperature excursion issue (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, product temperature excursion issue (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and poor quality product administered (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Age of patient: 73.36. On Feb 17, 2021, at 09:00 am, the temperature recorded: 22ºF. Vial initially moved to the fridge Feb 11, 2021. Beyond-use-date: Mar 13, 2021. Product moved to clinic: Feb 17, 2021. Vial was in cooler storage and not in frozen storage during high-pace COVID-19 vaccination. Vials only punctured right before administration. Vaccines not frozen at time of administration. It was reported each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1½ hour (approximately), when temperature data logger registered a temperature of 34ºF or 35ºF. Temperature recordings taken using a brand traceable temperature monitor at every hour. This case was linked to MOD-2022-566976 (patient link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 RNA, SARS-CoV-2 test
Clinical narrative: Relapse of COVID symptoms and positive antigen test indicating larger viral load on day 11; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Relapse of COVID symptoms and positive antigen test indicating larger viral load on day 11) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     The patient's past medical history included Allergy (Name of drug not reported).    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2022 at 6:00 PM, the patient experienced COVID-19 (Relapse of COVID symptoms and positive antigen test indicating larger viral load on day 11). At the time of the report, COVID-19 (Relapse of COVID symptoms and positive antigen test indicating larger viral load on day 11) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 RNA: larger (High) Viral load on day 11. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         The Co Suspect drug reported as COVID-19 Treatment start date was 10-May-2022 and last date of administration was 14-May-2022. (Drug name was not reported)  No, patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Yes, patient previously receive a COVID-19 Vaccine. Device date: 21-May-2022. Concomitant medication list was not provided.  Treatment information was not provided.  Company Comment:  This spontaneous case concerns a 42-year-old female patient, with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest COVID-19 that occurred approximately 6 months after receiving mRNA-1273 vaccine given as third dose in the COVID-19 vaccination series.  Patient experienced Relapse of COVID-19 symptoms (documented by a positive antigen test) after completion of a 5-day course of an unspecified COVID-19 treatment. No information was provided on the previous 2 doses of COVID-19 vaccines prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 42-year-old female patient, with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest COVID-19 that occurred approximately 6 months after receiving mRNA-1273 vaccine given as third dose in the COVID-19 vaccination series.  Patient experienced Relapse of COVID-19 symptoms (documented by a positive antigen test) after completion of a 5-day course of an unspecified COVID-19 treatment. No information was provided on the previous 2 doses of COVID-19 vaccines prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 1:16 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 1:16 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 72.13  Concomitant products were not provided.  On 07-Jan-2021 vials were moved to clinic. On 05-Jan-2021 the vaccines were moved to fridge. On 07-Jan-2021, the vial underwent the excursion on the following timings: at 09 AM temperature was 34 and at 10 AM temperature was 34  The vaccine beyond use date was reported as 27-Jan-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration. It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 11:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 11:45 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of the patient was provided as 73.74 for batch number  014M20A. The age of the patient was provided as 73.82 for batch number 019B21A.  Concomitant products were not provided.  On 28-Feb-2021, excursion time was 09 AM and 01 PM  and temperature was 27 and 26 respectively, total doses given for the day was 152, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were moved to clinic. Vaccine BUD date was 26-Mar-2021.  On 28-Mar-2021, excursion time was10 AM  and temperature was 35 , total doses given for the day was 150, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 15  vials were moved to clinic. Vaccine BUD date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a  temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021 at 1:39 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2021 at 1:39 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 70.89 for dose administered on 03-Mar-2021. No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 03-Mar-2021 with temperature 51 to 35 degrees Fahrenheit from 09:00 PM to 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 03-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 84.86. Concomitant products were not provided.  On 03-Nov-2021, Excursion time was 10 AM, temperature was 35, total doses given for the day was 117, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Nov-2021. 06 vials were sent to clinic. Vaccine BUD date was 05-Nov-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 3:07 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 3:07 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 83.92 for dose administered on 11-Jan-2021. No concomitant medications were reported. Batch number 041L20A underwent temperature excursion on 11-Jan-2021 with temperature 35 degrees Fahrenheit at 02:00 PM. This vial was moved to fridge on 01-Jan-2021 and beyond use date for the vial was reported as 07-Feb-2021. Product moved to clinic on 11-Jan-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 4:13 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 4:13 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 83.73   Concomitant products were not provided.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree F.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken by using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.   On 11-Jan-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 37, 11 AM: 37, 12 PM: 35, 1PM: 36, 2 PM: 37 and 3 PM: 37.  On 11-Jan-2021, Excursion time was 2 PM, temp was 35 , condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 11-Jan-2021. 9 vial was moved to clinic. Vaccine BUD date was 07-Feb-2021.  No treatment information was provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID rebound after Paxlovid) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination. Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19. No Medical History information was reported. On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 20-May-2022, the patient experienced COVID-19 (COVID rebound after Paxlovid). At the time of the report, COVID-19 (COVID rebound after Paxlovid) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. No treatment information was reported. Company Comment: This spontaneous case concerns a 31 year old female patient wit no medical history reported, who experienced Non-serious, unexpected, AESI of Covid-19 (COVID rebound after Paxlovid) which occurred 6 months 17 days post vaccination with the third dose of mRNA-1273 vaccine. The information regarding the Dose 1, Dose 2 Covid 19 vaccine of this patient was  not reported. This patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID, a Co-suspect non-company product) which started 3-May-2022 given at unspecified dose and frequency. The details surrounding the event like clinical course, treatment medication, results of laboratories/diagnostic procedures and if any medical consults was done  were not reported. Outcome of the event was reported as resolving. The benefit -risk relationship of mRNA -1273 (Moderna Covid 19 Vaccine) is not affected by this report. Sender's Comments: This spontaneous case concerns a 31 year old female patient wit no medical history reported, who experienced Non-serious, unexpected, AESI of Covid-19 (COVID rebound after Paxlovid) which occurred 6 months 17 days post vaccination with the third dose of mRNA-1273 vaccine. The information regarding the Dose 1, Dose 2 Covid 19 vaccine of this patient was not reported. This patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID, a Co-suspect non-company product) which started 3-May-2022 given at unspecified dose and frequency. The details surrounding the event like  clinical course,  treatment medication, results of laboratories/diagnostic procedures and if any medical consults was done were not reported. Outcome of the event was reported as resolving. The benefit -risk relationship of mRNA -1273 (Moderna Covid-19 Vaccine) is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Rebound COVID-19 test positivity; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound COVID-19 test positivity) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesterolemia, Degenerative joint disease and Drug allergy. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2022, the patient experienced COVID-19 (Rebound COVID-19 test positivity). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 11-May-2022 to 15-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound COVID-19 test positivity) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Patient received COVID 19 vaccine previously. Device Date : 22May2022  Company commnet: This spontaneous case concerns a 67-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 11-May-2022 to 15-may-2022.She was tested positive 4 days after the treatment with Paxlovid. SARS-CoV-2 test positive on 19-may-2022. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: Company comment: This spontaneous case concerns a 67-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 11-May-2022 to 15-may-2022.She was tested positive 4 days after the treatment with Paxlovid. SARS-CoV-2 test positive on 19-may-2022. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021 at 10:18 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 04-Jun-2021 at 10:18 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 65.69  for dose administered on 04-Jun-2021. No concomitant medications were reported. Batch number  026C21A underwent temperature excursion on 04-Jun-2021  with temperature 35 degrees Fahrenheit from 10:00 Am. This vial was moved to fridge on 18-May-2021. beyond use date for the vial was reported as 17-Jun-2021. Product moved to clinic on 04-Jun-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 immunisation.     No Medical History information was reported.    On 20-Mar-2021 at 4:57 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 4:57 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 57.87 for dose administered on 20-Mar-2021, Vaccination time 4:57 PM. No concomitant medications were reported. Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 37 degrees Fahrenheit from 09:00 Am to 10 AM.  This vial was moved to fridge on 09-Mar-2021. beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 20-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021 at 11:37 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Jan-2021 at 11:37 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 65.26 years. No concomitant medications were reported. Batch number 041L20A underwent temperature excursion on 12-Jan-2021 with temperature 34 degrees Fahrenheit from 8 AM to 9 AM. This vial was moved to fridge on 08-Jan-2021 and beyond use date for the vial was reported as 07-Feb-2021. Product moved to clinic on 12-Jan-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: administered with vaccine that experienced more than 1 temperature excursion; administered with vaccine that experienced more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 3:54 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 3:54 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient was reported as 83.61.  Concomitant medication of the patient was not reported.  Batch number 041L20A underwent temperature excursion on 11-Jan-2021 with temperature of 35 degrees Fahrenheit at 02:00 PM. These vials were moved to fridge on 08-Jan-2021 and beyond use date for the vials was reported as 07-Feb-2021. The vaccines moved to clinic on 11-Jan-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 12:57 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 12:57 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient was reported as 83.67.  Concomitant medication of the patient was not reported.  Batch number 031L20A underwent temperature excursion on 12-Feb-2021 with temperature of 29 degrees Fahrenheit at 09:00 AM, 35 degrees Fahrenheit at 10:00 AM and 11:00 AM respectively. These vials were moved to fridge on 02-Feb-2021 and 09-Feb-2021 and beyond use date for the vials was reported as 03-Mar-2021 and 10-Mar-29021. The vaccines moved to clinic on 05-Feb-2021 and 12-Feb-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Dose administered after more than 1 temperature excursion during a period of 33 weeks in 2021; Dose administered after more than 1 temperature excursion during a period of 33 weeks in 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion during a period of 33 weeks in 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursion during a period of 33 weeks in 2021) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 1:41 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 1:41 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion during a period of 33 weeks in 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursion during a period of 33 weeks in 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion during a period of 33 weeks in 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursion during a period of 33 weeks in 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   An age of patient was reported as 72.85 for dose administered on 07-Jan-2021.  No concomitant medications were reported. It was reported that for the vial Batch number of 025L20A, it was moved to fridge on 05-Jan-2021 that underwent temperature excursion on 07-Jan-2021 with temperature 34 degrees Fahrenheit from 09 AM to 10 AM. The product was moved to clinic on 07-Jan-2021 and beyond use date for the vial was reported as 27-Jan-2021.  The vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. The vials were only punctured right before administration. The vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).